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## Protocol Section ### Identification Module **NCT ID:** NCT06428942 **Acronym:** LPV in CKD **Brief Title:** Low-potassium Content Vegetables in Chronic Kidney Disease **Official Title:** Increased Low-potassium Content Vegetables Consumption in Patients With Moderate-to-severe Chronic Kidney Disease: a Randomized Controlled Trial #### Organization Study ID Info **ID:** 12-XD-093 #### Organization **Class:** OTHER **Full Name:** Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-27 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **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:** Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation #### Responsible Party **Investigator Affiliation:** Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation **Investigator Full Name:** Szu-Chun Hung **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:** Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. Thus, the investigators aim to evaluate whether proving low-potassium content vegetables to this population are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia. **Detailed Description:** Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. According to the suggestions from 2018 Ministry of Health and Welfare in Taiwan, vegetables intake are at least 3 to 5 servings daily based on the daily energy requirement. In our own data, the average daily vegetables intake was only 2.1 servings among patients with CKD stages 3 to 5 not yet on dialysis. Therefore, the investigators aim to evaluate whether proving low-potassium content vegetables to patients with CKD stages 3 to 5 not yet on dialysis are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia. ### Conditions Module **Conditions:** - the Recommended Target of Daily Vegetables Intake - Risk of Hyperkalemia **Keywords:** - chronic kidney disease - vegetables - hyperkalemia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants are randomized to intervention group or control group with ratio of 50:25. ##### Masking Info **Masking:** NONE **Masking Description:** Masking is not allowed in this study **Primary Purpose:** OTHER #### Enrollment Info **Count:** 75 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The participants in the intervention group would receive their daily low-potassium vegetables 3 to 5 serving according to their daily suggested requirement and routine CKD dietary education for 8 weeks. **Intervention Names:** - Other: low-potassium vegetables **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The participants in the control group would receive routine CKD dietary education for 8 weeks. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** low-potassium vegetables 3 to 5 serving according to their daily suggested requirement **Name:** low-potassium vegetables **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Percentage of participants who reach the targets of daily vegetable recommended **Measure:** Percentage of participants who reach the targets of daily vegetable recommended target **Time Frame:** 8 weeks #### Secondary Outcomes **Description:** Change in gut-derived uremic toxins ( indoxyl sulfate, p-cresyl sulfate) **Measure:** Gut-derived uremic toxins **Time Frame:** 8 weeks **Description:** Change in serum creatinine in mg/dL **Measure:** Serum creatinine **Time Frame:** 8 weeks **Description:** Change in proteinuria in g/day **Measure:** Proteinuria **Time Frame:** 8 weeks **Description:** serum \[potassium\] \>=5.5 mmol/L **Measure:** Occurrence of moderate hyperkalemia **Time Frame:** 8 weeks **Description:** Using the Chinese constipation questionnaire. The minimum value is 0, and the maximum value is 21, and the higher score represents a worse outcome. **Measure:** Status of constipation **Time Frame:** 8 weeks **Description:** Change in alpha- and beta-diversities indices **Measure:** Gut microbiome **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * CKD stage 3b\~5, not yet on dialysis * Age ≥20 years * Stable doses of medications for 4 weeks * Serum potassium level: ≥3.5 and \< 5.5 mmol/L Exclusion Criteria: * Anticipated to receive dialysis within 3 month * Major gastrointestinal diseases (inflammatory bowel disease, celiac disease) or intestinal resection * Patients with infection, malignancy, heart failure, liver cirrhosis or impaired cognitive or mental disorders * Patients who are just hospitalized due to an acute cardiovascular events or infection 3 months prior to the start of study * Patients with kidney transplants * Patients who receive immunosuppressant * Pregnant women or patients who are planning to become pregnant **Maximum Age:** 99 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** TIng-Yun Lin, MD **Phone:** 886-266289779 **Phone Ext:** 2350 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Szu-Chun Hung, MD **Phone:** 886-266289779 **Phone Ext:** 2350 **Role:** CONTACT #### Locations **Location 1:** **City:** New Taipei City **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ting-Yun Lin, MD - **Phone:** 8862-6628-9779 - **Phone Ext:** 2350 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Szu-chun Hung, MD - **Phone:** 8862-6628-9779 - **Phone Ext:** 2350 - **Role:** CONTACT **Country:** Taiwan **Facility:** Taipei Tzu Chi Hospital **Status:** RECRUITING **Zip:** 231 **Location 2:** **City:** New Taipei City **Contacts:** ***Contact 1:*** - **Name:** Szu-Chun Hung, MD - **Role:** CONTACT **Country:** Taiwan **Facility:** Taipei Tzu Chi Hospital **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Taichung Tzu Chi Hospital **Name:** Szu-Chun Hung, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** We do not have IPD sharing plan. **IPD Sharing:** NO ### References Module #### References **Citation:** Wakasugi M, Yokoseki A, Wada M, Momotsu T, Sato K, Kawashima H, Nakamura K, Onodera O, Narita I. Vegetable and Fruit Intake Frequency and Mortality in Patients With and Without Chronic Kidney Disease: A Hospital-Based Cohort Study. J Ren Nutr. 2023 Jul;33(4):566-574. doi: 10.1053/j.jrn.2023.01.011. Epub 2023 Feb 13. **PMID:** 36791982 **Citation:** Saglimbene VM, Wong G, Ruospo M, Palmer SC, Garcia-Larsen V, Natale P, Teixeira-Pinto A, Campbell KL, Carrero JJ, Stenvinkel P, Gargano L, Murgo AM, Johnson DW, Tonelli M, Gelfman R, Celia E, Ecder T, Bernat AG, Del Castillo D, Timofte D, Torok M, Bednarek-Skublewska A, Dulawa J, Stroumza P, Hoischen S, Hansis M, Fabricius E, Felaco P, Wollheim C, Hegbrant J, Craig JC, Strippoli GFM. Fruit and Vegetable Intake and Mortality in Adults undergoing Maintenance Hemodialysis. Clin J Am Soc Nephrol. 2019 Feb 7;14(2):250-260. doi: 10.2215/CJN.08580718. Epub 2019 Jan 31. **PMID:** 31738182 **Citation:** Pourafshar S, Sharma B, Kranz S, Mallawaarachchi I, Kurland E, Ma JZ, Scialla JJ. Patterns of Fruit and Vegetable Intake in Adults With and Without Chronic Kidney Disease in the United States. J Ren Nutr. 2023 Jan;33(1):88-96. doi: 10.1053/j.jrn.2022.06.007. Epub 2022 Jul 5. **PMID:** 35798188 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000014883 - Term: Water-Electrolyte Imbalance - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M9998 - Name: Hyperkalemia - Relevance: HIGH - As Found: Hyperkalemia - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Kidney Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M17624 - Name: Water-Electrolyte Imbalance - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000006947 - Term: Hyperkalemia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428929 **Brief Title:** The Effect of Using Musical and Lighted Baby Crib Mobile on Newborns' Pain and Stress During Blood Draw **Official Title:** The Effect of Using Musical and Lighted Baby Crib Mobile on Newborns' Pain and Stress During Blood Draw: Randomized Controlled Trial #### Organization Study ID Info **ID:** EysanUmac #### Organization **Class:** OTHER **Full Name:** Koç University ### Status Module #### Completion Date **Date:** 2022-07-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-07-30 **Type:** ACTUAL #### Start Date **Date:** 2022-02-04 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Koç University #### Responsible Party **Investigator Affiliation:** Koç University **Investigator Full Name:** Eysan Hanzade Umac **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:** It is widely recognized that the use of non-pharmacological methods in neonatal pain management is low both globally and in our country. Nurses play a crucial role in managing pain through various techniques and in preventing its negative effects on newborns. Toys with sounds, lights, and different features have been found to effectively capture infants' attention. Consequently, it is anticipated that baby crib mobiles, which combine these attention-grabbing features, could serve as effective distractions during needle interventions, potentially reducing pain and stress. However, there is a lack of research on this specific application. **Detailed Description:** Newborns often undergo needle procedures shortly after birth, such as vitamin K injections, hepatitis B vaccinations, screenings, and routine immunizations. Depending on the baby's condition, these procedures may need to be repeated, and additional blood samples might be required. These painful procedures can cause significant stress for the newborn and may lead to neurocognitive, physiological, metabolic, and behavioral issues. Pain experienced during these procedures can negatively impact the newborn's future reactions to pain. Therefore, inadequate pain management can result in both immediate and long-term adverse effects. Organizations such as the International Neuropsychiatric Pain Group and the American Academy of Pediatrics advocate for reducing pain in infants during procedures, recommending non-pharmacological methods as the first line of management. These methods, aimed at providing analgesic effects by creating a relaxing environment, are important because they do not have side effects. Some proven non-pharmacological techniques include breastfeeding, skin-to-skin contact, swaddling, music therapy, oral glucose, and pacifier use. Music therapy is a widely used non-pharmacological method that helps reduce pain perception in newborns. Studies have shown its effectiveness in various settings. For instance, research with premature newborns found that music therapy during central venous catheter placement reduced physiological and behavioral reactions. Another study with 120 healthy newborns reported that having a musical baby crib mobile in vaccination rooms decreased pain levels and crying times. Other studies have similarly highlighted the positive effects of listening to or singing lullabies during painful procedures. ### Conditions Module **Conditions:** - Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Newborns were randomly assigned groups as the musical and lighted baby crib mobile (intervention) group (40 newborns) and the control group (40 newborns) by the computer program (www.randomizer.org). Newborns of parents who did not meet the study criteria and did not agree to participate in the random selection were not included in the study. Parents and researchers could not be blinded. Newborns were included in the study by evaluating their compliance with the inclusion criteria according to the order of admission to the hospital. 10 children in the control group (5 parents did not volunteer and 5 newborns were crying) and 10 children in the intervention group (7 newborns received paracetamol and 3 newborns were crying) were excluded from the study. For this reason, the research was completed with 60 newborns. ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Infants in the control group received standard care, with no pharmacological or non-pharmacological methods used to reduce pain, except for allowing the parents to be present. Parents and nurses observed the infant's behavior during and immediately after the procedure to assess pain and stress. After the procedure, they were asked to mark the maximum pain and stress experienced by the baby on the "ALPS-Neo pain and stress rating scale." This assessment was done immediately after the needle was removed and a tampon was placed to stop the bleeding, approximately one minute after the procedure. **Label:** Control **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Before the procedure, the researcher informed the parents of the newborns in the musical and lighted baby crib mobile group about the study procedure and purpose. The mobile was fixed 60 cm above the newborn's eye level to prevent contamination and trauma. After obtaining written consent, the researcher collected data using the 'Newborn Information Form' through face-to-face interviews. Once the form was completed, the mobile was activated. One minute later, the nurse performed the blood draw. Parents and nurses observed the infant's behavior during and immediately after the procedure to assess pain and stress. They were then asked to mark the maximum pain and stress experienced by the baby on the ALPS-Neo pain and stress rating scale. **Intervention Names:** - Other: The musical and lighted baby crib mobile: **Label:** Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** The musical and lighted baby crib mobile: It measures 43.5x33x9.5 cm and is made of plastic. It is recommended for use in infants 0-12 months. It has music that makes it easier for babies to fall asleep by reducing stress. This baby mobile has a projection and music function. In addition, the mobile has a 360° flexible swivel bracket that can be adjusted as desired. The surface of the apparatus of the mobile, which is designed to be environmentally and baby friendly, is smooth. There are four rattles on the mobile **Name:** The musical and lighted baby crib mobile: **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** In this study, researchers used a mobile crib to help reduce pain in infants during needle procedures. Our primary outcome was the level of pain experienced by the infants. Pain was assessed using standardized pain assessment tools that are suitable for neonates. By comparing pain scores during the needle procedures, researchers aimed to determine the effectiveness of the mobile crib in reducing the infants' pain levels. **Measure:** ALPS-Neo pain and stress assessment scale **Time Frame:** immediately after the intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * born between 38-42 weeks, * being 0-28 days, * absence of visual and auditory problems, * not using any pain reliever or sedative medication in the last four hours, * parents' willingness to participate in the study, * parents' knowledge of Turkish, * parents' ability to read and write. Exclusion Criteria: * having a preterm birth, * having a disease that causes chronic pain, * having visual or auditory problems, * using any pain or sedative medication in the last four hours. **Healthy Volunteers:** True **Maximum Age:** 28 Days **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Koc University **State:** Zeytinburnu #### Overall Officials **Official 1:** **Affiliation:** Koç University **Name:** Eyşan Savaş, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: 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:** NCT06428916 **Brief Title:** Facilitated Tucking Position During Endotracheal Suctioning **Official Title:** The Effect of Facilitated Tucking Position During Endotracheal Suctioning on Physiological Measurement and Behavioral Responses of the Preterm Neonates #### Organization Study ID Info **ID:** KafrelsheikhU2 #### Organization **Class:** OTHER **Full Name:** Kafrelsheikh University ### Status Module #### Completion Date **Date:** 2023-07-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-05-01 **Type:** ACTUAL #### Start Date **Date:** 2022-12-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kafrelsheikh University #### Responsible Party **Investigator Affiliation:** Kafrelsheikh University **Investigator Full Name:** Eman Wardany Abdelaal Mohamed **Investigator Title:** assistant professor of pediatric nursing **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Aim of the present study The present study will aimed to determine the effect of facilitated tucking position during endotracheal suctioning on physiological criteria and behavioural responses of the preterm neonates. Research Hypotheses 1. Preterm neonates who receive facilitated tucking position during endotracheal suctioning exhibit more stable physiological criteria than those who do not. 2. Preterm neonates who receive facilitated tucking position during endotracheal suctioning exhibit more stable behavioral responses than those who do not. ### Conditions Module **Conditions:** - Respiratory Distress Syndrome **Keywords:** - Physiological measurement - Behavioral Responses of the Preterm Neonates - Facilitated Tucking Position - Endotracheal Suctioning ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Consisted of 20 neonates who will receive tucking position during endotracheal suctioning **Intervention Names:** - Procedure: tucking position during endotracheal suctioning **Label:** Study Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Consisted of 20 neonates who will receive routine care during Endotracheal suctioning **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Study Group **Description:** , the staff nurse will perform the endotracheal suctioning while the researcher will carried out the intervention **Name:** tucking position during endotracheal suctioning **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as Heart Rate (HR) **Measure:** Change from baseline of heart rate of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure **Time Frame:** during procedural and immediately after procedure **Description:** Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as Respiratory Rate (RR) **Measure:** Change from baseline of Respiratory Rate of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure **Time Frame:** during procedural and immediately after procedure **Description:** Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as oxygen saturation in blood(SPO2) **Measure:** Change from baseline of oxygen saturation in blood of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure **Time Frame:** during procedural and immediately after procedure #### Secondary Outcomes **Description:** This scale was adopted from Anderson et al.(1990) to assess the behavioral organization of preterm neonates. Neonates' behavioral states are assessed by observing their respiratory regularity, opening or closing of the eyes, limb and trunk activity, and the intensity of crying. Based on the observations, the scale will differentiate 12 behavioral states, including; regular quiet sleep (1), irregular quiet sleep (2), active sleep (3), very active sleep (4), drowsy (5), alert inactivity (6), quite awake (7), active awake (8), very active awake (9), fussing (10), crying (11) and hard crying (12). Scores from 1 to 5 indicate that the neonate is sleeping. Scores from 6 to 8 indicate that the neonate is awake and calm. Scores from 9 to 12 indicate that the neonate is in a state of restless activity or fussiness, which takes substantial energy **Measure:** change of baseline of Neonates' behavioral states on Anderson Behavioral State Scale during and immediately following the endotracheal suction procedure **Time Frame:** during procedural and immediately after procedure ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Gestational age between 32 and 36 weeks, weight 1200 grams or greater. * Postnatal age: two days after delivery to allow for resolution of analgesia or anesthesia received by their mothers during labor. * Have endotracheal intubation. Exclusion Criteria: * Preterm neonates who have congenital anomalies or neurological malformations, intracranial hemorrhage, seizures. * Preterm neonates who received sedatives within four hours before the intervention * Preterm neonates who exposed to any uncomfortable procedure for at least 30 minutes prior to the intervention. **Healthy Volunteers:** True **Maximum Age:** 36 Weeks **Minimum Age:** 32 Weeks **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Kafr Ash Shaykh **Country:** Egypt **Facility:** Kafrelsheikh University **State:** Kafr el-Sheikh **Zip:** 33516 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012120 - Term: Respiration Disorders - ID: D000007235 - Term: Infant, Premature, Diseases - ID: D000007232 - Term: Infant, Newborn, Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M14965 - Name: Respiratory Distress Syndrome - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: M14964 - Name: Respiratory Distress Syndrome, Newborn - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M25869 - Name: Premature Birth - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown - ID: M10279 - Name: Infant, Premature, Diseases - Relevance: LOW - As Found: Unknown - ID: M10276 - Name: Infant, Newborn, Diseases - Relevance: LOW - As Found: Unknown - ID: T4927 - Name: Respiratory Distress Syndrome, Infant - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: T192 - Name: Acute Respiratory Distress Syndrome - Relevance: HIGH - As Found: Respiratory Distress Syndrome ### Condition Browse Module - Meshes - ID: D000012128 - Term: Respiratory Distress Syndrome - ID: D000012127 - Term: Respiratory Distress Syndrome, Newborn ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428903 **Brief Title:** Comparative Bioavailability Study of Tablet and Granule Formulations of ADC189 and the Study of Ultra-high Dose **Official Title:** A Comparison Study of ADC189 Bioavailability Between Tablet and Granule in Healthy Chinese Adult Male Subjects, and the Safety and Pharmacokinetics of Ultra-high Dose ADC189 #### Organization Study ID Info **ID:** ADC-DNXV-189-GR #### Organization **Class:** INDUSTRY **Full Name:** Jiaxing AnDiCon Biotech Co.,Ltd ### Status Module #### Completion Date **Date:** 2024-07-31 **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:** 2024-07-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-12 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-19 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Jiaxing AnDiCon Biotech Co.,Ltd #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Part 1 of this study will compare the pharmacokinetic performance of tablet and granule formulations of ADC189 under fasted conditions in healthy volunteers. A randomized, two-period, two-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation without food. The purpose of Part 2 study is to determine the safety and pharmacokinetics of ultra high dose of ADC189 in healthy subjects. **Detailed Description:** In Part 1 study, a total of 32 subjects were randomly divided into two groups, A and B, with 16 subjects in each group. After a 28-day screening period, on the first day of Period 1 (D1), subjects in group A took ADC189 granules (a single oral dose, 45mg), and subjects in group B took ADC189 tablets (a single oral dose, 45mg), all subjects were under fasted conditon. In Period 2, two groups will change to the fomulation which is different in Period 1 respectively, and all the steps will keep the same as Period 1. Each period lasts for 15 days, and have a 7-day interval between 2 periods. Blood samples will be taken, pharmacokinetic and saftey profiles will be observed. In Part 2 study, the ultra high dose of ADC189 (a single oral dose, 180mg) will applied in 8 healty adult male subjects. The pharmacokinetic and saftey profiles will be observed during the following 15 days, and blood sample will be taken. ### Conditions Module **Conditions:** - Healthy Volunteer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 16 patients. **Intervention Names:** - Drug: ADC189 tablet - Drug: ADC189 granules **Label:** ADC189 tablet Group A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 16 patients. **Intervention Names:** - Drug: ADC189 tablet - Drug: ADC189 granules **Label:** ADC189 granules Group B **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** 8 patients. **Intervention Names:** - Drug: ADC189 180mg **Label:** ADC189 180mg Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - ADC189 granules Group B - ADC189 tablet Group A **Description:** ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study) **Name:** ADC189 tablet **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - ADC189 granules Group B - ADC189 tablet Group A **Description:** ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study) **Name:** ADC189 granules **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - ADC189 180mg Group **Description:** ADC189 tablet, 180 mg, single oral dose. (Part 2 study) **Name:** ADC189 180mg **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** ADC189 plasma exposure, area under the concentration-time curve **Measure:** ADC189 Granules **Time Frame:** 15 days **Description:** ADC189 plasma exposure, area under the concentration-time curve **Measure:** ADC189 Tablet **Time Frame:** 15 days **Description:** Single dose of 180mg ADC189 tablet plasma exposure, area under the concentration-time curve **Measure:** ADC189 Ultra high dose **Time Frame:** 15 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1. Healthy male subjects aged 18-45 years old * 2. Male subjects weight over 50 kg Exclusion Criteria: * 1. Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions * 2. Have a history of drug abuse in the past five years or use drugs in the three months prior to screening * 3. Blood donation or blood loss \> 400 mL in 3 months before screening **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Zhao Wei **Phone:** 0531-89268212 **Role:** CONTACT #### Locations **Location 1:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Name:** Wei Zhao, Dr - **Role:** CONTACT **Country:** China **Facility:** Zhao Wei **State:** Shang Dong **Status:** RECRUITING **Zip:** 250000 ### 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:** NCT06428890 **Brief Title:** Effect of 7 Days of Grape Seed Extract Supplementation on Cold Pressor Test and Muscle Metaboreflex in Individuals With Elevated and Stage 1 Hypertension **Official Title:** Effect of 7 Days of Grape Seed Extract Supplementation on Cold Pressor Test and Muscle Metaboreflex in Individuals With Elevated and Stage 1 Hypertension #### Organization Study ID Info **ID:** 030-2223-EXP #### Organization **Class:** OTHER **Full Name:** California Baptist University ### Status Module #### Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Start Date **Date:** 2022-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **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:** California Baptist University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aimed to assess the effect of the supplementation with grape seed extract (GSE) on blood pressure during static handgrip exercise and muscle metaboreflex in individuals with elevated and state 1 hypertension. **Detailed Description:** Muscle metatoreflex (MMR) has been known to play an important role in adjusting hemodynamic responses during exercise. The reflex increases sympathetic activity to heart and blood vessels to increase blood supply to contracting skeletal muscles. On the other hand, studies demonstrated that abnormal cardiovascular responses occurred by the overactive MMR in pathological conditions such as hypertension, diabetes, and congestive heart failure. Excessive blood pressure (BP) responses to exercise induce cardiovascular events such as stroke, heart attack, and coronary artery disease. Previously, a study found that dietary supplementation with grape seed extract (GSE) reduced BP response to dynamic exercise in individuals with elevated and stage 1 hypertension (ES1H) and associated with peripheral vasodilation. However, mechanisms underlying this phenomenon are not clear. Purpose: therefore, the purpose of this study is to investigate whether chronic dietary supplementation with GSE can decrease BP responses to exercise and this observation is associated with reduced MMR. Methods: 12 ES1H males were studied. Changes in cardiac output (Q), mean arterial pressure (MAP) and total peripheral resistance (TPR) were compared between the GSE and placebo supplementations during static handgrip exercise (SHE) and post exercise muscular ischemia (PEMI). Participants completed 3 min of SHE at 40% of MVC followed by 2 min of PEMI. ### Conditions Module **Conditions:** - Prehypertension ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 12 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants received the supplement (600 mg, capsules) via cross-over design for 7 days **Intervention Names:** - Dietary Supplement: Grape Seed Extract - Dietary Supplement: Placebo **Label:** Dietary Supplementation with Grape Seed Extract **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants received the placebo (600 mg, capsules) via cross-over design for 7 days **Intervention Names:** - Dietary Supplement: Grape Seed Extract - Dietary Supplement: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Dietary Supplementation with Grape Seed Extract - Placebo **Description:** dietary supplements that rich in polyphenolic compounds **Name:** Grape Seed Extract **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Dietary Supplementation with Grape Seed Extract - Placebo **Description:** Starch **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex **Measure:** heart rate (bpm) **Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively. **Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex **Measure:** stroke volume (ml) **Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively. **Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex **Measure:** cardiac output (l/min) **Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively. **Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex **Measure:** systolic blood pressure (mmHg) **Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively. **Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex **Measure:** diastolic blood pressure (mmHg) **Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively. **Description:** measured these variables at rest and during static handgrip exercise and muscle metaboreflex **Measure:** total peripheral resistance (mmHg/l/min) **Time Frame:** 5 minutes, 3 minutes, and 2 minutes, respectively. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * systolic blood pressure: 120-139 mmHg and/or a diastolic blood pressure: 80-89 mmHg Exclusion Criteria: * taking medications that could affect cardiovascular function or BP **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Riverside **Country:** United States **Facility:** California Baptist University **State:** California **Zip:** 92504 #### Overall Officials **Official 1:** **Affiliation:** California Baptist University **Name:** Jong-Kyung Kim, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** This study needs the Institutional Research Board (IRB) and participant's approvals to share the data. Without the approval, the data collected from this study will not be shared. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertension - ID: M29007 - Name: Prehypertension - Relevance: HIGH - As Found: Prehypertension - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006973 - Term: Hypertension - ID: D000058246 - Term: Prehypertension ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - 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: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M28517 - Name: Grape Seed Extract - Relevance: HIGH - As Found: Acetic acid - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: T173 - Name: Grape - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000056604 - Term: Grape Seed Extract ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428877 **Acronym:** ACSSim **Brief Title:** Monocentric Retrospective Observational Study; Analysis of Gore Excluder ACS Device Using Numerical Simulation **Official Title:** Monocentric Retrospective Observational Study; Analysis of Gore Excluder ACS Device Using Numerical Simulation #### Organization Study ID Info **ID:** 69HCL24_0514 #### Organization **Class:** OTHER **Full Name:** Hospices Civils de Lyon ### Status Module #### Completion Date **Date:** 2024-04-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-09-15 **Type:** ACTUAL #### Start Date **Date:** 2023-06-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-22 ### 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:** andated when the risk of rupture is low and interventional treatment is offered to patients at high risk of rupture. Rupture risk is driven by aneurysm diameter and growth rate. Aneurysms with diameter greater than 55 mm and/or growth rate greater than 1 cm per year are at high risk of rupture. Open surgery and endovascular treatment are the two types of interventions. Open repair consists in replacing the aneurysmal part of the aorta using a synthetic fabric prosthesis after the abdomen has been opened and the aorta clamped. This invasive procedure is associated with a 3-10% post-operative mortality. Endovascular repair (EVAR) consists in excluding the aneurysm sac by inserting a self-expanding prosthesis (called stent-graft) through very small groin incisions, without abdominal opening nor aortic clamping. This minimally invasive procedure is associated with a significantly reduced post-operative mortality (around 1%) . However, hostile proximal neck anatomy including high angulation is associated with higher rates of type IA endoleak, reintervention and long-term mortality . For this reason, a conformable design of the Excluder stent-graft has been engineered with initial satisfactory results in patients with highly angulated or short necks . However, these satisfactory results have been obtained in carefully selected patients from experienced centers and a tool demonstrating adequate apposition of the Gore ACS is lacking. Study Device Description Numerical simulation has been used successfully to predict stent-graft behavior during FEVAR . Preliminary studies have also demonstrated to applicability of the technology to standard infrarenal devices , including in the setting of very tortuous anatomies9 . The potential of numerical simulation to predict stent-graft apposition of Gore ACS in highly angulated necks appears very promising to enhance patient selection. ### Conditions Module **Conditions:** - Vascular Diseases - Surgery **Keywords:** - Endoprosthesis - Numerical simulation - Proximal neck ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 20 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients who underwent EVAR with ACS Gore excluder. Only patients with proximal neck angulation superior to 60 degrees will be considered. **Intervention Names:** - Other: analyzed on the post-operative scanner **Label:** Patients who underwent EVAR with ACS Gore excluder. ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients who underwent EVAR with ACS Gore excluder. **Description:** analyzed on the post-operative scanner **Name:** analyzed on the post-operative scanner **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Quantitative neck apposition parameters (including but not limited to malapposition length, width, angle) will be extracted both from numerical simulation and post-operative CT. Quantitative values will then be compared Comparison between quantitative neck apposition parameters (malapposition length, width, angle) derived from simulation and the one observed on post-op CT and/ or follow-up CT **Measure:** The aim of the present study is to investigate the accuracy of numerical simulation to predict stent-graft apposition of Gore ACS in highly angulated proximal AAA necks. **Time Frame:** up to 16 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: The patient: 1. Is age ≥18 at the time of inclusion. 2. Underwent EVAR with ACS Gore Excluder 3. AAA proximal neck angulation superior to 60 degrees 4. Pre-op CT and post-operative/follow-up CT available Exclusion Criteria: 1. Slice thickness of Pre-op or post-op / follow-up CT superior to 2mm. 2. Non-injected or poorly injected pre-operative CT-scan precluding technical feasibility of the aortic digital twin 3. Absence of post-operative or follow-up CT-scan 4. Patient refusal of his personal information/medical data to be used in the context of the study **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients who underwent EVAR with ACS Gore excluder. Only patients with proximal neck angulation superior to 60 degrees will be considered. ### Contacts Locations Module #### Locations **Location 1:** **City:** Bron **Country:** France **Facility:** Hôpital Louis Pradel **Zip:** 69500 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - 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: M17400 - Name: Vascular Diseases - Relevance: HIGH - As Found: Vascular Disease ### Condition Browse Module - Meshes - ID: D000014652 - Term: Vascular Diseases ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428864 **Acronym:** GSSCAN **Brief Title:** Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis **Official Title:** Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis #### Organization Study ID Info **ID:** 69HCL24_0513 #### Organization **Class:** OTHER **Full Name:** Hospices Civils de Lyon ### Status Module #### Completion Date **Date:** 2023-11-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-10-01 **Type:** ACTUAL #### Start Date **Date:** 2023-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-22 ### 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:** Neuromuscular scoliosis is the consequence of general hypotonia involved in certain neuromuscular diseases. Thoracic braces are necessary to slow down the deformation. In France, Garchois brace is largely used in this context because of a better pulmonary tolerance. Historically, molding of thoracic orthotic brace was based on a plaster cast directly on the patient. He/she is suspended in a frame or is lying on an examining table, and is held by 4 therapists (a physician, an orthoprosthesist, a nurse and a doctor). The position during molding could be very uncomfortable and anxious. With the development of new technologies, a 3D scan application on smartphone to obtain the volume and deformations of the patient was developed. This tool enables digital acquisition of trunk and head volume while bypassing the seated patient. No plaster strips are used. The resulting negative is digitally filled to obtain a positive. The positive is then corrected before the corset is made, either digitally or after 3D scanning, in plaster or foam. This application was first used in our department in 2017. The aim of this retrospective monocentric study is to show that this application can be used to produce brace that are as corrective and reliable as braces made after plaster casting, while improving the satisfaction of children, their families and professionals during impression taking. as their parents and of the professionals present during the molding. ### Conditions Module **Conditions:** - Neuromuscular Diseases - Scoliosis **Keywords:** - Scoliosis - Neuromuscular Diseases - Orthotic device - Brace - Cast - 3D Scan application ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patient with a Garchois brace produced after a plaster cast **Intervention Names:** - Device: Plaster cast **Label:** Cast #### Arm Group 2 **Description:** Patient with a Garchois brace produced after assessment of the thoracic volume with the 3D scan **Intervention Names:** - Device: 3D Scanning **Label:** Scan ### Interventions #### Intervention 1 **Arm Group Labels:** - Cast **Description:** Wearing a Garchois brace produced after a plaster cast **Name:** Plaster cast **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Scan **Description:** Wearing a Garchois brace produced after assessment of the thoracic volume with the 3D scan **Name:** 3D Scanning **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Mean differences in Cobb angles measured by spinal X-rays before and after wearing the brace for the 2 groups of patients **Measure:** Assessment of Cobb angles **Time Frame:** Up to 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Clinical suspicion or genetically confirmed neuromuscular disease * Neuromuscular scoliosis, with Garchois brace indication * Under 18 at the time of the first Garchois brace molding Exclusion Criteria: * Other neuro-orthopaedic disease such as cerebral palsy * Other thoracic brace than Garchois * Any spine surgery **Maximum Age:** 18 Years **Minimum Age:** 1 Year **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Neuromuscular patients from a paediatric rehabilitation center ### Contacts Locations Module #### Locations **Location 1:** **City:** Bron **Country:** France **Facility:** L'Escale - HFME **Zip:** 69500 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013121 - Term: Spinal Curvatures - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M15417 - Name: Scoliosis - Relevance: HIGH - As Found: Scoliosis - ID: M12411 - Name: Neuromuscular Diseases - Relevance: HIGH - As Found: Neuromuscular Diseases - ID: M15918 - Name: Spinal Curvatures - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012600 - Term: Scoliosis - ID: D000009468 - Term: Neuromuscular Diseases ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428851 **Brief Title:** Laser Therapy Versus Neuromuscular Electrical Nerve Stimulation at Hemiplegic Shoulder Pain **Official Title:** Comparison of Laser Therapy Versus Neuromuscular Electrical Nerve Stimulation at Hemiplegic Shoulder Pain and Upper Extremity Functions #### Organization Study ID Info **ID:** 2023-174 #### Organization **Class:** OTHER **Full Name:** Hitit University ### Status Module #### Completion Date **Date:** 2024-05-17 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-05-17 **Type:** ACTUAL #### Start Date **Date:** 2023-12-26 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hitit University #### Responsible Party **Investigator Affiliation:** Hitit University **Investigator Full Name:** Pınar Özge Başaran **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aimed to investigate whether laser and neuromuscular electrical nerve stimulation applied in addition to conventional physical therapy exercises in hemiplegic shoulder pain seen in patients with stroke provides an additional contribution to pain, range of motion, spasticity, upper extremity functions and whether the two treatment types are superior to each other. **Detailed Description:** Cerebrovascular events, which are estimated to affect approximately 9 million people worldwide, have emerged as a serious cause of morbidity and mortality due to prolonged human lifespan. With the use of effective treatment methods in acute treatment, the level of expectation regarding prognosis has increased. Secondary complications that develop after stroke are frequently encountered. These complications cause serious disruptions in the rehabilitation process. The upper extremity is affected more frequently than the lower extremity and recovery is more difficult and slower. Most of the functional impairments related to the upper extremity are shoulder problems. The most important reason is impaired shoulder biomechanics. Pain may occur in the first 2 weeks after stroke or typically occurs 1 to 3 months after stroke. Pain in the hemiplegic shoulder significantly reduces patients' function and rehabilitation capacity. Reducing pain with effective methods applied for pain increases participation in rehabilitation and increases the range of motion measurements and functional capacity. There are many physical therapy approaches in the treatment of hemiplegic shoulder pain. Light amplification by stimulated emission of radiation (laser) is one of these treatment approaches and briefly means intensified light. Laser principles are based on the quantum concept introduced by Einstein in 1927. Theodore Maiman developed the first laser device in 1960. According to the basic working principle of laser devices; the photon energy emitted from a light source is passed through a specific medium and it is thought to be effective in reducing pain in the tissue, increasing the range of motion, and improving upper extremity functions. As a result of all these mechanisms of action, laser beams are used in medicine to utilize their regenerative, biostimulating, analgesic, anti-inflammatory, and anti-edematous effects. These laser methods have been previously studied in knee osteoarthritis and shoulder adhesive capsulitis. Laser has also been investigated in hemiplegia. Neuromuscular electrical nerve stimulation (NMES) produces muscle contractions using electrical pulses. These electrical pulses are delivered to the current muscles through superficial electrodes. The action potential from the central nervous system is mimicked with NMES and contraction is produced in the muscle. There is no study in the literature comparing laser and neuromuscular electrical nerve stimulation in the hemiplegic shoulder. This study aimed to investigate whether laser and neuromuscular electrical nerve stimulation applied in addition to conventional physical therapy exercises in hemiplegic shoulder pain seen in patients with stroke provides an additional contribution to pain, range of motion, spasticity, upper extremity functions and whether the two treatment types are superior to each other. In this prospective randomized controlled study, 75 stroke patients aged 18-85 years with shoulder pain who were diagnosed with ischemic stroke for the first time and who applied to the Physical Therapy and Rehabilitation Outpatient Clinic between December 2023 and May 2024 were included in the study. The patients included in the study were divided into 3 groups by the same physiotherapist by envelope drawing method. Due to the nature of the study, the physiotherapist administering the treatment was aware of the groups of the patients. On the other hand, all evaluations were performed by the same researcher who was blinded to the type of treatment. All patients underwent a multidisciplinary rehabilitation program 5 days a week for 4 weeks for a total of 20 sessions. Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises. 1st group laser group (n:25) received laser for 5 minutes a day 3 days a week in addition to classical physical therapy, 2nd group ES group (n:25) received Neuromuscular electrical nerve stimulation for 20 minutes a day 5 days a week in addition to classical physical therapy. 3. Group, control group (n:25), classical physical therapy exercises were applied. ### Conditions Module **Conditions:** - Hemiplegic Shoulder Pain **Keywords:** - hemiplegic shoulder pain - electrical nerve stimulation - laser ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** 1. Laser therapy 2. Neuromuscular electrical nerve stimulation therapy (NMES) 3. Control: classical physical therapy exercises 3) ##### Masking Info **Masking:** TRIPLE **Masking Description:** Participants: stroke patients with shoulder pain Care provider: physiotherapist who applied the treatments to the patients Investigator: Researchers who were blinded to the treatment groups **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 75 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises. Group 1 Laser therapy group (n:25) in addition to classical physical therapy, laser was applied to the shoulder group muscles for 5 minutes a day, 3 days a week for 4 weeks. **Intervention Names:** - Other: Laser therapy **Label:** Laser therapy Group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises. In Neuromuscular electrical nerve stimulation group, in addition to these exercises, Neuromuscular electrical nerve stimulation was applied to the shoulder flexor and abductor muscle groups for 20 minutes a day, 5 days a week for a total of 4 weeks. **Intervention Names:** - Other: Neuromuscular electrical nerve stimulation **Label:** Neuromuscular electrical nerve stimulation Group **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises. **Intervention Names:** - Other: Control **Label:** Control Group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Laser therapy Group **Description:** Shoulder girdle muscles were lasered for 5 minutes a day, 3 days a week, total of 4 weeks. **Name:** Laser therapy **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Neuromuscular electrical nerve stimulation Group **Description:** Neuromuscular electrical nerve stimulation was applied to the shoulder flexor and abductor muscles for 20 minutes a day 5 days a week, total of 4 weeks. **Name:** Neuromuscular electrical nerve stimulation **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Control Group **Description:** Classical physical therapy exercises were applied according to the patient's needs and neurologic level. These exercises are determined by the physiotherapist according to the functional status of the patient and consist of passive, passive assisted, active range of motion exercises, stretching and strengthening exercises, mobilization exercises 5 days a week for 1 hour, total of 4 weeks. **Name:** Control **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The pain level of the patients will be measured with a scale given to the patient; visual pain scale. Patients rate their pain on a scale of 0-10. It consists of scores ranging from 0 (no pain) to 10 (most severe pain). Higher scores indicate more severe pain. **Measure:** Pain Level **Time Frame:** baseline and through study completion, an average of 4 weeks #### Secondary Outcomes **Description:** upper extremity functions were evaluated with Fugl-Meyer. Fugl-Meyer is a stroke-specific performance-based scale, fully filled by the same investigator, each parameter is scored between 0-2. The total score is between 0 to 100. 0: unsuccessful, 1: partially successful, 2: completely successful performance. A higher score indicates better performance **Measure:** upper extremity functions **Time Frame:** baseline and through study completion, an average of 4 weeks **Description:** he Shoulder Pain and Disability Index is a patient-completed scale consisting of 5 items on pain and 8 items on disability. Each item is marked by the patient on a 0-10 cm scale. High scores indicate high pain and disability. **Measure:** Disability **Time Frame:** baseline and through study completion, an average of 4 weeks **Description:** Barthel index It is filled out after the examination by the same investigator to evaluate the activities of daily living of the patients. Turkish version of the scale has been adapted. The Barthel index consists of 10 items related to activities of daily living and mobility. Nutrition, transition from wheelchair to bed and back, self-care, bathing, walking, climbing up and down stairs, dressing, bladder and bowel continence are evaluated. The items can be divided into two parts related to self-care and mobility. A scoring is based on whether the person is assisted in performing these tasks. The highest total score that can be achieved is 100, which means that the individual is completely independent in their physical functioning. The lowest score is 0, indicating that the individual is completely dependent **Measure:** Daily living activities **Time Frame:** baseline and through study completion, an average of 4 weeks **Description:** The Modified Ashworth Scale, the most widely used scale for tonus assessment, was used to evaluate spasticity. In this scale, muscle tone is evaluated between 0 normal and 4 being rigid. In our study, spasticity in shoulder adductors and internal rotators, forearm flexors, wrist flexors and finger flexors were recorded by the same investigator. **Measure:** Spasticity **Time Frame:** baseline and through study completion, an average of 4 weeks **Description:** Brunnstrom Recovery Stage is a 6-step scale that includes movement patterns with progressively increasing recovery evaluated separately for upper extremity, hand and lower extremity. 0: no movement, 6: full movement. Higher values indicate better motor recovery and were recorded by the same investigator. **Measure:** Recovery Stage **Time Frame:** baseline and through study completion, an average of 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria * diagnosed with unilateral ischemic stroke for the first time * 18-85 years old, * patients with shoulder pain Exclusion Criteria: * another disease that will affect the central nervous system * injections or physical therapy to the same shoulder in the last 3 months, * history of shoulder surgery, * cervical radiculopathy, * inflammatory rheumatic disease or infection, * serious cardiovascular disease such as heart failure, arrhythmia, myocardial infarction that will affect functional status, * disease that will cause cognitive dysfunction, * Alzheimer's disease, dementia, * severe visual loss, * pregnancy and lactation, * malignancy, * psychiatric diseases **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Corum **Country:** Turkey **Facility:** Hitit University **Zip:** 19040 #### Overall Officials **Official 1:** **Affiliation:** HİTİT UNİVERSİTY EROL OLÇOK RESEARCH HOSPİTAL **Name:** MUSTAFA KESER, Ass Prof **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018771 - Term: Arthralgia - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - 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: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M21907 - Name: Shoulder Pain - Relevance: HIGH - As Found: Shoulder Pain - ID: M20833 - Name: Arthralgia - 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: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020069 - Term: Shoulder Pain ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428838 **Brief Title:** Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context **Official Title:** Eptinezumab as an Adjunct to Standard of Care for MIGRANE in an Acute EmeRgency Context (Migraine ERase Study) #### Organization Study ID Info **ID:** Medvedev_001 #### Organization **Class:** INDUSTRY **Full Name:** HealthTech Connex Inc. ### Status Module #### Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** H. Lundbeck A/S **Class:** UNKNOWN **Name:** Centre for Neurology Studies, Surrey Neuroplasticity Clinic Inc. **Class:** UNKNOWN **Name:** Royal Columbian Hospital **Class:** UNKNOWN **Name:** Surrey Memorial Hospital #### Lead Sponsor **Class:** INDUSTRY **Name:** Dr George Medvedev #### Responsible Party **Investigator Affiliation:** HealthTech Connex Inc. **Investigator Full Name:** Dr George Medvedev **Investigator Title:** Principal Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of the study is to investigate how a medication called eptinezumab (Vyepti) given to patients in the Emergency Department (ED) might help prevent migraines from happening again. The results of this study may help inform better ways to manage patients with migraines in the ED. Eptinezumab is currently approved by Health Canada for the preventive treatment of migraine, but its short-term effectiveness in the ED context is unknown. Unlike other migraine treatments used in the ED, eptinezumab can rapidly interrupt the migraine process, potentially also preventing migraine from coming back in the short term. Most patients with a diagnosis of migraine have no access to preventative therapies. This study will be able to provide access to preventative therapy at the earliest stages of a migraine attack. Administering this medication in the ED may stop the attack more effectively compared to current therapies. This study wants to see if eptinezumab could help stop migraines from coming back after individuals have been treated in the ED. The study will also explore whether eptinezumab could reduce how often individuals with migraine might need to come back to the ED, what other medications they might need alongside eptinezumab, and how they feel overall. ### Conditions Module **Conditions:** - Migraine - Chronic Migraine **Keywords:** - acute treatment - emergency - monoclonal antibody ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized (1:1), controlled trial with standard of care (SoC) as control arm. ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 102 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** SoC will be delivered at the discretion of the treating physician **Intervention Names:** - Other: Standard of Care **Label:** Standard of Care **Type:** OTHER #### Arm Group 2 **Description:** In addition to standard of care, participants randomized to the Standard of Care + Eptinezumab arm will receive a single infusion of eptinezumab (100mg/mL). **Intervention Names:** - Biological: Eptinezumab - Other: Standard of Care **Label:** Standard of Care + Eptinezumab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Standard of Care + Eptinezumab **Description:** The study treatment consists of a single infusion of eptinezumab (100mg/mL). **Name:** Eptinezumab **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Standard of Care - Standard of Care + Eptinezumab **Description:** SoC may include a combination of Toradol, Metoclopramide, and/or Benadryl. Ketamine and/or Midazolam may also be used, according to a stepwise approach, at the discretion of the treating physician. The timing and dose of all medication(s) administered in the ED will be recorded. **Name:** Standard of Care **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Number of migraine days at week 1, as reported in daily Headache Diary **Measure:** Number of migraine days at week 1 **Time Frame:** Baseline to Week 1 #### Secondary Outcomes **Description:** Readmission to the Emergency Department (ED) as assessed by patient chart **Measure:** Readmission to the Emergency Department (ED) **Time Frame:** Baseline to Month 3 **Description:** The Generalized Anxiety Disorder 7-item (GAD-7) will be assessed at baseline, month 1 and month 3. The GAD-7 is a short self-report questionnaire assessing the severity of anxiety disorder. For each item, the participant is asked how bothered they have been by the problem in the last 2 weeks. The total score ranges from 0-21, and a score greater than 15 indicates severe anxiety. The recall period for the GAD-7 is 2 weeks. **Measure:** Generalized Anxiety Disorder 7-item (GAD-7) **Time Frame:** Baseline to Month 3 **Description:** The Headache Impact Test (HIT-6) will involve an assessment at baseline and at months 1 and 3. The HIT-6 (v1.0) is a Likert-type, self-reported questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. HIT-6 scores range from 36 to 78. Higher scores indicate a greater impact of headaches on the respondent's life, i.e., 36 = no impact, 78 = maximum impact. The HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The assessment was developed to measure a wide spectrum of factors contributing to headache burden, and it has demonstrated reliability and validity. The recall period for the HIT-6 is 4 weeks. **Measure:** Headache Impact Test (HIT-6) **Time Frame:** Baseline to Month 3 **Description:** The PHQ-9 is a short self-report questionnaire assessing signs and symptoms of depression. The questionnaire consists of nine items which ask about the frequency and severity of depressive symptoms based on DSM-IV criteria. For each item, the participant is asked to rate the severity of the symptom on a scale from 0 to 3. The total score ranges from 0-27 with a higher score indicating more severe depressive symptoms. The recall period for the PHQ-9 is 2 weeks. **Measure:** Patient Health Questionnaire (PHQ-9) **Time Frame:** Baseline to Month 3 **Description:** The PGI-C will involve an assessment at 24-72hrs, week 1, month 1 and month 3. PGI-C is a one-item measure rating of the overall patient perceived improvement on a seven-point scale. Patients rate their change since treatment initiation as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse. **Measure:** Patient Global Impression of Change (PGI-C) **Time Frame:** Baseline to Month 3 **Description:** Number of monthly headache days as assessed by the Migraine Disability Assessment (MIDAS) **Measure:** Number of monthly headache days **Time Frame:** Baseline to Month 3 **Description:** Recurrence of migraine as reported in daily Headache Diary **Measure:** Migraine recurrence **Time Frame:** Baseline to Month 3 **Description:** The WPAI is a six-item validated instrument that measures aspects of work productivity and activity impairment due to migraine over the past 7 days with higher values, in the form of percentages, indicating greater impairment due to the respondent's health. Only patients that are currently employed (full-time, part-time, or self-employed) are eligible to respond to the items assessing work-related activities. Item 6 in the WPAI will be administered to those not in employment, providing the possibility of calculating activity impairment for patients that are not employed. The six items are used to derive four subscales: Absenteeism (proportion of missed work hours out of the total; scale 0-100%), Presenteeism (level of work impairment; scale 0-10), Overall work impairment (combination of absenteeism and presenteeism; scale 0-100%), and Activity impairment (impairment in daily activities; scale 0-10). **Measure:** Work Productivity and Activity Impairment (WPAI) **Time Frame:** Baseline to Month 3 **Description:** Sleep quality will be assessed with the question, "On average, about how many hours of sleep do you get per night?" with responses including "7-9 hrs", "6-6.9 hrs", "5-5.9 hrs" or "less than 5 hrs". The recall period will be 1 week. **Measure:** Sleep Quality **Time Frame:** Baseline to Month 3 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adults between the ages of 19-75 with a history of migraines, as established at the time of presentation to the ED or known from the patient's chart; 2. Presenting to the emergency department with a migraine that meets ICHD-3 migraine headache criteria; 3. Provided signed informed consent; 4. Sufficient literacy and cognitive capacity to understand and complete patient self-rated questionnaires in English. Exclusion Criteria: 1. Secondary headaches caused by an injury or underlying illness, such as a concussion, bleeding in the brain, an infection or a brain tumor 2. Current or history of severe cardiovascular disease or renal dysfunction 3. A systemic condition in the stage of active treatment (vasculitis, etc.) 4. Pregnant or at risk of becoming pregnant (absent contraception) 5. Currently enrolled in another investigational drug trial 6. Dosed with eptinezumab within the past 3 months 7. Currently on anti-CGRP therapy with monoclonal antibodies 8. Currently involved in active litigation 9. Any other condition which, in the opinion of the Investigator, would exclude the participant due to reasons of safety or data integrity 10. Hypersensitivity to the active substance or to any of the excipients **Maximum Age:** 75 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Julia Joyes Clinical Research Coordinator **Phone:** 778-735-1945 **Role:** CONTACT #### Locations **Location 1:** **City:** New Westminster **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Vesna Ivkov - **Role:** CONTACT ***Contact 2:*** - **Name:** George Medvedev Neurologist, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** Royal Columbian Hospital **State:** British Columbia **Zip:** V3L 3W7 **Location 2:** **City:** Surrey **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Vesna Ivkov - **Role:** CONTACT ***Contact 2:*** - **Name:** Dr George Medvedev Neurologist, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** Surrey Memorial Hospital **State:** British Columbia **Zip:** V3V 1Z2 ### IPD Sharing Statement Module **Description:** If the results of the study are published in the public domain, only aggregate/group data will be published. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000051270 - Term: Headache Disorders, Primary - ID: D000020773 - Term: Headache Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11852 - Name: Migraine Disorders - Relevance: HIGH - As Found: Migraine - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M22700 - Name: Disease Attributes - 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: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008881 - Term: Migraine Disorders - ID: D000004630 - Term: Emergencies ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: Analg - Name: Analgesics - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: AAll - Name: Anti-Allergic Agents - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M4230 - Name: Antibodies, Monoclonal - Relevance: LOW - As Found: Unknown - ID: M4225 - Name: Antibodies - Relevance: LOW - As Found: Unknown - ID: M10184 - Name: Immunoglobulins - Relevance: LOW - As Found: Unknown - ID: M11845 - Name: Midazolam - Relevance: LOW - As Found: Unknown - ID: M10674 - Name: Ketamine - Relevance: LOW - As Found: Unknown - ID: M22645 - Name: Ketorolac - Relevance: LOW - As Found: Unknown - ID: M22646 - Name: Ketorolac Tromethamine - Relevance: LOW - As Found: Unknown - ID: M11760 - Name: Metoclopramide - Relevance: LOW - As Found: Unknown - ID: M7338 - Name: Diphenhydramine - Relevance: LOW - As Found: Unknown - ID: M14268 - Name: Promethazine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428825 **Brief Title:** A Study to Learn About the Safety of BAY3283142 in People With Mild to Moderate High Blood Pressure **Official Title:** Study in Participants With Mild to Moderate Arterial Hypertension to Investigate Safety and Tolerability of BAY3283142 in a Randomized, Single-blind, Placebo-controlled, Multi-center, Group Comparison Design #### Organization Study ID Info **ID:** 22723 #### Organization **Class:** INDUSTRY **Full Name:** Bayer #### Secondary ID Infos **Domain:** CTIS (EU) **ID:** 2024-512060-58-00 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-16 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bayer #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** In this study, researchers want to learn about the safety of BAY3283142 after a single dose and multiple doses in participants with mild to moderate high blood pressure. The study treatment called BAY3283142 helps to relax blood vessels. It is currently under development for the treatment of chronic kidney disease (CKD) and nonproliferative diabetic retinopathy (NPDR). CKD is a condition in which the kidneys' ability to work gradually decrease over time. NPDR is a condition in which high blood glucose levels cause damage to the blood vessels of the retina, which is a tissue at the back of the eyes. During this study, participants will take either different doses of the study drug BAY3283142 as tablets by mouth or a placebo. A placebo looks like the study drug but does not have any medicine in it. At the start of this study, the study doctor will check the medical history and current medications of the participants. They will also perform a complete health check on all the participants. Researchers will collect blood and urine samples from the participants at different time points to assess the safety and effects of BAY3283142. Each treatment scheme will consist of three doses that are given in a consecutive manner. For the first 7 days, participants will receive a lower dose of BAY3283142 in each treatment scheme. The middle and the higher dose of each treatment scheme will be given for 14 days each. Participants will not know which treatment (placebo or BAY3283142) they will be given, but the study doctor will know which group received which treatment. A participant can be in the study for 10 weeks. This study will be conducted on men or postmenopausal women participants with mild to moderate high blood pressure who may not directly benefit from treatment with BAY3283142. However, information collected in this study will serve as a basis for the development of BAY3283142 for the treatment of people with CKD or NPDR. Participants may experience pain and discomfort when blood samples are taken. The researchers will closely monitor and manage any medical problems that the participants may have during the study. ### Conditions Module **Conditions:** - Chronic Kidney Disease - Non-proliferative Diabetic Retinopathy - Arterial Hypertension ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 72 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Participants will receive either BAY3283142 or placebo once a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 14 days on the high dose. **Intervention Names:** - Drug: BAY3283142 - Drug: Placebo to BAY3283142 **Label:** Treatment scheme 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive either BAY3283142 or placebo once a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 14 days on the very high dose. **Intervention Names:** - Drug: BAY3283142 - Drug: Placebo to BAY3283142 **Label:** Treatment scheme 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will receive either BAY3283142 or placebo twice a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 14 days on the very high dose. **Intervention Names:** - Drug: BAY3283142 - Drug: Placebo to BAY3283142 **Label:** Treatment scheme 3 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Participants will receive either BAY3283142 or placebo twice a day. The treatment scheme consists of 3 dose steps. Treatment will start with the low dose for 7 days , followed for 14 days at the middle dose and 14 days on the high dose. **Intervention Names:** - Drug: BAY3283142 - Drug: Placebo to BAY3283142 **Label:** Treatment scheme 4 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment scheme 1 - Treatment scheme 2 - Treatment scheme 3 - Treatment scheme 4 **Description:** oral administration **Name:** BAY3283142 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Treatment scheme 1 - Treatment scheme 2 - Treatment scheme 3 - Treatment scheme 4 **Description:** oral administration **Name:** Placebo to BAY3283142 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Number of participants with treatment-emergent adverse events per treatment arm (pooled placebo analysis) **Time Frame:** up to 7 days after last intake of study intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participant must be 30 to 72 years of age inclusive, at the time of signing the informed consent. * Participants with diagnosis of mild to moderate systemic arterial hypertension receiving stable treatment for ≥8 weeks before the screening visit with not more than 2 antihypertensive drugs * No planned changes to antihypertensive treatment during active treatment phase of the study. * Estimated glomerular filtration rate ≥45 mL/min/1.73 m2 (CKD-Epi formula) at screening and Study Day -2. * Men and confirmed postmenopausal women (documented by medical report verification and defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for at least 6 months before screening with documented serum follicle-stimulating hormone levels \>40 miU/mL) or women with iatrogenic menopause due to bilateral oophorectomy Exclusion Criteria: * Systemic diseases: cancer (with the exception of appropriately treated basal cell carcinomas of the skin or uterine carcinoma in situ), autoimmune diseases (including also topically treated autoimmune diseases such as atopic dermatitis) * Any surgical or medical condition which significantly alters the absorption, distribution, metabolism or excretion of study drugs, including, but not limited to: history of major gastrointestinal tract surgery, cholecystectomy, inflammatory bowel disease, chronic diarrhea, currently active gastritis, and pancreatitis * Long-acting or short-acting nitrates or NO donors for any route including isosorbide dinitrate, isosorbide-5-mononitrate, pentaerythritol tetranitrate, nicorandil, nitrotriglyceride, molsidomin starting 7 days (or at least 5 half-lives of the active substance whichever is longer) before first study intervention until Follow-up. * PDE inhibitors starting 7 days (or at least 5 half-lives of the active substance whichever is longer) before first study intervention until Follow-up. * sGC stimulators or activators starting 7 days (or at least 5 half-lives of the active substance whichever is longer) before first study intervention until Follow-up. **Maximum Age:** 72 Years **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Bayer Clinical Trials Contact **Phone:** (+)1-888-84 22937 **Role:** CONTACT #### Locations **Location 1:** **City:** Mannheim **Country:** Germany **Facility:** Clinical Research Services | Clinical Research Services Mannheim - Phase one unit **State:** Baden-Württemberg **Zip:** 68167 **Location 2:** **City:** Berlin **Country:** Germany **Facility:** CRS Clinical Research Services Berlin GmbH **Zip:** 13353 ### IPD Sharing Statement Module **Description:** Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000012164 - Term: Retinal Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000003925 - Term: Diabetic Angiopathies - ID: D000048909 - Term: Diabetes Complications - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Arterial Hypertension - ID: M7125 - Name: Diabetic Retinopathy - Relevance: HIGH - As Found: Diabetic Retinopathy - ID: M14999 - Name: Retinal Diseases - Relevance: LOW - As Found: Unknown - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Kidney Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M7120 - Name: Diabetic Angiopathies - Relevance: LOW - As Found: Unknown - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003930 - Term: Diabetic Retinopathy - ID: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic - ID: D000006973 - Term: Hypertension ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428812 **Brief Title:** The Effect of Perineal Protective Package Application on Pelvic Floor in Labor **Official Title:** Phd Student Msc Midwife #### Organization Study ID Info **ID:** Hayatoktem02 #### Organization **Class:** OTHER **Full Name:** Gulhane School of Medicine ### Status Module #### Completion Date **Date:** 2025-05-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-25 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Öznur Hayat Öktem #### Responsible Party **Investigator Affiliation:** Gulhane School of Medicine **Investigator Full Name:** Öznur Hayat Öktem **Investigator Title:** Phd student Msc midwife **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aimed to evaluate the effect of perineal protection package application on labor outcomes, perineal integrity, postpartum urinary incontinence and pelvic floor muscle strength.In this study, a package including practices that have been proven to protect the perineum in labor was created and it was aimed to examine the effect of this perineal protection package; as a whole. The;perineal protective package; applications created by the researchers consisted of positioning on the gynecologic table (the back of the table was erected, the legs were removed from the hooks and placed on the sides of the table), open glottis pushing instead of closed glottis pushing, hot compress protection of the perineum instead of dry compress protection of the perineum, instead of lithotomy position in the second stage, which reduces the tension of the perineum and allows it to be observed and protected manually. **Detailed Description:** The pelvic floor plays a critical and important role in maintaining healthy functions of the urinary, genital and gastrointestinal systems. When tissues in a region of the pelvic floor are damaged for any reason, pelvic floor dysfunction develops. Pregnancy and childbirth are important risk factors for pelvic floor dysfunction. Hormonal and mechanical changes during pregnancy predispose to impaired pelvic floor function. During pregnancy, weight gain and increase in uterine weight increase intra-abdominal pressure. Therefore, ligaments and pelvic floor muscles are overstretched. He states that the main factor in pelvic floor dysfunction is vaginal delivery and that the passage of a particularly large fetal head through the birth canal is the trigger. During the passage and descent of the fetal head through the vaginal canal, the pelvic floor muscles can be overstretched, torn or damaged. Obstetric factors that cause pelvic floor damage include early or late age at first birth, high body mass index, large baby, length of the second stage of trauma (labor), forceps, vacuum, episiotomy and fundal compression. Damage to the pelvic floor during labor has many short- and long-term effects on a woman\&#39;s quality of life. These can be summarized as chronic perineal pain, pelvic organ prolapse, urinary and anal incontinence, fistula, sexual dysfunction, labor dissatisfaction, physical and psychological morbidities, and decreased quality of life. In addition, breastfeeding and mother-infant attachment problems may also occur due to perineal pain in the early postpartum period. Therefore, it is important to prevent pelvic floor damage in childbirth, which negatively affects physical, social and psychological well-being and leads to many short and long-term morbidities. The World Health Organization recommends the use of techniques such as hot compresses to reduce perineal damage and facilitate spontaneous delivery. In the literature, there are many studies examining interventions to protect the pelvic floor in labor. Studies show that perineal massage, perineal warm application, birth positions, hand maneuvers, pushing techniques, and limited episiotomy reduce the incidence of perineal injury. However, studies on these techniques and practices are generally studies investigating the effectiveness of a single method. In a recent qualitative study, midwives were asked to evaluate the effect of some protective practices called; perineal package; as a whole. However, in this study, midwives; own practices and opinions were evaluated, and their effects on the pelvic floor or labor were not examined. International organizations recommend the application of evidence-based, perineal, and pelvic floor supportive and protective methods to pregnant women in labor. However, the relationship between these practices and postpartum pelvic floor muscle strength and the presence of incontinence, which are indicators of pelvic floor damage, is unclear and studies to evaluate this relationship are limited. The research will be conducted in 4 stages. In Phase 1, pregnant women who meet the inclusion criteria will be interviewed when they are admitted to the delivery room. In the first interview, the relevant sections of the data collection form will be filled out, pelvic floor muscle strength will be measured with a perineometer, and the IIQ-7 and UDI-6 scales will be filled out. Pregnant women with incontinence detected in these scales will be excluded. Then, pregnant women will be randomized using the true random number generation method on the random.org website and assigned to the study and control groups. Then, the delivery process of all pregnant women in the study and control groups will be monitored and recorded using the relevant section of the data collection form. In phase 2, the perineal pain felt by pregnant women in both groups will be evaluated using VAS when the second stage of labor begins. The second stage of labor is the time from complete dilatation of the cervix until the fetal head is born. During this stage, the study group will receive a perineal protection package while the control group will receive routine care. Postpartum perineal pain, episiotomy length if episiotomy was applied and perineal length will be measured in both groups. The results of the trauma will be recorded in the labor follow-up form. In the 3rd stage, pregnant women in both groups will be interviewed at the 1st hour postpartum and perineal pain will be evaluated with VAS. In the 4th stage, the pregnant women in the study and control groups will be measured pelvic muscle strength with a perineometer, perineal length will be measured and recorded on the relevant form during routine hospital control at the 6th week postpartum. UDI-6 (urinary distress inventory) and IIQ-7 (incontinence impact questionnaire) will be completed. ### Conditions Module **Conditions:** - Pregnancy - Labor - Pelvic Floor ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This group includes those in the 2nd stage of labor upright position spontaneous pushing Hot application will be made **Intervention Names:** - Other: Experimental: perineal package application group **Label:** perineal package application group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Routine hospital care **Label:** Routine hospital care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - perineal package application group **Description:** This group includes those in the 2nd stage of labor upright position spontaneous pushing Hot application will be made **Name:** Experimental: perineal package application group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Perineal muscle strength will be measured in cmH2o with a perineometer. **Measure:** Perineal muscle strengt **Time Frame:** On initial admission to the delivery room and after 6 weeks postpartum **Description:** Perineal pain will be assessed by VAS at the beginning and end of the second stage of labor and at the end of the 1st hour postpartum. **Measure:** Perineal Pain **Time Frame:** 1st hour postpartum #### Secondary Outcomes **Description:** Episypotomy will be measured in cm with a paper ruler according to the application status. **Measure:** Episiotomy and laseration status **Time Frame:** 1st hour postpartum **Description:** Urinary incontinence status will be measured with UDI-6 and IIQ-7. **Measure:** Urinary incontinence status **Time Frame:** 6 weeks postpartum ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18- 35 years old * Primipar * Singleton pregnancy in the vertex position between 38 and 42 weeks * A reactive NST tracing * Without a systemic disease (heart, HT, diabetes) * No problem speaking and understanding Turkish * Who agreed to participate in the study Exclusion Criteria: * Obese pregnant women * Pregnant women who gained more than 25 kilograms during pregnancy * Pregnant women with urinary incontinence according to UDI-6 * Multiple pregnancies * Pregnant women with a neurological disease affecting the pelvic floor * Pregnant women who have undergone pelvic surgery * Contraindications for normal delivery (placenta previa, anomalies of presentation, etc.) * Estimated fetal weight of 4000 g or more * Who wants to opt out of the study * Pregnant women who are scheduled for cesarean section at any time of trauma **Gender Based:** True **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Nazan KARAHAN, Assosition Prof. **Phone:** 05074861414 **Role:** CONTACT #### Locations **Location 1:** **City:** Karabük **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Öznur HAYAT ÖKTEM, Phd Student Msc Midwife - **Phone:** 05050532025 - **Role:** CONTACT ***Contact 2:*** - **Name:** Nazan KARAHAN, Associate professor - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** MEHMET BÜLBÜL KBÜ, Associate professor - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Karabuk Training and Research Hospital, obstetrics clinic **Zip:** 78100 #### Overall Officials **Official 1:** **Affiliation:** Gulhane School of Medicine **Name:** Nazan KARAHAN, Associate professor **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Karabuk University **Name:** MEHMET BÜLBÜL, Associate professor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** undefined ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428799 **Acronym:** EMBLEDDA-MMG **Brief Title:** Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment **Official Title:** Evaluation of Carebot AI MMG Medical Device for Detection and Radiographic Assessment of Breast Lesions and Quantitative Analysis of Breast Density: A Multicentric, Multi-Reader Study #### Organization Study ID Info **ID:** 00003 #### Organization **Class:** INDUSTRY **Full Name:** Carebot s.r.o. ### Status Module #### Completion Date **Date:** 2024-04-24 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-24 **Type:** ACTUAL #### Start Date **Date:** 2022-01-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Carebot s.r.o. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2) 1. Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS) 2. Comparison of Accuracy of Lesion Assessment by Clinician and DLAD (MASS, CLASS) **Detailed Description:** The mammography studies were acquired from three independent sites: Site 1 (EUC Mamocentrum Brno) and Site 2 (Hospital Šumperk, a.s.) specialise in routine screening mammography, and Site 3 (Masaryk Memorial Cancer Institute) is a comprehensive oncology facility primarily dedicated to diagnostic mammography, i.e. performing additional examinations in case of a suspicious finding (recall). The ground truth was obtained by consensus of two board-certified radiologists with expertise in radiology and diagnostic methods, and 13 and 27 years of experience with mammography image interpretation, respectively. For comparative analysis, a team of five independent radiologists with clinical experience in interpreting mammography images was established. Three of the clinicians were junior (2, 2, and 4 years of experience, respectively) without board-certification; two physicians were senior (7 and 8 years of experience, respectively), board-certified. ### Conditions Module **Conditions:** - Breast Cancer - Breast Tumor Benign ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 122 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A total of 60 mammographic studies were retrospectively collected from Site 1 (EUC Mamocentrum Brno). The acquisition of mammography studies from Site 1 was enabled by the contract for the transfer of mammography images for medical research purposes, signed on 14 January 2022. **Intervention Names:** - Device: Carebot AI MMG **Label:** Retrospective collection of DICOM patient files for Site 1 #### Arm Group 2 **Description:** A total of 28 mammographic studies were retrospectively collected from Site 2 (Hospital Šumperk, a.s.). The acquisition of mammography studies from Institution 2 was enabled by the contract for the transfer of mammography images for medical research purposes, signed on 31 January 2023. **Intervention Names:** - Device: Carebot AI MMG **Label:** Retrospective collection of DICOM patient files for Site 2 #### Arm Group 3 **Description:** A total of 34 mammographic studies were retrospectively collected from Site 3 (Masaryk Memorial Cancer Institute). The acquisition of mammography studies from Institution 3 was enabled by the amendment to the contract for the transfer of X-ray images for medical research purposes, signed on 21 February 2023, which follows the contract for the transfer of X-ray images for medical research purposes, signed on 3 January 2022. **Intervention Names:** - Device: Carebot AI MMG **Label:** Retrospective collection of DICOM patient files for Site 3 ### Interventions #### Intervention 1 **Arm Group Labels:** - Retrospective collection of DICOM patient files for Site 1 - Retrospective collection of DICOM patient files for Site 2 - Retrospective collection of DICOM patient files for Site 3 **Description:** Carebot AI MMG is a software solution that utilizes artificial intelligence methods, specifically deep learning and computer vision algorithms, to evaluate and localize suspicious regions of potential lesions during the interpretation of digital breast x-rays as part of standard mammography screening procedures. The Carebot AI MMG medical device is not intended for use in diagnostic mammography. The Carebot AI MMG is intended for use in women over the age of 18. The predictive outputs of the Carebot AI MMG medical device are intended to aid decision-making in screening clinical practice, always in conjunction with other relevant patient information and based on the professional judgment of the examining clinician. The Carebot AI MMG is specifically designed to provide a supporting layer of analysis that helps in evaluating or prioritizing mammography images with additional patient information and the professional judgment of the examining physician. **Name:** Carebot AI MMG **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** A multicenter, multi-reader, retrospective study was designed to validate the clinical efficacy of the proposed Carebot AI MMG (also referred to as "DLAD"). Using a non-certified medical device, a test set of retrospectively collected mammography studies in standard projections (CC and MLO). The performance of the DLAD was evaluated against the ground truth for individual indications (breast density evaluation, breast lesion detection) using Accuracy. **Measure:** Performance Test **Time Frame:** 2024 #### Secondary Outcomes **Description:** Carebot AI MMG v2.2 classified mammography studies according to the ACR BI-RADS 5th edition, i.e. breast tissue density assessment into A/B/C/D classes. The performance of the Carebot AI MMG device was assessed relative to the ground truth and then compared with the performance of five independent radiologists with varying levels of experience (RAD 1-RAD 5). A rigorous statistical analysis was used in the BI-RADS breast density classification to evaluate the performance of each method - the proposed Carebot AI MMG v2.2 medical device and the compared radiologists in the multi-reader study. The analysis focused on key metrics including Accuracy, F1 Score (Macro-Averaged), Precision (Macro-Averaged), Recall (Macro-Averaged) and Cohen's Kappa (κ) to assess the strength of agreement. Given that all scans were evaluated by all radiologists in the comparison, a bootstrapping method that involves resampling the test data 1000 times. **Measure:** Comparison of Accuracy of Clinician and DLAD Image Evaluation (Carebot AI MMG v2.2) in Breast Density Assessment **Time Frame:** 2024 **Description:** The medical device (DLAD, Carebot AI MMG v2.2) analyzed mammography studies in standard projections (CC and MLO) and classified the presence of lesions ("present" x "absent") at the mammography study level. DLAD performance was assessed relative to the ground truth and then compared to the performance of five independent radiologists with varying levels of experience (RAD 1-RAD 5). The investigators quantified the performance of diagnostic tests based on Sensitivity, Specificity and Balanced Accuracy. The investigators further assessed the statistical significance of differences between DLAD and individual radiologists using appropriate statistical tests. To determine the reliability of the metrics examined, the investigators calculated 95% confidence intervals using Wilson scores. To evaluate the statistical significance of differences in Sensitivity and Specificity between DLAD and individual radiologists, the investigators applied McNemar's test with a continuity correction. **Measure:** Comparison of Accuracy of Clinician and DLAD Image Evaluation (Carebot AI MMG v2.2) in Breast Lesion Detection **Time Frame:** 2024 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The medical device is intended for use in women over 18 years of age who are indicated for screening mammography using digital mammography. Exclusion Criteria: * The medical device cannot be used in patients with breast implants. * The medical device cannot be used in male breast examination. * The medical device cannot be used in patients under 18 years of age. **Gender Based:** True **Gender Description:** The medical device cannot be used in male breast examination. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** A total of 122 mammography studies (488 images, the so-called "test data") were obtained from the reference sites for the evaluation by radiologists and the Carebot AI MMG v2.2. The target sites used different mammography X-ray machines: Site 1 and Site 2 used the Senographe Essential mammography machine from GE HealthCare to image patients, and Site 3 used the Selenia Dimensions mammography machine from Hologic and the MAMMOMAT Revelation mammography machine from Siemens Healthineers. ### Contacts Locations Module #### Locations **Location 1:** **City:** Brno **Country:** Czechia **Facility:** EUC Mamocentrum Brno **Zip:** 60200 **Location 2:** **City:** Brno **Country:** Czechia **Facility:** Masaryk Memorial Cancer Institute **Zip:** 60200 **Location 3:** **City:** Šumperk **Country:** Czechia **Facility:** Hospital Šumperk **Zip:** 78701 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Tumor - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428786 **Acronym:** PCOS **Brief Title:** The Effect of Polycystic Ovary Syndrome Phenotypes on Quality of Life and Sexual Function **Official Title:** The Effect of Polycystic Ovary Syndrome Phenotypes on Quality of Life and Sexual Function #### Organization Study ID Info **ID:** 02/08 28.02.2024 #### Organization **Class:** OTHER **Full Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-25 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-18 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital #### Responsible Party **Investigator Affiliation:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital **Investigator Full Name:** Mujde Can Ibanoglu **Investigator Title:** Assoc. Prof **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 was planned to examine whether different phenotypes of PCOS have an effect on quality of life, depression inventory and sexual function. **Detailed Description:** Polycystic ovary syndrome (PCOS) is the most common endocrinologic pathology in women of reproductive age. Although the prevalence varies according to race, ethnicity and geographical region, it averages between 5-10%. The so-called Rotterdam criteria are: 1. Oligo- and/or anovulation, 2. Clinical and/or biochemical signs of hyperandrogenism, 3. Polycystic ovarian morphology on ultrasound, 4. Other conditions causing or associated with androgen elevation must be ruled out before a diagnosis of PCOS is made. Treatment needs, types and options vary according to phenotypic characteristics. The OD+HA+PKOM phenotype is considered a complete (classic) phenotype according to the Rotterdam classification and has the highest rate. Other phenotypes according to the Rotterdam criteria can be OD+HA (non-PCO phenotype), HA+PKOM (ovulation phenotype) or OD+PKOM (non-HA phenotype). Clinical pictures (phenotype A: HA + OD + PCOM; phenotype B: HA + OD; phenotype C: HA + PCOM and phenotype D: OD + PCOM). According to the Rotterdam criteria, endocrine and metabolic abnormalities are lowest in the OD+PCOM group among these 4 different phenotypes. The prevalence and distribution characteristics of metabolic abnormalities (insulin resistance, metabolic disease pattern and glucose intolerance) did not differ significantly between the 4 groups. Therefore, metabolic abnormalities and distribution characteristics are not used to differentiate the different clinical PCOS phenotypes. Studies have shown that the "classic" PCOS group (phenotypes A and B) is more strongly associated with marked menstrual irregularity, elevated insulin levels and risk of metabolic syndrome; body mass index and obesity compared to the non-classic or non-hyperandrogenic PCOS phenotypes (phenotypes C and D). There are numerous studies on whether phenotypic differences are based on ethnicity. Studies have shown that African-American women and women of Hispanic origin are more prone to obesity and the development of metabolic syndrome, while Middle Eastern women and women of Mediterranean origin are more prone to hirsutism. PCOS symptoms such as clinical hyperandrogenism, anovulation and menstrual irregularities can lead to a reduced quality of life, depression, mood disorders and sexual dysfunction. The physical, emotional and environmental scores were significantly lower in Group A patients compared to the other PCOS groups and the control group. The Short Form 36 (SF 36), which has the characteristics of a general scale among quality of life scales and provides broad measurement, was developed and put into use by the Rand Corporation in 1992. The scale was designed to be short and easy to administer and has a wide range of applications. The main feature of the SF-36, whose psychometric properties and scope have been expanded, is that it is a self-report scale that includes items on physical functioning, social functioning, role limitations related to physical functioning, role limitations related to emotional problems, mental health, energy/vitality, pain, and general perception of health. The relationship between the severity of depressive symptoms and the different PCOS phenotypes is controversial. The Beck Depression Inventory (BDI-II), developed by Dr. Aaron T. Beck, is a questionnaire with 21 multiple-choice questions that can be used to measure the severity of depression. Scores ≥17 indicate severe depression requiring treatment.The depression inventory scores were higher in PCOS patients with infertility problems. A study found that there was no difference in depression scores between infertile and fertile groups. The Female Sexual Function Index (FSFI) inventory was used to assess sexual dysfunction in obese PCOS patients. The Female Sexual Function Index was developed in 2000 to assess sexual function in women. The scale consists of 19 items and has 6 sub-dimensions: Pleasure, Arousal, Lubrication, Orgasm, Satisfaction and Pain. The scale reflects women's sexual functioning in the past month by calculating 6 subgroup scores and the FSFI score. The FSFI score is calculated by adding the subgroup scores. The Female Sexual Function Index has proven to be a valid and reliable tool for measuring sexual function in Turkish women. Based on this information, the aim of this study was to investigate whether different phenotypes of PCOS have an impact on quality of life, depression inventory and sexual function. ### Conditions Module **Conditions:** - Polycystic Ovary - Depression - Sexual Dysfunction **Keywords:** - Female Sexual Function Index - phenotypes - polycystic ovary syndrome - The Beck Depression Inventory - Quality of life ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 176 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 6 Months ### Arms Interventions Module #### Arm Group 1 **Description:** PHENOTYPE A: Hyperandrogenism + Ovulatory Dysfunction + Polycystic ovary morphology 44 participants **Intervention Names:** - Other: Female Sexual Function Index **Label:** Phenotype A #### Arm Group 2 **Description:** PHENOTYPE B: Hyperandrogenism + Ovulatory Dysfunction 44 participants **Intervention Names:** - Other: Female Sexual Function Index **Label:** Phenotype B #### Arm Group 3 **Description:** PHENOTYPE C: Hyperandrogenism + Polycystic ovary morphology 44 participants **Intervention Names:** - Other: Female Sexual Function Index **Label:** Phenotype C #### Arm Group 4 **Description:** PHENOTYPE D: Ovulatory Dysfunction + Polycystic ovary morphology 44 participants **Intervention Names:** - Other: Female Sexual Function Index **Label:** Phenotype D ### Interventions #### Intervention 1 **Arm Group Labels:** - Phenotype A - Phenotype B - Phenotype C - Phenotype D **Description:** As part of the study, data on the socio-demographic characteristics of the individuals is collected by means of personal interviews using a questionnaire. The results of laboratory tests required for the diagnosis of PCOS will be taken from hospital records. The Female Sexual Function Index (FSFI), the Beck Depression Inventory and the KF-36 quality of life assessment form will be completed in person and the total scores will be analyzed taking into account four different PCOS phenotypes. **Name:** Female Sexual Function Index **Other Names:** - Beck Depression Inventory - Short Form 36 **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The aim of this study was to investigate whether different phenotypes of PCOS have an impact on quality of life, depression inventory and sexual function. **Measure:** Effect of PCOS phenotypes on SF-36. **Time Frame:** 6 months **Description:** The aim of this study was to investigate whether different phenotypes of PCOS have an impact on quality of life, depression inventory and sexual function. **Measure:** Effect of PCOS phenotypes on FSFI. **Time Frame:** 6 months **Description:** The aim of this study was to investigate whether different phenotypes of PCOS have an impact on quality of life, depression inventory and sexual function. **Measure:** Effect of PCOS phenotypes on Beck Deppression scale **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * least 1 year after menarche * over 18 years old * Patients who have given verbal and written informed consent will be included. Exclusion Criteria: * under 18 years of age * Endocrine disorders such as hyperprolactinemia, Cushing's syndrome, congenital adrenal hyperplasia, thyroid disorders * Neuromuscular, hepatic, pancreatic or gastrointestinal diseases * Users of hormone preparations such as antiandrogens, antidiabetics, glucocorticoids, insulin sensitizers, lipid regulators **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT **Study Population:** Sexually active people who are cared for at the PCOS Clinic of Etlik Zübeyde Hanım Gynecology Training and Research Hospital form the study group. The study involves 176 subjects who agreed to participate in the study and accepted the informed consent verbally and in writing. The ESHRE/ASRM 2023 guidelines will be used as a basis and those who fulfill both criteria below will be included in the PCOS group: 1. Oligo and/or anovulation\* 2. Clinical and/or biochemical hyperandrogenism 3. Polycystic ovarian morphology or AMH elevation Definition of the phenotype groups: PCOS has been categorized into 4 phenotypes: Phenotype A: Hyperandrogenism + ovarian dysfunction + PCOM PHENOTYPE B: HA+OD PHENOTYPE C: HA+PCOM PHENOTYPE D: OD+PKOM were grouped as. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mujde Can Ibanoglu **Phone:** 05323089488 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Yaprak Engin-Ustun **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey. **Name:** Mujde Can Ibanoglu **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Tian X, Ruan X, Du J, Cheng J, Ju R, Mueck AO. Sexual function in Chinese women with different clinical phenotypes of polycystic ovary syndrome. Gynecol Endocrinol. 2023 Dec;39(1):2221736. doi: 10.1080/09513590.2023.2221736. **PMID:** 37302412 **Citation:** Yilmaz M, Isaoglu U, Delibas IB, Kadanali S. Anthropometric, clinical and laboratory comparison of four phenotypes of polycystic ovary syndrome based on Rotterdam criteria. J Obstet Gynaecol Res. 2011 Aug;37(8):1020-6. doi: 10.1111/j.1447-0756.2010.01478.x. Epub 2011 Apr 12. **PMID:** 21481088 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000010048 - Term: Ovarian Cysts - ID: D000003560 - Term: Cysts - ID: D000009369 - Term: Neoplasms - ID: D000010049 - Term: Ovarian Diseases - ID: D000000291 - Term: Adnexal Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000006058 - Term: Gonadal Disorders - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases ### Condition Browse Module - Browse Leaves - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M13970 - Name: Polycystic Ovary Syndrome - Relevance: HIGH - As Found: Polycystic Ovary Syndrome - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M6765 - Name: Cysts - Relevance: LOW - As Found: Unknown - ID: M12971 - Name: Ovarian Cysts - Relevance: LOW - As Found: Unknown - ID: M12972 - Name: Ovarian Diseases - Relevance: LOW - As Found: Unknown - ID: M3643 - Name: Adnexal Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M9163 - Name: Gonadal Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000011085 - Term: Polycystic Ovary Syndrome - ID: D000003863 - Term: Depression ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428773 **Brief Title:** Effect of Exercise on Vessel Diameter in Hemodialysis Patients **Official Title:** Effect of Exercise on Vessel Diameter in Hemodialysis Patients #### Organization Study ID Info **ID:** 2021-4/35 #### Organization **Class:** OTHER **Full Name:** Kirsehir Ahi Evran Universitesi ### Status Module #### Completion Date **Date:** 2023-11-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-09-10 **Type:** ACTUAL #### Start Date **Date:** 2023-05-05 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Kirsehir Ahi Evran Universitesi #### Responsible Party **Investigator Affiliation:** Kirsehir Ahi Evran Universitesi **Investigator Full Name:** Mehmet Hanifi Kaya **Investigator Title:** Pilot Project Manager Lecturer Doctor. **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, 100 hemodialysis patients aged between 18-65 were examined. Participants were randomly divided into two groups: the exercise group and the control group. The exercise group performed moderate-intensity aerobic exercises for 30 minutes three times a week during hemodialysis sessions. Additionally, they engaged in walking exercises for 30 minutes three times a week outside of hemodialysis sessions, maintaining their heart rate between 50-60%. The exercise group also performed isolated exercises to expand wrist vessels 2-3 days a week outside of hemodialysis sessions. The vessel diameters of the patients were measured by ultrasound at the beginning and after 12 weeks. **Detailed Description:** Background: As it is known, many negative situations occur in CKD patients on hemodialysis. One of these is the problems seen in the vascular access. The prevention and management of vascular access complications may benefit from exercise The purpose of this study is to investigate the effect of exercise on the vessel diameter in HD patients. Methods: Present study we were included 100 hemodialysis patients between the ages of 18-65.Participants were randomly divided into two groups: the exercise group and the control group. The exercise group performed moderate-intensity aerobic exercise on a stationary bicycle ergometer for 30 minutes during hemodialysis sessions, three days a week over 12 weeks. Additionally, the exercise group engaged in walking exercise for 30 minutes, three days a week outside of hemodialysis sessions, maintaining the heart rate between 50-60%. The exercise group also performed isolated exercises to expand wrist vessels, including wrist and elbow flexion, extension, and rotation, repeated 10 times, 2-3 days a week outside of hemodialysis sessions. And the vessel diameters of patients were measured by ultrasound at the beginning and after 12 weeks. ### Conditions Module **Conditions:** - Chronic Kidney Diseases ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 100 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The exercise group performed moderate-intensity aerobic exercise on a stationary bicycle ergometer for 30 minutes during hemodialysis sessions, three days a week over 12 weeks. Additionally, the exercise group engaged in walking exercise for 30 minutes, three days a week outside of hemodialysis sessions, maintaining the heart rate between 50-60%. The exercise group also performed isolated exercises to expand wrist vessels, including wrist and elbow flexion, extension, and rotation, repeated 10 times, 2-3 days a week outside of hemodialysis sessions. **Intervention Names:** - Other: Exercise **Label:** Exercise Group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The control group did not engage in any exercise. **Intervention Names:** - Other: Exercise **Label:** control group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Exercise Group - control group **Description:** Participants were randomly divided into two groups: the exercise group and the control group. The exercise group performed moderate-intensity aerobic exercise on a stationary bicycle ergometer for 30 minutes during hemodialysis sessions, three days a week over 12 weeks. Additionally, the exercise group engaged in walking exercise for 30 minutes, three days a week outside of hemodialysis sessions, maintaining the heart rate between 50-60%. The exercise group also performed isolated exercises to expand wrist vessels, including wrist and elbow flexion, extension, and rotation, repeated 10 times, 2-3 days a week outside of hemodialysis sessions. **Name:** Exercise **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Baseline Vessel Diameter (mm) **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being between 18-65 years of age * Undergoing hemodialysis treatment for at least 6 months * Using arteriovenous fistula, arteriovenous graft, or permanent catheter as the vascular access type. * Having no orthopedic, neurological, cardiac, or respiratory diseases that could hinder exercise * Willingness to participate in exercise. Exclusion Criteria: * Access complications such as acute or chronic infections, inflammation, bleeding, aneurysms, stenosis, thrombosis, or any condition that hindered exercise, * Acute or chronic cardiovascular complications such as cardiac arrhythmias, ischemia, heart failure. * Hypertension, or hypotension that hindered exercise. * Acute or chronic musculoskeletal injuries, pain, inflammation, or deformities that hindered exercise. * Refusal to participate in exercise. were excluded from the study. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Kırşehir **Country:** Turkey **Facility:** Kırşehir Ahi Evran University **Zip:** 40100 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000051437 - Term: Renal Insufficiency - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### 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 - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: HIGH - As Found: Kidney Disease - ID: M26717 - Name: Renal Insufficiency, Chronic - Relevance: HIGH - As Found: Chronic Kidney Disease - ID: M26718 - Name: Renal Insufficiency - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007674 - Term: Kidney Diseases - ID: D000051436 - Term: Renal Insufficiency, Chronic ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428760 **Brief Title:** Relationship Between Preoperative Subcutaneous Trochanteric Fat Thickness and Postoperative Infection Risk **Official Title:** The Effect of Preoperative Subcutaneous Trochanteric Fat Thickness and Trochanteric Soft Tissue Thickness on Postoperative Infection Risk in Patients Undergoing Hemiarthroplasty for Femoral Neck Fracture #### Organization Study ID Info **ID:** ashmehmetonut #### Organization **Class:** OTHER **Full Name:** Ankara City Hospital Bilkent ### Status Module #### Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **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:** Ankara City Hospital Bilkent #### 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 effect of preoperative subcutaneous trochanteric fat thickness and trochanteric soft tissue thickness on postoperative infection risk in patients undergoing hemiarthroplasty for femoral neck fracture **Detailed Description:** Obesity is a growing problem for healthcare systems and orthopaedic surgeons, with 29% of the adult population in the UK and 40% in the US affected by obesity. The most commonly used measure of obesity in healthcare is body mass index (BMI), and the World Health Organisation defines obesity as a BMI ≥ 30 kg/m2. Much of the arthroplasty literature has also focused on the use of BMI as a measure of obesity. BMI-defined obesity is associated with an increased risk of perioperative complications (including infection and dislocation) in total hip arthroplasty. It has also been shown that there is a gradual increase in anaesthetic time, operative time and length of hospital stay as BMI increases in obese patients. BMI is an imperfect measure because it does not take into account age, sex, race, fat distribution or muscle mass. Previous studies have shown that subcutaneous fat depth (FD) is an independent risk factor for wound infection in cervical and lumbar spine surgery and after laparotomy. It is not known whether increased subcutaneous fat and soft tissue mass are associated with an increased risk of complications after arthroplasty for femoral neck fractures. The aim of this study was to investigate whether preoperative measurement of subcutaneous adipose tissue by radiography and computed tomography (CT) and muscle thickness in the gluteus medius/minus, gluteus maximus, anterior and medial compartments by computed tomography (CT) in femoral neck fractures correlate with infection rates at postoperative follow-up. Hypothesis: In patients with high body mass index (BMI) with femoral neck fractures, the investigators believe that the relationship between increased subcutaneous adipose tissue on radiographs and CT sections and wound infection is as effective as the relationship between increased muscle thickness in the gluteus medius/minimus, gluteus maximus, anterior and medial compartments measured on CT sections and wound infection. ### Conditions Module **Conditions:** - Hip Infection **Keywords:** - subcutaneous trochanteric fat thickness - infection - femoral neck fracture - soft tissue thickness - obesity - hemiarthroplasty ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 6 Months ### Outcomes Module #### Primary Outcomes **Description:** The aim of this study was to evaluate the effect of peritrochanteric fat thickness and hip soft tissue parameters on postoperative wound infection in patients with femoral neck fracture. Peritrochanteric fat thickness will be measured on preoperative radiographs along with sourcil to skin surface, greater trochanter tip to skin surface, and lateral greater trochanter to skin surface values. Hip soft tissue assessment will be measured with the parameters of gluteus medius/minus, gluteus maximus, muscle thickness in the anterior and medial compartments on preoperative CT sections. **Measure:** Effect of trochanteric fat and soft tissue **Time Frame:** Pre-operative **Description:** Wound infection is assessed using investigator dressings. In assessing surgical wound infection, an ASEPSIS score will be calculated for each patient to standardise for serous exudate, erythema, purulent exudate, deep tissue separation at the wound site. **Measure:** Wound infection **Time Frame:** First 3 months after surgery #### Secondary Outcomes **Description:** Hospital Length of Stay (LOS): Evaluate the duration of hospitalization following surgery, as prolonged LOS may be associated with increased risk of nosocomial infections including SSIs. **Measure:** Hospital Length of Stay (LOS) **Time Frame:** 1 months **Description:** Mortality Rate: Assess mortality rates within a defined follow-up period following surgery, as postoperative infections, especially in vulnerable populations such as elderly patients with femoral neck fractures, may contribute to increased mortality. Mortality risk is measured by the Charlson comorbidity index. **Measure:** Mortality Rate **Time Frame:** 6 months **Description:** It has been suggested that there is a relationship between body mass index and post-operative wound infection. This index is measured in kg/m2 using the patient's height and weight. **Measure:** Body Mass Index **Time Frame:** Measured once preoperatively **Description:** WBC, leukocyte, neutrophil, lymphocyte, albumin, CRP parameters will be evaluated in routine biochemistry scans **Measure:** Biochemistry Scans **Time Frame:** 1 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients over 65 years of age * Femoral neck fractures * Female patients * Patients undergoing hemiarthroplasty Exclusion Criteria: * Patients younger than 65 years * Male patients * Patients with immunosuppressive conditions * Intertrochanteric fractures * Patients with revision surgery * Pathological femoral neck fractures **Minimum Age:** 65 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - OLDER_ADULT **Study Population:** Female patients over 65 years of age who were admitted to our hospital with a history of a femoral neck fracture and who underwent hemiarthroplasty. ### Contacts Locations Module #### Locations **Location 1:** **City:** Ankara **Country:** Turkey **Facility:** Ankara Bilkent City Hospital **State:** Cankaya **Zip:** 06800 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000006620 - Term: Hip Fractures - ID: D000005264 - Term: Femoral Fractures - ID: D000050723 - Term: Fractures, Bone - ID: D000014947 - Term: Wounds and Injuries - 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 - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC01 - Name: Infections ### Condition Browse Module - Browse Leaves - ID: M26370 - Name: Fractures, Bone - Relevance: LOW - As Found: Unknown - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M8403 - Name: Femoral Neck Fractures - Relevance: HIGH - As Found: Femoral Neck Fractures - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M9696 - Name: Hip Fractures - Relevance: LOW - As Found: Unknown - ID: M8402 - Name: Femoral Fractures - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - 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: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000005265 - Term: Femoral Neck Fractures ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428747 **Brief Title:** Investigating Microparticle Levels In Filtered Packed Red Blood Cell Units **Official Title:** Investigating Microparticle Levels In Filtered Packed Red Blood Cell Units #### Organization Study ID Info **ID:** Doha Sholkamy #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Doha Fahmy **Investigator Title:** Assistant lecturer **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Red blood cell (RBC) transfusion is a common therapeutic approach, and almost 85 million packed red blood cells (pRBCs) are transfused annually worldwide.Transfusion efficacy largely depends on the patient's general health, but the composition of transfused pRBCs also can have an impact. **Detailed Description:** Red blood cell (RBC) transfusion is a common therapeutic approach, and almost 85 million packed red blood cells (pRBCs) are transfused annually worldwide.Transfusion efficacy largely depends on the patient's general health, but the composition of transfused pRBCs also can have an impact. pRBCs are prepared from donated whole blood and can be stored for up to 35 days.During storage, modifications of RBCs occur and affect product quality. Among other changes, these "storage lesions" induce microparticle (MP) formation. MPs are membrane particles measuring 0.1 to 1 µm produced by stimulated or apoptotic cells through modulation of membrane lipid organization and cytoskeleton reorganization. MPs can be produced from any cell type and express antigens characteristic of their original cell. Blood contains platelet-derived MPs (PMPs), which are the most frequent; RBC (erythrocyte)-derived MPs (ERMPs), representing 4% to 8% of total blood MPs; and, more rarely, MPs produced by endothelial cells and leukocyctes. In vivo, aging RBCs release ERMPs over their whole life cycle as a preventive effect of phagocytosis by macrophages. It seems that MPs quickly spread through the body, leading to a variety of biological effects by contact and interactions with many cells. MPs are well-known bioeffectors that mediate strong procoagulant potential, mainly because of phosphatidylserine and tissue factor expression. In this way, MPs are involved in coagulation disorders associated with atherothrombosis and cardiovascular diseases.Their ability to modulate inflammatory and immune responses is increasingly being studied as well as their capacity to carry and transport RNA, DNA, major histocompatibility complex molecules, and infectious agents. Moreover, depending on the type of stimulation that induces MP production, the size and biological functions of the MP can vary. ### Conditions Module **Conditions:** - Packed Red Cells Causing Adverse Effects in Therapeutic Use ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 7 Days ### Arms Interventions Module #### Arm Group 1 **Description:** detection of micro-particles. **Intervention Names:** - Diagnostic Test: b. Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer). **Label:** 30 filtered backed RBCs. #### Arm Group 2 **Description:** detection of micro-particles **Intervention Names:** - Diagnostic Test: b. Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer). **Label:** 30 non-filtered backed RBCs. ### Interventions #### Intervention 1 **Arm Group Labels:** - 30 filtered backed RBCs. - 30 non-filtered backed RBCs. **Description:** detection of micro-particles **Name:** b. Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer). **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer). * CD235 for red blood cell micro particles. * CD 45 for leukocyte micro particles. * CD41 for platelet micro particles. **Measure:** Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer). - CD235 for red blood cell micro particles. - CD 45 for leukocyte micro particles. - CD41 for platelet micro particles. formation. **Time Frame:** 7 days #### Secondary Outcomes **Description:** Detection of micro particles and their subtypes by flow cytometery on(BECKMAN COULTER CytoFLEX flow cytometer). * CD235 for red blood cell micro particles. * CD 45 for leukocyte micro particles. * CD41 for platelet micro particles. **Measure:** d. Quantification of micro particles in non filtered packed RBCs (pRBCs) versus filtered (pRBCs) over storage period at 4°C. **Time Frame:** 7 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Donors who met criteria of Egyptian National Transfusion Services. * Serological assays for all blood donors (HBsAgs, HCV antibodies, HIV Ag/Ab and Syphilis antibodies) on Architect i 2000 SR or Centaur XPT (chemoluminescence). Exclusion Criteria: * Donors who not met criteria of Egyptian National Transfusion Services. * Reactive serology. **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** Group 1: 30 filtered backed RBCs. Group 2: 30 non-filtered backed RBCs. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Doha Sholkamy, phD **Phone:** 01097858588 **Phone Ext:** 02 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** khaled Amir, phD **Phone:** 01141110942 **Phone Ext:** 02 **Role:** CONTACT #### Locations **Location 1:** **City:** Assiut **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** khaled Amir, phD - **Phone:** 01141110942 - **Phone Ext:** 02 - **Role:** CONTACT **Country:** Egypt **Facility:** Assiut university **Status:** RECRUITING **Zip:** 71511 ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428734 **Brief Title:** Clinical Outcome in Patients With INPH **Official Title:** Phenotypes, Biomarkers and Pathophysiology in INPH #### Organization Study ID Info **ID:** XWCOPINPH #### Organization **Class:** OTHER **Full Name:** Xuanwu Hospital, Beijing ### Status Module #### Completion Date **Date:** 2027-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Xuanwu Hospital, Beijing #### 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 determine the clinical spectrum and natural progression of idiopathic normal pressure hydrocephalus （iNPH ) and related disorders in a prospective single center study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the etiology and molecular mechanisms of these diseases. **Detailed Description:** Due to the heterogeneity of the etiology of idiopathic normal pressure hydrocephalus , almost all published studies on the clinical outcome and prognostic factors of iNPH are relatively limited, and most of them are retrospective. It is not clear which is the most reliable predictor of clinical outcome. Therefore, the researchers conducted this prospective cohort study to identify the occurrence, development and outcome of iNPH and determine the main prognostic factors through clinical scales, biomarkers and imaging. At study visits a standardized clinical examination will be performed including application of clinical rating scales. At all study visits, patients will be asked to donate biosamples; biomaterial collection is optional and participants can elect to participate in sampling of blood, urine, CSF, and/or a muscle biopsy. Optionally, additional examinations may be performed including imaging，such as DTIALPS, neurophysiological examination, analysis of patient or observer reported outcomes and analysis to characterize molecular biomarkers. ### Conditions Module **Conditions:** - Hydrocephalus - Idiopathic Normal Pressure Hydrocephalus - CSF - Glympathic System - Omic **Keywords:** - Hydrocephalus - Idiopathic Normal Pressure Hydrocephalus ### Design Module #### Bio Spec **Description:** Blood, cerebral spinal fluid, saliva, urine, biopsy and autopsy **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 2 Years ### Arms Interventions Module #### Arm Group 1 **Description:** high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS **Intervention Names:** - Diagnostic Test: hydrocephalus group **Label:** hydrocephalus #### Arm Group 2 **Description:** Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics **Intervention Names:** - Other: normal group **Label:** Normal group ### Interventions #### Intervention 1 **Arm Group Labels:** - hydrocephalus **Description:** Diagnostic Test: high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS **Name:** hydrocephalus group **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Normal group **Description:** Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS **Name:** normal group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Change of DTIALPS singal intensity in the resting state fMRI in iNPH patients compared with normal healthy group. Also, the responsive and non-responsive iNPH patients functional MRI were analzed. **Measure:** DTIALPS **Time Frame:** Change from Baseline at 6 months after VP shunt #### Secondary Outcomes **Description:** A score for iNPH severity; range 0-26; higher indicates higher severity. **Measure:** Kiefer score **Time Frame:** Change from Baseline at 6 months after VP shunt **Description:** A score for cognitive ability; range 0-30; higher indicates higher severity. **Measure:** Mini mental state Examination **Time Frame:** Change from Baseline at 6 months after VP shunt **Description:** 10 meters walking test were evaluated of iNPH patients. **Measure:** Gait evaluation **Time Frame:** Change from Baseline at 6 months after VP shunt **Description:** A score for functional neurological status ; range 0-5; higher indicates higher severity. **Measure:** modified Rankin scale **Time Frame:** Change from Baseline at 6 months after VP shunt **Description:** Change of BOLD singal intensity in the resting state fMRI in iNPH patients compared with normal healthy group. Also, the responsive and non-responsive iNPH patients functional MRI were analzed. **Measure:** Change in the resting state fMRI **Time Frame:** Change from Baseline at 6 months after VP shunt **Description:** Comparing the omic pattern differences in CSF between iNPH patients and normal age-matched normal volunteers by the analysis of mass spectrometry. Also, the responsive and non-responsive iNPH patients omic pattern were analzed. **Measure:** omic pattern of CSF in iNPH patients **Time Frame:** Before surgery in lumbar CSF **Description:** Comparing the omic pattern differences in CSF of iNPH patients before surgery and after VP shunt by the analysis of mass spectrometry. Also, the responsive and non-responsive iNPH patients omic pattern were analzed. **Measure:** omic pattern of CSF in iNPH patients **Time Frame:** Change from Baseline at 6 months after VP shunt ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * patients who was diagnosed as idiopathic normal pressure hydrocephalus Exclusion Criteria: * patient received surgical treatment or interventional treatment before patient is pregnant patient unable to complete follow-up patient with other types of hydrocephalus other nervous system diseases **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** patients who was diagnosed as idiopathic normal pressure hydrocephalus ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** fengzeng jian, md **Phone:** 01083198899 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** xin qu, md **Phone:** 01083198899 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yuan Chenghua - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Jian Fengzeng - **Role:** CONTACT ***Contact 3:*** - **Name:** xin qu, dr - **Role:** SUB_INVESTIGATOR **Country:** China **Facility:** Fengzeng Jian **State:** Beijing **Status:** RECRUITING **Zip:** 100053 ### References Module #### References **Citation:** Zhang C, Xu K, Zhang H, Sha J, Yang H, Zhao H, Chen N, Li K. Recovery of glymphatic system function in patients with temporal lobe epilepsy after surgery. Eur Radiol. 2023 Sep;33(9):6116-6123. doi: 10.1007/s00330-023-09588-y. Epub 2023 Apr 3. **PMID:** 37010581 **Citation:** Georgiopoulos C, Tisell A, Holmgren RT, Eleftheriou A, Rydja J, Lundin F, Tobieson L. Noninvasive assessment of glymphatic dysfunction in idiopathic normal pressure hydrocephalus with diffusion tensor imaging. J Neurosurg. 2023 Sep 8;140(3):612-620. doi: 10.3171/2023.6.JNS23260. Print 2024 Mar 1. **PMID:** 37724800 **Citation:** Yuan C, Xia P, Duan W, Wang J, Guan J, Du Y, Zhang C, Liu Z, Wang K, Wang Z, Wang X, Wu H, Chen Z, Jian F. Long-Term Impairment of the Blood-Spinal Cord Barrier in Patients With Post-Traumatic Syringomyelia and its Effect on Prognosis. Spine (Phila Pa 1976). 2024 Mar 15;49(6):E62-E71. doi: 10.1097/BRS.0000000000004884. Epub 2023 Nov 28. **PMID:** 38014747 ## 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: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - 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:** NCT06428721 **Brief Title:** The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population **Official Title:** The Preventive Role of Fractionated Laser Resurfacing Against Actinic Neoplasia in an At-Risk Geriatric Population #### Organization Study ID Info **ID:** 2023-346 #### Organization **Class:** OTHER **Full Name:** Wright State University ### Status Module #### Completion Date **Date:** 2031-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2031-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Wright State University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The purpose of this study is to determine if the Fractionated Laser Resurfacing (FLR) procedure can protect one forearm/wrist from precancerous actinic keratosis (AKs) as well as prevent skin cancer in older subjects with active AKs. This study builds on a similar study ongoing at the Dayton Veterans Administration dermatology clinic. This study is also testing if a photograph of the skin can be used to predict where the AKs and an skin cancers will form. ### Conditions Module **Conditions:** - Actinic Keratoses - Aging - Non-Melanoma Skin Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Right forearm treatment of fractionated laser resurfacing. **Intervention Names:** - Device: Fractionated Laser Resurfacing **Label:** Fractionated Laser Resurfacing - Right Arm **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Left forearm treatment of fractionated laser resurfacing. **Intervention Names:** - Device: Fractionated Laser Resurfacing **Label:** Fractionated Laser Resurfacing - Left Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Fractionated Laser Resurfacing - Left Arm - Fractionated Laser Resurfacing - Right Arm **Description:** A rejuvenating laser that makes tiny holes in the very superficial part of the skin. **Name:** Fractionated Laser Resurfacing **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Investigator will assess the number of actinic keratosis on both forearms at each visit. **Measure:** Change from baseline in the number of actinic keratosis due to FLR treatment. **Time Frame:** Up to 5 years **Description:** Investigator will assess the number of actinic keratosis on both forearms at each visit. **Measure:** Change from baseline in the number of non-melanoma skin cancers due to FLR treatment. **Time Frame:** Up to 5 years #### Secondary Outcomes **Description:** Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit. **Measure:** Skin dysplasia change, in regards to actinic keratosis, from baseline due to FLR treatment. **Time Frame:** Up to 5 years **Description:** Investigator will use the scattering patterns of light to assess the number of actinic keratosis on both forearms at each visit. **Measure:** Skin dysplasia change, in regards to non-melanoma skin cancer, from baseline due to FLR treatment. **Time Frame:** Up to 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult Males and Females aged 60 and older * Have at least 5 AKs on each forearm/wrist, but no more than 10 to allow for easy monitoring * Skin type fair (Fitzpatrick I-II) * Females must be post-menopausal and not be on systemic hormone replacement therapy * Able to comprehend procedures and risks Exclusion Criteria: * More than 10 AKs on an extremity * AKs that are large (2-3+, hyperkeratotic grade 3 lesions) * AKs that are very thick (\>3 mm) * Medical history of diabetes * History of poor wound healing or scarring * Large tattoos that can interfere with study * Other serious health issues and other skin diseases that could interfere with the study * Recent (within 1 year) field therapies such as efudex cream or PDT to forearms/wrists. * Planning to leave region in next 5 years * Subjects with allergies to xylocaine will be excluded if they need this topical anesthetic. **Minimum Age:** 60 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Manager, Clinical Research Operations **Phone:** 937-245-7500 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Regulatory Specialist **Phone:** 937-245-7500 **Role:** CONTACT #### Locations **Location 1:** **City:** Fairborn **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Pharmacology Translational Unit - **Phone:** 937-245-7500 - **Role:** CONTACT **Country:** United States **Facility:** Wright State Physicians **State:** Ohio **Status:** RECRUITING **Zip:** 45324 #### Overall Officials **Official 1:** **Affiliation:** Wright State University **Name:** Jeffrey Travers, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009369 - Term: Neoplasms - ID: D000012871 - Term: Skin Diseases - ID: D000011230 - Term: Precancerous Conditions ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15681 - Name: Skin Neoplasms - Relevance: LOW - As Found: Unknown - ID: M28268 - Name: Keratosis, Actinic - Relevance: HIGH - As Found: Actinic Keratosis - ID: M10668 - Name: Keratosis - Relevance: HIGH - As Found: Keratosis - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M14111 - Name: Precancerous Conditions - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000055623 - Term: Keratosis, Actinic - ID: D000007642 - Term: Keratosis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428708 **Brief Title:** [18F] PSMA-1007 PET/CT in Metastatic Clear Cell Renal Cell Carcinoma **Official Title:** Comparison of [18F] PSMA-1007 PET/CT and Conventional Imaging in the Detection of Metastatic Clear Cell Renal Cell Carcinoma #### Organization Study ID Info **ID:** ReDA 11465 #### Organization **Class:** OTHER **Full Name:** Western University ### Status Module #### Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Start Date **Date:** 2022-01-24 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Western University #### Responsible Party **Investigator Affiliation:** Western University **Investigator Full Name:** Melissa Huynh **Investigator Title:** Assistant Professor **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:** Staging of kidney cancer is primarily achieved by computerized tomography (CT) scans or magnetic resonance imaging (MRI). If a patient is found to have limited metastatic disease, surgical removal or radiation therapy could be considered in order to control the majority of the disease. However, if metastases are more widespread, systemic (drug) therapy may be the preferred management option. The identification of additional metastatic sites using more sensitive imaging modalities therefore has the potential to alter management, and this remains an unmet need in the field. This study will investigate the utility of positron emission tomography (PET) imaging with PSMA (prostate specific membrane antigen). Kidney cancer of the clear cell subtype has demonstrated high expression of PSMA, making it a disease in which PSMA-targeted PET imaging could help to identify occult metastatic disease. **Detailed Description:** This will be a single-institution prospective, open-label feasibility study involving patients ≥18 years of age with metastatic clear cell RCC who have not yet received systemic therapy. Patients with evidence of metastatic disease on conventional imaging will require histologic confirmation by biopsy. At our institution, approximately 30 new metastatic clear cell RCC (mRCC) patients are seen each year, and a previous analysis reported that 92% of 10,105 patients with mRCC in the International mRCC Database Consortium (IMDC) database were found to have clear cell histology; therefore, difficulty with recruitment into this study over a period of 2 years is not anticipated. ### Conditions Module **Conditions:** - Metastatic Clear Cell Renal Cell Carcinoma **Keywords:** - PSMA PET - Metastatic clear cell renal cell carcinoma - [18F]PSMA-1007 - PSMA ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All patients enrolled undergo a \[18F\] PSMA-1007 PET/CT **Intervention Names:** - Diagnostic Test: [18F] PSMA-1007 PET/CT **Label:** [18F] PSMA-1007 PET/CT **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - [18F] PSMA-1007 PET/CT **Description:** \[18F\] PSMA-1007 PET/CT scan **Name:** [18F] PSMA-1007 PET/CT **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** To identify additional metastatic lesions that may not be apparent on conventional cross-sectional imaging during the initial staging process. **Measure:** Number of metastatic lesions **Time Frame:** 5 weeks from initial baseline conventional imaging **Description:** To determine the proportion of patients in which results from the PSMA-PET imaging changes management. **Measure:** Change in management **Time Frame:** 1 month #### Secondary Outcomes **Description:** To determine histopathological correlation in lesions that are biopsied or removed surgically. **Measure:** Pathologic correlates **Time Frame:** 1 month or not applicable ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Men and women with histologically-proven, metastatic renal cell carcinoma (RCC)(TNM stage Tany, Nany, M1) 2. Must have baseline conventional imaging of the chest, abdomen, and pelvis with contrast-enhanced CT or MRI within 8 weeks of enrolment. Contrast is required unless the participant cannot for medical reasons (ie renal failure). Exception: Unenhanced CT of the chest is acceptable Exception: Unenhanced MRI of abdomen and pelvis is acceptable in cases of renal failure Exclusion Criteria: 1. Pregnant or breastfeeding 2. Age less than 18 3. Histology does not have any clear cell component 4. Unable to lie flat for 30 minutes for the scan 5. History of prior malignancy (except non-melanoma skin cancer) 6. Unable to provide informed consent 7. Inadequate liver function 8. Systemic or radiation-based cancer treatment is needed urgently and anticipated to begin before PSMA scan can take place 9. Previously exposed to systemic or radiation cancer therapy (except radiation for skin cancer) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Kaydee Connors **Phone:** 519-685-6366 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nicole Phillips **Phone:** 519-685-6366 **Role:** CONTACT #### Locations **Location 1:** **City:** London **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Kaydee Connors - **Phone:** 519-685-6366 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Nicole Phillips - **Phone:** 519-685-6366 - **Role:** CONTACT ***Contact 3:*** - **Name:** Melissa Huynh, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** London Health Sciences Centre - Victoria Hospital **State:** Ontario **Status:** RECRUITING **Zip:** N6A5W9 #### Overall Officials **Official 1:** **Affiliation:** Western University **Name:** Melissa Huynh, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Mittlmeier LM, Unterrainer M, Rodler S, Todica A, Albert NL, Burgard C, Cyran CC, Kunz WG, Ricke J, Bartenstein P, Stief CG, Ilhan H, Staehler M. 18F-PSMA-1007 PET/CT for response assessment in patients with metastatic renal cell carcinoma undergoing tyrosine kinase or checkpoint inhibitor therapy: preliminary results. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):2031-2037. doi: 10.1007/s00259-020-05165-3. Epub 2020 Dec 28. **PMID:** 33369689 **Citation:** Giesel FL, Hadaschik B, Cardinale J, Radtke J, Vinsensia M, Lehnert W, Kesch C, Tolstov Y, Singer S, Grabe N, Duensing S, Schafer M, Neels OC, Mier W, Haberkorn U, Kopka K, Kratochwil C. F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients. Eur J Nucl Med Mol Imaging. 2017 Apr;44(4):678-688. doi: 10.1007/s00259-016-3573-4. Epub 2016 Nov 26. **PMID:** 27889802 **Citation:** Rhee H, Blazak J, Tham CM, Ng KL, Shepherd B, Lawson M, Preston J, Vela I, Thomas P, Wood S. Pilot study: use of gallium-68 PSMA PET for detection of metastatic lesions in patients with renal tumour. EJNMMI Res. 2016 Dec;6(1):76. doi: 10.1186/s13550-016-0231-6. Epub 2016 Oct 22. **PMID:** 27771904 **Citation:** Yin Y, Campbell SP, Markowski MC, Pierorazio PM, Pomper MG, Allaf ME, Rowe SP, Gorin MA. Inconsistent Detection of Sites of Metastatic Non-Clear Cell Renal Cell Carcinoma with PSMA-Targeted [18F]DCFPyL PET/CT. Mol Imaging Biol. 2019 Jun;21(3):567-573. doi: 10.1007/s11307-018-1271-2. **PMID:** 30218388 **Citation:** Meyer AR, Carducci MA, Denmeade SR, Markowski MC, Pomper MG, Pierorazio PM, Allaf ME, Rowe SP, Gorin MA. Improved identification of patients with oligometastatic clear cell renal cell carcinoma with PSMA-targeted 18F-DCFPyL PET/CT. Ann Nucl Med. 2019 Aug;33(8):617-623. doi: 10.1007/s12149-019-01371-8. Epub 2019 May 30. **PMID:** 31147927 **Citation:** Baccala A, Sercia L, Li J, Heston W, Zhou M. Expression of prostate-specific membrane antigen in tumor-associated neovasculature of renal neoplasms. Urology. 2007 Aug;70(2):385-90. doi: 10.1016/j.urology.2007.03.025. **PMID:** 17826525 **Citation:** Chang SS, Reuter VE, Heston WD, Gaudin PB. Metastatic renal cell carcinoma neovasculature expresses prostate-specific membrane antigen. Urology. 2001 Apr;57(4):801-5. doi: 10.1016/s0090-4295(00)01094-3. **PMID:** 11306418 **Citation:** Kinoshita Y, Kuratsukuri K, Landas S, Imaida K, Rovito PM Jr, Wang CY, Haas GP. Expression of prostate-specific membrane antigen in normal and malignant human tissues. World J Surg. 2006 Apr;30(4):628-36. doi: 10.1007/s00268-005-0544-5. **PMID:** 16555021 **Citation:** Prasad V, Steffen IG, Diederichs G, Makowski MR, Wust P, Brenner W. Biodistribution of [(68)Ga]PSMA-HBED-CC in Patients with Prostate Cancer: Characterization of Uptake in Normal Organs and Tumour Lesions. Mol Imaging Biol. 2016 Jun;18(3):428-36. doi: 10.1007/s11307-016-0945-x. **PMID:** 27038316 **Citation:** Park JW, Jo MK, Lee HM. Significance of 18F-fluorodeoxyglucose positron-emission tomography/computed tomography for the postoperative surveillance of advanced renal cell carcinoma. BJU Int. 2009 Mar;103(5):615-9. doi: 10.1111/j.1464-410X.2008.08150.x. Epub 2008 Oct 24. **PMID:** 19007371 **Citation:** Majhail NS, Urbain JL, Albani JM, Kanvinde MH, Rice TW, Novick AC, Mekhail TM, Olencki TE, Elson P, Bukowski RM. F-18 fluorodeoxyglucose positron emission tomography in the evaluation of distant metastases from renal cell carcinoma. J Clin Oncol. 2003 Nov 1;21(21):3995-4000. doi: 10.1200/JCO.2003.04.073. **PMID:** 14581422 **Citation:** Lawrentschuk N, Davis ID, Bolton DM, Scott AM. Functional imaging of renal cell carcinoma. Nat Rev Urol. 2010 May;7(5):258-66. doi: 10.1038/nrurol.2010.40. **PMID:** 20448659 **Citation:** Sawicki LM, Buchbender C, Boos J, Giessing M, Ermert J, Antke C, Antoch G, Hautzel H. Diagnostic potential of PET/CT using a 68Ga-labelled prostate-specific membrane antigen ligand in whole-body staging of renal cell carcinoma: initial experience. Eur J Nucl Med Mol Imaging. 2017 Jan;44(1):102-107. doi: 10.1007/s00259-016-3360-2. Epub 2016 Mar 21. **PMID:** 26996777 **Citation:** Aide N, Cappele O, Bottet P, Bensadoun H, Regeasse A, Comoz F, Sobrio F, Bouvard G, Agostini D. Efficiency of [(18)F]FDG PET in characterising renal cancer and detecting distant metastases: a comparison with CT. Eur J Nucl Med Mol Imaging. 2003 Sep;30(9):1236-45. doi: 10.1007/s00259-003-1211-4. Epub 2003 Jul 4. **PMID:** 12845486 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000000230 - Term: Adenocarcinoma - ID: D000007680 - Term: Kidney Neoplasms - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5548 - Name: Carcinoma, Renal Cell - Relevance: HIGH - As Found: Clear Cell Renal 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: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M10703 - Name: Kidney Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: 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: T4906 - Name: Renal Cell Carcinoma - Relevance: HIGH - As Found: Renal Cell Carcinoma - ID: T1341 - Name: Clear Cell Renal Cell Carcinoma - Relevance: HIGH - As Found: Clear Cell Renal Cell Carcinoma ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002292 - Term: Carcinoma, Renal Cell ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428695 **Brief Title:** Education Session to Improve Program Adherence **Official Title:** Implementation of Education on Calorie Tracking Application to Improve Adherence to a Calorie Restricted Weight Management Program #### Organization Study ID Info **ID:** IRB00110851 #### Organization **Class:** OTHER **Full Name:** Wake Forest University Health Sciences ### Status Module #### Completion Date **Date:** 2024-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **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:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Wake Forest University Health Sciences #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** To examine is user knowledge of a dietary self-monitoring (DSM) calorie tracking app and improving patient adherence to daily caloric food intake to help with weight loss. **Detailed Description:** The research question guiding this project is: In adults with a BMI greater than 25 kg/m2, does a 1-hour education session on using a calorie-tracking application improve adherence to a calorie-restricted weight management program over eight weeks? This project aimed to increase patient knowledge with the DSM tool. To Increase adherence to the calorie-restricted diet program and, finally, to increase weight loss in the program participants of the 8-week program ### Conditions Module **Conditions:** - Weight Management **Keywords:** - calorie tracking - weight loss - weight management program - food intake ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** The subject population will consist of adults 18 years of age and older with a Body Mass Index (BMI) greater than 25 kg/m2 ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** access the impact of a one-hour dietary self-monitoring tool education session for participants in a calorie-restricted weight management program on their knowledge of the use of the tool to help them adhere to a calorie-restricted weight management program **Intervention Names:** - Behavioral: one-hour dietary self-monitoring tool education session **Label:** dietary self-monitoring tool education session **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - dietary self-monitoring tool education session **Description:** access the impact of a one-hour dietary self-monitoring tool education session for participants in a calorie-restricted weight management program on their knowledge of the use of the tool to help them adhere to a calorie-restricted weight management program **Name:** one-hour dietary self-monitoring tool education session **Other Names:** - education session **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The Perceived Competence Scale (PCS) will be the open-access validated tool used for this project. This will be the 4 questions pretest/posttest utilized. A 1-hour education session will provide training on the use of a DSM calorie-tracking app. Following this will be an 8-week in-person weight management program focusing on a daily calorie and carb restriction and protein goal. Each item is scored from 1 to 4, where a score of 1 indicates low perceived competence and a score of 4 reflects high perceived competence. Scores are summed and then averaged for each subscale, resulting in four separate subscale means. **Measure:** Perceived Competence Scale (PCS) Score **Time Frame:** Baseline **Description:** The Perceived Competence Scale (PCS) will be the open-access validated tool used for this project. This will be the 4 questions pretest/posttest utilized. A 1-hour education session will provide training on the use of a DSM calorie-tracking app. Following this will be an 8-week in-person weight management program focusing on a daily calorie and carb restriction and protein goal. Each item is scored from 1 to 4, where a score of 1 indicates low perceived competence and a score of 4 reflects high perceived competence. Scores are summed and then averaged for each subscale, resulting in four separate subscale means. **Measure:** Perceived Competence Scale (PCS) Score **Time Frame:** Week 8 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years of age and older with a Body Mass Index (BMI) greater than 25 kg/m2 Exclusion Criteria: * Younger than18 years of age with a Body Mass Index (BMI) less than 25 kg/m2 **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ben Ramirez, APNP, DNP **Phone:** 414-219-4263 **Role:** CONTACT #### Locations **Location 1:** **City:** Winston-Salem **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ben Ramirez, APNP, DNP - **Phone:** 414-219-4263 - **Role:** CONTACT **Country:** United States **Facility:** Wake Forest University Health Sciences **State:** North Carolina **Zip:** 27157 #### Overall Officials **Official 1:** **Affiliation:** Wake Forest University Health Sciences **Name:** Melanie Smith, DO **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5114 - Name: Body Weight - Relevance: HIGH - As Found: Weight - ID: M18102 - Name: Weight Loss - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001835 - Term: Body Weight ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428682 **Brief Title:** Role of TXA in Patients Undergoing Breast Free Flap Reconstruction **Official Title:** Role of Intravenous Tranexamic Acid Use in Patients Undergoing Breast Free Flap Reconstruction: Randomized Controlled Trial #### Organization Study ID Info **ID:** HSR220370 #### Organization **Class:** OTHER **Full Name:** University of Virginia ### Status Module #### Completion Date **Date:** 2026-05-13 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-13 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-13 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Virginia #### Responsible Party **Investigator Affiliation:** University of Virginia **Investigator Full Name:** John Stranix **Investigator Title:** Assistant Professor of Plastics Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** Tranexamic acid (TXA) is a synthetic, competitive lysine receptor inhibitor on plasminogen. It ultimately stabilizes the fibrin matrix, therefore used as a hemostatic agent for various indications. While there has been indications for orthopedic and trauma surgery, there is no clear data for its role in patients who are undergoing free tissue transfer. Studies have shown that patients undergoing free tissue transfer can have transfusion rates ranging from 7.2% to 34.9%, which data also showing association between transfusion requirement and higher free flap failure rate. There has been a few retrospective studies that evaluated the effect of TXA in free tissue transfer and the results showed no increased risk of microanastomosis failure but some showing decreased blood loss. This study aims to further analyze the role of TXA in patients undergoing breast free flap reconstruction with randomized, prospective trial. Control group will not receive TXA while experimental group will receive TXA. Both groups will receive standard of care breast free flap surgery as well as post-op care, which is streamlined with Early Recovery After Surgery (ERAS) protocol. Their pre and post-op hemoglobin will be compared, as well as rates of transfusion, surgical outcome and surgical complications including hematoma, flap failure, and any other medical complications such as Deep Vein Thrombosis (DVT)/ Pulmonary Embolism (PE). ### Conditions Module **Conditions:** - Breast Cancer - Blood Loss, Surgical **Keywords:** - Autologous breast reconstruction - Free Flap - Tranexamic Acid ### 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:** 100 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Women undergoing immediate or delayed free flap breast reconstruction and receiving IV TXA **Intervention Names:** - Drug: Tranexamic acid **Label:** TXA group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Women undergoing immediate or delayed free flap breast reconstruction and receiving same volume of IV saline **Intervention Names:** - Drug: Placebo **Label:** Placebo group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - TXA group **Description:** Experimental group will receive TXA intraoperatively (15mg/kg IV, once at beginning of case then re dose at 4hrs if operation goes longer) at the time of their surgery. **Name:** Tranexamic acid **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo group **Description:** Control group will receive same volume equivalent of saline intravenously at the time of their surgery. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Post-op day 1 Hemoglobin - Pre-op Hemoglobin **Measure:** Delta Hemoglobin **Time Frame:** 1 day after surgery **Description:** Transfusion rate during hospital stay **Measure:** Transfusion rate **Time Frame:** Typically 0-72 hours after surgery #### Secondary Outcomes **Description:** Thromboembolic event, hematoma, seroma, flap compromise/ failure **Measure:** Surgical complications **Time Frame:** 30 days after surgery **Description:** Total length of stay after surgery **Measure:** Length of Stay **Time Frame:** typically 2-4 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center Exclusion Criteria: * Subjects with ages \<18 years * Allergy to TXA * Subjects who has contraindications to TXA: anyone who has active intravascular thrombosis or anyone with subarachnoid hemorrhage * Subjects who have anemia (defined as baseline hemoglobin \<8 g/dL * Subjects who cannot read or understand English * Subjects who are pregnant **Gender Based:** True **Gender Description:** Biological females **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rachel Park, MD **Phone:** 5714287278 **Role:** CONTACT #### Locations **Location 1:** **City:** Charlottesville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Rachel H Park, MD - **Phone:** 571-428-7278 - **Role:** CONTACT **Country:** United States **Facility:** University of Virginia Medical Center **State:** Virginia **Status:** RECRUITING **Zip:** 22902 #### Overall Officials **Official 1:** **Affiliation:** University of Virginia **Name:** John Stranix, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006470 - Term: Hemorrhage - ID: D000010335 - Term: Pathologic Processes - ID: D000007431 - Term: Intraoperative Complications ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M18560 - Name: Blood Loss, Surgical - Relevance: HIGH - As Found: Blood Loss, Surgical - ID: M10465 - Name: Intraoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016063 - Term: Blood Loss, Surgical ### Intervention Browse Module - Ancestors - ID: D000000933 - Term: Antifibrinolytic Agents - ID: D000050299 - Term: Fibrin Modulating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000006490 - Term: Hemostatics - ID: D000003029 - Term: Coagulants ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16902 - Name: Tranexamic Acid - Relevance: HIGH - As Found: Stage IV - ID: M4252 - Name: Antifibrinolytic Agents - Relevance: LOW - As Found: Unknown - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M6259 - Name: Coagulants - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000014148 - Term: Tranexamic Acid ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428669 **Brief Title:** Effect of Nitropaste in Chest Masculinizing Surgery **Official Title:** The Effect of Nitropaste in Chest Masculinizing Surgery: Randomized, Prospective Trial #### Organization Study ID Info **ID:** HSR220217 #### Organization **Class:** OTHER **Full Name:** University of Virginia ### Status Module #### Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-06 **Type:** ESTIMATED **Last Update Submit Date:** 2024-06-03 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Start Date **Date:** 2022-08-15 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Virginia #### Responsible Party **Investigator Affiliation:** University of Virginia **Investigator Full Name:** John Stranix **Investigator Title:** Assistant Professor, Department of Plastic Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True ### Description Module **Brief Summary:** Nitropaste is a topical agent that contains 2% nitroglycerin. It is an effective vascular smooth dilator, with more powerful effect on venous vasculature than arterial vasculature. While its main indication is for angina pectoris, there have been many studies showing improved survival of axial and random pattern flaps. Furthermore, recent clinical studies highlight significantly decreased mastectomy flap wound complication and need for sharp debridement. Nitropaste has low rates of side effects and is very well tolerated in general. To this date, there's no study that investigates its utility on patients who are undergoing chest masculinizing surgery. The purpose of this study is to investigate the potential utility of nitropaste in reducing rates of wound complications in patients undergoing chest masculinizing surgery. **Detailed Description:** Nitropaste is a topical agent that contains 2% nitroglycerin. It is an effective vascular smooth dilator, with more powerful effect on venous vasculature than arterial vasculature. While its main indication is for angina pectoris, there have been many studies showing improved survival of axial and random pattern flaps. Furthermore, recent clinical studies highlight significantly decreased mastectomy flap wound complication and need for sharp debridement. Nitropaste has low rates of side effects and is very well tolerated in general. To this date, there's no study that investigates its utility on patients who are undergoing chest masculinizing surgery. The purpose of this study is to investigate the potential utility of nitropaste in reducing rates of wound complications in patients undergoing chest masculinizing surgery utilizing double incision with free nipple grafting technique. The investigators will conduct a prospective, randomized, single-blinded study and compare nitropaste vs. no nitropaste on mastectomy flaps. Nitropaste will be applied intraoperatively and the patients will not have to re-apply it. Follow up will occur on post-op day 5, 2 weeks, and 6 weeks during their routine postop visits. A study coordinator will document the condition of free nipple grafts and any other wounds at surgical site if present, which will be the primary outcome. Any complications including hematoma, seroma, infection, hypertrophic scarring, need for sharp debridement, 30 day ED visit or admission rates will be documented as secondary outcome. ### Conditions Module **Conditions:** - Gender Dysphoria **Keywords:** - Gender affirming surgery - Chest masculinizing Surgery - Nitropaste - Wound healing ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 256 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants get standard of care chest masculinizing surgery utilizing double incision and free nipple grafting surgery. They will get standard dressing applied, which includes Xeroform bolster over the nipple grafts + Tegederm over the bolster and surgical site and instructed not to remove the dressing until they come to clinic on POD5 for bolster take down. **Label:** No nitropaste group **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Participants get standard of care chest masculinizing surgery utilizing double incision and free nipple grafting surgery. They will then get 2 packets of nitropaste applied (1 on each chest) around the free nipple graft and surgical sites. They will then get standard dressing applied, which includes Xeroform bolster over the nipple grafts + Tegederm over the bolster and surgical site and instructed not to remove the dressing until they come to clinic on POD5 for bolster take down. **Intervention Names:** - Drug: Nitro-Bid 2 % Topical Ointment **Label:** Nitropaste group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Nitropaste group **Description:** Intervention group will get 30mg of Nitro-Bid topical ointment applied over the chest (15mg/ 1 packet on each side) one time intra-operatively **Name:** Nitro-Bid 2 % Topical Ointment **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Rate of partial nipple graft loss (0-50%, 50% or more) or Complete nipple graft loss **Measure:** Free Nipple Graft Take **Time Frame:** Will be assessed at 5 days, 2 weeks, 6 weeks post-op **Description:** Rate of superficial wound, deep wound, delayed wound healing **Measure:** Wounds **Time Frame:** Will be assessed at 5 days, 2 weeks, 6 weeks post-op #### Secondary Outcomes **Description:** hematoma, seroma, infection, hypertrophic scarring **Measure:** Complications **Time Frame:** Will be tracked up until 3 months post-op **Description:** Need for any sharp debridement (office or OR) **Measure:** Sharp debridement **Time Frame:** Will be tracked up until 3 months post-op **Description:** Need for any revision **Measure:** Revision **Time Frame:** Will be tracked up until 3 months post-op **Description:** 30 day ED or inpatient admission rate **Measure:** Readmission **Time Frame:** Will be tracked 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Any adult (18 or older) patients of any gender identity who are undergoing chest masculinizing surgery with double incision and free nipple grafting. Exclusion Criteria: * Minor patients (younger than 18) * Anyone who's not getting free nipple grafting * Anyone who's not utilizing double incision pattern * Prisoners, anyone who is allergic to nitropaste * Anyone who is taking phosphodiesterase inhibitor (ex)Sildenafil, tadalafil, vardenafil) * Anyone who's taking soluble guanylate cyclase stimulator riociguatdz **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rachel H Park, MD **Phone:** 434-327-2140 **Role:** CONTACT #### Locations **Location 1:** **City:** Charlottesville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Rachel H Park, MD - **Phone:** 571-428-7278 - **Role:** CONTACT **Country:** United States **Facility:** University of Virginia Medical Center **State:** Virginia **Status:** RECRUITING **Zip:** 22902 #### Overall Officials **Official 1:** **Affiliation:** UVA **Name:** John T Stranix, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2022-07-20 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 832469 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-24T15:16 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020018 - Term: Sexual Dysfunctions, Psychological - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M227 - Name: Gender Dysphoria - Relevance: HIGH - As Found: Gender Dysphoria - 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: D000068116 - Term: Gender Dysphoria ### Intervention Browse Module - Ancestors - ID: D000014665 - Term: Vasodilator Agents ### Intervention Browse Module - Browse Branches - Abbrev: VaDiAg - Name: Vasodilator Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9102 - Name: Nitroglycerin - Relevance: HIGH - As Found: ALD518 - ID: M17412 - Name: Vasodilator Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000005996 - Term: Nitroglycerin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428656 **Acronym:** PostBioExIn **Brief Title:** Postbiotics Supplementation, Gut Microbiota Composition, and Exercise-induced Inflammation **Official Title:** The Effect of Postbiotics Supplementation on Gut Microbiota Composition and Exercise-induced Inflammation #### Organization Study ID Info **ID:** PB-GM-Exercise-Inflammation #### Organization **Class:** OTHER **Full Name:** University of Thessaly ### Status Module #### Completion Date **Date:** 2024-10-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Thessaly #### Responsible Party **Investigator Affiliation:** University of Thessaly **Investigator Full Name:** Chariklia K. Deli **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study will investigate the effect of postbiotics supplementation on gut microbiota (GM) composition, exercise-induced oxidative stress and performance following eccentrically biased exercise. The study will be a cross-over, randomized, double-blind, controlled study that will be conducted in two cycles. Participants will be randomly assigned into one of the two trials: i) Postbiotics supplementation for 4 weeks, ii) Placebo supplementation for 4 weeks. Participants will then perform a 45-min treadmill running at (-15% slope, \~70% VO2max) followed by a time-trial (0% slope, \~95% VO2max) until exhaustion. Before, as well as 24 h, 48 h and 72 h following exercise, assessment of GM composition and metabolites (short-chain fatty acids), exercise induced muscle damage (EIMD) (delayed onset of muscle soreness, creatine kinase), complete blood count (CBC), blood inflammatory status (tumor necrosis factor alpha, interleukin 6, C-reactive protein), gut inflammatory status (lipopolysacharides-binding protein, zonulin), blood redox status (total antioxidant capacity, catalase, protein carbonyls, reduced glutathione, oxidized glutathione, and performance (knee-extensors' and knee-flexors' isometric, concentric, eccentric torque, countermovement jump) will be performed. In addition, metabolism (lactic acid) will be assessed before and 4 min following exercise. Afterwards, the participants will receive the postbiotics supplement or the placebo for 4 weeks, and will repeat the exercise protocol and measurements of EIMD, CBC, blood inflammatory status, blood redox status and performance at the same time-points. At the second cycle, the participants will repeat the above procedures under the remaining condition. Between conditions, there will be a 14-day washout period. The results of the research will provide important information for coaches and physically active individuals, regarding the effectiveness of postbiotics to favorably change the gut microbiota composition and alleviate gut inflammation, exercise-induced inflammation and oxidative stress, and improve performance after intense exercise. **Detailed Description:** Acute, vigorous and/or unaccustomed eccentric exercise can induce muscle injury and inflammatory reactions, and oxidative stress, but also reduced muscle performance. For this reason, many professional as well as amateur athletes, often consume nutritional supplements such as antioxidants, anticipating to reduce inflammation and oxidative stress after intense exercise. The human gastrointestinal tract is inhabited by various microorganisms, called the gut microbiome (GM). GM, among other things, contributes to the normal functioning of the immune system, contributes to the production of short-chain fatty acids (SCFAs) and vitamin synthesis as well as the digestion and absorption of food, protects against enteropathogens and regulates inflammatory and redox responses. Recent evidence also suggests that GM may be involved in athletic performance. In contrast, disruption of GM composition (dysbiosis) is characterized by reduced diversity, reduced abundance of health-promoting bacteria, and increased abundance of gram-negative and other pathogenic bacteria and is associated with various metabolic diseases such as obesity, diabetes, and various forms of cancer, systemic inflammation, oxidative stress and reduced performance. Thus, the supplementation of several "biotics" has been emerged as a means to regulate the GM in favor of health-promoting bacteria. Postbiotics is defined as a "preparation of inanimate microorganisms and/or their components that confers a health benefit on the host". Evidence suggests that supplementation with postbiotics may regulate the GM, and consequently, strengthen the immune system, reduce intestinal permeability, improve antioxidant mechanisms, as well as accelerate recovery after exercise-induced inflammation, enhance adaptations to exercise, and improve performance. However, the scientific data regarding the possible beneficial effect of supplemental administration of postbiotics is limited. More research is needed, in order to determine the role of postbiotics supplementation on GM composition and function, exercise-induced inflammation and redox status, but also on performance after intense exercise. This study will investigate the potential of postbiotics supplementation to alter the GM composition and affect the recovery of exercise-induced oxidative stress and performance following intense, eccentrically biased acute exercise. The study will be cross-over, randomized, double-blind, controlled, and will be conducted in two cycles. The participants, will be primarily informed regarding the study procedures, as well as the benefits and possible risks, and will sign an informed consent form for participation in the study. Before the experimental procedure, they will be involved in a week of familiarization to the evaluation tests and the exercise protocol, at a low intensity. Participants will undergo baseline measurements: anthropometric characteristics (body height, body mass, body mass index) via a stadiometer-scale (Stadiometer 208; Seca, Birmingham, UK), body composition (amount of body fat, lean body mass, fat mass, bone density) via by dual emission X-ray absorptiometry (DXA, GE-Healthcare, Lunar DPX NT, Belgium), aerobic capacity (VO2max) via an automated online pulmonary gas analyzer (Vmax Encore 29, BEBJO296, Yorba Linda, CA, USA) during a graded exercise protocol on a treadmill (Stex 8025T, Korea), isokinetic strength (isometric, concentric and eccentric torque of the knee extensors and knee flexors) on an isokinetic dynamometer (Cybex, HUMAC NORM 360, Ronkonkoma, NY), and muscle power via the assessment of countermovement jump (CMJ) via an optical measurement system (Optojump next, Microgate, USA). In addition, the participants will record their diet via a 7-days recall before their participation in the first experimental condition, and dietary data will be analyzed with ScienceFit Diet 200A diet analysis program (Science Technologies, Athens, Greece), in order to estimate that they do not consume nutrients that may affect muscle injury, inflammation and oxidative stress (e.g. antioxidants, etc.). Participants will then be randomized in one of the two conditions: i) Postbiotics supplementation (50mg/day of Heatkilled Lactobacillus plantarum L-137, Immuno-LP20TM) for 4 weeks, or ii) placebo supplementation for 4 weeks. Randomization of the conditions will be done by a software generating random integers available on the internet (Random.org). Participants will then perform an exercise protocol comprised of 45 min downhill running (-15% slope, \~70-75% VO2max) on a treadmill followed by a time-trial (0% slope, \~95% VO2max) until exhaustion. Before the exercise protocol, as well as 24 h, 48 h and 72 h after exercise, exercise-induced muscle damage (EIMD) \[delayed onset of muscle soreness (DOMS) via palpation of the knee extensors and knee flexors on a scale of 1 to 10 (1 = no pain at all; 10 = extreme pain), and muscle performance (CMJ, isometric, concentric and eccentric torque of the knee extensors and knee flexors)\], will be assessed. At the same time points, feces samples will be collected for the analysis of GM composition and function, and GM metabolites, as well as blood samples for the assessment of complete blood count (CBC), blood inflammatory status (creatine kinase, tumor necrosis factor alpha, interleukin 6, C-reactive protein), gut inflammatory status (lipopolysacharides-binding protein, zonulin), and blood redox status \[reduced glutathione (GSH), oxidized glutathione (GSSG), GSH/GSSG ratio, total antioxidant capacity, catalase, protein carbonyls, uric acid, bilirubin). Furthermore, metabolism (lactic acid) will be assessed before and 4 min following exercise by analyzing capillary blood with a portable lactate analyzer (Lactate Plus, Nova Biomedical, USA). Afterwards, the participants will receive the postbiotics supplement or the placebo for 4 weeks, and will repeat the exercise protocol and measurements of EIMD, CBC, blood inflammatory status, blood redox status and performance at the same time-points. At the second cycle, participants will repeat the exact same procedures for the remaining condition. Between cycles, a 14-days washout period will be applied. Additionally, the 7-day diet recall from the first cycle, will be given to the participants to follow the same diet before the experimental exercise protocol at the second cycle. ### Conditions Module **Conditions:** - Postbiotics Supplementation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** The randomization of the participants to the supplement or placebo condition will be performed via a random integer set generator (Random.org) available online. Neither the participants, nor the care provider, nor the investigator will be aware of whether participants receive the postbiotic supplement or the placebo. Additionally, blood samples will be masked during the biochemical analysis, and during the statistical analysis. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Supplementation of postbiotics for 4 weeks **Intervention Names:** - Dietary Supplement: Postbiotics supplementation **Label:** Postbiotics supplementation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Supplementation of placebo for 4 weeks **Intervention Names:** - Dietary Supplement: Placebo supplementation **Label:** Placebo supplementation **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Postbiotics supplementation **Description:** The participants will consume one capsule of postbiotics supplement per day **Name:** Postbiotics supplementation **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Placebo supplementation **Description:** The participants will consume one capsule of placebo per day **Name:** Placebo supplementation **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Gut microbiota composition will be assessed in feces **Measure:** Changes in gut microbiota composition **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Butyrate will be assessed in feces **Measure:** Changes in butyrate **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Propionate will be assessed in feces **Measure:** Changes in propionate **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Acetate will be assessed in feces **Measure:** Changes in acetate **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Complete blood count will be assessed in whole blood **Measure:** Changes in complete blood count **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Creatine kinase activity will be assessed in serum **Measure:** Changes in creatine kinase activity **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** TNF-α concentration will be assessed in serum **Measure:** Changes in TNF-α concentration **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** IL-6 concentration will be assessed in serum **Measure:** Changes in IL-6 concentration **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** C-reactive protein concentration will be assessed in serum **Measure:** Changes in high-sensitivity C-reactive protein concentration **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Lipopolysacharides-binding protein concentration will be assessed in serum **Measure:** Changes in lipopolysacharides-binding protein concentration **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Zonulin concentration will be assessed in serum and in feces **Measure:** Changes in zonulin concentration **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Protein carbonyls concentration will be assessed in plasma **Measure:** Changes in protein carbonyls concentration **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Malondialdehyde concentration will be assessed in plasma **Measure:** Changes in malondialdehyde concentration **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Glutathione concentration will be assessed in red blood cells lycate **Measure:** Changes in reduced glutathione concentration **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Oxidized glutathione concentration will be assessed in red blood cells lycate **Measure:** Changes in oxidized glutathione concentration **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** GSH/GSSG ratio will be assessed in red blood cells lycate **Measure:** Changes in GSH/GSSG ratio **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Catalase concentration will be assessed in red blood cells lycate **Measure:** Changes in catalase concentration **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Total antioxidant capacity will be assessed in red blood cells lycate **Measure:** Changes in total antioxidant capacity **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Uric acid concentration will be assessed in serum **Measure:** Changes in uric acid concentration **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Bilirubin concentration will be assessed in serum **Measure:** Changes in bilirubin concentration **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Bilirubin concentration will be assessed in whole blood **Measure:** Changes in blood lactate concentration **Time Frame:** At baseline (pre), 4 min post-exercise **Description:** Muscle soreness of the KF and KE will be assessed via palpation of the muscle belly and the distal regions following 3 squats, and the subjective pain will be recorded on a 10-point scale (1 = no pain, 10 = extreme pain) **Measure:** Changes in delayed onset of muscle soreness in the knee flexors and extensors of both limbs **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Countermovement jump height will be measured with an optical system **Measure:** Changes in countermovement jump height **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise **Description:** Isometric, concentric and eccentric peak torque of the knee extensors and knee flexors of both limbs will be assessed on an isokinetic dynamometer **Measure:** Changes in isokinetic strength of knee extensors and knee flexors **Time Frame:** At baseline (pre), 24 hours post-, 48 hours post-, 72 hours post-exercise ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Physically active subjects (VO2max ≥35ml/kg/min) * Absence of musculoskeletal injury (≥6 months) * Abstinence from the use of ergogenic supplements (≥1 month) * Abstinence from anti-inflammatory drugs (≥1 month) * Abstinence from pre-pro-postbiotic supplements (≥6 months) * Abstinence from participating in exercise with eccentric content for at least 7 days before exercise * Abstinence from alcohol and energy drinks before exercise Exclusion Criteria: * Recent history of musculoskeletal injury (\<6 months) * Use of ergogenic performance supplements (\<1 month) * Taking anti-inflammatory drugs (\<1 month) * Taking pre-pro-postbiotic supplements (\<6 months) * Participation in exercise with eccentric content in the previous 7 days before exercise * Consumption of alcohol and energy drinks before exercise **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Chariklia K Deli, PhD **Phone:** +302431047011 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Athanasios Z Jamurtas, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Trikala **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Chariklia K Deli, PhD - **Role:** CONTACT **Country:** Greece **Facility:** Department of Physical Education and Sport Science, Uninersity of Thessaly **State:** Thessaly **Status:** RECRUITING **Zip:** 42100 #### Overall Officials **Official 1:** **Affiliation:** University of Thessaly **Name:** Chariklia K Deli, 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: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation ### Condition Browse Module - Meshes - ID: D000007249 - Term: Inflammation ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428643 **Brief Title:** A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities **Official Title:** A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities in Black Youth Living in the Deep South #### Organization Study ID Info **ID:** 2024-377 #### Organization **Class:** OTHER **Full Name:** Tulane University ### Status Module #### Completion Date **Date:** 2029-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institutes of Health (NIH) **Class:** NIH **Name:** National Institute of Allergy and Infectious Diseases (NIAID) #### Lead Sponsor **Class:** OTHER **Name:** Tulane University #### Responsible Party **Investigator Affiliation:** Tulane University **Investigator Full Name:** Patricia Kissinger **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study includes testing for four STIs (chlamydia, gonorrhea, syphilis, and HIV) at no cost. If positive, individual subjects will also be counseled and offered options for treatment for themselves and their sex partners that may include no cost expedited treatment and the option to be rescreened 3 months after treatment. ### Conditions Module **Conditions:** - Chlamydia - Gonorrhea - Hiv - Syphilis **Keywords:** - Screening - Expedited Treatment ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Community based screening of young men for chlamydia, gonorrhea, HIV, and syphilis. Expedited treatment for positive subjects and their sexual partners. ##### Masking Info **Masking:** NONE **Masking Description:** None (Open Label) **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 2322 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Community screening of individuals for chlamydia and gonorrhea is not normally done. We are testing to see if this intervention will impact the rates of chlamydia among women. **Intervention Names:** - Other: Chlamydia, gonorrhea, syphilis, and HIV screening **Label:** Chlamydia, gonorrhea, syphilis, and HIV screening **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Chlamydia, gonorrhea, syphilis, and HIV screening **Description:** Individuals aged 15-26 years old will be tested for chlamydia, gonorrhea, HIV, and syphilis at community based venues. Individuals who test positive for chlamydia and gonorrhea and their sexual partners will be offered expedited treatment at participating pharmacies. Individuals who test positive will be asked to be rescreened for Ct/GC at 3 months post treatment. **Name:** Chlamydia, gonorrhea, syphilis, and HIV screening **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Primary outcome **Measure:** Rate of chlamydia in women **Time Frame:** up to 60 months #### Secondary Outcomes **Description:** Secondary outcome **Measure:** Rate of gonorrhea in women **Time Frame:** up to 60 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Identifies as African American or Black * 15-26 years of age * Lives or spends most of their time in Orleans Parish * Had vaginal sex at least once Exclusion Criteria: * Unwilling or unable to provide informed consent * Unable to speak or understand English * Previously enrolled in the study * Known to be pregnant * Known HIV positive status **Healthy Volunteers:** True **Maximum Age:** 26 Years **Minimum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Patricia Kissinger, PhD **Phone:** 504-988-7320 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002694 - Term: Chlamydiaceae Infections - ID: D000016905 - Term: Gram-Negative Bacterial Infections - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000015231 - Term: Sexually Transmitted Diseases, Bacterial - ID: D000012749 - Term: Sexually Transmitted Diseases - ID: D000003141 - Term: Communicable Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000016870 - Term: Neisseriaceae Infections - ID: D000014211 - Term: Treponemal Infections - ID: D000013145 - Term: Spirochaetales Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9174 - Name: Gonorrhea - Relevance: HIGH - As Found: Gonorrhea - ID: M18250 - Name: HIV Infections - Relevance: LOW - As Found: Unknown - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: LOW - As Found: Unknown - ID: M5934 - Name: Chlamydia Infections - Relevance: HIGH - As Found: Chlamydia - ID: M16364 - Name: Syphilis - Relevance: HIGH - As Found: Syphilis - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M19249 - Name: Gram-Negative Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M15558 - Name: Sexually Transmitted Diseases - Relevance: LOW - As Found: Unknown - ID: M17935 - Name: Sexually Transmitted Diseases, Bacterial - 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: M19218 - Name: Neisseriaceae Infections - Relevance: LOW - As Found: Unknown - ID: M16964 - Name: Treponemal Infections - Relevance: LOW - As Found: Unknown - ID: T5701 - Name: Treponema Infection - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002690 - Term: Chlamydia Infections - ID: D000006069 - Term: Gonorrhea - ID: D000013587 - Term: Syphilis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428630 **Brief Title:** Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus **Official Title:** Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus #### Organization Study ID Info **ID:** STUDY00004549 #### Organization **Class:** OTHER **Full Name:** Tufts University ### Status Module #### Completion Date **Date:** 2027-09-01 **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:** 2026-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tufts University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The objective of this study is to see the amount of systemic absorption of a standard dose of dexamethasone oral rinse for patients with symptomatic oral lichen planus (OLP) or oral lichenoid reactions (OLR) and healthy subjects (those who do not have OLP or OLR aka the control group). ### Conditions Module **Conditions:** - Oral Lichen Planus - Oral Lichenoid Reaction ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Investigative group: Subjects with symptomatic oral lichen planus (OLP) or oral lichenoid reactions (OLR) Control Group: Those otherwise healthy Both groups will receive the same intervention. 5 of the control subjects will swish for 5 minutes, 5 of the control subjects will swish for 2 minutes. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The investigative will apply the dexamethasone oral rinse 0.5 mg/5ml treatment. The oral rinse is considered a topical rinse because it is confined to the oral cavity (topical) and not swallowed. Subjects will be reminded by the study team via a phone call a few days before their visit that they must not drink water or eat at least 60 min before their visit. Once we get to the stage of the rinse, we will first their oral cavity with gauze. Then, we will instruct the subject to Rinse their mouth with 0.5mg/5ml dexamethasone for 2 min, then spit into a provided plastic cup the oral rinse. This will then be discarded down the drain. **Intervention Names:** - Drug: dexamethasone oral rinse **Label:** Investigative group- Those with OLP **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The first control group will apply the dexamethasone oral rinse 0.5 mg/5ml treatment. The oral rinse is considered a topical rinse because it is confined to the oral cavity (topical) and not swallowed. Subjects will be reminded by the study team via a phone call a few days before their visit that they must not drink water or eat at least 60 min before their visit. Once we get to the stage of the rinse, we will first their oral cavity with gauze. Then, we will instruct the subject to Rinse their mouth with 0.5mg/5ml dexamethasone for 5 min, then spit into a provided plastic cup the oral rinse. This will then be discarded down the drain. **Intervention Names:** - Drug: dexamethasone oral rinse **Label:** Control 1 - 5 minute rinse **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** The second control group will apply the dexamethasone oral rinse 0.5 mg/5ml treatment. The oral rinse is considered a topical rinse because it is confined to the oral cavity (topical) and not swallowed. Subjects will be reminded by the study team via a phone call a few days before their visit that they must not drink water or eat at least 60 min before their visit. Once we get to the stage of the rinse, we will first their oral cavity with gauze. Then, we will instruct the subject to Rinse their mouth with 0.5mg/5ml dexamethasone for 2 min, then spit into a provided plastic cup the oral rinse. This will then be discarded down the drain. **Intervention Names:** - Drug: dexamethasone oral rinse **Label:** Control 2- 2 minute rinse **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control 1 - 5 minute rinse - Control 2- 2 minute rinse - Investigative group- Those with OLP **Description:** The study drug is FDA approved (NDC- 0054-3177) and will be used as it would be used in a standard of care setting. The rinse will be administered on the same therapeutic dose to OLP/OLR (0.5 mg/5ml of dexamethasone oral rinse once (rinse for 2 minutes or 5 minutes), then spit the excess into a cup. The oral rinse dexamethasone 0.5 mg/5ml will be used only on the subjects who participated in the study. **Name:** dexamethasone oral rinse **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** If there is systemic absorption, does it differ based on length of time of rinsing? This is for those in the control group who will be rinsing for either 2 minutes or 5 minutes. The evaluation is if there is varying amounts of the rinse detected in the blood after the various blood draws. **Measure:** Length of rinsing impact on systemic absorption **Time Frame:** 2 hours per subject #### Primary Outcomes **Description:** To investigate the amount (level detected in blood), through blood draw, of how much dexamethasone oral rinse is absorbed in the blood stream over two hours. **Measure:** Systemic absorption of a standard dose of dexamethasone oral rinse **Time Frame:** 2 hours per subject #### Secondary Outcomes **Description:** A clinical oral examination will be conducted for the REU scoring system this will determine what severity category they are in (what their REU score is out of 30 with 30 being most severe and 0 being mild lichen planus). The oral cavity will be examined based on REU scoring system to determine the subject belong to mild , moderate or severe group. **Measure:** Assessment of correlation between the amount of systemic absorption and the severity of the oral mucosal disorder **Time Frame:** 2 hours per subject ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Over 18 years old 2. Non-pregnant 3. Newly diagnosed subjects with OLP/OLR. Definition of 'newly" in this case : new patient with complaint regarding oral erosions and ulceration, and diagnose clinically with OLP or OLR for the first time 4. Those not exposed to topical or systemic corticosteroids for the previous 1 month. Meaning, those willing to not take this OLP/OLR treatment for 1 month before their visit 5. Experimental group is clinically diagnosed with OLP/OLR 6. Controls must have no history of OLP/OLR Exclusion Criteria: 1 . Under 18 years old 2. Pregnant women 3. Recent history (\< than one month) of exposure to topical or systemic corticosteroids. 4. History of advanced kidney, liver disease, or systemic fungal infection. 5. Corticosteroids hypersensitivity. 6. Active oral candidiasis 7. Patients on blood thinners medication ,anemic or suffer from bleeding disorders **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:** Vidya Sankar, DMD, MHS **Phone:** 617-636-3932 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ann-Marie Billig **Phone:** 6176363931 **Role:** CONTACT #### Locations **Location 1:** **City:** Boston **Country:** United States **Facility:** Tufts University School of Dental Medicine **State:** Massachusetts **Zip:** 02111 #### Overall Officials **Official 1:** **Affiliation:** Tufts University School of Dental Medicine **Name:** Vidya Sankar, DMD, MHS **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Rice JB, White AG, Scarpati LM, Wan G, Nelson WW. Long-term Systemic Corticosteroid Exposure: A Systematic Literature Review. Clin Ther. 2017 Nov;39(11):2216-2229. doi: 10.1016/j.clinthera.2017.09.011. Epub 2017 Oct 19. **PMID:** 29055500 **Citation:** Meikle AW, Lagerquist LG, Tyler FH. A plasma dexamethasone radioimmunoassay. Steroids. 1973 Aug;22(2):193-202. doi: 10.1016/0039-128x(73)90085-8. No abstract available. **PMID:** 4795381 **Citation:** Spoorenberg SM, Deneer VH, Grutters JC, Pulles AE, Voorn GP, Rijkers GT, Bos WJ, van de Garde EM. Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014 Jul;78(1):78-83. doi: 10.1111/bcp.12295. **PMID:** 24400953 **Citation:** Jarvinen A, Granander M, Laine T, Viitanen A. Effect of dose on the absorption of estradiol from a transdermal gel. Maturitas. 2000 Apr 28;35(1):51-6. doi: 10.1016/s0378-5122(00)00101-8. **PMID:** 10802400 **Citation:** Aalto-Korte K, Turpeinen M. Quantifying systemic absorption of topical hydrocortisone in erythroderma. Br J Dermatol. 1995 Sep;133(3):403-8. doi: 10.1111/j.1365-2133.1995.tb02668.x. **PMID:** 8546995 **Citation:** Georgaki M, Piperi E, Theofilou VI, Pettas E, Stoufi E, Nikitakis NG. A randomized clinical trial of topical dexamethasone vs. cyclosporine treatment for oral lichen planus. Med Oral Patol Oral Cir Bucal. 2022 Mar 1;27(2):e113-e124. doi: 10.4317/medoral.25040. **PMID:** 34564686 **Citation:** Joly P, Roujeau JC, Benichou J, Picard C, Dreno B, Delaporte E, Vaillant L, D'Incan M, Plantin P, Bedane C, Young P, Bernard P; Bullous Diseases French Study Group. A comparison of oral and topical corticosteroids in patients with bullous pemphigoid. N Engl J Med. 2002 Jan 31;346(5):321-7. doi: 10.1056/NEJMoa011592. **PMID:** 11821508 **Citation:** Varoni EM, Molteni A, Sardella A, Carrassi A, Di Candia D, Gigli F, Lodi F, Lodi G. Pharmacokinetics study about topical clobetasol on oral mucosa. J Oral Pathol Med. 2012 Mar;41(3):255-60. doi: 10.1111/j.1600-0714.2011.01087.x. Epub 2011 Sep 22. **PMID:** 21950548 **Citation:** Sankar V, Hearnden V, Hull K, Juras DV, Greenberg MS, Kerr AR, Lockhart PB, Patton LL, Porter S, Thornhill M. Local drug delivery for oral mucosal diseases: challenges and opportunities. Oral Dis. 2011 Apr;17 Suppl 1:73-84. doi: 10.1111/j.1601-0825.2011.01793.x. **PMID:** 21382140 **Citation:** Plemons JM, Rees TD, Zachariah NY. Absorption of a topical steroid and evaluation of adrenal suppression in patients with erosive lichen planus. Oral Surg Oral Med Oral Pathol. 1990 Jun;69(6):688-93. doi: 10.1016/0030-4220(90)90349-w. **PMID:** 2356081 **Citation:** Einarsdottir MJ, Bankvall M, Robledo-Sierra J, Rodstrom PO, Bergthorsdottir R, Trimpou P, Hasseus B, Ragnarsson O. Topical clobetasol treatment for oral lichen planus can cause adrenal insufficiency. Oral Dis. 2024 Apr;30(3):1304-1312. doi: 10.1111/odi.14588. Epub 2023 Apr 27. **PMID:** 37103329 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017444 - Term: Skin Diseases, Papulosquamous - ID: D000012871 - Term: Skin Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M19896 - Name: Lichen Planus, Oral - Relevance: HIGH - As Found: Oral Lichen Planus - ID: M11012 - Name: Lichen Planus - Relevance: HIGH - As Found: Lichen Planus - ID: M19775 - Name: Lichenoid Eruptions - Relevance: HIGH - As Found: Lichenoid Reaction - ID: M8219 - Name: Exanthema - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M19713 - Name: Skin Diseases, Papulosquamous - 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 ### Condition Browse Module - Meshes - ID: D000017676 - Term: Lichen Planus, Oral - ID: D000008010 - Term: Lichen Planus - ID: D000017512 - Term: Lichenoid Eruptions ### Intervention Browse Module - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7102 - Name: Dexamethasone - Relevance: HIGH - As Found: Children - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M9047 - Name: Glucocorticoids - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000003907 - Term: Dexamethasone ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428617 **Brief Title:** Fundus Ablation Registry (Gastric Fundus Mucosal Ablation for Weight Loss) **Official Title:** A Multi-site, Prospective Registry of Patients Undergoing Gastric Fundal Mucosal Ablation at True You Weight Loss #### Organization Study ID Info **ID:** RGT-002 #### Organization **Class:** OTHER **Full Name:** True You Weight Loss ### Status Module #### Completion Date **Date:** 2028-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** True You Weight Loss #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to construct a multi-site, prospective registry to evaluate the clinical outcomes of patients who have undergone gastric fundus mucosal ablation at True You Weight Loss. **Detailed Description:** Obesity is a chronic, progressive, multifactorial disease that contributes to increasing morbidity, mortality, and economic costs worldwide. The oxyntic mucosa of the gastric fundus is the principal site for the production of the orexigenic peptide hormone ghrelin. Ghrelin activates hunger-promoting pathways of the hypothalamus and opposes the satiety-promoting actions of other gastrointestinal peptides, leading to calorie-ingesting behaviors and weight gain. A method to reduce ghrelin production and decrease fundal compliance and capacity through mucosal devitalization may confer benefit to patients seeking treatment for obesity. This is a multi-site, prospective registry of patients who have elected to undergo Gastric Fundus Mucosal Ablation (GFMA) at a True You Weight Loss site in Cary, NC or Atlanta, GA. Study participants will consist of up to 200 adult patients of ages 18 to 65 years old who have elected to undergo GFMA at a True You Weight Loss site (Cary, NC or Atlanta, GA) prior to their involvement in the study. Participants that meet the criteria below will be deemed eligible for participation after consultation with the study investigator. Study participants will receive follow-up care according to standard of care practices, regardless of their involvement in the research study. Standard of care nutritional practice includes a comprehensive lifestyle program with long-term nutritional support and monitoring. Patient weights and adverse events will be collected at each visit. Adverse events will be communicated to medical team members in between dedicated visits. We aim to establish a multi-site, prospective registry to longitudinally describe GMFA in adults with obesity, including patient characteristics, weight loss, improvement in weight-related medical conditions, and adverse events. ### Conditions Module **Conditions:** - Obesity **Keywords:** - obesity - ghrelin - hunger - ablation - True You Weight Loss - hunger hormone - fundus - fundus ablation - fundic ablation - GFMA ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 2 Years ### Outcomes Module #### Primary Outcomes **Description:** Measured percent change in total body weight over time following Gastric Fundus Mucosal Ablation. %TBWL = (pre-op weight - post op body weight) / (pre-op weight) \* 100 measured as a percentage. **Measure:** Percent Change in Total Body Weight Loss (TBWL) from Baseline **Time Frame:** 12 Months #### Secondary Outcomes **Description:** Measured percent change in total body weight over time following Gastric Fundus Mucosal Ablation. %TBWL = (pre-op weight - post op body weight) / (pre-op weight) \* 100 measured as a percentage. **Measure:** Percent Change in Total Body Weight Loss (TBWL) from Baseline **Time Frame:** 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months **Description:** Measured excess weight loss percentage from baseline following Gastric Fundic Mucosal Ablation. %EWL = (pre-op weight - post op body weight) / (pre-op weight - ideal body weight) \* 100 Ideal Body Weight (IBW): Males: IBW = 50 kg + 2.3 kg for each inch over 5 feet Females: IBW = 45.5 kg + 2.3 kg for each inch over 5 feet **Measure:** Percent Excess Weight Loss from Baseline (EWL) **Time Frame:** 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months **Description:** Measured Body Mass Index (BMI) from baseline following Gastric Fundic Mucosal Ablation. Body Mass Index (BMI) = (Weight in kilograms) / ((Height in meters)\^2) **Measure:** Change in Body Mass Index (BMI) from Baseline **Time Frame:** 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥ 18 years and ≤ 65 years old 2. BMI ≥ 27 and ≤55 kg/m² 3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure. 4. Ability to give informed consent 5. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods. 6. Those who plan to receive the gastric fundus mucosal ablation procedure at True You Weight Loss regardless of the research Exclusion Criteria: 1. Patients that do not meet eligibility requirements for the study as per the Principal Investigator's standard selection criteria 2. Active psychological issues preventing participation in a life-style modification program as determined by a psychologist. 3. Patients who are pregnant or breast-feeding. 4. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating. 5. Patients with previous or current tobacco use 6. Patients with prior gastric surgery (e.g., vertical sleeve gastrectomy, gastric bypass, hiatal hernia repair, Nissen fundoplication, adjustable gastric band). 7. Patients on therapeutic anticoagulation or antithrombotics that cannot be interrupted for at least 12 weeks following GFMA. 8. Patients who cannot commit to 12 weeks of post-GMFA pharmacologic ulcer prophylaxis 9. At the discretion of the PI for subject safety **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Study participants will consist of up to 200 adult patients of ages 18 to 65 years old who have elected to undergo Gastric Fundus Mucosal Ablation (GFMA) at a True You Weight Loss site (Cary, NC or Atlanta, GA) prior to their involvement in the study. Participants that meet the criteria below will be deemed eligible for participation after consultation with the study investigator. All eligibility criteria must be met at the time of enrollment. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Chase Wooley, BS **Phone:** 919-336-4171 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Shannon Casey, BS, MS **Phone:** (919) 391-7843 **Role:** CONTACT #### Locations **Location 1:** **City:** Atlanta **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Chase Wooley, BS - **Phone:** 919-336-4171 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Shannon Casey, BS, MS - **Phone:** (919) 391-7843 - **Role:** CONTACT ***Contact 3:*** - **Name:** Christopher McGowan, MD, MSCR - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Daniel Maselli, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Lauren Donnangelo, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** True You Weight Loss **State:** Georgia **Zip:** 30342 **Location 2:** **City:** Cary **Country:** United States **Facility:** True You Weight Loss **State:** North Carolina **Zip:** 27513 ### References Module #### See Also Links **Label:** Sponsor Website for more information **URL:** http://www.trueyouweightloss.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001835 - Term: Body Weight - ID: D000001836 - Term: Body Weight Changes ### 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: LOW - As Found: Unknown - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M18102 - Name: Weight Loss - Relevance: HIGH - As Found: Weight Loss - ID: M5115 - Name: Body Weight Changes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015431 - Term: Weight Loss ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428604 **Brief Title:** The Effect of Preoperative Oral Carbohydrate Administration on Perioperative Hypothermia in Pediatric Patients **Official Title:** The Effect of Preoperative Oral Carbohydrate Administration on Perioperative Hypothermia in Pediatric Patients #### Organization Study ID Info **ID:** 2019/64 #### Organization **Class:** OTHER_GOV **Full Name:** Başakşehir Çam & Sakura City Hospital ### Status Module #### Completion Date **Date:** 2019-07-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-07-31 **Type:** ACTUAL #### Start Date **Date:** 2019-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Başakşehir Çam & Sakura City Hospital #### Responsible Party **Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital **Investigator Full Name:** Sevil Azazoglu ERBEK **Investigator Title:** anesthesiologist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Hypothermia that may develop in the perioperative period is associated with many adverse clinical outcomes. In particular, pediatric patients were more susceptible to hypothermia and related complications such as respiratory distress, metabolic acidosis, hypoglycemia, hypoxemia, cardiac disorders, coagulopathy, and wound infection than adults. In this study, the effect of preoperative carbohydrate-rich feeding on temperature regulation in pediatric patients was investigated. ### Conditions Module **Conditions:** - Perioperative Hypothermia ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Day ### Arms Interventions Module #### Arm Group 1 **Description:** patient group given only 5 ml kg-1 oral water 3 hours before the surgery, **Label:** GRUP W #### Arm Group 2 **Description:** Patient group given 5 ml kg-1 clear carbohydrate-rich liquid orally 3 hours before surgery **Label:** GRUP C ### Outcomes Module #### Primary Outcomes **Description:** In order to benefit from the thermic effects of nutrients, intravenous or oral administration of nutrients before or during the operation has been used. These include administering amino acid solutions and administering carbohydrate solutions Providing essential nutrients increases metabolic heat production, reducing the inequality between heat production and loss. The primary goal of this approach is to increase energy expenditure following the administration of essential nutrients, causing a response known as diet-induced thermogenesis. The body temperatures of the patients were measured perioperative with a tympanic thermometer at regular intervals. Values lower than 36.0oC were considered as hypothermia. **Measure:** the effect of oral clear liquid intake containing carbohydrates 3 hours before preoperatively on body temperature in the pediatric age group, compared to the group taking water 3 hours before surgery. **Time Frame:** 1 March 2019- 31 july 2019 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients to be operated on by the Department of Pediatric Surgery 2. Being between the ages of 2 and 15 3. Not restricting oral intake 4. ASA I-II-III patients in anesthesia risk score 5. Patients operated between 01.03.2019 and 31.07.2019 6. Not having any communication problems (mental retardation, not knowing Turkish, etc.) 7. Not having gastroesophageal reflux 8. Not having any muscle disease 9. Informed volunteer consent must be obtained 10. Patients for whom emergency surgery is not planned 11. No disease related to the central nervous system Exclusion Criteria: 1. Pediatric patients outside the 2-15 age range 2. Having limited oral intake 3. ASA IV and above in anesthesia risk scoring 4. Patients operated before 01.03.2019 or after 31.07.2019 5. Patients who may have communication problems with their parents or themselves 6. Patients with gastroesophageal reflux 7. Patients with muscle disease 8. Patients for whom informed voluntary consent has not been obtained 9. Patients who will undergo emergency surgery 10. Patients with diseases related to the central nervous system **Maximum Age:** 15 Years **Minimum Age:** 2 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD **Study Population:** Being between the ages of 2 and 15 ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Başakşehir Çam and Sakura City Hospital ### References Module #### References **Citation:** Yatabe T, Kawano T, Yamashita K, Yokoyama M. Preoperative carbohydrate-rich beverage reduces hypothermia during general anesthesia in rats. J Anesth. 2011 Aug;25(4):558-62. doi: 10.1007/s00540-011-1170-z. Epub 2011 May 24. **PMID:** 21607766 **Citation:** Dilmen OK, Yentur E, Tunali Y, Balci H, Bahar M. Does preoperative oral carbohydrate treatment reduce the postoperative surgical stress response in lumbar disc surgery? Clin Neurol Neurosurg. 2017 Feb;153:82-86. doi: 10.1016/j.clineuro.2016.12.016. Epub 2016 Dec 29. **PMID:** 28073036 **Citation:** Castillo-Zamora C, Castillo-Peralta LA, Nava-Ocampo AA. Randomized trial comparing overnight preoperative fasting period Vs oral administration of apple juice at 06:00-06:30 am in pediatric orthopedic surgical patients. Paediatr Anaesth. 2005 Aug;15(8):638-42. doi: 10.1111/j.1460-9592.2005.01517.x. **PMID:** 16033337 **Citation:** Carvalho CALB, Carvalho AA, Nogueira PLB, Aguilar-Nascimento JE. CHANGING PARADIGMS IN PREOPERATIVE FASTING: RESULTS OF A JOINT EFFORT IN PEDIATRIC SURGERY. Arq Bras Cir Dig. 2017 Jan-Mar;30(1):7-10. doi: 10.1590/0102-6720201700010003. **PMID:** 28489159 **Citation:** Ozer AB, Demirel I, Kavak BS, Gurbuz O, Unlu S, Bayar MK, Erhan OL. Effects of preoperative oral carbohydrate solution intake on thermoregulation. Med Sci Monit. 2013 Jul 31;19:625-30. doi: 10.12659/MSM.883991. **PMID:** 23900128 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001832 - Term: Body Temperature Changes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10085 - Name: Hypothermia - Relevance: HIGH - As Found: Hypothermia - ID: M5111 - Name: Body Temperature Changes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007035 - Term: Hypothermia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428591 **Brief Title:** Tandem Freedom - Feasibility Trial 1 **Official Title:** Tandem Freedom - Feasibility Trial 1 #### Organization Study ID Info **ID:** TP-0017517 #### Organization **Class:** INDUSTRY **Full Name:** Tandem Diabetes Care, Inc. #### Secondary ID Infos **Domain:** ICTRP **ID:** U1111-1307-6267 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-06-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-29 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Tandem Diabetes Care, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is Unapproved Device:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use Control-IQ technology at home for a 1 week run-in, then will use Tandem Freedom in a supervised hotel setting for 3 days/nights. **Detailed Description:** After a 1 week Control-IQ run-in at home, 10 adults who are existing Control-IQ users with type 1 diabetes will use the Tandem Freedom System for 3 days/nights in a supervised hotel setting. Participants will perform meal and exercise challenges. The primary outcome is safety events. CGM time in ranges will also be evaluated. ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 1 **Keywords:** - type 1 diabetes - T1D - Tandem - t:slim X2 - automated insulin delivery ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system for 3 days/nights. **Intervention Names:** - Device: t:slim X2 insulin pump with Tandem Freedom Algorithm **Label:** Tandem Freedom **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Tandem Freedom **Description:** Participants will use the Tandem Freedom system for 3 day/nights in a supervised hotel setting, performing meal and exercise challenges. **Name:** t:slim X2 insulin pump with Tandem Freedom Algorithm **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) **Measure:** Severe Hypoglycemia events **Time Frame:** 3 days **Description:** Number of diabetic ketoacidosis events **Measure:** Diabetic Ketoacidosis events **Time Frame:** 3 days **Description:** Number of unanticipated adverse device effects **Measure:** Unanticipated adverse device effects **Time Frame:** 3 days **Description:** Number of other serious device-related adverse events **Measure:** Other serious device-related adverse events **Time Frame:** 3 days #### Secondary Outcomes **Description:** CGM measured percent time \<70 mg/dL, overall **Measure:** Percent Time <70 mg/dL, overall **Time Frame:** 3 days **Description:** CGM measured percent time \<70 mg/dL, during the daytime **Measure:** Percent Time <70 mg/dL, daytime **Time Frame:** 3 days **Description:** CGM measured percent time \<70 mg/dL, during the nighttime **Measure:** Percent Time <70 mg/dL, nighttime **Time Frame:** 3 days **Description:** CGM measured percent time \<54 mg/dL, overall **Measure:** Percent Time <54 mg/dL, overall **Time Frame:** 3 days **Description:** CGM measured percent time \<54 mg/dL, during the daytime **Measure:** Percent Time <54 mg/dL, daytime **Time Frame:** 3 days **Description:** CGM measured percent time \<54 mg/dL, during the nighttime **Measure:** Percent Time <54 mg/dL, nighttime **Time Frame:** 3 days **Description:** CGM measured percent time in range 70 - 180 mg/dL, overall **Measure:** Percent Time in Range 70 - 180 mg/dL, overall **Time Frame:** 3 days **Description:** CGM measured percent time in range 70 - 180 mg/dL, daytime **Measure:** Percent Time in Range 70 - 180 mg/dL, daytime **Time Frame:** 3 days **Description:** CGM measured percent time in range 70 - 180 mg/dL, nighttime **Measure:** Percent Time in Range 70 - 180 mg/dL, nighttime **Time Frame:** 3 days **Description:** CGM measured percent time in range 70 - 140 mg/dL, overall **Measure:** Percent Time in Range 70 - 140 mg/dL, overall **Time Frame:** 3 days **Description:** CGM measured percent time in range 70 - 140 mg/dL, daytime **Measure:** Percent Time in Range 70 - 140 mg/dL, daytime **Time Frame:** 3 days **Description:** CGM measured percent time in range 70 - 140 mg/dL, nighttime **Measure:** Nighttime Percent between 70-140 mg/dL, nighttime **Time Frame:** 3 days **Description:** CGM measured percent time \>180 mg/dL, overall **Measure:** Percent Time >180 mg/dL, overall **Time Frame:** 3 days **Description:** CGM measured percent time \>180 mg/dL, daytime **Measure:** Percent Time >180 mg/dL, daytime **Time Frame:** 3 days **Description:** CGM measured percent time \>180 mg/dL, nighttime **Measure:** Percent Time >180 mg/dL, nighttime **Time Frame:** 3 days **Description:** CGM measured percent time \>250mg/dL, overall **Measure:** Percent Time >250 mg/dL, overall **Time Frame:** 3 days **Description:** CGM measured percent time \>250mg/dL, daytime **Measure:** Daytime Percent time >250 mg/dL, daytime **Time Frame:** 3 days **Description:** CGM measured percent time \>250mg/dL, nighttime **Measure:** Nighttime Percent time >250 mg/dL, nighttime **Time Frame:** 3 days **Description:** CGM measured mean glucose (mg/dL), overall **Measure:** Mean glucose (mg/dL), overall **Time Frame:** 3 days **Description:** CGM measured mean glucose (mg/dL), daytime **Measure:** Mean glucose (mg/dL), daytime **Time Frame:** 3 days **Description:** CGM measured mean glucose (mg/dL), nighttime **Measure:** Mean glucose (mg/dL), nighttime **Time Frame:** 3 days **Description:** CGM measured Coefficient of Variation (%), overall **Measure:** Glycemic Variability as assessed by Coefficient of Variation (%), overall **Time Frame:** 3 days **Description:** CGM measured Coefficient of Variation (%), daytime **Measure:** Glycemic Variability as assessed by Coefficient of Variation (%), daytime **Time Frame:** 3 days **Description:** CGM measured Coefficient of Variation (%), nighttime **Measure:** Glycemic Variability as assessed by Coefficient of Variation (%), nighttime **Time Frame:** 3 days **Description:** CGM measured Standard Deviation (mg/dL), overall **Measure:** Glycemic Variability as assessed by Standard Deviation (mg/dL), overall **Time Frame:** 3 days **Description:** CGM measured Standard Deviation (mg/dL), daytime **Measure:** Glycemic Variability as assessed by Standard Deviation (mg/dL), daytime **Time Frame:** 3 days **Description:** CGM measured Standard Deviation (mg/dL), nighttime **Measure:** Glycemic Variability as assessed by Standard Deviation (mg/dL), nighttime **Time Frame:** 3 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥18 years old * Diagnosis of type 1 diabetes for at least 1 year * Current Control-IQ user, having been prescribed Control-IQ for at least 3 months * HbA1c ≤10%, recorded in the last 3 months * Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including performing the weekend hotel observed setting portion of the study. * Willing to use only aspart (novorapid) or lispro (humalog) insulin with the study pump, with no use of long-acting basal insulin injections, or inhaled insulin with the study pump. * Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (site will provide prescription if they do not have one) Exclusion Criteria: * More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months * More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months * Inpatient psychiatric treatment in the past 6 months * For Female: Currently pregnant or planning to become pregnant during the time period of study participation 1. A negative pregnancy test will be required for all females of child-bearing potential 2. Counseling on appropriate birth control options will be provided to all females of child-bearing potential * Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas). * Hemophilia or any other bleeding disorder * Hemoglobinopathy * History of heart, liver, lung or kidney disease determined by investigator to interfere with the study * History of allergic reaction to Humalog or Novorapid * Use of any medications determined by investigator to interfere with study * Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis * Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea * History of adrenal insufficiency * History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated * History of gastroparesis * A condition, which in the opinion of the investigator or designee, would put the participant or study at risk * Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation * Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Christchurch **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Renee Meier - **Phone:** 64 3 372 6763 - **Role:** CONTACT ***Contact 2:*** - **Name:** Martin de Bock, FRACP PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** New Zealand **Facility:** University of Otago **Status:** RECRUITING **Zip:** 8140 #### Overall Officials **Official 1:** **Affiliation:** Tandem Diabetes Care **Name:** Jordan Pinsker, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003920 - Term: Diabetes Mellitus - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - 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: LOW - As Found: Unknown - 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: D000003922 - Term: Diabetes Mellitus, Type 1 ### Intervention Browse Module - Ancestors - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: HIGH - As Found: Day 1 - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007328 - Term: Insulin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428578 **Brief Title:** Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas **Official Title:** Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas #### Organization Study ID Info **ID:** HSC-SPH-23-0795 #### Organization **Class:** OTHER **Full Name:** The University of Texas Health Science Center, Houston #### Secondary ID Infos **Domain:** American Heart Association **ID:** 24FIM1264463 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **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:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** American Heart Association #### 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:** Alexandra van den Berg **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to compare the short-term and long term impacts of Food is the Best Medicine (FBM)-Virtual on diet quality, food security status, breastfeeding rates, mental health status, rates of home cooking, and rationing coping strategies relative to FBM-In Person among food insecure, postpartum women and to compare implementation outcomes across the FBM-Virtual and FBM-In Person using process data collected from the participants, Community Health Worker (CHW)s, and partner organizations. ### Conditions Module **Conditions:** - Food Insecurity in Post Partum Women **Keywords:** - Food is Medicine (FIM) - food insecurity - free delivered nutritious meals - food boxes - Community Health Workers - The University of Texas Health Science Center at Houston School of Public Health - Austin ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: FBM-In person - Other: home delivered food boxes **Label:** FBM-In person **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: FBM-Virtual - Other: home delivered food boxes **Label:** FBM-Virtual **Type:** EXPERIMENTAL #### Arm Group 3 **Intervention Names:** - Other: home delivered food boxes **Label:** home delivered food **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - FBM-In person **Description:** Participants will receive two home visits by a CHW. Each home visit will last about 30 minutes, during which the CHW will assist the woman with community resources and help with enrolling in any state or federal nutrition and medical programs. Furthermore, the participants will be given access to a private Facebook group for nutrition, health education, and social support. Home visits will occur during the second and fifth weeks of the study. **Name:** FBM-In person **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - FBM-Virtual **Description:** Participants will receive access to a virtual platform which will have information on national, state, and local food and medical resources, as well as local community resources, and will have access to a private Facebook group for nutrition, health education, and social support. **Name:** FBM-Virtual **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - FBM-In person - FBM-Virtual - home delivered food **Description:** Participants will receive weekly deliveries of a box containing fresh produce and staple goods (approximately 5 meals a week), culturally tailored meals (6 meals a week), and prepared fruit, vegetable and grain-forward meal kits (4 units a week) plus standard nutrition education materials consisting of recipes inside of the boxes. Each participant will receive one box for eight consecutive weeks. **Name:** home delivered food boxes **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This is an 6 item questionnaire . Raw score will be reported and score ranges from 0-6. Raw score of 0-1 shows high or marginal food security, raw score of 2- indicates low food security and raw score of 5-6 shows very low food insecurity. **Measure:** Change in level of household food insecurity experienced as assessed by the US Household Food Security questionnaire **Time Frame:** Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention **Description:** This data will be reported categorically for 14 different food items as follows: 1. fruit 2. green leafy or lettuce salad 3. fried potatoes 4. other kind of potatoes 5. refired/baked/ cooked beans 6. other vegetables that were not deep-fried 7. salsa made with tomato 8. pizza 9. tomato sauce 10. lean protein 11. plant-based protein 12. brown rice or other cooked whole grains 13. whole grain bread 14. regular soda/pop **Measure:** Change in quality of diet as assessed by number of times participants ate certain food items in the past month as reported in the questionnaire **Time Frame:** Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention **Measure:** Number of participants that initiated breastfeeding as assessed by the pre test questionnaire **Time Frame:** Baseline **Measure:** Total duration of breastfeeding time as assessed by the post test questionnaires **Time Frame:** end of study (after 8 weeks of food delivery boxes) **Measure:** Total duration of breastfeeding time as assessed by the post test questionnaires **Time Frame:** 3 months follow up **Description:** This is a 10 item questionnaire , range of score for each item is 0-3 for a total score range of 0-30, score above 12 is worse outcome **Measure:** Change in number of participants who showed signs of depression as assessed by the Edinburgh Postnatal Depression Scale (EPDS) **Time Frame:** Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention **Description:** Participant will be asked how often he/she or anyone else in the family prepared breakfast from scratch during the past week, lunch from scratch during the past week or dinner from scratch during the past week. The responses from the 3 items will be summed to determine the number of home cooked meals during past week. **Measure:** Change in number of cooked meals as assessed by the number of home cooked meals made from scratch during the past week **Time Frame:** Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention **Description:** Scores for three questions from the Financial Stress Scale will be used and each will be scored from 0(never) to 6(Always) for a score range of 0-18; 18 being highest level of financial stress. **Measure:** Change in financial stress as assessed by the financial stress questionnaire **Time Frame:** Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention **Description:** A single item from the Financial Self Efficacy scale will be used. **Measure:** Percentage of participants that face financial challenges as assessed by the Financial Self-Efficacy Scale **Time Frame:** Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * food insecure * to communicate in English or Spanish. Exclusion Criteria: * not living within the food produce zip code delivery radius * having any dietary allergies. **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alexandra van den Berg, MPH, PhD **Phone:** (512) 391-2529 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Aida Nielsen, MPH **Phone:** (512) 482-6183 **Role:** CONTACT #### Locations **Location 1:** **City:** Austin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alexandra van den Berg, MPH,PhD - **Phone:** 512-391-2529 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Aida Nielsen, MPH - **Phone:** (512) 482-6183 - **Role:** CONTACT **Country:** United States **Facility:** Ascension Seton Medical Center **State:** Texas **Status:** RECRUITING **Zip:** 78705 **Location 2:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alexandra van den Berg, MPH, PhD - **Phone:** 512-391-2529 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Aida Nielsen - **Phone:** (512) 482-6160 - **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:** Alexandra van den Berg, MPH, 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:** NCT06428565 **Brief Title:** Conventional Exercises Plan With or Without Laser Guided Feedback for Patients With Non-Specific Low Back Pain **Official Title:** Conventional Exercises Plan With or Without Laser Guided Feedback for Patients With Non-Specific Low Back Pain #### Organization Study ID Info **ID:** MSRSW/Batch-Fall22/713 #### Organization **Class:** OTHER **Full Name:** Superior University ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-04-29 **Type:** ACTUAL #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Superior University #### Responsible Party **Investigator Affiliation:** Superior University **Investigator Full Name:** Muhammad Naveed Babur **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Low back pain (LBP) is a significant health issue. It impacts a significant portion of the adult population, reaching up to 80%, and results in substantial healthcare and socioeconomic expenses. To find out what changes occurred after the application of two exercise modalities \[Conventional Exercise (CE) and Laser-Guided Exercise (LGE)} and PNE on pain, pain pressure thresholds, disability, catastrophizing, kinesiophobia, and lumbar proprioception in subjects with NSCLBP. ### Conditions Module **Conditions:** - Low Back Pain ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 30 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** uses low-level lasers or light-emitting diodes to stimulate cellular function and improve healing. Physiotherapy, sports medicine, and rehabilitation use it as a non-invasive, painless complement or adjuvant therapy **Intervention Names:** - Diagnostic Test: Low-level laser therapy (LLLT) or cold laser therapy **Label:** Low-level laser therapy (LLLT) or cold laser therapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Low-level laser therapy (LLLT) or cold laser therapy **Description:** Low-level laser therapy (LLLT) or cold laser therapy **Name:** Low-level laser therapy (LLLT) or cold laser therapy **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** it is a simple and widely used tool for measuring pain intensity. It consists of a horizontal line with 11 numbered points, ranging from 0 (no pain) to 10 (worst pain imaginable). Patients are asked to rate their pain by selecting the number that best describes their current pain intensity **Measure:** The Numeric Pain Rating Scale (NRS) **Time Frame:** 12 Months **Description:** it is a patient-completed questionnaire used to measure the level of disability caused by low back pain. It is a widely used and validated tool in both research and clinical settings. Studies show high test-retest reliability of 0.90 **Measure:** The Oswestry Disability Index (ODI) **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Both male and female ages between 18 and 45 years (11). * Patients diagnosed with nonspecific low back pain (11). * patients with pain intensity of "3" or greater on numeric pain rating scale Exclusion Criteria: * Patients with neurological symptoms. * Patients diagnosed with fatigue syndrome * Females having pregnancy * History of low back surgery **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lahore **Country:** Pakistan **Facility:** Hameed Latif Hospital Lahore ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### 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 ### Condition Browse Module - Meshes - ID: D000001416 - Term: Back Pain - ID: D000017116 - Term: Low Back Pain ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6392 - Name: Complement System Proteins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428552 **Brief Title:** To Evaluate the Efficacy of Mobile Applications in Tailoring and Enhancing Rehabilitation Interventions for Pediatric CP **Official Title:** To Evaluate the Efficacy of Mobile Applications in Tailoring and Enhancing Rehabilitation Interventions for Pediatric Patients With Cerebral Palsy #### Organization Study ID Info **ID:** MSRSW/Batch-Fall22/712 #### Organization **Class:** OTHER **Full Name:** Superior University ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Superior University #### Responsible Party **Investigator Affiliation:** Superior University **Investigator Full Name:** Muhammad Naveed Babur **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The world of technology is changing and becoming more advanced. Children with cerebral palsy can benefit from the technology to enhance their mobility, balance, and coordination through mobile applications. A lot of applications are made to offer games and interactive therapy activities that focus on balance, coordination, and motor skills. **Detailed Description:** They may find these activities entertaining as well as helpful, which makes their rehabilitation more pleasurable. This work builds on previous studies by making a mobile application that may be accessed from any location, giving therapeutic treatments more distribution flexibility. This is especially helpful for those with cerebral palsy who might have mobility issues that make it challenging to consistently attend in-person therapy sessions. Cerebral palsy children can perform organized exercises at home with the help of mobile application made for therapeutic activities and rehabilitation. Therapeutic activities may be customized to meet the unique demands of each patient, guaranteeing that the treatment plan is in line with their capabilities and objectives. Caregiver's involvement in the treatment process is a common element of app created specifically for people with cerebral palsy. This might involve providing tools to enhance home-based care, educating caregivers through resources, and monitoring progress in order to promote a team-based approach to treatment. ### Conditions Module **Conditions:** - Cerebral Palsy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 96 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Daily rehabilitation program of 40 minutes duration using a mobile application to be completed 6 days per week for 12 weeks **Intervention Names:** - Device: Mobile Application **Label:** Usual care at home for 12 weeks **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Usual care at home for 12 weeks **Description:** Daily rehabilitation program of 40 minutes duration using a mobile application to be completed 6 days per week for 12 weeks **Name:** Mobile Application **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** questionnaire(QUIS)the application software has been given to the intervention group and after using the software for one week, all participants answered the user satisfaction interaction questionnaire(QUIS).This step has taken to assess the software's usability based on feedback taken from parents or caregivers of patient with cerebral palsy and to assess the impact of utilizing this mobile application. **Measure:** questionnaire(QUIS)the application software **Time Frame:** 12 Months **Description:** Pedi Cat Questionnaire To assess amount of recovery in patients with cerebral palsy, the intervention group answered valid and reliable Pedi Cat questionnaire at the first day of the study. The intervention group used the content and rehabilitation protocol of the app under the supervision of therapist for 12 weeks at home. After 12 weeks, the Pedi Cat questionnaire was answered by intervention group to assess recovery increasing or any change in the patients. **Measure:** Pedi Cat Questionnaire **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Children with cerebral palsy * Children aged between 5 to 16 years Exclusion Criteria: * Children with unstable epilepsy, chronic heart abnormalities , asthma , anemia and other medical conditions * undergone botulinum neurotoxin A (BoNT-A)injections or surgery in the previous 2 months or 6 months respectively. " **Maximum Age:** 16 Years **Minimum Age:** 5 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Lahore **Country:** Pakistan **Facility:** Hope Rehabilitaion Centre, Mansoor Hospital Lahore , ChildRehab Sangla Hill ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001925 - Term: Brain Damage, Chronic - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5796 - Name: Cerebral Palsy - Relevance: HIGH - As Found: Cerebral Palsy - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M5207 - Name: Brain Injuries - Relevance: LOW - As Found: Unknown - ID: M5202 - Name: Brain Damage, Chronic - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002547 - Term: Cerebral Palsy ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428539 **Brief Title:** T Regulatory Cells IN LUPUS NEPHRITIS **Official Title:** T Regulatory Cells in Lupus Nephritis #### Organization Study ID Info **ID:** T cells in lupus LN #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-25 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Mohamed AbdEllah Ahmed Hussein **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:** * To study the role FoxP3-positive T regulatory cells in the pathogenesis of Lupus Nephritis, and determine the factors associated with levels of T regs . * To compare the functional capacity of T regs in LN and in normal individuals. **Detailed Description:** Lupus Nephritis (LN) encompasses a group of glomerulonephrites, that occur in association with systemic lupus erythematosus (SLE). The mainstream theory that it is an immune disease resulting from loss of immune tolerance against body cells. The regulatory T cells (T regs ) are a subpopulation of immune cells that maintain tolerance to self-antigens and suppress autoimmune diseases. The main marker of Tregs is FoxP3 (forkhead box protein 3) positivity. Moreover, It has been suggested that functional capacity of Tregs is also compromised in autoimmune diseases. Studying the role of T regs in LN is a promising field that can help tailor current immune therapy and develop new treatment strategies. ### Conditions Module **Conditions:** - Lupus Nephritis ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 65 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients with active lupus nephritis as active urinary sediment, or rising renal chemistry **Intervention Names:** - Diagnostic Test: T-reg cells **Label:** patients with active lupus nephritis #### Arm Group 2 **Description:** Patients who were previously active, but now in remission **Intervention Names:** - Diagnostic Test: T-reg cells **Label:** patients with lupus nephritis in remission #### Arm Group 3 **Description:** normal healthy participants **Intervention Names:** - Diagnostic Test: T-reg cells **Label:** normal individuals ### Interventions #### Intervention 1 **Arm Group Labels:** - normal individuals - patients with active lupus nephritis - patients with lupus nephritis in remission **Description:** laboratory test **Name:** T-reg cells **Other Names:** - t regulatory cells **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** mean difference of FoxP3 between groups. **Measure:** FoxP3 between groups **Time Frame:** baseline **Description:** correlation between level of FoxP3 and activity index in the group with active LN. **Measure:** Association of FoxP3 and activity index **Time Frame:** baseline **Description:** mean difference of suppression capacity of Tregs between normal participants and patients with active LN. **Measure:** Tregs in normal and lupus participants **Time Frame:** baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: adults both genders clinical diagnosis of lupus nephritis Exclusion Criteria: patients diagnosed with other renal pathologies, e.g. diabetic kidney disease **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** patients with lupus nephritis, both currently active or in remission, divided in Group 1: active lupus nephritis, Group 2: lupus nephritis in remission. Besides including normal Group 3: healthy volunteers ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mohamed AH Hussein **Phone:** +966554599271 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Doglio M, Alexander T, Del Papa N, Snowden JA, Greco R; Autoimmune Diseases Working Party (ADWP) of the European Society for Blood and Marrow Transplantation (EBMT). New insights in systemic lupus erythematosus: From regulatory T cells to CAR-T-cell strategies. J Allergy Clin Immunol. 2022 Dec;150(6):1289-1301. doi: 10.1016/j.jaci.2022.08.003. Epub 2022 Sep 20. **PMID:** 36137815 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007674 - Term: Kidney Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000005921 - Term: Glomerulonephritis - ID: D000008180 - Term: Lupus Erythematosus, Systemic - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12338 - Name: Nephritis - Relevance: HIGH - As Found: Nephritis - ID: M11178 - Name: Lupus Nephritis - Relevance: HIGH - As Found: Lupus Nephritis - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M9031 - Name: Glomerulonephritis - Relevance: LOW - As Found: Unknown - ID: M11177 - Name: Lupus Erythematosus, Systemic - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3523 - Name: Lupus Nephritis - Relevance: HIGH - As Found: Lupus Nephritis - ID: T2525 - Name: Glomerulonephritis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009393 - Term: Nephritis - ID: D000008181 - Term: Lupus Nephritis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428526 **Brief Title:** Impact of Sensory Electrical Stimulation on Sensation and Tremor **Official Title:** Effects of Afferent-specific Peripheral Electrical Stimulation (asES) on Sensorimotor Control and Tremor #### Organization Study ID Info **ID:** STU00217703 #### Organization **Class:** OTHER **Full Name:** Shirley Ryan AbilityLab ### Status Module #### Completion Date **Date:** 2028-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **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:** Shirley Ryan AbilityLab #### Responsible Party **Investigator Affiliation:** Shirley Ryan AbilityLab **Investigator Full Name:** Jose Pons **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to understand the acute, short-term and long-term impact of transcutaneous and/or percutaneous electrical stimulation with afferent-specific electrical stimulation (asES) on proprioception and fine motor control in the upper extremity. For this purpose, the researchers will use transcutaneous and/or percutaneous asES, high-density electromyography (HD-EMG), arm kinematic measurements, and standardized clinical assessments. This study will be conducted in healthy able-bodied individuals and patients with essential tremor (ET). **Detailed Description:** The purpose of this study is to evaluate the impact of afferent-specific electrical stimulation (asES), delivered either transcutaneous or percutaneous electrodes, on proprioception and fine motor control. The researchers will study the effect of asES in force perception, joint position perception, and touch sensitivity as proxies for proprioception. The researchers will also study the effect of asES on fine motor control by investigating the change in neural drive to the muscles before and after asES using the motor unit spike trains extracted from HD-EMG recordings. Furthermore, the researchers will also study the difference in effects of transcutaneous versus percutaneous asES on proprioception, fine motor control, and tremor in ET through HD-EMG and standard clinical measurements such as TETRAS and Perdue pegboard test. These results will help the researchers understand the acute, short-term, and long-term effects of various methods of asES delivery (transcutaneous or percutaneous) and their impact on proprioception and fine motor control. Aim 1: Investigate the acute, short-term, and long-term effects of transcutaneous asES on proprioception and fine motor control. The overall goal of this study is to provide insight into the effect of transcutaneous stimulation of la afferent pathways targeted to modulate spinal reflexes in patients with ET to reduce tremors, which consequently might cause disruption in proprioception leading to changes in performance of fine motor control. The researchers hypothesize that asES might disrupt proprioception causing decreased performance in fine motor control tasks in the acute (during stimulation), and short-term (e.g., immediately following stimulation to 30 minutes post) but the effects will diminish in the long-term (up to 24 hours post stimulation) time periods. Aim 2: Investigate the acute, short-term, and long-term effects of percutaneous asES on proprioception and fine motor control. The goal of this aim is to evaluate the effects of percutaneous asES to modulate Ia afferents and spinal reflexes to result in tremor reduction in ET, which consequently might cause disruption in proprioception leading to changes in performance of fine motor control. The researchers hypothesize that percutaneous asES will disrupt proprioception and fine motor control, but will also result in tremor reduction in the acute, short-term and long-term periods. ### Conditions Module **Conditions:** - Essential Tremor - Healthy Individuals **Keywords:** - Essential Tremor - Proprioception - Fine motor control - Electrical nerve stimulation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will be administered transcutaneous afferent-specific electrical stimulation in the upper limb using conductive pads targeting the median and radial nerves at the wrist **Intervention Names:** - Device: Continuous stimulation strategy - Device: Closed-loop stimulation strategy **Label:** Transcutaneous asES **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will be administered percutaneous afferent-specific electrical stimulation in the upper limb using intramuscular leads targeting the flexor and extensor muscles of the wrist **Intervention Names:** - Device: Continuous stimulation strategy - Device: Closed-loop stimulation strategy **Label:** Percutaneous asES **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Percutaneous asES - Transcutaneous asES **Description:** Participants will be administered stimulation with a constant frequency stimulation. **Name:** Continuous stimulation strategy **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Percutaneous asES - Transcutaneous asES **Description:** Participants will be administered with an activity-dependent stimulation. **Name:** Closed-loop stimulation strategy **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Force perception will be measured by evaluating the participant's ability to match a target force. **Measure:** Force perception via force matching tasks **Time Frame:** Assessment will be performed before, immediately after, and 30 minutes following the administration of the intervention in a single visit **Description:** Position perception will be measured by evaluating the participant's ability to match a target joint position. **Measure:** Position perception via position matching tasks **Time Frame:** Assessment will be performed before, immediately after, and 30 minutes following the administration of the intervention in a single visit **Description:** Touch perception will be assessed through Semmes-Weinstein monofilament testing. Roshen scores will be computed based on the filaments that are perceived by the participant. The range of Roschen scores can be from 0 -5. Higher scores mean better touch perception. **Measure:** Touch perception using Semmes Weinstein monofilament testing **Time Frame:** Assessment will be performed before, immediately after, and 30 minutes following the administration of the intervention in a single visit **Description:** Fine motor control at the wrist and hands will be measured by evaluating the performance of the participants in tracking various forms of trajectory by moving their wrist and hand in flexion-extension movements. **Measure:** Fine motor control as assessed by visuomotor tracking performance **Time Frame:** Assessment will be performed before, immediately after, and 30 minutes after the administration of the intervention in a single visit #### Secondary Outcomes **Description:** The Essential Tremor Rating Assessment Scale (TETRAS) will be used to quantify tremor of the participants. The TETRAS scale ranges from 0 - 64. Higher scores mean worse tremor in the participant. **Measure:** Tremor assessment using TETRAS **Time Frame:** Assessment will be performed before, immediately after, and 30 minutes after the administration of the intervention in a single visit **Description:** Upper limb kinematics using inertial measurement units (IMUs) will be used to quantify tremor of the participants. IMUs will be placed on the hand, forearm, and upper arm of the participants. **Measure:** Tremor assessment using arm kinematics **Time Frame:** Assessment will be performed before, immediately after, and 30 minutes after the administration of the intervention in a single visit ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria for Healthy Participants: * Age from 18 to 80 years, inclusive * No history of a brain and/or skull lesion * Normal hearing and (corrected) vision * Able to understand and give informed consent * No neurological disorders * No tremor * Able to understand and speak English Exclusion Criteria for Healthy Participants: * History of significant head trauma (i.e., extended loss of consciousness, neurological damage) * Known structural brain lesion * Prior neurosurgical procedures * Tremors (as determined by study team) * Co-existence of other neurological diseases * Parkinsonism * Medical (e.g., cardiological, renal, hepatic, oncological) or psychiatric disease that would interfere with study procedures * Pathology that could cause abnormal movements of extremities (e.g., epilepsy, stroke, marked arthritis, etc.) * Inability to perform study tasks or assessments (e.g., follow instructions to stay still during asES procedures) or unable/unwilling to complete study forms * Non-prescribed drug use or recreational marijuana use * History of current substance abuse (exception: current nicotine use is allowed) * Pregnancy * Prisoners Inclusion Criteria for ET Patients: * Age from 18 to 80 years, inclusive * No prior history of skull lesions or craniotomy * Normal hearing and (corrected) vision * Able to understand and give informed consent * Diagnosis of ET (Tremor Research investigation Group criteria) by a physician * At least moderate-severe tremor (based on the TETRAS Tremor Rating Scale) in an upper limb with pure flexion-extension wrist tremor during posture * Stable medication doses for at least 30 days prior to study enrollment and during entire study period * Able to understand and speak English Exclusion Criteria for ET Patients: * History of significant head trauma (i.e., extended loss of consciousness, neurological damage) * Known structural brain lesion * Prior neurosurgical procedures * Mixed or complex tremors (as determined by study team) * Co-existence of other neurological diseases * Parkinsonism * Medical (e.g., cardiological, renal, hepatic, oncological) or psychiatric disease that would - interfere with study procedures * Pathology that could cause abnormal movements of extremities (e.g., epilepsy, stroke, marked arthritis, etc.) * Inability to perform the study tasks or assessments (e.g., follow instructions to stay still during asES procedures) or unable/unwilling to complete study forms * Non-prescribed drug use or recreational marijuana use * History of current substance abuse (exception: current nicotine use is allowed) * Pregnancy * Prisoners **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jose L Pons, PhD **Phone:** 312-238-4549 **Role:** CONTACT **Contact 2:** **Name:** Grace Hoo, MS **Phone:** 312-238-4548 **Role:** CONTACT #### Locations **Location 1:** **City:** Chicago **Country:** United States **Facility:** Shirley Ryan AbilityLab **State:** Illinois **Zip:** 60611 #### Overall Officials **Official 1:** **Affiliation:** Shirley Ryan AbilityLab **Name:** Jose L Pons, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020820 - Term: Dyskinesias - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000002493 - Term: Central Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16956 - Name: Tremor - Relevance: HIGH - As Found: Tremor - ID: M22137 - Name: Essential Tremor - Relevance: HIGH - As Found: Essential Tremor - ID: M22574 - Name: Dyskinesias - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014202 - Term: Tremor - ID: D000020329 - Term: Essential Tremor ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428513 **Acronym:** HCTP **Brief Title:** Health Coaching Telemedicine Program for Lung Transplant Candidates With End-stage Lung Disease. **Official Title:** SHEBA-9466-22-RP-CTIL Health Coaching Telemedicine Program for Lung Transplant Candidates With End-stage Lung Disease: A Feasibility Study #### Organization Study ID Info **ID:** 9466-22-SMC #### Organization **Class:** OTHER_GOV **Full Name:** Sheba Medical Center ### Status Module #### Completion Date **Date:** 2025-12 **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:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-19 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2023-11-22 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Sheba Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Lung transplantation has become standard of care for selected patients with end stage pulmonary disease. While on the lung transplantation waiting list, patient health, emotional wellbeing and quality of life can deteriorate. By improving or changing patient physical activity, healthy nutrition, tobacco cessation, patient preparation for lung transplantation can be optimized, risk of complications can be reduced, and outcomes post transplantation can be improved. The potential of health coaching to improve health outcomes has been demonstrated in several chronic diseases such as type 2 diabetes mellitus, congestive heart failure, and rheumatoid arthritis. In addition, health coaching was proven effective through telemedicine. No studies so far have addressed the potential effect of a pre-transplant health coaching program on existing medical conditions, transplant rates and post-transplant outcomes. Investigators hypothesized that health coaching can improve health outcomes and survival of lung transplantation candidates by supporting and growing patients' capacity to cope with the demands of their end stage pulmonary disease. **Detailed Description:** SCIENTIFIC BACKGROUND Lung transplantation has become an established standard of care for selected patients with end stage pulmonary disease. Candidate selection begins with a referral from the non-transplant pulmonologist and if deemed suitable, begins an evaluation process that determines eligibility for transplantation. Candidates who meet all requirements are listed for transplantation. While on the waiting list, physical activity, healthy nutrition, tobacco cessation, and a few other health behaviors are essential to maintain candidacy. In addition to the physical limitations imposed by end-stage lung disease, transplant candidates face a range of psychosocial issues relating to changes in functional capacity, including social roles, relationships, perceptions of self, and life plans and goals. Efforts targeted at these domains may improve quality of life, optimize patient preparation for transplantation, reduce the risk of complications, and improve outcomes. Health coaching has emerged as a widely adopted intervention that may help individuals with chronic conditions adopting health behaviors that improve quality of life, health, and emotional wellbeing. It is a patient-centered approach wherein the individual and coach work together through active health education processes and motivational interviewing to set goals that improve health outcomes. The potential of health coaching to improve health outcomes has been demonstrated in several chronic diseases such as type 2 diabetes mellitus, congestive heart failure, and rheumatoid arthritis. In addition, health coaching was proven effective through telemedicine; and recently, it has developed national standards and accreditations in the US. Therefore, health coaching was selected as our telemedicine approach, and a novel health coaching telemedicine program (HCTP) was developed at Sheba Medical Center for lung transplantation candidate. No studies so far have addressed the potential effect of pre-transplant health coaching program on existing medical conditions, transplant rates and post-transplant outcomes. Investigators hypothesized that health coaching can improve health outcomes and survival of lung transplantation candidates by supporting and growing patients' capacity to cope with the demands of their end stage pulmonary disease. SPECIFIC AIMS Specific Aim 1: To assess whether HCTP is feasible among participants with end stage lung disease who are candidate for lung transplantation. Specific Aim 2: To collect data on the impact of a HCTP on health-related quality of life, lung functions, functional capacity, cardiometabolic parameters (e.g., weight, lipid profile, fasting glucose), and hospital services utilization of participants with end stage lung disease who are candidate for lung transplantation Specific Aim 3: To collect data on experience and capacity to cope with the demands of the illness of participants with end stage lung disease who are candidate for lung transplantation. STUDY DESIGN Detailed Plan of the Study The health coaching tele-medicine program study is a randomized controlled feasibility trial in which study participants are randomly assigned into either a study group or a control group. Source of participants and recruitment methods: This study is a collaboration between the lung transplant program and the center of lifestyle medicine, within Sheba's cardiometabolic prevention center, a unique center in Israeli health care services that promote innovative lifestyle interventions. Our target population is 56 adults with end stage lung disease who refer to The Sheba Medical Center lung transplantation program for evaluation; over a period of 12 months. METHODS: This study is expected to be ongoing for 24 months but conducted for each subject in a 12-month timeframe. Data collection time points every quarter for 12 months. Assessment include: * Health related quality of life (HRQL) * Lung functions tests * Hospital services usage: will be evaluate using the hospital medical record. These services include health professional services in the rehabilitation hospital. * Health behaviors: Nutritional intake will be evaluated by a 4-day food record. * Physical activity questionnaire. * Cardiometabolic outcomes * Qualitative data: Investigators also expect to deepen our understanding about participants' experience in the program and their capacity to cope with the demands of their illness through the study's qualitative component. Qualitative data will be included in analyses for both participants who completed the intervention and participants who dropout. Information regarding demographics, medications, other health behaviors (e.g., smoking status, physical activity status), and use of other nutritional education resources during the program (e.g., dietitian and physician visits, apps) will be extracted from the medical record. PROCEDURE INTERVENTION: Both the intervention and control groups will receive the standard care for lung transplantation candidates. In addition for: Study group participants - study group participants will complete a HCTP program which includes 12 weekly one-on-one 30-minute tele-sessions through Zoom, delivered by a credential health coach (health care professional who also completed a health coaching certification). Prior to the beginning of the program participant will complete intake assessment that will include past and current medical history, medications, current lifestyle practices, self-reported health status, psychosocial status, and other relevant information. At the first session, participants identify their health vision and 3-month health goals. During each subsequent meeting, participants will review their progress towards reaching the prior week's goals and identify goals for the coming week, using a self-discovery process facilitated by the health coach. Based on the initial assessment individualized action plan will be formulated to help each participant achieve his/her goals. The action plan will focus on important lifestyle practices (especially physical activity/exercise training, correct nutrition, weight management, tobacco cessation, and stress management. Based on their interaction with the participant and/or input from the participant's physician or other health care providers, health coaches will revise goals and action plans. When patients detect the need for health care advice that is necessary for their progress, s/he will be referred to health care professionals in the rehabilitation hospital that provide care for lung transplantation candidate. 2. Control group: Control group participants will receive HCTP after the end of the study. Statistical methods: Patients will be randomized 1:1 between the 2 study arms. Investigators will use block randomization stratified by site. Power calculation indicates that 28 participants (14/ group) are required in each of the intervention groups in order to estimate a retention rate of 80% with 10% precision and 80% confidence. Every effort will be made to minimize dropouts, and further to follow-up with participants who do not complete the program to obtain measurements of study outcomes. In the event of missing data, the impact will be assessed and addressed, if necessary, according to current best practices. Demographic and other baseline characteristics as well as feasibility outcomes will be summarized using means and standard deviations for normally distributed variables, medians and interquartile ranges for non-normally distributed variables, and frequencies for count or dichotomous variables. For all outcomes and to address exploratory hypotheses. P-values and 95% confidence intervals will be presented for all effects of interest. ### Conditions Module **Conditions:** - Copd - End Stage Lung Disease ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 56 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Complete a HCTP program which includes 12 weekly one-on-one 30-minute tele-sessions through Zoom. Follow up will be for a year in total. **Intervention Names:** - Behavioral: HCTP **Label:** HCTP program **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control group participants do not receive the intervention but will receive HCTP after the end of the study. **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - HCTP program **Description:** 10 weekly 1-on-1 30-minute tele-sessions via Zoom, delivered by a certified health coach. At baseline assessment including full medical history, medications, lifestyle practices, self-reported health status, psychosocial status, and other relevant information will be taken. At the first session, participants identify their health vision and 3-month health goals. At subsequent meetings, participants review their progress towards reaching the prior week's goals and identify goals for the next week. An individualized action plan will be formulated to help each participant achieve their goals. The action plan will focus on important lifestyle practices (physical activity/exercise training, correct nutrition, weight management, tobacco cessation, and stress management. Patients can request further health care advice felt necessary for their progress, and will be referred to health care professionals in the rehabilitation hospital that provide care for lung transplantation candidates. **Name:** HCTP **Other Names:** - Health coaching telemedicine program **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Retention of participants in the program/research. Calculated as a percentage of participants completing all visits of the intervention. **Measure:** Feasibility outcomes **Time Frame:** Every quarter for one year **Description:** Participant percentage that adhered to the intervention. Calculated as a percentage of the intervention. **Measure:** Participant adherence **Time Frame:** Every quarter for one year **Description:** FEV1/FVC ratio expressed as a percentage. The lower the percentage, the more severe the lung condition. Predictive (normal) values are equal to or greater than 70%. Abnormal values are graded: Mild: 60-69% Moderate: 50-59% Severe: Under 50% **Measure:** Forced expiratory volume in one second (FEV1) and Forced vital capacity (FVC) ratio: FEV1/FVC Ratio **Time Frame:** Every quarter for one year **Description:** Total lung capacity (TLC), recorded in Liters (L) **Measure:** Total lung capacity (TLC) **Time Frame:** Every quarter for one year **Description:** Changes in DLCO test from the baseline used to determine progression or regression of disease. DLCO (also known as Transfer factor for carbon monoxide (TLCO)) Units ml/min/mmHg/L. Initial and final Carbon monoxide (CO) concentration, in mmol CO, and breath-holding time in minutes, are used to calculate DLCO Severity and classification of DLCO reduction: Normal DLCO: \>75% of predicted, up to 140% Mild: 60% to LLN (lower limit of normal) Moderate: 40% to 60% Severe: \<40% **Measure:** Diffusing capacity of the lungs for carbon monoxide (DLCO) **Time Frame:** Every quarter for one year **Description:** To assess a patient's functional status / to track functional change resulting from disease progression or therapeutic intervention. The higher a patient's score, the better their lung capacity. A low score correlates with lower function. Calculation measurements: weight in kilograms, height in centimetres, age of patient in years, distance walked meters. Calculation MEN: 6MWD = (7.57 × height) - (5.02 × age) - (1.76 × weight) - 309 WOMEN: 6MWD = (2.11 × height) - (2.29 × weight) - (5.78 × age) + 667 Heart rate and oxygen saturation will also be measured separately but included to provide an assessment of functional status. **Measure:** Functional lung capacity using six-minute walk test (6MWT) **Time Frame:** Every six months for one year **Description:** Oxygen saturation, measured as a percentage. Taken at rest and breathing room air, and during taken during exercise test. This is used as part of Functional lung capacity using six-minute walk test (6MWT) to assess functional capacity. **Measure:** Oxygen saturation **Time Frame:** Every six months for one year **Description:** Heart Rate measured as a beats per minute. Taken at rest and breathing room air, and during taken during exercise test. This is used as part of Functional lung capacity using six-minute walk test (6MWT) to assess functional capacity. **Measure:** Heart Rate **Time Frame:** Every six months for one year **Description:** Physical activity will be measured by the international physical activity questionnaire. A change in physical activity Scoring a HIGH level of physical activity on the IPAQ means the participant's physical activity levels equate to approximately one hour of activity per day or more at least a moderate intensity activity level. Scoring a MODERATE level of physical activity on the IPAQ means the participant is doing some activity more than likely equivalent to half an hour of at least moderate intensity physical activity on most days. Scoring a LOW level of physical activity on the IPAQ means that the participant is not meeting any of the criteria for either MODERATE of HIGH levels of physical activity. **Measure:** Physical activity variable **Time Frame:** Every quarter for one year **Description:** • Health behaviours: Nutritional intake will be evaluated by a 4-day food record in which subjects document and report their food consumption. Intake will be analyzed for its caloric content, nutritional values and group classifications and its Mediterranean index. **Measure:** Behavioural and nutritional evaluation **Time Frame:** Every quarter for one year **Description:** Evaluated using the St. George's respiratory questionnaire. Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.Scores range from 0 to 100, with higher scores indicating more limitations. **Measure:** Patient functioning and quality of life **Time Frame:** Every quarter for one year #### Secondary Outcomes **Description:** Height (cm) and weight (kg) will be combined to report BMI in kg/m\^2 **Measure:** Body mass index (BMI) **Time Frame:** Every quarter for one year **Description:** Hemoglobin A1c (glycated hemoglobin), HbA1c measured as percentage (%) Changes in measurements between visits over time will be analysed. **Measure:** Glucose control - glycated hemoglobin HbA1c **Time Frame:** Every quarter for one year **Description:** Includes total cholesterol, HDL-cholesterol, LDL-cholesterol, non-HDL cholesterol and triglycerides. Measured in milligrams (mg) of cholesterol per deciliter (dL) of blood (mg/dl) Changes in measurements between visits over time will be analysed. **Measure:** Blood lipid profile **Time Frame:** Every quarter for one year **Description:** Cardio-metabolic outcomes: (2) blood pressure systolic and diastolic Changes in measurements between visits over time will be analysed. **Measure:** Cardio-metabolic evaluation **Time Frame:** Every quarter for one year **Description:** Changes in the number of hospital services / engagements used i.e., physiotherapist, social worker, nutritionist, hospitalizations, and emergency room admissions engagements per month. **Measure:** Rate of hospital service usage **Time Frame:** One year **Description:** Qualitative data: To deepen our understanding about subjects' experience in the program and their capacity to cope with the demands of their illness through the study's qualitative component. Qualitative data will be included in analyses for both subjects who completed the intervention and subjects who dropout.Baseline/Visit 1 - a questionnaire with open questions to fill out about the subject's challenges and expectations before the program starts (both intervention and control group). **Measure:** Participant perception of the program **Time Frame:** Month 0 **Description:** Qualitative data Visit 2 - a questionnaire with open retrospective questions to fill out about the subject's experience at the HCTP (Intervention group only) **Measure:** Behavioural and psychosocial outcome **Time Frame:** Month 3 **Description:** Qualitative data Visit 3 - a follow-up interview to sum up the subject's experience **Measure:** Participant evaluation **Time Frame:** Month 6 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects with end stage lung disease assessed suitable for lung transplantation. * Able and willing to watch online instructional videos. Exclusion Criteria: * Unwilling or unable to provide consent * Uncooperative or combative * Unable to use / connect to video conferencing **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Liran Levy, MD **Phone:** +97235302735 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Rani Polak, PhD **Phone:** +97235307824 **Role:** CONTACT #### Locations **Location 1:** **City:** Ramat Gan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Rani Polak, PhD - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Daniel Zubli, BSc - **Role:** CONTACT ***Contact 3:*** - **Name:** Liran Levi, MD - **Role:** SUB_INVESTIGATOR **Country:** Israel **Facility:** Sheba Medical Center **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Sheba Medical Center **Name:** Rani Polak, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000012120 - Term: Respiration Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11168 - Name: Lung Diseases - Relevance: HIGH - As Found: Lung Disease - ID: M14968 - Name: Respiratory Insufficiency - Relevance: HIGH - As Found: End Stage Lung Disease - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M14957 - Name: Respiration Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008171 - Term: Lung Diseases - ID: D000012131 - Term: Respiratory Insufficiency ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428500 **Brief Title:** QTX3046 in Patients With KRAS G12D Mutations **Official Title:** A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of QTX3046 in Patients With Advanced Solid Tumors With KRAS G12D Mutations #### Organization Study ID Info **ID:** QTX3046-101 #### Organization **Class:** INDUSTRY **Full Name:** Quanta Therapeutics ### Status Module #### Completion Date **Date:** 2027-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **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:** Quanta Therapeutics #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab. ### Conditions Module **Conditions:** - Advanced Solid Tumor ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** QTX3046 will be administered orally at escalating doses as defined in the protocol based on dose level assignment **Intervention Names:** - Drug: QTX3046 **Label:** Part 1a: QTX3046 monotherapy dose escalation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** QTX3046 will be administered orally at escalating doses as defined in the protocol in combination with intravenous cetuximab based on dose level assignment **Intervention Names:** - Drug: QTX3046 - Combination Product: Cetuximab **Label:** Part 1b: QTX3046 dose escalation in combination with cetuximab **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) based on cohort assignment **Intervention Names:** - Drug: QTX3046 **Label:** Part 2: QTX3046 monotherapy dose expansion **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** QTX3046 will be administered orally at the recommended phase 2 dose (RP2D) in combination with intravenous cetuximab based on cohort assignment **Intervention Names:** - Drug: QTX3046 - Combination Product: Cetuximab **Label:** Part 3: QTX3046 dose expansion in combination with cetuximab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part 1a: QTX3046 monotherapy dose escalation - Part 1b: QTX3046 dose escalation in combination with cetuximab - Part 2: QTX3046 monotherapy dose expansion - Part 3: QTX3046 dose expansion in combination with cetuximab **Description:** QTX3046 will be administered at protocol defined dose. **Name:** QTX3046 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Part 1b: QTX3046 dose escalation in combination with cetuximab - Part 3: QTX3046 dose expansion in combination with cetuximab **Description:** Cetuximab will be administered at protocol defined dose. **Name:** Cetuximab **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** Define as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab. **Measure:** Number of participants with Treatment-emergent Adverse Events (TEAEs) **Time Frame:** up to 2 years **Description:** DLTs will be defined as the occurrence of any of the toxicities as described in the protocol. **Measure:** Number of participants with Dose Limiting Toxicities (DLTs) **Time Frame:** up to 21 days #### Secondary Outcomes **Description:** Plasma concentration data for QTX3046 will be used to evaluate the area under the plasma concentration-time curve (AUC) of QTX3046 **Measure:** Area under the plasma concentration-time curve (AUC) of QTX3046 **Time Frame:** up to 2 years **Description:** Plasma concentration data for QTX3046 will be used to evaluate peak plasma concentration (Cmax) of QTX3046 **Measure:** Peak plasma concentration of QTX3046 (Cmax) **Time Frame:** up to 2 years **Description:** The ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1. **Measure:** Objective response rate (ORR) **Time Frame:** up to 2 years **Description:** Duration of response (DoR) is defined as the time between first evidence of objective response and disease progression (as measured by RECIST 1.1) or death, whichever occurs earlier, in subjects who achieve CR or PR. **Measure:** Duration of response (DoR) **Time Frame:** up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutations identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic. * Part 1: Advanced solid tumors with at least one prior systemic therapy. * Evaluable and measurable disease per RECIST v1.1. * Part 2 and 3: Measurable disease per RECIST v1.1 Exclusion Criteria: * Active brain metastasis or carcinomatous meningitis * Significant cardiovascular disease * Active infection requiring intravenous (IV) antibiotics * Prior treatment with a KRAS inhibitor Other protocol-defined Inclusion/Exclusion Criteria may apply **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Quanta Therapeutics Clinical Trials **Phone:** 415-599-3892 **Role:** CONTACT ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - 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: M315 - Name: Cetuximab - Relevance: HIGH - As Found: Side - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068818 - Term: Cetuximab ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428487 **Brief Title:** Neoadjuvant Prolgolimab Monotherapy in Locally Advanced MMR-deficient Colorectal Cancer **Official Title:** Phase II,Open-label, Non-randomized Study of Neoadjuvant Prolgolimab Monotherapy in Patients With Locally Advanced Colorectal Cancer With Microsatellite Instability (MSI)/Mismatch Repair (dMMR) Deficiency #### Organization Study ID Info **ID:** 125 #### Organization **Class:** OTHER **Full Name:** Blokhin's Russian Cancer Research Center ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2022-03-31 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-03-05 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Blokhin's Russian Cancer Research Center #### Responsible Party **Investigator Affiliation:** Blokhin's Russian Cancer Research Center **Investigator Full Name:** Mikhail Fedyanin **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 this phase II study patients with stage II-III MSI/dMMR colorectal adenocarcinoma with no signs of distant metastases will be treated with immunotherapy (prolgolimab). The duration of treatment is 6 months (12 cycles) **Detailed Description:** In this open-label phase II non-randomized study the investigators will enroll 30 patients with stage II-III MSI/dMMR colorectal cancer to receive anti-PD1 inhibitor prolgolimab. Patients will be treated with 12 cycles (6 months) of prolgolimab 1 mg/kg every 2 weeks until surgery. ### Conditions Module **Conditions:** - Colorectal Cancer **Keywords:** - colorectal cancer - immune checkpoint inhibitors - microsatellite instability ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The patients will be treated with prolgolimab 1 mg/kg every 2 weeks during 6 months (12 cycles) until surgery **Intervention Names:** - Drug: Prolgolimab **Label:** Prolgolimab monotherapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Prolgolimab monotherapy **Description:** Prolgolimab infusions 1 mg/kg **Name:** Prolgolimab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Absence of malignant cells on the specimen of colon/rectal resection in patients who were previously treated with neoadjuvant immunotherapy **Measure:** Pathological complete response (pCR) **Time Frame:** up to 8 months #### Secondary Outcomes **Description:** a continuous response \[complete or partial objective response\] beginning within 6 months of treatment and lasting ≥6 months **Measure:** Durable complete clinical response rate (DRR) **Time Frame:** up to 12 months **Description:** Time from initiation of treatment to the occurrence of disease progression or death. **Measure:** Progression-free survival (PFS) **Time Frame:** 12 months **Description:** Time from initiation of treatment to death. **Measure:** Overall survival (OS) **Time Frame:** 12 months **Description:** percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more) **Measure:** Objective response rate (ORR) **Time Frame:** up to 8 months **Description:** Rate of R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed **Measure:** R0 resection rate **Time Frame:** up to 8 months **Description:** Rate of pathologic response TRG 1-2 **Measure:** Major pathologic response (MPR) **Time Frame:** up to 8 months **Description:** Incidence of Adverse Events assessed according to CTCAE version 5 **Measure:** Incidence of Treatment-Related Adverse Events as assessed by investigator **Time Frame:** up to 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Availability of voluntarily signed informed consent from the patient * Histologically confirmed adenocarcinoma of the colon or rectum; * Locally advanced tumor - cT3-4N0-2M0 according to CT for tumors of the colon and sigmoid colon; cT3 with a depth of tissue invasion ≥5mm (cT2N0 and higher for lower ampullary cancer) or T4 or involvement of the lateral resection margins according to MRI for rectal cancer; * Presence of MSI/dMMR in the tumor; * ECOG 0-2; * No contraindications to surgical treatment of malignancy Exclusion Criteria: * Previous therapy with the inclusion of monoclonal antibodies - anti-PD1, anti-PD-L1, anti PD-L2, anti-CTLA4 antibodies and other immunotherapy drugs * The presence of any other malignant tumor, with the exception of radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years before inclusion in the study * Pregnant and lactating women, as well as planning pregnancy during the period of therapy in a clinical trial and 6 months after the end of therapy * Patients with preserved reproductive potential who refuse to use adequate methods of contraception throughout the study and 6 months after the end of therapy or who agree to abstain from heterosexual contact. * Previous systemic therapy with immunosuppressive drugs (including, but not limited to: prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and TNF \[tumor necrosis factor\] antagonists) within 4 weeks before signing the informed consent form, or the need to use immunosuppressive therapy in during the first year of the study. * The use of systemic glucocorticosteroids (GCS) in replacement doses (for example, in a dose equivalent to 10 mg of prednisolone per day or less), short-term use of systemic GCS (≤7 days), inhaled and topical GCS are allowed. * Active, known or suspected autoimmune diseases (patients with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, as well as autoimmune diseases with only skin manifestations \[for example, vitiligo, alopecia or psoriasis without symptoms of psoriatic arthritis\] are allowed to participate), that do not require systemic therapy); * Patients with HIV infection, active hepatitis B, active hepatitis C. * Life expectancy less than 6 months. * The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the study. * Complicated course of the primary tumor, requiring urgent surgical intervention. * Previously performed radiation or chemotherapy for colorectal cancer, with the exception of cases of metachronous tumors over 5 years ago; * Persistence, progression or recurrence of the underlying disease or the presence of distant metastases * Conditions limiting the patient's ability to comply with the requirements of the protocol (in the opinion of the investigator); * Vaccination with live vaccines within 28 days before randomization; * Participation in other interventional clinical trials less than 30 days before randomization (except in cases of dropout before the introduction of study therapy) and while participating in an ongoing clinical trial; * Significant adverse events from previous therapy, with the exception of chronic and/or irreversible events that cannot influence the assessment of the safety of the study therapy (for example, alopecia); * Hypersensitivity or allergic reactions to the administration of drugs manufactured using Chinese hamster ovary cells, severe allergic reactions, anaphylaxis or other hypersensitivity reactions to chimeric or humanized antibodies, prolgolimab or any of the components of the study drug. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Olesya Kuznetsova **Phone:** +79279702179 **Role:** CONTACT #### Locations **Location 1:** **City:** Moscow **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Olesya Kuznetsova - **Phone:** +79279702179 - **Role:** CONTACT **Country:** Russian Federation **Facility:** N.N. Blokhin NMRCO **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## 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 - ID: D000042822 - Term: Genomic Instability - 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: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M27510 - Name: Microsatellite Instability - Relevance: HIGH - As Found: Microsatellite Instability - 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 - ID: M25088 - Name: Genomic Instability - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms - ID: D000053842 - Term: Microsatellite Instability ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428474 **Brief Title:** Implementation of Oral Health Educational Program on Orphan Children **Official Title:** Effectiveness of Oral Health Educational Program on the Knowledge and Practice of Institutionalized Orphan Children in Alexandria, Egypt #### Organization Study ID Info **ID:** UREAC-04-3-219 #### Organization **Class:** OTHER **Full Name:** Pharos University in Alexandria ### Status Module #### Completion Date **Date:** 2024-03-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-03-01 **Type:** ACTUAL #### Start Date **Date:** 2023-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Pharos University in Alexandria #### Responsible Party **Investigator Affiliation:** Pharos University in Alexandria **Investigator Full Name:** Inas Karawia **Investigator Title:** Lecturer, Faculty of Dentistry, Pharos University **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Oral diseases are most prevalent among children. Orphans children are one of the most vulnerable groups to diseases especially oral diseases. Knowledge toward oral cavity and oral hygiene measures is low among this group, leading to poor practice of oral hygiene measures, which outcomes to oral diseases. Implementation of health education program orphan children who are living in orphanages is important. the aim of this study is to evaluate the effectiveness of health education program on the knowledge and practice of orphan children. 80 children were enrolled in this study from different orphanages in Alexandria, Egypt. Knowledge and practice were evaluated before and after intervention using predesigned questionnaire, and oral hygiene was evaluated using simplified oral hygiene index **Detailed Description:** Background: Dental caries is a lifetime disease, with highest priority risk group between 11-14 years of age group. Environmental factors such as culture, socioeconomic status, life style and dietary pattern can have a greater impact on caries-resistance or development. It has been well-documented in dentistry and other health areas that correct health information or knowledge alone does not necessarily lead to desirable health behaviors. However knowledge gained may serve as a tool to empower population groups with accurate information about health and health care technologies, enabling them to take action to protect their health. According to global review of oral health, despite great improvements in the oral health of populations in several countries, the oral problem persists. This is particularly among underprivileged groups, in both developed and developing countries. One of the known high-risk groups is orphans. An orphan is defined as a child under 18 years, who has lost his father, mother, or both In developing countries like Egypt, there is little access to oral healthcare due to a lack of knowledge, insufficient financial resources, and inadequate dental manpower in the national healthcare system Aim of the study: is to evaluate the effectiveness of oral health education programs on knowledge and practice of participated orphan children Materials and Methods: A specially designed questionnaire was used to assess the dental problems and existing oral hygiene maintenance practice among children between 6 - 12 years of age (n=80) in orphanages. DMFT \[Decayed Missing Filled Teeth index (for permanent teeth)\] and dft \[ decayed filled teeth index ( for primary teeth) \], pre- and post-interventional intra-oral examinations was carried out to check their oral hygiene status which included and OHIS (Simplified Oral Hygiene Index). Information regarding tooth cleaning habits was obtained by a questionnaire to the children themselves, before, immediately and after 6 months. Statistical analysis Collected data will be analyzed using SPSS software ### Conditions Module **Conditions:** - Dental Caries - Knowledge - Practice **Keywords:** - Oral health education - knowledge - practice - oral hygiene ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 80 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Orphan children aged 6-12 **Intervention Names:** - Other: Health education **Label:** children who are living in orphanages **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - children who are living in orphanages **Description:** Oral health education program designed for orphans children **Name:** Health education **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The questionnaire consisted of 8 questions to collect data about the children knowledge about teeth number in each dentition, the parts of teeth and its function, causes of oral disease, and how to prevent it. **Measure:** Knowledge will be assessed using predesigned questionnaire **Time Frame:** Knowledge was measured immediately and after 6 months #### Secondary Outcomes **Description:** practices were measured using a predesigned questionnaire, consisting of 6 questions to collected data about the children's practices regarding tooth brushing, flossing and eating habits. **Measure:** Practice will be assessed using predesigned questionnaire **Time Frame:** Practice was evaluated after 6 months **Description:** Oral hygiene was evaluated using the simplified oral hygiene index - scores were ranged from 0-6 and 6 is the poorest oral hygiene score **Measure:** oral hygiene **Time Frame:** oral hygiene was evaluated after 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Orphan children aged between 6-12 years old Exclusion Criteria: * children suffering from any systemic diseases acute or chronic, congenital abnormalities, psychological or behavioral problems, or receiving medications **Maximum Age:** 12 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Alexandria **Country:** Egypt **Facility:** Pharos University in Alexandria **Zip:** 536733 #### Overall Officials **Official 1:** **Affiliation:** Pharos University in Alexandria **Name:** Inas M Karawia **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017001 - Term: Tooth Demineralization - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6928 - Name: Dental Caries - Relevance: HIGH - As Found: Dental Caries - ID: M19339 - Name: Tooth Demineralization - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003731 - Term: Dental Caries ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428461 **Brief Title:** Evaluation of Supraclavicular Brachial Plexus Blocks at Various Volumes: Impact on Optic Nerve Sheath Diameter **Official Title:** Evaluation of Supraclavicular Brachial Plexus Blocks at Different Volumes Under Ultrasound Guidance in Upper Extremity Surgery and Their Impact on Optic Nerve Sheath Diameter #### Organization Study ID Info **ID:** PAU-ANEST-RHE-IC-01 #### Organization **Class:** OTHER **Full Name:** Pamukkale University ### Status Module #### Completion Date **Date:** 2024-09-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Pamukkale University #### Responsible Party **Investigator Affiliation:** Pamukkale University **Investigator Full Name:** ismet çopur **Investigator Title:** Investigator - Medical doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aimed to evaluate the anesthesia adequacy, side effects, and complication rates, as well as the postoperative pain relief effectiveness of supraclavicular brachial plexus blocks administered at different volumes under ultrasound guidance. Additionally, the investigators utilized ultrasound to measure optic nerve sheath diameters and investigated their relationship with intracranial pressure across varying block volumes. **Detailed Description:** Regional anesthesia involves temporarily blocking nerve transmission and pain sensation in specific areas of the body without causing loss of consciousness. Regional anesthesia techniques include peripheral nerve blocks (PNB), topical anesthesia, infiltration anesthesia, regional intravenous anesthesia (RIVA), and neuroaxial blocks (spinal and epidural anesthesia). Brachial plexus blocks are among the most commonly used regional anesthesia methods within peripheral nerve block applications. Peripheral nerve blocks of the upper extremity can be used either alone for surgical anesthesia or added to general anesthesia for postoperative pain control. Brachial plexus blocks can be performed using various approaches including interscalene, supraclavicular, infraclavicular, and axillary approaches. The supraclavicular block aims to effectively control pain through a procedure targeting the shoulder and upper extremity nerves known as the brachial plexus. Complications of supraclavicular blocks may include pneumothorax secondary to lung trauma, hoarseness due to ipsilateral recurrent laryngeal nerve blockade, Horner syndrome due to stellate ganglion blockade, and hemidiaphragmatic paralysis due to phrenic nerve blockade. The incidence and severity of these complications are reduced with the use of ultrasound (USG) guidance and low-volume techniques. Intracranial pressure (ICP) refers to the pressure formed by the brain and spinal fluid, tissues, and blood surrounding the brain and spinal cord. Normally ranging between 5-15 mmHg, this pressure is critical for brain function and circulation. Abnormal increases in intracranial pressure can lead to intracranial hypertension, with main causes including brain tumors, edema, head trauma, brain aneurysms, intracranial hemorrhage, and issues related to the production and drainage of cerebrospinal fluid. External ventricular drainage (EVD) catheterization is the gold standard method for evaluating increased intracranial pressure. Measurement of optic nerve sheath diameter (ONSD) has been described as a valuable diagnostic method in clinical applications for evaluating intracranial pressure. Observational studies have shown that in cervical sympathetic blocks and interscalene blocks, indirect increases in intracranial pressure can be demonstrated through ultrasound (USG) measurements of optic nerve sheath diameter. It has been shown that hemidiaphragmatic paralysis due to ipsilateral phrenic nerve involvement, which is frequently seen in interscalene brachial plexus blocks, also occurs in supraclavicular brachial plexus blocks in a volume-dependent manner. There are studies in the literature on supraclavicular block applications with different volumes and doses. However, the investigators have not come across a study evaluating the clinical outcomes of optic nerve sheath diameter measurement along with anesthesia quality, side effects, and complications in ultrasound-guided supraclavicular blocks at different volumes. In this study, the investigators aimed to evaluate the anesthesia adequacy, side effects, and complication rates, as well as the postoperative analgesic efficacy of supraclavicular brachial plexus blocks performed at different volumes in our clinical practice under ultrasound guidance. Additionally, the investigators aimed to measure optic nerve sheath diameters with ultrasound and establish their relationship with intracranial pressure according to these different volumes. ### Conditions Module **Conditions:** - Upper Limb Injury - Intracranial Pressure Increase **Keywords:** - Supraclavicular brachial plexus block - Intracranial pressure - Optic nerve sheath diameter ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Four different volumes will be administered for the supraclavicular block: 1. For the control group, we plan to use a mixture of 7.5 mL of 0.5% bupivacaine (BUVICAINE-POLIFARMA-TEKIRDAG) and 7.5 mL of 2% prilocaine (PRILOC-VEM İlaç San. ve Tic. A.Ş. Kapaklı/TEKIRDAĞ) for a total of 15 mL. 2. For the research group, we plan to use a mixture of 10 mL of 0.5% bupivacaine and 10 mL of 2% prilocaine for a total of 20 mL. 3. For the research group, we plan to use a mixture of 12.5 mL of 0.5% bupivacaine and 12.5 mL of 2% prilocaine for a total of 25 mL. 4. For the research group, we plan to use a mixture of 15 mL of 0.5% bupivacaine and 15 mL of 2% prilocaine for a total of 30 mL. Glob axis and optic nerve sheath diameter measurements for both eyes will be re-measured and recorded using B-mode ultrasound at 20 and 60 minutes after the supraclavicular block. ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** SCREENING #### Enrollment Info **Count:** 64 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** For the control group, we plan to use a mixture of 7.5 mL of 0.5% bupivacaine (BUVİCAİNE®) and 7.5 mL of 2% prilocaine (PRİLOC®) for a total of 15 mL. single shot supraclavicular brachial plexus block. **Intervention Names:** - Procedure: Supraclavicular brachial plexus block - Device: Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound - Device: Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement - Device: End-Tidal Carbon Dioxide (EtCO2) Measurement **Label:** Total of 15 mL. **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** For the research group, we plan to use a mixture of 10 mL of 0.5% bupivacaine (BUVİCAİNE®) and 10 mL of 2% prilocaine (PRİLOC®) for a total of 20 mL. **Intervention Names:** - Procedure: Supraclavicular brachial plexus block - Device: Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound - Device: Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement - Device: End-Tidal Carbon Dioxide (EtCO2) Measurement **Label:** Total of 20 mL. **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** For the research group, we plan to use a mixture of 12.5 mL of 0.5% bupivacaine (BUVİCAİNE®) and 12.5 mL of 2% prilocaine (PRİLOC®) for a total of 25 mL. **Intervention Names:** - Procedure: Supraclavicular brachial plexus block - Device: Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound - Device: Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement - Device: End-Tidal Carbon Dioxide (EtCO2) Measurement **Label:** Total of 25 mL. **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** For the research group, we plan to use a mixture of 15 mL of 0.5% bupivacaine (BUVİCAİNE®) and 15 mL of 2% prilocaine (PRİLOC®) for a total of 30 mL. **Intervention Names:** - Procedure: Supraclavicular brachial plexus block - Device: Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound - Device: Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement - Device: End-Tidal Carbon Dioxide (EtCO2) Measurement **Label:** Total of 30 mL. **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Total of 15 mL. - Total of 20 mL. - Total of 25 mL. - Total of 30 mL. **Description:** A supraclavicular brachial plexus block will be performed under ultrasound guidance. The patient will be taken to the preoperative block room, positioned supine with the bed elevated at a 30° angle, and the head turned away from the arm being blocked. To avoid intraneural injection, the block will use both ultrasound and a nerve stimulator (Plexygon, Vygon-Italy) with a 22G 50 mm 20° stimulating needle (Echoplex, Braun-France). A low-frequency ultrasound probe will be placed above the clavicle to visualize the subclavian artery and vein. Using an in-plane approach, the needle will be inserted laterally to medially from the mid-clavicular point through the skin and subcutaneous tissue. Under ultrasound guidance, the needle will be advanced towards the anatomical corner where the brachial plexus and subclavian artery are adjacent (corner pocket), and a local anesthetic agent will be injected to perform the block. **Name:** Supraclavicular brachial plexus block **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Total of 15 mL. - Total of 20 mL. - Total of 25 mL. - Total of 30 mL. **Description:** Before the block, both eyes will be measured for optic nerve sheath diameter (ONSD) using B-mode ultrasound (USG) with a GE LOGIQ E device. The patient will be supine with the bed elevated at a 30° angle, eyes closed, and a protective barrier applied. Both globes will be filled with water-soluble ultrasound gel, and imaging will be done with a 7.5 MHz linear probe at a 7 cm depth. For transverse ONSD measurement, the probe will be placed transversely in the coronal plane, with the marker notch pointing right. When the optic nerve entry into the globe is clear, transverse ONSD will be measured 3 mm below. For sagittal measurement, the probe will be placed sagittally in the coronal plane, with the marker notch pointing towards the body. Sagittal ONSD will be measured 3 mm below the entry point. Both internal and external diameters of the optic nerve sheath will be measured in transverse and sagittal planes, and the transverse diameter of the globe will also be measured. **Name:** Measurement of Optic Nerve Sheath Diameter (ONSD) Using B-Mode Ultrasound **Type:** DEVICE #### Intervention 3 **Arm Group Labels:** - Total of 15 mL. - Total of 20 mL. - Total of 25 mL. - Total of 30 mL. **Description:** Investigator plan to measure the Perfusion Index (PI) as an objective method for determining the success of peripheral nerve blocks, different from traditional tests. PI is an indicator of peripheral perfusion that can be continuously measured non-invasively with a pulse oximeter. PI represents the ratio of pulsatile blood flow to non-pulsatile blood flow in peripheral tissue. The Mindray uMEC 12 device will be used for this measurement. **Name:** Assessment of Peripheral Nerve Block Success Using Perfusion Index Measurement **Type:** DEVICE #### Intervention 4 **Arm Group Labels:** - Total of 15 mL. - Total of 20 mL. - Total of 25 mL. - Total of 30 mL. **Description:** End-tidal carbon dioxide (EtCO2) measurement: The Medtronic Capnostream 35 device will be used for EtCO2 measurements. All patients will receive oxygen support at a rate of 1-2 L/min. If peripheral oxygen saturation falls below 95%, oxygen support will be increased to 3-6 L/min via nasal cannula. **Name:** End-Tidal Carbon Dioxide (EtCO2) Measurement **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Optic nerve sheath diameter will be measured using B-mode ultrasonography. **Measure:** Optic nerve sheath diameter measured by ultrasonography **Time Frame:** Before block, After block 20 minutes, After block 60 minutes #### Secondary Outcomes **Description:** PI, an objective method different from traditional tests, to determine the success of peripheral nerve block. PI is an indicator of peripheral perfusion that can be measured continuously and non-invasively with a pulse oximeter. PI is the ratio of pulsatile blood flow to non-pulsatile blood flow in peripheral tissue. Its normal value ranges from 0.02 to 20. After peripheral nerve block, vasodilation occurs in the vessels due to sympathetic blockade, resulting in an increase in PI values, which occurs earlier than motor and sensory block. PI monitoring provides more objective results for evaluating the onset of the block. The cut-off value indicating that the block is successful is a PI increase to 3.03 times the baseline value 10 minutes after the block is administered. **Measure:** Perfusion index (PI) **Time Frame:** The PI values will be measured and recorded at 0, 2, 4, 6, 8, 10, 15, 20, and 25 minutes in both arms. **Description:** Non-invasive EtCO2 measurement is a method used to monitor the concentration of carbon dioxide (CO2) at the end of expiration. **Measure:** Non-invazive end-tidal carbon dioxide (EtCO2) **Time Frame:** EtCO2 will be measured and recorded at 0, 10, 20, 30, 60 minutes, and at the end of surgery after the block is performed. **Description:** The pinprick test is a clinical procedure used to evaluate sensory nerve function. A small, sharp object, such as a pin or needle, is gently pressed against the skin to assess the patient's ability to feel pain. **Measure:** Pinprick test **Time Frame:** The pinprick test will be evaluated 5 minutes after the block is performed and subsequently at 5-minute intervals, up to a maximum of 30 minutes. The results will be recorded throughout these evaluations. **Description:** The Modified Bromage Scale is a clinical tool used to assess the degree of motor block in patients who have received regional anesthesia. The scale ranges from 0 to 3, with each level indicating a different degree of motor impairment: * 0: No motor block; full flexion of knees and feet. * 1: Partial motor block; able to move knees but not feet. * 2: Almost complete motor block; able to move feet only. * 3: Complete motor block; unable to move knees or feet. **Measure:** Modified Bromage Scale **Time Frame:** The Modified Bromage Scale will be evaluated 5 minutes after the block is performed and subsequently at 5-minute intervals, up to a maximum of 30 minutes. The results will be recorded throughout these evaluations. **Description:** The Verbal Pain Score is a subjective measure used to assess a patient's level of pain. Patients are asked to rate their pain on a scale from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable. **Measure:** Verbal Pain Score **Time Frame:** The Verbal Pain Score will be assessed at the following intervals after surgery: immediately in the recovery room, at 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperatively. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged between 18 and 50, of both genders, with planned surgery on the finger, wrist, elbow joint, and distal region, and classified as ASA I-II, will be included in the study. In this study, patients will be informed about the anesthesia method and the tests to be conducted, and those who consent will be asked to sign an informed consent form as voluntary participants. Exclusion Criteria: * Patients who do not accept the procedures and tests * Those with diseases that may cause increased intracranial pressure * Patients with severe heart failure * Patients with second or third degree atrioventricular block * Patients with unstable angina history * Patients with COPD and chronic asthma * Patients with a history of myocardial infarction (MI) within the last 6 weeks * Patients with a heart rate below 50 beats/min * Patients with systolic blood pressure below 90 mmHg * Patients with liver failure * Patients with kidney failure * Patients for whom supraclavicular block anatomically cannot be performed * Those with neurological or psychological diseases that make it difficult to assess the tests * Patients allergic to any of the study drugs * Pregnant women **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** ismet çopur, MD **Phone:** 5318469060 **Phone Ext:** +90 **Role:** CONTACT #### Locations **Location 1:** **City:** Denizli **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** ismet çopur, MD - **Phone:** 5318469060 - **Phone Ext:** +90 - **Role:** CONTACT **Country:** Turkey **Facility:** Pamukkale University **State:** Pamukkale **Zip:** 20020 #### Overall Officials **Official 1:** **Affiliation:** Pamukkale University **Name:** Rıza Hakan Erbay **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Gundogdu O, Avci O. Evaluation of the Effect of Interscalene Brachial Plexus Block on Intracranial Pressure Using Optic Nerve Sheath Diameter and Internal Jugular vein Collapsibility Index. J Coll Physicians Surg Pak. 2022 Oct;32(10):1249-1254. doi: 10.29271/jcpsp.2022.10.1249. **PMID:** 36205266 **Citation:** Pansell J, Bell M, Rudberg P, Friman O, Cooray C. Optic nerve sheath diameter measurement by ultrasound: Evaluation of a standardized protocol. J Neuroimaging. 2022 Jan;32(1):104-110. doi: 10.1111/jon.12936. Epub 2021 Sep 23. **PMID:** 34555223 **Citation:** Hylkema C. Optic Nerve Sheath Diameter Ultrasound and the Diagnosis of Increased Intracranial Pressure. Crit Care Nurs Clin North Am. 2016 Mar;28(1):95-9. doi: 10.1016/j.cnc.2015.10.005. Epub 2015 Dec 23. **PMID:** 26873762 ## 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: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M21521 - Name: Intracranial Hypertension - Relevance: HIGH - As Found: Intracranial Pressure Increase - ID: M4444 - Name: Arm Injuries - Relevance: HIGH - As Found: Upper Limb Injury - ID: M10024 - Name: Hypertension - 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: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000019586 - Term: Intracranial Hypertension - ID: D000001134 - Term: Arm Injuries ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M14191 - Name: Prilocaine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428448 **Brief Title:** Study to Evaluate the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections **Official Title:** A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the Treatment of Ankle-Related Infections #### Organization Study ID Info **ID:** SN-OR-001 #### Organization **Class:** INDUSTRY **Full Name:** OsteoRemedies, LLC ### Status Module #### Completion Date **Date:** 2026-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-08 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** MCRA #### Lead Sponsor **Class:** INDUSTRY **Name:** OsteoRemedies, LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** True **Is Unapproved Device:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is being conducted to evaluate the safety and effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the treatment of ankle-related infections. The study is expected to take approximately 18 months from first subject enrolled to the last follow-up visit. It will have a 12-month enrollment period and a 6-month follow-up. This study is a Prospective, multicenter, single-arm clinical trial. All subjects enrolled in this study will receive the REMEDY SPECTRUM IM Spacer Nail. ### Conditions Module **Conditions:** - Periprosthetic Joint Infection **Keywords:** - Ankle-related Infections ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This is the REMEDY Spectrum IM Spacer Nail treatment group. **Intervention Names:** - Combination Product: REMEDY Spectrum IM Spacer Nail **Label:** Subjects with REMEDY Spectrum IM Spacer Nail **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Subjects with REMEDY Spectrum IM Spacer Nail **Description:** The REMEDY SPECTRUM IM Spacer Nail is a single-use implant made of polymethylmethacrylate (PMMA) which is internally reinforced with a stainless-steel core (ASTM F138, ISO 5832-1). The PMMA of the REMEDY SPECTRUM IM Spacer Nail is laden with gentamicin and vancomycin. The nail has a slot at the distal end and can be combined with the surgeon's choice of fixation to prevent migration depending on the anatomy of the patient. The REMEDY SPECTRUM IM Spacer Nail is available in two lengths (150mm and 300mm) to accommodate variations in patient anatomy. The distal end has a threaded recess for mating with the optional distal cap, as well as the insertion and removal tools. **Name:** REMEDY Spectrum IM Spacer Nail **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** Healed wound and no infection recurrence caused by the same organism strain infection for duration of two weeks post antibiotic regimen. **Measure:** Successful Treatment of Infection Based on Lab Values and Culture **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Be ≥ 21 years of age 2. Have an ankle-related infection 3. Is skeletally mature, as evidenced by closed epiphyses. 4. Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study 5. Be willing and able to comply with all study procedures including all pre-operative, post-operative requirements 6. If female and of child-bearing potential, must have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant until study completion. Exclusion Criteria: 1. Infections that do not involve the ankle 2. Have a known immunodeficiency; including subjects who are receiving or have received immunosuppressants, immunostimulating agents or radiation therapy within 6 months prior to surgery 3. Affected limb is dysvascular 4. Where adequate soft-tissue coverage cannot be achieved 5. Have any mental or psychological disorder that would impair their ability to complete the study questionnaires 6. Are currently pregnant or breastfeeding, or planning to become pregnant or breastfeed any time during the course of the study 7. Are currently a prisoner 8. Have any medical condition or other circumstances, in the judgment of the Investigator, that might interfere with the ability to return for follow-up visits, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative activities. 9. History of vancomycin or gentamicin allergy 10. Are implanted with other antibiotic eluting products. **Healthy Volunteers:** True **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Grace Montes **Phone:** 5712292683 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Jacob Schafer **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** OsteoRemedies, LLC **Name:** Rachel McGuire Kennedy **Role:** STUDY_DIRECTOR ### 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: 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 - Abbrev: VaDiAg - Name: Vasodilator Agents ### Intervention Browse Module - Browse Leaves - ID: M17388 - Name: Vancomycin - Relevance: LOW - As Found: Unknown - ID: M8951 - Name: Gentamicins - Relevance: LOW - As Found: Unknown - ID: M21783 - Name: Polymethyl Methacrylate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428435 **Acronym:** NGHVA **Brief Title:** Next Generation Home Vision Assessment **Official Title:** Next Generation Home Vision Assessment #### Organization Study ID Info **ID:** 1.5 #### Organization **Class:** OTHER_GOV **Full Name:** NHS Forth Valley #### Secondary ID Infos **Domain:** IRAS Project ID **ID:** 286078 **Type:** OTHER **Domain:** REC Number **ID:** 20/WM/0285 **Type:** OTHER **Domain:** Edge ID **ID:** 136640 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** NHS Greater Glasgow and Clyde **Class:** OTHER **Name:** Birmingham Children's Hospital **Class:** OTHER_GOV **Name:** NHS Fife **Class:** OTHER **Name:** NHS Highland #### Lead Sponsor **Class:** OTHER_GOV **Name:** NHS Forth Valley #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Comparison of live remote paediatric digital vision testing outcomes versus face to face appointments in orthoptic clinic **Detailed Description:** Study Overview The "Next Generation Home Vision Assessment" study aims to evaluate the feasibility and accuracy of conducting vision assessments at home using a web-based platform. This prospective, non-interventional, multi-center study will compare home-based vision tests with traditional hospital-based assessments. Study Background The COVID-19 pandemic has significantly limited patients' ability to attend in-person eye clinic appointments, impacting vision assessments and management. Ramifications in delays continue to have an impact. Study Rationale This study seeks to validate home-based vision assessments against standard in-person evaluations to ensure patients can be effectively monitored and managed remotely. The use of a web-based platform for vision tests could offer a reliable alternative, reducing hospital visits and maintaining care standards. Objectives and Endpoints Primary Objective: To compare the accuracy of home-based visual acuity tests to hospital-based assessments. Secondary Objectives: To evaluate other aspects of visual function (e.g., visual fields, color vision, contrast sensitivity) and measure patient engagement and test duration. Study Design Type: Prospective, non-interventional Participants: Adults and children attending hospital eye services Sample Size: 360 completed assessments Duration: Minimum of 6 months Study Procedure Participants attending hospital eye services will be recruited and provided with a patient information leaflet. Those willing to participate will undergo a visual acuity test +/- additional vision tests (secondary outcomes) during a video consultation. Hospital-based assessment results will be compared to home-based test results to determine accuracy. ### Conditions Module **Conditions:** - Amblyopia - Vision; Low, One Eye (Other Eye Normal) - Pediatric Disorder **Keywords:** - teleophthalmology - remote consultations - amblyopia - paediatrics - telemedicine - digital health ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 360 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Tested with Ibis technology **Intervention Names:** - Diagnostic Test: Vision Test **Label:** Ibis #### Arm Group 2 **Description:** Tested with Optonet Technology **Intervention Names:** - Diagnostic Test: Vision Test **Label:** Optonet ### Interventions #### Intervention 1 **Arm Group Labels:** - Ibis - Optonet **Description:** Remote vision testing via digital screen **Name:** Vision Test **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Home versus Remote Acuity difference **Measure:** Acuity **Time Frame:** 2 weeks #### Secondary Outcomes **Description:** Digital versus in clinic standard **Measure:** Colour Vision **Time Frame:** 2 weeks **Description:** Digital versus in clinic standard **Measure:** Visual field **Time Frame:** 2 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion criteria - Patients attending hospital eye services will be eligible for enrolment. Age: less than 90 years old English speakers, as no available resource for translation services. Parents / patients must be able to provide consent Patient must be able to communicate what he / she sees on a vision assessment chart. Must have access to smartphone, tablet or home computer that can run video conferencing platforms. Exclusion criteria Non English speakers or lack of ability to consent Inability to communicate what is seen on a chart, or inability to complete a preferential looking visual acuity test Inability to connect to a video conferencing platform. **Maximum Age:** 90 Years **Minimum Age:** 0 Months **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Patients attending hospital and at home ### Contacts Locations Module #### Locations **Location 1:** **City:** Falkirk **Country:** United Kingdom **Facility:** NHS Forth Valley Research & Development Office **State:** Stirlingshire **Zip:** FK1 5SU **Location 2:** **City:** Birmingham **Country:** United Kingdom **Facility:** Birmingham Womens and Childens Hospital **Zip:** B4 6NH **Location 3:** **City:** Glasgow **Country:** United Kingdom **Facility:** NHS Greater Glasgow & Clyde **Location 4:** **City:** Inverness **Country:** United Kingdom **Facility:** NHS Fife **Zip:** IV2 3JH #### Overall Officials **Official 1:** **Affiliation:** NHS Forth Valley **Name:** Iain Livingstone, MBChB MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Open Access **Description:** Anonymised data will be made available as part of publication **IPD Sharing:** YES **Time Frame:** Aim: 12 months post completion of study ## 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: D000014786 - Term: Vision Disorders - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3891 - Name: Amblyopia - Relevance: HIGH - As Found: Amblyopia - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17530 - Name: Vision Disorders - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000550 - Term: Amblyopia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428422 **Brief Title:** The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients **Official Title:** The Impact of Bifidobacterium Lactis Supplementation on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients Receiving Immunotherapy (Nivolumab) #### Organization Study ID Info **ID:** BL-32769 #### Organization **Class:** OTHER **Full Name:** Necmettin Erbakan University ### Status Module #### Completion Date **Date:** 2026-12-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Health Institutes of Türkiye (TUSEB) #### Lead Sponsor **Class:** OTHER **Name:** Necmettin Erbakan University #### Responsible Party **Investigator Affiliation:** Necmettin Erbakan University **Investigator Full Name:** Mehmet Artac **Investigator Title:** Prof.Dr. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study is to evaluate the effect of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on the clinical effectiveness of immunotherapy in patients diagnosed with metastatic non-small cell lung cancer who are receiving immunotherapy. **Detailed Description:** Despite modern treatments, lung cancer remains a leading cause of high mortality worldwide. Over the past decade, significant improvements in patient survival have been achieved with immune checkpoint inhibitors, which enhance the T cell-mediated immune response to eradicate cancer cells. However, therapeutic resistance, drug side effects, and heterogeneous treatment responses limit their effectiveness. Recent studies have established a clear relationship between gut microbiota and cancer immunotherapy. The intestinal microbiota has been shown to stimulate the anti-tumor immune response by modulating immune system cells. Evidence from preclinical and clinical studies indicates that gut microbiota plays a crucial role in the efficacy of immunotherapy and the modulation of drug toxicity. Identifying the microbiota as a potential biomarker could facilitate personalized treatment protocols. Genetic, epigenetic, and microbiota modulation factors are essential for optimizing cancer immunotherapy outcomes. Consequently, research is increasingly focusing on personalized treatment protocols for microbiota modulation, including diet regulation, fecal microbiota transfer, prebiotics, and probiotics. There has been a significant rise in studies demonstrating the clinical benefits of microbial therapy products as complementary treatments. The functional role of microbiota in modulating the systemic immune response has prompted investigations into its impact on cancer immunotherapy, particularly with agents targeting immunological checkpoints like PD-1. Recent studies have identified both positive and negative regulatory bacteria that influence immunotherapy effectiveness. However, sociocultural and dietary lifestyle differences affect gut microbiota composition, leading to variations between populations. Therefore, studies are needed to identify the unique microbiome composition of each population to develop microbiota biological indicators for cancer immunotherapy. No research has been conducted in this area in our country. Our study aims to identify bacterial species that may serve as biomarkers for the microbiota specific to our country's cancer patients receiving immunotherapy and use them for prognostic purposes. Understanding the significant role of probiotics in modulating intestinal microbiota has increased the demand for these food supplements. Studies show that anti-tumor efficacy is specific to the bacterial strain. For instance, Bifidobacteriums have been reported to enhance the effectiveness of PD-1 blockers in experimental rat models. In another study, B. lactis BL-04 reduced immunotherapy-induced colitis in animals. Our planned study will investigate the effect of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on clinical objective response, clinical benefit rates, and intestinal microbiota in patients with metastatic non-small cell lung cancer (mNSCLC) receiving nivolumab. The results may facilitate the development of specific probiotic supplements as a complementary therapy for mNSCLC treatment. ### Conditions Module **Conditions:** - Metastatic Non-small Cell Lung Cancer **Keywords:** - immunotherapy - lung cancer - probiotics - Bifidobacterium animalis - microbiota ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention group will receive an oral dosage of 4 x 10\^9 cfu/g/day Bifidobacterium animalis subsp. lactis BL-04 strain (Danisco, USA) and 1 gram of maltodextrin (Danisco, USA) in conjunction with the conventional treatment, which consisted of systemic cancer immunotherapy with nivolumab at a dose of 3 mg/kg administered intravenously every two weeks. The immunotherapy with nivolumab will be completed in twelve weeks. A probiotic strain is provided to the intervention group in the form of a sachet. Patients will be asked to pour the entire sachet into a glass of water (100 mL, room temperature), mix, and drink it every day for 12 weeks. **Intervention Names:** - Dietary Supplement: Bifidobacterium animalis subsp. lactis Bl-04 **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The plasebo group will receive the conventional treatment, which consisted of systemic cancer immunotherapy with nivolumab at a dose of 3 mg/kg administered intravenously every two weeks. The immunotherapy with nivolumab will be completed in twelve weeks. In addition to the traditional treatment (nivolumab), the plasebo group will be given 1 g/day maltodextrin (Danisco, USA) as placebo. Maltodextrin will be provided to the intervention group in the form of a sachet. Patients will be asked to pour the entire sachet into a glass of water (100 mL, room temperature), mix, and drink it every day for 12 weeks. **Intervention Names:** - Other: Plasebo **Label:** Plasebo group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** 4 x 10\^9 cfu/g/day Bifidobacterium animalis subsp. lactis Bl-04 for 12 weeks **Name:** Bifidobacterium animalis subsp. lactis Bl-04 **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Plasebo group **Description:** 1 g/day maltodextrin for 12 weeks **Name:** Plasebo **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The clinical impact of the immunotherapy will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1 criteria based on radiological analysis. **Measure:** Evaluation of Clinical Response **Time Frame:** Week 12 **Description:** The progression-free survival (PFS) period will be defined as the interval between the initiation of treatment and the date of radiological progression. **Measure:** Progression-free survival **Time Frame:** Basaline and the date of radiological progression **Description:** The overall survival (OS) period will be defined as the interval between the date of disease diagnosis and death from any cause. **Measure:** Overall survival **Time Frame:** Basaline and the date of death from any case #### Secondary Outcomes **Description:** Microbiota and fatty acid analyses, including acetic acid, propionic acid, and butyric acid, will be conducted on fecal samples." **Measure:** Intestinal microbiota modulation **Time Frame:** Basaline and Week 12 **Description:** The concentrations of CD4+ T cell subgroups (Th1, Th2, Th9, Th17, Th1Th17, and Treg) and sitokins (IL-1β, IL-4, IL-10, IL-17, TNF-α, TGF-beta, IFN-gamma, IL-36 and trimethylamine N-oxide) will be quantified in the serum samples of the patients. **Measure:** Immunological findings **Time Frame:** Basaline and Week 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Volunteering to participate in the study. * Histologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC). * Patients must be in an advanced stage (incurable with surgery or radiotherapy) or have metastatic disease (Stage IV). * Male or female patients aged \>18 years. * Eastern Cooperative Oncology Group (ECOG) Performance Status less than 2. * Laboratory findings must confirm adequate bone marrow function, indicated by: White Blood Cell (WBC) count \> 2,000/mm³, Neutrophil count \> 1,500/mm³,Platelet count \> 100,000/mm³ Exclusion Criteria: * Previously received treatment with any of the following antibody blockers: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4. * Currently taking probiotic supplements or consuming probiotic bacteria-supported yogurt and similar food supplements. * Antibiotic utilization within the past month * Active interstitial lung disease or a history of interstitial lung disease requiring systemic steroid treatment. * A condition requiring systemic corticosteroids (greater than 10 mg of prednisone daily or equivalent) or who have received immunosuppressive treatment within 14 days prior to the first dose of the study. * Presence of uncontrolled adrenal insufficiency. * Pregnancy or breastfeeding. * Severe congestive heart failure (Class III or higher according to the New York Heart Association Functional Classification) or a history of myocarditis. * Uncontrolled cardiac arrhythmia that developed within six months prior to the start of the study. **Maximum Age:** 90 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mehmet Artaç, MD **Phone:** +90332236000 **Phone Ext:** 6434 **Role:** CONTACT #### Locations **Location 1:** **City:** Konya **Country:** Turkey **Facility:** Necmettin Erbakan University **Zip:** 42090 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M1854 - Name: Nivolumab - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: T367 - Name: Bifidobacterium - Relevance: HIGH - As Found: Neural ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428409 **Brief Title:** A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A) **Official Title:** A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers #### Organization Study ID Info **ID:** 9999-02A #### Organization **Class:** INDUSTRY **Full Name:** Merck Sharp & Dohme LLC #### Secondary ID Infos **Domain:** Merck **ID:** MK-9999-02A **Type:** OTHER **Domain:** EU CT **ID:** 2023-508703-21 **Type:** OTHER **Domain:** WHO/UTN **ID:** U1111-1298-8273 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2028-12-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-12-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-19 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Merck Sharp & Dohme LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with chemotherapy can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn: * About the safety and how well people tolerate sacituzumab tirumotecan lone or with chemotherapy * How many people have the cancer respond (get smaller or go away) to treatment ### Conditions Module **Conditions:** - Colorectal Cancer - Pancreatic Ductal Carcinoma - Biliary Tract Cancer ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 130 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy by intravenous (IV) infusion, every 2 weeks. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment. **Intervention Names:** - Biological: Sacituzumab tirumotecan - Drug: Fluorouracil (5-FU) - Drug: Leucovorin (LV) or levoleucovorin **Label:** Sacituzumab tirumotecan + Chemotherapy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive sacituzumab tirumotecan every 2 weeks via IV infusion. Participants will continue to receive the treatment until the cancner gets worse or they don't tolerate the treatment. **Intervention Names:** - Biological: Sacituzumab tirumotecan **Label:** Sacituzumab tirumotecan **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Sacituzumab tirumotecan - Sacituzumab tirumotecan + Chemotherapy **Description:** Given by IV infusion every 2 weeks (Day 1 and Day 15 of every 4-week cycle) **Name:** Sacituzumab tirumotecan **Other Names:** - MK-2870 **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Sacituzumab tirumotecan + Chemotherapy **Description:** 5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks **Name:** Fluorouracil (5-FU) **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Sacituzumab tirumotecan + Chemotherapy **Description:** LV or levoleucovorin is administered by IV infusion every 2 weeks **Name:** Leucovorin (LV) or levoleucovorin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. DLTs will be measured during Cycle 1 (the first 4 weeks) of treatment. **Measure:** Number of Participants Who Experience a Dose-limiting Toxicity (DLT) **Time Frame:** Up to approximately 4 weeks **Description:** An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported. **Measure:** Number of Participants Who Experience One or More Adverse Events (AEs): **Time Frame:** Up to approximately 54 months **Description:** An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported. **Measure:** Number of Participants who Discontinue Study Medication due to an AE **Time Frame:** Up to approximately 54 months **Description:** ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented. **Measure:** Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) **Time Frame:** Up to approximately 54 months #### Secondary Outcomes **Description:** For participants who demonstrate a confirmed Complete Response or Partial Response, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented. **Measure:** Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR **Time Frame:** Up to approximately 54 months **Description:** PFS is defined as the time from start of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. According to RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented. **Measure:** Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR **Time Frame:** Up to approximately 54 months **Description:** OS is the length of time from when the participant starts treatment until death from any cause **Measure:** Overall Survival (OS) **Time Frame:** Up to approximately 54 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has one of the following cancers: * Unresectable or metastatic colorectal cancer * Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) * Advanced and/or unresectable biliary tract cancer (BTC) * Has received prior therapy for the cancer * Has recovered from any side effects due to previous cancer treatment Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * History of severe eye disease * Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Merck Sharp & Dohme LLC **Name:** Medical Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf **IPD Sharing:** YES **URL:** http://engagezone.msd.com/ds_documentation.php ### References Module #### See Also Links **Label:** Merck Clinical Trials Information **URL:** https://www.merckclinicaltrials.com ## Derived Section ### Condition Browse Module - Ancestors - 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: D000001660 - Term: Biliary Tract Diseases - ID: D000000230 - Term: Adenocarcinoma - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000018299 - Term: Neoplasms, Ductal, Lobular, and Medullary - ID: D000010190 - Term: Pancreatic Neoplasms - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000010182 - Term: Pancreatic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M25356 - Name: Carcinoma, Ductal - Relevance: HIGH - As Found: Ductal Carcinoma - ID: M22725 - Name: Carcinoma, Pancreatic Ductal - Relevance: HIGH - As Found: Pancreatic Ductal Carcinoma - ID: M4947 - Name: Biliary Tract Neoplasms - Relevance: HIGH - As Found: Biliary Tract Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: HIGH - As Found: Gastrointestinal Cancer - 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: M4946 - Name: Biliary Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M13102 - Name: Pancreatic Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: T761 - Name: Biliary Tract Cancer - Relevance: HIGH - As Found: Biliary Tract Cancer - ID: T4387 - Name: Pancreatic Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001661 - Term: Biliary Tract Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000044584 - Term: Carcinoma, Ductal - ID: D000021441 - Term: Carcinoma, Pancreatic Ductal ### Intervention Browse Module - Ancestors - ID: D000000963 - Term: Antimetabolites - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000931 - Term: Antidotes - ID: D000020011 - Term: Protective Agents - ID: D000014803 - Term: Vitamin B Complex - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M8600 - Name: Fluorouracil - Relevance: HIGH - As Found: According - ID: M6191 - Name: Leucovorin - Relevance: HIGH - As Found: Video - ID: M29233 - Name: Levoleucovorin - Relevance: HIGH - As Found: Stevia - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M4250 - Name: Antidotes - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M17546 - Name: Vitamin B Complex - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: HIGH - As Found: Stevia - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000002955 - Term: Leucovorin - ID: D000005472 - Term: Fluorouracil - ID: D000058766 - Term: Levoleucovorin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428396 **Brief Title:** Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029) **Official Title:** A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (LITESPARK-029) #### Organization Study ID Info **ID:** 6482-029 #### Organization **Class:** INDUSTRY **Full Name:** Merck Sharp & Dohme LLC #### Secondary ID Infos **Domain:** Merck **ID:** MK-6482-029 **Type:** OTHER **Domain:** Merck **ID:** LITESPARK-029 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2028-05-24 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-06-24 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-26 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Merck Sharp & Dohme LLC #### 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 belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) unresectable metastatic breast cancer. There is no formal hypothesis testing in this study. ### Conditions Module **Conditions:** - Metastatic Breast Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive belzutifan 120 mg orally once daily (QD) PLUS fulvestrant 500 mg via intramuscular (IM) injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter until progressive disease or discontinuation. **Intervention Names:** - Drug: Belzutifan - Drug: Fulvestrant **Label:** Belzutifan + Fulvestrant **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive everolimus 10 mg orally QD PLUS investigator's choice of fulvestrant 500 mg via IM injection on Days 1 and 15 of Cycle 1, and Day 1 of each 28-day cycle thereafter OR exemestane 25 mg orally QD until progressive disease or discontinuation. **Intervention Names:** - Drug: Fulvestrant - Drug: Everolimus - Drug: Exemestane **Label:** Everolimus + ET (fulvestrant or exemestane) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Belzutifan + Fulvestrant **Description:** Belzutifan 120 mg administered QD as an oral tablet. **Name:** Belzutifan **Other Names:** - MK-6482 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Belzutifan + Fulvestrant - Everolimus + ET (fulvestrant or exemestane) **Description:** Fulvestrant 500 mg administered as an IM injection. **Name:** Fulvestrant **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Everolimus + ET (fulvestrant or exemestane) **Description:** Administered at 10mg via oral tablets QD. **Name:** Everolimus **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Everolimus + ET (fulvestrant or exemestane) **Description:** Administered at 25 mg via oral tablets QD. **Name:** Exemestane **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** PFS is defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. **Measure:** Progression-free Survival (PFS) **Time Frame:** Up to Approximately 30 months #### Secondary Outcomes **Description:** PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at 6 months using the entire PFS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 30 months. **Measure:** Progression-free Survival (PFS) at 6 months **Time Frame:** Up to Approximately 30 months **Description:** PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at 12 months using the entire PFS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 30 months. **Measure:** Progression-free Survival (PFS) at 12 months **Time Frame:** Up to Approximately 30 months **Description:** OS is defined as the time from randomization to death due to any cause. **Measure:** Overall Survival (OS) **Time Frame:** Up to Approximately 30 months **Description:** ORR is defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR. **Measure:** Objective Response Rate (ORR) **Time Frame:** Up to Approximately 30 months **Description:** CBR is defined as the percentage of participants who have CR: Disappearance of all target lesions, PR: At least a 30% decrease in the sum of diameters of target lesions, or stable disease (SD: Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study) for ≥24 weeks per RECIST 1.1 as assessed by BICR. **Measure:** Clinical Benefit Rate (CBR) **Time Frame:** Up to Approximately 30 months **Description:** An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. **Measure:** Number of Participants Who Experience an Adverse Event (AE) **Time Frame:** Up to Approximately 46 months **Description:** An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. **Measure:** Number of Participants Who Discontinue Study Treatment Due To an AE **Time Frame:** Up to Approximately 46 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Has a diagnosis of estrogen receptor positive (ER+)/human epidermal growth factor receptor negative (HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection or metastatic disease not treatable with curative intent * Has documented radiographic confirmation of disease progression during or after the last administered endocrine therapy (ET) * Provides a new or the most recently obtained core biopsy, taken from a locally advanced unresectable or from a metastatic lesion * Has received ET in the noncurative setting and has 1) Radiographic disease progression on 12 months or more of ET in combination with CDK4/6 inhibitor in the noncurative setting or 2) Received at least 2 lines of ET in the noncurative setting including CDK4/6 inhibitor where the CDK 4/6 inhibitor was discontinued due to intolerance * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization Exclusion Criteria: * Has Breast cancer amenable to treatment with curative intent * Is unable to receive any of the endocrine therapies (ETs) (ie, fulvestrant or exemestane) * Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications such as uncontrolled nausea or vomiting (ie, CTCAE =Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction, motility disorder, malabsorption syndrome, or prior gastric bypass * Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications * Has active, bleeding diathesis, or on oral anti-vitamin K medication * Has history of noninfectious pneumonitis/interstitial lung disease including radiation pneumonitis that required steroids or has current pneumonitis/interstitial lung disease * Has uncontrolled diabetes as defined as fasting serum glucose \>1.5 × upper limit of normal (ULN) * Has a known germline BRCA mutation (deleterious or suspected deleterious) and has received previous treatment with poly-ADP ribose polymerase (PARP) inhibition either in the adjuvant or metastatic setting * Has received prior fulvestrant in the adjuvant, unresectable locally advanced, or metastatic setting * Has received any line of cytotoxic chemotherapy or PARP inhibitor in the unresectable or noncurative advanced/metastatic setting * Has received prior radiotherapy for non-central nervous system (CNS) disease or required corticosteroids for radiation-related toxicities including radiation pneumonitis, within 14 days of the first dose of study intervention * Is currently receiving strong inducers of CYP3A4 that cannot be discontinued for the duration of the study * Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has concurrent active Hepatitis B and Hepatitis C virus infection * Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study medication administration, or New York Heart Association Class III or Class IV congestive heart failure * Has not adequately recovered from major surgery or have ongoing surgical complications **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Merck Sharp & Dohme LLC **Name:** Medical Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf **IPD Sharing:** YES **URL:** http://engagezone.msd.com/ds_documentation.php ### References Module #### See Also Links **Label:** Merck Clinical Trials Information **URL:** https://www.merckclinicaltrials.com/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Ancestors - ID: D000091203 - Term: MTOR Inhibitors - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000970 - Term: Antineoplastic Agents - ID: D000018931 - Term: Antineoplastic Agents, Hormonal - ID: D000065171 - Term: Estrogen Receptor Antagonists - ID: D000004965 - Term: Estrogen Antagonists - ID: D000006727 - Term: Hormone Antagonists - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000047072 - Term: Aromatase Inhibitors - ID: D000065088 - Term: Steroid Synthesis Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M255 - Name: Everolimus - Relevance: HIGH - As Found: Criteria - ID: M1723 - Name: Fulvestrant - Relevance: HIGH - As Found: Milligrams - ID: M247237 - Name: Exemestane - Relevance: HIGH - As Found: Add- - ID: M348353 - Name: Belzutifan - Relevance: HIGH - As Found: Injection volume - ID: M8116 - Name: Estrogens - Relevance: LOW - As Found: Unknown - ID: M21960 - Name: Sirolimus - Relevance: LOW - As Found: Unknown - ID: M353695 - Name: Temsirolimus - Relevance: LOW - As Found: Unknown - ID: M2827 - Name: MTOR Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M20966 - Name: Antineoplastic Agents, Hormonal - Relevance: LOW - As Found: Unknown - ID: M8114 - Name: Estrogen Antagonists - Relevance: LOW - As Found: Unknown - ID: M30483 - Name: Estrogen Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M9788 - Name: Hormone Antagonists - Relevance: LOW - As Found: Unknown - ID: M25769 - Name: Aromatase Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068338 - Term: Everolimus - ID: D000077267 - Term: Fulvestrant - ID: C000056516 - Term: Exemestane - ID: C000720612 - Term: Belzutifan ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428383 **Brief Title:** Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-043) **Official Title:** A Phase 3, Single-arm, Open-label Extension of the Vericiguat VALOR Study in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR EXT) #### Organization Study ID Info **ID:** 1242-043 #### Organization **Class:** INDUSTRY **Full Name:** Merck Sharp & Dohme LLC #### Secondary ID Infos **Domain:** Merck **ID:** MK-1242-043 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2032-04-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2032-04-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Merck Sharp & Dohme LLC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The primary objective of this study is to monitor the safety and tolerability of vericiguat. ### Conditions Module **Conditions:** - Systolic Dysfunction ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 342 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Vericiguat administered orally in either tablet or suspension once daily until end of treatment **Intervention Names:** - Drug: Vericiguat tablet - Drug: Vericiguat suspension **Label:** Vericiguat **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Vericiguat **Description:** Vericiguat tablet at doses 2.5 mg, 5 mg, or 10 mg taken orally once daily **Name:** Vericiguat tablet **Other Names:** - MK-1242 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Vericiguat **Description:** Vericiguat suspension at doses 0.2 mg/mL, 1 mg/mL taken orally once daily **Name:** Vericiguat suspension **Other Names:** - MK-1242 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Percentage of participants with AEs **Measure:** Participants with adverse events (AEs) **Time Frame:** Up to approximately 8 years **Description:** Percentage of participants who discontinued study drug due to an AE **Measure:** Participants who discontinued study drug due to an AE **Time Frame:** Up to approximately 8 years #### Secondary Outcomes **Description:** Change in NT-proBNP from baseline at Week 16. **Measure:** Change from baseline in n-terminal pro-brain natriuretic peptide (NT-proBNP) **Time Frame:** Baseline and Week 16 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), and completed the Week 52 visit and safety follow-up period for the VALOR base study. * A participant assigned female sex at birth is not pregnant or breastfeeding, and is not a participant/participants of childbearing potential (POCBP) or is a POCBP who Uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention., and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy. * Is able to receive medication via the oral or gastric route . Exclusion Criteria: * Is hypotensive for age at Visit 1 * Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC )stimulator. * Has undergone heart transplantation or has an implanted ventricular assist device. * Has severe chronic kidney disease * Has hepatic disorder * Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors during the study. * Has concurrent or anticipated use of an sGC stimulator. * Is both ≥18 years of age and vericiguat is commercially available to the participant **Minimum Age:** 1 Year **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** Merck Sharp & Dohme LLC **Name:** Clinical Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf **IPD Sharing:** YES **URL:** http://engagezone.msd.com/ds_documentation.php ### References Module #### See Also Links **Label:** Merck Clinical Trials Information **URL:** http://www.merckclinicaltrials.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000006337 - Term: Heart Murmurs - ID: D000018754 - Term: Ventricular Dysfunction ### 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: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M27583 - Name: Systolic Murmurs - Relevance: HIGH - As Found: Systolic - ID: M20591 - Name: Ventricular Dysfunction, Left - Relevance: HIGH - As Found: Left Ventricular Systolic Dysfunction - ID: M20824 - Name: Ventricular Dysfunction - Relevance: LOW - As Found: Unknown - ID: M9425 - Name: Heart Murmurs - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006333 - Term: Heart Failure - ID: D000018487 - Term: Ventricular Dysfunction, Left - ID: D000054160 - Term: Systolic Murmurs ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428370 **Acronym:** DACOSAD **Brief Title:** Damage Control Surgery Over the World in Acute Diverticulitis (DACOSAD) **Official Title:** An International Study Investigating the Adoption and Outcome of Damage Control Surgery in Hinchey III-IV Acute Diverticulitis (DACOSAD) #### Organization Study ID Info **ID:** LCU MEDS-06/A 01/2024 #### Organization **Class:** OTHER **Full Name:** Link Campus University ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-05 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-04 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2020-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Link Campus University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** To analyze the possible benefit of damage control surgery by performing bowel resection, open abdomen, and delayed anastomosis in the treatment of Hinchey III or IV diverticulitis. **Detailed Description:** Hartmann procedure (HP) is still widely performed in the treatment of purulent or fecal generalized peritonitis as a consequence of a complicated acute large bowel diverticulitis (the so labeled III and IV grade of the Hinchey's classification). More than half of those patients do not undergo to stoma reversal because of its association with significant morbidity and mortality. To date, the use of resection with primary anastomosis (PA) should be preferred, as it is reported in the literature that it is more favorable than HP in terms of morbidity, mortality, and length of postoperative stay. However, PA is often reserved for younger patients with few co-morbidities and a lesser degree of peritoneal contamination while HP is performed in the elderly. Initially described for the treatment of major abdominal injuries, indications for Damage Control Surgery (DCS) have subsequently been extended to septic shock, abdominal compartment syndrome and impossibility to perform a primary closure. In the last decade, DCS has emerged as a valid alternative to HP and Resection-Anastomosis (RA) in patients presenting a severe sepsis caused by purulent or fecal peritonitis in acute diverticulitis. Although DCS is cited as an option in case of impaired hemodynamic status in face of perforated acute diverticulitis, there is still no consensus about such use of DCS. Previous study demonstrated that DCS reduce the Hartmann rate in patients otherwise scheduled for such procedure. The aim of this study was to describe the potential rationale and outcome of the Damage Control Surgery in patients with purulent and fecal peritonitis. ### Conditions Module **Conditions:** - Diverticular Perforation - Open Abdomen **Keywords:** - Diverticulitis - Surgery - Open abdomen - Septic shock ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Simple resection, drop, and open abdomen in case of Hinchey III-IV **Name:** Damage Control Surgery **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Mortality rate related to treatment **Measure:** Mortality **Time Frame:** 60 days **Description:** Morbidity rate defined by the presence of at least one grade of the Clavien-Dindo Classification scoring system **Measure:** Morbidity **Time Frame:** 60 days **Description:** Morbidity calculated by means of the Comprehensive Complication Index **Measure:** Total morbidity **Time Frame:** 60 days #### Secondary Outcomes **Description:** Observed to expected (O:E) ratio of Hartmann's procedures **Measure:** Upfront Hartmann rate **Time Frame:** 60 days **Description:** Days of stay as inpatient **Measure:** Length of stay (LOS) **Time Frame:** 60 days **Description:** Days of stay in ICU **Measure:** ICU length of stay **Time Frame:** 60 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients \>18 year-old underwent surgery for Hinchey III and IV and submitted to resection, clip and drop, and open abdomen Exclusion Criteria: * Subjects \<18 year-old **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Same as above ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gianluca Costa, Prof. **Phone:** +39 06 22541 8851 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Giuseppina Catanzaro, Prof. **Role:** CONTACT #### Locations **Location 1:** **City:** Santiago de Chile **Country:** Chile **Facility:** Hospital de Urgencia Asistencia Publica **Status:** ENROLLING_BY_INVITATION **Location 2:** **City:** Roma **Contacts:** ***Contact 1:*** - **Name:** Marco Caricato, MD, PhD - **Role:** CONTACT ***Contact 2:*** - **Name:** Gabriella T Capolupo, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Italy **Facility:** Fondazione Policlinico Universitario Campus Bio-Medico **State:** Lazio **Status:** RECRUITING **Zip:** 00128 **Location 3:** **City:** Ostia **Contacts:** ***Contact 1:*** - **Name:** Gianluca Mazzoni, MD, PhD - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Anna Maria Bellotti, MD - **Role:** CONTACT ***Contact 3:*** - **Name:** Loretta Di Cristofaro, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Italy **Facility:** UOC Chirurgia Generale - Ospedale GB Grassi **State:** Roma **Status:** RECRUITING **Zip:** 00122 **Location 4:** **City:** Palestrina **Contacts:** ***Contact 1:*** - **Name:** Gianluca Liotta, MD, PhD - **Phone:** +39 06 95321 - **Role:** CONTACT **Country:** Italy **Facility:** UOC Chirurgia Generale Ospedale Coniugi Bernardini **State:** Roma **Status:** RECRUITING **Zip:** 00036 **Location 5:** **City:** Caserta **Contacts:** ***Contact 1:*** - **Name:** Mauro Andreano, Prof. - **Role:** CONTACT ***Contact 2:*** - **Name:** Alberto Mingione, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Italy **Facility:** UOC Chirurgia Generale Ospedale Sant'Anna e San Sebastiano **Status:** RECRUITING **Zip:** 81100 **Location 6:** **City:** Pisa **Contacts:** ***Contact 1:*** - **Name:** Massimo Chiarugi, MD, FACS - **Role:** CONTACT ***Contact 2:*** - **Name:** Dario Tartaglia, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Italy **Facility:** UOC Chirurgia Generale, Urgenza e Trauma Pisa University Hospital **Status:** RECRUITING **Zip:** 56124 **Location 7:** **City:** Roma **Contacts:** ***Contact 1:*** - **Name:** Gabriele Sganga, MD, FACS - **Role:** CONTACT ***Contact 2:*** - **Name:** Pietro Fransvea, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Italy **Facility:** Fondazione Policlinico Universitario "A.Gemelli" **Status:** RECRUITING **Zip:** 00168 **Location 8:** **City:** Roma **Contacts:** ***Contact 1:*** - **Name:** Luca Lepre, MD, PhD - **Role:** CONTACT ***Contact 2:*** - **Name:** Michela Giulii Capponi, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Italy **Facility:** UOC Chirurgia Generale ed Urgenza Ospedale Santo Spirito in Sassia **Status:** RECRUITING **Zip:** 00193 **Location 9:** **City:** Roma **Contacts:** ***Contact 1:*** - **Name:** Andrea Mingoli, Prof. - **Role:** CONTACT ***Contact 2:*** - **Name:** Gioia Brachini, MD, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Bruno Cirillo, MD, PhD - **Role:** SUB_INVESTIGATOR **Country:** Italy **Facility:** Dipartimento di Chirurgia AOU Policlinico Umberto I Sapienza Università di Roma **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Link Campus University **Name:** Gianluca Costa, Prof. **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Perrone G, Giuffrida M, Abu-Zidan F, Kruger VF, Livrini M, Petracca GL, Rossi G, Tarasconi A, Tian BWCA, Bonati E, Mentz R, Mazzini FN, Campana JP, Gasser E, Kafka-Ritsch R, Felsenreich DM, Dawoud C, Riss S, Gomes CA, Gomes FC, Gonzaga RAT, Canton CAB, Pereira BM, Fraga GP, Zem LG, Cordeiro-Fonseca V, de Mesquita Tauil R, Atanasov B, Belev N, Kovachev N, Melendez LJJ, Dimova A, Dimov S, Zelic Z, Augustin G, Bogdanic B, Moric T, Chouillard E, Bajul M, De Simone B, Panis Y, Esposito F, Notarnicola M, Lauka L, Fabbri A, Hentati H, Fnaiech I, Aurelien V, Bougard M, Roulet M, Demetrashvili Z, Pipia I, Merabishvili G, Bouliaris K, Koukoulis G, Doudakmanis C, Xenaki S, Chrysos E, Kokkinakis S, Vassiliu P, Michalopoulos N, Margaris I, Kechagias A, Avgerinos K, Katunin J, Lostoridis E, Nagorni EA, Pujante A, Mulita F, Maroulis I, Vailas M, Marinis A, Siannis I, Bourbouteli E, Manatakis DK, Tasis N, Acheimastos V, Maria S, Stylianos K, Kuzeridis H, Korkolis D, Fradelos E, Kavalieratos G, Petropoulou T, Polydorou A, Papacostantinou I, Triantafyllou T, Kimpizi D, Theodorou D, Toutouzas K, Chamzin A, Frountzas M, Schizas D, Karavokyros I, Syllaios A, Charalabopoulos A, Boura M, Baili E, Ioannidis O, Loutzidou L, Anestiadou E, Tsouknidas I, Petrakis G, Polenta E, Bains L, Gupta R, Singh SK, Khanduri A, Bala M, Kedar A, Pisano M, Podda M, Pisanu A, Martines G, Trigiante G, Lantone G, Agrusa A, Di Buono G, Buscemi S, Veroux M, Gioco R, Veroux G, Oragano L, Zonta S, Lovisetto F, Feo CV, Pesce A, Fabbri N, Lantone G, Marino F, Perrone F, Vincenti L, Papagni V, Picciariello A, Rossi S, Picardi B, Del Monte SR, Visconti D, Osella G, Petruzzelli L, Pignata G, Andreuccetti J, D'Alessio R, Buonfantino M, Guaitoli E, Spinelli S, Sampietro GM, Corbellini C, Lorusso L, Frontali A, Pezzoli I, Bonomi A, Chierici A, Cotsoglou C, Manca G, Delvecchio A, Musa N, Casati M, Letizia L, Abate E, Ercolani G, D'Acapito F, Solaini L, Guercioni G, Cicconi S, Sasia D, Borghi F, Giraudo G, Sena G, Castaldo P, Cardamone E, Portale G, Zuin M, Spolverato Y, Esposito M, Isernia RM, Di Salvo M, Manunza R, Esposito G, Agus M, Asti ELG, Bernardi DT, Tonucci TP, Luppi D, Casadei M, Bonilauri S, Pezzolla A, Panebianco A, Laforgia R, De Luca M, Zese M, Parini D, Jovine E, De Sario G, Lombardi R, Aprea G, Palomba G, Capuano M, Argenio G, Orio G, Armellino MF, Troian M, Guerra M, Nagliati C, Biloslavo A, Germani P, Aizza G, Monsellato I, Chahrour AC, Anania G, Bombardini C, Bagolini F, Sganga G, Fransvea P, Bianchi V, Boati P, Ferrara F, Palmieri F, Cianci P, Gattulli D, Restini E, Cillara N, Cannavera A, Nita GE, Sarnari J, Roscio F, Clerici F, Scandroglio I, Berti S, Cadeo A, Filippelli A, Conti L, Grassi C, Cattaneo GM, Pighin M, Papis D, Gambino G, Bertino V, Schifano D, Prando D, Fogato L, Cavallo F, Ansaloni L, Picheo R, Pontarolo N, Depalma N, Spampinato M, D'Ugo S, Lepre L, Capponi MG, Campa RD, Sarro G, Dinuzzi VP, Olmi S, Uccelli M, Ferrari D, Inama M, Moretto G, Fontana M, Favi F, Picariello E, Rampini A, Barberis A, Azzinnaro A, Oliva A, Totaro L, Benzoni I, Ranieri V, Capolupo GT, Carannante F, Caricato M, Ronconi M, Casiraghi S, Casole G, Pantalone D, Alemanno G, Scheiterle M, Ceresoli M, Cereda M, Fumagalli C, Zanzi F, Bolzon S, Guerra E, Lecchi F, Cellerino P, Ardito A, Scaramuzzo R, Balla A, Lepiane P, Tartaglia N, Ambrosi A, Pavone G, Palini GM, Veneroni S, Garulli G, Ricci C, Torre B, Russo IS, Rottoli M, Tanzanu M, Belvedere A, Milone M, Manigrasso M, De Palma GD, Piccoli M, Pattacini GC, Magnone S, Bertoli P, Pisano M, Massucco P, Palisi M, Luzzi AP, Fleres F, Clarizia G, Spolini A, Kobe Y, Toma T, Shimamura F, Parker R, Ranketi S, Mitei M, Svagzdys S, Pauzas H, Zilinskas J, Poskus T, Kryzauskas M, Jakubauskas M, Zakaria AD, Zakaria Z, Wong MP, Jusoh AC, Zakaria MN, Cruz DR, Elizalde ABR, Reynaud AB, Hernandez EEL, Monroy JMVP, Hinojosa-Ugarte D, Quiodettis M, Du Bois ME, Latorraca J, Major P, Pedziwiatr M, Pisarska-Adamczyk M, Waledziak M, Kwiatkowski A, Czyzykowski L, da Costa SD, Pereira B, Ferreira ARO, Almeida F, Rocha R, Carneiro C, Perez DP, Carvas J, Rocha C, Ferreira C, Marques R, Fernandes U, Leao P, Goulart A, Pereira RG, Patrocinio SDD, de Mendonca NGG, Manso MIC, Morais HMC, Cardoso PS, Calu V, Miron A, Toma EA, Gachabayov M, Abdullaev A, Litvin A, Nechay T, Tyagunov A, Yuldashev A, Bradley A, Wilson M, Panyko A, Lateckova Z, Lacko V, Lesko D, Soltes M, Radonak J, Turrado-Rodriguez V, Termes-Serra R, Morales-Sevillano X, Lapolla P, Mingoli A, Brachini G, Degiuli M, Sofia S, Reddavid R, de Manzoni Garberini A, Buffone A, Del Pozo EP, Aparicio-Sanchez D, Dos Barbeito S, Estaire-Gomez M, Viton-Herrero R, de Los Angeles Gil Olarte-Marquez M, Gil-Martinez J, Alconchel F, Nicolas-Lopez T, Rahy-Martin AC, Pelloni M, Banolas-Suarez R, Mendoza-Moreno F, Nisa FG, Diez-Alonso M, Rodas MEV, Agundez MC, Andres MIP, Moreira CCL, Perez AL, Ponce IA, Gonzalez-Castillo AM, Membrilla-Fernandez E, Salvans S, Serradilla-Martin M, Pardo PS, Rivera-Alonso D, Dziakova J, Huguet JM, Valle NP, Ruiz EC, Valcarcel CR, Moreno CR, Salazar YTM, Garcia JJR, Mico SS, Lopez JR, Farre SP, Gomez MS, Petit NM, Titos-Garcia A, Aranda-Narvaez JM, Romacho-Lopez L, Sanchez-Guillen L, Aranaz-Ostariz V, Bosch-Ramirez M, Martinez-Perez A, Martinez-Lopez E, Sebastian-Tomas JC, Jimenez-Riera G, Jimenez-Vega J, Cuellar JAN, Campos-Serra A, Munoz-Campana A, Gracia-Roman R, Alegre JM, Pinto FL, O'Sullivan SN, Antona FB, Jimenez BM, Lopez-Sanchez J, Carmona ZG, Fernandez RT, Sierra IB, de Leon LRG, Moreno VP, Iglesias E, Cumplido PL, Bravo AA, Simo IR, Dominguez CL, Caamano AG, Lozano RC, Martinez MD, Torres AN, de Quiros JTMB, Pellino G, Cloquell MM, Moller EG, Jalal-Eldin S, Abdoun AK, Hamid HKS, Lohsiriwat V, Mongkhonsupphawan A, Baraket O, Ayed K, Abbassi I, Ali AB, Ammar H, Kchaou A, Tlili A, Zribi I, Colak E, Polat S, Koylu ZA, Guner A, Usta MA, Reis ME, Mantoglu B, Gonullu E, Akin E, Altintoprak F, Bayhan Z, Firat N, Isik A, Memis U, Bayrak M, Altintas Y, Kara Y, Bozkurt MA, Kocatas A, Das K, Seker A, Ozer N, Atici SD, Tuncer K, Kaya T, Ozkan Z, Ilhan O, Agackiran I, Uzunoglu MY, Demirbas E, Altinel Y, Meric S, Hacim NA, Uymaz DS, Omarov N, Balik E, Tebala GD, Khalil H, Rana M, Khan M, Florence C, Swaminathan C, Leo CA, Liasis L, Watfah J, Trostchansky I, Delgado E, Pontillo M, Latifi R, Coimbra R, Edwards S, Lopez A, Velmahos G, Dorken A, Gebran A, Palmer A, Oury J, Bardes JM, Seng SS, Coffua LS, Ratnasekera A, Egodage T, Echeverria-Rosario K, Armento I, Napolitano LM, Sangji NF, Hemmila M, Quick JA, Austin TR, Hyman TS, Curtiss W, McClure A, Cairl N, Biffl WL, Truong HP, Schaffer K, Reames S, Banchini F, Capelli P, Coccolini F, Sartelli M, Bravi F, Vallicelli C, Agnoletti V, Baiocchi GL, Catena F. Goodbye Hartmann trial: a prospective, international, multicenter, observational study on the current use of a surgical procedure developed a century ago. World J Emerg Surg. 2024 Apr 16;19(1):14. doi: 10.1186/s13017-024-00543-w. **PMID:** 38627831 **Citation:** Cirocchi R, Sapienza P, Anania G, Binda GA, Avenia S, di Saverio S, Tebala GD, Zago M, Donini A, Mingoli A, Nascimbeni R. State-of-the-art surgery for sigmoid diverticulitis. Langenbecks Arch Surg. 2022 Feb;407(1):1-14. doi: 10.1007/s00423-021-02288-5. Epub 2021 Sep 23. **PMID:** 34557938 **Citation:** Sohn M, Agha A, Iesalnieks I, Gundling F, Presl J, Hochrein A, Tartaglia D, Brillantino A, Perathoner A, Pratschke J, Aigner F, Ritschl P. Damage control strategy in perforated diverticulitis with generalized peritonitis. BMC Surg. 2021 Mar 16;21(1):135. doi: 10.1186/s12893-021-01130-5. **PMID:** 33726727 **Citation:** Zizzo M, Castro Ruiz C, Zanelli M, Bassi MC, Sanguedolce F, Ascani S, Annessi V. Damage control surgery for the treatment of perforated acute colonic diverticulitis: A systematic review. Medicine (Baltimore). 2020 Nov 25;99(48):e23323. doi: 10.1097/MD.0000000000023323. **PMID:** 33235095 **Citation:** Khan A, Hsee L, Mathur S, Civil I. Damage-control laparotomy in nontrauma patients: review of indications and outcomes. J Trauma Acute Care Surg. 2013 Sep;75(3):365-8. doi: 10.1097/TA.0b013e31829cb65e. **PMID:** 23928745 **Citation:** Pavlidis ET, Pavlidis TE. Current Aspects on the Management of Perforated Acute Diverticulitis: A Narrative Review. Cureus. 2022 Aug 26;14(8):e28446. doi: 10.7759/cureus.28446. eCollection 2022 Aug. **PMID:** 36176861 **Citation:** Tartaglia D, Costa G, Camillo A, Castriconi M, Andreano M, Lanza M, Fransvea P, Ruscelli P, Rimini M, Galatioto C, Chiarugi M. Damage control surgery for perforated diverticulitis with diffuse peritonitis: saves lives and reduces ostomy. World J Emerg Surg. 2019 Apr 16;14:19. doi: 10.1186/s13017-019-0238-1. eCollection 2019. **PMID:** 31015859 **Citation:** Berg A, Rosenzweig M, Kuo YH, Onayemi A, Mohidul S, Moen M, Sciarretta J, Davis JM, Ahmed N. The results of rapid source control laparotomy or open abdomen for acute diverticulitis. Langenbecks Arch Surg. 2022 Feb;407(1):259-265. doi: 10.1007/s00423-021-02304-8. Epub 2021 Aug 28. **PMID:** 34455491 **Citation:** Costa G, La Torre M, Frezza B, Fransvea P, Tomassini F, Ziparo V, Balducci G. Changes in the surgical approach to colonic emergencies during a 15-year period. Dig Surg. 2014;31(3):197-203. doi: 10.1159/000365254. Epub 2014 Aug 28. **PMID:** 25170867 **Citation:** Horesh N, Lessing Y, Rudnicki Y, Kent I, Kammar H, Ben-Yaacov A, Dreznik Y, Avital S, Mavor E, Wasserberg N, Kashtan H, Klausner J, Gutman M, Zmora O, Tulchinsky H. Comparison between laparoscopic and open Hartmann's reversal: results of a decade-long multicenter retrospective study. Surg Endosc. 2018 Dec;32(12):4780-4787. doi: 10.1007/s00464-018-6227-8. Epub 2018 May 15. **PMID:** 29766303 **Citation:** Horesh N, Lessing Y, Rudnicki Y, Kent I, Kammar H, Ben-Yaacov A, Dreznik Y, Tulchinsky H, Avital S, Mavor E, Wasserberg N, Kashtan H, Klausner JM, Gutman M, Zmora O. Considerations for Hartmann's reversal and Hartmann's reversal outcomes-a multicenter study. Int J Colorectal Dis. 2017 Nov;32(11):1577-1582. doi: 10.1007/s00384-017-2897-2. Epub 2017 Sep 6. **PMID:** 28879552 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000076385 - Term: Diverticular Diseases - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC01 - Name: Infections - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M15577 - Name: Shock - Relevance: LOW - As Found: Unknown - ID: M7414 - Name: Diverticulitis - Relevance: HIGH - As Found: Diverticulitis - ID: M15580 - Name: Shock, Septic - Relevance: LOW - As Found: Unknown - ID: M7416 - Name: Diverticulum - Relevance: LOW - As Found: Unknown - ID: M1603 - Name: Diverticular 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: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004238 - Term: Diverticulitis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428357 **Brief Title:** Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation **Official Title:** Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation #### Organization Study ID Info **ID:** 23-3039 #### Organization **Class:** OTHER **Full Name:** University of North Carolina, Chapel Hill ### Status Module #### Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** TurtleTree Labs Inc #### 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:** Overall Objective: To determine the efficacy of rbLf supplementation in a healthy adult population, specifically with regard to iron regulation (primary), gut health (secondary), and immune function (secondary). Purpose: The purpose of this study is to determine the effects of rbLf on iron regulation, exercise performance, gut health, and immune function as compared to cow's milk derived bLf. Participants: To account for an approximate \~10% dropout rate (and rounding up to ensure equal number of enrolled participants per group), n=25 per group for males (N=50) and n=30 per group for females (N=60) will be enrolled for a total sample size of N=110. Procedures: Participation in this study will include 6 in-person visits over 14 weeks. Anemia will be checked and excluded at the first visit using a single finger prick, followed by a 10-20 min exercise test on a treadmill to evaluate exercise capacity. On visit 2 participants will perform three 3-15 minute exercise tests on a treadmill with rest in between each test in order to determine exercise performance. A finger prick will be performed before and after each run to determine lactate levels. After visits 2 participants will be randomized to their respective supplement group recombinant Bovine Lactoferrin supplement (rbLf) (Male and Fame), a bovine-milk derived Lactoferrin supplement (Female), or a placebo (Male) once daily for 4 weeks. Blood samples will be obtained prior to and after each supplement phase to determine change in iron levels and red blood cell capacity. After a 2-week washout participants will return to complete the same testing outcomes and will receive the subsequent supplement. At visit 6 a final blood sample will be collected. ### Conditions Module **Conditions:** - Exercise Performance **Keywords:** - Iron regulation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Randomized cross-over design ##### Masking Info **Masking:** DOUBLE **Masking Description:** Double-Blind **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 110 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After a 2-week run-in period, this arm will begin treatment with recombinant bovine lactoferrin for 4 weeks and following a 2-week washout start bovine milk derived lactoferrin for 4 weeks. **Intervention Names:** - Dietary Supplement: Recombinant Bovine Lactoferrin - Dietary Supplement: Bovine Milk-Derived Lactoferrin **Label:** Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** After a 2-week run-in period, this arm will begin treatment with bovine milk derived lactoferrin and then following a 2-week washout start recombinant bovine lactoferrin for 4 weeks. **Intervention Names:** - Dietary Supplement: Recombinant Bovine Lactoferrin - Dietary Supplement: Bovine Milk-Derived Lactoferrin **Label:** Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** After a 2-week run-in period, this arm will begin treatment with recombinant bovine lactoferrin for 4 weeks and following a 2-week washout start placebo for 4 weeks. **Intervention Names:** - Dietary Supplement: Recombinant Bovine Lactoferrin - Dietary Supplement: Placebo **Label:** Males: Recombinant Bovine Lactoferrin (rbLf), then placebo **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** After a 2-week run-in period, this arm will begin treatment with placebo for 4 weeks and following a 2-week washout start recombinant bovine lactoferrin for 4 weeks. **Intervention Names:** - Dietary Supplement: Recombinant Bovine Lactoferrin - Dietary Supplement: Placebo **Label:** Males: Placebo, then recombinant bovine lactoferrin (rbLf) **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin - Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin - Males: Placebo, then recombinant bovine lactoferrin (rbLf) - Males: Recombinant Bovine Lactoferrin (rbLf), then placebo **Description:** Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled. **Name:** Recombinant Bovine Lactoferrin **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin - Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin **Description:** Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled. **Name:** Bovine Milk-Derived Lactoferrin **Type:** DIETARY_SUPPLEMENT #### Intervention 3 **Arm Group Labels:** - Males: Placebo, then recombinant bovine lactoferrin (rbLf) - Males: Recombinant Bovine Lactoferrin (rbLf), then placebo **Description:** Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled. **Name:** Placebo **Other Names:** - Sugar Pill **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** change in serum blood values obtained before and after supplementation **Measure:** Change in serum iron (mcg/dL) **Time Frame:** baseline to 4 weeks **Description:** change in blood values obtained before and after supplementation **Measure:** Change in ferritin iron (ng/mL) **Time Frame:** baseline to 4 weeks **Description:** change in blood values obtained before and after supplementation **Measure:** Change in red blood cell count (trillion cells/L) **Time Frame:** baseline to 4 weeks **Description:** change in blood values obtained before and after supplementation **Measure:** change in iron binding capacity (mcg/dL) **Time Frame:** baseline to 4 weeks #### Secondary Outcomes **Description:** change in treadmill running to exhaustion before and after supplementation **Measure:** change in time to exhaustion running (seconds) **Time Frame:** baseline to 4 weeks **Description:** change in blood values obtained before and after supplementation **Measure:** change on tumor necrosis factor-a (pg/mL) **Time Frame:** baseline to 4 weeks **Description:** change in blood values obtained before and after supplementation **Measure:** change in interleukin-6 (pg/ml) **Time Frame:** baseline to 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-42 years * Body mass index less than 35 kg/m\^2 * Finger prick hemoglobin levels fitting within "normal range" * Males: 14-18g/dL * Females: 12-16g/dL * Active: meeting American College of Sports Medicine exercise guidelines or exercising more than 2 days per week of ● For females specifically: * Pre-menopausal: experiencing a regular period with no signs of perimenopause or menopause. Exclusion Criteria: * Clinically diagnosed iron-deficiency anemia, pagophagia, hemochromatosis, or other blood or iron related medical conditions. * Allergy or intolerance to milk, egg, soy, peanut, wheat, coconut, or almond dairy * Smokers or vapers of nicotine or nicotine products * Immunocompromised or diagnosed with Type I or II diabetes * Irritable Bowel Disease, Crohn's disease, Celiacs * Bowel movements less than three times per week, or clinically constipated * Oral contraceptive users that have combined iron supplementation, or non-monophasic oral contraceptive users. * Pregnant or nursing * Chronic eczema or clinically diagnosed asthma. * Current antibiotic use or antibiotic use within the past 6 weeks * If flu, corona virus, or cold occurs, subject will remain in the study with their original scheduled visits, but immune values will be excluded. * Vegan (due to supplement ingredients). **Healthy Volunteers:** True **Maximum Age:** 42 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Abbie E. Smith-Ryan, PhD **Phone:** 9199622574 **Role:** CONTACT #### Locations **Location 1:** **City:** Chapel Hill **Contacts:** ***Contact 1:*** - **Name:** Abbie Smith-Ryan - **Role:** CONTACT **Country:** United States **Facility:** Applied Physiology Laboratory **State:** North Carolina **Zip:** 27599 #### Overall Officials **Official 1:** **Affiliation:** University of North Carolina, Chapel Hill **Name:** Abbie Smith-Ryan, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Clear specific study aims and ethics approval must be present. **Description:** Deidentified individual data that supports the results will be shared beginning 9 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina. Additionally, clear aims and scope of the data request must be included. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** 9-24 Months after publication ## Derived Section ### Intervention Browse Module - Ancestors - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M10533 - Name: Iron - Relevance: LOW - As Found: Unknown - ID: M10799 - Name: Lactoferrin - Relevance: HIGH - As Found: Polyethylene glycol - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007781 - Term: Lactoferrin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428344 **Brief Title:** Accuracy of an Artificial Intelligence-assisted Diagnostic System for Caries Diagnosis: a Prospective Multicenter Clinical Study **Official Title:** Accuracy of an Artificial Intelligence-assisted Diagnostic System for Caries Diagnosis: a Prospective Multicenter Clinical Study #### Organization Study ID Info **ID:** KY2024060 #### Organization **Class:** OTHER **Full Name:** Zhejiang Provincial People's Hospital ### Status Module #### Completion Date **Date:** 2027-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhejiang Provincial People's Hospital #### Responsible Party **Investigator Affiliation:** Zhejiang Provincial People's Hospital **Investigator Full Name:** Fan Yang **Investigator Title:** Chief Physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This clinical trial was designed as a prospective, multicenter, multi-reader multi-case (MRMC), superiority, parallel-controlled study. Participants who met the trial criteria and signed the informed consent form were enrolled. The trial group involved diagnoses of caries on panoramic radiographs using an artificial intelligence-assisted diagnostic system, while the control group involved diagnoses made by dental practitioners specializing in operative dentistry and endodontics with five years of experience, who interpreted oral panoramic radiographs to determine the presence and severity of caries. ### Conditions Module **Conditions:** - Dental Caries - Artificial Intellegence - Diagnosis - Machine Learning **Keywords:** - Dental Caries - AI Diagnosis ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 220 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Dentist specializing in endodontics with over five years of experience independently reviewed the participants' oral panoramic radiographs in a random order. **Label:** Control group #### Arm Group 2 **Description:** The diagnoses of caries on oral panoramic radiographs were made with the assistance of an artificial intelligence-aided oral panoramic diagnostic system. **Label:** Trial group ### Outcomes Module #### Primary Outcomes **Description:** Sensitivity: Sensitivity assesses the diagnostic method's ability to identify the disease, that is, how many true cases of caries can be correctly identified among all actual cases of caries. Specificity: Specificity evaluates the diagnostic tool's ability to recognize the absence of disease, meaning how many true non-caries cases can be correctly identified among all actual non-caries cases. Accuracy: Accuracy evaluates the overall correctness of the diagnostic tool in diagnosing the disease. **Measure:** Sensitivity, specificity, and accuracy of caries diagnosis **Time Frame:** Immediately after the completion of all participant information collection. #### Secondary Outcomes **Description:** Miss rate (False Negative Rate): The miss rate refers to the proportion of true caries cases that the diagnostic method fails to correctly identify among all actual cases of caries. In this study, the effectiveness of the artificial intelligence-assisted diagnostic system is evaluated by comparing the miss rate of caries diagnosis between the artificial intelligence-assisted diagnostic system and dentists with five years of experience. False positive rate: The false positive rate refers to the proportion of cases that are incorrectly identified as having caries among all actual non-caries cases. In this study, the effectiveness of the artificial intelligence-assisted diagnostic system is evaluated by comparing the false positive rate of caries diagnosis between the artificial intelligence-assisted diagnostic system and dentists with five years of experience. **Measure:** Miss rate and false positive rate of caries diagnosis **Time Frame:** Immediately after the completion of all participant information collection. **Description:** This study utilizes the International Caries Detection and Assessment System (ICDAS) to evaluate the grading of caries severity, categorizing caries severity into five levels: E0, E1, E2, D1, and D2. Wherein: E0 indicates no apparent signs of caries; E1 represents early caries, primarily initial enamel lesions; E2 designates enamel caries without involvement of the dentin; D1 denotes superficial dentin caries, not reaching half of the dentin thickness; D2 signifies deep dentin caries, reaching or exceeding half of the dentin thickness. This study will assess and compare the diagnostic accuracy at each grading level between the trial group and the control group. **Measure:** Accuracy of Caries Severity Level Diagnosis **Time Frame:** Immediately after the completion of all participant information collection. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: - Inclusion Criteria: 1. Patients presenting with clinical manifestations of caries as their chief complaint; 2. Age ≥18 and ≤70 years, irrespective of gender; 3. Oral panoramic radiographs showing a complete dentition, specifically with the second molars and all premolars intact in each quadrant; 4. On the oral panoramic radiographs, the number of teeth with restorations or fillings does not exceed one in any quadrant; 5. Oral panoramic radiographs that are clear, easy to interpret, and free from significant artifacts; 6. Participants who voluntarily agree to partake, can comprehend the purpose of the study, and are capable of signing an informed consent form. Exclusion Criteria: 1. Oral panoramic radiographs that are unclear, with overlapping, blurring, or artifacts present; 2. Insufficient number of teeth available for study; 3. Severe tooth wear or erosion leading to significant alteration in tooth morphology; 4. Presence of supernumerary teeth, microdontia, or missing teeth; 5. Conditions not suitable for oral radiography, such as pregnancy or undergoing radiation therapy for tumors; 6. Limited mouth opening that precludes clinical examination; 7. Neurological disorders, psychiatric illnesses, or psychological impairments; 8. Participation in another clinical trial within the last three months; 9. Any other condition deemed by the researchers as unsuitable for inclusion in the study. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients visiting the all the three centers during the study period with symptoms of caries as their chief complaint. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000017001 - Term: Tooth Demineralization - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6928 - Name: Dental Caries - Relevance: HIGH - As Found: Dental Caries - ID: M19339 - Name: Tooth Demineralization - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003731 - Term: Dental Caries - ID: D000004194 - Term: Disease ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428331 **Brief Title:** A Study of SKB518 in Patients With Advanced Solid Tumors **Official Title:** A Phase 1, Multicenter, Open-label First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of SKB518 in Subjects With Advanced Solid Tumors #### Organization Study ID Info **ID:** SKB518-I-01 #### Organization **Class:** INDUSTRY **Full Name:** Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available. **Detailed Description:** This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available. Dose escalation and de-escalation decisions are based on the mTPI-2 design and depend on the number of subjects enrolled and the number of DLTs observed at the current dose level. ### Conditions Module **Conditions:** - Advanced Solid Tumors ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Several dose levels are tentatively planned for Phase 1 **Intervention Names:** - Drug: SKB518 for injection **Label:** Dose Escalation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Dose Escalation **Description:** SKB518 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first. **Name:** SKB518 for injection **Other Names:** - SKB518 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possiblyrelated to study drug. **Measure:** Number of subjects achieving Dose-limiting toxicity (DLT) **Time Frame:** From data of initial dose until up to 21 days for treatment **Description:** Once the dose escalation stopping criteria are met, the MTD estimated by mTPI-2 will be the dose at which the probability of posterior mean of the DLT rate is between 25% and 35%, closest to 30%, and no more than 35%. **Measure:** Maximum Tolerated Dose (MTD) **Time Frame:** From data of initial dose until up to 21 days for treatment #### Secondary Outcomes **Description:** The sum of the number of cases with Complete Response (CR) and Partial Response (PR) in all treated tumorpatients (CR + PR) divided by the total number of cases. **Measure:** Objective Response Rate (ORR) **Time Frame:** Up to 24 months **Description:** Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients withtumors. **Measure:** Progression Free Survival (PFS) **Time Frame:** Up to 24 months **Description:** Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason. **Measure:** Duration of Response (DOR) **Time Frame:** Up to 24 months **Description:** Time from start of treatment to death due to any reason. **Measure:** Overall Survival (OS) **Time Frame:** Up to 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subject must be at least 18 years of age at the time of signing the informed consent; 2. Histological or cytological diagnosis of solid tumor that is advanced/metastatic solid tumor by pathology report and have progressed on, have been intolerant to, or have been ineligible for standard of care treatments. 3. Subjects able to provide tumor blocks or 8\~10 slides \[fresh paraffin-embedded tumor tissue or archived paraffin-embedded tumor tissue (maximum time limit is not more than 2 years)\] before the first dose of study intervention for biomarkers testing. 4. At least one measurable lesion can be accurately measured per RECIST v1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. 5. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 6. Life expectancy of at least 3 months as assessed by the investigators. 7. Subjects with adequate organ and bone marrow function confirmed bylaboratory results within 7 days prior to the first dose. 8. Has recovered from all toxicities from previous therapy with the exception of stable, chronic (\>3 months) toxicities not considered a safety risk (e.g. alopecia, vitiligo), after consultation with the Sponsor. 9. Subjects of childbearing potential (male or female) must use effectivemedical contraception during the study until 6 months after the last dose. 10. Subjects must be able to provide documented voluntary informed consent. Exclusion Criteria: 1. Has known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible. 2. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. 3. Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases. 4. Has serious and/or uncontrolled concomitant diseases. 5. Has known active tuberculosis. 6. Has known human immunodeficiency virus (HIV) infection that is not well controlled. 7. Has any active viral hepatitis, hepatitis B or hepatitis C. 8. Has had major surgery within 28 days prior to the first dose. 9. Has known allergy or hypersensitivity to SKB518, or the excipients of SKB518. 10. Has a history of interstitial lung disease (ILD) or a history of non-infectious pneumonitis that required steroids. 11. Clinically serious lung injuries caused by lung diseases. 12. History of documented severe dry eye syndrome. 13. Has a history of allogeneic tissue/solid organ transplant. 14. Has known uncontrollable effusion. 15. Subjects who are vaccinated with live vaccine within 30 days before the first dose, or plan to be vaccinated with live vaccine during the study period. 16. Has received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or has received BCRP inhibitors within 2 weeks prior to the first dose. 17. Subjects who received any chemotherapy, radiotherapy, immunotherapy, or biologic therapy treatment within 4 weeks; or who received any small molecular tyrosine kinase inhibitor, antitumor hormonal therapy, system immune-stimulator, or therapy with traditional Chinese medicines approved for antitumor treatment, etc. within 2 weeks before the first dose. 18. Has an active infection requiring systemic therapy. 19. Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of \>10 mg/d) or other immunosuppressive therapy within 14 days before the first dose. 20. Is currently participating and receiving study therapy in a study of an investigational agent or has participated and received study therapy in a study of an investigational agent or has used an investigational device within 28 days of fist dose. 21. Before the first dose, the subject's condition deteriorates rapidly. 22. Has a known psychiatric or substance abuse disorders. 23. The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xiaoping Jin, PhD **Phone:** 86-028-67255165 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Fudan University **Name:** Jian Zhang **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Fudan University **Name:** Xiaohua Wu **Role:** STUDY_CHAIR ## Derived Section ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428318 **Brief Title:** Diagnostic Value of the Biofire®in Community Acquired Pneumonia **Official Title:** Diagnostic Value of the Biofire® Filmarray Pneumonia Panel Compared to Conventional Sputum Culture in Critically il Patients With Pneumonia #### Organization Study ID Info **ID:** FMASU MS267/2023 #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2024-04-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-30 **Type:** ACTUAL #### Start Date **Date:** 2023-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-21 **Study First Submit QC Date:** 2024-05-21 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Investigator Affiliation:** Ain Shams University **Investigator Full Name:** Rania Maher Hussien, MD **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aimed to determine the impact value of the BioFire FilmArray Pneumonia panel compared to conventional sputum culture in critically ill patients with pneumonia. **Detailed Description:** the BioFire® FilmArray Pneumonia Panel (BFPP) emerges as a promising candidate for a rapid and multifaceted diagnostic approach. This study compare the diagnostic accuracy, turnaround time, and impact on antibiotic management decisions of BFPP versus conventional sputum culture in critically ill patients admitted to the ICU with suspected pneumonia. ### Conditions Module **Conditions:** - Pneumonia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 60 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients subjected to Routine sputum culture Conventional Methods **Intervention Names:** - Diagnostic Test: Conventional Sputum culture **Label:** Group A: Routine Conventional Methods **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients subjected to BioFire Pneumonia Panel (BFPP **Intervention Names:** - Diagnostic Test: BioFire Pneumonia Panel (BFPP) **Label:** GroupB: BioFire Pneumonia Panel (BFPP). **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A: Routine Conventional Methods **Description:** Sputum culture was done to patients and they received Antibiotics According to its results **Name:** Conventional Sputum culture **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - GroupB: BioFire Pneumonia Panel (BFPP). **Description:** BioFire Pneumonia Panel (BFPP) was done to patients and they received Antibiotics According to its results **Name:** BioFire Pneumonia Panel (BFPP) **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The potential correlation between the use of BFPP and its relation to the ICU length of stay **Measure:** the ICU length of stay **Time Frame:** Five days after admission ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients admitted to the ICU with community acquired pneumonia Exclusion Criteria: * Age less than 18 years old. * End stage malignant patients, * Patients admitted to the ICU with Acute Lung Injury (ALI). * Patients admitted to the ICU with Acute Respiratory Distress Syndrome (ARDS). * Patients with radiological findings suggesting atypical pneumonia. * Immunocompromised as defined by HIV/AIDS, known immunodeficiency, chronic steroids \> 20mg/day Prednisone equivalent, other immunosuppressants. * Solid organ or bone marrow transplant patients, cystic fibrosis. * Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete the study requirements. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Ain Shams University **State:** Abassia ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M13904 - Name: Pneumonia - Relevance: HIGH - As Found: Pneumonia - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011014 - Term: Pneumonia ### 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: 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:** NCT06428305 **Brief Title:** Providing Hygiene Education Using the Teach-back Method to Pregnant Women Diagnosed With Urinary Tract Infections **Official Title:** The Effect of Hygiene Education Given Using the Teach-Back Method to Pregnant Women Diagnosed With Urinary Tract Infections on Hygiene Behaviors and Symptoms: A Randomized Controlled Trial #### Organization Study ID Info **ID:** KARATAYU-EBE-AÇ-01 #### Organization **Class:** OTHER **Full Name:** KTO Karatay University ### Status Module #### Completion Date **Date:** 2025-05-27 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-21 **Type:** ACTUAL #### Start Date **Date:** 2024-04-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** KTO Karatay University #### Responsible Party **Investigator Affiliation:** KTO Karatay University **Investigator Full Name:** Arzu Çiftçi **Investigator Title:** Graduate student **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study proves that the hygiene education given to pregnant women diagnosed with tract infection by explaining what they have learned increases the duration of genital health, thus ensuring the positive health development of women and protecting and improving their health. At the same time, it is aimed to inform the professional "tell what you have learned" method and to guide the practices of those working in the field of health. The research will be conducted in a randomized control design with a pretest-posttest control group. The population of the research will consist of pregnant women who were followed up in the relevant hospital and who met the inclusion criteria on the dates the research was conducted. The number of samples for the study was determined as 70 participants, 35 in each group. While hygiene training will be given to the intervention group using the tell-what-you-learned method, no training will be given to the control group. Personal Information Form and Genital Hygiene Behavior Scale will be used as data collection tools in the research. Data will be collected at the first encounter, day 7, day 21, and day 30. In evaluating the data, the suitability of the variables to normal distribution will be examined using visual analytical methods. When comparing application results within and between groups, parametric or nonparametric tests will be used depending on whether they show a normal distribution or not, and t test or Mann-Withney U Test will be used to compare the difference between two groups. Wilcoxon test will be used to analyze pre- and post-intervention results within the same group. Statistical significance level will be accepted as p\<0.05. When the literature is examined, there are studies on different health education plans for women diagnosed with urinary tract infection during pregnancy, but since there is no research on the tell-what-you-learned method, it is an original study, and at the same time, the previous knowledge levels of pregnant women diagnosed with UTI were learned and the effect of the education given on their behavior was examined. It is thought that this teaching method will contribute positively to the knowledge level and behavior of women. **Detailed Description:** Urinary tract infection in women is the second most common discomfort after anemia that occurs during certain periods of life during pregnancy and is also one of the most common bacterial infections (Fihn, 2003; Griebling, 2005; Czajkawski, Bras-Konopeielka and Teliga-Czajkowska, 2021). About 50% of women have urinary tract infections at least once in their lifetime (Gilbert, O'bien, Hutgen et al., 2013). In the presence of urinary tract infection, painful urination is usually observed, frequent emergency toilet trips, while other symptoms include lower abdominal or pelvic pain and pressure, blood in the urine, milky, cloudy or pink/red urine color, fever, heavily scented urine, nausea, vomiting and diarrhea (Habak and Griggs Dec, 2023). Pregnancy, number of pregnancies, age, diabetes mellitus, urethrogenital anomalies, genetic and behavioral factors, hygiene deficiency, anemia, history of urinary system infection (Bekzac, Orgul, Tanacan et al., 2019), factors such as low socio-economic level, inadequate perineal hygiene, vaginal douching, long-term use of antibiotics and steroids, smoking, alcohol consumption and immune deficiencies increase the incidence (Özdemir, Ortabağ, Tosun et al., 2012; Ejder Apay, Özdemir, Nazik et al., 2014; Karahan, 2017). The frequency of sexual experience, the number of sexual partners (current or previous years), not urinating after sexual intercourse, the direction of wiping the perineum after the toilet, urine retention, daily insufficient water consumption also play an important role (Seid, Markas, Aklilu et al., 2023). Physiological, anatomical and hormonal changes experienced during pregnancy increase the predisposition to urinary tract infection (Helli, Dolapçıoğlu and Hammer, 2011). Urinary tract infection has a prevalence rate of 20% among pregnant women (Abdel- Deciz Elzayat, Barnett-Vanes, Dabour et al., 2013; Salari, Khoshbakht, Hemmati et al., 2023). Approximately 5-12% of pregnant women are affected by asymptomatic bacteria, while 30% of women with symptoms may develop cystitis or 50% pyelonephritis. Asymptomatic bacteriuria can lead to many undesirable maternal and neonatal problems if left untreated (De Oliveira Neto et al., 2021). Preeclampsia can cause undesirable consequences such as hypertensive diseases, pyelonephritis, permanent kidney damage, anemia, premature rupture of membranes, premature birth threat, low birth weight, fetal deaths and cesarean section (Lawani, Alade and Oyelaran, 2015; Willy, Wanyoike and Mugo, 2015). These are conditions that cause many physiological and anatomical damages and are common, requiring urgent treatment (Sevil, Özdemir, Aleattin et al., 2013; Apay, Özdemir, Nazik et al., 2014; Karahan, 2017). In addition, more than half of the patients complain of clinical depression and 38.5% of them complain of anxiety. It is reported that significant improvement in quality of life has been observed after appropriate treatment and prophylaxis (Renard, Ballarini, Mascarenhas et al., 2015). It is an important public health problem and can negatively affect the life of women and families, causing deterioration of the quality of life (Sevil, Özdemir, Aleattin et al., 2013; Apay, Özdemir, Nazik et al., 2014; Karahan, 2017). It causes a significant financial impact of up to billions of dollars on both the health system and society (Akram, Shahid and Khan, 2007; Martini, Horner, Roehrs et al., 2007; De Oliveira Neto et al., 2021). Therefore, it is important to plan and implement initiatives aimed at improving and preventing urinary tract infections. When the studies were examined, it was found that incorrect, incomplete or faulty hygiene behaviors increased the incidence of urinary tract infections (Özdemir et al., 2012; Sevil et al., 2013; Karahan, 2017). In urinary tract infections, it is necessary to determine the wrong behaviors first about hygiene and to provide permanent and positive behavioral changes by providing trainings for them (Karahan, 2017). Genital hygiene behaviors are an important factor in the formation and prevention of urinary tract infections. Öner and Çeber Turfan (2020) stated that in addition to medical treatment, urinary tract infection symptoms can be prevented with hygiene education and that it also positively affects genital hygiene behaviors (Öner and Çe October Turfan, 2020). Regarding the educational methods, Sinan et al. A study conducted by (2020) concluded that genital infection awareness training based on the knowledge-motivation-behavior skills model increases women's knowledge level and positively reinforces women's hygiene behaviors (Sinan, Kaplan, Sahin et al., 2020). In another study conducted on genital hygiene behavior training given using audiovisual and brochure, it was found that the intervention group developed more positive behaviors than the control group (Hayati et al., 2018). Parlas and Eryilmaz (2023) It is stated that the knowledge, attitudes and behaviors of women who receive education based on the PRECEDE-PROCEED model are positively affected (Parlas \& Eryilmaz, 2023). In particular, in another study, it is stated that planned education and home visits on genital hygiene have a positive effect (Abic, Yatmaz, Altınışık et al., 2024). In addition, web-based genital hygiene education has a positive effect on self-care power and genital hygiene behaviors (Gül and Yağmur, 2023), peer education provided under the guidance of the health improvement model is effective and increases the knowledge levels of young October adults about genital hygiene behaviors (Polat, Küçükkelepçe et al., 2022) is stated. Another study conducted to determine the effect of genital hygiene education given by three different methods, oral education after medical curettage, education with written material and just demonstration on genital hygiene behaviors, found that oral education alone is not effective in providing and developing genital hygiene behaviors, and the demonstration method is more effective than oral and written education methods (Uzun and Göktaş, 2022). As a result of the current literature review, although the importance of genital hygiene education is emphasized, it is clear that there is a need for teaching techniques that will provide permanent behavioral changes. Midwives, who are in contact the most during the pregnancy period and conduct face-to-face interviews, undertake the most important task in teaching genital hygiene behaviors effectively and correctly (Ünsal, Özyazıcıoğu, Sezgin et al. 2010). For this reason, midwives should plan training with a permanent teaching technique that fills in gaps in the lack of knowledge, can get feedback, can be evaluated, while advising pregnant women diagnosed with urinary tract infection on genital hygiene behaviors. The teach back method is a method used for the education, learning, evaluation and development of personal care behaviors of individuals. This approach provides an opportunity for individuals to understand educational materials, improve their level of retention in mind, and evaluate themselves. One of the important advantages is that the educational content is presented as simply as possible, free from medical terms, and that the clients repeat the practices at the end of the training (Ahmed Abd El- hamed, 2023). The practice involves asking patients by a health professional to explain in their own sentences what they have just been told. If there is any misunderstanding, it is clarified by the health professional and the understanding status is evaluated by checking again. This condition continues until the patient tells the truth and remembers the information given to him (Farris, 2015; Talevski, Wong Shee, Rasmussen et al., 2020). The patient's learning about issues related to health information can be improved through continuous feedback. It is stated that this method-based communication approach helps patients to better understand their own medical conditions and health information, and provides benefits in improving their skills of remembering and applying medical information (Tamura, 2013; Laws, 2018; Cheng, Chen, 2023).The Tell what you have learned method provides positive effects on information acquisition, remembering, keeping in mind, as well as health behavior management, personal care behavior development, hospitalization, quality of life and patient satisfaction (Yen and Leasure, 2019; Talevski et al., 2020; Cheng et al., 2023). In addition, it is stated that self-care increases strength and comfort, reduces the cost of health care (Badeczewski et al., 2017; Imanipour, Molazem, Rakhshan et al., 2022). For this reason, midwives can use the tell what you've learned method, which is a permanent teaching technique that fills in gaps in the lack of information, can be reversed, evaluated, while advising pregnant women diagnosed with urinary tract infection on genital hygiene behaviors. Pregnant women diagnosed with urinary tract infection have been given trainings on genital hygiene behaviors in many different methods in the literature, but when the trainings given were examined, it was determined that teaching techniques aimed at improving the education, learning level, evaluation and personal care behaviors of individuals are needed. It is thought that using the tell what you have learned method in order to fill these gaps in education will be beneficial. In this context, the fact that there are no studies on the subject in our country, the fact that evidence-based teaching techniques are tried in new areas constitutes the original value of the project and our main motivation. The project has unique value for a sustainable future in terms of its effects on pregnant women in particular and qualified midwifery care at the social level in general. It will also enable data to be obtained for comparing innovative educational methods with traditional educational methods. Thus, it will help to improve, organize or develop capacity for future initiatives. Hypotheses 1. The education given to pregnant women who have been diagnosed with urinary tract infection by the tell me what you have learned method positively affects genital hygiene behavior. 2. Education given to pregnant women who have been diagnosed with urinary tract infection by the tell-what-you-learned method reduces the level of symptoms. ### Conditions Module **Conditions:** - Urinary Tract Infections During Pregnancy **Keywords:** - Pregnant - Genital hygiene - Teach Back Method - Health Educatio - Urinary system ınfections ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The intervention group receiving planned education on genital hygiene using the teach-back method and the control group not receiving education ##### Masking Info **Masking:** DOUBLE **Masking Description:** The statistician will be blinded in the research. Researcher blinding cannot be done because he is a practitioner. But the researcher will open the envelope created by the statistician just before the application and find out which group the mother belongs to. In order to prevent bias in the evaluation of the data, groups will be coded as A and B, and the analysis of the data will be carried out by an independent statistical expert. After the analysis and interpretation of the data are completed, the codes of the intervention and control groups of the study will be revealed. **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All pregnant women diagnosed with UTI at the maternity outpatient clinic are prescribed antibiotics containing the active substance fosfomycin tromethamol, which is recommended for uncomplicated urinary tract infections of adults. The duration of the antibiotic's effect is seven days (Due date). After completing the treatment process determined according to the physician's request, training and counseling will be provided using the Genital Hygiene Training Guide based on the Tell me what you have learned method. In this context, 4 interviews will be held during the project. **Intervention Names:** - Other: Providing hygiene education based on the method of teaching what has been learned in the context of a genital hygiene guide **Label:** The intervention group receiving planned education on genital hygiene using the teach-back method **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control Group: Research data were collected from pregnant women who were in the control group at the December intervals with the experimental group, as shown in the Flow Chart of the study. After the completion of the study, this group will also be given an education and training booklet. **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - The intervention group receiving planned education on genital hygiene using the teach-back method **Description:** As shown in the Flow Chart of the study, research data were collected from pregnant women who were in the control group at the December intervals with the experimental group. After the completion of the study, this group will also be given an education and training booklet. **Name:** Providing hygiene education based on the method of teaching what has been learned in the context of a genital hygiene guide **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** It was developed by Karahan (2017) to evaluate genital hygiene behaviors in women. General hygiene habits (top 12 items), menstrual hygiene (13th item on the five-point likert scale).-20. substances) and abnormal finding awareness (21-23. it consists of three sub-dimensions (substances) and a total of 23 substances. The cronbach alpha value of the entire scale is 0.80, and it is stated that the general hygiene sub-dimension is 0.70, the menstrual hygiene sub-dimension is 0.74, and the abnormal finding awareness sub-dimension is 0.81. 7 of the scale., 14., 19., 20., 23. items are scored in reverse. The lowest 23 highest 115 points are taken from the scale and the high scores indicate that genital hygiene behavior is positive (Karahan, 2017). **Measure:** The Scale of Genital Hygiene Behaviors **Time Frame:** 1. day, 7. day, 21, day, 30.. day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Able to read and write Turkish, * Those between the ages of 18-35 December, * Diagnosed with urinary tract infection, * Pregnant women who are open to communication (who are competent to understand and answer questions) will be included in the sample. Exclusion Criteria: * Leaving the research of his own accord, * Having a diagnosis related to risky pregnancy other than the diagnosis of urinary tract infection * With a history of psychiatric illness (self-report), * Pregnant women with a history of gynecological diseases (self-information) will be excluded from the research. **Gender Based:** True **Gender Description:** Pregnant women who have been diagnosed with a urinary tract infection **Maximum Age:** 35 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Arzu YL ÇİFTÇİ, post graduate **Phone:** +905545618080 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Hediye KARAKOÇ, assistant professor **Phone:** 05412291726 **Role:** CONTACT #### Locations **Location 1:** **City:** Konya **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hediye KARAKOÇ, assistant professor - **Phone:** +905412291726 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Arzu ÇİFTÇİ, post graduate - **Phone:** +905545618080 - **Role:** CONTACT ***Contact 3:*** - **Name:** Hediye KARAKOÇ, assistant professor - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Arzu ÇİFTÇİ, post graduate - **Role:** SUB_INVESTIGATOR **Country:** Turkey **Facility:** KTO Karatay University **Status:** RECRUITING **Zip:** 42020 #### Overall Officials **Official 1:** **Affiliation:** KTO Karatay University **Name:** Hediye KARAKOÇ, assistant professor **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** KTO Karatay University **Name:** Arzu ÇİFTÇİ, post graduate **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** have no plans to make individual participant data (IPD) available to other researchers. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M17302 - Name: Urinary Tract Infections - Relevance: HIGH - As Found: Urinary Tract Infections - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000014552 - Term: Urinary Tract 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: M8700 - Name: Fosfomycin - 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:** NCT06428292 **Brief Title:** Fully Immersive Virtual Reality Applications in Children With Cerebral Palsy **Official Title:** Comparison of the Effects of Fully Immersive Virtual Reality in Combination With Treadmill and Bicycle on Functional Capacity in Children With Cerebral Palsy #### Organization Study ID Info **ID:** IstanbulUC-FTR-OA-01 #### Organization **Class:** OTHER **Full Name:** Istanbul University - Cerrahpasa (IUC) ### Status Module #### Completion Date **Date:** 2024-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Omer Ayhan #### Responsible Party **Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC) **Investigator Full Name:** Omer Ayhan **Investigator Title:** Principal investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study was conducted in children diagnosed with Cerebral Palsy (CP); It is a prospective randomized clinical study planned to examine the effects of treadmill and bicycle ergometer applications combined with fully immersive virtual reality (TISG) on motor function, balance and walking. **Detailed Description:** The aim of this study is in children diagnosed with Cerebral Palsy (CP); It is a comparative study of the effects of treadmill and bicycle ergometer applications combined with total immersive virtual reality (TISG) on motor function, balance and walking. 34 cases diagnosed with Cerebral Palsy between the ages of 12-18 and attending a rehabilitation center will be included in the study. The sample will be divided into two groups by randomization (TİSG combined with treadmill group n = 17, TİSG combined with bicycle ergometer group = 17). Evaluations will be made before and at the end of treatment. An exercise program that will last 45 minutes twice a week for six weeks will be applied to both study groups. The treadmill combined with TİSG group will be given walking training on the treadmill in a virtual environment using virtual reality glasses. The TISG and combined bicycle ergometer group will be given exercise training on the bicycle ergometer in a virtual environment using virtual reality glasses. For both groups, this process will continue in the same order for each exercise in the session. It is assumed that performing the bicycle ergometer in a sitting position makes this exercise safe, easier to perform, and can be performed at different levels of motor function, regardless of the severity of motor impairment. Based on this assumption, this study aimed to compare the use of bicycle ergometer combined with TISG with the treadmill combined with TISG in improving functional capacity, balance and walking functions in children with CP. ### Conditions Module **Conditions:** - Cerebral Palsy **Keywords:** - Virtual Reality - Function - Balance - Physical Therapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** The investigator administering the treatment and the investigator performing the evaluations will be different. The evaluator will not know about the interventions that the participants received. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 32 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Combining a virtual reality device with a treadmill and using it in a virtual environment, allowing the person to walk in different virtual environments **Intervention Names:** - Device: Virtual reality device branded ''Meta Quest 2'' **Label:** combined treadmill with virtual reality **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Combining a virtual reality device with a stationary bike and using it in a virtual environment, allowing the person to walk in different virtual environments **Intervention Names:** - Device: Virtual reality device branded ''Meta Quest 2'' **Label:** stationary bike combined with virtual reality **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - combined treadmill with virtual reality - stationary bike combined with virtual reality **Description:** Combining different exercise equipment with a virtual reality device and using them in a virtual environment can be used to decide which one is more effective. **Name:** Virtual reality device branded ''Meta Quest 2'' **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Gross Motor Function Measure - 88 is a well-known scoring system that evaluates changes in gross motor function. Gross Motor Function Measure - 88 has no age limit and is divided into five gross motor function dimensions: (A) lying and rolling, (B) sitting, (C) crawling and kneeling, (D) standing, and (E) walking, running and jumping. It consists of 88 items. Each item is scored on a 4-point scale (0-1-2-3). A higher score means better motor function. **Measure:** Gross Motor Function Measure - 88 **Time Frame:** 2 times in 8 weeks **Description:** 6 Minute Walk Test is a standardized, inexpensive and easy-to-implement walking test in which the distance walked in 6 minutes is measured under controlled conditions, the person determines his/her own pace. 6 Minute Walk Test is commonly used to assess functional capacity in children with cerebral palsy (CP) **Measure:** 6 Minute Walk Test **Time Frame:** 2 times in 8 weeks #### Secondary Outcomes **Description:** It is a test used to evaluate the walking speed of individuals. They walk at their normal speed, with or without assistance, on a 14-meter walkway, and the time required for each participant to cover a 10-meter walking distance is measured, starting from 2 marked points 2 m after the starting point and 2 m before the end point. **Measure:** 10 Meter Walk Test **Time Frame:** 2 times in 8 weeks **Description:** Timed Up and Down Stair Test attempts to obtain information about the individual's functional mobility by evaluating how long it takes to ascend and descend a 14-step staircase. **Measure:** Timed Up And Down Stairs Test **Time Frame:** 2 times in 8 weeks **Description:** Timed Up and Go Test is a valid and reliable test method used to evaluate functional mobility and static and dynamic balance in children with CP. Participants have to stand up from a chair without armrests from the starting position with hips, knees and ankles bent at 90°, walk 3 meters, and return. and they are asked to sit on the chair. Completing the test in less time means more mobility. **Measure:** Timed Up and Go Test **Time Frame:** 2 times in 8 weeks **Description:** Gross Motor Function Classification System was developed to measure the 'severity of movement disability' in children with cerebral palsy (CP). Gross Motor Function Classification System provides a method to classify the functional abilities of children with CP into one of five levels. As the grade level approaches five, it means that the child's functional ability decreases and he becomes more dependent. **Measure:** Gross Motor Function Classification System **Time Frame:** 2 times in 8 weeks **Description:** The Pediatric Berg Balance Scale, a modified version of the Berg Balance Scale, is a 14-item, criterion-referenced measurement method that examines functional balance in the context of daily tasks. The 14 items that make up the Pediatric Berg Balance Scale are scored on a 4-point scale. A higher score means better balance. **Measure:** Pediatric Berg Balance Scale **Time Frame:** 2 times in 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being diagnosed with spastic cerebral palsy * Being between the ages of 12 - 18 * Being at Level 1 and 2 according to the Gross Motor Function Classification System (GMFSS) * Being able to understand and speak Turkish * Not using medical treatment (including botox) in the last six months * No visual or auditory problems that would hinder communication during applications. * Having the cognitive skills to adapt to the application and application controls where the intervention is required. Exclusion Criteria: * Presence of secondary orthopedic and neurological problems/problems that are severe enough to affect participation in the study (advanced joint instability, severe scoliosis, nystagmus, etc.). * Having a neurodegenerative disease that may cause attacks during virtual reality applications * Presence of epilepsy * Having undergone lower extremity surgery within the last year * Presence of hypersensitivity to visual stimuli * Development of vestibular problems with the use of virtual reality devices **Maximum Age:** 18 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ömer Ayhan, BSc **Phone:** +905350848014 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ayşenur Erekdağ, MSc **Phone:** 05548959013 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Secde N Atamtürk - **Phone:** +902124040300 - **Phone Ext:** 16601-16602 - **Role:** CONTACT **Country:** Turkey **Facility:** İstanbul Ünivesitesi - Cerrahpaşa **State:** Büyükçekmece **Status:** RECRUITING **Zip:** 34500 #### Overall Officials **Official 1:** **Affiliation:** Istanbul University - Cerrahpasa (IUC) **Name:** Ipek Yeldan, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ochandorena-Acha M, Terradas-Monllor M, Nunes Cabrera TF, Torrabias Rodas M, Grau S. Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project). BMJ Open. 2022 Nov 3;12(11):e061988. doi: 10.1136/bmjopen-2022-061988. **PMID:** 36328390 **Citation:** Cho C, Hwang W, Hwang S, Chung Y. Treadmill Training with Virtual Reality Improves Gait, Balance, and Muscle Strength in Children with Cerebral Palsy. Tohoku J Exp Med. 2016 Mar;238(3):213-8. doi: 10.1620/tjem.238.213. **PMID:** 26947315 **Citation:** Zeng N, Pope Z, Gao Z. Acute Effect of Virtual Reality Exercise Bike Games on College Students' Physiological and Psychological Outcomes. Cyberpsychol Behav Soc Netw. 2017 Jul;20(7):453-457. doi: 10.1089/cyber.2017.0042. **PMID:** 28715263 **Citation:** Gagliardi C, Turconi AC, Biffi E, Maghini C, Marelli A, Cesareo A, Diella E, Panzeri D. Immersive Virtual Reality to Improve Walking Abilities in Cerebral Palsy: A Pilot Study. Ann Biomed Eng. 2018 Sep;46(9):1376-1384. doi: 10.1007/s10439-018-2039-1. Epub 2018 Apr 27. **PMID:** 29704186 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases - ID: D000001925 - Term: Brain Damage, Chronic - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5796 - Name: Cerebral Palsy - Relevance: HIGH - As Found: Cerebral Palsy - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M5207 - Name: Brain Injuries - Relevance: LOW - As Found: Unknown - ID: M5202 - Name: Brain Damage, Chronic - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002547 - Term: Cerebral Palsy ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428279 **Acronym:** S&C **Brief Title:** Survey of Sexual Health in Cancer Patients **Official Title:** Sexual Health in Cancer Patients: a Survey and Pilot Study of Psychosexual Therapy as a Non-pharmacological Supportive Care #### Organization Study ID Info **ID:** IR-2024-001 #### Organization **Class:** OTHER **Full Name:** Institut Rafael #### Secondary ID Infos **Domain:** ANSM **ID:** 2024-A00387-40 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2024-05-19 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-05-19 **Type:** ACTUAL #### Start Date **Date:** 2024-04-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Institut Rafael #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Sexual health, a vital aspect of the overall human health and a critical component of quality of life, can be negatively affected by cancer and cancer treatments. Although prevalence rates of sexual difficulties vary depending on several factors including primary diagnosis, treatment modality and methods of assessment, estimates rates are reported to range from 40% to 100%. Despite the abundant literature on sexuality and intimacy, communication about sexual health is often absent or inadequate between patients and health care providers. In this context, more research is needed to understand patients' priorities and needs for information about sexuality. The purpose of this study is to assess the main difficulties faced by patients in their sexual life and to evaluate patient's satisfaction after having followed sessions of psychosexual therapy proposed at Rafaël Institute, France. The survey will be conducted using questionnaires developed specifically for this study. All questions will be coded through a Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses to each question will be analyzed with higher mean scores (\>4) indicating main difficulties faced by patients in their sexual life. Patients will also express their positive or negative state of agreement regarding questions evaluating their satisfaction after following a program of psychosexual therapy. Approximately 200 patients will be invite to participated in this survey after provided oral consent. **Detailed Description:** Sexual health, a vital aspect of the overall human health can be negatively affected by cancer and cancer treatments. Sexual dysfunctions affect the quality of life of an individual since sexual health is a critical component of overall quality of life. The World Health Organization (WHO) defines sexual health as "a state of physical, emotional, mental and social well-being in relation to sexuality; and not merely the absence of disease, dysfunction or infirmity". Indeed, regular sexual activity reduces stress, regularizes sleep cycle, and regulates our mental wellbeing as a whole. Although prevalence rates of sexual difficulties vary among cancer patients and depend on several factors including primary diagnosis, treatment modality and methods of assessment, estimates rates can range from 40% to 100%. For example, in a French national survey focusing on sexual health of patients with colorectal or breast cancer two years after diagnosis, 54% of patients (235 of 435) reported to have a decrease in sexual desire and 61% had a decrease in frequency of intercourse. Despite these problems have been well documented in the literature and in practice guidelines, many cancer survivors have limited access to high quality information on sexual health. Indeed, communication about sexual health is often absent or inadequate between patients and the medical team. Among barriers reported by health care providers for avoiding discussing this topic are lack of time, insufficient training, absence of awareness about the subject and unavailable access to integrative medicine solutions where they could send their patients. Cultural values, religious beliefs and social norms may also have significant implications. Recognizing patients' sexual problems can help health care providers to offer appropriate integrative non-pharmacological interventions to different group of patients. In this context, more research is needed to understand patients' priorities and needs for information about sexuality. The purpose of this study is to assess the main difficulties faced by patients in their sexual life and to evaluate patient's satisfaction after having followed sessions of psychosexual therapy proposed at Rafaël Institute, France. ### Conditions Module **Conditions:** - Integrative Oncology **Keywords:** - Sexual health - Quality of life - Integrative oncology ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 200 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** survey **Name:** Survey **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** questionnaire **Measure:** patients' satisfaction with their sexual lives **Time Frame:** 1 month #### Secondary Outcomes **Description:** questionnaire **Measure:** identification of the main physiological and psychological difficulties encountered by patients in their sexual lives **Time Frame:** 1 month **Description:** questionnaire **Measure:** patients perceived emotions **Time Frame:** 1 month **Description:** questionnaire **Measure:** description of the impact of sex therapy sessions on the sexual health of the participants **Time Frame:** 1 month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * cancer patients * adults aged \> 18 years old Exclusion Criteria: * \<18years old **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Eligible participants will be adults aged 18 years old or older diagnosed with cancer and undergoing non-pharmacological supportive care during or after their standards cancer treatments at Rafael Institute ### Contacts Locations Module #### Locations **Location 1:** **City:** Levallois Perret **Country:** France **Facility:** Institute Rafaël **State:** Institut Rafael **Zip:** 92300 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428266 **Acronym:** DICvsBIcanal **Brief Title:** Closed Dacryointubation vs Bicanalicular Intubation for Proximal Tear Duct Obstruction **Official Title:** Comparative Study of Safety and Efficacy of Closed Dacryointubation vs Bicanalicular Intubation in the Treatment of Proximal Tear Duct Obstruction in Adult Patients #### Organization Study ID Info **ID:** CI 09 015 008 #### Organization **Class:** OTHER **Full Name:** Instituto de Oftalmología Fundación Conde de Valenciana ### Status Module #### Completion Date **Date:** 2022-07-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-06-30 **Type:** ACTUAL #### Start Date **Date:** 2021-07-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Instituto de Oftalmología Fundación Conde de Valenciana #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** In Mexico, upper lacrimal duct obstruction (ULDO) is a common pathology, and the standard surgical treatment is closed dracryointubation. Based on statistics from our headquarters, in 30% of cases there is a failure of the technique and recurrence of symptoms due to associated complications. Because of this, the application of a self-stable bicananlicular intubation set is proposed. The aim of this study is to describe the difference in efficacy and complication rate between the application of the self-stable bicanalicular intubation set II (FCI) and closed dacryointubation in patients with ULDO . **Detailed Description:** Upper lacrimal duct obstruction (ULDO) or proximal lacrimal tract obstruction occurs when an occlusion is located in the lacrimal point, in superior and inferior canaliculi, or in the common canaliculus. When the ULDO is at the level of the canaliculi (superior, inferior or common), the alternatives available for its management are closed dacryointubation with Crowford catheter, conjunctivadacryocystorhinostomy, and bicanalicular intubation. Closed dacryointubation with Crowford tube is a technique effective in approximately 90% of children diagnosed with congenital occlusion of the lacrimal duct, however, in adults the reported surgical success rate is lower, approximately 70% according to different authors. The conjunctivadacryocystorhinostomy is the procedure proposed by many authors when there is point and canaliculi obstruction in which canalicular intubation cannot be performed due to atresia or total obstruction. The bicanaliculalr intubation with the Self-Stable Canalicular Intubation Set (FCI R), an FDA-approved silicone bicanalicular retention device, is especially indicated for the treatment of lacrimal point stenosis and horizontal canalicular obstruction. The aim of this study is to describe the difference in efficacy and complication rate between the application of the self-stable bicanalicular intubation set II (ICF) and closed dacryointubation in patients with ULDO ### Conditions Module **Conditions:** - Lacrimal Duct Obstruction - Lacrimal Apparatus Diseases - Lacrimal Stenosis - Lacrimal Elimination **Keywords:** - upper lacrimal duct obstruction - bicanalicular intubation - closed dacriointubation ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Patients from the consultation of the Oculoplastics Department of the Institute of Ophthalmology "Conde de Valenciana I.A.P", between July 2021 and July 2022 who met the inclusion and exclusion criteria were enrolled ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 31 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients undergoing conventional closed dacryointubation with Crawford's tube **Intervention Names:** - Procedure: Closed dacryointubation **Label:** Closed dacryointubation **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients undergoing bicanalicular intubation with Self-Stable Intubation Set II FCI **Intervention Names:** - Device: Bicanalicular intubation **Label:** Bicanalicular Intubation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Bicanalicular Intubation **Description:** Placement of the bicanalicular intubation set at each lacrimal point and fixed by means of its flaps at the level of the opening of the lacrimal sac. **Name:** Bicanalicular intubation **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Closed dacryointubation **Description:** Placement of dacryointubation tube through the canaliculus until it reaches the medial wall of the lacrimal sac and then passed the nasolacrimal duct until it empties out at the level of the inferior meatus. **Name:** Closed dacryointubation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Irrigation of the lacrimal duct with saline solution to seek for permeability **Measure:** Irrigation of tha lacrimal duct **Time Frame:** three and four months after the procedure **Description:** evidence of epiphora as told by the subject **Measure:** Epiphora **Time Frame:** one, three and four months after surgery #### Secondary Outcomes **Description:** postoperative bleeding throug the nose **Measure:** Occurrence of epistaxis **Time Frame:** one, three and four months after surgery **Description:** extruded or non-extruded **Measure:** Presence of extrusion of bicanalicular intubation tubes **Time Frame:** one, three and four months after surgery **Description:** how well positioned or poorly positioned the tubes are **Measure:** How well is the positioning of the silicone tubes **Time Frame:** one, three and four months after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients over 18 years of age * Patients with stenosis and incomplete obstruction of the upper lacrimal duct with epiphora \> 2 on the Munk scale who have not previously undergone surgery on the affected tear duct * Patients who may undergo general anesthesia and sedation * Patients who are able to present and continue follow-up for the duration of the study * Acceptance to participate in the study by signing an informed consent Exclusion Criteria: * Patients with ocular surface involvement affecting the upper lacrimal duct, such as blepharitis with tear point epithelialization * Patients with lacrimal point malposition and/or eyelid malposition due to entropion or ectropion * Patients with congenital or acquired obstruction of the lower lacrimal duct * Patients with a history of facial paralysis * Patients with systemic inflammatory disease such as scarring pemphigoid or Steven Johnson * Patients in whom tumour involvement of the lacrimal duct is suspected * Patients with reflex tear hypersecretion due to ocular surface involvement or other causes. * Pregnancy and breastfeeding * Active infection, eye trauma, history of facial trauma with broken bones of the nose, or history of sinus surgery. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Mexico City **Country:** Mexico **Facility:** Institiuto de Oftalmología Fundación Conde de Valenciana **Zip:** 06800 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** 1. Schaefer DP. Acquired Etiologies of Lacrimal System Obstructions. In: Cohen AJ, Mercandetti M, Brazzo BG, editors. The Lacrimal System [Internet]. Springer New York; 2006 [cited 2020 Jan 15]. p. 43-65. **Citation:** Fulcher T, O'Connor M, Moriarty P. Nasolacrimal intubation in adults. Br J Ophthalmol. 1998 Sep;82(9):1039-41. doi: 10.1136/bjo.82.9.1039. **PMID:** 9893595 **Citation:** Pashby RC, Rathbun JE. Silicone tube intubation of the lacrimal drainage system. Arch Ophthalmol. 