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## Protocol Section ### Identification Module **NCT ID:** NCT06421532 **Acronym:** Clear-Brain **Brief Title:** Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy **Official Title:** A Partial Randomised Clinical Trial Investigating Stimulation of the Glymphatic System by Either Deepening Sleep With Lower-sodium Oxybate or Inhibiting Cortical Spreading Depressions With Non-invasive Vagus Nerve Stimulation, or Both, in Patients With Cerebral Amyloid Angiopathy (CAA) #### Organization Study ID Info **ID:** P23.100 #### Organization **Class:** OTHER **Full Name:** Leiden University Medical Center ### Status Module #### Completion Date **Date:** 2026-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** The Dutch Brain Foundation (funding) #### Lead Sponsor **Class:** OTHER **Name:** Leiden University Medical Center #### Responsible Party **Investigator Affiliation:** Leiden University Medical Center **Investigator Full Name:** RolfFronczek **Investigator Title:** principal investigator and neurologist **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:** A pre-post study will be conducted to assess whether treatment with LXB, nVNS or a combination of both interventions can enhance the clearance of Aβ in patients with CAA. A total of 60 subjects, 30 with sCAA and 30 with D-CAA, will be randomly assigned to receive LXB, or both interventions. The primary outcome measure will be the morning levels of Aβ40 and Aβ42 in cerebrospinal fluid (CSF) before and after the intervention. The investigators will assess disease progression with (non-)haemorrhagic imaging markers on 7-Tesla Magnetic Resonance Imaging (7-T MRI) as a secondary outcome. Additionally, the activity of the glymphatic system by means of fluid dynamics will be assessed using 7-T MRI. ### Conditions Module **Conditions:** - Cerebral Amyloid Angiopathy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** pre-post study with additional randomisation ##### 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:** Deepening sleep **Intervention Names:** - Drug: XYWAV **Label:** Low-sodium oxybate (LXB) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Inhibiting cortical spreading depolarisations **Intervention Names:** - Device: gammaCore Sapphire **Label:** Non-invasive vagus nerve stimulation (nVNS) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Deepening sleep and inhibiting cortical spreading depolarisations **Intervention Names:** - Drug: XYWAV - Device: gammaCore Sapphire **Label:** Combination of both **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Combination of both - Low-sodium oxybate (LXB) **Description:** Daily before bedtime for 3 months **Name:** XYWAV **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Combination of both - Non-invasive vagus nerve stimulation (nVNS) **Description:** Twice daily for 3 months **Name:** gammaCore Sapphire **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Difference between before and after intervention **Measure:** Amyloid-beta 40 and 42 in cerebrospinal fluid **Time Frame:** 3 months #### Secondary Outcomes **Description:** Intracerebral haemorrhages, cerebral microbleeds, cortical superficial siderosis, white matter hyperintensities, perivascular spaces, cerebrovascular reactivity **Measure:** Disease progression with (non-)haemorrhagic imaging markers on 7-T MRI **Time Frame:** 2x 3 months **Description:** Levels of amyloid-beta 38, 43, t-tau and p-tau181 in CSF and levels of amyloid-beta 40 and 42 in serum. **Measure:** Other liquid biomarkers **Time Frame:** 3 months **Description:** CSF motion **Measure:** Activity of the glymphatic system by means of fluid dynamics on 7-T MRI **Time Frame:** 2x 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with D-CAA with a proven amyloid precursor protein (APP) mutation or a history of ≥1 lobar intracerebral haemorrhage (ICH) and a positive family history for D-CAA in ≥1 first degree relative * Age ≥30 years old * ≤ 2 symptomatic ICH (occurrence of ICH at least \> 1 year ago) or presence of ≥ 1 haemorrhagic marker (cortical superficial siderosis, cerebral microbleeds) or non-haemorrhagic marker (white matter hyperintensities, enlarged perivascular spaces). * When presymptomatic, patients are aware that they have D-CAA * Probable sporadic CAA (sCAA) according to the Modified Boston criteria 2.0 * Age ≥50 years old * ≤ 2 symptomatic ICH (occurrence of ICH at least \> 1 year ago) * Provisional CAA when the criteria for probable sCAA are not met due to presence of deep haemorrhagic lesions but there are mostly lobar microbleeds (MBs) and cortical superficial siderosis (cSS) present or a ratio of 10 times more lobar MBs than deep MBs without cSS. * Age ≥50 years old * ≤ 2 symptomatic ICH (occurrence of ICH at least \> 1 year ago) * Participants able to read and understand the patient information folder and who freely provide written informed consent Exclusion Criteria: * Modified Rankin Score ≥ 4 * A life expectancy of less than six months * Pregnancy/breast feeding * Contraindications for lumbar puncture * Unwillingness to refrain from consuming \> 1 alcohol unit per day and not later than 8 pm, during the intervention period. Contraindications for using LXB: * Sleep apnea; patients will be screened with respiratory polygraphy before inclusion and screening by questionnaire during intervention with LXB. * Restless legs (RLS) needing active treatment with RLS medication. * Currently suffering from severe depression and using medication or receiving cognitive therapy. * Porphyria * Succinic semialdehyde dehydrogenase (SSADH-)deficiency * Use of opiates, barbiturates, sedatives (dexmedetomidine, temazepam, oxazepam, midazolam) * Use certain medication before inclusion: * When benzodiazepine is used: a two nights washout before the intervention (T3) will be started, is needed. * When LXB or SXB is used before inclusion: one week washout before inclusion and no use of LXB or SXB during inclusion except for the intervention dose. Contraindications for lumbar puncture: * Compression of the spinal cord * Signs and symptoms of increased intracranial pressure * Local infections of the skin at the puncture site * Coagulopathy or thrombocytopenia (\<100) * (Use of acetylsalicylic acid, NSAIDs, COX2 inhibitors or prophylactic low-molecular-weight heparin are no contraindications for lumbar puncture.) * Participants deemed at risk for brain replacement due to known aqueduct stenosis, Arnold chiari malformations. * Participants with a lumbo-sacral neural tube defect or who have a ventriculo-atrial or ventriculo-peritoneal drain. Contraindications for nVNS: * An active implantable medical device such as a pacemaker, deep brain stimulator, or any implanted electronic device. * A recent (\< 1 month) brain infarction or transient ischemic attack due to a symptomatic stenosis or dissection of the carotid artery (in these patients the other side will be stimulated unless a significant stenosis or dissection on the other side is present as well). * If someone knows to have a structural abnormality e.g. lymphadenopathy, previous surgery or abnormal anatomy (in these patients the other side will be stimulated) * Metal cervical spine hardware or metallic implant near the stimulation site * Cervical vagotomy (in these patients the other side will be stimulated) Contraindications for 7 Tesla MRI as determined by the 7 Tesla safety committee. Examples of possible contra-indications are: * Claustrophobia * Pacemakers and defibrillators * Nerve stimulators * Intracranial clips * Intraorbital or intraocular metallic fragments * Cochlear implants * Ferromagnetic implants * Hydrocephalus pump * Intra-uterine device * Permanent make-up * Tattoos above the shoulders Specific contraindications for checkerboard functional Magnetic Resonance Imaging (fMRI): * Seizure within prior year * Photosensitive epilepsy * Non-correctable visual impairment **Minimum Age:** 30 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** clear-brain@lumc.nl **Name:** Sanne Schriemer, MD **Phone:** +31715261825 **Role:** CONTACT **Contact 2:** **Email:** clear-Brain@lumc.nl **Name:** Rolf Fronczek, PhD **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000057165 - Term: Proteostasis Deficiencies - ID: D000008659 - Term: Metabolic Diseases - ID: D000002539 - Term: Cerebral Arterial Diseases - ID: D000020765 - Term: Intracranial Arterial Diseases - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000020739 - Term: Brain Diseases, Metabolic, Inborn - ID: D000001928 - Term: Brain Diseases, Metabolic - ID: D000059345 - Term: Cerebral Small Vessel Diseases - ID: D000028226 - Term: Amyloidosis, Familial - ID: D000008661 - Term: Metabolism, Inborn Errors - ID: D000030342 - Term: Genetic Diseases, Inborn ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M4021 - Name: Amyloidosis - Relevance: HIGH - As Found: Amyloid - ID: M19026 - Name: Cerebral Amyloid Angiopathy - Relevance: HIGH - As Found: Cerebral Amyloid Angiopathy - ID: M23333 - Name: Cerebral Amyloid Angiopathy, Familial - Relevance: HIGH - As Found: Cerebral Amyloid Angiopathy - ID: M28747 - Name: Proteostasis Deficiencies - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M5788 - Name: Cerebral Arterial Diseases - Relevance: LOW - As Found: Unknown - ID: M22521 - Name: Intracranial Arterial Diseases - Relevance: LOW - As Found: Unknown - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M5205 - Name: Brain Diseases, Metabolic - Relevance: LOW - As Found: Unknown - ID: M22498 - Name: Brain Diseases, Metabolic, Inborn - Relevance: LOW - As Found: Unknown - ID: M29437 - Name: Cerebral Small Vessel Diseases - Relevance: LOW - As Found: Unknown - ID: M23329 - Name: Amyloidosis, Familial - Relevance: LOW - As Found: Unknown - ID: M11641 - Name: Metabolism, Inborn Errors - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: T2740 - Name: Hereditary Cerebral Hemorrhage With Amyloidosis - Relevance: HIGH - As Found: Cerebral Amyloid Angiopathy ### Condition Browse Module - Meshes - ID: D000016657 - Term: Cerebral Amyloid Angiopathy - ID: D000028243 - Term: Cerebral Amyloid Angiopathy, Familial - ID: D000000686 - Term: Amyloidosis ### Intervention Browse Module - Browse Branches - Abbrev: AdjAn - Name: Adjuvants, Anesthesia - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M15780 - Name: Sodium Oxybate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421519 **Brief Title:** Different Levels of BiPAP **Official Title:** Crossover Study of the Work of Breathing at Different Levels of BiPAP Settings in Neonates #### Organization Study ID Info **ID:** IRAS 327794 #### Organization **Class:** OTHER **Full Name:** King's College Hospital NHS Trust ### Status Module #### Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-22 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** King's College Hospital NHS Trust #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Some infants with breathing problems at birth may need to be connected to a machine to help support their breathing. The purpose of this study is to optimise the level of breathing support on Bi level continuous airway pressure (BiPAP), a support which gives two levels of support (pressure) to premature infants. The study is investigating which upper pressure gives the best support, that is results in the baby having to breathe less hard (work of breathing). Researchers will measure the work of breathing using a small catheter. Infants will receive three different upper pressures of BiPAP with the same baseline pressure for 20 minutes each. In between each upper level they will receive the standard upper pressure for 20 minutes. **Detailed Description:** Bilevel continuous positive airway pressure (BiPAP) is a type of non-invasive respiratory support which can be used as breathing support in neonates requiring some pressure support to help their breathing. BiPAP provides cycles of higher and lower pressure levels at set intervals, usually with a baseline pressure constant of 5cm H2O. In the UK, other forms of non-invasive ventilation, such as NIPPV and NIV-NAVA, have been shown to be efficacious, however they are expensive. BiPAP may therefore provide a viable and cost-effective alternative. Currently there are no written guidelines about BiPAP use. The investigators aim to identify the most efficacious BiPAP settings for preterm infants as primary support and post-extubation as well as in those with evolving BPD. Infants will be studied at three different upper pressure settings for a period of 20 minutes each. The work of breathing will be measured from small pressure transducers situated on a thin catheter, the size of a feeding tube. The catheter will be passed through the mouth and positioned so the tip is in the stomach. Simultaneous measurements for work of breathing using transcutaneous diaphragm electromyography will also be taken. Following the study the infant will subsequently be nursed on the breathing support type associated with the lower work of breathing. The investigators aim to recruit 21 patients, with 7 in each arm of the trial. Sample size was derived using previous study results in which the SD of the PTPdi was 78cmH2Os/min in 40 preterm infants of 28-34 weeks gestation and a clinically significant difference of 133cmH2Os/min was observed between infants on SNIPPV against high flow NIV support. To detect such a difference with 90% power and 5% significance, 7 infants would be required in each group, that is 21 infants in total in 3 groups. The parents of potential participants will be approached by the clinical team initially, subsequently the research fellow will provide them with the study information. Responsibility for recording and dating oral, electronic, and written informed consent or advice will be with the researchers identified in the formal delegation log. Full analyses will be detailed in a statistical analysis plan (SAP), which will be finalised prior to the end of data collection Any exploratory analyses of sub-groups that are of clinical interest will be pre-specified in the SAP. Any deviations from the original SAP will be described and justified in protocol and/or in final report, as appropriate. This trial will be reported according to the CONSORT guidelines for clinical trials (Consolidated Standards Of Reporting Trials statement). Statistical significance will be at 5% level, and analyses will be conducted in STATA. A summary of the planned statistical analysis is included here: * Descriptive statistics will be used to describe infant demographics. Standard statistical summaries e.g. medians and ranges or means and variances, or proportions and percentages, dependent on the distribution of the outcomes. * The main analysis will investigate work of breathing at baseline and at each of the 3 upper BiPAP pressure settings. Data will be assessed for normality. If data is not normally distributed, non-parametric statistics will be used. 95% confidence intervals will be reported throughout. Missing data will be described with reasons given where available. Data collected during the study will be handled and stored in accordance with the General Data Protection Regulation and Data Protection Act (2018), which requires data to be de-identified as soon as it is practical to do so. All data will be completely anonymised for purposes of analysis and any subsequent reports or publications. For the purposes of ongoing data management, once randomised, individual patients will only be identified by trial numbers. Data will be downloaded from ventilators and pressure transducers to excel using secure password encrypted USB device Data will be uploaded on password protected servers only and anonymised at the point of entry. Data will be anonymised and identified by a unique identification number (Trial number) only. A trial enrolment log at the sites will list the ID numbers. Paper study documents will be held at the trial site in a secure location for the duration of the trial. All essential documents will be retained until children reach 25 years old, as per protocol. A statement of permission to access source data by study staff and for regulatory and audit purposes will be included within the primary care givers consent form with explicit explanation as part of the consent process and Participant Information Sheet. In principle, anonymised data will be made available for meta-analysis and if requested by other authorised researchers and journals for publication purposes. Requests for access to data will be reviewed by the Chief Investigator. Each adverse event will be assessed for severity, causality, seriousness and expectedness. All adverse events will be recorded in the medical records in the first instance. All adverse events will be recorded with clinical symptoms and accompanied with a simple, brief description of the event, including dates as appropriate. All serious adverse events will be recorded in the medical records and the CRF. The Chief Investigator will ensure there are adequate quality and number of monitoring activities conducted by the study team. This will include adherence to the protocol, procedures for consenting and ensure adequate data quality. ### Conditions Module **Conditions:** - Bronchopulmonary Dysplasia **Keywords:** - Biphasic continuous positive airway pressure (BiPAP) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Infants receive receive three upper pressures of BiPAP: 7, 10 or 13cmH2O for a period of 20 minutes each. Additionally, there will be a control period of 20 minutes between each upper pressure with a baseline pressure constant of 5cmH2O. The order in which they receive the levels of respiratory support will be randomised using an excel random number generator. This allows each infant to be used as their own control, minimising the impact of any underlying confounding factors. The results on each pressure setting will be meaned and compared to each other ##### Masking Info **Masking:** DOUBLE **Masking Description:** During the study the infant and their parents will not be aware of which pressures they are on. Due to the nature of the study it is not possible to blind the care provider who in this case is the investigator since they need to manipulate the ventilator settings. However, data analysis with be done using anonymous data and the investigator will be blinded to which pressure settings were used. **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 21 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Infants \<34 weeks gestational age who require non-invasive respiratory support who may go on to require invasive ventilation. **Intervention Names:** - Other: BiPAP setting **Label:** Pre-term infants requiring primary respiratory support before intubation **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Infants \<34 weeks gestational age who were previously invasively ventilated and are currently being weaned onto non-invasive respiratory support and eventually into self-ventilating in room air. **Intervention Names:** - Other: BiPAP setting **Label:** Pre-term infants requiring respiratory support after extubation **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Infants \<34 weeks gestational age who have an ongoing need for non-invasive respiratory support after seven days of life and are likely to develop bronchopulmonary dysplasia. **Intervention Names:** - Other: BiPAP setting **Label:** Pre-term infants requiring respiratory support after seven days **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Pre-term infants requiring primary respiratory support before intubation - Pre-term infants requiring respiratory support after extubation - Pre-term infants requiring respiratory support after seven days **Description:** Infants in this arm of the study will each rotate through three different BiPAP settings. The following BiPAP settings will be used: 13cmH2O / 5cmH2O, 10cmH2O / 5cmH2O, 7cmH2O / 5cmH2O **Name:** BiPAP setting **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Oesophageal (Poes) and gastric pressures(Pgas) will be measured using a catheter with dual pressure tipped transducers (Gaeltec, Dunvegan, Scotland, UK). Transdiaphragmatic pressure (PTPdi) will be calculated by digital subtraction of the oesophageal from the gastric pressure and tidal volume obtained by digital integration of the flow signal by the acquisition software. The mean PTPdi will be calculated from 20 consecutive breaths to measure work of breathing. **Measure:** Work of breathing **Time Frame:** Over the last 5 minutes of the 20 minute study period on each setting of BiPAP **Description:** Transcutaneous diaphragm electromyography (EMG) will be monitored using a portable 16-channel digital physiological amplifier (Dipha-16; Inbiolab, Groningen, the Netherlands) and three surface electrodes (Kendall H59P cloth electrodes; Covidien, Massachusetts) placed on the infant's abdomen. The device wirelessly transmits to a bedside computer running Polybench (Applied Biosignals, Weener, Germany). Work of breathing will be calculated using the voltages measured from a 5 minute period of recording. **Measure:** Work of breathing **Time Frame:** Over the last 5 minutes of the 20 minute study period on each setting of BiPAP ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Preterm infants born \<34 weeks of gestation at KCH requiring primary respiratory support before intubation, after extubation or requiring respiratory support after seven days * Infants aged between 2 days and 2 months at time of study Exclusion Criteria: * Infants with congenital abnormalities of the respiratory system. * Infants with blood-culture confirmed sepsis. * Recent gastrointestinal surgery (within 7 days) * Non-English speakers **Maximum Age:** 2 Months **Minimum Age:** 2 Days **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** oishi.sikdar2@nhs.net **Name:** Oishi Sikdar **Phone:** 07901931550 **Role:** CONTACT #### Locations **Location 1:** **City:** London **Contacts:** ***Contact 1:*** - **Email:** oishi.sikdar2@nhs.net - **Name:** Oishi Sikdar - **Phone:** 07901931550 - **Role:** CONTACT ***Contact 2:*** - **Name:** Theodore Dassios - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Oishi Sikdar - **Role:** SUB_INVESTIGATOR **Country:** United Kingdom **Facility:** King's College Hospital **Status:** RECRUITING **Zip:** SE5 9RS #### Overall Officials **Official 1:** **Affiliation:** King's College Hospital NHS Trust **Name:** Theodore Dassios **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** In principle, anonymised data will be made available for meta-analysis and if requested by other authorised researchers and journals for publication purposes. Requests for access to data will be reviewed by the Chief Investigator. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000055397 - Term: Ventilator-Induced Lung Injury - ID: D000055370 - Term: Lung Injury - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - 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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M27137 - Name: Respiratory Aspiration - Relevance: LOW - As Found: Unknown - ID: M5273 - Name: Bronchopulmonary Dysplasia - Relevance: HIGH - As Found: Bronchopulmonary Dysplasia - ID: M28143 - Name: Lung Injury - Relevance: LOW - As Found: Unknown - ID: M28152 - Name: Ventilator-Induced Lung Injury - 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: M25869 - Name: Premature Birth - 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: T874 - Name: Bronchopulmonary Dysplasia - Relevance: HIGH - As Found: Bronchopulmonary Dysplasia ### Condition Browse Module - Meshes - ID: D000001997 - Term: Bronchopulmonary Dysplasia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421506 **Brief Title:** Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants **Official Title:** Does Less Invasive Surfactant Administration (LISA) During High-flow Nasal Cannula Oxygen Treatment Reduces the Need for Invasive Ventilation in Late Preterm and Term Born Infants With Respiratory Distress? #### Organization Study ID Info **ID:** 324607 #### Organization **Class:** OTHER **Full Name:** King's College Hospital NHS Trust ### Status Module #### Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Chiesi Limited #### Lead Sponsor **Class:** OTHER **Name:** King's College Hospital NHS Trust #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the need for invasive ventilation in babies with breathing problems born 2-6 weeks early. Less invasive surfactant administration is where surfactant (a naturally produced substance which helps open up the tiny air sacs in the lungs making it easier for babies to breathe) is given into the lungs by putting a small tube into the windpipe through the mouth whilst the baby is awake. The surfactant is given slowly and breathed in. High flow nasal cannula is a form of non-invasive support where a machine delivers warmed, moist oxygen and air through short tubes in the nose. The investigators will be assessing whether a lower percentage of neonates need invasive ventilation within 72 hrs from birth when they have had LISA during HFNC treatment, compared to when they don't receive this treatment. The investigators will also be looking at the length of neonatal unit stay and the cost of the stay. The investigators will also be measuring the lung function of the babies before and after they receive LISA. **Detailed Description:** This study is looking at babies born 2- 6 weeks early who have breathing problems soon after birth. Some babies need to go onto a breathing machine (ventilator) or require 'non-invasive' breathing support. Either a machine delivers warmed, moist oxygen + air through short tubes in the nose (humidified high flow nasal cannula, HHFNC) or a machine delivers oxygen and air via a small mask which fits over the nose (continuous positive airway pressure, CPAP). Mechanical ventilation via a ventilator, although life-saving, can cause problems such as infection and lung injury and, therefore, whenever possible baby's breathing is supported with 'non-invasive' methods. The use of CPAP in more mature babies may also cause discomfort or lung collapse, whereas use of HHFNC may avoid those problems. The lungs of healthy full-term babies naturally produce a substance called surfactant that helps open up the tiny air sacs in the lungs and makes it easier for them to breathe. Babies born early or those with problems at birth, do not have enough of their own surfactant or it does not work properly, causing difficulty in taking in oxygen. A natural, animal-derived surfactant medication can be given into the lungs, using a small tube put into the windpipe through the mouth. This is done routinely in ventilated babies born prematurely. More recently, a technique called 'Less invasive surfactant administration (LISA)' has been developed that allows us to give surfactant to babies who are receiving 'non-invasive' breathing support (ie HHFNC) and, thus, avoiding the complications related to mechanical ventilation. A small tube is passed into the windpipe whilst the baby is awake and breathing (supported on HHFNC or CPAP) and the surfactant is slowly given and breathed into the lungs. At the moment, there have been no research studies assessing the use of LISA in more mature infants receiving HHFNC as 'non-invasive' respiratory support. In this study the investigators want to determine if in babies born between 34 and 38+6 weeks gestation who have breathing problems and receive HHFNC oxygen treatment with LISA within 24 hours of birth will reduce the need for mechanical ventilation. The investigators will also be looking a the length on neonatal unit stay, and the cost of the stay. Lung function of the babies before and after they receive LISA will be measured. There will be no change in the management of babies taking part in the study. Use of HHFNC, administration of LISA and respiratory monitoring is all part of routine practice. The investigators are asking for consent to analyse the routine monitoring that will be undertaken before, during and after the surfactant administration and follow up on the outcome of the baby after they have had the LISA procedure. Surfactant is routinely used in babies and there are no extra risks from taking part in this study. HHFNC is routinely used to support babies of this gestational age who require respiratory support. There are no known or expected risks from using HHFNC with LISA but as of yet there have been no studies using this combination. Giving surfactant may help to avoid mechanical ventilation and its side effects, but this has not been studied before in these gestational ages, hence the need for this study. Theoretically giving surfactant with HHFNC should aid even distribution of surfactant throughout the lungs whilst protecting the lungs from potential damage caused by other forms of non-invasive support such as CPAP but again there is not yet evidence supporting this. The study will be running at King's College Hospital on the Neonatal Intensive Care Unit at the Denmark hill site and at the Local Neonatal Unit at the Princess Royal Hospital site. The study has received ethical approval and is due to commence imminently (May 2024). The study is aiming to recruit 245 patients which is estimated to take 2yrs and 4 months. The study is funded by Chiesi Limited. The chief investigator for the study is Theodore Dassios: theodore.dassios@kcl.ac.uk ### Conditions Module **Conditions:** - Respiratory Distress Syndrome - Preterm Pregnancy - Surfactant Deficiency Syndrome Neonatal ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This will be a prospective single centre study with a treatment arm and a control group. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 245 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Infants between 34-38+6 weeks gestation will receive surfactant via less invasive administration whilst on high flow nasal cannula oxygen treatment. They will have respiratory function monitoring before and after LISA. **Intervention Names:** - Procedure: Less invasive surfactant administration during high flow nasal cannula treatment **Label:** Neonates given LISA during HFNC treatment **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Infants between 34-38+6 will receive routine care and will not receive surfactant unless intubated. **Label:** Neonates not given LISA **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Neonates given LISA during HFNC treatment **Description:** Surfactant distilled through a small tube inserted into the windpipe via the mouth whilst the baby is awake and supported with HFNC. **Name:** Less invasive surfactant administration during high flow nasal cannula treatment **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The percentage of babies requiring more respiratory support and therefore needing invasive ventilation within 72 hrs from birth. The percentage from the intervention group will be compared with the control group **Measure:** The percentage of neonates needing invasive ventilation within 72 hours from birth **Time Frame:** 72 hours from birth #### Secondary Outcomes **Description:** The duration of stay on the neonatal unit will be compared between the babies receiving the intervention, and those who are not. **Measure:** The length of neonatal unit stay **Time Frame:** The length of time the neonate is in hospital, up to 20 weeks **Description:** Standard NHS tariffs will be used to calculate the total cost of the stay for the babies in the intervention vs control group. **Measure:** The cost of stay as estimated via standard NHS tariffs according to level of care **Time Frame:** The length of time the neonate is in hospital, up to 20 weeks **Description:** The following lung function parameter: tidal volume will be measured for all babies receiving LISA. **Measure:** The lung function parameters two minutes before and two minutes after the administration of LISA **Time Frame:** The first 24 hours of life **Description:** The following lung function parameter: respiratory rate will be measured for all babies receiving LISA. **Measure:** The lung function parameters two minutes before and two minutes after the administration of LISA **Time Frame:** The first 24 hours of life **Description:** The following lung function parameter: fraction of inspired oxygen (FiO2) will be measured for all babies receiving LISA. **Measure:** The lung function parameters two minutes before and two minutes after the administration of LISA **Time Frame:** The first 24 hours of life **Description:** The following lung function parameter: End Tidal CO2 (ETCO2) will be measured for all babies receiving LISA. **Measure:** The lung function parameters two minutes before and two minutes after the administration of LISA **Time Frame:** The first 24 hours of life **Description:** The following lung function parameter: ratio of oxygen saturations/ fractions of inspired oxygen (SpO2/ FiO2 ratio) will be measured for all babies receiving LISA. **Measure:** The lung function parameters two minutes before and two minutes after the administration of LISA **Time Frame:** The first 24 hours of life **Description:** Lung function parameter: ratio SpO2/FiO2 will be measured two hours after LISA administration for all babies receiving LISA **Measure:** The SpO2/FiO2 ratio will be measured two hours after LISA administration **Time Frame:** The first 24 hours of life ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Infants born at 34+0 to 38+6 weeks of gestation, requiring resuscitation at birth, but who achieve regular spontaneous breathing and have a heart rate over 100 beats per minute while receiving non-invasive support. * Infants enrolled in the Surfon trial, born at 34+0 to 38+6 weeks of gestation, who are less than or equal to 24 hours old and exhibit signs of respiratory distress, defined as an FiO2 greater or equal to 0.30 but less than 0.45 needed to maintain an SpO2 greater than or equal to 92% or a clinically significant work of breathing regardless of the FiO2 and a clinical decision to provide non-invasive respiratory support. Exclusion Criteria: * Infants requiring intubation at birth * Infants with severe congenital anomalies. **Maximum Age:** 38 Weeks **Minimum Age:** 34 Weeks **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** eleanor.jeffreys@nhs.net **Name:** Eleanor Jeffreys, MBBS **Phone:** +447519 974813 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** King's College London **Name:** Theodore Dassios, PHD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** The General Data Protection Regulation and Data Protection Act 2018 will be adhered to. Data will be anonymised before being entered into a secure database. Each participant will be issued a unique study identifier number when enrolled and this will be used on all data collection forms. Patient paper data will be stored in a locked filing cabinet in a room that is only accessible to the research team and that is based on the Neonatal Intensive Care Unit facilities at King's College Hospital. De-identified electronic patient data will be stored on encrypted computers or memory stick devices. On completion, the data will be analysed and a final report prepared that could be accessed via the sponsor. The study will be presented at research meetings at King's College Hospital. Anonymised study data will be presented at conferences and published by the investigators in peer reviewed journals. Participants will be notified of the outcome of the study via provision of the publication. **IPD Sharing:** NO ### References Module #### References **Citation:** Herting E, Hartel C, Gopel W. Less invasive surfactant administration (LISA): chances and limitations. Arch Dis Child Fetal Neonatal Ed. 2019 Nov;104(6):F655-F659. doi: 10.1136/archdischild-2018-316557. Epub 2019 Jul 11. **PMID:** 31296694 **Citation:** Shetty S, Egan H, Cornuaud P, Kulkarni A, Duffy D, Greenough A. Less Invasive Surfactant Administration in Very Prematurely Born Infants. AJP Rep. 2021 Jul;11(3):e119-e122. doi: 10.1055/s-0041-1735632. Epub 2021 Sep 22. **PMID:** 34567837 **Citation:** Smithhart W, Wyckoff MH, Kapadia V, Jaleel M, Kakkilaya V, Brown LS, Nelson DB, Brion LP. Delivery Room Continuous Positive Airway Pressure and Pneumothorax. Pediatrics. 2019 Sep;144(3):e20190756. doi: 10.1542/peds.2019-0756. Epub 2019 Aug 9. **PMID:** 31399490 **Citation:** Spence KL, Murphy D, Kilian C, McGonigle R, Kilani RA. High-flow nasal cannula as a device to provide continuous positive airway pressure in infants. J Perinatol. 2007 Dec;27(12):772-5. doi: 10.1038/sj.jp.7211828. Epub 2007 Aug 30. **PMID:** 17762844 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000007752 - Term: Obstetric Labor, Premature - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: 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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M25869 - Name: Premature Birth - Relevance: HIGH - As Found: Preterm - ID: M14965 - Name: Respiratory Distress Syndrome - Relevance: HIGH - As Found: Respiratory Distress Syndrome - ID: M14964 - Name: Respiratory Distress Syndrome, Newborn - Relevance: HIGH - As Found: Surfactant Deficiency Syndrome Neonatal - ID: M10772 - Name: Obstetric Labor, Premature - Relevance: LOW - As Found: Unknown - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: 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: Surfactant Deficiency Syndrome Neonatal - 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 - ID: D000047928 - Term: Premature Birth - ID: D000013577 - Term: Syndrome ### Intervention Browse Module - Ancestors - ID: D000019141 - Term: Respiratory System Agents ### Intervention Browse Module - Browse Branches - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M14517 - Name: Pulmonary Surfactants - Relevance: HIGH - As Found: Testicular - ID: M21137 - Name: Respiratory System Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000011663 - Term: Pulmonary Surfactants ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421493 **Acronym:** MATER **Brief Title:** Role of the Maternal Microbiota on the Immune Response and Metabolism During Hypertensive Disorders **Official Title:** Role of the Maternal Microbiota on the Immune Response and Metabolism During Hypertensive Disorders #### Organization Study ID Info **ID:** 0004622 #### Organization **Class:** OTHER **Full Name:** Istituto Clinico Humanitas ### Status Module #### Completion Date **Date:** 2025-06-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-06 **Type:** ESTIMATED #### Start Date **Date:** 2020-06-06 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico #### Lead Sponsor **Class:** OTHER **Name:** Istituto Clinico Humanitas #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Preeclampsia (PE) is a significant cause of maternal and fetal morbidity and mortality, characterized by high blood pressure and proteinuria during pregnancy. It has two main phenotypes: one linked to placental damage and the other to metabolic factors like obesity. Early identification of high-risk groups is crucial, though there's ongoing disagreement over its classification. Research suggests a potential connection between maternal gut bacteria and PE, offering avenues for improved prevention strategies. This study aims to investigate the differences in maternal gut microbiota between these two PE phenotypes. **Detailed Description:** Preeclampsia (PE) is one of the leading causes of maternal and fetal morbidity and mortality. It is defined as the presence of systolic blood pressure (SBP) ≥ 140 and diastolic blood pressure (DBP) ≥ 90 on two consecutive measurements six hours apart, associated with proteinuria \>300 mg/24 h or 2++ detected by urine dipstick or the presence of organ damage or intrauterine growth restriction. Preeclampsia complicates 3-8% of pregnancies and is responsible for more than 76,000 maternal deaths annually. Scientific evidence suggests the existence of two distinct phenotypes of the disease: preeclampsia due to placental damage and preeclampsia on a metabolic basis. The former phenotype recognizes altered invasion of the maternal endometrium by the trophoblast as its pathogenesis, where defective trophoblast invasion leads to the development of preeclampsia often associated with early presentation in pregnancy, intrauterine growth restriction (IUGR), and the need for delivery at low gestational ages. The latter phenotype recognizes a metabolic basis, which represents about 4% of hypertensive disorders of pregnancy (HDP), and is dependent on maternal predisposition in patients with visceral obesity and metabolic syndrome. Evidence suggests that maternal risk factors for metabolic dysfunction may lead to late placental dysfunction in pregnancy. Metabolic-based preeclampsia manifests in patients with pre-existing low-grade inflammation related to truncal obesity and metabolic syndrome, compounded by pregnancy-related inflammation and insulin resistance. Today, starting as early as the first trimester of pregnancy, maternal cardiovascular and hemodynamic function can be assessed using a non-invasive and safe method for both the mother and fetus through the USCOM (Ultra Sonic Cardiac Output Monitor) system. This system provides real-time data on numerous central and peripheral hemodynamic parameters. There is still disagreement among scientific societies regarding the classification of preeclampsia and its possible different clinical phenotypes, making personalized clinical approaches to this condition challenging. However, early identification of high-risk groups is becoming increasingly important for diagnostic follow-up and therapeutic strategies based on pathogenesis. Recently, a screening method at 11-13 weeks of gestation has been developed to predict 75% of pregnancies that will develop preterm preeclampsia (\<37 weeks of gestation) based on a risk calculation algorithm combining weight and height measurements, mean arterial pressure measured with automated devices, blood sampling for PLGF measurement, and Doppler ultrasound measurement of the mean pulsatility index (PI) of the uterine arteries. However, this screening method can only predict a portion of patients who will develop preeclampsia before 37 weeks and who may benefit from aspirin intake if administered at doses \>100mg and before 16 weeks. Predicting and effectively preventing preeclampsia that occurs after 37 weeks remains the subject of debate and scientific research. Among emerging etiopathogenetic hypotheses, numerous scientific publications suggest that alterations in maternal immunity and immune tolerance are the basis of hypertensive disorders in pregnancy. Recent discoveries suggest that changes in maternal intestinal microbiota may underlie these immune alterations. Alterations in gut microbiota diversity and composition, known as "dysbiosis," can influence systemic immune responses and metabolic disturbances such as gestational diabetes and preeclampsia, posing risks of metabolic alterations in the neonate. Based on these premises, this study aims to define the characteristics of maternal intestinal microbiota in the two different clinical phenotypes of preeclampsia: placental preeclampsia associated with growth restriction and metabolic-based preeclampsia associated with a fetus of appropriate weight for gestational age. ### Conditions Module **Conditions:** - Preeclampsia **Keywords:** - microbiome - immune system - metabolome ### Design Module #### Bio Spec **Description:** The protocol involves analyzing the maternal microbiota and metabolome from fecal samples and blood samples collected from women who have consented to the study. The blood will be centrifuged to separate the plasma from the cellular fraction. The isolated plasma will be frozen at -80°C for subsequent metabolomic and microbiota analyses, while the cells will be resuspended in phosphate-buffered saline (PBS) in equal volume to the isolated plasma. focal material will be stored at -80°C. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Age \> 18 years Singleton pregnancy Live fetus at 11-13 weeks of gestation Pregnancies complicated by hypertensive disorders (HDP) and fetal growth restriction (FGR) Women with pregnancies complicated by HDP and a fetus with appropriate weight for gestational age (AGAf) Women with pregnancies complicated solely by early fetal growth restriction (before 34 weeks) Women with pregnancies complicated solely by late fetal growth restriction (after 34 weeks) Women identified as high-risk in first-trimester screening for preeclampsia Women identified as high-risk in first-trimester screening for fetal growth restriction **Label:** Case group #### Arm Group 2 **Description:** Age \> 18 years Singleton pregnancy Feto vivo a 11-13 settimane di gravidanza Low-risk pregnancies in first-trimester screening for preeclampsia and fetal growth restriction, with physiological follow-up visits until delivery (homogeneous control sample) **Label:** Controls ### Outcomes Module #### Primary Outcomes **Description:** Study of the characteristics of the microbiota in fecal samples from women with pregnancies complicated by hypertensive disorders, with or without fetal growth restriction. **Measure:** Study of the Characteristics of Maternal Gut Microbiota in Women with Pregnancies Complicated by Hypertensive Disorders, with or without Fetal Growth Restriction. **Time Frame:** through study completion, an average of 1 year **Description:** Study of the characteristics of the metabolites in fecal and blood samples from women with pregnancies complicated by hypertensive disorders, with or without fetal growth restriction. **Measure:** Study of the Characteristics of Metabolome, in Women with Pregnancies Complicated by Hypertensive Disorders, with or without Fetal Growth Restriction. **Time Frame:** through study completion, an average of 1 year **Description:** Study of the characteristics of NK and B cells in blood samples from women with pregnancies complicated by hypertensive disorders, with or without fetal growth restriction. **Measure:** Study of the Characteristics of NK and B Cells in Women with Pregnancies Complicated by Hypertensive Disorders, with or without Fetal Growth Restriction. **Time Frame:** through study completion, an average of 1 year #### Secondary Outcomes **Description:** Assessment of Changes in Maternal Microbiota, in High-Risk Patients in the First Trimester for Preeclampsia or Fetal Growth Restriction **Measure:** Study of the Characteristics of Microbiota in Women with Pregnancies **Time Frame:** through study completion, an average of 1 year **Description:** Assessment of Changes in Maternal Metabolites in High-Risk Patients in the First Trimester for Preeclampsia or Fetal Growth Restriction **Measure:** Study of the Evolution of Metabolome in Women with Pregnancies **Time Frame:** through study completion, an average of 1 year **Description:** Assessment of Changes in B and NK Cells in High-Risk Patients in the First Trimester for Preeclampsia or Fetal Growth Restriction **Measure:** Study of the Evolution of NK and B Cells in Women with Pregnancies **Time Frame:** through study completion, an average of 1 year **Description:** The diet record will be obtained through a validated questionnaire on dietary habits and lifestyle. Spearman correlation of α-diversity microbiota measures and dietary intake will be performed. **Measure:** Evaluation of a Possible Correlation Between Dietary Habits and Maternal Gut Microbiota **Time Frame:** through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age \> 18 years * Singleton pregnancy * Live fetus at 11-13 weeks of gestation * Pregnancies complicated by hypertensive disorders (HDP) and fetal growth restriction (FGR) Women with pregnancies complicated by HDP and a fetus with appropriate weight for gestational age (AGAf) * Women with pregnancies complicated solely by early fetal growth restriction (before 34 weeks) * Women with pregnancies complicated solely by late fetal growth restriction (after 34 weeks) * Women identified as high-risk in first-trimester screening for preeclampsia Women identified as high-risk in first-trimester screening for fetal growth restriction * Low-risk pregnancies in first-trimester screening for preeclampsia and fetal growth restriction, with physiological follow-up visits until delivery (homogeneous control sample) Exclusion Criteria: * Multiple pregnancies * Pregnancies complicated by major fetal abnormalities identified during the 11-13 week gestational assessment * Women who are unconscious or severely ill, women with learning difficulties, and those with severe psychiatric disorders * Age \<18 years * Women who have not provided informed consent for the study * Women with HIV, HBV, HCV infection * Women with a history of leukemia and lymphoma * Women with immunodeficiency * Women who have used corticosteroids or other immunosuppressants in the last 3 months **Gender Based:** True **Gender Description:** Pregnant women **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Women with pregnancies complicated by hypertensive disorders associated with or without fetal growth restriction in the second and third trimesters, and women identified as high-risk for the development of preeclampsia from the first trimester of pregnancy, will be offered the opportunity to participate in the study. To obtain a control sample, equal participation (1:1 ratio) of pregnant women identified as low-risk in first-trimester screening for preeclampsia and fetal growth restriction, who will undergo physiological follow-up visits until delivery, will also be requested. Recruitment of controls will follow an alternating principle: high risk-low risk-high risk-low risk. Patients will be followed up at defined intervals, varying depending on the underlying condition. High-risk patients and controls will be seen once per trimester if the pregnancy remains uncomplicated. ### Contacts Locations Module #### Locations **Location 1:** **City:** Pieve Emanuele **Contacts:** ***Contact 1:*** - **Email:** silvia.giugliano@hunimed.eu - **Name:** Silvia Giugliano, PhD - **Phone:** +390282243190 - **Role:** CONTACT ***Contact 2:*** - **Name:** Silvia Giugliano, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Italy **Facility:** Humanitas University **State:** Milan **Status:** RECRUITING **Zip:** 20072 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000046110 - Term: Hypertension, Pregnancy-Induced - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: HIGH - As Found: Hypertensive Disorders - ID: M14106 - Name: Pre-Eclampsia - Relevance: HIGH - As Found: Preeclampsia - ID: M7633 - Name: Eclampsia - Relevance: LOW - As Found: Unknown - ID: M25635 - Name: Hypertension, Pregnancy-Induced - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T2019 - Name: Eclampsia - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011225 - Term: Pre-Eclampsia - ID: D000006973 - Term: Hypertension ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421480 **Brief Title:** Using Machine Learning to Detect Risky Behavior in Psychiatric Clinics **Official Title:** Detecting Risky Behaviors and Providing a Safe Environment in Patients Receiving Inpatient Treatment in a Psychiatric Clinic Using Machine Learning Model #### Organization Study ID Info **ID:** İstanbulMedeniyet #### Organization **Class:** OTHER **Full Name:** Istanbul Medeniyet University ### Status Module #### Completion Date **Date:** 2024-08-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-29 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-20 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul Medeniyet University #### Responsible Party **Investigator Affiliation:** Istanbul Medeniyet University **Investigator Full Name:** CEYDA ÖZTÜRK AKDENİZ **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this study is to ensure the safety of patients in a psychiatric clinic and to detect risky behaviors by using machine learning method. Risky behaviors are defined as behaviors that are personally, socially and developmentally undesirable and endanger life and health.Patient safety and maintaining a safe environment are among the primary duties of healthcare professionals. Suicide is the most important evidence-based risk factor, especially among individuals with psychiatric illnesses, and is one of the most important factors that threaten patient safety. At the end of this study, it is aimed to detect risky behaviors of patients before they harm themselves and to enable healthcare professionals to make early intervention for these behaviors, thus supporting a safe treatment environment, with the computer system that has been trained with the machine learning model installed in the clinics. **Detailed Description:** The aim of this study is to detect risky behaviors of patients in a psychiatric clinic using machine learning method. Risky behavior; It is defined as behaviors that are personally, socially and developmentally undesirable and endanger life and health. Patient safety and ensuring a safe environment are among the primary duties of healthcare professionals. Suicide is the most important evidence-based risk factor, especially in individuals with psychiatric illnesses, and is one of the most important factors that threaten patient safety. Suicide attempt is a crisis situation frequently encountered in clinics. It is known that the rate of suicide attempts increases 5-10 times in hospitalized patients. In clinics with inpatients, suicide attempts as well as other risky behaviors are frequently encountered. Preventing risky behavior and providing a safe environment in psychiatric clinics is an important issue in our country and in the world. In order to detect risky behaviors and ensure patient/employee safety, there are measures to monitor patients with cameras in psychiatric clinics within the scope of quality standards in health. However, these measures are not sufficient to completely solve the problem. In psychiatric clinics, patient monitoring is provided by a nurse who constantly monitors the camera images placed in the rooms on the computer screen. The low number of nurses, especially on night shifts, makes camera monitoring difficult during night shifts and poses a problem in terms of patient safety. Constant monitoring of monitors by the nurse reduces the time spent with the patient and increases the workload. Additionally, when screen monitoring is not done, risky behaviors cannot be detected. Therefore, new methods need to be developed to ensure a safe environment in psychiatric clinics. In this sense, the machine learning method, which is increasingly used in artificial intelligence and data analysis, is a specialized sub-branch of artificial intelligence algorithms that tries to derive meaningful results/predictions from existing data. Machine learning method is frequently used in the field of health, and psychiatry is one of these fields. The main purpose of this study is to detect risky and high-risk behaviors of patients treated in a psychiatric clinic using machine learning method and to ensure that patients receive treatment in a safer environment. ### Conditions Module **Conditions:** - Machine Learning - Dangerous Behavior **Keywords:** - psychiatric clinic - machine learning - risky behavior ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 1 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Using machine learning, the computer will be trained to detect suicide and violent behavior. Cameras will be placed in patient rooms. These cameras will transfer the image to the computer. The computer will process these images and detect suicidal and violent behavior early. A warning will appear on the computer screen **Name:** Detecting Risky Behaviors and Providing a Safe Environment in Patients Receiving Inpatient Treatment in a Psychiatric Clinic Using Machine Learning Model **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Detection of suicide and violent behaviors using machine learning method **Measure:** Targeted Output **Time Frame:** 01.05.2024-01.08.2024 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * It is suitable for all adult patients receiving inpatient treatment in psychiatric clinics. It is designed for the room where patients sleep. Exclusion Criteria: * People under the age of 18 will be excluded from the study **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The population of the study was theater and drama actors who randomly exhibited suicidal and violent behavior, using an empty room in a psychiatric clinic for training and testing the machine learning model. The number of actors is 4-5 people ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ceyda.ozturk@artvin.edu.tr **Name:** ceyda öztürk akdeniz, 1 **Phone:** 05394124524 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Detecting Risky Behaviors and Providing a Safe Environment in Patients Receiving Inpatient Treatment in a Psychiatric Clinic Using Machine Learning Model **Zip:** 34000 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421467 **Brief Title:** Insulin Injection Practices in Spain **Official Title:** Insulin Injection Practices in People With Diabetes in Spain #### Organization Study ID Info **ID:** EPID-ES #### Organization **Class:** OTHER **Full Name:** Fundación para la Investigación del Hospital Clínico de Valencia ### Status Module #### Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-01-19 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Novo Nordisk A/S #### Lead Sponsor **Class:** OTHER **Name:** Fundación para la Investigación del Hospital Clínico de Valencia #### Responsible Party **Investigator Affiliation:** Fundación para la Investigación del Hospital Clínico de Valencia **Investigator Full Name:** Francisco Javier Ampudia Blasco **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** In this era of pharmaceutical and technological advancements, gaining insights into prevalent insulin administration practices under real-life conditions becomes pivotal for healthcare professionals. The investigators aim to explore insulin injection habits through an online survey among a broad, unselected group of participants with type 1 and type 2 diabetes undergoing daily prandial and/or basal insulin treatment. Eligible participants will access and complete the survey at their convenience after providing online informed consent within the study period **Detailed Description:** HYPOTHESIS The study hypothesis posits that there is significant variability in the practices of insulin administration among patients with diabetes using daily insulin injections. This diversity in administration practices may have a notable impact on the overall efficacy of treatment regimens and the successful management of the disease, thereby emphasizing the need for a comprehensive understanding of these practices to enhance patient outcomes and optimize diabetes care. OBJECTIVES The main objective of the study is to comprehensively assess and characterize the diverse insulin administration practices among individuals with diabetes using injections, focusing on both prandial and basal insulin. By employing an online survey methodology and targeting a broad demographic through a diabetes information platform Canal Diabetes, the investigators aim to gain valuable insights into the variability, challenges, and overall patterns of insulin administration. The findings will contribute to a better understanding of real-world practices, facilitating improvements in patient guidance and optimizing diabetes care strategies. STUDY DESIGN The study follows a cross-sectional observational design, allowing the investigators to capture a snapshot of the current insulin administration practices via an online questionnaire among the diverse population of diabetes patients using multiple insulin injections. STUDY PROCEDURE AND SCHEDULE The study, focusing on insulin administration practices among participants with diabetes using multiple insulin injections, will employ a two-month online survey accessible on the designated online platform Canal Diabetes. Recruitment efforts through the diabetes information platform Canal Diabetes will inform eligible participants about the study's voluntary nature, emphasizing response confidentiality. Participants meeting the criteria, will access and complete the online informed consent and survey at their convenience within the designated two-month period. Post-survey, collected data will be securely stored and anonymized for subsequent analysis. STUDY DURATION The anticipated duration of this study will be 4 months, with subject recruitment set to begin in July 2024 and aiming for the completion of statistical analysis by the 31st of October 2024. GOOD CLINICAL PRACTICE The procedures set out in this study protocol, pertaining to the conduct, evaluation, and documentation of this study, are designed to ensure that the sponsor and investigator (in this case the same person) comply with the principle of the good clinical practice guidelines and the Declaration of Helsinki in the conduct, evaluation and documentation of this study. The study will also be carried out in keeping with local legal requirements. SUBJECTS INFORMATION AND INFORMED CONSENT Prior to taking the online questionnaire, participants will be required to provide explicit consent to participate in the study. An online informed consent document, encompassing details about the study and the consent form, will be prepared and supplied to participants. This document will be presented in a language accessible to participants, and clear contact information will be provided for any questions that may arise. ENSURING DATA CONFIDENTIALITY The study database will not contain any information that could allow the individual identification of the study participants. The data obtained will be used exclusively for the purposes described in this research project. The information will be treated as confidential and will be stored and processed in accordance with the provisions of EU Regulation 2016/679 of the European Parliament and the Council of 27 April 2016 on the protection of personal data and the free movement of such data, as well as Organic Law 3/2018 of December. ### Conditions Module **Conditions:** - Diabetes ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 400 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Number of total insulin injections per day **Measure:** Number of total insulin injections **Time Frame:** through study completion, an average of 16 weeks **Description:** Number of prandial insulin injections per day **Measure:** Number of prandial insulin injections **Time Frame:** through study completion, an average of 16 weeks **Description:** Number of basal insulin injections per day **Measure:** Number of basal insulin injections **Time Frame:** through study completion, an average of 16 weeks **Description:** Timing of prandial insulin injection: before meals, during meals, after meals, or at some point during the day **Measure:** Timing of prandial insulin injection **Time Frame:** through study completion, an average of 16 weeks **Description:** If insulin administration occurs before starting the meal: time interval (minutes) **Measure:** Time interval before prandial insulin injection **Time Frame:** through study completion, an average of 16 weeks **Description:** If insulin administration occurs after the meal: time interval (minutes) **Measure:** Time interval after prandial insulin injection **Time Frame:** through study completion, an average of 16 weeks **Description:** Insulin overdosing when correcting abnormal glucose values (Y/N) **Measure:** Insulin overdosing **Time Frame:** through study completion, an average of 16 weeks **Description:** Insulin overdosing when correcting abnormal glucose values (Y/N) **Measure:** Insulin underdosing **Time Frame:** through study completion, an average of 16 weeks **Description:** Insulin administration site: abdomen, thigh, arm **Measure:** Insulin administration site **Time Frame:** through study completion, an average of 16 weeks **Description:** Injection site rotation: (Yes/No) **Measure:** Site rotation **Time Frame:** through study completion, an average of 16 weeks **Description:** Frequency in the change of the insulin needle **Measure:** Change of the insulin needle **Time Frame:** through study completion, an average of 16 weeks **Description:** Use of smart pens (Y/N) **Measure:** Use of smart pens **Time Frame:** through study completion, an average of 16 weeks **Description:** Type of prandial insulin used **Measure:** Type of prandial insulin **Time Frame:** through study completion, an average of 16 weeks **Description:** Daily dose of prandial insulin (IU/kg) **Measure:** Daily dose of prandial insulin **Time Frame:** through study completion, an average of 16 weeks **Description:** Type of basal insulin used **Measure:** Type of basal insulin **Time Frame:** through study completion, an average of 16 weeks **Description:** Daily dose of basal insulin (IU/kg) **Measure:** Daily dose of basal insulin **Time Frame:** through study completion, an average of 16 weeks **Description:** Last HbA1c value **Measure:** Last HbA1c **Time Frame:** through study completion, an average of 16 weeks **Description:** Date of last HbA1c value **Measure:** Date of last HbA1c **Time Frame:** through study completion, an average of 16 weeks **Description:** Diabetic ketoacidosis (DKA) in the last year (Y/N) **Measure:** Diabetic ketoacidosis **Time Frame:** through study completion, an average of 16 weeks **Description:** Severe hypoglycemic episodes in the last year (Y/N) **Measure:** Hypoglycemic episodes **Time Frame:** through study completion, an average of 16 weeks **Description:** Hyperglycemic episodes with medical support in the last year (Y/N) **Measure:** Hyperglycemic episodes **Time Frame:** through study completion, an average of 16 weeks **Description:** Age of diabetes onset (years/months) **Measure:** Age of diabetes onset **Time Frame:** through study completion, an average of 16 weeks **Description:** Self-monitoring of capillary blood glucose (SMBG) (Y/N) **Measure:** Self-monitoring of capillary glucose **Time Frame:** through study completion, an average of 16 weeks **Description:** Continuous glucose monitoring (CGM) in real-time or intermittently scanned (Y/N) **Measure:** Glucose monitoring in real-time or intermittently scanned **Time Frame:** through study completion, an average of 16 weeks **Description:** Lack of daily glucose monitoring (Y/N) **Measure:** Lack of daily glucose monitoring **Time Frame:** through study completion, an average of 16 weeks **Description:** Lack of correction based on glucose values (Y/N) **Measure:** Lack of correction based on glucose values **Time Frame:** through study completion, an average of 16 weeks **Description:** If CGM user, CGM parameters from the last 28 days: Time in Range (%TIR) **Measure:** Time in Range (%TIR) **Time Frame:** through study completion, an average of 16 weeks **Description:** If CGM user, CGM parameters from the last 28 days: Time Below Range (%TbR) **Measure:** Time Below Range (%TbR) **Time Frame:** through study completion, an average of 16 weeks **Description:** If CGM user, CGM parameters from the last 28 days: Time Above Range (%TaR) **Measure:** Time Above Range (%TaR) **Time Frame:** through study completion, an average of 16 weeks **Description:** If CGM user, CGM parameters from the last 28 days: mean glucose (mg/dL) **Measure:** Mean glucose (mg/dL) **Time Frame:** through study completion, an average of 16 weeks **Description:** If CGM user, CGM parameters from the last 28 days: coefficient of variation of continuous glucose sensor values (CV) **Measure:** Coefficient of variation of continuous glucose sensor values (CV) **Time Frame:** through study completion, an average of 16 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Individuals aged 18 or above * Individuals diagnosed with diabetes (type 1 or type 2 diabetes) * Individuals receiving multiple daily doses of insulin Exclusion Criteria: * Individuals utilizing continuous subcutaneous insulin infusion * Individuals engaging in sensor-augmented pump therapy * Individuals using automatic insulin delivery systems **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Individuals aged 18 or above, diagnosed with either Type 1 or Type 2 diabetes, who actively incorporate insulin injections-both prandial and basal-into their treatment plan, with a minimum requirement of at least one injection of prandial insulin and/or basal insulin. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ana.palanca@gmail.com **Name:** Ana Palanca **Phone:** 961973517 **Role:** CONTACT **Contact 2:** **Email:** ampudia_fra@gva.es **Name:** F. Javier Ampudia-Blasco **Phone:** 961973500 **Role:** CONTACT #### Locations **Location 1:** **City:** Valencia **Country:** Spain **Facility:** INCLIVA **Zip:** 46010 #### Overall Officials **Official 1:** **Affiliation:** HCUV-INCLIVA **Name:** F. Javier Ampudia-Blasco **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421454 **Brief Title:** Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers **Official Title:** Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers #### Organization Study ID Info **ID:** PHM-2021-001 #### Organization **Class:** OTHER **Full Name:** Fundacion Rioja Salud ### Status Module #### Completion Date **Date:** 2025-11-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2021-12-03 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Pharmamel S.L. **Class:** OTHER **Name:** Universidad de Granada **Class:** OTHER_GOV **Name:** Instituto de Salud Carlos III #### Lead Sponsor **Class:** OTHER **Name:** Fundacion Rioja Salud #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** Melatonin has been shown to prevent cellular damage produced by oxidative stress or in situations of ischaemia, inhibiting the synthesis of oxidants and pro inflammatory factors such as pro-inflammatory cytokines, substances which are present in pressure ulcers and can affect the healing process, slowing it down. Melatonin gel has also been shown to prevent ulcers in the oral mucosa due to radiotherapy. Therefore, the hypothesis for this study is that the melatonin cream provides greater ulcer area reduction than standard pressure ulcer treatment. **Detailed Description:** Melatonin has been shown to prevent cellular damage produced by oxidative stress or in situations of ischaemia, inhibiting the synthesis of oxidants and pro inflammatory factors such as pro-inflammatory cytokines, substances which are present in pressure ulcers and can affect the healing process, slowing it down. Melatonin gel has also been shown to prevent ulcers in the oral mucosa due to radiotherapy. Therefore, the hypothesis for this study is that the melatonin cream provides greater ulcer area reduction than standard pressure ulcer treatment. In order to o determine the efficacy of melatonin in healing pressure ulcer it has been designed a multicentre, single-blind, randomized clinical trial comparing melatonin cream as an experimental pressure ulcer treatment versus control group with standard treatment based on moist environment wound healing with a time frame of 8 weeks. In order to assess the healing rate, changes in Resvech 2.0 scale scores will be measured, as well as the ulcer surface reduction. To avoid variability in measuring ulcer surface, it will be done by using software HELCOS after taking a photograph of the wound weekly. An intention-to-treat analysis will be carried out. The t-test or Mann-Whitney will be used to check difference of means in the reduction of the area of the ulcer and variation in the Resvech 2.0 scale. Survival curves will be used to check possible differences in the follow-up time until epithelization. ### Conditions Module **Conditions:** - Pressure Ulcer **Keywords:** - melatonin, ischemia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Ulcers will be treated daily with melatonin cream for 8 weeks **Intervention Names:** - Drug: Melatonin **Label:** Melatonin **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Ulcers will be treated daily with hydrogel for 8 weeks **Intervention Names:** - Drug: Hydrogel **Label:** Control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Melatonin **Description:** Pressure Ulcer will be treated with a melatonin cream daily **Name:** Melatonin **Other Names:** - Mel13Rx **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Control **Description:** Pressure ulcer will be treated with hydrogel daily as a comparator **Name:** Hydrogel **Other Names:** - Intransite **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Percentage of completely epithelialized ulcers **Measure:** Epithelialisation **Time Frame:** Up to 8 weeks #### Secondary Outcomes **Description:** Percentage of reduction in pressure ulcer area **Measure:** Pressure ulcer area **Time Frame:** Up to 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Present at least one category II, III or IV pressure ulcer according to National Group for the Study and Assessment of Pressure Ulcers (GNEAUPP) classification. * Ulcer area between 1 and 100 cm2. * People over 18 years of age who have freely given their informed consent in writing of their own volition or it has been given on their behalf by a legal guardian Exclusion Criteria: * Ulcer of category I, non-classifiable or affecting internal tissues, but with no break in the skin * People currently undergoing chemotherapy treatment or who have done so in the previous 6 months * People with a presumed life expectancy of less than 6 months or in palliative care. **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** marco.aldonza.torres@navarra.es **Name:** Marco Aldonza-Torres **Phone:** +34 848 4229505 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Fundacion Rioja Salud **Name:** Marco Aldonza -Torres **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000012883 - Term: Skin Ulcer - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6870 - Name: Pressure Ulcer - Relevance: HIGH - As Found: Pressure Ulcer - ID: M17206 - Name: Ulcer - Relevance: HIGH - As Found: Ulcer - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M15686 - Name: Skin Ulcer - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003668 - Term: Pressure Ulcer - ID: D000014456 - Term: Ulcer ### Intervention Browse Module - Ancestors - ID: D000000975 - Term: Antioxidants - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000020011 - Term: Protective Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000002492 - Term: Central Nervous System Depressants ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M11533 - Name: Melatonin - Relevance: HIGH - As Found: Profile - ID: M4292 - Name: Antioxidants - Relevance: LOW - As Found: Unknown - ID: M21869 - Name: Protective Agents - Relevance: LOW - As Found: Unknown - ID: T410 - Name: Melatonin - Relevance: HIGH - As Found: Profile ### Intervention Browse Module - Meshes - ID: D000008550 - Term: Melatonin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421441 **Brief Title:** The Effect of Self-Management Skills Training Given to Nursing Students According to Peer Education Module on Problematic Internet Use and Academic Procrastination Behavior **Official Title:** The Effect of Self-Management Skills Training Given to Nursing Students According to Peer Education Module on Problematic Internet Use and Academic Procrastination Behavior #### Organization Study ID Info **ID:** 1919B012203792 #### Organization **Class:** OTHER **Full Name:** Istanbul Aydın University ### Status Module #### Completion Date **Date:** 2024-04-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-01-15 **Type:** ACTUAL #### Start Date **Date:** 2023-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2023-01-30 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Scientific and Technological Research Council of Turkey #### Lead Sponsor **Class:** OTHER **Name:** Istanbul Aydın University #### Responsible Party **Investigator Affiliation:** Istanbul Aydın University **Investigator Full Name:** Cennet Ciriş Yıldız **Investigator Title:** Dr. Faculty Member **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of the study is to evaluate the effect of self-management skills training given with the peer education module on the problematic internet use and academic procrastination behavior of nursing students. . **Detailed Description:** A total of 12 hours of self-management skills training will be given to the peer groups, two days a week for three weeks, two lesson hours a day (60 min. + 60 min.).The effect of self-management skills training on problematic internet use and academic procrastination behavior of nursing students will be evaluated. ### Conditions Module **Conditions:** - Problem Behavior - Problematic Internet Use - Academic Procrastination Behavior ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Group 1: Experimental group (Education group) Goup 2: Control group ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 175 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Experimental group (Education group) **Intervention Names:** - Other: Self Management Skills Training **Label:** Experimental **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control group **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** Nursing students will be given self-management skills training for a total of 12 hours, two days a week, two hours a day (60 min. + 60 min.) for three weeks. **Name:** Self Management Skills Training **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** It was developed in order to reveal the healthy and unhealthy usage levels of the Internet. The total score varies between 27 and 135. This scale aims to reveal healthy and unhealthy internet usage levels. In this context, high scores that can be obtained from the scale should be considered as a sign that individuals' internet use has become unhealthy, the internet has a negative impact on their lives, and may create a tendency towards a pathology such as addiction. **Measure:** Problematic Internet Use Scale **Time Frame:** Before training, immediately in the first and third months after training **Description:** It was developed to determine students' academic procrastination behaviors. The highest score that can be obtained from the scale is 95 and the lowest score is 19. A high score from the scale indicates that students are academic procrastinators. **Measure:** Academic Procrastination Scale **Time Frame:** Before training, immediately in the first and third months after training. ### Eligibility Module **Eligibility Criteria:** Research Inclusion Criteria; * Being 18 years or older, * Volunteering to participate in the study, * Using the internet for an average of 2 hours or more per day, * Not having any communication problems, * To continue self-management skills training. Criteria for Exclusion from the Research; * Having any communication barrier, * Not continuing self-management skills training. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Istanbul Aydın Üniversity ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M85 - Name: Problem Behavior - Relevance: HIGH - As Found: Problem Behavior - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000066553 - Term: Problem Behavior ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421428 **Acronym:** LEI **Brief Title:** Lived Experienced Incontinence Lived Experienced Incontinence - LEI **Official Title:** Urinary Incontinence: Lived Experience of Adult Women. A Phenomenological Study #### Organization Study ID Info **ID:** LEI #### Organization **Class:** OTHER **Full Name:** IRCCS San Raffaele ### Status Module #### Completion Date **Date:** 2025-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-10-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Università Vita-Salute San Raffaele #### Lead Sponsor **Class:** OTHER **Name:** IRCCS San Raffaele #### Responsible Party **Investigator Affiliation:** IRCCS San Raffaele **Investigator Full Name:** Sara Trapani **Investigator Title:** Principal Investigator, Midwife (RM), PhD student **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Study Description: Scientific literature demonstrated the negative influence of Urinary Incontinence (UI) on the quality of life connected to the physical, psychological, and social health of women. However, a limited number of studies investigated in depth the emotional experience of women affected by this disorder, their behaviors, and their experiences in managing the problem. Health professionals need to understand these aspects to offer the best care, also taking into account women's cultural and territorial differences. Research conducted on the topic in the Italian context is lacking, therefore the present study aims to explore, in a Northern Italian context, the experience of adult women affected by UI. Study Design: Qualitative phenomenological study (observational, cross-sectional, monocenter) Objective: To explore, in a Northern Italian context, the experience of women aged ≥ 18 years affected by Urinary Incontinence (UI) Study Population: Women ≥ 18 years old, not pregnant nor having given birth for less than 40 days, suffering from urinary incontinence who access the Pelvic Floor Rehabilitation Outpatient Clinic of the San Raffaele Hospital in Milan. Sample Size: Women who have already had at least a couple of pelvic floor rehabilitation meetings at the outpatient clinic of the San Raffaele Hospital in Milan, within the time frame foreseen by the study. These subjects represent a precious resource and are considered "more informative for the researcher" as they testify to the emotions and daily life that influence the symptoms of urinary incontinence, but they are also able to narrate their experience of re-education of the pelvic floor. It is assumed that approximately 20 women will be involved to reach data saturation. Statistical Design: The interviews will be analyzed with the hermeneutic-phenomenological IPA (Interpretative phenomenological analysis) method, which involves the identification of units of meaning, categories and themes in accordance with the language of the speakers. The analysis of qualitative data will be made possible thanks to the use of data management software (NViVO). The socio-demographic data collected will be presented with absolute and relative frequencies ### Conditions Module **Conditions:** - Urinary Incontinence - Experience, Life ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The population under investigation will be made up of women aged ≥ 18 years (excluding pregnant women and women who have given birth less than 40 days) suffering from urinary incontinence and who understand and speak in the Italian language. Will be enrolled on a voluntary basis women who have already had at least a couple of pelvic floor rehabilitation meetings at the outpatient clinic of the San Raffaele Hospital in Milan, within the time frame foreseen by the study, because they are also able to narrate their experience of re-education of the pelvic floor. **Intervention Names:** - Other: LEI Interview - Other: LEI Survey **Label:** Women's single sample ### Interventions #### Intervention 1 **Arm Group Labels:** - Women's single sample **Description:** In accordance with the IPA (Interpretative phenomenological analysis) methodology, a semi-structured interview outline will be defined, aimed at understanding the lived experiences of women ("lived experience") during their coexistence with urinary incontinence and during the treatment process. The screwdriver questions were formulated starting from the reference literature and will be discussed in a focus group composed of a uro-gynecologist, two midwives, a nurse, an expert in qualitative methodology. The final screwdriver questions resulting from the focus group will be tested on a small group of women. **Name:** LEI Interview **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Women's single sample **Description:** Some sociodemographic data identified from the reference literature will be collected in paper form immediately at the end of each interview, for the description of the sample. The data will concern: age, nationality, marital status, level of education, number of children, menopause, social relationships, level of information, period of onset of symptoms, type of symptomatology, frequency of episodes of urinary incontinence, quantity of urinary leakage, uro-gynecological pathological history. **Name:** LEI Survey **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** To explore, in a Northern Italian context, the experience of women aged ≥ 18 years affected by Urinary Incontinence (UI) through a semi-structured interview (open questions). Specifically, the topics addressed in the interview will be: * Emotions and daily life of women with UI (i.e. subjective meaning of UI, lifestyle changes, women's mood) * Behavioral strategies implemented to deal with the problem (i.e. choice to give up leisure activities, society's attention to the problem, tools and sources of information) * Perceptions regarding UI treatment plan (i.e. health expectations and desires, decision-making process that led to undertaking the treatment) **Measure:** LEI (Lived Experience Incontinence) Interview **Time Frame:** Baseline #### Secondary Outcomes **Description:** To collect some sociodemographic data regarding women affected by UI: age, nationality, marital status, level of education, number of children, menopause, social relationships, level of information, period of onset of symptoms, type of symptomatology, frequency of episodes of urinary incontinence, quantity of urinary leakage, uro-gynecological pathological history. **Measure:** LEI (Lived Experience Incontinence) survey **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Female sex 2. Age ≥ 18 years old 3. Urinary Incontinence 4. Informed consent signed 5. Comprehension of written and spoken Italian language 6. Female patients of the pelvic floor rehabilitation outclinic at San Raffaele Hospital Exclusion Criteria: 1. Male sex 2. Young age (\< 18 years) 3. Pregnancy 4. Puerperium (up to 40 days post-partum) **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The population under investigation will be made up of women aged ≥ 18 years (excluding pregnant women and women who have given birth less than 40 days) suffering from urinary incontinence and who understand and speak in the Italian language. Will be enrolled on a voluntary basis women who have already had at least a couple of pelvic floor rehabilitation meetings at the outpatient clinic of the San Raffaele Hospital in Milan, within the time frame foreseen by the study, because they are also able to narrate their experience of re-education of the pelvic floor. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** trapani.sara@hsr.it **Name:** Sara Trapani **Phone:** 3389879403 **Role:** CONTACT **Contact 2:** **Email:** villa.giulia@hsr.it **Name:** Giulia Villa **Phone:** 0291751779 **Role:** CONTACT #### Locations **Location 1:** **City:** Milan **Contacts:** ***Contact 1:*** - **Email:** trapani.sara@hsr.it - **Name:** Sara Trapani - **Phone:** 3389879403 - **Role:** CONTACT ***Contact 2:*** - **Email:** villa.giulia@hsr.it - **Name:** Giulia Villa - **Phone:** 0291751779 - **Role:** CONTACT ***Contact 3:*** - **Name:** Massimo Candiani - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Stefano Salvatore - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Duilio F. Manara - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 6:*** - **Name:** Stefania Rinaldi - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 7:*** - **Name:** Ilaria Baini - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 8:*** - **Name:** Giulia Villa - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 9:*** - **Name:** Sara Trapani - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Italy **Facility:** IRCCS Ospedale San Raffaele **Zip:** 20132 #### Overall Officials **Official 1:** **Affiliation:** Director of Center for Nursing Research and Innovation (CeNRI) **Name:** Duilio F. Manara **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Director of U.O. Obstetrics and Gynecology **Name:** Massimo Candiani **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** U.O. Obstetrics and Gynecology **Name:** Stefano Salvatore **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** U.O. Obstetrics and Gynecology **Name:** Stefania Rinaldi **Role:** STUDY_CHAIR **Official 5:** **Affiliation:** U.O. Obstetrics and Gynecology **Name:** Ilaria Baini **Role:** STUDY_CHAIR **Official 6:** **Affiliation:** Center for Nursing Research and Innovation (CeNRI) **Name:** Giulia Villa **Role:** STUDY_CHAIR **Official 7:** **Affiliation:** U.O. Obstetrics and Gynecology **Name:** Sara Trapani **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014555 - Term: Urination Disorders - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000059411 - Term: Lower Urinary Tract Symptoms - ID: D000020924 - Term: Urological Manifestations - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019960 - Term: Elimination Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M17299 - Name: Urinary Incontinence - Relevance: HIGH - As Found: Urinary Incontinence - ID: M7936 - Name: Enuresis - Relevance: HIGH - As Found: Urinary Incontinence - ID: M27171 - Name: Nocturnal Enuresis - Relevance: LOW - As Found: Unknown - ID: M17305 - Name: Urination Disorders - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M29464 - Name: Lower Urinary Tract Symptoms - Relevance: LOW - As Found: Unknown - ID: M22659 - Name: Urological Manifestations - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21832 - Name: Elimination Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014549 - Term: Urinary Incontinence - ID: D000004775 - Term: Enuresis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421415 **Brief Title:** Long Term Effect of AIT in Children **Official Title:** Long Term Effect of AIT in Children #### Organization Study ID Info **ID:** HCA-AIT #### Organization **Class:** OTHER **Full Name:** Odense University Hospital ### Status Module #### Completion Date **Date:** 2037-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-23 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2036-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Odense University Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The present study will investigate the long term effect of allergen immunotherapy in a real-life study in children with allergy undergoing subcutaneous or sublingual immunotherapy with grass pollen, birch, house dust mites or venom. **Detailed Description:** The study will include children aged 5- 18 years who are treated with immunotherapy at Hans Christian Andersen Children' Hospital, Odense University Hospital. Informed consent to be registered in a database and to receive a questionnaire 5 and 10 years after end of treatment are obtained before start of immunotherapy. Base line data include information from the patient record: symptoms, medication, blood test and skin prick test results. During treatment effect, medication use, lung function and adverse events are monitored systematically once a year. The questionnaires 5 and 10 years after end of treatment will focus on allergy symptoms, use of medication and asthma symptoms. ### Conditions Module **Conditions:** - Allergy in Children ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 14 Years ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Patients will be treated as usual. The study is an observation of the long term effect of the treatment **Name:** Allergen Immunotherapy Extract **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Medication use for allergy and asthma and the patient's experience of effect of the AIT on a scale from 0-4 (0= no effect, 1= modest effect, 2= some effect, 3= good effect, 4= very good effect) **Measure:** Effect of immunotherapy 5 years after end of treatment **Time Frame:** 5 years #### Secondary Outcomes **Description:** Medication use for allergy and asthma and the patient's experience of effect of the AIT on a scale from 0-4 (0= no effect, 1= modest effect, 2= some effect, 3= good effect, 4= very good effect) **Measure:** Effect of immunotherapy 10 years after end of treatment **Time Frame:** 10 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: treated with allergen immunotherapy at HCA Children'sHospital, Odense University Hospital - Exclusion Criteria: received less than 12 months of treatment with allergen immunotherapy - **Maximum Age:** 18 Years **Minimum Age:** 4 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Children with moderate to severe allergy to grass pollen, birch, house dust mites or venom who are prescribed allergen immunotherapy ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** josefine.gradman@rsyd.dk **Name:** Josefine Gradman, PhD **Phone:** 0045 29241375 **Role:** CONTACT #### Locations **Location 1:** **City:** Odense **Contacts:** ***Contact 1:*** - **Email:** j.gradman@dadlnet.dk - **Name:** Josefine Gradman - **Phone:** 004529241375 - **Role:** CONTACT **Country:** Denmark **Facility:** Hans Christian Andersen Children's Hospital **State:** Odense C **Status:** RECRUITING **Zip:** 5000 **Location 2:** **City:** Odense **Contacts:** ***Contact 1:*** - **Email:** josefine.gradman@rsyd.dk - **Name:** Josefine Gradman, PhD - **Phone:** 0045 29241375 - **Role:** CONTACT **Country:** Denmark **Facility:** Hans Christian Andersen Children's Hospital **Status:** RECRUITING **Zip:** 5000 #### Overall Officials **Official 1:** **Affiliation:** Odense University Hospital **Name:** Josefine Gradman, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M2853 - Name: Immunomodulating Agents - Relevance: HIGH - As Found: CAR- - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000091369 - Term: Immunomodulating Agents ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421402 **Brief Title:** K-HEALTH in AIR - Barcelona Pilot - Cohort **Official Title:** Knowledge for Improving Indoor Air Quality and Health: Follow up of 200 High-risk Chronic Respiratory Patients During 24 Months. #### Organization Study ID Info **ID:** HCB/2023/0126 #### Organization **Class:** OTHER **Full Name:** Institut d'Investigacions Biomèdiques August Pi i Sunyer #### Secondary ID Infos **Domain:** HaDEA **ID:** 101057693 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2026-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-13 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Hospital Clinic of Barcelona #### Lead Sponsor **Class:** OTHER **Name:** Institut d'Investigacions Biomèdiques August Pi i Sunyer #### Responsible Party **Investigator Affiliation:** Institut d'Investigacions Biomèdiques August Pi i Sunyer **Investigator Full Name:** Josep Roca Torrent **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study protocol is part of the European (EU) project "Knowledge for improving indoor AIR quality and HEALTH" (K-HEALTHinAIR, 2022-2026 - registry 101057693), which focuses on enhancing our understanding of how poor indoor air quality (IAQ) affects human health. Specifically, the project aims to identify IAQ determinants of adverse health events and to explore the development of cost-effective strategies for the precise monitoring and improvement, of IAQ across Europe. With the current study protocol, the Barcelona Pilot, at the Integrated Health District of Barcelona-Esquerra (AISBE, 520 k citizens), is conducting a cohort study over a two-year period (January 2024 to December 2025) to explore the relationships between IAQ (assessment of chemical pollutants in patients' homes) and health status (acute episodes) in multimorbid patients with chronic respiratory diseases (asthma and Chronic Obstructive Pulmonary Disease - COPD) over a two-year period. The protocol investigates the effectiveness of customized interventions across four critical areas: i) Advanced lung function testing, ii) Continuous IAQ monitoring, iii) Advanced digital support to innovative clinical processes, and iv) Predictive modeling for early identification and management of exacerbations. The ultimate objective is to design and evaluate an innovative integrated care service aiming at enhancing both IAQ and the management of multimorbid patients with chronic obstructive respiratory diseases, with focus on COPD and severe asthma. **Detailed Description:** The study is structured as a comprehensive two-phase approach. From January to December 2024 (Phase I) the protocol focuses on the assessment, and refinement, of the four core components of the study: i) Enhanced lung function testing, ii) IAQ home monitoring, iii) Advanced digital support to innovative clinical processes, and iv) Predictive modelling for early detection and management of exacerbations. The main outcome at the end of Phase I is the design of an innovative integrated care service aiming at enhanced management of exacerbations and reduction of unplanned hospitalizations in high-risk patients. From January to December 2025 (Phase II), the protocol aims to refine the novel clinical process, including the four core components alluded to above, as well as to evaluate the potential for healthcare value generation and scalability/transferability of the new integrated care service. PHASE I (2024): 1. Enhanced Lung Function Testing: Adoption of oscillometry (forced oscillation technique) to measure respiratory system resistance and reactance, as a complementary tool of forced spirometry, exploring its potential for patients' monitoring and management of exacerbations. 2. Continuous Monitoring of IAQ at patients' homes: Assessment of advanced monitoring systems in patients' homes to continuously track air quality parameters, enabling the identification of environmental triggers linked to respiratory exacerbations. 3. Advanced Digital Support to innovative clinical processes with a two-fold aim: i) patient's empowerment for self-management of his/her condition, and ii) enhancing the role of the nurse case manager for early detection and management of exacerbations promoting share care agreements between the patient and the reference doctor (primary care physician and/or specialist). To this end, adoption of an Adaptive Case Management (ACM) Approach constitutes a key element. 4. Predictive Modeling: Development, and refinement, of machine learning-based modelling for early detection and management exacerbations. Key input data in the modelling approach will be: i) Clinical information (symptoms, Patient Reported Outcome Measures - PROMs), ii) Lung function testing, and iii) Patient's self-capturing physiological data through wrist sensors (health rate, heart rate variability and physical activity). Moreover, the impact of IAQ monitoring in the modelling will be explored. The implementation, and refinement, of the four components alluded to above, as well as the design of the novel integrated care service, will be done with active engagement of patients, healthcare professionals, and other stakeholders in a co-design process using the Plan-Do-Study-Act (PDSA) methodology. Two PDSA cycles, with a six-month duration each, will be undertaken during 2024. PHASE II (2025): From January to December 2025, two additional PDSA cycles (six-month duration each) are planned to cover the following objectives: 1. Refinement of the novel integrated care service for enhanced management of exacerbations, as well as the implementation and continuous assessment of the four core components described in PHASE I. 2. Assessment of the outcomes of the novel integrated care service using the Quintuple Aim framework, that is, considering: i) Healthcare outcomes, ii) PROMs/Patient Reported Expirence Measures (PREMs), iii) healthcare professionals' engagement, iv) operational costs, and v) assessing equity. Comparison with conventional care will be done using a propensity score matching to elaborate a control group. 3. Evaluation of the process of deployment of the service using the Consolidated Framework for Implementation Research (CFIR) to identify barriers/facilitators for achieving a sustainable adoption, target candidates for the novel service, as well as potential for service transferability to other sites. At the end of PHASE II, a mature service design ready for adoption should be available. Besides fulfilment of the objectives of K-Health in Air, the key lessons learned in the two-years period should provide novel insights for enhanced management of chronic patients with multimorbid conditions. (Enclosed find: i) the Patient's Informed Consent approved by the Ethics Committee, as well as ii) the study protocol approved by the Ethics Committee of the Hosptial Clínic de Barcelona (HCB-2023-0126)). ### Conditions Module **Conditions:** - Severe Asthma - COPD **Keywords:** - Prevention of Unplanned Hospital Admissions - Nurse Case Manager - COPD - Severe Asthma - Integrated Care - Digital support - Indoor Air Quality ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 24 Months ### Arms Interventions Module #### Arm Group 1 **Description:** The INTERVENTION (PHASE I, 2024) will have four components: i) Assessment of Lung Function Testing, ii) Monitoring of IAQ at patients' homes (and analysis of the relationships between IAQ and health events), iii) Evaluation of advanced digital support to a novel clinical process to enhance early identification and management of exacerbations (questionnaires, chat, patients' self-capturing sensors, and iv) Development, and refinement, of machine learning-based predictive modelling for supporting clinical decision making. During PHASE II (2025), the INTERVENTION will consist of the assessment (Quintuple Aim) of the novel integrated care service, as well as the evaluation of its potential for scalability (CFIR). See inclusion/exclusion criteria and planned measurements in the enclosed documents. **Intervention Names:** - Other: Air quality monitoring at patient's home - Other: Questionnaires: Baseline & every six months - Diagnostic Test: Lung function Testing: Baseline & every six months & during exacerbations - Other: EMR & registry data - Device: Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023) - Device: Physiological data - Beat One Watch - Device: Patient Empowerment - Other: Characteristics of exacerbations **Label:** Follow-up 200 high-risk chronic respiratory outpatients for 2 years. #### Arm Group 2 **Description:** The control group will be introduced in Phase II (2025) to estimate the potential for healthcare value generation of the novel integrated care service. It will include patients with equivalent characteristics who receive standard of care practice, without the interventions carried out in the cohort group. The control group will be shaped using 1-to-1 propensity score matching techniques. Data from the control group will be obtained from electronic medical records and registry information. In a randomly selected subset of 50 individuals from the control group a Quintuple Aim assessment will be done. **Intervention Names:** - Other: EMR & registry data **Label:** Control Group ### Interventions #### Intervention 1 **Arm Group Labels:** - Follow-up 200 high-risk chronic respiratory outpatients for 2 years. **Description:** Indoor Air Quality: - MICA-INBIOT system: temperature (ºC), humidity (%), CO2 (ppm), total Volatile Organic Ccompounds (VOCs) (ppb), Formaldehyde (µg/m3); and Particulate Matter (PM) 1/2.5/4/10 (µg/m3) Outdoor Air Quality: - Aeris Weather platform: NO, NO2, NOx, SO2, SO3, CO, and PM10, all expressed in µg/m3 **Name:** Air quality monitoring at patient's home **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Follow-up 200 high-risk chronic respiratory outpatients for 2 years. **Description:** General surveys: * PROMs: ICHOM Adult Set; encompassing Patient Reported Outcomes Measurement Information System (PROMIS 10), World Health Organization Wellbeing Index (WHO 5) and World Health Organization Disability Assessment Schedule (WHO-DAS 12) questionnaires. * PREMs: Patient-Reported Indicator Survey (PaRIS) Disease specific questionaires: * COPD: COPD Assessment Test (CAT); modified Medical Research Council (mMRC) Dyspnea scale. * Asthma: Asthma Control Test (ACT); Test of Adherence to Inhalers (TAI-12); Asthma Quality of Life Questionnaire (mini AQLQ); Sino-Nasal Outcome Test (SNOT-22). **Name:** Questionnaires: Baseline & every six months **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Follow-up 200 high-risk chronic respiratory outpatients for 2 years. **Description:** * Forced Spirometry: Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) * Forced Oscillation Technique: Impedance, resistance and reactance. Ancillary measurements: Systemic arterial pressure and pulse oximetry. **Name:** Lung function Testing: Baseline & every six months & during exacerbations **Type:** DIAGNOSTIC_TEST #### Intervention 4 **Arm Group Labels:** - Control Group - Follow-up 200 high-risk chronic respiratory outpatients for 2 years. **Description:** Electronic Medical Records (EMRs): Updated every twelve months to track clinical events from Hospital and Primary Care databases. Registry data: from the Catalan Health Surveillance System (CHSS). **Name:** EMR & registry data **Type:** OTHER #### Intervention 5 **Arm Group Labels:** - Follow-up 200 high-risk chronic respiratory outpatients for 2 years. **Description:** Health Circuit: chat, short questionnaires (Likert scale). As needed. **Name:** Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023) **Type:** DEVICE #### Intervention 6 **Arm Group Labels:** - Follow-up 200 high-risk chronic respiratory outpatients for 2 years. **Description:** Enhanced with real-time physiological data tracking (heart rate, steps walked and Heart Rate Variability (HRV)) **Name:** Physiological data - Beat One Watch **Type:** DEVICE #### Intervention 7 **Arm Group Labels:** - Follow-up 200 high-risk chronic respiratory outpatients for 2 years. **Description:** Mobile App Health Circuit: follow-up of the personalized action plan agreed with the patient \& reference doctor **Name:** Patient Empowerment **Type:** DEVICE #### Intervention 8 **Arm Group Labels:** - Follow-up 200 high-risk chronic respiratory outpatients for 2 years. **Description:** Health Circuit: home-based oscillometry, daily disease-specific questionnaire during the acute episode and continuous assessment of physiological variables. **Name:** Characteristics of exacerbations **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Number of unplanned hospital admissions. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals **Measure:** Changes in use of healthcare resources - Unplanned hospital admissions **Time Frame:** During 2025 **Description:** Number and severity of exacerbations. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals **Measure:** Changes in use of healthcare resources - Exacerbations **Time Frame:** During 2025 **Description:** Number of emergency room visits. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals **Measure:** Changes in use of healthcare resources - Emergency room visits **Time Frame:** During 2025 **Description:** Number of primary care visits. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals **Measure:** Changes in use of healthcare resources - Primary care visits. **Time Frame:** During 2025 #### Secondary Outcomes **Description:** Healthcare costs in € This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals **Measure:** Healthcare costs **Time Frame:** During 2025 **Description:** Enjoyment of life: ICEpop CAPability measure for Older people (ICECAP-O) Scored on a scale from 0 to 1, where 0 represents no capability and 1 represents full capability. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. **Measure:** Patient reported experience (PREMs) - Enjoyment of life **Time Frame:** During 2025 **Description:** Resilience: Brief Resilience Scale (BRS) Scores range from 1 to 5, with higher scores indicating greater resilience. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. **Measure:** Patient reported experience (PREMs) - Resilience **Time Frame:** During 2025 **Description:** Physical functioning: 36-Item Short Form Survey (SF-36) Scores range from 0 to 100, where a higher score indicates better health status. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. **Measure:** Patient reported experience (PREMs) - Physical functioning **Time Frame:** During 2025 **Description:** Continuity of care: Nijmegen Continuity Questionnaire (NCQ) Scores ranging on a Likert scale from 1 to 5. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. **Measure:** Patient reported experience (PREMs) - Continuity of care **Time Frame:** During 2025 **Description:** Physiological wellbeing: Mental Health Inventory-5 (MHI-5) Scored on a scale of 0 to 100, where higher scores indicate better mental health. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. **Measure:** Patient reported experience (PREMs) - Physiological wellbeing **Time Frame:** During 2025 **Description:** Social Participation: Impact on Participation and Autonomy (IPA) Uses a scoring system based on a Likert scale ranging from 0 to 4 where higher scores indicate greater impairment in participation and autonomy. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. **Measure:** Patient reported experience (PREMs) - Social Participation **Time Frame:** During 2025 **Description:** Person-centeredness: Patient Perceptions of Patient-Centeredness Questionnaire (P3CEQ) Typically uses a Likert scale from 1 to 5, with higher scores indicating better perceptions of patient-centeredness. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. **Measure:** Patient reported experience (PREMs) - Person-centeredness **Time Frame:** During 2025 **Description:** Asthma symptoms: Asthma Control Test (ACT) 5 questions, each scored from 1 (poor control of asthma) to 5 (complete control of asthma). Higher scores indicate better asthma control. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. \*Depending on whether the primary disorder is asthma or COPD **Measure:** Patient reported outcomes (PROMs) - Asthma symptoms **Time Frame:** During 2025 **Description:** Functional problems related to asthma: Asthma Quality of Life Questionnaire (miniAQLQ) Designed to measure the functional problems (physical, emotional, social, and occupational) that are most troublesome to adults with asthma. It includes a series of questions scored from 1 (maximum impairment) to 7 (no impairment), with higher scores indicating better quality of life. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. \*Depending on whether the primary disorder is asthma or COPD **Measure:** Patient reported outcomes (PROMs) - Functional problems related to asthma **Time Frame:** During 2025 **Description:** COPD symptoms: COPD Assessment Test (CAT) Each question is scored from 0 (no impact) to 5 (maximum impact), with the total score ranging from 0 (less impact) to 40 (more impact), indicating the severity of COPD. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. \*Depending on whether the primary disorder is asthma or COPD **Measure:** Patient reported outcomes (PROMs) - COPD symptoms **Time Frame:** During 2025 **Description:** Dyspnea: Modified Medical Research Council (mMRC) Dyspnea Scale. It ranges from 0 (no breathlessness except with strenuous exercise) to 4 (too breathless to leave the house or breathless when dressing/undressing), with higher scores indicating more severe dyspnea. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. \*Depending on whether the primary disorder is asthma or COPD **Measure:** Patient reported outcomes (PROMs) - Dyspnea **Time Frame:** During 2025 **Description:** Sino-Nasal symptoms: Sino-Nasal Outcome Test (SNOT-22) 22 items, each scored from 0 (no problem) to 5 (problem as bad as it can be). The total score can thus range from 0 (no sinus-related health problems) to 110 (severe sinus-related health problems). This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. \*Depending on whether the primary disorder is asthma or COPD **Measure:** Patient reported outcomes (PROMs) - Sino-Nasal symptoms **Time Frame:** During 2025 **Description:** Adherence to inhalers: Test of Adherence to Inhalers (TAI-12) 12-item questionnaire used to assess a patient's adherence to inhaler medication in respiratory diseases. Each item is scored on a 5-point scale, with higher scores indicating better adherence. The total score ranges from 12 (poor adherence) to 60 (excellent adherence). This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. \*Depending on whether the primary disorder is asthma or COPD **Measure:** Patient reported outcomes (PROMs) - Adherence to inhalers **Time Frame:** During 2025 **Description:** Access to the service across different population groups: age, ethnicity, gender, socioeconomic status. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals **Measure:** Equity of the intervention **Time Frame:** During 2025 **Description:** Model accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve **Measure:** Performance of Predictive Modeling for Enhanced Management of Exacerbations **Time Frame:** During 2025 **Description:** Customer Satisfaction: Net Promoter Score (NPS) Measures customer loyalty and satisfaction. It is derived from asking customers a single question on a 0-10 scale Assessed in the intervention group only. **Measure:** Performance of the digital support in terms of robustness and usability - Customer Satisfaction **Time Frame:** During 2025 **Description:** Usability: System Usability Scale (SUS) Scored on a scale of 0 to 100, scores above 80 is an indicator of excellent usability, while a score below 60 could be problematic and suggests that the design needs improvements. Assessed in the intervention group only. **Measure:** Performance of the digital support in terms of robustness and usability - Usability **Time Frame:** During 2025 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged Maximum 85 years * Diagnosed with chronic obstructive pulmonary conditions such as COPD or treatment-resistant asthma. * Exhibiting a high burden of co-morbidities, assessed above the 80th percentile of the regional risk stratification pyramid using Adjusted Morbidity Groups (AMG) scoring. * Residing in Barcelona-Esquerra, except for treatment-resistant asthma patients, live in any district of the city of Barcelona. Exclusion Criteria: * Dementia. * Inability to perform independent daily activities. **Maximum Age:** 85 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The study is recruiting 80% of participants from seven AISBE primary care facilities, each serving around 20,000 people. Recruitment leverages Catalan Health Surveillance System data to identify potential participants and link them with their primary care physicians, who engage with patients to assess participation willingness and ensure contact throughout follow-up. Initial contact involves a phone call from a nurse case manager to introduce the project and set up a home visit. The remaining 20% of the cohort, consisting of patients with treatment-resistant asthma, are recruited from the outpatient Severe Asthma Clinics at Hospital Clínic de Barcelona, using a similar approach. ### Contacts Locations Module #### Locations **Location 1:** **City:** Barcelona **Country:** Spain **Facility:** Fundació de Recerca Clínic Barcelona - Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS) **Zip:** 08036 #### Overall Officials **Official 1:** **Affiliation:** Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS) **Name:** JOSEP ROCA TORRENT, MD, PHD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** During the entirety of the project, it is not allowed to disseminate data. Nonetheless, should a formal request be submitted, it may be permissible to disclose certain elements of the information, albeit not in its totality. **IPD Sharing:** NO ### References Module #### References **Citation:** Herranz C, Martin-Moreno Banegas L, Dana Muzzio F, Siso-Almirall A, Roca J, Cano I. A Practice-Proven Adaptive Case Management Approach for Innovative Health Care Services (Health Circuit): Cluster Randomized Clinical Pilot and Descriptive Observational Study. J Med Internet Res. 2023 Jun 14;25:e47672. doi: 10.2196/47672. **PMID:** 37314850 **Citation:** Herranz C. A Co-Creation Process Toward Sustainable Adoption of Integrated Care for Prevention of Unplanned Hospitalizations. medRxiv. Published online January 1, 2023:2023.08.03.23293537. doi:10.1101/2023.08.03.23293537 **Citation:** Veneroni C, Valach C, Wouters EFM, Gobbi A, Dellaca RL, Breyer MK, Hartl S, Sunanta O, Irvin CG, Schiffers C, Pompilio PP, Breyer-Kohansal R. Diagnostic Potential of Oscillometry: A Population-based Approach. Am J Respir Crit Care Med. 2024 Feb 15;209(4):444-453. doi: 10.1164/rccm.202306-0975OC. **PMID:** 37972230 **Citation:** Yamagami H, Tanaka A, Kishino Y, Mikuni H, Kawahara T, Ohta S, Yamamoto M, Suzuki S, Ohnishi T, Sagara H. Association between respiratory impedance measured by forced oscillation technique and exacerbations in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2017 Dec 22;13:79-89. doi: 10.2147/COPD.S146669. eCollection 2018. **PMID:** 29317813 **Citation:** Wu CT, Li GH, Huang CT, Cheng YC, Chen CH, Chien JY, Kuo PH, Kuo LC, Lai F. Acute Exacerbation of a Chronic Obstructive Pulmonary Disease Prediction System Using Wearable Device Data, Machine Learning, and Deep Learning: Development and Cohort Study. JMIR Mhealth Uhealth. 2021 May 6;9(5):e22591. doi: 10.2196/22591. **PMID:** 33955840 **Citation:** Herranz C. An Adaptive Case Management Approach to Prevent Unplanned Hospital Admissions in a Care Continuum Scenario. Published online 2023. #### See Also Links **Label:** EU PROJECT K-HEALTH IN AIR **URL:** https://k-healthinair.eu/ **Label:** IDIBAPS Members of \&#34;Mecanismes fisiopatològics de les malalties respiratòries\&#34; **URL:** https://www.clinicbarcelona.org/ca/idibaps/arees-i-programes/biopatologia-i-bioenginyeria-respiratoria-cardiovascular-i-renal/mecanismes-fisiopatologics-de-les-malalties-respiratories/membres ## Document Section ### Large Document Module #### Large Docs - Date: 2023-11-30 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 1027016 - Type Abbrev: Prot - Upload Date: 2024-04-29T12:42 - Date: 2023-11-08 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 232490 - Type Abbrev: ICF - Upload Date: 2024-05-07T03:43 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M8681 - Name: Formaldehyde - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421389 **Brief Title:** Precise Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Bleeding: A Randomized Controlled Trial **Official Title:** Precise Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Bleeding: A Randomized Controlled Trial #### Organization Study ID Info **ID:** B-BR-113-014 #### Organization **Class:** OTHER **Full Name:** National Cheng-Kung University Hospital ### Status Module #### Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** National Cheng-Kung University Hospital #### Responsible Party **Investigator Affiliation:** National Cheng-Kung University Hospital **Investigator Full Name:** Hsueh-Chien Chiang **Investigator Title:** Attending physician **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:** Background and Aim: Gastrointestinal bleeding (GIB) is a common problem in the hospital. GIB can be divided into upper GIB, small bowel bleeding, and lower GIB. Endoscopic hemostasis includes epinephrine injection, hemoclipping, heat probe coagulation, and Argon plasma coagulation. Although the successful hemostasis rate is high, recurrent bleeding can occur, ranging from 10% to 50% according to the bleeding etiology. Therefore, how to reduce the rebleeding of GIB is an important clinical issue. Methods: This is a randomized clinical trial. Patients with gastrointestinal bleeding for endoscopy screening and treatment at National Cheng Kung University Hospital were enrolled. The study will recruit 60 patients. After randomization, 30 patients will be classified into the intervention group and 30 into the control group. The participants will receive standard endoscopic hemostasis by either local injection of diluted epinephrine, heater probe coagulation, hemoclipping, or band ligation. After then, we will spray 2g of sucralfate powder and 1g of tranexamic acid through duodenoscopy precisely on the bleeding site in the intervention group. All enrolled patients will be monitored for rebleeding for 28 days after the first endoscopy. **Detailed Description:** Gastrointestinal bleeding (GIB) is a common problem in the hospital. The annual rate of hospitalization for any type of GI hemorrhage is estimated to be 350 hospital admissions/100,000 population. GIB can be divided into upper GIB, small bowel bleeding, and lower GIB. Approximately 50% of admissions for GIB are for UGI bleeding (from the esophagus, stomach, and duodenum), 40% are for LGI bleeding (from the colon and anorectum), and 10% are for small intestine bleeding. Ulceration bleeding, variceal bleeding, angiodysplasia, Dieulafoy lesion, and tumor bleeding are common cause for UGIB, while diverticulosis, colitis, angioectasia, cancer bleeding, and polypectomy ulcer attribute to the LGIB. GI endoscopy can identify the bleeding site and permit therapeutic hemostasis in most patients with GI bleeding. Endoscopic hemostasis includes epinephrine injection, hemoclipping, heat probe coagulation, and Argon plasma coagulation. Although the successful hemostasis rate is high, recurrent bleeding can occur, ranging from 10% to 50% according to the bleeding etiology. Therefore, how to reduce the rebleeding of GIB is an important clinical issue. Tranexamic acid (TXA) is a well-known antifibrinolytic agent that inhibits fibrin degradation by binding to tissue plasminogen, thereby preventing blood clot lysis and reducing bleeding. A recent study evaluating the effect of topical tranexamic acid (TXA) powder on bleeding peptic ulcers demonstrated that the precise endoscopic administration of TXA powder can enhance the stop-bleeding effect. Sucralfate, a complex of aluminum hydroxide and sucrose octa sulfate, can bind to the wound base. This protective barrier can prevent the wound from further environmental injury. Sucralfate has been widely used for wounds and ulcer treatment, e.g., skin wounds, oral ulcers, and peptic ulcers. With the protective effect of the papilla mucosa, sucralfate can cover the wound and has the potential to avoid further environmental damage. In combination with TXA powder in stabilizing the clotting, we expect the rebleeding event will reduce. Therefore, this study aimed to investigate whether the combination therapy of topical administration of TXA and sucralfate after standard endoscopic hemostasis can reduce the rebleeding event. Furthermore, the adhesion time of the hemostasis powder at the bleeding site is also an unknown issue. High-dose barium enema use provides better clinical outcomes for initial hemostasis and long-term prevention of rebleeding than conservative therapy in LGIB. In combination of barium, the position of hemostasis powder can be identified by Xray. Subjects and protocols Participants will be recruited from the volunteers with gastrointestinal bleeding at National Cheng Kung University Hospital. Eligible participants include patients aged ≥ 18 years who accept endoscopy for GIB, including hematemesis, Tarry stool, or bloody stool. Patient consent forms will be given and explained to all patients before the endoscopy. Exclusion criteria include patients with no need of endoscopic hemostasis, allergy to sucralfate, tranexamic acid, or barium, pregnancy, and patients with hollow organ perforation. After patient enrollment, we will randomize the patient into either the intervention group or control group by sealed envelope randomization method. After the standard endoscopic hemostasis by either epinephrine injection, hemoclipping, heat coagulation, or band ligation, we will randomly assign the patients to either a control or an intervention group. After then, we will spray 2g of sucralfate powder, 1g of tranexamic acid powder, and 1g of barium through the endoscopy precisely on the bleeding site in the intervention group. Blood tests As ward routine for bleeding patient, a blood sample is obtained to measure creatinine, albumin, total bilirubin, hemoglobin, platelet, prothrombin time (PT), and activated partial thromboplastin time (APTT). All lab data are checked by the central laboratory of the National Cheng Kung University Hospital. ### Conditions Module **Conditions:** - Bleed Ulcer **Keywords:** - Bleeding ulcer - Sulcralfate - Tranexamic acid ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All patients will receive the standard endoscopic hemostasis by either epinephrine injection, hemoclipping, heat coagulation, or band ligation. After then, patients in intervention group will receive 2g of sucralfate powder, 1g of tranexamic acid powder, and 1g of barium spray through the endoscopy precisely on the bleeding site. **Intervention Names:** - Drug: Tranexamic Acid Powder **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** All patients will receive the standard endoscopic hemostasis by either epinephrine injection, hemoclipping, heat coagulation, or band ligation. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** 2g of sucralfate powder, 1g of tranexamic acid powder, and 1g of barium will be sprayed through the endoscopy precisely on the bleeding site **Name:** Tranexamic Acid Powder **Other Names:** - sucralfate powder - barrium sulfate powder **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Recurrent bleeding was defined as remarkable hematochezia or Tarry stool with endoscopic evidence of the same site bleeding. **Measure:** the recurrent rate of GI bleeding during the study period **Time Frame:** 28 days #### Secondary Outcomes **Description:** rebleeding requiring transarterial embolization or emergency surgery **Measure:** the rate of rebleeding requiring transarterial embolization or emergency surgery **Time Frame:** 28 days **Description:** length of hospitalization **Measure:** length of hospitalization **Time Frame:** 28 days **Description:** all-cause mortality **Measure:** all-cause mortality rate **Time Frame:** 28 days **Description:** adverse events from powder spray, such as perforation or thrombotic events **Measure:** adverse events rate from powder spray **Time Frame:** 28 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Eligible participants include patients aged ≥ 18 years who accept endoscopy for GIB, including hematemesis, Tarry stool, or bloody stool Exclusion Criteria: * no need of endoscopic hemostasis * allergy to sucralfate, tranexamic acid, or barium * pregnancy * patients with hollow organ perforation **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** scion456scion@gmail.com **Name:** Hsueh-Chien Chiang, M.D. **Phone:** 062353535 **Role:** CONTACT **Contact 2:** **Email:** linxz@mail.ncku.edu.tw **Name:** Xi-Zhang Lin, M.D. **Phone:** 062353535 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** The IPD will be shared once the trial completed and study published **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Saydam SS, Molnar M, Vora P. The global epidemiology of upper and lower gastrointestinal bleeding in general population: A systematic review. World J Gastrointest Surg. 2023 Apr 27;15(4):723-739. doi: 10.4240/wjgs.v15.i4.723. **PMID:** 37206079 **Citation:** Chiang HC, Chen PJ, Yang EH, Hsieh MT, Shih IC, Cheng HC, Chang WL, Chen WY, Chiu HC, Kuo HY, Tsai WC, Lo YN, Yang KC, Chiang CM, Chen WC, Huang KK, Tseng HH, Chen CY, Lin XZ, Chuang CH. Precise application of topical tranexamic acid to enhance endoscopic hemostasis for peptic ulcer bleeding: a randomized controlled study (with video). Gastrointest Endosc. 2023 Nov;98(5):755-764. doi: 10.1016/j.gie.2023.06.013. Epub 2023 Jun 24. **PMID:** 37356632 **Citation:** Masuelli L, Tumino G, Turriziani M, Modesti A, Bei R. Topical use of sucralfate in epithelial wound healing: clinical evidences and molecular mechanisms of action. Recent Pat Inflamm Allergy Drug Discov. 2010 Jan;4(1):25-36. doi: 10.2174/187221310789895649. **PMID:** 19832693 **Citation:** Nagata N, Niikura R, Shimbo T, Ishizuka N, Yamano K, Mizuguchi K, Akiyama J, Yanase M, Mizokami M, Uemura N. High-dose barium impaction therapy for the recurrence of colonic diverticular bleeding: a randomized controlled trial. Ann Surg. 2015 Feb;261(2):269-75. doi: 10.1097/SLA.0000000000000658. Erratum In: Ann Surg. 2016 Mar;263(3):e58. **PMID:** 25569028 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - 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 ### Condition Browse Module - Browse Leaves - ID: M17206 - Name: Ulcer - Relevance: LOW - As Found: Unknown - ID: M9556 - Name: Hemorrhage - Relevance: HIGH - As Found: Bleeding - ID: M9557 - Name: Gastrointestinal Hemorrhage - Relevance: HIGH - As Found: Gastrointestinal Bleeding - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006471 - Term: Gastrointestinal Hemorrhage - ID: D000006470 - Term: Hemorrhage ### 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 - ID: D000000897 - Term: Anti-Ulcer Agents - ID: D000005765 - Term: Gastrointestinal Agents ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: Gast - Name: Gastrointestinal Agents ### Intervention Browse Module - Browse Leaves - ID: M16902 - Name: Tranexamic Acid - Relevance: HIGH - As Found: Stage IV - ID: M7992 - Name: Epinephrine - Relevance: LOW - As Found: Unknown - ID: M16179 - Name: Sucralfate - Relevance: HIGH - As Found: Frozen section - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M30371 - Name: Racepinephrine - Relevance: LOW - As Found: Unknown - ID: M211043 - Name: Epinephryl borate - Relevance: LOW - As Found: Unknown - ID: M4252 - Name: Antifibrinolytic Agents - Relevance: LOW - As Found: Unknown - ID: M6259 - Name: Coagulants - Relevance: LOW - As Found: Unknown - ID: M4188 - Name: Antacids - Relevance: LOW - As Found: Unknown - ID: M4219 - Name: Anti-Ulcer Agents - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000013392 - Term: Sucralfate - ID: D000014148 - Term: Tranexamic Acid ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421376 **Brief Title:** Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer **Official Title:** Efficacy and Safety of Inductive Chemoimmunotherapy Followed by Chemoradiotherapy With or Without Surgery in Locally Advanced Esophageal Squamous Cell Cancer: a Single-arm, Prospective, Phase II Trial #### Organization Study ID Info **ID:** NCC4475 #### Organization **Class:** OTHER **Full Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences #### Responsible Party **Investigator Affiliation:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences **Investigator Full Name:** Jianjun Qin **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:** Although unprecedented advances have been made in the field of esophageal cancer in recent decades, the prognosis for patients with locally advanced esophageal squamous cell carcinoma (ESCC) remains extremely poor, accounting for 30-40% of overall survival at 5 year. In recent years, multimodal treatments have proven to be an appropriate therapeutic approach for locally advanced ESCC. Recently, immunotherapy developed rapidly. The purpose of this study was to observe the efficacy and safety of cardonilizumab combined with chemoradiotherapy in the treatment of locally advanced ESCC. ### Conditions Module **Conditions:** - Esophageal Cancer - Immunotherapy - Induction Therapy - Chemoradiotherapy - Surgery ### 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:** In this group, the patients were given 2 cycles of inductive therapy of cardonilizumab combined with chemotherapy, followed by concurrent chemoradiotherapy with two cycles of nab-paclitaxel and cisplatin plus radiotherapy of 50-50.4 Gy. After clinical evaluation, surgery was feasible for a part of patients. **Intervention Names:** - Drug: Cardonilizumab - Radiation: Chemoradiotherapy ±immunotherapy - Procedure: Radical surgery **Label:** Inductive chemoimmunotherapy+chemoradiotherapy±surgery **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Inductive chemoimmunotherapy+chemoradiotherapy±surgery **Description:** Two cycles of Inductive therapy： nab-paclitaxel 250mg/ m2+cisplatin 75mg/ m2+Cardonilizumab 10mg/kg，ivgtt，3 weeks per cycle for 2 cycles **Name:** Cardonilizumab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Inductive chemoimmunotherapy+chemoradiotherapy±surgery **Description:** Chemoradiotherapy ± immunotherapy： * PTV: 50-50.4Gy/1.8-2Gy/25-28fractions ②nab-paclitaxel 100mg+cisplatin 25mg/ m2, d1, every 7 days for 3-5 weeks ③Cardonilizumab 10mg/kg，ivgtt，3 weeks per cycle for 2 cycles **Name:** Chemoradiotherapy ±immunotherapy **Type:** RADIATION #### Intervention 3 **Arm Group Labels:** - Inductive chemoimmunotherapy+chemoradiotherapy±surgery **Description:** Surgery was evaluated after concurrent chemoradiotherapy according to patients willing and the surgeons' assessment. If patients were accessed with unresectable disease after radiotherapy or refused to receive surgery, Cardonilizumab would be administered for 2 years or until disease progression. **Name:** Radical surgery **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Time from treatment initiation to locoregional or distant recurrence, or death from any cause. **Measure:** Event-free survival **Time Frame:** 1-year #### Secondary Outcomes **Description:** The 1-year OS rate was defined as the proportion of patients who still alive within one year from treatment initiation. **Measure:** Overall survival **Time Frame:** 1-year **Description:** In terms of adverse events of radiation, chemotherapy and immunotherapy **Measure:** Adverse events **Time Frame:** 1-year **Description:** The 1-year rate was defined as the proportion of patients who did not have any locoregional recurrence from treatment initiation. **Measure:** Locoregional recurrence free survival **Time Frame:** 1-year **Description:** The 1-year rate was defined as the proportion of patients who did not have any distant metastasis from treatment initiation. **Measure:** Distant metastasis free survival **Time Frame:** 1-year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18-80 years old； * Eligible patients were histologically confirmed esophageal squamous cell carcinoma; * Eligible patients were proven locally advanced ESCC (cT1-2N1-3M0-1, cT3/T4N0-3M0-1, M1 was limited to supraclavicular lymph node metastasis）diagnosed by computed tomography \[CT\] and/or endoscopic ultrasonography \[EUS\] according to the American Joint Committee on Cancer (AJCC) 8th edition staging system； * ECOG PS score: 0\~1； * Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL; Exclusion Criteria: * Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); * patients who had previously received other treatments * At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites * Those who already have esophageal perforation or are at high risk of esophageal perforation * Patients whose tumors invade close to large blood vessels and are at risk of bleeding in the * there are active infections, such as active tuberculosis and hepatitis * There are contraindications to immunotherapy. * Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures * Combined with serious cardiovascular diseases, such as uncontrolled heart failure, coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or a history of myocardial infarction within the past 6 months; and those combined with other uncontrolled acute and chronic diseases such as hypertension and diabetes. * Violation of inclusion and exclusion criteria, or other reasons that the researcher believes cannot continue the study of drug treatment. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** beryl_wx2000@163.com **Name:** Xin Wang, M.D. **Phone:** +861013311583220 **Role:** CONTACT #### Locations **Location 1:** **City:** Anyang **Contacts:** ***Contact 1:*** - **Name:** Xiaomin Wang, M.D. - **Role:** CONTACT **Country:** China **Facility:** Anyang Cancer Hospital **State:** Henan **Status:** NOT_YET_RECRUITING **Location 2:** **City:** Xinxiang **Contacts:** ***Contact 1:*** - **Name:** Xiaomei Liu, M.D. - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Xinxiang Medical University **State:** Henan **Status:** NOT_YET_RECRUITING **Location 3:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** beryl_wx2000@163.com - **Name:** Xin Wang, MD - **Phone:** +861013311583220 - **Role:** CONTACT **Country:** China **Facility:** Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) **Status:** RECRUITING **Zip:** 100021 #### Overall Officials **Official 1:** **Affiliation:** Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) **Name:** Xin Wang **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M8088 - Name: Esophageal Neoplasms - Relevance: HIGH - As Found: Esophageal Cancer - ID: M1733 - Name: Esophageal Squamous Cell Carcinoma - 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: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8085 - Name: Esophageal Diseases - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: HIGH - As Found: Esophageal Cancer ### Condition Browse Module - Meshes - ID: D000004938 - Term: Esophageal Neoplasms ### Intervention Browse Module - Ancestors - ID: D000007155 - Term: Immunologic Factors - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: HIGH - As Found: CAR- - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000091369 - Term: Immunomodulating Agents ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421363 **Acronym:** CAPRICI **Brief Title:** Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease **Official Title:** Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease #### Organization Study ID Info **ID:** CORONARIA 1/2023 #### Organization **Class:** OTHER **Full Name:** Hospital Clinico Universitario de Santiago ### Status Module #### Completion Date **Date:** 2027-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **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:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-24 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Jose Seijas Amigo #### Responsible Party **Investigator Affiliation:** Hospital Clinico Universitario de Santiago **Investigator Full Name:** Jose Seijas Amigo **Investigator Title:** PhD MS Pharmacy. Head of Clinical Trial Unit of Cardiology **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** 1.1. Background Cardiovascular disease (CVD) remains the leading cause of death in our country for over four decades. The pathophysiology of CVD begins with various cardiovascular risk factors (CRFs) and their poor management, leading to subclinical lesions in target organs such as albuminuria or left ventricular hypertrophy, which may evolve into CVD. This progression is referred to as the cardiovascular continuum. Patients with chronic cardiovascular conditions require comprehensive periodic health monitoring in primary care (PC), including lifestyle advice and an assessment of comorbidities. Risk factors linked to disease progression are monitored and managed, along with medication reconciliation and planning follow-up care. Such activities, especially post-COVID, help maintain clinical stability and organize healthcare demand, reducing unnecessary interventions and costs. In Galicia, continuity of care programs for ischemic heart disease focus on optimizing service delivery at appropriate levels, including electronic consultations that improve healthcare accessibility, outcomes, and cost-effectiveness. Introducing Inclisiran for chronic CVD patients post-acute coronary syndrome (ACS) hospitalization might streamline care continuity, reducing healthcare costs and improving outcomes. 1.2. Purpose The disruption of care continuity in patients post-ACS increases their risk of mortality and hospitalizations due to coronary complications and comorbidities, as well as emergency visits and unplanned healthcare interactions, thus elevating healthcare costs. We propose reorganizing care continuity for ACS patients by establishing a PC pathway with scheduled semi-annual visits to assess overall and cardiovascular health and to evaluate patient prognosis and healthcare resource utilization. 2. Objectives 2.1. Primary Objectives The main goal is to evaluate whether a follow-up program incorporating Inclisiran treatment in patients with chronic coronary syndrome can optimize follow-up (reducing unscheduled visits to PC and hospital emergency departments), improve control of risk factors (like physical activity, adherence to a Mediterranean diet, lipid profiles, blood pressure, glycemic profile, and renal function), and decrease direct economic costs. 2.2. Secondary Objectives The secondary objectives include analyzing adherence to prescribed chronic pharmacological treatment, factors driving higher demand among patients with chronic coronary syndrome, reasons for emergency visits, hospital admissions, and causes of mortality among these patients. 3. Methodology 3.1. Study Design A pilot, multicentric, analytical intervention study will be conducted involving five health centers in the Santiago de Compostela health area, with specific inclusion and exclusion criteria outlined. The study will monitor patients over 27 months, following a detailed protocol. ### Conditions Module **Conditions:** - Ischemic Heart Disease - Acute Coronary Syndrome **Keywords:** - inclisiran ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Label:** CONTROL GROUP **Type:** NO_INTERVENTION #### Arm Group 2 **Intervention Names:** - Drug: Inclisiran **Label:** INTERVENTIONAL GROUP **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - INTERVENTIONAL GROUP **Description:** Implementation of a follow-up program that incorporates Inclisiran treatment in patients with a history of chronic coronary syndrome **Name:** Inclisiran **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number of unplanned visits for patients with chronic coronary syndrome in family medicine, nursing, telemedicine, and hospital consultations during follow-up. **Measure:** Change in Unplanned Medical Visits **Time Frame:** 2 YEARS **Description:** Change in adherence to the Mediterranean diet using the validated questionnaire PREDIMED. The test consists of 14 questions, in which the higher the score, the better the relationship with a healthy life. TOTAL SCORE: \< 9 low adherence \>= 9 good adherence to the Mediterranean diet **Measure:** Variation in Adherence to the Mediterranean Diet **Time Frame:** 2 YEARS **Description:** Change in LDL cholesterol levels in mg/dL from baseline to follow-up. Unit of Measure: mg/dL **Measure:** Change in Lipid Profile. **Time Frame:** 2 YEARS **Description:** Change in systolic/diastolic blood pressure (specify how it's measured, e.g., mmHg). Unit of Measure: mmHg. **Measure:** Change in Blood Pressure **Time Frame:** 2 YEARS #### Secondary Outcomes **Description:** Adherence to medication, measured as the proportion of days covered (PDC) based on the total number of days medications were supplied through the electronic prescription system. Unit of Measure: Percentage (%) Calculation of the PDC for a specific drug: The numerator represents the total number of days a drug was supplied between the first and last electronic prescription picked up (a + b + c + d). The denominator represents the total number of days in the interval (from x to t). PDC: proportion of days covered. **Measure:** Adherence to Medication **Time Frame:** 2 YEARS **Description:** Outcome Measure: Number of hospital emergency attendances during the study period. Unit of Measure: Number of attendances. **Measure:** Emergency Room Attendances **Time Frame:** 2 YEARS **Description:** Hospital Admissions Description: Number of hospital admissions related to cardiovascular disease Unit of Measure: Number of admissions Mortality Description: Number of deaths and primary cause during the study period. Unit of Measure: Number of admissions **Measure:** Patient Prognosis **Time Frame:** 2 YEARS **Description:** Physical Activity Description: Change in physical activity, assessed via a validated questionnaire SF-36 Unit of Measure: Score on the questionnaire. Scale Details: Full Scale Name: Short Form (36) Health Survey Scale Range: The SF-36 scale typically ranges from 0 to 100. Interpretation: Higher scores indicate a better quality of life and health status. **Measure:** Change in Patient Risk Factors **Time Frame:** 2 YEARS **Description:** Costs associated with unplanned medical visits, adherence, hospitalizations, and medication adherence. Unit of Measure: Cost (currency) **Measure:** Cost Analysis **Time Frame:** 2 YEARS **Description:** Outcome Measure: Number of unplanned nursing consultations in primary care. Unit of Measure: Number of consultations. **Measure:** Healthcare Organization 1 **Time Frame:** 2 years **Description:** Outcome Measure: Number of unplanned family doctor consultations in primary care. Unit of Measure: Number of consultations. **Measure:** Healthcare Organization 2 **Time Frame:** 2 yeras **Description:** Outcome Measure: Number of attendances at continuous care points in primary care. Unit of Measure: Number of attendances. **Measure:** Healthcare Organization 3 **Time Frame:** 2 years **Description:** Outcome Measure: Number of telemedicine hospital consultations. Unit of Measure: Number of consultations. **Measure:** Healthcare Organization 4 **Time Frame:** 2 yeras **Description:** Outcome Measure: Number of in-person hospital consultations. Unit of Measure: Number of consultations. **Measure:** Healthcare Organization 5 **Time Frame:** 2 years **Description:** Outcome Measure: Number of hospital emergency attendances. Unit of Measure: Number of attendances. **Measure:** Healthcare Organization 5 **Time Frame:** 2 years **Description:** Outcome Measure: Lab samples results. Unit of Measure: Specific measure (e.g., mg/dL for cholesterol). **Measure:** Lab samples results **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥18 years 2. Prior diagnosis of chronic coronary disease At least one of the following: 1. Type 2 diabetes mellitus 2. Familial hypercholesterolemia 3. Recurrent coronary disease 4. Chronic kidney disease 3. Currently undergoing pharmacological treatment with high-potency statins, with or without ezetimibe. The allowed statins and daily doses are: 1. Atorvastatin 80mg 2. Rosuvastatin 20mg 3. Rosuvastatin 40mg 4. Patients on other statins or lower doses are acceptable if there has been documented intolerance to the specified molecules and doses. 4. Blood analysis with a lipid profile in the last 6 months and with the current treatment showing LDL levels \>100mg/dl. Exclusion Criteria: 1. Not receiving statins in the therapeutic regimen. 2. Concomitant treatment with PCSK9 inhibitors. 3. Pregnancy, breastfeeding, or a desire to conceive by the patient. 4. Patients who, in the opinion of the investigator, are unable to adequately follow up in the chronic care program under routine clinical practice. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** scinzas@semergen.es **Name:** SERGIO CINZA SANJURJO, PHD MD **Phone:** +34915002171 **Role:** CONTACT **Contact 2:** **Email:** jose.seijas.amigo@sergas.es **Name:** JOSE SEIJAS AMIGO, PhD MS Pharm **Phone:** +34981955764 **Role:** CONTACT #### Locations **Location 1:** **City:** A Estrada **Contacts:** ***Contact 1:*** - **Name:** DANIEL REY ALDANA - **Role:** CONTACT ***Contact 2:*** - **Name:** DANIEL REY ALDANA - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Cenro de Salud de La Estrada **State:** A Coruña **Location 2:** **City:** Ames **Contacts:** ***Contact 1:*** - **Email:** scinzas@semergen.es - **Name:** SERGIO CINZA - **Role:** CONTACT ***Contact 2:*** - **Name:** SERGIO CINZA SANJURJO - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** ANDREA GRELA BEIROA - **Role:** SUB_INVESTIGATOR **Country:** Spain **Facility:** Centro de Salud de Milladoiro **State:** A Coruña **Location 3:** **City:** Ribeira **Contacts:** ***Contact 1:*** - **Name:** ISABEL REGO - **Role:** CONTACT ***Contact 2:*** - **Name:** ISABEL REGO - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** ANA SUAREZ DIOS - **Role:** SUB_INVESTIGATOR **Country:** Spain **Facility:** Centro de Salud de Ribeira **State:** A Coruña **Location 4:** **City:** Santiago De Compostela **Contacts:** ***Contact 1:*** - **Email:** jose.ramon.gonzalez.juanatey@sergas.es - **Name:** JOSE RAMON GONZALEZ JUNATEY - **Phone:** +34981950000 - **Role:** CONTACT ***Contact 2:*** - **Email:** jose.seijas.amigo@sergas.es - **Name:** JOSE SEIJAS AMIGO - **Phone:** +34981955764 - **Role:** CONTACT ***Contact 3:*** - **Name:** JOSE RAMON GONZALEZ JUANATEY - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** JOSE SEIJAS AMIGO - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** PILAR MAZON RAMOS - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** PALOMA SEMPERE - **Role:** SUB_INVESTIGATOR ***Contact 7:*** - **Name:** FRANCISCO REYES SANTÍAS - **Role:** SUB_INVESTIGATOR **Country:** Spain **Facility:** Hospital Clinico Univesitario de Santiago de Compostela **State:** A Coruña **Zip:** 15706 **Location 5:** **City:** Melide **Contacts:** ***Contact 1:*** - **Name:** MONICA BARRAL CARREGAL - **Role:** CONTACT ***Contact 2:*** - **Name:** MONICA BARRAL CARREGAL - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Centro de Salud de Melide **Location 6:** **City:** Pontevedra **Contacts:** ***Contact 1:*** - **Name:** TERESA FERREIRO - **Role:** CONTACT ***Contact 2:*** - **Name:** TERESA FERREIRO - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Spain **Facility:** Centro de Salud A Cañiza ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000003327 - Term: Coronary Disease - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M6546 - Name: Coronary Artery Disease - Relevance: HIGH - As Found: Ischemic Heart Disease - ID: M19506 - Name: Myocardial Ischemia - Relevance: HIGH - As Found: Ischemic Heart Disease - ID: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Heart Disease - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: HIGH - As Found: Ischemic - ID: M27545 - Name: Acute Coronary Syndrome - Relevance: HIGH - As Found: Acute Coronary Syndrome - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown - 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: D000006331 - Term: Heart Diseases - ID: D000054058 - Term: Acute Coronary Syndrome - ID: D000017202 - Term: Myocardial Ischemia - ID: D000003324 - Term: Coronary Artery Disease - ID: D000007511 - Term: Ischemia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421350 **Brief Title:** Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome **Official Title:** Efficacy of Closed-Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome #### Organization Study ID Info **ID:** 24-8347 #### Organization **Class:** OTHER **Full Name:** Scripps Health ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Scripps Health #### Responsible Party **Investigator Affiliation:** Scripps Health **Investigator Full Name:** David Hiller, MD **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** The primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase. **Detailed Description:** After being informed about the study and the potential risks, all patients given written informed consent will be organized into group 1 (acute or subacute) and group 2 (chronic). They will undergo a trial period with a temporary spinal cord stimulator for 7 days. After the trial period, if the provider determines the device improved the patient's pain and function, the permanent device will be implanted. The patient will fill out an outcomes packet at baseline, end of trial period, 3 months and 6 months. There will also be a blood draw to evaluate prolactin levels, which are associated with stress and pain, at baseline, end of trial period, and 3 months. ### Conditions Module **Conditions:** - Complex Regional Pain Syndromes ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 32 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants diagnosed with acute and subacute phases of CRPS will be assigned to this group. **Intervention Names:** - Device: Spinal Cord Stimulation Device **Label:** Acute and Subacute Phases of CRPS **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants diagnosed with chronic CRPS will be assigned to this group. **Intervention Names:** - Device: Spinal Cord Stimulation Device **Label:** Chronic Phase of CRPS **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Acute and Subacute Phases of CRPS - Chronic Phase of CRPS **Description:** The closed-loop spinal cord stimulation mechanism uses dynamic adjusting stimulation parameters based on real-time physiologic response and is uniquely positioned to mitigate the aberrant inflammatory and neurosensory processing and autonomic dysfunction driving CRPS and its progression between phases. **Name:** Spinal Cord Stimulation Device **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** (CRPS SS) This will be determined at baseline by the provider based on his diagnosis of the patient's condition, being acute and subacute or chronic. This is based on the presence or absence of 16 clinically-assessed signs and symptoms, and complements the diagnostic criteria for CRPS. A higher score indicates greater severity of the condition. This will be followed up at the 7 day trial period, 3 months and 6 months post procedure by evaluation. **Measure:** Change in Complex Regional Pain Syndrome Severity Scores **Time Frame:** Baseline, 7 day trial period, 3 months, 6 months **Description:** Spinal cord stimulation device parameters will be collected to determine if a lower voltage is required to treat acute phase of complex regional pain syndrome as compared to later phases. This will be conducted at follow up visits and analyzed by the medical device representative. The data will be pulled and analyzed to determine the activation point for each patient. This will be captured at the 7 day trial period, 3 months, and 6 months. **Measure:** Change in Target Activation Amplitude Levels by the Spinal Cord Stimulation Device **Time Frame:** 7 day trial period, 3 months, and 6 months. #### Secondary Outcomes **Description:** We plan to include a physiological marker of pain response by assessing serum prolactin levels, which are linked to dopamine levels in the brain. We will use prolactin as a convenient marker of abnormal dopamine levels due to chronic pain and the response to spinal cord stimulation treatment as an objective quantifiable metric of success with treatment. We will collect this via blood draw at our lab at baseline, at the 7 day trial period, and 3 months. **Measure:** Change in Prolactin Levels **Time Frame:** Baseline, 7 day trial period, and 3 months **Description:** (VAS) This will be used to determine the pain intensity the patient is experiencing. It will be on a scale from 0-10, 0 being no pain and 10 being the worst pain. **Measure:** Visual Analogue Pain Scale **Time Frame:** Baseline, 7 day trial period, 3 months, and 6 months **Description:** (EQ-5D-5L) Used to capture quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A lower score would indicate a severe score and the patient has a low quality of life. The patient also rates how good or bad their health is on a scale of 0-100, 100 being the best health and 0 being the worst health they could imagine. **Measure:** Quality of Life Questionnaire **Time Frame:** Baseline, 7 day trial period, 3 months, and 6 months **Description:** (PROMIS-29v2.1) Used to assess pain intensity using a single 0-10 numeric rating item and seven health domains: physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. **Measure:** Patient Reported Outcomes Measurement Information System-29 v 2.1 **Time Frame:** Baseline, 7 day trial period, 3 months, and 6 months **Description:** (GAD-7) Used for the screening and severity measuring of generalized anxiety disorder. It consists of seven items the patients rate based on their experiences over the past two weeks. Each item is scored from 0 (none) to 3 (every day). The cumulative score, ranging from 0-21, indicates the severity of GAD symptoms, with higher scores corresponding to greater anxiety levels. **Measure:** General Anxiety Disorder-7 **Time Frame:** Baseline, 7 day trial period, 3 months and 6 months. **Description:** (PHQ-9) Used for screening and measuring the severity of depression. A higher score would indicate the patient has a worse outcome. **Measure:** Patient Health Questionnaire-9 **Time Frame:** Baseline, 7 day trial period, 3 months, 6 months **Description:** (SF-MPQ-2) Used to rate the intensity of each type of pain and related symptoms. A higher score means the patient has a worse outcome. They rate their pain and symptoms on a scale of 0-10, with a 0 being no pain and 10 being the worst pain. **Measure:** Short-Form McGill Pain Questionnaire-2 **Time Frame:** Baseline, 7 day trial period, 3 months, 6 months **Description:** (PCS) Used to assess catastrophic thinking related to pain among adults with or without chronic pain. A higher score would mean the patient has a worse outcome. **Measure:** Pain Catastrophizing Scale **Time Frame:** Baseline, 7 day trial period, 3 months, 6 months **Description:** (PGIC) Used to measure the patient's belief about the effectiveness of the treatment. A higher score would reflect the patient believes the treatment is not effective and they have been doing much worse. **Measure:** Patient Global Impression of Change **Time Frame:** 7 day trial period, 3 months and 6 months **Description:** Used to track amount of pain medication taken by the patient on a daily basis or what they are taking and when they are taking it. **Measure:** Amount of Pain Medication Consumed by Patient **Time Frame:** Baseline, 7 day trial period, 3 months and 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years or older * neuromodulation naive patients with unilateral CRPS type 1 or type 2 (defined by Budapest Criteria) * pre-procedure psychological clearance Exclusion Criteria: * younger than 18 years * prior neuromodulation including spinal cord stimulation * prior dorsal root ganglion stimulation * prior peripheral nervous system stimulation * anatomical obstacles to dorsal column lead placement **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mccauley.julie@scrippshealth.org **Name:** Julie C McCauley **Phone:** 585-554-7122 **Role:** CONTACT **Contact 2:** **Email:** kackman.roslyn@scrippshealth.org **Name:** Roslyn M Kackman **Phone:** 858-554-7122 **Role:** CONTACT #### Locations **Location 1:** **City:** La Jolla **Contacts:** ***Contact 1:*** - **Email:** mccauley.julie@scrippshealth.org - **Name:** Julie C McCauley - **Phone:** 585-554-7122 - **Role:** CONTACT ***Contact 2:*** - **Email:** kackman.roslyn@scrippshealth.org - **Name:** Roslyn M Kackman - **Phone:** 858-554-7122 - **Role:** CONTACT ***Contact 3:*** - **Name:** David B Hiller, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Scripps Clinic Torrey Pines **State:** California **Zip:** 92037 #### Overall Officials **Official 1:** **Affiliation:** Physician **Name:** David B Hiller, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000001523 - Term: Mental Disorders - ID: D000001342 - Term: Autonomic Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M22653 - Name: Complex Regional Pain Syndromes - Relevance: HIGH - As Found: Complex Regional Pain Syndrome - ID: M14861 - Name: Reflex Sympathetic Dystrophy - Relevance: HIGH - As Found: Complex Regional Pain Syndrome - ID: M15803 - Name: Somatoform Disorders - Relevance: HIGH - As Found: Pain Syndrome - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M4643 - Name: Autonomic Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M27979 - Name: Primary Dysautonomias - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: T1440 - Name: Complex Regional Pain Syndrome - Relevance: HIGH - As Found: Complex Regional Pain Syndrome ### Condition Browse Module - Meshes - ID: D000020918 - Term: Complex Regional Pain Syndromes - ID: D000012019 - Term: Reflex Sympathetic Dystrophy - ID: D000013577 - Term: Syndrome - ID: D000013001 - Term: Somatoform Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421337 **Acronym:** PROMISE-GLOB **Brief Title:** BraiN20® Medical Device in Suspected Acute Stroke Patients **Official Title:** Somatosensory Evoked Potential (SEP) N20 Monitoring With BraiN20® Medical Device for Prediction of Functional Independence Defined as Rankin Scale Score 0-2 in Global Patients With Suspected Acute Stroke. #### Organization Study ID Info **ID:** PROMISE GLOBAL CIP V2.0 #### Organization **Class:** OTHER **Full Name:** Fundació Institut Germans Trias i Pujol ### Status Module #### Completion Date **Date:** 2025-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-15 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Alicia Martínez Piñeiro #### Responsible Party **Investigator Affiliation:** Fundació Institut Germans Trias i Pujol **Investigator Full Name:** Alicia Martínez Piñeiro **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:** Time is Brain company (http://www.tibtimeisbrain.com/about_us/) developed BraiN20®, a medical device to assess the presence and characteristics of the N20 signal of SEP. Investigators have demonstrated a high prognostic accuracy of N20 on functional recovery of patients with acute ischemic stroke (AIS) due to large vessel occlusion (LVO) undergoing endovascular thrombectomy (EVT), the gold standard treatment. The aim if this new project is to validate BraiN20® in global patients presenting with suspected acute ischemic or hemorrhagic stroke in three comprehensive stroke centers in Spain. The primary objective is to establish the predictive performance of the presence of the N20 SEP over functional recovery as the primary outcome measure (likelihood of having a modified Rankin Scale (mRS) score 0-2 at 3 months evaluated by blinded independent raters). The effect will be measured by the metrics sensitivity, specificity, and predictive values, and compared with clinical and imaging predictive models by Receiving Operating Characteristics (ROC) curve analysis in the global population, stroke subtype and stroke mimics. Secondary aims are: 1) to determine the area under the curve (AUC) of the presence of the N20 SEP as biomarker of functional recovery in small subcortical infarctions and in patients with cortical infarctions and no large vessel occlusion; 2) to characterize N20 SEP signal in hemorrhagic stroke and stroke mimics; and 3) to evaluate the discriminant capacity of an explanatory new algorithm combining pre-hospital clinical variables and N20-SEP signal characteristics between ischemic, hemorrhagic and stroke mimics. This project would represent the first pilot study to validate the ability of BraiN20® to predict the functional recovery in the different types of acute stroke but also its ability to discriminate between stroke subtypes. Thus, BraiN20® monitoring could arise as a paradigm shift in acute stroke management, since it would standardize and accelerate patient triage, enable real time monitoring, increase access to EVT treatment and improve its outcome The trial is sponsored by Time is Brain S.L. and started in March 2024. Primary endpoint results are expected by the end of the 2024. BraiN20® could be a useful medical device aiding stroke subtype diagnosis and functional recovery. **Detailed Description:** The likelihood of a favourable outcome of acute stroke is critically dependent on patients presenting promptly after symptom onset and on hospitals providing immediate access to the gold standard treatment: the EVT. The current clinical stroke management is complex, time-consuming, requires different hospital settings with specialized equipment, and diagnostic is based on momentaneous snapshot providing brain imaging and clinical scores, without real-time monitoring tools. In addition, the current standard of care is unfavourable to patients localized far from a Comprehensive Stroke Center (CSC), especially for those living in rural regions. Thus, 50% undergoing EVT do not respond to the treatment because their brain tissue has been already irreversibly damaged. Thus, neurologists from the Germans Trias I Pujol CSC (Barcelona, Spain) started a new research line by introducing a new diagnostic approach based on neurophysiological techniques to optimize the selection of patients benefiting from EVT and improve its outcome. In 2018, the Somatosensory Evoked Potentials MonItoring During Acute Ischemic Stroke (PROMISE) clinical trial confirmed in a large cohort (n=228) that the N20 SEP determined before EVT increases 30% the diagnostic accuracy of salvageable brain compared to the technologies currently used. Time is Brain S.L. (TiB) was founded in July 2020 by neurologists from Germans Trias I Pujol CSC to develop BraiN20®, a medical device to assess presence and characteristics of N20 SEP signal from AIS onset and during the entire stroke patient journey. It promises to be an accurate, relatively inexpensive, userfriendly device to quickly determine N20 signal of the SEPs. This technology is safe and non-invasive and therefore may be especially useful at the pre-hospital stage of stroke patients, monitoring brain viability in-hospital and in particular in the angio-room guiding therapeutic strategies. PROMISE20 (Somatosensory Evoked Potentials Monitoring in Patients with Acute Ischemic Stroke and Large Anterior Vessel Occlusion Undergoing Endovascular Thrombectomy. A Clinical Validation of the BraiN20® Medical Device) (NCT06149754) is underway. The primary aim is to prove that the percentage of patients with optimal or good reliability of the BraiN20® Medical Device automatic recording of N20 is higher than 75% (i.e., the lower limit of the one-sided 95% confidence interval is higher or equal to 75%), assuming a true proportion equal to 87.5%, according to the classification by two expert physicians blind to BraiN20® reading results. While the usefulness of N20 SEP in AIS patients undergoing EVT has already been demonstrated, the predictive performance of BraiN20® is unknown in other stroke subtypes and stroke mimics. This project aims to validate for the first time BraiN20® monitoring in global patients presenting with suspected acute ischemic or hemorrhagic stroke. The accomplishments so far make a strongly believe that BraiN20® will enable a step improvement and become the cornerstone of the acute stroke patient journey The study will investigate the ability of the BraiN20® medical device to detect and characterize N20 signal in a global population of suspected stroke patients. The primary objective is to establish the predictive performance of the presence of N20 SEP registered by BraiN20® over functional recovery (primary outcome) (likelihood of having a mRS score 0-2 at 90 days evaluated by blinded independent raters). The effect will be measure by the metrics sensitivity, specificity and predictive values, and compared with clinical and imaging predictive models by ROC curve analysis in the global population, stroke subtypes and stroke mimics. Secondary aims are: * to determine the area under the AUC of the N20 amplitude predicting functional recovery in small subcortical infarctions and in patients with spontaneous LVO revascularization. * to characterize N20 signal in intracranial hemorrhage (ICH) and stroke mimics. * to evaluate the discriminant capacity of an explanatory new algorithm combining prehospital clinical variables and N20 signal characteristics between ischemic stroke, ICH and stroke mimics. * to characterize N20 signal in posterior ischemic strokes and basilar occlusion. Safety outcomes related to BraiN20® monitoring are: * Frequency of patients in whom N20+ recording prior to treatment disappears after specific treatment such as thrombectomy procedure, or surgical treatment. * Mortality at day 7. * Tolerability of the BraiN20® monitoring. * Number of consumables used with mean and standard deviation PROMISE-GLOB is a prospective, interventional, single arm, multi-center, open trial with blinded evaluation of the primary endpoint of a cohort of patients with suspected acute stroke admitted in the emergency department of a CSC. The study will be performed in consecutive patients fulfilling eligibility criteria in three comprehensive stroke centers in Spain. Patients will be studied and managed according to local protocols. No special recommendations are given, but protocols must define criteria for acute medical treatment, intravenous thrombolysis, endovascular thrombectomy, hemicraniectomy and surgical evacuation of ICH. Regarding diagnostic tools, computed tomography (CT), CT angiography (CTA), magnetic resonance (MR) or MR angiography (MRA) and ultrasound will be used at discretion of investigators for a required classification of stroke subtype or stroke mimics. SEP monitoring with the BraiN20® medical device will be performed as soon as possible after admission preferably before IV thrombolysis as long as it does not entail a delay in the acute emergency therapies. In patients undergoing EVT or surgical therapies, baseline SEP monitoring should be performed before these procedures, and repeated at the end of them. SEP monitoring should also be repeated in case of neurologic deterioration ≥ 4 points in the National Institute of Health Stroke Scale (NIHSS) within the first 24 hours. Patients' cohort will be followed up to 90 days after inclusion. mRS score will be determined at day 7 or discharge and at day 90 by a local investigator blind to the BraiN20® recordings, both face to face or by telephone interview. There are no specific study interventions. Patients will be discharged at home, other centers or admitted at acute stroke units (or intensive care units if needed) and treated following the European Stroke Organization guidelines. SEP monitoring will be carried out using the BraiN20® medical device and appropriate electrodes. SEP of both median nerves will be recorded, transferred, and stored to the internal card for their evaluation. BraiN20® Medical Device provides an automatic reading of the presence and feature of a N20 response both ipsilateral and contralateral (as control) to the cerebral hemisphere affected by the stroke and do not require specific training. Furthermore, the device provides an outcome prediction (percentage of likelihood of having mRS ≤ 2 day 7 and 90 after stroke onset) based on an internal algorithm. BraiN20® measures one N20 wave per 33 seconds. Scalp electrodes are easily embedded on a headband and the wrist electrodes on a glove. SEP recording will be done in the emergency room or in the angiography or surgical room (if required). Examiners will be physicians or nurses in charge of the patient. N20 recordings will be stored in the device for review at the end of the trial. It is recommended to obtain three recordings of the N20 response to confirm its presence or absence and exclude a noisy registration in the affected side (this takes approximately 3 min). Presence of the N20 response in the contralateral side will be used as control to rule out technical issues or the effect of other conditions that could affect the SEPs recordings. At admission at the Emergency Unit, patients with suspected acute stroke will be immediately attended by neurologists. NIHSS will be evaluated, blood will be drawn for baseline analysis and CT/CTA neuroimaging performed if indicated by local protocols. Anytime during these procedures BraiN20® electrodes will be placed and three N20 recordings obtained from each brain side (stroke side and control hemisphere). Serum glucose, body temperature and blood pressure will be controlled following the American Stroke Association guidelines. Alberta Stroke Program Early CT (ASPECT) score, ICH volume (AxBxC/2) and location will be measured by local investigators on baseline CT. Informed consent either, oral, signed or deferred will be obtained. Stroke subtype will be classified according to the Oxfordshire Community Stroke Project (OCSP) complemented with neuroimaging findings as total anterior cerebral infarction (TACI), partial anterior cerebral infarction (PACI), posterior cerebral infarction (POCI) and lacunar infarction (LACI); in addition deep ICH and lobar ICH. Stroke etiology following the classification of the Cerebrovascular Diseases Study Group of the Spanish Neurological Society as small vessel disease, large artery atherosclerosis (extracranial or intracranial), atrial fibrillation (AF) or other cardioembolic diseases, Unknown, Other (e.i. arterial dissection) and stroke mimic. A specific case record form (CRF) will be generated for each eligible patient. The completion of the CRF will be made by authorized site personnel. A copy of the CRF will be kept in the hospital records and the original will be collected by the sponsor. The investigator must ensure the accuracy, completeness and timeliness of data reported in the CRF. The sponsor will test all data for completeness, consistency, and plausibility, and produce queries for erroneous, incomplete and missing data. Any necessary queries will be sent to the investigator by email. Periodic monitoring visits will be made by the sponsor throughout the investigation to ensure that the investigator's obligations are being fulfilled. The database will be keep anonymized and confidentially at the sponsor workplace for centralized monitoring of the electronic records. Resolved queries will be returned to the sponsor by email. If answers are incomplete or discrepant with other data, re-queries may be necessary. No a priori sample size calculation has been done because it is unknown the potential predictive capacity of BraiN20® in a non-selected stroke population. This population has not been previously studied and this pilot study aims to establish the proof of concept for a future phase III design. The study period is limited to 8-12 months inclusion in three stroke centers and 500 evaluable patients are expected. This sample size is appropriate for including more than 100 patients in each stroke subtype. Patients that do not fulfil eligibility criteria will be replaced in order to obtain 500 evaluable patients. No risk or benefit for patients is expected in the trial since it is an study without any specific decision-making based on the BraiN20® results. Any device malfunction or unexpected characteristics will be registered, and the device unit discarded (returned to Time is Brain, S.L. for inspection). ### Conditions Module **Conditions:** - Acute Stroke **Keywords:** - Somatosensory evoked potentials - Acute stroke ischemic - Acute stroke hemorrhagic - Stroke mimics - Prognosis - Functional recovery - Medical device - Diagnostic ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Masking Description:** Outcome will be evaluated by an independent assessor blinded to the monitoring results at the acute phase **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects presenting at emergency departments of participating hospitals with suspected acute stroke within 24 hours from symptom onset with or without stroke code activation **Intervention Names:** - Device: BraiN20(R) **Label:** Study group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Study group **Description:** SEP monitoring will be carried out using the BraiN20® medical device and appropriate electrodes. SEP of both median nerves will be recorded, transferred, and stored to the internal card for their evaluation. BraiN20® Medical Device provides an automatic reading of the presence and feature of a N20 response both ipsilateral and contralateral (as control) to the cerebral hemisphere affected by the stroke and do not require specific training. Furthermore, the device provides an outcome prediction (percentage of likelihood of having mRS ≤ 2 day 7 and 90 after stroke onset) based on an internal algorithm. BraiN20® measures one N20 wave per 33 seconds. Scalp electrodes are easily embedded on a headband and the wrist electrodes on a glove. **Name:** BraiN20(R) **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** Comfortability of the patients during the 3-5 minutes of monitoring **Measure:** Tolerability of the BraiN20® monitoring **Time Frame:** At admission within 24 hours from stroke onset #### Primary Outcomes **Description:** Functional recovery is defined by modified Rankin Scale score 0-2 (min 0, no disability; max 6, death) at day 90 after stroke. Modified Rankin Scale score will be measured by blinded local raters according to a structured interview at day 7 or before discharge and at day 90 by telephone interview or face to face. Two cohort groups are defined: Stroke functional recovery: mRS lower or equal than 2 at 90 ± 15 days. Stroke functional dependence: mRS higher than 2 at 90 ± 15 days. **Measure:** Functional recovery at 3 months **Time Frame:** Day 90 #### Secondary Outcomes **Description:** Amplitude, latency and wave characteristics of the N20 response will be used to make a new algorithm able to discriminate between ischemic, hemorrhagic and stroke mimics. **Measure:** N20 signal characteristics **Time Frame:** At admission within 24 hours from stroke onset **Description:** Evaluation of the severity of the focal neurologic deficit (NIHSS: min 0, no neurological deficit; max 42) **Measure:** National Institute of Health Stroke Scale score (NIHSS) **Time Frame:** Days 7 and 90 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients with suspected acute stroke ischemic or hemorrhagic admitted in the emergency department within 24 hours from symptoms onset or from the last time seen normal. 2. Stroke mimics classified after neurologic examination and diagnostic procedures will be also included. 3. Age ≥18. 4. No significant pre-stroke functional dependence (mRS ≤ 2). 5. Baseline NIHSS score obtained prior to procedure must be equal or higher than 1 point. Patients with TIA and full recovery on admission must not be included. 6. Patients in whom BraiN20® monitoring can be performed without delay of acute stroke therapies. 7. Participation in other treatment or diagnostic test clinical trial is allowed if the patients fulfill the inclusion criteria of PROMISE-GLOBAL. 8. Informed consent obtained from patient or acceptable patient surrogate; or the deferred informed consent, to avoid the delay in the start of the stroke emergency therapies. Exclusion Criteria: - Clinical criteria 1. Patients with a well-documented history of neuromuscular diseases and other severe neurodegenerative disorders (Mild Cognitive Impairment is not exclusion criteria), prior stroke (TIA is not exclusion criteria) or nervous system tumors that could interfere with SEP assessment. 2. Serious, advanced, or terminal illness with an anticipated life expectancy of less than three months. 3. Women in the premenopausal period. - Neuroimaging criteria 4. Acute infarct volume (ASPECTS) or ICH volume (AxBxC/2) on plane CT should be measured but they are not exclusion criteria and should not preclude any specific treatment according to local protocols (i.e., mechanical thrombectomy, hemicraniectomy or ICH evacuation). 5. Evidence of intracranial tumor (except small meningioma). - BraiN20® medical device safety issues: 6. Subjects with a demand-type cardiac pacemaker, defibrillator, or other electrical implant or metal. 7. Patients with suspected or well-known cancerous skin lesions in the area where electrical stimulation is to be applied. 8. Patients who have a localized disorder in the wrist and forearm where electrical stimulation is to be applied (i.e., fractures or dislocations, vein puncture). **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** aliciamp@tibtimeisbrain.com **Name:** Alicia Martinez, MD, PhD **Phone:** +34662121408 **Role:** CONTACT **Contact 2:** **Email:** antonide@tibtimeisbrain.com **Name:** Antoni Dávalos, MD, PhD **Phone:** +34616968690 **Role:** CONTACT #### Locations **Location 1:** **City:** Barcelona **Contacts:** ***Contact 1:*** - **Email:** PCamps@santpau.cat - **Name:** Pol Camps, MD, PhD - **Phone:** +34935565986 - **Role:** CONTACT ***Contact 2:*** - **Email:** RMarin@santpau.cat - **Name:** Rebeca Marin, RN - **Phone:** +34935565986 - **Role:** CONTACT ***Contact 3:*** - **Name:** Garbiñe Ezcurra, MD - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Anna Ramos, MD, PhD - **Role:** SUB_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitari de la Santa Creu i Sant Pau **Status:** RECRUITING **Zip:** 08025 **Location 2:** **City:** Lleida **Contacts:** ***Contact 1:*** - **Email:** fpurroy.lleida.ics@gencat.cat - **Name:** Francisco Purroy, MD, PhD - **Phone:** +34973702935 - **Role:** CONTACT ***Contact 2:*** - **Email:** cpereira@irblleida.cat - **Name:** Cristina Pereira, PhD - **Phone:** +34973702935 - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitari Arnau de Vilanova **Status:** RECRUITING **Zip:** 25198 **Location 3:** **City:** Madrid **Contacts:** ***Contact 1:*** - **Email:** jvivancos@neurogps.com.es - **Name:** Jose A Vivancos, MD, PhD - **Phone:** +34915202416 - **Role:** CONTACT ***Contact 2:*** - **Email:** sobrado.m@gmail.com - **Name:** Mónica Sobrado, PhD - **Phone:** +34915202416 - **Role:** CONTACT ***Contact 3:*** - **Name:** Alvaro Ximénez-Carrillo, MD - **Role:** SUB_INVESTIGATOR **Country:** Spain **Facility:** Hospital Universitario La Princesa **Status:** RECRUITING **Zip:** 28006 #### Overall Officials **Official 1:** **Affiliation:** Fundació Institut d'Investigació en Ciències de la Salut Germans Trias iPujol **Name:** Antoni Dávalos, MD, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** Result will be presented at the European Stroke Organization Conference and published **IPD Sharing:** NO ### References Module #### References **Citation:** Alicia Martinez-Piñeiro MD, PhD aliciamp@tibtimeisbrain.com , Giuseppe Lucente MD, PhD , María Hernandez-Perez MD, PhD , Jordi Cortés PhD , Andrea Arbex MD , Natalia Pérez de la Ossa MD, PhD , Alba Ramos-Fransí MD, PhD , Miriam Almendrote MD , Mònica Millán MD, PhD , Meritxell Gomis MD, PhD , Laura Dorado MD, PhD , Carlos Castaño MD, PhD , Sebastián Remollo MD , Patricia Cuadras MD, PhD , Alicia Garrido MD , Nicolau Guanyabens MD , Joaquim Broto MD , Elena López-Cancio MD, PhD , Jaume Coll-Canti MD, PhD , Antoni Dávalos MD, PhD , and PROMISE (Somatosensory Evoked POtEntials MonItoring During Acute Ischemic StrokE) Study Group. Prognostic Accuracy of N20 Somatosensory Potential in Patients With Acute Ischemic Stroke and Endovascular Thrombectomy. Stroke: Vascular and Interventional Neurology. 2023 | Volume 3, Issue 5: e000735 **Citation:** Pittock SJ, Meldrum D, Hardiman O, Thornton J, Brennan P, Moroney JT. The Oxfordshire Community Stroke Project classification: correlation with imaging, associated complications, and prediction of outcome in acute ischemic stroke. J Stroke Cerebrovasc Dis. 2003 Jan;12(1):1-7. doi: 10.1053/jscd.2003.7. **PMID:** 17903897 **Citation:** Sobrino Garcia P, Garcia Pastor A, Garcia Arratibel A, Vicente Peracho G, Rodriguez Cruz PM, Perez Sanchez JR, Diaz Otero F, Vazquez Alen P, Villanueva Osorio JA, Gil Nunez A. [Aetiological classification of ischaemic strokes: comparison of the new A-S-C-O classification and the classification by the Spanish Society of Neurology's Cerebrovascular Disease Study Group]. Neurologia. 2013 Sep;28(7):417-24. doi: 10.1016/j.nrl.2012.07.005. Epub 2012 Sep 19. Spanish. **PMID:** 22998938 #### See Also Links **Label:** Startup developing BraiN20(R) **URL:** http://timeisbrain.com ## 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 - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: HIGH - As Found: Acute Stroke - ID: M2400 - Name: Ischemic Stroke - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M2404 - Name: Hemorrhagic Stroke - Relevance: LOW - As Found: Unknown - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020521 - Term: Stroke ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421324 **Acronym:** AIDA **Brief Title:** Personalised Health Recommendations to the General Population Through an Integrated AI Guided **Official Title:** Interventional Study Focused on Providing Personalised Health Recommendations to the General Population Through an Integrated AI Guided App as a Strategy for Gastric Cancer Prevention (AIDA) #### Organization Study ID Info **ID:** AIDA_HE #### Organization **Class:** OTHER **Full Name:** Fundación para la Investigación del Hospital Clínico de Valencia ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tania Fleitas Kanonnikoff #### Responsible Party **Investigator Affiliation:** Fundación para la Investigación del Hospital Clínico de Valencia **Investigator Full Name:** Tania Fleitas Kanonnikoff **Investigator Title:** MD, PhD **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This clinical study aims to be used to implement and validate the AIDA tool in two phases: * Phase 1: Risk stratification and personalised recommendations \& Model development * Phase 2: Mechanistic Model (Bioresource) development \& testing **Detailed Description:** The AIDA objective (project) is to develop and validate a multidisciplinary AI-powered assistant that helps clinicians diagnose precancerous inflammation, suggests personalised therapeutic strategies for medical treatment and follow-up, and makes personalised recommendations for monitoring patient health status, thus contributing to gastric cancer prevention. This prospective clinical study aims to implement and validate such tool. ### Conditions Module **Conditions:** - Gastric Cancer - Cancer Prevention - Helicobacter Pylori Infection - Artificial Intelligence ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** In practice, for rare diseases we chose a sample size that will allow estimation of sensitivity of the risk score to a pre-specified precision. We have chosen the sample size assuming that the resulting precancer detection model will have a sensitivity of at least 85%, and so that the lower 95% confidence interval will exceed 76%, with 80% power. The R package MKmisc estimates sample size for a proportion based on the Binomial distribution rather than a Normal approximation. In this case, we have estimated a sample size of 141 GIM + cancer and 141 GIM controls (282 in total). With 5% of samples assumed to be failing to be analysed due to a variety of technical reasons, we would need \~300 samples in total. In addition, to train the system 150 gastric cancer cases will be recruited which will provide pathology samples images and endoscopy images that will be taken as part of the clinical practice. ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 450 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects will be recruited prospectively from the Digestive Medicine/Endoscopy Departments of the centres involved. Patients will be treated according to the medical and patient decisions according to the clinical practice protocols of each site. Sample collection will be performed during a gastroscopy for pathological and molecular characterisation. This gastroscopy will be always indicated within usual clinical practice, so no additional risk is planned for the subjects included. Inclusion criteria: Subjects ≥18 years old to whom an endoscopy is performed due to gastric symptoms, without previous history of gastric chronic inflammation or Helicobacter pylori infection **Label:** Healthy controls **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Subjects will be recruited prospectively from the Digestive Medicine/Endoscopy Departments of the centres involved. Patients will be treated according to the medical and patient decisions according to the clinical practice protocols of each site. Sample collection will be performed during a gastroscopy for pathological and molecular characterisation. This gastroscopy will be always indicated within usual clinical practice, so no additional risk is planned for the subjects included. Inclusion criteria: Subjects ≥18 years old with a diagnosis of Gastric Cancer, to whom a gastroscopy is indicated within clinical care naive for chemotherapy. **Label:** Gastric cancer controls **Type:** NO_INTERVENTION #### Arm Group 3 **Description:** Subjects will be recruited prospectively from the Digestive Medicine/Endoscopy Departments of the centres involved. Patients will be treated according to the medical and patient decisions according to the clinical practice protocols of each site. Sample collection will be performed during a gastroscopy for pathological and molecular characterisation. This gastroscopy will be always indicated within usual clinical practice, so no additional risk is planned for the subjects included. Inclusion criteria: Subjects ≥18 years old with a diagnosis of GIM or previous or current H. pylori infection, to whom a gastroscopy is indicated within clinical care **Intervention Names:** - Behavioral: Health reccommendations **Label:** GIM cases **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - GIM cases **Description:** Patients are given recommendations according to their risk group, based on the model which already predicted health indicators. This information will be sent to the patient's treating physician so that treatment and recommendations are aligned with the clinical care practice based on the European Code of Cancer guidelines, the H. pylori best practices guidelines and European GIM guidelines **Name:** Health reccommendations **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Scoring patients as low (\>30) / medium / high risk (\<6) according to: * Degree of 'healthiness' of lifestyle (1 to 10, with 10 as very low and 10 as very high) * Co-morbidities (Yes = 1 / No = 5) * H. pylori infection history (Yes = 1 / No = 5) * Previous gastric intestinal metaplasia (Yes = 1 / No = 5) * Dysplasia or atrophy related to chronic gastritis (Yes = 1 / No = 5) * Family history of cancer (Yes = 1 / No = 5) **Measure:** Risk of developing Gastric Cancer based on medical records **Time Frame:** At the recruitment stage **Description:** AI driven H. pylori Eradication Therapy Recommendation **Measure:** H. pylori Eradication Therapy Recommendation **Time Frame:** From 30 days after the H.Pylori positive test result to one year after the first recommendation **Description:** AI driven GIM risk score assessment of pre-cancerous lesions using imaging modalities based on: QLQ C30 and STO22 EORTC questionnaire, Healthy lifestyle questionnaire (adapted from EPICs), Baseline clinical data, If H. pylori positive: adherence to treatment: yes/no; eradication yes/no, If GIM: adherence to follow-up guidelines yes/no **Measure:** GIM risk score assessment using imaging modalities **Time Frame:** At the recruitment stage ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects ≥ 18 years old with a diagnosis of GIM or previous or current H. pylori infection, to whom a gastroscopy is indicated within clinical care * Availability of a signed informed consent form to participate in the study Exclusion Criteria: * Patients to whom an endoscopy is performed for the follow-up of another illness such as oesophageal varices and/or for therapy such as endoscopic dilation, feeding tube placement or endoscopic resection * Subjects with a clinical diagnosis of gastric diseases other than GIM or GC * Patients who have received antimicrobials during the four weeks prior to the endoscopy * Patients who have received proton pump inhibitors and/or bismuth-based treatments at least two weeks prior to the endoscopy * Subjects for whom clinical data are not available: H. pylori status, eradication treatment, sex, age, tobacco smoking, and first-degree family history of gastric cancer * Subjects who lack the mental capacity to understand the nature and requirements of the study and who lack the ability to give informed consent **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** amiralles@incliva.es **Name:** Ana Miralles Marco, PhD **Phone:** +34 689567412 **Role:** CONTACT #### Locations **Location 1:** **City:** Valencia **Country:** Spain **Facility:** Hospital Clínico Universitario de Valencia **Zip:** 46010 #### Overall Officials **Official 1:** **Affiliation:** Fundación para la Investigación del Hospital Clínico de Valencia **Name:** Tania Fleitas, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Website **URL:** https://www.aidaeuproject.org/ ## Document Section ### Large Document Module #### Large Docs - Date: 2023-02-07 - Filename: ICF_000.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 499898 - Type Abbrev: ICF - Upload Date: 2024-05-07T10:27 ## Derived Section ### Condition Browse Module - Ancestors - 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: D000013272 - Term: Stomach Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - 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: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastric Cancer - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - 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: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: HIGH - As Found: Gastric Cancer ### Condition Browse Module - Meshes - ID: D000013274 - Term: Stomach Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421311 **Acronym:** URADJ **Brief Title:** Observational Study of Muscle Invasive Urothelial Carcinoma Participants Treated With Adjuvant Nivolumab in France **Official Title:** Ambispective Observational Study of Muscle Invasive Urothelial Carcinoma Patients Treated With Adjuvant Nivolumab in France #### Organization Study ID Info **ID:** CA209-1416 #### Organization **Class:** INDUSTRY **Full Name:** Bristol-Myers Squibb ### Status Module #### Completion Date **Date:** 2028-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bristol-Myers Squibb #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** This study will estimate the real-world effectiveness of adjuvant nivolumab therapy in adult participants with muscle invasive urothelial carcinoma (MIUC) in France. ### Conditions Module **Conditions:** - Urothelial Carcinoma ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** OTHER #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: nivolumab **Label:** Participants with muscle invasive urothelial carcinoma receiving nivolumab ### Interventions #### Intervention 1 **Arm Group Labels:** - Participants with muscle invasive urothelial carcinoma receiving nivolumab **Description:** According to approved product label (France) **Name:** nivolumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Disease-free survival (DFS) of participants **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60 #### Secondary Outcomes **Measure:** Time to recurrence (TRR) **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 **Measure:** Distance metastases-free survival (DMFS) **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60 **Measure:** Non-urothelial tract recurrence free survival (NUTRFS) **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60 **Measure:** Locoregional disease free survival (LRFDS) **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60 **Measure:** Overall survival (OS) **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60 **Measure:** Disease specific survival (DSS) **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60 **Measure:** Second progression-free survival (PFS2) **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60 **Measure:** Participant demographics **Time Frame:** Baseline **Measure:** Participant baseline clinical characteristics **Time Frame:** Baseline **Measure:** Participant history of other cancer(s **Time Frame:** Baseline **Measure:** Participant comorbidities pre-existing at the time of adjuvant therapy initiation **Time Frame:** Index date **Measure:** Participant renal function at treatment initiation **Time Frame:** Day 1 **Measure:** Participant concomitant systemic treatment(s) **Time Frame:** Day 1 and at months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 **Measure:** Diagnosis of muscle-invasive urothelial carcinoma diagnosis **Time Frame:** Baseline **Measure:** Systemic neoadjuvant treatment history **Time Frame:** Baseline **Measure:** Surgery for muscle-invasive urothelial carcinoma **Time Frame:** Baseline **Measure:** Participant history of previous urothelial carcinoma **Time Frame:** Baseline **Measure:** PD-L1 status testing results **Time Frame:** Baseline **Measure:** Participant muscle Invasive urothelial carcinoma disease characteristics **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 **Measure:** Time from initial diagnosis of muscle invasive disease to adjuvant treatment initiation **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 **Measure:** Delay in adjuvant nivolumab treatment initiation related to post-operative complications **Time Frame:** Baseline **Measure:** Time from radical surgery to adjuvant nivolumab treatment initiation **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 **Measure:** Adjuvant nivolumab treatment duration **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 **Measure:** Number of adjuvant nivolumab treatment cycles **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 **Measure:** Dose adjuvant nivolumab per cycle **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 **Measure:** Reason for adjuvant nivolumab treatment interruption **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 **Measure:** Reason for adjuvant nivolumab treatment discontinuation **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 **Measure:** Non-systemic treatments prescribed post adjuvant nivolumab discontinuation **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 **Measure:** Systemic treatment prescribed post adjuvant nivolumab discontinuation **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 **Measure:** Participant response to prescribed systemic treatment post adjuvant nivolumab discontinuation **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 **Measure:** Participant adverse events **Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 **Description:** Prospective participants only **Measure:** Participant reported outcomes as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire **Time Frame:** Baseline, and at months 3, 6, 9, 12, 18, 24, 30, and 36 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Participants with pathological evidence of muscle invasive urothelial carcinoma (originating in bladder, ureter, or renal pelvis) at high risk of recurrence after radical resection with programmed death-ligand 1 (PD-L1) tumour cell expression ≥ 1%: * Who received neoadjuvant chemotherapy OR * Who did not receive neoadjuvant chemotherapy and who are not eligible or refusing adjuvant cisplatin chemotherapy * At least 18 years of age at the time of treatment decision * Decision to treat with adjuvant nivolumab therapy has already been taken * Participants who provide oral informed consent to participate in the study (or who express non-opposition to data collection during their lifetime for deceased patients enrolled retrospectively) Exclusion Criteria: * Participants with a current primary diagnosis of a cancer other than muscle invasive urothelial carcinoma within the past 5 years, ie, a cancer other than urothelial carcinoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator) * Participants currently enrolled in an interventional clinical trial for their urothelial carcinoma. Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival (OS) can be enrolled. Patients enrolled in a clinical trial not evaluating an investigational drug can be enrolled (e.g. trial investigating novel imaging modalities). * Pregnant women * Participants under guardianship **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult participants in France with muscle invasive urothelial carcinoma (MIUC) that have been prescribed adjuvant nivolumab treatment. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Clinical.Trials@bms.com **Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com **Phone:** 855-907-3286 **Role:** CONTACT **Contact 2:** **Name:** First line of the email MUST contain NCT # and Site #. **Role:** CONTACT #### Locations **Location 1:** **City:** Strasbourg **Country:** France **Facility:** ICANS Institut de Cancérologie Strasbourg Europe **Zip:** 67200 #### Overall Officials **Official 1:** **Affiliation:** Bristol-Myers Squibb **Name:** Bristol-Myers Squibb **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### See Also Links **Label:** BMS Clinical Trial Information **URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html **Label:** FDA Safety Alerts and Recalls **URL:** https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5551 - Name: Carcinoma, Transitional Cell - Relevance: HIGH - As Found: Urothelial 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: 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 ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000082082 - Term: Immune Checkpoint Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1854 - Name: Nivolumab - Relevance: HIGH - As Found: Prospective - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M2342 - Name: Immune Checkpoint Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077594 - Term: Nivolumab ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421298 **Brief Title:** A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy. **Official Title:** A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy. #### Organization Study ID Info **ID:** Immune rechallenge #### Organization **Class:** OTHER **Full Name:** Beijing Chest Hospital, Capital Medical University ### Status Module #### Completion Date **Date:** 2027-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-17 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Jinghui Wang #### Responsible Party **Investigator Affiliation:** Beijing Chest Hospital, Capital Medical University **Investigator Full Name:** Jinghui Wang **Investigator Title:** chief physician **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The second-line treatment for patients who have progressed after first-line immune checkpoint inhibitor therapy, is chemotherapy based on docetaxel and other drugs. The treatment effect is limited. The median survival time of them are 6 months. So there is a huge unmet medical need. This study is a Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy. 30 patients will be enrolled. The main endpoint is PFS，and the secondary endpoint are OS,DCR,DOR,ORR, and so on. **Detailed Description:** This is a Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy. 30 patients will be enrolled. These patients will be treated with chemotherapy combined with sintilimab and Tafolecimab. The main endpoint is PFS，and the secondary endpoint are OS,DCR,DOR,ORR, and so on. ### Conditions Module **Conditions:** - Lung Cancer **Keywords:** - Immune rechallenge ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy. ##### 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:** tafolecimab sintilimab nab-paclitaxel docetaxel gemcitabine **Intervention Names:** - Drug: Tafolecimab - Drug: Sintilimab - Drug: Nab paclitaxel - Drug: Docetaxel - Drug: Gemcitabine **Label:** Tafolecimab and Sintilimab Combined With Chemotherapy **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Tafolecimab and Sintilimab Combined With Chemotherapy **Description:** 450mg Q4W ≤6cycle **Name:** Tafolecimab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Tafolecimab and Sintilimab Combined With Chemotherapy **Description:** 200mg Q3W ≤2years **Name:** Sintilimab **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Tafolecimab and Sintilimab Combined With Chemotherapy **Description:** 130mg/m² Q3W 4-6cycles **Name:** Nab paclitaxel **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Tafolecimab and Sintilimab Combined With Chemotherapy **Description:** 75mg/m² Q3W 4-6cycles **Name:** Docetaxel **Type:** DRUG #### Intervention 5 **Arm Group Labels:** - Tafolecimab and Sintilimab Combined With Chemotherapy **Description:** 1250mg/m² Q3W 4-6cycles **Name:** Gemcitabine **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** To explore the use of iRECIST to evaluate the efficacy treatment of tolecizumab **Measure:** To explore the use of iRECIST to evaluate the efficacy treatment of tolecizumab **Time Frame:** up to 24 months **Description:** Explore potential biomarkers that can predict efficacy, including but not limited to PD-L1 expression levels and TMB. **Measure:** Explore potential biomarkers that can predict efficacy, including but not limited to PD-L1 expression levels and TMB. **Time Frame:** up to 24 months #### Primary Outcomes **Description:** PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause. **Measure:** PFS **Time Frame:** up to 24 months #### Secondary Outcomes **Description:** OS is defined as the time until death due to any cause. OS is defined as the time until death due to any cause. OS is defined as the time until death due to any cause. **Measure:** OS **Time Frame:** up to 24 months **Description:** Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1. **Measure:** DCR **Time Frame:** up to 24 months **Description:** defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier Defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier **Measure:** DOR **Time Frame:** up to 24 months **Description:** ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy. **Measure:** ORR **Time Frame:** up to 24 months **Description:** Evaluation of adverse event rate according to CTCAE(Common terminology criteria for adverse events) v5.0 **Measure:** AE **Time Frame:** up to 24 months ### Eligibility Module **Eligibility Criteria:** inclusion criteria： 1. Sign a written informed consent before implementing any procedures related to the trial; 2. Age ≥18 years old and ≤75 years old; 3. Life expectancy ≥3 months; 4. Subjects with histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic, or recurrent (Stage IV) NSCLC (International Association for the Study of Lung Cancer and Joint American Committee on Cancer Classification 8th Edition TNM Staging of Lung Cancer) relapse or disease progression following multimodal therapy (radiotherapy, surgical resection, or radical chemoradiotherapy for locally advanced disease); 5. Patients must have previously used PD-1 or PD-Ll inhibitors and have disease progression; 1) Participants receiving maintenance therapy (meaning maintenance therapy after an immune checkpoint inhibitor regimen) and who have progressed are eligible for inclusion. 2) Participants treated with adjuvant, neoadjuvant, or radical chemoradiotherapy containing PD-1 or PD-Ll inhibitors for locally advanced disease and who experienced tumor recurrence or metastasis within 6 months after completion of treatment were eligible for inclusion. 6. No EGFR, ALK and other mutations; 7. There was at least one radiographically measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST v1.1 edition). Lesions located in the previous radiation field can be considered measurable lesions if progression is demonstrated; 8. Patients with stable brain metastases or whose brain metastases can be controlled were allowed to enroll; 9. ECOG score was 0-1; 10. With sufficient organ function, subjects must meet the following laboratory indicators: 1. Absolute neutrophil count (ANC) ≥1.5x10\^9/L without using granulocyte colony-stimulating factor in the past 14 days; 2. Without blood transfusion in the past 14 days, platelets ≥100×10\^9/L; 3. Hemoglobin \>9g/dL without blood transfusion or erythropoietin use in the past 14 days; 4. Total bilirubin ≤1.5×upper limit of normal (ULN); 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤2.5×ULN (subjects with liver metastases are allowed ALT or AST ≤5×ULN); 6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using Cockcroft-Gault formula) ≥60 ml/min; 7. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8. Euthyroid, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects can also be enrolled if total T3 (or FT3) and FT4 are within the normal range; 9. Myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judges that simple laboratory abnormalities without clinical significance are also allowed to be included); 11. Female subjects of childbearing potential should undergo a urine or serum pregnancy test with a negative result within 3 days before receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-reproductive age were defined as at least 1 year postmenopausal, or had undergone surgical sterilization or hysterectomy; 12. If there is a risk of pregnancy, all subjects (regardless of male or female) need to use low annual failure rate during the entire treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of study drug). Contraceptive measures at 1%; 13. Subjects determined by the researcher to meet the admission criteria; Exclusion Criteria: 1. The pathology is small cell lung cancer (SCLC), including lung cancer that is a mixture of SCLC and NSCLC; 2. Have received the following treatments: 1) Received systemic anti-tumor treatment within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal treatment with anti-tumor indications), etc.; 2) Have received any investigational drug treatment within 4 weeks before treatment; 3) Received large doses of immunosuppressive drugs (systemic glucocorticoids exceeding 10 mg/day of prednisone or its equivalent) within 4 weeks before treatment; 4) Have received live attenuated vaccines within 4 weeks before treatment (or plan to receive live attenuated vaccines during the study); 5) Have undergone major surgery (such as open cavity, thoracotomy or Kaifu surgery) within 4 weeks before treatment, or have unhealed surgical wounds, ulcers or fractures. 3. There is clinically uncontrollable pleural effusion/abdominal effusion (subjects who do not need to drain the effusion or who stop drainage for 3 days without significant increase in effusion can be enrolled); 4. Subjects who have received chest radiation therapy greater than 30Gy within 6 months before treatment or palliative radiation therapy with a dose of 30Gy or less within 7 days before treatment (palliative treatment for bone lesions or intracranial lesions is allowed) Radiation Therapy); 5. Active autoimmune disease that requires systemic treatment (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments; 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7. Those who are known to be allergic to the active ingredients or excipients of tolesimab, the study drug; 8. Have not fully recovered from toxicity and/or complications caused by any intervention before initiating treatment (i.e., ≤Grade 1 or reaching baseline, excluding fatigue or alopecia); 9. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 10. Untreated active hepatitis B (defined as HBsAg positivity and a detected HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled: 1. If the HBV viral load is \<1000 copies/ml (200 IU/ml) before the first dose, the subject should receive anti-HBV treatment during the entire study chemotherapy drug treatment period to avoid viral reactivation. 2. Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV treatment, but need to be closely monitored for viral reactivation 11. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher than the lower limit of detection); 12. Get live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Injectable inactivated virus vaccine against seasonal influenza is allowed within 30 days before the first dose; however, intranasal live attenuated influenza vaccine is not allowed. 