1979 Jul;97(7):1318-22. doi: 10.1001/archopht.1979.01020020060014. **PMID:** 454271 **Citation:** Tabatabaie SZ, Rajabi MT, Rajabi MB, Eshraghi B. Randomized study comparing the efficacy of a self-retaining bicanaliculus intubation stent with Crawford intubation in patients with canalicular obstruction. Clin Ophthalmol. 2012;6:5-8. doi: 10.2147/OPTH.S25172. Epub 2011 Dec 20. **PMID:** 22259230 #### See Also Links **Label:** characteristics of the Self-Stable Intubation Set II FCI **URL:** http://www.accessdata.fda.gov/cdrh_docs/pdf13/K130375.pdf ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC11 - Name: Eye Diseases ### Condition Browse Module - Browse Leaves - ID: M6475 - Name: Constriction, Pathologic - Relevance: LOW - As Found: Unknown - ID: M15241 - Name: Rupture - Relevance: LOW - As Found: Unknown - ID: M22785 - Name: Lacerations - Relevance: LOW - As Found: Unknown - ID: M10787 - Name: Lacrimal Duct Obstruction - Relevance: HIGH - As Found: Lacrimal Duct Obstruction - ID: M10786 - Name: Lacrimal Apparatus Diseases - Relevance: HIGH - As Found: Lacrimal Apparatus Diseases - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007767 - Term: Lacrimal Duct Obstruction - ID: D000007766 - Term: Lacrimal Apparatus Diseases ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428253 **Brief Title:** Efficacy and Safety of HMM1-022 in Temporary Correction of Crow's Feet **Official Title:** A Single Center, Subject & Evaluator-blind, Randomized, Matched Pairs, Active-controlled, Confirmatory Study to Evlualte the Efficacy and Safety of HMM1-022 in Temporary Correction of Crow's Feet #### Organization Study ID Info **ID:** HMM1-022 #### Organization **Class:** INDUSTRY **Full Name:** Humedix Co., Ltd. ### Status Module #### Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Humedix Co., Ltd. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** The purpose of this study is to compare the efficacy and safety of HMM1-022 with Rejuran to improve Crow's feet ### Conditions Module **Conditions:** - Crows Feet ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** subject/evaluator blinding **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 171 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive injections into the wrinkles at the corners of each eye, up to 1 mL each, four times at two-week intervals. **Intervention Names:** - Device: HMM1-022 **Label:** HMM1-022 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive injections into the wrinkles at the corners of each eye, up to 1 mL each, four times at two-week intervals. **Intervention Names:** - Device: HMM1-022 **Label:** REJURAN® **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - HMM1-022 - REJURAN® **Description:** intradermal injection **Name:** HMM1-022 **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Compared to Rejuran, the improvement rate on the crow's feet at rest evaluation scale (IGA-LCL severity scale) by external independent evaluators to prove that HMM1-022 is non-inferior **Measure:** IGA-LCL severity scale **Time Frame:** 18 weeks after initial inejction ### Eligibility Module **Eligibility Criteria:** Crows feet (both eyes) is at least 3 points (Moderate) on the lGA-LCL severity scale, and the wrinkles are symmetrical by the investigator **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** development Humedix **Phone:** 82-70-7492-5647 **Role:** CONTACT #### Locations **Location 1:** **City:** Seoul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Beom Joon Kim, M.D - **Role:** CONTACT **Country:** Korea, Republic of **Facility:** Chung-Ang University Hospital **State:** Heukseok-ro, Dongjak-gu **Status:** RECRUITING **Zip:** 06973 #### Overall Officials **Official 1:** **Affiliation:** Dermatology **Name:** Beom-joon Kim, M.D. **Role:** STUDY_DIRECTOR ### 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:** NCT06428240 **Acronym:** AMI_CAT **Brief Title:** Acute Mesenteric Ischemia, Reality in Catalonia **Official Title:** Reality of Acute Mesenteric Ischemia in Catalonia, is There a Chance to Improvement? #### Organization Study ID Info **ID:** AMICat Reality #### Organization **Class:** OTHER **Full Name:** Hospital del Mar ### Status Module #### Completion Date **Date:** 2026-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-03 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-31 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Hospital Clinic of Barcelona **Class:** OTHER **Name:** Germans Trias i Pujol Hospital **Class:** OTHER **Name:** Parc Taulí Hospital Universitari **Class:** OTHER **Name:** Hospital de la Santa creu i Sant Pau - Barcelona **Class:** OTHER **Name:** Hospital Vall d'Hebron **Class:** OTHER **Name:** Hospital Universitari Joan XXIII de Tarragona. **Class:** UNKNOWN **Name:** Hospital de Manresa **Class:** OTHER **Name:** Hospital de Mataró **Class:** OTHER **Name:** Hospital Universitari Sant Joan de Reus **Class:** OTHER **Name:** Hospital de Sant Joan Despí Moisès Broggi **Class:** OTHER **Name:** Hospital d'Igualada **Class:** OTHER **Name:** Consorci Hospitalari de Vic **Class:** OTHER **Name:** Hospital Arnau de Vilanova **Class:** UNKNOWN **Name:** Hospital de Mollet **Class:** OTHER **Name:** Hospital de Terrassa **Class:** OTHER **Name:** Hospital Universitari de Bellvitge #### Lead Sponsor **Class:** OTHER **Name:** Hospital del Mar #### Responsible Party **Investigator Affiliation:** Hospital del Mar **Investigator Full Name:** Ana María González Castillo **Investigator Title:** Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Acute mesenteric ischaemia (AMI) is a notorious disease with a high mortality, the diagnostic and management is truly multidisciplinary, but not very extended. The aim of this study is to analyse the results of the patients admited with an AMI in Catalonia. **Detailed Description:** Acute mesenteric ischaemia (AMI) is a notorious disease with a high mortality from 50 to 80%. Even though AMI is a relatively rare condition (1:1,000) the incidence rises exponentially with increasing age, in patients older than 75 years, the incidence of AMI has been reported higher than that of acute appendicitis. AMI patients benefit from early assessment in a surgical unit with capabilities to definitive management. The diagnosis and management of AMI are truly multidisciplinary, requiring high index of suspicion and awareness from emergency department physicians, preferably computed tomography angiography with precise interpretation, but usually this is not the truth reality and the diagnostic is delayed as well as the treatment, and the management is not multidisciplinary. The aim of this study is to analyse the management and results of the patients admitted with an AMI in Catalonia from November 2024 to April 2026. ### Conditions Module **Conditions:** - Acute Mesenteric Ischemia **Keywords:** - Mesenteric ischemia - Acute Mesenteric ischemia - Abdominal pain - Elderly - Complications - Mortality ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** To describe the mortality in patients with a diagnostic of AMI **Measure:** Mortality **Time Frame:** 2024-2026 #### Secondary Outcomes **Description:** To describe the complications in patients with a diagnostic of AMI **Measure:** Complications **Time Frame:** 2024-2026 **Description:** To describe the management in patients with a diagnostic of AMI **Measure:** Management **Time Frame:** 2024-2026 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnostic of Acute Mesenteric Ischemia Exclusion Criteria: * Chronic Mesenteric Ischemia * Ischemic Colitis * Bowel obstruction strangulation * Inflammatory bowel necrosis **Gender Based:** True **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study populations is all pacients with the diagnostic of Acute Mesenteric Ischemia that are admitted in the Hospital in Catalonia. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000010532 - Term: Peritoneal Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10543 - Name: Ischemia - Relevance: HIGH - As Found: Ischemia - ID: M30554 - Name: Mesenteric Ischemia - Relevance: HIGH - As Found: Mesenteric Ischemia - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M18311 - Name: Abdominal Pain - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal 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: M13441 - Name: Peritoneal Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000065666 - Term: Mesenteric Ischemia - ID: D000007511 - Term: Ischemia ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428227 **Brief Title:** Exercise Capacity and Fatigue in Heart Failure Patients With and Without Inspiratory Muscle Weakness **Official Title:** A Comparison of Exercise Capacity, Respiratory Functions, and Quality of Life in Heart Failure Patients With and Without Inspiratory Muscle Weakness and Healthy Controls #### Organization Study ID Info **ID:** GaziU5 #### Organization **Class:** OTHER **Full Name:** Gazi University ### Status Module #### Completion Date **Date:** 2024-02-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-01-01 **Type:** ACTUAL #### Start Date **Date:** 2010-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Gazi University #### Responsible Party **Investigator Affiliation:** Gazi University **Investigator Full Name:** Meral Boşnak Güçlü **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 patients with heart failure, diaphragm dysfunction contributes to decreased quality of life while simultaneously increasing morbidity and mortality. Inspiratory muscle weakness is observed in 30-50% of patients, with the severity of weakness increasing as the disease progresses. Patients exhibit reduced exercise capacity, peripheral and respiratory muscle strength, decreased respiratory function, increased dyspnea, fatigue, and worsened quality of life. However, it is unclear how these parameters will change in patients with inspiratory muscle weakness. Therefore, the study aimed to compare functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without inspiratory muscle weakness and healthy controls **Detailed Description:** It is believed that respiratory muscle abnormalities develop earlier and more extensively than extremity muscle abnormalities in heart failure. Diaphragm dysfunction contributes to decreased quality of life while simultaneously increasing morbidity and mortality. Inspiratory muscle weakness is observed in 30-50% of patients, with the severity of weakness increasing as the disease progresses. Heart failure patients exhibit increased airway resistance and ventilatory response during exercise. Fatigue and dyspnea are common symptoms associated with exercise intolerance and decreased quality of life in heart failure patients.There is no study in the literature comparing functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without inspiratory muscle weakness (IMW). The aim of the study was to compare functional exercise capacity, pulmonary function, peripheral muscle strength, dyspnea, fatigue, quality of life and physical activity level in heart failure patients with and without IMW and healthy controls. The study was planned as a cross-sectional, retrospective. Heart failure patient were divided into IMW group or not IMW group due to their MIP values. Also healthy controls who were matched for age-gender were included. ### Conditions Module **Conditions:** - Heart Failure **Keywords:** - heart failure - exercise capacity - respiratory muscle ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 102 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Exercise capacity (6 minute walking test), pulmonary function (spirometry), respiratory muscle strength (mouth pressure device), peripheral muscle strength (hand-held dynometer), dyspnea (The Modified Medical Research Council (MMRC) dyspnea scale), fatigue (Fatigue Severity Scale), quality of life (The Short Form 36 (SF-36) questionnaire), physical activity level (The International Physical Activity Questionnaire) were evaluated. **Label:** Heart failure patients with inspiratory muscle weakness #### Arm Group 2 **Description:** Exercise capacity (6 minute walking test), pulmonary function (spirometry), respiratory muscle strength (mouth pressure device), peripheral muscle strength (hand-held dynometer), dyspnea (The Modified Medical Research Council (MMRC) dyspnea scale), fatigue (Fatigue Severity Scale), quality of life (The Short Form 36 (SF-36) questionnaire), physical activity level (The International Physical Activity Questionnaire) were evaluated. **Label:** Heart failure patients without inspiratory muscle weakness #### Arm Group 3 **Description:** Exercise capacity (6 minute walking test), pulmonary function (spirometry), respiratory muscle strength (mouth pressure device), peripheral muscle strength (hand-held dynometer), dyspnea (The Modified Medical Research Council (MMRC) dyspnea scale), fatigue (Fatigue Severity Scale), quality of life (The Short Form 36 (SF-36) questionnaire), physical activity level (The International Physical Activity Questionnaire) were evaluated. **Label:** Healthy controls ### Outcomes Module #### Primary Outcomes **Description:** According to the American Thoracic Society (ATS) guidelines, the 6-minute walk test (6MWT) was used to evaluate functional exercise capacity **Measure:** Functional exercise capacity **Time Frame:** First day #### Secondary Outcomes **Description:** Pulmonary function FEV1 was assessed by a spirometer according to the ATS/ERS criteria **Measure:** Pulmonary function FEV1 **Time Frame:** First day **Description:** Pulmonary function FVC was assessed by a spirometer according to the ATS/ERS criteria **Measure:** Pulmonary function FVC **Time Frame:** First day **Description:** Pulmonary function FEV1/FVC was assessed by a spirometer according to the ATS/ERS criteria **Measure:** Pulmonary function FEV1/FVC **Time Frame:** First day **Description:** Pulmonary function PEF was assessed by a spirometer according to the ATS/ERS criteria **Measure:** Pulmonary function PEF **Time Frame:** First day **Description:** Pulmonary function FEF25-75 was assessed by a spirometer according to the ATS/ERS criteria **Measure:** Pulmonary function FEF25-75 **Time Frame:** First day **Description:** Respiratory muscle strength (maximal inspiratory pressure , maximal expiratory pressure; MIP, MEP) was evaluated with a mouth pressure device according to ATS/ERS guidelines. **Measure:** Respiratory muscle strength **Time Frame:** First day **Description:** Peripheral muscle strength was assessed by using a hand-held dynamometer **Measure:** Peripheral muscle strength **Time Frame:** First day **Description:** The dyspnea was assessed with The Modified Medical Research Council (MMRC)dyspnea scale. Levels of dyspnea were graded 0-4. Higher scores mean a worse dyspnea level. **Measure:** Dyspnea **Time Frame:** First day **Description:** The Fatigue Severity Scale (FSS) was used to identify fatigue. The total score ranges from 0 to 63. Scores above 36 indicate severe fatigue. **Measure:** Fatigue **Time Frame:** First day **Description:** Quality of life was evaluated with The Short Form 36 (SF-36) questionnaire. The scores range from 0 to 100. Higher values are indicative of better health. **Measure:** The quality of life **Time Frame:** Fist day **Description:** The International Physical Activity Questionnaire (IPAQ) was used to evaluate physical activity level. The total scores of \<600 MET-min/week, 600-3000 MET-min/week, and \>3000 MET-min/ week were classified as inactive, minimally active, and sufficiently active, respectively **Measure:** Physical activity level **Time Frame:** First day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * HF patients were being aged over18 years * clinically stable at least four weeks * having no change in medications over three months The inclusion criteria for healthy controls were being aged over 18 without a chronic disease Exclusion Criteria: * having unstable angina, acute myocardial infarction, uncontrolled hypertension, significant valvular disease, history of malignancy or orthopedic, rheumatologic, neurological, or pulmonary diseases The exclusion criteria for the healthy controls were having any chronic or systemic disease, and having physical limitation **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Forty-one heart failure patients with inspiratory muscle weakness, 30 heart failure patients without inspiratory muscle weakness and 41 healthy controls were included. ### Contacts Locations Module #### Locations **Location 1:** **City:** Ankara **Country:** Turkey **Facility:** Gazi University Facutly of Health Sciences Department of Physiotheraphy and Rehabilitation, Cardiopulmonary Rehabilitation Unit **State:** Çankaya **Zip:** 06490 #### Overall Officials **Official 1:** **Affiliation:** Gazi University **Name:** Meral Boşnak Güçlü, Prof. Dr **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Mustafa Kemal University **Name:** Nihan Katayıfçı, Dr. **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Lista-Paz A, Langer D, Barral-Fernandez M, Quintela-Del-Rio A, Gimeno-Santos E, Arbillaga-Etxarri A, Torres-Castro R, Vilaro Casamitjana J, Varas de la Fuente AB, Serrano Veguillas C, Bravo Cortes P, Martin Cortijo C, Garcia Delgado E, Herrero-Cortina B, Valera JL, Fregonezi GAF, Gonzalez Montanez C, Martin-Valero R, Francin-Gallego M, Sanesteban Hermida Y, Gimenez Moolhuyzen E, Alvarez Rivas J, Rios-Cortes AT, Souto-Camba S, Gonzalez-Doniz L. Maximal Respiratory Pressure Reference Equations in Healthy Adults and Cut-off Points for Defining Respiratory Muscle Weakness. Arch Bronconeumol. 2023 Dec;59(12):813-820. doi: 10.1016/j.arbres.2023.08.016. Epub 2023 Sep 29. English, Spanish. **PMID:** 37839949 **Citation:** Silva Andrade NS, Almeida L, Noronha I, Lima JM, Eriko Tenorio de Franca E, Pedrosa R, Siqueira F, Onofre T. Analysis of respiratory muscle strength and its relationship with functional capacity between different field tests in patients with heart failure. Physiother Theory Pract. 2023 Nov 2;39(11):2427-2437. doi: 10.1080/09593985.2022.2077270. Epub 2022 May 26. **PMID:** 35619283 **Citation:** Kasahara Y, Izawa KP, Watanabe S, Osada N, Omiya K. The Relation of Respiratory Muscle Strength to Disease Severity and Abnormal Ventilation During Exercise in Chronic Heart Failure Patients. Res Cardiovasc Med. 2015 Sep 15;4(4):e28944. doi: 10.5812/cardiovascmed.28944. eCollection 2015 Nov. **PMID:** 26528451 **Citation:** Miyagi M, Kinugasa Y, Sota T, Yamada K, Ishisugi T, Hirai M, Yanagihara K, Haruki N, Matsubara K, Kato M, Yamamoto K. Diaphragm Muscle Dysfunction in Patients With Heart Failure. J Card Fail. 2018 Apr;24(4):209-216. doi: 10.1016/j.cardfail.2017.12.004. Epub 2017 Dec 28. **PMID:** 29289723 **Citation:** Bosnak Guclu M, Bargi G, Katayifci N, Sen F. Comparison of functional and maximal exercise capacity, respiratory and peripheral muscle strength, dyspnea, and fatigue in patients with heart failure with pacemakers and healthy controls: a cross-sectional study. Physiother Theory Pract. 2021 Feb;37(2):295-306. doi: 10.1080/09593985.2019.1630878. Epub 2019 Jun 17. **PMID:** 31204872 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000009135 - Term: Muscular Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M20944 - Name: Muscle Weakness - Relevance: HIGH - As Found: Muscle Weakness - ID: M9421 - Name: Heart Failure - Relevance: HIGH - As Found: Heart Failure - ID: M27137 - Name: Respiratory Aspiration - Relevance: LOW - As Found: Unknown - ID: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown - ID: M4554 - Name: Asthenia - Relevance: LOW - As Found: Unknown - ID: M13204 - Name: Paresis - Relevance: HIGH - As Found: Muscle Weakness - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000018908 - Term: Muscle Weakness - ID: D000010291 - Term: Paresis - ID: D000006333 - Term: Heart Failure ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428214 **Acronym:** ARTIST **Brief Title:** A Restylane Treatment Algorithm Approach for Participants With Appearance of Insufficient Bone Structure in the Lower Face Alone or in Combination With Facial Soft Tissue Deficiencies **Official Title:** A Post-market, Open-label, 3-Armed, Parallel Group, Multicenter Study to Evaluate Aesthetic Improvement and Safety of Restylane Shaype for Temporary Augmentation of the Chin Region Alone or in Combination With Restylane Defyne and Restylane Lyft Lidocaine Treatment in the Lower Face and Midface #### Organization Study ID Info **ID:** 05DF2307 #### Organization **Class:** INDUSTRY **Full Name:** Galderma R&D ### Status Module #### Completion Date **Date:** 2024-09-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-13 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Galderma R&D #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study's main purpose is to evaluate the overall aesthetic improvement of the treated areas by treatment group, as assessed by the Investigator. ### Conditions Module **Conditions:** - Chin Augmentation **Keywords:** - lower face - Mid face ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive Restylane Shaype in the chin area only. **Intervention Names:** - Device: Restylane Shaype **Label:** Restylane Shaype **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin. **Intervention Names:** - Device: Restylane Shaype - Device: Restylane Defyne **Label:** Restylane Shaype with Restylane Defyne **Type:** OTHER #### Arm Group 3 **Description:** Participants will receive Restylane Shaype in the chin area and Restylane Defyne in the marionette line areas laterally to the chin. Participants in this group will be treated with Restylane Lyft lidocaine in the midface, nasolabial folds (NLF) and /or jawline. **Intervention Names:** - Device: Restylane Shaype - Device: Restylane Defyne - Device: Restylane Lyft lidocaine **Label:** Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Restylane Shaype - Restylane Shaype with Restylane Defyne - Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine **Description:** Injection **Name:** Restylane Shaype **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Restylane Shaype with Restylane Defyne - Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine **Description:** Injection **Name:** Restylane Defyne **Type:** DEVICE #### Intervention 3 **Arm Group Labels:** - Restylane Shaype with Restylane Defyne and Restylane Lyft Lidocaine **Description:** Injection **Name:** Restylane Lyft lidocaine **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the Global Aesthetic Improvement Scale (GAIS) at Week 8 **Time Frame:** At week 8 #### Secondary Outcomes **Measure:** Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by Investigator Using the GAIS at Week 4 **Time Frame:** At week 4 **Measure:** Percentage of Participants Rated "Improved" or "Much Improved" or "Very Much Improved" as Assessed by the Participant Using the GAIS at week 4 and 8 **Time Frame:** At weeks 4 and 8 **Measure:** Percentage of Participants Reporting "Agree" or "Strongly Agree", "Satisfied" or "Very satisfied" as per Participant Satisfaction Questionnaire at Week 8 **Time Frame:** At week 8 **Measure:** Percentage of Participants in Each Response Category for Every Question in the Participant Satisfaction Questionnaire at Week 8 **Time Frame:** At week 8 **Measure:** Percentage of Investigators Reporting "Agree" or "Strongly agree" as per Investigator Satisfaction Questionnaire at Week 8 **Time Frame:** At week 8 **Measure:** Percentage of Participants in Each Response Category for Every Question in the Investigator Satisfaction Questionnaire at Week 8 **Time Frame:** At week 8 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participant is willing to comply with the requirements of the study including being photographed, following post-treatment care instructions, attending all study visits and providing a signed written informed consent. * Males or non-pregnant, non-breastfeeding females, over the age of 18. * Intent to receive treatment for temporary augmentation in the chin region. Exclusion Criteria: * Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics * Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions. * Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from the lower orbital rim. * Any previous aesthetic procedures or implants. * Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation. * Participation in any other interventional clinical study within 30 days (about 4 and a half weeks) before baseline. * Women who are pregnant or breast feeding, or women of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Galderma Research & Development **Phone:** 1-866-735-4137 **Role:** CONTACT #### Locations **Location 1:** **City:** Vancouver **Country:** Canada **Facility:** Galderma Investigational Site # 8754 **State:** British Columbia **Status:** RECRUITING **Zip:** V6H 4E1 **Location 2:** **City:** Burlington **Country:** Canada **Facility:** Galderma Investigational Site 8379 **State:** Ontario **Status:** RECRUITING **Zip:** L7N3N2 **Location 3:** **City:** Westmount **Country:** Canada **Facility:** Galderma Investigational Site 8690 **State:** Quebec **Status:** RECRUITING **Zip:** H3Z 1C3 ## 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 ### Intervention Browse Module - Ancestors - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000061567 - Term: Voltage-Gated Sodium Channel Blockers - ID: D000026941 - Term: Sodium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000276 - Term: Adjuvants, Immunologic - ID: D000007155 - Term: Immunologic Factors - ID: D000055675 - Term: Viscosupplements - ID: D000020011 - Term: Protective Agents ### Intervention Browse Module - Browse Branches - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11014 - Name: Lidocaine - Relevance: HIGH - As Found: Solution - ID: M9878 - Name: Hyaluronic Acid - Relevance: HIGH - As Found: Site of - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M23177 - Name: Sodium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M30025 - Name: Diuretics, Potassium Sparing - Relevance: LOW - As Found: Unknown - 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 ### Intervention Browse Module - Meshes - ID: D000008012 - Term: Lidocaine - ID: D000006820 - Term: Hyaluronic Acid ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428201 **Brief Title:** The Efficacy of Tele Rehabilitation- Based Task-Specific Training for Cognitive Function Improvement **Official Title:** The Efficacy of Tele Rehabilitation- Based Task-Specific Training for Cognitive Function Improvement in Multiple Sclerosis (MS) Patients #### Organization Study ID Info **ID:** MSRSW/Batch-Fall22/711 #### Organization **Class:** OTHER **Full Name:** Superior University ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Start Date **Date:** 2023-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Superior University #### Responsible Party **Investigator Affiliation:** Superior University **Investigator Full Name:** Muhammad Naveed Babur **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** "This study investigates the feasibility of tele-rehabilitation combined with targeted training for cognitive enhancement in individuals with Multiple Sclerosis (MS). Multiple sclerosis (MS) is a chronic illness that affects the central nervous system, often resulting in cognitive impairments that significantly impact quality of life. Tele-restoration provides an accessible and effective method for delivering therapeutic interventions, particularly beneficial for those with mobility limitations. **Detailed Description:** The study was a randomized controlled trial with multiple sclerosis patients divided into two groups: one receiving tele-rehabilitation-based task-specific training and the other receiving conventional care. The mediation group participated in structured cognitive training sessions conducted using a tele-rehabilitation platform, focusing on tasks designed to enhance memory, attention, and executive functions. Psychological assessments were conducted during the mediation period to measure improvements. ### Conditions Module **Conditions:** - Sclerosis, Multiple ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 52 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Diagnostic Test: Control Group **Label:** Control Group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Combination Product: Experimental Group **Label:** EXP group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Control Group **Description:** The control group receives standard care, which includes routine medical management and general physical rehabilitation exercises. This involves regular consultations with healthcare providers and exercises aimed at maintaining mobility and physical function. The control group also follows a schedule of three 45-minute sessions per week for 12 weeks, ensuring a consistent comparison with the experimental group. **Name:** Control Group **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - EXP group **Description:** The experimental intervention involves tele-rehabilitation-based task-specific training to enhance cognitive functions in multiple sclerosis (MS) patients. This program includes cognitive exercises targeting memory, attention, executive function, and processing speed, conducted remotely via a tele-rehabilitation platform. Patients participate in three 45-minute sessions per week for 12 weeks. Each session is guided by a trained therapist, ensuring personalized support and real-time feedback. **Name:** Experimental Group **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** The MoCA scale is a comprehensive tool designed to evaluate various cognitive domains, including attention and concentration, executive functions, memory, language, visuospatial skills, conceptual thinking, calculations, and orientation. It provides a detailed assessment of cognitive performance, making it an ideal measure for tracking cognitive improvements in MS patients participating in the tele-rehabilitation and task-specific training programs. **Measure:** Montreal Cognitive Assessment (MoCA) scale **Time Frame:** 12 Months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Individuals with a diagnosis of MS confirmed by a neurologist. * Between 18 and 65 years of age. * Presence of psychosis confirmed by standardized psychometric testing. * A stable treatment environment that allows intervention. * Internet access with camera and computer/tablet. * Ability to understand and follow course directions. * Willingness to give informed consent. Exclusion Criteria: * Severe psychiatric co-morbidities affecting cognitive function. * Concurrent intervention with other psychological rehabilitation programs. * Lack of availability or use of technology necessary for tele-rehabilitation. * Further research interventions. * Unstable medical condition **Maximum Age:** 45 Years **Minimum Age:** 20 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lahore **Country:** Pakistan **Facility:** District Head Quarters Hospital Narowal, Circular Road, Near Jassar Bypass, Narowal Location: Khalid Eye & Medical Care Block C Commercial Area, Jubilee Town, Lahore **State:** Punjab ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020278 - Term: Demyelinating Autoimmune Diseases, CNS - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000003711 - Term: Demyelinating Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Sclerosis, Multiple - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22098 - Name: Demyelinating Autoimmune Diseases, CNS - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M6909 - Name: Demyelinating Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009103 - Term: Multiple Sclerosis - ID: D000012598 - Term: Sclerosis ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428188 **Acronym:** BAH247 **Brief Title:** Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases **Official Title:** Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases #### Organization Study ID Info **ID:** ESBI202497 #### Organization **Class:** OTHER **Full Name:** Essen Biotech ### Status Module #### Completion Date **Date:** 2026-12-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-29 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Essen Biotech #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or CD19 or both sequentially in the treatment of Relapsed/ Refractory Autoimmune Disease such as Sjogren's Syndrome or Systemic Lupus Erythematosus and other Autoimmune Disease. **Detailed Description:** Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may have the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD19/BCMA in patients with Autoimmune Disease. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated. The purpose of this clinical trial is to assess the feasibility, safety, and efficacy of multiple CAR T-cell therapy that combines CAR T cells against Autoimmune Disease B Cells with CAR T cells targeting BCMA or CD19 or both in patients with relapsed and refractory Autoimmune Disease. The study also aims to learn more about the function of CAR T cells and their persistence in Autoimmune Disease patients. ### Conditions Module **Conditions:** - Autoimmune Diseases - Systemic Lupus Erythematosus - Systemic Lupus Erythematosus Acute - Sjogren's Syndrome **Keywords:** - Sjogren's Syndrome - Systemic Lupus Erythematosus - Autoimmune Diseases - CAR-T ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Patients enrolled in this clinical trial will receive a carefully designed treatment regimen. Before the infusion of BCMA and CD19 CAR-T cells, participants will undergo preconditioning chemotherapy. This chemotherapy serves to create an optimal environment for CAR-T cell therapy to effectively target and eliminate B cells. Following chemotherapy, participants will receive the infusion of CD19 and BCMA CAR-T cells. ##### Masking Info **Masking:** NONE **Masking Description:** Open-label clinical trials are a category of clinical research where the masking is minimal or nonexistent. In such trials, both the participants and the researchers are fully aware of the treatment assignments, which means participants know the treatment they are receiving, and researchers are aware of each participant's treatment group. **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will be administered fludarabine phosphate intravenously (IV) over a 30-minute period on days -4 to -2. Additionally, cyclophosphamide will be administered intravenously (IV) over 60 minutes on day -2. Subsequently, patients will receive BCMA/CD19 CAR T cells intravenously (IV) over a duration of 10-20 minutes on day 0. Patients who exhibit positive responses to the initial dose of BCMA/CD19 CAR T cells, do not experience unacceptable side effects, and have a sufficient quantity of cells available may be eligible to receive 2 or 3 additional doses of BCMA/CD19 CAR T cells. **Intervention Names:** - Biological: BCMA/CD19 CAR-T cells **Label:** CD19/BCMA-CAR T cells, chemotherapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - CD19/BCMA-CAR T cells, chemotherapy **Description:** The intervention in this clinical trial involves a novel approach using BCMA/CD19 Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies. Treatment Regimen: Patients in the trial will undergo the following regimen: Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy. Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2. BCMA/CD19 Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, BCMA/CD19 CAR T cells, over 10-20 minutes on day 0. Additional Doses: Eligible patients responding well to the initial BCMA/CD19 CAR-T cell infusion without unacceptable side effects and sufficient CAR-T cell availability may receive 2 or 3 additional doses. **Name:** BCMA/CD19 CAR-T cells **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at three dose levels until the maximum tolerated dose (MTD) is determined. **Measure:** Incidence and severity of dose-limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/BCMA chimeric antigen receptor (CAR) T cells **Time Frame:** 28 days #### Secondary Outcomes **Description:** satisfy the targeted dose level and meet the required release specifications outlined in the Certificate of Analysis (COA) **Measure:** Rate of successful manufacture and expansion of the CD19/BCMA chimeric antigen receptor (CAR) T cells **Time Frame:** 60 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Expected survival time ≥3 months; * Subjects with recurrent/refractory autoimmune diseases who have failed standard treatment or lack effective treatment, Including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, IGG4-associated diseases, primary Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc. * Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction. * Liver and kidney function, cardiopulmonary function meet the following requirements: * Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands; * Blood oxygen saturation \>91% in non-oxygen state; * Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN. * No serious mental disorders; * Can understand this test and have signed the informed consent. Exclusion Criteria: * Malignant tumors other than R/R AID disease in the 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery; * Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) Antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) Antibody positive; Syphilis positive; * Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia; * Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment; * Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration; * Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partners plan pregnancy within 2 years after cell transfusion; * Patients who received CAR-T therapy or other gene-modified cell therapy before screening; * Participated in other clinical studies 1 month before screening; * Evidence of central nervous system invasion during subject screening; * Mental patients with depression or suicidal thoughts; * Situations considered unsuitable for inclusion by other researchers. **Maximum Age:** 90 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** JAMAL ALKHAYER **Phone:** +97333799773 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** SAMI XI, dr - **Phone:** +14012275001 - **Role:** CONTACT **Country:** China **Facility:** District One Hospital **State:** Beijing **Status:** RECRUITING **Zip:** 086-373 **Location 2:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Name:** Sami Madsion - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Phone:** +97336386689 - **Role:** CONTACT **Country:** China **Facility:** District one hospital **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000007154 - Term: Immune System Diseases - ID: D000001172 - Term: Arthritis, Rheumatoid - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000014987 - Term: Xerostomia - ID: D000012466 - Term: Salivary Gland Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000015352 - Term: Dry Eye Syndromes - ID: D000007766 - Term: Lacrimal Apparatus Diseases - ID: D000005128 - Term: Eye Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC11 - Name: Eye Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M11177 - Name: Lupus Erythematosus, Systemic - Relevance: HIGH - As Found: Systemic Lupus Erythematosus - ID: M15664 - Name: Sjogren's Syndrome - Relevance: HIGH - As Found: Sjogren's Syndrome - ID: M4629 - Name: Autoimmune Diseases - Relevance: HIGH - As Found: Autoimmune Diseases - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M4480 - Name: Arthritis, Rheumatoid - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown - ID: M17724 - Name: Xerostomia - Relevance: LOW - As Found: Unknown - ID: M15285 - Name: Salivary Gland Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M18040 - Name: Dry Eye Syndromes - Relevance: LOW - As Found: Unknown - ID: M10664 - Name: Keratoconjunctivitis Sicca - Relevance: LOW - As Found: Unknown - ID: M10786 - Name: Lacrimal Apparatus Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012859 - Term: Sjogren's Syndrome - ID: D000008180 - Term: Lupus Erythematosus, Systemic - ID: D000001327 - Term: Autoimmune Diseases ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6727 - Name: Cyclophosphamide - Relevance: LOW - As Found: Unknown - ID: M283230 - Name: Fludarabine - Relevance: LOW - As Found: Unknown - ID: M225513 - Name: Fludarabine phosphate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428175 **Acronym:** H2H-CYSHCN **Brief Title:** Hospital-to Home Care Care Transition Interventions (H2H-CTI) Children/Youth With Special Health Care Needs (CYSHCN) **Official Title:** Hospital-to-Home Care Transition Intervention (H2H-CTI) for Children and Youth With Special Health Care Needs (CYSHCN) #### Organization Study ID Info **ID:** Pro00114934 #### Organization **Class:** OTHER **Full Name:** Duke University ### Status Module #### Completion Date **Date:** 2028-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Duke University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Aim 1: Compare the effectiveness of focused dose vs extended dose hospital-to-home care transition interventions (H2H-CTI) on health service use and parent-reported confidence for hospitalized CYSHCN. Aim 2: Compare the effectiveness of focused and extended dose H2H-CTI among vulnerable CYSHCN subgroups. Hypothesis: Both H2H-CTI arms will improve primary outcomes more for CYSHCN with higher versus lower clinical complexity; while extended H2H-CTI will better mitigate racial/ethnic outcome disparities than focused H2H-CTI. Aim 3: Evaluate implementation context, processes, and mechanisms via a multi-phase mixed methods study design. **Detailed Description:** Primary Aims Aim 1: Compare the effectiveness of focused dose vs extended dose hospital-to-home care transition interventions (H2H-CTI) on health service use and parent-reported confidence for hospitalized CYSHCN. Hypothesis: Extended H2H-CTI will be associated with lower acute care use and higher confidence than focused H2H-CTI. Secondary Aims Aim 2: Compare the effectiveness of focused and extended dose H2H-CTI among vulnerable CYSHCN subgroups. Hypothesis: Both H2H-CTI arms will improve primary outcomes more for CYSHCN with higher versus lower clinical complexity; while extended H2H-CTI will better mitigate racial/ethnic outcome disparities than focused H2H-CTI. Aim 3: Evaluate implementation context, processes, and mechanisms via a multi-phase mixed methods study design. The study populations consist of adult parent/caregivers' dyad and children/youth with special health care needs. Participants will be randomized to focused dose intervention after discharge or an extended dose intervention. the single dose will receive one phone call from an interventionist post discharge, the extended dose group will receive weekly phone calls for one month from an interventionist. Analysis of data from the confidence-mediated and vulnerable patient/family characteristics-moderated pathways will address Aims 1 and 2, respectively. During extraction of data from each site's Electronic Health Record (EHR) data security risks will be mitigated by following established standard operating procedures at Duke and the University of North Carolina (UNC). During preparation of site-based analytical datasets risks will be mitigated by limiting Protected Health Information (PHI) as much as and as early as is practical. All datasets will be stored and reviewed on a secure, cloud-based Protected Analytical and Computing Environment (PACE) at Duke and at UNC in the Secure Research Workspace (SRW). The investigators will plan to create a Data Safety and Monitoring Board (DSMB) that includes expert clinicians who are not active study team members and are independent of the study sponsor. The DSMB will oversee the safety of volunteers participating in the study as needed. ### Conditions Module **Conditions:** - Health Care - Pediatrics - Transitional Care - Comparative Effectiveness - Family Engagement **Keywords:** - Special Needs - Hospital to Home Care - Children and Youth with Special Health Care Needs - Randomized Trial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 480 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Focused Dose Hospital-to-Home Care Transition Intervention **Label:** Focused Dose Hospital-to-Home Care Transition Intervention **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Behavioral: Extended Dose Hospital-to-Home Care Transition Intervention **Label:** Extended Dose Hospital-to-Home Care Transition Intervention **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Focused Dose Hospital-to-Home Care Transition Intervention **Description:** Focused dose H2H-CTIs will consist of a one-time post-discharge phone call completed within 72 hours post-hospital discharge by a clinical interventionist (e.g., nurse care coordinator or care manager). Calls will follow a structured template that provides empirically supported core H2H-CTI functions (follow-up care access, contingency planning, medication review, family education). The interventionist will also conduct a pre-hospital discharge clinical needs assessment with the parent. **Name:** Focused Dose Hospital-to-Home Care Transition Intervention **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Extended Dose Hospital-to-Home Care Transition Intervention **Description:** Extended dose H2H-CTIs will include a pre-discharge clinical needs assessment and initial phone call within 72 hours post-discharge, similar to the focused arm. After the initial contact, the dose of the extended H2H-CTI will increase as subjects receive high-intensity support during weekly post-discharge phone contacts through 30 days post-discharge. All contacts in the extended dose arm will be completed by a transition coach interventionist (e.g., nurse care coordinator or care manager) who will be formally trained on pillars of the Care Transitions Intervention© (CTI), a multi-faceted H2H-CTI that is the basis for the extended dose arm. **Name:** Extended Dose Hospital-to-Home Care Transition Intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** 30-day, all-cause composite readmission and emergency department (ED) visit rate **Measure:** 30-day acute care use **Time Frame:** 30 days post-hospital discharge **Description:** Change in caregiver-reported confidence that their child can avoid hospitalization within the next one month (1=not confident; 10=fully confident; \<5 is low confidence) **Measure:** Caregiver confidence **Time Frame:** Baseline, 30 days post-discharge #### Secondary Outcomes **Description:** All-cause composite readmission and ED visit rate at 7 days **Measure:** 7-day acute care use **Time Frame:** 7-days post-discharge **Description:** All-cause composite readmission and ED visit rate at 14 days **Measure:** 14-day acute care use **Time Frame:** 14 days post-discharge **Description:** All-cause readmission rate at 7, 14, and 30 days **Measure:** Readmissions **Time Frame:** 7, 14, 30 days post-discharge **Description:** All-cause ED visits at 7, 14, and 30 days **Measure:** Emergency Department (ED) visits **Time Frame:** 7, 14, 30 days post-discharge **Description:** Completed outpatient visits by clinical area (primary, specialty, allied health) **Measure:** Outpatient follow-up visit attendance **Time Frame:** 7, 14, 30 days post-discharge **Description:** Annualized days without clinical visits (clinical days without healthcare visits) **Measure:** Days at home **Time Frame:** 30 and 90 days post-discharge **Description:** Change in caregiver-reported strain (measured by scores on seven-item Caregiver Strain Questionnaire Short Form 7, CGSQ-SF7 survey), where a higher score indicates a higher level of caregiver strain. **Measure:** Caregiver strain **Time Frame:** Baseline, 7, 14, 30, and 90-days post-discharge **Description:** Change in caregiver-reporter PROMIS global health status survey. PROMIS assessments are scored on a T-score metric. High scores mean more of the concept being measured. 10 points on the T-score metric is one standard deviation (SD). PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. **Measure:** Global health status **Time Frame:** Baseline, 7, 14, 30, and 90-days post-discharge **Description:** Change in caregiver-reported mental HR-QOL as scored on the Medical Outcomes Short Form 12 (SF12) survey. **Measure:** Caregiver mental health-related quality of life (HR-QOL) **Time Frame:** Baseline, 7, 14, 30, and 90-days post-discharge **Description:** Pediatric Transition Experience Measure (P-TEM): eight-item, parent-reported measure of overall process and quality of hospital-to-home transitions. **Measure:** Quality of hospital-to-home care transitions **Time Frame:** 30 days post-discharge **Description:** Percentage of intervention core components delivered as planned (goal: ≥80%) **Measure:** Fidelity **Time Frame:** approximately 90 days post-discharge **Description:** Clinical staff and caregiver-reported composite score responses to Feasibility of Implementation, Acceptability of Implementation, and Implementation Appropriateness surveys (4 items each) **Measure:** Feasibility Acceptability Appropriateness **Time Frame:** approximately 90 days post-discharge ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * For this study, eligible children/youth with special health care needs (CYSHCN) and adult parent/caregiver dyads will be those who meet the following inclusion criteria: 1. Child is a CYSHCN, defined as having seen two or more distinct specialty areas for outpatient visits during the 12 months prior to index hospitalization admission date 2. Age of hospitalized child is under 18 years old 3. Child hospitalized on a general pediatrics inpatient service line at participating site 4. Adult parent/caregiver for the child is 18 years or older Exclusion Criteria: * Child exclusion criteria: 1. Child will be discharged to any location besides home (e.g., long-term care or residential facility, skilled nursing facility, inpatient acute rehabilitation, psychiatric facility) 2. Child is a ward of the state or has an ongoing social services investigation * Parent/caregiver exclusion criteria include: 1. Age less than 18 years old 2. Diminished capacity to provide consent/participate 3. Primary language for parent/caregiver is any language besides English **Maximum Age:** 18 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Shannon A Widman **Phone:** 919-681-7252 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Duke University **Name:** David Ming, 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:** NCT06428162 **Brief Title:** An Evaluation of Healthcare Providers' Adherence to Pharmacovigilance Practices in an African Community **Official Title:** an Observational Study for the Prevalence of Pharmacovigilance Practices Between Healthcare Providers in North African Nation #### Organization Study ID Info **ID:** 2024 PV #### Organization **Class:** OTHER **Full Name:** Deraya University ### Status Module #### Completion Date **Date:** 2024-06-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-05-20 **Type:** ACTUAL #### Start Date **Date:** 2024-02-18 **Type:** ACTUAL **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Deraya University #### Responsible Party **Investigator Affiliation:** Deraya University **Investigator Full Name:** Soad Ali **Investigator Title:** associate professor of pharamcy practices, faculaty of pharmacy, Deraya University **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Egypt's several regions-rural, mixed, and urban-were given pre-designed surveys pertaining to drug adverse events and the role of pharmacovigilance in detection and reporting. The three sections of the survey were dedicated to studying health care professionals' knowledge concerning pharmacovigilance concepts and practices, as well as demographics and people reported or not reported. The survey also asked more questions regarding adverse occurrences that were reported. ### Conditions Module **Conditions:** - Drug Reaction - Drug Hypersensitivity - Drug Abuse - Drug Interaction ### Design Module #### Design Info **Observational Model:** ECOLOGIC_OR_COMMUNITY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 300 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** three sections questioner including: demographics, reported cases, unreported cases **Name:** questionner **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** collect recent adverse drug reaction reports **Measure:** reported adverse drug reactions **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * all health care providers are invited to share in the study * minimum experience required is one year in health carrier. * accept sharing in the study Exclusion Criteria: * health care providers who refuse to complete all data required in the survey. * fresh experience or participants who left health carrier **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 25 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** all health care providers that deals with drugs and medications as pharmacists, physicians, Dentists, nurses and medical reps are invited to share in this survey as a hard template. study included 300 subject in different disciplines at the period at 3 months. complete survey composed of 3 sections included previous reported ADVEs ### Contacts Locations Module #### Locations **Location 1:** **City:** Minya **Country:** Egypt **Facility:** Deraya university **Zip:** 05673 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007154 - Term: Immune System Diseases - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: HIGH - As Found: Hypersensitivity - ID: M30303 - Name: Drug-Related Side Effects and Adverse Reactions - Relevance: HIGH - As Found: Drug Reactions - ID: M7517 - Name: Drug Hypersensitivity - Relevance: HIGH - As Found: Drug Hypersensitivity - ID: M21837 - Name: Substance-Related Disorders - Relevance: HIGH - As Found: Drug Abuse - ID: M10200 - Name: Immune System Diseases - 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: D000006967 - Term: Hypersensitivity - ID: D000019966 - Term: Substance-Related Disorders - ID: D000064420 - Term: Drug-Related Side Effects and Adverse Reactions - ID: D000004342 - Term: Drug Hypersensitivity ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428149 **Brief Title:** Three Types of Papilla Incision in Periodontal Surgery **Official Title:** Wound Healing After Different Types of Papilla Incision in Periodontal Reconstruction Surgery. A Randomized Clinical Trial #### Organization Study ID Info **ID:** 2937/2020 #### Organization **Class:** OTHER **Full Name:** Universidad de Murcia ### Status Module #### Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-06-01 **Type:** ACTUAL **Status Verified Date:** 2024-01 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidad de Murcia #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Three types of papilla incision in periodontal reconstruction techniques will be compared. ### Conditions Module **Conditions:** - Periodontitis - Periodontal Diseases - Periodontal Pocket ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Marginal approach by midline interproximal soft tissue incision and a limited papilla elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces. **Intervention Names:** - Procedure: Midline interproximal soft-tissue incision **Label:** Midline interproximal soft-tissue incision **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** A small incision in the palatal aspect and a limited papilla elevation to the buccal aspect will be made for treating isolated periodontal defect. Enamel matrix derivates will be applied on the debrided root surfaces. **Intervention Names:** - Procedure: Marginal approach by palatal incision **Label:** Marginal approach by palatal incision **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** The incision of the defect-associated papilla will be performed according to the principles of the papilla preservation techniques. Enamel matrix derivates will be applied on the debrided root surfaces. Stable primary closure of the flaps will be obtained with internal modified mattress sutures. **Intervention Names:** - Procedure: Minimally invasive surgical technique **Label:** Minimally invasive surgical technique **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Midline interproximal soft-tissue incision **Description:** Firstly, the marginal tissue will be elevated around the periodontal defect, through the tunneling of the tissues, entering through the gingival sulcus and the periodontal pocket of the teeth involved in the defect periodontal. Once the marginal tissues have been disinserted to full thickness, the soft supra-alveolar component of the defect to be reconstructed will be stretched, in a buccal direction, with a blunt instrument, applying pressure on the lingual aspect. Visualizing the midpoint of the interproximal tissue, the papilla will be dissected at its midpoint, entering through the mesial aspect, with the scalpel blade perpendicular to the central axis of the teeth. **Name:** Midline interproximal soft-tissue incision **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Marginal approach by palatal incision **Description:** First, an incision will be made in the palatal aspect of the interproximal papilla, at the base of the papilla, parallel to the axis of the tooth until touching the palatine alveolar crest, in order to detach and move the papilla from its base, attached to the vestibular flap. From the palatal incision the interproximal tissue will be elevated towards the buccal until the buccal bone crest is exposed. **Name:** Marginal approach by palatal incision **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Minimally invasive surgical technique **Description:** The defect will be accessed through an incision at the base of the papilla on the vestibular aspect. Depending on the anatomy of the interproximal space, two types of incisions will be made: simplified papilla preservation flap (SPPF) when the width of the interproximal space is equal to or less than 2 mm, or modified papilla preservation technique (MPPT) when the width is greater than 2 millimeters. The interproximal incision will extend intrasulcular on the lingual and buccal aspect of the teeth adjacent to the defect, and mesio-distally it will extend as necessary to allow access to the defect and its debridement. The papilla will move from its base towards the palatine. **Name:** Minimally invasive surgical technique **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Bleeding on probing could be positive or negative **Measure:** Bleeding on probing **Time Frame:** 12 months **Description:** Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket **Measure:** Clinical attachment level (CAL) **Time Frame:** 12 months **Description:** Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket **Measure:** Probing pocket depth (PD) **Time Frame:** 12 months **Description:** Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith. **Measure:** Recession (REC) **Time Frame:** 12 months **Description:** Location of the tip of the papillae. Taking as reference the level of the mid-axis of the tooth, will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise. This outcome will be assessed with a periodontal probe and measured in mm. **Measure:** Location of the tip of the papillae (TP) **Time Frame:** 12 months **Description:** Keratinized tissue width will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line. **Measure:** Keratinized tissue width (KT) **Time Frame:** 12 months #### Secondary Outcomes **Description:** Subtracting the 12 month CAL from the intrasurgically Bone Component-CEJ will provide the SUPRA-AG result. **Measure:** Supra-alveolar attachment gain (SUPRA-AG) **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients diagnosed with periodontal disease. * Active residual pockets associated with intraosseous defects that did not resolve with non-surgical treatment after 1 year of maintenance. * Intraosseous lesions with probing depth greater than 5 mm or extension of the radiographic defect greater than 4 mm. * Plaque index and bleeding index less than 30%. Exclusion Criteria: * Systemic disease that contraindicates periodontal surgery. * Pregnant women. * Third molars or teeth with incorrect endodontic or restorative treatment. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** ANTONIO J ORTIZ-RUIZ, MD **Phone:** +34 868888581 **Role:** CONTACT #### Locations **Location 1:** **City:** Murcia **Contacts:** ***Contact 1:*** - **Name:** JOSÉ ANTONIO MORENO-RODRIGUEZ, DDS - **Phone:** +34 620538483 - **Role:** CONTACT **Country:** Spain **Facility:** Centro Odontologico Del Sureste Slp **Status:** RECRUITING **Zip:** 30007 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M13427 - Name: Periodontitis - Relevance: HIGH - As Found: Periodontitis - ID: M13423 - Name: Periodontal Pocket - Relevance: HIGH - As Found: Periodontal Pocket - ID: M13419 - Name: Periodontal Diseases - Relevance: HIGH - As Found: Periodontal Diseases - ID: M1112 - Name: Surgical Wound - 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 ### Condition Browse Module - Meshes - ID: D000010518 - Term: Periodontitis - ID: D000010510 - Term: Periodontal Diseases - ID: D000010514 - Term: Periodontal Pocket ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428136 **Brief Title:** Comparative Effects of Clamshell Technique With EMS vs CTin Iliotibial Band Tightness for Pain and Function **Official Title:** Comparative Effects of Clamshell Technique With Electrical Muscle Stimulation Versus Conservative Treatment in Iliotibial Band Tightness for Pain and Function #### Organization Study ID Info **ID:** MSRSW/Batch-Fall22/709 #### Organization **Class:** OTHER **Full Name:** Superior University ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Superior University #### Responsible Party **Investigator Affiliation:** Superior University **Investigator Full Name:** Muhammad Naveed Babur **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Iliotibial band syndrome (ITBS) is a common knee injury that usually presents with pain and/or tenderness on palpation of the lateral aspect of the knee, superior to the joint line and inferior to the lateral femoral epicondyle. The current theory is that this condition is likely to be caused by compression of the innervated tissues beneath the iliotibial band (ITB), leading to inflammation. **Detailed Description:** There were effects of clamshell exercises on gluteus medius, quadratus lumborum and anterior hip flexor. However their effect was limited on iliotibial band tightness. Hip/knee coordination and running style have also been identified as key factors in the treatment of ITBS, highlighting the complexity of the condition. The present study will focus on effect of clamshell techniques with electrical muscle stimulation versus Conservative treatment in iliotibial band tightness for pain and function.The goal is to determine which technique is more effecient in improving function and reducing pain and soreness of Iliotibial band. ### Conditions Module **Conditions:** - Tibial Muscular Dystrophy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 62 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Diagnostic Test: Clamshell exercises with Electrical Muscle Stimulation (CT + EMS) **Label:** Clamshell exercises with Electrical Muscle Stimulation (CT + EMS) **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Other: Conservative Treatment (CT) **Label:** Conservative Treatment (CT) **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Clamshell exercises with Electrical Muscle Stimulation (CT + EMS) **Description:** Side-lying clamshells: 3 sets of 10 repetitions per leg, 3 times per week Hip abduction with theraband: 3 sets of 10 repetitions per leg, 3 times per week Bridge with hip abduction: 3 sets of 10 repetitions per leg, 3 times per week Electrical muscle stimulation: Applied to the gluteus medius and minimus muscles for 20 minutes per session, 3 times per week Frequency and intensity adjusted to individual tolerance **Name:** Clamshell exercises with Electrical Muscle Stimulation (CT + EMS) **Type:** DIAGNOSTIC_TEST #### Intervention 2 **Arm Group Labels:** - Conservative Treatment (CT) **Description:** Stretching: Iliotibial band stretch: 30-second hold, 3 repetitions per leg, 2 times per day Quadriceps stretch: 30-second hold, 3 repetitions per leg, 2 times per day Hamstring stretch: 30-second hold, 3 repetitions per leg, 2 times per day **Name:** Conservative Treatment (CT) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** ranging from 0 (no pain) to 10 (worst imaginable pain) assessed at baseline, after intervention, and at 1-month follow-up. **Measure:** Measured using a numeric pain rating scale (NPRS) **Time Frame:** 12 Months **Description:** Measured using the Lower Extremity Functional Scale (LEFS) assessed at baseline, after intervention, and at 1-month follow-up **Measure:** Lower Extremity Functional Scale (LEFS) **Time Frame:** 12 months **Description:** Measured using a goniometer at baseline, after intervention, and at 1-month follow-up. **Measure:** ITBT length **Time Frame:** 12 months **Description:** Measured using a goniometer for knee flexion and extension at baseline, after intervention, and at 1-month follow-up." **Measure:** Range of motion (ROM): **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults aged 45-65 years old (Jeong et al., 2019) * Both genders will be included (Jeong et al., 2019) * Diagnosed with iliotibial band tightness (ITBT) based on clinical examination and positive Noble compression test (Hutchinson et al., 2022) * Reporting lateral knee pain aggravated by activity (Hutchinson et al., 2022) Exclusion Criteria: * Recent history of knee surgery or other knee injuries (Peterson et al., 2022) * Presence of other musculoskeletal conditions affecting the knee (Peterson et al., 2022) * Inflammatory conditions such as rheumatoid arthritis or gout (Peterson et al., 2022) * Neurological conditions affecting leg function (Peterson et al., 2022) * Pregnancy (Jeong et al., 2019) **Maximum Age:** 65 Years **Minimum Age:** 45 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lahore **Country:** Pakistan **Facility:** The University of Lahore Teaching Hospital **State:** Punjab ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M26047 - Name: Distal Myopathies - Relevance: HIGH - As Found: Tibial Muscular Dystrophy - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M4589 - Name: Atrophy - 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 ### Condition Browse Module - Meshes - ID: D000009136 - Term: Muscular Dystrophies - ID: D000049310 - Term: Distal Myopathies ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428123 **Brief Title:** Comparison of Efficacy of Mirror Therapy vs Mental Imagery in Reduction of Phantom Limb Pain in AKAP **Official Title:** Comparison of Efficacy of Mirror Therapy vs Mental Imagery in Reduction of Phantom Limb Pain in Above Knee Amputee Patients: A Comparative Study #### Organization Study ID Info **ID:** MSRSW/Batch-Fall22/708 #### Organization **Class:** OTHER **Full Name:** Superior University ### Status Module #### Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Superior University #### Responsible Party **Investigator Affiliation:** Superior University **Investigator Full Name:** Muhammad Naveed Babur **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Limb amputation results in many types of pain, including localized pain at the stump and projected pain experienced by the patient in the location where the amputated limb used to be, known as phantom limb pain (PLP). The aim of this study is to determine the relative benefits of mirror therapy vs mental imagery in reduction of phantom limb pain. Randomized clinical trial study design will be followed. ### Conditions Module **Conditions:** - Phantom Limb Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 24 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Mirror Therapy on present Lower Limb **Label:** Mirror Therapy **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Diagnostic Test: Mental Imagery on present Lower Limb **Label:** Mental Imagery **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Mirror Therapy **Description:** Patients will be seated close to a table on which a mirror will placed vertically. The normal (i.e., no amputated limb) will be placed in front of the mirror and made to perform movements of the different joints while the patient looking into the mirror. **Name:** Mirror Therapy on present Lower Limb **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Mental Imagery **Description:** Mental imagery technique in which patients will be instructed to concentrate on sensations from each area of the body, including the phantom limb. Patients will be advised to imagine comfortable, thorough movement and sensation in the phantom limb, such that they could "stretch away the pain," and finally to "allow the limb to rest in a comfortable position." The actual therapy of "moving" and "feeling" the limb will lasted for 5 minutes. Patients will be asked to perform 40 minutes of meditation and imagery exercises. **Name:** Mental Imagery on present Lower Limb **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** it is a simple and widely used tool for measuring pain intensity. It consists of a horizontal line with 11 numbered points, ranging from 0 (no pain) to 10 (worst pain imaginable). Patients are asked to rate their pain by selecting the number that best describes their current pain intensity **Measure:** The Numeric Rating (NRS) **Time Frame:** 12 Months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Both male and female gender with ages from 12 to 75 years (17). * Individuals with a unilateral above-knee amputation (AKA) at least 6 months prior to the study. * Experiencing phantom limb pain at least 3 months (16). Exclusion Criteria: * History of neurological disorders affecting pain perception or motor function (e.g., stroke, spinal cord injury, brain injury). * Uncontrolled diabetes or other medical conditions that could affect healing or participation in the study. * Pregnancy or breastfeeding. **Maximum Age:** 75 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lahore **Country:** Pakistan **Facility:** Azra Naheed Medical College, Superior University **State:** Punjab **Location 2:** **City:** Lahore **Country:** Pakistan **Facility:** Ghurkee Hospital **State:** Punjab ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010468 - Term: Perceptual Disorders - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000010149 - Term: Pain, Postoperative - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M13498 - Name: Phantom Limb - Relevance: HIGH - As Found: Phantom Limb - ID: M13379 - Name: Perceptual 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 - ID: M13069 - Name: Pain, Postoperative - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010591 - Term: Phantom Limb ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428110 **Brief Title:** A Prospective Cohort Study on Warfarin Personalized Medication **Official Title:** Personalized Medication Research of Warfarin Based on Vascular Aging Assessment #### Organization Study ID Info **ID:** 2020081 #### Organization **Class:** OTHER **Full Name:** Shanghai 5th People's Hospital ### Status Module #### Completion Date **Date:** 2023-12-12 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-27 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-12 **Type:** ACTUAL #### Start Date **Date:** 2021-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Haobin Li #### Responsible Party **Investigator Affiliation:** Shanghai 5th People's Hospital **Investigator Full Name:** Haobin Li **Investigator Title:** Principal Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Analyze the impact of the degree of blood vessel aging on the anticoagulant effect and bleeding risk of warfarin. Evaluating the possibility of using the degree of blood vessel aging to guide individualized use of the anticoagulant drug warfarin. ### Conditions Module **Conditions:** - Warfarin Sodium Causing Adverse Effects in Therapeutic Use ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 272 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Label:** Patients taking warfarin with vascular aging group #### Arm Group 2 **Label:** Patients taking warfarin with normal vascular group ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients taking warfarin with normal vascular group - Patients taking warfarin with vascular aging group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Numbers of patients with bleeding events during warfarin treatment **Measure:** Numbers of patients with bleeding events **Time Frame:** 1 year during the follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 65 years and older, taking warfarin, with or without premature vascular aging, regardless of gender. * Patients who have not concurrently or intermittently used anticoagulant drugs, including antiplatelet drugs, heparin, low molecular weight heparin, and non-vitamin K-dependent oral anticoagulants, such as dabigatran and apixaban. * Signing an informed consent form before blood sample collection. Exclusion Criteria: * Patients who are allergic to warfarin or lactose. * Patients who are receiving immunosuppressive agents or low molecular weight heparin anticoagulants. * Patients with bleeding tendencies, blood disorders with platelet counts \> 400 × 10\^9 /L or \< 100 × 10\^9 /L, hemoglobin \> 169 or \< 100 g/L. * History of peptic ulcer disease. * Malignant tumors, severe multi-organ dysfunction or failure such as heart, liver, and kidney. * Neurological disorders such as epilepsy. **Maximum Age:** 100 Years **Minimum Age:** 65 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** Patients taking warfarin ### Contacts Locations Module #### Locations **Location 1:** **City:** Shanghai **Country:** China **Facility:** The Fifth People's Hospital of Shanghai **State:** Shanghai **Zip:** 200240 #### Overall Officials **Official 1:** **Affiliation:** The Fifth People's Hospital of Shanghai **Name:** Guangchun Sun **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M17602 - Name: Warfarin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428097 **Acronym:** Levo **Brief Title:** Levothyroxine Supplementation for Heart Transplant Recipients **Official Title:** Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial #### Organization Study ID Info **ID:** 23-39323 #### Organization **Class:** OTHER **Full Name:** University of California, San Francisco ### Status Module #### Completion Date **Date:** 2027-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-29 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-03-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-29 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of California, San Francisco #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine. **Detailed Description:** Studies have shown that thyroid hormone results in a higher number of organs available for transplant. Increasingly, thyroid hormone supplementation is used amongst transplant donors. However, it is not the current standard of practice to supplement recipients without a prior medical history of hypothyroidism with levothyroxine. Two large retrospective studies have demonstrated improved 30-days survival and lower risk of all-cause mortality for heart transplant recipients who receive levothyroxine in the post-operative context. No randomized trials have tested this hypothesis and so the investigators aim to trial the use of levothyroxine for heart transplant recipients at University of California San Francisco using a double-blinded and placebo controlled randomized control trial study design. This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine. ### Conditions Module **Conditions:** - Heart Transplant Failure - Heart Transplant Infection ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 97 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will be double-blinded and randomized to receive levothyroxine. **Intervention Names:** - Drug: Levothyroxine **Label:** Levothyroxine **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients will be double-blinded and randomized to receive no levothyroxine. The placebo will be normal saline. **Intervention Names:** - Drug: Normal saline **Label:** No Levothyroxine **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Levothyroxine **Description:** Dosing will be based on pre-existing protocols in the setting of organ donation.This will be the protocol for the first 18-38 hours starting intra-operatively after the donated heart is sewn in. **Name:** Levothyroxine **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - No Levothyroxine **Description:** Placebo will be normal saline and will be dosed at the same rate and time as the study drug. **Name:** Normal saline **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Measured using the vasoactive-inotropic score (VIS) scale. VIS calculation: dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min) **Measure:** Number of participants who receive Levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use. **Time Frame:** 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis #### Secondary Outcomes **Description:** Measured as a yes or no diagnosis. **Measure:** Do the participants receiving levothyroxine experience lower frequencies of primary graft dysfunction? **Time Frame:** 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis **Description:** Measured using the vasoactive-inotropic score (VIS) scale. VIS calculation: dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min) **Measure:** Does the total vasoactive-inotropic score (VIS) decrease for patients who receive levothyroxine? **Time Frame:** 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis **Description:** Cardiac output is calculated using stroke volume and heart rate and measured in liters/minute. (Cardiac output = stroke volume x heart rate) **Measure:** Do the participants have improved cardiac output? **Time Frame:** 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Participants must be listed for heart transplantation 2. Age ≥18 years 3. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients with pre-existing thyroid related condition including hypothyroidism, hyperthyroidism and malignancy 2. Patients with a known allergy or intolerance to levothyroxine 3. Patients participating in another study evaluating an investigational drug within the past 30 days. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Lea Daran **Phone:** 415-502-4320 **Role:** CONTACT #### Locations **Location 1:** **City:** San Francisco **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lea Daran - **Phone:** 415-502-4320 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jason Smith, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of California, San Francisco **State:** California **Status:** RECRUITING **Zip:** 94143 #### Overall Officials **Official 1:** **Affiliation:** University of California, San Francisco **Name:** Jason Smith, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428084 **Brief Title:** Comparative Efficacy of Dexamethasone - Ondansetron Versus Dexamethasone - Haloperidol in Reducing PONV **Official Title:** Comparative Efficacy of Dexamethasone - Ondansetron Versus Dexamethasone - Haloperidol in Reducing Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Randomized Controlled Trial #### Organization Study ID Info **ID:** AN-202405.01 #### Organization **Class:** OTHER **Full Name:** Universitas Padjadjaran ### Status Module #### Completion Date **Date:** 2024-02-28 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-02-28 **Type:** ACTUAL #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **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:** Universitas Padjadjaran #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Nausea and vomiting following laparoscopic cholecystectomy remain common, with occurrence rates of 40-70% during the initial 24 hours post-operation. The underlying mechanisms of postoperative nausea and vomiting engage five distinct neurotransmitter receptors. Consequently, employing a combination of antiemetics from diverse classes that target various receptors for effective prevention is advised. Ondansetron's antiemetic properties derive from its ability to inhibit serotonin receptors, whereas Haloperidol targets dopamine receptors, and Dexamethasone reduces prostaglandin production. **Detailed Description:** Postoperative nausea and vomiting (PONV) are also known as the little problem interpreted as a seemingly less significant complication but lead to increased morbidity, longer hospital stays, increased medical costs, and diminished patient satisfaction with healthcare services. These symptoms are reported more frequently than postoperative pain, making its prevention as important as postoperative pain management. In laparoscopic cholecystectomy, the occurrence of PONV can range from 40 - 70%, which is higher than the 33 - 49% observed in other types of surgeries under general anesthesia within the first 24 hours post-procedure. The mechanism of PONV is complex, involving multiple neurotransmitters. Targeted neurotransmitter receptors in the action of antiemetic drugs include muscarinic-1-acetylcholine (M1), dopamine-2 (D2), histamine-1 (H1), 5-Hydroxytryptamine-3-serotonin (5HT3), and neurokinin1-substance P (NK1) receptors. Based on this, the prevention of postoperative nausea and vomiting is recommended using a combination of various groups of antiemetics that work on different receptors. Studies have shown that combining different antiemetic classes is more effective than using a single agent. A meta-analysis study stated that dexamethasone, ondansetron, and droperidol are the most used types of antiemetics alone or in combination. Dexamethasone with a 5HT3 antagonist such as ondansetron is the most used antiemetic combination. Another viable option includes dexamethasone with Butypherone group drugs, such as droperidol, which acts as a D2 antagonist. However, droperidol was subject to FDA black box warnings in 2003 due to its association with arrhythmias caused by QT interval prolongation. Subsequent research has suggested haloperidol, another Butypherone group drug, as a safer alternative to droperidol. ### Conditions Module **Conditions:** - Laparoscopic Cholecystectomy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 38 **Type:** ACTUAL **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 19 participants in group O received 4 mg of ondansetron intravenously. **Intervention Names:** - Drug: Ondansetron **Label:** Ondansetron **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** 19 participants in group H received 1 mg of Haloperidol intravenously. **Intervention Names:** - Drug: Haloperidol **Label:** Haloperidol **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Ondansetron **Description:** 4 mg of ondansetron intravenously **Name:** Ondansetron **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Haloperidol **Description:** 1 mg of Haloperidol intravenously **Name:** Haloperidol **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Score 0 (No nausea, no vomiting); Score 1 (Nausea present, no vomiting); Score 2 (Nausea present, vomiting present); Score 3 (Vomiting \>2 episodes in 30 minutes) **Measure:** Nausea and Vomiting Score **Time Frame:** 24 hours post-operation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients undergoing laparoscopic cholecystectomy * aged 18 - 65 years * ASA physical status 1 and 2 * Apfel score ≥2 Exclusion Criteria: * a history of allergies * routine use of antipsychotic drugs, steroids, antihistamines, and antiemetics before surgery * cardiac rhythm disorders * elevated liver enzyme levels (SGOT/SGPT) ≥5 times upper limit normal * BMI ≥35 kg/m2 Dropout Criteria: * if they experienced hypotension, defined as systolic blood pressure below 90 mmHg or mean arterial pressure (MAP) below 60 mmHg, or a decrease in systolic blood pressure and/or MAP greater than 20% from baseline for a duration exceeding two minutes, surgical procedures extending \>3 hours, and any alterations in the planned surgical intervention. **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Bandung **Country:** Indonesia **Facility:** Hasan Sadikin General Hospital **State:** West Java **Zip:** 40161 #### Overall Officials **Official 1:** **Affiliation:** Faculty of Medicine Universitas Padjadjaran Bandung **Name:** Dian Mardiani, M.D **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17582 - Name: Vomiting - Relevance: LOW - As Found: Unknown - ID: M22074 - Name: Postoperative Nausea and Vomiting - Relevance: LOW - As Found: Unknown - ID: M12273 - Name: Nausea - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000000982 - Term: Antipruritics - ID: D000003879 - Term: Dermatologic Agents - ID: D000058831 - Term: Serotonin 5-HT3 Receptor Antagonists - ID: D000012702 - Term: Serotonin Antagonists - ID: D000018490 - Term: Serotonin Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000014150 - Term: Antipsychotic Agents - ID: D000014149 - Term: Tranquilizing Agents - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000011619 - Term: Psychotropic Drugs - ID: D000018492 - Term: Dopamine Antagonists - ID: D000015259 - Term: Dopamine Agents - ID: D000018726 - Term: Anti-Dyskinesia Agents ### Intervention Browse Module - Browse Branches - Abbrev: AnEm - Name: Antiemetics - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnDyAg - Name: Anti-Dyskinesia Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: CaAg - Name: Cardiotonic Agents ### Intervention Browse Module - Browse Leaves - ID: M19588 - Name: Ondansetron - Relevance: HIGH - As Found: Mental health - ID: M7102 - Name: Dexamethasone - Relevance: LOW - As Found: Unknown - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown - ID: M9312 - Name: Haloperidol - Relevance: HIGH - As Found: Dendritic cells - ID: M215475 - Name: Haloperidol decanoate - Relevance: HIGH - As Found: Dendritic cells - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown - ID: M15512 - Name: Serotonin - Relevance: LOW - As Found: Unknown - ID: M29246 - Name: Serotonin 5-HT3 Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M16904 - Name: Antipsychotic Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown - ID: M7473 - Name: Dopamine - Relevance: LOW - As Found: Unknown - ID: M20596 - Name: Dopamine Antagonists - Relevance: LOW - As Found: Unknown - ID: M17962 - Name: Dopamine Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000006220 - Term: Haloperidol - ID: D000017294 - Term: Ondansetron - ID: C000033563 - Term: Haloperidol decanoate ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428071 **Brief Title:** Decompression Versus Heat and Decompression in Knee OA **Official Title:** Mechanical Knee Decompression With and Without Heating: Impact on Pain, Function, and Range of Motion #### Organization Study ID Info **ID:** H-2024-265 #### Organization **Class:** OTHER **Full Name:** University of Hail ### Status Module #### Completion Date **Date:** 2024-11-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-11-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Hail #### Responsible Party **Investigator Affiliation:** University of Hail **Investigator Full Name:** Hisham Mohamed Hussein **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:** a randomized controlled trial tends to compare the effects of adding superficial heating during the application of knee decompression session to the results of decompression alone without heating. **Detailed Description:** Osteoarthritis (OA) is a progressive multifactorial joint disease characterized by chronic pain and functional disability due to the degeneration of the articular cartilage. The knee joint is the most vulnerable joint in the human body and occupies four-fifths of the burden of OA worldwide. Subjects having KOA demonstrate deferent clinical and radiological characteristics such as narrowed joint space, osteophytes around the articular surface, subchondral sclerosis, pain, limited range of motion (ROM), and declined functional status. Except for the arthroplasty for the severely arthritic knee joint, there is no cure for the degeneration of joint cartilage. Medications, exercises, and physical agents can be used to address the associated pain, muscular tightness, weakness, and physical disability. Interestingly, previous efforts that applied traction (decompression) on the arthritic knee joint demonstrated favorable results even on the thickness of the articular cartilage. However, these methods were mainly invasive surgical procedures that encountered disadvantages like the risk of infection and prolonged bedridden that might affect the general health of the patients ### Conditions Module **Conditions:** - Knee Osteoarthritis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** 3 arm parallel randomized controlled trial ##### Masking Info **Masking:** DOUBLE **Masking Description:** This study will be double-blinded consequently neither the assessor nor the data analyzer will be aware of the allocation sequence. Each participant will be coded using special numbers that refer to the correct allocation. The interpretation of these code numbers will be kept with the senior author who will not be involved in the treatment or assessment. The therapist will only be allowed to get the code number interpretation after the end of the allocation process and at the beginning of the study. In this study, the participants and the therapist will be blind. **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All Patients in the three groups will receive supervised systematic exercise therapy that was performed effectively in previous work. This program consisted of lower limb static, dynamic, and flexibility exer¬cises that targeted the quadriceps, hamstrings, and gluteus muscles; and core strength training for 20 minutes per day. This program will be applied 3 times per week for 6 weeks **Intervention Names:** - Other: standard physical therapy **Label:** Standard physical therapy program **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The ACUTRAC AT270 Traction System device will be used for traction. The patient will assume the supine position with the hip of the treated limb in semi-flexion and the ipsilateral knee in 25-30º flexion. 15 minutes of continuous mechanical traction using 20% of the patient's weight will be used. The session will be 15 minutes, once a day, three-times a week for 6 weeks. This group will receive decompression and standard physical therapy. **Intervention Names:** - Other: standard physical therapy - Other: knee Decompression **Label:** knee Decompression **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** this group will receive the standard physical therapy, the mechanical decompression and superficial heating using heat pad on the knee joint for 20 minutes while the patient receives the decompression session **Intervention Names:** - Other: standard physical therapy - Other: knee Decompression - Other: hot pack **Label:** Decompression plus heating **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Decompression plus heating - Standard physical therapy program - knee Decompression **Description:** All Patients in the three groups will receive supervised systematic exercise therapy that was performed effectively in previous work. This program consisted of lower limb static, dynamic, and flexibility exer¬cises that targeted the quadriceps, hamstrings, and gluteus muscles; and core strength training for 20 minutes per day. This program will be applied 3 times per week for 6 weeks to all the participants **Name:** standard physical therapy **Other Names:** - routine physical therapy **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Decompression plus heating - knee Decompression **Description:** continuous mechanical decompression using 20% of the body weight as a traction force for 15 minutes. **Name:** knee Decompression **Other Names:** - knee traction **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Decompression plus heating **Description:** hot pack over the treated knee joint will be applied for 20 minutes. this application will be performed while the patient is receiving the decompression session **Name:** hot pack **Other Names:** - superficial heating - moist heat **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Visual Analog Scale (VAS) will be used to assess pain. This scale is proved to be valid and reliable mean of assessing pain. The patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The outcomes range between no pain to sever pain according to the distance in mm measured from the 0 point of the horizontal line. **Measure:** pain intensity **Time Frame:** at base line **Description:** Visual Analog Scale (VAS) will be used to assess pain. This scale is proved to be valid and reliable mean of assessing pain. The patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." The outcomes range between no pain to sever pain according to the distance in mm measured from the 0 point of the horizontal line. **Measure:** pain intensity **Time Frame:** after the end of the treatment (after 6 weeks) **Description:** this outcome will be assessed using a vlaid and reliable android-mobile application designed to assess joint range of motion (ROM). The mobile phone will be secured to the lateral aspect of the leg so that the normal extension will be represented as zero on the app screen. The patient will be asked to move the tested knee from the maximum extension to the maximum available flexion. The value of the angle will be recorded. The difference between the extension angle and flexion angle will be calculated. **Measure:** active knee range of motion **Time Frame:** at baseline **Description:** this outcome will be assessed using a vlaid and reliable android-mobile application designed to assess joint range of motion (ROM). The mobile phone will be secured to the lateral aspect of the leg so that the normal extension will be represented as zero on the app screen. The patient will be asked to move the tested knee from the maximum extension to the maximum available flexion. The value of the angle will be recorded. The difference between the extension angle and flexion angle will be calculated. **Measure:** active knee range of motion **Time Frame:** after the end of the treatment (after 6 weeks) **Description:** It is consisted of 24 questions, five related to pain, two related to stiffness and 17 to physical function. Its reliability was proved in previous work.the questions in this scale takes from 0 to 4 points and the total will be calculated. higher scores indicate more disability **Measure:** function **Time Frame:** at baseline **Description:** It is consisted of 24 questions, five related to pain, two related to stiffness and 17 to physical function. Its reliability was proved in previous work.the questions in this scale takes from 0 to 4 points and the total will be calculated. higher scores indicate more disability **Measure:** function **Time Frame:** after the end of the treatment (after 6 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Both sexes * age between 45 to 60 years. * Normal and or overweight categories of BMI 19-30 kg/m2 * Unilateral (grade 2 and 3) knee OA according to the Kellgren-Lawrence radiological rating scale Exclusion Criteria: * lower limb deformities as genu varum, valgus, flat foot * leg length discrepancy * previous trauma and or surgery to the knee joint * Bone disease * Inability to refrain from analgesic/anti-inflammatory medications for 6 weeks **Maximum Age:** 60 Years **Minimum Age:** 45 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hail **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hisham Hussein - **Role:** CONTACT **Country:** Saudi Arabia **Facility:** Hisham Hussein **Zip:** 3994 ### IPD Sharing Statement Module **Description:** the data will be available with the senior author up on request **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Knee Osteoarthritis - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428058 **Acronym:** THP-2 **Brief Title:** Training for Health Professionals 2: Aim 1 **Official Title:** Evaluating the Effects of Reproductive Health Training on Provider Behavior #### Organization Study ID Info **ID:** R01HD092655 **Link:** https://reporter.nih.gov/quickSearch/R01HD092655 **Type:** NIH #### Organization **Class:** OTHER **Full Name:** University of Minnesota ### Status Module #### Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Muhimbili University of Health and Allied Sciences **Class:** OTHER **Name:** Johns Hopkins University #### Lead Sponsor **Class:** OTHER **Name:** University of Minnesota #### 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 randomized, controlled, single blinded trial is to evaluate the medium to long-term effects of an Afrocentric sexual health curriculum on health professional students' knowledge, attitudes, and clinical skills in providing sexual health in Tanzania. **Detailed Description:** All enrollees will be health students at MUHAS recruited through announcements in class, flyers on student noticeboards, and email. Students who are interested in learning more about the study can do so by asking questions of the recruiting faculty member, by going to, telephoning, or emailing the study office (at MUHAS). Students can also visit the study website. In addition, all students who contact the office will be given a copy of a flyer advertising the study and a copy of the consent documents to preview prior to participation. Students contacting the office by email will be sent electronic versions of the same documents. Participants in Aim 1 are informed to schedule an appointment (in the month prior to the seminar) to complete a pre-evaluation. At the study site, participants complete pen and paper surveys, and are videotaped interviewing two standardized patients. Next, participants are randomized to either the intervention or waitlist control condition. Participants in the intervention will attend the 4-day sexual health seminar and complete a short post-test. In addition, at 6- and 12-month follow-up after the pre-test, participants in both arms complete surveys and two videotaped interviews (at each follow-up) and a final survey at 24-month follow-up. At the end of the study, participants assigned to the control condition can attend the seminar. ### Conditions Module **Conditions:** - Health Knowledge, Attitudes, Practice - Training ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Testing of an Afrocentric sexual health curriculum for Midwifery, Nursing and Medical Students. ##### Masking Info **Masking:** SINGLE **Masking Description:** A randomized, controlled, single blinded trial, stratified by health profession, of the intervention vs waitlist control. **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 310 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants received a four-day comprehensive sexual health curriculum tailored for Africa. **Intervention Names:** - Behavioral: Comprehensive sexual health curriculum **Label:** Comprehensive Sexual Health Curriculum **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in this arm completed a follow-up survey and scheduled to receive the intervention after the end of the trial. **Label:** Waitlist Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Comprehensive Sexual Health Curriculum **Description:** This is a randomized, controlled, single blinded, trial, stratified by health profession, of the intervention versus waitlist control assessing the effects on sexual health knowledge, attitudes, and sexual history and counseling skills at medium (6-) and long-term (12 and 24 months) follow-up. At the end of the intervention as compared with waitlist controls. The intervention was a 4-day, Afrocentric, comprehensive sexual health curriculum. Tanzanian faculty wrote the curriculum in English and Kiswahili to address the most common sexual health challenges clinicians experience in Tanzania. The 4-day curriculum covers sexual health across the lifespan, lesbian, gay, bisexual, and transgender (LGBT) and sexual violence, clinical skills training, ethics, and community resources and cultural considerations. **Name:** Comprehensive sexual health curriculum **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Sexual health knowledge was assessed using 16 multichoice items created by the research team. The items covered female sexual health concerns (2 items), sexual development and masturbation (3 items), sexual orientation (3 items), sexual violence (3 items), sexuality in middle age (3 items), sexual history taking and sexual counseling (2 items). Total scores were used for analysis (maximum total score of 16). Participants get one point for every item answer correctly. Because there are 16 items in this section, participants can have a minimum total score of 0 and a maximum total score of 16. A higher score signifies better sexual health knowledge. **Measure:** Change in Sexual Health Knowledge Score **Time Frame:** Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up. **Description:** Confidence in their ability to discuss the sexual health of patients, and confidence in their ability to discuss their patients' sexual health concerns were assessed using the Sexual Health Education for Professionals Scale (SHEPS). This section consists of 37 items where participants rate their confidence from (1) very unconfident to (5) confident. Because there are 37 items in this section, participants can have a minimum total score of 37 and a maximum total score of 185. A higher value signifies better confidence in the ability to discuss sexual health topics. **Measure:** Change in Sexual Health Attitudes: Confidence in Ability to Discuss **Time Frame:** Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up. **Description:** Confidence in their knowledge to assess the sexual health of patients, and confidence in their ability to discuss their patient's sexual health concerns were assessed using the Sexual Health Education for Professionals Scale (SHEPS). This section consists of 37 items where participants rate their confidence from (1) very unconfident to (5) confident. Because there are 37 items in this section, participants can have a minimum total score of 37 and a maximum total score of 185. A higher value signifies better confidence in having knowledge of sexual health topics. **Measure:** Change in Sexual Health Attitudes: Confidence in Having Knowledge **Time Frame:** Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up. **Description:** Skills were assessed by faculty raters assessing two videos (per each time point) of student counseling blind to whether the participant was in the intervention or control group and whether the assessment was at baseline or follow-up. Each participant was rated on 10 items assessing their interpersonal communication (IC) abilities. Each item was on a 3-point scale (0=not done; 1=partially done; 2=done). The scale has a minimum score of 0 and a maximum score of 20 per video. The investigators aggregated scores for each time point by summing the two videos at each time point. Therefore, the minimum total score is 0 and the maximum total score is 40. A higher score value signifies better interpersonal communication skills. **Measure:** Change in Sexual Counseling Skills: Interpersonal Communications **Time Frame:** Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up. **Description:** Skills were assessed by faculty raters assessing the two videos (per time point) of student counseling blind to whether the participant was in the intervention or control group and whether the assessment was at baseline or follow-up. Medical history taking (MHT) was rated by six key pieces of information on a 2-point scale, where 0=not obtained information and 1=obtained information. The scale has a minimum score of 0 and a maximum score or 6 per video. The investigators aggregated scores for each time point by summing the two videos at each time point. Therefore, the minimum total score is 0 and the maximum total score is 12. **Measure:** Change in Sexual Counseling Skills: Medical History Taking **Time Frame:** Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up. **Description:** The SHEPS Attitudes section comprises 27 items. Participants rate their level of agreement (1=strongly agree; 5=strongly disagree), with 13 items being reverse coded. Because there are 27 items in this section, participants can have a minimum total score of 27 and a maximum total score of 135. Low scores correspond to "liberal" views and high scores correspond to "conservative" views. **Measure:** Change in Sexual Health Beliefs **Time Frame:** Baseline, 6-month follow-up, 12-month follow-up, and 24-month follow-up. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * A health student studying at MUHAS and verified by being registered as a pre-final year midwifery, nursing or medical student (or its equivalent). * "Pre-final" year is defined as a student who is just about to enter year 3 of nursing, or year 4 of midwifery or medicine. * Living or studying in Tanzania * Experienced, operationalized as having worked at least 100 hours as a health worker in a clinic, hospital or community setting so students can discuss what happens in the clinical setting * Able to speak English and Kiswahili. Exclusion Criteria: * Students who will not be able to attend all days of the seminar at their health institution or be on their campus for the follow-up. * Students who express any reservations about attending (e.g., due to religious objections) * Students who express a fear of violence due to attending (e.g., from a spouse or relative). * Students who attended the sexual health seminar (e.g., during THP-1 or at another site). This is to prevent a student participating more than once. **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:** B.R. Simon Rosser, PhD **Phone:** 612-624-0358 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Michael Ross, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Dar Es Salaam **Contacts:** ***Contact 1:*** - **Name:** Dickson Mkoka, PhD - **Role:** CONTACT ***Contact 2:*** - **Name:** Lucy Mgopa, MD - **Role:** CONTACT **Country:** Tanzania **Facility:** Muhimbili University of Health and Allied Sciences #### Overall Officials **Official 1:** **Affiliation:** University of Minnesota **Name:** B.R. Simon Rosser, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Only group data will be analyzed. **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428045 **Acronym:** STARLITE **Brief Title:** STARLITE for Unresectable High-Grade Gliomas **Official Title:** Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study #### Organization Study ID Info **ID:** 20231163 #### Organization **Class:** OTHER **Full Name:** University of Miami ### Status Module #### Completion Date **Date:** 2029-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-31 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Medtronic #### Lead Sponsor **Class:** OTHER **Name:** University of Miami #### Responsible Party **Investigator Affiliation:** University of Miami **Investigator Full Name:** Ashish Shah **Investigator Title:** Assistant Professor of Clinical **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to determine whether newly diagnosed high-grade glioma(s) that cannot be removed surgically change as a result of the study treatment; and to identify and evaluate the potential side effects (good and bad) of the study treatment in patients with newly diagnosed high-grade glioma(s) that cannot be removed surgically. ### Conditions Module **Conditions:** - High Grade Glioma **Keywords:** - Unresectable High Grade Glioma ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Phase 1 dose escalation/de-escalation and dose expansion design. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this group will undergo Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MR-guided LITT) on Day 0 after stereotactic needle biopsy. On Day 7, participants will begin combination antiretroviral therapy (ART) consisting of Abacavir, Lamivudine, and dose escalation/de-escalation of Ritonavir (RTV), to determine the recommended Phase 2 dose (RP2D) of Ritonavir. Participants will receive up to 12 months of ART. Beginning Day 14 through Day 180, participants will receive adjuvant therapy, standard of care consisting of focal radiotherapy and Temozolomide therapy. Participants will receive focal radiotherapy for six weeks (42 days). Participants will be administered Temozolomide up to Day 180. Participants will receive up to 12 months of study therapy, followed by up to 12 months of follow-up. Total participation duration is up to 24 months. **Intervention Names:** - Procedure: Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT) - Drug: Abacavir - Drug: Lamivudine - Drug: Ritonavir - Drug: Temozolomide - Radiation: Focal Radiotherapy **Label:** Part 1: STARLITE Dose Escalation/De-Escalation Cohort **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in this group will undergo Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MR-guided LITT) after biopsy on Day 0. On Day 7, participants will begin combination antiretroviral therapy (ART) consisting of Abacavir, Lamivudine, and the recommended phase 2 dose (RP2D) of Ritonavir determined in Part 1. Participants will receive up to 12 months of ART. Beginning Day 14 through Day 180, participants will receive adjuvant therapy, standard of care consisting of focal radiotherapy and Temozolomide therapy. Participants will receive focal radiotherapy for six weeks (42 days), and Temozolomide therapy, during and following radiotherapy up to Day 180. Participants will receive up to 12 months of study therapy, followed by up to 12 months of follow-up. Total participation duration is up to 24 months. Total participation is approximately two years. **Intervention Names:** - Procedure: Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT) - Drug: Abacavir - Drug: Lamivudine - Drug: Ritonavir - Drug: Temozolomide - Radiation: Focal Radiotherapy **Label:** Part 2: STARLITE Dose Expansion Cohort **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part 1: STARLITE Dose Escalation/De-Escalation Cohort - Part 2: STARLITE Dose Expansion Cohort **Description:** Participants will be administered MR-guided Laser Interstitial Thermal Therapy (LITT) as a single procedure, following stereotactic needle biopsy. **Name:** Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT) **Other Names:** - MR-Guided LITT **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Part 1: STARLITE Dose Escalation/De-Escalation Cohort - Part 2: STARLITE Dose Expansion Cohort **Description:** Participants will take one 600mg tablet of Abacavir orally once daily, as part of combination antiretroviral therapy (ART). **Name:** Abacavir **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Part 1: STARLITE Dose Escalation/De-Escalation Cohort - Part 2: STARLITE Dose Expansion Cohort **Description:** Participants will take one 300mg tablet of Lamivudine orally once daily, as part of combination antiretroviral therapy (ART) **Name:** Lamivudine **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Part 1: STARLITE Dose Escalation/De-Escalation Cohort - Part 2: STARLITE Dose Expansion Cohort **Description:** Participants will take one tablet of Ritonavir (RTV) orally twice daily, as part of combination antiretroviral therapy (ART), at one of the following dose levels: * Dose Level -1: 100mg * Dose Level 1 (starting dose): 300mg * Dose Level 2: 450mg * Dose Level 3: 600mg **Name:** Ritonavir **Other Names:** - Norvir - RTV **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Part 1: STARLITE Dose Escalation/De-Escalation Cohort - Part 2: STARLITE Dose Expansion Cohort **Description:** Participants will take Temozolomide (TMZ) via capsule orally, during and after focal radiotherapy, as part of standard of care adjuvant therapy. During focal radiotherapy, Temozolomide will be administered at a dose of 75 mg/m2 once daily for six weeks (42 days) on a continuous dosing regimen, including weekends and holidays. After completion of focal radiotherapy, Temozolomide will be administered 150-200 mg/m2 on days 1 through 5 of a four-week cycle for a total of six cycles of maintenance therapy. **Name:** Temozolomide **Other Names:** - TMZ **Type:** DRUG #### Intervention 6 **Arm Group Labels:** - Part 1: STARLITE Dose Escalation/De-Escalation Cohort - Part 2: STARLITE Dose Expansion Cohort **Description:** Participants will be administered focal radiotherapy for six weeks (42 days), as part of adjuvant therapy, at a total dose of 50-60 grays (Gy) in 1.8-2.0 Gy fractions, depending on prognosis and as determined by the treating radiation oncologist. **Name:** Focal Radiotherapy **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** The number of participants experiencing dose-limiting toxicity (DLT) during the first 28 days of antiretroviral therapy (ART) will be reported. Toxicity will be assessed by the treating physician and assigned severity and attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE v6.0). **Measure:** Number of Participants Experiencing Dose-Limiting Toxicity **Time Frame:** Up to 28 days **Description:** The number of participants experiencing serious adverse events (SAEs) and Grade 3 or higher adverse events (AEs) will be reported. SAEs and AEs will be assessed by the treating physician and assigned severity and attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 (NCI CTCAE v6.0). **Measure:** Number of Participants Experiencing Serious Adverse Events and Grade 3 or Higher Adverse Events **Time Frame:** Up to 12 months #### Secondary Outcomes **Description:** PFS is defined as percentage of participants without disease progression at time of study discontinuation. **Measure:** Progression-Free Survival (PFS) **Time Frame:** Up to 24 months **Description:** Overall Survival is defined as the percentage of participants who are still living at the time of study discontinuation. **Measure:** Overall Survival (OS) **Time Frame:** Up to 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥ 18 years. 2. Patients with a histologically confirmed or suspected high-grade glioma (HGG) by MRI. a. For cases with suspected HGG, intraoperative frozen section diagnoses of HGG must be made by pathologists (Section 4.4.1). 3. Uni-focal or butterfly gliomas that can receive ≥70% of lesion volume ablated as determined by the treating surgeon. 4. Gliomas must be located or positioned where surgical resection is either not feasible or high-risk as deemed by a group of surgical neuro-oncologists. 5. Preoperative Karnofsky score ≥ 70 (APPENDIX A). 6. Patients must have demonstrable normal organ function as defined below within 14 days of surgery. 1. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 2. Platelets ≥ 100,000 cells/mm3 3. Hemoglobin ≥ 9.0 g/dL. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable. 4. Blood urea nitrogen (BUN) ≤ 35 mg/dL and creatinine ≤ 1.9 mg/dL and estimated glomerular filtration rate (eGFR) or creatinine clearance rate \> 50 mL per minute. 5. Electrocardiogram (ECG) without evidence of acute cardiac ischemia. 6. Prothrombin time (PT)/International Normalized Ratio (INR) \<1.4 7. Liver function tests: Aspartate aminotransferase (AST) and alanine transaminase (ALT) at or below 2.5 times the upper limit of normal (ULN). 8. Sodium level \> 130 mg/L. Use of salt resection or hypertonic saline to achieve this sodium level is acceptable. 7. Patients must be able to understand and sign informed consent. Exclusion Criteria: 1. Patients with human leukocyte antigen (HLA) HLA-B\*5701 hypersensitivity (Section 10.1.6.7). 2. Patients with sensitivity to abacavir, lamivudine, or ritonavir (Section 7.3.1). 3. Patients with a previous history of HIV infection. 4. Patients with uncontrolled hepatitis B or C infection. 5. Patients who have received any surgical resection for this tumor. a. Patients who have received an open biopsy for this disease are still eligible for participation. 6. Patients who have received chemotherapy or radiation for this disease. 7. Patients who are taking dofetilide (Section 4.10.1). 8. Patients on a regimen of 1 or more prohibited medications as described in Section 4.10.1 that cannot be discontinued or switched to a more compatible medication. For more information on prohibited and precautionary use medications for patients on this study, please see Section 4.10. 9. Patients not eligible to obtain MRI with and without contrast. 10. Recurrent HGG. 11. Presence of current infection, such as sepsis, meningitis, bacteremia, or pneumonia. 12. Fever within 48 hours of surgery (Temperature\> 38.0°C). 13. Severe co-morbidity that would confer excess risk of surgery, radiation, or chemotherapy, as determined by the treating physician. 14. Any co-morbidity or psychiatric ailment that in the Investigator's opinion will prevent administration or completion of protocol therapy. 15. Pregnant women. 16. Patients must be willing to use contraception as described in Section 4.11. 17. Patients receiving other investigational agents or concurrent enrollment in another therapeutic clinical trial. 18. Prisoners. 19. Adults unable to consent. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ashish Shah, MD **Phone:** (305) 243-6946 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Macarena De La Fuente, MD **Phone:** (305) 243-2858 **Role:** CONTACT #### Locations **Location 1:** **City:** Miami **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ashish Shah, MD - **Phone:** 305-243-6946 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Macarena De La Fuente, MD - **Phone:** (305) 243-2858 - **Role:** CONTACT ***Contact 3:*** - **Name:** Ashish Shah, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Macarena De La Fuente, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Miami **State:** Florida **Zip:** 33136 #### Overall Officials **Official 1:** **Affiliation:** University of Miami **Name:** Ashish Shah, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Miami **Name:** Macarena De La Fuente, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000018302 - Term: Neoplasms, Neuroepithelial - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009380 - Term: Neoplasms, Nerve Tissue ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9020 - Name: Glioma - Relevance: HIGH - As Found: Glioma - ID: M20446 - Name: Neoplasms, Neuroepithelial - Relevance: LOW - As Found: Unknown - ID: M19845 - Name: Neuroectodermal Tumors - Relevance: LOW - As Found: Unknown - ID: M20388 - Name: Neuroectodermal Tumors, Primitive - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: T2519 - Name: Glioma - Relevance: HIGH - As Found: Glioma - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005910 - Term: Glioma ### Intervention Browse Module - Ancestors - ID: D000017320 - Term: HIV Protease Inhibitors - ID: D000084762 - Term: Viral Protease Inhibitors - ID: D000011480 - Term: Protease Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000019380 - Term: Anti-HIV Agents - ID: D000044966 - Term: Anti-Retroviral Agents - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000065692 - Term: Cytochrome P-450 CYP3A Inhibitors - ID: D000065607 - Term: Cytochrome P-450 Enzyme Inhibitors - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents - ID: D000000970 - Term: Antineoplastic Agents - ID: D000018894 - Term: Reverse Transcriptase Inhibitors - ID: D000019384 - Term: Nucleic Acid Synthesis Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M1692 - Name: Temozolomide - Relevance: HIGH - As Found: Skills - ID: M21394 - Name: Ritonavir - Relevance: HIGH - As Found: 6 weeks - ID: M21243 - Name: Lamivudine - Relevance: HIGH - As Found: Spray - ID: M350770 - Name: Abacavir - Relevance: HIGH - As Found: High frequency - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown - ID: M19609 - Name: HIV Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M14343 - Name: Protease Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M21350 - Name: Anti-HIV Agents - Relevance: LOW - As Found: Unknown - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M30564 - Name: Cytochrome P-450 CYP3A Inhibitors - Relevance: LOW - As Found: Unknown - ID: M30537 - Name: Cytochrome P-450 Enzyme Inhibitors - 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: M20935 - Name: Reverse Transcriptase Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000019438 - Term: Ritonavir - ID: D000019259 - Term: Lamivudine - ID: C000106538 - Term: Abacavir - ID: D000077204 - Term: Temozolomide ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428032 **Acronym:** FuN HABIT-ILE **Brief Title:** Functional and Neuroplastic Effects of HABIT-ILE in Children With Bilateral Cerebral Palsy **Official Title:** Functional and Neuroplastic Effects of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Children With Bilateral Cerebral Palsy: a Randomized Controlled Trial #### Organization Study ID Info **ID:** NEUROLAB_UNAB_001 #### Organization **Class:** OTHER **Full Name:** Universidad Nacional Andres Bello ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidad Nacional Andres Bello #### Responsible Party **Investigator Affiliation:** Universidad Nacional Andres Bello **Investigator Full Name:** Rodrigo Araneda, PhD **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This randomized controlled trial will compare the effects of neuroplastic and functional changes of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) when presented in two periods (2HG; n=24) versus a single period (1HG; n=24) in people with bilateral CP. The 1HG will receive 65 hours of HABIT-ILE over one intervention period; the 2HG will receive 130 hours over two intervention periods, within 6 months apart. Children will be assessed at 6 time points: baseline, three weeks after the start, at 3, 6, 7 and 9 months after the start of the study. **Detailed Description:** This study aims to compare, for the first time, the effects of a double period of HABIT-ILE therapy on functional and neuroplastic changes against a single period, in people with bilateral cerebral palsy (CP). Previous HABIT-ILE protocols have only assessed the effects of a single intervention period. Still, the literature suggests a possible dose-response relationship between the number of intensive therapy periods and progress in motor function. A randomized controlled trial will be conducted, comparing the effects of a double period of HABIT-ILE; (2HG; n=24) versus a single period (1HG; n=24) in children and youth with bilateral CP. Each HABIT-ILE period will consider 6.5 hours of intervention during 10 consecutive working days. Children will be assessed at 6-time points: baseline, three weeks after, at 3 months, at 6 months, at 7 months, and at 9 months, to evaluate the long-term effect of HABIT-ILE and the summative effects of the double period in functional and neuroplastic variables. The 1HG will receive only 65 hours of HABIT-ILE after baseline; the 2HG will perform 130 hours over two intervention periods, after baseline and again at 6 months. Overall, this study aims to provide evidence for the effectiveness of HABIT-ILE in producing functional and neuroplastic changes in children with bilateral CP. It will allow us to approach the possible mechanisms underlying the effect of HABIT-ILE. ### Conditions Module **Conditions:** - Cerebral Palsy **Keywords:** - HABIT-ILE - Intensive motor therapy - Motor skill learning - Children ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects will receive 130 hours of HABIT-ILE performed in two intervention periods as camp format for 6,5-hours/day, 5 days/week for two weeks. Each intervention period will be 6-months apart. **Intervention Names:** - Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities **Label:** Double period **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects will receive 65 hours of HABIT-ILE performed in one intervention period as camp format for 6,5-hours/day, 5 days/week for two weeks **Intervention Names:** - Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities **Label:** Single period **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Double period **Description:** Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities. **Name:** Hand-Arm Bimanual Intensive Therapy Including Lower Extremities **Other Names:** - HABIT-ILE **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Single period **Description:** Structured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities. **Name:** Hand-Arm Bimanual Intensive Therapy Including Lower Extremities **Other Names:** - HABIT-ILE **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The Gross Motor Function Measure is a standardized observational instrument designed to measure changes in gross motor function over time or following an intervention in children and youth with cerebral palsy using Rasch analysis. It is scored on a scale of 0 to 3, where 0 means the person cannot perform the activity and 3 means the person can complete the item. The score is converted to a percentage. A higher percentage means a better gross motor function. **Measure:** Changes in Gross Motor Function **Time Frame:** Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5) #### Secondary Outcomes **Description:** The Both Hands Assessment is a valid test for children with mild to moderate bilateral manual abilities impairments. It can evaluate bimanual activity performance and the level of upper extremity asymmetry. It rates performance between 1 (does not do) and 4 (effective). The final score is converted to BoHA units (logit 0 - 100), where higher scores reflect better bimanual use. **Measure:** Both Hands Assessment (BoHA) **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)] **Description:** The Melbourne 2 Assessment (MA2) assesses the unilateral performance of the upper extremities, quantifying the dexterity, fluency, accuracy, and range of movement during several tasks of reaching and manipulation. The result is obtained as a percentage of the function of each item. A higher percentage means a better unilateral performance of the upper extremity. **Measure:** Melbourne 2 Assessment (MA2) **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5)] **Description:** The TASC test assesses the selective voluntary motor control of upper limbs in individuals with cerebral palsy. The participant must execute eight movements in the upper extremity. The execution of each sequence will be assessed on a scale of 0, 1, or 2, from absence, impairment, or normality of voluntary selective motor control, respectively, with a maximum of 16 points per side and 32 points overall. **Measure:** Test of Arm Selective Control (TASC) **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5) **Description:** The SCALE test assesses the selective voluntary motor control of lower limbs in individuals with cerebral palsy. The participant must execute five movements in the lower extremity. The execution of each sequence will be assessed on a scale of 0, 1 or 2, from absence, impairment, or normality of voluntary selective motor control respectively, with a maximum of 10 points per side and 20 points overall. **Measure:** Selective Control Assessment of the Lower Extremity (SCALE) **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5) **Description:** The 6MWT measures the maximum distance a participant can walk in a 6-minute period in a 30-meter corridor at his or her own pace. More distance walked (in meters) indicates better performance. **Measure:** Six minutes walk test (6MWT) **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5) **Description:** The ANT assesses the efficiency of the three attentional networks: alerting, orienting, and executive control networks. It measures the accuracy (in terms of the amount of errors) and the reaction time (milliseconds) of each network. Fewer errors mean more accuracy, the lower the score, the faster the reaction time. **Measure:** Attention network test (ANT) **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5) **Description:** This parent's filled questionnaire measures the ability of the participant with cerebral palsy to perform activities of daily living that require the use of the upper extremities. The difficulty to perform the activities are rating as "Impossible", "Difficult" or "Easy". The result is obtained in logits and can be interpreted as a percentage, where 0% indicates minimum ability and 100% maximum ability to perform the activities. **Measure:** ABILHAND-Kids questionnaire **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5) **Description:** This parent's filled questionnaire measures a child performance of daily activities requiring the use of the upper and/or the lower extremities through 43 items specific to patients with cerebral palsy. It ranges from - 7 to +7 logits (higher score means better performance). The result is obtained in logits and can be interpreted as a percentage, where 0% indicates minimum ability and 100% maximum ability to perform the activities. **Measure:** ACTIVLIM-CP questionnaire **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5) **Description:** This parent's filled questionnaire measures the performance of the child in the daily life activities and movement domains, focusing on the capacity of upper extremities and lower extremities during these activities. It ranges from 20 to 80 (higher score means better performance). **Measure:** Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5) **Description:** This parent's filled questionnaire measures participation of children and youth with or without disability, in the home, school and community, along with environmental factors within each of these settings. For each environment, it assesses how frequently they participate in a given activity (8-point scale; 0-7), how involved they are in that activity (5-point scale; 1-5), and whether they want to make a change in the type of participation they perform (6-point scale; 1-6). For each setting, the participation frequency (percentage), involvement (score 1-5), desires for change (percentage), and environmental supportiveness (percentage) are calculated. **Measure:** Participation and Environment Measure - Children and Youth (PEM-CY) **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5) **Description:** This is an interview-setting designed to capture a patient's self-perception of performance and satisfaction of it in everyday activities, observed over time. During the interview, parents set up 5 activities considered difficult in daily life. These are then assessed, in a 1 to 10 scale, regarding the child's self-perception of performance and satisfaction of it. The total score is the average of the scores for perception and satisfaction separately (score from 1 to 10; higher score means better performance/satisfaction). **Measure:** Canadian Occupational Performance Measure (COPM) **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 3 months (T2), at 6 months (T3), at 7 months (T4), and at 9 months (T5) **Description:** The BRIEF-2 is a caregiver-reported questionnaire measuring executive functioning in children between 5 and 18 years old. It consists of 63 items arranged in nine scales: inhibition, self-monitoring, flexibility, emotional control, initiative, working memory, planning and organization, task supervision, and organization of materials. It is scored using T scores (Range= 34 - 90; Mean=50, Standard Deviation=10), where higher scores indicate greater problems with executive functioning. **Measure:** Behaviour Rating Inventory of Executive Function (BRIEF-2) **Time Frame:** Time Frame: Baseline (T0), at 3 months (T2), at 6 months (T3), and at 9 months (T5) **Description:** A single-pulse transcranial magnetic stimulation is a noninvasive technique that directly assesses cortical function and connectivity in the motor system. It will be used to assess the corticospinal tract excitability in both brain hemispheres. It will stimulate the primary motor cortex with a figure-8 coil, searching for the first dorsal interosseous muscle area. The changes of peak-to-peak amplitude of motor evoked potential will be measured in milliAmpere (mA). **Measure:** Changes of peak-to-peak amplitude of motor evoked potential **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4) **Description:** A single-pulse transcranial magnetic stimulation is a noninvasive technique that directly assesses cortical function and connectivity in the motor system. It will be used to assess the corticospinal tract excitability in both brain hemispheres. It will stimulate the primary motor cortex with a figure-8 coil, searching for the first dorsal interosseous muscle area. The changes of resting motor threshold will be measured in percentage. **Measure:** Changes of Resting Motor Threshold **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4) **Description:** A single-pulse transcranial magnetic stimulation is a noninvasive technique that directly assesses cortical function and connectivity in the motor system. It will be used to assess the corticospinal tract excitability in both brain hemispheres. It will stimulate the primary motor cortex with a figure-8 coil, searching for the first dorsal interosseous muscle area. The changes of latency in motor evoked potential will be measured in milliseconds. **Measure:** Changes of latency in motor evoked potential **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4) **Description:** A functional near-infrared spectroscopy will be used to assess cortical activity. It is a noninvasive brain imaging tool that records optical density measurements to determine the change in oxyhemoglobin concentration (μM) in sensorimotor cortex area during manual tasks. **Measure:** Changes of oxyhemoglobin concentration in sensorimotor cortex **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4) **Description:** A functional near-infrared spectroscopy will be used to assess cortical activity. It is a noninvasive brain imaging tool that records optical density measurements to determine the change in oxyhemoglobin concentration (μM) in prefrontal cortex area during manual tasks. **Measure:** Changes of oxyhemoglobin concentration in prefrontal cortex **Time Frame:** Time Frame: Baseline (T0), two weeks after start (T1), at 6 months (T3), and at 7 months (T4) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Children with medical diagnosis of bilateral cerebral palsy * Cognitive capacity and language that allows understanding and following the therapist's instructions. * Manual Ability Classification System (MACS) levels I to III * Bimanual Fine Motor Function (BFMF) levels I to III * Gross Motor Function Classification System (GMFCS) levels I to III Exclusion Criteria: * Severe visual problems * Movement restriction due to orthopedic surgery in less than a year * Treatment with botulinum toxin and/or baclofen pump in the last 6 months * Contraindications to receive transcranial magnetic stimulation (epileptic history, metallic implants, neoplasm, etc.) **Maximum Age:** 18 Years **Minimum Age:** 8 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Rodrigo Araneda, PhD **Phone:** +56 22 6618608 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Natalia Perez, MSc **Phone:** +56 22 6618075 **Role:** CONTACT #### Locations **Location 1:** **City:** Santiago **Contacts:** ***Contact 1:*** - **Name:** Rodrigo Araneda, PhD - **Role:** CONTACT **Country:** Chile **Facility:** Exercise and Rehabilitation Sciences Institute, Universidad Nacional Andres Bello **State:** Region Metropolitana **Zip:** 7591538 #### Overall Officials **Official 1:** **Affiliation:** Universidad Nacional Andres Bello **Name:** Rodrigo Araneda, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases - ID: D000001925 - Term: Brain Damage, Chronic - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5796 - Name: Cerebral Palsy - Relevance: HIGH - As Found: Cerebral Palsy - ID: M13157 - Name: Paralysis - Relevance: LOW - As Found: Unknown - ID: M5207 - Name: Brain Injuries - Relevance: LOW - As Found: Unknown - ID: M5202 - Name: Brain Damage, Chronic - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002547 - Term: Cerebral Palsy ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428019 **Brief Title:** A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL) **Official Title:** A Prospective, Open-Label, Phase IIb/III Study to Evaluate the Risk of TLS and Optimization of the Initiation of Venetoclax in Combination With Obinutuzumab or Acalabrutinib With Different Ramp- Up Periods in Previously Untreated Subjects With CLL #### Organization Study ID Info **ID:** M24-287 #### Organization **Class:** INDUSTRY **Full Name:** AbbVie #### Secondary ID Infos **Domain:** EU CT **ID:** 2024-512147-23-00 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-10-21 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-10-21 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AbbVie #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 120 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide. Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. ### Conditions Module **Conditions:** - Chronic Lymphocytic Leukemia **Keywords:** - Chronic Lymphocytic Leukemia - CLL - Venetoclax - ABT-199 - Obinutuzumab - Acalabrutinib ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will receive venetoclax in combination with obinutuzumab, with a 5 week venetoclax ramp up. **Intervention Names:** - Drug: Venetoclax - Drug: Obinutuzumab **Label:** Arm A: Venetoclax + Obinutuzumab **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will receive venetoclax in combination with acalabrutinib, with a 5 week venetoclax ramp up. **Intervention Names:** - Drug: Venetoclax - Drug: Acalabrutinib **Label:** Arm B: Venetoclax + Acalabrutinib **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will receive venetoclax in combination with acalabrutinib, with a 6 week venetoclax ramp up. **Intervention Names:** - Drug: Venetoclax - Drug: Acalabrutinib **Label:** Arm C: Venetoclax + Acalabrutinib **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Participants will receive venetoclax in combination with acalabrutinib, with a 7 week venetoclax ramp up. **Intervention Names:** - Drug: Venetoclax - Drug: Acalabrutinib **Label:** Arm D: Venetoclax + Acalabrutinib **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm A: Venetoclax + Obinutuzumab - Arm B: Venetoclax + Acalabrutinib - Arm C: Venetoclax + Acalabrutinib - Arm D: Venetoclax + Acalabrutinib **Description:** Oral: Tablet **Name:** Venetoclax **Other Names:** - ABT-199 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Arm B: Venetoclax + Acalabrutinib - Arm C: Venetoclax + Acalabrutinib - Arm D: Venetoclax + Acalabrutinib **Description:** Oral: Tablet **Name:** Acalabrutinib **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Arm A: Venetoclax + Obinutuzumab **Description:** Intravenous Infusion **Name:** Obinutuzumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** TLS is defined per Howard criteria that require a clinical intervention per independent review committee (IRC) assessment during the venetoclax ramp-up period in previously untreated participants with chronic lymphocytic leukemia (CLL) achieving a medium tumor burden with creatinine clearance (CrCl) of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy. **Measure:** Part 1: Percentage of Participants with Treatment-Emergent Laboratory Tumor Lysis Syndrome (TLS)-Venetoclax **Time Frame:** Up to 28 Months **Description:** Hyperkalemia (potassium \>6.0 mmol/L) is defined per Howard criteria that require a clinical intervention per IRC assessment during the venetoclax ramp-up period in previously untreated participants with CLL achieving a medium tumor burden with CrCl of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy. **Measure:** Part 1: Percentage of Participants with Hyperkalemia-Venetoclax **Time Frame:** Up to 28 Months #### Secondary Outcomes **Description:** TLS is defined per Howard criteria that require a clinical intervention per IRC assessment, at each dose level and at each laboratory monitoring point during ramp-up period in previously untreated participants with CLL achieving a medium tumor burden with CrCl of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy. **Measure:** Part 1: Percentage of Participants with Treatment-Emergent Laboratory TLS **Time Frame:** Up to 28 Months **Description:** Hyperkalemia (potassium \>6.0 mmol/L) is defined per Howard criteria that require a clinical intervention per independent review committee (IRC) assessment during the venetoclax ramp-up period in previously untreated participants with CLL achieving a medium tumor burden with CrCl of at least 80 ml/min or low tumor burden (regardless of CrCl level) after debulking therapy. **Measure:** Part 1: Percentage of Participants with Hyperkalemia **Time Frame:** Up to 28 Months **Description:** TLS-related events are defined as laboratory TLS per Howard criteria requiring clinical intervention per IRC assessment, hyperkalemia (potassium \>6.0 mmol/L) requiring clinical intervention per IRC assessment, laboratory TLS per Howard criteria irrespective of clinical intervention, Hyperkalemia (potassium \>6.0 mmol/L) irrespective of clinical intervention, clinical TLS per Howard criteria irrespective of clinical intervention, any single TLS-related lab abnormality requiring clinical intervention per Investigator. **Measure:** Part 1: Percentage of Participants with TLS-Related Events **Time Frame:** Up to 28 Months **Description:** AEs of TLS is defined as a blood chemistry changes or symptom suggestive of TLS. **Measure:** Part 1: Percentage of Participants with Adverse Events (AE) of TLS **Time Frame:** Up to 28 Months **Description:** Percentage of participants with reduction of tumor burden. **Measure:** Part 1: Percentage of Participants with Reduction of Tumor Burden from Baseline **Time Frame:** Up to 28 Months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of \> 6 months. * Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation. * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2. * Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol. * Creatinine clearance (CrCl) \>= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion, while individuals with lymph nodes \> 5 cm and CrCl \< 80 mL/min are excluded. Exclusion Criteria: - Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** ABBVIE CALL CENTER **Phone:** 844-663-3742 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** AbbVie **Name:** ABBVIE INC. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ **Description:** AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/ **URL:** https://vivli.org/ourmember/abbvie/ ### References Module #### See Also Links **Label:** Related Info **URL:** https://www.abbvieclinicaltrials.com/study/?id=M24-287 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000015448 - Term: Leukemia, B-Cell - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10951 - Name: Leukemia, Lymphoid - Relevance: HIGH - As Found: Lymphocytic Leukemia - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M18116 - Name: Leukemia, Lymphocytic, Chronic, B-Cell - Relevance: HIGH - As Found: Chronic Lymphocytic Leukemia - ID: M17975 - Name: Tumor Lysis Syndrome - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - 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: M18115 - Name: Leukemia, B-Cell - 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 - ID: T1308 - Name: Chronic Lymphocytic Leukemia - Relevance: HIGH - As Found: Chronic Lymphocytic Leukemia ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000007945 - Term: Leukemia, Lymphoid - ID: D000015451 - Term: Leukemia, Lymphocytic, Chronic, B-Cell ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000092004 - Term: Tyrosine Kinase Inhibitors - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M249656 - Name: Venetoclax - Relevance: HIGH - As Found: 15 minutes - ID: M42185 - Name: Acalabrutinib - Relevance: HIGH - As Found: Varenicline - ID: M288906 - Name: Obinutuzumab - Relevance: HIGH - As Found: Nervous - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2889 - Name: Tyrosine Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T22 - Name: Tyrosine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000579720 - Term: Venetoclax - ID: C000543332 - Term: Obinutuzumab - ID: C000604908 - Term: Acalabrutinib ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06428006 **Acronym:** CALM **Brief Title:** Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis **Official Title:** Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms and Fatigue in Individuals With Multiple Sclerosis #### Organization Study ID Info **ID:** STUDY00160476 #### Organization **Class:** OTHER **Full Name:** University of Kansas Medical Center ### Status Module #### Completion Date **Date:** 2027-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Kansas Medical Center #### Responsible Party **Investigator Affiliation:** University of Kansas Medical Center **Investigator Full Name:** Catherine Siengsukon, PT, PhD **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 incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3). ### Conditions Module **Conditions:** - Multiple Sclerosis - Insomnia **Keywords:** - Cognitive behavioral therapy for insomnia - CBT-I ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 70 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1x/week, 6-week 45-60 min one-one-one manualized program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes time in bed restriction, stimulus control, relaxation strategies, cognitive restructuring, and sleep health promotion education. **Intervention Names:** - Behavioral: Cognitive behavioral therapy for insomnia **Label:** Cognitive behavioral therapy for insomnia **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 1x/week, 6 weekly 45-60 min one-on-one program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes gentle stretching activities for major muscle groups accompanied by sleep and lifestyle education. **Intervention Names:** - Behavioral: Sleep and lifestyle education **Label:** Sleep and lifestyle education **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cognitive behavioral therapy for insomnia **Description:** The general sessions outlines are as follows with each session: Session 1: determine treatment plan, set up sleep schedule and stimulus control, discuss strategies for how to stay awake to prescribed hour and what to do if wake up in middle of night, sleep hygiene education Session 2: continue upward titration of total sleep time, review sleep hygiene; introduce diaphragmatic breathing Session 3: continue upward titration of total sleep time, introduce mindfulness Session 4: continue upward titration of total sleep time, introduce progressive muscle relaxation Session 5: continue upward titration of total sleep time, discuss negative sleep beliefs Session 6: assess global treatment gains, discuss relapse prevention **Name:** Cognitive behavioral therapy for insomnia **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Sleep and lifestyle education **Description:** The general sessions outlines are as follows with each session: Session 1: Basic sleep education, stretching exercises Session 2: Sleep hygiene education (environmental factors \& sleep positions), stretching exercises Session 3: Sleep hygiene education (lifestyle factors), stretching exercises Session 4: Diet recommendations, stretching exercises Session 5: Exercises recommendations, stretching exercises Session 6: Discus maintaining achievements \& preventing relapses, stretching exercises **Name:** Sleep and lifestyle education **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Disability will be assessed using the PDDS scale which is a single-item 9 point scale ranging from "normal" (score of 0) to "bedridden" (score of 8). **Measure:** Patient-Determined Disability Steps (PDDS) **Time Frame:** baseline **Description:** Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9), with a score of ≥20 suggesting severe depression. It consists of 9 items with a score ranging from 0-27. **Measure:** Patient Health Questionnaire (PHQ-9) **Time Frame:** baseline, Week 6, Month 6 **Description:** Anxiety symptoms will be assessed using the 7-item GAD-7, with a score of ≥15 indicating severe anxiety. This questionnaire consists of 7 items, and the score from each item is summed for an overall score ranging from 0-21 with a higher score indicating a higher level of anxiety **Measure:** Generalized Anxiety Disorder Assessment (GAD-7) **Time Frame:** baseline, Week 6, Month 6 **Description:** To assess adherence to the CBT-I intervention, the sleep log will be used to assess number of mornings/week got out of bed at agreed upon time and the number of times got out of bed if unable to sleep. A total percentage will be calculated and used as the outcome of interest. **Measure:** Adherence to CBT-I intervention **Time Frame:** Each CBT-I session Week 1-6 **Description:** Participants will be asked "In general, how healthy is your overall diet?" and will rate on a 5-point Likert scale (5 = "excellent", 4 = "very good", 3 = "good", 2 = "fair", 1 = "poor") **Measure:** Diet quality **Time Frame:** baseline **Description:** Participants will mark on the sleep log at each assessment period the time period for eating breakfast, lunch, and dinner. Variability in mealtime will be quantified as the standard deviation from the individual's mean meal start time. **Measure:** Eating regularity **Time Frame:** baseline, Week 6, Month 6 **Description:** Participants will mark on the sleep log the number of times they wake up to void their bladder during the sleep opportunity window. **Measure:** Nighttime urination frequency **Time Frame:** baseline, Week 6, Month 6 **Description:** PainDetect includes 13 items that assesses neuropathic pain. A total score ranges from -1 to 38, with higher scores indicating higher levels of neuropathic pain. **Measure:** PainDetect **Time Frame:** baseline, Week 6, Month 6 **Description:** Fibromyalgia Survey Questionnaire includes the assessment of the number of painful body regions. Scores ranges from 0-31. A higher score indicates worse symptoms. **Measure:** Fibromyalgia Survey Questionnaire **Time Frame:** baseline, Week 6, Month 6 **Description:** Measures max and average pain intensity during past 7 days. The T-score value, with a mean of 50 and standard deviation of 10 representing the rescaled raw score, will be reported. **Measure:** PROMIS SF v.1.0 - Pain Intensity **Time Frame:** baseline, Week 6, Month 6 #### Primary Outcomes **Description:** The ISI consists of 7 questions, each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with a score of ≥ 10 suggesting clinical insomnia. The lower the score the less severe insomnia. **Measure:** Insomnia Severity Index (ISI) **Time Frame:** baseline, Week 6, Month 6 #### Secondary Outcomes **Description:** The PSQI consists of 9 items within 7 sleep categories. The 7 sleep category scores are summed to form a single global score ranging from 0-21. A global score of \>5 reflects poor sleep quality. **Measure:** Pittsburgh Sleep Quality Index (PSQI) **Time Frame:** baseline, Week 6, Month 6 **Description:** Consists of eight scenarios of daily activity, and participants use a four-point Likert scale to rate how likely they are to doze. Score ranges 0-24 with a higher score indicating daytime sleepiness. **Measure:** Epworth Sleepiness Scale (ESS) **Time Frame:** baseline, Week 6, Month 6 **Description:** This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs. **Measure:** Dysfunctional Beliefs About Sleep **Time Frame:** baseline, Week 6, Month 6 **Description:** is a 20-item self-report questionnaire used to measure positive and negative emotions. There are two subscales (Positive Affect and Negative Affect) with 10 items each. The respondent scores how applicable a list of emotions are on a 5-point Likert scale with 1 = "Very slightly or not at all" to 5 = "Extremely". A higher score on the Positive Affect subscale indicates greater intensity of positive emotions, and a high score on Negative Affect indicate greater intensity of negative emotions. **Measure:** Positive Affect and Negative Affect Schedule (PANAS) **Time Frame:** baseline, Week 6, Month 6 **Description:** Sleep Self-Efficacy is a 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. Scores range from 0-45 and a higher score indicates higher sleep self-efficacy. **Measure:** Sleep Self-Efficacy Scale (SESS) **Time Frame:** baseline, Week 6, Month 6 **Description:** Participants will wear an actigraph on their non-dominant wrist for 7 nights to assess sleep/wake cycle. Mains variables of interest are sleep regularity, timing, efficiency, and duration **Measure:** Actigraphy **Time Frame:** baseline, Week 6, Month 6 **Description:** The MFIS assesses the impact of fatigue on daily activities for the month prior. The MFIS consists of 21 items with 3 subscales: physical, cognitive, and psychosocial. The score on the 21 items are scored with a range of 0-84 with a higher score indicating a greater impact of fatigue. **Measure:** Modified Fatigue Impact Scale (MFIS) **Time Frame:** baseline, Week 6, Month 6 **Description:** The FSS assesses the impact of fatigue on activities for the week prior and consists of 9 questions. The mean of the 9 scores is calculated with a range of 0-7. **Measure:** Fatigue Severity Scale (FSS) **Time Frame:** baseline, Week 6, Month 6 **Description:** Quality of life will be assessed using the Multiple Sclerosis Impact Scale (MSIS-29). MSIS-29 is total of 29 items scale, with subscales of physical (20 items) and psychological (9 items). Responses computed in a range from 0-100, and higher scores indicating a worse quality of life due to physical and physiological impacts of MS **Measure:** Multiple Sclerosis Impact Scale (MSIS-29) **Time Frame:** baseline, Week 6, Month 6 **Description:** Cognitive Failures Questionnaire (CFQ) assesses perception of cognitive abilities over the past 6 months. consists of 25 items that the individual rates on a 5-point Likert scale with 0 = "never" and 4 = "Very Often" with a summary score of 0-100 with a higher score indicating poorer perceived cognitive abilities. **Measure:** Cognitive Failures Questionnaire (CFQ) **Time Frame:** baseline, Week 6, Month 6 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-65 years old * Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines20 and verified by their neurologist * Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale) * Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5 * ≥10 on Insomnia Severity Index * English speaking * ≥31 on modified Telephone Interview of Cognitive Status23 * Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study * Report having access to internet service or a data plan and access to a computer, tablet, or smart phone Exclusion Criteria: * Known untreated sleep disorder (such as sleep apnea or restless legs syndrome) * \>3 on STOP BANG indicating increased risk of sleep apnea * Restless legs syndrome as determined by RLS-Diagnosis Index * Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised * Parasomnia as determined by the Sleep Disorders-Revised * Currently taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia * Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9) * Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety * Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria * History of other nervous system disorder such as stroke or Parkinson's disease * Currently pregnant or intending to become pregnant in the next 6 months * Severe mental illness such as schizophrenia or bipolar disorder * Severe neurological or sensory impairments that would interfere significantly with testing * Relapse and/or corticosteroid use in the past 8 weeks * History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am * Currently receiving a behavioral sleep health intervention **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:** Eryen Nelson, MPH **Phone:** 913-945-7349 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Catherine Siengsukon, PhD **Phone:** 913-588-6913 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000020278 - Term: Demyelinating Autoimmune Diseases, CNS - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000009422 - Term: Nervous System Diseases - ID: D000003711 - Term: Demyelinating Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases - ID: D000020919 - Term: Sleep Disorders, Intrinsic - ID: D000020920 - Term: Dyssomnias - ID: D000012893 - Term: Sleep Wake Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M12060 - Name: Multiple Sclerosis - Relevance: HIGH - As Found: Multiple Sclerosis - ID: M15415 - Name: Sclerosis - Relevance: HIGH - As Found: Sclerosis - ID: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown - ID: M10356 - Name: Sleep Initiation and Maintenance Disorders - Relevance: HIGH - As Found: Insomnia - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22098 - Name: Demyelinating Autoimmune Diseases, CNS - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M6909 - Name: Demyelinating Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M22242 - Name: Parasomnias - Relevance: LOW - As Found: Unknown - ID: M22654 - Name: Sleep Disorders, Intrinsic - Relevance: LOW - As Found: Unknown - ID: M22655 - Name: Dyssomnias - Relevance: LOW - As Found: Unknown - ID: M15696 - Name: Sleep Wake Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009103 - Term: Multiple Sclerosis - ID: D000007319 - Term: Sleep Initiation and Maintenance Disorders - ID: D000012598 - Term: Sclerosis ### Intervention Browse Module - Browse Branches - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M5373 - Name: Caffeine - Relevance: LOW - As Found: Unknown - ID: T370 - Name: Caffeine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427993 **Brief Title:** Urine DNA Methylation Detection for Hematuria Evaluation **Official Title:** Urine Exfoliated Cell DNA Methylation Detection for Urothelial Carcinomas Diagnosis in Patients With Hematuria--A Prospective, Single-center, Cohort Study #### Organization Study ID Info **ID:** CH_Hematuria_Metest #### Organization **Class:** OTHER **Full Name:** Changhai Hospital ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Changhai Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Background: Hematuria, a common symptom of urinary system diseases, can result from various causes including infection, stones, trauma, and tumors. Urothelial carcinoma (UC), the most common malignancy of the urinary system, often presents with hematuria. Current diagnostic methods like urine cytology and cystoscopy have limitations in sensitivity and specificity, and cystoscopy is invasive. DNA methylation biomarkers offer potential for non-invasive UC detection, improving diagnostic accuracy in hematuria patients. Objective: This study aims to evaluate the diagnostic performance of DNA methylation biomarkers in detecting UC in patients with hematuria. Methods: This prospective pilot study will involve collecting preoperative urine samples from hematuria patients for DNA methylation testing using MSRE-qPCR. Sample size calculation was based on an assumed 25% prevalence of UC in hematuria patients, resulting in a total of 71 participants after accounting for a 20% dropout rate. Sensitivity, specificity, and diagnostic performance will be assessed using ROC curves. Conclusion: This study seeks to validate the effectiveness of urine DNA methylation testing for UC detection in hematuria patients, providing a basis for its clinical application and informing the design of larger future studies. **Detailed Description:** 1. Background Hematuria is a common symptom of urinary system diseases and can be caused by various factors, including infection, stones, trauma, and tumors. Urothelial carcinoma (UC) is the most common malignant tumor of the urinary system, primarily occurring in the bladder, renal pelvis, and ureter. The early symptoms of UC are often not obvious, with hematuria being the most common symptom. However, current diagnostic methods such as urine cytology and cystoscopy have limitations in sensitivity and specificity for diagnosing UC. Additionally, cystoscopy is invasive and can cause discomfort for patients. DNA methylation biomarkers have shown potential in detecting UC, providing a non-invasive method to improve diagnostic sensitivity and specificity, especially in patients with hematuria. 2. Objective This study aims to evaluate the diagnostic performance of DNA methylation biomarkers in detecting urothelial carcinoma in patients with hematuria. By collecting preoperative urine samples from a small cohort of hematuria patients and performing DNA methylation testing, we aim to explore the feasibility and advantages of this method in clinical applications. 3. Methods Study Design: This is a prospective pilot study aimed at evaluating the effectiveness of DNA methylation biomarkers in detecting urothelial carcinoma in patients with hematuria. Sample Size Calculation: Based on our previous observations, the incidence of urothelial carcinoma in patients with hematuria is 20%-30%, slightly higher than reported in other literature. Therefore, we hypothesize that 25% of the patients in the hematuria cohort have UC. The group allocation ratio (R): N-/N+ = 75%/25% = 3. Assumptions: Area under the curve (AUC) under H0: 0.5 AUC under H1: 0.8 Power: 0.95 Significance level (Alpha): 0.05 Type of data: Continuous FPR range: 0.00 to 1.00 Results: Using PASS 15.0 software for sample size calculation to ensure sufficient statistical power. The calculated sample size is: N+ (number of patients with UC): 14 N- (number of patients without UC): 42 Total sample size (N): 56 Considering a 20% dropout rate, the adjusted sample size is: N+': 18 N-': 53 Total sample size (N'): 71 Inclusion and Exclusion Criteria: Inclusion Criteria: Aged between 18 and 99 years, with gross or microscopic hematuria (\>5/HP). Able to provide 50ml urine for testing before surgery. Consent to participate in the study and sign the informed consent form. Exclusion Criteria: With history of malignancy or concomitant malignancies other than UC. Severe urinary tract infection leading to sepsis. Patients with indwelling catheters, nephrostomy, or cystostomy. Severe liver or kidney failure or other conditions deemed unsuitable for the study. Patients who did not undergo surgical treatment for various reasons. Samples with insufficient DNA content or other quality control failures. Sample Collection: Clinicians will collect fresh urine samples from enrolled hematuria patients and record their basic information, clinical information, and medical history. Samples will be randomly numbered and provided to DNA methylation testing personnel to ensure blinding. Testing Method: Testing personnel will analyze urine samples using MSRE-qPCR based DNA methylation testing methods to evaluate DNA methylation levels. Unblinding and Data Organization: After the last sample is successfully enrolled and tested, non-recruiting personnel and testing personnel will unblind the samples and organize clinical and pathological information. Data Analysis: Using pathological results as the gold standard. Calculate the sensitivity, specificity, positive predictive value, and negative predictive value of DNA methylation biomarkers. Use statistical methods (such as ROC curves) to evaluate the diagnostic performance of DNA methylation biomarkers and calculate the AUROC. Ethics and Informed Consent: This study has been approved by the hospital's ethics committee, and all participants must sign an informed consent form. 4. Conclusion This study aims to validate the effectiveness of urine DNA methylation testing in detecting urothelial carcinoma in patients with hematuria and provide evidence for its clinical application. The results of this preliminary study will offer essential data support and design optimization suggestions for future larger-scale studies. ### Conditions Module **Conditions:** - Hematuria - Urothelial Carcinoma - Bladder Cancer - Ureter Cancer - Renal Pelvis Cancer **Keywords:** - Hematuria - Urothelial Carcinoma - Urine DNA Methylation ### Design Module #### Bio Spec **Description:** Urine sediment DNA. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 71 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Evaluate the diagnostic performance of DNA methylation biomarkers by calculating the AUROC value. **Measure:** Diagnostic performance of DNA methylation test **Time Frame:** 1 year #### Secondary Outcomes **Description:** Calculate the sensitivity, specificity, positive predictive value, and negative predictive value of DNA methylation biomarkers. **Measure:** Sensitivity, specificity, positive predictive value, and negative predictive value of DNA methylation biomarkers **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Aged between 18 and 99 years, with gross or microscopic hematuria (\>5/HP). 2. Able to provide 50ml urine for testing before surgery. 3. Consent to participate in the study and sign the informed consent form. Exclusion Criteria: 1. With history of malignancy or concomitant malignancies other than UC. 2. Severe urinary tract infection leading to sepsis. 3. Patients with indwelling catheters, nephrostomy, or cystostomy. 4 Severe liver or kidney failure or other conditions deemed unsuitable for the study. 5. Patients who did not undergo surgical treatment for various reasons. 6. Samples with insufficient DNA content or other quality control failures. **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** This is a prospective pilot study aimed at evaluating the effectiveness of DNA methylation biomarkers in detecting urothelial carcinoma in patients with hematuria. ### Contacts Locations Module #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Qing Chen, Dr - **Phone:** +86 18301921727 - **Role:** CONTACT ***Contact 2:*** - **Name:** Chuanliang Xu, Dr - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Changhai Hospital **State:** Shanghai ## 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: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000014555 - Term: Urination Disorders - ID: D000006470 - Term: Hemorrhage - ID: D000010335 - Term: Pathologic Processes - ID: D000014515 - Term: Ureteral Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5030 - Name: Urinary Bladder Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5551 - Name: Carcinoma, Transitional Cell - Relevance: HIGH - As Found: Urothelial Carcinoma - ID: M9504 - Name: Hematuria - Relevance: HIGH - As Found: Hematuria - ID: M17266 - Name: Ureteral Neoplasms - Relevance: HIGH - As Found: Ureter Cancer - ID: M13297 - Name: Pelvic Neoplasms - Relevance: HIGH - As Found: Pelvis Cancer - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M17305 - Name: Urination Disorders - Relevance: LOW - As Found: Unknown - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M17265 - Name: Ureteral Diseases - Relevance: LOW - As Found: Unknown - ID: T5693 - Name: Transitional Cell Carcinoma - Relevance: HIGH - As Found: Urothelial Carcinoma ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002295 - Term: Carcinoma, Transitional Cell - ID: D000014516 - Term: Ureteral Neoplasms - ID: D000010386 - Term: Pelvic Neoplasms - ID: D000006417 - Term: Hematuria ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427980 **Acronym:** CHARM **Brief Title:** Efficacy and Safety of Chinese Herbal Formula HuoXue LiShui for Chronic Subdural Hematoma **Official Title:** Efficacy and Safety of Chinese Herbal Formula HuoXue LiShui for Chronic Subdural Hematoma: a A Prospective, Randomized, Double-blinded, Placebo-controlled, Multicenter Trail #### Organization Study ID Info **ID:** KY2023-265 #### Organization **Class:** OTHER **Full Name:** Beijing Tiantan Hospital ### Status Module #### Completion Date **Date:** 2025-02-28 **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:** 2025-02-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Tiantan Hospital #### Responsible Party **Investigator Affiliation:** Beijing Tiantan Hospital **Investigator Full Name:** Weiming Liu **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:** A prospective, randomized, double-blinded, placebo-controlled, multicenter trail is designed to compare differences of operation rate and clinical outcome from treatment up to 24 weeks between HXLS group and placebo group. **Detailed Description:** The CHARM trial is a prospective, randomized, double-blinded, placebo-controlled, multicenter clinical study. The trial aims to investigate the efficacy of Chinese herbal formula HXLS as an addition to a primary conservative treatment of CSDH, in an effort to prevent surgery. We hypothesize that compared with placebo, Chinese herbal formula HXLS reduces operation rates and improves clinical outcomes at 24 weeks in patients with CSDH. Consequently, the defined null hypothesis will be that there is no difference between the groups. In total, 160 patients will be randomly assigned to the HXLS group and placebo group at 1:1 ratio. ### Conditions Module **Conditions:** - Chronic Subdural Hematoma **Keywords:** - Chronic Subdural Hematoma - Chinese herbal formula - HuoXue LiShui - Pharmacotherapy - Randomized controlled trial ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** The investigators in charge of the recruitment and follow-up evaluation and participants will be blinded, along with the outcome assessors and data analysts. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The HXLS granules are produced from four Chinese herbal pieces: Yi Mu Cao (益母草, Leonurus heterophyllus, 15.0g), Zhi Shui Zhi (炙水蛭, Hirudo, 1.5g), Tao Ren (桃仁, Semen persicae, 6.0g), and Hong Hua (红花, Carthamus tinctorius L, 6.0g). **Intervention Names:** - Drug: Chinese Herbal formula HuoXue LiShui **Label:** HXLS group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The placebo will be consistent with the HXLS oral granules in appearance, taste, and weight, to the greatest extent possible. It included Hu Jing (糊精 28.0g) **Intervention Names:** - Drug: Chinese Herbal formula Placebo **Label:** placebo group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - HXLS group **Description:** The intervention consists of the oral administration of granule with either HXLS or a placebo substance, one bag (28.5 g) twice daily after meals for a period of 8 weeks. The granules are produced from four Chinese herbal pieces: Yi Mu Cao (益母草, Leonurus heterophyllus, 15.0g), Zhi Shui Zhi (炙水蛭, Hirudo, 1.5g), Tao Ren (桃仁, Semen persicae, 6.0g), and Hong Hua (红花, Carthamus tinctorius L, 6.0g). **Name:** Chinese Herbal formula HuoXue LiShui **Other Names:** - HuoXue LiShui **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - placebo group **Description:** The placebo will be consistent with the HXLS oral granules in appearance, taste, and weight, to the greatest extent possible. In terms of outer packing, the HXLS and placebo granules will be exactly the same. It included Hu Jing (28.5g) **Name:** Chinese Herbal formula Placebo **Other Names:** - Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Rate of operation **Measure:** Rate of operation **Time Frame:** From baseline up to 24 weeks after the start of treatment with the study medication #### Secondary Outcomes **Description:** CSDH volume measured on head CT **Measure:** Chronic subdural hematoma volume **Time Frame:** At baseline, and at 4, 12, and 24 weeks **Description:** Modified Rankin Scale ranges from score 1 to 6, and higher scores mean a worse clinical outcome, where score 1 indicates normal daily functionality and score 6 indicates death. **Measure:** Change of Modified Rankin Scale (MRS) between group **Time Frame:** At baseline, and at 1, 4, 8, 12, and 24 weeks **Description:** Markwalder Grading Scale ranges from grade 0 to 4, and higher scores mean a worse neurological outcome, where grade 0 indicates normal neurological function and grade 4 indicates coma. **Measure:** Change of Markwalder Grading Scale (MGS) between groups **Time Frame:** At baseline, and at 1, 4, 8, 12, and 24 weeks **Description:** A standardized instrument, EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire, will be used as a generic measure of health related quality of life. The questionnaire contains 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension rates across five levels, including 'No problems-Slight problems-Moderate problems-Severe problems-Unable to'. **Measure:** Change of Quality of life **Time Frame:** At baseline, and at 4, 8, 12, and 24 weeks **Description:** The Barthel Index is scored from 0 to 100. \>60 is good, with mild dysfunction, able to perform some activities of daily living independently, and needing some help; 60-41 is moderate. 60-41 is classified as moderate, with moderate dysfunction, requiring a great deal of help to complete activities of daily living; ≤40 is classified as poor, with severe dysfunction, unable to complete most of the activities of daily living or needing help from others. **Measure:** Change of performance in activities of daily living **Time Frame:** At baseline, and at 4, 8, 12, and 24 weeks **Description:** Montreal Cognitive Assessment, MOCA score **Measure:** Change of cognitive functioning **Time Frame:** At baseline, and at 4, 8, 12, and 24 weeks **Description:** Number of falling incidents **Measure:** Number of falling incidents **Time Frame:** At 24 weeks **Description:** Mortality **Measure:** Mortality **Time Frame:** At 24 weeks **Description:** Rate of complications and adverse events between groups **Measure:** Rate of complications and adverse events between groups **Time Frame:** Within 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age between 18 years and 90 years and either gender. 2. Supratentorial, unilateral or bilateral CSDH verified on cranial CT or magnetic resonance imaging. 3. Stable vital signs and neurological deficit with GCS score ≥ 14 and modified Rankin Scale (mRS) score ≤ 2. 4. No risk of brain herniation and recent immediate needs for surgery evaluated by 2 attending neurosurgeons. 5. Written informed consent from patients or their next of kin according to the patient's cognitive status. Exclusion Criteria: 1. Unstable vital signs or symptoms of brain herniation including severe headache, nausea and vomiting, or disturbed consciousness. 2. Progressive or apparent neurological deficit with GCS score \< 14 or mRS score \> 2. 3. Midline shift \> 10 mm on radiological image. 4. Previous treatment (surgery or medication) for CSDH. 5. Previous intracranial surgery for any other neurological disorders. 6. Structural causes for secondary CSDH, including arachnoid cysts, intracranial tumors, vascular malformations, spontaneous intracranial hypotension, coagulopathy, and conversion from acute subdural hematoma. 7. Known hypersensitivity or allergy to HXLS or to any of the ingredients. 8. Malignant tumor. 9. Abnormal liver function or liver diseases including uncontrolled hepatitis (alanine transaminase \> 120U/L). 10. Severe renal impairment (estimated glomerular filtration rate \< 30ml/min or serum creatinine \> 150μmol/L). 11. Moderate or severe anemia (hemoglobin ≤ 90g/L). 12. Severe coagulopathy or high risk of life-threatening bleeding. 13. Existing poor medication condition or severe comorbidity so that treatment cannot be tolerated, or follow-up cannot be completed. 14. Routine oral antithrombotic or antifibrinolytic drugs, steroids, statins, or other traditional Chinese medicine before randomization or who are expected to take such medications in the next 24 weeks. 15. Difficulty in swallowing oral medication. 16. Pregnancy or lactation. 17. Participating in another research. **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:** Liang Wu, M.D. **Phone:** 15001333582 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Weiming Liu, M.D. **Phone:** 13701182770 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** Beijing Luhe Hospital, Capital Medical University **State:** Beijing **Zip:** 101100 **Location 2:** **City:** Lianyungang **Country:** China **Facility:** First People's Hospital of Lianyungang **State:** Jiangsu **Location 3:** **City:** Beijing **Country:** China **Facility:** Beijing Tiantan Hospital, Capital Medical University **Zip:** 100070 #### Overall Officials **Official 1:** **Affiliation:** Beijing Tiantan Hospital **Name:** Weiming Liu, M.D. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006470 - Term: Hemorrhage - ID: D000010335 - Term: Pathologic Processes - ID: D000020198 - Term: Intracranial Hemorrhage, Traumatic - ID: D000020300 - Term: Intracranial Hemorrhages - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000006259 - Term: Craniocerebral Trauma - ID: D000020196 - Term: Trauma, Nervous System - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014947 - Term: Wounds and Injuries - 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: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9493 - Name: Hematoma - Relevance: HIGH - As Found: Hematoma - ID: M9495 - Name: Hematoma, Subdural - Relevance: HIGH - As Found: Subdural Hematoma - ID: M22027 - Name: Hematoma, Subdural, Chronic - Relevance: HIGH - As Found: Chronic Subdural Hematoma - ID: M9556 - Name: Hemorrhage - Relevance: LOW - As Found: Unknown - ID: M22113 - Name: Intracranial Hemorrhages - Relevance: LOW - As Found: Unknown - ID: M22025 - Name: Intracranial Hemorrhage, Traumatic - Relevance: LOW - As Found: Unknown - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M9349 - Name: Craniocerebral Trauma - Relevance: LOW - As Found: Unknown - ID: M22023 - Name: Trauma, Nervous System - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M6147 - Name: Chronic Disease - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: HIGH - As Found: Chronic ### Condition Browse Module - Meshes - ID: D000006408 - Term: Hematoma, Subdural - ID: D000020200 - Term: Hematoma, Subdural, Chronic - ID: D000006406 - Term: Hematoma ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427967 **Brief Title:** A Novel Social Emotional Learning Curriculum for Youth With Epilepsy **Official Title:** Beyond Watching and Waiting: A Pilot Study of a Novel Social Emotional Learning Curriculum-Based Intervention Designed for Youth With Epilepsy at Increased Risk of Future Mental Illness #### Organization Study ID Info **ID:** H-43875 #### Organization **Class:** OTHER **Full Name:** Boston Medical Center #### Secondary ID Infos **Domain:** Charles F. Hood Foundation **ID:** 4301210001 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Charles H. Hood Foundation #### Lead Sponsor **Class:** OTHER **Name:** Boston Medical Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Youth with epilepsy (YWE) are significantly more likely than their peers without epilepsy to experience isolation, interpersonal victimization, and low relationship satisfaction. This is a serious health concern. Poor social support, real or perceived, is consistently correlated to worsened outcomes in every domain of health-related quality of life. As YWE are two to five times more likely than their peers without epilepsy to develop a mental health condition, poor social support is likely a bidirectional risk factor. Currently, there are no best practices or recommendations for clinicians or other youth-serving professionals to reference when it comes to improving the perceived social support of YWE specifically. The research team has drawn from multiple fields of scientific knowledge to develop a novel intervention that aims to provide YWE with knowledge, skills, connections, and positive emotional support that can help them to bolster their support system at every level of the social ecological model (SEM). The proposed study is a pilot of this intervention to test its acceptability and appropriateness according to YWE participants ages 12 to 26. The intervention's impact on participants social-emotional learning skills and the feasibility of expanding the study protocol for use in a large, multisite randomized control trial will also be explored. The goal of this research study is to help evaluate a new program for young people diagnosed with epilepsy that will build up young people's social opportunities, interpersonal skills, and sources of emotional support. The investigators want to research the impact of this program. From this study, the investigators hope to learn what the program does well, and in what ways it could be improved from the perspective of YWE. ### Conditions Module **Conditions:** - Epilepsy **Keywords:** - Youth with epilepsy (YWE) - Positive Youth Development - Social-Emotional Learning - Social Ecological Model - Youth Thrive Framework - Perceived Social Support - Health-Related Quality of Life - Adult Epilepsy Self-Management Measurement Instrument ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** One-group pretest-posttest ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants assigned to this arm will receive Project Dream Team, the new 5 session SEL curriculum for YWE. **Intervention Names:** - Behavioral: Project Dream Team **Label:** Novel Social-Emotional Learning (SEL) curriculum **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Novel Social-Emotional Learning (SEL) curriculum **Description:** Five total sessions, 60-minutes each, with one session every 7 days (+/- 21 days between sessions), Session activities include discussion prompts, interactive learning methods, skill rehearsals, mindfulness / somatic exercises and lecture slides facilitated by a trained facilitator. **Name:** Project Dream Team **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** The Youth Thrive (YT) Framework Survey Part 2: Youth Resilience, Cognitive and Social-Emotional Competence subscales will be used to assess this outcome. Each YT subscale includes 10 to 16 individual Likert scale questions. Scores are generated by assigning values of 1 to 5 to the Likert scale (1 = not at all like me, 5 = very much like me) for 'positive items' and an inverse value scale for 'negative items' and then totalling all the items within the subscale. Higher total scores indicate a greater depth of knowledge, higher mastery over key skills and more frequent use of prosocial behaviors. **Measure:** Change in social emotional skills and behaviors **Time Frame:** Baseline, 4 months **Description:** This outcome will be assessed using the 25 subscale items from the Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65). The responses are Likert scale-rated from 0 to 5 for positively phrased items, and inversely scored for negatively phrased items. Each subscale will be scored individually and also totaled for a single composite score. Higher scores indicate higher use of effective epilepsy self-management strategies. **Measure:** Change in leveraging social support for epilepsy self management **Time Frame:** Baseline, 4 months #### Primary Outcomes **Description:** Number of sessions attended per participant. **Measure:** Feasibility of study processes **Time Frame:** 4 months **Description:** A likert scale will be used to assess satisfaction from 1 to 10 where 10 is highly acceptable and 1 is not acceptable. **Measure:** Acceptability of the intervention **Time Frame:** 4 months #### Secondary Outcomes **Description:** This outcome will be assessed with the Youth Thrive (YT) Framework Survey Part 1: Social Connections and Concrete Supports combine subscales. Each YT subscale includes 10 to 16 individual Likert scale questions. Scores are generated by assigning values of 1 to 5 to the Likert scale (1 = not at all like me, 5 = very much like me) for 'positive items' and an inverse value scale for 'negative items' and then totalling all the items within the subscale. Higher total scores indicate a higher level of PSS. **Measure:** Change in perceived social support (PSS) **Time Frame:** Baseline, 4 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Able to read, write, and communicate in English at 3rd grade level * Active epilepsy diagnosis (currently on anti-seizure medication or does not yet meet remission standards of 10 years without seizure and off all medication) * Epilepsy diagnosis clinically established for at least 6 months prior to the time of recruitment * The pediatric neurologist feels the patient would benefit from program participation. * Able to consistently join meetings on Zoom with functional audio and video reception Exclusion Criteria: * During the consent process, if an eligible potential participant feels that participation would pose too much of a burden on their health or mental wellbeing, they will be excluded. **Maximum Age:** 26 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Laurie Douglass, MD **Phone:** (617) 414-4590 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Kiya Walker, MPH **Phone:** (617) 414-4588 **Role:** CONTACT #### Locations **Location 1:** **City:** Boston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Laurie Douglass, MD - **Phone:** 617-414-4590 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Kiya Walker, MPH - **Role:** CONTACT **Country:** United States **Facility:** Boston Medical Center, Neurology and remote **State:** Massachusetts **Zip:** 02118 #### Overall Officials **Official 1:** **Affiliation:** Boston Medical Center, Department of Neurology **Name:** Laurie Douglass, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M7983 - Name: Epilepsy - Relevance: HIGH - As Found: Epilepsy - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000004827 - Term: Epilepsy ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M12478 - Name: Nicotine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427954 **Acronym:** THRIVE **Brief Title:** Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer **Official Title:** Randomized Trial of Mobile Application to Improve Health-Related Outcomes in Patients With Advanced Lung Cancer #### Organization Study ID Info **ID:** 24-091 #### Organization **Class:** OTHER **Full Name:** Massachusetts General Hospital ### Status Module #### Completion Date **Date:** 2027-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **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:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-17 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** FED **Name:** United States Department of Defense #### Lead Sponsor **Class:** OTHER **Name:** Massachusetts General Hospital #### Responsible Party **Investigator Affiliation:** Massachusetts General Hospital **Investigator Full Name:** Jennifer Temel, MD **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Multi-site randomized trial of the THRIVE digital health application versus usual care to evaluate the effect of THRIVE on quality of life (QOL), physical and psychological symptoms, coping, and self-efficacy in 250 patients with newly diagnosed advanced lung cancer. **Detailed Description:** Multi-site randomized controlled trial of the THRIVE digital health application versus usual care in 250 patients diagnosed with advanced lung cancer within the previous 12 weeks to examine the effect of the intervention on patient-reported QOL, physical symptoms, anxiety and depression symptoms, coping, and self-efficacy. Participants will be randomized in a 1:1 fashion and stratified by study site and lung cancer type to ensure a balanced representation of these factors between the two study groups. The study team will provide iPads to patients assigned to THRIVE and provide instructions on how to use the iPad and digital app. The study team will administer patient-reported outcome measures at enrollment and again at six, 12, and 24 weeks post-enrollment to evaluate the short and long-term impact of THRIVE. ### Conditions Module **Conditions:** - Lung Cancer **Keywords:** - Quality of life ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 250 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients assigned to the intervention will be provided a study-issued tablet computer from which they will access the THRIVE digital health app. Study staff will give intervention patients a comprehensive tutorial and detailed instructions regarding how to use the app. Tutorial sessions may be conducted in person during a clinic appointment, via telephone, and/or via Zoom videoconferencing. Participants will complete the intervention modules at their desired pace over approximately 10 weeks. **Intervention Names:** - Behavioral: Digital Health App **Label:** THRIVE Digital Health App **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patients assigned to the usual care group will not receive the digital app but rather standard oncology care. **Label:** Usual Care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - THRIVE Digital Health App **Description:** access to a digital health app **Name:** Digital Health App **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Coping (higher scores indicate greater use of coping strategy) **Measure:** Brief Cope (Modified) **Time Frame:** 12 weeks **Description:** Self-efficacy (higher scores indicate greater self-efficacy) **Measure:** Cancer Self-Efficacy Scale **Time Frame:** 12 weeks **Description:** Quality of Life (higher scores indicate better quality of life) **Measure:** FACT-L **Time Frame:** Over 24 weeks **Description:** Physical Symptoms (higher scores indicate worse symptoms) **Measure:** MDASI **Time Frame:** Over 24 weeks **Description:** Anxiety and Depression Symptoms (higher scores indicate worse symptoms) **Measure:** HADS **Time Frame:** Over 24 weeks #### Primary Outcomes **Description:** Quality of Life (higher scores indicate better quality of life) **Measure:** Functional Assessment of Cancer Therapy - Lung (FACT-L) **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** Physical Symptoms (higher scores indicate worse symptoms) **Measure:** MD Anderson Symptom Inventory (MDASI) **Time Frame:** 12 weeks **Description:** Anxiety and Depression Symptoms (higher scores indicate worse symptoms) **Measure:** Hospital Anxiety and Depression Scale (HADS) **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults (greater than or equal to 18 years) * Diagnosed with advanced non-small cell lung cancer (NSCLC) that is not being treated with curative intent or extensive stage small cell lung cancer (SCLC) within the past 12 weeks. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0-2 (i.e., fully active to at least ambulatory and up and about more than 50% of waking hours). * Sufficient English proficiency to utilize THRIVE in English (Note: patients can complete outcome measures in Spanish if preferred). Exclusion Criteria: * Significant uncontrolled psychiatric disorder (e.g., psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the ability to participate in study procedures. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M12478 - Name: Nicotine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427941 **Brief Title:** A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Advanced or Metastatic Solid Tumors **Official Title:** A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Selected Advanced or Metastatic Solid Tumors #### Organization Study ID Info **ID:** BGB-B2033-101 #### Organization **Class:** INDUSTRY **Full Name:** BeiGene ### Status Module #### Completion Date **Date:** 2026-10-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-10-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-23 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** BeiGene #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study is a first-in-human (FIH) Phase 1 study of BGB-B2033 to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of the BGB-B2033 in participants with advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors, non-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC). The study will also identify the recommended Phase 2 dose (RP2D) of BGB-B2033 alone and in combination with tislelizumab for subsequent proof-of-concept studies. BGB-B2033 will be administered by intravenous infusion. The Phase 1 study will be conducted in 2 parts: Part A (Monotherapy Dose Escalation and Safety Expansion) and Part B (Combination Dose Escalation and Safety Expansion). ### Conditions Module **Conditions:** - Metastatic Hepatocellular Carcinoma - Advanced Hepatocellular Carcinoma - Alpha-fetoprotein (AFP)-Producing Gastric Cancer - Extragonadal Yolk Sac Tumors - Glypican-3 (GPC3)-Positive Squamous Non-small Cell Lung Cancer - Metastatic Solid Tumor **Keywords:** - HCC - GC - GPC-3 - GPC3-positive squamous non-small cell lung cancer - NSCLC - BGB-B2033 - tislelizumab - metastatic hepatocellular carcinoma - Advanced Hepatocellular Carcinoma - alpha-fetoprotein (AFP)-producing gastric cancer - extragonadal yolk sac tumors - Squamous Non-small-cell Lung Cancer - Non-dysgerminomas squamous non-small cell lung cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 140 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ascending dose levels of BGB-B2033 monotherapy will be sequentially enrolled to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and initial anti-tumor effects **Intervention Names:** - Drug: BGB-B2033 **Label:** Part A (Monotherapy Dose Escalation and Safety Expansion) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Cohorts of BGB-B2033 in combination with tislelizumab will be sequentially enrolled to evaluate the safety, tolerability, PK, pharmacodynamics, and initial anti-tumor effects of this combination **Intervention Names:** - Drug: BGB-B2033 - Drug: Tislelizumab **Label:** Part B (Combination Dose Escalation and Safety Expansion) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part A (Monotherapy Dose Escalation and Safety Expansion) - Part B (Combination Dose Escalation and Safety Expansion) **Description:** Administered by intravenous infusion **Name:** BGB-B2033 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Part B (Combination Dose Escalation and Safety Expansion) **Description:** Administered by intravenous infusion **Name:** Tislelizumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0/American Society for Transplantation and Cellular Therapy \[ASTCT\] for cytokine release syndrome \[CRS\] and immune effector cell-associated neurotoxicity syndrome \[ICANS\]), timing, seriousness, and relationship to study therapy; assessment of adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria; **Measure:** Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) **Time Frame:** Up to approximately 2 years **Description:** The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to a target toxicity rate of 30% or the highest dose administered, respectively. **Measure:** Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033 **Time Frame:** Up to approximately 2 years **Description:** The RP2D(s) will be determined based on a biologically effective dose by taking the totality of available preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration **Measure:** Recommended Phase 2 dose (RP2D) of BGB-B2033 alone and in combination with tislelizumab **Time Frame:** Up to approximately 2 years #### Secondary Outcomes **Description:** ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1). **Measure:** Overall Response Rate (ORR) **Time Frame:** Up to approximately 2 years **Description:** DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator. **Measure:** Duration of Response (DOR) **Time Frame:** Up to approximately 2 years **Description:** DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease as determined from tumor assessments by the investigator using RECIST v1.1. **Measure:** Disease Control Rate (DCR) **Time Frame:** Up to approximately 2 years **Description:** PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first. **Measure:** Progression Free Survival (PFS) **Time Frame:** Up to approximately 2 years **Measure:** Serum concentration of BGB-B2033 **Time Frame:** Up to approximately 2 years **Measure:** Number of participants with anti-drug antibodies (ADAs) to BGB-B2033 **Time Frame:** Up to approximately 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. Age ≥ 18 years on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place, whichever is older). 3. Participants with any of the following unresectable locally advanced or metastatic tumor types: 1. HCC 2. Histologically confirmed AFP-producing GC (serum AFP \> 20 ng/mL or tumor tissue AFP positive by a validated IHC assay according to local testing criteria) 3. Histologically confirmed germ cell tumor including extragonadal yolk sac tumors located in mediastinum, vagina, brain, and retroperitoneum, etc) and non-dysgerminomas 4. Histologically confirmed GPC3-positive squamous NSCLC 4. ≥ 1 evaluable lesion for dose escalation and ≥ 1 measurable lesion for safety expansion, per RECIST v1.1 5. ECOG Performance Status score ≤ 1 Exclusion Criteria: 1. Prior therapy targeting glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (also known as CD137) 2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis 3. Active autoimmune diseases or history of autoimmune diseases that may relapse 4. Any malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent 5. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s). Note: Other protocol defined Inclusion/Exclusion criteria may apply. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Study Director **Phone:** 1.877.828.5568 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** BeiGene **Name:** Study Director **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms - ID: D000000230 - Term: Adenocarcinoma - ID: D000008113 - Term: Liver Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000008107 - Term: Liver Diseases - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000013272 - Term: Stomach Diseases - ID: D000008649 - Term: Mesonephroma - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastric Cancer - ID: M9613 - Name: Carcinoma, Hepatocellular - Relevance: HIGH - As Found: Hepatocellular Carcinoma - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: HIGH - As Found: Non-Small Cell Lung Cancer - ID: M20386 - Name: Endodermal Sinus Tumor - Relevance: HIGH - As Found: Yolk sac tumor - 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: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M11113 - Name: Liver Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown - ID: M12318 - Name: Neoplasms, Germ Cell and Embryonal - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown - ID: T5605 - Name: Testicular Yolk Sac Tumor - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000009369 - Term: Neoplasms - ID: D000008175 - Term: Lung Neoplasms - ID: D000002289 - Term: Carcinoma, Non-Small-Cell Lung - ID: D000006528 - Term: Carcinoma, Hepatocellular - ID: D000013274 - Term: Stomach Neoplasms - ID: D000018240 - Term: Endodermal Sinus Tumor ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - 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: M137899 - Name: Tislelizumab - Relevance: HIGH - As Found: Intensive Care - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000707970 - Term: Tislelizumab ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427928 **Acronym:** anxiety in ped **Brief Title:** Effect on Anxiety in Pediatric Patients; Successful Randomized Controlled Trial **Official Title:** The Effect of Explaining the Perioperative Process With Our Drawings on Anxiety in Pediatric Patients; Prosperative Randomized Controlled Study #### Organization Study ID Info **ID:** HTSoner #### Organization **Class:** OTHER **Full Name:** Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital ### Status Module #### Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital #### Responsible Party **Investigator Affiliation:** Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital **Investigator Full Name:** Hülya Tosun Söner **Investigator Title:** Anesthesiology and Reanimation Spesialist **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Preoperative anxiety is characterized by subjective emotions such as irritability, irritability, sadness, and unhappiness. Studies have shown that preoperative anxiety negatively affects children both psychologically and physiologically. Preoperative anxiety occurs in 60-80% of children undergoing anesthesia and surgery and is associated with undesirable consequences such as nightmares, separation anxiety, eating disorders, negative behavioral changes such as increased fear of doctors, increased need for analgesics. The aim of this study is to evaluate the preoperative and pre-sedation anxiety levels in pediatric patients by explaining the peroperative process to the patients with drawings. ### Conditions Module **Conditions:** - Anxiety **Keywords:** - perioperative anxiety - pediatric - general anhesthesia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 74 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Explains the perioperative process with pictures - Behavioral: The perioperative process is only explained **Label:** Explains the perioperative process with pictures **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Behavioral: Explains the perioperative process with pictures - Behavioral: The perioperative process is only explained **Label:** The perioperative process is only explained **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Explains the perioperative process with pictures - The perioperative process is only explained **Description:** We will draw pictures of the preoperative area, operating room and postoperative areas of our operating room and explain the process to 34 of the children who will undergo surgery with these pictures. We will explain the process to the other 34 people without the pictures we have. We planned to measure the anxiety levels between the two groups with the modified Yale scale. **Name:** Explains the perioperative process with pictures **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Explains the perioperative process with pictures - The perioperative process is only explained **Description:** We will draw pictures of the preoperative area, operating room and postoperative areas of our operating room and explain the process to 34 of the children who will undergo surgery with these pictures. We will explain the process to the other 34 people without the pictures we have. We planned to measure the anxiety levels between the two groups with the modified Yale scale. **Name:** The perioperative process is only explained **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Activity Interested in his/her surroundings, curious, playing with toys, reading (or other age-appropriate activities); may wander around the waiting room or operating room or go to the parent to retrieve a toy; Can gravitate towards operating room equipment 1 He is indifferent to his surroundings, does not play, looks at the ground, plays with his hands and fingers, sucks his thumb; may sit very close to the parent while waiting. 2 Aimless movements directed from the toy towards the parent in an unfocused manner; crazy/exaggerated movements or tricks; writhing, moving on the couch; may push the mask or hug the parent during induction. 3 The person who actively tries to move away, pushing with his feet and arms, can use his whole body to move away; may not be able to separate from the parent who is running around in the waiting room without focusing, not paying attention to toys, or clinging desperately.4 Speech Reading (may not speak in relation to the activity), asking **Measure:** Modified Yale Preoperative Anxiety Scale **Time Frame:** While being taken from the preoperative room to the operating room and just before anesthetizing in the operating room #### Secondary Outcomes **Description:** 7 -Dangerous Agitation, 6 - Very Agitated, 5 - Agitated, 4 - Calm and Cooperative, 3 - sedated, 2- Very Sedated, 1 -Unarousable **Measure:** Riker agitation scala **Time Frame:** after extubation ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA I patients without any comorbidities who were operated on by the ENT, * Patients between the ages of 5-12, * And patients who could be contacted and did not have any anxiety problems were included. Exclusion Criteria: * Patients with liver and/or kidney failure, trauma patients, ASAII-III-IV patients, patients with bleeding disorders, * those using medications that would affect the coagulation system, patients with local anesthetic allergy, patients with immobility and malnutrition, .And patients who did not want to participate in the study were excluded from the study. **Maximum Age:** 12 Years **Minimum Age:** 5 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hülya Tosun Söner **Phone:** +905352792102 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### 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:** NCT06427915 **Acronym:** SODA-SWAP **Brief Title:** Studying Glucose and Appetite Response With Alternatives to Soda Pop **Official Title:** Studying GlucOse anD Appetite ResponseS With Alternatives to Pop (SODA-SWAP) #### Organization Study ID Info **ID:** BIO-2401 #### Organization **Class:** INDUSTRY **Full Name:** Olipop, PBC ### Status Module #### Completion Date **Date:** 2024-08-02 **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:** 2024-07-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** BioFortis #### Lead Sponsor **Class:** INDUSTRY **Name:** Olipop, PBC #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The primary aim of this clinical trial is to determine the acute effects of OLIPOP (a lower sugar, high fiber prebiotic soda) consumption, compared to consumption of a commercially available sugar-sweetened soda pop, on blood glucose in response to the beverages alone and in combination with a carbohydrate-rich mixed lunch meal in free-living, generally healthy adults.This study will consist of one screening/randomization clinic visit (day 0) and one follow-up clinic visit (day 5), with participants consuming study products on their own (e.g., at home) following an assigned treatment sequence on days 1, 2, 3, and 4. The main questions answered by this trial are the impacts of a prebiotic rich soda versus a traditional soda on: 1) blood glucose levels with and without a meal, 2) perceived hunger levels, 3) perceived alertness levels and 4) total caloric intake. ### Conditions Module **Conditions:** - Healthy Nutrition ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** One 12oz serving of soda consumed alone after a 4 hour fasting period **Intervention Names:** - Other: OLIPOP prebiotic soda - Other: Traditional sugar-sweetened cola **Label:** Soda consumption in fasted state **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** One 12oz serving of soda consumed with a defined carbohydrate rich meal after a 4 hour fasting period **Intervention Names:** - Other: OLIPOP prebiotic soda - Other: Traditional sugar-sweetened cola **Label:** Soda consumption with a defined carbohydrate rich meal **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Soda consumption in fasted state - Soda consumption with a defined carbohydrate rich meal **Description:** 12oz serving containing Carbonated Water, OLISMART(TM) (Cassava Root Fiber, Acacia Fiber, Guar Fiber, Nopal Cactus\*, Marshmallow Root\*, Calendula Flower\*, Kudzu Root\*), Cassava Root Syrup, Apple Juice Concentrate, Lime Juice, Natural Cola Flavor, Alpinia Galanga Root\*, Stevia Leaf\*, Himalayan Pink Salt, Green Tea Caffeine\*, Natural Caramel Flavor, Natural Vanilla Flavor, Cinnamon\* (\*Extract) **Name:** OLIPOP prebiotic soda **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Soda consumption in fasted state - Soda consumption with a defined carbohydrate rich meal **Description:** 12oz serving containing carbonated water, high fructose corn syrup, caramel color, phosphoric acid, natural flavors, caffeine **Name:** Traditional sugar-sweetened cola **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Incremental area under the curve (iAUC) for glucose from t = -30 min prior to test product consumption to t = 120 min following test-product consumption (iAUC0-120 min), where t = 0 is the start of beverage consumption either alone or in combination with a meal (depending on the test sequence). **Measure:** Blood Glucose iAUC **Time Frame:** For 2 hours post intervention #### Secondary Outcomes **Description:** Blood glucose maximum concentration **Measure:** Blood Glucose Cmax **Time Frame:** For 2 hours post intervention **Description:** Time to maximum blood glucose concentration **Measure:** Time to Blood Glucose Cmax (Tmax) **Time Frame:** For 2 hours post intervention **Description:** The maximum concentration above the average baseline glucose concentration within the 2-hour period following study product consumption, expressed as a percentage of the average baseline glucose concentration **Measure:** Blood Glucose Rise 0-2 Hours **Time Frame:** For 2 hours post intervention **Description:** The difference between the lowest glucose concentration in hours 2-3 after study product consumption and the average baseline glucose concentration, expressed as a percentage of average baseline glucose concentration **Measure:** Blood Glucose Dip 2-3 Hours **Time Frame:** For time frame of 2 to 3 hours post intervention **Description:** The number of participants with a reduction in glucose in hours 2-3 after study product consumption compared to the average baseline glucose concentration **Measure:** Blood Glucose Reduction **Time Frame:** For time frame of 2 to 3 hours post intervention **Description:** The number of minutes after consumption of the study product that elapsed before the next meal of at least 50 kcal is consumed **Measure:** Time Until Next Meal **Time Frame:** Within same day post interevention **Description:** Energy intake (kcals) within 3 to 4 hours post-product consumption **Measure:** Energy Intake - Short Term **Time Frame:** For time frame of 3 to 4 hours post intervention **Description:** The total daily consumption covers the full period from 4 hours before the participant's breakfast to 20 hours after **Measure:** Energy Intake - 24 Hours **Time Frame:** Time frame from 4 hours before the participant's breakfast to 20 hours after participant's breakfast **Description:** The change in hunger ratings from pre-meal to post meal where post meal is defined as the average of the hunger ratings in the 2- 3 hour time frame **Measure:** Change in Perceived Hunger Level **Time Frame:** For time frame of 2 to 3 hours post intervention **Description:** The change in alertness ratings from pre-meal to post meal where the post meal is defined as the average alertness ratings in the 2-3 hour time frame **Measure:** Change in Perceived Alertness Level **Time Frame:** For time frame of 2 to 3 hours post intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male or female, ≥18 to ≤65 years of age at visit 1a. 2. Body mass index (BMI) of ≥25.0 kg/m2 to \<35.0 kg/m2 at visit 1a. 3. Fasting capillary (fingerstick) glucose \<126 mg/dL at visit 1a. One repeat will be allowed for glucose values between ≥126 and ≤140 mg/dL (same day if subjects are confirmed fasting or a separate day if subjects were not fasting). If a repeat is taken, the second reading will be used to determine eligibility. 4. Willing to wear a continuous glucose monitor (CGM) sensor throughout study period and willing to adhere to instructions/ restrictions associated with the proper use and care of the CGM. 5. Non-user or former user (cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period. 6. Non-user of marijuana and hemp products, including cannabidiol (CBD) products, within 60 d of visit 1a. 7. Willing to avoid alcohol 24 h prior to visit 1a/1b and throughout the study. 8. Willing to maintain habitual diet (with the exception of study products) and physical activity patterns throughout the trial. 9. Willing to use personal smart phone with operating system (Android version 12.0 or newer; Apple iPhone operating system (iOS) version 16 or newer) capable of downloading the Dexcom G7 CGM app and the Cronometer app for diet records. 10. Willing to adhere to all study procedures and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator. Exclusion Criteria: 1. Inability to consume a standard 12 fl. oz. carbonated beverage with or without food within 15 min. 2. Extreme dietary habits (e.g., Atkins diet, very high protein, and/or vegan) in the judgment of the Investigator or has been diagnosed with an eating disorder. 3. Habitual (e.g., daily) use of fiber supplements or prebiotic supplements within 30 d of visit 1a. 4. Known allergy or sensitivity to any of the ingredients in the study products and/or meals provided. 5. Weight loss or gain \>4.5 kg within 90 d of visit 1a. 6. Currently or planning to be on a weight loss or weight gain/ muscle-building regimen program during the study. 7. Use of vitamin C-containing supplements (including multivitamins) within 24 hours of visit 1a and during the study intervention period. 8. Shift workers with eating patterns not consistent with the study product consumption schedule. 9. History or presence of uncontrolled and/or clinically important endocrine, cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic, dermatologic, rheumatic, and/or biliary conditions that, in the opinion of the Principal Investigator, could interfere with the interpretation of the study results. 10. Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit 1a. 11. Gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, inflammatory bowel disease (Crohn's or ulcerative colitis), celiac disease, history of gastric bypass surgery). 12. Use of oral or injectable steroids (topical and inhaled are allowed) within 90 d of visit 1a. 13. Use of products containing salicylic acid (skin-care products are allowed if not used on the area surrounding the CGM sensor) within 24 hours of visit 1a/1b and during the study intervention period. If use occurs during the intervention period (e.g., subject takes an aspirin), details of the use (e.g., time, amount, product) should be documented. 14. Unstable use of any prescription medications that affect blood glucose levels, whereby stable is defined as no change in regimen within 90 d prior to visit 1a. Examples include diabetes medications, glucagon-like-peptide-1 (GLP-1) agonists, medications for anxiety, attention deficit/hyperactivity disorder (ADHD), depression, and other mental health problems (e.g., clozapine, olanzapine, quetiapine, and risperidone), thyroid hormone replacement medications, statins, protease inhibitors, adrenergic receptor blockers, and isotretinoin. 15. History or presence of cancer, except non-melanoma skin cancer, within 2 years of visit 1a. 16. Exposure to any non-registered drug product or has participated in another intervention study within 30 d prior to visit 1a. 17. Signs or symptoms of an active infection of clinical relevance within 5 d of visit 1a. The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 d prior to visit 1a. 18. Recent history (within 12 months of visit 1) of alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 11⁄2 oz. distilled spirits). 19. History of any major trauma or major surgical event within 60 d of visit 1a. 20. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document. 