13. Pregnant or lactating women; **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jinghuiwang2006@163.com **Name:** Jinghui Wang **Phone:** 13683128239 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** jinghuiwang2006@163.com - **Name:** Jinghui Wang - **Phone:** 13683128239 - **Role:** CONTACT **Country:** China **Facility:** Beijing Chest Hospital, Capital Medical University **State:** Beijing **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Employment relationship **Name:** Beijing C Beijing Chest Hospital **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5546 - Name: Carcinoma, Non-Small-Cell Lung - Relevance: LOW - As Found: Unknown - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Cancer - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000972 - Term: Antineoplastic Agents, Phytogenic - ID: D000000970 - Term: Antineoplastic Agents - ID: D000050257 - Term: Tubulin Modulators - ID: D000050256 - Term: Antimitotic Agents - ID: D000050258 - Term: Mitosis Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000964 - Term: Antimetabolites, Antineoplastic - ID: D000000963 - Term: Antimetabolites ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: HIGH - As Found: Surgery - ID: M2985 - Name: Gemcitabine - Relevance: HIGH - As Found: Activity - ID: M1668 - Name: Docetaxel - Relevance: HIGH - As Found: Physical - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown - ID: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown - ID: M4281 - Name: Antimetabolites - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel - ID: D000077143 - Term: Docetaxel - ID: D000093542 - Term: Gemcitabine ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421285 **Brief Title:** Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients **Official Title:** Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients #### Organization Study ID Info **ID:** 2024-0255 #### Organization **Class:** OTHER **Full Name:** Asan Medical Center ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-27 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Asan Medical Center #### Responsible Party **Investigator Affiliation:** Asan Medical Center **Investigator Full Name:** Jae Yong Jeon, MD **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:** Research purpose: Lymphedema is a very common complication in breast cancer patients. However, since there is currently no curable treatment, it is important to prevent and reduce the severity of lymphedema. The purpose of this study is to evaluate whether preoperative exercise is effective in preventing lymphedema after surgery. For secondary outcome, the preventive effects of exercise on other upper extremity dysfunctions (eg. pectoralis tightness, Axillary web syndrome, Adhesive capsulitis), which are common in breast cancer patients, were assessed. **Detailed Description:** Study subjects: * Patients aged 20 or older who were first diagnosed with breast cancer * BMI over 23 * Patients scheduled to undergo neoadjuvant chemotherapy before surgery Study design: Prospective randomized controlled comparative clinical study * Intervention is performed for at least 3 months during the neoadjuvant chemotherapy period before surgery. * Treatment group: Individually tailored exercise consisting of aerobic, strength, and flexibility exercises is prescribed, self-exercise compliance monitoring through an application, and diet management education through nutritional counseling. * Control group: One session of flexibility exercise training, diet management education through nutritional counseling Result variable: * Primary outcome variable: 1) Incidence and severity of postoperative lymphedema: bilateral upper limb volume, ICG lymphography * Secondary outcome variables: 1. Clinical information: Demographic, disease and treatment-related data 2. Physical-related: height/weight/waist circumference measurement, body composition test, physical examination (axillary membrane evaluation) 3. Upper extremity function (shortening of the pectoralis major muscle, adhesive capsulitis): evaluation of shoulder range of motion, upper extremity muscle strength/grip strength 4. Quality of life assessment: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast cancer module 23(EORTC QLQ-BR23) Assessment Schedule: * Initial treatment and evaluation: Immediately after breast cancer diagnosis * Follow-up evaluation: Immediately after completion of exercise intervention (preoperatively), and at 1, 3, and 6 months postoperatively. Number of study subjects: * This study will be conducted as a preliminary study for future research, and will be conducted on a total of 60 patients (30 in the experimental group and 30 in the control group) with an allocation ratio between groups of 1:1. ### Conditions Module **Conditions:** - Breast Neoplasms **Keywords:** - Preoperative Exercise - Lymphedema - Breast Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** * Intervention group * Control group ##### Masking Info **Masking:** SINGLE **Masking Description:** * Patients aged 20 or older and younger than 80 years old who were first diagnosed with breast cancer * BMI of 23 or higher * Patients scheduled to undergo neoadjuvant chemotherapy before surgery **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Individually tailored exercise consisting of aerobic, strength, and flexibility exercises is prescribed, self-exercise compliance monitoring through an application, and diet management education through nutritional counseling. **Intervention Names:** - Behavioral: Aerobic exercise, Strength training, Flexibility exercise **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** One session of flexibility exercise education, diet management education through nutritional counseling **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** Aerobic exercise: 30-40 minutes/time, 3-5 times a week, intensity of 4-6 points on the Rating of Perceived Exertion(RPE) 10-point scale(A simple conversation is possible during exercise, but the intensity is such that you feel out of breath) Strength training: 2-3 times a week, 3 sets of 10 repetitions per movement * Upper extremities: Biceps brachii, triceps brachii, deltoid, pectoralis muscle exercise * Lower extremities: gluteus maximus, hamstrings, quadriceps exercise Flexibility exercise: Stretching and mobility exercises reflecting post-surgery rehabilitation **Name:** Aerobic exercise, Strength training, Flexibility exercise **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Using a tape measure, measure the circumference from the wrist to the armpit every 4cm, then apply the ΣCircumference2/π formula to calculate the volume of the upper limb. **Measure:** Bilateral upper limb volume **Time Frame:** Immediately, Preoperatively, 1 month, 3 months, 6 months. **Description:** Indocyanine green (ICG) contrast agent is injected subcutaneously in the distal area, and lymph fluid flowing to the proximal area through collateral lymphatic vessels is checked with an infrared camera. **Measure:** ICG lymphography **Time Frame:** Immediately, 6 months. #### Secondary Outcomes **Description:** After attaching electrodes to both hands and feet using the Inbody S10 equipment, quantitatively evaluate body composition by measuring human body impedance using multiple frequencies. **Measure:** Body composition **Time Frame:** Immediately, 6 months. **Description:** Measurements are made according to a standardized protocol using a goniometer. **Measure:** Shoulder range of motion **Time Frame:** Immediately, Preoperatively, 1 month, 3 months, 6 months. **Description:** Using a digital hand held dynamometer, the strength of elbow flexion and extension, shoulder abduction, and flexor extensor muscles was measured. Measure grip strength using a digital hand held dynamometer **Measure:** Upper limb strength, grip strength **Time Frame:** Immediately, 6 months **Description:** Evaluate the patient's quality of life through the corresponding questionnaire **Measure:** EORTC QLQ-C30 **Time Frame:** Immediately, 6 months **Description:** Evaluate the patient's quality of life through the corresponding questionnaire **Measure:** EORTC QLQ-BR23 **Time Frame:** Immediately, 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 20 or older and younger than 80 who were first diagnosed with breast cancer * Patients scheduled for surgery and starting neoadjuvant chemotherapy before surgery * Patients with body mass index (BMI) of 23 or more Exclusion Criteria: * Patients with medical contraindications to exercise intervention or pain or musculoskeletal conditions that may limit active exercise intervention **Maximum Age:** 80 Years **Minimum Age:** 20 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jyjeon71@gmail.com **Name:** Jaeyong Jeon **Phone:** +82-2-3010-3791 **Role:** CONTACT **Contact 2:** **Email:** miracleofs@naver.com **Name:** Seungwoo Cha **Phone:** +82-2-3010-3799 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Asan Medical Center **Name:** Jaeyong Jeon **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Asan Medical Center **Name:** Heejeong Kim **Role:** STUDY_CHAIR **Official 3:** **Affiliation:** Asan Medical Center **Name:** Seungwoo Cha **Role:** STUDY_CHAIR **Official 4:** **Affiliation:** Asan Medical Center **Name:** Chul Jung **Role:** STUDY_CHAIR **Official 5:** **Affiliation:** Asan Medical Center **Name:** Hwayeong Cheon **Role:** STUDY_CHAIR **Official 6:** **Affiliation:** Asan Medical Center **Name:** Junghwa Do **Role:** STUDY_CHAIR **Official 7:** **Affiliation:** Asan Medical Center **Name:** Woojin Jeong **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001941 - Term: Breast Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000008206 - Term: Lymphatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M11206 - Name: Lymphedema - Relevance: HIGH - As Found: Lymphedema - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Neoplasms - ID: M12307 - Name: Neoplasm Metastasis - 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 - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms - ID: D000008209 - Term: Lymphedema ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421272 **Brief Title:** APP-based Emotion Recognition Training Improve ASD Social Function **Official Title:** APP-based Emotion Recognition Training Improve ASD Social Function #### Organization Study ID Info **ID:** UESTC-neuSCAN-94 #### Organization **Class:** OTHER **Full Name:** University of Electronic Science and Technology of China ### Status Module #### Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Electronic Science and Technology of China #### Responsible Party **Investigator Affiliation:** University of Electronic Science and Technology of China **Investigator Full Name:** Weihua Zhao **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The main aim of the study is to investigate whether APP-based emotional recognition training improve social function in autistic children. **Detailed Description:** 50 ASD children age ranged from 4-10 years old will be randomly allocated to either app-based emotional recognition training or memory training groups for 2 months. Before and after training, some assessements were measured including Autism Diagnostic Observation Schedule-2, Childhood Autism Rating Scale, Wechsler Intelligence Scale and Psychoeducational Profile-3. Some other questionnaires are also collected including Social Responsibility Scale-2,Repetitive behavior scale-Revised,Caregiver Strains Questionnaire，Social Communication Questionnaire，Social Anxiety Scale for Children，Adaptive behavior assessment Schedule. Four eye-tracking tasks as follows: (1) Dynamic geometrical paired with dynamic child dancing; (2) Static neutral and emotional faces; (3) A dynamic gaze-following task; (4) social interaction behaviors paired with the toys alone; (5) spinning actions conducted via children paired with objects. ### Conditions Module **Conditions:** - Autism Spectrum Disorder High-Functioning ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Experimental group (emotion recognition); control group (memory training) ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Experimental group: ASD children were asked to do emotion recognition for eight weeks using iPAD. Two 15-minsute sessions each day was required. **Intervention Names:** - Behavioral: APP-based emotion recognition intervention **Label:** APP-based emotion recognition trainning **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control group: ASD children were asked to do memory training (i.e. 1 back) for eight weeks using iPAD. Two 15-minsute sessions each day was required. **Intervention Names:** - Behavioral: APP-based memory intervention **Label:** APP-based memory training **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - APP-based emotion recognition trainning **Description:** ASD children were asked to play emotion recognition-related games for eight weeks using iPAD. Two 15-minsute sessions each day was required. **Name:** APP-based emotion recognition intervention **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - APP-based memory training **Description:** ASD children were asked to play memory-related games for eight weeks using iPAD. Two 15-minsute sessions each day was required. **Name:** APP-based memory intervention **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** CARS **Measure:** Other questionnaires and assessment **Time Frame:** 1-2 hour **Description:** PEP-3 **Measure:** Other questionnaires and assessment **Time Frame:** 1-2 hour **Description:** RBS-R **Measure:** Other questionnaires and assessment **Time Frame:** 1-2 hour **Description:** SCQ **Measure:** Other questionnaires and assessment **Time Frame:** 1-2 hour **Description:** CSQ **Measure:** Other questionnaires and assessment **Time Frame:** 1-2 hour #### Primary Outcomes **Description:** ADOS-2 assessment **Measure:** ADOS-2 assessment **Time Frame:** 1-2 hour **Description:** SRS-2 **Measure:** SRS-2 **Time Frame:** half an hour #### Secondary Outcomes **Description:** Tasked based eye-tracking performance including fixation time, fixation counts **Measure:** Visual performance across five tasks based on eye-tracking **Time Frame:** half an hour ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: Clinical diagnosis of Autism Spectrum Disorder and follow these criteria: (1) Age range: 4-10 years old, gender not limited;(2) Ethnicity: Han nationality;(3) Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) Comparison Score greater than or equal to 5 points (Le et al., 2022);(4) Considering that only high-functioning autism individuals can successfully complete the eye-tracking tasks, children with a Wechsler score greater than or equal to 60 points are selected; Exclusion criteria: (1) No neurological complications, such as epilepsy, cerebral palsy, fragile X syndrome, etc.;(2) No prior medical interventions, such as taking antipsychotic drugs, receiving transcranial magnetic stimulation, acupuncture, etc.;(3) No abnormal imaging diagnosis or any brain injury. **Maximum Age:** 10 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Chendu **Contacts:** ***Contact 1:*** - **Email:** zarazhao@uestc.edu.cn - **Name:** Weihua Zhao, Phd - **Phone:** +86 18780247797 - **Role:** CONTACT **Country:** China **Facility:** University of Electronic Science and Technology **State:** Sichuan **Status:** RECRUITING **Zip:** 611731 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002659 - Term: Child Development Disorders, Pervasive - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4623 - Name: Autistic Disorder - Relevance: LOW - As Found: Unknown - ID: M206 - Name: Autism Spectrum Disorder - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M5903 - Name: Child Development Disorders, Pervasive - Relevance: LOW - As Found: Unknown - ID: M5902 - Name: Developmental Disabilities - Relevance: LOW - As Found: Unknown - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000067877 - Term: Autism Spectrum Disorder ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421259 **Brief Title:** Descriptive Analysis of Changes in Hepatitis B Markers in People Living With HIV on Injectable Therapy. **Official Title:** To Switch or Not to Switch to CAB/RPV in PLWH With Past HBV Infection? Risk of HBV Reactivation? A Need for New HBV Markers? #### Organization Study ID Info **ID:** 24Infectio01 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire de Nice ### Status Module #### Completion Date **Date:** 2026-05-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Universitaire de Nice #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In order to assess the risk of hepatitis B reactivation in people living with HIV and undergoing injection therapy, we propose to carry out a descriptive analysis of the evolution of hepatitis B markers in this population. ### Conditions Module **Conditions:** - Hiv Infection - Hepatitis B ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** HIV infected patients under injectable ART **Label:** HIV infected patients under injectable ART ### Outcomes Module #### Primary Outcomes **Description:** HBV serology, DNA HBV levels **Measure:** Risk of HBV reactivation under injectable HIV ART **Time Frame:** From start of injectable HIV treatment to hepatitis B reactivation, assessed up to 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: -HIV infected patients under injectable ART Exclusion Criteria: -Active HBV infection **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** HIV infected patients attending care in the infectiious disease department of the Universitary Hospital of Nice ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** naqvi.a@chu-nice.fr **Name:** Alissa NAQVI **Phone:** 492035468 **Phone Ext:** +33 **Role:** CONTACT #### Locations **Location 1:** **City:** Nice **Contacts:** ***Contact 1:*** - **Email:** naqvi.a@chu-nice.fr - **Name:** naqvi.a@chu-nice.fr NAQVI - **Phone:** 0492035468 - **Phone Ext:** +33 - **Role:** CONTACT ***Contact 2:*** - **Email:** naqvi.a@chu-nice.fr - **Name:** Alissa NAQVI - **Phone:** 0492035468 - **Phone Ext:** +33 - **Role:** CONTACT **Country:** France **Facility:** CHU NiICE **State:** Alpes Maritimes **Zip:** 0600 #### Overall Officials **Official 1:** **Affiliation:** Centre Hospitalier Universitaire de Nice **Name:** Alissa NAQVI **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000006525 - Term: Hepatitis, Viral, Human - ID: D000014777 - Term: Virus Diseases - ID: D000004769 - Term: Enterovirus Infections - ID: D000010850 - Term: Picornaviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000018347 - Term: Hepadnaviridae Infections - ID: D000004266 - Term: DNA Virus Infections ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: HIGH - As Found: Infection - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M9592 - Name: Hepatitis A - Relevance: HIGH - As Found: Hepatitis - ID: M9591 - Name: Hepatitis - Relevance: HIGH - As Found: Hepatitis - ID: M9595 - Name: Hepatitis B - Relevance: HIGH - As Found: Hepatitis B - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: LOW - As Found: Unknown - ID: M18250 - Name: HIV Infections - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M9610 - Name: Hepatitis, Viral, Human - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M7930 - Name: Enterovirus Infections - Relevance: LOW - As Found: Unknown - ID: M13745 - Name: Picornaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M20487 - Name: Hepadnaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M7442 - Name: DNA Virus Infections - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000006506 - Term: Hepatitis A - ID: D000006509 - Term: Hepatitis B - ID: D000006505 - Term: Hepatitis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421246 **Brief Title:** Activity in Geriatric Patients and Validation of the Danish Version of the Acute Care Mobility Assessment **Official Title:** Activity in Geriatric Patients and Validation of the Danish Version of the Acute Care Mobility Assessment #### Organization Study ID Info **ID:** F-24023831 #### Organization **Class:** OTHER **Full Name:** Copenhagen University Hospital, Hvidovre ### Status Module #### Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Copenhagen University Hospital, Hvidovre #### Responsible Party **Investigator Affiliation:** Copenhagen University Hospital, Hvidovre **Investigator Full Name:** Mette Merete Pedersen **Investigator Title:** Senior Researcher **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study aim to assess 24-hour activity during hospitalization in older adults admitted to a geriatric ward and to validate the Danish version of the Acute Care Mobility Assessment. **Detailed Description:** During two month, 24-hour activity will be assessed in all patients (65+) admitted to a geriatric ward in Denmark, who are able to walk and to provide informed consent (or vicarious consent. Activity will be measured for a maximum of 7 days. Demografic characteristics will be collected (sex, age, place of residence, comorbidities, admission diagnosis, civil status, frailty), and the patients will be asked about their: daily activities, walking ability, life space activity, present activity, use of walking aids, and falls. On inclusion, the patients will be assessed for their basic mobility, cognition, gait speed, and their level of mobility. The Acute Care Mobility Assessment will be validated on the initial 5-10 patients via cognitive debriefing interviews. ### Conditions Module **Conditions:** - Acute Disease - Old Age ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** 24- hour activity will be assessed by SENS motion acitivity monitors, and the Acute Care mobility assessment will be validated by cognitive debriefing interviews in 5-10 patients **Name:** Activity monitoring and validity of the Danish Version of the Acute Care Mobility Assessement **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Number of daily steps taken assessed by a SENS motion accelerometer from inclusion and throughout hospitalization **Measure:** Daily steps **Time Frame:** 7 days #### Secondary Outcomes **Description:** Self-reported mobility by the Acute Care Mobility Assessment. A score of 0-12 can be obtained, with 0 reflecting poor mobility and 12 reflecting a high level of mobility. **Measure:** Self-reported mobility **Time Frame:** Days 2, 4 and 6 after inclusion **Description:** By the Life Space Assessment-DK, which measure mobility and level of dependence in mobility. A score of 0-120 can be obtained, with 0 reflecting poor mobility and 120 reflecting high mobility. **Measure:** Life Space mobility **Time Frame:** At inclusion **Description:** By the New Mobility Score, which assesses the ability to walk indoors and outdoors and the ability to go shopping. A score from 0-9 can be obtained, with 0 reflecting low mobility and 9 reflecting high mobility. **Measure:** Self-reported pre-admission mobility **Time Frame:** At inclusion **Description:** By the Clinical Frailty Scale, which is a clinical evaluation of the degree of frailty of a person. It is scored by health care professionals on a scale from 1 (very fit) to 9 (terminally ill) **Measure:** Frailty **Time Frame:** At inclusion **Description:** By the Orientation Memory Concentration Test, which is a screening of cognitive function. A score from 0 to 28 i obtained with lower scores reflecting poorer cognition (0-7: highly impaired; 8-17 points: moderately imparied; 18-24 points: mildly impaired; 25-28 points: no or insignificatn impairment). **Measure:** Cognitive status **Time Frame:** At inclusion **Description:** By the Katz index, which assesses independence in 6 Activities of Daily Living on a scale from 0 to 6 with 0 reflecting dependence in all activities and 6 reflecting independence in all activities. **Measure:** Activities of daily living **Time Frame:** At inclusion **Description:** By the The Cummulated Ambulation Score, which assessed the ability of a person to get in an out of bed, sit to stand from a chair and walk. It is scored from 0 to 6 with 0 reflecting inability to perform the 3 activities and a score of 6 refelcting independence in the three activities. **Measure:** Basic mobility **Time Frame:** Days 2, 4 and 6 after inclusion **Description:** By the Johns Hopkins Higest Level of Mobility Scale which evaluates a patient's level of mobiltiy on a 1 (lying) to 8 (waling more than 250 feet) point scale **Measure:** Highest level of mobility **Time Frame:** At inclusion **Description:** By the 4 meter habitual gait speed test. It assesses the patient's habitual gait speed on a 4-meter course. The test is scored in m/s. **Measure:** Gait speed **Time Frame:** At inclusion **Description:** Daily time spent walking assessed by a SENS motion accelerometer from inclusion and throughout hospitalization **Measure:** Daily walking **Time Frame:** 7 days **Description:** Daily time spent standing assessed by a SENS motion accelerometer from inclusion and throughout hospitalization **Measure:** Daily standing **Time Frame:** 7 days **Description:** Daily time spent sitting/lying assessed by a SENS motion accelerometer from inclusion and throughout hospitalization **Measure:** Daily lying/sitting **Time Frame:** 7 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 65 years * no delirium * ability to ambulate Exclusion Criteria: * in isolation * teminally ill **Minimum Age:** 65 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** Older adults admitted to a geriatric ward at Copenhagen University Hospital, Hvidovre ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mette.merete.pedersen@regionh.dk **Name:** Mette M Pedersen, PhD **Phone:** +4538623350 **Role:** CONTACT **Contact 2:** **Email:** lea.kromann.johansen.01@regionh.dk **Name:** Lea K Johansen, MHSc **Phone:** +4538621590 **Role:** CONTACT #### Locations **Location 1:** **City:** Hvidovre **Contacts:** ***Contact 1:*** - **Email:** mette.merete.pedersen@regionh.dk - **Name:** Mette M Pedersen, PhD - **Phone:** +4538623350 - **Role:** CONTACT ***Contact 2:*** - **Email:** lea.kromann.johansen.01@regionh.dk - **Name:** Lea K Johansen, MHSc - **Phone:** +4538621590 - **Role:** CONTACT ***Contact 3:*** - **Name:** Mette M Pedersen, PhD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Lea K Johansen, MHSc - **Role:** SUB_INVESTIGATOR **Country:** Denmark **Facility:** Copenhagen University Hospital, Hvidovre **Status:** RECRUITING **Zip:** 2650 ### 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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M3564 - Name: Acute Disease - Relevance: HIGH - As Found: Acute Disease - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000208 - Term: Acute Disease ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421233 **Brief Title:** The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels **Official Title:** The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels #### Organization Study ID Info **ID:** 2023/516 #### Organization **Class:** OTHER **Full Name:** TC Erciyes University ### Status Module #### Completion Date **Date:** 2023-11-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-11-30 **Type:** ACTUAL #### Start Date **Date:** 2023-09-04 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** TC Erciyes University #### Responsible Party **Investigator Affiliation:** TC Erciyes University **Investigator Full Name:** Nurseli Soylu Erener **Investigator Title:** Research Assistant **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The postpartum period, especially in the first few weeks, can be a difficult period for mothers to adapt to the new situation of having a baby. During this process, physiological, psychological and social changes occur in the mother's body. While many mothers adapt to these changes easily, some mothers may experience psychological disorders at different levels.Among these, anxiety and depression are the most common diseases. Anxiety can negatively affect mothers, especially during birth and the postpartum period.During the postpartum period, nurses have the opportunity to improve maternal and infant health by recognizing and treating anxiety.Physical symptoms associated with postpartum anxiety include fatigue, irritability, difficulty concentrating, and sleep disturbances. However, during the vaginal birth process, mothers may feel tired in the early postpartum period, as the pregnant woman spends a lot of energy by staying hungry for a long time. When the literature was examined, it was determined that endorphin massage reduces back pain in pregnant women, reduces anxiety level in pregnant women, accelerates the involution process in the postpartum period, and has positive effects on postpartum depression.Similar to endorphin massage, it has been determined that back massage reduces back pain in the postpartum period and provides the mother with both physiological and psychological relief. In addition, no study has been found examining the effect of endorphin massage applied to postpartum women on anxiety levels and fatigue in the postpartum period. Therefore, this study aimed to determine the effect of endorphin massage applied to postpartum women who gave birth vaginally on postpartum anxiety and fatigue levels. **Detailed Description:** Birth is a very important experience in a woman's life. The postpartum period is a period of 6-8 weeks after birth. During this process, physiological, psychological and social changes occur in the puerperal woman's body. While many postpartum women easily adapt to these changes, some postpartum women may experience psychological disorders at different levels. Anxiety can negatively affect postpartum women, especially during birth and the postpartum period. Although it is generally desirable to experience anxiety at a normal and mild level, excessive anxiety can tire the individual emotionally.In addition, postpartum women may feel tired in the early postpartum period due to the pregnant woman fasting for a long time and spending too much energy during the vaginal birth process.This situation can be caused by many physical, psychological and situational factors. Postpartum fatigue can lead to deterioration in the general health of the mother and her baby, as well as other serious problems.Postpartum fatigue negatively affects women's physical and mental functions, wound healing, self-care skills and behaviors, energy, motivation and cognitive status, adaptation to motherhood, baby care behaviors, relationships with marriage and family members, including sexuality, work performance and quality of life. is a symptom.In this process, applications applied to postpartum women increase the quality of life by reducing fatigue.Endorphin massage is among the practices performed to improve the quality of life of women during the postpartum period. Endorphin is a natural painkiller known as the happiness hormone, which is similar to opioids secreted by the body, reduces pain, provides relaxation, protects the body against infections, accelerates metabolism. It is known that massage increases endorphin levels by having a relaxing effect on the muscles. Endorphin massage increases the release of endorphins, allowing the individual to relax, relaxing the muscles and reducing pain. Endorphin massage is a light massage technique that can increase the release of oxytocin and endorphin hormones and provide a feeling of calmness and comfort. When the literature was examined, it was determined that endorphin massage reduces back pain in pregnant women, reduces anxiety level in pregnant women, accelerates the involution process in the postpartum period, and has positive effects on postpartum depression.Similar to endorphin massage, it has been determined that back massage reduces back pain in the postpartum period and provides the mother with both physiological and psychological relief. In addition, no study has been found examining the effect of endorphin massage applied to postpartum women on anxiety levels and fatigue in the postpartum period. Therefore, this study aimed to determine the effect of endorphin massage applied to postpartum women who gave birth vaginally on postpartum anxiety and fatigue levels. ### Conditions Module **Conditions:** - Birth - Anxiety - Fatigue **Keywords:** - Birth - Vaginal Birth - Massage - anxiety - Endorphin - Fatigue ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 50 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** * Personal introduction form, state and trait anxiety scale and visual similarity scale for fatigue were applied. * Endorphin massage was applied twice by the researcher for 15 minutes every two hours. * After the endorphin massage applied for the second time, the visual similarity scale and the state and trait anxiety scale were applied again for fatigue. **Intervention Names:** - Other: massage **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** * A personal introduction form, state and trait anxiety scale, and visual similarity scale for fatigue were applied. * Two hours after the first evaluation, the visual similarity scale and the state and trait anxiety scale were applied again for fatigue. **Label:** Control gruop **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** Endorphin massage will be given for 15 minutes every 2 hours. **Name:** massage **Other Names:** - endorphin massage **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The state anxiety scale determines how the individual feels at a certain moment and under certain conditions. The scale consists of 20 questions and is asked to choose one of the options 'not at all', 'somewhat', 'a lot' and 'completely' depending on the severity of the thoughts or behaviors. The trait anxiety scale determines how the individual feels, regardless of the situation and conditions, and consists of 20 questions. In answering this scale, one is asked to choose one of the following options: 'almost never', 'sometimes', 'most of the time' and 'almost always', depending on the frequency of the thoughts or behaviors. **Measure:** State and Trait Anxiety Scale **Time Frame:** It was applied twice in total, two hours apart. #### Secondary Outcomes **Description:** The scale has sub-dimensions of fatigue and energy . It consists of a total of 18 items in two sub-dimensions. The scale consists of 10 cm horizontal lines with positive expressions at one end and negative expressions at the other end of each item. While the items of the fatigue sub-dimension progress from positive to negative expressions, the items of the energy sub-dimension are in the opposite order. The lowest score obtained in the fatigue sub-dimension is zero and the highest score is 130. In the energy sub-dimension, scores are calculated between 0 and 50 points. A high score of the fatigue sub-dimension and a low score of the energy sub-dimension indicate that the severity of fatigue increases. **Measure:** Visual Similarity Scale for Fatigue **Time Frame:** It was applied twice in total, two hours apart. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Giving birth vaginally at term, * Postpartum within 24 hours, * Primiparous, * Those who are healthy and have given birth to a single baby, * Postpartum women who volunteered to participate in the study were included. Exclusion Criteria: * Those with psychiatric illness (Bipolar Disorder, Depression, Obsessive Compulsive Disorder), * People with chronic diseases (Heart disease, Thyroid problems, Diabetes mellitus, Hypertension, asthma, COPD, * Those who have been diagnosed with a risky pregnancy (Pre-eclampsia, Arthritis, Pregnancy-related hypertension, Gestational diabetes), * Whose baby was admitted to neonatal intensive care, * Postpartum women with postpartum bleeding were not included in the study. **Healthy Volunteers:** True **Maximum Age:** 40 Years **Minimum Age:** 19 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Kocasinan **Country:** Turkey **Facility:** Kayseri City Hospital **State:** Kayseri #### Overall Officials **Official 1:** **Affiliation:** TC Erciyes University **Name:** Nurseli SOYLU ERENER **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Only the name of the research can be shared. **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Qian, J., Sun, S., Liu, L., \& Yu, X. (2021). Protocol: Effectiveness of non-pharmacological interventions for reducing postpartum fatigue: a systematic review protocol. BMJ Open, 11(10), 51136 **URL:** http://doi.org/10.1136/BMJOPEN-2021-051136 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M8364 - Name: Fatigue - Relevance: HIGH - As Found: Fatigue - 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: D000005221 - Term: Fatigue - ID: D000001008 - Term: Anxiety Disorders ### Intervention Browse Module - Ancestors - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M7885 - Name: Endorphins - Relevance: HIGH - As Found: Intracutaneous - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000004723 - Term: Endorphins ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421220 **Brief Title:** Evaluation of the Efficacy and Safety of Indocyanine Green Tracing in 3D Fluorescent Laparoscopic Lymph Node Dissection for Gastric Cancer **Official Title:** Clinical Efficacy and Safety Evaluation of Submucosal Injection of Indocyanine Green Tracer in 3D Fluorescent Laparoscopic Lymph Node Dissection for Gastric Cancer: a Prospective, a Multicenter, Randomized, Controlled Study Clinical Trial #### Organization Study ID Info **ID:** KYLL-202403-012-1 #### Organization **Class:** OTHER **Full Name:** Qilu Hospital of Shandong University ### Status Module #### Completion Date **Date:** 2028-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Qilu Hospital of Shandong University #### Responsible Party **Investigator Affiliation:** Qilu Hospital of Shandong University **Investigator Full Name:** Wenbin Yu **Investigator Title:** Professor， and Chief of Gastrointestinal Surgery Department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Purpose of the study To evaluate whether the clinical efficacy of submucosal injection of indocyanine green tracer laparoscopic gastric cancer lymph node dissection is superior to that of laparoscopic gastric cancer lymph node dissection without indocyanine green tracer in 3D fluorescence laparoscopic mode in patients with gastric adenocarcinoma (cT1-4a, N-/+, M0). To observe the role of submucosal injection of ICG for tumor localization in fluorescence 3D fluorescence laparoscopic surgery and the application of lymph node dissection in laparoscopic radical surgery for gastric cancer. Study design. Multicenter, randomized, open, parallel-controlled, superiority design. Subgroups Group A (experimental group): indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group Group B (control group): no indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group. Study population Patients who met all the inclusion criteria and did not fall into any of the exclusion criteria were eligible to enter this study. Randomization Patients were first evaluated preoperatively to determine that they could receive laparoscopic radical gastric cancer treatment and receive endoscopic indocyanine green labeling. Once the enrolled cases were determined to meet the admission criteria after laparoscopic exploration, they could be enrolled in this study for randomization. The central dynamic, stratified zone randomization method was used in this study, and the control factors considered were age, tumor site, and preoperative stage. Given the number of seeds and the length of the zones, SAS 9.2 programming was applied to generate the treatment allocation corresponding to the running number 484, which was deposited in the data center. A person at the participating research center was responsible for sending the enrolled case information (age, tumor site, and preoperative stage) to the randomization implementation department at the data center by email, phone, or SMS, and the contact person at each respective research center confirmed that the patient met the enrollment criteria, contacted the contact person for the assigned case in this study, and determined the enrollment of the case by further analyzing the case information, and at the same time, notified the contact person at the research center where the case was located The contact person of the research center where the case is located will be notified at the same time. Competitive enrollment was used in this study. Blinding. **Detailed Description:** Case enrollment period: complete enrollment of the required cases within 2 years. Follow-up period: The 1st case enrollment is the starting point for follow-up, and the last case enrollment to the time of return of the postoperative pathology report (usually 2 weeks postoperatively) is the endpoint of follow-up for secondary study purposes except for the 2-year recurrence type. 2 years after the last 1 case enrollment is the follow-up endpoint for the primary study purpose. Estimated time: 2024.5-2026.4 (completion of enrollment) - 2028.4 (completion of follow-up) Standardization of Surgical Procedures. Commonly followed principles of handling in both groups Anesthesia All surgeries were performed under general anesthesia with tracheal intubation; the use of epidural-assisted anesthesia depended on the anesthesiologist and was not prescribed in this study. Obtaining cytologic specimens for abdominal lavage After entering the abdominal cavity, firstly, the cytology specimen of abdominal lavage was retained for postoperative examination (Specific method: ascites was taken directly when ascites was found to be present. If there is no ascites, 100 ml of saline is slowly injected into the abdominal cavity, and the washings are collected and sampled in the Douglas fossa for examination.) Intraoperative exploration After obtaining cytologic specimens from abdominal lavage, the abdominal cavity is explored to check for metastases to the liver, peritoneum, mesentery, and pelvis, and invasion of the gastric plasma membrane. Provisions for lymph node dissection Gastric cancer D2 lymph node dissection is performed according to the Japanese Guidelines for the Treatment of Gastric Cancer (5th ed.) Lymph node dissection is performed in patients in group A. After lymph node dissection, the NIR mode is used to check for the presence of missing lymph nodes, and if there are any, remedial dissection is performed. The rules about off-site lymph node dissection: when the tumor is located in the greater curvature of the stomach, or the splenic hilar lymph nodes are enlarged on preoperative imaging, or the lymph nodes in group 10 are visualized intraoperatively, selective splenic preservation and splenic hilar lymph node dissection will be performed for the lymph nodes in group 10; group 14 lymph nodes will also be selectively disseminated when they are visualized intraoperatively; and other off-site lymph nodes will be disseminated or not by decision of the surgeon if they are visualized intraoperatively. The cleared extrastriate lymph nodes should be sent for examination and recorded separately. Provisions for gastrectomy According to the "Japanese Guidelines for the Treatment of Gastric Cancer" (5th edition), distal or total gastrectomy should be performed as long as the oncologic principle can be guaranteed. If the operator decides to perform total laparoscopic gastrointestinal reconstruction, a sterile marker pen is required to determine the surgical incision line based on the indocyanine green range or other methods before dissecting the gastric wall, and to preserve the photographic data. Provision for resection of the greater omentum This study protocol requires total greater omentectomy for patients with progressive gastric cancer, and the remainder is not prescribed. Provisions for digestive tract reconstruction The way of digestive tract reconstruction shall be decided by the surgeon according to his/her own experience and intraoperative conditions, if instrumental anastomosis is used, whether to manually reinforce the anastomosis with suture shall be decided by the surgeon, and it is not stipulated in this study protocol. Provisions for Surgery-Related Devices and Instruments Energy devices, methods of vascular ligation, GI cutting and closing, and GI reconstruction instruments are determined by the surgeon responsible for the procedure based on experience and actual needs, and are not specified in this study protocol. Provisions for gastric tube and abdominal drainage tube Whether to keep gastric tube or abdominal drainage tube after surgery is decided by the responsible surgeon based on experience and actual needs, and is not stipulated in this study protocol. Provisions for other surgeries performed at the same time If intraoperative findings of comorbidities of other systems/organs are detected, and the surgeon in charge of the surgery and the consulting surgeon of the relevant department jointly decide that concurrent surgery is needed to deal with them, concurrent surgery can be performed, and the sequence is decided according to the clinical routine; however, cases are excluded from the PP set according to the exclusion criteria, and the cases are excluded from the PP set. Provisions for the treatment of excluded cases found during surgery After the patient is judged to be a cull case by the surgeon responsible for the surgery during the operation, this study protocol is suspended, and the surgeon responsible for the surgery decides the follow-up treatment by himself/herself in accordance with the clinical practice routines of the participating centers (therapeutic decision-making on whether or not to carry out the resection of the primary gastric lesion, metastasis, etc., shall be decided by the surgeon responsible for the surgery) Provisions for laparoscopic surgery Provisions for pneumoperitoneum Carbon dioxide pneumoperitoneum is used with a maintenance pressure of 12-13 mmHg, which may be appropriately lowered in advanced age. Provisions for poking holes and auxiliary incisions The location of puncture holes and auxiliary small incisions is not regulated, and the number of puncture holes should not exceed 5. Only 1 auxiliary small incision may be made, and it must usually be less than 10 cm. when an auxiliary small incision of more than 10 cm is required, the decision must be made at the discretion of the surgeon in charge of the procedure, and the rationale must be documented in detail in the CRF. Definition of laparoscopic access Intra-abdominal operations must be performed using laparoscopic instruments supported by a camera system. Perigastric freeing, resection of the greater omentum, resection of the omental bursa, lymph node dissection, and management of the vasculature should be accomplished laparoscopically. Gastric resection, and digestive tract reconstruction, are permitted to be accomplished in the open state using auxiliary small incisions. Provisions for intermediate open abdomen In the event of intraoperative intra-abdominal hemorrhage, organ injury, or other serious/life-threatening complications due to surgical manipulation, which are difficult to control laparoscopically, the abdomen must be actively staged and opened. If intraoperative complications due to carbon dioxide pneumoperitoneum occur, and the anesthesiologist and the surgeon in charge of the operation discuss that it may threaten the patient's life safety, the abdomen must be actively transferred and opened. Other technical, instrumental, and other factors that lead to an intermediate open abdomen are decided by the surgeon in charge of the operation, and the reasons are recorded. The length of the incision for a mid-rotation open abdomen was not regulated in this study. The reason for the mid-excision needs to be clearly documented in the CRF. Follow-up of rejected cases in the laparoscopic group Whether to continue the surgery under laparoscopy or to intermediate open surgery is at the discretion of the surgeon in charge of the surgery based on clinical experience. Technical approach to indocyanine green tracing in the study group Patients enrolled in group A (study group) were injected with 1 ml of indocyanine green (indocyanine green for injection, 25 mg/strike, indocyanine green for injection diluted to 0.625 mg/ml with sterilized water for injection) into the submucosal layer of the tumor at a total of four points in the four quadrants of the tumor before the operation, and the submucosal dark-green elevation could be observed after the injection of ICG. Intraoperative visualization of the SLN tracer was performed using ICG system products. (In cT1-2 patients, if the intraoperative position is difficult to determine, preoperative marking with a harmonized titanium clip is added). ### Conditions Module **Conditions:** - Gastric Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 484 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: Preoperative injection of indocyanine green **Label:** Indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** Indocyanine green tracer-free 3D laparoscopic gastric cancer lymph node dissection group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group **Description:** Submucosal injection of indocyanine green into the gastric mucosa prior to surgery， indocyanine green，25mg，powder，once **Name:** Preoperative injection of indocyanine green **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Observation of the rate of disease-free survival of patients two years after surgery **Measure:** 2-year disease free survival rate **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Age: 18-75 years old Gastric adenocarcinoma diagnosed histopathologically by endoscopic biopsy of the primary gastric lesion (pap, tub, muc, sig, por) The preoperative clinical stage was cT1-4a, N-/+, M0, according to the AJCC-8th TNM tumor stage. Preoperative examination did not show distant metastasis, and the tumor did not directly invade the pancreas, spleen and other adjacent organs. Preoperative ECOG physical status score 0/1 Preoperative ASA score I-III. Patient informed consent Exclusion Criteria: Pregnant or nursing women Serious mental illness History of upper abdominal surgery (except history of laparoscopic cholecystectomy) History of gastric surgery (including ESD/EMR for gastric cancer) Preoperative imaging suggestive of regional fusion of enlarged lymph nodes (maximum diameter ≥3cm) History of other malignant diseases within 5 years. Neoadjuvant therapy has been implemented History of unstable angina or myocardial infarction within 6 months History of cerebral infarction or cerebral hemorrhage within 6 months History of continuous systemic corticosteroid therapy within 1 month Require concomitant surgical treatment for other diseases. Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery. Pulmonary function test FEV1 \<50% of the expected value Diffusely invasive gastric cancer Preoperatively confirmed tumor invading the dentate line or duodenum Previous history of iodine allergy Refusal of laparoscopic surgery **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Jinan **Contacts:** ***Contact 1:*** - **Email:** wenbin_yu2003@163.com - **Name:** Wenbin Yu, Phd - **Phone:** +8618560082483 - **Role:** CONTACT **Country:** China **Facility:** Qilu hospital of Shandong University **State:** Shandong **Zip:** 250012 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Wei M, Liang Y, Wang L, Li Z, Chen Y, Yan Z, Sun D, Huang Y, Zhong X, Liu P, Yu W. Clinical Application of Indocyanine Green Fluorescence Technology in Laparoscopic Radical Gastrectomy. Front Oncol. 2022 Mar 4;12:847341. doi: 10.3389/fonc.2022.847341. eCollection 2022. **PMID:** 35311067 **Citation:** Kwon IG, Son T, Kim HI, Hyung WJ. Fluorescent Lymphography-Guided Lymphadenectomy During Robotic Radical Gastrectomy for Gastric Cancer. JAMA Surg. 2019 Feb 1;154(2):150-158. doi: 10.1001/jamasurg.2018.4267. **PMID:** 30427990 **Citation:** Kim TH, Kong SH, Park JH, Son YG, Huh YJ, Suh YS, Lee HJ, Yang HK. Assessment of the Completeness of Lymph Node Dissection Using Near-infrared Imaging with Indocyanine Green in Laparoscopic Gastrectomy for Gastric Cancer. J Gastric Cancer. 2018 Jun;18(2):161-171. doi: 10.5230/jgc.2018.18.e19. Epub 2018 Jun 28. **PMID:** 29984066 **Citation:** Lan YT, Huang KH, Chen PH, Liu CA, Lo SS, Wu CW, Shyr YM, Fang WL. A pilot study of lymph node mapping with indocyanine green in robotic gastrectomy for gastric cancer. SAGE Open Med. 2017 Aug 21;5:2050312117727444. doi: 10.1177/2050312117727444. eCollection 2017. **PMID:** 28856007 **Citation:** Huh YJ, Lee HJ, Kim TH, Choi YS, Park JH, Son YG, Suh YS, Kong SH, Yang HK. Efficacy of Assessing Intraoperative Bowel Perfusion with Near-Infrared Camera in Laparoscopic Gastric Cancer Surgery. J Laparoendosc Adv Surg Tech A. 2019 Apr;29(4):476-483. doi: 10.1089/lap.2018.0263. Epub 2018 Dec 27. **PMID:** 30589374 **Citation:** Sherwinter DA, Boni L, Bouvet M, Ferri L, Hyung WJ, Ishizawa T, Kaleya RN, Kelly K, Kokudo N, Lanzarini E, Luyer MDP, Mitsumori N, Mueller C, Park DJ, Ribero D, Rosati R, Ruurda JP, Sosef M, Schneider-Koraith S, Spinoglio G, Strong V, Takahashi N, Takeuchi H, Wijnhoven BPL, Yang HK, Dip F, Lo Menzo E, White KP, Rosenthal RJ. Use of fluorescence imaging and indocyanine green for sentinel node mapping during gastric cancer surgery: Results of an intercontinental Delphi survey. Surgery. 2022 Dec;172(6S):S29-S37. doi: 10.1016/j.surg.2022.06.036. **PMID:** 36427927 **Citation:** Chen QY, Xie JW, Zhong Q, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng HL, Li P, Zheng CH, Huang CM. Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):300-311. doi: 10.1001/jamasurg.2019.6033. **PMID:** 32101269 ## Derived Section ### Condition Browse Module - Ancestors - 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: D000013272 - Term: Stomach Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastric Cancer - 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: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: HIGH - As Found: Gastric Cancer ### Condition Browse Module - Meshes - ID: D000013274 - Term: Stomach Neoplasms ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421207 **Brief Title:** Open Label Study Exploring Tissue Histopathology After Ellacor® Procedure in an Abdominoplasty Model. **Official Title:** Open Label Study to Explore Tissue Histopathology Following Reduction in Skin Surface Using the Ellacor® Micro-Coring™ Procedure in an Abdominoplasty Model. #### Organization Study ID Info **ID:** TP-00379 #### Organization **Class:** INDUSTRY **Full Name:** Cytrellis Biosystems, Inc. ### Status Module #### Completion Date **Date:** 2023-10-04 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-06-19 **Type:** ACTUAL #### Start Date **Date:** 2023-02-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-01-29 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Dallas Plastic Surgery Institute #### Lead Sponsor **Class:** INDUSTRY **Name:** Cytrellis Biosystems, Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study to better understand how the ellacor® Micro-Coring™ procedure works using an abdominoplasty, or tummy tuck surgery, model. The people participating in the study will have already decided that they want to have an abdominoplasty procedure. The main questions this study aims to answer are: 1. how does the ellacor® procedure change skin tissue? 2. is the ellacor® device safe to use at specific treatment depths? The ellacor® procedure will be performed on people who are going to have abdominoplasty surgery. The ellacor® treatment areas will be limited to the areas marked for removal of skin during the abdominoplasty. The treated tissue will be sent to a lab for microscopic study after the abdominoplasty procedure is complete. A minimum of 3 people will be treated in each of 2 groups for a total of 6 total participants. 3 participants in the first group will have the ellacor® procedure done 30 days before their abdominoplasty surgery. The ellacor® procedure will be done at different depths in designated locations: 4mm, 5mm and 7mm. The participants will be asked about any changes to their health or medications while on the study. 3 participants in the second group will have the ellacor® procedure done at 3 different timepoints, 30 days apart, all at the same depth of 4mm. They will also be asked about any changes to their health or medications while on the study. Researchers will study the abdominoplasty tissue under a microscope after it has been removed from the participants. They will compare the areas treated by the ellacor® device to an area left untreated. This will reveal any changes in the skin tissue between treated and untreated areas, if they occur. ### Conditions Module **Conditions:** - Histopathology - Wrinkle - Rhytides **Keywords:** - Mechanism of Action - Micro-Coring - Abdominoplasty - histopathology - immunohistochemistry - wrinkle treatment ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Abdominoplasty model ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 6 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Each subject will be treated a single time at 4mm, 5mm and 7 mm depths at a minimum of 3 treatment areas. A non-treated control area will also be designated. Histology evaluations for all treatment areas and the control area will occur 30 days after treatment (Day 30). **Intervention Names:** - Device: ellacor® Micro-Coring procedure **Label:** Cohort 1 Safety Evaluation of Treatment Depths **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Each subject will be treated at a specified depth (4mm). Treatment area 1 will have 3 treatments with the study device, each treatment 30 days apart starting on Day 0. Treatment area 2 will have 2 treatments with the study device 30 days apart starting on Day 30. Treatment area 3 will have a single treatment with the study device on Day 60. A non-treated control area will also be designated. Histology evaluations for all treatment areas and the control area will occur 30 days after the area 3 treatment (Day 90). **Intervention Names:** - Device: ellacor® Micro-Coring procedure **Label:** Cohort 2 Multiple Treatment Histology **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort 1 Safety Evaluation of Treatment Depths - Cohort 2 Multiple Treatment Histology **Description:** ellacor® Micro-Coring Technology is FDA approved for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. **Name:** ellacor® Micro-Coring procedure **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The incidence and severity of adverse events will be evaluated for both Study Cohorts. **Measure:** Incidence and severity of adverse events **Time Frame:** Adverse events will be collected from Day 0 (the initial ellacor treatment day) through the day of the scheduled abdominoplasty procedure (Day 30 for Cohort 1 or Day 90 for Cohort 2). **Description:** Compare histopathology of stained tissue isolated after a single ellacor® treatment on abdominal tissue. Tissue being evaluated by staining will be isolated from excised abdominal tissue following abdominoplasty. Tissue will have an untreated control area compared to three treated areas wherein the depth of treatment will be 4mm, 5mm, and 7mm. The evaluation will include staining with: Hematoxylin and Eosin (H\&E), Herovici, and Movat stains. The use of these stains will provide a comparison of the structural tissue changes (H\&E stain), change in the presence of Type III (young) collagen and Type I (mature) collagen (Herovici stain) and change in the presence of collagen, fibrin and elastic fibers (Movat stain) of treated areas compared to untreated control area. Histopathology of the excised abdominal tissue will be performed at a central pathology laboratory by a designated pathologist who will provide detailed report of the findings. **Measure:** The change in histopathology of abdominoplasty tissue samples after a single treatment with the ellacor® device at depths of 4mm, 5mm and 7mm as compared to an untreated control area. **Time Frame:** Histopathological studies will be performed on excised abdominoplasty tissue approximately 30 days after a single ellacor® treatment. **Description:** Evaluate the comparative histopathology of tissue isolated after multiple treatments on abdominal tissue. Tissue being evaluated by staining will be isolated from excised abdominal tissue after abdominoplasty. Tissue will have an untreated control area compared to three treated areas. Area 1 will have 3 treatments. Area 2 will have 2 treatments. Area 3 will have treatment. The evaluation will include staining with: Hematoxylin and Eosin, Herovici, and Movat stains. These stains will provide comparison of the structural tissue change (H\&E stain), change in the presence of Type III (young) and Type I (mature) collagen (Herovici stain) and change in the presence of collagen, fibrin and elastic fibers (Movat stain) of treated areas compared to the untreated control area. Histopathology of the excised abdominal tissue will be performed at a central pathology laboratory by a designated pathologist who will provide detailed report of the findings. **Measure:** The change in histopathology of abdominoplasty tissue after 1, 2 and 3 ellacor® treatments (depth of 4mm) compared to untreated control area. Treatments are separated by 30 days with a final tissue comparison 90 days after the first treatment. **Time Frame:** The histopathological studies will be performed on the excised abdominoplasty tissue approximately 90 days after the first ellacor® treatment, 60 days after the second treatment and 30 days after the final treatment is performed. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Undergoing planned abdominoplasty * Are willing to donate their tissue for evaluation * BMI ≤ 30 * Women 18 years or older * Fitzpatrick scale I-VI * Females of childbearing potential will have a negative urine pregnancy test prior to each procedure * Are judged to be in good health based on the results of a medical history and physical examination (standard of care for abdominoplasty) at screening * Has been informed of the nature of the study and agrees to its provisions and has provided written informed consent on a form, as approved by the IRB of the respective clinical site. * Able and willing to comply with all visits, procedures and evaluation schedules and requirements Exclusion Criteria: * Having an active bleeding disorder or currently taking anticoagulants * History of keloid formation or abnormal wound healing * Inflammation or active infection and treatment area * Compromised immune system (e.g., diabetes) * Any surgery or treatments in the abdominal area 12 months prior to procedure * Comorbid condition that could limit ability to participate in the study or to comply with follow up requirements * Pregnant or breastfeeding * Tattoo and/or mole located within the planned treatment area(s) * Vulnerable populations include those defined 45 CFR 46 Subparts B, and those mentioned in 45 CFR 46.111(b): mentally disabled persons, or economically or educationally disadvantaged persons * Any issue that at the discretion of the investigator would contraindicate the subject's participation **Gender Based:** True **Gender Description:** Self-representation. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Dallas **Country:** United States **Facility:** Dallas Plastic Surgery Institute **State:** Texas **Zip:** 75231 #### Overall Officials **Official 1:** **Affiliation:** Dallas Plastic Surgery Institute **Name:** Rod Rohrich, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421194 **Brief Title:** Functional and Nutritional Plant-based Mixed Protein Study (FuN Protein Study) **Official Title:** Functional and Nutritional Plant-based Mixed Protein Study (FuN Protein Study) #### Organization Study ID Info **ID:** 2023/00944 #### Organization **Class:** OTHER_GOV **Full Name:** Clinical Nutrition Research Centre, Singapore ### Status Module #### Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Clinical Nutrition Research Centre, Singapore #### Responsible Party **Investigator Affiliation:** Clinical Nutrition Research Centre, Singapore **Investigator Full Name:** Melvin Leow **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study aims to investigate the effects of optimized plant protein mixtures versus their animal protein equivalents on satiety, protein metabolism, and overall metabolic health **Detailed Description:** The research described in this application is crucial as it addresses a fundamental issue - the nutrition quality of plant-based diets. Plant-based diets are widely acknowledged for their health benefits as they are known to reduce disease risks and all-cause mortality. However, concerns about plant protein quality arise due to disparities in amino acid profiles, particularly their essential amino acid adequacy, which remains a challenge in adopting a plant-based protein diet as part of a healthy diet. Other challenges include low palatability, poor texture, flavor, and mouthfeel. To address this, the Singapore Institute of Food and Biotechnology Innovation (SIFBI) has developed Asian-centric plant-based food products by combining multiple plant-protein sources to emulate the amino acid profile of animal proteins. This approach aims to optimize plant-based diets by ensuring enhanced protein quantity and quality in a mixed meal, not only to encourage adaptation of plant based protein into daily meals for environmental sustainability but also with the long-term objectives to use diet as a means to improve metabolic health in the Asian demographics. This human study is designed to explore the effects of consuming optimized plant-protein-based products compared to conventional animal protein- based products on postprandial metabolism and overall metabolic health. The study is structured around several specific objectives: 1. Evaluate Nutritional Impact: The study aims to assess the nutritional efficacy of the investigational food products. This will involve measuring circulating amino acids and protein metabolism markers, such as blood urea and amino acid metabolites. Additionally, the study will examine the effects of these foods on overall metabolic health, including their impact on glycaemic response and inflammatory markers. 2. Investigate Postprandial Satiety: Another key aim is to explore the effects of investigational food items on postprandial appetite and satiety. This will help determine how these foods influence hunger and fullness sensations following consumption, which is crucial for understanding their potential role in weight management and metabolic regulation. 3. Investigate Consumer Acceptance: The study will also assess consumer acceptance of the investigational food products to identify the potential barriers. This includes evaluating the palatability of these products, as their taste, texture, and overall appeal are vital factors in determining their potential integration into regular diets. 4. Gain Mechanistic Insight: The study seeks to gain deeper mechanistic insights by systematically investigating changes in the postprandial circulating proteome. This analysis will enhance our understanding of the biological processes and pathways involved in the body's response to these food products post-consumption. ### Conditions Module **Conditions:** - Nutrition, Healthy **Keywords:** - plant-based protein - Asian - diet - health outcomes - animal-based protein ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** A randomized controlled crossover trial, where participants will undergo four sessions, each followed by a six-day wash-out period. ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 28 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Animal-based protein meal; Isoproteic at \~30g of total protein per meal. Siew mai (6 pieces) - steamed Ngoh Hiang (2 pieces) - oven baked **Intervention Names:** - Other: Investigational meal 1 - Commercial animal-based protein foods [Siew mai (6 pieces) and Ngoh hiang (2 pieces)] **Label:** Treatment 1 Animal-based protein meal **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Animal-based protein meal; Isoproteic at \~30g of total protein per meal. Gyoza (11 pieces) - steamed Luncheon meat (5 pieces) - oven baked **Intervention Names:** - Other: Investigational meal 2- Commercial animal-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)] **Label:** Treatment 2 Animal-based protein meal **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Plant-based protein meal; Isoproteic at \~30g of total protein per meal. Siew mai (6 pieces) - steamed Ngoh Hiang (1 piece cut into 2) - oven baked **Intervention Names:** - Other: Investigational meal 3- Formulated plant-based protein foods [Siew mai (6 pieces) and Ngoh hiang (1 piece cut into 2)] **Label:** Treatment 3 Plant-based protein meal **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Plant-based protein meal; Isoproteic at \~30g of total protein per meal. Gyoza (11 pieces) - steamed Luncheon meat (5 pieces) - oven baked **Intervention Names:** - Other: Investigational meal 4- Formulated plant-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)] **Label:** Treatment 4 Plant-based protein meal **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment 1 Animal-based protein meal **Description:** Participants consume a meal consisting of commercial animal-based protein foods (steamed Siew mai and oven-baked Ngoh hiang) in a fasted state. **Name:** Investigational meal 1 - Commercial animal-based protein foods [Siew mai (6 pieces) and Ngoh hiang (2 pieces)] **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Treatment 2 Animal-based protein meal **Description:** Participants consume a meal consisting of commercial animal-based protein foods (steamed Gyoza and oven-baked Luncheon meat) in a fasted state. **Name:** Investigational meal 2- Commercial animal-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)] **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Treatment 3 Plant-based protein meal **Description:** Participants consume a meal consisting of formulated plant-based protein foods (steamed Siew mai and oven-baked Ngoh hiang) in a fasted state. **Name:** Investigational meal 3- Formulated plant-based protein foods [Siew mai (6 pieces) and Ngoh hiang (1 piece cut into 2)] **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Treatment 4 Plant-based protein meal **Description:** Participants consume a meal consisting of formulated plant-based protein foods (Gyoza and Luncheon meat) in a fasted state. **Name:** Investigational meal 4- Formulated plant-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)] **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum) **Measure:** Free amino acids **Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes. **Description:** Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum) **Measure:** Protein utilization **Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes. **Description:** Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (serum) **Measure:** Glucose homeostasis **Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes. **Description:** Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum) **Measure:** Gut hormones **Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes. **Description:** Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum) **Measure:** Markers related to general metabolic health **Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes. #### Secondary Outcomes **Description:** To study molecular mechanism underlying the observed outcomes (plasma and serum). **Measure:** Untargeted proteomics **Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes. **Description:** To assess participant's postprandial appetite and satiety, participants complete, C a Visual Analogue Scale (VAS) questionnaire pertaining to their appetite. At baseline time 0 minute, one question will be asked and participants will mark on a scale to indicate how they feel at that moment. A. Questions on appetite and desire for specific food type (how hungry you feel, how satisfied you feel, how full you feel, how much do you think you can eat) Time 15 minute to time 180 minute (8 time points, post meal), following two questions will be asked and participants will mark on a scale to indicate how they feel at that moment. A. Questions on appetite and desire for specific food type (how hungry you feel, how satisfied you feel, how full you feel, how much do you think you can eat) B. Questions on palatability of test meal (to complete immediately after meal intake) (visual appeal, smell, taste, aftertaste, palatibility) **Measure:** Visual Analogue Scale Questionnaire **Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes. **Description:** Participants complete a questionnaire pertaining to their gastrointestinal (GI) symptoms before investigational meal (0 minute) and at the end of the session (180 minute). Gastrointestinal symptoms pertaining to flatulence, rumbling, bloating, abdominal pain, abdominal cramps, nausea. **Measure:** Gastrointestinal Symptoms Questionnaire **Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male * Chinese ethnicity * Age between 21 to 45 years * Body Mass Index (BMI) between 18.5 to 27.5 kg/m2 * English-literate Exclusion criteria: * Smoking * Having allergies or intolerances to any common food ingredients including eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, pea, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, etc. * Following special diets or having intentional dietary restrictions (e.g., vegetarians/vegans) * Having a dislike towards plant-based or chicken-based foods * Not willing to adhere to diet modification as in the study's instructions * Not willing to stop any strenuous activity during or within 24 hours of test days * Having glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency) * Having alcohol consumption on \> 4 days per week with ≥ 6 alcoholic drinks per week * Having sustained elevation of blood pressure (\>160/95 mm Hg) * HbA1c reading ≥ 6.5% (raised non-fasted/random HbA1c as defined by WHO/ IDF) * Having previously undergone any gastrointestinal surgery or having history of gastrointestinal disorders * Having a history of heart, liver, kidney, blood disorders (e.g., thalassemia) or thyroid dysfunctions * Diabetic * Having history of tuberculosis, HIV, Hepatitis B or Hepatitis C infections * Having any prescription medication or any other alternative medicines or supplements (amino acids supplements, e.g. L-carnitine, glutamine and arginine) which may interfere with study measurements in the opinion of the study investigators * Having antibiotics or suffering from diarrhoea within the last 4 weeks * Having donated blood within 4 weeks of study participation * Having poor veins or having history of severe vasovagal syncope (blackouts or fainting) from blood draws * Employees of the SIFBI (Singapore Institute of Food and Biotechnology Innovation). **Gender Based:** True **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 21 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** melvin_leow@sifbi.a-star.edu.sg **Name:** Melvin Leow, Professor **Role:** CONTACT **Contact 2:** **Email:** wu_jia_yee@sifbi.a-star.edu.sg **Name:** Wu Jia Yee, PhD **Phone:** 6407 0778 **Role:** CONTACT #### Locations **Location 1:** **City:** Singapore **Contacts:** ***Contact 1:*** - **Email:** melvin_leow@sifbi.a-star.edu.sg - **Name:** Melvin Leow, Professor - **Role:** CONTACT ***Contact 2:*** - **Email:** wu_jia_yee@sifbi.a-star.edu.sg - **Name:** Wu Jia Yee, PhD - **Phone:** 6279-2730 - **Role:** CONTACT **Country:** Singapore **Facility:** Clinical Nutrition Research Centre **Status:** RECRUITING **Zip:** 117599 #### Overall Officials **Official 1:** **Affiliation:** Singapore Institute of Food and Biotechnology Innovation (SIFBI), A*STAR **Name:** Melvin Leow, Professor **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421181 **Acronym:** KEM-HEN **Brief Title:** Hemodynamic Effects of Anesthesia Induction **Official Title:** Hemodynamic Effects of Anesthesia Induction #### Organization Study ID Info **ID:** KEM-HEN #### Organization **Class:** OTHER **Full Name:** Kliniken Essen-Mitte ### Status Module #### Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Heinrich-Heine University, Duesseldorf #### Lead Sponsor **Class:** OTHER **Name:** Kliniken Essen-Mitte #### 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 idea of that project is to characterize the hemodynamic changes of a daily used clinical intervention (induction of anesthesia) in a highly controlled environment by two hemodynamic monitoring devices. The aim is an advanced hemodynamic profiling of this intervention and additionally screen for changes in flow patterns in an exploratory fashion. Both devices complement one another in their hemodynamic profiling ability. One device is a continuous monitoring with instant traceable changes and the other an intermittent point-of-care ultrasound/echocardiography device with advanced possibilities for differential diagnostics. A second purpose is to test the possibility to implement advanced echocardiography in a point-of-care approach during anaesthesia induction and evaluate the time and quality of a comprehensive analysis by a not-certified anaesthetists with an echocardiography device with features of artificial intelligence versus a certified expert. **Detailed Description:** Mortality after surgery is still high and high-risk procedures are associated to high postoperative complication rates. For hemodynamic monitoring, a meta-analysis showed a reduction in mortality and especially for the esophageal Doppler a reduction in postoperative complications. However, the effects reducing mortality and morbidity have to be considered as low. Probably, this is the reason why daily clinical implementation rates of hemodynamic monitoring are low, too. However, hemodynamic studies only focus on intraoperative optimization, but recent publications suggested that taking preoperative individual hemodynamic values for arterial blood pressure and cardiac index as targets for optimization provides advanced therapeutic options. Lastly, both studies do not provide data about the preoperative values and their changes during the induction of anesthesia. Our own data confirm that the induction of anesthesia, the establishment of a working epidural and the surgical incision of the abdomen leads to decreased cardiac index and markers of inotropy in otherwise cardiovascular healthy patients. However, the intervention studies and our own data strongly suggest that starting hemodynamic monitoring after the induction of anesthesia or the surgical incision may foreclose that the clinician can guide the hemodynamic therapy towards individualized goals. Additionally, the corrective treatment in this scenario could be different from just vasopressors. Nevertheless, in contrast to our own data a recent study showed that hypotension in the post-induction period is primarily associated with a decreased vascular tone due to anesthetic agents, suggesting that the appropriate treatment is vasopressors. A detailed hemodynamic profiling of non-cardiac patients undergoing high-risk cancer surgery prior, during and after the induction of anaesthesia may provide new insights about the effects of anaesthetic drugs, positive pressure ventilation, and changes of sympathetic tone. ### Conditions Module **Conditions:** - Patients Undergoing Anaesthesia Induction **Keywords:** - Hemodynamic monitoring - Point-of-care ultrasound - Point-of-care echocardiography - Anaesthesia induction - Respiratory effects ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Other Outcomes **Description:** The characteristics of an echocardiographic assessment will be analysed to examine the feasibility within clinical routine and the results will be compared to the results of a certified echocardiographic expert **Measure:** Examination times of the echocardiographic assessment by a not-certified expert **Time Frame:** Time from the start of anaesthesiological monitoring up to the start of anaesthesia induction, up to four hours **Description:** The characteristics of an echocardiographic assessment will be analysed to examine the feasibility within clinical routine and the results will be compared to the results of a certified echocardiographic expert **Measure:** Implementation rates in percentages of the echocardiographic assessment by a not-certified expert during clinical care **Time Frame:** Time from the start of anaesthesiological monitoring up to the start of anaesthesia induction, up to four hours **Description:** The characteristics of an echocardiographic assessment will be analysed to examine the feasibility within clinical routine and the results will be compared to the results of a certified echocardiographic expert **Measure:** Number of missed diagnositics of the echocardiographic assessment by a not-certified expert vs. an assessment by a certified examiner **Time Frame:** Time from the start of anaesthesiological monitoring up to the start of anaesthesia induction, up to four hours **Description:** The complications will be graded according to the "Clavien-Dindo" classification from one to five with one being a minor complication and five being death **Measure:** Incidence and description of postoperative complications **Time Frame:** Time of hospital stay, i.d. from the time of surgery up to discharge from the hospital, up to 30 days after surgery **Description:** The incidence of organ dysfunctions will be based on laboratory results and or pathophysiological features like delayed bowel opening after surgery **Measure:** Incidence and description of postoperative organ dysfunctions **Time Frame:** Time of hospital stay, i.d. from the time of surgery up to discharge from the hospital, up to 30 days after surgery #### Primary Outcomes **Description:** The heart rate will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages. **Measure:** Longitudinal change of heart rate assessed in percentages during the induction of anaesthesia **Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours **Description:** The arterial blood pressures will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages. **Measure:** Longitudinal change of arterial blood pressure assessed in percentaqes during the induction of anaesthesia **Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours **Description:** The stroke volume will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages. **Measure:** Longitudinal change of stroke volume assessed in percentaqes during the induction of anaesthesia **Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours **Description:** The echocardiographic feature of strain imaging for the analysis of contractile performance of the myocardium will be monitored prior to induction and after induction of anaesthesia to detect any changes **Measure:** Longitudinal change of myocardial strain imaging assessed by transthoracic echocardiography during the induction of anaesthesia **Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours #### Secondary Outcomes **Description:** The echocardiographic features will be monitored prior to induction and after induction of anaesthesia to detect any changes **Measure:** Changes in percentages in a comprehensive echocardiographic assessment of the right ventricle and atrium **Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours **Description:** The echocardiographic parameter will be monitored prior to induction and after induction of anaesthesia to detect any changes. **Measure:** Changes of the left ventricular and atrial volume in percentages assessed by a transthoracic echocardiography **Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours **Description:** The echocardiographic features will be monitored prior to induction and after induction of anaesthesia to detect any changes **Measure:** Changes of the left ventricular systolic and diastolic function in percentages assessed by a transthoracic echocardiography **Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours **Description:** The echocardiographic features will be monitored prior to induction and after induction of anaesthesia to detect any changes of the cardiac valve functions like increase of regurgitation **Measure:** Changes of function of the cardiac valves assessed by a transthoracic echocardiography **Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours **Description:** The haemodynamic features will be monitored prior to the start of induction up to the end of induction of anaesthesia to detect any changes **Measure:** Changes in percentage of the cardiocirculatory flow in an advanced hemodynamic monitoring device based on a pulse-contour methodology in a continuous fashion during induction of anaesthesia **Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours **Description:** The ultrasound features will be monitored prior to induction and after induction of anaesthesia to detect any changes **Measure:** Changes of flow profiles of the splanchnic vessels as well as peripheral arteries determined by ultrasound **Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours **Description:** The MSFP will be determined based on the stop-flow-methodology to determine additionally venous return characteristics **Measure:** Mean systemic filling pressure (MSFP) **Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours **Description:** BRS will be determined to analyse the impact of drugs of anaesthesia induction on the vegetative nervous system. The assessment is based on invasive measurement of the arterial blood pressure in combination with the electrocardiogram **Measure:** Baroreceptor sensitivity (BRS) **Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients undergoing elective laparotomy in the hospital Evangelische Kliniken Essen-Mitte * Due to the invasiveness of the planned surgery there is an indication for an arterial and central-venous line as well as an peridural catheter Exclusion Criteria: * Age \< 18 years * Lack of written informed consent * Insufficient language skills * Unwillingness to have pseudonymized disease data stored at the study site and lack of consent to share anonymized data as part of the clinical trial * American society of anaesthesiologists physical status higher as grade 3 * congestive heart failure with a grade of 2 or higher according to the New York heart association (NYHA) * Ischemic cardiopathy with a grade of 2 or higher according to the Canadian cardiovascular society (CCS) * Known severe valve pathologies of the heart * Chronic kidney disease with dependency of hemodialysis * Atrial fibrillation ora trail flutter * Pulmonary hypertension **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with the diagnosis of advanced primary ovarian cancer will be screened prior to cytoreductive surgery in cooperation with the colleagues of gynaecological oncology. If the patients are eligible they will be informed to give consent. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** a.feldheiser@kem-med.com **Name:** Aarne Feldheiser, M.D., PhD. **Phone:** +49201174 **Phone Ext:** 31001 **Role:** CONTACT **Contact 2:** **Email:** s.boland@kem-med.com **Name:** Stefan Boland **Phone:** +49201174 **Phone Ext:** 31001 **Role:** CONTACT #### Locations **Location 1:** **City:** Essen **Contacts:** ***Contact 1:*** - **Email:** a.feldheiser@kem-med.com - **Name:** Aarne Feldheiser, M.D., PhD. - **Phone:** +49201174 - **Phone Ext:** 31001 - **Role:** CONTACT ***Contact 2:*** - **Email:** s.boland@kem-med.com - **Name:** Stefan Boland, M.D. - **Phone:** +49201174 - **Phone Ext:** 31001 - **Role:** CONTACT **Country:** Germany **Facility:** Evangelische Kliniken Essen-Mitte **State:** NRW **Zip:** 45136 #### Overall Officials **Official 1:** **Affiliation:** Evangelische Kliniken Essen-Mitte **Name:** Aarne Feldheiser, M.D., PhD. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Chong MA, Wang Y, Berbenetz NM, McConachie I. Does goal-directed haemodynamic and fluid therapy improve peri-operative outcomes?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2018 Jul;35(7):469-483. doi: 10.1097/EJA.0000000000000778. **PMID:** 29369117 **Citation:** Ripolles-Melchor J, Casans-Frances R, Espinosa A, Abad-Gurumeta A, Feldheiser A, Lopez-Timoneda F, Calvo-Vecino JM; EAR Group, Evidence Anesthesia Review Group. Goal directed hemodynamic therapy based in esophageal Doppler flow parameters: A systematic review, meta-analysis and trial sequential analysis. Rev Esp Anestesiol Reanim. 2016 Aug-Sep;63(7):384-405. doi: 10.1016/j.redar.2015.07.009. Epub 2016 Feb 10. English, Spanish. **PMID:** 26873025 **Citation:** Sessler DI, Bloomstone JA, Aronson S, Berry C, Gan TJ, Kellum JA, Plumb J, Mythen MG, Grocott MPW, Edwards MR, Miller TE; Perioperative Quality Initiative-3 workgroup; POQI chairs; Miller TE, Mythen MG, Grocott MP, Edwards MR; Physiology group; Preoperative blood pressure group; Intraoperative blood pressure group; Postoperative blood pressure group. Perioperative Quality Initiative consensus statement on intraoperative blood pressure, risk and outcomes for elective surgery. Br J Anaesth. 2019 May;122(5):563-574. doi: 10.1016/j.bja.2019.01.013. Epub 2019 Feb 27. **PMID:** 30916004 **Citation:** Kouz K, Wegge M, Flick M, Bergholz A, Moll-Khosrawi P, Nitzschke R, Trepte CJC, Krause L, Sessler DI, Zollner C, Saugel B. Continuous intra-arterial versus intermittent oscillometric arterial pressure monitoring and hypotension during induction of anaesthesia: the AWAKE randomised trial. Br J Anaesth. 2022 Oct;129(4):478-486. doi: 10.1016/j.bja.2022.06.027. Epub 2022 Aug 23. **PMID:** 36008202 **Citation:** Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172. **PMID:** 28973220 **Citation:** Nicklas JY, Diener O, Leistenschneider M, Sellhorn C, Schon G, Winkler M, Daum G, Schwedhelm E, Schroder J, Fisch M, Schmalfeldt B, Izbicki JR, Bauer M, Coldewey SM, Reuter DA, Saugel B. Personalised haemodynamic management targeting baseline cardiac index in high-risk patients undergoing major abdominal surgery: a randomised single-centre clinical trial. Br J Anaesth. 2020 Aug;125(2):122-132. doi: 10.1016/j.bja.2020.04.094. **PMID:** 32711724 **Citation:** Saugel B, Bebert EJ, Briesenick L, Hoppe P, Greiwe G, Yang D, Ma C, Mascha EJ, Sessler DI, Rogge DE. Mechanisms contributing to hypotension after anesthetic induction with sufentanil, propofol, and rocuronium: a prospective observational study. J Clin Monit Comput. 2022 Apr;36(2):341-347. doi: 10.1007/s10877-021-00653-9. Epub 2021 Feb 1. **PMID:** 33523352 **Citation:** Middel C, Stetzuhn M, Sander N, Kalkbrenner B, Tigges T, Pielmus AG, Spies C, Pietzner K, Klum M, von Haefen C, Hunsicker O, Sehouli J, Konietschke F, Feldheiser A. Perioperative advanced haemodynamic monitoring of patients undergoing multivisceral debulking surgery: an observational pilot study. Intensive Care Med Exp. 2023 Sep 8;11(1):61. doi: 10.1186/s40635-023-00543-1. **PMID:** 37682496 **Citation:** Feldheiser A, Juhl-Olsen P, Nordine M, Stetzuhn M, Wiegank L, Knebel F, Treskatsch S, Berger C. A comprehensive echocardiographic analysis during simulated hypovolaemia: An observational study. Eur J Anaesthesiol. 2023 Aug 1;40(8):578-586. doi: 10.1097/EJA.0000000000001863. Epub 2023 Jun 1. **PMID:** 37265333 ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421168 **Brief Title:** Lung Function in Bariatric Surgery Candidates **Official Title:** The Impact of Body Mass Index on Lung Function in Bariatric Surgery Candidates #### Organization Study ID Info **ID:** CJBariatric006 #### Organization **Class:** OTHER **Full Name:** China-Japan Friendship Hospital ### Status Module #### Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-08-31 **Type:** ACTUAL #### Start Date **Date:** 2017-09-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** China-Japan Friendship Hospital #### Responsible Party **Investigator Affiliation:** China-Japan Friendship Hospital **Investigator Full Name:** Yuntao Nie **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aims to retrospectively investigate the impact of body mass index on lung function metrics, e.g. FEV1%, FVC%, FEV1/FVC%. ### Conditions Module **Conditions:** - Lung Function Decreased - Obesity ### Design Module #### Design Info **Observational Model:** CASE_CROSSOVER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 1834 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Class 1 obesity: 27.5 kg/m2 \< body mass index \< 32.5 kg/m2; Class 2 obesity: 32.5 kg/m2 \< body mass index \< 37.5 kg/m2; Class 2 obesity: body mass index \> 37.5 kg/m2. **Measure:** FEV1, FVC, FEV1/FVC% in class 1, 2, and 3 obesity **Time Frame:** At the time of pulmonary function testing ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects with obesity (BMI ≥ 27.5 kg/m2 according to Chinese guidelines, guidelines from the American Society for Metabolic and Bariatric Surgery and International Federation for the Surgery of Obesity and Metabolic Disorders); * Age \> 16 years; * Complete preoperative pulmonary function tests Exclusion Criteria: * Patients with a history of lung surgery and/or respiratory diseases (e.g. asthma, pulmonary emphysema, and interstitial pulmonary fibrosis). **Minimum Age:** 16 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Bariatric surgery candidates who completed lung function tests preoperatively were enrolled. ### Contacts Locations Module #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** Yuntao Nie **Zip:** 100029 #### Overall Officials **Official 1:** **Affiliation:** China-Japan Friendship Hospital **Name:** Yuntao Nie, M.D. **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421155 **Brief Title:** Brain MRF in Children, Adolescents and Young Adults With Acute Leukemia **Official Title:** A Pilot Study of Brain Magnetic Resonance Fingerprinting in Children, Adolescents and Young Adults With Acute Leukemia #### Organization Study ID Info **ID:** CASE3923 #### Organization **Class:** OTHER **Full Name:** Case Comprehensive Cancer Center ### Status Module #### Completion Date **Date:** 2028-11-14 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-11-14 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Case Comprehensive Cancer Center #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The survival of children, adolescents and young adults (AYA) with acute leukemia has improved dramatically over the last two decades. This success is a result of using multiple chemotherapy drugs in combination, with the inclusion of drugs that enter the brain and prevent leukemia cells from growing there. Studies in these cancer survivors have shown that the exposure to these chemotherapy drugs can lead to risks for impaired brain function, also referred to as neurocognitive side effects of chemotherapy. There is an opportunity to identify participants at risk for these side effects and to prevent their development. The purpose of this study is to incorporate a brain imaging tool known as Magnetic Resonance Fingerprinting (MRF) to look for brain matter changes in acute leukemia participants receiving chemotherapy. The MRF scan will be performed at diagnosis and repeated at multiple times during the entire therapy duration as well as at defined intervals after therapy is complete. Investigators would also do an electronic test of memory and brain function (cognitive function), which would be administered in a gaming format on iPads or a similar device. The goal will be to correlate results of MRF imaging with the tests of cognitive function. The benefits of this imaging technique include that it can be done quickly (in minutes), it is non-invasive, it is resistant to motion-artifacts and it can be easily repeated for comparison purposes. The advantages of the cognitive test include its short duration of 20 minutes and its gaming format making it friendly for children to use. **Detailed Description:** Acute leukemia (AL), including Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML) and myeloproliferative neoplasms (MPN) are among the most common childhood cancers, the 5-year overall survival of children with leukemia has significantly improved with the current treatment methods, and is now \~90 % for ALL participants and \~70 % for AML participants. There has been a remarkable shift in the treatment strategy for childhood acute leukemia to reduce the burden of therapy related complications. Most notably, the addition of central nervous system (CNS)-directed, intensified intravenous and intrathecal chemotherapy regimens for most standard risk participants has obviated the need for craniospinal radiation therapy (CRT), thus reserving CRT for high-risk participants. With the improved overall survival rates, there is an increasing focus on characterizing and mitigating the long-term effects of the disease and therapy that may affect the quality of life of these participants. The results of multiple studies have indicated that the long-term survivors of ALL and AML experience varying degrees of neurocognitive deficits including memory loss, poor concentration, deficits in executive functioning and personality changes5-9. Methotrexate which is an important chemotherapeutic agent in the treatment of acute leukemia is known to cause chemotherapy induced cognitive impairment (CICI), by causing complex glial dysfunction leading to disruption of activity-dependent myelination in the CNS. Studies designed to characterize normal brain development in early childhood have not only contributed significantly to our understanding of healthy neurodevelopment, but have also helped to identify neurodevelopmental problems at an early stage, enabling the application of treatment interventions in a timely fashion. Although magnetic resonance imaging (MRI) has been used for this purpose, its application has been hampered by several limitations including the sensitivity to motion artifact, the length of time required to perform a scan, and the requirement for sedation for younger participants. These limitations can be overcome using a new technology known as magnetic resonance fingerprinting (MRF), which allows for rapid, efficient and simultaneous quantification of multiple tissue properties, and quantifies T1, T2 and Myelin Water Fraction (MWF) simultaneously. Sedation is not necessary since whole brain MRF imaging takes approximately 5 minutes to complete and is resistant to motion artifacts. These properties position MRF for use to assess multiple tissue properties in both pediatric and AYA participants diagnosed with acute leukemia, before, during and after exposure to CNS directed chemotherapy. The investigator proposes to use MRF to monitor demyelination, which has been documented as an underlying mechanism contributing to the long-term neurocognitive deficits seen in participantsundergoing chemotherapy. The goal of using MRF in this context is that it might ultimately serve as a valuable imaging biomarker that would enable early detection of the participants that are at an increased risk of developing neurocognitive deficits due to exposure to anti-neoplastic chemotherapy, by detecting the myelin changes as defined by MRF quantification of myelin water fraction. The capacity for detection would facilitate development of early interventions for these high-risk participants, so that their quality of life can be preserved as much as possible. The study will evaluate the feasibility of obtaining MRF imaging data along with assessments of neurocognitive function. Chanages/decline in neurocognitive function in pediatric participants undergoing treatment for acute leukemia have been tested, validated and reported by the Children's Oncology Group using a battery of assessment developed by Cogstate®. The computerized cognitive tests are rapid, reliable, and have demonstrated sensitivity to drug related changes in cognition. The tests have been designed and validated to withstand operational challenges during the conduction of clinical trials. The data system is HIPAA compliant U.S. FDA Class II Exempt Digital Medical Device. ### Conditions Module **Conditions:** - Acute Leukemia - Acute Lymphoblastic Leukemia, Pediatric - Acute Myeloid Leukemia in Children - Myeloproliferative Neoplasm **Keywords:** - Acute Leukemia Children - Acute Leukemia Adolescents - Acute Leukemia Young Adults ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Once the participants meeting the inclusion criteria are identified and formally consent to participate in the study, each participant will undergo a baseline MRF imaging exam along with the neurocognative testing, preferably prior to starting induction chemotherapy. The total treatment duration for an individual participant can vary anywhere between 6 months - 3 years depending on the type of acute leukemia, so investigator plans to obtain MRF scans every 6 months during the therapy as well as during the first year of the off -therapy period **Intervention Names:** - Other: MRF with neurocognative studies **Label:** MRF +/-Neurocognitive Testing **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - MRF +/-Neurocognitive Testing **Description:** Magnetic Resonance Imaging is used to assess the risk of neurocognitive side effects in pediatric and AYA patients with acute leukemia receiving chemotherapy and participants will also be asked to complete a neurocognitive battery designed by Cogstate and administered on iPad in a simple gaming format **Name:** MRF with neurocognative studies **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Cognitive assessment using Cogstate software **Measure:** Incidence of brain tissue changes using neurocognitive testing **Time Frame:** Baseline, every 6 months during the duration of therapy(up to 3.5 years), and every 6 months during the first year of the off-therapy period. #### Primary Outcomes **Description:** Mean myelin water fraction is measured by Student's T-test. The two-tailed means comparison will be considered statistically significant if a p-value of less than 0.5 is observed. **Measure:** Incidence of alterations in brain structure as measured by mean myelin water fraction **Time Frame:** Baseline and during chemotherapy(up to 3.5 years) #### Secondary Outcomes **Description:** Brain tissue property maps assessed using MRF scans **Measure:** Incidence of change in tissue evaluation using brain property mapping **Time Frame:** Baseline, every 6 months during the duration of therapy(up to 3.5 years), and every 6 months during the first year of the off-therapy period. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age range: 0 - 30 years * Participants from University Hospitals Rainbow Babies \& Children's Hospital, UH Seidman Cancer Center, and participants referred from outside facilities diagnosed with acute leukemia. * Meets diagnostic criteria for acute leukemia including acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML) and myeloproliferative neoplasm/leukemia. * Participants must have the ability to understand and the willingness to sign a written informed consent document. Participants who are 14 years and older must have the ability to understand and the willingness to sign a written informed consent document. Participants who are between the ages of 7 to 13 will be given an information sheet that explains the study to them. The information sheet may be used for study participants between the ages of 14-17 if it would better inform the child about the nature and procedures that will undergo as a participant in the study. Exclusion Criteria: * Individuals that are \>2 weeks into the induction chemotherapy for acute leukemia. * Individuals with either a heart pacemaker, heart defibrillator, metal in the eye, some types of metal elsewhere within the body such as certain surgical clips for aneurysms in the head, heart valve prostheses, electrodes, some other implanted devices, or any other MRI contraindication **Maximum Age:** 30 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Mari.dallas@uhhospitals.org **Name:** Mari Dallas, MD **Phone:** 216-844-6223 **Role:** CONTACT #### Locations **Location 1:** **City:** Cleveland **Contacts:** ***Contact 1:*** - **Email:** Mari.dallas@uhhospitals.org - **Name:** Mari Dallas, MD - **Phone:** 216-844-6223 - **Role:** CONTACT ***Contact 2:*** - **Name:** Mari Dallas, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University Hospitals Cleveland Medical Center, Rainbow Babies & Children's Hospital, Case Comprehensive Cancer Center **State:** Ohio **Zip:** 44106 #### Overall Officials **Official 1:** **Affiliation:** University Hospitals Cleveland Medical Center, Rainbow Babies & Children's Hospital, Case Comprehensive Cancer Center **Name:** Mari Dallas, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Study team will only have access to submit data **Description:** Clinical diagnosis, treatment, MRI/MRF and neurocognitive testing **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** Data will be provided within 12 months from study completion and for at least 6 years after study closure. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases - ID: D000007945 - Term: Leukemia, Lymphoid - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000008206 - Term: Lymphatic Diseases - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000001855 - Term: Bone Marrow Diseases ### 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: M27585 - Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma - Relevance: HIGH - As Found: Acute Lymphoblastic Leukemia - ID: M10951 - Name: Leukemia, Lymphoid - Relevance: LOW - As Found: Unknown - ID: M10955 - Name: Leukemia, Myeloid - Relevance: LOW - As Found: Unknown - ID: M18127 - Name: Leukemia, Myeloid, Acute - Relevance: LOW - As Found: Unknown - ID: M12149 - Name: Myeloproliferative Disorders - Relevance: HIGH - As Found: Myeloproliferative Neoplasms - ID: M11220 - Name: Lymphoma - Relevance: LOW - As Found: Unknown - ID: M3564 - Name: Acute Disease - Relevance: HIGH - As Found: Acute Leukemia - 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: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M5134 - Name: Bone Marrow Diseases - Relevance: LOW - As Found: Unknown - ID: T3995 - Name: Myeloid Leukemia - Relevance: LOW - As Found: Unknown - ID: T182 - Name: Acute Myeloid Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T175 - Name: Acute Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Lymphoblastic Leukemia - ID: T3533 - Name: Lymphoblastic Lymphoma - Relevance: LOW - As Found: Unknown - ID: T188 - Name: Acute Non Lymphoblastic Leukemia - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: HIGH - As Found: Acute - ID: T1311 - Name: Chronic Myeloproliferative Disorders - Relevance: HIGH - As Found: Myeloproliferative Neoplasms - ID: T1134 - Name: Childhood Acute Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Lymphoblastic Leukemia, Pediatric - ID: T3543 - Name: Lymphosarcoma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000054198 - Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma - ID: D000009196 - Term: Myeloproliferative Disorders - ID: D000000208 - Term: Acute Disease ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421142 **Brief Title:** FAPI and FDG PET/MRI in Diagnosis and Therapy Prediction of Bladder Cancer **Official Title:** Application Research of FAPI Positron Emission Tomography(PET)/MRI, 18F-Fluorodeoxyglucose (FDG) PET/MRI, and MRI in the Diagnosis of Muscular Invasive Bladder Cancer and Evaluation of Neoadjuvant Therapy Efficacy #### Organization Study ID Info **ID:** 2024-041-02 #### Organization **Class:** OTHER **Full Name:** First Affiliated Hospital of Fujian Medical University ### Status Module #### Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **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:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** First Affiliated Hospital of Fujian Medical University #### Responsible Party **Investigator Affiliation:** First Affiliated Hospital of Fujian Medical University **Investigator Full Name:** Ning Xu **Investigator Title:** Deputy Director of Department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The aim of this trial is to investigate the value of FAPI PET/MRI, FDG PET/MRI and MRI in diagnosing MIBC and predicting the efficacy of neoadjuvant therapy for MIBC patients, so as to guide the clinic to adjust the treatment plan in time and benefit MIBC patients. **Detailed Description:** The MIBC diagnostic study was a prospective trial. According to the inclusion and exclusion criteria, patients with suspected MIBC were enrolled and underwent FAPI PET/MRI, FDG PET/MRI and MRI examination, and the imaging data and clinical laboratory and pathologic data were collected, and the postoperative pathological results were used as the gold standard to compare the accuracy of FAPI PET/MRI, FDG PET/MRI and MRI in diagnosing MIBC. The MIBC neoadjuvant therapy efficacy assessment study was a prospective trial. Patients with MIBC were enrolled according to the inclusion and exclusion criteria, the regimen was selected individually according to the patient's condition, and the indicators were followed up until the end of time or the occurrence of an endpoint event to obtain information on survival time. FAPI PET/MRI, FDG PET/MRI and MRI were performed once before the start of neoadjuvant therapy and once after the end of therapy, and after the end of neoadjuvant therapy, patients received transurethral cystectomy of bladder tumors or radical cystectomy according to the efficacy and condition, and the combination of the imaging data and the clinical laboratory and pathological data were used to compare FAPI PET/MRI, FDG PET/ MRI and MRI in the assessment of the efficacy of neoadjuvant therapy in MIBC patients to guide clinical treatment options. ### Conditions Module **Conditions:** - Urinary Bladder Neoplasms **Keywords:** - Neoadjuvant Chemotherapy - Neoplasm Staging ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** In the MIBC diagnostic study and neoadjuvant efficacy prediction study, each patient underwent FAPIPET/MRI, FDGPET/MRI and MRI examinations, and were grouped and analyzed according to different examination methods. ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** suspected MIBC participants receive FAPI PET/MRI examination after entering the group. **Intervention Names:** - Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI **Label:** MIBC diagnostic study-FAPI PET/MRI **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** suspected MIBC participants receive FDG PET/MRI examination after entering the group. **Intervention Names:** - Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI **Label:** MIBC diagnostic study-FDG PET/MRI **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** suspected MIBC participants receive MRI examination after entering the group. **Intervention Names:** - Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI **Label:** MIBC diagnostic study-MRI **Type:** ACTIVE_COMPARATOR #### Arm Group 4 **Description:** Patients diagnosed with MIBC receive FAPI PET/MRI examination before and after neoadjuvant therapy. **Intervention Names:** - Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI **Label:** MIBC neoadjuvant evaluation study-FAPI PET/MRI **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** Patients diagnosed with MIBC receive FDG PET/MRI examination before and after neoadjuvant therapy. **Intervention Names:** - Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI **Label:** MIBC neoadjuvant evaluation study-FDG PET/MRI **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** Patients diagnosed with MIBC receive MRI examination before and after neoadjuvant therapy. **Intervention Names:** - Procedure: imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI **Label:** MIBC neoadjuvant evaluation study-MRI **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - MIBC diagnostic study-FAPI PET/MRI - MIBC diagnostic study-FDG PET/MRI - MIBC diagnostic study-MRI - MIBC neoadjuvant evaluation study-FAPI PET/MRI - MIBC neoadjuvant evaluation study-FDG PET/MRI - MIBC neoadjuvant evaluation study-MRI **Description:** FAPI PET/MRI and FDG PET/MRI examination Data acquisition was performed using a GE Healthcare SIGNA PET/MR instrument. Enrolled patients were injected intravenously with 68Ga-FAPI or 18F-FDG tracer and underwent simultaneous PET and MRI scanning approximately 30-60 minutes after intravenous administration of the tracer at a dose of 1.85-3.7 MBq/kg. MRI examination MRI examination was performed using a Skyra 3.0T MRI scanner from Siemens, Germany, with a 16-channel phased-array surface coil, and the scanning range was from the superior margin of the iliac wing to the inferior margin of the pubic symphysis. **Name:** imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** It is the percentage of patients who will be correctly judged as positive (true positive) if they actually have muscle invasive bladder cancer. The formula is TP/(TP+FN)×100%.TP is true positive and FN is false negative. **Measure:** Diagnostic Sensitivity **Time Frame:** Within 1 week after obtaining the surgical pathology report and imaging report results **Description:** the percentage of patients who are not actually suffering from muscle invasive bladder cancer correctly judged as negative (true negative). The formula is TN/(TN+FP)×100%.TN is true negative, FP is false positive. **Measure:** Diagnostic Specificity **Time Frame:** Within 1 week after obtaining the surgical pathology report and imaging report results **Description:** the ratio of true positives among the positive results obtained by a specific test method. The formula is: PPV=TP/(TP+FP)×100%. **Measure:** Positive Expected Value (PPV) **Time Frame:** Within 1 week after obtaining the surgical pathology report and imaging report results **Description:** refers to the ratio of true negatives among the negative results obtained by a specific test method. The formula is: NPV=TN/(TN+FN)×100%. **Measure:** Negative Expected Value (NPV) **Time Frame:** Within 1 week after obtaining the surgical pathology report and imaging report results **Description:** the ratio of the probability that a patient who actually has muscle invasive bladder cancer is judged to be positive to the probability that a patient who actually does not have muscle invasive bladder cancer is judged to be positive. The formula was calculated as +LR = sensitivity/(1-specificity) × 100%. **Measure:** Positive Likelihood Ratio (PLR) **Time Frame:** Within 1 week after obtaining the surgical pathology report and imaging report results **Description:** the ratio of the probability that a patient who actually has muscle invasive bladder cancer is judged negative to the probability that a patient who actually does not have muscle invasive bladder cancer is judged negative. The formula is: -LR=(1-sensitivity)/specificity×100%. **Measure:** Negative Likelihood Ratio (NLR) **Time Frame:** Within 1 week after obtaining the surgical pathology report and imaging report results **Description:** the sum of sensitivity and specificity minus 1. Correct diagnostic index can be used for the comparison of two diagnostic methods, and the ideal correct diagnostic index is 100%. r = (specificity + sensitivity) - 1 = 1 - (false positive rate + false negative rate) **Measure:** Youden Index **Time Frame:** Within 1 week after obtaining the surgical pathology report and imaging report results **Description:** changes in SUVmax, SUVmean, and SUVpeak of the tumor lesion before and after treatment obtained from PET/MRI images. **Measure:** Standardized uptake values peak, maximum, and mean (SUVpeak , SUVmax, SUVmean) **Time Frame:** Within 1 week after obtaining the surgical pathology report and imaging report results **Description:** changes in the ratio of the radioactivity of tumor tissue to the radioactivity of background tissue obtained from PET/MRI images before and after treatment. **Measure:** Tumor-to-Background Ratio (TBR) **Time Frame:** Within 1 week after obtaining the surgical pathology report and imaging report results **Description:** In RECIST 1.1 Efficacy assessment criteria for conventional imaging, CR was defined as the disappearance of all target lesions, the absence of new lesions, and the normalization of tumor markers for at least 4 weeks. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, CR refers to the complete disappearance of tracer uptake. **Measure:** Complete Remission (CR) **Time Frame:** Within 1 month after obtaining the surgical pathology report and imaging report results **Description:** In RECIST 1.1 Efficacy assessment criteria for conventional imaging, PR was defined as a decrease of ≥30% in the sum of the largest diameters of target lesions for at least 4 weeks. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, PR refers to a decrease of \>30% in the peak SUV. **Measure:** Partial Remission (PR) **Time Frame:** Within 1 month after obtaining the surgical pathology report and imaging report results **Description:** In RECIST 1.1 Efficacy assessment criteria for conventional imaging, SD was defined as a decrease in the sum of the largest diameters of the target lesions that did not reach PR or an increase in the size of the largest diameters of target lesions that did not reach PD. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, SD refers to a decrease of \>30% in the peak SUV. **Measure:** Stable Disease (SD) **Time Frame:** Within 1 month after obtaining the surgical pathology report and imaging report results **Description:** In RECIST 1.1 Efficacy assessment criteria for conventional imaging, PD was defined as an increase in the sum of the largest diameters of the target lesions by at least ≥20% or the emergence of new lesions. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, PD refers to an increase of \>30% in the peak SUL or the appearance of new lesions. **Measure:** Progressive Disease (PR) **Time Frame:** Within 1 month after obtaining the surgical pathology report and imaging report results **Description:** For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, CMR refers to the complete disappearance of tracer uptake. **Measure:** Complete Metabolic Response (CMR) **Time Frame:** Within 1 month after obtaining the surgical pathology report and imaging report results **Description:** For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, PMR refers to a reduction in SUV of ≥15%-25% after one cycle of treatment and a reduction in SUV of \>25% after greater than one cycle of treatment. **Measure:** Partial Metabolic Response (PMR) **Time Frame:** Within 1 month after obtaining the surgical pathology report and imaging report results **Description:** For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, SMD refers to an increase in SUV of \<25% or a decrease of \<15%, and tumor no significant increase in the extent of uptake (\>20% increase in maximum diameter) **Measure:** Stable Metabolic Disease (SMD) **Time Frame:** Within 1 month after obtaining the surgical pathology report and imaging report results **Description:** For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, PMD refers to an increase in SUV value of \>25% and a significant increase in the extent of tumor uptake (increase in the largest diameter of \>20%), or the appearance of new foci. **Measure:** Progressive Metabolic Disease (PMD) **Time Frame:** Within 1 month after obtaining the surgical pathology report and imaging report results **Description:** According to pathological efficacy assessment criteria, Pathological Complete Remission(pCR) refers to no detectable tumor (pT0) or residual cancer confined to the original site (pTis) after treatment. According to pathological efficacy assessment criteria, A decrease in tumor stage from cT2 (Muscle-Invasive Bladder Cancer - MIBC) to non-muscle-invasive bladder cancer (NMIBC), including stages pT0, pTis, pTa, and pT1, indicates a treatment-sensitive tumor and is considered a good pathologic response. Conversely, if the tumor stage remains the same or increases, it is considered a poor pathologic response. **Measure:** Pathologic Response **Time Frame:** Within 1 month after obtaining the surgical pathology report and imaging report results #### Secondary Outcomes **Description:** the duration from the time a patient receives systemic therapy to the time of death from any cause. **Measure:** Overall Survival (OS) **Time Frame:** 1 years to 3 years after receiving treatment **Description:** the duration from the start of treatment to the occurrence of imaging progression or death due to any cause (whichever occurs first). Conventional imaging (RECIST 1.1 criteria), and FAPI PET/MRI (PERCIST 1.0 criteria) were used to assess the imaging progression of patients after receiving treatment, respectively. **Measure:** Radiographic Progression Free Survival (rPFS) **Time Frame:** 1 years to 3 years after receiving treatment **Description:** usually includes patient cases with CR+PR. Among them, conventional imaging was used to assess the proportion of patients meeting the criteria for CR or PR using the RECIST 1.1 criteria; FAPI PET/MRI was used to assess the proportion of patients meeting the criteria for CR or PR using the PERCIST 1.0 criteria; **Measure:** Overall Remission Rate (Objective Response Rate, ORR) **Time Frame:** Within 1 month after obtaining the surgical pathology report and imaging report results **Description:** usually includes the proportion of patients with CR+PR+SD. Among them, conventional imaging uses RECIST 1.1 criteria to assess the proportion of patients meeting the criteria of CR or PR or SD; FAPI PET/MRI uses PERCIST 1.0 criteria to assess the proportion of patients meeting the criteria of CR or PR or SD. **Measure:** Disease Control Rate (DCR) **Time Frame:** Within 1 month after obtaining the surgical pathology report and imaging report results ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Inclusion criteria for MIBC diagnostic studies 1. Patients with suspected muscle-invasive bladder cancer; 2. Completion of FAPI PET/MRI, FDG PET/MRI and MRI; 3. Complete clinical laboratory and pathological data. * Inclusion criteria for MIBC neoadjuvant therapy efficacy evaluation study 1. Patients diagnosed with muscle invasive bladder cancer; 2. Completion of FAPI PET/MRI, FDG PET/MRI, and MRI before neoadjuvant therapy; 3. Complete clinical laboratory and pathological data. Exclusion Criteria: * Exclusion criteria for MIBC diagnostic study 1. Combined with other malignant tumors; 2. Not receiving surgical treatment; 3. Receiving neoadjuvant therapy before surgery; 4. Previous allergy to contrast components or similar components; 5. Serious organ function abnormalities, such as heart, lung, liver, kidney function serious abnormalities; 6. Incomplete clinicopathological data * Exclusion criteria of MIBC neoadjuvant therapy efficacy evaluation study 1. Combination of other malignant tumors; 2. FAPI PET/MRI, FDG PET/MRI and MRI were not completed after neoadjuvant therapy; 3. Prior hypersensitivity to contrast components or similar components; 4. Serious organ function abnormalities, such as serious abnormalities of heart, lung, liver and kidney function; 5. Incomplete clinicopathological data. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** drxun@fjmu.edu.cn **Name:** Ning Xu, Doctor **Phone:** 13235907575 **Phone Ext:** 0086 **Role:** CONTACT **Contact 2:** **Email:** lixiaodong@fjmu.edu.cn **Name:** Xiao-Dong Li, Master **Phone:** 15980273075 **Phone Ext:** 0086 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** First Affiliated Hospital of Fujian Medical University **Name:** Xue-Yi Xue, Master **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** We have chosen not to share the individual participant data (IPD) from this clinical study due to privacy and confidentiality concerns, as well as potential proprietary interests. Additionally, sharing IPD requires considerable resources for data de-identification and preparation, which may not be feasible within the scope of this study. However, we remain committed to transparency and will provide summary results and findings through appropriate channels, ensuring the dissemination of key insights while safeguarding participant privacy and confidentiality **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - 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: 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: Urinary Bladder Neoplasms - 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 ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21686 - Name: Fluorodeoxyglucose F18 - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421129 **Brief Title:** Identifying Landmark Factors of Anal Fistulas **Official Title:** Identifying Landmark Factors of Anal Fistulas Through Predictive Modeling for Adverse Surgical Outcomes: a Retrospective Cohort Study #### Organization Study ID Info **ID:** Number: 2024【546】 #### Organization **Class:** OTHER **Full Name:** First Hospital of China Medical University ### Status Module #### Completion Date **Date:** 2024-02-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-02-01 **Type:** ACTUAL #### Start Date **Date:** 2020-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Guanlin Liu #### Responsible Party **Investigator Affiliation:** First Hospital of China Medical University **Investigator Full Name:** Guanlin Liu **Investigator Title:** Principal Investigator **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this observational study is to understand the effects of anatomical factors, etiology, and complexity of anal fistula on the prognosis of patients undergoing anal fistula surgery within one year post-operation.The main question it aims to answer is: Which factors are indicative of the prognosis of anal fistula surgery? Which factors are landmark factors of anal fistulas? Participants who have already undergone anal fistula surgery at our hospital will receive outpatient and telephone follow-up to assess their prognosis. **Detailed Description:** The search function of the electronic medical record system and surgical records were used to screen patients. For the enrolled patients, the electronic medical record system, imaging report query system, medical order system, outpatient follow-up and telephone follow-up were used to collect data Data were entered into Excel 2021 (Microsoft Corp., Redmond, WA, USA) and checked for errors before conducting statistical analyses using R software (version 4.2.2; The R Foundation, Vienna, Austria). ### Conditions Module **Conditions:** - Anal Fistulas - Anal Fistula **Keywords:** - anal fistula - perianal and rectal spaces - surgery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 326 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A good prognosis within 1-year post-surgery was defined as healing of the internal and external openings of the fistula, no recurrence of the fistula, no secondary perianal infection, no symptoms of incontinence, no persistent pain, and the ability of the patient to perform activities independently **Intervention Names:** - Procedure: anal fistula surgery **Label:** good prognosis #### Arm Group 2 **Description:** outcomes that did not meet good prognosis criteria indicated a poor prognosis **Intervention Names:** - Procedure: anal fistula surgery **Label:** poor prognosis ### Interventions #### Intervention 1 **Arm Group Labels:** - good prognosis - poor prognosis **Description:** anal fistula surgery consists of;Fistulotomy and Fistulotomy with seton placement **Name:** anal fistula surgery **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Electronic medical record collection **Measure:** history of perianal abscess and fistula **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Electronic medical record collection **Measure:** Age **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Hypertension, heart disease and diabetes (Electronic medical record collection) **Measure:** History of underlying diseases **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive. **Measure:** perianal and perirectal space involvement-perianal subcutaneous space **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive. **Measure:** perianal and perirectal space involvement-Posterior superficial anal space **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive. **Measure:** perianal and perirectal space involvement-Deep posterior anal space **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive. **Measure:** perianal and perirectal space involvement-Anterior superficial anal space **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive. **Measure:** perianal and perirectal space involvement-Deep anterior anal space **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive. **Measure:** perianal and perirectal space involvement-Submucosal space **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive. **Measure:** perianal and perirectal space involvement-Intersphincteric anal space **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Electronic medical record collection **Measure:** Fistula origin **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the anal sphincters was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive. **Measure:** fistula traversal through the internal and external sphincters **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Preoperative imaging examination data, electronic medical and record-surgery records were collected.The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive. **Measure:** perianal and perirectal space involvement-Ischioanal space **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive. **Measure:** perianal and perirectal space involvement-Ischiorectal space **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Preoperative imaging examination data, electronic medical and record-surgery records were collected. The extent of anal fistula invasion into the perianal and rectal spaces was assessed based on preoperative imaging examinations and observations made during surgery. All surgical procedures were performed and documented by Associate Chief Physicians in our department. In cases in which the intraoperative findings differed from the imaging results, the findings observed during surgery were considered definitive. **Measure:** perianal and perirectal space involvement-Pelvirectal space **Time Frame:** between 1 January 2020 and 1 February 2023 #### Secondary Outcomes **Description:** Electronic medical record collection **Measure:** Sex **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Electronic medical record collection **Measure:** Duration of preoperative symptoms **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Electronic medical record collection **Measure:** Smoking history **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Electronic medical record collection **Measure:** Anesthesia method **Time Frame:** between 1 January 2020 and 1 February 2023 **Description:** Electronic medical record collection **Measure:** Alcohol history **Time Frame:** between 1 January 2020 and 1 February 2023 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients diagnosed with an anal fistula through clinical and radiological examinations; surgeries performed by physicians at our hospital who had at least a title of Associate Chief Physician, with operative records completed after surgery; patients with complete clinical data; and patients who completed post-operative outpatient follow-up and agreed to participate in telephone follow-up surveys. Exclusion Criteria: * Patients who were assessed clinically as unable to tolerate surgery; patients who refused surgical treatment; and patients who failed to complete the outpatient follow-up, refused telephone follow-up, or were lost to follow-up. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** This retrospective cohort study was conducted at The First Affiliated Hospital of China Medical University ### Contacts Locations Module #### Locations **Location 1:** **City:** Shenyang **Country:** China **Facility:** The First Affiliated Hospital of China Medical University **State:** Liaoning **Zip:** 110001 #### Overall Officials **Official 1:** **Affiliation:** First Hospital of China Medical University **Name:** Qiang Meng **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Access Criteria:** This study contains clinical data from medical records in our hospital. The datasets used and/or analysed during the current study are available from the study leader on reasonable request. **Description:** All IPD that underlie results in a publication **Info Types:** - STUDY_PROTOCOL - SAP - ICF **IPD Sharing:** YES **Time Frame:** Six months after the completion of the experiment **URL:** https://clinicaltrials.gov ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000007412 - Term: Intestinal Fistula - ID: D000016154 - Term: Digestive System Fistula - ID: D000004066 - Term: Digestive System Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M8532 - Name: Fistula - Relevance: HIGH - As Found: Fistula - ID: M14845 - Name: Rectal Fistula - Relevance: HIGH - As Found: Anal Fistula - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M10446 - Name: Intestinal Fistula - Relevance: LOW - As Found: Unknown - ID: M18616 - Name: Digestive System Fistula - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012003 - Term: Rectal Fistula - ID: D000005402 - Term: Fistula ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421116 **Acronym:** ORGANOSPA **Brief Title:** Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis **Official Title:** Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis #### Organization Study ID Info **ID:** 6378 #### Organization **Class:** OTHER **Full Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-07 **Type:** ACTUAL **Status Verified Date:** 2024-02 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-02-09 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This project aims to develop and validate a model of human organoids derived from patients with Spondyloarthritis, focusing on synovial and intestinal tissues as targets of the gut-joint axis. The tissue marker profile of patient-derived organoids studied by gene expression, immunohistochemistry, and cytokine production profile will be compared with that of controls in order to test for the presence of specific biomarkers. ### Conditions Module **Conditions:** - Spondyloarthritis - Inflammatory Bowel Diseases ### Design Module #### Bio Spec **Description:** Synovial biopses and intestinal biopses **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Patients will undergo biopsies if needed for standard-of-care follow-up and after clinical indication. **Name:** Synovial ultrasound-guided biopsy Intestinal biopsy **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** Fibroblast-like synoviocytes (FLS) will be dispensed into a well of a Fluorobook invasion plate. The fluorescence will be measured as an index of FLS invasion capacity in the presence of a basement membrane extract. **Measure:** Invasion capacity assessment (synovial organoids) **Time Frame:** 24 months #### Primary Outcomes **Description:** The viability of organoids will be determined using an adenosine triphosphate (ATP) detection assay based on luminescence using a commercially available luciferase. **Measure:** Viability assessment **Time Frame:** 24 months #### Secondary Outcomes **Description:** The production of cytokines in the culture supernatant of organoids will be evaluated using enzyme-linked immunosorbent assay (ELISA) **Measure:** Production of pro-inflammatory cytokines **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * More than 18 years of age; * Ability to understand and sign an informed consent form; * Clinical indication for intestinal and/or synovial biopsy; * Only for SpA patients group: meeting ASAS classification criteria. Exclusion Criteria: * Actively treated cancer; * Severe comorbidities that, in the investigator\&#39;s opinion, may affect the quality of samples for planned experimental applications; * Only for patients undergoing ileal-colic biopsy: history of colorectal cancer disease, celiac disease; * Only for patients undergoing a synovial biopsy: septic arthritis. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients affected by Spondyloarthtitis. Controls with inflammatory or non-inflammatory conditions. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mariaantoniettadagostino@policlinicogemelli.it **Name:** Maria Antonietta D'Agostino, Professor **Phone:** +390630157807 **Role:** CONTACT **Contact 2:** **Email:** gerlando.natalello1@guest.policlinicogemelli.it **Name:** Gerlando Natalello, Dr **Phone:** +390630157807 **Role:** CONTACT #### Locations **Location 1:** **City:** Rome **Contacts:** ***Contact 1:*** - **Email:** mariaantoniettadagostino@policlinicogemelli.it - **Name:** Maria Antonietta D'Agostino, Professor - **Phone:** +390630157807 - **Role:** CONTACT ***Contact 2:*** - **Name:** Maria Antonietta D'Agostino, Professor - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Gerlando Natalello, Dr - **Role:** SUB_INVESTIGATOR **Country:** Italy **Facility:** Fondazione Policlinico Universitario A. Gemelli IRCCS **State:** RM **Status:** RECRUITING **Zip:** 00168 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000005759 - Term: Gastroenteritis - ID: D000001850 - Term: Bone Diseases, Infectious - ID: D000007239 - Term: Infections - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000013122 - Term: Spinal Diseases - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M15961 - Name: Spondylitis - Relevance: HIGH - As Found: Spondyloarthritis - ID: M17917 - Name: Inflammatory Bowel Diseases - Relevance: HIGH - As Found: Inflammatory Bowel Disease - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M23035 - Name: Spondylarthritis - Relevance: HIGH - As Found: Spondyloarthritis - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8875 - Name: Gastroenteritis - 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: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M5129 - Name: Bone Diseases, Infectious - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000013166 - Term: Spondylitis - ID: D000025241 - Term: Spondylarthritis - ID: D000015212 - Term: Inflammatory Bowel Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421103 **Brief Title:** Micro-dosing Indocyanine Green (ICG) in Children **Official Title:** Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment in Children. #### Organization Study ID Info **ID:** 23BO01 #### Organization **Class:** OTHER **Full Name:** Great Ormond Street Hospital for Children NHS Foundation Trust ### Status Module #### Completion Date **Date:** 2028-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-08 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-01-08 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Great Ormond Street Hospital for Children NHS Foundation Trust #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this cohort study is to identify the lowest dose of Indocyanine Green (ICG) that achieves satisfactory intra-operative fluorescence for the assessment of gastrointestinal or genitourinary tract perfusion in children. **Detailed Description:** Indocyanine Green (ICG) fluorescence-guided surgery (FGS) can be used to assess gastrointestinal and genitourinary tract perfusion intra-operatively. In adults, the use of ICG has been shown to improve surgical outcomes. ICG is safely used intra-operatively in children, but there is a lack of evidence regarding the lowest clinically useful dose of ICG. This is a single centre open-label dose escalation study that aims to: 1. identify the minimal clinically useful dose of ICG for intra-operative perfusion assessment in children (0 - 18 years old) 2. assess the safety profile of intra-operative ICG in children 3. characterise the intra-operative fluorescence of ICG in children ### Conditions Module **Conditions:** - Perfusion - Fluorescence Imaging - Gastrointestinal Tract Disorders - Genitourinary Disease **Keywords:** - Paediatric Surgery - Pediatric Surgery - Fluorescence - Imaging - Fluorescence Guided Surgery (FGS) - Intra-operative perfusion assessment - Indocyanine Green ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Dose escalation with backfilling. ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Multiple dose levels of intravenous Indocyanine Green (ICG) administered intra-operatively. Starting dose will be 10% of standard (for the study institution) and escalated as per protocol. **Intervention Names:** - Drug: Indocyanine Green (ICG) **Label:** Micro-dosing Indocyanine Green (ICG) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Micro-dosing Indocyanine Green (ICG) **Description:** Cohorts will receive 0.01 mg/kg, 0.02 mg/kg, 0.04mg/kg, 0.06 mg/kg, or 0.08 mg/kg intra-venous ICG at surgery. Patients will be consecutively allocated to different doses as per protocol. **Name:** Indocyanine Green (ICG) **Other Names:** - Verdye by DiagnosticGreen **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Identify the minimum dose of ICG at which intra-operative perfusion assessment is achieveable. Assessment will be based objectively on mean fluorescence intensity and the fluorescence-time curve, and subjectively by the operating surgeon. **Measure:** Minimum clinically useful dose of ICG in children **Time Frame:** 60 minutes (intra-operative) **Description:** An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product **Measure:** Number of adverse drug events at each dose level **Time Frame:** 30 days #### Secondary Outcomes **Description:** Intra-operative and early postoperative complications and mortality (defined as an event observed within 30 days after surgery). Frequency and details. **Measure:** Surgical complications **Time Frame:** 30 days **Description:** Further procedures, complications and mortality occuring within the 30 - 90 day time period (late post-operative complications). Frequency and details. **Measure:** Post-operative morbidity **Time Frame:** 90 days **Description:** Time in hospital post-procedure **Measure:** Length of stay **Time Frame:** 90 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Children aged ≤18 years of age * Elective surgery including gastrointestinal or genitourinary tract perfusion assessment Exclusion Criteria: * Renal and liver dysfunction * Active infection * Coagulopathy * Complex congenital heart defect * Previous documented allergy to ICG injection or other iodinated contrast agents * Patients suffering from hyperthyroidism or autonomic thyroid adenomas * Premature infants or neonates in whom exchange transfusion is indicated, due to the hyperbilirubinaemia risk * Concurrent use of sodium bisulphite-containing preparations, such as certain heparin preparations **Maximum Age:** 18 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** stefano.giuliani@gosh.nhs.uk **Name:** Stefano Giuliani **Phone:** 02074059200 **Phone Ext:** 0669 **Role:** CONTACT #### Locations **Location 1:** **City:** London **Contacts:** ***Contact 1:*** - **Email:** stefano.giuliani@gosh.nhs.uk - **Name:** Stefano Giuliani - **Phone:** 02074059200 - **Phone Ext:** 0669 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Great Ormond Street Hospital for Children **Status:** RECRUITING **Zip:** WC1N 3JH #### Overall Officials **Official 1:** **Affiliation:** Great Ormond Street Hospital **Name:** Stefano Giuliani **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: HIGH - As Found: Gastrointestinal Tract Disorders - ID: M7255 - Name: Digestive System Diseases - Relevance: HIGH - As Found: Gastrointestinal Tract Disorders - ID: M2875 - Name: Urogenital Diseases - Relevance: HIGH - As Found: Genitourinary Disease ### Condition Browse Module - Meshes - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000091642 - Term: Urogenital Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421090 **Acronym:** Vnstar-IIa **Brief Title:** Transauricular Vagal Nerve Stimulation Improves Postoperative Delirium in Elderly Patients **Official Title:** Safety and Feasibility of Transauricular Vagus Nerve Stimulation in Improving Postoperative Delirium in Elderly Patients: a Randomized Controlled Study #### Organization Study ID Info **ID:** VNS20240510IIa #### Organization **Class:** OTHER **Full Name:** Beijing Tiantan Hospital ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Tiantan Hospital #### Responsible Party **Investigator Affiliation:** Beijing Tiantan Hospital **Investigator Full Name:** Ruquan Han **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:** To investigate the efficacy and safety of perioperative Transauricular vagal nerve stimulation in improving Postoperative Delirium in elderly patients undergoing elective surgery Lay the groundwork for a Phase III study. **Detailed Description:** This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of Transauricular vagal nerve stimulation(taVNS) to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive taVNS, while the control group will only wear a taVNS stimulator without current stimulation. ### Conditions Module **Conditions:** - Vagus Nerve Stimulation ### 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:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: Transauricular Vagal Nerve Stimulation **Label:** Transauricular Vagal Nerve Stimulation **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Device: Transauricular Vagal Nerve Stimulation **Label:** Transauricular Vagal Nerve sham Stimulation **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Transauricular Vagal Nerve Stimulation - Transauricular Vagal Nerve sham Stimulation **Description:** Transauricular vagal nerve stimulation，Intervention group25Hz，Control group1Hz **Name:** Transauricular Vagal Nerve Stimulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The proportion of subjects who completed all the expected interventions **Measure:** TaVNS tolerance **Time Frame:** 1-5 days after surgery **Description:** Myocardial infarction, cardiac arrest, pulmonary embolism, infection, etc **Measure:** Incidence of adverse events **Time Frame:** At discharge，an average of 2 weeks #### Secondary Outcomes **Description:** POD assessment was performed using the 3D-CAM scale estimate. Assessed 2 times daily until postoperative day 5 or hospital discharge. **Measure:** Incidence of POD at discharge or within 5 days postoperatively **Time Frame:** At discharge or within 5 days postoperatively **Description:** The MMSE scale and MoCA scale was used for evaluation **Measure:** Incidence of cognitive decline **Time Frame:** Day 1 before surgery, day 5 after surgery, day 90 after surgery **Measure:** All-cause mortality **Time Frame:** on the 90 days **Description:** VAS score **Measure:** Postoperative pain **Time Frame:** 1-5 days after surgery **Measure:** Time of anesthesia recovery **Time Frame:** Within 2 hours after the end of the surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age≥65 years * Expected operation time≥ 2 hours * Postoperative hospital stay≥ 4 days * Sign the informed consent form Exclusion Criteria: * Neurosurgery or cardiac surgery * Emergency surgery within 6 hours of admission * End-stage disease with an expected survival of \< 3 months * Preoperative intention cognitive impairment * Severe sinus bradycardia, AVB of degree II and above, pacemaker placement **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ruquan.han@ccmu.edu.cn **Name:** Ruquan Han, MD **Phone:** 8610-59976660 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** ruquan.han@gmail.com - **Name:** Ruquan Han, M.D., Ph.D - **Phone:** 8610-59976660 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ruquan Han, M.D., Ph.D - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Beijing Tiantan Hospital, Capital Medical University **Status:** RECRUITING **Zip:** 100070 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003221 - Term: Confusion - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6894 - Name: Delirium - Relevance: HIGH - As Found: Delirium - ID: M772 - Name: Emergence Delirium - Relevance: HIGH - As Found: Postoperative Delirium - ID: M6446 - Name: Confusion - 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: 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: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003693 - Term: Delirium - ID: D000071257 - Term: Emergence Delirium ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421077 **Acronym:** Vnstar **Brief Title:** Transauricular Vagus Nerve Stimulation Improves Postoperative Delirium in Elderly Patients **Official Title:** Transauricular Vagus Nerve Stimulation（taVNS）Improves Postoperative Delirium in Elderly Patients: a Randomized Controlled Study #### Organization Study ID Info **ID:** VNS20240510 #### Organization **Class:** OTHER **Full Name:** Beijing Tiantan Hospital ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Tiantan Hospital #### Responsible Party **Investigator Affiliation:** Beijing Tiantan Hospital **Investigator Full Name:** Ruquan Han **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:** According to the 3D-CAM scale, evaluate the incidence of Postoperative Delirium within 5 days after surgery in elderly patients receiving Transauricular vagal nerve stimulation.The results are expected to provide evidence of the safety and efficacy of perioperative prophylactic use of taVNS in the clinical application of improving postoperative brain health in elderly patients, as well as theoretical and practical basis for subsequent studies or clinical applications. **Detailed Description:** This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of Transauricular vagal nerve stimulation to improve the incidence of Postoperative Delirium in elderly patients undergoing anesthesia surgery. The intervention group will receive taVNS, while the control group will only wear a taVNS stimulator without current stimulation. The main outcome measure of the study was the incidence of POD within 5 days after surgery. Secondary outcome measures include incidence of new mild and severe postoperative neurocognitive impairment during hospitalization and 90 days, all-cause mortality rate at 90 days, incidence of related adverse events, and length of stay. ### Conditions Module **Conditions:** - Vagus Nerve Stimulation ### 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:** 1438 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: Transauricular Vagal Nerve Stimulation **Label:** Transauricular Vagal Nerve Stimulation **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Device: Transauricular Vagal Nerve Stimulation **Label:** Transauricular Vagal Nerve sham Stimulation **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Transauricular Vagal Nerve Stimulation - Transauricular Vagal Nerve sham Stimulation **Description:** Transauricular vagal nerve stimulation **Name:** Transauricular Vagal Nerve Stimulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** POD assessment was performed using the 3D-CAM scale estimate. Assessed 2 times daily until postoperative day 5 or hospital discharge **Measure:** Incidence of POD at discharge or within 5 days postoperatively **Time Frame:** At discharge or within 5 days postoperatively #### Secondary Outcomes **Description:** The MMSE scale and MoCA scale was used for evaluation **Measure:** Incidence of cognitive decline **Time Frame:** Day 1 before surgery, day 5 after surgery, day 90 after surgery **Measure:** All-cause mortality **Time Frame:** on the 90 days **Measure:** Incidence of unplanned ICU or HDU admissions **Time Frame:** on the 90 days **Measure:** Length of hospital stay **Time Frame:** on the 90 days **Measure:** Time of anesthesia recovery **Time Frame:** Within 2 hours after the end of the surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age≥65 years * Expected operation time≥ 2 hours * Postoperative hospital stay≥ 4 days * Sign the informed consent form Exclusion Criteria: * Neurosurgery or cardiac surgery * Emergency surgery within 6 hours of admission * End-stage disease with an expected survival of \< 3 months * Preoperative intention cognitive impairment * Severe sinus bradycardia, AVB of degree II and above, pacemaker placement **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ruquan.han@ccmu.edu.cn **Name:** Ruquan Han, MD **Phone:** 8610-59976660 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** ruquan.han@gmail.com - **Name:** Ruquan Han, M.D., Ph.D - **Phone:** 8610-59976660 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ruquan Han, M.D., Ph.D - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** Beijing Tiantan Hospital, Capital Medical University **Status:** RECRUITING **Zip:** 100070 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003221 - Term: Confusion - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M6894 - Name: Delirium - Relevance: HIGH - As Found: Delirium - ID: M772 - Name: Emergence Delirium - Relevance: HIGH - As Found: Postoperative Delirium - ID: M6446 - Name: Confusion - 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: 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: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003693 - Term: Delirium - ID: D000071257 - Term: Emergence Delirium ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421064 **Acronym:** PUD **Brief Title:** Clinical Profile and Outcome of Perforated PUD **Official Title:** Clinical Profile and Surgical Treatment Outcome of Perforated Peptic Ulcer Disease in Public Hospitals of Eastern Ethiopia: a Prospective Multicenter Study. #### Organization Study ID Info **ID:** HURG-2020 #### Organization **Class:** OTHER **Full Name:** Haramaya Unversity ### Status Module #### Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-12-31 **Type:** ACTUAL #### Start Date **Date:** 2021-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Badhaasaa #### Responsible Party **Investigator Affiliation:** Haramaya Unversity **Investigator Full Name:** Badhaasaa **Investigator Title:** Assistant professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Perforated peptic ulcer disease (PPUD) is series illness that need emergency intervention. Its overall clinical profile and treatment outcome was also not well studied in developing countries. Therefore the study was aimed to see the outcome of surgical intervention and associated factors. The study was a retrospective observational study conducted using the medical records of patients operated on for perforated peptic ulcer disease at a multicenter, in eastern Ethiopia. **Detailed Description:** This study was designed to investigate the clinical characteristics and treatment outcomes among adult patients presented to the study areas. Three teaching Hospitals and one Regional Hospital were chosen and data collection was effected for two years. One hundred seventy patients participated in this observational study. ### Conditions Module **Conditions:** - Diseases or Conditions ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 170 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** All patients were operated with slight difference but all had perforation repaired. **Name:** Perforation repair **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** This is a dichotomous variable, either survived or deceased. **Measure:** Survival outcome of perforated PUD **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All adults with a diagnosis of perforated PUD managed at HU until discharged Exclusion Criteria: * Patients who were referred to other institutions before official discharge, Incomplete Medical record **Healthy Volunteers:** True **Maximum Age:** 90 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** All surgical emergency admissions. ### Contacts Locations Module #### Locations **Location 1:** **City:** Harar **Country:** Ethiopia **Facility:** Haramaya University **Zip:** 251 ### IPD Sharing Statement Module **Description:** Owned by the university **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M17206 - Name: Ulcer - Relevance: LOW - As Found: Unknown - ID: M13348 - Name: Peptic Ulcer - Relevance: LOW - As Found: Unknown - ID: M13350 - Name: Peptic Ulcer Perforation - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421051 **Acronym:** Vnstep **Brief Title:** Transauricular Vagus Nerve Stimulation Improves Postoperative Sleep Disorders in Elderly Patients. **Official Title:** Transauricular Vagus Nerve Stimulation (taVNS) Improves Postoperative Sleep Disorders in Elderly Patients:a Randomized Controlled Study. #### Organization Study ID Info **ID:** HX-B-2024016 #### Organization **Class:** OTHER **Full Name:** Beijing Tiantan Hospital ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Beijing Tiantan Hospital #### Responsible Party **Investigator Affiliation:** Beijing Tiantan Hospital **Investigator Full Name:** Ruquan Han **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:** Postoperative sleep disorder is one of the common complications after general anesthesia. Compared to patients of various ages, elderly patients have a much higher incidence of postoperative sleep disturbance. Postoperative sleep disorders can have many adverse effects, including cognitive impairment, altered pain perception, and emotional disorders, which are not conducive to the long-term prognosis of elderly patients. Enhancing postoperative sleep quality in older patients has become a significant public health concern in the current day due to its direct relationship to both maximizing surgical outcomes and enhancing physical health. This study intends to conduct a prospective, randomized controlled, triple-blind clinical trial on use of transauricular vagal nerve stimulation to improve sleep disorders in elderly patients after general anesthesia surgery, aiming to investigate the efficacy of transauricular vagal nerve stimulation in postoperative sleep disorders in elderly patients. ### Conditions Module **Conditions:** - Vagus Nerve Stimulation ### 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:** 164 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: Transauricular Vagal Nerve Stimulation **Label:** Transauricular Vagal Nerve Stimulation **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Device: Transauricular Vagal Nerve Stimulation **Label:** Transauricular Vagal Nerve sham Stimulation **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Transauricular Vagal Nerve Stimulation - Transauricular Vagal Nerve sham Stimulation **Description:** Transauricular vagal nerve stimulation **Name:** Transauricular Vagal Nerve Stimulation **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Measure:** Incidence of sleep disorders within 5 days after surgery. **Time Frame:** Day 1 to day 5 after surgery. #### Secondary Outcomes **Description:** The investigators collected patient-related information on postoperative days 1, 3, and 5 by using the Pittsburgh Sleep Quality Index (total score ranges from 0 to 21, with higher scores indicating poorer sleep quality) and a sleep monitoring bracelet, and analyzed the subsequent data. **Measure:** Sleep quality after surgery. **Time Frame:** Day 1,3,5 after surgery. **Description:** The investigators collected information from the patients on the 1st and 2nd postoperative days by Visual Analogue Scale and analyzed the data subsequently. The scale is based on a 10-cm horizontal line drawn on a piece of paper, with 0 cm at one end of the line indicating "no pain at all" and 10 cm at the other end indicating "extreme pain"; the level of pain increases from 0 to 10 cm, with higher scores indicating more intense pain. The higher the score, the more severe the pain. **Measure:** Postoperative pain score **Time Frame:** Day1 and 2 after surgery. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients undergoing non-craniocerebral surgery under elective general anesthesia * Age ≥65 years old * American society of Aneshesiologists Grade I to III * Sign informed consent Exclusion Criteria: * Patients who are expected to retain tracheal intubation after surgery * Disturbance of consciousness, mental disorder, inability to cooperate * Expected survival \< 3 months * The estimated operation time is \< 2 hours * The expected postoperative hospital stay is \< 5 days **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ruquan.han@ccmu.edu.cn **Name:** Ruquan Han, MD **Phone:** 8610-59976660 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009422 - Term: Nervous System Diseases - ID: D000009461 - Term: Neurologic Manifestations - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M22242 - Name: Parasomnias - Relevance: HIGH - As Found: Sleep Disorders - ID: M15696 - Name: Sleep Wake Disorders - Relevance: HIGH - As Found: Sleep Disorders - ID: M12404 - Name: Neurologic Manifestations - 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: D000012893 - Term: Sleep Wake Disorders - ID: D000020447 - Term: Parasomnias ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421038 **Brief Title:** Efficacy of Thyme Honey in The Management of Oral Aphthous Ulcers **Official Title:** Efficacy of Thyme Honey in The Management of Oral Aphthous Ulcers: A Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** 24-031 #### Organization **Class:** OTHER **Full Name:** British University In Egypt ### Status Module #### Completion Date **Date:** 2024-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-05-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** British University In Egypt #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Recurrent aphthous stomatitis (RAS) is considered the most common oral mucosal lesion, present first in childhood or adolescence. Aphthous ulcers affect up to 25% of the general population, and 3-month recurrence rates are as high as 50%, it is more common in female, also it increases by increasing age and minor aphthous ulcers are 80% of suffered patient. Due to the antimicrobial, anti-inflammatory, antifungal, and analgesic effects of Thyme honey, and the lack of evidence in the considered population, the present study aimed to assess the effect of honey on the pain relief in patients with minor RAU as a primary objective and to assess the healing effect of natural thyme honey on minor RAU, and the Oral Health Impact Profile (OHIP-14) as a secondary objectives. **Detailed Description:** Treatment of aphthous will usually be for three purposes: reduction of pain and inflammation, prevention of secondary infection, reduction of duration and repetition of aphthous. The most common treatments, after oral hygiene, are: use of local and oral steroids that have effect on T-lymphocytes and reduce inflammation, use of local antibiotics, for example, chlorohexidine, benzidamine, solving vitamin and mineral deficiency, such as B12, iron, folic acid, and avoidance of food allergens. Other treatments such as amelexanox, a potent inhibitor of inflammation due to mast cells and neutrophils. levamisol, talidomide are effective too. Many factors may be involved in its progression, such as genetic predisposition, immunological abnormalities, microbial infection, psychological stress, and hormonal state. Since the etiology and pathogenesis of RAS remains unclear, there is currently no consensus regarding a definitive curative therapy. The commonly accepted treatment strategy is to lessen the pain and duration of lesions. Topical corticosteroids, antibiotics, and analgesics are highly recommended for patients with RAS. However, longer treatment and frequent exposure to these medications may cause fungal infection and drug resistance, which may further lead to more severe adverse effects or even life-threatening complications. Natural herbal medicines as an alternative therapy for RAS have been widely used in many countries for decade. Clinical studies on the use of such remedies have reported favorable benefits to patients by reducing the discomfort and duration of ulcers. The large volume of literatures reported the effectiveness of honey. It indicates that it may potentially be useful to treat periodontal diseases, mouth ulcers and other problems of oral health. Furthermore, the application of honey to a wound has been demonstrated to stimulate the production and release of pro-inflammatory cytokines that assist in the wound healing process, such as interleukin-1 and tumor necrosis factor-alpha. The topical application of honey to various injured tissues has also been shown to stimulate wound repair through the stimulation of growth of epithelial cells, reduction of edema, and wound debridement. Takzaree et al in 2017 have evaluated the effects of local application of thyme honey in open cutaneous wound healing and concluded that local application of honey two times per day could boost the healing process as it reduces the inflammation, increases granulation tissue formation, and promotes angiogenesis and epithelialization, and this would eventually result in a quicker wound healing process. These antioxidants and wound healing effects have also been validated for Tulkarm honey and Thymus vulgaris honey. A recent study revealed substantial beneficial effects of Thymus vulgaris honey on skin wound healing and recommended its use in various types of wounds. Recent research aimed to evaluate the effect of thyme honey oral gel in the prevention of chemotherapy-induced oral mucositis in patients with breast cancer with an emphasis on patient-reported symptoms. The study concluded that the use of thyme honey oral gel reduced the incidence, duration, and severity of symptoms of oral mucositis, in addition to delaying the occurrence of grade ≥2 oral mucositis. ### Conditions Module **Conditions:** - Aphthous Stomatitis (Major) (Minor) - Treatment Compliance **Keywords:** - Oral diseases - Thyme honey - anti-inflammatory - natural products ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Thyme honey on recurrent aphthous stomatitis ##### Masking Info **Masking:** DOUBLE **Masking Description:** the care provider and the outcomes assessor will not know which treatment will be given to the patients. **Who Masked:** - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 10 patients will be treated by thyme honey application (100% pure natural honey, applied by themselves) on their ulcers three times a day for 7 days. **Intervention Names:** - Other: Thyme honey **Label:** Thyme honey **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 10 patients will be treated by kenalog in orabase (Triamcinolone acetonide 0.1% in oral paste 5g), three times a day for 7 days only. **Intervention Names:** - Drug: Kenalog **Label:** kenalog in orabase **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Thyme honey **Description:** Thyme honey is a rich monofloral honey variety formed by bees that collect nectar from thymus vulgaris flowers. thyme honey application (100% pure natural honey, applied by themselves) on their ulcers three times a day for 7 days **Name:** Thyme honey **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - kenalog in orabase **Description:** kenalog in orabase (Triamcinolone acetonide 0.1% in oral paste 5g) **Name:** Kenalog **Other Names:** - kenalog in orabase **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Visual Analog Scale (0-10) will be used to determine the intensity of pain on day 0, day 3, day 5, and day 7. **Measure:** Pain intensity **Time Frame:** 7 days. #### Secondary Outcomes **Description:** after starting treatment, ulcer size will be recorded on day 0, day 3, day 5, and day 7, using a calibrated dental probe with millimeter marking. **Measure:** Size of ulcers (in mm) **Time Frame:** 7 days. **Description:** The Oral Health Impact Profile (OHIP-14) questionnaire has been assessed 1 week after intervention. OHIP-14 utilizes a scale with five categories (1 = never, 2 = hardly ever, 3 = occasionally, 4 = fairly often, and 5 = very often). A lower score in any of the five categories indicates higher satisfaction **Measure:** The Oral Health Impact Profile (OHIP-14) questionnaire **Time Frame:** 7 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * • The study involved patients who had a positive history of having similar oral mucosal ulcers for 3-4 months and ulcers for \<48 h. * Clinically diagnosed patients with chronic aphthous stomatitis measuring ≤5 mm in size in the oral cavity and who gave written consent for participation. * Only single ulcers were considered for the study. * Systemically health patients. Exclusion Criteria: * The study excluded patients with a history of associated systemic disease. * Cases of chronic aphthous stomatitis (major), lesions of herpetic form, numerous RAS lesions, and smoking. * In addition, no consideration was given to patients with a history of hypersensitivity to honey. **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Dalia.ghalwash@bue.edu.eg **Name:** Dalia Ghalwash, Phd **Phone:** 01005120159 **Role:** CONTACT **Contact 2:** **Email:** asmaa.aboubakr@bue.edu.eg **Name:** Asmaa A Ras, Phd **Phone:** 01098015060 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** Dalia.ghalwash@bue.edu.eg - **Name:** Dalia Ghalwash, Phd - **Phone:** 01005120159 - **Role:** CONTACT ***Contact 2:*** - **Email:** asmaa.aboubakr@bue.edu.eg - **Name:** Asmaa A Ras, Phd - **Phone:** 01098015060 - **Role:** CONTACT **Country:** Egypt **Facility:** The British University in Egypt ### IPD Sharing Statement Module **Description:** Confidentiality of data: All data will be stored in an Excel sheet for research purposes and respecting patient confidentiality. Patients have the right to withdraw from the research at any point for any reason and with no penalty subject to them. **IPD Sharing:** NO ### References Module #### References **Citation:** Bang LM, Buntting C, Molan P. The effect of dilution on the rate of hydrogen peroxide production in honey and its implications for wound healing. J Altern Complement Med. 2003 Apr;9(2):267-73. doi: 10.1089/10755530360623383. **PMID:** 12804080 **Citation:** Eisen D, Carrozzo M, Bagan Sebastian JV, Thongprasom K. Number V Oral lichen planus: clinical features and management. Oral Dis. 2005 Nov;11(6):338-49. doi: 10.1111/j.1601-0825.2005.01142.x. **PMID:** 16269024 **Citation:** Embil JA, Stephens RG, Manuel FR. Prevalence of recurrent herpes labialis and aphthous ulcers among young adults on six continents. Can Med Assoc J. 1975 Oct 4;113(7):627-30. **PMID:** 1181018 ## Derived Section ### Condition Browse Module - Ancestors - 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: BC07 - Name: Mouth and Tooth Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M17206 - Name: Ulcer - Relevance: LOW - As Found: Unknown - ID: M16070 - Name: Stomatitis - Relevance: HIGH - As Found: Stomatitis - ID: M16071 - Name: Stomatitis, Aphthous - Relevance: HIGH - As Found: Aphthous Stomatitis - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: T455 - Name: Aphthous Stomatitis - Relevance: HIGH - As Found: Aphthous Stomatitis ### Condition Browse Module - Meshes - ID: D000013280 - Term: Stomatitis - ID: D000013281 - Term: Stomatitis, Aphthous ### Intervention Browse Module - Ancestors - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000005938 - Term: Glucocorticoids - ID: D000006728 - Term: Hormones - ID: D000006730 - Term: Hormones, Hormone Substitutes, and Hormone Antagonists - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000007166 - Term: Immunosuppressive Agents - ID: D000007155 - Term: Immunologic Factors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: HB - Name: Herbal and Botanical ### Intervention Browse Module - Browse Leaves - ID: M16974 - Name: Triamcinolone - Relevance: HIGH - As Found: 10 hours - ID: M16975 - Name: Triamcinolone Acetonide - Relevance: HIGH - As Found: 10 hours - ID: M237966 - Name: Triamcinolone hexacetonide - Relevance: HIGH - As Found: 10 hours - ID: M209573 - Name: Triamcinolone diacetate - Relevance: HIGH - As Found: 10 hours - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4854 - Name: Benzocaine - 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: M10212 - Name: Immunosuppressive Agents - Relevance: LOW - As Found: Unknown - ID: M10201 - Name: Immunologic Factors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown - ID: T315 - Name: Thyme - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000014222 - Term: Triamcinolone Acetonide - ID: D000014221 - Term: Triamcinolone - ID: C000005900 - Term: Triamcinolone hexacetonide - ID: C000030262 - Term: Triamcinolone diacetate ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421025 **Acronym:** POLYVISCO **Brief Title:** Blood Viscosity in Polycythemia Patients **Official Title:** Evaluation of Blood Viscosity and Hyperviscosity-related Complications Relationship in Patients With Patients With Polycythemia #### Organization Study ID Info **ID:** 69HCL23_0915 #### Organization **Class:** OTHER **Full Name:** Hospices Civils de Lyon #### Secondary ID Infos **Domain:** ID-RCB **ID:** 2023-A02208-37 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2031-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-19 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2031-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### 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:** Polycythemia (PG) corresponds to an increase in erythrocyte parameters on a blood test. A distinction is usually made between primary and secondary PG. The most common primary PG is Vaquez's disease, a hematological cancer. In Vaquez disease, an increase in hematocrit has been reported to be associated with a logarithmic increase in blood viscosity. The main complications of primary PGs (especially in Vaquez disease) are thromboembolic complications. In contrast, thromboembolic complications are rarer in secondary PG. In Vaquez disease, a hematocrit ≤ 45% has been defined as the therapeutic goal for significantly reducing thromboembolic risk. However, this has not been established for secondary PGs. All in all, the definition of the 45% threshold is based solely on clinical studies with no obvious biological argument. What's more, simply lowering blood mass through cytoreduction alone does not appear to be sufficient to significantly reduce thromboembolic risk. To investigator knowledge, there are no studies prospectively evaluating blood viscosity, its determinants and coagulation in different types of polycythemia. Nor are there any data on the direct effect on blood viscosity of the various treatments usually offered. ### Conditions Module **Conditions:** - Polycythemia Secondary - Polycythemia, Primary **Keywords:** - Polycythemia - viscosity - thromboelastometry - thrombosis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with polycythemia defined as hematocrit level greater than or equal to 49% in men and 48% in women, whatever the suspected etiology. Primitive and secondary polycythemia are eligible in this observational study. Patients should not have start any cytoreductive therapy prior inclusion. **Label:** Patients with polycythemia ### Outcomes Module #### Primary Outcomes **Description:** The investigators expect higher blood viscosity values in polyglobulic patients with symptoms of clinical hyperviscosity than in polyglobulic patients without symptoms of clinical hyperviscosity, but no differences in hematocrit between the two polycythemia groups **Measure:** Whole blood viscosity levels in patients with polycythemia **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years of age or older * Followed for a diagnosis or suspicion of polycythemia (hematocrit greater than or equal to 49% in men and 48% in women), whatever the suspected etiology. * Patient affiliated to a social security scheme or similar Exclusion Criteria: * Patient having undergone therapeutic bloodletting within 3 months prior to inclusion, or having initiated cytoreductive therapy prior to inclusion. * Any disease or condition other than polycythemia, chronic or not, likely to induce a change in blood viscosity (at the investigator's discretion) * Patient participating in another interventional research protocol that may interfere with the present protocol (at the investigator's discretion). * Patient under guardianship, curatorship or safeguard of justice * Person under psychiatric care * Patient under legal protection. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with polycythemia defined as hematocrit level greater than or equal to 49% in men and 48% in women, whatever the suspected etiology. Primitive and secondary polycythemia are eligible in this observational study. Patients should not have start any cytoreductive therapy prior inclusion. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mael.heiblig@chu-lyon.fr **Name:** Mael HEIBLIG, MD,PhD **Phone:** 478862240 **Phone Ext:** +33 **Role:** CONTACT #### Locations **Location 1:** **City:** Pierre-Bénite **Country:** France **Facility:** Service d'hématologie, Hôpital Lyon Sud **State:** Lyon **Zip:** 69495 ### References Module #### References **Citation:** Marchioli R, Finazzi G, Specchia G, Cacciola R, Cavazzina R, Cilloni D, De Stefano V, Elli E, Iurlo A, Latagliata R, Lunghi F, Lunghi M, Marfisi RM, Musto P, Masciulli A, Musolino C, Cascavilla N, Quarta G, Randi ML, Rapezzi D, Ruggeri M, Rumi E, Scortechini AR, Santini S, Scarano M, Siragusa S, Spadea A, Tieghi A, Angelucci E, Visani G, Vannucchi AM, Barbui T; CYTO-PV Collaborative Group. Cardiovascular events and intensity of treatment in polycythemia vera. N Engl J Med. 2013 Jan 3;368(1):22-33. doi: 10.1056/NEJMoa1208500. Epub 2012 Dec 8. **PMID:** 23216616 **Citation:** Vogel J, Kiessling I, Heinicke K, Stallmach T, Ossent P, Vogel O, Aulmann M, Frietsch T, Schmid-Schonbein H, Kuschinsky W, Gassmann M. Transgenic mice overexpressing erythropoietin adapt to excessive erythrocytosis by regulating blood viscosity. Blood. 2003 Sep 15;102(6):2278-84. doi: 10.1182/blood-2003-01-0283. Epub 2003 May 15. **PMID:** 12750170 **Citation:** Wade JP, du Boulay GH, Marshall J, Pearson TC, Russell RW, Shirley JA, Symon L, Wetherley-Mein G, Zilkha E. Cerebral blood flow, haematocrit and viscosity in subjects with a high oxygen affinity haemoglobin variant. Acta Neurol Scand. 1980 Apr;61(4):210-5. doi: 10.1111/j.1600-0404.1980.tb01485.x. **PMID:** 7376820 **Citation:** Barbui T, De Stefano V, Ghirardi A, Masciulli A, Finazzi G, Vannucchi AM. Different effect of hydroxyurea and phlebotomy on prevention of arterial and venous thrombosis in Polycythemia Vera. Blood Cancer J. 2018 Nov 26;8(12):124. doi: 10.1038/s41408-018-0161-9. No abstract available. **PMID:** 30478311 **Citation:** Pearson TC. Hemorheology in the erythrocytoses. Mt Sinai J Med. 2001 May;68(3):182-91. **PMID:** 11373690 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006402 - Term: Hematologic Diseases - ID: D000019046 - Term: Bone Marrow Neoplasms - ID: D000019337 - Term: Hematologic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000001855 - Term: Bone Marrow Diseases - ID: D000009196 - Term: Myeloproliferative Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12307 - Name: Neoplasm Metastasis - Relevance: LOW - As Found: Unknown - ID: M16686 - Name: Thrombosis - Relevance: LOW - As Found: Unknown - ID: M13971 - Name: Polycythemia - Relevance: HIGH - As Found: Polycythemia - ID: M13972 - Name: Polycythemia Vera - Relevance: HIGH - As Found: Polycythemia, Primary - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M21070 - Name: Bone Marrow Neoplasms - Relevance: LOW - As Found: Unknown - ID: M21314 - Name: Hematologic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5134 - Name: Bone Marrow Diseases - Relevance: LOW - As Found: Unknown - ID: M12149 - Name: Myeloproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: T4614 - Name: Polycythemia Vera - Relevance: HIGH - As Found: Polycythemia, Primary - ID: T1311 - Name: Chronic Myeloproliferative Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011087 - Term: Polycythemia Vera - ID: D000011086 - Term: Polycythemia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06421012 **Acronym:** POXTRA **Brief Title:** Preoxygenation for Tracheal Aspirations in Intensive Care **Official Title:** Preoxygenation for Tracheal Aspirations in Intensive Care, a Randomized Controlled Trial #### Organization Study ID Info **ID:** APHP230486 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris #### Secondary ID Infos **Domain:** ANSM **ID:** 2023-A00694-41 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-09-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-07-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Clearing the airways is a complex phenomenon involving the production of secretions, the nature of mucus (viscosity, elasticity, stringiness, and adhesiveness), ciliary movement, and coughing. In intubated and ventilated patients, endotracheal suctioning occur when the patient is "unable to clear the airways of obstructions hindering the free passage of air." These suctioning can lead to transient desaturation exacerbated by a decrease in cardiac output due to increased mean arterial pressure, promoting cardiac arrhythmias. To minimize these effects, it is recommended to perform additional preoxygenation, by increasing the fraction of O2 in the air delivered to the patient by the ventilator 2-3 minutes before the procedure. These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning that required disconnecting the patient from the ventilator. Currently, suctioning are performed on-demand, based on the patient's congestion status, either through the endotracheal tube cap or a "closed system." Desaturations have become infrequent without establishing that additional preoxygenation can prevent them. Moreover, additional preoxygenation is not without risks. By inducing de-nitrogenation atelectasis with a loss of lung volume, it can exacerbate pre-existing lung injuries in the most severe patients. In less severe cases, preoxygenation leads to transient hyperoxia, with various deleterious effects impacting patient prognosis. Thus, a short-term risk, such as deep desaturations, must be balanced against a medium-term risk of hyperoxia and de-nitrogenation. **Detailed Description:** Clearing the airways is a complex phenomenon involving the production of secretions, the nature of mucus (viscosity, elasticity, stringiness, and adhesiveness), ciliary movement, and coughing. Endotracheal suctioning are performed when the patient is "unable to clear the airways of obstructions hindering the free passage of air." Classically, endotracheal suctioning cause transient desaturation exacerbated by a decrease in cardiac output due to an increase in mean arterial pressure, promoting cardiac arrhythmias. To minimize these effects, it is recommended to perform additional preoxygenation, i.e., increasing the fraction of O2 in the air delivered to the patient by the ventilator 2-3 minutes before the procedure. These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning and/or disconnecting the patient from the ventilator. Today, suctioning are performed on-demand, based on the patient's congestion status, either through the endotracheal tube cap or a "closed system." Desaturations have become rare without establishing that additional preoxygenation can prevent them. Moreover, additional preoxygenation is not without risks. In the short term, it induces de-nitrogenation atelectasis resulting in a loss of lung volume that can worsen pre-existing lung injuries in the most severe patients. In less severe cases, preoxygenation is responsible for transient hyperoxia, with various deleterious effects impacting patient prognosis. Thus, a short-term risk, such as deep desaturations, is juxtaposed with a medium-term risk of hyperoxia and de-nitrogenation. The investigators hypothesize that the absence of additional preoxygenation is not inferior, in terms of deep desaturations, to the strategy with additional preoxygenation, and it would avoid exposing patients to the risks of de-nitrogenation-induced atelectasis and hyperoxia. The investigators retained a margin of non-inferiority for the relative risk of 1.1, i.e. an increase of 10% of deep desaturations. The main analysis will be performed on the per-protocol population (more conservative in non-inferiority trials).The per-protocol population will include patients who had at least one suctioning and for whom the additional preoxygenation strategy allocated by randomisation was followed in at least 70% of all suctioning reported in the patient's care record. Patients who stopped their participation in the study before endpoint timeframe and those who had never had an suctioning will not be included in the per protocol population. The unit of analysis will be the patient, and a rate of suctioning leading to deep desaturation will be calculated for each patient, as described in the primary endpoint. The mean rate of suctioning leading to deep desaturation will then be calculated by treatment group (with additional preoxygenation / without additional preoxygenation). ### Conditions Module **Conditions:** - ICU Patients Under Invasive Mechanical Ventilation **Keywords:** - Endotracheal suctioning - Preoxygenation - Ventilation - ICU ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 2260 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: Experimental : Patients without additional preoxygenation **Label:** Patients without additional preoxygenation **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Procedure: Active Comparator : Patients with additional preoxygenation **Label:** Patients with additional preoxygenation **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients without additional preoxygenation **Description:** Throughout the entire period of their mechanical ventilation, patients will not receive additional preoxygenation before any endotracheal suctioning; their FiO2 value will be maintained constant **Name:** Experimental : Patients without additional preoxygenation **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Patients with additional preoxygenation **Description:** Throughout the entire period of their mechanical ventilation, patients will receive additional preoxygenation at 100% FiO2 for a systematic 2-minute duration prior to any endotracheal suction. Subsequently, the FiO2 will be reset to the previous default value. **Name:** Active Comparator : Patients with additional preoxygenation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** It will be calculated for each patient as the number of suctioning leading to deep desaturation (SpO2 88% or less, and 85% or less for patients with chronic obstructive pulmonary disease COPD), divided by the total number of endotracheal suctioning throughout the period. Oxygen saturation values will be collected every minute during the 15 minutes post-suctioning. Endotracheal suctioning in patients already ventilated with 100% FiO2 started prior to the decision to aspirate will not be taken into account **Measure:** Rate of suctioning leading to deep desaturation **Time Frame:** from Day 0 to ventilator weaning, and at the latest Day 28 #### Secondary Outcomes **Description:** It will be calculated for each patient as the number of suctioning leading to severe desaturation (SpO2 85% or less, and 80% or less for patients with COPD), divided by the total number of endotracheal suctioning throughout the period **Measure:** Suctioning rate leading to severe desaturation **Time Frame:** From Day 0 to ventilator weaning, and at the latest Day 28 **Description:** Number of days without ventilation. In case of death value will be set to zero **Measure:** Number of ventilator free days at D28 **Time Frame:** From Day 0 to Day 28 **Description:** Ventilator-associated pneumonia, as defined by the Formalized Recommendation of Experts from the SFAR-SRLF in 2017 **Measure:** Ventilator-associated pneumonia **Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28 **Description:** Delirium occurring in ICU, defined by a positive result on the CAM-ICU clinical assessment tool specific to ICU delirium **Measure:** Intensive care delirium **Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28 **Description:** Composite criteria including at least one of the following: ischemic stroke, myocardial infarction, digestive ischemia **Measure:** Composite criteria of ischemic phenomena in ICU, including one of the following: stroke, myocardial infarction, digestive ischemia **Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28 **Description:** Ischemic stroke occurring in intensive care, defined by the combination of the onset of focal motor deficit and compatible cerebral imaging **Measure:** Ischemic stroke **Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28 **Description:** Myocardial infarction occurring in intensive care, defined by an acute coronary syndrome with ST segment elevation and troponin elevation **Measure:** Myocardial infarction **Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28 **Description:** Digestive ischemia occurring in intensive care, diagnosed by CT scan or digestive endoscopy **Measure:** Digestive ischemia **Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28 **Description:** Cardiac arrest occuring in intensive care **Measure:** Cardiac arrest **Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28 **Description:** Acute kidney injury occurring in intensive care, defined by the initiation of renal replacement therapy **Measure:** Acute kidney injury **Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28 **Description:** Time to first bowel movements **Measure:** First bowel movements **Time Frame:** From Day 0 to ICU-discharge, and at the latest Day 28 **Description:** Vital status at discharge from ICU **Measure:** ICU discharge vital status **Time Frame:** At ICU discharge and at the latest Day 90 **Description:** Vital status at discharge from hospital **Measure:** Hospital discharge vital status **Time Frame:** At hospital discharge, and at the latest Day 90 **Description:** Mean saturation over all the period of 15 minutes post suctioning **Measure:** Mean saturation over 15 minutes post-suctioning **Time Frame:** From Day 0 to ventilator weaning, and at the latest Day 28 **Description:** ARDS according to the Berlin definition, characterized by 1) acute respiratory failure evolving for a week or less, 2) bilateral opacities on thoracic imaging, 3) no evidence of predominant hydrostatic edema, 4) hypoxemia with a PaO2/FIO2 ratio \< 300 mmHg for positive end-expiratory pressure set at 5 cmH2O or more, with 3 severity stages defined based on hypoxemia **Measure:** Acute respiratory distress syndrome (ARDS) **Time Frame:** From Day 0 to hospital discharge, and at the latest Day 90 **Description:** Length of stay in intensive care **Measure:** Length of ICU stay **Time Frame:** at ICU discharge, and at the latest Day 90 **Description:** Length of stay in hospital **Measure:** Length of hospital stay **Time Frame:** at hospital discharge, and at the latest Day 90 **Description:** For each desaturation, time in minutes between endotracheal suctioning and desaturation **Measure:** Time in minutes between endotracheal suctioning and eventual desaturation **Time Frame:** From Day 0 to ventilator weaning, and at the latest Day 28 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years of age or older * Hospitalized in ICU, under invasive mechanical ventilation for less than 24 hours * Information and signature of consent by patient or relative/trusted person, or emergency inclusion procedure Exclusion Criteria: * Not affiliated to a social security system * Pregnant * Under legal protection (curatorship, guardianship or safeguard of justice) * Patient under AME **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** claire.fazilleau@aphp.fr **Name:** Claire FAZILLEAU **Phone:** 01 42 16 22 75 **Role:** CONTACT **Contact 2:** **Email:** jean-michel.constantin@aphp.fr **Name:** Jean Michel CONSTANTIN, Pr **Phone:** 01 42 17 73 05 **Role:** CONTACT #### Locations **Location 1:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** claire.fazilleau@aphp.fr - **Name:** Claire FAZILLEAU - **Phone:** 01 42 16 22 75 - **Role:** CONTACT ***Contact 2:*** - **Email:** jean-michel.constantin@aphp.fr - **Name:** Jean Michel CONSTANTIN, Pr - **Phone:** 01 42 17 73 05 - **Role:** CONTACT **Country:** France **Facility:** Hôpital Pitié Salpêtrière **Zip:** 75013 #### Overall Officials **Official 1:** **Affiliation:** Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris **Name:** Claire FAZILLEAU **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Researchers who provide a methodologically sound proposal. **Description:** The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations. **Info Types:** - STUDY_PROTOCOL - SAP - ICF **IPD Sharing:** YES **Time Frame:** Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420999 **Acronym:** PRODIGY **Brief Title:** Incidence and Impact of ICU-acquired Diaphragm Weakness **Official Title:** Incidence and Impact of ICU-acquired Diaphragm Weakness #### Organization Study ID Info **ID:** APHP240248 #### Organization **Class:** OTHER **Full Name:** Assistance Publique - Hôpitaux de Paris ### Status Module #### Completion Date **Date:** 2025-09-16 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09-16 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Assistance Publique - Hôpitaux de Paris #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** ICU survivors are at an increased risk of hospital and ICU readmission. Among the complications of ICU stay, diaphragmatic dysfunction is common, with a prevalence of 60 to 80%, and is associated with increased mortality and prolonged hospital stays. Furthermore, several studies have reported that the observation of impaired respiratory muscle function upon ICU discharge is associated with a poor long-term prognosis. However, the incidence and prognostic impact of persistent diaphragmatic dysfunction at ICU discharge have never been evaluated. The measurement of dyspnea, a composite evaluation of respiratory muscle function, has not been assessed for predicting prognosis upon ICU discharge. The hypothesis of the project is that the presence of ICU-acquired diaphragmatic dysfunction at ICU discharge is associated with a poorer prognosis within 90 days. **Detailed Description:** Diaphragmatic function of patients will be assessed by ultrasound within 24 hours following the weaning from ventilatory support and on the day the patient is deemed eligible for ICU discharge. ICU discharge will be defined a priori using a checklist. Diaphragmatic activity will be assessed by bedside diaphragmatic ultrasound. Patients will be positioned in a semi-sitting position (trunk inclination between 30 and 45°) to allow for better visualization of the right hemidiaphragm. The diaphragmatic assessment will include the measurement of inspiratory and expiratory thickness to calculate the diaphragmatic thickening fraction (intercostal approach) and the measurement of diaphragmatic excursion (subcostal approach) during the respiratory cycle. These measurements will be taken at rest. Diaphragmatic dysfunction will be defined by a thickening fraction strictly less than 20% and/or a diaphragmatic excursion strictly less than 1 cm at rest. Dyspnea will be assessed using a visual analog scale (VAS) ranging from 0 (no dyspnea) to 10 (maximum dyspnea). It will be evaluated within 24 hours following the weaning from ventilatory support and on the day the patient is deemed eligible for ICU discharge. ### Conditions Module **Conditions:** - Diaphragm Dysfunction **Keywords:** - ICU - diaphragmatic activity - Respiratory support ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 194 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Adults admitted to ICU receiving either invasive mechanical ventilation for at least 48 hours, non-invasive ventilation or high-flow humidified oxygen therapy for at least 48 hours, and who have been weaned from ventilatory support within the last 24 hours. **Intervention Names:** - Other: Diaphragmatic ultrasound and data collection **Label:** Patients weaned from mechanical or non invasive ventilation ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients weaned from mechanical or non invasive ventilation **Description:** At the inclusion visit, anamnestic data available in the medical record and clinical data (vitals, chest X-ray) will be collected. At the same time, a diaphragmatic ultrasound will be performed in the half-seated position to measure diaphragmatic excursion and the thickening fraction of the right hemi-diaphragm at rest. A follow-up visit will be made on the day of discharge from intensive care, during which diaphragmatic ultrasound will be performed At D90 (+/- 15 days), the following information will be collected by consulting the electronic medical record, or by telephone if the information is not available in the record: date of discharge from hospital, date of death, date and reason for readmission to hospital or intensive care, possible introduction of long-term non-invasive ventilation, new respiratory complication after discharge from intensive care (pneumonia, atelectasis). **Name:** Diaphragmatic ultrasound and data collection **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Mortality **Measure:** Association between diaphragmatic dysfunction on the day of discharge from intensive care and mortality at D90 **Time Frame:** 90 days after inclusion (+/- 15 days) #### Secondary Outcomes **Description:** Measurement of dyspnea on day of discharge from intensive care, assessed by visual analog scale (VAS). Scale of 1 to 10 with 10 corresponding to minimal comfort **Measure:** Association between dyspnea on the day of discharge and prognosis at D90 (composite criterion: respiratory complications, readmissions, mortality). **Time Frame:** The day of discharge from ICU **Description:** Presence of diaphragmatic dysfunction defined on ultrasound by a thickening fraction\<20%. **Measure:** Quantify the proportion of patients with diaphragmatic dysfunction on the day of discharge from intensive care. **Time Frame:** The day of discharge from ICU **Description:** Clinically significant dyspnea defined by a VAS\>3/10. Scale of 1 to 10 with 10 corresponding to minimal comfort **Measure:** Quantify the proportion of patients with clinically significant dyspnea on the day of discharge from intensive care. **Time Frame:** The day of discharge from ICU **Description:** Length of hospital stay **Measure:** Association between the presence of diaphragmatic dysfunction on the day of discharge from intensive care and length of hospital stay. **Time Frame:** 90 days after inclusion (+/- 15 days) **Description:** Presence of diaphragmatic dysfunction defined on ultrasound by a thickening fraction\<20%. **Measure:** Association between the presence of diaphragmatic dysfunction within 24 hours of weaning from ventilation and length of hospital stay. **Time Frame:** On the day ventilation is weaned **Description:** Percentage of readmissions to intensive care and hospital at D90. **Measure:** Association between diaphragmatic dysfunction and the risk of hospital and intensive care readmissions **Time Frame:** 90 days after inclusion (+/- 15 days) **Description:** The percentage of respiratory complications at D90, defined by the occurrence of pneumonia, reintubation, atelectasis (or worsening in case of pre-existing abnormality). **Measure:** Association between diaphragmatic dysfunction and the risk of respiratory complications at D90. **Time Frame:** 90 days after inclusion (+/- 15 days) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age ≥ 18 years 2. Invasive or non-invasive respiratory support (ventilation, high-flow oxygen therapy, whatever the reason) for at least 48 hours. 3. Weaning from respiratory support (invasive or not) within the last 24 hours. 4. Patient (or trusted person/relative) informed and not opposed to the study. Exclusion Criteria: 1. Known pre-existing diaphragmatic dysfunction (phrenic lesion, neuromuscular disease, etc.) 2. Patients with tracheostomy 3. Non-communicating patients 4. Patients deprived of liberty by court or administrative order, or under legal protection (guardianship, curators). **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The eligible population will be that of adult patients who have been in intensive care and have received invasive mechanical ventilation for at least 48 hours or non-invasive ventilation or humidified high-flow oxygen therapy for at least 48 hours, with a PaO2/FiO2 ratio \< 200 before ventilatory support was introduced. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** martin.dres@aphp.fr **Name:** Martin Dres, MD,PHD **Phone:** 0142167809 **Role:** CONTACT ### IPD Sharing Statement Module **Access Criteria:** Researchers who provide a methodologically sound proposal. **Description:** The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations. **Info Types:** - STUDY_PROTOCOL - ICF **IPD Sharing:** YES **Time Frame:** Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4554 - Name: Asthenia - Relevance: HIGH - As Found: Weakness ### Condition Browse Module - Meshes - ID: D000001247 - Term: Asthenia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420986 **Brief Title:** Open Hemorrohoidectomy Vs Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptoms **Official Title:** Open Hemorrohoidectomy Versus Transanal Hemorrhoidal Desarterialization in Hemorrhoids Grade III: The Effect on Symptons: An Open-label Randomized Controlled Trial #### Organization Study ID Info **ID:** IB4323-20PI #### Organization **Class:** OTHER **Full Name:** Hospital Son Llatzer ### Status Module #### Completion Date **Date:** 2024-04-17 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-17 **Type:** ACTUAL #### Start Date **Date:** 2021-08-12 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** Fundació d'investigació Sanitària de les Illes Balears #### Lead Sponsor **Class:** OTHER **Name:** Hospital Son Llatzer #### Responsible Party **Investigator Affiliation:** Hospital Son Llatzer **Investigator Full Name:** Ignacio Fernandez Hurtado **Investigator Title:** Specialist in General Surgery. Specialist in Digestive Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if open hemorroidectomy diminishes symptoms compared to transanal hemorrhoidal desarterialization (THD) in patients presenting with hemorrhoids grade III. The main question it aims to answer is: - Do patients undergoing open hemorroidectomy present with lesser symptoms 1 year after surgery, compared to those undergoing a THD? Researchers will compare open hemorroidectomy to THD in terms of symptom response one year after the procedure. Participants will: * Undergo surgical treatment of hemorroids performed by one of the two techniques: open hemorroidectomy versus THD. * Fill in symptom forms before and one year after the surgical procedure. * Attend control visits one week, one month, three months and one year after the surgical procedure. ### Conditions Module **Conditions:** - Hemorrhoids Third Degree **Keywords:** - hemorrhoids third degree - botulinum Toxin - Hemorrhoidectomy - Transanal Hemorrhoidal Dearterialization - hemorrhoidal Disease Symptom Score ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: Open Hemorrhoidectomy **Label:** Hemorrhoidectomy **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Procedure: Transanal Hemorrhoidal Dearterialization **Label:** Transanal Hemorrhoidal Dearterialization **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Hemorrhoidectomy **Description:** Surgical treatment of Hemorrhoids. Removal of hemorrohids leaving the wounds open. Surgical technique described by Milligan Morgan **Name:** Open Hemorrhoidectomy **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Transanal Hemorrhoidal Dearterialization **Description:** Surgical treatment of Hemorrhoids. This operation involves no excision. The hemorrhoidal arteries are ligated and the hemorrhoial prolapse is treated by a suture mucopexi. Described by Rato **Name:** Transanal Hemorrhoidal Dearterialization **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** A score that defines the frecuency of pain, pruritus, bleeding, soiling and prolapse. Score 0 to 20. Higher scores mean a worse outcome **Measure:** hemorrhoidal disease symptom score **Time Frame:** one year **Description:** a subjective scale which defines symptom intensity, the patient's worrying and the role in impairment of daily activity. Score 4 to 28. Higher scores mean a worse outcome **Measure:** short health scale in hemorrhoidal disease **Time Frame:** one year #### Secondary Outcomes **Description:** pain measured in visual analogic scale (VAS) Scale: 0 to 10. Higher scores mean a worse outcome **Measure:** postoperative pain **Time Frame:** 1 week after surgical procedure **Description:** measured in Wexner scale. Score 0 to 20. Higher scores mean a worse outcome **Measure:** fecal incontinence **Time Frame:** baseline and 1 week, 3 months and 1 year after surgical procedure ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: * Age older than 18. * Hemorroids grade III. * Surgical indication for hemorroid treatment. * Signed informed consent. Exclusion criteria: * Acute hemorroidal disease. * Previous hemorroidal surgery. * Concomitant anal fissure. * Concomitant perianal fistulae. * Concomitant rectal prolapse. * Inflamatory bowel disease. * Anal or colorrectal cancer. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Palma De Mallorca **Country:** Spain **Facility:** Hospital Son Llatzer **State:** Illes Balears **Zip:** 07198 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012002 - Term: Rectal Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9570 - Name: Hemorrhoids - Relevance: HIGH - As Found: Hemorrhoids - ID: M14844 - Name: Rectal Diseases - 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: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006484 - Term: Hemorrhoids ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M5183 - Name: Botulinum Toxins - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420973 **Brief Title:** RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression **Official Title:** A Single-arm, Multicenter, Phase II Study of RC48 Plus Platinum With or Without Bevacizumab in the Treatment of HER-2 Expression Platinum-Sensitive Recurrent Ovarian Cancer #### Organization Study ID Info **ID:** RCVDODIIR017 #### Organization **Class:** OTHER **Full Name:** Peking University Cancer Hospital & Institute ### Status Module #### Completion Date **Date:** 2027-09-17 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-05-17 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-16 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-11 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Peking University Cancer Hospital & Institute #### Responsible Party **Investigator Affiliation:** Peking University Cancer Hospital & Institute **Investigator Full Name:** Hong Zheng **Investigator Title:** M.D. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate the efficacy, safety, and quality of life scores of patients with HER2-expressing platinum-sensitive recurrent epithelial ovarian cancer treated with the combination therapy regimen of RC48 plus platinum with or without bevacizumab. **Detailed Description:** This study set up a safety introduction period, during which the first 6 subjects who were initially enrolled in the study will slowly undergo safety monitoring. Each patient received RC48 \[2.5 mg/kg, Q3W\]+carboplatin (AUC5 d1 q3w) ± bevacizumab(7.5-15mg/kg d1 q3w) treatment. The monitoring time window is within 28 days after receiving the study drug treatment for the first time. If ≥ 2 dose limited toxicity (DLT) cases were observed in the first 6 subjects, and after evaluation by the research team, it was found that the toxicity was related to treatment with RC48, the initial dose of RC48 treatment for subsequent enrolled patients was adjusted to 2.0mg/kg, Q3W. Treatment period: RC48+carboplatin ± bevacizumab, repeated every three weeks for a total of 6 cycles； Maintenance period: RC48± bevacizumab (if combined with bevacizumab during the treatment period, maintain treatment with RC48 in combination with bevacizumab; if not used during the treatment period, maintain treatment with RC48 monotherapy). Maintenance duration: Until disease progression or intolerable toxicity occurs, the longest duration of RC48 is 6 months (8 cycles). ### Conditions Module **Conditions:** - Ovarian Carcinoma - Fallopian Tube Carcinoma - Primary Peritoneal Carcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 54 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** RC48 (2.5mg/kg iv on d1 , every 21d for 6 cycles) + Carboplatin (AUC5 iv on d1 every 21d for 6 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for 6 cycles) for treatment followed by RC48 (2.5mg/kg iv on d1 , every 21d for 8 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for progress ) maintenance therapy. **Intervention Names:** - Drug: RC48+carboplatin±bevacizumab **Label:** RC48+carboplatin±bevacizumab **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - RC48+carboplatin±bevacizumab **Description:** RC48 (2.5mg/kg iv on d1 , every 21d for 6 cycles) + Carboplatin (AUC5 iv on d1 every 21d for 6 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for 6 cycles) for treatment followed by RC48 (2.5mg/kg iv on d1 , every 21d for 8 cycles)±Bevacizumab (7.5-15mg/kg iv on d1 every 21d for progress ) maintenance therapy. **Name:** RC48+carboplatin±bevacizumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** PFS is defined as time (in months) from date of randomization to the date of the first documentation of objective progressive disease (PD) or death due to any cause in the absence of documented PD (whichever occurs first). PFS will be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on investigator response assessment. **Measure:** Progression-Free Survival (PFS) **Time Frame:** Up to approximately 2 years #### Secondary Outcomes **Description:** ORR is defined as Investigator-assessed CR + PR, per RECIST 1.1 **Measure:** Objective Response Rate（ORR） **Time Frame:** Up to approximately 2 years **Description:** DCR is defined as the percentage of cases with remission (PR+CR) and stable disease (SD) after treatment in the evaluable cases. **Measure:** Disease Control Rate (DCR) **Time Frame:** Up to approximately 2 years **Description:** OS is defined as the time (in months) from randomization to the date of death, regardless of the actual cause of the subject's death. **Measure:** Overall Survival（OS） **Time Frame:** Up to approximately 2 years **Description:** Assessment of the toxicity profile of regimen according to the National Cancer Institute Common Toxicity Criteria version 5.0 (NCI CTCAE v 5.0). **Measure:** Number of Participants With Adverse Events (AEs) **Time Frame:** Up to approximately 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Female subjects aged from 18 to 75 years old; * Pathology confirmed the diagnosis of primary epithelial ovarian/fallopian tube/peritoneal carcinoma; * Previous treatment lines ≥1 and ≤4, first-line treatment may include maintenance therapy after complete clinical or pathological response;Previously not receiving targeted HER2 drug therapy (including monoclonal antibodies and ADC drugs) * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry; * Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); * Estimated life expectancy of more than 3 months; * Local laboratory confirmed HER2 expression: IHC 1+, 2+, or 3+; Subjects were able to provide samples of the primary or metastatic site of the tumor for HER2 detection（Paraffin blocks, paraffin embedded sections or fresh tissue sections ） * Adequate haematological, hepatic and renal functions defined by the protocol; * Negative blood pregnancy test at Screening for women of childbearing potential; Highly effective contraception for female subjects if the risk of conception exists; Exclusion Criteria: * The pathological type is non epithelial ovarian/fallopian tube/peritoneal cancer or metastatic ovarian cancer; * The patient has ≥ grade 2 peripheral neuropathy; * Patients with active bleeding or pathological conditions with high risk of bleeding, such as known hemorrhagic diseases, coagulation disorders, or tumors involving large blood vessels; * Suffering from central nervous system metastasis and/or cancerous meningitis. Except for stable brain metastases; 5.The toxicity caused by previous anti-tumor treatments has not yet recovered to CTCAE (version 5.0) level 0-1 (excluding 2nd degree hair loss); * Patients who require parenteral hydration or nutrition and have evidence of partial intestinal obstruction or perforation; * Except for patients with primary endometrial cancer or a history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-B stage; No more than superficial muscle infiltration, no vascular or lymphatic infiltration; No poorly differentiated subtypes, including papillary fluid, clear cells, or other FIGO grade 3 lesions; * For patients undergoing cell reduction surgery before treatment, if combined with bevacizumab, they must wait for at least 28 days before starting the treatment with bevacizumab; * Have undergone major surgery within 4 weeks prior to the start of study administration and have not fully recovered; * A large amount of pleural or ascitic fluid accompanied by clinical symptoms or requiring symptomatic treatment; * Within 30 days of initial medication or expected to receive attenuated live vaccines during the study period; * Serious arterial/venous thrombotic events or cardiovascular and cerebrovascular accidents that occurred within one year prior to drug administration were studied; * There are systemic diseases that have not been controlled stably according to the judgment of the researcher, including diabetes, liver cirrhosis (Child Pugh Class B or C), interstitial pneumonia, obstructive pulmonary disease, etc; * Clinically significant cardiovascular disease patients(According to the specific requirements of the plan); * Individuals with active autoimmune diseases or immunodeficiency, or a history of the aforementioned conditions, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituitary inflammation, vasculitis, nephritis, etc., shall not be included. The following exceptions apply: Patients with a history of autoimmune hypothyroidism who have received thyroid hormone replacement therapy may be included in the study. Patients with type 1 diabetes whose blood sugar can be controlled after treatment with insulin administration scheme can participate in this study; * Subjects with a history of other malignant tumors within five years (excluding complete treatment for in situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma skin cancer); * Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 2000 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C; * Severe infection (e.g. need for intravenous antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever (\>38.5%) of unknown reason occurred during the screening period/before the first administration； * Currently participating in intervention clinical research treatment, or receiving other investigational drugs or research instruments within 4 weeks prior to the first administration; Not fully recovered from toxicity and/or complications caused by any intervention measures prior to initial administration (i.e. ≤ level 1 or reaching baseline, excluding fatigue or hair loss); * Has a clear history of allergies and may have potential allergies or intolerance to the investigational drug and its similar biological agents; * Individuals with a history of abuse of psychotropic substances who are unable to quit or have mental disorders; **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** zhhong306@hotmail.com **Name:** Hong Zheng, M.D. **Phone:** 86-010-88196100 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Contacts:** ***Contact 1:*** - **Email:** zhhong306@hotmail.com - **Name:** Hong Zheng, PhD - **Phone:** 13641356816 - **Role:** CONTACT **Country:** China **Facility:** Hong Zheng **State:** Beijing **Status:** RECRUITING **Zip:** 100142 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC20 - Name: Immune System Diseases - 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: M12974 - Name: Ovarian Neoplasms - Relevance: LOW - As Found: Unknown - ID: M1704 - Name: Carcinoma, Ovarian Epithelial - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14850 - Name: Recurrence - 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: T4352 - Name: Ovarian Cancer - Relevance: HIGH - As Found: Ovarian Cancer - ID: T4354 - Name: Ovarian Epithelial Cancer - Relevance: LOW - As Found: Unknown - ID: T2189 - Name: Fallopian Tube Cancer - Relevance: HIGH - As Found: Fallopian Tube Carcinoma ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000020533 - Term: Angiogenesis Inhibitors - ID: D000043924 - Term: Angiogenesis Modulating Agents - ID: D000006133 - Term: Growth Substances - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000006131 - Term: Growth Inhibitors ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M18650 - Name: Carboplatin - Relevance: HIGH - As Found: System - ID: M246 - Name: Bevacizumab - Relevance: HIGH - As Found: Non- - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown - ID: M9231 - Name: Growth Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000068258 - Term: Bevacizumab - ID: D000016190 - Term: Carboplatin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420960 **Acronym:** WAHOE **Brief Title:** Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG **Official Title:** Rentabilité Diagnostique Des Montres connectées Par Rapport au Holter ECG Externe Dans l'Expertise Des Palpitations Fugaces Symptomatiques Sans Documentation électrocardiographique Per Critique. #### Organization Study ID Info **ID:** HNO23_0001 #### Organization **Class:** OTHER **Full Name:** L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône #### Secondary ID Infos **Domain:** ANSM **ID:** 2023-A01853-42 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2027-02-17 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-01-18 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-17 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône #### 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:** Palpitations are a frequent reason for consultation (16% of total volume) and management in the emergency department. Conventional diagnostic management in our establishment is based on a 48-hour external ECG holter, combined with a stress test if symptoms are triggered by physical activity. The diagnostic difficulty lies in the frequency and duration of this transient symptom. At the time of consultation, the patient is often asymptomatic. The initial strategy is to demonstrate an electrocardiographic trace during the attack, in order to adapt management to the chosen etiology. The HOLTER ECG is the gold standard, but it is not very cost-effective due to the infrequent and random nature of the onset of symptoms. The advent of accessible connected tools such as connected watches seems to be an interesting alternative for acquiring a per-critical trace of symptoms. They are widely adopted by the general population, with ease of use by the individual and long monitoring times. The main aim of the study is to establish the diagnostic cost-effectiveness of one or other of the two diagnostic strategies (rate of identification of the causal arrhythmia) at 6 months from the cardiological consultation. ### Conditions Module **Conditions:** - Heart Disease **Keywords:** - palpitations - yield diagnostic - connected watch - device - HOLTER ECG - monitoring - profitability ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 81 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All patients will be equipped by HOLTER for 48-hour monitoring, with an event form to be filled in, at the same time as receiving a connected watch for a 6 -months period. They will be asked to record an ECG with the watch only when they experience symptoms that have included them in the study **Intervention Names:** - Device: Wearing the connected watch **Label:** connected watch **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** All patients will be equipped by HOLTER for 48-hour monitoring, with an event form to be filled in, at the same time as receiving a connected watch for a 6 -months period. They will be asked to record an ECG with the watch only when they experience symptoms that have included them in the study **Intervention Names:** - Device: Wearing the connected watch **Label:** HOLTER ECG 48 hours **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - HOLTER ECG 48 hours - connected watch **Description:** All patients will receive a connected watch from the research associate, along with instructions on its usage and support for creating an account on the Healtmate application using an anonymized e-mail address. They will be able to transmit up to 3 ECG tracings deemed to be per-critical. A follow-up phone call at 2- months will assess understanding of the device and its proper use, as well as the occurrence of adverse events and compliance. **Name:** Wearing the connected watch **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** We will compare the diagnostic performance of the connected watch with the HOLTER ECG, by identifying a symptomatic arrhythmia, , in the purpose of a faster and adapted cardiological management. **Measure:** Rate of diagnostic profitability of the connected watch compared with the conventional procedure (48-hour ECG Holter). **Time Frame:** at 6 months or when the watch is returned, whether a diagnosis has been made or whether there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia. #### Secondary Outcomes **Description:** A diagnosis is defined by the documentation of an objective cardiac arrhythmia (focal atrial tachycardia/atrial fibrillation HR \>110 bpm/atrial fibrillation HR\<110 bpm/atrial flutter/junctional tachycardia/sustained or non-sustained ventricular tachycardia/peak tachycardia/sinus tachycardia/ventricular fibrillation/high-degree conduction disorder) concomitant with the symptomatology motivating the initial consultation. **Measure:** Type of diagnosis recorded. **Time Frame:** at 6 months or when the watch is returned if a diagnosis has been made. **Description:** Symptomatic objective cardiac arrythmia recorded with the smarwatch, the HOLTER or the both **Measure:** Rate of concomitant diagnoses with either device **Time Frame:** at 6 months or when the watch is returned if a diagnosis has been made. **Description:** Rate of ECGs failing to explain symptomatology (no ECG abnormality detected ECG) Time Frame : at 6 months or when the watch is returned if a diagnosis has been made or if there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia. **Measure:** Rate of causal non-rhythmological diagnosis (symptoms without pathological per-critical ECG tracing) **Time Frame:** at 6 months or when the watch is returned if a diagnosis has been made or if there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia. **Description:** Fitting of holter ECG equipment, handover of watch and explanation of how it works, analysis of holter/ ECG tracings, reconsultation) **Measure:** Medical/paramedical time per diagnosis and per patient **Time Frame:** at 6 months or when the watch is returned, whether a diagnosis has been made or whether there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * - Any patient consulting for the main reason of \&#34;palpitations\&#34; without a previous diagnosis of arrhythmia, unless the current symptomatology appears different from that associated with the previous rythmological diagnosis; * Palpitations requiring cardiological consultation or emergency hospital treatment; * Absence of suggestive diagnosis on intercritical 12-lead ECG (pre-excitation, AVB M2/3, high-grade atrioventricular block, non-sustained tachyventricular, atrial fibrillation with heart rate \&gt; 110 per minute, atrial tachycardia or flutter); * Non-contributory stress test (no electrical abnormality, occurrence of arrhythmia or reproduction of palpitations) if isymptoms occur during exercise; * Accepts to wear the watch all the time outside the charging time; * Using a personal smartphone or tablet compatible with the Health Mate application and with an Internet connection; * Affiliated with a social security system ; * Providing dated and signed an informed consent form. Exclusion Criteria: * - Refusal to wear the connected watch; * Refusal to use the watch provided for the study because they use a personal connected watch; * Unable to use the connected watch (lack of understanding of its use and rationale); * No smartphone; * Wearer of an implantable device (PM, ICD); * Already known and treated arrhythmia with identical symptoms; * Heart disease with indication for primary/secondary prevention implantable device; * Associated syncope; * Obvious extra-cardiac cause; * Pregnant or breast-feeding woman; * Inability to undergo study follow-up for geographical, linguistic, social or psychological reasons; * Participating in another clinical study which can interfere with this study * Patient under guardianship or deprived of liberty. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** olevavasseur@hno.fr **Name:** OLIVIER LE VAVASSEUR, MEDECINE **Phone:** 0474092753 **Phone Ext:** +33 **Role:** CONTACT **Contact 2:** **Email:** cperrier@hno.fr **Name:** COLINE PERRIER, ARC **Phone:** 0474092473 **Phone Ext:** +33 **Role:** CONTACT #### Locations **Location 1:** **City:** Gleize **Contacts:** ***Contact 1:*** - **Email:** recherche@hno.fr - **Name:** COLINE PERRIER, ARC - **Phone:** 0474092473 - **Phone Ext:** +33 - **Role:** CONTACT ***Contact 2:*** - **Name:** OLIVIER LE VAVASSEUR, MEDECINE - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Hopitaux Nord-Ouest Villefranche Sur Saone **Zip:** 69400 ### IPD Sharing Statement Module **Description:** Confidentialité et protection de la vie privée : Le partage des données IPD pourrait compromettre la confidentialité et la protection de la vie privée des participants. Les données individuelles, même anonymisées, pourraient potentiellement être utilisées pour identifier des individus, en particulier dans le cas de petites cohortes ou de données sensibles. Sensibilité des données : Les données IPD inclusent des informations sensibles sur la santé. Le partage de telles données est soumis à des réglementations strictes sur la protection des données et nécessite des mesures supplémentaires pour garantir la sécurité et la confidentialité. Ressources et coûts : Le partage des IPD nécessite des ressources supplémentaires pour l'anonymisation, la gestion et la mise à disposition des données. Nous n'avons pas les ressources nécessaires pour effectuer ces tâches car notre budget est limité. **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: M9419 - Name: Heart Diseases - Relevance: HIGH - As Found: Heart Disease ### Condition Browse Module - Meshes - ID: D000006331 - Term: Heart Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420947 **Brief Title:** Application of Electrically Driven Atomized Surface Anesthesia **Official Title:** Application of Electrically Driven Atomized Surface Anesthesia to Awake Endotracheal Intubation in Patients With Predictably Difficult Airway. #### Organization Study ID Info **ID:** Henan xixi #### Organization **Class:** OTHER **Full Name:** Henan Provincial People's Hospital ### Status Module #### Completion Date **Date:** 2022-08-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-05-31 **Type:** ACTUAL #### Start Date **Date:** 2021-01-29 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Henan Provincial People's Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a parallel and randomized-controlled clinical study aimed to identify the optimized size of atomized particles of 2% lidocaine that can provide the best topical anesthesia during ATI. To determine the effect of nebulization with different sizes of atomized particles of 2% lidocaine on cough, reaction, and comfort during ATI in patients with predicted difficult airway. ### Conditions Module **Conditions:** - Anesthesia, Endotracheal **Keywords:** - Lidocaine atomized particles - Nebulization - Awake tracheal intubation - Individual topicalization technique ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 230 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in the A group received 2% lidocaine by A model atomizer. **Intervention Names:** - Other: atomizer **Label:** Group A **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in the B group received 2% lidocaine by B model atomizer. **Intervention Names:** - Other: atomizer **Label:** Group B **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants in the C group received 2% lidocaine by C model atomizer. **Intervention Names:** - Other: atomizer **Label:** Group C **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Participants in the D group received 2% lidocaine by D model atomizer. **Intervention Names:** - Other: atomizer **Label:** Group D **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A - Group B - Group C - Group D **Description:** Participants received 2% lidocaine by atomizer. **Name:** atomizer **Other Names:** - a wearable and disposable vibrating mesh nebulizer **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Investigators will record cough score during intubation. **Measure:** cough score **Time Frame:** during intubation #### Secondary Outcomes **Description:** Investigators will record reaction and discomfort scores during intubation. **Measure:** reaction and discomfort scores **Time Frame:** during intubation. **Description:** endotracheal tube insertion inflation of the tracheal tube cuff systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR) **Measure:** intraoperative hemodynamic parameters **Time Frame:** endotracheal tube insertion, inflation of the tracheal tube cuff and 1 minute after endotracheal tube insertion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients with distinctly difficult airways：(1) Patients with medical history indicating difficult airways.(2) Patients suffering from severe burn scars.(3) Patients suffering from severe obstructive sleep apnea syndrome.(4)Patients suffering from severe congenital dysplasia. Patients with suspected difficult airway: Patients with risk factors underwent a medical history for evaluation:(1)Patients with ankylosing spondylitis.(2) Patients with rheumatoid arthritis.(3)Patients with degenerative osteoarthritis.(4)Patients with epiglottitis. (5)Patients with acromegaly.(6)Patients with morbid obesity.(7)Patients with subglottic stenosis. (8) Patients with enlarged thyroid or tonsils.(9)Patients with mediastinal mass.(10)Patients with throat tumors. Patients with risk factors underwent a physical examination for evaluation:(1)Patients with BMI \> 26 kg/m2. (2)Patients with Mallampati class 3 or 4. (3)Patients with thyromental distance\<60 mm (corresponding to an average distance of 3 finger breadths).(4)Patients with limited mouth opening with interincisor distance\<30 mm.(5)edentulous patients.(6)When the patient closed his mouth in a natural state, the upper incisor was situated in front of the lower incisor.(7)When the mandible is extended forward, the lower incisors of the patient can not protrude beyond the upper incisors.(8)The patient's jaw exhibits stiffness, with minimal elasticity or presence of a tumor.(9)The patients have a short neck with a thick circumference.(10)The patients are unable to touch their chest wall with their jaw, or extend their neck.(11)The patients's palate shape is either characterized by a high arch or is extremely narrow. Exclusion Criteria:(1) refusal to participate in the study; (2) airway bleeding; and (3) known allergies to local anesthetics. - **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 19 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Zhengzhou **Country:** China **Facility:** Henan Provincial People's Hospital **State:** Henan **Zip:** 450003 #### Overall Officials **Official 1:** **Affiliation:** Henan Provincial People's Hospital **Name:** Jiaqiang Zhang, PHD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M11014 - Name: Lidocaine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420934 **Brief Title:** Surgical Handwashing: Drying With One or Two Surgical Towels **Official Title:** Comparison of the Breach of the Aseptic Barrier After Surgical Handwashing: Drying With One or Two Surgical Towels #### Organization Study ID Info **ID:** 2022121502-001 #### Organization **Class:** OTHER **Full Name:** Instituto de Ortopedia Infantil Roosevelt ### Status Module #### Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-26 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Hospital Universitario San Ignacio **Class:** OTHER **Name:** Hospital Militar Central, Argentina #### Lead Sponsor **Class:** OTHER **Name:** Instituto de Ortopedia Infantil Roosevelt #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to determine whether the use of two sterile towels for drying after surgical handwashing results in fewer contamination events compared to the use of only one towel among healthcare personnel. This randomized, multicenter, superiority-controlled trial will enroll up to 72 healthcare workers and surgical residents from three hospitals in Bogotá, Colombia. A fluorescent product will simulate bacteria, and contamination will be assessed by evaluating the presence of fluorescent cream after hand drying technique with either two or one surgical sterile towel. Data will be collected through REDCap and deidentified. Differences in the proportion of contamination between the two groups will be assessed using an exact Fischer test, and confounding variables will be included in the analysis through logistic multivariate regression, with a significance level set a priori at 0.05. Results will be submitted for publication in a peer-reviewed journal. **Detailed Description:** Approval was obtained from the ethics committee of three healthcare institutions. A process of informed consent will be conducted with all participants, and confidentiality and data protection will be guaranteed. A research assistant, unaware of the operational hypotheses and study objectives, will execute the experiment and record the results. There will be no blinding of the intervention for the participants or the assistant. At each institution, randomization will be conducted a priori to determine the operating room where participants should be recruited. Likewise, the intervention to be administered will be randomized. All these data will be stored in opaque envelopes that will be opened at the time of recruitment. A total of 72 participants will be recruited, with 36 exposed to drying with one towel and 36 to drying with two towels. Recruitment will cease upon completion of the respective participants stipulated for each intervention. The primary outcome of interest will be the presence or absence of contamination. To evaluate this outcome, the gold standard would be the collection of cultures and the analysis of the presence or absence of bacterial contamination. However, due to the costs and methodological difficulties of taking cultures, an indirect method, previously validated as a surrogate, will be employed instead. 2 mL of fluorescent cream (Glo Germ ™) will be applied with a brush proximal to the normally washed area during surgical scrubbing (3 cm above the elbow). Participants will be shown a video on how to dry with one or two surgical towels and will be given one minute to do so. Subsequently, the presence or absence of fluorescent cream on the upper extremities will be evaluated using a UV light lamp. If fluorescence is evidenced in the washed area where it was not applied, it will be considered that there was contamination during the hand drying process. No interim analyses will be executed. Data will be de-identified for the analysis. Descriptive statistics will be conducted using R studio, and proportions of contamination when drying with one or two towels will be compared. A simple logistic regression will be performed to assess the relationship between the intervention and the proportion of contamination events, and a multivariate logistic regression will be conducted to assess the effect of confounding variables on the outcome. The results will be reported collectively for publication in a peer-reviewed journal. ### Conditions Module **Conditions:** - Hand Hygiene - Surgical Wound Infection - Healthcare Associated Infection - Medical Errors **Keywords:** - Surgical Scrubbing - Handwashing - Disinfection - Healthcare Associated Infection - Hand Hygiene ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** Masking will be provided to data analysis expert. **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 72 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will be asked to remove all accessories from the forearm, wrist, fingers and to roll up any clothing until at least 5 cm above the humeral condyles are exposed. They will be instructed to perform conventional surgical scrubbing and to dry their hands with a conventional paper towel. The research assistant will open the opaque envelope, which will indicate that the participant needs to dry their hands with one surgical towel. **Intervention Names:** - Other: Drying procedure after surgical handwashing **Label:** One surgical towel **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Participants will be asked to remove all accessories from the forearm, wrist, fingers and to roll up any clothing until at least 5 cm above the humeral condyles are exposed. They will be instructed to perform conventional surgical scrubbing and to dry their hands with a conventional paper towel. The research assistant will open the opaque envelope, which will indicate that the participant needs to dry their hands with two surgical towels, one for each hand. **Intervention Names:** - Other: Drying procedure after surgical handwashing **Label:** Two surgical towel **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - One surgical towel - Two surgical towel **Description:** Participants will dry their hands with one surgical towel **Name:** Drying procedure after surgical handwashing **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Presence or absence of fluorescent cream on the upper extremities will be evaluated using a UV light lamp in a dark room. If fluorescence is observed in the washed area where it was not applied, it will be considered that there was contamination during the hand drying process. **Measure:** Contamination **Time Frame:** 3 minutes after handwash and hand drying. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Workers and students who have a current affiliation with the institutions where the study will be executed. * Workers and students whose practice or work involves performing surgical handwashing at least once a week for invasive procedures. Exclusion Criteria: * Workers and students who do not wish to participate in the study. * Workers and students whose work activities do not allow them time to participate in the study. * Workers and students who are allergic to the fluorescent cream * Workers and students whose nails exceed a length of 0.5 cm from the fingertip edge. * Workers and students whose nails are painted with polish. * Workers and students who refuse to remove jewelry and accessories from wrists and hands. * Workers and students with recent wounds on hands or forearms, including tattoos done in the last month. * Workers and students who do not adhere to the handwashing and drying technique taught prior to the study's implementation. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** monica.botero@javeriana.edu.co **Name:** Monica Botero-Bermúdez, MD, MSc **Phone:** +573203049826 **Role:** CONTACT **Contact 2:** **Email:** f.garcia@ioir.org.co **Name:** Maria F Garcia, MD, MSc **Phone:** +573208541343 **Role:** CONTACT #### Locations **Location 1:** **City:** Bogotá **Contacts:** ***Contact 1:*** - **Email:** f.garcia@ioir.org.co - **Name:** Maria Fernanda Garcia, MD, MSc - **Phone:** +573208541343 - **Role:** CONTACT ***Contact 2:*** - **Email:** mquiroga@ioir.org.co - **Name:** Manuela Quiroga-Carrillo, MD - **Phone:** +576013534000 - **Phone Ext:** 263 - **Role:** CONTACT ***Contact 3:*** - **Name:** Monica Botero-Bermúdez, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Maria F Garcia-Rueda, MD - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Sergio Nossa-Almanza, MD - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Ana M Prado-Quintero, MD - **Role:** SUB_INVESTIGATOR ***Contact 7:*** - **Name:** Juan P Melo - **Role:** SUB_INVESTIGATOR **Country:** Colombia **Facility:** Instituto Ortopedia Infantil Roosevelt **State:** Bogotá D.C. **Status:** RECRUITING **Zip:** 110231 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** WHO Guidelines on Hand Hygiene in Health Care: First Global Patient Safety Challenge Clean Care Is Safer Care. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK144013/ **PMID:** 23805438 **Citation:** Nicolay CR. Hand hygiene: an evidence-based review for surgeons. Int J Surg. 2006;4(1):53-65. doi: 10.1016/j.ijsu.2005.06.002. Epub 2005 Aug 1. **PMID:** 17462314 **Citation:** Huang C, Ma W, Stack S. The hygienic efficacy of different hand-drying methods: a review of the evidence. Mayo Clin Proc. 2012 Aug;87(8):791-8. doi: 10.1016/j.mayocp.2012.02.019. Epub 2012 May 31. **PMID:** 22656243 **Citation:** Gustafson DR, Vetter EA, Larson DR, Ilstrup DM, Maker MD, Thompson RL, Cockerill FR 3rd. Effects of 4 hand-drying methods for removing bacteria from washed hands: a randomized trial. Mayo Clin Proc. 2000 Jul;75(7):705-8. doi: 10.4065/75.7.705. **PMID:** 10907386 **Citation:** Suen LKP, Lung VYT, Boost MV, Au-Yeung CH, Siu GKH. Microbiological evaluation of different hand drying methods for removing bacteria from washed hands. Sci Rep. 2019 Sep 24;9(1):13754. doi: 10.1038/s41598-019-50239-4. **PMID:** 31551459 **Citation:** Mutters R, Warnes SL. The method used to dry washed hands affects the number and type of transient and residential bacteria remaining on the skin. J Hosp Infect. 2019 Apr;101(4):408-413. doi: 10.1016/j.jhin.2018.12.005. Epub 2018 Dec 8. **PMID:** 30537524 **Citation:** Handaya AY, Werdana VAP. Adherence to preoperative hand hygiene and sterile gowning technique among consultant surgeons, surgical residents, and nurses: a pilot study at an academic medical center in Indonesia. Patient Saf Surg. 2019 Mar 11;13:11. doi: 10.1186/s13037-019-0193-5. eCollection 2019. **PMID:** 30899331 **Citation:** Skodova M, Garcia Urra F, Gimeno Benitez A, Jimenez Romano MR, Gimeno Ortiz A. Hand hygiene assessment in the workplace using a UV lamp. Am J Infect Control. 2015 Dec 1;43(12):1360-2. doi: 10.1016/j.ajic.2015.07.003. Epub 2015 Aug 18. **PMID:** 26297523 **Citation:** Szilagyi L, Lehotsky A, Nagy M, Haidegger T, Benyo B, Benyo Z. Stery-hand: A new device to support hand disinfection. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:4756-9. doi: 10.1109/IEMBS.2010.5626377. **PMID:** 21096021 **Citation:** Sakmen KD, Sterz J, Stefanescu MC, Zabel J, Lehmann M, Ruesseler M. Impact of the teaching method of the rub-in technique for learning hygienic hand disinfection in medical studies: a comparative effectiveness analysis of two techniques. GMS Hyg Infect Control. 2019 Nov 13;14:Doc17. doi: 10.3205/dgkh000332. eCollection 2019. **PMID:** 31815090 **Citation:** Marena C, Lodola L, Zecca M, Bulgheroni A, Carretto E, Maserati R, Zambianchi L. Assessment of handwashing practices with chemical and microbiologic methods: preliminary results from a prospective crossover study. Am J Infect Control. 2002 Oct;30(6):334-40. doi: 10.1067/mic.2002.125809. **PMID:** 12360141 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000014947 - Term: Wounds and Injuries - ID: D000011183 - Term: Postoperative Complications - ID: D000007049 - Term: Iatrogenic Disease ### 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: M17685 - Name: Wounds and Injuries - 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: M6642 - Name: Cross Infection - Relevance: HIGH - As Found: Healthcare Associated Infection - ID: M1112 - Name: Surgical Wound - Relevance: HIGH - As Found: Surgical Wound - ID: M17684 - Name: Wound Infection - Relevance: HIGH - As Found: Wound Infection - ID: M16310 - Name: Surgical Wound Infection - Relevance: HIGH - As Found: Surgical Wound Infection - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M10099 - Name: Iatrogenic Disease - Relevance: LOW - As Found: Unknown - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007239 - Term: Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000014946 - Term: Wound Infection - ID: D000013530 - Term: Surgical Wound Infection - ID: D000003428 - Term: Cross Infection - ID: D000072836 - Term: Surgical Wound ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420921 **Acronym:** MIRACLE **Brief Title:** MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE **Official Title:** MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE #### Organization Study ID Info **ID:** 2023-153 #### Organization **Class:** INDUSTRY **Full Name:** Institut Pasteur ### Status Module #### Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Institut de l'Audition #### Lead Sponsor **Class:** INDUSTRY **Name:** Institut Pasteur #### 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 interventional study is to describe how people with cochlear implants perceive the perceive speech in noise and their sound environment on adults who are native French speakers with typical hearing or with cochlear implant(s). The measures and strategies developed in this project could benefit all current and future cochlear implant wearers by improving their perception of the sound environment and their quality of life on a daily basis. Researchers will compare normal hearing participant and participants with cochlear implant to describe the speech in noise and their perception of the sound environment. Participants will perform audiological tests to assess their perception of the sound environment, with and without speech enhancement. ### Conditions Module **Conditions:** - Cochlear Hearing Loss ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Speech in noise comprehension test - Behavioral: Objective tests of perception of ambient sound cues in noise - Behavioral: Subjective tests of perception of ambient sound cues in noise **Label:** Participants with cochlear implant **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Behavioral: Speech in noise comprehension test - Behavioral: Objective tests of perception of ambient sound cues in noise - Behavioral: Subjective tests of perception of ambient sound cues in noise **Label:** Normal hearing participants **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Normal hearing participants - Participants with cochlear implant **Description:** Speech in noise comprehension tests consisting of listening to a speech source and one or more competing sources (noise, speech or sound cues) simultaneously. The volunteers will have to repeat the speech source in order to assess intelligibility for each situation, as a function of the intensity ratio of the two sources (SNR). **Name:** Speech in noise comprehension test **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Normal hearing participants - Participants with cochlear implant **Description:** Tests of perception of the sound environment consisting of listening to a source of noise, sound cues and a competing source of speech simultaneously. The volunteers will have to identify sound cues in order to assess the ability to perceive the sound environment for each situation, depending on the intensity ratio of the different sources. **Name:** Objective tests of perception of ambient sound cues in noise **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Normal hearing participants - Participants with cochlear implant **Description:** Tests of perception of the sound environment consisting of listening to a source of noise, sound cues and a competing source of speech simultaneously. Using a simple interface, the volunteers will have to identify the intensity ratio of the sources that they consider to be the best compromise between understanding speech and perceiving the sound environment. **Name:** Subjective tests of perception of ambient sound cues in noise **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Measure:** percentage of environmental sound cues correctly identified when presented simultaneously with other signals **Time Frame:** 2 years #### Secondary Outcomes **Measure:** comparison of the percentages of correctly identified environmental sound cues obtained objectively and deduced from the signal-to-noise ratio corresponding to the trade-off indicated by the participant **Time Frame:** 2 years **Measure:** the percentages of words correctly repeated by participants using non-personalised speech enhancement strategies **Time Frame:** 2 years **Measure:** percentages of words correctly repeated by participants using personalised speech enhancement strategies **Time Frame:** 2 years **Measure:** comparison of the percentages of correctly identified sound cues and the SNR corresponding to the subjective trade-off **Time Frame:** 2 years **Measure:** percentages of sound cues correctly identified by the participants using non-personalised speech enhancement strategies **Time Frame:** 2 years **Measure:** percentages of sound cues correctly identified by the participants using personalised speech enhancement strategies **Time Frame:** 2 years **Measure:** comparison of percentages of words correctly repeated **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: For all participants: * 18 years of age or over, * Native French speaker, * Having given their consent to take part in the research. For cochlear implant patients: * Adult implanted and declaring that they have been using the implant for at least 18 months, * Normal speech audiometry in silence For controls reporting normal hearing: * Normal tonal audiometry (defined as a mean tonal loss not exceeding 30 decibel (dB) HL) * Normal speech audiometry in noise (SNR between -8 dB and -4dB inclusive) Exclusion Criteria: * Be under guardianship or curatorship, * deprived of liberty by judicial or administrative decision, or subject to legal protection, * Non- native French speaker. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** clement.gaultier@pasteur.fr **Name:** Clément Gaultier, PhD **Phone:** 0176535126 **Phone Ext:** +33 **Role:** CONTACT **Contact 2:** **Email:** paul.avan@pasteur.fr **Name:** Paul Avan, MD **Role:** CONTACT #### Locations **Location 1:** **City:** Paris **Country:** France **Facility:** CEntre de Recherche et d'Innovation en Audiologie Humaine **Zip:** 75015 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006311 - Term: Hearing Disorders - ID: D000004427 - Term: Ear Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M24420 - Name: Hearing Loss - Relevance: HIGH - As Found: Hearing Loss - ID: M6840 - Name: Deafness - Relevance: LOW - As Found: Unknown - ID: M9407 - Name: Hearing Loss, Sensorineural - Relevance: HIGH - As Found: Cochlear Hearing Loss - ID: M9400 - Name: Hearing Disorders - Relevance: LOW - As Found: Unknown - ID: M7601 - Name: Ear Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000034381 - Term: Hearing Loss - ID: D000006319 - Term: Hearing Loss, Sensorineural ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420908 **Brief Title:** Adebrelimab Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) **Official Title:** Induction Adebrelimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC): A Prospective, Single-arm, Phase II Clinical Study #### Organization Study ID Info **ID:** ARL-ESCC-001 #### Organization **Class:** OTHER **Full Name:** Hebei Medical University Fourth Hospital ### Status Module #### Completion Date **Date:** 2027-05-30 **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:** 2026-05-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hebei Medical University Fourth Hospital #### Responsible Party **Investigator Affiliation:** Hebei Medical University Fourth Hospital **Investigator Full Name:** Jun wang **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aims to evaluate the efficacy and safety of induction Adebrelimab (anti-PD-L1 antibody) combined with chemotherapy, then guided by PET-CT assessment to change the following chemoradiotherapy regiment for locally advanced unresectable ESCC. ### Conditions Module **Conditions:** - Esophageal Squamous Cell Carcinoma ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** SUV (PETr) reduction \>35% **Intervention Names:** - Drug: Adebrelimab+TP/FP+ radiation therapy **Label:** PET-CT responders **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** SUV (PETr) reduction ≤35% **Intervention Names:** - Drug: Adebrelimab+FP/TP+ radiation therapy **Label:** PET-CT non-responders **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - PET-CT responders **Description:** Induction stage： Adebrelimab : 1200mg d1, iv, q3w TP : nab-paclitaxel paclitaxel 180mg/m2, or paclitaxel 135-175mg/m2, d1, iv; carboplatin AUC=5-6, d1, iv, q3w FP : fluorouracil 400mg/m2, 2400 mg/m2 (48 hours), d1; cisplatin 75mg/m2, d1, iv, q3w 2 cycles; Treatment stage: TP : nab-paclitaxel paclitaxel 60-70mg/m2, or paclitaxel 75mg/m2, d1, iv; carboplatin AUC=5, d1, iv, q3w FP : fluorouracil 300mg/m2/d, iv; cisplatin 75mg/m2, d1, iv, q3w Radiation therapy (50.4Gy-60Gy/28-33f); Consolidation stage: Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs. **Name:** Adebrelimab+TP/FP+ radiation therapy **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - PET-CT non-responders **Description:** Induction stage： Adebrelimab : 1200mg d1, iv, q3w TP : nab-paclitaxel paclitaxel 180mg/m2, or paclitaxel 135-175mg/m2, d1, iv; carboplatin AUC=5-6, d1, iv, q3w FP : fluorouracil 400mg/m2, 2400 mg/m2 (48 hours), d1; cisplatin 75mg/m2, d1, iv, q3w 2 cycles; Treatment stage: (switch to a different chemotherapy drug which not used during the earlier induction phase) FP : fluorouracil 300mg/m2/d, iv; cisplatin 75mg/m2, d1, iv, q3w TP : nab-paclitaxel paclitaxel 60-70mg/m2, or paclitaxel 75mg/m2, d1, iv; carboplatin AUC=5, d1, iv, q3w Radiation therapy (50.4Gy-60Gy/28-33f); Consolidation stage: Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs. **Name:** Adebrelimab+FP/TP+ radiation therapy **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Baseline to measured date of progression or death from any cause **Measure:** Progression free survival (PFS) **Time Frame:** evaluated in 24 months since the treatment began #### Secondary Outcomes **Description:** Baseline to measured stable disease **Measure:** 1. Objective response rate (ORR) **Time Frame:** tumor assessment every 6 weeks since the treatment began，up to 24 monthss **Description:** The duration of overall response is measured from the time that measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented. **Measure:** 2. Duration of Overall Response（DoR） **Time Frame:** tumor assessment every 6 weeks since the treatment began，up to 24 months **Description:** Baseline to measured date of death from any cause **Measure:** 3. Overall survival (OS) **Time Frame:** the first day of treatment to death or last survival confirm date,up to 24 months **Description:** Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. The number of Participants with adverse events will be recorded at each treatment visit. **Measure:** 4. Adverse events **Time Frame:** up to 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1.Age 18-75 years old, both men and women; 2.Histopathology confirmed as esophageal squamous cell carcinoma，stage II-IVa：T1N2-3M0，T2-4bN+M0； 3.If technically feasible, all patients are recommended to have local staging determined by endoscopic ultrasound (EUS); The endoscopic examination report or gastrointestinal (GI) clinical records should clearly indicate the T and N stages; Perform PET-CT examination; 4.Except for basal or squamous cell skin cancer, bladder cancer in situ or cervical cancer, there is no history of malignant tumor within 5 years; Patients with malignant tumors who have undergone surgical treatment in the past and those who have survived disease-free for more than 5 years meet the inclusion criteria; 5.Have not received any systemic anti-tumor treatment in the past (systemic chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) 6.According to RECIST 1.1, at least one measurable lesion; 7.ECOG: 0\~1; 8.Expected survival period ≥ 12 weeks; 9.Major organ function has to meet the following certeria: 1. Blood routine examination: 1. HB≥90g/L; 2. ANC ≥ 1.5 × 109 / L; 3. PLT ≥ 100 × 109 / L; 2. Biochemical examination: 1. ALT and AST \< 2.5×ULN; 2. TBIL ≤ 1.5×ULN; 3. Cr ≤ 1.5×ULN; 9. Left ventricular ejection fraction (LVEF) ≥50%; 11. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment And must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 12. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up. Exclusion Criteria: 1. Previous history of esophageal cancer surgery； 2. Higher risk of esophageal perforation or fistula； 3. Received systemic immunosuppressive therapy within 14 days prior to the first study medication； 4. Known or suspected to have interstitial pneumonia; Other moderate to severe lung diseases that may seriously affect respiratory function; 5. The patient has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, enteritis, systemic lupus erythematosus, rheumatoid arthritis; patients with vitiligo, Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included); 6. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 1000 copies/ml or 500IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method)； 7. Within 6 months, cerebral vascular accidents (including transient ischemic attacks or symptomatic pulmonary embolism) occur; 8. History of cardiovascular disease with significant clinical significance, including but not limited to: (1) congestive heart failure (NYHA grade\>2); (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within 3 months; (4) Any supraventricular arrhythmias or ventricular arrhythmias that require treatment or intervention; 9. Severe infections within 4 weeks before study drug administration, or active infection with CTCAE ≥ 2 grade treated with antibiotics within 2 weeks before study drug administration; 10. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 12. The researchers think inappropriate. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** wangjunzr@163.com **Name:** Jun Wang, Dr. **Phone:** 13931182128 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000018307 - Term: Neoplasms, Squamous Cell - ID: D000004938 - Term: Esophageal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M5550 - Name: Carcinoma, Squamous Cell - Relevance: HIGH - As Found: Squamous Cell Carcinoma - ID: M1733 - Name: Esophageal Squamous Cell Carcinoma - Relevance: HIGH - As Found: Esophageal Squamous Cell Carcinoma - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M20451 - Name: Neoplasms, Squamous Cell - Relevance: LOW - As Found: Unknown - ID: M8088 - Name: Esophageal 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: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8085 - Name: Esophageal Diseases - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000002294 - Term: Carcinoma, Squamous Cell - ID: D000077277 - Term: Esophageal Squamous Cell Carcinoma ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M19537 - Name: Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M18650 - Name: Carboplatin - Relevance: LOW - As Found: Unknown - ID: M8600 - Name: Fluorouracil - Relevance: LOW - As Found: Unknown - ID: M231 - Name: Albumin-Bound Paclitaxel - Relevance: LOW - As Found: Unknown - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420895 **Acronym:** EDS-AI **Brief Title:** Health Data Warehouse on Aortic Insufficiency **Official Title:** Setting up a Health Data Warehouse on Aortic Insufficiency #### Organization Study ID Info **ID:** EDS-2023-02 #### Organization **Class:** OTHER **Full Name:** Lille Catholic University ### Status Module #### Completion Date **Date:** 2033-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2028-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2011-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Lille Catholic University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This project aims to create a data warehouse based on care data of patients with an aortic insufficiency admitted to the Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) since 2011. The aim is to enable the utilisation of this data for research purposes. **Detailed Description:** All eligible patients will be informed about the collection of their data during their care at the Valvulopathies Center of Groupement des Hopitaux de l'Institut Catholique de Lille (GHICL). Their consent will be needed for the inclusion. Data will be collected exclusively by the person responsible for implementing the data processing and his/her authorised staff. For all patients, data will be collected retrospectively, based on medical records (electronic or paper), and information available on the various care software linked to the patient's file. There will not be changes in the the patient's care. At the GHICL Valvulopathy Centre, in accordance with European recommendations, patients with aortic insufficiency are monitored as follows, depending on the severity of the pathology: * Minimal aortic insufficiency: follow-up every 3-5 years (approximately) including clinical examination and transthoracic echocardiogram (TTE) * Moderate/medium aortic insufficiency: follow-up every 1-2 years with clinical examination, laboratory tests and TTE. * Significant aortic insufficiency: follow-up every 6-12 months including a clinical examination, a biological assessment and a c+/- TTE coupled with an exercise test. * Cardiac Magnetic Resonance Imaging (MRI) indicated as a second-line procedure after TTE in cases of moderate/medium aortic insufficiency with arguments or doubts about an underestimation of the severity of the aortic insufficiency on TTE, aortic insufficiency of undetermined quantification on TTE, or significant aortic insufficiency on TTE to confirm the severity using a multiparametric approach. * TEE (transesophageal echocardiogram) is indicated as 2nd line after TTE in cases of significant aortic insufficiency as part of the preoperative work-up or moderate/undetermined aortic insufficiency on TTE. The choice between cardiac MRI or TEE, or both, as second-line treatment after TEE, is left to the clinician in current practice, in accordance with the recommendations. ### Conditions Module **Conditions:** - Aortic Insufficiency - Heart Valve Diseases **Keywords:** - aortic insufficiency - valvulopathy - Transthoracic echocardiogram - ultrasound - transesophageal echocardiogram - Data Warehouse ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients already assessed at GHICL's Valvulopathy Centre from 2011 to October 2023 will be identified retrospectively, by queries based on keywords and/or diagnostic codes in echocardiography interpretation software (Viewpoint/EchoPAC, ISCV). GHICL's Medical Information Department will also be involved. **Intervention Names:** - Other: Clinical follow-up - Other: Transthoracic Echocardiogram (TTE) - Other: Magnetic resonance imaging (MRI) - Other: Transesophageal echocardiogram (TEE) **Label:** Group of patients with aortic insufficiency ### Interventions #### Intervention 1 **Arm Group Labels:** - Group of patients with aortic insufficiency **Description:** Clinical follow-up of patients **Name:** Clinical follow-up **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Group of patients with aortic insufficiency **Description:** Transthoracic Echocardiogram **Name:** Transthoracic Echocardiogram (TTE) **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Group of patients with aortic insufficiency **Description:** Magnetic resonance imaging **Name:** Magnetic resonance imaging (MRI) **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Group of patients with aortic insufficiency **Description:** Transesophageal echocardiogram **Name:** Transesophageal echocardiogram (TEE) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Whereas this is a data mining process, no description can be provided **Measure:** Number of patients with aortic insufficiency **Time Frame:** one day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adult patients (age \>= 18 years) * Cared for at GHICL Since 1st January 2011 * With chronic aortic insufficiency of any grade. Exclusion Criteria: * Patients who have undergone prosthetic aortic valve surgery prior to diagnostic transthoracic echocardiography * Patients with acute heart failure * Patients with an intracardiac shunt or other complex congenital heart disease or obstructive hypertrophic cardiomyopathy * Patients with aortic prosthesis * Patients with active endocarditis or sequelae \< 6 months old * Patients under legal protection * Patient who refused to take part in the study * Patients with other than minimal left heart valve disease (with the exception of secondary mitral insufficiency) **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients already assessed at GHICL's Valvulopathy Centre from 2011 to October 2023 will be identified retrospectively, by queries based on keywords and/or diagnostic codes in echocardiography interpretation software (Viewpoint/EchoPAC, ISCV). GHICL's Medical Information Department (DIM) will also be involved. Eligible patients assessed at GHICL's Valvulopathy Centre after the implementation of the repository (from November 2023) will be identified by the cardiologist as and when required. ### Contacts Locations Module #### Overall Officials **Official 1:** **Affiliation:** altes.alexandre@ghicl.net **Name:** Alexandre Altes, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000082862 - Term: Aortic Valve Disease ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M9437 - Name: Heart Valve Diseases - Relevance: HIGH - As Found: Heart Valve Diseases - ID: M4338 - Name: Aortic Valve Insufficiency - Relevance: HIGH - As Found: Aortic Insufficiency - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M2379 - Name: Aortic Valve Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006349 - Term: Heart Valve Diseases - ID: D000001022 - Term: Aortic Valve Insufficiency ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420882 **Brief Title:** Comparison of Different Treatment Methods in Patella Chondromalacia **Official Title:** Comparison of Different Treatment Methods in Patella Chondromalacia #### Organization Study ID Info **ID:** E-10840098-772.02-7994 #### Organization **Class:** OTHER **Full Name:** Istanbul Medipol University Hospital ### Status Module #### Completion Date **Date:** 2024-11-21 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul Medipol University Hospital #### Responsible Party **Investigator Affiliation:** Istanbul Medipol University Hospital **Investigator Full Name:** gamze demircioglu **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:** Chondromalacia patella (CMP) is a common condition in patients presenting to healthcare units with anterior knee pain (1). **Detailed Description:** Patellofemoral pain syndrome (PFPS) is the most common type of pain in runners with a prevalence of 17%; it is limited to the anterior knee or the area behind the patella between the edges of the patella. Although PFPS and CMP are often considered to be the same disease, there is still controversy about the subject. It is caused by decreased quadriceps muscle strength, change in mechanical loading, lower limb kinematics and differentiation in muscle activation patterns during running . ### Conditions Module **Conditions:** - Knee Injuries ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** rehabilitation group. **Intervention Names:** - Other: The rehabilitation group. **Label:** The rehabilitation group. **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The home exercise group **Intervention Names:** - Other: The home exercise group **Label:** The home exercise group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - The rehabilitation group. **Description:** In the rehabilitation group, patella mobilisation, muscle strengthening exercises, range of motion exercises will be performed 3 days a week with a therapist for 3 sessions per week **Name:** The rehabilitation group. **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - The home exercise group **Description:** Participants in both groups will be included in a 3-week treatment programme. **Name:** The home exercise group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The Turkish version of the WOMAC scale will be used to evaluate the pain, stiffness and physical function of the individuals included in the study. The score of each section is calculated within itself and the total score varies between 0 and 100. High scores indicate an increase in pain and stiffness and impairment in physical function (12,13). **Measure:** WOMAC **Time Frame:** 3 weeks **Description:** Stair ascent and descent test: The patient's ascent and descent time of the 11-step staircase with a height of 14 cm and a depth of 29 cm were recorded separately with a stopwatch. **Measure:** Stair climbing test **Time Frame:** 3 weeks **Description:** Knee joint range of motion will be measured with a goniometer. **Measure:** Range of motion of the joint **Time Frame:** 3 weeks **Description:** The test is a simple but time-consuming test in terms of its application and is used to measure dynamic postural balance (1). The test is based on the ability to reach the farthest possible distance on the supporting leg with the free foot in 8 different directions **Measure:** Star balance test **Time Frame:** 3 weeks **Description:** They jump to the farthest distance they can jump using their single and double legs and the best result obtained after at least 2 trials is recorded in cm. In this test, it should be noted that when contact with the ground after the jump, the measurement should be made at the heel level of the back foot, which is close to the starting line. Another point to be considered is that the participant should be stationary at the starting line. The participant cannot come to the line running and jump. But it is allowed to make a springing movement in front of the line **Measure:** Horizontal jump test **Time Frame:** 3 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: * 18-65 years of age. * Being diagnosed with chondromalacia * Participate in the work on a voluntary basis * Obtaining informed consent from them Exclusion criteria: * Fracture, ligament or muscle tear in the lower extremity within the last 3 months. * Having a systemic disease * Having a serious injury in the last 3 months **Maximum Age:** 25 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** gamzekantardemircioğlu@gmail.com **Name:** gamze demircioğlu, PhD **Phone:** 05348689544 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Name:** gamze demircioğlu - **Role:** CONTACT **Country:** Turkey **Facility:** Gamze Demircioğlu **State:** None Selected **Status:** RECRUITING **Zip:** 34353 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007869 - Term: Leg Injuries - ID: D000014947 - Term: Wounds and Injuries - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000003240 - Term: Connective Tissue Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M25707 - Name: Chondromalacia Patellae - Relevance: HIGH - As Found: Patella Chondromalacia - ID: M10738 - Name: Knee Injuries - Relevance: HIGH - As Found: Knee Injuries - ID: M5611 - Name: Cartilage Diseases - Relevance: HIGH - As Found: Chondromalacia - ID: M10881 - Name: Leg Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002357 - Term: Cartilage Diseases - ID: D000046789 - Term: Chondromalacia Patellae - ID: D000007718 - Term: Knee Injuries ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420869 **Brief Title:** Investigation of the Effect of Thoracic Kyphosis Proprioception **Official Title:** Investigation of the Effect of Thoracic Kyphosis on Posture, Proprioception and Perception of Postural Appearance in Young Individuals #### Organization Study ID Info **ID:** MedipolFTROPZ #### Organization **Class:** OTHER **Full Name:** Istanbul Medipol University Hospital ### Status Module #### Completion Date **Date:** 2024-09-16 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-08-16 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-16 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul Medipol University Hospital #### Responsible Party **Investigator Affiliation:** Istanbul Medipol University Hospital **Investigator Full Name:** sena ozdemir **Investigator Title:** Assist. Prof. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Although the negative effect of increased thoracic kyphosis in elderly individuals has been reported in the literature, the effect of the thoracic kyphosis angle on trunk and foot proprioception in young individuals has not been investigated. The aim of this study was to investigate the effect of the thoracic kyphosis on posture, proprioception and perception of postural appearance in young individuals. **Detailed Description:** The term kyphosis is defined as an increase in the anterior curvature of the spine in the sagittal plane. Along with cosmetic deformity, individuals may experience pain with movement, increased forward head posture, unequal shoulder levels and fatigue. Kyphosis occurs when people with insufficient general muscle strength are in an upright position and high external stress is applied to the spine. Kyphosis is frequently seen in young people and children due to the demands of their school programmes and prolonged and non-ergonomic sitting positions. The prevalence of thoracic kyphosis has been reported to be 15.3% in children aged 11 years, 35% in individuals aged 20-64 years, and 38% in individuals aged 20-50 years. The ability to perceive body positions in space without visual inputs is determined by the proprioceptive sense. Proprioceptive data from muscles, ligaments and joints contribute to the awareness of the relative orientation of the functional units of the spine at rest and in motion, enabling the control of posture and balance. Since proprioception is fundamental for movement, posture and balance, joint position sensory information from the trunk is essential for the production of synchronised muscle contractions during spinal movements. Therefore, a decrease in proprioception information may lead to an increase in the degree of kyphosis. In the literature, a negative relationship between joint position sense and the angle of kyphosis of the thoracic region has been reported in elderly individuals with thoracic kyphosis. It has been suggested that alignment problems of the spine may be related to the lack of position sense. Over time, young people may become accustomed to inappropriate postures and poor postural awareness. Changes in posture can lead to differences in the sense of touch. These differences consist of posture-related changes in the structural properties of the skin. When dorsal skin tension increases with spinal flexion, the tactile sensitivity threshold, the longitudinal spatial acuity threshold and the transversal stretch sensitivity threshold increase. In addition, the dorsal skin decreased the sensitivity threshold to longitudinal stretch stimuli, again due to spinal flexion-induced skin tension. This suggests that sensitivity to skin stretching in a direction parallel to the spine increases as individuals move from a normal position to flexion. Changes in the flexion and extension positions of the spine produce large changes in skin stiffness, tension and thickness. Changes in posture affect the load distribution of the foot function. A shift in the body axis away from the midline causes asymmetric loading of the extremities and affects the disproportion of the postural muscles, thus shifting the centre of gravity. Changes in the position of the trunk with deviations in the centre of gravity cause changes in the plantar load distribution with the hip and ankle. Pressure in the plantar region stimulates receptors in that region. Sensory feedback from the plantar region is important for perceiving changes in postural position and controlling postural oscillations. Feedback from cutaneous mechanoreceptors contributes functionally to proprioception of postural position and support status. However, there is a relationship between the magnitude of the kyphosis angle and the distribution of lower extremity ground reaction forces. In this context, the distribution of plantar pressure affects the sensory sensitivity of the sole of the foot. In the forward head posture, the flexion moment of the spine is increased by maintaining the weight of the head in front of the gravity line. There is a functional and mechanical correlation between kyphosis and a forward-head posture. This position of the head can lead to further postural deviations in the body, such as rounded shoulders and increased thoracic kyphosis, in order to compensate for the deviated gravity line. This leads to a vicious circle of further deformity. The angle of the shoulder and the craniovertebral angle are negatively correlated with the forward head position and positively correlated with the sagittal head angle. Although the negative effect of increased thoracic kyphosis in elderly individuals has been reported in the literature, the effect of the thoracic kyphosis angle on trunk and foot proprioception in young individuals has not been investigated. The aim of this study was to investigate the effect of the thoracic kyphosis on posture, proprioception and perception of postural appearance in young individuals. ### Conditions Module **Conditions:** - Kyphosis - Proprioception - Posture ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 46 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study group 1, comprised 23 subjects, comprising both males and females, with an age range of between 18 and 25 years. The subjects exhibited a thoracic kyphosis angle of ≥40° and had not undergone treatment for kyphosis in the previous six months. **Intervention Names:** - Diagnostic Test: Assessment **Label:** Group 1 #### Arm Group 2 **Description:** The study group 2, comprised 23 subjects, comprising both males and females, with an age range of between 18 and 25 years.The subjects were selected based on the criteria that their thoracic kyphosis angle was less than 40° and that they did not exhibit any spinal deformities. **Intervention Names:** - Diagnostic Test: Assessment **Label:** Group 2 ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1 - Group 2 **Description:** A postural evaluation will be conducted, including the measurement of the thoracic kyphosis angle and the assessment of sagittal head posture.A proprioception evaluation will be conducted, whereby the cervical region, trunk and ankle joint position sense and trunk and foot sensation will be evaluated for the purpose of assessing the proprioception of the spine.Turkish adaptation of the Kyphosis Specific Spine Appearance Questionnaire (KSAQ) will be employed to assess postural appearance perception. The KSAQ is a reliable and valid patient-reported outcome tool for assessing individual perception of various aspects of kyphotic deformity and appearance in young patients with kyphosis. KSAQ is a 10-item questionnaire based on a five-point Likert scale, with responses ranging from 1 to 5. The mean of the responses is used to obtain a total score for the KSAQ. The questionnaire is related to patients' perception of appearance, with higher scores indicating a worsening of the deformity. **Name:** Assessment **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The BASELINE brand digital goniometer (Baseline 10044E Digital Absolute + Axis Goniometer 10044E SKU: CM10044E) can be employed for the measurement of joint position sense. Prior to commencing the measurement, participants are instructed to assume four different positions in a comfortable standing position. The participants are required to perform 30° flexion, 15° extension, 15° right and left lateral flexion for an active proprioceptive positioning test with their eyes closed. Following each position, the participants are instructed to wait for three seconds and to feel the position. They then return to the upright position and are asked to return to the position they felt and measured in that position. The deviation degrees of the participants are recorded. This process is repeated three times, with the resulting degrees of deviation averaged. During the measurement, it is essential to ensure that flexion in the knees is avoided. **Measure:** Proprioception evaluation; Evaluation of Trunk Joint Position Sensation **Time Frame:** 10 minute #### Secondary Outcomes **Description:** The Body Sensation Assessment is a procedure designed to evaluate the physical sensations experienced by the subject. The assessor will then proceed to touch the T4, T5 and T6 spinous processes with a monofilament. The Semmes-Weinstein monofilament kit will be employed for the purpose of sensory evaluation. The monofilament is applied at an angle of 90°C until the tip of the monofilament is curled. The areas to be tested are maintained in contact with the monofilament for a period of 1.5 seconds, after which the monofilament is removed from the skin. Subsequently, the participant is queried as to whether they perceive the sensation and is requested to provide feedback as to whether they do or do not feel it. In the monofilament kit, starting from 2.83 and continuing up to 6.65, the initial filament, 2.83, was tested. If the participant did not perceive it, the next higher level, the thicker filament, was then evaluated. **Measure:** The Body Sensation Assessment **Time Frame:** 10 minute **Description:** The sole of the foot is tested at four sites: the heel, medial arch, lateral arch and first metatarsal. The heel position was determined to be the centre of the heel at 15% of the sole length. The medial arch position is located at 15% of the arch width from the medial border. The lateral arch is defined as the projection of the medial arch. The first metatarsal position is marked at 15% of the metatarsal width from the lateral and medial borders, respectively. For the dorsum of the foot, a region was delineated with the proximal boundary at 15% of the length from the lateral malleoli to the fibular head and the distal boundary at 75% of the length from the lateral malleoli to the fifth metatarsal. The dorsum test sites included a proximal, middle and distal region, each marked at a distance of 10%, 50% and 90% from the proximal border of the reference region, respectively. The Semmes-Weinstein monofilament kit will be employed for the purpose of sensory evaluation. **Measure:** The evaluation of foot sensation **Time Frame:** 10 min **Description:** The baseline brand digital goniometer (Baseline 10044E Digital Absolute + Axis Goniometer 10044E SKU: CM10044E) can be utilised for the measurement of joint position sense. The participants are blindfolded in order to prevent visual notifications. For the measurement of plantarflexion and dorsiflexion, the pivot point of the digital goniometer is placed 1.5 cm below the lateral malleolus. The fixed arm is parallel to the longitudinal axis of the fibula and aligned with the fibular head, while the mobile arm is parallel to the longitudinal axis of the fifth metatarsal. Participants are asked to perform 10° dorsiflexion, 10° and 20° plantarflexion. Individuals are instructed to actively perform the desired target angles, sense the position of the ankle for three seconds, and then return to the starting position. Individuals are then asked to repeat the target angle, and the measurement is taken in this position. **Measure:** Ankle Joint Position Sensation Evaluation **Time Frame:** 10 min **Description:** Cervical position sense can be evaluated by utilising a laser pointer mounted on a lightweight headband. The subject is seated in a relaxed position with their knees and hips at 90° angles, their hands placed on their knees, in front of a sheet of paper containing a coordinate plane of A2 size and 40 cm in diameter at a distance of 90 cm, positioned at eye level. The participants are requested to focus on the natural resting head position and the origin for a period of three seconds. Subsequently, the participants are instructed to perform flexion, extension, and right-left rotation movements with their eyes closed, pausing for three seconds after each position. Subsequently, the participants are instructed to attempt to return to the initial focused position as much as possible. The point at which the participant perceives the laser beam to have reached the focal starting point is marked. The procedure should be repeated three times, and the mean value should be recorded. **Measure:** Cervical Joint Position Sense Assessment **Time Frame:** 10 min **Description:** A postural assessment will be conducted using the PostureScreen Mobile application. PostureScreen Mobile represents a pioneering application for the rapid assessment of posture. It has been demonstrated to be both valid and reliable. A camera, mounted on a tripod at shoulder height, was used to photograph the subject in lateral posture while standing in a comfortable, natural position. The angles corresponding to the photograph were then calculated. The craniovertebral angle (CVA) is the angle between the line joining the tragus of the ear to C7 and the horizontal line at C7. The shoulder angle (SA) is defined as the angle between the line joining C7 to the acromion process and the horizontal line at the acromion process. The sagittal head angle (SHA) is the angle between the line joining the tragus of the ear to the canthus of the eye and the horizontal line at the tragus. **Measure:** Postural Assessment **Time Frame:** 5 min **Description:** The Kyphosis Specific Spine Appearance Questionnaire (KSAQ), adapted into Turkish, will be used to assess the perception of postural appearance. The KSAQ is a reliable and valid patient-reported outcome tool to assess individual perception of various aspects of kyphotic deformity and appearance in young patients with kyphosis. The KSAQ is a 10-item questionnaire based on a five-point Likert scale ranging from 1 to 5, with 1 being not true; 2, somewhat true; 3, true; 4, very true; and 5, completely true. For the Kyphosis Specific Spine Appearance Questionnaire, the mean of the responses is used to obtain a total score. It is related to patients' perception of appearance, with higher scores indicating worsening of the deformity. **Measure:** Postural Appearance Perception **Time Frame:** 5 min ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Between 18 and 25 years of age * Not being treated for kyphosis in the last 6 months Exclusion Criteria: * Those diagnosed with scoliosis and/or structural spinal deformity * Those with any neurological deficit * Those with concomitant disorders such as Scheuermann's disease, genetic diseases such as Beckwith-Wiedemann Syndrome or metabolic diseases that may affect body axis disorders * Those with lower limb deformities * Those with a history of spinal fracture and/or surgery and/or shoulder joint injury * Those with mental disorders and intellectual disabilities. **Gender Based:** True **Gender Description:** The age range of the participants was between 18 and 25 years old. **Maximum Age:** 25 Years **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** The study will include healthy individuals aged 18 to 25 years. A power analysis was conducted to determine the number of individuals to be included in the study. A sample size of 46 individuals was determined, with 23 individuals per group. The power of the test was calculated using the G\*Power 3.1 program. A similar study in the relevant literature by Fatemeh et al. (2022) calculated the effect size to be 0.991. In order to exceed the 95% value in determining the power of the study, 46 people must be included, including 23 people in groups with a significance level of 5% and an effect size of 0.991 (df=44; t=1.711). All participants will be provided with and required to sign an informed consent form, which will be based on the principle of voluntariness. ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Istanbul Medipol University **State:** Beykoz **Zip:** 34810 #### Overall Officials **Official 1:** **Affiliation:** Medipol University **Name:** SENA ÖZDEMİR GÖRGÜ, PhD,PT **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013121 - Term: Spinal Curvatures - ID: D000013122 - Term: Spinal Diseases - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10758 - Name: Kyphosis - Relevance: HIGH - As Found: Kyphosis - ID: M15918 - Name: Spinal Curvatures - Relevance: LOW - As Found: Unknown - ID: M15919 - Name: Spinal Diseases - Relevance: LOW - As Found: Unknown - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007738 - Term: Kyphosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420856 **Brief Title:** Changes of Various Structures After Lisfranc Injury Compared to Healthy Individuals. **Official Title:** Is There a Relationship Between Protective Sole Sense, Ankle Proprioception, Ankle Mobility and Balance in Patients With Treated Lisfranc Injury? #### Organization Study ID Info **ID:** SBU-FTR-AI-02 #### Organization **Class:** OTHER **Full Name:** Istanbul Saglik Bilimleri University ### Status Module #### Completion Date **Date:** 2024-06-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-17 **Type:** ACTUAL #### Start Date **Date:** 2024-01-02 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istanbul Saglik Bilimleri University #### Responsible Party **Investigator Affiliation:** Istanbul Saglik Bilimleri University **Investigator Full Name:** Ali Ilez **Investigator Title:** Research Assistant **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The effect of muscular strength deficits on postural control after Lisfranc injury has been explained in relation to stance duration and strength. However, the relationship between protective sole sensation and changes in ankle proprioception, balance, ankle mobility and Achilles tendon structural properties has been shown in previous studies. The aim of our study was to determine the possible changes in protective sole sensation, ankle proprioception, balance and functional capacity after Lisfranc injury and to analyse the relationship between these variables. **Detailed Description:** 'Lisfranc injury' refers to an injury in which one or more metatarsals are displaced. Lisfranc injury covers a wide network of injuries. It includes various types, including a low-energy sports injury or a high-energy lesion, as well as a purely connective tissue injury. 20% of Lisfranc injuries are undiagnosed or diagnosed late. Early and accurate diagnosis of injuries is a basic requirement for appropriate treatment and prevention of secondary problems that may arise in the long term . Fracture-dislocation in the tarsometatarsal junction of the foot is treated with anatomical reduction, internal fixation or primary arthrodesis. However, many individuals have poor functional outcomes . Anatomical repositioning and excellent postoperative radiographic findings may not result in high patient satisfaction. As a result, no matter what type of treatment is used after Lisfranc injury, it should be supported by a good rehabilitation protocol. As a result of our research in the literature, the investigators encountered studies that performed gait analysis, muscle strength and plantar pressure measurements after Lisfranc injury. However, no study has been encountered examining parameters such as sole sense, proprioception, and balance after injury of the foot, which is the only limb in contact with the ground. After determining these values, revising the rehabilitation protocols specifically for the evaluation parameters will reduce the morbidity rate after injury and accelerate functional recovery. Rehabilitation protocols that emphasize the use of exercises to improve joint range of motion, muscle strength, neuromuscular coordination, and gait mechanics after foot and ankle injuries have been found to improve function . There is also evidence that the plantar flexor muscles of these patients are weakened after injury. There are also groups of patients who complain of instability when walking barefoot or on uneven ground after foot or ankle injuries. In a different study examining the dynamic plantar pressure distribution, force capacity and postural control change after Lisfranc injury, it was found that atrophy occurred after long-term immobilization in both the injured extremity and the contralateral extremity. Altered postural control after injury was manifested by a significant decrease in unilateral stance time. Adequate rehabilitation following anatomical open reduction after Lisfranc injury is very important for clinical outcome. A detailed evaluation is required to determine adequate rehabilitation. Considering these studies, evaluating balance will be important for patients with Lisfranc injuries.In our study, the investigators aim to provide information about postural control change after injury by evaluating dynamic balance with the Modified star excursion test. In this way, the intensity of balance exercises can be adjusted while shaping the post-injury rehabilitation program. Evaluated gait analysis and functional results in patients following a designated rehabilitation program after Lisfranc injury. In this study evaluating patients with lisfranc injury treated with 3 different methods (conservative, open reduction internal fixation and primary arthrodesis), significantly reduced joint range of motion, lower walking speed and significantly lower flexion/extension of the midfoot compared to healthy subjects during the pushing phase. These changes may result from loss of muscle strength, differences in surgical methods or different rehabilitation protocols. This change during the pushing phase and the decrease in walking speed negatively affect the lives of patients functionally. Determination of ankle mobility after injury, determination of rehabilitation effectiveness and functional evaluation will be used for the first time in our study for patients with lisfranc injury. In addition to this information, in our study, the investigators aim to evaluate functional capacity with AOFAS (American Orthopaedic Foot and Ankle Society) Midfoot Score , FAOS(Foot and Ankle Outcome Score) and heel-rise tests and be the first study in the literature to apply this test on ligamentous injury. The data obtained after the evaluation may increase the clinical use of these easy and inexpensive tests. Thus, function after Lisfranc injury can be evaluated much more easily, quickly and objectively. Lisfranc injury does not only cause deficits in muscle strength and joint range of motion. Many factors, such as long-term immobilization after injury, damage to structures rich in mechanoreceptors, or surgery, can lead to changes in both sole sensation and joint position sense. ### Conditions Module **Conditions:** - Lisfranc Injury **Keywords:** - Proprioception - Postural Balance - Foot Injuries ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 24 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Sense of light touch will be used with the Semmes-Weinstein Monofilament test, Proprioception evaluation will be used with the Dr.Goniometer application, Muscular strength and endurance will be evaluated with the cybex isokinetic device, Weight-Bearing Lunge test will be used to evaluate ankle mobility and Modified Star Excursion Balance Test will be used to evaluate dynamic balance. Patients' functional levels will be evaluated under two headings: 1. Questionnaire-based functional evaluation: American Orthopedic Foot and Ankle Society (AOFAS) midfoot score and foot and ankle functions Rating Foot and Ankle Outcome Score (FAOS) will be used and will be evaluated. 2. Physical performance evaluation: Heel raise test would be used **Intervention Names:** - Other: Assessment of the musculoskeletal system and its functions **Label:** Lisfranc injury patients #### Arm Group 2 **Description:** Sense of light touch will be used with the Semmes-Weinstein Monofilament test, Proprioception evaluation will be used with the Dr.Goniometer application, Muscular strength and endurance will be evaluated with the cybex isokinetic device, Weight-Bearing Lunge test will be used to evaluate ankle mobility and Modified Star Excursion Balance Test will be used to evaluate dynamic balance. Patients' functional levels will be evaluated under two headings: 1. Questionnaire-based functional evaluation: American Orthopedic Foot and Ankle Society (AOFAS) midfoot score and foot and ankle functions Rating Foot and Ankle Outcome Score (FAOS) will be used and will be evaluated. 2. Physical performance evaluation: Heel raise test would be used **Intervention Names:** - Other: Assessment of the musculoskeletal system and its functions **Label:** Healthy Volunteers ### Interventions #### Intervention 1 **Arm Group Labels:** - Healthy Volunteers - Lisfranc injury patients **Description:** Measurement of sub sole pressure sense, light touch sense, vibration sense and two-point discrimination sense. will be evaluated with. For the evaluation of proprioception, active joint position sense technique was used in plantar flexion (PF): 7°, 14° and 21°; In dorsiflexion (DF), 7° target angles will be used. An Dr. Goniometer will be used to determine target angles. To measure plantarflexion and dorsiflexion muscular strength and endurance will be used with the isokinetic system. Weight-Bearing Lunge test will be used to evaluate ankle mobility. For balance assessment, the Modified Star Excursion Balance Test will be measured using the anterior, posteromedial and posterolateral directions. American Orthopedic Foot and Ankle Society midfoot score and foot and ankle functions Rating Foot and Ankle Outcome Score , which are subjective evaluation methods, will be used to determine the functional level. A heel lift test will be performed to evaluate physical performance. **Name:** Assessment of the musculoskeletal system and its functions **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Our primary outcome is to determine the difference in plantar sensation changes in people with Lisfranc injuries after treatment compared to healthy volunteers with similar demographic characteristics. According to the monofilament test results, increasing numerical values indicate that proprioception is negatively affected. **Measure:** Difference in plantar sensation in people with Lisfranc injuries compared to healthy people **Time Frame:** 2 months #### Secondary Outcomes **Description:** American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot Rating System range from 0 to 100, with a healthy midfoot receiving 100 points. This score may be used to assess the intercuneiform, lateral cuneiform-cuboid, naviculocuneiform, and tarsometatarsal levels and may be useful for fractures and arthrodesis procedures. **Measure:** AOFAS (American Orthopaedic Foot and Ankle Society) midfoot Score **Time Frame:** 1 months **Description:** Foot and Ankle Outcome Score (FAOS) subscale scores range from 0 to max , with higher scores indicating better outcomes. A score of 100 on a subscale indicates no symptoms or limitations in that particular area, while a score of 0 indicates extreme symptoms and limitations. **Measure:** FAOS (Foot and Ankle Outcome Score) Score **Time Frame:** 1 months **Description:** For balance assessment, the Modified Star Excursion Balance Test will be measured using the anterior, posteromedial and posterolateral directions. Lower Extremity Normalization Score and Composite Score will be used for this measurement.Higher values indicate a better balance. **Measure:** Modified Star Excursion Test **Time Frame:** 1 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria for Lisfranc Injury Group: * Having had a Lisfranc injury * Having only one extremity injured * Having received surgical treatment * Being over 18 years old Exclusion Criteria for Lisfranc Injury Group : * Having a neurological problem, * diabetes * smoking * untreated Lisfranc injury * incomplete medical record * not wanting to participate in the study * having a neurovascular injury Inclusion Criteria for Healthy Volunteer Group * Being healthy * Any foot pain, history of fractures, etc. Absence of circumstances * Being over 18 years of age Exclusion Criteria for Healthy Volunteer Group * Not being healthy * Any foot pain, history of fractures, etc. * Not being over 18 years of age **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** A total of 24 people will be included in our study. It will be conducted with 12 Lisfranc injury patients and 12 healthy volunteer participants. All participants will be over 18 years of age. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** aliilez156@gmail.com **Name:** ALİ İLEZ **Phone:** +905050275038 **Role:** CONTACT #### Locations **Location 1:** **City:** İ̇stanbul **Contacts:** ***Contact 1:*** - **Email:** aliilez156@gmail.com - **Name:** Ali İLEZ - **Phone:** +905050275038 - **Role:** CONTACT **Country:** Turkey **Facility:** İstanbul Tıp Fakültesi Ortopedi ve Travmatoloji Anabilimdalı **State:** Fatih **Status:** RECRUITING **Zip:** 34093 #### Overall Officials **Official 1:** **Affiliation:** Istanbul Saglik Bilimleri University **Name:** ALİ İLEZ **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M20528 - Name: Foot Injuries - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury ### Condition Browse Module - Meshes - ID: D000014947 - Term: Wounds and Injuries ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420843 **Acronym:** PN-AI-21 **Brief Title:** Microbiota, Metabolome and Nutrition: an 'Artificially Intelligent' Way to Personalized Nutrition **Official Title:** Microbiota, Metabolome and Nutrition: an 'Artificially Intelligent' Way to Personalized Nutrition #### Organization Study ID Info **ID:** 3007 #### Organization **Class:** OTHER **Full Name:** Istituto Clinico Humanitas ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2021-12-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Istituto Clinico Humanitas #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Intervention: (Weeks 1-2, Visit 3-4) - Starting from the second week after the date of consent, patients with IBS will be randomized 1:1 into two groups. The first group (20 patients) will receive one week of a low FODMAP supplemented with fermented milk followed by one week of a low FODMAP content supplemented with fermented beans. The second group (20 patients) will receive a low FODMAP diet supplemented for one week with fermented beans followed by a second week of a diet with a low FODMAP diet supplemented with fermented milk. The microbiome of the patients will be evaluated after the first and second weeks along with data related to weight. After the second week, the metabolome and physical characteristics. The enrollment period will last for one year. The analysis of clinical data will be completed within one year after patient enrollment. Analysis of laboratory data will be performed in parallel. **Detailed Description:** Irritable bowel syndrome (IBS) is a chronic intestinal condition whose high incidence and prevalence make it a major healthcare problem(3-7). IBS affects 7-15% of the general population(6, 7). It is twice as frequent in women(8) and is diagnosed more often in patients less than 50 years of age(9). It is characterized by recurrent episodes of functional gastrointestinal symptoms whose pathophysiological mechanisms are not completely clear(10). The most common symptoms include abdominal pain, bloating, constipation, and/or diarrhea(10). IBS negatively impacts quality of life and causes a substantial burden on healthcare resources(11, 12). Like the clinical phenotypes, the pathophysiological mechanisms underlying the syndrome are heterogeneous and not fully understood(13). However, there is evidence that IBS may result from a combination of gastrointestinal motility changes, visceral hypersensitivity, low-grade inflammation, altered microbiota, and food components(14-17). Due to the diversity of IBS symptoms and their considerable variability over time, a wide range of pharmacological treatments are employed which often only target the primary symptom; thus, when multiple symptoms are present, the treatments administered are often inadequate. This has led to the investigation of use of dietary therapies as a treatment option. Dietary restriction of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) have been recently investigated in the management of functional gut symptoms in IBS. An increasing number of uncontrolled and controlled trials have examined the clinical effectiveness of a low FODMAP diet in patients with IBS using either dietary advice or feeding protocols. Uncontrolled and unblinded controlled trials suggest symptom response rates in patients with IBS are as high as 85%(18). Similarly, a beneficial impact on symptoms has been reported in blinded randomized controlled trials(19-22). A potential shortcoming of the low FODMAP diet and of any diet that involves multiple food exclusion, is the risk of nutritional inadequacy, and this is especially pertinent if the excluded foods are nutrient-rich. The low FODMAP diet requires substitution of selected food items across a number of food groups and, therefore, there is the potential for inadequate intake of nutrients, particularly carbohydrate, fiber, iron, B vitamins, and calcium. Another potential safety concern associated with implementation of the diet relates to the impact on the gastrointestinal microbiota, which has been implicated in the pathogenesis of IBS(23) and has been associated with clinical features of IBS including abdominal pain, anxiety, and depression(24, 25). Hence, we propose to evaluate the microbiome and metabolome in IBS patients to create datasets of integrated data through AI tools. Furthermore, we aim to determine the effects of a low FOODMAP diet based on fermented products on the microbiome and metabolome in IBS patients. These evaluations will allow to assess patient's nutrient deficiency and the general quality of life pre and post intervention among groups and to develop a personalized treatment that will increase the quality of life in IBS patients. The low FODMAPs diet is associated with limitations particularly due to the elimination of several food items which can cause worsening of the side effects due to significant alteration of the intestinal microbiota composition and an overall reduction of the nutritional status. Although, probiotics seem to have beneficial effects on improving this side effect, their way of function is still relatively unknown. Much remains to be answered as to which strains is/are most effective across the broad spectrum of IBS patients and whether single or combination of strains work best. This leads to the question of whether individual differences among IBS patients in terms of microbiome diversity could affect the efficacy of probiotics therapy. Therefore, with our approach we propose a reshaping of the host-microbiota interactions through personalized nutrition which could be a new therapeutic avenue for both disease control and prevention. Specifically, we believe that a diet supplemented with previously fermented food items will be beneficial for the patient's condition. This fermentation will be controlled and performed with Lactobacillus paracasei strain CNCM I-5220. Through the longitudinal study we will be able to evaluate their grade of the disorder at baseline (one week of low FODMAP diet), and the effect of the fermented food items on their microbiota and metabolome after one and two weeks. Furthermore, by adopting new efficacious treatment options, it might be possible to decrease the high recurrence rate of IBS patients to the public health system, improving patient's quality of life and decreasing the costs for the National Sanitary System (SSN). The primary objective will be to assess the enterotypes of IBS patient at baseline and to analyze how supplementation of fermented food modifies the microbiome and metabolome in IBS patients following a low FODMAP diet. As secondary objective, we will compare the efficacy and safety of two different nutritional approaches on IBS symptoms. ### Conditions Module **Conditions:** - IBS - Irritable Bowel Syndrome ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 48 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive one week of low FODMAP diet supplemented with fermented milk followed by one week of low FODMAP diet supplemented with fermented beans. **Intervention Names:** - Dietary Supplement: FOODMAP **Label:** low FODMAP milk **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The second group will receive low FODMAP diet supplemented for one week with fermented beans followed by a second week of low FODMAP diet supplemented with fermented milk. **Intervention Names:** - Dietary Supplement: FOODMAP **Label:** low FODMAP beans **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - low FODMAP beans - low FODMAP milk **Description:** Dietary restriction of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) have been recently investigated in the management of functional gut symptoms in IBS. **Name:** FOODMAP **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint will be the change in the phenotype of microbiome and metabolome in the two-study group at the end of the assumption of fermented food. Stool samples will be thoroughly analyzed for microbiome (amplified for 16S rDNA sequencing and/or shotgun) and metabolome composition (untargeted). IBS-related symptoms will also be evaluated at the end of one week of low FODMAP diet consumption. **Measure:** Microbiome **Time Frame:** 1 week #### Secondary Outcomes **Description:** to assess and compare the changes in the microbiome and metabolome phenotype at baseline and 1 week after the low FODMAP diet assumption, and after 1 week of addition of fermented food.Patients' microbiome will be assessed after the first and second week by collecting a fecal sample together with data regarding the weight. Metabolome and IBS-related symptoms will be evaluated in a longitudinal study after the second week as previously mentioned. **Measure:** Microbiome after baseline **Time Frame:** 2 weeks **Description:** to assess and compare any change in the GSRS score at baseline, after 1 week of low FODMAP diet assumption and at the end of the study in the two study groups. GSRS is a symptom assessment tool that measures the baseline severity and frequency of these symptoms, as well as the response to treatment(1). **Measure:** GSRS score **Time Frame:** 1 week ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients of both sex and any race * Age ≥18 and ≤70. * IBS confirmed by Rome IV diagnostic criteria * Willing to adhere to the proposed diet * Provision of written informed consent * Commitment of availability throughout the study period Exclusion Criteria: * Patient age \<18 and \> 70 * Diabetes (Type 1 or 2) * Subjects who have used probiotic, antibiotic, lactic ferment or pump inhibitors within 15 days prior to screening. * Pregnant or planning to become pregnant or is lactating. * History of HIV or hepatitis B or C * Participation in investigational study within past 30 days * Unstable cardiovascular or pulmonary disease, with change in treatment in last 30 days due to worsening disease condition * Any concomitant disease requiring specialized nutrition (e.g. renal failure, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity) **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** vincenzo.craviotto@humanitas.it **Name:** Vincenzo Craviotto, MD **Phone:** 0282243113 **Role:** CONTACT **Contact 2:** **Email:** alessandro.daprano@humanitas.it **Name:** Alessandro D'Aprano **Phone:** 0282243678 **Role:** CONTACT #### Locations **Location 1:** **City:** Rozzano **Contacts:** ***Contact 1:*** - **Email:** vincenzo.craviotto@humanitas.it - **Name:** Vincenzo Craviotto, MD - **Phone:** 0282243113 - **Role:** CONTACT ***Contact 2:*** - **Name:** Alessandro Repici, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Vincenzo Craviotto, MD - **Role:** SUB_INVESTIGATOR **Country:** Italy **Facility:** Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital **State:** Milano **Status:** RECRUITING **Zip:** 20089 ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Svedlund J, Sjodin I, Dotevall G. 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World J Gastroenterol. 2016 May 28;22(20):4946-57. doi: 10.3748/wjg.v22.i20.4946. **PMID:** 27239121 **Citation:** Burisch J, Jess T, Martinato M, Lakatos PL; ECCO -EpiCom. The burden of inflammatory bowel disease in Europe. J Crohns Colitis. 2013 May;7(4):322-37. doi: 10.1016/j.crohns.2013.01.010. Epub 2013 Feb 8. **PMID:** 23395397 **Citation:** American College of Gastroenterology Task Force on Irritable Bowel Syndrome; Brandt LJ, Chey WD, Foxx-Orenstein AE, Schiller LR, Schoenfeld PS, Spiegel BM, Talley NJ, Quigley EM. An evidence-based position statement on the management of irritable bowel syndrome. Am J Gastroenterol. 2009 Jan;104 Suppl 1:S1-35. doi: 10.1038/ajg.2008.122. No abstract available. **PMID:** 19521341 **Citation:** Andrews EB, Eaton SC, Hollis KA, Hopkins JS, Ameen V, Hamm LR, Cook SF, Tennis P, Mangel AW. Prevalence and demographics of irritable bowel syndrome: results from a large web-based survey. Aliment Pharmacol Ther. 2005 Nov 15;22(10):935-42. doi: 10.1111/j.1365-2036.2005.02671.x. **PMID:** 16268967 **Citation:** Muller-Lissner SA, Bollani S, Brummer RJ, Coremans G, Dapoigny M, Marshall JK, Muris JW, Oberndorff-Klein Wolthuis A, Pace F, Rodrigo L, Stockbrugger R, Vatn MH. Epidemiological aspects of irritable bowel syndrome in Europe and North America. Digestion. 2001;64(3):200-4. doi: 10.1159/000048862. **PMID:** 11786669 **Citation:** El-Salhy M, Gundersen D, Gilja OH, Hatlebakk JG, Hausken T. Is irritable bowel syndrome an organic disorder? World J Gastroenterol. 2014 Jan 14;20(2):384-400. doi: 10.3748/wjg.v20.i2.384. **PMID:** 24574708 **Citation:** Horwitz BJ, Fisher RS. The irritable bowel syndrome. N Engl J Med. 2001 Jun 14;344(24):1846-50. doi: 10.1056/NEJM200106143442407. No abstract available. **PMID:** 11407347 **Citation:** Chang L. Review article: epidemiology and quality of life in functional gastrointestinal disorders. Aliment Pharmacol Ther. 2004 Nov;20 Suppl 7:31-9. doi: 10.1111/j.1365-2036.2004.02183.x. **PMID:** 15521853 **Citation:** Maxion-Bergemann S, Thielecke F, Abel F, Bergemann R. Costs of irritable bowel syndrome in the UK and US. Pharmacoeconomics. 2006;24(1):21-37. doi: 10.2165/00019053-200624010-00002. **PMID:** 16445300 **Citation:** Chey WD, Kurlander J, Eswaran S. Irritable bowel syndrome: a clinical review. JAMA. 2015 Mar 3;313(9):949-58. doi: 10.1001/jama.2015.0954. **PMID:** 25734736 **Citation:** Anastasi JK, Capili B, Chang M. Managing irritable bowel syndrome. Am J Nurs. 2013 Jul;113(7):42-52; quiz 54, 53. doi: 10.1097/01.NAJ.0000431911.65473.35. **PMID:** 23764698 **Citation:** Mayer EA. Clinical practice. Irritable bowel syndrome. N Engl J Med. 2008 Apr 17;358(16):1692-9. doi: 10.1056/NEJMcp0801447. **PMID:** 18420501 **Citation:** Mayer EA, Labus JS, Tillisch K, Cole SW, Baldi P. Towards a systems view of IBS. Nat Rev Gastroenterol Hepatol. 2015 Oct;12(10):592-605. doi: 10.1038/nrgastro.2015.121. Epub 2015 Aug 25. **PMID:** 26303675 **Citation:** Rajilic-Stojanovic M, Jonkers DM, Salonen A, Hanevik K, Raes J, Jalanka J, de Vos WM, Manichanh C, Golic N, Enck P, Philippou E, Iraqi FA, Clarke G, Spiller RC, Penders J. Intestinal microbiota and diet in IBS: causes, consequences, or epiphenomena? Am J Gastroenterol. 2015 Feb;110(2):278-87. doi: 10.1038/ajg.2014.427. Epub 2015 Jan 27. **PMID:** 25623659 **Citation:** Staudacher HM, Irving PM, Lomer MC, Whelan K. Mechanisms and efficacy of dietary FODMAP restriction in IBS. Nat Rev Gastroenterol Hepatol. 2014 Apr;11(4):256-66. doi: 10.1038/nrgastro.2013.259. Epub 2014 Jan 21. **PMID:** 24445613 **Citation:** Staudacher HM, Lomer MC, Anderson JL, Barrett JS, Muir JG, Irving PM, Whelan K. Fermentable carbohydrate restriction reduces luminal bifidobacteria and gastrointestinal symptoms in patients with irritable bowel syndrome. J Nutr. 2012 Aug;142(8):1510-8. doi: 10.3945/jn.112.159285. Epub 2012 Jun 27. **PMID:** 22739368 **Citation:** Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology. 2014 Jan;146(1):67-75.e5. doi: 10.1053/j.gastro.2013.09.046. Epub 2013 Sep 25. **PMID:** 24076059 **Citation:** Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Simren M. Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial. Gastroenterology. 2015 Nov;149(6):1399-1407.e2. doi: 10.1053/j.gastro.2015.07.054. Epub 2015 Aug 5. **PMID:** 26255043 **Citation:** Eswaran SL, Chey WD, Han-Markey T, Ball S, Jackson K. A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D. Am J Gastroenterol. 2016 Dec;111(12):1824-1832. doi: 10.1038/ajg.2016.434. Epub 2016 Oct 11. **PMID:** 27725652 **Citation:** Simren M, Barbara G, Flint HJ, Spiegel BM, Spiller RC, Vanner S, Verdu EF, Whorwell PJ, Zoetendal EG; Rome Foundation Committee. Intestinal microbiota in functional bowel disorders: a Rome foundation report. Gut. 2013 Jan;62(1):159-76. doi: 10.1136/gutjnl-2012-302167. Epub 2012 Jun 22. **PMID:** 22730468 **Citation:** Sundin J, Rangel I, Fuentes S, Heikamp-de Jong I, Hultgren-Hornquist E, de Vos WM, Brummer RJ. Altered faecal and mucosal microbial composition in post-infectious irritable bowel syndrome patients correlates with mucosal lymphocyte phenotypes and psychological distress. Aliment Pharmacol Ther. 2015 Feb;41(4):342-51. doi: 10.1111/apt.13055. Epub 2014 Dec 18. **PMID:** 25521822 **Citation:** Parkes GC, Rayment NB, Hudspith BN, Petrovska L, Lomer MC, Brostoff J, Whelan K, Sanderson JD. Distinct microbial populations exist in the mucosa-associated microbiota of sub-groups of irritable bowel syndrome. Neurogastroenterol Motil. 2012 Jan;24(1):31-9. doi: 10.1111/j.1365-2982.2011.01803.x. Epub 2011 Nov 9. **PMID:** 22070725 **Citation:** Pasolli E, Truong DT, Malik F, Waldron L, Segata N. Machine Learning Meta-analysis of Large Metagenomic Datasets: Tools and Biological Insights. PLoS Comput Biol. 2016 Jul 11;12(7):e1004977. doi: 10.1371/journal.pcbi.1004977. eCollection 2016 Jul. **PMID:** 27400279 **Citation:** Troisi J, Sarno L, Landolfi A, Scala G, Martinelli P, Venturella R, Di Cello A, Zullo F, Guida M. Metabolomic Signature of Endometrial Cancer. J Proteome Res. 2018 Feb 2;17(2):804-812. doi: 10.1021/acs.jproteome.7b00503. Epub 2018 Jan 2. **PMID:** 29235868 **Citation:** Bar-Joseph Z, Gifford DK, Jaakkola TS. Fast optimal leaf ordering for hierarchical clustering. Bioinformatics. 