21. Any condition the Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk. **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:** Michael J Weiser, PhD **Phone:** ‪303-834-7240 **Role:** CONTACT #### Locations **Location 1:** **City:** Addison **Contacts:** ***Contact 1:*** - **Name:** John Marshall - **Phone:** 630-617-2000 - **Role:** CONTACT **Country:** United States **Facility:** Biofortis **State:** Illinois **Status:** RECRUITING **Zip:** 60101 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: CNSSti - Name: Central Nervous System Stimulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M5373 - Name: Caffeine - Relevance: LOW - As Found: Unknown - ID: T370 - Name: Caffeine - Relevance: LOW - As Found: Unknown - ID: T312 - Name: Tea - Relevance: LOW - As Found: Unknown - ID: T120 - Name: Cola - Relevance: LOW - As Found: Unknown - ID: T115 - Name: Cinnamon - Relevance: LOW - As Found: Unknown - ID: T176 - Name: Guar - Relevance: LOW - As Found: Unknown - ID: T301 - Name: Stevia - Relevance: LOW - As Found: Unknown - ID: T431 - Name: Stevioside - Relevance: LOW - As Found: Unknown - ID: T89 - Name: Calendula - Relevance: LOW - As Found: Unknown - ID: T205 - Name: Kudzu - Relevance: LOW - As Found: Unknown - ID: T93 - Name: Cassava - Relevance: LOW - As Found: Unknown - ID: T260 - Name: Prickly Pear - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427902 **Brief Title:** Inflammatory Biomarkers in Saliva at Depression **Official Title:** Salivary Biomarkers of Gingival Inflammation Are Associated With Depression #### Organization Study ID Info **ID:** Depression #### Organization **Class:** OTHER **Full Name:** Medipol University ### Status Module #### Completion Date **Date:** 2019-09-16 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2019-06-14 **Type:** ACTUAL #### Start Date **Date:** 2018-12-10 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-16 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Medipol University #### Responsible Party **Investigator Affiliation:** Medipol University **Investigator Full Name:** DUYGU ILHAN **Investigator Title:** Asst. Prof **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 evaluate the inflammatory saliva biomarkers in depression and gingivitis. The main question will be ; Will there be an increase at salivary biomarkers with depression patients and is it associated with gingivitis? **Detailed Description:** Background: The neuroimmune regulation disorder in depression patients causes the progression of inflammatory periodontal disease. The present study was to evaluate the periodontal health status and the levels of Triggering receptor expressed on myeloid cells 1 (TREM-1), peptidoglycan recognition protein 1 (PGLYRP1) and interleukin-1 beta (IL-1β) in individuals diagnosed with depression and to compare these findings with those of systemically healthy individuals. Methods: Forty-two depression patients were classified in two groups: depression with gingivitis (DG) and depression with periodontally healthy (DPH) patients. Additionally, 23 systemically and periodontally healthy (SPH) individuals were enrolled to the study. Periodontal parameters were recorded. Saliva samples were collected and salivary levels of TREM-1, PGLYRP1, IL-1β were measured using Enzyme-linked Immunosorbent Assay (ELISA) kits. depression regardless of periodontal status. ### Conditions Module **Conditions:** - Gingivitis - Depression - Inflammation - Inflammatory Response ### Design Module #### Bio Spec **Description:** Saliva **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 65 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The diagnosis of depressive disorder was established using the Structured Clinical Interviews for Axis I Disorders (SCID) criteria of the Diagnostic and Statistical Manual of Mental Disorders. the gingivitis group was determined by the criteria of pocket depth of 3 mm or less. **Intervention Names:** - Other: Periodontal clinical measurements, Saliva sampling **Label:** depression with gingivitis (DG) group #### Arm Group 2 **Description:** The diagnosis of depressive disorder was established using the Structured Clinical Interviews for Axis I Disorders (SCID) criteria of the Diagnostic and Statistical Manual of Mental Disorders. **Intervention Names:** - Other: Periodontal clinical measurements, Saliva sampling **Label:** depression with periodontally healthy (DPH) patients #### Arm Group 3 **Description:** This group contists of individuals who are systemically and periodontally healthy **Intervention Names:** - Other: Periodontal clinical measurements, Saliva sampling **Label:** systemically and periodontally healthy (SPH) individuals ### Interventions #### Intervention 1 **Arm Group Labels:** - depression with gingivitis (DG) group - depression with periodontally healthy (DPH) patients - systemically and periodontally healthy (SPH) individuals **Description:** Clinical periodontal indices; Probing depth, Clinical attachment level, bleeding on probing, gingival index, and plaque **Name:** Periodontal clinical measurements, Saliva sampling **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Both, soluble and membrane-bound TREM-1, are detected by the TREM-1 ELISA. **Measure:** SalivaryTREM-1 **Time Frame:** 06-09 2019 **Description:** Both, soluble and membrane-bound PGLYRP1 are detected by the PGLYRP1 ELISA. **Measure:** Salivary PGLYRP1 **Time Frame:** 06-09 2019 **Description:** Both, soluble and membrane-bound IL-1β detected by the IL-1β ELISA. **Measure:** Salivary IL-1β **Time Frame:** 06-09 2019 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients who were moderate in severity according to the test result, who had not started drug therapy yet and who had not received antidepressant medication in the last 12 months Exclusion Criteria: Patients with * psychotic disorders * autism spectrum disorders * other anxiety disorders * bipolar disorder * mental any organic mental disorder and * smokers, substance users **Healthy Volunteers:** True **Maximum Age:** 53 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** This study was carried out on 65 participants in total, including 42 individuals who applied to Aydın State Hospital Psychiatry Outpatient Clinic, diagnosed with depressive disorder, were classified in 2 different groups; depression with gingivitis (DG), depression with periodontally healthy (DPH) patients and 23 systemically and periodontally healthy (SPH) individuals who applied to Adnan Menderes University Faculty of Dentistry. ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Duygu Ilhan **State:** Select State **Zip:** 34365 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000010335 - Term: Pathologic Processes - ID: D000007239 - Term: Infections - ID: D000005882 - Term: Gingival Diseases - ID: D000010510 - Term: Periodontal Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### 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: BC01 - Name: Infections - Abbrev: BC07 - Name: Mouth and Tooth Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M9003 - Name: Gingivitis - Relevance: HIGH - As Found: Gingivitis - 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: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M8994 - Name: Gingival Diseases - Relevance: LOW - As Found: Unknown - ID: M13419 - Name: Periodontal Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005891 - Term: Gingivitis - ID: D000007249 - Term: Inflammation - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427889 **Brief Title:** Treatment Effects of Two Pharmaceutical Skin Care Creams for Xerotic Feet Among Persons With Diabetes **Official Title:** A Superiority Study Comparing Two Pharmaceutical Skin Care Creams Containing Different Humectants With a Non-humectant Containing Skin Care Cream for the Treatment of Xerotic Foot of Persons With Diabetes #### Organization Study ID Info **ID:** 2022-500907-27-01 #### Organization **Class:** OTHER **Full Name:** Malmö University ### Status Module #### Completion Date **Date:** 2026-08-07 **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:** 2025-11-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Malmö University #### Responsible Party **Investigator Affiliation:** Malmö University **Investigator Full Name:** Tautgirdas Ruzgas **Investigator Title:** Professor,Biomedical technology, Study director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Introduction Diabetic foot-ulcers leads to decreased quality of life, risk of major amputation, and resource demanding health-care. To minimize the risk of developing foot-ulcers, persons with diabetes are given the advice to daily inspect their feet and to apply skincare formulations. However, commercially available skincare products have rarely been developed and evaluated for diabetes foot care specifically. The primary aim of this randomized controlled trial (RCT) is to evaluate the effects in reducing foot xerosis in persons with diabetes without foot-ulcers using two skincare creams containing different humectants (interventions) against a cream base non-humectant (comparator). Secondary outcomes are to evaluate differences on skin barrier integrity, low-molecular weight biomarkers and skin microbiota, microcirculation including transcutaneous oxygen pressure, degree of neuropathy, and HbA1c between intervention-comparator cream. Methods Two-armed double-blind RCT. With 80% power, two-tailed significance of 2.5% in each arm, 39 study persons is needed in each arm, total 78 persons, to be able to prove a reduction of at least one category in the Xerosis Severity Scale with the intervention creams compared to the comparator. In one arm, each participant will treat one foot with one of the intervention creams (Oviderm® or Canoderm®), while the opposite foot will be treated with the comparator cream (Decubal® lipid cream®), twice a day. If needed, participants are enrolled after a wash-out period of two weeks. The participants will undergo examinations at baseline, day 14 and day 28. Discussion This RCT evaluate the potential effects of humectants in skin creams against foot xerosis in persons with diabetes. The outcomes of this trial could have implications on treatment recommendations of foot care and for the prevention of foot ulcer. ### Conditions Module **Conditions:** - Diabetes Mellitus - Skin and Connective Tissue Diseases **Keywords:** - Diabetes Mellitus - Dry Skin - Self Care - Dry Feet - Prevention ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 98 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Topical on feet twice a day **Intervention Names:** - Drug: Canoderm **Label:** Canoderm **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Topical on feet twice a day **Intervention Names:** - Drug: Oviderm **Label:** Oviderm **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Topical on feet twice a day **Intervention Names:** - Drug: Decubal **Label:** Decubal **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Canoderm **Description:** humectant **Name:** Canoderm **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Oviderm **Description:** humectant + antimicrobial **Name:** Oviderm **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Decubal **Description:** Non-humectant **Name:** Decubal **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Change in Xerosis Severity (Scale scores 0 - 6, 6 is the worst) **Measure:** Xerosis Severity **Time Frame:** 4 weeks #### Secondary Outcomes **Description:** Trans epidermal water loss (TEWL) (grams per square meter per hour) **Measure:** Transepidermal water loss **Time Frame:** 4 weeks **Description:** Skin resistance in Ohms (Ω) **Measure:** Skin resistance **Time Frame:** 4 weeks **Description:** Skin Capacitance in Farads (F) **Measure:** Skin Capacitance **Time Frame:** 4 weeks **Description:** Skin pH (5-8) **Measure:** Skin pH **Time Frame:** 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Persons above 18 years of age diagnosed with diabetes mellitus, both type I and II, with self-experienced dry skin. * Dry skin on both feet with a Xerosis Severity Scale (XSS) score between two to six. No more than one XSS score in difference between the subjects' feet. * Ability to understand sufficient Swedish language to complete the necessary forms and understand the procedure of the study. Exclusion Criteria: * Known sensibility to any of the ingredients in the products. * Other diagnosed skin disease on the feet. * Active lesions on either foot. * Treatment with local medications, including topical moisturizers or keratolytic agents on the feet, within two weeks before the beginning of the study. * Potential study subjects judged unable to comply with treatment schedule and study specific information. * Female of childbearing potential that do not use effective medically accepted contraception. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tautgirdas Ruzgas, Professor **Phone:** +46406657431 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Malmo University **Name:** Christine Kumlien, Professor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M6464 - Name: Connective Tissue Diseases - Relevance: HIGH - As Found: Connective Tissue Diseases - 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: D000003240 - Term: Connective Tissue Diseases - ID: D000003920 - Term: Diabetes Mellitus ### 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: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427876 **Brief Title:** Fasenra Pediatric Japan Post-Marketing Study(PMS) **Official Title:** FASENRA® Subcutaneous Injection 30 mg / 10mg Syringe Protocol of Specific Drug Use Result Study for Pediatric Patients #### Organization Study ID Info **ID:** D3250C00100 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2027-03-17 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-03-17 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-31 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The purpose of the investigation is to confirm the followings under the post-marketing actual use of Fasenra® Subcutaneous Injection 30 mg / 10mg Syringe (hereinafter referred to as Fasenra). 1. Development of unexpected related AEs\* 2. To grasp development of related AEs\* in the real-world post-marketing setting. 3. Effectiveness (pulmonary function and asthma control) \* AEs investigator or MAH considers that there is a reasonable possibility that the experience may have been caused by the drug **Detailed Description:** This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Act on Securing Quality, Effectiveness and Safety of Products Including Pharmaceuticals and Medical Devices. The purpose of the investigation is to confirm the followings under the post-marketing actual use of Fasenra® Subcutaneous Injection 30 mg / 10mg Syringe (hereinafter referred to as Fasenra). 1. Development of unexpected related AEs\* 2. To grasp development of related AEs\* in the real-world post-marketing setting. 3. Effectiveness (pulmonary function and asthma control) \* AEs investigator or MAH considers that there is a reasonable possibility that the experience may have been caused by the drug ### Conditions Module **Conditions:** - Bronchial Asthma ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** The incidence of ADRs related to Fasenra Safety Specification, Serious infection and other **Measure:** Incidence of ADRs **Time Frame:** from baseline to 1year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: The evaluable patients in children aged ≥6 years to \<15 years are those treated with Fasenra for the first time due to "Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy) Exclusion Criteria: none **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The evaluable patients in children aged ≥6 years to \<15 years are those treated with Fasenra for the first time due to "Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy) ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** AstraZeneca K.K. **Name:** Shunsuke Hiroki **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. **Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. **IPD Sharing:** YES **Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. **URL:** https://astrazenecagroup-dt.pharmacm.com/DT/Home ## Derived Section ### Condition Browse Module - Ancestors - ID: 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: Bronchial Asthma - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Intervention Browse Module - Browse Branches - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M287399 - Name: Benralizumab - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427863 **Brief Title:** Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Chronic Constipation **Official Title:** Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Chronic Constipation in Adults: a Multi-center, Randomized, Placebo-controlled Clinical Study #### Organization Study ID Info **ID:** WMT-Anti-CC-202405 #### Organization **Class:** OTHER **Full Name:** The Second Hospital of Nanjing Medical University ### Status Module #### Completion Date **Date:** 2029-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Faming Zhang #### Responsible Party **Investigator Affiliation:** The Second Hospital of Nanjing Medical University **Investigator Full Name:** Faming Zhang **Investigator Title:** Professor, Gastroenterology **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This is a randomized controlled trial to explore the efficacy of antibiotic pretreatment on the efficacy of WMT in the treatment of chronic constipation in adults: a multi-center, randomized, placebo-controlled clinical study **Detailed Description:** All included in the standard but do not accord with standard of any rule out subjects will be included in this study. Demographic characteristics, complete spontaneous bowel movements（CSBM), Constipation assessment scale (CAS), Patient-Assessment of Constipation Quality Of Life（PAC-QOL) and clinical outcomes were collected. After the treatment, the efficacy and safety were evaluated during the follow-up period. ### Conditions Module **Conditions:** - Chronic Constipation **Keywords:** - chronic constipation - washed microbiota transplantation - antibiotic pretreatment - randomized controlled trial - transendoscopic enteral tube ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 96 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive three enemas of ornidazole 0.5g+50ml saline through the TET tube, followed by WMT once daily for a duration of 3 days. **Intervention Names:** - Drug: Ornidazole **Label:** Treatment **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients will receive three enemas of a placebo of equal volume through the TET tube, followed by WMT once daily for a duration of 3 days. **Intervention Names:** - Drug: Placebo **Label:** Control **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment **Description:** Patients will receive three consecutive enemas of ornidazole 0.5g+50ml saline through the TET tube, followed by WMT treatment once daily for a duration of 3 days **Name:** Ornidazole **Other Names:** - washed microbiota transplantation **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control **Description:** Patients will receive three consecutive enemas of placebo of equal volume through the TET tube, followed by WMT treatment once daily for a duration of 3 days **Name:** Placebo **Other Names:** - washed microbiota transplantation **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Overall CSBM respondents defined in the study of drug treatment in patients with the number of weeks of at least 50% of the time meet the CSBM weeks response week (4/8). Response was defined as a CSBM of at least three times in the week and an increase of at least one CSBM from baseline. CSBM was defined as the number of voluntary bowel movements with complete defecation sensation without taking remedial laxatives or manual assistance. **Measure:** Response rate of complete spontaneous bowel movements（CSBM） **Time Frame:** One-week, Four-week and Eight-week post-WMT **Description:** The CAS consisted of 8 items, including abdominal distension, changes in exhaust volume, decreased frequency of defecation, watery stool, rectal obstruction or pressure, rectal pain during defecation, thinness of stool, and unsuccessful defecation. Each item was scored from 0 to 2 according to the severity of symptoms. Each item score was summed, with 0 as no constipation and 16 as the most severe constipation. **Measure:** The extent of change observed in Constipation assessment scale (CAS) of participants **Time Frame:** One-week, Four-week and Eight-week post-WMT **Description:** The Constipation Quality of Life Scale (PAC-QOL) contains 28 items, including physical discomfort, anxiety, psychosocial discomfort, and satisfaction. It reflects the impact of constipation on daily life in the past two weeks. **Measure:** The extent of change observed in Patient-Assessment of Constipation Quality Of Life（PAC-QOL）of participants **Time Frame:** One-week, Four-week and Eight-week post-WMT #### Secondary Outcomes **Description:** Bristol stool form scale(BSFS) was used, which can be divided into seven types. **Measure:** The extent of change observed in stool properties of participants **Time Frame:** One-week post-WMT **Description:** The rate of adverse events after antibiotic pretreatment **Measure:** Rate of Adverse Events **Time Frame:** One-week, Four-week and Eight-week post-WMT ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Subjects must meet all of the following inclusion criteria to enter the study: 1. Male and female, aged ≥18 years old, provided written informed consent; 2. Subjects diagnosed with chronic constipation, with a duration of at least 6 months, and with the following conditions: 1) spontaneous bowel movement frequency \<3 times/week (spontaneous bowel movement was defined as spontaneous bowel movement without rescue laxatives or manual assistance); 2) waste hard: at least 25% of defecation in Bristol stool traits scale type 1 or 2. 3. The subjects or their legal representatives gave informed consent, fully understood the purpose of the study, were able to communicate well with the researchers, and understood and complied with the requirements of the study. Exclusion Criteria: Subjects meeting any of the following exclusion criteria must be excluded fromthe study: 1. Presence of outlet obstruction and constipation, such as rectal mucosal prolapse 2. Combined with the results of colonoscopy in the past 24 months, those with intestinal stenosis caused by organic lesions of the digestive tract (such as tumor, inflammation, anal fissure, Crohn's disease, ulcerative colitis, intestinal adhesion, intestinal tuberculosis, etc.) and constipation; 3. Constipation caused by other systemic diseases involving the digestive tract, such as nervous system diseases (such as Parkinson's disease, spinal cord injury, multiple sclerosis, etc.), muscle diseases (such as amyloidosis, dermatomyositis, etc.), mental disorders (such as depression, etc.), metabolic and endocrine disorders (such as diabetes, hypothyroidism, etc.) or opioids, etc. 4. Has a history of abdominal pelvic surgery, but after cystic resection, cesarean section, does not appear after appendectomy postoperative intestinal complications, and intestinal polyps except after treatment; 5. Has a history of major surgery within 3 months or a history of severe trauma, and recovery is not completely; 6. There are contraindications to colonic transendoscopic intestinal tube implantation, such as severe intestinal stenosis, obstruction, deep ulcer, and high risk of operation perforation; Severe ulcers or a large number of pseudopolyps exist in the fixed area of titanium clips, which are not suitable for fixation. The subjects' behavior was seriously uncontrolled. 7. Any of the following abnormalities in cardiac function and performance: 1. According to the New York Heart Association (NYHA) cardiac function classification, cardiac function grade Ⅲ or above; 2. new onset myocardial infarction or unstable angina pectoris within 6 months; 3. ECG showed QTc prolongation (QTc≥ 450ms in men and ≥470ms in women); 4. Drug-refractory atrial arrhythmias and drug-refractory ventricular arrhythmias (including grade 2 or higher atrioventricular block). 8. Patients with poor lung function that is considered by the investigator to have an impact on the study treatment, such as patients with acute exacerbation of COPD or patients requiring long-term use of oral or intravenous steroids for control (except inhalers/sprays); 9. No control autoimmune disease and/or need long-term use of hormone (except local external use sex); 10. Patients with metabolic diseases and poorly controlled by drugs (such as thyroid dysfunction), or patients with metabolic diseases accompanied by gastrointestinal function complications (such as gastrointestinal autonomic nerve dysfunction, diabetic gastroparesis, etc.); 11. Suffering from reproductive system diseases (including but not limited to ovarian cysts, endometriosis, primary dysmenorrhea, etc.) that may lead to abdominal pain; 12. Significant laboratory abnormalities that, in the judgment of the investigator, may affect the safety of the subjects or the completion of the clinical study, including: A) the hemoglobin \< 100 g/L; B) Serum creatinine ≥1.5 times the upper limit of normal (ULN) C) abnormal liver function, defined as AST\>1.5×ULN and/or ALT\>1.5×ULN and/or total bilirubin \>1.5×ULN; D) blood clotting function: PLT acuities were 80 x 109 / L, APTT \> 1.5 x ULN, PT \> 1.5 x ULN, INR \> 1.5 x ULN; E) abnormal results or defecate occult blood stool and has prompted the clinical significance of the gastrointestinal tract. 13. Have active hepatitis (requiring or taking long-term treatment), HIV, or active tuberculosis; 14. A history of drug or alcohol abuse (i.e., drinking more than 14 servings per week of beer, 45 mL of 40% spirits, or 150 mL of wine) or substance abuse; 15. The known allergic to research similar drugs, drugs or accessories; 16. Use of anti-infective drugs (antibiotics, antifungal, antiviral) within 14 days before enrollment, or need anti-infective treatment at enrollment evaluation; 17. Drugs and supplements that affect gastrointestinal motility and function cannot be stopped during the study, including but not limited to: antibiotics such as erythromycin; Drugs that modulate the intestinal microecology, such as probiotics such as Bifidobacterium; The parasympathetic nerve inhibitors, some scopolamine and atropine, belladonna, etc; Muscle relaxants, such as succinylcholine; Antidiarrheal agents such as loperamide, smecta; Opioid preparations; Drugs that inhibit gastric acid secretion; 18. Pregnant or lactating women, or refusing to use an effective contraceptive method within 3 months after the last dose of treatment; 19. 3 months prior to dosing involved in drug interventional clinical trials; 20. Suffering from malignant tumors; 21. There were other circumstances that the investigator considered inappropriate for participating 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:** Faming Zhang, PhD **Phone:** 086-025-58509883 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Bota Cui **Phone:** 086-025-58509884 **Role:** CONTACT #### Locations **Location 1:** **City:** Nanjing **Country:** China **Facility:** Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University **State:** Jiangsu **Zip:** 210011 #### Overall Officials **Official 1:** **Affiliation:** The Second Hospital of Nanjing Medical University **Name:** Faming Zhang, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Keshteli AH, Millan B, Madsen KL. Pretreatment with antibiotics may enhance the efficacy of fecal microbiota transplantation in ulcerative colitis: a meta-analysis. Mucosal Immunol. 2017 Mar;10(2):565-566. doi: 10.1038/mi.2016.123. Epub 2016 Dec 21. No abstract available. **PMID:** 28000680 **Citation:** Singh P, Alm EJ, Kelley JM, Cheng V, Smith M, Kassam Z, Nee J, Iturrino J, Lembo A. Effect of antibiotic pretreatment on bacterial engraftment after Fecal Microbiota Transplant (FMT) in IBS-D. Gut Microbes. 2022 Jan-Dec;14(1):2020067. doi: 10.1080/19490976.2021.2020067. **PMID:** 35014601 **Citation:** Khalif IL, Quigley EM, Konovitch EA, Maximova ID. Alterations in the colonic flora and intestinal permeability and evidence of immune activation in chronic constipation. Dig Liver Dis. 2005 Nov;37(11):838-49. doi: 10.1016/j.dld.2005.06.008. Epub 2005 Oct 5. **PMID:** 16169298 **Citation:** Bazzocchi G, Giovannini T, Giussani C, Brigidi P, Turroni S. Effect of a new synbiotic supplement on symptoms, stool consistency, intestinal transit time and gut microbiota in patients with severe functional constipation: a pilot randomized double-blind, controlled trial. Tech Coloproctol. 2014 Oct;18(10):945-53. doi: 10.1007/s10151-014-1201-5. Epub 2014 Aug 5. **PMID:** 25091346 **Citation:** Xu J, Xu H, Guo X, Zhao H, Wang J, Li J, He J, Huang H, Huang C, Zhao C, Li Y, Zhou Y, Peng Y, Nie Y. Pretreatment with an antibiotics cocktail enhances the protective effect of probiotics by regulating SCFA metabolism and Th1/Th2/Th17 cell immune responses. BMC Microbiol. 2024 Mar 18;24(1):91. doi: 10.1186/s12866-024-03251-2. **PMID:** 38500062 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012817 - Term: Signs and Symptoms, Digestive ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6472 - Name: Constipation - Relevance: HIGH - As Found: Constipation - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: HIGH - As Found: Chronic ### Condition Browse Module - Meshes - ID: D000003248 - Term: Constipation ### Intervention Browse Module - Ancestors - ID: D000000563 - Term: Amebicides - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000994 - Term: Antitrichomonal 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: LOW - As Found: Unknown - ID: M12876 - Name: Ornidazole - Relevance: HIGH - As Found: Vacuum aspiration - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M3904 - Name: Amebicides - Relevance: LOW - As Found: Unknown - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000009950 - Term: Ornidazole ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427850 **Brief Title:** Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF) **Official Title:** Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF): A Randomized Controlled Trial #### Organization Study ID Info **ID:** 123678 #### Organization **Class:** OTHER **Full Name:** Ramathibodi Hospital ### Status Module #### Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Thanawan Longsuwan #### Responsible Party **Investigator Affiliation:** Ramathibodi Hospital **Investigator Full Name:** Thanawan Longsuwan **Investigator Title:** Doctor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The randomized controlled study which compare the efficacy outcomes (reducing blood loss and drainage output in patients) in patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) and received topical tranexamic acid injection in the surgical site to those who received placebo injection. **Detailed Description:** Detail : Randomization of Patients for intra-surgical site topical tranexamic acid injection Objective : To compare the efficacy of topical tranexamic acid (TXA) injection into the surgical wound versus placebo injection in reducing blood loss and drainage output in patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) surgery. Methods: Patient: Patients with degenerative spine conditions undergoing single-level MI-TLIF surgery, who received treatment at Ramathibodi Hospital and Chakri Naruebodindra Medical Institute from 2024 to 2027. Randomization : Patients will be randomly by various block randomization (1:1) was performed using STATA 16.0 to ensure that the two groups were comparable in size and that the sequence of randomization was unpredictable. Intervention : Group 1 : Patients in this group will receive an injection of topical tranexamic acid (TXA) into the surgical site(50mg/ml) 10 ml after wound exposure and after wound decompression. Group 2: Patients in this group will receive a placebo injection (Normal saline 10 ml) into the surgical site after wound exposure and after wound decompression. Allocation Concealment : A central randomization service will prepare sealed envelopes labeled with sequence numbers corresponding to the sample size. This method decreasing selection bias in assigning participants to the treatment groups. The envelopes were opened and equipment prepared after anesthesia was administered and before the surgeon began the incision. Blinding : The study participants and assessors will be blinded to treatment allocation. The surgeons were blinded by clear fluid as same in 2 groups but if tranexamic acid can be effective to decrease blood loss in intraoperation. So we cannot controlled blinding surgeons. Primary outcome measurement: postoperative drainage (ml) Secondary outcome measurement: calculated total blood loss, intraoperative blood loss, blood transfusion rate, duration of drain maintenance, length of hospital stay, complication of tranexamic acid (TXA) and surgery. Statistical Analysis: Demographic Analysis : For continuous data reported as Mean and Standard Deviation (S.D.) and analyzed by Independent t-test or Mann-Whitney U test. For categorical data reported as Percentages and analyzed by Chi-square test. Compare the results of the study: Postoperative drainage (ml),calculated total blood loss (ml), intraoperative blood loss (mL) , duration of drain maintenance (day), length of hospital stay (day)were report to Mean and Standard Deviation (S.D.) analyzed by Independent t-test or Mann-Whitney U test for continuous data. Complication of tranexamic acid (TXA) and surgery(%), blood transfusion rate (%) were reported to Percentages and analyzed by Chi-square test. Use STATA 16.0 software for statistical calculations. ### Conditions Module **Conditions:** - Degenerative Spine Diseases - Surgical Wound **Keywords:** - Degenerative spine diseases - Surgical wound - Tranexamic acid (TXA) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### 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:** receive an injection of topical tranexamic acid (TXA) into the surgical site **Intervention Names:** - Drug: Tranexamic acid **Label:** Topical tranexamic acid (TXA) injection **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** receive an injection Normal saline into the surgical site **Intervention Names:** - Drug: Normal saline **Label:** Placebo group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Topical tranexamic acid (TXA) injection **Description:** receive an injection of Tranexamic acid into the surgical site **Name:** Tranexamic acid **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo group **Description:** receive an injection of Normal saline into the surgical site **Name:** Normal saline **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Fluid drainage after operation **Measure:** postoperative drainage (mL) **Time Frame:** 120 hours #### Secondary Outcomes **Description:** calculated total blood loss by Gross formular **Measure:** calculated total blood loss (mL) **Time Frame:** 120 hours **Description:** Evaluated by anesthesiologists **Measure:** intraoperative blood loss (mL) **Time Frame:** Intraoperative time **Description:** Duration time of drain insertion to off drain **Measure:** duration of drain maintenance (day) **Time Frame:** 120 hours **Description:** Duration time of patients stay in hospital **Measure:** length of hospital stay (day) **Time Frame:** 120 hours **Description:** The patients who had complication from tranexamic acid (TXA) and surgery in each group **Measure:** complication of tranexamic acid (TXA) and surgery(%) **Time Frame:** 120 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 30-80 years old * Degenerative spine problems including spinal stenosis, disc degeneration, spondylolithesis that indicated for single level MI-TLIF Exclusion Criteria: * Revision surgery * Patients who had high risk of complication from TXA * History of seizure, PE, DVT, thromboembolic episode * History of TXA allergy * Patients who had high risk for bleeding * U/D : CKD stage more than IIIb (GFR\< 45 ml/min/1.73m2), hepatic disease, bleeding disorder * On anticoagulation drug or antiplatelet drug in 7 days before surgery * Abnormal coagulation profile (INR \> 1.5) or CBC (platelet \< 100000) **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Thanawan Longsuwan, Doctor of medicine **Phone:** (+66)892966855 **Role:** CONTACT **Contact 2:** **Name:** Kan Kaewroj, Diploma of Orthopaedics **Phone:** (+66) 022011589 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24. **PMID:** 30560029 **Citation:** Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):936-43. doi: 10.1097/01.brs.0000158953.57966.c0. **PMID:** 15834339 **Citation:** Harms JG, Jeszenszky D. Die posteriore, lumbale, interkorporelle Fusion in unilateraler transforaminaler Technik. Oper Orthop Traumatol. 1998 Jun;10(2):90-102. doi: 10.1007/s00064-006-0112-7. No abstract available. German. **PMID:** 17332991 **Citation:** Holly LT, Schwender JD, Rouben DP, Foley KT. Minimally invasive transforaminal lumbar interbody fusion: indications, technique, and complications. Neurosurg Focus. 2006 Mar 15;20(3):E6. doi: 10.3171/foc.2006.20.3.7. **PMID:** 16599422 **Citation:** Moskowitz A. Transforaminal lumbar interbody fusion. Orthop Clin North Am. 2002 Apr;33(2):359-66. doi: 10.1016/s0030-5898(01)00008-6. **PMID:** 12389281 **Citation:** Hong JY, Kim WS, Park J, Kim CH, Jang HD. Comparison of minimally invasive and open TLIF outcomes with more than seven years of follow-up. N Am Spine Soc J. 2022 Jun 11;11:100131. doi: 10.1016/j.xnsj.2022.100131. eCollection 2022 Sep. **PMID:** 35783004 **Citation:** Kleinert K, Theusinger OM, Nuernberg J, Werner CM. Alternative procedures for reducing allogeneic blood transfusion in elective orthopedic surgery. HSS J. 2010 Sep;6(2):190-8. doi: 10.1007/s11420-009-9151-6. Epub 2010 Jan 28. **PMID:** 21886535 **Citation:** Dodd RY. The risk of transfusion-transmitted infection. N Engl J Med. 1992 Aug 6;327(6):419-21. doi: 10.1056/NEJM199208063270610. No abstract available. **PMID:** 1625717 **Citation:** Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussieres JS, McGuinness S, Byrne K, Chan MT, Landoni G, Wallace S; ATACAS Investigators of the ANZCA Clinical Trials Network. Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery. N Engl J Med. 2017 Jan 12;376(2):136-148. doi: 10.1056/NEJMoa1606424. Epub 2016 Oct 23. Erratum In: N Engl J Med. 2018 Feb 22;378(8):782. **PMID:** 27774838 **Citation:** Danninger T, Memtsoudis SG. Tranexamic acid and orthopedic surgery-the search for the holy grail of blood conservation. Ann Transl Med. 2015 Apr;3(6):77. doi: 10.3978/j.issn.2305-5839.2015.01.25. No abstract available. **PMID:** 25992376 **Citation:** Badeaux J, Hawley D. A systematic review of the effectiveness of intravenous tranexamic acid administration in managing perioperative blood loss in patients undergoing spine surgery. J Perianesth Nurs. 2014 Dec;29(6):459-65. doi: 10.1016/j.jopan.2014.06.003. Epub 2014 Nov 20. **PMID:** 25458625 **Citation:** Xiong Z, Liu J, Yi P, Wang H, Tan M. Comparison of Intravenous versus Topical Tranexamic Acid in Nondeformity Spine Surgery: A Meta-Analysis. Biomed Res Int. 2020 Mar 9;2020:7403034. doi: 10.1155/2020/7403034. eCollection 2020. **PMID:** 32219141 **Citation:** Winter SF, Santaguida C, Wong J, Fehlings MG. Systemic and Topical Use of Tranexamic Acid in Spinal Surgery: A Systematic Review. Global Spine J. 2016 May;6(3):284-95. doi: 10.1055/s-0035-1563609. Epub 2015 Sep 21. **PMID:** 27099820 **Citation:** Gulabi D, Yuce Y, Erkal KH, Saglam N, Camur S. The combined administration of systemic and topical tranexamic acid for total hip arthroplasty: Is it better than systemic? Acta Orthop Traumatol Turc. 2019 Jul;53(4):297-300. doi: 10.1016/j.aott.2019.03.001. Epub 2019 Apr 4. **PMID:** 30954338 **Citation:** Li J, Wang L, Bai T, Liu Y, Huang Y. Combined use of intravenous and topical tranexamic acid efficiently reduces blood loss in patients aged over 60 operated with a 2-level lumbar fusion. J Orthop Surg Res. 2020 Aug 20;15(1):339. doi: 10.1186/s13018-020-01758-8. **PMID:** 32819445 **Citation:** Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054. **PMID:** 22611164 **Citation:** Murkin JM, Falter F, Granton J, Young B, Burt C, Chu M. High-dose tranexamic Acid is associated with nonischemic clinical seizures in cardiac surgical patients. Anesth Analg. 2010 Feb 1;110(2):350-3. doi: 10.1213/ANE.0b013e3181c92b23. Epub 2009 Dec 8. **PMID:** 19996135 **Citation:** Cravens GT, Brown MJ, Brown DR, Wass CT. Antifibrinolytic therapy use to mitigate blood loss during staged complex major spine surgery: Postoperative visual color changes after tranexamic acid administration. Anesthesiology. 2006 Dec;105(6):1274-6. doi: 10.1097/00000542-200612000-00029. No abstract available. **PMID:** 17122592 **Citation:** Murao S, Nakata H, Roberts I, Yamakawa K. Effect of tranexamic acid on thrombotic events and seizures in bleeding patients: a systematic review and meta-analysis. Crit Care. 2021 Nov 1;25(1):380. doi: 10.1186/s13054-021-03799-9. **PMID:** 34724964 **Citation:** Mikhail C, Pennington Z, Arnold PM, Brodke DS, Chapman JR, Chutkan N, Daubs MD, DeVine JG, Fehlings MG, Gelb DE, Ghobrial GM, Harrop JS, Hoelscher C, Jiang F, Knightly JJ, Kwon BK, Mroz TE, Nassr A, Riew KD, Sekhon LH, Smith JS, Traynelis VC, Wang JC, Weber MH, Wilson JR, Witiw CD, Sciubba DM, Cho SK. Minimizing Blood Loss in Spine Surgery. Global Spine J. 2020 Jan;10(1 Suppl):71S-83S. doi: 10.1177/2192568219868475. Epub 2020 Jan 6. **PMID:** 31934525 **Citation:** Montroy J, Hutton B, Moodley P, Fergusson NA, Cheng W, Tinmouth A, Lavallee LT, Fergusson DA, Breau RH. The efficacy and safety of topical tranexamic acid: A systematic review and meta-analysis. Transfus Med Rev. 2018 Feb 19:S0887-7963(17)30151-7. doi: 10.1016/j.tmrv.2018.02.003. Online ahead of print. **PMID:** 29567052 **Citation:** Mallepally AR, Mahajan R, Rustagi T, Goel SA, Das K, Chhabra HS. Use of Topical Tranexamic Acid to Reduce Blood Loss in Single-Level Transforaminal Lumbar Interbody Fusion. Asian Spine J. 2020 Oct;14(5):593-600. doi: 10.31616/asj.2019.0134. Epub 2020 Mar 30. **PMID:** 32213797 **Citation:** Wang F, Wang SG, Yang Q, Nan LP, Cai TC, Wu DS, Zhang L. Cytotoxicity and Effect of Topical Application of Tranexamic Acid on Human Fibroblast in Spine Surgery. World Neurosurg. 2021 Sep;153:e380-e391. doi: 10.1016/j.wneu.2021.06.125. Epub 2021 Jul 2. **PMID:** 34224885 **Citation:** Schwarzkopf R, Dang P, Luu M, Mozaffar T, Gupta R. Topical tranexamic Acid does not affect electrophysiologic or neurovascular sciatic nerve markers in an animal model. Clin Orthop Relat Res. 2015 Mar;473(3):1074-82. doi: 10.1007/s11999-014-4098-4. Epub 2015 Jan 6. **PMID:** 25560955 **Citation:** Ren Z, Li S, Sheng L, Zhuang Q, Li Z, Xu D, Chen X, Jiang P, Zhang X. Topical use of tranexamic acid can effectively decrease hidden blood loss during posterior lumbar spinal fusion surgery: A retrospective study. Medicine (Baltimore). 2017 Oct;96(42):e8233. doi: 10.1097/MD.0000000000008233. **PMID:** 29049210 **Citation:** Sudprasert W, Tanaviriyachai T, Choovongkomol K, Jongkittanakul S, Piyapromdee U. A Randomized Controlled Trial of Topical Application of Tranexamic Acid in Patients with Thoracolumbar Spine Trauma Undergoing Long-Segment Instrumented Posterior Spinal Fusion. Asian Spine J. 2019 Feb;13(1):146-154. doi: 10.31616/asj.2018.0125. Epub 2018 Oct 24. **PMID:** 30347526 **Citation:** Gybel M, Kristensen K, Roseva-Nielsen N. [Cardiac arrest caused by massive pulmonary embolism during treatment with tranexamic acid]. Ugeskr Laeger. 2013 May 13;175(20):1426-7. Danish. **PMID:** 23663400 **Citation:** Taparia M, Cordingley FT, Leahy MF. Pulmonary embolism associated with tranexamic acid in severe acquired haemophilia. Eur J Haematol. 2002 May;68(5):307-9. doi: 10.1034/j.1600-0609.2002.01607.x. **PMID:** 12144537 **Citation:** Krivokuca I, Lammers JW. Recurrent pulmonary embolism associated with a hemostatic drug: tranexamic acid. Clin Appl Thromb Hemost. 2011 Feb;17(1):106-7. doi: 10.1177/1076029609340902. Epub 2009 Oct 14. **PMID:** 19833620 **Citation:** Colomina MJ, Contreras L, Guilabert P, Koo M, M Ndez E, Sabate A. Clinical use of tranexamic acid: evidences and controversies. Braz J Anesthesiol. 2022 Nov-Dec;72(6):795-812. doi: 10.1016/j.bjane.2021.08.022. Epub 2021 Oct 7. **PMID:** 34626756 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: HIGH - As Found: Spine Disease - ID: M1112 - Name: Surgical Wound - Relevance: HIGH - As Found: Surgical Wound - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013122 - Term: Spinal Diseases - ID: D000072836 - Term: Surgical Wound ### Intervention Browse Module - Ancestors - ID: D000000933 - Term: Antifibrinolytic Agents - ID: D000050299 - Term: Fibrin Modulating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000006490 - Term: Hemostatics - ID: D000003029 - Term: Coagulants ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16902 - Name: Tranexamic Acid - Relevance: HIGH - As Found: Stage IV - ID: M4252 - Name: Antifibrinolytic Agents - Relevance: LOW - As Found: Unknown - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M6259 - Name: Coagulants - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000014148 - Term: Tranexamic Acid ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427837 **Brief Title:** Child Snack Variety Study **Official Title:** Child Snack Variety Study #### Organization Study ID Info **ID:** ChildFood802 #### Organization **Class:** OTHER **Full Name:** Penn State University ### Status Module #### Completion Date **Date:** 2024-09-27 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Penn State University #### Responsible Party **Investigator Affiliation:** Penn State University **Investigator Full Name:** Barbara J. Rolls **Investigator Title:** Professor of Nutritional Sciences **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 determine how consumption of a snack food at a first course affects the hedonic ratings of that snack food compared to other foods, and how it affects intake of a second course. The results will have implications for guidance about the provision of snacks for preschool children and may help in identifying strategies for the prevention of obesity in children. ### Conditions Module **Conditions:** - Eating Behavior ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The same snack food will be served in the second course **Intervention Names:** - Other: Same 2nd course **Label:** Same 2nd course **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** A different snack food will be served in the second course **Intervention Names:** - Other: Different 2nd course **Label:** Different 2nd course **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Same 2nd course **Description:** The same snack food will be served in the second course **Name:** Same 2nd course **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Different 2nd course **Description:** A different snack food will be served in the second course **Name:** Different 2nd course **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Weight (grams) of food and water consumed **Measure:** Change between interventions of snack intake by weight **Time Frame:** Study weeks 1 and 2 **Description:** Energy (kcal) of food consumed **Measure:** Change between interventions of snack intake by energy **Time Frame:** Study weeks 1 and 2 #### Secondary Outcomes **Description:** Change between interventions in liking (before to after consumption) of the 5 test foods, measured using a visual analog scale (0-100 points). **Measure:** Change between interventions in liking of each test food **Time Frame:** Study weeks 1 and 2 **Description:** Change in ranked preference (before to after consumption) of the 5 test foods. **Measure:** Change between interventions in ranked preference of each test food from before to after consumption **Time Frame:** Study weeks 1 and 2 **Description:** Change in fullness ratings (before to after consumption) measured using a 4-point scale ranging from empty to full. **Measure:** Change between interventions in fullness ratings from before to after consumption **Time Frame:** Study weeks 1 and 2 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Children who are enrolled in a participating childcare center * Children who are between the ages of 6 and 14 years old at the time of enrollment Exclusion Criteria: * Children who are allergic to any of the foods served * Children whose diets exclude any of the foods served * Children who are absent from the childcare center on study days * Children who are not able to complete study measures (e.g. refuse to eat study foods, only use the anchors or have low variability for their liking ratings, etc.) **Healthy Volunteers:** True **Maximum Age:** 14 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Cara Meehan **Phone:** 814-863-8481 **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:** NCT06427824 **Brief Title:** Comprehensive Geriatric Assessment (Tests) for Bladder Cancer Participants Undergoing Radical Cystectomy **Official Title:** Comprehensive Geriatric Assessment Utilization for Bladder Cancer Patients Undergoing Radical Cystectomy: A Randomized Controlled Trial #### Organization Study ID Info **ID:** IRB23-0773 #### Organization **Class:** OTHER **Full Name:** University of Chicago ### Status Module #### Completion Date **Date:** 2026-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-10-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **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:** University of Chicago #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study focuses on providing an educational program for people/participants with bladder cancer who plan to have a cystectomy (surgery) as part of their standard care. Participants in this study will watch videos designed to teach them strategies to help lower their risk of experiencing negative side effects (such as mobility problems, issues with taking medication, and poor quality of life) before and after they have surgery. They will also be asked to fill out questionnaires. **Detailed Description:** This study focuses on providing an educational program for participants/people with bladder cancer who plan to have a cystectomy (surgery) as part of their standard care. Participants in this study will watch videos designed to teach them strategies to help lower their risk of experiencing negative side effects (such as mobility problems, issues with taking medication, and poor quality of life) before and after they have surgery. The goal of this study is to educate people with bladder cancer and ask them to also fill out questionnaires about the education program and if they used any of the strategies that learn during the study. Participants in this study will be divided into two different study groups (one group that watches educational videos before surgery and one group that watches educational videos before surgery and also receives geriatric services and follow up visits after surgery). Each participant will be randomized (randomly assigned) to one of two study groups. That means that there is a 50/50 chance (like flipping a coin) that each participant will end up in either group. ### Conditions Module **Conditions:** - Bladder Cancer **Keywords:** - cystectomy - radical cystectomy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 85 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this group will attend an educational session in a conference room that includes 4 learning modules on strategies to reduce mobility loss, improve medication management, prevent delirium, and to document what matters most before and after surgery (cystectomy). These learning modules will be in video format. Participants will watch videos to learn about pre/post surgical strategies and they will receive informational handouts after watching the videos. The study team will also ask participants to fill out questionnaires/surveys before and after surgery. **Intervention Names:** - Other: Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery) - Other: Questionnaires **Label:** Participants Who Watch Educational Videos Before Surgery **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in this group will also attend an educational session in a conference room that includes 4 learning modules on strategies to reduce mobility loss, improve medication management, prevent delirium, and to document what matters most before and after surgery (cystectomy). These learning modules will be in video format. Participants will watch videos to learn about pre/post surgical strategies and they will receive informational handouts after watching the videos. The study team will also ask participants to fill out questionnaires/surveys before surgery. In addition to attending the educational program (via video) and receiving informational handouts, participants in this group will also meet with the study doctor and/or members of the study team after surgery to help plan their hospital discharge and reinforce/use the strategies they learned in the educational session after surgery. **Intervention Names:** - Other: Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery) - Other: Geriatric Service/ Discharge Planning - Other: Questionnaires **Label:** Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Participants Who Watch Educational Videos Before Surgery - Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services **Description:** An educational program designed by geriatricians, surgeons, anesthesiologists and palliative care physicians to help people with bladder cancer who plan to receive a cystectomy learn strategies to improve their mobility, medication management, mental clarity/delirium and how they document important side effects or health issues after surgery. **Name:** Educational Video Modules on Risk Prevention Before and After Cystectomy (Surgery) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services **Description:** A geriatric team will meet with participants after surgery to help them reinforce the strategies they learned in the education video sessions. As part of a geriatric service, this team will also help participants plan/coordinate their discharge from the hospital after surgery. **Name:** Geriatric Service/ Discharge Planning **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Participants Who Watch Educational Videos Before Surgery - Participants Who Watch Educational Videos Before Surgery and Receive Geriatric Follow Up Services **Description:** These questionnaires will ask about the participants' mobility, frailty, quality of life and additional health/risk factors before and after surgery. **Name:** Questionnaires **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Assess the feasibility of an educational program designed for participants undergoing radical cystectomy by measuring the number of participants referred to the study team/program. **Measure:** Number of Participants Referred to Educational Program **Time Frame:** 90 days #### Secondary Outcomes **Description:** Assess the acceptability of an educational program designed for participants undergoing radical cystectomy by measuring/surveying the number of study participants who completed at least some of the intervention. **Measure:** Survey responses from participants who completed some or all of educational program **Time Frame:** 90 days **Description:** Assess the adoptability of an educational program designed for participants undergoing radical cystectomy by measuring the number of self-reported interventions that participants reported after the educational program **Measure:** Number of self-reported interventions/strategies used among participants after watching educational videos **Time Frame:** 90 days **Description:** Assess impact of educational program by comparing the differences between hospital readmission rate at 30 days between both study cohorts. **Measure:** 30-day Hospital Readmission Rates Among All Participants **Time Frame:** 30 days **Description:** Assess impact of educational program by comparing the differences between hospital readmission rate at 90 days between both study cohorts. **Measure:** 90-day Hospital Readmission Rates Among All Participants **Time Frame:** 90 days **Description:** Assess impact of educational program by comparing the differences between complication rates reported among study participants in both groups. **Measure:** Complication Rates Reported Among Participants **Time Frame:** 90 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria * Participants capable of giving consent * Participants undergoing radical cystectomy (both for curative and palliative intent) for bladder cancer diagnosed by tissue pathology with urinary diversion at the University of Chicago * Participants undergoing neoadjuvant chemotherapy will be included * Participants will be included regardless of gender, race or ethnicity * Participants greater than or equal to 65 years of age Exclusion Criteria * Radical cystectomy for non-oncologic indications * Palliative cystectomy for cancers other than bladder cancer (i.e. prostate, rectal, cervical) **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Piyush K Agarwal, MD **Phone:** 773-702-3080 **Role:** CONTACT #### Locations **Location 1:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Name:** Piyush Agarwal, MD - **Phone:** 773-702-3080 - **Role:** CONTACT **Country:** United States **Facility:** University of Chicago Medicine Comprehensive Cancer Center **State:** Illinois **Zip:** 60615 #### Overall Officials **Official 1:** **Affiliation:** University of Chicago **Name:** Piyush Agarwal **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL - ICF **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014571 - Term: Urologic Neoplasms - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000001745 - Term: Urinary Bladder Diseases - ID: D000014570 - Term: Urologic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5030 - Name: Urinary Bladder Neoplasms - Relevance: HIGH - As Found: Bladder Cancer - ID: M17320 - Name: Urologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M5026 - Name: Urinary Bladder Diseases - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001749 - Term: Urinary Bladder Neoplasms ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427811 **Acronym:** ASC4INDIA **Brief Title:** Clinical Study of Asciminib in Previously Treated Indian Patients With Ph+ CML-CP Without T315I Mutation and in Patients With Ph+ CML-CP With T315I Mutation **Official Title:** A Prospective, Multicenter, Single-arm, Open-label, Phase IV, Post-authorization Interventional Study to Assess the Safety and Efficacy of Asciminib in Indian Patients With Ph+ CML-CP (Without T315I Mutation), Previously Treated With Two or More Tyrosine Kinase Inhibitors and Ph+ CML-CP With T315I Mutation #### Organization Study ID Info **ID:** CABL001A2005 #### Organization **Class:** INDUSTRY **Full Name:** Novartis ### Status Module #### Completion Date **Date:** 2025-04-23 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-04-23 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Novartis Pharmaceuticals #### 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 Drugs Controller General of India (DCGI) has granted approval for Asciminib film-coated 40 mg tablets on 20 Oct 2023 with the condition to perform a Phase IV clinical study in Indian patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) per the India Prescribing Information (PI). The purpose of this prospective, multicenter, single-arm, open-label, Phase IV study is, therefore, to confirm the safety and efficacy of Asciminib in Indian patients with Ph+ CML-CP (without threonine-315 residue with isoleucine \[T315I\] mutation), previously treated with 2 or more tyrosine kinase inhibitors (TKIs) and patients with Ph+ CML-CP with T315I mutation. **Detailed Description:** This is a Phase IV, prospective, multicenter, single-arm, open-label, post-authorization interventional study to assess the safety and efficacy of asciminib in Indian participants with Ph+ CML-CP (without T315I mutation), previously treated with 2 or more TKIs and participants with Ph+ CML-CP with T315I mutation irrespective of the line of treatment. The study will include 3 periods: a screening period (up to 21 days), a treatment period of up to 6 months with asciminib (with dosing according to mutation status), and a safety follow-up period for 30 days after the last dose of the study treatment. Completion of the safety follow-up period after the last dose of the study treatment will be considered as the End of Study (EOS). After obtaining the written informed consent form (ICF) from the participant or their legally authorized representatives (LARs), the participants will undergo screening procedures to confirm their eligibility for the study. The results of the breakpoint cluster region gene-Abelson proto-oncogene 1, nonreceptor tyrosine kinase gene (BCR::ABL1) real-time quantitative polymerase chain reaction (RQ-PCR) as well as the T315I mutation report need to be established and documented prior to enrollment into the study in the screening period in line with the inclusion criteria of the study. Participants with previously documented T315I mutated CML-CP will be directly considered for the screening procedures. If the status of the T315I mutation is not known, the participant will undergo a standardized Sanger sequencing/PCR/next-generation sequencing (NGS)-based T315I mutation test (as per the availability at the site). ### Conditions Module **Conditions:** - Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase **Keywords:** - ABL001 - Asciminib - Ph+ CML-CP - T315I mutation - Ph+ CML-CP without T315I mutation - Ph+ CML-CP with the T315I mutation - Myelogenous - Chronic - Chronic Myeloid Leukemia - Ph1 Positive Myeloid Leukemia - Philadelphia Positive Myeloid Leukemia - BCR-ABL Positive - Post-authorization Interventional Study - Tyrosine Kinase Inhibitors - TKI - Chronic Leukemia - Ph1 Positive Leukemia - Without T315I mutation - with the T315I mutation ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 85 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 80 mg once daily at approximately the same time each day or 40 mg twice daily per Investigator's discretion at approximately 12-hour intervals **Intervention Names:** - Drug: Asciminib **Label:** Asciminib 80 mg **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 200 mg twice daily at approximately 12-hour intervals **Intervention Names:** - Drug: Asciminib **Label:** Asciminib 200 mg **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Asciminib 200 mg - Asciminib 80 mg **Description:** Film-coated tablets with 40 mg dose strength taken orally **Name:** Asciminib **Other Names:** - ABL001 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Frequency and severity of adverse events(AEs)/serious AEs (SAEs) in participants with Ph+ CML-CP (without T315I mutation), previously treated with 2 or more TKIs up to 6 months **Measure:** Frequency and severity of adverse events(AEs)/serious AEs (SAEs) in participants with Ph+ CML-CP without T315I mutation **Time Frame:** up to 6 months **Description:** Frequency and severity of AEs/SAEs in participants with Ph+ CML-CP with T315I mutation up to 6 months **Measure:** Frequency and severity of AEs/SAEs in participants with Ph+ CML-CP with T315I mutation **Time Frame:** up to 6 months #### Secondary Outcomes **Description:** Percentage of participants with dose interruptions, reductions, and discontinuation up to 6 months. **Measure:** Percentage of participants with dose interruptions, reductions, and discontinuation (without T3151 mutation) **Time Frame:** up to 6 months **Description:** A CHR is defined as the presence of all of the following for ≥4 weeks: white blood count (WBC) \<10 x 109/L, platelet count \<450 x 109/L, basophils \<5%, no blasts and promyelocytes in peripheral blood, myelocytes + metamyelocytes \<5% in peripheral blood, no evidence of extramedullary disease, including spleen and liver. **Measure:** Percentage of participants achieving a complete hematologic response (CHR) at 3 and 6 months (without T3151 mutation) **Time Frame:** 3 months, 6 months **Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample. Early molecular response (EMR) is defined as ≤10% BCR::ABL1 international scale (IS). **Measure:** Percentage of participants achieving early molecular response (EMR) at 3 and 6 months (without T3151 mutation) **Time Frame:** 3 months, 6 months **Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample. The rate of MR2 is defined as ≥2 log reduction of BCR::ABL (transcript from standardized baseline or ≤1% BCR::ABL/ABL1 % by IS), measured by RQ-PCR. **Measure:** Percentage of participants achieving molecular response (MR2) at 3 and 6 months (without T3151 mutation) **Time Frame:** 3 months, 6 months **Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample. Major molecular response (MMR) is defined as ≤0.1% BCR::ABL1 on the IS. **Measure:** Percentage of participants achieving major molecular response (MMR) at 3 and 6 months (without T3151 mutation) **Time Frame:** 3 months, 6 months **Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample. MR4 is defined ≤0.01% BCR::ABL1 on the IS. MR4.5 is defined as ≤0.0032% BCR::ABL1 on the IS. **Measure:** Percentage of participants achieving molecular response of MR4 and MR4.5 at 3 and 6 months of the treatment period (without T3151 mutation) **Time Frame:** 3 months, 6 months **Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Time to achieve complete hematologic response (without T3151 mutation) **Time Frame:** up to 6 months **Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Time to achieve early molecular response (EMR) (without T3151 mutation) **Time Frame:** up to 6 months **Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Time to achieve mplecular response (MR2) (without T3151 mutation) **Time Frame:** up to 6 months **Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Time to achieve major molecular response (MMR) (without T3151 mutation) **Time Frame:** up to 6 months **Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Time to achieve MR4 and MR4.5 (without T3151 mutation) **Time Frame:** up to 6 months **Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Duration of CHR (without T3151 mutation) **Time Frame:** up to 6 months **Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Duration of EMR (without T3151 mutation) **Time Frame:** up to 6 months **Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Duration of MR2 (without T3151 mutation) **Time Frame:** up to 6 months **Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Duration of MMR (without T3151 mutation) **Time Frame:** up to 6 months **Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Duration of MR4 & MR4.5 (without T3151 mutation) **Time Frame:** up to 6 months **Description:** Percentage of participants with dose interruptions, reductions, and discontinuation up to 6 months. **Measure:** Percentage of participants with dose interruptions, reductions, and discontinuation (with T315I mutation) **Time Frame:** up to 6 months **Description:** A CHR is defined as the presence of all of the following for ≥4 weeks: white blood count (WBC) \<10 x 109/L, platelet count \<450 x 109/L, basophils \<5%, no blasts and promyelocytes in peripheral blood, myelocytes + metamyelocytes \<5% in peripheral blood, no evidence of extramedullary disease, including spleen and liver. **Measure:** Percentage of participants achieving a CHR at 3 and 6 months of the treatment period (with T315I mutation) **Time Frame:** up to 6 months **Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample. Early molecular response (EMR) is defined as ≤10% BCR::ABL1 international scale (IS). **Measure:** Percentage of participants achieving EMR at 3 and 6 months of the treatment period (with T315I mutation) **Time Frame:** up to 6 months **Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample. The rate of MR2 is defined as ≥2 log reduction of BCR::ABL (transcript from standardized baseline or ≤1% BCR::ABL/ABL1 % by IS), measured by RQ-PCR. **Measure:** Percentage of participants achieving MR2 at 3 and 6 months of the treatment period (with T315I mutation) **Time Frame:** up to 6 months **Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample. Major molecular response (MMR) is defined as ≤0.1% BCR::ABL1 on the IS. **Measure:** Percentage of participants achieving MMR at 3 and 6 months of the treatment period (with T315I mutation) **Time Frame:** up to 6 months **Description:** Levels of BCR::ABL1 transcripts will be determined by RQ-PCR testing of peripheral blood and analyzed at a central testing laboratory. Log reduction in BCR::ABL1 transcripts levels from the standardized baseline value, or the percent ratio of BCR::ABL1 transcripts versus control gene (ABL1) transcripts converted to a reference standard, will be calculated for each sample. MR4 is defined ≤0.01% BCR::ABL1 on the IS. MR4.5 is defined as ≤0.0032% BCR::ABL1 on the IS. **Measure:** Percentage of participants achieving MR4 and MR4.5 at 3 and 6 months of the treatment period (with T315I mutation) **Time Frame:** up to 6 months **Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Time to achieve CHR during the treatment period (with T315I mutation) **Time Frame:** Up to 6 months **Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Time to achieve EMR during the treatment period (with T315I mutation) **Time Frame:** Up to 6 months **Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Time to achieve MR2 during the treatment period (with T315I mutation) **Time Frame:** Up to 6 months **Description:** ime to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Time to achieve MMR during the treatment period (with T315I mutation) **Time Frame:** Up to 6 months **Description:** Time to achieve a response level (hematologic or molecular) is defined as the time from the date of the first dose of study treatment to the first documented achievement of each defined response level. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Time to achieve MR4 and MR4.5 during the treatment period (with T315I mutation) **Time Frame:** Up to 6 months **Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Duration of CHR during the treatment period (with T315I mutation) **Time Frame:** Up to 6 months **Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Duration of EMR during the treatment period (with T315I mutation) **Time Frame:** Up to 6 months **Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Duration of MR2 during the treatment period (with T315I mutation) **Time Frame:** Up to 6 months **Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Duration of MMR during the treatment period (with T315I mutation) **Time Frame:** Up to 6 months **Description:** Duration of Response (DOR) is the time from the date of the first documented hematologic or molecular response level to the date of the first documented loss of the response level or death due to any cause, whichever occurs first. It will be calculated for the treatment duration ie, up to 6 months from baseline. **Measure:** Duration of MR4 and MR4.5 during the treatment period (with T315I mutation) **Time Frame:** Up to 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male or female participants ≥18 years of age at the screening visit with a confirmed diagnosis of Ph+ CML-CP. Participants must meet all of the following laboratory values as confirmed by the available reports of the peripheral blood test or bone marrow examination (performed within 12 months before the screening) at the screening visit to meet the criteria of Ph+ CML-CP: * \<15% blasts in peripheral blood and/or bone marrow * \<30% blasts plus promyelocytes in peripheral blood and/or bone marrow * \<20% basophils in the peripheral blood * ≥50 x 109/L (≥50,000/mm3) platelets# * No evidence of extramedullary leukemic involvement, apart from hepatosplenomegaly. #Transient prior therapy related thrombocytopenia (\<50,000/mm3 for ≤30 days prior to screening) is acceptable. - a. For Ph+ CML-CP participants with T315I mutation, mutational analysis testing at any time point showing a documented T315I mutation. b. For Ph+ CML-CP participants without T315I mutation, at least 2 prior ATP-site TKIs (i.e., imatinib, nilotinib, bosutinib, dasatinib, or ponatinib) with failure\* (adapted from the 2020 European LeukemiaNet \[ELN\] Recommendations) or intolerance\*\* to the most recent TKI therapy at the time of screening. \*Failure for Ph+ CML-CP participants (CP at the time of initiation of last therapy) is defined as meeting at least one of the following criteria: * Three months after the initiation of therapy: \>10% BCR::ABL1 on IS if confirmed within 1-3 months * Six months after the initiation of therapy: BCR::ABL1 ratio \>10% IS * Twelve months after initiation of therapy: BCR::ABL1 ratio \>1% IS * At any time after the initiation of therapy, loss of CHR, MR2 * At any time after the initiation of therapy, the development of new BCR::ABL1 mutations which potentially cause resistance to current treatment * At any time 12 months after the initiation of therapy, BCR::ABL1 ratio ≥1% IS or loss of MMR * At any time after the initiation of therapy, new clonal chromosome abnormalities in Ph+ cells (CCA/Ph+) \*\*Intolerance is defined as: * Non-hematologic toxicity: Participants with grade .3 or 4 toxicity while on therapy, or with persistent grade 2 toxicity, unresponsive to optimal management,including dose adjustments (unless dose reduction is not considered in the best interest of the participant if the response is already suboptimal) * Hematologic toxicity: Participants with grade 3 or 4 toxicity (absolute neutrophil count \[ANC\] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses recommended by India PI. * ECOG performance status of 0, 1, or 2. * Evidence of typical BCR::ABL1 transcript (e14a2 and/or e13a2) at the time of screening which is amenable to standardized RQ-PCR quantification. * Participants must have adequate end organ function as per the investigator's judgement. * Participants must have the following electrolyte values within normal limits or corrected to be within normal limits with supplements prior to the first dose of study treatment: * Potassium (potassium increase of up to 6.0 mmol/L is acceptable at study entry if associated with creatinine clearance within normal limits) * Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dL or 3.1 mmol/L is acceptable at study entry if associated with creatinine clearance within normal limits) * Magnesium, except for magnesium increase \>upper level of normal (ULN) - 3.0 mg/dL or \>ULN - 1.23 mmol/L associated with creatinine clearance (calculated using Cockcroft-Gault formula) within normal limits. Exclusion Criteria: * Known second chronic phase of CML after previous progression to CML-AP/CML-BC. * Previous treatment with a hematopoietic stem-cell transplantation. * Cardiac or cardiac repolarization abnormality, including any of the following: * History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, and coronary artery bypass graft (CABG) * Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block) * QT corrected for heart rate by Fridericia's cube root formula (QTcF) at screening ≥450 msec (both male and female participants) * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: * Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia. * Inability to determine the QTcF interval.1. Known second chronic phase of CML after previous progression to CML-AP/CML-BC. * Previous treatment with a hematopoietic stem-cell transplantation. * Cardiac or cardiac repolarization abnormality, including any of the following: * History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, and coronary artery bypass graft (CABG) * Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block) * QT corrected for heart rate by Fridericia's cube root formula (QTcF) at screening ≥450 msec (both male and female participants) * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: * Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia. * Inability to determine the QTcF interval * Concomitant medication(s) with a "Known risk of TdP" (per www.crediblemeds.org) that cannot be discontinued or replaced 7 days prior to starting study treatment by safe alternative medication. * Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g., uncontrolled diabetes, active or uncontrolled infection, pulmonary hypertension). * History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis. * Known infection with human immunodeficiency virus (HIV) or active hepatitis B or C. * Known presence of significant congenital or acquired bleeding disorder unrelated to cancer. * History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively. * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery). * Previous treatment with or known/suspected hypersensitivity to asciminib or any of its excipients. * Participants must avoid consumption of grapefruit, Seville oranges, or products containing the juice of each during the entire study and 7 days before the first dose of study treatment, due to potential CYP3A4 interaction with the study treatment. Orange juice is allowed. Participants must avoid consumption of over-the-counter medications or herbal supplements as these can interact with each other and may alter the effects of asciminib. * Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer. * Pregnant or breastfeeding women. * Women of childbearing potential, defined as all women physiologically capable of becoming pregnant unless they are using highly effective methods of contraception. Highly effective contraception methods include: * Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. * Female sterilization (have had surgical bilateral oophorectomy (with or without hysterectomy) total hysterectomy or bilateral tubal ligation at least 6 weeks before taking study treatment). In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. * Male sterilization (vasectomy) of the male partner(s) of the female participant at least 6 months prior to screening. The vasectomized male partner should be the sole partner for that participant. * Use of oral, injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example, hormone vaginal ring or transdermal hormone contraception. In the case of the use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment. * Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least 6 weeks before taking study treatment. In the case of oophorectomy alone, women are considered menopausal and not of childbearing potential only when the reproductive status of the woman has been confirmed by a follow-up hormone level assessment. - If a participant is presenting with symptoms suggestive of possible Coronavirus Disease (COVID-19) infection, advise ruling it out by appropriate testing recommended by health authorities. * Nucleic acid amplification tests for viral RNA (polymerase chain reaction), to measure current infection with SARS-CoV-2 * Antigen tests for rapid detection of SARS-CoV-2 * Antibody (serology) tests to detect the presence of antibodies to SARS-CoV-2. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Novartis Pharmaceuticals **Phone:** +41613241111 **Role:** CONTACT **Contact 2:** **Name:** Novartis Pharmaceuticals **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Novartis Pharmaceuticals **Name:** Novartis Pharmaceuticals **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com **IPD Sharing:** YES **URL:** https://www.clinicalstudydatarequest.com ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases - ID: D000009196 - Term: Myeloproliferative Disorders - ID: D000001855 - Term: Bone Marrow Diseases - ID: D000002908 - Term: Chronic Disease - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000014178 - Term: Translocation, Genetic - ID: D000002869 - Term: Chromosome Aberrations ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10955 - Name: Leukemia, Myeloid - Relevance: HIGH - As Found: Myeloid Leukemia - ID: M18123 - Name: Leukemia, Myelogenous, Chronic, BCR-ABL Positive - Relevance: HIGH - As Found: Chronic Myeloid Leukemia - ID: M13582 - Name: Philadelphia Chromosome - Relevance: HIGH - As Found: Philadelphia Chromosome - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M12149 - Name: Myeloproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M5134 - Name: Bone Marrow 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: M16932 - Name: Translocation, Genetic - Relevance: LOW - As Found: Unknown - ID: M6109 - Name: Chromosome Aberrations - Relevance: LOW - As Found: Unknown - ID: T3995 - Name: Myeloid Leukemia - Relevance: HIGH - As Found: Myeloid Leukemia - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T1309 - Name: Chronic Myeloid Leukemia - Relevance: HIGH - As Found: Chronic Myeloid Leukemia - ID: T1311 - Name: Chronic Myeloproliferative Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000007951 - Term: Leukemia, Myeloid - ID: D000015464 - Term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive - ID: D000010677 - Term: Philadelphia Chromosome ### Intervention Browse Module - Ancestors - ID: D000092004 - Term: Tyrosine Kinase Inhibitors - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M81032 - Name: Asciminib - Relevance: HIGH - As Found: Domestic - ID: M2889 - Name: Tyrosine Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M25820 - Name: Protein Kinase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T22 - Name: Tyrosine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000621806 - Term: Asciminib ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427798 **Brief Title:** Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR+ Gastrointestinal Neuroendocrine Tumor and Pheochromocytoma/Paraganglioma Previously Treated With Systemic Targeted Radioligand Therapy **Official Title:** Phase I/II Trial of Systemic Targeted Radioligand Therapy (TRT) With Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR Positive (SSTR+) Gastrointestinal (GI) Neuroendocrine Tumors (NET) and Pheochromocytoma/ Paragangliomas Previously Treated With Systemic Radiolig and Therapy #### Organization Study ID Info **ID:** 10001711 #### Organization **Class:** NIH **Full Name:** National Institutes of Health Clinical Center (CC) #### Secondary ID Infos **ID:** 001711-C ### Status Module #### Completion Date **Date:** 2039-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-06 **Type:** ESTIMATED **Last Update Submit Date:** 2024-06-05 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2029-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-11 **Type:** ESTIMATED **Status Verified Date:** 2024-05-22 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-23 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NIH **Name:** National Cancer Institute (NCI) #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** Background: Gastrointestinal neuroendocrine tumors (GI NET) are a type of cancer that affects the stomach and intestines; pheochromocytoma/paragangliomas (PPGL) are tumors that grow in or near the adrenal glands. Both of these types of tumor have high levels of a protein called somatostatin receptors (SSTR) on their surfaces. Researchers want to test a treatment that targets SSTR. Objective: To test a drug (\[212Pb\]VMT-alpha-NET) in people with GI NET or PPGL. The drug has 2 components: a protein to bind to SSTR and a radioactive agent to kill the cancer cells. Eligibility: Adults aged 18 years or older with GI NET or PPGL tumors that have spread and cannot be removed with surgery. Design: Participants will be screened. They will have a physical exam, with imaging scans, blood tests, and tests of their heart function. \[212Pb\]VMT-alpha-NET is given through a tube attached to a needle inserted into a vein (infusion). Treatment will be given in four 8 week cycles. Participants will receive the drug on the first day of each cycle. They will remain in the clinic at least 4 hours after each infusion and may nee to stay in th hospital for up to 48 hour for monitoring and testing. They will have blood tests every week of each cycle. Some participants will also get a related study drug (\[203Pb\]VMT-alpha-NET). They will receive this drug a few days before the first 2 cycles. At 4, 24, and 48 hours after each infusion, they will have whole body scans. These scans will show where the study drug went in their body. Follow-up visits will continue for 10 years.... **Detailed Description:** Background: * Somatostatin receptors (SSTR) have been shown to be over-expressed in a number of human tumors, including gastrointestinal (GI) neuroendocrine tumors (NET) and pheochromocytoma/paragangliomas (PPGL) * Targeted radioligand therapy (TRT) is a class of cancer therapeutic agents formed by attaching a radioactive isotope to a ligand that can target specific surface receptors such as SSTR on a tumor cell membrane. Efficacy is typically determined by the radiation dose deposited onto a tumor, which is determined by the radioactive isotope being used as well as the binding characteristics of the ligand-receptor/transporter pair * While there have been clinical successes with treating gastrointestinal neuroendocrine tumors (GI NET) and PPGL with SSTR-targeting beta-emitting TRTs, tumors will invariably start to progress after some time. Re-treatment using the same beta-emitting agents at the time of progression can be done but has decreased efficacy compared to the TRT-naive setting * Alpha emitters such as 212Pb emit alpha particles that are more damaging to tumor cells than beta emitters such as 177Lu. Therefore, TRT agents using alpha emitters are considered to be more potent and could be better than betas in the re-treatment setting * VMT-alpha-NET is a peptide that binds to SSTR, which when attached to 212Pb becomes an alpha particle-emitting TRT that can be used to treat tumors that have SSTR surface expression * \[203Pb\]VMT-alpha-NET is the chemically identical imaging surrogate for \[212Pb\]VMT-alpha-NET and has the same mechanism of action via binding to SSTR2. The nuclide 203Pb contained in \[203Pb\]VMT-alpha-NET emits gamma radiation suitable for single-photon emission computerized tomography (SPECT) imaging. These images can be used to assess drug product biodistribution throughout the body Objectives: * Phase I: To determine the maximal tolerated dose (MTD) of \[212Pb\]VMT-alpha-NET using a 3+3 dose escalation design in GI NET and PPGL in a re-treatment setting * Phase II: To determine the Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors 1.1 of participants treated with \[212Pb\]VMT-alpha-NET at the MTD at the completion of 4 cycles of treatment, reported by disease groups Eligibility: * Age \>= 18 years * Histopathologically confirmed GI NET or PPGL that are metastatic or inoperable * At least 1 prior systemic radioligand therapy * Eastern Cooperative Oncology Group (ECOG) Performance Status \<= 1 Design: * This is an open-label, single-arm, single-center, phase I/II study evaluating the safety, preliminary efficacy, and pharmacokinetic properties of \[212Pb\]VMT-alpha-NET in GI NET and PPGL in a re-treatment setting * Phase I participants will be accrued using a 3+3 dose escalation design with 3 dose levels to estimate MTD of \[212Pb\]VMT-alpha-NET. Once MTD is estimated, Phase II participants with GI NET and PPGL will be accrued in separate cohorts and treated at MTD of \[212Pb\]VMT-alpha-NET * \[212Pb\]VMT-alpha-NET will be given IV every 8 weeks for a total of 4 administrations * A subset of participants (Dosimetry Arm 1) will have \[203Pb\]VMT-alpha-NET administration followed by whole-body gamma scans combined with dosimetry SPECT/ Computed Tomography (CT) scans and collection of blood and urine samples prior to the first and the second doses of \[212Pb\]VMT-alpha-NET (Cycles 1-2) * All participants will undergo serial whole-body dose rate measurements after \[203Pb\]VMT-alpha-NET and/or \[212Pb\]VMT-alpha-NET administration * Participants will have timed clinical laboratory evaluations, imaging studies, and research blood, and urine samples while on the study therapy for safety and efficacy evaluations * Following completion of treatment, participants will be seen at the NIH Clinical Center approximately 30 days later, every 12 weeks for years 1-3, every 6 months for years 4-6 for safety and efficacy assessments. Beyond 6 years, participants will be contacted annually through any NIH-approved platform to assess for overall survival and health status * The overall study accrual ceiling will be set to 53 participants ### Conditions Module **Conditions:** - Somatostatin Receptor Positive - Gastrointestinal Neuroendocrine Tumors - Pheochromocytoma - Paragangliomas **Keywords:** - 212Pb - Targeted Therapy - Image-Guided Dosimetry - VMT- -NET ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 53 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Escalating doses of \[212Pb\]VMT-alpha-NET, imaging with \[203Pb\]VMT-alpha-NET. **Intervention Names:** - Drug: 68Ga-DOTATATE - Drug: [203Pb]VMT-alpha-NET - Drug: [212Pb]VMT-alpha-NET **Label:** 1/Dosimetry Arm 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Escalating doses of \[212Pb\]VMT-alpha-NET. **Intervention Names:** - Drug: 68Ga-DOTATATE - Drug: [212Pb]VMT-alpha-NET **Label:** 2/Arm 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** \[212Pb\]VMT-alpha-NET at MTD. **Intervention Names:** - Drug: 68Ga-DOTATATE - Drug: [212Pb]VMT-alpha-NET **Label:** 3/Arm 3 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 1/Dosimetry Arm 1 - 2/Arm 2 - 3/Arm 3 **Description:** 68Ga-DOTATATE PET/CT whole-body scanning will be done at target dose of 5 mCi. The whole-body PET/CT scan will be started approximately 60 minutes after the tracer injection and will take up to 2 hours. **Name:** 68Ga-DOTATATE **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 1/Dosimetry Arm 1 **Description:** \[203Pb\]VMT-alpha-NET (6 mCi) will be given IV at 7 days prior. **Name:** [203Pb]VMT-alpha-NET **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - 1/Dosimetry Arm 1 - 2/Arm 2 - 3/Arm 3 **Description:** \[212Pb\]VMT-alpha-NET will be given IV on Day 1 of every cycle for 4 cycles total at escalating doses in Phase I and at MTD during Phase II. One cycle is 8 weeks. **Name:** [212Pb]VMT-alpha-NET **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The MTD will be presented as a recommended dose to be used as the recommended phase II dose (RP2D) for the combined participant population, as well as for each disease group being studied (GI-NET, PPGL). **Measure:** Phase I: MTD of [212Pb]VMT-alpha-NET using a 3+3 dose escalation design in GI NET and PPGL in a re-treatment setting **Time Frame:** DLT period (through 12 weeks after initial 212Pb]VMT-alpha-NET administration). **Description:** The overall response rate will be presented as a percentage along with 95% confidence intervals. Only evaluable participants will be included. **Measure:** Phase II: ORR by RECIST 1.1 of participants treated with [212Pb]VMT-alpha-NET at the MTD at the completion of 4 cycles of treatment, reported by disease groups **Time Frame:** Baseline until progression or 6 years after receiving the first infusion of study drug. #### Secondary Outcomes **Description:** PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Kaplan-Meier curves of PFS will be constructed. Median PFS will be reported with 95% confidence intervals. **Measure:** Progression Free Survival **Time Frame:** Baseline until progression or 10 years after receiving the first infusion of study drug **Description:** Descriptive tabulations of toxicity will be provided, along with the agent attribution determination and CTCAE grade for each toxicity event. The data will be presented as an absolute count of the event at a participant level as well as a percentage of total evaluable participants. **Measure:** Safety of [203Pb]VMT-alpha-NET and [212Pb]VMT-alpha-NET **Time Frame:** Study duration **Description:** Kaplan-Meier curves of OS, will be constructed. Median OS will be reported with 95% confidence intervals. **Measure:** Overall Survival **Time Frame:** Baseline until progression or 10 years after receiving the first infusion of study drug **Description:** PK data will be represented as a scatter plot graphing time vs. the amount of radioactivity found in blood and urine samples. **Measure:** PK properties of [212Pb]VMT-alpha-NET via blood and urine sampling **Time Frame:** After every infusion of [212Pb]VMT-alpha-NET **Description:** Biodistribution and dosimetry data will be represented in a tabular format which indicates the percentage of the injected dose calculated to be in each of the major organs using gamma scan results. Radiation dose calculations will be performed using OLINDA/EXM software. Absorbed doses in organs and the whole body will be determined using the appropriate adult phantom (e.g., adult male, adult female). Tumor lesion absorbed doses will be determined using the sphere model in OLINDA. **Measure:** Dosimetry properties of [212Pb]VMT-alpha-NET via SPECT/CT, using [203Pb]VMT-alpha-NET as a surrogate with and without the administration of amino acids (Dosimetry Arm 1 only) **Time Frame:** In Dosimetry Arm 1 after every [203Pb]VMT-alpha-NET infusion ### Eligibility Module **Eligibility Criteria:** * INCLUSION CRITERIA: * Participants must have histopathologically confirmed gastrointestinal neuroendocrine tumors (GI NET) or pheochromocytoma/paraganglioma (PPGL) cancers that are metastatic or inoperable per Standard of Care. * Have received at least 1 prior systemic radioligand therapy for definitive therapeutic purposes. Note: Participants with prior external beam radiation treatment (EBRT) will also be eligible as long as they have had at least 1 prior administration of a systemic radioligand therapy. * Must have at least 1 measurable lesion by RECIST 1.1 (phase II only). * History of progression by imaging (e.g., RECIST 1.1) or clinically (defined as increase in severity or frequency of symptoms related to disease) within the past 36 months prior to the first dose of \[203Pb\]VMT-alpha-NET. * Evidence of somatostatin receptors (SSTR) expression on at least 50% of the radiographically identifiable (i.e., visible on an anatomic scan such as CT or magnetic resonance imaging \[MRI\]) tumor, as indicated by a positive (uptake qualitatively identifiable as above the local background) on SSTR PET scan. * Age \>= 18 years. * ECOG performance status \<= 1. * Participants must have adequate organ and marrow function as defined below: * Leukocytes: 3,000/microliter * Absolute Neutrophil Count: 1,500/microliter * Platelets: 100,000/miroliter * Hemoglobin: \>= 9.0 g/dL * Total bilirubin: within normal institutional limits. Note: \<= 5 X institutional upper limit of normal (ULN) if bilirubin elevation is due to a benign process such as Gilbert syndrome * AST: \<= 2.5 X institutional ULN * ALT: \<= 2.5 X institutional ULN * Creatinine: within normal institutional limits OR * Calculated creatinine clearance (glomerular filtration rate (eGFR): \>= 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal * Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression at screening. * Participants with new or progressive brain metastases or leptomeningeal disease are eligible as long as the participant is asymptomatic and not requiring medication for symptom control from the brain lesions at screening. * Participants seropositive for human immunodeficiency virus (HIV) must: * be on effective anti-retroviral therapy; and * have an undetectable viral load at screening. * Participants seropositive for hepatitis B virus (HBV), must have HBV viral load undetectable at screening. -Participants seropositive for hepatitis C virus (HCV) must: * received curative treatment; and * have an undetectable HCV viral load at screening. * Participants may enroll in this study while on another therapeutic trial in order to start the screening process. However, all other investigational agents should be stopped at least 28 days prior to receiving \[203Pb\]VMT-alpha-NET. * Women of child-bearing potential (WOCBP) and men must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \[IUD\], surgical sterilization, abstinence) at study entry and up to 6 months after the last dose of the study agent(s). * Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6 months after the last dose of the study agents. * The ability of the participant to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * History of allergic reactions attributed to compounds of similar chemical or biologic composition to VMT-alpha-NET. * Positive Beta human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening. * QTc \> 450 ms on electrocardiogram (EKG) at screening. Note: Framingham correction for QTc will be used * History of or detection at screening of active/untreated secondary malignancy except nonmelanoma skin cancer and carcinoma in situ of the uterine cervix. * Uncontrolled intercurrent illness, factors, evaluated by medical history and physical exam which would potentially increase in the risk of the participant. **Maximum Age:** 120 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Joy Zou, R.N. **Phone:** (240) 760-6153 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Frank I Lin, M.D. **Phone:** (240) 760-6166 **Role:** CONTACT #### Locations **Location 1:** **City:** Bethesda **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** National Cancer Institute Referral Office - **Phone:** 888-624-1937 - **Role:** CONTACT **Country:** United States **Facility:** National Institutes of Health Clinical Center **State:** Maryland **Zip:** 20892 #### Overall Officials **Official 1:** **Affiliation:** National Cancer Institute (NCI) **Name:** Frank I Lin, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Data from this study may be requested by contacting the PI. **Description:** .All IPD recorded in the medical record will be shared with intramural investigators upon request. This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review. **Info Types:** - STUDY_PROTOCOL - SAP - ICF **IPD Sharing:** YES **Time Frame:** Data from this study may be requested by other researchers after the completion of the primary endpoint. ### References Module #### See Also Links **Label:** NIH Clinical Center Detailed Web Page **URL:** https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_001711-C.html ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017599 - Term: Neuroectodermal Tumors - ID: D000009373 - Term: Neoplasms, Germ Cell and Embryonal - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000009380 - Term: Neoplasms, Nerve Tissue - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000004701 - Term: Endocrine Gland Neoplasms - ID: D000010182 - Term: Pancreatic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000013272 - Term: Stomach Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13578 - Name: Pheochromocytoma - Relevance: HIGH - As Found: Pheochromocytoma - ID: M13149 - Name: Paraganglioma - Relevance: HIGH - As Found: Paraganglioma - ID: M20495 - Name: Neuroendocrine Tumors - Relevance: HIGH - As Found: Neuroendocrine Tumors - ID: M10448 - Name: Intestinal Neoplasms - Relevance: HIGH - As Found: Gastrointestinal Neuroendocrine Tumor - ID: M13110 - Name: Pancreatic Neoplasms - Relevance: HIGH - As Found: Gastrointestinal Neuroendocrine Tumor - ID: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastrointestinal Neuroendocrine Tumor - 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: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7863 - Name: Endocrine Gland Neoplasms - Relevance: LOW - As Found: Unknown - ID: M13102 - Name: Pancreatic Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown - ID: T4530 - Name: Pheochromocytoma - Relevance: HIGH - As Found: Pheochromocytoma - ID: T4409 - Name: Paragangliomas 1 - Relevance: HIGH - As Found: Paraganglioma - ID: T4091 - Name: Neuroendocrine Tumor - Relevance: HIGH - As Found: Neuroendocrine Tumors - ID: T2442 - Name: Gastro-enteropancreatic Neuroendocrine Tumor - Relevance: HIGH - As Found: Gastrointestinal Neuroendocrine Tumor - ID: T4387 - Name: Pancreatic Cancer - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000018358 - Term: Neuroendocrine Tumors - ID: D000010673 - Term: Pheochromocytoma - ID: D000010235 - Term: Paraganglioma - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000010190 - Term: Pancreatic Neoplasms - ID: D000013274 - Term: Stomach Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M15806 - Name: Somatostatin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427785 **Brief Title:** The Effect of Wavelet Index in Monitoring the Sedation Depth of Remimazolam Besylate **Official Title:** The Effect of Wavelet Index in Monitoring the Sedation Depth of Remimazolam Besylate #### Organization Study ID Info **ID:** 2024-ke-75 #### Organization **Class:** OTHER **Full Name:** Beijing Chao Yang Hospital ### Status Module #### Completion Date **Date:** 2025-05-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-05-17 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-04-11 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Chao Yang Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To explore the sedative effect of remimazolam in patients undergoing spinal anesthesia without pain stimulation. Both the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) and the Wavelet index (WLi) were used to monitor the depth of anesthesia of remimazolam, and exploring the correlation and consistency between MOAA/S score and WLi value at the same time. **Detailed Description:** Patients undergoing spinal anesthesia were received remimazolam besylate for sedation continuously. Both the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) and the Wavelet index (WLi) were used to monitor the depth of anesthesia of remimazolam, and exploring the correlation and consistency between MOAA/S score and WLi value at the same time. ### Conditions Module **Conditions:** - Remimazolam - Anesthesia Awareness - Sedative, Hypnotic, or Anxiolytic Withdrawal **Keywords:** - Wavelet Index - Remimazolam - Depth of Sedation ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Thirty patients underwent elective lower extremity surgery receive spinal anesthesia, and then, remimazolam besylate was given intravenously with an induction dose of 3mg/min. When the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score was ≤1, remimazolam besylate was maintained at 1mg/min for 24min, and finally stopped. Wavelet index, MOAA/S score, blood pressure, heart rate, respiratory rate, and pulse oxygen saturation were continuously monitored during the period. **Intervention Names:** - Drug: Remimazolam besylate **Label:** Remimazolam group ### Interventions #### Intervention 1 **Arm Group Labels:** - Remimazolam group **Description:** Thirty patients underwent elective lower extremity surgery receive spinal anesthesia, and then remimazolam besylate was given intravenously with an induction dose of 3mg/min. When the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score was ≤1, remimazolam besylate was maintained at 1mg/min for 24min, and finally stopped. Wavelet index, MOAA/S score, blood pressure, heart rate, respiratory rate, and pulse oxygen saturation were continuously monitored during the period. **Name:** Remimazolam besylate **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Sedation was assessed using the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scale. It ranges from 5(alert) to 0(deep sedation). Wavelet index (WLi) is a parameter that potentially could be used to regulate the sedative depth of anesthesia. The range of WLi values is 0-100, with a value of 0 indicating no EEG activity, a value of 100 indicating complete wakefulness, and a value of 40-60 taken to indicate an appropriate level of general anesthesia. **Measure:** The value of the Wavelet index (WLi) when MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score ≤ 1. **Time Frame:** Through study completion, an average of 1 day #### Secondary Outcomes **Description:** Sedation was assessed using the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scale. It ranges from 5(alert) to 0(deep sedation). The mean time from drug administration to MOAA/S score ≤1 was recorded. **Measure:** Mean time from initiation of drug administration to MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score ≤1 **Time Frame:** Through study completion, an average of 1 day **Description:** Sedation was assessed using the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scale. It ranges from 5(alert) to 0(deep sedation). The mean time from drug withdrawal to MOAA/S score = 5 was recorded **Measure:** The average time from drug withdrawal to full recovery **Time Frame:** Through study completion, an average of 1 day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA was classified as I-III * The operation time was less than 120 minutes * Informed consent is signed by all study participants * Elective lower extremity surgery under spinal anesthesia was performed Exclusion Criteria: * Pregnant or lactating women * Patients with Difficult Airways * History of severe neurological and muscular diseases and mental retardation * Patients with severe respiratory and circulatory diseases, including acute heart failure. Unstable angina pectoris. Resting ECG heart rate \<50 beats/min. QTc: ≥470ms in men and ≥480ms in women. Third degree atrioventricular block. Severe arrhythmia. Moderate to severe heart valve disease. Chronic obstructive pulmonary disease. A history of severe asthma. * Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range * Take diazole drugs and/or opioids in one month or nearly three months * Patients who were allergic to or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone, etc * Patients who could not monitor the depth of anesthesia for various reasons **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** This was an unrandomized, single-group study. The sample size was calculated using PASS 15™(NCSS, LLC. Kaysville, Utah, USA.) software. The degree of confidence (1-β) was set at 0.90, and the α value was set at 0.05. ρ0, the baseline correlation, was set to 0. The ρ1, alternating correlation, was set to 0.3 based on the expected minimum r value of 0.3 obtained in previous literature. Final calculations show that 112 pairs of data were needed to complete the experiments. Approximately 20 pairs of data were expected to be recorded per participant, and 30 participants were expected to be enrolled in this study. So, the sample size was adequate. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Anshi Wu, doctor **Phone:** 010-85231330 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007431 - Term: Intraoperative Complications - 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: M29299 - Name: Intraoperative Awareness - Relevance: HIGH - As Found: Anesthesia Awareness - ID: M10465 - Name: Intraoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000058926 - Term: Intraoperative Awareness ### 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:** NCT06427772 **Brief Title:** Incidence of Early Infection After Bipolar Hemiarthroplasty and Its Associated Factors in Fracture Neck of Femur **Official Title:** Incidence of Early Infection After Bipolar Hemiarthroplasty and Its Associated Factors in Fracture Neck of Femur #### Organization Study ID Info **ID:** Sallam #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2025-06-30 **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:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-23 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assiut University #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Ahmed Sallam Abo El-azaiem Mohamed **Investigator Title:** principal investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Periprosthetic joint infections (PJI) following hemiarthroplasty for hip fractures are a catastrophic complication that results in severe worsening of patients' daily function and quality of life. The incidence of prosthetic joint infection (PJI) in hemiarthroplasty after femoral neck fracture varies from 2% to 17%. Identifying risk factors associated with early infection following HA for hip fractures may provide an opportunity to treat and prevent this potential complication with preoperative planning in many patients. So investigators will study the rate of early infection and its associated factor after bipolar hemiarthroplasty. **Detailed Description:** Femoral neck fractures (FNF) have a significant incidence and a rising trend worldwide. FNF is associated with a high mortality and disability rate, decreasing the independence and quality of life for affected patients. Acute displaced intracapsular femoral neck fractures account for about half of all hip fractures, with the majority of these fractures in older patients being treated surgically with hip hemiarthroplasty(HA), total hip arthroplasty, or internal fixation. Hemiarthroplasty is also used to treat femoral neck nonunion, failed screw fixation, and pathological femoral neck fracture. The treatment aims are to reduce pain, allow early mobilization, and restore the patient's pre-injury level of function while limiting perioperative surgical and medical complications. Patients with FNF frequently undergo hemiarthroplasty to restore joint biomechanics. Two types of implants are used in hemiarthroplasty: monopolar and bipolar . The bipolar implants have a polyethylene bearing between the stem and head of the endoprosthesis, which allows the components to rotate. There are debatable findings and a lack of consensus on the optimal component for hemiarthroplasty. Periprosthetic joint infections (PJI) following hemiarthroplasty for hip fractures are a catastrophic complication that results in severe worsening of patients' daily function and quality of life. The incidence of prosthetic joint infection (PJI) in hemiarthroplasty after femoral neck fracture varies from 2% to 17%. Identifying risk factors associated with early infection following HA for hip fractures may provide an opportunity to treat and prevent this potential complication with preoperative planning in many patients. So investigators will study the rate of early infection and its associated factor after bipolar hemiarthroplasty. ### Conditions Module **Conditions:** - Prosthetic-joint Infection ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 74 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** the presence of persistent discharge after 7 days diagnostic for early infection follow up period first 4 week postoperative bipolar hemiarthroplasty in fracture neck of femur study the risk factors in this group **Intervention Names:** - Procedure: bipolar hemiarthroplasty **Label:** group 1 diseased group(infected) #### Arm Group 2 **Description:** no infection after hemiarthroplasty follow up period first 4 week postoperative bipolar hemiarthroplasty in fracture neck of femur **Intervention Names:** - Procedure: bipolar hemiarthroplasty **Label:** group 2 : control group (normal ) ### Interventions #### Intervention 1 **Arm Group Labels:** - group 1 diseased group(infected) - group 2 : control group (normal ) **Description:** bipolar hemiarthroplasty for neck femur fracture **Name:** bipolar hemiarthroplasty **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** investigators will take all cases with bipolar hemiarthroplasty after femoral neck fracture then follow up them for 4 weeks. An infection was categorized as early, if it occurred within 4 weeks after surgery After that investigators will classify them to infected (disease group) and non infected (control group) and studying risk factor predisposing to early infection after HA. For diagnosis of infection : the presence of persistent discharge after 7 days **Measure:** incidence of early infection after bipolar hemiarthroplasty **Time Frame:** 4 weeks postoperative **Description:** Age in years **Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters :Patient age **Time Frame:** preoperative evaluation 1 week **Description:** male or female **Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters :sex **Time Frame:** preoperative evaluation 1 week **Description:** present or not **Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters :Chronic diseases as Diabetes, rheumatoid arthritis and other inflammatory or autoimmune arthritis. **Time Frame:** preoperative evaluation 1 week **Description:** present or not **Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters : • Active skin disease (at site of surgical incision) **Time Frame:** preoperative evaluation 1 week **Description:** yes or no **Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters : • Smoking and alcohol consumption **Time Frame:** preoperative evaluation 1 week **Description:** present or no **Measure:** risk factor predisposing to early infection after HA.1-preoperative parameters : • Distant septic focus after arthroplasty as (pneumonia ,UTI ,abdominal ,oral and cutaneous infection). **Time Frame:** preoperative evaluation 1 week **Description:** in hours **Measure:** risk factor predisposing to early infection after HA.2-intraoperative parameters : • Surgery time . **Time Frame:** at time of operation **Description:** yes or no **Measure:** risk factor predisposing to early infection after HA.2-intraoperative parameters :• Appropriate antibiotics prophalyxis and Need to blood transfusion. **Time Frame:** at time of operation **Description:** time in days **Measure:** risk factor predisposing to early infection after HA.3-postoperative parameters :• Persistent drainage after 7 days. **Time Frame:** 1 week postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with femoral neck fractures and treated by bipolar hemiarthroplasty. * Patients or their legal representative able to give informed consent. Exclusion Criteria: * Patients that received HA secondary to a failed internal fixation of a femoral neck fracture. * Patients with a pathological fracture due to malignancy. **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** * Study Setting: Department of Orthopedic and Trauma Surgery, Assiut University. * Study subjects: a. Inclusion criteria: * Patients with femoral neck fractures and treated by bipolar hemiarthroplasty. * Patients or their legal representative able to give informed consent. b. Exclusion criteria: * Patients that received HA secondary to a failed internal fixation of a femoral neck fracture. * Patients with a pathological fracture due to malignancy. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ahmed Sallam AboElazaiem, bachelor's **Phone:** 01005732964 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000006620 - Term: Hip Fractures - ID: D000005264 - Term: Femoral Fractures - ID: D000050723 - Term: Fractures, Bone - ID: D000014947 - Term: Wounds and Injuries - 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 - Abbrev: BC01 - Name: Infections - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M26370 - Name: Fractures, Bone - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: HIGH - As Found: Infection - ID: M8403 - Name: Femoral Neck Fractures - Relevance: HIGH - As Found: Fracture Neck of Femur - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M9696 - Name: Hip Fractures - Relevance: LOW - As Found: Unknown - ID: M8402 - Name: Femoral Fractures - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - 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 - ID: T4756 - Name: Prosthetic Joint Infection - Relevance: HIGH - As Found: Prosthetic Joint Infection ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000005265 - Term: Femoral Neck Fractures ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427759 **Brief Title:** Optimizing Aesthetic Outcome for Arm Contouring Surgery by Utilizing Anthropometric Measurements **Official Title:** Optimizing Aesthetic Outcome for Arm Contouring Surgery by Utilizing Anthropometric Measurements #### Organization Study ID Info **ID:** 241094084 #### Organization **Class:** OTHER **Full Name:** Assiut University ### Status Module #### Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Abdelrahman Mostafa Shehata Mohammed #### Responsible Party **Investigator Affiliation:** Assiut University **Investigator Full Name:** Abdelrahman Mostafa Shehata Mohammed **Investigator Title:** assistant lecturer **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Brachioplasty is a popular plastic surgery procedure. Current and common various techniques are based on either surgeon 's sense preoperatively. A method is needed to define how much skin and soft tissue should be excised precisely, or what can be a reference point to design a brachioplasty mathematically.(1) Anthropometric reference measurements can be applied in designing arm aesthetic surgery. Classically, anthropometry binds the upper arm length with forearm circumference and upper arm circumference to make postoperative results more harmonious and natural . (2)a 2020). **Detailed Description:** 2.4.1- Type of the study: 2.4. 2- Study Setting: Plastic and Reconstructive Surgery Department, Assuit University Hospital 2.4. 3- Study subjects: a. Inclusion criteria: * Group (A) this group will be available for measurements only with no interventions needed. * Group (B) Include patients asking for arm aesthetic surgery . * Group B1: patients will be submitted for liposuction only. liposuction is the preferred approach, particularly in young patients after massive weight loss. * Group B2: patients will be submitted for liposuction and brachioplasty in same setting. When skin laxity is excessive, even in young patients, an extensive arm-long operation that extends across the axilla and onto the lateral chest is indicated. * Group B3: patients will be submitted for liposuction then brachioplasty after 3 months. in borderline cases to take chance for skin retraction . c. Sample Size Calculation: sample size was calculated using g power program version 3.1.9.7 in order to detect anthropometric measures of arm and compare these measures with post operative cases, assumed effect size 0.8 based on clinical assumption (novel study) , α error 0.2 power 0.8 and allocation 1:1:1 the sample size will be 40 patients for each group. 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...): Group (A) will be subjected to these measures \*Arm length : Lateral length from acromion to lateral epicondyle Medial length from axilla to medial epicondyle \*Arm circumference : upper arm circumference Mid arm Lower arm * Forearm circumference at widest point Arm assessed with elbow flexed at 90 degree and shoulder abducted at 90 degree. Group (B) will be subjected to * Group B1: patients will be submitted for liposuction only. * Group B2: patients will be submitted for liposuction and brachioplasty in the same setting. * Group B3: patients will be submitted for liposuction then brachioplasty after 3, 6 and 12 months. Pre-operative Assessment: 1. Patient history. 2. History of massive weight loss or any operation 3. Preoperative investigations 4. Informed consent. 5. Pre-operative photography. operative technique :- 1- most patients will take general anaesthesia . 2- then sterilization with betadine solution . 3 - pt positioned in supine position . 4- patient will be subjected according to its group to group(A): after injection of tumescent fluids - waiting 15 minutes - liposuction will be done circumferential in arm with cannula 4 . group(B): after injection of tumescent fluids in the medial part of arm only(excised part ) - waiting 15 minute - then excision of medial part according to pinch test . group (C): after injection of tumescent fluids all around _ waiting 15 minutes - liposuction will be done circumferential in arm with cannula 4 . excision of the excessed part medially will be done after 3 months . Patients will be subjected to arm measures before and after operation * Arm length : Lateral length from acromion to lateral epicondyle Medial length from axilla to medial epicondyle \*Arm circumference : upper arm circumference Mid arm Lower arm * Forearm circumference at widest point Arm assessed with elbow flexed at 90 degree and shoulder abducted at 90 degree * Pinch Test: * Excess skin : * Site of maximum redundancy:(Upper - Middle - Lower) arm * Grade of Lipodystrophy: Grade 1 :minimal fat with no ptosis Grade 2A :moderate fat with ptosis less than 5 cm Grade 2B : moderate to severe fat with ptosis 5- 10 cm Grade 3: extreme fat with ptosis more than 10 cm Grade 4 : mild to moderate fat with ptosis more than 10 cm. (3) Then comparing of post operative measurements after 3 , 6 and 12 months with the anthropometric measures of group (A) . ### Conditions Module **Conditions:** - Arm Aesthetics ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Optimizing Aesthetic Outcome for Arm Contouring Surgery by Utilizing Anthropometric Measurements. ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** \*Group (A) Inclusion criteria of study: Anthropometric databases and studies done on females with normal BMI, In reproductive period , No history of pregnancy or weight fluctuation , No medical comorbidities . **Label:** anthropometric measures **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** * Group (B) Include patients asking for arm aesthetic surgery . * Group B1: patients will be submitted for liposuction of arms only. * Group B2: patients will be submitted for liposuction and brachioplasty in same setting. * Group B3: patients will be submitted for liposuction then brachioplasty after 3 months. **Intervention Names:** - Procedure: arm aesthetic surgery **Label:** arm aesthetic surgery **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - arm aesthetic surgery **Description:** liposuction of arms brachioplasty of arms **Name:** arm aesthetic surgery **Other Names:** - liposuction, brachioplasty **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Group(A) anthropometric measures of arm length , arm circumference and forearm circumference . Group (B) compare postoperative measures of arm length , arm circumference and forearm circumference with anthropometric measures of Group A **Measure:** Group(A) anthropometric measures of arm length , arm circumference and forearm circumference . Group (B) compare postoperative measures of arm length , arm circumference and forearm circumference with anthropometric measures of Group A **Time Frame:** 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * group A : Anthropometric databases and studies done on females with normal BMI, In reproductive period , No history of pregnancy or weight fluctuation , No medical comorbidities . * group B :Include patients asking for arm aesthetic surgery . * Group B1: patients will be submitted for liposuction only. * Group B2: patients will be submitted for liposuction and brachioplasty in same setting. * Group B3: patients will be submitted for liposuction then brachioplasty after 3 months. Exclusion Criteria: * 1) Males 2) Athletes 3) Current morbidities **Gender Based:** True **Maximum Age:** 40 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Assiut **Country:** Egypt **Facility:** Assiut University ### 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:** NCT06427746 **Acronym:** AIPO **Brief Title:** Enhancing Prehospital Stroke Diagnosis **Official Title:** Accuracy and Implementation of Diagnostic Ability in Stroke in the Pre-Hospital Setting #### Organization Study ID Info **ID:** AREU_A.I.P.O. #### Organization **Class:** OTHER_GOV **Full Name:** Agenzia Regionale emergenza Urgenza ### Status Module #### Completion Date **Date:** 2024-08-31 **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:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2022-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-22 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Agenzia Regionale emergenza Urgenza #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Current American Heart Association Guidelines recommend that stroke patients be promptly rescued and identified so that the accepting hospital can be alerted and prepared to receive and treat them promptly. It is also recommend that stroke identification be performed using validated and standardized assessment scales. This study aims to analyze the possibility to increase the correct identification of stroke patients after implementation of several new operative procedures by the emergency medical service (EMS) of the metropolitan area of Milan (SOREU). The interventions adopted include: 1. the evaluation of patients with suspected stroke via video call between the lay rescue personnel and the dispatch healthcare personnel 2. the training of lay rescue personnel, operating in the metropolitan area, aimed at implementing the application of the Cincinnati Prehospital Stroke Scale (CPSS) scale and to expand the neurological examination with the addiction of the Large ARtery Intracranial Occlusion Stroke Scale (LARIO) in the clinical evaluation. ### Conditions Module **Conditions:** - Stroke **Keywords:** - stroke - video call ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2197 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** stroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers **Intervention Names:** - Procedure: Standard **Label:** Standard #### Arm Group 2 **Description:** stroke diagnosis in the pre-hospital settings, based on the CPSS scale assessed by lay rescuers during live video call with the healthcare personnel in EMS dispatch **Intervention Names:** - Procedure: Video call **Label:** Video call #### Arm Group 3 **Description:** stroke diagnosis in the pre-hospital settings, based on the CPSS + LARIO scales assessed by lay rescuers (with specific training on the 2 scales) during live video call with the healthcare personnel in EMS dispatch **Intervention Names:** - Procedure: Video call + LARIO **Label:** Video call + LARIO ### Interventions #### Intervention 1 **Arm Group Labels:** - Standard **Description:** Basic ambulance personnel are trained in the application of the CPSS scale in suspected stroke. The CPSS scale is a tool used to quickly assess stroke severity in pre-hospital settings. It is a three-point scale that takes into account the patient's level of consciousness, facial droop, and arm weakness. If a patient with suspected stroke meets certain criteria, they will be coded as having a suspected stroke by the SOREU. These criteria include having one item in three of the CPSS scale, being of adult age, and being independent at home. **Name:** Standard **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Video call **Description:** Among the tools already available to improve evaluation of patients rescued in the field, SOREU has video calls between the dispatch room physician and the rescuer in the field. Thus, the rescuer in the field will perform the CPSS during ongoing video call with the dispatch room, allowing the remote evaluation of the patient by the healthcare worker present in the control room, potentially increasing the ability to identify a stroke. **Name:** Video call **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Video call + LARIO **Description:** LARIO scale's effectiveness in identifying patients with ischemic stroke caused by a large vessel occlusion in the anterior cerebral circulation. The anterior cerebral circulation supplies blood to the front and upper parts of the brain. Occlusion of a large vessel in this area can lead to a severe stroke. Rescuer in the field will perform the CPSS and the LARIO during ongoing video call with the dispatch room, allowing the remote evaluation of the patient by the healthcare worker present in the control room. **Name:** Video call + LARIO **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Evaluate if the use of the video call with or without the assessment of the LARIO scale, between the prehospital lay rescuer and the medical dispatch improve the identification of stroke patients in comparison to the only CPSS scale evaluated by the lay rescuer. The diagnosis accuracy is evaluated by confirmation of stroke at the cerebral angio-CT scan **Measure:** Accuracy of prehospital stroke diagnosis **Time Frame:** within 2 hours from hospital admission #### Secondary Outcomes **Description:** LARIO is a stroke scale is a simple 5-item clinical scale that can be used to predict the presence of large vessel occlusion (LVO) in patients with acute ischemic stroke. A large vessel of the anterior cerebral circulation is defined as occlusion of the intracranial segment of the internal carotid artery, anterior cerebral artery segments A1 and A2, and middle cerebral artery segments M1 and M2. Final diagnosis is based on the cerebral angio CT scan **Measure:** Accuracy of the Large ARtery Intracranial Occlusion (LARIO) scale to identify a stroke with occlusion of a large vessels **Time Frame:** within 2 hours from hospital admission **Description:** incidence of hemorrhagic stroke among patients identified as stroke patients. Diagnosis is based on the results of the cerebral CT **Measure:** incidence of hemorrhagic stroke **Time Frame:** within 2 hours hospital admission ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * suspected stroke * rescued by basic life support vehicle * consciousness * informed consent Exclusion Criteria: * age \< 18 years * rescued by an advanced life support vehicle **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients in the prehospital setting with suspected ischemic stroke rescued by the emergency medical service in the Milan metropolitan area ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Anna Coppo, MD **Phone:** 0267129001 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Giuseppe Ristagno, MD, PhD **Phone:** 0267129001 **Role:** CONTACT #### Locations **Location 1:** **City:** Milan **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Paola Manzoni, MD - **Phone:** 02 52872802 - **Role:** CONTACT ***Contact 2:*** - **Name:** Michela Generali, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Italy **Facility:** SOREU Metropolitana **Status:** RECRUITING **Zip:** 20100 #### Overall Officials **Official 1:** **Affiliation:** AREU **Name:** Anna Coppo, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Stroke - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427733 **Brief Title:** Green Banana Peel Extract for Stasis Dermatitis Treatment **Official Title:** Green Banana Peel Extract for Stasis Dermatitis Treatment #### Organization Study ID Info **ID:** Sponsor #### Organization **Class:** OTHER **Full Name:** Universidade do Vale do Sapucai ### Status Module #### Completion Date **Date:** 2024-05-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-03-02 **Type:** ACTUAL #### Start Date **Date:** 2024-02-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **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:** Universidade do Vale do Sapucai #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of stasis dermatitis. **Detailed Description:** Objective: to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of stasis dermatitis. Methods: it will be a clinical, interventional, longitudinal study, random sampling, Sample will have 20 patients divided into two groups. In the Control Group, a moisturizing cream with SPF 30 sunscreen plus a pharmaceutical formulation without green banana peel extract will be used, and in the Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used. Patients will undergo treatment for 90 days, applying the formulation twice a day, evaluated every 45 days through clinical, photographic and Chromatic Palette evaluation. ### Conditions Module **Conditions:** - Stasis Dermatitis **Keywords:** - Stasis dermatitis - Hyperpigmentation - banana skin - Musa sapientum ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ACTUAL **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** SPF 30 and Placebo Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract **Intervention Names:** - Biological: Placebo comparator **Label:** Control Group without green banana peel **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** SPF 30 and pharmaceutical formulation with green banana peel In Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing the extract of the green banana peel will be used. **Intervention Names:** - Biological: Active Comparator **Label:** Study Group with green banana peel **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control Group without green banana peel **Description:** SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract **Name:** Placebo comparator **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Study Group with green banana peel **Description:** SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract **Name:** Active Comparator **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Macroscopic Analysis: The occurrence of stasis dermatitis will be determined by hyperpigmentation, measured using the Chromatic Palette. Changes in skin color vary from ecchymosis, hematomas, erythema, hyperpigmentation, hypochromia and cyanosis. The focus of our study being hyperpigmentation, the shades vary between brownish, grayish and reddish, depending on the evolution, clinical duration and skin color and severity of stasis dermatitis. The positioning of colors on a gradient scale in columns and lines favors the comparative process and location between nearby shades corresponding to the observed evidence. The inclusion of codes makes it possible to locate and classify skin colors in the situations in which they will be evaluated. In the final version that will be used, there are 72 color possibilities. **Measure:** Occurence of stasis dermatitis **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with stasis dermatitis. * Patients aged 18 years or over and 60 years or less. * Patients who agree to participate in the study. - Exclusion Criteria: * Patients who have other types of hyperchromia in the legs. * Patients known to have an allergic reaction to bananas. * Patients who give up, for any reason, to continue treatment. **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Pouso Alegre **Country:** Brazil **Facility:** Vale do Sapucaí University **State:** Minas Gerais **Zip:** 37550-000 #### Overall Officials **Official 1:** **Affiliation:** Vale do Sapucaí University **Name:** Adriana R dos Anjos Mendonça, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7067 - Name: Dermatitis - Relevance: HIGH - As Found: Dermatitis - ID: M19760 - Name: Hyperpigmentation - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003872 - Term: Dermatitis ### Intervention Browse Module - Browse Branches - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M16255 - Name: Sunscreening Agents - Relevance: LOW - As Found: Unknown - ID: T255 - Name: Plantain - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427720 **Brief Title:** LINC00511/miR-185-3p Axis and miR-301a-3p Markers for Breast Cancer Diagnosis **Official Title:** Competitive Endogenous Role of the LINC00511/miR-185-3p Axis and miR-301a-3p From Liquid Biopsy as Molecular Markers for Breast Cancer Diagnosis #### Organization Study ID Info **ID:** RHDIRB2020110301REC#259 #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2021-07-20 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-05-25 **Type:** ACTUAL #### Start Date **Date:** 2019-09-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Investigator Affiliation:** Ain Shams University **Investigator Full Name:** Prof. Nadia M. Hamdy, Ph.D. **Investigator Title:** Professor of biochemistry and molecular biology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Breast cancer is a leading cause of death among women globally, with significant incidence in Egypt. It is characterized by aggressive behavior and resistance to treatment, necessitating early detection methods. Research has revealed that many cancer-related mutations are in non-coding DNA, including microRNAs (miRNAs) and long non-coding RNAs (LncRNAs). miRNAs like miR-185-3p and miR-301a, and LncRNAs such as LINC00511, are potential biomarkers for cancer diagnosis due to their roles in gene regulation and stability in circulation. This study aims to explore the diagnostic utility of these biomarkers in breast cancer. **Detailed Description:** 1. Introduction 1.1. Background: Breast cancer is one of the leading causes of death for women globally, according to the world health organization (WHO), the number of cancer cases expected in 2025 will be 19.3 million cases. In Egypt, cancer is an increasing problem and especially breast cancer \[1\]. Breast cancer is the most common female malignant tumor and a major threat to women's health and its development is considerably aggressive local invasion, early metastases, and multidrug resistance to chemotherapy \[2, 3\]. Therefore, developments of minimally-invasive markers for early detection of breast cancer are of great interest. The cancer genome Atlas (TCGA) revealed that many of the mutations and copy number changes found in cancer do not overlap with protein coding genes \[4\], but are frequently located in non-coding DNA-including non-coding RNA genes \[5\]. MicroRNAs (miRNAs) were among the first non-coding RNAs to be investigated cancer, and their roles as therapeutic targets or biomarkers in cancer \[6\]. MiRNAs are short, single-stranded RNA sequences (usually 19-23 nucleotides) that control gene expression in a variety of physiological and developmental process, thus having a critical role in posttranscriptional regulation of gene expression in a broad range of biological systems \[7, 8\]. MiRNAs mediate the repression of target mRNA by base pairing to complementary sequence in the 3'-UTR, causing transcript destabilization, translational repression or both \[9\]. It has been reported that miRNAs also modulate gene expression by binding to other regions, including protein-coding exons \[10\], and can even induce gene expression in mammalian cells \[11\]. Cell-free circulating miRNAs usually exist bound to ribonucleoprotien complexes or high-density lipoprotein or they are released from cells in lipid vesicles, micro-vesicles, exosomes or apoptotic bodies \[12-15\].Thus, circulating miRNAs may reflect homeostatic response of the organism, as well as signs of disease progression. Owing to their stability and resistance to endogenous RNAse activity, these miRNAs have been proposed as diagnostic and prognostic biomarkers for diseases, including cancer \[16\]. Among these miRNAs, MiR-185-3p has been identified as a tumor suppressor gene in various types of cancer. The expression of miR-185-3p was decreased in breast cancer cells MDA-MB-231, and MCF-7. Moreover, miR-185-3p was over-expressed in the LINC00511 silenced transfection, while decreased in the enhancedLINC00511 plasmid transfection \[17\]. MicroRNA-301a is another oncomiR that has been related to tumor progression in several types of cancer. For example, in prostate cancer, gastric cancer as well as pancreatic cancer \[18-21\]. However, its role in breast cancer is not fully investigated. Long non-coding RNA (LncRNAs) are those longer than 200 nucleotides, and many of them can also act as primary transcripts to produce short RNAs. Generally, LncRNAs have been implicated in gene-regulatory roles, such as chromatin dosage compensation, imprinting, epigenetic regulation, cell cycle control, nuclear and cytoplasmic trafficking, and cell differentiation \[22\]. Furthermore, pre-mRNA interaction where the primary transcript is interacting with LncRNAs and ends up with a different functional spliced sequence or is degraded into endogenous small interfering RNAs, miRNA sponges, modulation of protein activity or localization and facilitation of riboprotein complex formation. Not in the least, LncRNAs can stand as precursors for smaller fragments like miRNAs or piRNAs. The main function of ciRNAs consists in miRNAs capturing through complementary interactions, functioning like miRNAs sponge \[23\]. LncRNAs have already been implicated in human disease including cancer \[24\]. Long intergenic noncoding RNA 00511 (LINC00511); is an oncogene that influences tumor size, metastasis, and poor prognosis. LINC00511 binds histone methyltransferase EZH2 and specifies the histone modification pattern on p57 \[25\]. It also acts as an oncogene in squamous cell carcinoma and pancreatic ductal adenocarcinoma \[26\]. In particular, little is known whether LncRNAs can serve as biomarkers for cancer prognosis or diagnosis. \[27\] 1.2. Problem: The role of these biomarkers are not investigated yet in breast cancer early diagnosis. 1.3. Hypothesis: Tumor Suppressor or Oncogenic Biomarkers and LncRNA used in early diagnosis of breast cancer" 2. Aim of the Work: The ultimate aim of the work is to provide a clearer picture of the functions of miR-185-3p, miR-301a, in association with LINC00511in the early diagnosis of breast tumors with measuring both sensitivity and specificity. 3. Previous Studies Findings: in half page. No previous clinical studies were made on the aspect of the diagnostic utilities of the studied biomarkers. 4. Problem Statement: The role of these biomarkers are not investigated yet in breast cancer early diagnosis in Egyptian patients. 5. Research Significance: Primary Outcome: • To identify Peripheral blood circulating Tumor Suppressor or Oncogenic Small Biomarkers breast cancer and to compare with normal control expression Secondary Outcome: • To calculate sensitivity and specificity of miR-185-3p, miR-301a, and LINC00511 as compared to the protein-based markers (CEA and CA15-3) as diagnostic markers. 6. Research Objectives: 1. Analyze the expression level of two miRNA (miR-185-3p, miR-301a) and their predicted interacted lncRNA (LINC00511) as minimal noninvasive molecular markers for diagnosing the primary breast cancer. 2. Compare miR-185-3p, miR-301a, and LINC00511 with the protein based markers (CEA and CA15-3) as diagnostic markers, regarding to sensitivity and specificity. 3. Study the relation between miR-185-3p, miR-301a, and LINC00511and the clinicopathological characters of breast cancer. 4. Research Methodology: This study will first be approved by the Ethical Committee of Faculty of Pharmacy, Ain Shams University and by the Ethical Committee of National Cancer Institute, New Cairo. Moreover, it will be performed in adherence to the Declaration of Helsinki Guidelines, where two groups will be included and all subjects will give their written consent, to be archived. Group 1 the control group: A total of 50 healthy volunteers' who are age matched healthy female volunteers not suffering from any disease or taking any medication. Group 2 (Malignant Breast Tumor): 50 women with non-metastatic primary breast cancer Patients recently diagnosed who haven't yet received any chemotherapy or radiotherapy, attending the National Cancer Institute, New Cairo. Full history will be taken for all cases and control. The characteristics of the breast cancer patients with regards to age, menopausal status, histopathological type, tumor size, lymph node metastasis and tumor grade, as well as estrogen receptor (ER) and progesterone receptor (PR) will be collected for data analysis. Exclusion criteria Patients with: * Blood disorder diseases, -Any cancer other than breast cancer * Liver Cirrhosis, Uterine \& Urinary bladder diseases Methods: Routine Work: Blood Sampling: 5 ml blood will be collected into plain vaccutainer tubes for serum preparation. Serum samples will be stored at -80 ºC until biochemical assessment at the Biochemistry Department Research Lab, Faculty of Pharmacy, Ain Shams University. Assay of miR-185-3p, miR-301a, and LINC00511by Quantitative PCR: MiRNA and LncRNAs will be extracted from serum using Qiagen miRNeasy Mini Kit according to the manufactures' protocol and their concentration and purities will be detected by nanodrop spectrophotometer. Enriched RNA will be reverse transcribed with miroRNA or LncRNAs reverse transcription kit according to the manufactures' protocol. Expression of miRNA and LncRNAs will be quantified by qRT-PCR using human MicroRNA and LncRNAs assay kits and their specific primers. The expression levels of the investigated miRNA will be evaluated using the ∆Ct method \[28\]. The cycle threshold (Ct) value is the number of qPCR cycles required for the fluorescent signal to cross a specific threshold. ∆Ct will be calculated by subtracting the Ct values of RNU6-2 and GAPDH from those of investigated miRNAs and LncRNAs, respectively. The ∆∆Ct will be calculated by subtracting the ∆Ct of the control samples from the ∆Ct of the cancer samples. Examination of Hormone Receptors and Protein-based tumor Markers: Both estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2 (HER-2neu), in addition to CEA and CA15.3 tumor markers using ELISA kits will be obtained from National Cancer Institute, New Cairo. SAMPLE SIZE ESTIMATION The aim of this study is to investigate the Role of some circulating MiRNAs from independent control and breast cancer cases with 1 control per experimental subject. Based on previous study(Hu et al. 2012) the oncogenic small biomarkers expression was normally distributed with standard deviation 2.9 and large effect size (1.09). If the true differences in the breast cancer group and control group means is 2.25 we will need to study 25 experimental subjects and 25 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. As regards the tumor suppressor expression means was normally distributed with large effect size (1.4). If the true differences in the breast cancer group and control group means is 14 we will need to study 15 experimental subjects and 15 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. Total sample size will be 80 cases, this number will be increased by 25% for expected losses, and total sample is 100 subjects, 50 subjects per group. Sample size estimation was performed by G power\* sample size calculator. Statistical Analysis: SPSS 21.0 software package (SPSS,Chicago,IL) will be used to perform the statistical analyses. T-test or Mann-Whitney's U test will be used to compare the difference of continuous variables in two groups as appropriate. Pearson's Chi-square analysis or Fisher's exact test will be employed to compare the difference of categorical variables. Receiver operating characteristic (ROC) curve and area under the ROC curve (AUC) will be plotted to determine the best cutoff point that discriminates between cancer and non-cancer groups; the sensitivities and specificities will be calculated for the miRNAs and their diagnostic efficacy For all analyses, a two-tailed P value of 0.05 or less will be considered as statistically significant. 5. Research Time Plan/Frame i. Time plan Q/year Actions Q1 Preparation of the official documents for sample collection, data collection and ethical approval and calculate sample size for control and patients Q2 Sample collection from patients with selected criteria and separation of serum in aliquots Q3 Continue sample collections and separation of serum in aliquots + Extraction of RNA from the samples Q4 Collection of control samples and Extraction of RNA Q1 cDNA synthesis for all samples + qPCR Q2 Statistical analysis of the data and starting to write a paper + collection of related articles for thesis writing Q3 Publication of the paper and finalizing the thesis for revision ii. Paper title: "The Diagnostic Utility of Tumor Suppressor or Oncogenic Small Biomarkers in Association with LncRNA in Breast Cancer" Authors: Marwa M. Mohamed, Dr. Eman Fouad Sanad, Dr. Reham Ali Abbas El-Shimy, Nadia M. Hamdy. Corresponding Submitting Author: Prof. Nadia M. Hamdy First Author: Marwa M. Mohamed Contributing Author(S): Dr. Eman Fouad Sanad, Dr. Reham Ali Abbas El-Shimy 6. References List: 1. D. A. Ragab, M. Sharkas, S. Marshall, and J. Reen,"Breast cancer detection using deep convolutional neural networks and support vector machines," PeerJ, vol. 7, p. e6201, 2019. 2. A. E. Cyr and J. A.Margenthaler,"Molecular profiling of breast cancer, "Surgical Oncology Clinics of North America, vol. 23, no. 3. Pp. 451-462, 2014. 3. W. J. Gradishar,"Treatment of metastatic breast cancer, "in JNCCN Journal of the National Comprehensive Cancer Network, 2014, vol. 12, no. 5 SUPPL., pp, 759-761. 4. H. L. Martin, L. Smith, and D. C. Tomlinson, "Multidrug-resistant breast cancer: Current perspectives, "Breast Cancer: Targets and Therapy, vol. 6, no. 0. Pp. 1-13, 2014. 5. S. Nik-Zainal et al., "Landscape of somatic mutations in 560 breast cancer whole-genome sequences, "Nature, vol. 534, no. 7605, pp. 47-54, 2016. 6. M. T. Maurano et al., "Systematicc localization of common disease-associated variation in regulatory DNA," Science (80-.)., vol. 337, no. 6099, pp. 1190-1195, 2012. 7. M. V. Iorio and C. M. Croce, "MicroRNA dysregulation in cancer: Diagnostics, monitoring and therapeutics. A comprehensive review, "EMBO Molecular Medicine, vol. 4, no. 3. Pp. 143-159, 2012. 8. D. Baek, J. Villen, C. Shin, F. D. Camargo, S. P. Gygi, and D. P. Bartel, "The impact of microRNAs on protein output, "Nature, vol. 7209, pp. 64-71, 2008. 9. L. P. Lim et al., "Microarray analysis shows that some microRNAs downregulate large numbers of target mRNAs, "Nature, vol. 433, no. 7027, pp. 769-773, 2005. 10. W. Filipowicz, S. N. Bhattacharyya, and N. Sonenberg, "Mechanisms of post-transcriptional regulation by microRNAs: Are the Answers in sight?," Nature Reviews Genetics, vol. 9, no. 2. Pp. 102-114, 2008. 11. J. J. Forman, A. Legesse-Miller, and H. A. Coller,"A search for conserved sequences in coding regions reveals that the let-7 microRNA targets Dicer within its coding sequence, "Proc. Natl. Acad. Sci., vol. 105, no. 39, pp. 14879-14884, 2008. 12. S. Vasudevan, Y. Tong, and J. A. Steitz, "Switching from repression to activation: MicroRNAs can up-regulate translation, "Science (80-.)., vol. 318, no. 5858, pp. 1931-1934, 2007. 13. K. C. Vickers, B. T. Palmisano, B. M. Shoucri, R. D. Shamburek, and A. T. Remaley, "MicroRNAs are transported in plasma and delivered to recipient cells by high-denisty lipoproteins, "Nat. Cell Biol., vol. 13, no. 4, pp. 423-435, 2011. 14. H. Valadi, K. Ekstrom, A. Bossios, M. Sjostrand, J. J. Lee, and J. O. Lotvall, "Exosome-mediated transfer of mRNA and microRNAs is a novel mechanism of genatic exchange between cells., "Nat. Cell Biol., vol. 9, no. 6, pp. 654-9, 2007. 15. J. L. Lindenberg et al., "Funcional delivery of viral miRNAs via exosomes, "Proc. Natl. Acad. Sci., vol. 107, no. 14, pp. 6328-6333, 2010. 16. A. Turchinovich, L. Weiz, and B. Burwinkel, "Extracellular miRNAs: The mystery of their origin and function, "Trends Biochem. Sci., vol. 37, no. 11, pp. 460-465, 2012. 17. L. J. Chin and F. J. Slack, "A truth serum for cancer---- microRNAs have major potential as cancer biomarkers, "Cell Res., vol. 18, no. 10, pp. 983-984, 2008. 18. Lu et al, "Journal of Experimental \& Clinical Cancer Research" (2018) 19. Cui, L. et al. Expression of MicroRNA-301a and its Functional Roles in Malignant Melanoma. Cellular physiology and biochemistry: international journal of experimental cellular physiology, biochemistry, and pharmacology 40, 230-244, (2016). 20. Shi, Y. K., Zang, Q. L., Li, G. X., Huang, Y. \& Wang, S. Z. Increased expression of microRNA-301a in nonsmall-cell lung cancer and its clinical significance. Journal of cancer research and therapeutics 12, 693-698, (2016). 21. Chen, Z. et al. miR-301a promotes pancreatic cancer cell proliferation by directly inhibiting Bim expression. Journal of cellular biochemistry 113, 3229-3235, (2012). 22. Ma, X. et al. Modulation of tumorigenesis by the pro-inflammatory microRNA miR-301a in mouse models of lung cancer and colorectal cancer. Cell discovery 1, 15005, (2015). 23. O. Wapinski and H. Y. Chang, "Long noncoding RNAs and human disease," Trends in Cell Biology, vol. 21, no.6. pp. 354-361, 2011. 24. D. Gulei, N. Mehterov, S. M. Nabavi, A. G. Atanasov, and I. Berindan-Neagoe, "Targeting ncRNAs by plant secondary metabolites: The ncRNAs game in balance towards malignancy inhibition, "Biotechnology advances, vol. 36, no. 6. Pp. 1779-1799, 2018. 25. T. Derrien, R. Guigo, and R. Johnson, "The long non-coding rnas: A new (p)layer in the 'dark matter, "Frontiers in Genetics, vol. 2, no. Jan. 2012. 26. Ding J, Yang C, Yang S. LINC00511 interacts with miR-765 and modulate tongue squamous cell carcinoma progression by targeting LAMC2. J Oral Pathol Med. 2018;47:46876. 27. Zhao X, Liu Y, Li Z, Zheng S, Wang Z, Li W, Bi Z, Li L, Jiang Y, Luo Y, Lin Q, Fu Z, Rufu C. Linc00511 acts as a competing endogenous RNA to regulate VEGFA expression through sponging hsa-miR-29b-3p in pancreatic ductal adenocarcinoma. J Cell Mol Med. 2018;22:655-67 28. S. H. Kim et al., "Correlation of ultrasound finfings with histology, tumor grade, and biological markers in breast cancer, "ActaOncol. (Madar)., vol. 47, no. 8, pp. 1531-1538, 2008. 29. M. H. Zweig and G. Campbell, "Receiver-operating characteristic (ROC) plots: A fundamental evaluation tool in clinical medicine, "Clinical Chemistry, vol. 39, no. 4. Pp. 561-577, 1993. (30)Hu, Z. B., J. Dong, L. E. Wang, H. X. Ma, J. B. Liu, Y. Zhao, J. H. Tang, X. Chen, J. C. Dai, Q. Y. Wei, C. Y. Zhang \& H. B. Shen (2012) Serum microRNA profiling and breast cancer risk: the use of miR-484/191 as endogenous controls. Carcinogenesis, 33, 828-834. ### Conditions Module **Conditions:** - Early Diagnosed Breast Cancer **Keywords:** - easy diagnosed - stage I/II - Non treated ### Design Module #### Bio Spec **Description:** Four milliliters of peripheral blood was withdrawn once from controls and BC patients, at the time patients were first diagnosed clinically with BC and before any medical (neo)adjuvant therapy or surgical intervention, under strict sterile conditions, following standard biosecurity and international safety procedures, into polymer gel vacutainers with a clot activator (Greiner Bio-One GmbH, Australia), left for 15 min at room temperature to clot, followed by a 10-min centrifugation at 10,000g at 4°C. Sera obtained were aliquoted into three clean Eppendorf tubes and stored at -80°C. **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 95 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** free from any medical, psychosocial, emotional conditions, or cancer (age interval was 28-82) were included in the study as well, matched with BC patients' group in sex and race, menopausal status, and randomly chosen from the female Egyptian population. **Label:** Control #### Arm Group 2 **Description:** full family disease/cancer history was recorded, as well as patients' previous surgical procedures, other than breast surgery, that do not affect the tumor burden, such as splenectomy, tonsillectomy, cesarean birth, and plastic surgery, offspring numbers, menopausal or not, and taking hormonal contraceptives or not. Patients' individual current cancer status and the tumor clinical assessment, done at the NCI, using the tumor-node-metastasis (TNM) categorization (43) and the Bloom-Richardson Scale for histological grading (44), were collected from patients' data files, after a biopsy was taken at the time of BC examination **Label:** BC patients ### Outcomes Module #### Primary Outcomes **Description:** as minimal noninvasive molecular markers for diagnosing the primary breast cancer. **Measure:** 1. Analyze the expression level of two miRNA (miR-185-3p, miR-301a) and their predicted interacted lncRNA (LINC00511) **Time Frame:** 12 Month **Description:** with the protein based markers (CEA and CA15-3) as diagnostic markers, regarding to sensitivity and specificity. **Measure:** 2. Compare miR-185-3p, miR-301a, and LINC00511 **Time Frame:** 6 Month **Description:** LINC00511and the clinicopathological characters of breast cancer. **Measure:** 3. Study the relation between miR-185-3p, miR-301a, and LINC00511 **Time Frame:** 2 Month ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * were being an adult female, with breast invasive carcinoma of no specific type, confirmed pathologically Exclusion Criteria: * Patients with: * were blood disease, any cancer other than BC, liver cirrhosis, and uterine and urinary bladder diseases, or metastatic BC patients who received chemo/radiotherapy, or had previous mastectomy. **Gender Based:** True **Healthy Volunteers:** True **Maximum Age:** 82 Years **Minimum Age:** 28 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The current retrospective cohort study included 70 female volunteer patients first diagnosed with primary BC, without any medical or surgical intervention, from the Clinical Oncology Department, NCI, Cairo University, Egypt. BC diagnosis is carried out with mammogram and MRI. ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Country:** Egypt **Facility:** Faculty of Pharmacy, Ain Shams University, Advanced Biochemistry Research Lab **Zip:** 11566 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6494 - Name: Contraceptive Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427707 **Brief Title:** The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions in Nasal Surgeries. **Official Title:** The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions as An Opioid Free Anaesthesia on Surgical Field in Patients Undergoing Nasal Surgeries. A Randomized Controlled Trial #### Organization Study ID Info **ID:** FMASU R84/2024 #### Organization **Class:** OTHER **Full Name:** Ain Shams University ### Status Module #### Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-26 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Ain Shams University #### Responsible Party **Investigator Affiliation:** Ain Shams University **Investigator Full Name:** Rania Maher Hussien, MD **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** Nasal surgeries are common day case procedures. Although surgical complications are rare, bleeding decreases surgical field visibility and may cause vascular, orbital or intracranial complications in addition to failure of procedure. So, it is crucial to maintain hypotensive anaesthesia to optimize the surgical field. **Detailed Description:** In this study the investigators compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality, intraoperative haemodynamics, surgical time, recovery time, sedation score, time to first rescue analgesic and incidence of PONV in patients undergoing nasal surgeries ### Conditions Module **Conditions:** - Intraoperative Bleeding ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality in patients undergoing nasal surgeries. ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** intravenous infusion of propofol, lidocaine and magnesium sulfate. **Intervention Names:** - Drug: Intravenous Infusion of propofol, lidocaine, Magnesium sulfate **Label:** Group PLM (propofol-lidocaine-magnesium) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** intravenous infusion of Ketamine, lidocaine and magnesium sulfate **Intervention Names:** - Drug: Intravenous infusion of ketamine, lidocaine, Magnesium sulfate **Label:** Group KLM (ketamine-lidocaine-magnesium) **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Intravenous infusion of Dexmeditomidine, lidocaine and magnesium sulfate **Intervention Names:** - Drug: Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate **Label:** Group DLM (Dexmeditomidine-lidocaine-magnesium) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group PLM (propofol-lidocaine-magnesium) **Description:** intravenous infusion of propofol 6-10 mg.kg-1.h-1, lidocaine (lidocaine 2% 400mg in 20 ml) bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. the effect of either Propofol injection, or ketamine injection or dexmeditomidine injection on intraoperative bleeding **Name:** Intravenous Infusion of propofol, lidocaine, Magnesium sulfate **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Group KLM (ketamine-lidocaine-magnesium) **Description:** Patients will receive intravenous infusion of Ketamine 0.1-0.2 mg.kg-1.h-1 (intravenous infusion of propofol 6-10 mg.kg-1.h-1, lidocaine (lidocaine 2% 400mg in 20 ml) bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. dose of 1 mg.kg-1), lidocaine bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1. **Name:** Intravenous infusion of ketamine, lidocaine, Magnesium sulfate **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Group DLM (Dexmeditomidine-lidocaine-magnesium) **Description:** Dexmeditomidine (Precedex® 200 mcg.2ml-1) with a rate of 0.2-0.6 mcg.Kg-1.h-1. lidocaine bolus of 1.5 mg.kg-1 followed by infusion with a rate of 1.5 mg.kg-1.h-1 and magnesium sulfate 40 mg.kg-1 loading followed by infusion of 20 mg.kg-1.h-1 **Name:** Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate **Other Names:** - Precedex **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Degree of surgical field bleeding **Measure:** surgical field using the average category scale (ACS). **Time Frame:** During the operation #### Secondary Outcomes **Description:** Degree of sedation using Ramsy sedation score **Measure:** sedation using Ramsy sedation score **Time Frame:** First hour postoperative ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA I-II, * scheduled for elective nasal surgery Exclusion Criteria: * Patients with uncontrolled hypertension. * Patients with cardiac disease. * Patients with renal, hepatic or cerebral insufficiency. * Patients with coagulopathy or receiving drugs influencing blood coagulation. * Anaemia, haemoglobinopathies or polycythemia. * Pregnancy. * Patients with known sensitivity to any of the study drug. **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** RANIA M Hussien, MD **Phone:** 01000544520 **Phone Ext:** 202 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Fathy Tash, MD **Phone:** 26857539 **Phone Ext:** 202 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Rania M Hussien, MD - **Phone:** 026213948 - **Phone Ext:** 202 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Hala S El Ozairy, MD - **Phone:** 01001191199 - **Phone Ext:** 202 - **Role:** CONTACT **Country:** Egypt **Facility:** Ain Shams University **Zip:** 69711 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006470 - Term: Hemorrhage - ID: D000010335 - Term: Pathologic Processes - ID: D000007431 - Term: Intraoperative Complications ### 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: LOW - As Found: Unknown - ID: M18560 - Name: Blood Loss, Surgical - Relevance: HIGH - As Found: Intraoperative Bleeding - ID: M10465 - Name: Intraoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016063 - Term: Blood Loss, Surgical ### Intervention Browse Module - Ancestors - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000061567 - Term: Voltage-Gated Sodium Channel Blockers - ID: D000026941 - Term: Sodium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000006993 - Term: Hypnotics and Sedatives - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000058647 - Term: Adrenergic alpha-2 Receptor Agonists - ID: D000000316 - Term: Adrenergic alpha-Agonists - ID: D000000322 - Term: Adrenergic Agonists - ID: D000018663 - Term: Adrenergic Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000018686 - Term: Anesthetics, Intravenous - ID: D000018681 - Term: Anesthetics, General - ID: D000000778 - Term: Anesthetics, Dissociative - ID: D000018691 - Term: Excitatory Amino Acid Antagonists - ID: D000018683 - Term: Excitatory Amino Acid Agents - ID: D000000927 - Term: Anticonvulsants - ID: D000002121 - Term: Calcium Channel Blockers - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents - ID: D000015149 - Term: Tocolytic Agents - ID: D000012102 - Term: Reproductive Control Agents ### 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: Analg - Name: Analgesics - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: BDCA - Name: Bone Density Conservation Agents ### Intervention Browse Module - Browse Leaves - ID: M11014 - Name: Lidocaine - Relevance: HIGH - As Found: Solution - ID: M11270 - Name: Magnesium Sulfate - Relevance: HIGH - As Found: Increasing - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M22662 - Name: Dexmedetomidine - Relevance: HIGH - As Found: Placebo-controlled - ID: M10674 - Name: Ketamine - Relevance: HIGH - As Found: Any - ID: M18307 - Name: Propofol - Relevance: HIGH - As Found: COVID-19 - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M23177 - Name: Sodium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M30025 - Name: Diuretics, Potassium Sparing - Relevance: LOW - As Found: Unknown - ID: M10043 - Name: Hypnotics and Sedatives - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M20746 - Name: Adrenergic Agents - Relevance: LOW - As Found: Unknown - ID: M3668 - Name: Adrenergic alpha-Agonists - Relevance: LOW - As Found: Unknown - ID: M3673 - Name: Adrenergic Agonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M20766 - Name: Anesthetics, Intravenous - Relevance: LOW - As Found: Unknown - ID: M20761 - Name: Anesthetics, General - Relevance: LOW - As Found: Unknown - ID: M4108 - Name: Anesthetics, Dissociative - Relevance: LOW - As Found: Unknown - ID: M20771 - Name: Excitatory Amino Acid Antagonists - Relevance: LOW - As Found: Unknown - ID: M4246 - Name: Anticonvulsants - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5384 - Name: Calcium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M17869 - Name: Tocolytic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008012 - Term: Lidocaine - ID: D000008278 - Term: Magnesium Sulfate - ID: D000020927 - Term: Dexmedetomidine - ID: D000007649 - Term: Ketamine - ID: D000015742 - Term: Propofol ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427694 **Acronym:** IVORY-FINALE **Brief Title:** Low-Dose IL-2 For The Reduction Of Vascular Inflammation In ACS -Clinical Outcomes & Follow-up Study **Official Title:** The Low-Dose Interleukin-2 For The Reduction Of Vascular Inflammation In Acute Coronary Syndromes -Clinical Outcomes And Follow-up Study #### Organization Study ID Info **ID:** IVORY-FINALE (A096877) #### Organization **Class:** OTHER **Full Name:** Cambridge University Hospitals NHS Foundation Trust #### Secondary ID Infos **Domain:** IRAS **ID:** 339102 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2030-02-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-06 **Type:** ESTIMATED **Last Update Submit Date:** 2024-06-05 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-20 **Study First Submit QC Date:** 2024-05-20 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cambridge University Hospitals NHS Foundation Trust #### Responsible Party **Investigator Affiliation:** Cambridge University Hospitals NHS Foundation Trust **Investigator Full Name:** Joseph Cheriyan, MBChB, MA, FRCP, FESC, FACC **Investigator Title:** Dr Joseph Cheriyan, Consultant Clinical Pharmacologist/Affilitated Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The preceding IVORY trial (NCT04241601) has completed. As atherosclerosis and its complications are driven by inflammation the investigators hypothesise that treatment with low-dose IL2 may reduce adverse cardiovascular outcomes compared to placebo. In this follow-up study, the investigators aim to collect cardiovascular clinical outcome data for patients who completed the IVORY clinical trial and will look at major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, resuscitated cardiac arrest, ischaemic stroke, or unplanned coronary revascularization. In addition, data on adverse events such as all cause death, haemorrhagic stroke, new atrial fibrillation, ventricular arrhythmias, hospitalisation due to cardiovascular causes (e.g. stable and unstable angina, TIAs, heart failure), amputations and revascularisation due to peripheral vascular disease. **Detailed Description:** A heart attack occurs when there is reduced blood flow to heart muscle cells which results from narrowings or blockages in walls of blood vessels supplying the heart, due to fatty deposits and inflammatory cells that build up over time. This build-up leads to heart muscle damage called a heart attack. The immune system plays an important role in both the development of the narrowings and the damage to the heart muscle during a heart attack. Studies have shown that there is a lower level of protective immune cells called regulatory T-cells (Tregs) in heart attack patients. Increasing the number of circulating Tregs may have a direct effect in reducing the inflammation in arteries, preventing further narrowings in blood vessels and improving heart muscle function. Aldesleukin, also known as interleukin-2 (IL2), is a medicine that stimulates the production of Treg cells when given at low doses. The effectiveness of IL2 in influencing the immune system was tested in a phase 2 trial, IVORY. Participants were recruited to the IVORY trial following a sudden narrowing/blockages in walls of blood vessels to the heart resulting in a heart attack (Acute Coronary Syndrome (ACS)). Participants were randomised to receive either low dose IL2 or placebo, researchers and participants were blinded to the treatment allocation. Participants underwent two PET/CT (Positron emission tomography-computed tomography) scans to observe change of inflammation in the blood vessels from baseline between the two trial groups. ### Conditions Module **Conditions:** - Acute Coronary Syndromes **Keywords:** - Acute Coronary Syndromes ### 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:** Aldesleukin loading dose 1.5 x 10\^6 IU followed by maintenance dose of 1.5 x 10\^6 IU **Intervention Names:** - Drug: Aldesleukin **Label:** Aldesleukin #### Arm Group 2 **Description:** Dextrose 5% **Intervention Names:** - Drug: Dextrose 5% in water **Label:** Placebo ### Interventions #### Intervention 1 **Arm Group Labels:** - Aldesleukin **Description:** IL2 antagonist **Name:** Aldesleukin **Other Names:** - Proleukin **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** matched placebo to active **Name:** Dextrose 5% in water **Other Names:** - Dextrose **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number of major adverse cardiovascular outcomes **Measure:** Major adverse cardiovascular outcomes **Time Frame:** 1 year from when initially dosed in preceding IVORY trial **Description:** Number of major adverse cardiovascular outcomes **Measure:** Major adverse cardiovascular outcomes **Time Frame:** 2 years from when initially dosed in preceding IVORY trial **Description:** Number of major adverse cardiovascular outcomes **Measure:** Major adverse cardiovascular outcomes **Time Frame:** 5 years from when initially dosed in preceding IVORY trial #### Secondary Outcomes **Description:** Number of deaths due to cardiovascular causes comparing IL2 to placebo **Measure:** Death due to cardiovascular causes **Time Frame:** 1 year from when initially dosed in preceding IVORY trial **Description:** Number of deaths due to cardiovascular causes comparing IL2 to placebo **Measure:** Deaths due to cardiovascular causes comparing IL2 to placebo **Time Frame:** 2 years from when initially dosed in preceding IVORY trial **Description:** Number of deaths due to cardiovascular causes comparing IL2 to placebo **Measure:** Deaths due to cardiovascular causes comparing IL2 to placebo **Time Frame:** 5 years from when initially dosed in preceding IVORY trial **Description:** Numbers of resuscitated cardiac arrests comparing IL2 to placebo **Measure:** Resuscitated cardiac arrests comparing IL2 to placebo **Time Frame:** 1 year from when initially dosed in preceding IVORY trial **Description:** Numbers of resuscitated cardiac arrests comparing IL2 to placebo **Measure:** Resuscitated cardiac arrests comparing IL2 to placebo **Time Frame:** 2 years from when initially dosed in preceding IVORY trial **Description:** Numbers of resuscitated cardiac arrests comparing IL2 to placebo **Measure:** Resuscitated cardiac arrests comparing IL2 to placebo **Time Frame:** 5 years from when initially dosed in preceding IVORY trial **Description:** Number of non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo **Measure:** Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo **Time Frame:** 1 year from when initially dosed in preceding IVORY trial **Description:** Number of non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo **Measure:** Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo **Time Frame:** 2 years from when initially dosed in preceding IVORY trial **Description:** Number of non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo **Measure:** Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo **Time Frame:** 5 years from when initially dosed in preceding IVORY trial **Description:** Number of ischaemic strokes comparing IL2 to placebo **Measure:** Ischaemic strokes comparing IL2 to placebo **Time Frame:** 1 year from when initially dosed in preceding IVORY trial **Description:** Number of ischaemic strokes comparing IL2 to placebo **Measure:** Ischaemic strokes comparing IL2 to placebo **Time Frame:** 2 years from when initially dosed in preceding IVORY trial **Description:** Number of ischaemic strokes comparing IL2 to placebo **Measure:** Ischaemic strokes comparing IL2 to placebo **Time Frame:** 5 years from when initially dosed in preceding IVORY trial **Description:** Number of unplanned coronary vascularisations comparing IL2 to placebo **Measure:** Unplanned coronary vascularisations comparing IL2 to placebo **Time Frame:** 1 year from when initially dosed in preceding IVORY trial **Description:** Number of unplanned coronary vascularisations comparing IL2 to placebo **Measure:** Unplanned coronary vascularisations comparing IL2 to placebo **Time Frame:** 2 years from when initially dosed in preceding IVORY trial **Description:** Number of unplanned coronary vascularisations comparing IL2 to placebo **Measure:** Unplanned coronary vascularisations comparing IL2 to placebo **Time Frame:** 5 years from when initially dosed in preceding IVORY trial **Description:** Number of hospitalisations due to cardiovascular causes comparing IL2 to placebo **Measure:** Hospitalisations due to cardiovascular causes comparing IL2 to placebo **Time Frame:** 1 year from when initially dosed in preceding IVORY trial **Description:** Number of hospitalisations due to cardiovascular causes comparing IL2 to placebo **Measure:** Hospitalisations due to cardiovascular causes comparing IL2 to placebo **Time Frame:** 2 years from when initially dosed in preceding IVORY trial **Description:** Number of hospitalisations due to cardiovascular causes comparing IL2 to placebo **Measure:** Hospitalisations due to cardiovascular causes comparing IL2 to placebo **Time Frame:** 5 years from when initially dosed in preceding IVORY trial **Description:** Number of all-cause deaths comparing IL2 to placebo **Measure:** All-cause deaths comparing IL2 to placebo **Time Frame:** 1 year from when initially dosed in preceding IVORY trial **Description:** Number of all-cause deaths comparing IL2 to placebo **Measure:** All-cause death comparing IL2 to placebo **Time Frame:** 2 years from when initially dosed in preceding IVORY trial **Description:** Number of all-cause deaths comparing IL2 to placebo **Measure:** All-cause death comparing IL2 to placebo **Time Frame:** 5 years from when initially dosed in preceding IVORY trial **Description:** Number of hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo **Measure:** Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo **Time Frame:** 1 year from when initially dosed in preceding IVORY trial **Description:** Number of hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure)comparing IL2 to placebo **Measure:** Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo **Time Frame:** 2 years from when initially dosed in preceding IVORY trial **Description:** Number of hospitalisation due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo **Measure:** Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo **Time Frame:** 5 years from when initially dosed in preceding IVORY trial **Description:** Number of revascularisations for peripheral vascular disease comparing IL2 to placebo **Measure:** Revascularisations for peripheral vascular disease comparing IL2 to placebo **Time Frame:** 1 year from when initially dosed in preceding IVORY trial **Description:** Number of revascularisations for peripheral vascular diseasecomparing IL2 to placebo **Measure:** Revascularisations for peripheral vascular disease comparing IL2 to placebo **Time Frame:** 2 years from when initially dosed in preceding IVORY trial **Description:** Number of revascularisations for peripheral vascular disease comparing IL2 to placebo **Measure:** Revascularisations for peripheral vascular disease comparing IL2 to placebo **Time Frame:** 5 years from when initially dosed in preceding IVORY trial **Description:** Number of amputations due to peripheral vascular disease comparing IL2 to placebo **Measure:** Amputations due to peripheral vascular disease comparing IL2 to placebo **Time Frame:** 1 year from when initially dosed in preceding IVORY trial **Description:** Number of amputations due to peripheral vascular disease comparing IL2 to placebo **Measure:** Amputations due to peripheral vascular disease comparing IL2 to placebo **Time Frame:** 2 years from when initially dosed in preceding IVORY trial **Description:** Number of amputations due to peripheral vascular disease comparing IL2 to placebo **Measure:** Amputations due to peripheral vascular disease comparing IL2 to placebo **Time Frame:** 5 years from when initially dosed in preceding IVORY trial **Description:** Number of haemorrhagic strokes comparing IL2 to placebo **Measure:** Haemorrhagic strokes comparing IL2 to placebo **Time Frame:** 1 year from when initially dosed in preceding IVORY trial **Description:** Number of haemorrhagic strokes comparing IL2 to placebo **Measure:** Haemorrhagic strokes comparing IL2 to placebo **Time Frame:** 2 years from when initially dosed in preceding IVORY trial **Description:** Number of haemorrhagic strokes comparing IL2 to placebo **Measure:** Haemorrhagic strokes comparing IL2 to placebo **Time Frame:** 5 years from when initially dosed in preceding IVORY trial **Description:** Number of new atrial fibrillation diagnoses comparing IL2 to placebo **Measure:** New atrial fibrillation diagnosis comparing IL2 to placebo **Time Frame:** 1 year from when initially dosed in preceding IVORY trial **Description:** Number of new atrial fibrillation diagnoses comparing IL2 to placebo **Measure:** New atrial fibrillation diagnosis comparing IL2 to placebo **Time Frame:** 2 years from when initially dosed in preceding IVORY trial **Description:** Number of new atrial fibrillation diagnoses comparing IL2 to placebo **Measure:** New atrial fibrillation diagnosis comparing IL2 to placebo **Time Frame:** 5 years from when initially dosed in preceding IVORY trial **Description:** Number of ventricular arrhythmia episodes (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo **Measure:** Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo **Time Frame:** 1 year from when initially dosed in preceding IVORY trial **Description:** Number of ventricular arrhythmia episodes (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo **Measure:** Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo **Time Frame:** 2 years from when initially dosed in preceding IVORY trial **Description:** Number of ventricular arrhythmia episodes (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo **Measure:** Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo **Time Frame:** 5 years from when initially dosed in preceding IVORY trial ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants who completed the full per-protocol treatment regime of low-dose IL2 or placebo having attended the final dosing visit in the IVORY trial. IVORY patients who previously consented to have their medical records inspected in the IVORY trial and who have already passed away at the commencement of IVORY-FINALE will also be included in analyses Exclusion Criteria: * Patients who decline participation * Patients who did not consent to being contacted about future research * Patients who were withdrawn from the IVORY trial for any reason **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Participants of the IVORY trial (NCT04241601) and who consented to be contacted for future research received all scheduled doses of either placebo or IL2 and are alive at the time of data collection will be approached. ### Contacts Locations Module #### Locations **Location 1:** **City:** Cambridge **Country:** United Kingdom **Facility:** Addenbrooke's Hospital **State:** Cambridgeshire **Zip:** CB20QQ #### Overall Officials **Official 1:** **Affiliation:** Cambridge University Hospitals NHS Foundation Trust **Name:** Joseph Cheriyan, MBChB, FRCP **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** On completion of the study the data will be analysed and tabulated and a Final Study Report prepared. Data will be published in an open access journal. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M27545 - Name: Acute Coronary Syndrome - Relevance: HIGH - As Found: Acute Coronary Syndrome - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000054058 - Term: Acute Coronary Syndrome - ID: D000013577 - Term: Syndrome - ID: D000007249 - Term: Inflammation ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000019380 - Term: Anti-HIV Agents - ID: D000044966 - Term: Anti-Retroviral Agents - ID: D000000998 - Term: Antiviral Agents - ID: D000000890 - Term: Anti-Infective Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M225496 - Name: Aldesleukin - Relevance: HIGH - As Found: Spinal Cord - ID: M10411 - Name: Interleukin-2 - Relevance: LOW - As Found: Unknown - ID: M21350 - Name: Anti-HIV Agents - Relevance: LOW - As Found: Unknown - ID: M25428 - Name: Anti-Retroviral Agents - Relevance: LOW - As Found: Unknown - ID: M4314 - Name: Antiviral Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000082598 - Term: Aldesleukin ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427681 **Brief Title:** An Relative Bioavailability Study of BH006 for Injection in Healthy Subjects **Official Title:** An Open-label, Randomized, Single-dose, Two-period Cross-over Study to Evaluate the Relative Bioavailability Between BH006 for Injection Per the Intended Dosage Regimen and Fosaprepitant and Palonosetron in Healthy Subjects #### Organization Study ID Info **ID:** BH006-BE-102 #### Organization **Class:** INDUSTRY **Full Name:** Zhuhai Beihai Biotech Co., Ltd ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Zhuhai Beihai Biotech Co., Ltd #### 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 study is an open label, randomized, balanced, two period, two sequence, crossover, single dose, relative bioavailability study in healthy subjects.Each subject, meeting all the inclusion criteria and none of the exclusion criteria, will receive test product or reference product in a crossover manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 15 (Period II). ### Conditions Module **Conditions:** - Bioavailability ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 150 mg fosaprepitant/0.25 mg palonosetron intravenously 30 minutes (±1 minute) **Intervention Names:** - Drug: BH006 for injection **Label:** BH006 for injection **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Fosaprepitant for injection：150 mg fosaprepitant intravenously 30 minutes (±1 minute) ; Palonosetron hydrochloride injection： 0.25 mg palonosetron in 5 mL (0.05 mg/mL) infusion time is 30 seconds (﹢5seconds) . **Intervention Names:** - Drug: Fosaprepitant for injection+Palonosetron hydrochloride injection **Label:** Fosaprepitant for injection+Palonosetron hydrochloride injection **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - BH006 for injection **Description:** According to the random administration plan, the test product BH006 \[(fosaprepitant and palonosetron) for injection\] 150mg/0.25mg or the reference product \[EMEND® (fosaprepitant) for injection 150 mg + Palonosetron hydrochloride injection 0.25 mg) were injected, and crossovered after a sufficient washing period (14 days), dosing is carried out for the second cycle study. **Name:** BH006 for injection **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Fosaprepitant for injection+Palonosetron hydrochloride injection **Description:** According to the random administration plan, the test product BH006 \[(fosaprepitant and palonosetron) for injection\] 150mg/0.25mg or the reference product \[EMEND® (fosaprepitant) for injection 150 mg + Palonosetron hydrochloride injection 0.25 mg) were injected, and crossovered after a sufficient washing period (14 days), dosing is carried out for the second cycle study. **Name:** Fosaprepitant for injection+Palonosetron hydrochloride injection **Other Names:** - EMEND®+PALONOSETRON **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** All adverse events (AE) defined by CTCAE version 5.0. **Measure:** Incidence of Adverse Events [Safety and Tolerability] **Time Frame:** from the time of first study drug administration till end of study（ Day24 Visit or Early Termination Visit） #### Primary Outcomes **Description:** The PK endpoints will be studied and assessed by PK parameters for aprepitant and palonosetron:Area Under the Curve From Time 0 Hours to Last Quantifiable Concentration(AUC0-t). **Measure:** Pharmacokinetic Analysis **Time Frame:** Period I&Period II：pre-dose to 168.000 hours after starting the infusion. **Description:** The PK endpoints will be studied and assessed by PK parameters for aprepitant and palonosetron:Area Under the Curve From Time 0 Hours to Infinity(AUC0-∞). **Measure:** Pharmacokinetic Analysis **Time Frame:** Period I&Period II：pre-dose to 168.000 hours after starting the infusion. **Description:** The PK endpoints will be studied and assessed by PK parameters for aprepitant :Maximum Concentration (Cmax). **Measure:** Pharmacokinetic Analysis **Time Frame:** Period I&Period II：pre-dose to 168.000 hours after starting the infusion. #### Secondary Outcomes **Description:** For aprepitant, aprepitant and palonosetron : Apparent Terminal Elimination Half-Life (t1/2). **Measure:** Pharmacokinetic Analysis **Time Frame:** Period I&Period II：pre-dose to 168.000 hours after starting the infusion. **Description:** For aprepitant, aprepitant and palonosetron : Time to Cmax (Tmax). **Measure:** Pharmacokinetic Analysis **Time Frame:** Period I&Period II：pre-dose to 168.000 hours after starting the infusion. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Willing and able to provide signed and dated informed consent prior to any study-related procedures. 2. Willing and able to comply with all study procedures. 3. Subjects and their spouses must agree to use adequate contraception 14 days prior to the first dose, for the duration of study participation, and for 6 months following completion of therapy. 4. Healthy subjects of either gender, ≥18 years of age, or ≤ 55 years of age. 5. Have a body weight (BW) of ≥ 45.0 kg(female) / ≥ 50.0 kg(male) and 18 ≤ body mass index (BMI) ≤ 28 kg/m2. 6. Subjects had normal vital signs (T: 35.9\~37.6℃; P: 50\~100 beats/min; BP: 90\~139mmHg/60\~89mmHg, all including critical values) and good organ function prior to enrollment: * 12-ECG: QTc \<450 milliseconds for males and \<470 milliseconds for females; * Platelets ≥ 100 × 109/L; neutrophil count ≥ 1.5 × 109/L; hemoglobin ≥ 110 g/L; * Alanine aminotransferase, aspartate aminotransferase and bilirubin ≤ ULN; * Subjects with abnormal values on physical examination and the rest of the laboratory tests were also enrolled if the investigator determined that the abnormality was not clinically significant in the context of past medical history. Exclusion Criteria: 1. Those who are known to be allergic to the investigational drug, its excipients, or similar drugs, or those who suffer from allergic diseases or belong to an allergic constitution (such as allergies to two or more drugs, food, or pollen). 2. Those who have a history of clinically serious disease and have not been cured, or those who currently have a disease that may significantly affect the PK or safety evaluation of the study drug. 3. Those with abnormal and clinically significant vital signs, 12-ECG, and clinical laboratory tests. 4. Major surgery within 90 days prior to study entry; minor surgery within 2 weeks prior to study entry. 5. Subjects who have received a vaccination within 30 days prior to the first dose. 6. Subjects who have used or using any drug within 30 days prior to the first dose that may have a significant impact on the PK or safety evaluation of this study drug, including, but not limited to, CYP3A4 inhibitors/agonists, drugs that may alter activity of drug metabolizing enzyme of liver. 7. Subjects who have participated in and used any clinical trial drug within 90 days prior to the first dose, or plan to participate in other clinical trials during this study. 8. Those with a history of alcohol abuse, or regular drinkers within 90 days prior to the first dose (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), or those who could not abstain during the test, or had a positive alcohol breath test. (1 unit = 1 unit of alcohol = about 285 mL of beer or about 100 mL of red wine or about 25 mL of beverage containing 40% (v/v) alcohol). 9. Subjects who are addicted to tobacco (more than 5 cigarettes or equivalent per day) within 30 days prior to the first dose, or who were unable to quit smoking during the trial. 10. Subjects who have lost/donated more than 450 mL of blood (except physiological blood loss in females) within 90 days prior to the first dose, or who have received a blood transfusion or used a blood product, or who plan to donate blood during the trial or within 30 days of the end of the trial. 11. Subjects who have taken a special diet (including pitaya, mango, grapefruit, etc.) or have had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, or excretion within 14 days prior to the first dose. 12. Consumption of food or beverages containing alcoholic products or caffeine or xanthine within 48 hours before the first dose. 13. Subjects have a history of drug abuse within the past five years or a positive drug abuse screen. 14. Subjects have presence of Hepatitis B surface antigen (HBsAg) or a Positive Hepatitis C antibody test result, or positive human immunodeficiency virus (HIV) antibody test, or Positive test for syphilis spirochete antibodies at screening. 15. Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test result at screening. 16. Subjects have other clinical significant findings within the 12 months prior to screening that indicate clinically significant disease of the following (including, but not limited to, gastrointestinal, renal, hepatic, neurological, haematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular disorders); and suffering from any condition that increases the risk of haemorrhage such as haemorrhoids, acute gastritis, or gastric and duodenal ulcers, intractable constipation. 17. Subjects who have a history of needle sickness, blood sickness or have a problem in collecting blood. 18. Subjects who have an acute illness or concomitant medication from the screening phase until the first dose. 19. Subjects who are engaged in high-altitude work, vehicle driving and other operators of machinery associated with danger. 20. Subjects have other issues that may lead to non-compliance or be unsuitable for inclusion by investigators' judgement. **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:** Xiaohua Wei, PMD **Phone:** +86 13500248359 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Tianqi Hua, PM **Phone:** +86 15928870240 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** The First Hospital of Jilin University **Name:** Hong Zhang, PI **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: Rare - Name: Rare Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000932 - Term: Antiemetics - ID: D000001337 - Term: Autonomic Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000058831 - Term: Serotonin 5-HT3 Receptor Antagonists - ID: D000012702 - Term: Serotonin Antagonists - ID: D000018490 - Term: Serotonin Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000064729 - Term: Neurokinin-1 Receptor Antagonists ### Intervention Browse Module - Browse Branches - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1926 - Name: Palonosetron - Relevance: HIGH - As Found: Arrhythmia - ID: M44622 - Name: Fosaprepitant - Relevance: HIGH - As Found: CAR-T Cell Therapy - ID: M1864 - Name: Aprepitant - Relevance: HIGH - As Found: CAR-T Cell Therapy - ID: M4251 - Name: Antiemetics - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M15512 - Name: Serotonin - Relevance: LOW - As Found: Unknown - ID: M29246 - Name: Serotonin 5-HT3 Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown - ID: M30376 - Name: Neurokinin-1 Receptor Antagonists - Relevance: LOW - As Found: Unknown - ID: M16161 - Name: Substance P - Relevance: LOW - As Found: Unknown - ID: M17988 - Name: Neurokinin A - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077924 - Term: Palonosetron - ID: C000579707 - Term: Fosaprepitant - ID: D000077608 - Term: Aprepitant ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427668 **Brief Title:** Safety, Tolerability, and Efficacy of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD) **Official Title:** A Phase 2, Randomized, Placebo-controlled, Double-Blind Multicenter Study to Assess the Safety, Tolerability, and Pharmacodynamics (PD) in Adult Participants With Mild-to Moderate Alzheimer's Disease (AD) Administered SPG302 #### Organization Study ID Info **ID:** SPG302-ALZ-101 #### Organization **Class:** INDUSTRY **Full Name:** Spinogenix ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-06-04 **Type:** ACTUAL **Last Update Submit Date:** 2024-06-03 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-06 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Spinogenix #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This phase 2 study will evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate AD. **Detailed Description:** This is a phase 2, multicenter study to assess the safety, tolerability, CNS effects, pharmacokinetics, pharmacodynamics and clinical efficacy of SPG302 in adult participants with mild-to-moderate AD. The study will consist of 2 parts: Part A: Placebo-controlled, randomized, safety and preliminary efficacy cohort with daily dosing for 28 day cycles Part B: a randomized expansion cohort of daily dosing for 28 day cycles ### Conditions Module **Conditions:** - Alzheimer Disease **Keywords:** - Alzheimer Disease - synapse - neural connectivity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Phase 2 randomized, double-blind, placebo-controlled safety and tolerability study in adult participants with Alzheimer's Disease ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Double blinded **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cohort 1: 12 participants with Alzheimer's Disease will be randomized in a 2:1 ratio to receive SPG302 or placebo. Study intervention will be 300 mg orally once daily for 28 days (cycle 1). All participants will receive open-label SPG302 for cycles 2-7. This arm may be expanded to cohort 2: 12 additional participants pending review of data, for additional dose exploration. **Intervention Names:** - Drug: SPG302 **Label:** Part A: Active SPG302 to be administered to adult participants with AD **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Cohort 1: 12 participants with Alzheimer's Disease will be randomized in a 2:1 ratio to receive SPG302 or placebo. Study intervention will be placebo capsule orally daily for 28 days (cycle 1). All participants will receive open-label SPG302 for cycles 2-7. This arm may be expanded to 12 additional participants as cohort 2 pending review of data, for additional dose exploration. **Intervention Names:** - Drug: Placebo **Label:** Part A: Placebo comparator to be administered to adult participants with AD **Type:** PLACEBO_COMPARATOR #### Arm Group 3 **Description:** Dose to be used and size of dosing cohort to be determined by Data Safety and Monitoring Committee following completion of Part A. **Intervention Names:** - Drug: SPG302 **Label:** Part B: Expansion Cohort **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part A: Active SPG302 to be administered to adult participants with AD - Part B: Expansion Cohort **Description:** synthetic small molecule **Name:** SPG302 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Part A: Placebo comparator to be administered to adult participants with AD **Description:** Placebo **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Electroencephalogram (EEG) will provide non-invasive measurement of brain activity. This test will be used to measure resting state cognitive activity as well as cognitive activity after auditory stimulation. Sound stimuli is 500Hz and 2000Hz. **Measure:** Change in Electroencephalogram (EEG) at resting state and at auditory evoked P300 from baseline to endpoint **Time Frame:** 8 months **Description:** The Alzheimer's Disease Assessment Scale-Cognitive Subscale test (ADAS-Cog) measures language and memory, focusing on cognitive and non-cognitive functioning. It evaluates word recall, naming of objects, word recognition, comprehension and word finding. The ADAS-COG is scored 0-70. The higher the score the greater the impairment. **Measure:** Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint **Time Frame:** 8 months **Description:** The Mini-Mental State Exam (MMSE) is a test of cognitive function. It includes tests of orientation, attention, memory, language and visual-spatial skills. The lower the score the greater the impairment. **Measure:** Change in Mini-Mental State Examination (MMSE) from baseline to endpoint **Time Frame:** 8 months **Description:** Prospective suicidality assessment is performed using the Columbia-Suicide Severity Rating Scale (C-SSRS), a questionnaire to evaluate suicidal ideation and behavior. Answer "yes" on item 4 or 5 of the Suicidal Ideation section or "yes" on any item of the Suicidal Behavior section is considered positive. The suicidal behavior lethality sub-scale inquires about the level of actual or potential medical damage. **Measure:** C-SSRS (Columbia Suicide Severity Rating Scale) **Time Frame:** 8 months **Description:** The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) is a metric for clinical assessment of symptom severity. It consists of 2 parts. First a baseline evaluation of patient and caregiver is performed to collect necessary clinical information. The clinician will then conduct the second phase of the assessment after a specified time period, and changes in symptom severity are indicated on a seven point scale. A higher scale indicates a worsening of symptoms. **Measure:** Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint **Time Frame:** 8 months **Description:** The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale is an scale that assesses the performance of daily tasks and activities. A lower score indicates lower functional performance. **Measure:** Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale from baseline to endpoint **Time Frame:** 8 months **Description:** The Quality of Life in Alzheimer's Disease (QOL-AD) is a test to evaluate the quality of life through a series of questions of ability to complete daily activities and tasks. A lower score indicates lower functional quality of life. **Measure:** Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint **Time Frame:** 8 months #### Secondary Outcomes **Description:** Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs) **Measure:** Safety and tolerability of SPG302 **Time Frame:** 8 months **Description:** Blood will be collected following administration of SPG302 and plasma levels will be evaluated to measure the maximum concentration. **Measure:** Plasma pharmacokinetics of SPG302 in participants with AD-Maximum Plasma Concentration (Cmax) **Time Frame:** 8 months **Description:** To assess the effect of SPG302 on Neurofilament light (NfL), a protein elevated in AD. This will be measured in picometers/milliliter. **Measure:** Change in biomarkers in participants with AD from baseline to endpoint. **Time Frame:** 8 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 45-85 * Diagnosis of mild to moderate AD * Clinical laboratory values within normal range or \< 1.5 times ULN * If receiving AD-specific treatment, have been on stable dose for ≥ 3 months prior to first dose of study drug. * Life expectancy of \>2 years * Able and willing to provide written informed consent Exclusion Criteria: * Any physical or psychological condition that prohibits study completion * Known cardiac disease * Active or history of malignancy in the past 5 years * Serious infection that will not be resolved by first day of study intervention. * History of clinically significant CNS event or diagnosis in the past 5 years. * Acute illness within 30 days of Day 1 * History of suicidal behavior or suicidal ideation * History of chronic alcohol use or substance abuse in the last 5 years * HIV, hepatitis B and/or hepatitis C positive * Vaccines within 14 days * Receipt of investigational products within 30 days * Blood donation within 30 days * Pregnant or breastfeeding **Maximum Age:** 85 Years **Minimum Age:** 45 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Aimee Cayzer **Phone:** +61 482 130622 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Lauren Priest, MBSS **Phone:** +61 8 8404 2311 **Phone Ext:** 62311 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Flinders Medical Center **Name:** Lauren Priest, MBBS **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003704 - Term: Dementia - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000024801 - Term: Tauopathies - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M3885 - Name: Alzheimer Disease - Relevance: HIGH - As Found: Alzheimer's Disease - ID: M6904 - Name: Dementia - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M23002 - Name: Tauopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M21836 - Name: Neurocognitive Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T2192 - Name: Familial Alzheimer Disease - Relevance: HIGH - As Found: Alzheimer's Disease ### Condition Browse Module - Meshes - ID: D000000544 - Term: Alzheimer Disease ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False

## Protocol Section ### Identification Module **NCT ID:** NCT06427655 **Brief Title:** Benefit of the SALAD Technique on CPR Quality During Intubation in Contaminated Airway **Official Title:** Benefit of the SALAD Technique on CPR Quality During Intubation in Contaminated Airway #### Organization Study ID Info **ID:** 20220903R #### Organization **Class:** OTHER **Full Name:** Shin Kong Wu Ho-Su Memorial Hospital ### Status Module #### Completion Date **Date:** 2024-03-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-03-31 **Type:** ACTUAL #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-19 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Shin Kong Wu Ho-Su Memorial Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Management of airways in contaminated environments can compromise the quality of cardiopulmonary resuscitation (CPR). This study examined the effectiveness of SALAD (Suction Assisted Laryngoscopy Airway Decontamination) compared to intermittent suction in maintaining CPR quality during intubation in a simulated scenario of regurgitation. Following 2.5 hours of training in the SALAD technique, 36 emergency medicaltechnician-paramedics (EMT-Ps) were randomly assigned in equal numbers to two groups: one utilizing the SALAD technique and the other employing intermittent suction during intubation on a manikin. The manikin simulates regurgitation of gastric contents into the oropharynx during CPR. Primary outcomes assessed were CPR quality metrics, such as chest compression rate, depth, and interruption. Secondary outcomes included the success rate and time of intubation. **Detailed Description:** The study was conducted in March 2024. Participants were emergency medical technician-paramedics (EMT-Ps) employed by fire departments across Taiwan, recruited on a nationwide basis. All participants provided signed informed consent forms. 36 EMT-Ps are involved in this study. Simulation setup : The CPR-induced regurgitation model was adapted from an Airway Larry Airway Management Trainer Torso (Nasco, Fort Atkinson, WI, USA) to simulate oropharyngeal regurgitation during CPR. To emulate the stomach, a manual pump was attached at the base of the manikin's torso. A transparent vinyl tube connected the manikin's esophagus to the pump's outlet port. A HQCPR device was used for CPR quality record. Training program The 36 participants received 2.5 hours of SALAD training. The training included 5 rounds of intubation teaching and practice. The first two rounds of training involve using the SALAD technique with the video laryngoscope, while the third round used the C-MAC S video laryngoscope as a direct laryngoscope for practice. Technique adjustments can be made during the initial three rounds through monitoring with the video system. The fourth round will involve intubation using a direct laryngoscope with a size 3 Macintosh blade on the SALAD Simulator. The final round involved intubation on the CPR-induced regurgitation model, using a direct laryngoscope and employing the SALAD technique for intubation during chest compressions. Simulation protocol After completing 2.5 hours of training, participants were randomly assigned to one of two groups for suction techniques: SALAD or intermittent suction. Randomization was conducted using the simple randomization method with a random number table. Participants assigned to the same suction technique group formed a resuscitation team, taking on roles as the airway manager, first chest compressor, or second chest compressor. Each participant rotated through these three roles during three simulation sessions.In each simulation, the airway manager was responsible for BVM ventilation and intubation. The first and second chest compressors performed chest compressions alternately, once every five CPR cycles, adhering to a 30:2 compression-to- ventilation ratio. The initial 30 chest compressions were followed by two ventilations, and suction was not performed during this phase, even if regurgitation was present. This was intended to simulate a scenario where the oral cavity was filled with regurgitant material during intubation, maintaining consistency across participants. After the first two ventilations, intubation could proceed while the team continued chest compressions. The airway manager could request a temporary reduction, lightening, or even cessation of chest compressions to facilitate intubation, or to continue up to 60 compressions without interruption if necessary. If the intubation attempt was unsuccessful, the airway manager had to administer two BVM ventilations before attempting intubation again. Depending on the group assignment, either SALAD or intermittent suction techniques were employed to assist in airway decontamination. After intubation, the airway manager assessed lung expansion using the BVM to verify successful intubation. A failed intubation was defined as any esophageal intubation or three unsuccessful intubation attempts. Each simulation concluded following either a successful or failed intubation. Measurement The primary outcomes were CPR quality metrics, including chest compression rate, chest compression depth, and time of interruption. The secondary outcomes were the intubation success rate and intubation time. The rate and depth of the first 30 chest compressions (pre-intubation period) were measured. After the initial 30 compressions, interruptions for ventilation or airway management, as well as the quality of chest compressions during intubation, were also measured (intubation period). An intubation attempt was defined as the insertion of the laryngoscope blade into the mouth and its subsequent withdrawal during an unsuccessful attempt, or as the insertion of the laryngoscope blade followed by confirmation from the airway manager that the tube was inserted. Intubation time was defined as the period between the start and the end of an intubation attempt. Two video cameras were set up to record the entire simulation process. Two observers reviewed the video records independently to identify any intubation attempts. Disagreements were resolved by reaching a mutual consensus. The HQCPR application on an Android device recorded chest compression depth, rate, and interruptions (defined as no chest compression for more than 1 second). The data from both the video recordings and the HQCPR application were used in subsequent analyses. Statistical analysis The characteristics of EMT-Ps were described using frequency and percentage for categorical variables, while mean values with standard deviation (SD) were used for continuous variables. Continuous data were compared using the independent t-test between the SALAD and intermittent suction groups, while categorical data were compared using the Fisher's exact test or the Chi-Squared test between these two groups. CPR quality metrics and intubation time were summarized using mean values with 95% confidence intervals (CI). Compression depth greater than or equal to 5 cm, first-pass intubation success, and esophageal intubation were presented as frequency and percentage. Continuous data were compared using the independent t test between the SALAD and intermittent suction groups, while categorical data were compared using Fisher's exact test between these two groups. CPR quality metrics between the pre-intubation period and the intubation period were analyzed using the paired t test in both the SALAD and intermittent suction groups. A two- tailed p-value of less than 0.05 indicated statistical significance. All data analyses and sample size determination were performed using MedCalc Statistical Software version 22.023 (MedCalc Software, Ostend, Belgium). ### Conditions Module **Conditions:** - Airway Aspiration - Cardiopulmonary Arrest **Keywords:** - airway decontamination - suction assisted - resuscitation - cardiopulmonary resuscitation quality ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Participants were randomized into two groups. One group utilizing the SALAD technique and the other employing intermittent suction during intubation on a manikin. ##### Masking Info **Masking:** SINGLE **Masking Description:** single **Who Masked:** - PARTICIPANT **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 36 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** intermittent suction during intubation **Label:** intermittent suction **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** SALAD suction during intubation **Intervention Names:** - Device: SALAD intubation **Label:** SALAD **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - SALAD **Description:** SALAD suction during intubation **Name:** SALAD intubation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** the proportion of time spent performing chest compressions during arrest **Measure:** chest compression fraction **Time Frame:** 3 hour #### Secondary Outcomes **Description:** the rate of successful intubation **Measure:** success rate of intubation **Time Frame:** 3 hour ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * emergency medical technician-paramedics experienced in advanced airway management and CPR Exclusion Criteria: * N/A **Healthy Volunteers:** True **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Taipei **Country:** Taiwan **Facility:** Shinkong Wu-Ho-Su memorial hospital **State:** Shih-Lin **Zip:** 111 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Simons RW, Rea TD, Becker LJ, Eisenberg MS. The incidence and significance of emesis associated with out-of-hospital cardiac arrest. Resuscitation. 2007 Sep;74(3):427-31. doi: 10.1016/j.resuscitation.2007.01.038. Epub 2007 Apr 11. **PMID:** 17433526 **Citation:** Benger JR, Kirby K, Black S, Brett SJ, Clout M, Lazaroo MJ, Nolan JP, Reeves BC, Robinson M, Scott LJ, Smartt H, South A, Stokes EA, Taylor J, Thomas M, Voss S, Wordsworth S, Rogers CA. Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of-Hospital Cardiac Arrest on Functional Outcome: The AIRWAYS-2 Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):779-791. doi: 10.1001/jama.2018.11597. **PMID:** 30167701 **Citation:** Wang HE, Simeone SJ, Weaver MD, Callaway CW. Interruptions in cardiopulmonary resuscitation from paramedic endotracheal intubation. Ann Emerg Med. 2009 Nov;54(5):645-652.e1. doi: 10.1016/j.annemergmed.2009.05.024. Epub 2009 Jul 2. **PMID:** 19573949 **Citation:** Ruetzler K, Gruber C, Nabecker S, Wohlfarth P, Priemayr A, Frass M, Kimberger O, Sessler DI, Roessler B. Hands-off time during insertion of six airway devices during cardiopulmonary resuscitation: a randomised manikin trial. Resuscitation. 2011 Aug;82(8):1060-3. doi: 10.1016/j.resuscitation.2011.03.027. Epub 2011 Apr 6. **PMID:** 21514986 **Citation:** Wang HE, Jaureguibeitia X, Aramendi E, Jarvis JL, Carlson JN, Irusta U, Alonso E, Aufderheide T, Schmicker RH, Hansen ML, Huebinger RM, Colella MR, Gordon R, Suchting R, Idris AH. Airway strategy and chest compression quality in the Pragmatic Airway Resuscitation Trial. Resuscitation. 2021 May;162:93-98. doi: 10.1016/j.resuscitation.2021.01.043. Epub 2021 Feb 11. **PMID:** 33582258 **Citation:** Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044. **PMID:** 30167699 **Citation:** Piegeler T, Roessler B, Goliasch G, Fischer H, Schlaepfer M, Lang S, Ruetzler K. Evaluation of six different airway devices regarding regurgitation and pulmonary aspiration during cardio-pulmonary resuscitation (CPR) - A human cadaver pilot study. Resuscitation. 2016 May;102:70-4. doi: 10.1016/j.resuscitation.2016.02.017. Epub 2016 Feb 26. **PMID:** 26921473 **Citation:** Lin LW, DuCanto J, Hsu CY, Su YC, Huang CC, Hung SW. Compromised cardiopulmonary resuscitation quality due to regurgitation during endotracheal intubation: a randomised crossover manikin simulation study. BMC Emerg Med. 2022 Jul 9;22(1):124. doi: 10.1186/s12873-022-00662-0. **PMID:** 35810275 **Citation:** DuCanto J, Serrano KD, Thompson RJ. Novel Airway Training Tool that Simulates Vomiting: Suction-Assisted Laryngoscopy Assisted Decontamination (SALAD) System. West J Emerg Med. 2017 Jan;18(1):117-120. doi: 10.5811/westjem.2016.9.30891. Epub 2016 Nov 8. **PMID:** 28116021 **Citation:** Lin LW, Huang CC, Ong JR, Chong CF, Wu NY, Hung SW. The suction-assisted laryngoscopy assisted decontamination technique toward successful intubation during massive vomiting simulation: A pilot before-after study. Medicine (Baltimore). 2019 Nov;98(46):e17898. doi: 10.1097/MD.0000000000017898. **PMID:** 31725637 **Citation:** Pilbery R, Teare MD. Soiled airway tracheal intubation and the effectiveness of decontamination by paramedics (SATIATED): a randomised controlled manikin study. Br Paramed J. 2019 Jun 1;4(1):14-21. doi: 10.29045/14784726.2019.06.4.1.14. **PMID:** 33328824 **Citation:** Fiore MP, Marmer SL, Steuerwald MT, Thompson RJ, Galgon RE. Three Airway Management Techniques for Airway Decontamination in Massive Emesis: A Manikin Study. West J Emerg Med. 2019 Aug 6;20(5):784-790. doi: 10.5811/westjem.2019.6.42222. **PMID:** 31539335 **Citation:** Kleinman ME, Brennan EE, Goldberger ZD, Swor RA, Terry M, Bobrow BJ, Gazmuri RJ, Travers AH, Rea T. Part 5: Adult Basic Life Support and Cardiopulmonary Resuscitation Quality: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S414-35. doi: 10.1161/CIR.0000000000000259. No abstract available. **PMID:** 26472993 **Citation:** Agostinucci JM, Weisslinger L, Marzouk N, Zouaghi H, Ekpe K, Genthillomme A, Adnet F, Guenin A, Reuter PG, Lapostolle F. Relation between chest compression rate and depth: the ENFONCE Study. Eur J Emerg Med. 2021 Oct 1;28(5):352-354. doi: 10.1097/MEJ.0000000000000802. **PMID:** 33758145 **Citation:** McAlister O, Harvey A, Currie H, McCartney B, Adgey J, Owens P, Idris A. Temporal analysis of continuous chest compression rate and depth performed by firefighters during out of hospital cardiac arrest. Resuscitation. 2023 Apr;185:109738. doi: 10.1016/j.resuscitation.2023.109738. Epub 2023 Feb 16. **PMID:** 36806652 **Citation:** Stiell IG, Brown SP, Nichol G, Cheskes S, Vaillancourt C, Callaway CW, Morrison LJ, Christenson J, Aufderheide TP, Davis DP, Free C, Hostler D, Stouffer JA, Idris AH; Resuscitation Outcomes Consortium Investigators. What is the optimal chest compression depth during out-of-hospital cardiac arrest resuscitation of adult patients? Circulation. 2014 Nov 25;130(22):1962-70. doi: 10.1161/CIRCULATIONAHA.114.008671. Epub 2014 Sep 24. **PMID:** 25252721 **Citation:** Voss S, Rhys M, Coates D, Greenwood R, Nolan JP, Thomas M, Benger J. How do paramedics manage the airway during out of hospital cardiac arrest? Resuscitation. 2014 Dec;85(12):1662-6. doi: 10.1016/j.resuscitation.2014.09.008. Epub 2014 Sep 26. **PMID:** 25260723 **Citation:** Deakin CD, Nolan JP, Ji C, Fothergill RT, Quinn T, Rosser A, Lall R, Perkins GD. The effect of airway management on CPR quality in the PARAMEDIC2 randomised controlled trial. Resuscitation. 2021 Jan;158:8-13. doi: 10.1016/j.resuscitation.2020.11.005. Epub 2020 Nov 12. **PMID:** 33189805 **Citation:** Donoghue A, Hsieh TC, Nishisaki A, Myers S. Tracheal intubation during pediatric cardiopulmonary resuscitation: A videography-based assessment in an emergency department resuscitation room. Resuscitation. 2016 Feb;99:38-43. doi: 10.1016/j.resuscitation.2015.11.019. Epub 2015 Dec 17. **PMID:** 26703462 **Citation:** Robinson AE, Driver BE, Prekker ME, Reardon RF, Horton G, Stang JL, Collins JD, Carlson JN. First attempt success with continued versus paused chest compressions during cardiac arrest in the emergency department. Resuscitation. 2023 May;186:109726. doi: 10.1016/j.resuscitation.2023.109726. Epub 2023 Feb 9. **PMID:** 36764570 **Citation:** Murphy DL, Bulger NE, Harrington BM, Skerchak JA, Counts CR, Latimer AJ, Yang BY, Maynard C, Rea TD, Sayre MR. Fewer tracheal intubation attempts are associated with improved neurologically intact survival following out-of-hospital cardiac arrest. Resuscitation. 2021 Oct;167:289-296. doi: 10.1016/j.resuscitation.2021.07.001. Epub 2021 Jul 14. **PMID:** 34271128 **Citation:** Jost D, Minh PD, Galinou N, Alhanati L, Dumas F, Lemoine F, Tourtier J-P. What is the incidence of regurgitation during an out-of-hospital cardiac arrest? Observational study Resuscitation. 2015;96:70. **Citation:** Ko S, Wong OF, Wong CHK, Ma HM, Lit CHA. A pilot study on using Suction-Assisted Laryngoscopy Airway Decontamination techniques to assist endotracheal intubation by GlideScope® in a manikin simulating massive hematemesis. Hong Kong Journal of Emergency Medicine. 2021;28(5):305-313. **Citation:** Choi I, Choi YW, Han SH, Lee JH. Successful endotracheal intubation using suction- assisted laryngoscopy assisted decontamination technique and a head-down tilt position during massive regurgitation. Soonchunhyang Med Sci. 2020; 26 ( 2 ):75-9. **Citation:** Frantz E, Sarani N, Pirotte A, Jackson BS. Woman in respiratory distress. J Am Coll Emerg Physicians Open. 2021 Jan 14;2(1):e12344. doi: 10.1002/emp2.12344. eCollection 2021 Feb. No abstract available. **PMID:** 33490996 **Citation:** Vittinghus, S., Thomsen, J.E., Harpsø, M. Bo Løfgren. Does the age of medical emergency technicians influence the quality of chest compressions. Scand J Trauma Resusc Emerg Med. 2015;23 (Suppl 1): A9 #### See Also Links **Label:** Related Info **URL:** https://www.anesthesiologynews.com/Review-Articles/Article/07-23/Airway-Contamination-To-Stop-or-Continue-CPR-During-Intubation-Attempts/70740?ses=ogst ## 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: M9411 - Name: Heart Arrest - Relevance: HIGH - As Found: Cardiopulmonary Arrest - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006323 - Term: Heart Arrest ### Misc Info Module - Version Holder: 2024-06-06 **Has Results:** False