2001;17 Suppl 1:S22-9. doi: 10.1093/bioinformatics/17.suppl_1.s22. **PMID:** 11472989 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003109 - Term: Colonic Diseases, Functional - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - 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 ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M25118 - Name: Irritable Bowel Syndrome - Relevance: HIGH - As Found: Irritable Bowel Syndrome - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M6337 - Name: Colonic Diseases, Functional - 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 ### Condition Browse Module - Meshes - ID: D000043183 - Term: Irritable Bowel Syndrome ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420830 **Brief Title:** Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis. **Official Title:** Title Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis. #### Organization Study ID Info **ID:** RESILIA #### Organization **Class:** OTHER **Full Name:** Institut universitaire de cardiologie et de pneumologie de Québec, University Laval ### Status Module #### Completion Date **Date:** 2034-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Institut universitaire de cardiologie et de pneumologie de Québec, University Laval #### Responsible Party **Investigator Affiliation:** Institut universitaire de cardiologie et de pneumologie de Québec, University Laval **Investigator Full Name:** Josep Rodes-Cabau **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 issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity burden. The SAPIEN 3 Ultra RESILIA valve represents the last generation of the SAPIEN valve system and includes several important iterations (newer leaflet calcium-blocking technology targeting calcium-attracting free aldehydes, dry tissue storage, newer skirt textile design) that should translate into a favorable impact on valve durability at mid- to long- term follow-up **Detailed Description:** Prospective observational registry including patients with severe aortic stenosis undergoing TAVR with the SAPIEN 3 Ultra RESILIA valve. All patients who will survive the procedure will undergo a clinical and echocardiographic follow-up at 1-3 months (± 15 days), at 1-year (±30 days), 3-5 year (±30 days), 6-8 year (±30 days) and 9-10 year (±30 days) after valve implantation. Transthoracic echocardiography (TTE) exams (baseline, 1-3-month, 1 year, 3-5 years, 6-8 years, and 9-10 years post-procedure) will be evaluated in a Centralized Echocardiographic Core Lab at the Quebec Heart and Lung Institute. The measurements obtained in the Core Lab regarding transvalvular gradient, EOA, PPM and PVL at 1-3 months will determine the primary outcome of the study. ### Conditions Module **Conditions:** - Aortic Valve Stenosis - Transcatheter Aortic Valve Replacement ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve. **Name:** SAPIEN 3 Ultra RESILIA Valve **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Residual (peak and mean) transvalvular gradient **Measure:** Transvalvular gradient **Time Frame:** 1-3 months **Description:** EOA evaluated by echocardiography imaging **Measure:** Effective orifice area (EOA) **Time Frame:** 1-3 months **Description:** Moderate or severe prothesis-patient mismatch (defines as an index aortic valve area 0.85-0.66 cm2/m2 (moderate), ≤0.65 cm2/m2 (severe) for patient with BMI ˂30km/m2 and 0.70-0.56 cm2/m2 (moderate), ≤0.55 cm2/m2 (severe) for patient with BMI ≥30km/m2 and/or moderate-severe aortic regurgitation (AR) (VARC-3 definition). **Measure:** Prosthesis-patient mismatch **Time Frame:** 1-3 months **Description:** Paravalvular leaks evaluated by echocardiography imaging **Measure:** Paravalvular leaks **Time Frame:** 1-3 months #### Secondary Outcomes **Description:** Residual (maximal and mean) transvalvular gradient **Measure:** Transvalvular gradient **Time Frame:** 1-, 3-5-, 6-8-, and 9-10-year follow-up. **Description:** EOA evaluated by echocardiography imaging **Measure:** Effective orifice area (EOA) **Time Frame:** 1-, 3-5-, 6-8-, and 9-10-year follow-up. **Description:** Bioprosthetic valve dysfunction evaluated by VARC3 criteria **Measure:** Bioprosthetic valve dysfunction **Time Frame:** 1-, 3-5-, 6-8-, and 9-10-year follow-up. **Description:** Paravalvular leaks evaluated by echocardiography imaging **Measure:** Paravalvular leaks **Time Frame:** 1-, 3-5-, 6-8-, and 9-10-year follow-up. **Description:** Incidence rate (per 100 patient-years) of bioprosthetic valve dysfunction (stage 2 or 3) **Measure:** Bioprosthetic valve dysfunction **Time Frame:** yearly **Description:** Incidence rate (per 100 patient-years) of bioprosthetic valve failure **Measure:** Bioprosthetic valve failure **Time Frame:** yearly **Description:** Bioprosthetic valve failure evaluated by VARC3 criteria **Measure:** Bioprosthetic valve failure **Time Frame:** 1-, 3-5-, 6-8-, and 9-10-year follow-up. **Description:** Individual: mortality, stroke, bleeding type 2-4, cardiac rehospitalization, heart failure rehospitalization **Measure:** Clinical events **Time Frame:** 1month and yearly up to 10-year **Description:** Number of patients with valve thrombosis **Measure:** Valve thrombosis **Time Frame:** 1-3 months and yearly up to 10-year **Description:** Number of patients with valve endocarditis **Measure:** Valve endocarditis **Time Frame:** 1-3 months and yearly up to 10-year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Inclusion criteria - Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve. * Successful valve implantation of the SAPIEN 3 Ultra RESILIA valve. VARC-3- defined technical success defined as: * Freedom from mortality * Successful access, delivery of the device, and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access related, or cardiac structural complication - Absence of severe procedural or in-hospital complications (VARC-3 definitions): mortality, stroke, bleeding type 2-4, myocardial infarction, need for a second valve, valve embolization, coronary obstruction, annular rupture. Exclusion Criteria: * Age \>80 years * Severe pulmonary disease (FEV1 \<50% predicted or need for home oxygen) * Severe renal dysfunction (eGFR \<30 ml/min/1.73m2) * Frailty (Clinical Frailty Scale \> 4) * Severe coronary disease (SYNTAX score \>32) * Left ventricular ejection fraction ≤30% * Moderate-to-severe mitral regurgitation * Severe tricuspid regurgitation * Pulmonary systolic pressure \>60 mmHg * STS-PROM \>5% * Any disease leading to a life expectancy \<5 years **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Population Patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra RESILIA valve. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** josep.rodes@criucpq.ulaval.ca **Name:** Josep Rodés-Cabau, MD **Phone:** 4186568711 **Role:** CONTACT **Contact 2:** **Email:** emilie.pelletier-beaumont@criucpq.ulaval.ca **Name:** Emilie Pelletier beaumont, MSc **Phone:** 418-656-8711 **Phone Ext:** 3929 **Role:** CONTACT #### Locations **Location 1:** **City:** Quebec **Country:** Canada **Facility:** IUCPQ **Zip:** G1V 4G5 #### Overall Officials **Official 1:** **Affiliation:** IUCPQ-UL **Name:** Josep Rodés-Cabau, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Fondation IUCPQ **Name:** Emilie Pelletier beaumont, MSc **Role:** STUDY_DIRECTOR ### References Module #### References **Citation:** Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C; ACC/AHA Joint Committee Members; O'Gara PT, Beckman JA, Levine GN, Al-Khatib SM, Armbruster A, Birtcher KK, Ciggaroa J, Deswal A, Dixon DL, Fleisher LA, de Las Fuentes L, Gentile F, Goldberger ZD, Gorenek B, Haynes N, Hernandez AF, Hlatky MA, Joglar JA, Jones WS, Marine JE, Mark D, Palaniappan L, Piano MR, Spatz ES, Tamis-Holland J, Wijeysundera DN, Woo YJ. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Thorac Cardiovasc Surg. 2021 Aug;162(2):e183-e353. doi: 10.1016/j.jtcvs.2021.04.002. Epub 2021 May 8. No abstract available. **PMID:** 33972115 **Citation:** Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available. Erratum In: Eur Heart J. 2022 Feb 18;: **PMID:** 34453165 **Citation:** Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16. **PMID:** 30883058 **Citation:** Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16. **PMID:** 30883053 **Citation:** Montarello NJ, Willemen Y, Tirado-Conte G, Travieso A, Bieliauskas G, Sondergaard L, De Backer O. Transcatheter aortic valve durability: a contemporary clinical review. Front Cardiovasc Med. 2023 May 9;10:1195397. doi: 10.3389/fcvm.2023.1195397. eCollection 2023. **PMID:** 37229228 **Citation:** Ferreira-Neto AN, Rodriguez-Gabella T, Guimaraes L, Freitas-Ferraz A, Bernier M, Figueiredo Guimaraes C, Pasian S, Paradis JM, Delarochelliere R, Dumont E, Mohammadi S, Kalavrouziotis D, Cote M, Pibarot P, Rodes-Cabau J. Multimodality evaluation of transcatheter structural valve degeneration at long-term follow-up. Rev Esp Cardiol (Engl Ed). 2021 Mar;74(3):247-256. doi: 10.1016/j.rec.2020.02.002. Epub 2020 Apr 8. English, Spanish. **PMID:** 32278660 **Citation:** Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22. **PMID:** 20961243 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000082862 - Term: Aortic Valve Disease - ID: D000006349 - Term: Heart Valve Diseases - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000014694 - Term: Ventricular Outflow Obstruction ### 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: M6475 - Name: Constriction, Pathologic - Relevance: LOW - As Found: Unknown - ID: M4340 - Name: Aortic Valve Stenosis - Relevance: HIGH - As Found: Aortic Valve Stenosis - ID: M2379 - Name: Aortic Valve Disease - Relevance: LOW - As Found: Unknown - ID: M9437 - Name: Heart Valve Diseases - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17440 - Name: Ventricular Outflow Obstruction - Relevance: LOW - As Found: Unknown - ID: T449 - Name: Aortic Valve Stenosis - Relevance: HIGH - As Found: Aortic Valve Stenosis ### Condition Browse Module - Meshes - ID: D000001024 - Term: Aortic Valve Stenosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420817 **Acronym:** CLIP **Brief Title:** Effect of a Customised Lifestyle Medicine Strategy on Lowering Blood Lipid Levels in Indian Physicians **Official Title:** Effect of a Customised Lifestyle Medicine Strategy on Lowering Blood Lipid Levels in Indian Physicians #### Organization Study ID Info **ID:** CLIP #### Organization **Class:** OTHER **Full Name:** Jubilee Mission Medical College and Research Institute ### Status Module #### Completion Date **Date:** 2024-08-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Christian Medical College, Vellore, India #### Lead Sponsor **Class:** OTHER **Name:** Jubilee Mission Medical College and Research Institute #### Responsible Party **Investigator Affiliation:** Jubilee Mission Medical College and Research Institute **Investigator Full Name:** Dr. Manoj Varanattu **Investigator Title:** Professor of Pediatrics & Neonatology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Lifestyle medicine is a medical specialty that uses evidence-based therapeutic interventions to prevent, treat, and reverse chronic conditions. Studies have shown that a 50 mg/dl reduction in LDL reduces the risk of developing stroke by 20%, and a 10 mm Hg reduction in systolic BP reduces the risk of developing MACE by 22% and stroke by 41%. The CLIP (Cholesterol Lowering Lifestyle Intervention Project) is an innovative initiative proposed to evaluate the combined effect of an Indian version of Portfolio diet-based nutrition strategy, intermittent fasting, exercise, sleep, and stress reduction techniques on lowering blood lipid levels in health professionals and their family. The study aims to evaluate the effect of CLIP on changes in blood pressure, weight, HbA1C levels, blood CRP levels, and other blood parameters. **Detailed Description:** Lifestyle medicine is a medical specialty that uses evidence based therapeutic lifestyle interventions as a primary modality to prevent, treat and often reverse chronic conditions using whole food plant-based diet, physical activity, restorative sleep, stress reduction, avoiding risky substances and positive social connections with or without medications. Epidemiological and interventional studies have shown clearly that a 50 mg/dl reduction in LDL reduces the risk of developing stroke by 20% and a 10 mm Hg reduction in systolic BP reduces the risk of developing MACE by 22% and the risk of developing stroke by 41%.(Enas EA, et al, Indian Heart Journal, 2011, cadiresearch.org,) Studies by the nutrition expert David J.A. Jenkins and colleagues from Toronto University have shown that grouping plant based whole foods, which have their own cholesterol lowering ability when eaten alone, will have a larger effect when they are eaten together or combined into a "portfolio" as part of a regular diet (https://jamanetwork.com/journals/jama/fullarticle /196970). The 'portfolio diet' plan has been subsequently shown to reduce cholesterol similar to powerful cholesterol-lowering drugs without any side effects in various other studies as well. However, no study has so far looked at the effects of this diet on Indian population. Also, no reported study in the world so far has looked at the effects of a combination of lifestyle medicine interventions including the Indianized version of portfolio diet on the reduction of lipid levels in health care workers CLIP (Cholesterol lowering Lifestyle Intervention Project) is an innovative lifestyle medicine intervention project that we propose to carry out under the academic guidance of the Dept of Lifestyle Medicine , CMC, Vellore. Research Question: Will a customised lifestyle medicine strategy over a period of 4 weeks lower blood lipid levels significantly in adults between 18 and 70 years? Null Hypothesis: A customised lifestyle medicine strategy over a period of 4 weeks will not significantly lower blood lipid levels in adults between 18 and 70 years Type of study: A Quasi Experimental Study Time duration: Preparation: 4 weeks Intervention: 4 weeks Result compilation and analysis: 4 months Total: 6 months AIM: To evaluate the combined effect of an Indian version of Portfolio diet-based nutrition strategy, Intermittent fasting, Exercise, Sleep and Stress Reduction Techniques on lowering blood lipid levels in health professionals and their family Secondary objectives: To evaluate the effect of the CLIP interventions on the changes in * Blood Pressure * Weight * HbA1C levels * Blood CRP levels * Other blood Parameters including Lipo A The study would be done in 2 phases. In the first phase the pretest questionnaire would be administered through google forms and health education on whole food plant-based diet, physical activity, restorative sleep, stress reduction \& avoiding risky substances would be given. In the second phase Intervention would be carried out and monitoring would be done online daily / weekly by the investigative team. Population: Willing members of health professionals and their family Inclusion Criteria: All willing health professionals and their family aged between 18 and 70 years Exclusion Criteria: * Those who have been started on any medication for chronic illnesses unless sufficient period (3 months) is over for stabilization of parameters on those medications. * People on insulin, steroids and warfarin. * Those who alter their medications during the intervention * Those who are unfit to exercise Methods: Enrolment and Training: All the participants who meet the criteria for the study will be enrolled from an already existing WhatsApp group of Modern Medicine doctors and their family interested in lifestyle interventions. The study protocol will be familiarised online through social media platforms on the basic concepts of lifestyle medicine in general and the interventions adopted in particular, before the commencement of the intervention. Consenting members will be enrolled in the study and will undergo the following interventions: I. Baseline Screening: The following parameters will be evaluated (by the participants) during the preparation stage before the commencement of the intervention: Anthropometry \& Clinical: Height, Weight, Waist Circumference, Waist to Hip Ratio, BP Biochemistry: Lipid Profile, Apolipoprotein B, Lipoprotein A, HbA1C, Blood sugar (Fasting and PP), CRP, LFT, RFT, Uric Acid, TSH II. Lifestyle Interventions: The participants will be supervised to * follow the prescribed diet plan * do intermittent fasting for 12 hours daily and * join for an hour of group online exercise program 3 days a week. * Monitor the sleep duration as per PSQI (Pittsburgh sleep quality index) scores * (Exercise Duration = 180 minutes per week including cardio, strength training and flexibility) * Compliance: Adherence to all interventions planned will be monitored through a weekly questionnaire, software like habit tracker and online Zoom meetings III. Final Evaluation: Final Anthropometry, Clinical and Biochemical Parameters achieved will be obtained at the end of 4 weeks. (Pre and post biochemical evaluation will be done by the participants in the same lab) Expected outcome of the study: It is expected that diet and other lifestyle interventions included in the study will lower total cholesterol and LDL levels (primary outcomes) of the participants in proportion to their degree of compliance to interventions. 1. Proportion of participants achieving reduction in BMI \& Waist to Hip Ratio 2. Proportion of hypertensive participants achieving reduction in BP 3. Proportion of DM participants achieving reduction in HbA1C 4. Proportion of participants achieving reduction in TC \& LDL levels 5. Proportion of participants achieving reduction in all the other biochemical parameters studied ### Conditions Module **Conditions:** - Lifestyle Risk Reduction - Cholesterol, Elevated - LDL Hyperlipoproteinemia - Hypertension - Lipoprotein(A) - HbA1C - BMI **Keywords:** - Intermittend fasting - Blood lipid level lowering ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** The study would be done in 2 phases. In the first phase the pretest questionnaire would be administered throughGoogle forms and health education on various Lifestyle Medicine interventions would be given. In the second phase Intervention would be carried out and monitoring would be done online daily / weekly by the investigative team. The following five strategies of lifestyle medicine will be tried to lower the lipid levels in the study group: 1. Nutrition - modified/Indianized Portfolio diet - (Primary Intervention) 2. adequate exercise - 180 minutes of moderate intensity exercises every week 3. intermittent fasting of 12 hours every day 4. sleep monitoring and 5. monitoring stress levels ##### 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:** Lifestyle Interventions (a prescribed whole food plant-based diet, physical activity and intermittent fasting along with monitoring of sleep and stress levels) would be carried out to the enrolled participants **Intervention Names:** - Behavioral: Indian version of a 'Portfolio' diet - Behavioral: Physical Activity - Behavioral: Intermittent fasting - Behavioral: Monitoring of sleep and stress levels **Label:** Lifestyle Interventions **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Lifestyle Interventions **Description:** The participants will be required to follow the prescribed diet plan for 4 weeks **Name:** Indian version of a 'Portfolio' diet **Other Names:** - Indian version of a dietary portfolio of cholesterol lowering foods **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Lifestyle Interventions **Description:** The participants will be required to join for an hour of group online exercise program 3 days a week for 4 weeks • (Exercise Duration = 180 minutes per week including cardio, strength training and flexibility) **Name:** Physical Activity **Other Names:** - Exercise - Workout **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Lifestyle Interventions **Description:** The participants will be required to do intermittent fasting for 12 hours daily for 4 weeks **Name:** Intermittent fasting **Other Names:** - Time Restricted Eating **Type:** BEHAVIORAL #### Intervention 4 **Arm Group Labels:** - Lifestyle Interventions **Description:** The participants will be required to monitor their sleep and stress levels **Name:** Monitoring of sleep and stress levels **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The combined effect of an Indian version of Portfolio diet-based nutrition strategy, Intermittent fasting, Exercise, Sleep and Stress Reduction Techniques on lowering blood lipid levels **Measure:** Changes in the blood lipid levels **Time Frame:** 4 weeks #### Secondary Outcomes **Description:** The effect of a customised lifestyle intervention technique on changes in Blood Pressure, Weight, BMI, HbA1C levels, Blood HS CRP levels and Other blood Parameters including Lipoprotein A **Measure:** Changes in the anthropometric and biochemical parameters **Time Frame:** 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: All willing Indian doctors and their family aged between 18 and 70 years Exclusion Criteria: * Those who have been started on any medication for chronic illnesses unless sufficient period (3 months) is over for stabilization of parameters on those medications. * People on insulin, steroids and warfarin. * Those who alter their medications during the intervention * Those who are unfit to exercise **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Thrissur **Country:** India **Facility:** Manoj Varanattu **State:** Kerala **Zip:** 680005 ### References Module #### References **Citation:** Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, Trautwein EA, Lapsley KG, Josse RG, Leiter LA, Singer W, Connelly PW. Direct comparison of a dietary portfolio of cholesterol-lowering foods with a statin in hypercholesterolemic participants. Am J Clin Nutr. 2005 Feb;81(2):380-7. doi: 10.1093/ajcn.81.2.380. **PMID:** 15699225 **Citation:** Khodamoradi K, Khosropanah MH, Ayati Z, Chang D, Nasli-Esfahani E, Ayati MH, Namazi N. The Effects of Fenugreek on Cardiometabolic Risk Factors in Adults: A Systematic Review and Meta-analysis. Complement Ther Med. 2020 Aug;52:102416. doi: 10.1016/j.ctim.2020.102416. Epub 2020 Apr 28. **PMID:** 32951700 **Citation:** Heshmat-Ghahdarijani K, Mashayekhiasl N, Amerizadeh A, Teimouri Jervekani Z, Sadeghi M. Effect of fenugreek consumption on serum lipid profile: A systematic review and meta-analysis. Phytother Res. 2020 Sep;34(9):2230-2245. doi: 10.1002/ptr.6690. Epub 2020 May 8. **PMID:** 32385866 **Citation:** Gopa B, Bhatt J, Hemavathi KG. A comparative clinical study of hypolipidemic efficacy of Amla (Emblica officinalis) with 3-hydroxy-3-methylglutaryl-coenzyme-A reductase inhibitor simvastatin. Indian J Pharmacol. 2012 Mar;44(2):238-42. doi: 10.4103/0253-7613.93857. **PMID:** 22529483 **Citation:** Akhtar MS, Ramzan A, Ali A, Ahmad M. Effect of Amla fruit (Emblica officinalis Gaertn.) on blood glucose and lipid profile of normal subjects and type 2 diabetic patients. Int J Food Sci Nutr. 2011 Sep;62(6):609-16. doi: 10.3109/09637486.2011.560565. Epub 2011 Apr 18. **PMID:** 21495900 **Citation:** Uma Maheswari K, Dilara K, Vadivel S, Johnson P, Jayaraman S. A review on hypo-cholesterolemic activity of Nigella sativa seeds and its extracts. Bioinformation. 2022 Apr 30;18(4):343-348. doi: 10.6026/97320630018343. eCollection 2022. **PMID:** 36909699 **Citation:** Hallajzadeh J, Milajerdi A, Mobini M, Amirani E, Azizi S, Nikkhah E, Bahadori B, Sheikhsoleimani R, Mirhashemi SM. Effects of Nigella sativa on glycemic control, lipid profiles, and biomarkers of inflammatory and oxidative stress: A systematic review and meta-analysis of randomized controlled clinical trials. Phytother Res. 2020 Oct;34(10):2586-2608. doi: 10.1002/ptr.6708. Epub 2020 May 11. **PMID:** 32394508 **Citation:** Sahebkar A, Beccuti G, Simental-Mendia LE, Nobili V, Bo S. Nigella sativa (black seed) effects on plasma lipid concentrations in humans: A systematic review and meta-analysis of randomized placebo-controlled trials. Pharmacol Res. 2016 Apr;106:37-50. doi: 10.1016/j.phrs.2016.02.008. Epub 2016 Feb 10. **PMID:** 26875640 **Citation:** Prasad K, Khan AS, Shoker M. Flaxseed and Its Components in Treatment of Hyperlipidemia and Cardiovascular Disease. Int J Angiol. 2020 Dec;29(4):216-222. doi: 10.1055/s-0040-1709129. Epub 2020 Apr 14. **PMID:** 33268971 **Citation:** Sadat Masjedi M, Mohammadi Pour P, Shokoohinia Y, Asgary S. Effects of Flaxseed on Blood Lipids in Healthy and Dyslipidemic Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Curr Probl Cardiol. 2022 Jul;47(7):100931. doi: 10.1016/j.cpcardiol.2021.100931. Epub 2021 Jul 16. **PMID:** 34384619 **Citation:** Amiri M, Raeisi-Dehkordi H, Sarrafzadegan N, Forbes SC, Salehi-Abargouei A. The effects of Canola oil on cardiovascular risk factors: A systematic review and meta-analysis with dose-response analysis of controlled clinical trials. Nutr Metab Cardiovasc Dis. 2020 Nov 27;30(12):2133-2145. doi: 10.1016/j.numecd.2020.06.007. Epub 2020 Jun 18. **PMID:** 33127255 **Citation:** Schwingshackl L, Bogensberger B, Bencic A, Knuppel S, Boeing H, Hoffmann G. Effects of oils and solid fats on blood lipids: a systematic review and network meta-analysis. J Lipid Res. 2018 Sep;59(9):1771-1782. doi: 10.1194/jlr.P085522. Epub 2018 Jul 13. **PMID:** 30006369 **Citation:** Wilson TA, Ausman LM, Lawton CW, Hegsted DM, Nicolosi RJ. Comparative cholesterol lowering properties of vegetable oils: beyond fatty acids. J Am Coll Nutr. 2000 Oct;19(5):601-7. doi: 10.1080/07315724.2000.10718957. **PMID:** 11022873 **Citation:** Saedi S, Noroozi M, Khosrotabar N, Mazandarani S, Ghadrdoost B. How canola and sunflower oils affect lipid profile and anthropometric parameters of participants with dyslipidemia. Med J Islam Repub Iran. 2017 Jan 15;31:5. doi: 10.18869/mjiri.31.5. eCollection 2017. **PMID:** 28638812 **Citation:** Craig WJ, Mangels AR, Fresan U, Marsh K, Miles FL, Saunders AV, Haddad EH, Heskey CE, Johnston P, Larson-Meyer E, Orlich M. The Safe and Effective Use of Plant-Based Diets with Guidelines for Health Professionals. Nutrients. 2021 Nov 19;13(11):4144. doi: 10.3390/nu13114144. **PMID:** 34836399 **Citation:** Sabate J, Oda K, Ros E. Nut consumption and blood lipid levels: a pooled analysis of 25 intervention trials. Arch Intern Med. 2010 May 10;170(9):821-7. doi: 10.1001/archinternmed.2010.79. **PMID:** 20458092 **Citation:** Liu AG, Ford NA, Hu FB, Zelman KM, Mozaffarian D, Kris-Etherton PM. A healthy approach to dietary fats: understanding the science and taking action to reduce consumer confusion. Nutr J. 2017 Aug 30;16(1):53. doi: 10.1186/s12937-017-0271-4. **PMID:** 28854932 **Citation:** Zhang Z, Lanza E, Kris-Etherton PM, Colburn NH, Bagshaw D, Rovine MJ, Ulbrecht JS, Bobe G, Chapkin RS, Hartman TJ. A high legume low glycemic index diet improves serum lipid profiles in men. Lipids. 2010 Sep;45(9):765-75. doi: 10.1007/s11745-010-3463-7. Epub 2010 Aug 24. **PMID:** 20734238 **Citation:** Ha V, Sievenpiper JL, de Souza RJ, Jayalath VH, Mirrahimi A, Agarwal A, Chiavaroli L, Mejia SB, Sacks FM, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Bazinet RP, Josse RG, Beyene J, Kendall CW, Jenkins DJ. Effect of dietary pulse intake on established therapeutic lipid targets for cardiovascular risk reduction: a systematic review and meta-analysis of randomized controlled trials. CMAJ. 2014 May 13;186(8):E252-62. doi: 10.1503/cmaj.131727. Epub 2014 Apr 7. **PMID:** 24710915 **Citation:** Schoeneck M, Iggman D. The effects of foods on LDL cholesterol levels: A systematic review of the accumulated evidence from systematic reviews and meta-analyses of randomized controlled trials. Nutr Metab Cardiovasc Dis. 2021 May 6;31(5):1325-1338. doi: 10.1016/j.numecd.2020.12.032. Epub 2021 Jan 16. **PMID:** 33762150 **Citation:** Richter CK, Skulas-Ray AC, Champagne CM, Kris-Etherton PM. Plant protein and animal proteins: do they differentially affect cardiovascular disease risk? Adv Nutr. 2015 Nov 13;6(6):712-28. doi: 10.3945/an.115.009654. Print 2015 Nov. **PMID:** 26567196 **Citation:** Erdman JW Jr. AHA Science Advisory: Soy protein and cardiovascular disease: A statement for healthcare professionals from the Nutrition Committee of the AHA. Circulation. 2000 Nov 14;102(20):2555-9. doi: 10.1161/01.cir.102.20.2555. No abstract available. **PMID:** 11076833 **Citation:** Yu-Poth S, Zhao G, Etherton T, Naglak M, Jonnalagadda S, Kris-Etherton PM. Effects of the National Cholesterol Education Program's Step I and Step II dietary intervention programs on cardiovascular disease risk factors: a meta-analysis. Am J Clin Nutr. 1999 Apr;69(4):632-46. doi: 10.1093/ajcn/69.4.632. **PMID:** 10197564 **Citation:** Anderson JW, Johnstone BM, Cook-Newell ME. Meta-analysis of the effects of soy protein intake on serum lipids. N Engl J Med. 1995 Aug 3;333(5):276-82. doi: 10.1056/NEJM199508033330502. **PMID:** 7596371 **Citation:** Teixeira SR, Potter SM, Weigel R, Hannum S, Erdman JW Jr, Hasler CM. Effects of feeding 4 levels of soy protein for 3 and 6 wk on blood lipids and apolipoproteins in moderately hypercholesterolemic men. Am J Clin Nutr. 2000 May;71(5):1077-84. doi: 10.1093/ajcn/71.5.1077. **PMID:** 10799368 **Citation:** Chiavaroli L, Nishi SK, Khan TA, Braunstein CR, Glenn AJ, Mejia SB, Rahelic D, Kahleova H, Salas-Salvado J, Jenkins DJA, Kendall CWC, Sievenpiper JL. Portfolio Dietary Pattern and Cardiovascular Disease: A Systematic Review and Meta-analysis of Controlled Trials. Prog Cardiovasc Dis. 2018 May-Jun;61(1):43-53. doi: 10.1016/j.pcad.2018.05.004. Epub 2018 May 26. **PMID:** 29807048 **Citation:** Li SS, Blanco Mejia S, Lytvyn L, Stewart SE, Viguiliouk E, Ha V, de Souza RJ, Leiter LA, Kendall CWC, Jenkins DJA, Sievenpiper JL. Effect of Plant Protein on Blood Lipids: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2017 Dec 20;6(12):e006659. doi: 10.1161/JAHA.117.006659. **PMID:** 29263032 **Citation:** Reddy KR, Freeman AM. Lifestyle Medicine: An Antidote to Cardiovascular Diseases. Am J Lifestyle Med. 2022 Oct 3;18(2):216-232. doi: 10.1177/15598276221130684. eCollection 2024 Mar-Apr. **PMID:** 38559785 **Citation:** Lo K, Glenn AJ, Yeung S, Kendall CWC, Sievenpiper JL, Jenkins DJA, Woo J. Prospective Association of the Portfolio Diet with All-Cause and Cause-Specific Mortality Risk in the Mr. OS and Ms. OS Study. Nutrients. 2021 Dec 3;13(12):4360. doi: 10.3390/nu13124360. **PMID:** 34959911 **Citation:** Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, Lapsley KG, Trautwein EA, Josse RG, Leiter LA, Connelly PW. Effects of a dietary portfolio of cholesterol-lowering foods vs lovastatin on serum lipids and C-reactive protein. JAMA. 2003 Jul 23;290(4):502-10. doi: 10.1001/jama.290.4.502. **PMID:** 12876093 **Citation:** Wang Y, Xu D. Effects of aerobic exercise on lipids and lipoproteins. Lipids Health Dis. 2017 Jul 5;16(1):132. doi: 10.1186/s12944-017-0515-5. **PMID:** 28679436 **Citation:** Muscella A, Stefano E, Marsigliante S. The effects of exercise training on lipid metabolism and coronary heart disease. Am J Physiol Heart Circ Physiol. 2020 Jul 1;319(1):H76-H88. doi: 10.1152/ajpheart.00708.2019. Epub 2020 May 22. **PMID:** 32442027 **Citation:** Smiley A, King D, Harezlak J, Dinh P, Bidulescu A. The association between sleep duration and lipid profiles: the NHANES 2013-2014. J Diabetes Metab Disord. 2019 Jun 22;18(2):315-322. doi: 10.1007/s40200-019-00415-0. eCollection 2019 Dec. **PMID:** 31890656 **Citation:** Makarem N, Castro-Diehl C, St-Onge MP, Redline S, Shea S, Lloyd-Jones D, Ning H, Aggarwal B. Redefining Cardiovascular Health to Include Sleep: Prospective Associations With Cardiovascular Disease in the MESA Sleep Study. J Am Heart Assoc. 2022 Nov;11(21):e025252. doi: 10.1161/JAHA.122.025252. Epub 2022 Oct 19. **PMID:** 36259552 **Citation:** Zhang J, Zhang J, Wu H, Wang R. Sleep duration and risk of hyperlipidemia: a systematic review and meta-analysis of prospective studies. Sleep Breath. 2022 Sep;26(3):997-1010. doi: 10.1007/s11325-021-02504-y. Epub 2021 Oct 7. **PMID:** 34618292 **Citation:** Assadi SN. What are the effects of psychological stress and physical work on blood lipid profiles? Medicine (Baltimore). 2017 May;96(18):e6816. doi: 10.1097/MD.0000000000006816. **PMID:** 28471984 **Citation:** Kivimaki M, Steptoe A. Effects of stress on the development and progression of cardiovascular disease. Nat Rev Cardiol. 2018 Apr;15(4):215-229. doi: 10.1038/nrcardio.2017.189. Epub 2017 Dec 7. **PMID:** 29213140 **Citation:** Sara JD, Prasad M, Eleid MF, Zhang M, Widmer RJ, Lerman A. Association Between Work-Related Stress and Coronary Heart Disease: A Review of Prospective Studies Through the Job Strain, Effort-Reward Balance, and Organizational Justice Models. J Am Heart Assoc. 2018 Apr 27;7(9):e008073. doi: 10.1161/JAHA.117.008073. No abstract available. **PMID:** 29703810 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050171 - Term: Dyslipidemias - ID: D000052439 - Term: Lipid Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M10024 - Name: Hypertension - Relevance: LOW - As Found: Unknown - ID: M10000 - Name: Hyperlipidemias - Relevance: HIGH - As Found: Hyperlipoproteinemia - ID: M10002 - Name: Hyperlipoproteinemias - Relevance: HIGH - As Found: Hyperlipoproteinemia - ID: M9988 - Name: Hypercholesterolemia - Relevance: HIGH - As Found: Cholesterol, Elevated - ID: M26181 - Name: Dyslipidemias - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M27029 - Name: Lipid Metabolism Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000006951 - Term: Hyperlipoproteinemias - ID: D000006949 - Term: Hyperlipidemias - ID: D000006937 - Term: Hypercholesterolemia ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420804 **Brief Title:** Evaluation of the Safety and Efficacy of an Acne Treatment Device **Official Title:** Evaluation of the Safety and Efficacy of an Acne Treatment Device #### Organization Study ID Info **ID:** DCS-46-20 #### Organization **Class:** INDUSTRY **Full Name:** ZIIP Beauty ### Status Module #### Completion Date **Date:** 2021-10-03 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2021-09-01 **Type:** ACTUAL #### Start Date **Date:** 2020-10-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** NETWORK **Name:** Dermatology Consulting Services, PLLC #### Lead Sponsor **Class:** INDUSTRY **Name:** ZIIP Beauty #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** A 50-patient study in which 400 microamps of direct current was applied 3 days per week. All tolerability, safety and efficacy endpoints were met. **Detailed Description:** A 50-patient study in which 400 microamps of direct current, applied 3 days per week on non-consecutive days, on all areas afflicted by acne. The results were as follow: TOLERABILITY ASSESSMENT The tolerability endpoint was the investigator-assessed absence of skin irritation from the facial study device at any time during the 12-week study. The tolerability endpoint was met. No statistically significant skin irritation was observed by the dermatologist investigator at any time during the study. SAFETY ASSESSMENT The safety endpoint was the absence of significant adverse reactions. No adverse reactions occurred. The safety endpoint was met. EFFICACY ASSESSMENT The efficacy endpoint was the investigator assessed improvement in investigator global assessment (IGA) after 12 weeks of every other day device use as compared to baseline. The efficacy endpoint was met. There was a 62% reduction in inflammatory lesions and a 49% reduction in noninflammatory lesions at week 12. The IGA was reduced by 44% after 12 weeks of device use from a baseline average of 2.56 to a week 12 average of 1.42. The ZIIP Acne Treatment Study was conducted in compliance with 21 CFR Parts 50, 56 and 812. No protocol deviations were reported during the ZIIP Acne Treatment Study. ### Conditions Module **Conditions:** - Mild to Moderate Acne **Keywords:** - Acne, Acne self care, Adult facial acne ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single-site monadic study to evaluate the effect of a device on acne treatment. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Single-site monadic study to evaluate the effect of a device on acne treatment. **Intervention Names:** - Device: ZIIP Acne Treatment Device **Label:** Single-site monadic study **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Single-site monadic study **Description:** Evaluation of the Safety and Efficacy of a ZIIP Acne Treatment Device **Name:** ZIIP Acne Treatment Device **Other Names:** - Historical Control **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** The tolerability endpoint was the investigator-assessed absence of skin irritation from the facial study device at any time during the 12-week study. **Measure:** Tolerability Assessment **Time Frame:** 12 weeks #### Primary Outcomes **Description:** The efficacy endpoint was the investigator assessed improvement in investigator global assessment (IGA) after 12 weeks of every other day device use as compared to baseline. **Measure:** Efficacy Assessment **Time Frame:** 12 weeks #### Secondary Outcomes **Description:** The safety endpoint was the absence of significant adverse reactions. No adverse reactions occurred. **Measure:** Safety Assessment **Time Frame:** 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * The following represented the inclusion criteria: 1. Subjects with mild to moderate acne (5-30 inflammatory lesions and no nodules/cysts). 2. Male and female subjects age 18-50 years. 3. Subjects with all Fitzpatrick skin types. 4. Subjects of all complexion types (normal, oily, dry, combination). 5. Subjects must have an acne lesion in all 4 zones. . 6. Subjects who have used the same moisturizer without difficulty for 30 days and will continue using same moisturizer during the 12-week study. 7. Subjects agree not to introduce any new colored cosmetics (lipsticks, eye shadows, facial foundations, blush, or powder). 8. Subjects who are using no other acne products for the duration of the study. 9. No known medical conditions that, in the investigator's opinion, may interfere with study participation. 10. Women of childbearing potential were willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant®, Depo-Provera®, double barrier methods (e.g., condom and spermicide) and abstinence. 11. Subjects have signed an Informed Consent Form in compliance with 21CFR, Part 50: "Protection of Human Subjects." Exclusion Criteria: * The following represented the exclusion criteria: 1. Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, except for the study condition of acne. 2. Subjects who are not willing to use the assigned study device to their face as instructed. 3. Subjects who have used any topical prescription or OTC acne products for 2 weeks prior to study entry. 4. Subjects who have taken any oral prescription or OTC acne products for 4 weeks prior to study entry. 5. Subjects who have used a non-OTC cleanser without benzoyl peroxide, sulfur or salicylic acid for at least 2 weeks prior to study entry. 6. Subject who have not had any facial treatments in the past 6 months and are willing to withhold all facial treatments during the course of the study including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, and/or facial plastic surgery. 7. Subjects who are pregnant, breast feeding or planning a pregnancy. 8. Subjects with clinically significant and/or unstable medical disorders. 9. Subjects who are unwilling or unable to comply with the requirements of the protocol. 10. Subjects who have a history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study. 11. Subjects who have undergone recent facial surgery. 12. Subjects currently participating in any other clinical trial. 13. Subjects having started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to the study entry; or who plan on starting, stopping or changing doses of HRT or hormones for birth control during the study. 14. Subjects who have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. 15. Subjects who are wearing EKG monitoring equipment. 16. Subjects with phlebitis, thrombophlebitis, broken capillaries, or varicose veins. 17. Subjects who have seizures, epilepsy, or cancer/tumors. 18. Subjects who have a history of hypertrophic scarring or keloid formation. **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Pleasant Hill **Country:** United States **Facility:** ZIIP Beauty **State:** California **Zip:** 94523 #### Overall Officials **Official 1:** **Affiliation:** Lead Investigator **Name:** Zoe D Draelos, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** At this time there is no plan to share IPD data **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2020-10-05 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 437093 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-13T14:24 - Date: 2020-10-15 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 690428 - Type Abbrev: ICF - Upload Date: 2024-05-13T14:37 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000017486 - Term: Acneiform Eruptions - ID: D000012871 - Term: Skin Diseases - ID: D000012625 - Term: Sebaceous Gland Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M21089 - Name: Facies - Relevance: LOW - As Found: Unknown - ID: M3512 - Name: Acne Vulgaris - Relevance: HIGH - As Found: Acne - ID: M8219 - Name: Exanthema - Relevance: LOW - As Found: Unknown - ID: M19751 - Name: Acneiform Eruptions - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M15439 - Name: Sebaceous Gland Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000152 - Term: Acne Vulgaris ### Intervention Browse Module - Ancestors - ID: D000003879 - Term: Dermatologic Agents ### Intervention Browse Module - Browse Branches - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4872 - Name: Benzoyl Peroxide - Relevance: HIGH - As Found: Analgesic therapy - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000001585 - Term: Benzoyl Peroxide ### Misc Info Module #### Submission Tracking - Estimated Results First Submit Date: 2024-05-29 ##### Submission Infos - MCP Release N: Unknown - Release Date: 2024-05-29 - Reset Date: Unknown - Unrelease Date: Unknown - Unrelease Date Unknown: Unknown - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420791 **Brief Title:** The Dual Impact of Cirrhosis on Transplantation for Hepatocellular Carcinoma：a Two-center Retrospective Cohort Study in China **Official Title:** The Dual Impact of Cirrhosis on Transplantation for Hepatocellular Carcinoma：a Two-center Retrospective Cohort Study in China #### Organization Study ID Info **ID:** CT2024-ZJU-OBS9 #### Organization **Class:** OTHER **Full Name:** Zhejiang University ### Status Module #### Completion Date **Date:** 2024-05-06 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-05-03 **Type:** ACTUAL #### Start Date **Date:** 2024-02-28 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Xiao Xu #### Responsible Party **Investigator Affiliation:** Zhejiang University **Investigator Full Name:** Xiao Xu **Investigator Title:** Principal Investigator, Clinical Professor,PHD,MD **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Background: This study aims to investigate the correlation between cirrhosis and hepatocellular carcinoma (HCC) recurrence after Liver Transplantation. Methods: The study retrospectively collected data enrolled from 519 HCC patients who underwent liver transplantation from two center(the First Affiliated Hospital, Zhejiang University School of Medicine and Shulan (Hangzhou) Hospital, January 2015 to December 2020), Based on important variables, 1:3 propensity score matching (PSM) were performed respectively. ### Conditions Module **Conditions:** - Hepatocellular Carcinoma - Cirrhosis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 1 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** The overall survival rate was evaluated by follow-up investigation and outpatient review **Time Frame:** 2-5 years #### Secondary Outcomes **Measure:** The tumor-free survival rate was evaluated by follow-up investigation and outpatient review **Time Frame:** 2-5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: The patients undergoing liver transplantation for HCC from January 2015 to December 2020. Exclusion Criteria: Re-transplantation or combined liver-kidney transplantation; incomplete laboratory or clinical data; death within 90 days. **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** Previously registered liver transplant recipients ### Contacts Locations Module #### Locations **Location 1:** **City:** Hangzhou **Country:** China **Facility:** Zhejiang University school of Medicine **State:** Zhejiang **Zip:** 310000 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000000230 - Term: Adenocarcinoma - ID: D000008113 - Term: Liver Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000004066 - Term: Digestive System Diseases - ID: D000008107 - Term: Liver Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms ### Condition Browse Module - Browse Leaves - ID: M11103 - Name: Liver Cirrhosis - Relevance: HIGH - As Found: Cirrhosis - ID: M5534 - Name: Carcinoma - Relevance: HIGH - As Found: Carcinoma - ID: M9613 - Name: Carcinoma, Hepatocellular - Relevance: HIGH - As Found: Hepatocellular Carcinoma - ID: M8485 - Name: Fibrosis - Relevance: HIGH - As Found: Cirrhosis - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M11113 - Name: Liver Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002277 - Term: Carcinoma - ID: D000006528 - Term: Carcinoma, Hepatocellular - ID: D000008103 - Term: Liver Cirrhosis - ID: D000005355 - Term: Fibrosis ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420778 **Brief Title:** A Randomized Controlled Study on the Treatment of Postherpetic Neuralgia in the Head and Face With Superficial Needling Combined With Electroacupuncture **Official Title:** A Randomized Controlled Study on the Treatment of Postherpetic Neuralgia in the Head and Face With Superficial Needling Combined With Electroacupuncture #### Organization Study ID Info **ID:** 2023ZR030 #### Organization **Class:** OTHER_GOV **Full Name:** Zhejiang Chinese Medical University ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Zhejiang Chinese Medical University #### Responsible Party **Investigator Affiliation:** Zhejiang Chinese Medical University **Investigator Full Name:** Xiaoyu Li **Investigator Title:** Attending Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Based on the inclusion and exclusion criteria, patients with head and face PHN who met the requirements were selected as trial subjects, and the efficacy was clarified in a randomized controlled design trial. The visual analog score VAS was used as the primary evaluation index, and the depression self-assessment scale score , Hamilton depression scale, Pittsburgh sleep quality index scale, and quality of life evaluation scale (SF-36) were used as the secondary evaluation indexes, and oral pregabalin was used as the control group, and the subjects in the pregabalin and the plexus superficial stabbing combined with electroacupuncture groups were observed respectively at the time of Before treatment, immediately after the first treatment, after 2 days of treatment, after 2 weeks of treatment, after 4 weeks of treatment, after 1 month of follow-up after the end of treatment and after 2 months of follow-up after the end of treatment. **Detailed Description:** On the one hand, it was clarified whether plexus needle shallow stabbing combined with electroacupuncture for the treatment of PHN in the head and face has clear and stable advantages in pain reduction, improvement of mood, sleep quality and quality of life, and formed the clinical standardization of plexus needle shallow stabbing combined with electroacupuncture for the treatment of postherpetic neuralgia in the head and face, which in turn lays the foundation for the further popularization of acupuncture for the treatment of postherpetic neuralgia in the head and face, and also provides a new, scientific and effective way of thinking about clinical analgesic therapies for postherpetic neuralgia. On the other hand, this study will clarify the correlation between facial thermal radiation characteristics and clinical symptoms in patients with head and face PHN, and apply infrared thermography as an objective evaluation of the efficacy index of plexus needling and shallow stabbing combined with electroacupuncture in the treatment of head and face PHN, which will provide a new method for objectively verifying the clinical efficacy of PHN. ### Conditions Module **Conditions:** - Postherpetic Neuralgia - Electroacupuncture - Infrared Thermography ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 124 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects in this group will be treated with Cluster needle shallow stabbing combined with electroacupuncture.The treatment time was 60 minutes each time, once every other day, and the treatment was carried out 3 times a week for 4 consecutive weeks, for a total of 12 treatments. **Intervention Names:** - Other: electroacupuncture **Label:** therapy group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Subjects in this group will be treated with oral pregabalin capsules only, 150 mg twice daily for 4 weeks.Pregabalin was administered with Lerica (specification: 75 mg\*8 capsules,manufactured by Pfizer Pharmaceuticals Ltd). **Intervention Names:** - Drug: Pregabalin **Label:** Control group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - therapy group **Description:** The patient takes the supine position, the whole body relaxes, the facial skin is routinely sterilized. Local acupuncture points along the head and face herpes zoster lesion branches with 0.18 × 25 mm millimetre needle series of shallow stabbing method row stabbing method.Han's Acupoint Neurostimulator (model HANS-200) was selected, local acupoints were chosen as Xiaguan+Quanliao or Xiaguan+Jiache, and distal acupoints were chosen as Hegu+Waiguan connected with electroacupuncture, sparse and dense wave 2/100 Hz was selected, and the treatment time was 60 minutes, and the intensity of the current was all to the extent that the patient could tolerate it. The needles were left in place for 60 minutes each time, once every other day, and the treatment was performed 3 times a week for 4 weeks, for a total of 12 treatments. **Name:** electroacupuncture **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Control group **Description:** Subjects in this group will be treated with oral pregabalin capsules only, 150 mg twice daily for 4 weeks.Pregabalin was administered with Lerica (specification: 75 mg\*8 capsules,manufactured by Pfizer Pharmaceuticals Ltd). **Name:** Pregabalin **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** This scale is performed by two trained raters to perform a Self-rating depression scale（SDS）, usually in the form of conversation and observation. After the examination, the two raters will score independently.Baseline values were taken from the pre-treatment assessment, mean values from weeks 1 and 2 of the treatment period were taken at mid-treatment (2 weeks), and mean values from weeks 3 and 4 of the treatment period were taken at the end of treatment (4 weeks). Daily mean values were taken for one month at one month follow-up and for two months at two months follow-up. **Measure:** Visual Analogue Scale/Score **Time Frame:** VAS will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect. #### Secondary Outcomes **Description:** This scale is performed by two trained raters to perform a Self-rating depression scale（SDS）, usually in the form of conversation and observation. After the examination, the two raters will score independently. **Measure:** Self-rating depression scale **Time Frame:** SDS will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect. **Description:** This scale is performed by two trained raters to perform a Hamilton depression scale (HAMD), usually in the form of conversation and observation. After the examination, the two raters will score independently. **Measure:** Hamilton depression scale **Time Frame:** HAMD will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect. **Description:** This scale is performed by two trained raters to perform a Pittsburgh Sleep Quality Index Scale（PSQI）, usually in the form of conversation and observation. After the examination, the two raters will score independently. **Measure:** Pittsburgh Sleep Quality Index Scale **Time Frame:** PSQI will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect. **Description:** This scale is performed by two trained raters to perform aQuality of Life Rating Scale（SF-36）, usually in the form of conversation and observation. After the examination, the two raters will score independently. **Measure:** Quality of Life Rating Scale **Time Frame:** SF-36 will be performed at the baseline (pre-treatment), the 2 week after intervention,the 1 month after intervention,the 1 month follow-up and the 2 month follow-up to evaluate the severity of the disease and the treatment effect. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: ① Meet the diagnostic criteria in the 2016 Chinese Expert Consensus on the Diagnosis and Treatment of Postherpetic Neuralgia; ② Age 50-80 years (including telangiectasia), gender is not limited; ③ Have a history of herpes zoster on the head and face, and the lesions on the head and face have been healed and subsided, and the symptoms of neuralgia lasted ≥1 month after lesions were healed, with baseline scores of ≥4 on the Facial Pain Profile, and abnormal sensation of the skin around the lesions, pain sensitivity; ④ Be conscious and have a clear sense of pain and discriminative ability; ⑤ Sign the informed consent to participate in this study voluntarily. Only those who satisfy the above 5 items at the same time can be included in this study. Exclusion Criteria: ① those who did not meet the above diagnostic criteria; ② herpes zoster occurring in the perineum, or special types such as visceral herpes zoster, meningeal herpes zoster, and generalized herpes zoster; ③ those who were taking oral pregabalin at a dose of less than 0.2 g or more than 0.6 g per day before inclusion to relieve analgesia; ④ those who had a serious adverse reaction to pregabalin, were allergic to acupuncture, or belonged to patients who were within the range of contraindications to electro-acupuncture; ⑤ Combined with severe cardiac, hepatic, renal damage, epilepsy, head injury, or cognitive dysfunction, aphasia, psychiatric disorders, and other major diseases, who are unable to cooperate with the treatment; ⑥ Combined with poorly controlled hypertension and diabetes mellitus patients; ⑦ Pregnant or breastfeeding patients; ⑧ Patients who are currently participating in other studies, and who have been enrolled in other clinical trials within the last 3 months. Anyone who meets any of these criteria will be excluded. **Maximum Age:** 80 Years **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** 673426608@qq.com **Name:** Xiaoyu Li **Phone:** +8618758240921 **Role:** CONTACT #### Locations **Location 1:** **City:** Hangzhou **Contacts:** ***Contact 1:*** - **Email:** 673426608@qq.com - **Name:** Xiaoyu Li - **Phone:** +8618758240921 - **Role:** CONTACT **Country:** China **Facility:** Xiaoyu Li **State:** Zhejiang **Status:** RECRUITING **Zip:** 310053 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### 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: M12381 - Name: Neuralgia - Relevance: HIGH - As Found: Neuralgia - ID: M21089 - Name: Facies - Relevance: LOW - As Found: Unknown - ID: M26725 - Name: Neuralgia, Postherpetic - Relevance: HIGH - As Found: Postherpetic Neuralgia - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009437 - Term: Neuralgia - ID: D000051474 - Term: Neuralgia, Postherpetic ### Intervention Browse Module - Ancestors - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000927 - Term: Anticonvulsants - ID: D000002121 - Term: Calcium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents - ID: D000014151 - Term: Anti-Anxiety Agents - ID: D000014149 - Term: Tranquilizing Agents - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000011619 - Term: Psychotropic Drugs ### Intervention Browse Module - Browse Branches - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: Analg - Name: Analgesics - Abbrev: AntiConv - Name: Anticonvulsants - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: BDCA - Name: Bone Density Conservation Agents ### Intervention Browse Module - Browse Leaves - ID: M476 - Name: Pregabalin - Relevance: HIGH - As Found: Digital - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4246 - Name: Anticonvulsants - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5384 - Name: Calcium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M16905 - Name: Anti-Anxiety Agents - Relevance: LOW - As Found: Unknown - ID: M14474 - Name: Psychotropic Drugs - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000069583 - Term: Pregabalin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420765 **Brief Title:** A Microneurography Study of NaV1.8 Inhibition in Healthy Adults **Official Title:** A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Effects of Single Doses of NaV1.8 Inhibitors on C-Nociceptor Action Potentials in Healthy Adults #### Organization Study ID Info **ID:** VX23-PMI-001 #### Organization **Class:** INDUSTRY **Full Name:** Vertex Pharmaceuticals Incorporated ### Status Module #### Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Vertex Pharmaceuticals Incorporated #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True ### Description Module **Brief Summary:** The purpose of this study is to determine the effects of Nav1.8 inhibition on activity-dependent slowing (ADS) of C-nociceptor nerve fibers, evoked action potential (AP) conduction velocity of C-nociceptor nerve fibers using VX-150 and VX-548. **Detailed Description:** This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.). ### Conditions Module **Conditions:** - Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will be randomized to receive a single dose of VX-150. **Intervention Names:** - Drug: VX-150 **Label:** VX-150 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will be randomized to receive a single dose of different dose levels of VX-548. **Intervention Names:** - Drug: VX-548 **Label:** VX-548 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Participants will receive single dose of non-matching placebo. **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - VX-150 **Description:** Suspension for oral administration. **Name:** VX-150 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - VX-548 **Description:** Solution or suspension for oral administration. **Name:** VX-548 **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Placebo **Description:** Suspension for oral administration. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Change From Baseline in Activity Dependent Slowing (ADS) Over Time **Time Frame:** From Pre-dose up to 2-hours Post Dose #### Secondary Outcomes **Measure:** Change From Baseline in Conduction Velocity at 0.25 Hz Over Time **Time Frame:** From Pre-dose up to 2-hours Post Dose **Measure:** Change From Baseline in Action Potential (AP) Latency at 0.25 Hz Over Time **Time Frame:** From Pre-dose up to 2-hours Post Dose **Measure:** Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) **Time Frame:** From Day 1 up to Day 16 ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m\^2) * A total body weight of more than (\>) 50 kg Key Exclusion Criteria: * History of febrile illness or other acute illness that has not fully resolved within 14 days before study drug dosing * Any condition possibly affecting drug absorption * Any dermatological (generalized) or autoimmune disease that may affect C-nociceptor excitability * Participants with Type 1 or Type 2 diabetes mellitus * Participants who have any 1 of the following criteria in the foot in which microneurography (MNG) will be performed: * Injection of local anesthetics or steroids within 35 days prior to randomization. * Unsuitable anatomy of the superficial peroneal nerve (i.e., nerve cannot be seen or palpated at the dorsum of the foot) * Infection, disease (dermatologic or vascular), ongoing pain, or recent trauma or surgery that may affect study assessments Note: Participants must have 1 foot that does not meet any of the above criteria to be eligible. Other protocol defined Inclusion/Exclusion criteria may apply. **Healthy Volunteers:** True **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** medicalinfo@vrtx.com **Name:** Medical Information **Phone:** 617-341-6777 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing **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 ### Intervention Browse Module - Browse Branches - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420752 **Brief Title:** Passive Stretching in Peripheral Arterial Disease Patients **Official Title:** Passive Stretching and Dietary Nitrate Rescue Functional Capacity in Peripheral Arterial Disease #### Organization Study ID Info **ID:** 232-JC-230.2 #### Organization **Class:** OTHER **Full Name:** University of Wisconsin, La Crosse ### Status Module #### Completion Date **Date:** 2028-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Wisconsin, La Crosse #### Responsible Party **Investigator Affiliation:** University of Wisconsin, La Crosse **Investigator Full Name:** Jacob Caldwell **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** Peripheral artery disease (PAD) leads to higher mortality rates and strains healthcare systems due to increased costs. It causes leg pain during walking due to reduced blood flow. Nitric oxide (NO) deficiency contributes to vascular issues in PAD, with few effective treatments available. Passive calf muscle stretching boosts NO levels, vascular health, and walking ability in PAD patients. However, the inflammatory processes underlying these improvements are unclear. This study aims to track inflammatory markers and cardiovascular changes during 12 weeks of passive stretching. Additionally, combining stretching with dietary nitrate could further enhance walking capacity by reducing reactive oxygen species. The study will monitor inflammation, vascular function, and oxidative capacity to understand the effects on functional ability in PAD patients. This research is crucial for improving physical function and addressing exercise intolerance in PAD. ### Conditions Module **Conditions:** - Peripheral Arterial Disease - Walking, Difficulty - Inflammation **Keywords:** - Cardiovascular ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** Double blind placebo controlled. **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 64 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Passive stretching of the calf muscles 5 days per week for 12-weeks **Intervention Names:** - Device: Calf Plantar flexion - Dietary Supplement: Dietary nitrate **Label:** Functional Walking capacity **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Blood and muscle biopsy samples pre/post passive stretching to assess local and systemic inflammation **Intervention Names:** - Device: Calf Plantar flexion - Dietary Supplement: Dietary nitrate **Label:** Inflammation **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Functional Walking capacity - Inflammation **Description:** Daily passive calf stretching **Name:** Calf Plantar flexion **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Functional Walking capacity - Inflammation **Description:** Weekday 140 ml dietary nitrate consumption two hours prior to passive stretching **Name:** Dietary nitrate **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** 6-minute walking distance will be assessed prior to an at various time points during the 12-week study **Measure:** Functional capacity **Time Frame:** 12-14 weeks #### Secondary Outcomes **Description:** Blood and calf muscle biopsy will be used to assess various inflammatory markers pre/post treatment. **Measure:** Inflammatory markers **Time Frame:** 12-14 weeks **Description:** Large vessel (flow-mediated vasodilation) and small vessel (Near-infrared spectroscopy on the calf) will be measured prior to and at various time points during the 12-week study. **Measure:** Vascular function **Time Frame:** 12-14 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Ankle-brachial index of 0.90 or less Stable condition for at least 3 months Exclusion Criteria: Habitual exercise or cardiovascular rehabilitation program during the past 3 months Critical limb ischemia, amputation, or leg pain at rest Major surgery or lower extremity revascularization in the last 3 months Heart Failure Kidney disease Beet alergy Crohn's Current smoker **Maximum Age:** 90 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jcaldwell@uwlax.edu **Name:** Jacob T Caldwell, Ph.D. **Phone:** 608-785-8684 **Role:** CONTACT #### Locations **Location 1:** **City:** La Crosse **Contacts:** ***Contact 1:*** - **Name:** Jacob T Caldwell, Ph.D. - **Phone:** 608-785-8684 - **Role:** CONTACT **Country:** United States **Facility:** University of Wisconsin La Crosse **State:** Wisconsin **Status:** RECRUITING **Zip:** 54650 #### Overall Officials **Official 1:** **Affiliation:** Assistant Professor **Name:** Jacob T Caldwell, Ph.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Researchers. **Description:** The study datasets will be submitted to a generalist repository (Aging Research Bio Bank or similar). This allows for individual-level data submission from clinical studies. This study will not generate genomics data and will not submit to the database of Genotypes and Phenotypes. To our understanding, the NIA repository is the only current general repository for aging related work **Info Types:** - STUDY_PROTOCOL - SAP - ICF **IPD Sharing:** YES **Time Frame:** Raw data will be available after two years post data collection to allow for publication and only available for one year after data collection is complete. ## Document Section ### Large Document Module #### Large Docs - Date: 2024-05-06 - Filename: Prot_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: False - Label: Study Protocol - Size: 265095 - Type Abbrev: Prot - Upload Date: 2024-05-07T12:29 - Date: 2024-05-06 - Filename: SAP_001.pdf - Has ICF: False - Has Protocol: False - Has SAP: True - Label: Statistical Analysis Plan - Size: 84459 - Type Abbrev: SAP - Upload Date: 2024-05-07T12:30 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000050197 - Term: Atherosclerosis - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive 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: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M10293 - Name: Inflammation - Relevance: HIGH - As Found: Inflammation - ID: M29213 - Name: Peripheral Arterial Disease - Relevance: HIGH - As Found: Peripheral Arterial Disease - ID: M18894 - Name: Peripheral Vascular Diseases - Relevance: HIGH - As Found: Peripheral Arterial Disease - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M26689 - Name: Mobility Limitation - Relevance: HIGH - As Found: Walking, Difficulty - ID: M26188 - Name: Atherosclerosis - Relevance: LOW - As Found: Unknown - ID: M4469 - Name: Arteriosclerosis - Relevance: LOW - As Found: Unknown - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000058729 - Term: Peripheral Arterial Disease - ID: D000016491 - Term: Peripheral Vascular Diseases - ID: D000007249 - Term: Inflammation - ID: D000051346 - Term: Mobility Limitation ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420739 **Brief Title:** The Semaglutide Study **Official Title:** Improving Patient Safety for Surgical Patients on Semaglutide: A Gastric Ultrasound Initiative #### Organization Study ID Info **ID:** 23-5873 #### Organization **Class:** OTHER **Full Name:** University Health Network, Toronto ### Status Module #### Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-04-10 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Health Network, Toronto #### 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 goal of this study is to evaluate the incidence of "full stomach" in fasting elective surgical patients on Semaglutide medication. The other goals are to study the impact of the time interval since the last dose of the medication on the incidence of full stomach and to develop evidence-based recommendations for the perioperative management of these patients. **Detailed Description:** Pulmonary aspiration of gastric contents has long been recognized as a threat to anesthesia patient safety. Most elective surgical patients, however, are considered to be at low risk for this complication provided they abstain from eating solid food for at least 8 hours prior to anesthesia and for clear fluids for at least 2 hours. The recent introduction of GLP-1 agonists (such as Semaglutide), a new class of drugs for the treatment of diabetes and weight loss, has challenged the status quo, and is posing a new threat to perioperative patient safety.There are recent reports of aspiration of large amounts of particulate undigested food in the perioperative period on patients taking Semaglutide despite prolonged fasting of over 12 hours, one of those cases happening at the UHN.This is of great concern given the explosive increase in use of these medications globally.In the month of June 2023, three North American anesthesiology societies (the Canadian Anesthesiologists' Society, the American Society of Anesthesiologists and the Anesthesia Patient Safety Foundation) have raised the alert regarding an increased risk of aspiration under anesthesia while on these drugs.Given the long half-life of up to 7 days, a true reduction of risk would necessitate holding these drugs preoperatively for longer periods than are usually feasible. Management strategies recommended to date include treating every patient on Semaglutide as if they have a 'full stomach", avoiding general anesthesia if possible and even considering surgical cancellation if the patient presents symptoms such as nausea and vomiting, which are common while on these medications. While these recommendations stand to reason, they are over-arching, targeted to all patients and could result in unnecessary surgical cancellations or invasive procedures (such as nasogastric tube insertion, endotracheal intubation and rapid sequence induction) which have their own set of risks. This timely study addresses the current knowledge gap and a recently identified threat to perioperative patient safety that has been highlighted by three major anesthesiology societies in the past 2-3 months. Our team at the UHN is uniquely positioned to shed some light into these pressing questions and develop management recommendations that optimize safety while avoiding unnecessary surgical cancellations and targeting invasive procedures for airway management only to those patients that really need them. Our group has previously developed and validated a simple, non-invasive bedside ultrasound test that can differentiate a safe "empty stomach" from a "full stomach" that may pose an increased risk of aspiration under anesthesia. The investigators have validated this bedside test in the adult, pediatric, obstetric and morbidly obese populations. Hypothesis: Patients on Semaglutide will have an increased incidence of full stomach to at least 10%, compared to a baseline of 5%, a difference that the investigators consider clinically significant. Study design: This is a prospective cohort study. Study population: The investigators propose to study a cohort of 100 patients undergoing elective surgery while under treatment with Semaglutide for either diabetes or for losing weight. Patients who are on Semaglutide for at least a month will be identified, screened for eligibility, and invited to participate in this study.All identified patients will be given standard pre-operative fasting instructions as per current institutional practice for elective surgical patients (a minimum of 8 hours of fasting for solid food and 4 hours for clear fluids). A bedside gastric ultrasound examination will be performed using a portable ultrasound unit and a curvilinear low-frequency probe with abdominal settings. The exam will be done in two positions (supine and right lateral decubitus). The gastric antrum will be identified in a sagittal plane in the epigastric area between the left lobe of the liver anteriorly and the pancreas and aorta posteriorly. The type of gastric content (nothing, clear fluid or solid) will be documented based on qualitative findings. If clear fluid is present our mathematical model will be used to estimate the volume based on a cross-sectional area of the gastric antrum: (Volume (ml) = 27.0 + 14.6 x CSA (cm2) - 1.28x age (year).11 A stomach will be considered: 1. "empty" and consistent with "low aspiration risk" if the antrum appears completely empty in both supine and right lateral decubitus position (Grade 0 antrum) or there is clear fluid with a volume \< 1.5 mL/Kg which is consistent with a low-risk situation. 2. "full" or at risk of aspiration if there is any amount of solid content or clear fluid with a volume, \> 1.5 mL/Kg. The result of the gastric ultrasound study will be shared with the attending anaesthesiologist in charge of every patient who will be free to establish what they consider the safest management plan based on their clinical judgement and the ultrasound results. The surgical timing (on time, delayed or cancelled), the type of anaesthetic used, and the airway management strategies will be documented. Changes in anaesthetic management from the a priori plan will be documented. Any episodes of regurgitation or aspiration in the perioperative period will be documented. Information on anaesthetic technique, airway management and the incidence of regurgitation and aspiration throughout the intraoperative period will be recorded. ### Conditions Module **Conditions:** - Fasting **Keywords:** - Gastric Ultrasound - Fasting - Semaglutide - Elective surgery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Bedside Gastric Ultrasound to determine the volume and nature of gastric content in patients before their surgery. **Name:** Gastric Ultrasound **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Frequency of full stomach in patients taking semaglutide and fasting before surgery. Analysis of the primary outcome will be based on a chi-square analysis. **Measure:** Incidence of full stomach. **Time Frame:** Pre-Surgical fasting duration per guideline #### Secondary Outcomes **Description:** The investigators will measure the frequency of changes in management plan **Measure:** Any changes in anesthetic management from the a priori plan following the result of the gastric ultrasound examination. **Time Frame:** Pre-operative anesthesia management plan **Description:** The investigators will compare the absolute incidence of "full stomach" in patients receiving the last dose less than 7 days before surgery with those with last dose between 7-14 days and \> 14 days. **Measure:** Impact of age, sex and the time since the last dose of Semaglutide, on the incidence of "full stomach". **Time Frame:** Pre-Surgical fasting duration per guideline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Patients scheduled for elective surgery at Toronto Western Hospital 2. Aged ≥ 18 years of age 3. American Society of Anaesthesia physical status classification I to III 4. Patients being treated with Semaglutide for at least 1 month Exclusion Criteria: 1. Current pregnancy evidenced by positive urinary pregnancy test 2. Previous surgery of the upper gastrointestinal tract **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** A cohort of 100 patients undergoing elective surgery while under treatment with Semaglutide for either diabetes or for losing weight. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** anahi.perlas@uhn.ca **Name:** Anahi Perlas, MD FRCPC **Phone:** 4166035800 **Phone Ext:** 3942 **Role:** CONTACT **Contact 2:** **Email:** jayanta.chowdhury@uhnresearch.ca **Name:** Jayanta Chowdhury, MBBS, MD **Phone:** 4166035800 **Phone Ext:** 2016 **Role:** CONTACT #### Locations **Location 1:** **City:** Toronto **Contacts:** ***Contact 1:*** - **Email:** jayanta.chowdhury@uhn.ca - **Name:** Jayanta Chowdhury - **Phone:** 416-603-5800 - **Phone Ext:** 2016 - **Role:** CONTACT ***Contact 2:*** - **Name:** Anahi Perlas, MD,FRCPC - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** Toronto Western Hospital **State:** Ontario **Status:** RECRUITING **Zip:** M5T 2S8 #### Overall Officials **Official 1:** **Affiliation:** Investigator-Sponsor **Name:** Anahi Perlas **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M353561 - Name: Semaglutide - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420726 **Brief Title:** Resistance Exercise and Creatine in Colorectal Cancer **Official Title:** The Feasibility and Acceptability of Resistance Training and Creatine Supplementation to Promote Physical Function in Sarcopenic Colorectal Cancer Survivors #### Organization Study ID Info **ID:** Pro00127362 #### Organization **Class:** OTHER **Full Name:** University of South Carolina ### Status Module #### Completion Date **Date:** 2025-07-22 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-07-22 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-09 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of South Carolina #### Responsible Party **Investigator Affiliation:** University of South Carolina **Investigator Full Name:** Ciaran Fairman **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** skeletal muscle mass and function, is prevalent in up to 60% of colorectal cancer patients. This condition arises from a combination of factors such as aging, inactivity, treatment side effects, malnutrition, tumor burden, and inflammation. Given this complexity, singular interventions may not be sufficient to address sarcopenia in this group. Creatine monohydrate, a compound vital for energy during exercise, has been extensively researched and proven safe and effective across various demographics, including older adults and clinical populations. Studies show that creatine enhances benefits from resistance training, indicating potential to counter muscle mass and function decline post-cancer treatment. This study aims to assess the feasibilty of combining creatine supplementation with resistance training versus resistance training alone in sarcopenic colorectal cancer survivors. A randomized controlled pilot trial will compare a 10-week program of resistance exercise plus creatine (EXSUPP) with resistance exercise alone (EXPLA), each with 20 participants. **Detailed Description:** Colorectal cancer is the third most commonly diagnosed cancer in the world. Sarcopenia, defined as a loss of skeletal muscle mass and function, is highly prevalent in colorectal cancer, with rates of up to 60% reported. Sarcopenia etiology in cancer is multifactorial, with aging and inactivity compounded by treatment toxicities, malnutrition, tumor burden, and high-grade inflammation. Consequently, it's unlikely that unimodal interventions will be sufficient to overcome the burden of sarcopenia in this population. Creatine monohydrate is a naturally occurring compound in the body that plays a critical role in energy provision during exercise.4 Creatine is the most widely studied nutritional supplement to date, with well over 1,000 studies establishing its safety and effectiveness in men, women and older adults, in addition to other clinical populations. There is strong and consistent evidence that creatine supplementation can enhance the positive adaptations to resistance training in older adults and clinical populations. Therefore, there is strong potential for the application of creatine and resistance training to offset the decline in muscle mass and function after cancer treatment. The purpose of the proposed study is to examine the feasibility and acceptability of creatine supplementation combined with resistance exercise, compared to resistance exercise alone in individuals treated for colorectal cancer who are sarcopenic. We propose a randomized controlled pilot trial, examining the effects of 10-week multimodal resistance exercise and creatine supplementation (EXSUPP) (n=20) relative to resistance exercise alone (EXPLA) (n=20) in individuals treated for colorectal cancer who have sarcopenia. The specific aims of this project are to 1) determine the feasibility and acceptability of the intervention in colorectal cancer patients? diagnosed with sarcopenia after cancer treatment, 2) compare the effects of an exercise and creatine supplementation intervention (EXSUPP) to exercise alone (EXPLA) on body composition, muscle strength, physical function, and quality of life and 3) explore muscle molecular-level adaptations, i.e., mitochondrial health and protein turnover, in response to the interventions. This project will be one of the first to combine exercise with creatine, specifically targeting sarcopenia in individuals previously treated for colorectal cancer. This project is directly in line with the priority research initiative from the NCI Cancer MoonshotSM to "minimize Cancer Treatment's Debilitating Side Effects." Our trial is innovative in addressing one of the most important health problems for individuals treated for colorectal cancer in that it will be the first to 1) examine the feasibility and acceptability of a multimodal exercise and nutritional intervention relative to exercise alone in individuals treated for colorectal cancer who are sarcopenic and 2) explore the molecular mechanisms underpinning the response to exercise and nutritional interventions. ### Conditions Module **Conditions:** - Colorectal Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Two-arm Randomized Controlled Trial ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 3 days a week of resistance exercise for 10-weeks + 5g day of creatine monohydrate supplementation **Intervention Names:** - Behavioral: Resistance Exercise **Label:** Exercise + Creatine **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 3 days a week of resistance exercise for 10-weeks + 5g day of placebo (dextrose supplementation **Intervention Names:** - Behavioral: Resistance Exercise **Label:** Exercise + Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Exercise + Creatine - Exercise + Placebo **Description:** Supervised resistance exercise **Name:** Resistance Exercise **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Number of individuals enrolled across study timeframe **Measure:** Recruitment **Time Frame:** 10-weeks **Description:** Proportion of individuals who return for follow-up testing **Measure:** Retention **Time Frame:** 10-weeks **Description:** Proportion of daily supplementation taken **Measure:** Supplementation Adherence **Time Frame:** 10-weeks **Description:** Proportion of total exercise achieved **Measure:** Exercise Adherence **Time Frame:** 10-weeks #### Secondary Outcomes **Description:** Leg Press and Chest press 5 repetition maximum **Measure:** Muscular Strength **Time Frame:** 0 and 10-weeks **Description:** Handgrip Dynamometry (Jamar Plus+) **Measure:** Handgrip Strength **Time Frame:** 0 and 10-weeks **Description:** DEXA **Measure:** Body Composition **Time Frame:** 0 and 10-weeeks **Description:** Short Physical Performance Battery **Measure:** Physical Function **Time Frame:** 0 and 10-weeks **Description:** European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 (EORTC-QLQ-C30). **Measure:** Health-Related Quality of Life **Time Frame:** 0 and 10-weeks **Description:** Sarcopenia-related HRQOL will be assessed using a sarcopenia-specific questionnaire (SarQoL). **Measure:** Sarcopenia related quality of life **Time Frame:** 0 and 10-weeks **Description:** C reative protein, Interleukin 6 and Tumor necrosis factor alpha **Measure:** Inflammatory Markers **Time Frame:** 0 and 10-weeks **Description:** Intramuscular markers of mitochondrial content and biogenesis (complex I-V content, citrate synthase activity, and PGC-1a protein expression) **Measure:** Intramuscular Signaling and Mitochondrial Health and skeletal muscle regulation **Time Frame:** 0 and 10-weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * . Individuals ≥12 months post treatment for colorectal cancer * \>18 years Exclusion Criteria: 1. are receiving active treatment for their cancer; 2. have a any contraindication to exercise participation; 3. have been participating in structured resistance exercise 2 or more times per week for the past 6 months; 4. are currently taking supplements containing creatine for 4 weeks prior to the start of the RCT, or 5. are receiving medications that might alter body composition (metformin, corticosteroids etc.). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** cfairman@mailbox.sc.edu **Name:** Ciaran Fairman **Phone:** 803-576-8397 **Role:** CONTACT **Contact 2:** **Email:** amb91@email.sc.edu **Name:** Alex Brooks **Role:** CONTACT #### Locations **Location 1:** **City:** Columbia **Contacts:** ***Contact 1:*** - **Email:** cfairman@mailbox.sc.edu - **Name:** Ciaran Fairman - **Phone:** 803-576-8397 - **Role:** CONTACT **Country:** United States **Facility:** University of South Carolina **State:** South Carolina **Status:** RECRUITING **Zip:** 29201 #### Overall Officials **Official 1:** **Affiliation:** University of South Carolina **Name:** Ciaran Fairman, PhD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007414 - Term: Intestinal Neoplasms - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000012002 - Term: Rectal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17890 - Name: Colorectal Neoplasms - Relevance: HIGH - As Found: Colorectal Cancer - ID: M10448 - Name: Intestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M14844 - Name: Rectal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015179 - Term: Colorectal Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T385 - Name: Creatine - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420713 **Brief Title:** Horizontal Bone Augmentation of Alveolar Ridge: A Randomized Controlled Clinical Trial. **Official Title:** Use of Xenogeneic Bone Graft Associated With Autogenous Bone Graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) for Horizontal Bone Augmentation of Alveolar Ridge: A Randomized Controlled Clinical Trial #### Organization Study ID Info **ID:** 13102219.0.0000.5419 #### Organization **Class:** OTHER **Full Name:** University of Sao Paulo ### Status Module #### Completion Date **Date:** 2024-05-09 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-30 **Type:** ACTUAL #### Start Date **Date:** 2019-10-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Sao Paulo #### Responsible Party **Investigator Affiliation:** University of Sao Paulo **Investigator Full Name:** Michel Reis Messora **Investigator Title:** Associate professor at the department of Oral and Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirao Preto, University of Sao Paulo-USP, Ribeirao Preto, São Paulo, Brazil **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The objective of this randomized controlled clinical trial was to evaluate the effects of particulate xenogeneic bone grafts associated with autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) for horizontal alveolar ridge augmentation. Twenty-eight patients presenting edentulous regions and requiring horizontal bone augmentation prior to dental implant placement were included in this study and randomly divided into two groups according to the proposed guided bone regeneration (GBR) treatment. Fourteen surgical sites corresponding to Group A received bone regeneration with particulate autogenous bone tissue associated with deproteinized bovine bone graft (Bio-Oss Small®; Geistlich AG, Wolhusen, Switzerland). In Group B, fourteen surgical sites were regenerated with deproteinized bovine bone graft (Bio-Oss Small®) associated with L-PRF. In both groups, the grafted region was protected by a collagen membrane (Bio-Gide® Compressed; Geistlich AG, Wolhusen, Switzerland) fixed to the buccal and palatal bone plates using titanium pins. Cone-beam computed tomography (CBCT) scans were performed preoperatively, immediately after the GBR surgical procedure, after 8 months of GBR healing, and immediately after dental implant placement to measure linear and volumetric changes in the alveolar ridge. At the time of dental implant placement, after an average period of 8 months following the guided bone regeneration procedures, bone biopsies were taken from the grafted area for histological, histomorphometric, and micro-CT analysis. After a period of 6 months, the dental implants were reopened to receive implant-supported prosthetic rehabilitation. Implant stability was assessed using resonance frequency analysis at the time of implant placement in the grafted area and after an average of 6 months during the reopening surgical stage. Patient pain perception following bone regeneration procedures was assessed using a visual analog scale. All obtained data were statistically analyzed. ### Conditions Module **Conditions:** - Platelet-rich Fibrin - Bone Substitutes - Atrophic Maxilla - Cone-beam Computed Tomography - Bone Regeneration ### 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:** 28 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Procedure: Groups **Label:** Autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Procedure: Horizontal Bone Augmentation of Alveolar Ridge **Label:** Groups **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Intervention Names:** - Procedure: Dental Implants **Label:** Dental Implants **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Groups **Description:** Elevation of the flap in the anterior region of atrophic maxilla to receive particulate autogenous bone mixed with deproteinized bovine bone graft (Group A) or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) mixed with deproteinized bovine bone graft (Group B). In both groups, bone augmentations were covered with a collagen membrane stabilized with pins. **Name:** Horizontal Bone Augmentation of Alveolar Ridge **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) **Description:** The patients underwent Guided Bone Regeneration (GBR) procedures for the reconstruction of atrophic edentulous alveolar ridges and were divided into two groups according to the proposed treatment: Group A - GBR using a mixture of particulate autogenous bone graft and deproteinized bovine bone graft (Bio-Oss® Small; Geistlich AG, Wolhusen, Switzerland). Group B - GBR using a mixture of deproteinized bovine bone graft (Bio-Oss® Small) and L-PRF + Liquid Fibrinogen. **Name:** Groups **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Dental Implants **Description:** After 8 months of GBR healing, dental implants were placed in the grafted regions using guided surgery techniques. Cone beam computed tomography (CBCT) scans were performed preoperatively, immediately after the surgical procedure, and after 8 months of follow-up to measure the linear and volumetric changes in the alveolar ridge. At the time of dental implant placement, after an 8-month period following the GBR procedures, bone biopsies were obtained from the grafted area for histological and micro-CT analysis. The stability of the implants was assessed using resonance frequency analysis in the immediate postoperative period and at 6 months postoperatively. After the 6-month period following dental implant placement, the patients were cleared for implant-supported prosthetic rehabilitation. **Name:** Dental Implants **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** After the period of 8 months from Horizontal Bone Augmentation of Alveolar Ridge, during the dental implant placement by guided surgery, bone samples will be collected at the same location of the implants preparation. The collected bone tissue will be prepared and submitted to Micro-CT and histometric analyses. **Measure:** Micro-CT and Histometric analyses **Time Frame:** 8 months #### Secondary Outcomes **Description:** ISQ will be measured at the moment of implant placement and after 6 months. **Measure:** Dental Implants ISQ measurement **Time Frame:** 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * a requirement for the placement of one to four dental implants exclusively in the maxilla; * insufficient horizontal bone remaining for dental implant placement (maximum width of 4mm); * sufficient vertical bone height for subsequent placement of dental implant(s). Exclusion Criteria: * any contraindication for dental implant placement; * the need for vertical bone augmentation; * inflammatory or autoimmune disease in the oral cavity; * use of immunosuppressants, corticosteroids, or bisphosphonates; * a history of malignancy in the past 5 years; * smokers; * patients reporting excessive alcohol consumption; * decompensated systemic condition; * uncontrolled periodontal disease; * insulin-dependent diabetic patients; * patients with blood-related diseases. **Maximum Age:** 74 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Ribeirão Preto **Country:** Brazil **Facility:** School of Dentistry of Ribeirão Preto - USP **State:** São Paulo **Zip:** 14040-904 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4589 - Name: Atrophy - Relevance: HIGH - As Found: Atrophic - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001284 - Term: Atrophy ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420700 **Brief Title:** Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss) **Official Title:** A Multi-site, Prospective Registry of Patients Undergoing Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty at True You Weight Loss #### Organization Study ID Info **ID:** RGT-001 #### Organization **Class:** OTHER **Full Name:** True You Weight Loss ### Status Module #### Completion Date **Date:** 2028-01-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-01-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-31 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### 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 combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss. **Detailed Description:** Obesity is a chronic disease state driven by the imbalance of caloric intake and expenditure and mediated by multiple central and peripheral pathways that may serve as targets for therapeutic interventions. The endoscopic sleeve gastroplasty (ESG) is a per oral gastric remodeling technique that employs full-thickness suturing to imbricate the stomach along the greater curvature to achieve a restricted, sleeve-like configuration. While the ESG recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). A major difference between ESG and LSG is that the former does not involve the gastric fundus. The proximal stomach, and the fundus in particular, produces ghrelin, the only known orexigenic hormone, which has been linked to increased calorie intake and weight gain. Studies have observed reduced levels of ghrelin along multiple timepoints following LSG and this has been attributed to targeting of the fundus, as bariatric surgeries that did not involve the fundus did not see a decrease in circulating plasma ghrelin. In contrast, in a small comparative study of ESG and LSG, patients who had undergone ESG did not show any decrease in fasting ghrelin levels, ostensibly due to fundic-sparing. In a preliminary, first-in-human study conducted by True You Weight Loss (ABLATE Weight), gastric fundus ablation via hybrid argon plasma coagulation was followed sequentially by ESG after 6 months. In this 10-patient study, fundus ablation was performed safely in all cases and without serious adverse events. A subsequent first-in-human study (ABLATE WEIGHT 2) further investigated gastric fundus ablation in a single-stage approach by combining fundus ablation and ESG during the same endoscopic session. Preliminary data revealed enhanced clinical effectiveness for the single-stage approach when compared to traditional endoscopic sleeve gastroplasty while maintaining a clinically feasible safety profile. By constructing a multi-site, prospective registry, the investigators aim to longitudinally collect and assess the clinical outcomes and characteristics of patients undergoing combined gastric mucosal ablation with endoscopic sleeve gastroplasty (ESG) at True You Weight Loss. ### Conditions Module **Conditions:** - Obesity **Keywords:** - ghrelin - fundus ablation - gastric mucosal ablation - endoscopic sleeve gastroplasty - ESG-MAX - obesity - ablation - hunger - True You Weight Loss ### Design Module #### Bio Spec **Description:** (Optional) Gastric fundus biopsy **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 2 Years ### Arms Interventions Module #### Arm Group 1 **Description:** All patients included in the multi-site, prospective registry will undergo the combined gastric mucosal ablation with endoscopic sleeve gastroplasty procedure, regardless of their participation in the research study. **Intervention Names:** - Procedure: Combined gastric mucosal ablation with endoscopic sleeve gastroplasty **Label:** Combined gastric mucosal ablation with endoscopic sleeve gastroplasty ### Interventions #### Intervention 1 **Arm Group Labels:** - Combined gastric mucosal ablation with endoscopic sleeve gastroplasty **Description:** Combined gastric mucosal ablation with endoscopic sleeve gastroplasty in the treatment of adults with obesity **Name:** Combined gastric mucosal ablation with endoscopic sleeve gastroplasty **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Measured percent change in total body weight over time following combined Gastric 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 combined Gastric 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 combined Gastric 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 combined Gastric 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 ≥ 28 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 mucosal ablation with ESG 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. Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months. 5. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating. 6. 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:** Patients (Age ≥ 18 years and ≤ 65 and BMI ≥ 28 and ≤55 kg/m²) who underwent combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss locations (Cary, NC and Atlanta, GA) regardless of their voluntary participation in the research ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** Chase@trueyouweightloss.com **Name:** Chase Wooley, BS **Phone:** (919) 336-4171 **Role:** CONTACT **Contact 2:** **Email:** Shannon@trueyouweightloss.com **Name:** Shannon Casey, BS, MS **Phone:** (919) 391-7843 **Role:** CONTACT #### Locations **Location 1:** **City:** Atlanta **Contacts:** ***Contact 1:*** - **Email:** Chase@trueyouweightloss.com - **Name:** Chase Wooley, BS - **Phone:** 919-336-4171 - **Role:** CONTACT ***Contact 2:*** - **Email:** Shannon@trueyouweightloss.com - **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 **Status:** RECRUITING **Zip:** 30342 **Location 2:** **City:** Cary **Contacts:** ***Contact 1:*** - **Email:** Chase@trueyouweightloss.com - **Name:** Chase Wooley, BS - **Phone:** 919-336-4171 - **Role:** CONTACT ***Contact 2:*** - **Email:** Shannon@trueyouweightloss.com - **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:** North Carolina **Status:** RECRUITING **Zip:** 27513 ### References Module #### References **Citation:** Fukunishi Y. [Electron microscopic findings in peripheral nerve lesions of nude mouse inoculated with M. leprae--perineural lesion]. Nihon Rai Gakkai Zasshi. 1985 Jul-Sep;54(3):82-7. doi: 10.5025/hansen1977.54.82. No abstract available. Japanese. **PMID:** 3915747 **Citation:** Cummings DE, Overduin J. Gastrointestinal regulation of food intake. J Clin Invest. 2007 Jan;117(1):13-23. doi: 10.1172/JCI30227. **PMID:** 17200702 **Citation:** Goitein D, Lederfein D, Tzioni R, Berkenstadt H, Venturero M, Rubin M. Mapping of ghrelin gene expression and cell distribution in the stomach of morbidly obese patients--a possible guide for efficient sleeve gastrectomy construction. Obes Surg. 2012 Apr;22(4):617-22. doi: 10.1007/s11695-011-0585-9. **PMID:** 22231739 **Citation:** Anderson B, Switzer NJ, Almamar A, Shi X, Birch DW, Karmali S. The impact of laparoscopic sleeve gastrectomy on plasma ghrelin levels: a systematic review. Obes Surg. 2013 Sep;23(9):1476-80. doi: 10.1007/s11695-013-0999-7. **PMID:** 23794092 **Citation:** McCarty TR, Jirapinyo P, Thompson CC. Effect of Sleeve Gastrectomy on Ghrelin, GLP-1, PYY, and GIP Gut Hormones: A Systematic Review and Meta-analysis. Ann Surg. 2020 Jul;272(1):72-80. doi: 10.1097/SLA.0000000000003614. **PMID:** 31592891 **Citation:** Langer FB, Reza Hoda MA, Bohdjalian A, Felberbauer FX, Zacherl J, Wenzl E, Schindler K, Luger A, Ludvik B, Prager G. Sleeve gastrectomy and gastric banding: effects on plasma ghrelin levels. Obes Surg. 2005 Aug;15(7):1024-9. doi: 10.1381/0960892054621125. **PMID:** 16105401 **Citation:** Peterli R, Wolnerhanssen B, Peters T, Devaux N, Kern B, Christoffel-Courtin C, Drewe J, von Flue M, Beglinger C. Improvement in glucose metabolism after bariatric surgery: comparison of laparoscopic Roux-en-Y gastric bypass and laparoscopic sleeve gastrectomy: a prospective randomized trial. Ann Surg. 2009 Aug;250(2):234-41. doi: 10.1097/SLA.0b013e3181ae32e3. **PMID:** 19638921 **Citation:** Lopez-Nava G, Negi A, Bautista-Castano I, Rubio MA, Asokkumar R. Gut and Metabolic Hormones Changes After Endoscopic Sleeve Gastroplasty (ESG) Vs. Laparoscopic Sleeve Gastrectomy (LSG). Obes Surg. 2020 Jul;30(7):2642-2651. doi: 10.1007/s11695-020-04541-0. **PMID:** 32193741 **Citation:** Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available. **PMID:** 20189503 #### See Also Links **Label:** Study Sponsor Website **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: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M18102 - Name: Weight Loss - Relevance: HIGH - As Found: Weight Loss - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown - ID: M5115 - Name: Body Weight Changes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015431 - Term: Weight Loss ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420687 **Brief Title:** GaMA Metric to Quantify Functional Importance of Various Upper Limb Prosthetic Devices **Official Title:** The Functional Importance of Powered Wrist Flexion for Transradial Prosthetic Users #### Organization Study ID Info **ID:** STU00211352 #### Organization **Class:** OTHER **Full Name:** Shirley Ryan AbilityLab ### Status Module #### Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2020-04-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Alberta #### Lead Sponsor **Class:** OTHER **Name:** Shirley Ryan AbilityLab #### Responsible Party **Investigator Affiliation:** Shirley Ryan AbilityLab **Investigator Full Name:** Laura Miller **Investigator Title:** Team Scientist III **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this study is to utilize the Gaze and Movement Assessment (GaMA) metric to assess the effect of different prosthetic components on compensatory movements used to complete activities of daily living. **Detailed Description:** Evaluating the benefit of new prosthetic components and control mechanisms can be challenging, as most validated outcome measures assess the time required to complete various tasks without assessing the quality of the movement or the specific DOF(s) activated to accomplish the task. There are no adequate methods to evaluate the impact of new technology. The functional outcome measures recommended by The Academy of Prosthetics and Orthotics Upper Limb Prosthetic Outcome Measures (ULPOM) committee, which provided recommendations for measuring functional effectiveness of prosthetic treatment, mainly focus on the time to complete the task rather than assessing the compensatory movements. The Gaze and Movement Assessment (GaMA) is a new validated and standardized metric to quantify the functional characteristics of prosthesis use by quantifying motion (three dimensional angular kinematics), gaze behavior and performance during simulated real-world tasks. There are two tasks, the Cup Transfer Task and the Pasta Box Task, used with the GAMA testing hardware. The tasks require movements representing day-to-day functional requirements, while challenging typical prosthetic limitations such as reaching and transporting objects at varying heights and across the body and lack of wrist motion. Each task can be subdivided into specific phases of reaching, grasping, transporting and releasing objects. A performance aspect encourages the participant to work efficiently, and tasks are short to allow multiple repetitions within a reasonable testing time frame to assess performance consistency. By breaking down each task into movements (i.e., of the pasta box from one shelf to the next), and each movement into specific phases (reach, grasp, transport, and release), the investigators can examine these components individually. It is hypothesized that additional degrees-of-freedom (for example wrist flexion) may require more time but will reduce the compensatory movements required to complete the tasks. The primary endpoint of the study is to quantify the effect of various prosthetics components on kinematics. The secondary endpoint is to obtain normative data for the GaMA system and system validation. ### Conditions Module **Conditions:** - Amputation - Amputation, Traumatic - Amputation; Traumatic, Hand - Amputation; Traumatic, Limb **Keywords:** - Upper Limb Prosthetic Users ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** FACTORIAL **Intervention Model Description:** The GaMA metric will utilize motion capture and eye tracking hardware and software during the administration of functional tasks while research participants are using commercially available prosthetic devices and investigational prosthetic devices currently in development. ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 45 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants without amputation were enrolled to collect normative data for system validation. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant wears a specialized headband/glasses with an attached camera for eye tracking. The participant will pick up and move objects of different shapes to and from various heights. **Label:** Able-bodied participants **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Individuals using their home prosthesis when available. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights. **Intervention Names:** - Device: Clinically prescribed prosthesis **Label:** Transradial amputee participants **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Individuals with transradial amputation fit with experimental prosthesis consisting of wrist rotation and one degree of freedom hand. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights. **Intervention Names:** - Device: Experimental prosthesis - Wrist rotation + 1-DOF **Label:** Transradial amputee participants - Wrist rotation+1 dof hand **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Individuals with transradial amputation fit with experimental prosthesis consisting of wrist rotation, wrist flexion and one degree of freedom hand. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights. **Intervention Names:** - Device: Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOF **Label:** Transradial amputee participants - Wrist rotation + wrist flexion +1 dof hand **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** Individuals with transradial amputation fit with experimental prosthesis consisting of wrist rotation and multi degree freedom hand. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights. **Intervention Names:** - Device: Experimental prosthesis - Wrist rotation + Multi DOF hand **Label:** Transradial amputee participants - Wrist rotation + multi degree freedom hand **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** Individuals with transradial amputation fit with experimental prosthesis consisting of wrist rotation, wrist flexion and multi degree freedom hand. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights. **Intervention Names:** - Device: Experimental prosthesis - Wrist rotation + wrist flexion + Multi DOF hand **Label:** Transradial amputee participants - Wrist rotation + wrist flexion + multi degree freedom hand **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Transradial amputee participants **Description:** Clinically prescribed prosthesis: **Name:** Clinically prescribed prosthesis **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Transradial amputee participants - Wrist rotation+1 dof hand **Description:** 1-DOF wrist rotation and1-DOF hand **Name:** Experimental prosthesis - Wrist rotation + 1-DOF **Type:** DEVICE #### Intervention 3 **Arm Group Labels:** - Transradial amputee participants - Wrist rotation + wrist flexion +1 dof hand **Description:** 2-DOF wrist (rotation and flexion) and 1-DOF hand **Name:** Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOF **Type:** DEVICE #### Intervention 4 **Arm Group Labels:** - Transradial amputee participants - Wrist rotation + multi degree freedom hand **Description:** 1-DOF wrist rotation and multi-DOF hand **Name:** Experimental prosthesis - Wrist rotation + Multi DOF hand **Type:** DEVICE #### Intervention 5 **Arm Group Labels:** - Transradial amputee participants - Wrist rotation + wrist flexion + multi degree freedom hand **Description:** 2-DOF wrist (rotation and flexion) and multi-DOF hand **Name:** Experimental prosthesis - Wrist rotation + wrist flexion + Multi DOF hand **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Utilizes motion capture hardware during prosthesis use and collects three dimensional angular kinematics, gaze behavior and performance during simulated tasks. Participants move a pasta box from the target on a side cart at the right side of the body onto a mid-height shelf target in front of them. Then they move the box from the mid-height shelf target to the high shelf target on the opposite side. Finally, they pick up the pasta box from the high shelf target and return it to the initial position. Each task can be subdivided into specific phases of reaching, grasping, transporting and releasing objects. By breaking down each task into movements, and each movement into specific phases (reach, grasp, transport, and release), the investigators can examine these components individually. **Measure:** Kinematics data while performing the Pasta Box Task **Time Frame:** After 6-week home trial **Description:** Utilizes motion capture hardware during prosthesis use and collects three dimensional angular kinematics, gaze behavior and performance during simulated tasks. The Cup transfer task consists of moving two cups filled with beads (simulating being filled with liquid) over a partition and back again for a total of four object movements. The cups are deformable and will spill beads if grabbed too hard. Like in the Pasta task, participants start each trial with their hand in the home position and their eyes fixated on a centered motion capture marker. Each task can be subdivided into specific phases of reaching, grasping, transporting and releasing objects. By breaking down each task into movements, and each movement into specific phases (reach, grasp, transport, and release), the investigators can examine these components individually. **Measure:** Kinematics data while performing the Cup Transfer Task **Time Frame:** After 6-week home trial #### Secondary Outcomes **Description:** Eye tracking hardware during prosthesis use the GAMA collects three dimensional gaze behavior and performance during simulated tasks. **Measure:** Eye gaze data while performing the Pasta Box Task **Time Frame:** After 6 week home trial **Description:** Eye tracking hardware during prosthesis use the GAMA collects three dimensional gaze behavior and performance during simulated tasks. **Measure:** Eye gaze data while performing the Cup Transfer Task **Time Frame:** After 6 week home trial ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * A unilateral upper limb amputation or absence below the elbow * Ability to use a myoelectric prosthesis * English Speaking Exclusion Criteria: * Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions. * Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. * Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** sfinucane@sralab.org **Name:** Suzanne Finucane **Phone:** 312-238-0937 **Role:** CONTACT **Contact 2:** **Email:** lmiller1@sralab.org **Name:** Laura Miller, PhD **Role:** CONTACT #### Locations **Location 1:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** sfinucane@sralab.org - **Name:** Suzanne Finucane - **Phone:** 312-238-0937 - **Role:** CONTACT ***Contact 2:*** - **Name:** Laura Miller, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Shirley Ryan AbilityLab **State:** Illinois **Status:** RECRUITING **Zip:** 60611 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4009 - Name: Amputation, Traumatic - Relevance: HIGH - As Found: Amputation; Traumatic - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000673 - Term: Amputation, Traumatic ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11767 - Name: Metronidazole - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420674 **Acronym:** RE-FER moodle **Brief Title:** Online Prevention of Emotional Disorders in Women Undergoing Fertility Treatments **Official Title:** Online Prevention of Emotional Disorders in Women Undergoing Fertility Treatments (RE-FER Moodle) #### Organization Study ID Info **ID:** IPES/RE-FER/moodle #### Organization **Class:** OTHER **Full Name:** Instituto de Investigación Sanitaria Aragón ### Status Module #### Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Hospital General Universitario de Castellón **Class:** UNKNOWN **Name:** Hospital Universitario La Plana de Castellón #### Lead Sponsor **Class:** OTHER **Name:** Jorge Javier Osma López #### Responsible Party **Investigator Affiliation:** Instituto de Investigación Sanitaria Aragón **Investigator Full Name:** Jorge Javier Osma López **Investigator Title:** Associate Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The main aim of this pilot study is to study the clinical utility and acceptability of a transdiagnostic psychological intervention, the Unified Protocol, delivered in online format to prevent the onset of emotional disorders in a sample of women undergoing fertility treatments (artificial insemination). The main questions it aims to answer are: 1. Can the Unified Protocol help to prevent the onset of emotional disorders during fertility treatments? The investigators expect to find a maintenance or improvement in anxiety and depressive symptoms as well as on quality of life and fertility-related stress. 2. Would the Unified Protocol delivered in online format be well accepted by women undergoing fertility treatments? The investigators expect to find high satisfaction rates both with the Unified Protocol contents and the online format. **Detailed Description:** Women who can not achieve a spontaneous pregnancy (i.e., couples who had fertility problems, single women or same-sex couples) frequently ask for fertility treatments. These treatments can provide the opportunity to get the desired pregnancy. However, they are also experienced as a highly stressful situation which has a direct impact on women's lives. It has been reported that fertility treatments are associated with high levels of stress, worse quality of life, high interference with women's life and the development of emotional disorders such as anxiety and depression. Between 25 and 65% of women undergoing fertility treatments suffer from anxiety and depressive symptoms, frequently with high comorbidity rates between these two psychological conditions. Also worrisome, these emotional disorders are one of the most notable reasons to discontinue fertility treatments. In this scenario, different national and international organizations have postulated the need to implement psychological assessments and interventions in women undergoing fertility treatments. However, some personal (i.e., lack of time) and logistical barriers (i.e., lack of psychologist in Human Reproduction Units and high distances to the hospital), impede that these psychological programs are finally implemented in Human Reproduction Units. New Information and Communication Technologies have been widely developed to provide psychological care in populations suffering emotional disorders, even in women undergoing fertility treatments. However, these technology-based solutions have not been yet implemented in the Spanish national healthcare system. According to this information, the purpose of this study is to explore the clinical utility and acceptability of a web-based transdiagnostic psychological intervention, the Unified Protocol, to prevent the onset of anxiety and depressive symptoms in women undergoing artificial inseminations. ### Conditions Module **Conditions:** - Infertility - Emotional Disorder - Anxiety Depression **Keywords:** - Unified Protocol - Prevention - Anxiety - Depression - Reproduction ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** This study will be offered to all women undergoing artificial inseminations in two public hospitals. ##### Masking Info **Masking:** NONE **Masking Description:** Masking is not applicable in this study as it includes only one condition. **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study will be offered to all women receiving artificial inseminations in two Spanish public hospitals (Hospital Universitario General de Castellón and Hospital Universitario La Plana). **Intervention Names:** - Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders **Label:** RE-FER web **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - RE-FER web **Description:** The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders is a psychological intervention that focuses on a wide range of emotional disorders (i.e., anxiety, depression and related disorders). It allows care for comorbid disorders, subclinical or unspecified symptoms reducing associated costs and improving response to treatment. In our study, the Unified Protocol preventive program will be applied throughout 10 online modules. Women will have access to a web-page (moodle version) that includes audiovisual materials (e.g., written manual, videos, editable registers) and psychological assessments. **Name:** Unified Protocol for Transdiagnostic Treatment of Emotional Disorders **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** This questionnaire consist of 5 items that evaluate the frequency and the intensity of depressive symptoms and their interference in life (e.g., work, school and social life). It is responded on a 5-point Likert scale (0=No depression - 4=The worst depression possible). The total score range from 0 to 20 points. Higher scores are indicative of greater severity and functional impairment as a result of depressive symptoms. In the Spanish population the clinical cut-off has been stablished in 10 points. **Measure:** Overall Depression Severity and Impairment Scale (ODSIS) **Time Frame:** Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment. **Description:** It consist of 5 items that evaluate the frequency and the intensity of anxious symptoms and their interference with the person's work or school life and social life. It is responded on a 5-point Likert scale (0=No anxiety- 4=The worst anxiety possible). The total score range from 0 to 20 points. Higher scores are indicative of greater severity and functional impairment as a result of anxious symptoms. In the Spanish population the clinical cut-off has been stablished in 10 points. **Measure:** Overall Anxiety Severity and Impairment Scale (OASIS) **Time Frame:** Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment. **Description:** It is composed by 46 items that assess infertility-related stress. It is responded by a 7-points Likert scale (0=completely disagree - 6=completely agree). It is possible to obtain a total score of perceived stress and also it is possible to calculate 5 subscale scores (social concerns, sexual concerns, relationship concerns, need for parenthood and, reject to child-free living). Higher scores indicate greater stress. **Measure:** Fertility Problem Inventory (FPI) **Time Frame:** Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment. **Description:** This instrument is composed by 36 items assessing quality of life during fertility treatments. It is responded by a 5-point Likert scale (0=very bad - 4 = very good). Total scores range from 0 to 136 points, higher global scores indicating greater quality of life. **Measure:** Fertility Quality of Life Questionnaire (FertiQoL) **Time Frame:** Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment. **Description:** Consists of 36-item of six dimension of emotion regulation (nonacceptance of emotions, difficulties in engaging in goal-directed behaviours, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies and lack of emotional clarity). Items are rated on a scale of 1 ("almost never \[0-10%\]") to 5 ("almost always \[91-100%\]"). Higher scores indicate more difficulties in emotion regulation. **Measure:** Difficulties in Emotion Regulation Scale (DERS) **Time Frame:** Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment. **Description:** This is a self-report measure that includes 49 items assessing the main transdiagnostic dimensions of Emotional Disorders: Neurotic Temperament; Positive Temperament; Depressed Mood; Autonomic Arousal; Somatic Anxiety; Social Anxiety; Intrusive Cognitions, Traumatic Re-experiencing; Avoidance. It is responded by a 9-point Likert scale (0=not characteristic of me - 8=extremely characteristic of me). Result for each dimension allows to obtain a profile to emotional disorders. **Measure:** The Multidimensional Emotional Disorder Inventory (MEDI) **Time Frame:** Pre-intervention; Post-intervention, 11 weeks from pre-assessment; 1 month follow-up after post-assessment; 3 months follow-up after post-assessment; 6 months follow-up after post-assessment. **Description:** The web automatically records the number of modules completed. At the end of the intervention, the number of modules completed will be analyzed in proportion to the number of modules programmed. **Measure:** Web-page adherence **Time Frame:** Post-intervention (11 weeks from pre-intervention assessment). **Description:** This adaptation is composed of 7 items assessing (a) quality of the intervention and quality of its components, (b) discomfort experienced during treatment, (c) satisfaction with their participation in an online individual format. **Measure:** Adaptation of the Client Satisfaction Questionnaire (CSQ-8) **Time Frame:** Post-intervention (11 weeks from pre-intervention assessment). **Description:** It consists of 7 questions that assess the general usefulness of the Unified Protocol to improve emotion regulation skills and the specific usefulness of each of the Unified Protocol skills. **Measure:** Unified Protocol Satisfaction questionaire **Time Frame:** Post-intervention (11 weeks from pre-intervention assessment). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Be at least 18 years of age. * Have a good understanding of Spanish. * Have started fertility treatment (at least one artificial insemination received). * Signed the informed consent. Exclusion Criteria: * Not having Internet access to access the web-page. * Having a diagnosis of severe mental disorder. * Active suicidal ideation at the time of evaluation. **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** osma@unizar.es **Name:** Jorge Osma, PhD **Phone:** 978618101 **Phone Ext:** +34 **Role:** CONTACT #### Locations **Location 1:** **City:** Teruel **Country:** Spain **Facility:** Jorge Osma **Zip:** 44003 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000001523 - Term: Mental Disorders - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M10290 - Name: Infertility - Relevance: HIGH - As Found: Infertility - ID: M21835 - Name: Mood Disorders - Relevance: HIGH - As Found: Emotional Disorders - ID: M4818 - Name: Behavioral Symptoms - 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: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007246 - Term: Infertility - ID: D000003863 - Term: Depression - ID: D000019964 - Term: Mood Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420661 **Acronym:** SPACE **Brief Title:** School Partnered Collaborative Care (SPACE) Intervention for Children With Type 1 Diabetes **Official Title:** School Partnered Collaborative Care (SPACE) for Pediatric Type 1 Diabetes: A Pilot Feasibility Trial #### Organization Study ID Info **ID:** STUDY23120069 #### Organization **Class:** OTHER **Full Name:** University of Pittsburgh #### Secondary ID Infos **ID:** 1K23DK135800-01 **Link:** https://reporter.nih.gov/quickSearch/1K23DK135800-01 **Type:** NIH ### Status Module #### Completion Date **Date:** 2027-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) #### Lead Sponsor **Class:** OTHER **Name:** University of Pittsburgh #### Responsible Party **Investigator Affiliation:** University of Pittsburgh **Investigator Full Name:** Christine March **Investigator Title:** Assistant Professor of Pediatrics **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is a pilot trial of a school-partnered collaborative care (SPACE) model for pediatric type 1 diabetes. The trial will investigate the feasibility and acceptability of SPACE for children with type 1 diabetes in the school setting. SPACE is adapted from a collaborative care model used to treat depression and other mental health care conditions in adolescents and adults. **Detailed Description:** This pilot cluster randomized controlled trial will examine the feasibility of a school-partnered collaborative care (SPACE) model for children with type 1 diabetes (SPACE for T1D). School districts will be randomized to the intervention or control arm in a 2:1 allocation ratio. School districts randomized to the control arm in Year 1 of the study will be invited to participate in SPACE in Year 2. All children with type 1 diabetes meeting inclusion criteria in each school district will be approached to participate through their school nurse. All research activities will be conducted using a virtual video-conferencing platform. The intervention arm will consist of four monthly virtual meetings between the child, school nurse, diabetes care and education specialist (DCES), and any other identified school-related support people. The purpose of these meetings will be to determine a shared treatment plan, make treatment recommendations, and determine progress towards meeting the child's goals. The control arm will receive usual care in the school and the clinical setting as well as monthly phone calls from the DCES to the parent to offer review of blood glucoses. No additional contact with the school will be offered. Participants and their parents will be asked to complete surveys regarding their overall health and well-being and provide us access to their glucometer/continuous glucose monitor data. Additional information will be collected from the electronic health record (hemoglobin A1c, care utilization, referrals). At the end of study, surveys for the parent and school nurse will assess feasibility and other implementation outcomes. ### Conditions Module **Conditions:** - Type 1 Diabetes **Keywords:** - school - collaborative care model - diabetes care and education - health services ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Cluster randomized controlled trial ##### Masking Info **Masking:** NONE **Primary Purpose:** HEALTH_SERVICES_RESEARCH #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention consists of four monthly virtual visits between the school nurse, diabetes care and education specialist (DCES), parent, and any other school-related supports identified by the parent (e.g., coaches, counselors, social workers). At the first visit, the parent and child, school nurse, and DCES will discuss and determine a shared treatment plan. This will include a diabetes medical management plan and shared treatment goals for the child. At each virtual visit, the DCES and school nurse will co-lead the group through review of the shared treatment plan, a review of glucose records and insulin dosing for diabetes management, provide counseling/education, and identify any needed internal (academic) or external (health-related) supports or referrals. Families will be encouraged to set new treatment goals if any milestones are met. **Intervention Names:** - Behavioral: SPACE for T1D **Label:** SPACE Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In addition to usual care (clinical and in school), parents of children enrolled in the control group will receive four monthly phone calls from the DCES to review diabetes management, mirroring the timing of the virtual visits of the intervention group. This study will employ a wait list control. **Intervention Names:** - Behavioral: Enhanced usual care **Label:** Control **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - SPACE Intervention **Description:** school-partnered collaborative care model **Name:** SPACE for T1D **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Control **Description:** routine diabetes care with optional monthly insulin dose adjustment **Name:** Enhanced usual care **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome is feasibility, defined as the extent to which the intervention can be successfully carried out in the school setting. Feasibility will be measured by the FIM, a 4-item scale with an ordinal scoring system from strongly disagree to strongly agree. The scale scores can range from 1-5 with higher scores indicating higher feasibility. The FIM will be completed by the participating child's parent and school nurse. The school nurses will be asked to complete the measure for each iteration of SPACE, which will mean that the same nurse may complete the measure multiple times. Nurses will need to complete the measure within 14 days of the end of that iteration of SPACE, allowing us to descriptively assess change in an individual school nurse's response over time. The intervention will be deemed "feasible" if the mean overall score is \>4/5 (80%). **Measure:** Feasibility of Intervention Measure (FIM) **Time Frame:** Month 4 #### Secondary Outcomes **Description:** Acceptability is defined as the perception that the intervention is agreeable or satisfactory. Acceptability will be measured with AIM, a 4-item scale with an ordinal scoring system from strongly disagree to strongly agree. The scale scores can range from 1-5 with higher scores indicating higher acceptability. The AIM will be completed by the participating child's parent and school nurse. The school nurses will be asked to complete the measure for each iteration of SPACE, which will mean that the same nurse may complete the measure multiple times. Nurses will need to complete the measure within 14 days of the end of that iteration of SPACE, allowing us to descriptively assess change in an individual school nurse's response over time. The intervention will be deemed "acceptable" if the mean overall score is \>4/5 (80%). **Measure:** Acceptability of Intervention Measure (AIM) **Time Frame:** Month 4 **Description:** Appropriateness is defined as the perceived fit or relevance of the intervention to the school setting. Appropriateness will be measured with the IAM, a 4-item scale with an ordinal scoring system from strongly disagree to strongly agree. The scale scores can range from 1-5 with higher scores indicating higher appropriateness. The IAM will be completed by the participating child's parent and school nurse. The school nurses will be asked to complete the measure for each iteration of SPACE, which will mean that the same nurse may complete the measure multiple times. Nurses will need to complete the measure within 14 days of the end of that iteration of SPACE, allowing us to descriptively assess change in an individual school nurse's response over time. The intervention will be deemed "appropriate" if the mean overall score is \>4/5 (80%). **Measure:** Intervention Appropriateness Measure (IAM) **Time Frame:** Month 4 **Description:** Usability is defined as the degree to which the intervention is able to be used. Usability will be measured by the IUS, a 10-item scale with an ordinal scoring system from strongly disagree to strongly agree. The scale scores can range from 1-5 with higher scores indicating higher usability. The IUS will be completed by the participating child's parent and school nurse. The school nurses will be asked to complete the measure for each iteration of SPACE, which will mean that the same nurse may complete the measure multiple times. Nurses will need to complete the measure within 14 days of the end of that iteration of SPACE, allowing us to descriptively assess change in an individual school nurse's response over time. The intervention will be deemed "usable" if the mean overall score is \>4/5 (80%). **Measure:** Intervention Usability Scale (IUS) **Time Frame:** Month 4 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of type 1 diabetes for at least 6 months * Attend school in one of the partnered school districts * Receive daily oversight from the school nurse for their diabetes * Managed by the Children's Hospital of Pittsburgh Diabetes center * Able to participate in English Exclusion Criteria: * Child has developmental delay or neuropsychiatric disorder which would preclude their participation in their diabetes care and/or completion of study questionnaires * Child is completely independent in diabetes care in school **Maximum Age:** 12 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** christine.eklund@chp.edu **Name:** Christine A March, MD **Phone:** 412-692-9156 **Role:** CONTACT #### Locations **Location 1:** **City:** Pittsburgh **Contacts:** ***Contact 1:*** - **Email:** christine.eklund@chp.edu - **Name:** Christine A March, MD, MS - **Phone:** 412-692-9156 - **Role:** CONTACT ***Contact 2:*** - **Name:** Victoria Stouffer - **Role:** CONTACT **Country:** United States **Facility:** University of Pittsburgh **State:** Pennsylvania **Zip:** 15237 #### Overall Officials **Official 1:** **Affiliation:** Univeristy of Pittsburgh **Name:** Christine A March, MD **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 - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Type 1 Diabetes - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003922 - Term: Diabetes Mellitus, Type 1 ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: LOW - As Found: Unknown - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420648 **Brief Title:** A Randomized Controlled Trial Comparing Controlled Active Motion and Early Passive Mobilization Protocols for Rehabilitation of Repaired Flexor Tendons in Zone II **Official Title:** A Randomized Controlled Trial Comparing Controlled Active Motion and Early Passive Mobilization Protocols for Rehabilitation of Repaired Flexor Tendons in Zone II #### Organization Study ID Info **ID:** 000-000 #### Organization **Class:** OTHER **Full Name:** University of Hail ### Status Module #### Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-08-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** 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 2 rehabilitation approaches - early passive mobilization (EPM) and controlled active motion (CAM) - that are commonly used in the treatment of post-surgical flexor tendon repair of the hand **Detailed Description:** a randomized controlled trial tends to compare 2 rehabilitation approaches commonly used in the treatment of post-surgical flexor tendon repair of the hand. in this study, the authors try to fill the gap in the literature regarding the more effective approach. the comparisons between both approaches were scarce in previous literature. Participants will be randomly allocated to one of two treatment groups: early passive mobilization (EPM) using a modified Kleinert protocol or controlled active motion (CAM) using a modified Duran technique (n=20). Patients were assessed at baseline and then at the 6th and 12th weeks of interventions to quantify total active motion (TAM) of the proximal and distal interphalangeal joints using goniometry, and grip strength with dynamometry. the disability level will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. ### Conditions Module **Conditions:** - Flexor Tendon Rupture ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** 2 arm randomized controlled trial ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The modified Kleinert protocol will be used as an EPM procedure. Within 3 to 5 days following surgery, the affected hand will be placed inside the dorsal slab Kleinert splint with the wrist in 30-40 flexion; metacarpophalangeal joint (MP) in 60-70-degree flexion; PIP and DIP joints in extension. Rubber band traction will be directed to the fingernail from the wrist, with a palmar pulley system. All patients will perform passive flexion and active extension exercises with an active hold for 2-3 seconds 10 times per hour. Traction will be removed at the end of 3rd week and very gentle active flexion will start at the 4th week. The splint will be removed in the 5th-6th weeks. Blocking exercises will be started at 7th-8th weeks and resisted exercises will be started after the 8th week with the full function permitted by week 12th week . **Intervention Names:** - Other: Early passive mobilization **Label:** Early passive mobilization group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** A modified CAM protocol will be used. Exercises will be performed hourly for 10 repetitions in the form of passive flexion and active extension exercises with an active hold of the fingers in the flexed position for 2-3 seconds. **Intervention Names:** - Other: Controlled active motion **Label:** Controlled active motion group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Early passive mobilization group **Description:** a rehabilitation protocol for post-surgical repair of flexor tendons of the hand **Name:** Early passive mobilization **Other Names:** - modified Kleinert protocol **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Controlled active motion group **Description:** a rehabilitation protocol for post-surgical repair of flexor tendons of the hand **Name:** Controlled active motion **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Active range of motion in proximal interphalangeal joint (PIP) and the distal interphalangeal joint (DIP) of the injured digits will be measured by manual hand goniometry. Outcome will be expressed by Strickland formula. TAM (%) = (Active flexion of PIP+DIP) - Extension Lag of both joints/175× 100 This formula can determine the percentage of recovery of TAM. The results of TAM (%) are classified in four categories: "Excellent, good, fair, and poor" **Measure:** Total active motion (TAM) **Time Frame:** at baseline **Description:** This formula can determine the percentage of recovery of TAM. The results of TAM (%) are classified in four categories: "Excellent, good, fair, and poor" This formula determined the percentage of recovery of TAM. The results of TAM (%) were classified in four categories: "Excellent, good, fair, and poor" **Measure:** Total active motion (TAM) **Time Frame:** after the 12th week of intervention **Description:** Hand dynamometer (Jammer dynamometer) will be used to evaluate hand grip strength. Measurements will be taken for both hands for three times. The mean of three trials will be taken for every measurement occasion. The mean value in the injured hand will be expressed as percentage of the mean value in the non-injured hand as follows: % of hand grip strength = Mean grip strength in the involved hand/ Mean grip strength in the uninvolved hand × 100. **Measure:** handgrip strength **Time Frame:** baseline **Description:** Hand dynamometer (Jammer dynamometer) will be used to evaluate hand grip strength. Measurements will be taken for both hands for three times. The mean of three trials will be taken for every measurement occasion. The mean value in the injured hand will be expressed as percentage of the mean value in the non-injured hand as follows: % of hand grip strength = Mean grip strength in the involved hand/ Mean grip strength in the uninvolved hand × 100. **Measure:** handgrip strength **Time Frame:** after the 12th week of intervention **Description:** The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to measure the functional disabilities. It is a valid questionnaire used in a number of other disabling conditions of the hand. A DASH-questionnaire score, ranges from 0 to 100. A score of 0 means no difficulties in daily living and a score of 100 means maximum difficulties in performing tasks of daily living **Measure:** Functional disability **Time Frame:** at baseline **Description:** The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to measure the functional disabilities. It is a valid questionnaire used in a number of other disabling conditions of the hand. A DASH-questionnaire score, ranges from 0 to 100. A score of 0 means no difficulties in daily living and a score of 100 means maximum difficulties in performing tasks of daily living **Measure:** Functional disability **Time Frame:** after the 12th week of intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * males or females * between 25-50 years * Post-surgical repair of the flexor digitorum profundus (FDP) and superficialis (FDS) tendons of a single-digit * the case should be recent (2-3 days post-surgical) Exclusion Criteria: * age below 25 or above 50 * a systemic disease affecting hand joints such as rheumatic arthritis * thumb flexor tendon repair will be excluded * chronic cases * concurrent injuries such as phalangeal fractures, joint injuries, or significant skin loss **Maximum Age:** 50 Years **Minimum Age:** 25 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Hail **Country:** Saudi Arabia **Facility:** Hail University Poly Clinic **Zip:** 2442 **Location 2:** **City:** Hail **Country:** Saudi Arabia **Facility:** Hisham Hussein **Zip:** 3994 ### IPD Sharing Statement Module **Description:** data will be available with the senior author upon request **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M15241 - Name: Rupture - Relevance: HIGH - As Found: Rupture - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012421 - Term: Rupture ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420635 **Brief Title:** Maternal Self-efficacy and Motor Development in Premature Infants: Clinical Trial Protocol **Official Title:** Effect of an Interdisciplinary Intervention Program on Maternal Self-efficacy and Motor Development of Premature Children: Clinical Trial Protocol #### Organization Study ID Info **ID:** ENF-64-2022 #### Organization **Class:** OTHER **Full Name:** Universidad de la Sabana ### Status Module #### Completion Date **Date:** 2025-12-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-09-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-25 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Universidad de Boyacá **Class:** UNKNOWN **Name:** Hospital Universitario de La Samaritana **Class:** UNKNOWN **Name:** Universidade Franciscana (UFN)- Brasil #### Lead Sponsor **Class:** OTHER **Name:** Universidad de la Sabana #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Mothers of premature newborns face special home care situations due to the conditions of their children after hospital discharge; This requires promoting the positive perception of maternal self-efficacy and thus achieving the reinforcement of behaviors related to the demand for care in relation to motor development. * Objective: Determine the effect of an interdisciplinary intervention program on maternal self-efficacy and motor development of premature children in the cities of Bogotá and Tunja in comparison with the traditional kangaroo program. * Methodology: Experimental study, with pretest/posttest design, with experimental and control group, which determines the baseline. With initial evaluation of the groups, randomized assignment, and post-intervention evaluation at 4 weeks and flow-up at 8 weeks. The intervention will be developed in two scenarios, in the outpatient kangaroo plan consultation and at home. The experimental group will receive an intervention based on the promotion of maternal self-efficacy and the motor development of the premature baby. The control group will have traditional kangaroo program care. The sample calculation is 92 participants, 46 in the experimental group and 46 in the control group. The intervention, evaluations and data analysis will be developed by blinded professionals. An analysis of the data will be done by intention to treat. * Type of results expected to be obtained: It is expected to obtain an intervention that promotes maternal self-efficacy for the adequate stimulation of the motor development of the premature baby. It is expected to enhance the confidence and empowerment of the maternal role, the motor development of children in accordance with the corrected age and the incorporation of ICT for monitoring at home. ### Conditions Module **Conditions:** - Premature Birth - Mothers of Newborn Infants **Keywords:** - Premature newborn - Mothers - self-efficacy - motor skills - motor praxis - outpatient care - information and communication technologies - kangaroo mother care - nursing - physical therapy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 92 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Interdisciplinary intervention program on maternal self-efficacy and the motor development of premature children. **Intervention Names:** - Behavioral: Interdisciplinary intervention program on maternal self-efficacy and the motor development of premature children **Label:** Interdisciplinary intervention program on maternal self-efficacy and motor development **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group will receive the conventional family-centered care plan, including kangaroo position, exclusive breastfeeding, and monitoring of the child's progress. **Intervention Names:** - Behavioral: Traditional kangaroo program **Label:** Traditional Kangaroo Program **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Interdisciplinary intervention program on maternal self-efficacy and motor development **Description:** The experimental group will receive an intervention about maternal self-efficacy and motor stimulation strategies for premature children applied by mothers. There will be two face-to-face meetings: the first with a theoretical session on motor development, a practical workshop on stimulation skills using a baby simulator and strengthening of maternal self-efficacy. The second meeting seeks for mothers to reflect on self-efficacy and carry out practical simulation of strategies with their children. At home (for four weeks), self-efficacy will be strengthened through 4 strategies twice a week, for 8 sessions. Mothers will put into practice with the baby the 10 stimulation strategies explained in the face-to-face sessions, must complete 14 sessions per week, 2 times a day, for a total of 56 sessions. The initial measurement will be carried out before the intervention, the second at 4 weeks and the third at 8 weeks after the intervention began. **Name:** Interdisciplinary intervention program on maternal self-efficacy and the motor development of premature children **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Traditional Kangaroo Program **Description:** The control group will receive the conventional family-centered care plan, including kangaroo position, exclusive breastfeeding, and outpatient follow-up. The traditional intervention for the control group is based on the Kangaroo Mother Method (KMC) program, proposed according to technical guidelines, which promotes skin-to-skin contact between mother and premature baby. In periodic outpatient consultations, clinical assessments are carried out focused on optimal growth (goal 15-20g/kg/day), neurological and psychomotor development, and timely detection of pathologies that require specialized care according to findings. Compliance with the vaccination schedule and medical indications, and assurance of breastfeeding, are monitored. The frequency of check-ups is daily initially, then weekly until 40 weeks and then monthly. The approach includes early stimulation and follow-up until 12 months of corrected age. **Name:** Traditional kangaroo program **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Parental Evaluation Scale (PES). The total score is 10, the minimum value is 0, and the maximum is 10. Higher scores indicate a greater perception of self-efficacy and maternal satisfaction. **Measure:** Maternal self-efficacy **Time Frame:** Two months **Description:** Alberta Infant Motor Scale (EMIA). The total score is 90, the minimum value is 5, and the maximum is 90. Higher scores indicate a greater motor development, which is directly proportional to the corrected age of children. **Measure:** Motor Development **Time Frame:** Two months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Mothers of a child born prematurely who attend the outpatient kangaroo mother program in Bogotá, Tunja and Zipaquirá in the period between 2024 and 2025. * Premature children between 32 to 36.6 weeks who participate in the outpatient kangaroo mother program in Bogotá, Tunja and Zipaquirá in the period between 2024 and 2025. Exclusion Criteria: * Mothers who manifest any diagnosed mental limitation to participate in the study. * Premature children with hemodynamic alterations, congenital malformations, chromosomal syndromes, esophageal atresia, ductus arteriovenosus, heart disease and neurological pathologies. **Healthy Volunteers:** True **Maximum Age:** 37 Weeks **Minimum Age:** 32 Weeks **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** angelica.ospina@unisabana.edu.co **Name:** Angélica Ospina, PhD **Phone:** +573106095732 **Role:** CONTACT **Contact 2:** **Email:** empinto@uniboyaca.edu.co **Name:** Erika Pinto, RN **Phone:** +573003385739 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Universidad de la Sabana **Name:** Angélica Ospina, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007752 - Term: Obstetric Labor, Premature - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M25869 - Name: Premature Birth - Relevance: HIGH - As Found: Premature - ID: M10772 - Name: Obstetric Labor, Premature - Relevance: LOW - As Found: Unknown - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000047928 - Term: Premature Birth ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420622 **Acronym:** INDICATOR **Brief Title:** INDIcators for Clarifying the bAckground of exTreme Obesity in childRen **Official Title:** INDIcators for Clarifying the bAckground of exTreme Obesity in childRen (INDICATOR) #### Organization Study ID Info **ID:** INDICATOR Study #### Organization **Class:** OTHER **Full Name:** University of Leipzig ### Status Module #### Completion Date **Date:** 2026-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-10-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Rhythm Pharmaceuticals, Inc. #### Lead Sponsor **Class:** OTHER **Name:** University of Leipzig #### Responsible Party **Investigator Affiliation:** University of Leipzig **Investigator Full Name:** Antje Koerner, Prof. Dr. med. **Investigator Title:** Prof. Dr. med. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study investigates the genetic backgrounds of extreme childhood obesity (using saliva sample) and contains short online questionnaires on family history, phenotypical characteristics and hunger behavior. It is an observational study in a predefined cohort (subjects with data in CrescNet aged 0-18 with BMI measurement(s) above the 99.5th percentile). Recruitment will initially be from CrescNet data through the cooperating pediatric and adolescent medical institutions associated with these initiative of data collection in Germany. **Detailed Description:** In order to be able to investigate the genetic background of extreme obesity, current BMI developments above the 99.5 BMI percentile (extreme obesity) are selected in the existing CrescNet register. Pediatricians (submitting the data) will be informed about these cases. They will be ask to re-identify the patient using the pseudonym (CrescNet-ID) maintained in the registry and to contact the family with a request to participate in the study. The study physician of the study center at the Leipzig University Hospital will take over the study inclusion as well as all necessary clarifications and consents for the study and the genetic examination contained therein. Since the potential probands may live anywhere in Germany, telemedical contact between the study center and the family (interested in participation) will be used. In addition to the above-mentioned study inclusion, the study physician is also responsible for instructing the family on the correct drawing, collection and sending of saliva samples to the study center, as well as instructing them on how to complete the hyperphagia questionnaire. At this appointment, the proband is assigned an internal study identification number (INDICATOR-ID). Saliva sample and all questionnaires are assigned to this number. ### Conditions Module **Conditions:** - Gene Abnormality - Child Obesity - Hunger ### Design Module #### Bio Spec **Description:** Saliva samples, Whole Exom Sequencing **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Other Outcomes **Description:** alert pediatricians to a monogenic form of obesity that may be present and treatable **Measure:** Modifying of screening algorithms **Time Frame:** 2 Years #### Primary Outcomes **Description:** trait among children with early onset severe obesity **Measure:** Prevalence of each monogenetic obesity **Time Frame:** 2 years **Description:** distinguish monogenetic obesity from classical polygenetic forms **Measure:** Typical patterns of weight gain for each form of obesity **Time Frame:** 2 years #### Secondary Outcomes **Description:** ZIP-Code related, place of residence of the test subjects **Measure:** Statements about spatial distribution **Time Frame:** 2 years **Description:** method to identify the form of obestity **Measure:** Role of hyperphagia symptoms **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Test subjects older 5 years: BMI SDS between 0-5 years \> 1.881 (= p97) BMI SDS between 5 and 18 \>2.567 (=p99.5) Parents and subjects agree that the study information will be provided during a telemedical consultation by the study physician Exclusion Criteria: * Known cause of servere early obesity **Healthy Volunteers:** True **Maximum Age:** 18 Years **Minimum Age:** 2 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Cohort from the registry CrescNet (NCT03072537) , data collection of body height and body weight in childhood by primary care pediatricians in Germany ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** antje.koerner@medizin.uni-leipzig.de **Name:** Antje Körner, Prof. **Phone:** +49 341 9726500 **Role:** CONTACT **Contact 2:** **Email:** eric.goepel@medizin.uni-leipzig.de **Name:** Eric Göpel, PhD **Phone:** +49 341 9720465 **Role:** CONTACT #### Locations **Location 1:** **City:** Leipzig **Contacts:** ***Contact 1:*** - **Email:** roland.pfaeffle@medizin.uni-leipzig.de - **Name:** Roland W Pfaeffle, Prof. - **Phone:** +49 341 9726330 - **Role:** CONTACT ***Contact 2:*** - **Email:** antje.koerner@medizin.uni-leipzig.de - **Name:** Antje Koerner, Prof. - **Phone:** +49 341 9726500 - **Role:** CONTACT ***Contact 3:*** - **Name:** Eric Göpel, MD - **Role:** SUB_INVESTIGATOR **Country:** Germany **Facility:** Children's Hospital University of Leipzig **State:** Saxony **Status:** RECRUITING **Zip:** 04103 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: HIGH - As Found: Obesity - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M30155 - Name: Pediatric Obesity - Relevance: HIGH - As Found: Child Obesity - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M5114 - Name: Body Weight - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009765 - Term: Obesity - ID: D000063766 - Term: Pediatric Obesity ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420609 **Acronym:** Go-TAD **Brief Title:** Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer **Official Title:** Efficacy of a Proactive Approach to Death Thoughts in People With Advanced Cancer: a Randomized Clinical Trial #### Organization Study ID Info **ID:** PI22/01536 #### Organization **Class:** OTHER **Full Name:** Universitat Internacional de Catalunya ### Status Module #### Completion Date **Date:** 2025-12-21 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-14 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Institut Català d'Oncologia **Class:** OTHER **Name:** Hospital Arnau de Vilanova **Class:** OTHER **Name:** Fundacion Rioja Salud #### Lead Sponsor **Class:** OTHER **Name:** Universitat Internacional de Catalunya #### Responsible Party **Investigator Affiliation:** Universitat Internacional de Catalunya **Investigator Full Name:** Iris Crespo Martin **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 aim of this study is to demonstrate the efficacy of a proactive intervention to approach death thoughts among people with advanced cancer compared to usual care (the reactive approach) via a feasible approach with previous indicators of efficacy: Go-TAD (Give the Opportunity to Talk about Death). The benefits of the intervention will be evaluated in terms of: reduction of emotional distress and hopelessness and improvement the doctor-patient relationship, as well as improvement of quality of life for the patient. A Phase II randomized controlled mixed methods clinical trial (RCT) will be carried out within 4 Palliative Care units of tertiary care hospitals in Catalonia. Participants will be persons with advanced cancer defined according to the criteria of the American Society of Clinical Oncology. Participants will be randomly assigned to an intervention group or control group. In the intervention group, the participants will receive a medical visit that will include the 4 open-ended questions comprising the Go-TAD intervention, while the control group will receive usual care. Between 24 and 96 hours later, a researcher from outside the center will assess study outcome measures. To strengthen the study conclusions, a qualitative study will be carried out in which the experiences of the participants in the intervention group and of their professionals who administered the Go-TAD will be explored in depth. ### Conditions Module **Conditions:** - Death - Advanced Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** This study proposes a randomized controlled clinical trial (RCT) with a stepped-wedge design, in which 6 palliative care units from second and third level hospitals in Spain will collaborate. The six units will contribute with both experimental and control participants, starting with the recruitment of the control group participants and subsequently starting the intervention group. The time at which they will transition to the intervention will be chosen at random. The centers will be randomized to know at what point in the study they should begin the intervention and each center will be informed of the number of patients they should include in each of the groups. The clusters correspond to the different palliative care units that participate in the study. Six sequences will be carried out, seven periods with 4 patients in each period. Patients will be different in each of the periods. **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 168 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** the participants will receive a medical visit that will include the 4 open-ended questions comprising the Go-TAD intervention **Intervention Names:** - Other: Go-TAD **Label:** Go-TAD **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** the participants will receive a medical visit that will include the 4 open-ended questions comprising hobbies and other personal themes, but not death. **Label:** CONTROL **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Go-TAD **Description:** The participants will receive a medical visit that will include the 4 open-ended questions comprising the Go-TAD intervention **Name:** Go-TAD **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** age, gender, marital status, type of cancer, months since diagnosis. **Measure:** Clinical and sociodemographic variables **Time Frame:** 4 days #### Primary Outcomes **Description:** The main outcome will be emotional distress, which will be evaluated using an instrument validated and developed in the context of palliative care in Spain, the Emotional Distress Detection (DME) questionnaire. This questionnaire is characterized by the simplicity and ease of application and the short application time, given that it only consists of 4 items. The first three items are questions with answers in the format of a visual numerical scale from 0 to 10, in which the state of mind and the perception of coping with the situation are evaluated, and another that records the presence or absence of concerns. The last question is based on the observation, by the healthcare professional, of the presence of external signs of emotional distress. The DME gives a total score (0 to 20) made up of the sum of the scores of the first three items, one of them in reverse format, with the highest scores indicating greater discomfort. **Measure:** Emotional distress **Time Frame:** 4 days #### Secondary Outcomes **Description:** Hopelessness will be assessed with the Beck Hopelessness Questionnaire (BHQ). This validated and widely used questionnaire in palliative care research originally consists of 20 items that were reduced to 7 items with true/false responses in a brief version specially adapted to the area of palliative care. The total score ranges from 0 to 7, with higher scores indicating a higher level of hopelessness. **Measure:** Hopelessness assessed by the Beck Hopelessness Questionnaire (BHQ). **Time Frame:** 4 days **Description:** The quality of the doctor-patient relationship from the patient's perspective will be evaluated with the Patient-Doctor-Relationship Questionnaire -PDRQ-9-. This questionnaire consists of 9 items with a 5-point Likert-type response format and has been previously used in the field of palliative care. The total score ranges between 9-45, with higher scores indicating a better relationship between doctor and patient. **Measure:** Doctor-patient relationship evaluated with the Patient-Doctor-Relationship Questionnaire -PDRQ-9-. **Time Frame:** 4 days **Description:** It will be evaluated using the Palliative Outcome Scale (POS). This scale has been validated with a proxy for quality of life in patients with palliative care. It consists of 12 items with multiple response format that address the physical and psychological dimensions, the information given, communication with family and friends, the meaning of life and other practical aspects related to the disease. The range of scores is 0-40, with higher scores indicating worse quality of life. **Measure:** Quality of life related to health evaluated using the Palliative Outcome Scale (POS) **Time Frame:** 4 days ### Eligibility Module **Eligibility Criteria:** The inclusion criteria will be: 1. patients with advanced cancer defined according to ASCO (American Society of Clinical Oncology) criteria referred for the initial palliative care (PC) consultation. 2. age over 18 years 3. ECOG 0-3 (functionality status) 4. outpatients and inpatients 5. patients who can sign the informed consent 6. patients with the ability to maintain a conversation The exclusion criteria will be: 1. patients with acute symptoms that may affect their consciousness. 2. patients with any uncontrolled symptoms that prevent collaboration in the study assessed according to clinical judgment 3. moderate or severe cognitive impairment assessed according to clinical judgment 4. patients included in another incompatible clinical trial **Maximum Age:** 100 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Lee JJ, Liu DD. A predictive probability design for phase II cancer clinical trials. Clin Trials. 2008;5(2):93-106. doi: 10.1177/1740774508089279. **PMID:** 18375647 **Citation:** Limonero JT, Mateo D, Mate-Mendez J, Gonzalez-Barboteo J, Bayes R, Bernaus M, Casas C, Lopez M, Sirgo A, Viel S. [Assessment of the psychometric properties of the Detection of Emotional Distress Scale in cancer patients]. Gac Sanit. 2012 Mar-Apr;26(2):145-52. doi: 10.1016/j.gaceta.2011.07.016. Epub 2011 Oct 26. Spanish. **PMID:** 22033008 **Citation:** Martin-Fernandez J, del Cura-Gonzalez MI, Gomez-Gascon T, Fernandez-Lopez E, Pajares-Carabajal G, Moreno-Jimenez B. [Patient satisfaction with the patient-doctor relationship measured using the questionnaire (PDRQ-9)]. Aten Primaria. 2010 Apr;42(4):196-203. doi: 10.1016/j.aprim.2009.09.026. Epub 2010 Feb 8. Spanish. **PMID:** 20116893 **Citation:** Serra-Prat M, Nabal M, Santacruz V, Picaza JM, Trelis J; Grupo Catalan de Estudio de la Efectividad de los Cuidados Paliativos. [Validation of the Spanish version of the Palliative Care Outcome Scale]. Med Clin (Barc). 2004 Oct 2;123(11):406-12. doi: 10.1016/s0025-7753(04)74535-2. Spanish. **PMID:** 15482713 **Citation:** Crespo I, Monforte-Royo C, Balaguer A, Pergolizzi D, Cruz-Sequeiros C, Luque-Blanco A, Porta-Sales J. Screening for the Desire to Die in the First Palliative Care Encounter: A Proof-of-Concept Study. J Palliat Med. 2021 Apr;24(4):570-573. doi: 10.1089/jpm.2020.0276. Epub 2020 Sep 18. **PMID:** 32945714 **Citation:** Porta-Sales J, Crespo I, Monforte-Royo C, Marin M, Abenia-Chavarria S, Balaguer A. The clinical evaluation of the wish to hasten death is not upsetting for advanced cancer patients: A cross-sectional study. Palliat Med. 2019 Jun;33(6):570-577. doi: 10.1177/0269216318824526. Epub 2019 Jan 28. **PMID:** 30688146 ## 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: M6845 - Name: Death - Relevance: HIGH - As Found: Death ### Condition Browse Module - Meshes - ID: D000009369 - Term: Neoplasms - ID: D000003643 - Term: Death ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420596 **Brief Title:** The Effectiveness of Remote App-assisted Physiotherapy in Patients With Non-specific Low Back Pain (RemotePT) **Official Title:** A Randomised Controlled Trial on the Effectiveness of Remote App-assisted Physiotherapy in Patients With Non-specific Low Back Pain (RemotePT) #### Organization Study ID Info **ID:** 2024-00430; mu24Netzer #### Organization **Class:** OTHER **Full Name:** University Hospital, Basel, Switzerland ### Status Module #### Completion Date **Date:** 2025-01 **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:** 2025-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Basel, Switzerland #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The aim of this single-center, observational randomised controlled trial is to evaluate the effectiveness of using Akina Cloud, a remote app-assisted physiotherapy, in managing non-specific low back pain among patients. **Detailed Description:** In Switzerland, 1.5 million people suffer from low back pain (LBP), which is often the cause of disability. Non-specific LBP is a major cause of high healthcare costs in developed countries and often leads to early retirement. The development of musculoskeletal assessment through remote app-assisted therapeutic home training may be useful for individuals with non-specific LBP, providing initial support for its implementation in primary care in the patient's home. App-supported therapeutic solutions allow healthcare professionals to prescribe and monitor rehabilitation programs remotely. These innovative solutions have the potential to reduce healthcare costs and provide clinical outcomes comparable or even better than conventional physiotherapy, especially for patients in remote areas. Akina Cloud, a digital health application that supports therapeutic exercises in people with musculoskeletal disorders, is the first remote app-assisted therapeutic home training solution available in Switzerland. It provides patients with exercise and educational content and facilitates communication between patients and therapists via the application. The aim of this single-center, observational randomised controlled trial is to show the efficacy of Akina Cloud-mediated physiotherapy in patients with non-specific LBP. Therefore, all enrolled patients receive one prescription of physiotherapy treatment, while patients in the intervention group in contrast to the control group additionally receive the Akina Cloud-mediated physiotherapy. The efficacy of the remote app-assisted physiotherapy through Akina Cloud in regards to reducing the functional disability (primary objective), reducing perceived pain and increasing quality of life (secondary objectives) in comparison to conventional physiotherapy alone is evaluated. The results of the trial will demonstrate whether app-assisted therapeutic home training is promising approach for managing non-specific low back pain, with the potential to significantly impact patient outcomes and healthcare delivery in Switzerland. ### Conditions Module **Conditions:** - Low Back Pain **Keywords:** - Physiotherapy - Remote app-assisted physiotherapy - Akina Cloud - Musculoskeletal assessment ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In the control group, patients receive conventional physiotherapy. **Intervention Names:** - Other: Conventional Physiotherapy **Label:** Control intervention **Type:** OTHER #### Arm Group 2 **Description:** In the interventional group, patients receive 12 weeks of a remote physiotherapy via Akina Cloud in addition to conventional physiotherapy (treatment according to FMH Switzerland guidelines). Patients are encouraged to complete at least three app-guided training sessions per week. **Intervention Names:** - Other: Conventional Physiotherapy - Device: Akina Cloud **Label:** Study Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Control intervention - Study Intervention **Description:** Conventional physiotherapy is one prescription of 9 in person physiotherapy sessions (according to FMH Switzerland guidelines). The frequency of the physiotherapy sessions are at the discretion of the treating clinician, but the recommendation is 1 to 2 sessions per week. **Name:** Conventional Physiotherapy **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Study Intervention **Description:** Akina Cloud is a digital health application that supports therapeutic exercises in people with musculoskeletal disorders. It is the first app-supported physiotherapy solution available in Switzerland. **Name:** Akina Cloud **Other Names:** - Remote physiotherapy **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The patient's functional disability is assessed using the Oswestry Disability Index (ODI). The ODI is a patient-completed questionnaire that provides a subjective percentage score indicating the level of disability in daily activities. Scores range from 0 to 100, with higher scores indicating greater disability. To evaluate whether the remote app-assisted physiotherapy using Akina Cloud in addition to conventional physiotherapy is more effective than conventional physiotherapy alone, the average ODI scores between the two groups are compared. **Measure:** Assessment of the functional disability **Time Frame:** Baseline, 0.5, 4, 8, and 12 weeks #### Secondary Outcomes **Description:** The pain intensity is assessed by asking the patient to rate his/her pain on a Numerical Rating Scale (ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain). To evaluate whether the remote app-assisted physiotherapy using Akina Cloud in addition to conventional physiotherapy is more effective in reducing perceived pain than conventional physiotherapy alone, the average values between the two groups are compared. **Measure:** Assessment of pain **Time Frame:** Baseline, 0.5, 4, 8, and 12 weeks **Description:** The health-related quality of life is assessed using the Veterans RAND 12-Items Health Survey (VR-12), which measures various aspects of physical and mental health, generating Physical Component Summary and Mental Component Summary scores. Scores range from 0 to 100, with higher scores indicating better health outcomes. To evaluate whether the remote app-assisted physiotherapy using Akina Cloud in addition to conventional physiotherapy is more effective in increasing the quality of life than conventional physiotherapy alone, the average scores between the two groups are compared. **Measure:** Assessment of the quality of life by the Veterans RAND 12-Items Health Survey **Time Frame:** 0.5, 4, 8, and 12 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 * Diagnosis of non-specific low back pain (International Classification of Diseases, 10th edition M54.5) with the pain duration of at least 6 weeks * Low back pain score of \>3 out of 0-10, based on the numerical pain rating scale at the time of enrolment * Ability to provide informed consent and participation in the study * Prescription for physiotherapy * German speaking * Presence of an email address, internet connection and a private laptop as well as being able to use the laptop Exclusion Criteria: * Inpatient pain therapy (red flags) * History of lumbar spine surgery during the last year * Known diagnosis of performance-limiting illnesses as psychological disorders, diseases of the cardiovascular system, etc. * Known pregnancy **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** cordula.netzer@usb.ch **Name:** Cordula Netzer, PD Dr. med. **Phone:** +41 61 265 78 30 **Role:** CONTACT **Contact 2:** **Email:** mandy.mathys@usb.ch **Name:** Mandy Mathys **Phone:** +41 61 55 65 279 **Role:** CONTACT #### Locations **Location 1:** **City:** Basel **Contacts:** ***Contact 1:*** - **Email:** cordula.netzer@usb.ch - **Name:** Cordula Netzer, PD Dr. med. - **Phone:** +41 61 265 78 30 - **Role:** CONTACT ***Contact 2:*** - **Email:** Mandy.Mathys@usb.ch - **Name:** Mandy Mathys - **Phone:** +41 61 55 65 279 - **Role:** CONTACT ***Contact 3:*** - **Name:** Cordula Netzer, PD Dr. med. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Switzerland **Facility:** Department of Spine Surgery, University Hospital Basel, Bethesda Spital **State:** Basel-Stadt **Zip:** 4052 Basel #### Overall Officials **Official 1:** **Affiliation:** Department of Spine Surgery, University Hospital Basel **Name:** Cordula Netzer, PD Dr. med. **Role:** PRINCIPAL_INVESTIGATOR ## 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: PhSol - Name: Pharmaceutical Solutions - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420583 **Brief Title:** Post Operative Pain and Oral Health Related Quality of Life Following Pulpotomy VS Extraction of Permanent First Molar **Official Title:** Post Operative Pain and Oral Health Related Quality of Life Following Pulpotomy VS Extraction for the Management of Permanent First Molar With Poor Prognosis: A Randomized Clinical Trial #### Organization Study ID Info **ID:** 2111991 #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-11 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Aya Amr Abo ElMagd **Investigator Title:** principle investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to compare between post operative pain and oral health related quality of life in participants receiving two treatments for first permanent mandibular molars with poor prognosis. Group I (Experimental group): Complete Pulpotomy with the use of MTA followed by stainless steel crown. Group II (Control group): Non-surgical extraction. **Detailed Description:** The principal investigator will carry out all treatment procedures, and the patients will be assigned. For both interventions: 1. Informed consent from participating parents. 2. Baseline records photographs, percussion test, periapical and panoramic radiographs, and personal data collection. 3. A diagnostic chart with personal, medical, and dental history will be filled 4. Baseline Oral Health related quality of life questionnaire for each participant. 5. A clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination). 6. Preoperative and Postoperative photographs will be taken. 7. The radiographic examination will be performed by taking a periapical radiograph and a Panoramic radiograph through a machine to assess the inclusion criteria. The preoperative radiograph will serve as a reference for the follow-up radiographs. Standardization of the technique to avoid any distortion in the vertical dimension and to provide reproducible images using an X-ray holding device. 8. Preoperative and postoperative radiographs in the pulp therapy group will be taken by a parallel technique using an XCP film holder (Super Bite, Hawe Neos DentalSA, Switzerland). 9. Participants will then be allocated into either one of the groups according to the indicated intervention needed as follows: 10. Administration of inferior alveolar nerve block and long buccal infiltration: Septocaine® and epinephrine 1:100,000 (Articaine HCl. 4% and Epinephrine 1:100,000 Injection) at the side of the affected tooth. ### Conditions Module **Conditions:** - Irreversible Pulpitis **Keywords:** - first permanent molar - pulpotomy - extraction - oral health related quality of life - post operative pain - visual analog scale ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 42 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** MTA Pulpotomy **Intervention Names:** - Procedure: MTA pulpotomy **Label:** Pulpotomy **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Extraction **Intervention Names:** - Procedure: Extraction **Label:** Extraction **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Pulpotomy **Description:** 1. Application of rubber dam for isolation, then a standardized access cavity procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, a sharp spoon excavator will remove pulpal tissues to the orifice level, bleeding control in the pulp chamber will be achieved by using 5% sodium hypochlorite. 2. gentle condensation of MTA mix in the pulp chamber will be done by a wet sterile cotton pellet and then the rest of the pulp chamber will be filled with Glass Ionomer restoration. 3. The tooth will be restored with a stainless steel crown. **Name:** MTA pulpotomy **Other Names:** - vital pulp therapy **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Extraction **Description:** After complete Anesthetic application in the affected area, non-surgical extraction will be done. **Name:** Extraction **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** clinical absence of signs and symptoms of infection, inflammation, swelling , pain and mobility Radiographic absence of periapical radiolucency **Measure:** Clinical and radiographic success **Time Frame:** 12 months #### Primary Outcomes **Description:** will be measured using visual analog scale (VAS) The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. **Measure:** Post operative pain **Time Frame:** 24 hours post operatively #### Secondary Outcomes **Description:** will be measured using Child Oral Impact on Daily Performances. It consists of 25 items distributed among 4 domains: oral symptoms, functional limitations, emotional well-being, and social well-being. It is self-reported by 8-10-year-old children using a 5-point Likert scale, and responses range from 0-4 for each item. Total scores range from 0 to100, and higher scores indicate poorer OHRQoL **Measure:** Oral health related quality of life **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Children aged between 8 years and 9.5 years. * Decayed Mandibular Permanent first molars. * Symptomatic Mandibular permanent first molar (caries-related pulpal symptoms or hypersensitivity relating to enamel hypo mineralization) Exclusion Criteria: * Children who are not apparently healthy. * Lack of informed consent by the child patient's parent. * Patients who are allergic to any of the materials used in the procedure. * Unable to attend follow-up visits. * Refusal of participation. **Healthy Volunteers:** True **Maximum Age:** 10 Years **Minimum Age:** 8 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** aya.aboelmagd@dentistry.cu.edu.eg - **Name:** Aya A AboElMagd, M.Sc - **Phone:** +201016794067 - **Role:** CONTACT ***Contact 2:*** - **Email:** passant.nagi@dentistry.cu.edu.eg - **Name:** Passant Nagi, Ph.D - **Phone:** +201280557107 - **Role:** CONTACT ***Contact 3:*** - **Name:** Hala M Abbas, Professor - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Egypt **Facility:** Cairo University ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000003788 - Term: Dental Pulp Diseases - ID: D000014076 - Term: Tooth Diseases - ID: D000009057 - Term: Stomatognathic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Post Operative Pain - ID: M14525 - Name: Pulpitis - Relevance: HIGH - As Found: Pulpitis - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M6984 - Name: Dental Pulp Diseases - Relevance: LOW - As Found: Unknown - ID: M16831 - Name: Tooth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000011671 - Term: Pulpitis - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M15775 - Name: Sodium Hypochlorite - Relevance: LOW - As Found: Unknown - ID: M44557 - Name: Eusol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420570 **Brief Title:** Sensory Changes Associated With Thoracic Surgery **Official Title:** Dysaesthesia Associated With Thoracic Surgery #### Organization Study ID Info **ID:** AC21136 #### Organization **Class:** OTHER **Full Name:** University of Edinburgh ### Status Module #### Completion Date **Date:** 2022-08-19 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-08-19 **Type:** ACTUAL #### Start Date **Date:** 2022-01-19 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2021-11-16 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** NHS Lothian #### Lead Sponsor **Class:** OTHER **Name:** University of Edinburgh #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Many patients experience chronic pain after thoracic surgery and this is caused by nerve damage during surgery. Changes in skin sensation (dysaesthesia) is typically associated with chronic nerve pain. We hypothesise that thoracic surgery causes sensory changes. Another hypothesis is that minimally invasive thoracic surgery using video cameras results in less nerve damage and so a smaller area of altered skin sensation, when compared to the traditional method of chest surgery using a large surgical incision. A final hypothesis is that the extent of nerve damage during surgery is associated with the severity of pain early after surgery. This study is designed to compare the total areas of sensory changes after thoracic surgery on the operated side of the chest with that on the non-operated side of the chest. We also aim to identify the type, pattern, location and area of sensory changes associated with thoracic surgery, comparing the operated with the non-operated side of the chest. In addition, we aim to compare the total area of sensory changes between the traditional method of chest surgery and the minimally invasive method of chest surgery. We would also like to determine whether the severity of pain early after surgery is associated with the area of sensory changes. ### Conditions Module **Conditions:** - Thoracic Surgery ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 14 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Patients will either undergo thoracic surgery, specifically thoracotomy (traditional method of chest surgery using a large surgical incision) or video-assisted thoracic surgery (minimally invasive method using video cameras) **Name:** Thoracic Surgery **Type:** PROCEDURE ### Outcomes Module #### Other Outcomes **Description:** This will be assessed by asking the patient to complete a hospital anxiety and depression questionnaire. **Measure:** The patient's mood **Time Frame:** Days after thoracic surgery (at least 3 hours after chest drain removal) #### Primary Outcomes **Description:** Areas of dysaesthesia will be detected by applying von frey hair and a sterile, manually blunted 20g hypodermic needle on the patient's chest and back whilst asking the patient to report any sensory changes. The areas of dysaesthesia will be marked on chest using different coloured pens for different types of dysaesthesia. The non-operated side of the chest will act as a control. Tracing paper of known weight per unit area will be cut to the same size and shape as the areas of dysaesthesia. Areas of dysaesthesia will be estimated after placing the tracing paper on a sensitive weight scale. **Measure:** Area of dysaesthesia on a patient's chest wall **Time Frame:** Days after thoracic surgery (at least 3 hours after chest drain removal) #### Secondary Outcomes **Description:** This will be measured using a verbal rating scale: no pain, 0; mild pain, 1; moderate pain, 2; severe pain, 3. **Measure:** Acute post-operative pain experienced by the patient **Time Frame:** Days after thoracic surgery (at least 3 hours after chest drain removal) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients 18 years old or older admitted for elective thoracic surgery Exclusion Criteria: * Emergency thoracic surgery * Thoracic surgery involving sternotomy * Damage to the spinal cord and/ or intercostal nerves prior to surgery * Neurological diseases that may alter the skin sensation to the chest wall such as multiple sclerosis and neuropathies, previous surgery of chest wall, a history of chronic pain **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients will be identified from the thoracic surgery operative list at the Royal Infirmary of Edinburgh. ### Contacts Locations Module #### Locations **Location 1:** **City:** Edinburgh **Country:** United Kingdom **Facility:** Royal Infirmary of Edinburgh **Zip:** EH16 4SA #### Overall Officials **Official 1:** **Affiliation:** University of Edinburgh **Name:** R Peter Alston **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** The data will be shared if contacted by email. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR **IPD Sharing:** YES **Time Frame:** One year after completion of study. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000094665 - Term: Dissection, Blood Vessel - ID: D000000783 - Term: Aneurysm - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000094683 - Term: Acute Aortic Syndrome - ID: D000001018 - Term: Aortic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4114 - Name: Aortic Dissection - Relevance: HIGH - As Found: Thoracic - ID: M3081 - Name: Dissection, Blood Vessel - Relevance: LOW - As Found: Unknown - ID: M4113 - Name: Aneurysm - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M3085 - Name: Acute Aortic Syndrome - Relevance: LOW - As Found: Unknown - ID: M4334 - Name: Aortic Diseases - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000784 - Term: Aortic Dissection ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420557 **Acronym:** DecNef **Brief Title:** Unconscious Reduction of Fear Through Decoded Neuro-Reinforcement **Official Title:** Unconscious Reduction of Fear Through Decoded Neuro-Reinforcement #### Organization Study ID Info **ID:** R33MH135002 **Link:** https://reporter.nih.gov/quickSearch/R33MH135002 **Type:** NIH #### Organization **Class:** OTHER **Full Name:** University of California, Los Angeles ### Status Module #### Completion Date **Date:** 2026-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of California, Los Angeles #### Responsible Party **Investigator Affiliation:** University of California, Los Angeles **Investigator Full Name:** Michelle Craske **Investigator Title:** Distinguished 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 application investigates the efficacy of a novel method of neuro-reinforcement based on decoded fMRI activity to reduce fear responses in individuals with phobias (e.g., spiders, snakes). This method works unconsciously in the brain, without the need for participants to endure repeated conscious exposures to their feared stimuli. Fear-related disorders such as specific phobia, post-traumatic stress disorder (PTSD), and other anxiety disorders present a major challenge, as effective treatment options usually involve repeated exposures to feared stimuli, leading to high levels of distress, fear, and panic that can motivate premature treatment termination. Consequently, there is an unmet need for treatment that minimizes subjective discomfort and attrition in order to maximize efficacy. Recent developments in computational neuroimaging have enabled a method that can deliver unconscious exposure to feared stimuli, resulting in effective fear reduction while bypassing a primary cause of treatment attrition. Because this treatment method happens unconsciously in the brain, changes in behavior outcomes are potentially more likely to generalize to different contexts, thereby overcoming a limitation of traditional treatments. **Detailed Description:** The gold standard treatment for specific phobias is exposure therapy, wherein the individual repeatedly faces the object of their fear. However, for many patients, the level of distress prohibits them from either starting or completing exposure therapy. The objective of this application is to use focal neuro-reinforcement based on decoded fMRI information (from the ventral temporal temporal cortex) to reduce fear responses to feared animal stimuli (e.g., spiders, birds) in individuals with phobias, directly and unconsciously in the brain, without repeatedly consciously exposing participants to their feared stimuli. Because the induced representations are unconscious, participants do not experience negative emotional responses and the procedure is double-blind placebo-controlled, thus providing a level of experimental rigor not afforded to standard psychological therapies. Extending from our pilot data, we are positioned to test the mechanisms and behavioral outcomes of a novel treatment for phobias that at the same time advances our understanding of the role of consciousness in fear responses and their change over time. The specific aims are to: (1) confirm that our method engages the neurobiological target (amygdala reactivity to images of feared animals) in a population of individuals with specific phobias of animals; (2) quantify how changes in amygdala reactivity with neuro-reinforcement mediate changes in behavioral outcomes, as measured by attentional capture, approach/avoidance behavior, or subjective fear ratings, immediately post neuro-reinforcement; (3) assess the longer term effects four weeks after neuro-reinforcement; and (4) explore the impact of three dosage levels of neuro-reinforcement to identify the optimal dosage for future research. If proven effective, the results will inform applications for other fear related disorders, such as posttraumatic stress disorder, social anxiety disorder and panic disorder. ### Conditions Module **Conditions:** - Phobia **Keywords:** - unconscious fear extinction - anxiety disorders - decoded neuro-reinforcement ### 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:** 60 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 1 neuro-reinforcement session **Intervention Names:** - Behavioral: Unconscious Neuro-reinforcement **Label:** 1 Session **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 3 neuro-reinforcement sessions **Intervention Names:** - Behavioral: Unconscious Neuro-reinforcement **Label:** 3 Sessions **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** 5 neuro-reinforcement sessions **Intervention Names:** - Behavioral: Unconscious Neuro-reinforcement **Label:** 5 sessions **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 1 Session **Description:** Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 1 session of neuro-reinforcement. **Name:** Unconscious Neuro-reinforcement **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - 3 Sessions **Description:** Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 3 sessions of neuro-reinforcement. **Name:** Unconscious Neuro-reinforcement **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - 5 sessions **Description:** Individuals will complete an implicit fmri neuro-reinforcement task where real-time brain activity is matched to a desired activation. Individuals will also receive financial reward for activating the desired activation. Visual feedback will be presented to indicate how well individuals' brain activity matches the desired activation. Individuals will complete 5 sessions of neuro-reinforcement. **Name:** Unconscious Neuro-reinforcement **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The neural measure of difference in amygdala reactivity (measured by fMRI) to target phobic animals compared to control phobic animals from pre-treatment to post-treatment. Lower numbers (i.e. more negative numbers) indicate greater amygdala decrease and and better outcomes. **Measure:** Change in Amygdala Reactivity **Time Frame:** 10 days (measured at pre-treatment and post-treatment) **Description:** Subjective Fear Ratings of images of targeted phobic stimuli Minimum score of 0, Maximum score of 180, higher scores mean worse outcome. **Measure:** Subjective Fear Post-treatment Minus Pre-treatment **Time Frame:** 10 days (measured at pre-treatment and post-treatment) #### Secondary Outcomes **Description:** Skin conductance to image presentation of targeted phobic stimuli post-treatment minus pre-treatment **Measure:** Skin Conductance Response: Physiological Arousal Post-treatment Minus Pre-treatment **Time Frame:** 10 days (measured at pre-treatment and post-treatment) **Description:** Subjective fear ratings of a list of typical phobic stimuli Minimum score of 40, maximum of 200, higher scores mean worse outcome. **Measure:** Fear Survey Schedule **Time Frame:** 10 days (measured at pre-treatment and post-treatment) **Description:** Measure of preferential allocation of attentional resources measured in reaction time (seconds) for visual presentation of the targeted phobic stimulus **Measure:** Stroop Task Post-treatment Minus Pre-treatment **Time Frame:** 10 days (measured at pre-treatment and post-treatment) **Description:** Maximal approach distance will be assessed in a behavioral avoidance test conducted in a virtual reality context. The Behavioral Approach Task (BAT) follows a ten-step procedure of increasing difficulty to approach a feared animal (e.g. snakes), beginning with a first step such as standing in the same room as the feared animal. Then, participants approach the feared animal step-by-step, taking time at each step, until a final step such as holding the feared animal or having it touch you is reached. Behavioral outcomes that will be measured from the BAT include a) maximal approach distance and b) subjective fear ratings at each distance. **Measure:** Approach/Avoidance Behavior in VR Post-treatment Minus Pre-treatment **Time Frame:** 10 days (measured at pre-treatment and post-treatment) **Description:** Subjective fear ratings will be assessed at each distance in a behavioral avoidance test conducted in a virtual reality context. The BAT follows a ten-step procedure of increasing difficulty to approach a feared animal (e.g. snakes), beginning with a first step such as standing in the same room as the feared animal. Then, participants approach the feared animal step-by-step, taking time at each step, until a final step such as holding the feared animal or having it touch you is reached. **Measure:** Subjective Fear Ratings in Virtual Reality (VR) Post-treatment Minus Pre-treatment **Time Frame:** 10 days (measured at pre-treatment and post-treatment) **Description:** Self-reported depression severity. Scores range from 0-27, with higher scores indicating greater severity. **Measure:** Patient Health Questionnaire (PHQ-9) **Time Frame:** 10 days (measured at pre-treatment and post-treatment) **Description:** Self-reported anxiety severity. Scores range from 0-21, with higher scores indicating greater severity. **Measure:** Generalized Anxiety Disorder-7 (GAD-7) **Time Frame:** 10 days (measured at pre-treatment and post-treatment) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Individual has normal or corrected to normal vision 2. Individual has normal or corrected to normal hearing 3. Individual is competent to understand informed consent 4. Individual must meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for specific phobias, animal subtype Exclusion Criteria: 1. Individual is unable to fill in consent form correctly 2. Individual is unable to respond adequately to screening questions 3. Individual is unable to maintain focus or to sit during assessment 4. Individual has history of: neurological disease or defect (e.g., stroke, traumatic brain injury, schizophrenia or other psychological disorders, or seizures) Individual has vision problems (including cataracts, amblyopia, or glaucoma) Individual presents with: PTSD, Obsessive Compulsive Disorder, Substance Use Disorder, Current Major Depression, Bipolar Disorder, Psychosis, neurologic diagnoses or unstable serious medical conditions 5. Individual does not present with more than one object of specific phobia 6. Individual can touch the phobic object category during the pre-treatment Behavioral Approach Test without presenting significant distress 7. Individual is currently prescribed psychotropic medication **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** shawnwang@psych.ucla.edu **Name:** Shawn Wang, B.A. **Phone:** 916-792-1756 **Role:** CONTACT **Contact 2:** **Email:** brookecullen@psych.ucla.edu **Name:** Brooke Cullen, B.A. **Phone:** 310-990-4459 **Role:** CONTACT #### Locations **Location 1:** **City:** Los Angeles **Country:** United States **Facility:** University of California, Los Angeles **State:** California **Zip:** 90095 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003244 - Term: Consciousness Disorders - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M17224 - Name: Unconsciousness - Relevance: HIGH - As Found: Unconscious - ID: M13603 - Name: Phobic Disorders - Relevance: LOW - As Found: Unknown - ID: M6468 - Name: Consciousness Disorders - Relevance: LOW - As Found: Unknown - ID: M21826 - Name: Neurobehavioral Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000014474 - Term: Unconsciousness ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420544 **Acronym:** Japi **Brief Title:** Japi: Cognitive, Emotional and Social Stimulation for Preschool Children **Official Title:** Japi: Cognitive, Emotional and Social Stimulation for Preschool Children #### Organization Study ID Info **ID:** FONDEF ID22I10126 #### Organization **Class:** OTHER **Full Name:** Universidad de los Andes, Chile ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Talca #### Lead Sponsor **Class:** OTHER **Name:** Universidad de los Andes, Chile #### Responsible Party **Investigator Affiliation:** Universidad de los Andes, Chile **Investigator Full Name:** Jorge Gaete **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:** Mental health disorders are one of the leading causes of illness globally, and their relevance is expected to increase. Low and Middle Income Countries (LMIC), already facing psychological and behavioral issues due to chronic adversity, were further impacted during the COVID-19 pandemic. A study showed that symptoms of depression and anxiety in youth doubled during the first year of the pandemic compared to the pre-pandemic period. A study in China found that the prevalence of the total difficulties was (8.2%), with conduct problems (7.0%), peer problems (6.6%), and hyperactivity-inattention (6.3%) among the most prevalent. In this study emotional problems reached 4.7%. Finally, recent evidence has revealed that students' psychosocial and behavioral problems have increased in the early stage of schools reopened. Several international agencies have calls on governments, and public and private sector partners, to commit, communicate and act to promote mental health for all children, protect those in need of help, and care for the most vulnerable. The importance of psychosocial skills acquired in early childhood, such as emotional regulation and social problem-solving, for preventing mental disorders was highlighted. Studies indicate that the development of executive functions and non-cognitive skills in early childhood has a positive impact on long-term health and economic productivity. However, the treatment gap for mental disorders in LMIC is significant, with only one in ten affected receiving treatment. Preventive interventions are needed, particularly in early childhood, to improve cognitive and socio-emotional skills. Objetive: The research proposal aims to develop a gaming platform aiming to improve cognitive and non-cognitive skills in early childhood at schools with high socio-economic vulnerability, supported by Early Years Educators and Parents using a dashboard integrated in a whole system housed in local server, and to evaluate the acceptability and feasibility of this gaming platform and dashboards, with the ultimate goal of reducing behavioral problems, and improving functional and performance outcomes later in life. Outcomes: Acceptability; Feasibility; Cognitive and non-cognitive skills; Working Memory; Inhibitory control; Emotion recognition; Social competence; Behavioral problems and psychological assessment. **Detailed Description:** Problem and opportunity: Mental health disorders are among the leading causes of the Global Burden of Disease, and their relative importance is predicted to rise globally. Adversity is one of the most important risk factors associated with an increased incidence of psychological and behavioral problems. Acute or chronic adversity is common in Low and Middle Income Countries (LMIC) settings and unsurprisingly, psychological and behavioral problems are highly prevalent in LMIC, which have to deal with these emerging problems with scarce resources. During the COVID-19 pandemic, this scenario has worsened globally. One recent systematic review has showed that pooled estimates obtained in the first year of the COVID-19 pandemic suggest that 25.2% (95% Confidence Interval (CI), 21.2%-29.7%) of youth globally are experiencing clinically elevated depression symptoms, while 20.5% (95% CI, 17.2%-24.4%) of youth are experiencing clinically elevated anxiety symptoms. These pooled estimates, which increased over time, are double of pre pandemic estimates. And regarding behavioral problems, a study in China found that the prevalence of the total difficulties was (8.2%), with conduct problems (7.0%), peer problems (6.6%), and hyperactivity-inattention (6.3%) among the most prevalent. In this study emotional problems reached 4.7%. Finally, recent evidence has revealed that students' psychosocial and behavioral problems have increased in the early stage of schools reopened. Several international agencies have calls on governments, and public and private sector partners, to commit, communicate and act to promote mental health for all children, protect those in need of help, and care for the most vulnerable. The State of the World's Children 2021, UNICEF's most comprehensive look at the mental health of children in the 21st century, calls on "urgent investment in child and adolescent mental health across sectors, not just in health, to support a whole-of-society approach to prevention, promotion and care" and "integrating and scaling up evidence-based interventions across health, education and social protection sectors \[...\]; and ensuring schools support mental health through quality services and positive relationships". Along with the magnitude of the problem, the treatment gap for mental health disorders is large: one in every ten people with mental disorders receives treatment in LMIC. The ideal strategy to tackle this gap should be that of preventing the onset of these conditions. Most adult mental disorders start in childhood or adolescence, and delaying or preventing the onset can have a substantial impact. However, few preventive interventions or interventions to increase resilience to adversity have been developed, and even fewer tested in LMIC. There is evidence to suggest that strengthening cognitive and socio-emotional skills might result in a reduced incidence of mental disorders. For instance, reduced emotional regulation, and poor social problem-solving have been associated with increased incidence of depression. Basic psychological skills acquired early in life have been associated with a range of important social and economic outcomes later in life. Early childhood is a critical time for psychosocial development. Until recently, years of education and Intelligence Quotient (IQ) were the main measures to assess the relationship between human capital and economic development. More recently, researchers have acknowledged that skills such as maintaining good interpersonal relations, controlling impulses, or demonstrating goal-directed behavior are critical to physical and mental health and economic productivity. The Nobel prize economist, James Heckman, highlighted the importance of these skills, which he originally called non-cognitive skills, for economic development. Scientific evidence has recently indicated that the stimulation of cognitive and non-cognitive skills in the first years of life promotes general development and has a beneficial long-term impact on health and on different economic indicators . However, much of this evidence comes from studies in the United States, Europe of other develop countries, such as the High/Scope Perry Preschool Study, the Abecedarian Project , Head Start, and Early Head Start. Many of these interventions were costly and difficult to implement. Several studies have investigated how the capacity to regulate emotions and behaviors is associated with social, health, educational, and labor outcomes. Studies from neurobiology to behavioral economics show that emotions affect a person's ability to self-regulate and that this, in turn, affects cognitive skills and subsequent self-regulatory capacity. Executive functions, involving the regulation and control of cognitive processes, are closely linked to skills leading to better problem solving, task persistence, self-esteem, school performance, and better social adjustment with a reduction in aggressive and other behavioral problems. Healthy development of executive functions early in life predicts better self-regulatory capacity later. The growing scientific knowledge-based emotional self-regulation or social skills linked to the developing brain can be leveraged to engender new intervention approaches. There is significant evidence that structural and functional plasticity in many brain core centers involved in executive functions and self-regulatory processes develops rapidly during early childhood. Most of the evidence to support the association between early acquired psychosocial skills and functional outcomes later in life comes from developed countries. There is a need to replicate these findings in resource-poor settings. In addition, the evidence suggests that children from low-income families may begin the preschool stage with less development of academic (such as pre-calculus and initial language) and non-academic skills (such as emotional, social, and health competence in general) when compared with children from higher-income families. These differences would contribute to the increase in socio-emotional, educational, and health disparities in the long term. If we add to this the evidence that critical aspects of human development occur between 3 and 7 years, such as the recognition of emotions, the control of behavior, and the development of Executive Functions, it is essential to work with children who have greater economic vulnerability and to stimulate these skills early. As our approaches become more interdisciplinary, several important questions arise: What is the effect of improving psychosocial skills on health, educational, and economic outcomes? What interventions are most effective at bolstering these functions and abilities? What is the applicability of such interventions across diverse cultural groups and in low-resource settings? Valid and reliable measures to assess these skills are lacking, especially for use in less developed countries. Furthermore, it would be important to incorporate more objective neurocognitive and physiological variables into the study of these regulatory processes. A concerted effort is needed to identify these critical psychosocial skills that can be incorporated into interventions to improve children's wellbeing globally. Multi-disciplinary research efforts can advance our understanding of these essential elements of human capital formation and their role in social and economic success in diverse settings. The penetration of new technologies (smartphones, tablets, wearable devices) is increasing all over the world and opening unimaginable opportunities to advance this field, especially due to the effect of the covid-19 pandemic. Technological platforms offer an incredible opportunity to reach out to underserved and remotely located populations. The use of smartphones and tablets is increasing at a fast speed in most LMIC. These devices allow us to use more sophisticated software as well as all 'old' functionalities such as text messaging or live telephony. Gaming offers an excellent opportunity to engage young kids and deliver early life interventions at a low cost and at a large scale. The use of games in the educational sector is wide and continues to grow. There is good evidence that the use of technology among pre-school kids is feasible and growing. There are already recommendations of the features that apps need to have to promote learning and creativity. We are not aware of other tablet-based games for young children aiming to stimulate several skills (working memory or inhibitory control, self-regulation and social problem-solving) with one single unified game. Other than teaching skills, technology might also allow capturing large amounts of data, which can help at the same time with one piece of software us understand better the mechanisms whereby skills are learned and the pathways to larger impact later in life. If these interventions effectively strengthen skills vital to improve health, social, and economic outcomes, the gains for society could be substantial. A large number of applications have been launched, though very few tested, to prevent mental disorders or behavioral problems. However, there is a marked paucity in the development of preventive interventions delivered via technology, especially early in life. There are a few games to foster specific psychosocial skills among pre-school children but comprehensive platforms that stimulate diverse functions, such as working memory, inhibitory control, emotion recognition or social competence, are not available. Latin America has been a leading region pioneering initiatives aiming to stimulate basic psychosocial skills early in life. In Chile, programs to encourage mothers to stimulate the psychosocial skills of their children started in the seventies but the initial interest somehow lost impetus for political and economic reasons. More recently, as part of a major World Bank project in which members of our group participated, parents of low socioeconomic status were trained to improve the skills of their young children (aged \<=5). Our group also undertook a large Randomized Controlled Trail (RCT) of a mental health school intervention for adolescents. One of the main lessons of this study was the need to focus on interventions at earlier ages to prevent rather than treat mental health problems. There is also evidence from other Chilean school programs that psychosocial skills are associated with better educational outcomes. Overall, there is consensus that in spite of the importance of the topic, there has been little research from LMICs. This proposal brings together a wide range of expertise across multiple disciplines including psychology, neuroscience, epidemiology, intervention trials, education, and economics. New methods and technologies are also being incorporated into this proposal. Developing effective early life interventions and assessing the mechanisms leading to changes using top-of-the-range, non-invasive technology are key features of this proposal. The results of this research will lay the foundations for future programs to learn how young children acquire skills, how the developing brain works, whether or not these skills predict future outcomes, and how these interventions can be scaled up. Pandemic effect on tech use: The digital revolution is evolving with an unprecedented explosion of technology development to transform mental health care delivery, with its emphasis on computing power and mobile technology. These platforms are becoming the medium through which assessment and intervention are taking place. The COVID-19 crisis has fast forwarded the use of technology in mental health care; therefore, it is crucial to scale up access to mental health interventions during and after COVID-19. Taking all into account, the general objective of this study is to develop a gaming platform aiming to improve cognitive and non-cognitive skills in early childhood at schools with high socio-economic vulnerability, supported by Early Years Educators and Parents using a dashboard integrated in a whole system housed in local server, and to evaluate the acceptability and feasibility of this gaming platform and dashboards, with the ultimate goal of reducing behavioral problems, and improving mental health and functional and performance outcomes later in life. ### Conditions Module **Conditions:** - Behavioral Problem of Child **Keywords:** - Executive Functions - Behavioral Problem - Children - Videogame - Non-cognitive skills - Cognitive skills ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Acceptability, feasibility and efficacy of this intervention will be measured, including the measurement of outcomes (skill formation) compared with a 'placebo' control group among pre-school children from low socio-economic backgrounds in Santiago. A mixed-method design with a strong qualitative component to understand better the factors that might facilitate or interfere with the delivery and acceptability of this intervention will be conducted. At the start of the study there will be a mapping the structure of the schools, the locations, staff composition, characteristics of the children and families, and other contextual factors important for the successful implementation of the intervention. Schools that fulfil the inclusion and exclusion criteria will be invited to participated. Six schools be selected and will be randomized and allocated in 1:1 proportion to intervention and control group. ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Those children in the intervention group will play with the game two to three times a week, each lasting 15 minutes, over a period of 12 weeks. The minimum intervention dosage will be considered two sessions of 15 min per week for 12 weeks. The whole intervention has 24 sessions. Each sesion stimulates two skills (one cognitive and one non-cognitive skills) and has eight activities with increasing levels of difficulty. **Intervention Names:** - Behavioral: JAPI: Cognitive, Emotional and Social Stimulation for Preschool Children **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** There will be a control arm in which children will be in the normal academic activities included curriculum of the school. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** The proposed intervention is an 12 weeks program using a video game designed to stimulate cognitive, emotional, and social development in preschool children. 6 educators, as well as the parents of participating children, will be selected and trained to ensure proper guidance during gaming sessions. The children will play the video game two to three times a week in 15-minute sessions, and they can also engage in similar sessions at home under parental supervision without a minimum requirement, although the effective minimum dose remains at two sessions per week. The game includes various modules with activities that progressively increase in difficulty, and research assistants will provide technical support for the correct use of the equipment. **Name:** JAPI: Cognitive, Emotional and Social Stimulation for Preschool Children **Other Names:** - JAPI **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Acceptability will be evaluated using one questionnaire that will be answered every week by the Early Year Educators (EYE). It will include questions regarding the fidelity of the implementation (e.g. "How many sessions children were able to play during the week?" "Be the panel to know the progress of the children?" "How many minutes were used to support each child during the week?", "Was the activity in this session interesting/relevant?" They also ask about the things they liked about the sessions and what they would change; and specifically, for EYE: "was feedback given to parents to promote the use of the gaming platform?"). The team will also solicit feedback on possible changes to be included in the future (e.g. "Is there anything that would be changed/replaced/included?"). **Measure:** Acceptability: Early Year Educators **Time Frame:** through study completion, an average of 6 month **Description:** A brief assisted survey will also be carried out on the students, carried out in the middle and at the end of the intervention to assess if a children liked the intervention. **Measure:** Acceptability: Students **Time Frame:** through study completion, an average of 6 month **Description:** Data will be collected on the number of schools that are eligible, those that are contacted, and those that agree to participate. Data will also be collected on the number of students, parents, and Educators contacted and those who consent and agree to participate. **Measure:** Feasibility of the intervention: Recruitment **Time Frame:** through study completion, an average of 6 month **Description:** Data will also be collected on the time needed to complete the questionnaires and student assessment tests, and the loss of participants during follow-up. **Measure:** Feasibility of the intervention: Assesment parameters **Time Frame:** through study completion, an average of 6 month **Description:** Automated data on the use of the game (number of sessions played, activities completed and level reached) will be captured via a server in those 3 schools with intense EYE support. **Measure:** Feasibility of the intervention: Progress on the videogame **Time Frame:** through study completion, an average of 6 month #### Secondary Outcomes **Description:** This test assesses visuo-spatial short-term working memory. It involves repeating a sequence of up to nine identical spatially separated blocks on a screen. The sequence starts out simple but becomes more complex until the subject's performance begins to decline. This number is known as the Corsi Span. The higher score the better the skill. **Measure:** Working Memory: Corsi Block Test **Time Frame:** through study completion, an average of 6 month **Description:** A sequence of audio messages of increased difficulty is presented, and the child is requested to remember these messages. The higher score the better the skill. **Measure:** Working Memory: Auditive Working Memory test **Time Frame:** through study completion, an average of 6 month **Description:** The Hearts and Flowers task is a hybrid combining elements of Simon and spatial Stroop tasks. For congruent trials, subjects are to obey the rule, "Press on the same side as the stimulus (Hearts)." For incongruent trials, subjects are to follow the rule, "Press on the side opposite the stimulus (Flowers)." It requires working memory and inhibition control. The higher score the better the skill. **Measure:** Inhibitory control: The Hearts and Flowers task **Time Frame:** through study completion, an average of 6 month **Description:** It consists of facial expressions task aiming to evaluate emotion expression knowledge and whether the subjects exhibit any anger bias. The 26-item scale consists of colour photographs of ethnically diverse elementary schoolchildren depicting four expressions of each of the four basic emotions (happy, sad, angry, and scared) and 10 images of children without obvious facial expressions. The examiner shows the child the photographs one at a time and each time asks, "Is the child in the picture happy, sad, angry, or scared?" Then the examiner registers the child's answer. The emotion accuracy score reflects how many items the children answer correctly, and the anger bias score is the percentage of time the children incorrectly identify the faces as displaying anger. The higher score the better the skill. **Measure:** Emotion recognition: Assessment of Children's Emotions Skills **Time Frame:** through study completion, an average of 6 month **Description:** This instrument evaluates the ability of children to solve social problems. The children are presented six vignettes that describe problems between peers. Following the presentation of each challenging situation, four pictures of happy, sad, angry, and neutral affect are presented in random order. The child is asked to point to the picture that best describes how they feel when \[this situation\] happens. Then four pictures of behavioral responses (prosocial, aggressive, manipulation of others' feelings, and avoidant) are presented in random order and the child is asked "What do in this situation\]?" The answers are categorized into four possibilities: prosocial, aggressive, cry, and avoidant. Scores for affective and behavioral responses used are the number of times each affect and each behavioral response is chosen by each child across the six situations. The higher score the better the skill. **Measure:** Social competence: Challenging Situations Task **Time Frame:** through study completion, an average of 6 month **Description:** This 25-question questionnaire explores different symptoms grouped into 5 sub-scales (with 5 items each): (1) emotional symptoms, (2) behavioral problems, (3) problems with peers, (4) symptoms of lack of attention and hyperactivity, and (5) prosocial skills. The first four sub-scales refer to difficulties that children may have and may be grouped together in a general sub-scale of difficulties (20 items). The sub-scale of prosocial skills refers to positive and adaptive behaviours in relationships with others. Each item is answered on a scale of responses from 1=not true to 3=absolutely true. There is a version for Educators, parents (to evaluate children from 4 to 16 years old), and a self-report for teenagers (ages 11 to 16 years old). It has been widely used and has shown good psychometric characteristics. The Educators' and parents' version of this instrument will be used. The higher score the better the skill. **Measure:** Behavioral problems and psychological assessment: The Strengths and Difficulties Questionnaire **Time Frame:** through study completion, an average of 6 month **Description:** The ECBI is a behaviorally specific rating scale that assesses the current frequency and severity of disruptive behaviors in the home setting, as well as the extent to which parents find the behavior troublesome. By evaluating the variety and frequency of behaviors commonly exhibited by all children, the instrument distinguishes normal behavior problems from conduct-disordered behavior in children and adolescents. This instrument requires the project pay a license per each time it is responded. The higher score the better the skill. **Measure:** Behavioral problems and psychological assessment: The Eyberg Child Behavior Inventory (ECBI) **Time Frame:** through study completion, an average of 6 month **Description:** Empathy Scale for Children (ESC) is a tool which is developed for measuring children's empathic skills. The scale consists of picture cards about four basic emotions (happiness, sadness, anger and fear) and cards about facial expressions. The higher score the better the skill. **Measure:** Empathy Scale for Children **Time Frame:** through study completion, an average of 6 month **Description:** Its objective is to evaluate cognitive planning. The Tower of London was developed by Shallice (1982), based on the pre-existing Tower of Hanoi. This instrument is applied to children through individual interviews. The participants' task is to convert the initial position of the balls to the position demonstrated by the evaluator. Ball movements are limited by the fact that pegs differ in terms of the maximum number of balls they can hold at any time, and participants cannot move more than one ball at a time. The higher score the better the skill. **Measure:** The Tower of London **Time Frame:** through study completion, an average of 6 month ### Eligibility Module **Eligibility Criteria:** Children of pre-kindergarten attending schools belonging to INTEGRA network or other educational networks. Inclusion criteria for schools. Educational institutions that meet the following inclusion criteria will be invited to participate: 1. Municipal educational institutions 2. Mixed educational institutions. 3. Educational institutions with preschool education and, at least, one class per level. 4. Educational institutions with a high vulnerability index as assessed by a School Vulnerability Index-National System of Equality Allocation (IVE-SINAE) ≥75%. Exclusion criteria for schools. A criterion for exclusion will be educational institutions that are already developing or implementing a manualized program to promote cognitive or social-emotional skills or participating in a similar study. This criterion is considered important if the educational institutions already have a prevention program of this nature or are participating in a similar study, and it is possible that they have already invested time and resources in its implementation, so it would be counterproductive to ask them to incorporate another intervention program or replace theirs. However, educational institutions may be implementing activities that promote cognitive and social-emotional skills outside of a manualized program. **Healthy Volunteers:** True **Maximum Age:** 5 Years **Minimum Age:** 3 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jgaete@uandes.cl **Name:** Jorge Gaete, MD, PhD **Phone:** +56226181000 **Phone Ext:** 2277 **Role:** CONTACT **Contact 2:** **Email:** nmrios@miuandes.cl **Name:** Natalia Ríos, BA **Phone:** +56978783002 **Role:** CONTACT #### Locations **Location 1:** **City:** Santiago **Contacts:** ***Contact 1:*** - **Email:** jgaete@uandes.cl - **Name:** Jorge Gaete, Md, Phd - **Phone:** +56226181000 - **Phone Ext:** 2277 - **Role:** CONTACT **Country:** Chile **Facility:** Universidad de los Andes **State:** Metropolitana **Status:** RECRUITING **Zip:** 7620086 **Location 2:** **City:** Santiago **Contacts:** ***Contact 1:*** - **Email:** jgaete@uandes.cl - **Name:** Jorge Gaete, Md, PhD - **Phone:** +56226181000 - **Phone Ext:** 2277 - **Role:** CONTACT **Country:** Chile **Facility:** Universidad de los Andes **State:** Metropolitana **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Universidad de Los Andes **Name:** Jorge Gaete, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Any researchers who ask the principal investigator fot secondary analysis, data anonymized. **Description:** Data about primary and secondary outcomes without identifiable variables such as name, date of birth, or others. **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** At the end of the study and until five years after the end of the study. **URL:** https://www.ismeuandes.cl/ ### References Module #### References **Citation:** Sawyer SM, Azzopardi PS, Wickremarathne D, Patton GC. 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Epub 2021 Jun 3. **PMID:** 34090582 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M85 - Name: Problem Behavior - Relevance: HIGH - As Found: Behavioral Problems - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000066553 - Term: Problem Behavior ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420531 **Brief Title:** Optimizing Human Milk Intake for Growth and Gut Health in Very Preterm Infants **Official Title:** A Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm #### Organization Study ID Info **ID:** IRB-300013026 #### Organization **Class:** OTHER **Full Name:** University of Alabama at Birmingham ### Status Module #### Completion Date **Date:** 2030-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-06 **Type:** ESTIMATED #### Start Date **Date:** 2025-04 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Alabama at Birmingham #### Responsible Party **Investigator Affiliation:** University of Alabama at Birmingham **Investigator Full Name:** Ariel A. Salas **Investigator Title:** Associate Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation. **Detailed Description:** Participants will be randomized once they reach 120 mL/kg/day. Clinicians will be able to increase feeds each day as they see fit, until the patient reaches the target goal of 140-160 mL/kg/day or 180-200 mL/kg/day. They will then maintain this volume until 34 weeks postmenstrual age. Researchers will compare these two targets to see if higher feeding volumes prevent faltering growth without causing adverse metabolic outcomes. Participants will: * Have a feeding volume of 180-200 mL/kg/day or a volume of 140-160 mL/kg/day until 34 weeks corrected age * Have four body composition assessments with a bioelectrical impedance analyzer throughout study period * Have four stool samples collected throughout study period * Have four maternal breastmilk samples collected and analyzed throughout the study period * Have one blood sample collected at 36 weeks corrected age * Have the option to participate in a follow-up survey completed by parents at 2-3 years of age ### Conditions Module **Conditions:** - Prematurity ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Parallel Assignment ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 486 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Study participants randomized to the intervention group will receive 180-200 mL/kg/day of human milk for 34 weeks corrected age. **Intervention Names:** - Biological: Human milk **Label:** Intervention: 180-200 mL/kg/day of human milk **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Study participants randomized to the control group will receive 140-160 mL/kg/day of human milk for 34 weeks corrected age. **Intervention Names:** - Biological: Human milk **Label:** Control:140-160 mL/kg/day of human milk **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Control:140-160 mL/kg/day of human milk - Intervention: 180-200 mL/kg/day of human milk **Description:** maternal breastmilk or donor breastmilk **Name:** Human milk **Type:** BIOLOGICAL ### Outcomes Module #### Other Outcomes **Description:** Determined by molecular analyses of fecal samples **Measure:** Changes in Intestinal Microbiome **Time Frame:** Birth to 36 weeks postmenstrual age **Description:** Determined by molecular analyses of serum samples **Measure:** Changes in Metabolic Pathways **Time Frame:** 36 weeks postmenstrual age or discharge (whichever occurs first) **Description:** Neurodevelopmental outcomes measured by voluntary PARCA-R survey **Measure:** Cognitive scores **Time Frame:** 2 - 3 years of age #### Primary Outcomes **Description:** Estimated by bioelectric impedance analysis. FFM measurements will be converted into Z-scores using updated, sex specific reference curves of body composition in preterm infants **Measure:** Fat-free Mass (FFM)-For-age-Z-score **Time Frame:** 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer #### Secondary Outcomes **Description:** Estimated by bioelectric impedance analysis. Body fat measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants. **Measure:** Body fat percentage **Time Frame:** Birth to 36 weeks postmenstrual age **Description:** Weight, length, and head circumference measurements. Measurements will be converted into Z-scores based on Fenton growth curves (2013). **Measure:** Anthropometric Measurements **Time Frame:** Birth to 36 weeks postmenstrual age **Description:** Number of participants receiving supplemental oxygen at 36 weeks (PMA) **Measure:** Bronchopulmonary Dysplasia **Time Frame:** 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer **Description:** Time to full enteral feeding days **Measure:** Number of Days Alive and Receiving Full Enteral Feeding **Time Frame:** Birth to 28 days **Description:** From day of admission to day of hospital discharge to home **Measure:** Duration of Hospital Stay in Days **Time Frame:** Birth to 120 days or discharge, whichever occurs first **Description:** Weight gain in g/kg/day **Measure:** Growth Rate **Time Frame:** Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first). **Description:** Diagnosis of faltering growth (weight z score decline from birth to 36 weeks \> 1) using the 2013 Fenton growth curve. **Measure:** Number of Participants with Postnatal Faltering Growth **Time Frame:** 36 weeks or hospital discharge (whichever occurs first) **Description:** Diagnosis of necrotizing enterocolitis stage 2 or 3 **Measure:** Number of Participants diagnosed with Necrotizing Enterocolitis **Time Frame:** From birth up to 120 days following birth **Description:** Diagnosis of intestinal perforation **Measure:** Number of Participants with Diagnosis of Intestinal Perforation **Time Frame:** From birth up to 120 days following birth **Description:** Death prior to 121 days of life **Measure:** Death **Time Frame:** Birth to 120 days **Description:** Diagnosis of sepsis with positive blood cultures **Measure:** Culture-proven Sepsis **Time Frame:** Birth to 120 days **Description:** Estimated by bioelectric impedance analysis. FM measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants. **Measure:** Fat Mass (FM)- For age Z-score **Time Frame:** 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer **Description:** Estimated by bioelectric impedance analysis. BF measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants. **Measure:** Body Fat (BF)-For age Z-score **Time Frame:** 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Gestational age between 27 0/7 and 31 6/7 weeks * Birthweight of 1500 grams or less * Human milk feeding during the first 14 days after birth * Full enteral feeding (120mL/kg/day or more) within the first 14 days after birth Exclusion Criteria: * Necrotizing enterocolitis stage 2 or greater * Spontaneous intestinal perforation * Major congenital/chromosomal anomalies * Terminal illness requiring limited or withheld support * Intention to restrict fluid intake after the first 14 postnatal days due to the presence of a symptomatic patent ductus arteriosus (PDA) * Any formula feeding within the first 14 days after birth **Maximum Age:** 4 Days **Minimum Age:** 6 Hours **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** asalas@uab.edu **Name:** Ariel A. Salas, MD, MSPH **Phone:** 205-934-4680 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** UAB Hospital **Name:** Ariel A. Salas, MD, MSPH **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007752 - Term: Obstetric Labor, Premature - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M25869 - Name: Premature Birth - Relevance: HIGH - As Found: Prematurity - ID: M10772 - Name: Obstetric Labor, Premature - Relevance: LOW - As Found: Unknown - ID: M10764 - Name: Obstetric Labor Complications - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000047928 - Term: Premature Birth ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420518 **Acronym:** CKM 1 **Brief Title:** Accuracy of a Continuous Ketone Monitoring (CKM) System in Individuals With Type 1 Diabetes on Insulin Pump Therapy. **Official Title:** A Phase I Clinical Trial Testing the Accuracy of a Continuous Ketone Monitoring (CKM) System in Individuals With Type 1 Diabetes on Insulin Pump Therapy. #### Organization Study ID Info **ID:** 2024-10140 #### Organization **Class:** OTHER **Full Name:** McGill University ### Status Module #### Completion Date **Date:** 2024-12-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-30 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** McGill University #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this 14-day randomized pilot trial is to assess the accuracy of a continuous ketone monitoring (CKM) system when compared to standard point-of-care capillary ketone monitors in individuals with type 1 diabetes on insulin pump therapy. The main question it aims to answer is: - Can a CKM system demonstrate equivalent ketone monitoring compared to a capillary ketone monitor with accuracy within a mean absolute difference of no more than ± 0.1 mmol/L. Participants will be asked to wear the SiBio KS1 CKM system for 14-days while undergoing two sequential ketogenic diets which are interspaced by an inpatient insulin-suspension period. **Detailed Description:** In this study, all study participants will wear the CKM system and collect multiple standard point-of-care capillary ketone measurements. Therefore, there will be two groups in terms of measurements methods, one acting as an active comparator (the CKM system) and, the other serving as a control (point-of-care capillary ketone measurements). Both groups of measurement methods will be assessed in all study participants for both the outpatient phase (sequential ketogenic diets) and, the inpatient phase (insulin-suspension period) of the study to evaluate the accuracy of the CKM system. ### Conditions Module **Conditions:** - type1diabetes **Keywords:** - Continuous ketone monitoring system - Ketone monitoring - Diabetes ketoacidosis - diabetes ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** All study participants will wear the CKM system for the 2-week study duration. This timeframe is overlapped with both the outpatient phase (sequential ketogenic diets) and, inpatient phase (insulin-suspension period) of the study. The accuracy of the ketone values from the CKM will be assessed using standard point-of-care capillary ketone measurements as reference (control). **Intervention Names:** - Other: Ketogenic diets - Other: 6-hour insulin-suspension period **Label:** Continuous ketone monitoring (CKM) system #### Arm Group 2 **Description:** All study participants will be asked to measure their ketone levels with a standard point-of-care capillary ketone meter once upon waking, before a meal and, 2-hours post-meal for the entire 2-week study duration. These ketone measurements will be used as reference values (control) for comparison with the readings from the CKM. **Intervention Names:** - Other: Ketogenic diets - Other: 6-hour insulin-suspension period **Label:** Standard point-of-care capillary ketone meter ### Interventions #### Intervention 1 **Arm Group Labels:** - Continuous ketone monitoring (CKM) system - Standard point-of-care capillary ketone meter **Description:** During the outpatient phase of the study, all participants will undergo a very low-carbohydrate diet (less than 50grams/day) and, a fasting diet (12 hours) in a randomized order. Both diets are 6 days in duration and, will be interspaced by an inpatient insulin-suspension period. These ketogenic diets are implemented to drive higher ketone levels, within a safe threshold, to assess the accuracy of the CKM sensor. All the while, study participants will be wearing the CKM and, taking multiple daily ketone measurements with a standard point-of-cate ketone meter. **Name:** Ketogenic diets **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Continuous ketone monitoring (CKM) system - Standard point-of-care capillary ketone meter **Description:** Interspaced between both ketogenic diets, on day 8 of the study, participants will have their insulin pumps suspended for 6 hours; therefore, participants will not receive any basal or bolus insulin. Ketone levels will be monitored on-site every 30 minutes with standard point-of-care capillary ketone meters and, if ketones measurements exceed the safety threshold, participants will be treated accordingly. Clearly defined stopping criteria and corrective treatments have been outlined in the study protocol to ensure participants safety. **Name:** 6-hour insulin-suspension period **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Overall MAD of ketone concentration of the CKM (active device) compared to ketone capillary-measurements (control) during the 6-hour insulin-suspension study. **Time Frame:** 2 weeks #### Secondary Outcomes **Measure:** Overall mean absolute difference (MAD) of ketone CKM (active device) concentration compared to ketone capillary-measurements at home (control). **Time Frame:** 2 weeks **Measure:** Mean difference (MD) of ketone CKM concentration compared to ketone capillary-measurements during the 6h insulin-suspension study. **Time Frame:** 2 weeks **Measure:** MD of ketone CKM concentration compared to ketone capillary-measurements at home. **Time Frame:** 2 weeks **Description:** i)During the overall study period, ii) In the first 2 days of sensor life, iii)In the 13-14 days (last 2 days) of sensor life **Measure:** MAD & MD according to duration during outpatient period: **Time Frame:** 2 weeks **Description:** i) ≥1.0, ii) ≥0.6, iii) ≤0.6 **Measure:** MAD & MD across ketone levels during insulin-suspension visit: **Time Frame:** 2 weeks **Description:** i) ≥0.6 during overall study period, inpatient period, outpatient period, ii) ≥1.0 during overall study period, inpatient period, outpatient period, iii) ≥1.5 mmol/L during overall study period, inpatient period, outpatient period **Measure:** Number of participants experiencing ketones by both the CKM and capillary-ketone meter. **Time Frame:** 2 weeks **Description:** i) Between 3.9 and 7.8 mmol/L, ii) Below 3.9 mmol/L and 3.0 mmol/L, iii) Above 10.0 mmol/L and 13.9 mmol/L **Measure:** Glycemic and insulin outcomes will be compared between the very low-carbohydrate diet and the intermittent fasting diet. **Time Frame:** 2 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adults ≥ 18 years of age. 2. A clinical diagnosis of T1D for at least one year, as per their treating diabetes physician in agreement with the primary investigator's clinical judgment (confirmatory C-peptide and antibodies will not be required). 3. On stable, commercial closed-loop pump therapy for the past 30 days. 4. Stable use of continuous glucose monitor system for the past 30 days. 5. Cellular phone with Android OS operating system 8.1 and above or iOS11 and above operating system, for data compatibility with continuous ketone monitor mobile app (SiCKM app). 6. Able to perform study related tasks. Exclusion Criteria: 1. Current or ≤ 2 weeks use of SGLT2 inhibitor medication (e.g. empagliflozin). 2. Current use of ascorbic acid (Vitamin C) as it may impair accuracy of the sensor. 3. Severe hypoglycemic episode within one month of admission, defined as an event where glucose was \<4 mmol/L resulting in seizure, loss of consciousness, needing third party assistance, or need to present to the emergency department. 4. Diabetic ketoacidosis episode requiring medical attention or intravenous insulin within one month. 5. Planned or ongoing pregnancy or breastfeeding individuals. 6. Any serious medical or psychiatric illness likely to interfere with ability to complete the trial, as per judgement of investigators. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The population of this study are individuals with a type 1 diabetes diagnosis exceeding 1 year, using insulin pump therapy for more than one month. Participant recruitment for the study will predominantly occur through the Hygea Medical Clinic, complemented by outreach to previous study participants who have consented to future contact for research opportunities. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** nicholas.sabelli@mail.mcgill.ca **Name:** Nicholas Sabelli, B.Sc (Hons.) **Phone:** (514) 377-9455 **Role:** CONTACT #### Locations **Location 1:** **City:** Montreal **Contacts:** ***Contact 1:*** - **Email:** louise@cmhygea.com - **Name:** Louise Ullyatt - **Phone:** 514-938-0995 - **Role:** CONTACT **Country:** Canada **Facility:** Hygea Clinic **State:** Quebec **Status:** RECRUITING **Zip:** H4A 3T2 #### Overall Officials **Official 1:** **Affiliation:** Hygea Medical Clinic **Name:** Melissa-Rosina Pasqua, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** The raw data (that is, insulin delivery, glucose levels and individual participant data) and informed consent form will be shared by the corresponding author, for academic purposes, subject to a material transfer agreement and approval of the McGill University Health Center's Research Ethics Board. All data shared will be de-identified. Raw data will be shared for non-commercial use upon reasonable request and a material transfer agreement. **Info Types:** - ICF **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes - ID: M7117 - Name: Diabetes Mellitus, Type 1 - Relevance: HIGH - As Found: Type 1 Diabetes - ID: M10687 - Name: Ketosis - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M25403 - Name: Glucose Metabolism Disorders - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003922 - Term: Diabetes Mellitus, Type 1 ### Intervention Browse Module - 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: M16759 - Name: Tin Fluorides - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007328 - Term: Insulin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420505 **Acronym:** CELEBRITY **Brief Title:** MULTICENTER OBSERVATORY EVALUATING THE POLYMER-FREE SIROLIMUS ELUTING CORONARY STENT SYSTEM VIVO ISAR IN ROUTINE CLINICAL PRACTICE **Official Title:** Multicenter Observatory Evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System VIVO ISAR in Routine Clinical Practice (CELEBRITY Observatory) #### Organization Study ID Info **ID:** TRANSLUMINA #### Organization **Class:** INDUSTRY **Full Name:** Translumina GmbH ### Status Module #### Completion Date **Date:** 2027-01-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-11-29 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-29 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** EVAMED #### Lead Sponsor **Class:** INDUSTRY **Name:** Translumina GmbH #### 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 rationale for this observatory is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent System in Real World CAD Patients with follow-up at 12 months. All medications and procedures to be used/ performed in this observatory are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles. ### Conditions Module **Conditions:** - Artery Coronary Stenosis ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 3000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** The Vivo ISAR is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease. **Name:** Percutaneous Coronary Intervention **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** • The rate of target lesion failure at 12 months follow-up defined as the composite endpoint of: * Cardiac death * Myocardial infarction related to the target vessel * Clinically documented target lesion revascularization **Measure:** rate of target lesion failure **Time Frame:** 12 months post-procedure #### Secondary Outcomes **Description:** • Device success rate defined as successful placement and deployment of the device at the target lesion site with successful removal of the delivery system leaving a final residual stenosis \<30% of the segment of the culprit lesion covered by the stent at 1 year **Measure:** Device success rate **Time Frame:** 12 months post-procedure **Description:** * Procedural success rate defined as device success without major ischemia-related adverse cardiac events during hospitalization and up to a maximum of 7 days post-procedure : * Cardiac death * Any MI * Target-vessel MI **Measure:** Procedural success rate **Time Frame:** 7 days post-procedure **Description:** Target Lesion Revascularization at 12 months **Measure:** Assess reperfusion **Time Frame:** 12 months post-procedure **Description:** antiplatelet consumption during 1 year after the procedure **Measure:** • Evaluate the antiplatelet treatment **Time Frame:** 12 months post-procedure ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ≥18 years old * Ability to provide signed informed consent form. * Male or non-pregnant female patient (Pregnancy status to be confirmed verbally from the female patient of reproductive age) * Presentation with acute coronary syndrome or chronic coronary syndrome with stable angina or angina equivalent symptoms or with a positive noninvasive test for ischemia or evidence of a functionally significant coronary stenosis. * Patient having social security number. * Patient treated only with Vivo ISAR stent in case of single or multiple vessel stenting Exclusion Criteria: * Concurrent participation in another clinical trial. * Having benefited from an angioplasty of ≤ 1 month with a stent other than Vivo ISAR. * Planned elective surgery in next 6 months * Cardiogenic shock/ hemodynamically unstable patients * Concurrent medical condition with a life expectancy of less than 12 months * History of cerebrovascular accident in the last 6 months. * Vulnerable patient under guardianship or curatorship **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** all-comers population who qualify for percutaneous coronary intervention (consisting of patients with symptomatic coronary artery disease including chronic coronary syndromes (CCS) and ACS) of any gender, ≥ 18 years old ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** beatrice.godefroy@translumina.fr **Name:** Béatrice GODEFROY **Phone:** 0623822906 **Phone Ext:** +33 **Role:** CONTACT #### Locations **Location 1:** **City:** Aix-en-Provence **Contacts:** ***Contact 1:*** - **Email:** luc.maillard@laposte.net - **Name:** Luc Maillard, Dr - **Role:** CONTACT **Country:** France **Facility:** Clinique Axium **Status:** RECRUITING **Zip:** 13100 **Location 2:** **City:** Caen **Contacts:** ***Contact 1:*** - **Email:** beygui-f@chu-caen.fr - **Name:** Farzin Begui, Pr - **Role:** CONTACT **Country:** France **Facility:** CHU CAEN **Status:** NOT_YET_RECRUITING **Zip:** 14000 **Location 3:** **City:** Colmar **Contacts:** ***Contact 1:*** - **Email:** amine.matari@diaconat-mulhouse.fr - **Name:** Amine Matari, Dr - **Role:** CONTACT **Country:** France **Facility:** Hôpital A. Schweitzer - GHCA **Status:** RECRUITING **Zip:** 68003 **Location 4:** **City:** Essey-lès-Nancy **Contacts:** ***Contact 1:*** - **Email:** ju.lemoine54@gmail.com - **Name:** Julien Lemoine, Dr - **Role:** CONTACT **Country:** France **Facility:** Clinique Louis Pasteur **Status:** RECRUITING **Zip:** 54271 **Location 5:** **City:** Haguenau **Contacts:** ***Contact 1:*** - **Email:** fabien@ch-haguenau.fr - **Name:** Fabien DE POLI, Dr - **Role:** CONTACT **Country:** France **Facility:** CH Haguenau **Status:** RECRUITING **Zip:** 67500 **Location 6:** **City:** Marseille **Contacts:** ***Contact 1:*** - **Email:** thomas.cuisset@mail.ap-hm.fr - **Name:** Thomas Cuisset, Pr - **Role:** CONTACT **Country:** France **Facility:** CHU La Timone **Status:** RECRUITING **Zip:** 13005 **Location 7:** **City:** Marseille **Contacts:** ***Contact 1:*** - **Email:** laurent.bonello@ap-hm.fr - **Name:** Laurent Bonello, Pr - **Role:** CONTACT **Country:** France **Facility:** Hopital Nord **Status:** NOT_YET_RECRUITING **Zip:** 13015 **Location 8:** **City:** Massy **Contacts:** ***Contact 1:*** - **Email:** p.garot@icps.com.fr - **Name:** Philippe Garot, Dr - **Role:** CONTACT **Country:** France **Facility:** HP Jacques Cartier **Status:** RECRUITING **Zip:** 91300 **Location 9:** **City:** Montauban **Contacts:** ***Contact 1:*** - **Email:** romain-andre@hotmail.fr - **Name:** Romain André, Dr - **Role:** CONTACT **Country:** France **Facility:** Clinique Pont de Chaume **Status:** NOT_YET_RECRUITING **Zip:** 82000 **Location 10:** **City:** Nantes **Contacts:** ***Contact 1:*** - **Email:** ashok.tirouvanziam@groupeconfluent.fr - **Name:** Ashok Tirouvanziam, Dr - **Role:** CONTACT **Country:** France **Facility:** Hôpital Privé du Confluent **Status:** RECRUITING **Zip:** 44277 **Location 11:** **City:** Ollioules **Contacts:** ***Contact 1:*** - **Name:** La Scala, Dr - **Role:** CONTACT **Country:** France **Facility:** Polyclinique Les Fleurs **Status:** RECRUITING **Zip:** 83190 **Location 12:** **City:** Paris **Contacts:** ***Contact 1:*** - **Email:** gilles.montalescot@aphp.fr - **Name:** Gille Montalescot, Dr - **Role:** CONTACT **Country:** France **Facility:** APHP **Status:** NOT_YET_RECRUITING **Zip:** 75013 **Location 13:** **City:** Quincy-sous-Sénart **Contacts:** ***Contact 1:*** - **Email:** t.unterseeh@icps.com.fr - **Name:** Thierry Unterseeh, Dr - **Role:** CONTACT **Country:** France **Facility:** HP Claude Galien **Status:** NOT_YET_RECRUITING **Zip:** 91480 **Location 14:** **City:** Reims **Contacts:** ***Contact 1:*** - **Email:** lfaroux@chu-reims.fr - **Name:** Laurent Faroux, Dr - **Role:** CONTACT **Country:** France **Facility:** CHU Reims **Status:** RECRUITING **Zip:** 51000 **Location 15:** **City:** Rouen **Contacts:** ***Contact 1:*** - **Email:** mgodin@clinique-sainthilaire.fr - **Name:** Matthieu Godin, Dr - **Role:** CONTACT **Country:** France **Facility:** Clinique Saint Hilaire **Status:** RECRUITING **Zip:** 76000 **Location 16:** **City:** Strasbourg **Contacts:** ***Contact 1:*** - **Email:** Olivier.Morel@chru-strasbourg.fr - **Name:** Olivier Morel, Pr - **Role:** CONTACT **Country:** France **Facility:** CHRU Strasbourg **Status:** NOT_YET_RECRUITING **Zip:** 67091 **Location 17:** **City:** Tarbes **Contacts:** ***Contact 1:*** - **Email:** mabdennadher@ch-tarbes-vic.fr - **Name:** Majdi Abdennadher, Dr - **Role:** CONTACT **Country:** France **Facility:** CH de Bigorre **Status:** RECRUITING **Zip:** 65013 **Location 18:** **City:** Toulouse **Contacts:** ***Contact 1:*** - **Email:** dtchetche@clinique-pasteur.com - **Name:** Didier Tchétché, Dr - **Role:** CONTACT **Country:** France **Facility:** Clinique Pasteur **Status:** NOT_YET_RECRUITING **Zip:** 31076 **Location 19:** **City:** Toulouse **Contacts:** ***Contact 1:*** - **Email:** lhermusier.t@chu-toulouse.fr - **Name:** Thibault Lhermusier, Pr - **Role:** CONTACT **Country:** France **Facility:** Chu Toulouse **Status:** RECRUITING **Zip:** 31400 #### Overall Officials **Official 1:** **Affiliation:** CHU Toulouse **Name:** Thibault Lhermusier, Pr **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000003327 - Term: Coronary Disease - ID: D000017202 - Term: Myocardial Ischemia - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: 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 ### Condition Browse Module - Browse Leaves - ID: M6475 - Name: Constriction, Pathologic - Relevance: LOW - As Found: Unknown - ID: M22913 - Name: Coronary Stenosis - Relevance: HIGH - As Found: Coronary Stenosis - ID: M6546 - Name: Coronary Artery Disease - Relevance: LOW - As Found: Unknown - ID: M6549 - Name: Coronary Disease - Relevance: LOW - As Found: Unknown - ID: M19506 - Name: Myocardial Ischemia - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M9419 - Name: Heart Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000023921 - Term: Coronary Stenosis ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M21960 - Name: Sirolimus - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420492 **Acronym:** SHARC **Brief Title:** Study of Novel Therapeutics for Acute Remedy of Colitis **Official Title:** Study of Novel Therapeutics for Acute Remedy of Colitis #### Organization Study ID Info **ID:** Unknown (Pending approval) #### Organization **Class:** OTHER **Full Name:** Brigham and Women's Hospital ### Status Module #### Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Brigham and Women's Hospital #### Responsible Party **Investigator Affiliation:** Brigham and Women's Hospital **Investigator Full Name:** Joshua Korzenik **Investigator Title:** MD-Director, Brigham and Women's Hospital Crohn's and Colitis Center **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with acute ulcerative colitis. Patients who qualify are adults who have not responded to treatments for their severe ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as an open-label pilot study in which participants will take the study drug for 4 weeks in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 7 study visits, all of which will be conducted at a study site. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool and urine sample for a few lab tests throughout the study. Participants may also undergo a flexible sigmoidoscopy at the beginning and end of the study. ### Conditions Module **Conditions:** - Ulcerative Colitis - Ulcerative Colitis Chronic Moderate - Ulcerative Colitis Chronic Severe ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** This is an open-label study in which everyone will receive active treatment. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 15 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In Group 1 of the study, subjects will take oral study drug at 2g twice daily, PO (4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 2 of the study, subjects will take oral study drug at 2g twice daily, PO (4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 2.5g dose of study drug at initiation. In Group 3 of the study, subjects will take oral study drug at 2g twice daily, PO (4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive one 2.5g dose of study drug at initiation and a second 2.5g intravenous dose of study drug at week 2. **Intervention Names:** - Drug: BRS201 **Label:** BRS201 Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - BRS201 Arm **Description:** Groups 1, 2, and 3 will all contain 5 subjects each, with each subject receiving active study drug for four weeks. **Name:** BRS201 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint for this study is change in Total Mayo Score with improvement being a reduction in 3 points and remission being a score of 0 or 1 from day 0 to end of week 4 (at second flexible sigmoidoscopy). **Measure:** Mayo Score **Time Frame:** 4 weeks #### Secondary Outcomes **Description:** Clinical symptoms assessed by SCCAI which measures patient reported outcomes on a scale of 0 to 19, where a higher score indicates more severe activity and active disease is a score of 5 or more. **Measure:** Simple Clinical Colitis Activity Index (SCCAI) **Time Frame:** 12 weeks **Description:** Correlation between changes in plasma nitrite, nitrate or nitrosothiol level in relation to calprotectin **Measure:** Plasma nitrite, nitrate, or nitrosothiol **Time Frame:** 8 weeks **Description:** The capacity of study drug to normalize fecal calprotectin levels from baseline (week 0) compared to end of active treatment (4 weeks) and at week 6. **Measure:** Normalization of fecal calprotectin lab measurements **Time Frame:** 8 weeks **Description:** Reduction in fecal calprotectin to \< ULN at the end of active treatment **Measure:** Reduction in fecal calprotectin lab measurements **Time Frame:** 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Severe outpatient or hospitalized for an acute UC flare * Ability to give consent * Patients with a confirmed diagnosis of UC for \> 3 months * History of ≥ 15 cm of colonic involvement as confirmed by colonoscopy * Total Mayo score of \> 6 * Patients with primary sclerosing cholangitis are eligible to enroll * Patients will have failed 3 days of IV steroids or 5 days of oral prednisone 30 mg or greater for 5 days and still having a SCCAI of \> 6 * Anticipated to be administered ustekinumab, vedolizumab or 6-MP/azathioprine as their subsequent medication. Exclusion Criteria: * History of uncontrolled hypertension with systolic BP \> 140 and systolic BP \> 90 * Chronic kidney disease as defined by GFR \<60mL/min * Impaired hepatic function (transaminases elevated \> 2.5 x ULN) unless due to PSC * Evidence of C. difficile (Negative test result within 1 month is acceptable) * Infectious Colitis or drug induced colitis * Crohn's Disease or Indeterminate colitis * Decompensated liver disease * Patients who are pregnant or breastfeeding * Patients who have a confirmed malignancy or cancer within 5 years * Congenital or acquired immunodeficiencies * Other comorbidities including: Diabetes mellitus, systemic lupus * Participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trial * Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease * Prohibited medications: Vitamin C, prednisone, immune modulators (including but not limited to, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, interleukin-10 and interleukin-11) and anti-TNF agents within the past six weeks * Patients are planned to be started on a fast- acting medication including an anti-TNF agent (infliximab, adalimumab, golimumab, certolizumab), on a JAKi (upadacitinib, tofacitinib) **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jkorzenik@bwh.harvard.edu **Name:** Joshua Korzenik, MD **Phone:** 617 732-6389 **Role:** CONTACT **Contact 2:** **Email:** sellis13@bwh.harvard.edu **Name:** Siani Ellis **Phone:** 617-396-7703 **Role:** CONTACT #### Locations **Location 1:** **City:** Chestnut Hill **Contacts:** ***Contact 1:*** - **Email:** sellis13@bwh.harvard.edu - **Name:** Siani Ellis - **Phone:** 617-396-7703 - **Role:** CONTACT ***Contact 2:*** - **Email:** smitchell22@bwh.harvard.edu - **Name:** Sophie Mitchell - **Role:** CONTACT ***Contact 3:*** - **Name:** Joshua Korzenik, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Brigham and Women's Hospital **State:** Massachusetts **Zip:** 02467 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000015212 - Term: Inflammatory Bowel 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M17206 - Name: Ulcer - Relevance: HIGH - As Found: Ulcerative - ID: M6320 - Name: Colitis - Relevance: HIGH - As Found: Colitis - ID: M6321 - Name: Colitis, Ulcerative - Relevance: HIGH - As Found: Ulcerative Colitis - 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: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M17917 - Name: Inflammatory Bowel Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: HIGH - As Found: Chronic - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003092 - Term: Colitis - ID: D000003093 - Term: Colitis, Ulcerative - ID: D000014456 - Term: Ulcer ### Intervention Browse Module - Browse Branches - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M6263 - Name: Coal Tar - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420479 **Brief Title:** The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality **Official Title:** The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality #### Organization Study ID Info **ID:** 2024-00558-01 #### Organization **Class:** OTHER **Full Name:** Karolinska Institutet ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Karolinska Institutet #### Responsible Party **Investigator Affiliation:** Karolinska Institutet **Investigator Full Name:** Conor Macdonald **Investigator Title:** Dr. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The association between weight, and cardiovascular disease and mortality is well established, however, the causal effect of weight-loss in midlife on these outcomes is less clear. Bariatric surgery results in substantial weight-loss and is an ideal candidate to study the causal effects of weight-loss. We propose a project that will use causal inference and machine learning methods to answer two important questions: 1. Is bariatric surgery effective for reducing cardiovascular disease and mortality, and if so, for who? 2. Which type of bariatric surgery (gastric bypass or sleeve gastrectomy) is most effective, and for who? We will use data from various Swedish registers to identify individuals with obesity who are eligible for bariatric surgery. We will then compare cardiovascular and mortality outcomes among those undergoing different types of bariatric surgery with those receiving non-surgical obesity management using causal inference methods. We will use causal forests and expert knowledge to estimate indiviual treatment effects, and identify the groups of patients who benefit the most from these surgeries. ### Conditions Module **Conditions:** - Bariatric Surgery Candidate - Cardiovascular Diseases - Morality **Keywords:** - bariatric surgery - Cardiovascular Diseases - Mortality ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 100000 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 20 Years ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** A well-known intervention known to induce substantial weight loss **Name:** Bariatric surgery **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** myocardial infarction, stroke, and death from cardiovascular causes **Measure:** Cardiovascular disease **Time Frame:** 20 year #### Secondary Outcomes **Measure:** Death from any cause **Time Frame:** 20 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Men and women of reproductive age with a diagnosis of obesity, no prior history of cardiovascular disease or cancer, and no contraindications for surgery after 1982 Exclusion Criteria: * Contraindications to bariatric surgery **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** A cohort of individuals eligible for bariatric surgery in Sweden ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** conor.macdonald@ki.se **Name:** Conor MacDonald, PhD **Phone:** 0000 **Phone Ext:** 000 **Role:** CONTACT **Contact 2:** **Email:** anita.berglund@ki.se **Name:** Anita Berglund, PhD **Phone:** 0000 **Phone Ext:** 000 **Role:** CONTACT #### Locations **Location 1:** **City:** Stockholm **Contacts:** ***Contact 1:*** - **Email:** conor.macdonald@ki.se - **Name:** Conor MacDonald, PhD - **Phone:** 0000 - **Phone Ext:** 000 - **Role:** CONTACT ***Contact 2:*** - **Email:** anita.berglund@ki.se - **Name:** Anita Berglund, PhD - **Phone:** 0000 - **Phone Ext:** 000 - **Role:** CONTACT **Country:** Sweden **Facility:** Karolinska Institutet **Status:** RECRUITING ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Meshes - ID: D000002318 - Term: Cardiovascular Diseases ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420466 **Brief Title:** Time-Restricted Feeding on Cardiovascular Health Effects **Official Title:** Dietary Intake Status and Time-Restricted Feeding on Cardiovascular Health Effects in the Overweight Population: A Study of Students at a Shenzhen University #### Organization Study ID Info **ID:** KY-2022-101-01 #### Organization **Class:** OTHER **Full Name:** Macau University of Science and Technology Hospital ### Status Module #### Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2024-04-01 **Type:** ACTUAL #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-04 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** The Seventh Affiliated Hospital of Sun Yat-sen University **Class:** OTHER **Name:** Shenzhen University #### Lead Sponsor **Class:** OTHER **Name:** Zhengqi Qiu #### Responsible Party **Investigator Affiliation:** Macau University of Science and Technology Hospital **Investigator Full Name:** Zhengqi Qiu **Investigator Title:** Associate researcher **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Study Design and Participants This intervention study was conducted as a randomized controlled trial (RCT) aimed at investigating the effects of time-restricted feeding (TRF) on cardiovascular health markers among overweight male university students in Shenzhen, China. The study recruited male university students aged between 18 and 24 years, with a Body Mass Index (BMI) ranging from 24 to less than 28. All participants were free from severe psychiatric illnesses, metabolic syndrome, diabetes, alcoholic fatty liver disease, hyperthyroidism, or hypothyroidism. Inclusion criteria required participants to be non-smokers, not currently on any diet pills, and have no history of cardiovascular or metabolic diseases. Randomization and Intervention Fifty eligible participants were randomly assigned to either the intervention group (n=25) or the control group (n=25). The intervention group underwent a 6-hour daily TRF from noon to 6 P.M., while the control group did not participate in TRF but maintained their usual eating patterns. No restrictions were placed on the type or quantity of food consumed by participants in either group. Data Collection and Measures Body Composition and Anthropometry: Measurements included body mass index, body fat percentage, muscle mass, hydration levels, protein content, and visceral fat, all assessed using a bioelectrical impedance analysis scale (Mi Body Composition Scale 2 by Huami Technology). Waist circumference was manually measured by experienced nurses using a tape measure. Blood Pressure and Heart Rate: These vital signs were monitored using an arm cuff electronic blood pressure monitor (Panasonic EW3153), with the arm positioned at heart level to ensure accuracy. Measurements were taken after at least five minutes of seated rest. Nutritional Intake Although time-restricted feeding interventions do not usually change the content or quantity of dietary intake, the total daily intakes of energy, fat, protein, carbohydrate, cholesterol, and fibre were calculated using the Nutritionist Pro food analysis program. This was used to determine possible changes in the subjects' dietary composition as a result of the intervention. Compliance and Ethical Considerations The study protocol was approved by the Ethics Committee of the Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen), with the approval number KY-2022-101-01. All data were handled confidentially, and measures were taken to ensure high adherence and minimal loss to follow-up. Statistical Analysis Descriptive statistics such as range, mean, standard deviation, and percentages were used to describe the sample characteristics. To compare differences, the change from baseline levels was assessed to account for initial variability, employing an independent samples t-test for the analysis. ### Conditions Module **Conditions:** - Time Restricted Feeding - Cardiovascular Health - Body Composition - Blood Pressure - Young Adult ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized Controlled Trial ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 50 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Controlling the eating time to 6 hours per day, but not being prescriptive about the quantity and content of dietary intake. **Intervention Names:** - Behavioral: Time-restricted Feeding **Label:** Time-restricted Feeding group **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Time-restricted Feeding group **Description:** Controlling the eating time to 6 hours per day, but not being prescriptive about the quantity and content of dietary intake. **Name:** Time-restricted Feeding **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** BMI is calculated using a standardized ratio of weight to height (kg/m²), offering a quantitative measure of body composition. This outcome will be assessed using digital scales for accurate weight measurement and stadiometers for height, ensuring precise BMI calculation. **Measure:** Body Mass Index (BMI) **Time Frame:** 4 Weeks **Description:** Waist circumference is measured using a flexible measuring tape, which allows for a direct quantification of visceral fat accumulation. This measure provides critical insights into metabolic health risks, differentiating it from BMI by focusing specifically on central obesity. **Measure:** Waist Circumference **Time Frame:** 4 Weeks **Description:** Revised Description: Blood pressure will be measured using a standardized sphygmomanometer, ensuring consistent and reproducible results. This tool will help monitor changes in systolic and diastolic blood pressure, which are vital for evaluating the effects of time-restricted eating on cardiovascular health. **Measure:** Blood pressure **Time Frame:** 4 Weeks **Description:** Nutritional indicators will be assessed through detailed 24-hour dietary recall interviews and food diaries analyzed using nutritional analysis software. This approach will quantify changes in nutrient intake, highlighting the dietary impact of time-restricted feeding interventions. **Measure:** Nutritional indicators **Time Frame:** 4 Weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects were able to provide signed and dated written informed consent. * Subjects are male undergraduates aged 18-24 years old. * BMI between 24 and 28. * Normal sleep duration, usually between 7-9 hours per day. * Stable sleep habits, typically going to bed around midnight (±1 hour). Exclusion Criteria: * Inability to comply with the time-limited diet plan. * Experiencing hypoglycemic reactions during the time-limited diet program. * Presence of metabolic diseases such as diabetes. * Participation in high-intensity physical training for more than 5 hours per week. * Extreme chronotypes, as indicated by scores ≤30 or ≥70 on the Morning and Evening Questionnaire Self-Assessment Scales (MEQ-SA). * Severe weight instability, defined as weight gain or loss of more than 5 kg in the 3 months prior to the study. * Severe food allergy or intolerance. * Participation in another medical study within 6 months prior to the first study visit. **Gender Based:** True **Gender Description:** A single physiological group of others was chosen for the study because dietary habits and physiological indicators may differ between genders. **Maximum Age:** 24 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Shenzhen **Country:** China **Facility:** Shenzhen university **State:** Guangdong **Zip:** 518000 ### IPD Sharing Statement Module **Description:** No external funding was received for this study and there are no plans to make individual participant data available to other researchers **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420453 **Brief Title:** How Long Can Labor Last? Person Centred Care During Labor to Increase Safety for Women and Newborn **Official Title:** How Long Can Labor Last? Person Centred Care During Labor to Increase Safety for Women and Newborn #### Organization Study ID Info **ID:** 2023-02010 #### Organization **Class:** OTHER **Full Name:** Karolinska Institutet ### Status Module #### Completion Date **Date:** 2020-08-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2020-08-31 **Type:** ACTUAL #### Start Date **Date:** 2008-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER_GOV **Name:** The Swedish Research Council #### Lead Sponsor **Class:** OTHER **Name:** Karolinska Institutet #### Responsible Party **Investigator Affiliation:** Karolinska Institutet **Investigator Full Name:** Mia Ahlberg **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:** "How long will my labor last" is a very common question for midwives who care for women during birth. To evaluate safe labor duration largely determines management and care during birth. Today a standardized tool is used by midwives to evaluate normal and safe labor called the partograph. The World Health Organization partograph is a decision-making support tool designed to assist midwives in identifying normal labor duration and women at risk of developing complications. The tool guide the use of care interventions intended to mitigate any perceived risks. The partograph has been in use since the 1950ies and has had a profound impact on care and management during labor. Normal labor progression according to the partograph is a linear progression with cervical dilation of 1 centimeter per hour (alert line) and any deviation from this should lead to an intervention.The purpose of this research project is to increase person-centred care during labor. Specifically, we want to provide updated comprehensive information on labor duration and patient safety for reduction of; unnecessary medical interventions during normal labor; morbidity and mortality in the new-born; maternal complications during delivery and the puerperal period. ### Conditions Module **Conditions:** - Birth Outcome, Adverse - Labor Long - Labor Complication - Maternal Injury - Maternal Distress During Labor and Delivery - Neonatal and Perinatal Conditions - Labor Duration ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 300000 **Type:** ACTUAL **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 1 Month ### Arms Interventions Module #### Arm Group 1 **Label:** Exposed to prolonged labor duration #### Arm Group 2 **Label:** Not exposed to prolonged labor duration ### Outcomes Module #### Primary Outcomes **Measure:** Adverse neonatal outcomes **Time Frame:** 1 month postpartum **Measure:** Adverse maternal outcomes **Time Frame:** 1 month postpartum ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: All births with labor duration Exclusion Criteria: Elective Cesarean birth **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** This is an epidemiological research project using the largest cohort in the world containing detailed information on labor progression and care during labor. The cohort used is built from detailed data from medical records in the Stockholm-Gotland Obstetric Cohort, including all births from 2008 to 2020 (\> 300 000 births). This includes data from the partograph with information about start of labor, all cervical examinations, care interventions, total duration of labor, maternal and neonatal outcomes. For completeness of data on infant outcomes, the cohort has been linked with the Swedish Neonatal Quality Register (SNQ). ### Contacts Locations Module #### Locations **Location 1:** **City:** Stockholm **Country:** Sweden **Facility:** Karolinska Institutet ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M10764 - Name: Obstetric Labor Complications - Relevance: HIGH - As Found: Labor Complications - ID: M14127 - Name: Pregnancy Complications - Relevance: HIGH - As Found: Birth Outcome, Adverse - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007744 - Term: Obstetric Labor Complications - ID: D000011248 - Term: Pregnancy Complications ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420440 **Brief Title:** Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model **Official Title:** Efficacy and Safety of Neoadjuvant HAIC Combined With Tislelizumab and Lenvatinib in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model: a Multicenter Randomized Controlled Trial. #### Organization Study ID Info **ID:** Neoadj-Net01 #### Organization **Class:** OTHER **Full Name:** Tongji Hospital ### Status Module #### Completion Date **Date:** 2027-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Chen Xiaoping #### Responsible Party **Investigator Affiliation:** Tongji Hospital **Investigator Full Name:** Chen Xiaoping **Investigator Title:** Professor **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Primary liver cancer is one of the most common malignant tumors in the world, and about 80%\~90% of primary liver cancers are pathologically characterized as hepatocellular carcinoma (HCC). Radical surgery is the main method for patients with HCC to obtain long-term survival. However, there is no consensus on surgical treatment for patients with BCLC-stage B or C HCC. New tools are urgently needed to guide the choice of treatment options. **Detailed Description:** Primary liver cancer is one of the most common malignant tumors in the world, and about 80%\~90% of primary liver cancers are pathologically characterized as hepatocellular carcinoma (HCC). Radical surgery is the main method for patients with HCC to obtain long-term survival. However, there is no consensus on surgical treatment for patients with BCLC-stage B or C HCC. Transarterial chemoembolization and systemic medication were the first line of treatment for this patients. In eastern countries, such as China, BCLC-B is further categorized into stages IIa and IIb, and surgical resection is recommended as the first-line treatment option for stage IIa, while surgical resection can also be considered for stage IIb. Moreover, many studies have found that patients with BCLC-C stage tumors can also benefit from surgery and the overall prognosis were better than non-surgical treatment. However, the rate of postoperative recurrence is higher than that of early HCC. To address this issue, new tools are urgently needed to guide the selection of appropriate treatment regimens to reduce the risk of postoperative recurrence and improve overall survival. Our multidisciplinary team used deep learning technology to construct an artificial intelligence prediction model of neoadjuvant therapy (Neoadj-Net) benefit based on pre-treatment genetic testing data, digital pathology slides and imaging data (enhanced MRI) of 536 intermediate-stage HCC patients treated with HAIC in combination with lenvatinib and PD-1 monoclonal antibody in six centers, and external center data validated the model's good ability to identify the beneficiary population of the combination regimen ( AUC 0.89, Accuracy 0.86). This study is to explore the effectiveness and safety of Neoadj-Net in reducing postoperative recurrence by observing the benefit of the combined neoadjuvant regimen in patients who are potentially benefited from neoadjuvant therapy and direct surgery from the perspective of precision therapy. ### Conditions Module **Conditions:** - HCC **Keywords:** - Hepatocellular carcinoma - Neoadjuvant tehrapy - recurrence - Deep learning ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients in the neoadjuvant group received neoadjuvant therapy prior to surgery (two cycles of HAIC combined with Tislelizumab and Lenvatinib), and adjuvant therapy (Tislelizumab for 8 cycles) after surgery. **Intervention Names:** - Procedure: Hepatic arterial infusion chemotherapy - Drug: Lenvatinib - Drug: Tislelizumab - Procedure: Liver resection **Label:** Neoadjuvant therapy group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients in the control group underwent liver resection directly and received adjuvant therapy (Tislelizumab for 8 cycles) after surgery. **Intervention Names:** - Procedure: Liver resection - Drug: Tislelizumab **Label:** Direct liver resection group **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Neoadjuvant therapy group **Description:** Patients in the neoadjuvant group received two cycles of neoadjuvant hepatic arterial infusion chemotherapy (HAIC, adoption of the FOFOLX6 program, Folinic acid+5-fluorouracil+Oxaliplatin, 21 days between second HAIC treatments with a window of ±3 days) **Name:** Hepatic arterial infusion chemotherapy **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Neoadjuvant therapy group **Description:** Patients in the neoadjuvant therapy group received Lenvatinib before surgery(Len was started before HAIC treatment, discontinued during HAIC treatment, and discontinued approximately two weeks before surgery, Oral 8 mg or 12mg once a day depending body weight). **Name:** Lenvatinib **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Neoadjuvant therapy group **Description:** Patients in the neoadjuvant therapy group received two cycles of Tislelizumab therapy before surgery (First treatment with Tislelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later) **Name:** Tislelizumab **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Direct liver resection group - Neoadjuvant therapy group **Description:** Patients in the neoadjuvant therapy group were evaluated for tumor status and surgical safety after neoadjuvant therapy, and eligible patients subsequently underwent surgical resection. Patients in the direct surgery group underwent liver resection. **Name:** Liver resection **Type:** PROCEDURE #### Intervention 5 **Arm Group Labels:** - Direct liver resection group - Neoadjuvant therapy group **Description:** Given the high risk of postoperative recurrence, patients in both groups received adjuvant Tis therapy (every 21 days for 8 cycles) starting about one month after surgery. **Name:** Tislelizumab **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** EFS is defined as the time from randomization to disease recurrence and/or disease progression or death from any cause. **Measure:** Median event-free survival (EFS) **Time Frame:** From date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months. #### Secondary Outcomes **Description:** Any adverse event during treatment that is incompatible with the therapeutic purpose of the medication.The incidence and severity of adverse events and serious adverse events as assessed by CTCAE v5.0. **Measure:** Safety Assessment **Time Frame:** Baseline up to 12 months **Description:** OS is defined as the time from randomization to death from any cause **Measure:** Overall Survival (OS) **Time Frame:** From date of randomization until the date of death from any cause, assessed up to 60 months. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Aged 18-75. 2. No previous local or systemic treatment for hepatocellular carcinoma. 3. Child-Pugh liver function score ≤ 7. 4. ECOG PS 0-1. 5. No serious organic diseases of the heart, lungs, brain, kidneys, etc. 6. Enhanced MRI determines that the tumor stage is BCLC B or C without distant metastasis, and is technically resectable. 7. Pathologic type of hepatocellular carcinoma confirmed by puncture biopsy. 8. Multimodal Deep Learning Model Screening Based on Pathology, Imaging, and Genetic Data Suggests Benefit from HAIC in Combination with Lenvatinib and PD-1 inhibitors. Exclusion Criteria: 1. Pregnant and lactating women. 2. Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.). 3. A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication/esophageal varices), as determined by the investigator. 4. Active infection. 5. Other significant clinical and laboratory abnormalities that affect the safety evaluation. 6. Inability to follow the study protocol for treatment or follow up as scheduled. **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** wgzhang@tjh.tjmu.edu.cn **Name:** WanGuang Zhang **Phone:** 13886195965 **Role:** CONTACT **Contact 2:** **Email:** chenxpchenxp@163.com **Name:** xiaoping Chen **Phone:** 027-83663400 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M9613 - Name: Carcinoma, Hepatocellular - Relevance: LOW - As Found: Unknown - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Ancestors - ID: D000000970 - Term: Antineoplastic Agents - ID: D000047428 - Term: Protein Kinase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000074322 - Term: Antineoplastic Agents, Immunological ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Micro - Name: Micronutrients - Abbrev: Hemat - Name: Hematinics - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M353738 - Name: Lenvatinib - Relevance: HIGH - As Found: Primary care - ID: M137899 - Name: Tislelizumab - Relevance: HIGH - As Found: Meet - ID: M6191 - Name: Leucovorin - Relevance: LOW - As Found: Unknown - ID: M8600 - Name: Fluorouracil - Relevance: LOW - As Found: Unknown - ID: M29233 - Name: Levoleucovorin - Relevance: LOW - As Found: Unknown - ID: M1674 - Name: Oxaliplatin - Relevance: LOW - As Found: Unknown - ID: M8618 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: M11110 - Name: Liver Extracts - 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: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: T447 - Name: Folinic Acid - Relevance: LOW - As Found: Unknown - ID: T446 - Name: Folic Acid - Relevance: LOW - As Found: Unknown - ID: T448 - Name: Folate - Relevance: LOW - As Found: Unknown - ID: T475 - Name: Vitamin B9 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000531958 - Term: Lenvatinib - ID: C000707970 - Term: Tislelizumab ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420427 **Brief Title:** Dynamic Monitoring of ctDNA and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery **Official Title:** Dynamic Monitoring of Circulating Tumor DNA (ctDNA) and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery/Treatment #### Organization Study ID Info **ID:** CCA2024005 #### Organization **Class:** OTHER **Full Name:** The Third Affiliated Hospital of Guangzhou Medical University ### Status Module #### Completion Date **Date:** 2027-01-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The Third Affiliated Hospital of Guangzhou Medical University #### Responsible Party **Investigator Affiliation:** The Third Affiliated Hospital of Guangzhou Medical University **Investigator Full Name:** Sheng Xiujie **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:** Assess the sensitivity, specificity, positive predictive value, and negative predictive value of dynamic monitoring of circulating tumor DNA (ctDNA) combined with circulating HPV DNA (cfHPV DNA) for early prediction of recurrence in cervical cancer post-surgery or post-treatment, and compare its advantages and disadvantages with existing diagnostic methods. ### Conditions Module **Conditions:** - cfHPV DNA in Plasma of Cervical Cancer Patients **Keywords:** - cfHPV DNA - cervical cancer ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Evaluation of recurrence risk and medication efficacy through liquid biopsy **Name:** Assess the risk of recurrence and the efficacy of medication **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** true positive rate **Measure:** sensitivity **Time Frame:** 2 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with newly diagnosed HPV-positive cervical malignancy at stages I-IV who have not undergone surgery, radiation therapy, or chemotherapy. * Patients must be older than 18 years of age. * Cervical cancer patients who are eligible for surgery and/or chemoradiotherapy. * Estimated life expectancy of more than three months. * Understands the study protocol and voluntarily participates in the research by signing the informed consent form. * Able to provide specimens and corresponding clinical information at each time point. Exclusion Criteria: * Patients who are participating in other clinical trials. * Pregnant or breastfeeding women. * Patients with severe mental illness. * Patients who voluntarily withdraw. * Patients unable to complete the study protocol. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with newly diagnosed HPV-positive cervical malignancy at stages I-IV who have not undergone surgery, radiation therapy, or chemotherapy. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** 2008691150@gzhmu.edu.cn **Name:** Xiujie Sheng, Prof **Phone:** 86-20-81292726 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** 19902275248@163.com - **Name:** Baixue Li, MD - **Phone:** 86-02-81292726 - **Role:** CONTACT **Country:** China **Facility:** The Third Affiliated Hospital of Guangzhou Medical University **State:** Guangdong **Status:** RECRUITING **Zip:** 510150 #### Overall Officials **Official 1:** **Affiliation:** The Third Affiliated Hospital of Guangzhou Medical University **Name:** Xiujie Sheng, Prof **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** publish an article **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014594 - Term: Uterine Neoplasms - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000002577 - Term: Uterine Cervical Diseases - ID: D000014591 - Term: Uterine Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions ### Condition Browse Module - Browse Leaves - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrence - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: HIGH - As Found: Cervical Cancer - ID: M17342 - Name: Uterine Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5825 - Name: Uterine Cervical Diseases - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002583 - Term: Uterine Cervical Neoplasms - ID: D000012008 - Term: Recurrence ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420414 **Brief Title:** Physiological and Psychological Effects of Virtual Reality vs Traditional Exercise **Official Title:** Comparing Physiological and Psychological Effects of Virtual Reality Vs. Traditional HIIT In Healthy Individuals: Results From A Preliminary Pilot Randomised Controlled Trial #### Organization Study ID Info **ID:** 10853 #### Organization **Class:** OTHER **Full Name:** Teesside University ### Status Module #### Completion Date **Date:** 2023-01-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-01-31 **Type:** ACTUAL #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Teesside University #### Responsible Party **Investigator Affiliation:** Teesside University **Investigator Full Name:** Jonathan Robinson, Ph.D **Investigator Title:** Senior Lecturer in Research Methods **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 explore the feasibility and effectiveness of immersive Virtual Reality (VR) as an alternative to traditional High-Intensity Interval Training (HIIT) by comparing physiological and psychological outcomes in physically active university students. The pilot randomised controlled trial utilised a parallel design involving two groups: one group performed HIIT using the Facebook Oculus Quest 2 VR headset with the "FitXR" fitness game, while the other undertook traditional HIIT training that mirrored the movements and actions of the VR game. The study's findings suggest that fully immersive VR provides a unique and potentially more enjoyable alternative to traditional HIIT, particularly because it may enhance motivation while still achieving health benefits. This pilot research study highlights VR's potential to reach high-flow states in exercise, where individuals become deeply absorbed and derive satisfaction from the activity. It also lays the groundwork for future studies involving larger sample sizes and clinical populations to further investigate the psychological and physiological impacts of VR-based exercise. In summary, this pilot randomised controlled trial found that immersive VR could be a feasible and effective alternative to traditional HIIT training, offering similar physiological benefits while enhancing exercise motivation and enjoyment. Further research is necessary to validate these preliminary results and extend them to diverse populations. **Detailed Description:** Study Objectives and Design This study was designed as a pilot randomised controlled trial (RCT) to investigate the feasibility, efficacy, and effects of immersive VR compared to traditional HIIT on physiological and psychological outcomes in physically active university students. The parallel-design trial was conducted in accordance with the CONSORT guidelines and approved by the Teesside University Health Research Ethics Sub-Committee. The VR intervention used the Facebook Oculus Quest 2 VR headset with the fitness game "FitXR," while the non-VR group completed traditional HIIT that replicated the same movements as in the VR game. Participants and Recruitment A purposive sampling method was used to recruit ten healthy physiotherapy students from Teesside University. Participants had to lead an active lifestyle, defined as performing either 150 minutes of moderate exercise weekly or 75 minutes of vigorous-intensity aerobic exercise, and have no prior experience with VR-based exercise. Those with medical conditions preventing them from exercising or those unable to give informed consent were excluded. Participants were recruited via email through a gatekeeper, indicating their willingness to participate by contacting the research physiotherapist directly. The allocation to either the VR or non-VR group was stratified by gender and block-randomised in blocks of five using a computer-generated software (Research Randomizer). Interventions Exergaming via VR: Participants in the VR group used the Facebook Oculus Quest 2 and "FitXR," a fitness game in high-speed HIIT class mode. The 15-minute session included functional movements such as squats, lunges, and trunk rotations while trying to hit virtual targets by punching. The training session had a 10-second rest between each interval, and participants followed instructions from a virtual trainer. Traditional HIIT: The non-VR group followed a traditional HIIT session that mirrored the movements from the "FitXR" game. Participants replicated movements such as squats with punches, as pre-recorded and displayed on a laptop. The session matched the VR group's overall duration and intervals. Safety and Blinding To ensure safety while using the VR headset, participants were restricted to a 3m by 3m safety boundary. Stepping out of the boundary automatically paused the game, activating external cameras to provide real-world visibility. Blinding was not feasible due to the nature of the intervention, but the researcher responsible for the data analysis was unaware of the group allocations to reduce bias. Outcome Measures Physiological Outcomes: Heart Rate: Measured using a Polar RS400 monitor. Exercise intensity was calculated as a percentage of the maximum heart rate (%HRmax) and heart rate reserve (%HRR). The intensity was categorised according to American Heart Association standards. Rating of Perceived Exertion (RPE): Measured using Borg's CR-10 scale every five minutes. Scores ranged from 0 (rest) to 10 (maximum effort). Psychological Outcomes: Flow State Scale (FSS): Assessed engagement and motivation using a 36-item questionnaire with nine subscales. Participants rated items on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). The subscales measured challenge-skill balance, action-awareness merging, clear goals, unambiguous feedback, and other factors. Statistical Analysis A frequentist approach was employed with SPSS software (version 26). Independent-samples t-tests were used with a significance level of 0.05, and effect sizes were expressed using Cohen's d (small = 0.2, moderate = 0.5, large = 0.8). Bayesian data analysis was conducted with JASP software to assess the robustness of findings. Bayes factors were calculated to compare evidence for alternative versus null hypotheses. Robustness checks were performed to ensure results remained consistent across different prior distributions. Sample Size and Feasibility Given that this was a pilot study, the emphasis was placed on assessing feasibility rather than ensuring the study was fully powered. As such, recruitment spanned a period of time with the objective of enrolling as many patients as possible, without specifying a target participant number to achieve optimal study power. An aim of this study was, therefore, to explore feasibility and preliminary outcomes, which will inform future, larger-scale research Conclusion This pilot study provides preliminary evidence that immersive VR training can offer a feasible alternative to traditional HIIT, achieving comparable physiological benefits with potentially greater intrinsic motivation and engagement. Future studies with larger sample sizes are needed to validate these findings and assess VR's impacts on diverse clinical populations. ### Conditions Module **Conditions:** - Healthy - Physical Activity - Virtual Reality - Exergame - Inactivity, Physical **Keywords:** - Exergaming - Virtual Reality - Meta Oculus Quest - Heart rate - Rate of perceived exertion - Technology acceptance - Bayesian Inferences - Pilot - RCT - Healthy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This parallel-design pilot randomised controlled trial (RCT) had two arms, each representing a different intervention: one group used a virtual reality (VR) exergaming system ("FitXR" on the Facebook Oculus Quest 2) and the other performed traditional High-Intensity Interval Training (HIIT), mirroring the same movements and durations as in the VR game. Participants were allocated to the two arms via block randomisation, stratified by gender. Both groups underwent a 15-minute HIIT session with 10-second intervals, aimed at comparing physiological and psychological effects between VR and non-VR interventions. ##### Masking Info **Masking:** NONE **Masking Description:** The researcher who completed the data analysis (JR) was blinded to the participants and specifics of the intervention. **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 10 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this arm underwent a single session of High-Intensity Interval Training (HIIT) via the Facebook Oculus Quest 2 virtual reality headset and "FitXR" fitness game. This immersive VR environment engaged participants in a 15-minute HIIT session, involving squats, lunges, and punches to virtual targets. The intensity was comparable to traditional HIIT, with a 10-second rest between intervals. **Intervention Names:** - Other: Virtual Reality **Label:** Virtual Reality (VR) HIIT **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants in this arm underwent a single session of traditional High-Intensity Interval Training (HIIT), mirroring the movements and duration of the "FitXR" VR game. Exercises like squats, lunges, and punching targets were replicated, ensuring the same 15-minute workout duration and 10-second rest intervals, as in the VR arm. **Intervention Names:** - Other: Traditional HIIT **Label:** Traditional HIIT **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Virtual Reality (VR) HIIT **Description:** Participants engaged in a 15-minute HIIT session using the Facebook Oculus Quest 2 VR headset with the "FitXR" fitness game. The advanced level workout (High Speed) was chosen, where participants performed functional movements like squats, lunges, and trunk rotations while punching virtual targets. The VR environment provided a 10-second rest period between intervals and featured a virtual trainer's guidance. **Name:** Virtual Reality **Other Names:** - Facebook Oculus Quest 2 **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Traditional HIIT **Description:** Participants followed a non-VR 15-minute HIIT programme designed to replicate the exercises and patterns seen in the "FitXR" game. The traditional exercises included squats, lunges, and punches, matching the VR programme's intensity and interval structure. Participants watched a pre-recorded video on a laptop, which guided them through the workout. The 10-second rest periods were also maintained for consistency. **Name:** Traditional HIIT **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Average percentage of maximum heart rate (%HRmax) and heart rate reserve (%HRR), measured using the Polar HR monitor RS400. The intensity levels were classified according to American Heart Association guidelines: ≥50% HRmax or ≥45% HRR as moderate intensity and ≥70% HRmax or ≥60% HRR as vigorous intensity. **Measure:** Heart Rate (HR) **Time Frame:** During each 15-minute HIIT session for both VR and traditional groups. **Description:** Average score on the CR-10 BORG's scale, where 0 represents "rest" and 10 represents "maximal" effort. Perceived exertion scores were obtained every 5 minutes, and an average score was calculated. Higher scores are an indication of greater exertion. **Measure:** Perceived Exertion (RPE) **Time Frame:** Every 5 minutes throughout the 15-minute HIIT session for both groups. **Description:** The Flow State Scale (FSS) questionnaire measured the extent to which participants experienced flow states during their respective HIIT sessions. There is a total of 36 items with 9 subscales measuring challenge-skill balance, action awareness merging, clear goals, unambiguous feedback, concentration on the task at hand, paradox (or sense) of control, loss of self-consciousness, time transformation, and autotelic experience. Each question is measured using a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate a better outcome, reflecting a higher degree of flow experience. **Measure:** Flow Experience **Time Frame:** Immediately after each 15-minute HIIT session. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Teesside University physiotherapy student. 2. Participants willing and able to give informed consent. 3. Have an active lifestyle (performing either 150 minutes of moderate exercise weekly or 75 minutes of vigorous intensity aerobic exercise). 4. No prior experience with exercise using the VR headset. Exclusion Criteria: 1. Have a known medical condition that would prevent them from exercising. 2. Are not able to provide informed consent. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Middlesbrough **Country:** United Kingdom **Facility:** Teesside University #### Overall Officials **Official 1:** **Affiliation:** Teesside University **Name:** Jonathan Robinson, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420401 **Brief Title:** Prebiotics and the Management of Hyperuricemia **Official Title:** Precision Treatment of Hyperuricemia Based on Different Combinations of Prebiotics #### Organization Study ID Info **ID:** Prebiotics-2024 #### Organization **Class:** OTHER **Full Name:** Sun Yat-sen University ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sun Yat-sen University #### Responsible Party **Investigator Affiliation:** Sun Yat-sen University **Investigator Full Name:** Min Xia **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:** Hyperuricemia is a major risk factor for many chronic diesease. Recently, gut mcirobiota has been identified as a novel theraputic target for hyperuricemia. Both annimal studies and pilot human trials have demonstrated that administration of prebiotics help delay the progression of hyperuricemia throuh several mechanisms. This trial aims to examine its protective effects and potential mechanisms in clinical trials. **Detailed Description:** Hyperuricemia is a major risk factor for many chronic diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of hyperuricemia. Animal studies have demonstrated that administration of prebiotics help delay the progression of hyperuricemia through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids and hippuric acid. However, whether administration of prebiotics also has a protective effect in subjects with hyperuricemia remain under-explored. Moreover, whether the original gut microbiota will influence the protective effect of prebiotics remains largely unknown. ### Conditions Module **Conditions:** - Subjects With Hyperuricemia ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Eligilable subjects are instructed to take one pocket of araboxylan during the first week, followed by two pockets of araboxylan during the remaining 11 weeks. **Intervention Names:** - Dietary Supplement: araboxylan **Label:** Dietary supplement: araboxylan **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Eligilable subjects are instructed to take one pocket of inulin during the first week, followed by two pockets of inulin during the remaining 11 weeks. **Intervention Names:** - Dietary Supplement: inulin **Label:** Dietary supplement: inulin **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Eligilable subjects are instructed to take one pocket of inulin and arabosylan during the first week, followed by two pockets of inulin and araboxylan during the remaining 11 weeks. **Intervention Names:** - Dietary Supplement: inulin and araboxylan **Label:** Dietary supplement: inulin and araboxylan **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Eligilable subjects are instructed to take one pocket of maltodextrin during the first week, followed by two pockets of maltodextrin during the remaining 11 weeks. **Intervention Names:** - Dietary Supplement: placebo control **Label:** Dietary supplement: placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Dietary supplement: araboxylan **Description:** During the study period, subjects are instructed to take one pocket of arabosylan per day during the first week, followed by two pockets of araboxylan per day during the remianing 11 weeks. Aside from the dietary supplement provided, all participants are instructed to continue their normal routine and not make any changes to their dietary habits or physical activity. **Name:** araboxylan **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Dietary supplement: inulin **Description:** During the study period, subjects are instructed to take one pocket of inulin per day during the first week, followed by two pockets of inulin per day during the remianing 11 weeks. Aside from the dietary supplement provided, all participants are instructed to continue their normal routine and not make any changes to their dietary habits or physical activity. **Name:** inulin **Type:** DIETARY_SUPPLEMENT #### Intervention 3 **Arm Group Labels:** - Dietary supplement: inulin and araboxylan **Description:** During the study period, subjects are instructed to take one pocket of inulin and araboxylan per day during the first week, followed by two pockets of inulin and araboxylan per day during the remianing 11 weeks. Aside from the dietary supplement provided, all participants are instructed to continue their normal routine and not make any changes to their dietary habits or physical activity. **Name:** inulin and araboxylan **Type:** DIETARY_SUPPLEMENT #### Intervention 4 **Arm Group Labels:** - Dietary supplement: placebo **Description:** During the study period, subjects are instructed to take one pocket of placebo control per day during the first week, followed by two pockets of placebo control per day during the remianing 11 weeks. Aside from the dietary supplement provided, all participants are instructed to continue their normal routine and not make any changes to their dietary habits or physical activity. **Name:** placebo control **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** change of fasting uric acid level assessed by biochemical detector **Measure:** Change of serum uric acid **Time Frame:** from baseline to 12 weeks after intervention **Description:** excretion rate of uric acid assessed by secretion rate of uric acid in urine during 3 hours **Measure:** Change of excretion of uric acid **Time Frame:** from baseline to 12 weeks after intervention #### Secondary Outcomes **Description:** Alterations of the composition of gut microbiota evaluated by metagenomics **Measure:** Change of gut microbiota **Time Frame:** from baseline to 12 weeks after intervention **Description:** Untargeted metabolomics will be used to assess the alterations of microbial metabolites with high performance liquid chromatography-mass spectrometry **Measure:** Change of microbial metabolites **Time Frame:** from baseline to 12 weeks after intervention **Description:** HOMA-IR will be used to assess the change of insulin sensitivity **Measure:** Change in insulin sensitivity **Time Frame:** from baseline to 12 weeks after intervention **Description:** change in waist circumference assessed by tape **Measure:** Change in waist circumference **Time Frame:** from baseline to 12 weeks after intervention **Description:** change in blood pressure assessed by electronic sphymomanometer **Measure:** Change in blood pressure **Time Frame:** from baseline to 12 weeks after intervention **Description:** change in total cholesterol, triglycerides, LDL-c and HDL-c assessed by biochemical detector **Measure:** Change in lipid profiles **Time Frame:** from baseline to 12 weeks after intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Local residents aged between 18-80 years old; * Stable weight (\<5% weight change over the past 3 months); * Fsating uric acid \> 420 umol/L for male and \> 360 umol/L for female on two different days; * Not taking uric acid lowering drugs or have stopped taking uric acid lowering drugs for over 4 weeks at the time of recruitment; * Absence of any diet or medication that might interfere with uric acid metabolims or gut microbiota, especially antibiotics, prebiotics or probiotics at the least 4 weeks before recruitment Exclusion Criteria: * Acute illness or evidence of any acute or chronic inflammatroy of infective diseases; * Participation in regular diet program more than 2 times per week in the lastest 3 months prior to recruitment; * Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study; * Women of childbearing age who are pregant, breast-feeding or preparing for pregnancy; patients who had surgey within the past 6 months or planned surgery during the trial period. **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:** liuyan215@mail.sysu.edu.cn **Name:** Yan Liu, PhD **Phone:** +86-20-87331974 **Role:** CONTACT #### Locations **Location 1:** **City:** Guangzhou **Contacts:** ***Contact 1:*** - **Email:** xiamin@mail.sysu.edu.cn - **Name:** Min Xia, PhD - **Phone:** +86-2087332433 - **Role:** CONTACT **Country:** China **Facility:** Sun Yat-Sen University **State:** Guangdong **Status:** RECRUITING **Zip:** 510080 ### IPD Sharing Statement Module **IPD Sharing:** NO ## 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: M24343 - Name: Hyperuricemia - Relevance: HIGH - As Found: Hyperuricemia ### Condition Browse Module - Meshes - ID: D000033461 - Term: Hyperuricemia ### Intervention Browse Module - Browse Branches - Abbrev: Ot - Name: Other Dietary Supplements - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T401 - Name: Inulin - Relevance: HIGH - As Found: GnRH ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420388 **Brief Title:** 2% Lidocaine Gel in Reducing Postoperative Pain Following Haemorrhoidectomy **Official Title:** Efficacy of 2% Lidocaine Gel in Reducing Postoperative Pain and Analgesic Consumption Following Haemorrhoidectomy: A Randomized, Double-Blind, Controlled Trial #### Organization Study ID Info **ID:** EMRP28112N #### Organization **Class:** OTHER **Full Name:** E-DA Hospital ### Status Module #### Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-05-01 **Type:** ACTUAL **Status Verified Date:** 2023-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-12 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** E-DA Hospital #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study is a randomized, double-blind, controlled trial evaluating the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption after haemorrhoidectomy. 222 patients undergoing Ferguson haemorrhoidectomy will be randomly assigned to receive either 2% lidocaine gel or a non-anaesthetic lubricant gel control. Pain scores using a visual analog scale (VAS) will be assessed at 12 and 24 hours, and 2, 3, and 7 days postoperatively. Analgesic consumption will also be measured. **Detailed Description:** Title: Efficacy of 2% Lidocaine Gel in Reducing Postoperative Pain and Analgesic Consumption Following Haemorrhoidectomy: A Randomized, Double-Blind, Controlled Trial Objective: To assess the effect of 2% lidocaine gel on postoperative pain intensity and analgesic consumption following haemorrhoidectomy. Endpoints: Primary: Postoperative pain measured using a VAS at 12 and 24 hours and 2, 3, and 7 days after surgery Secondary: Analgesic consumption and postoperative complications Intervention: Intervention group: 5 mL 2% lidocaine gel three times per day postoperatively Control group: 5 mL non-anaesthetic water-based lubricant gel Key eligibility criteria: Inclusion: Age ≥18 years, Grade III-IV haemorrhoids, candidate for Ferguson haemorrhoidectomy Exclusion: Not a candidate for Ferguson haemorrhoidectomy, recurrent hemorrhoidal disease, concurrent anal pathology, history of diabetes/liver disease/IBD/neuropathy/coagulopathy, on anticoagulants, allergy to study drugs Planned statistical analyses: Descriptive statistics will be used for qualitative and quantitative variables. Chi-square test, Student's t-test, and ANOVA will be used depending on the nature of the data. A p-value \<0.05 will be considered statistically significant. ### Conditions Module **Conditions:** - Surgery - Pain, Postoperative **Keywords:** - hemorrhoids - pain management ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This study is a single-center, randomized, double-blind, controlled clinical trial comparing the efficacy of 2% lidocaine gel versus a non-anaesthetic lubricant gel control in reducing postoperative pain and analgesic consumption following haemorrhoidectomy. Patients were randomly assigned in a 1:1 ratio to either the intervention group receiving 5 mL 2% lidocaine gel three times per day postoperatively or the control group receiving 5 mL of a non-anaesthetic water-based lubricant gel. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** This study employed a double-blind masking approach to minimize potential bias. Patients, surgeons, and outcome assessors were blinded to treatment allocation. The randomization scheme was generated by a third party not involved in patient care, and sealed envelopes containing the allocation were opened only after the haemorrhoidectomy procedure was completed. The study gels were packaged identically to maintain blinding. Unblinding occurred only after data analysis was completed. This double-blind design ensured that knowledge of treatment allocation did not influence postoperative care, patient-reported pain scores, or the assessment of outcomes. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 400 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Description: Patients in this group received 5 mL of 2% lidocaine gel applied to the perianal region three times per day postoperatively. The gel was self-administered by the patient or applied by a nurse if the patient was unable to do so. Treatment continued for 7 days after the haemorrhoidectomy procedure. Arm Sample Size: 200 **Intervention Names:** - Drug: 2% Lidocaine Gel - Drug: Standard Postoperative Analgesics **Label:** Lidocaine Gel **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Description: Patients in this group received 5 mL of a non-anaesthetic, water-based lubricant gel (K-Y gel) applied to the perianal region three times per day postoperatively. The gel was self-administered by the patient or applied by a nurse if the patient was unable to do so. Treatment continued for 7 days after the haemorrhoidectomy procedure. This group served as a control to compare the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption. Arm Sample Size: 200 **Intervention Names:** - Drug: Water-based Lubricant Gel (K-Y Gel) - Drug: Standard Postoperative Analgesics **Label:** Controlled **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Lidocaine Gel **Description:** The intervention group received 5 mL of 2% lidocaine gel applied topically 3 times per day after undergoing Ferguson hemorrhoidectomy surgery. The control group received 5 mL of a non-anesthetic water-based lubricant gel applied topically 3 times per day after surgery. The application of the gels began immediately after surgery and continued for the postoperative period evaluated in the study. Both groups received standard postoperative analgesics (acetaminophen, celecoxib, Dynastat/parecoxib as needed) in addition to the topical gel applications. **Name:** 2% Lidocaine Gel **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Controlled **Description:** The intervention group received 5 mL of mL of a non-anesthetic water-based lubricant gel (K-Y gel) applied topically 3 times per day after undergoing Ferguson hemorrhoidectomy surgery. **Name:** Water-based Lubricant Gel (K-Y Gel) **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Controlled - Lidocaine Gel **Description:** Acetaminophen (Paracetamol) Dosage: 500 mg per tablet Frequency: Every 6 hours Route: Oral Acetaminophen is a common over-the-counter pain reliever and fever reducer. It works by blocking the production of prostaglandins, which are responsible for causing pain and inflammation. Celecoxib Dosage: 200 mg per tablet Frequency: Every 12 hours Route: Oral Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that specifically inhibits the COX-2 enzyme. By reducing the production of prostaglandins, celecoxib helps alleviate pain and inflammation. Dynastat (Parecoxib) Dosage: 40 mg per injection Frequency: Every 12 hours as needed for poorly controlled pain Route: Intravenous **Name:** Standard Postoperative Analgesics **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Postoperative pain measured by Visual Analog Scale (VAS) The Visual Analog Scale (VAS) is a unidimensional measure of pain intensity. Patients mark their pain level on a 10-cm line, where 0 represents "no pain" and 10 represents "the worst pain imaginable". Higher scores indicate greater pain intensity. **Measure:** Postoperative pain **Time Frame:** Assessed at 12 hours, 24 hours, 2 days, 3 days, and 7 days after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18 years or older * Diagnosed with Grade III or IV hemorrhoids * Candidate for Ferguson haemorrhoidectomy Exclusion Criteria: * Not a candidate for Ferguson haemorrhoidectomy * Recurrent hemorrhoidal disease * Concurrent anal pathology diagnosed preoperatively, including: * Anal fistula * Anal fissure * Anal polyp * History of diabetes mellitus * History of liver cirrhosis * History of inflammatory bowel disease * Documented neuropathy * Coagulation disorders * Currently on anticoagulants * Documented allergy to any of the drugs included in the protocol **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ed111988@edah.org.tw **Name:** Chen Chih-i **Phone:** +886978060015 **Role:** CONTACT #### Locations **Location 1:** **City:** Kaohsiung **Contacts:** ***Contact 1:*** - **Email:** ed111988@edah.org.tw - **Name:** Chen Chih-I - **Phone:** +886978060015 - **Role:** CONTACT **Country:** Taiwan **Facility:** E-Da hospital **Status:** RECRUITING **Zip:** 812 #### Overall Officials **Official 1:** **Affiliation:** E-DA Hospital **Name:** Chen Chih-I **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** The study is a randomized, double-blind, controlled trial evaluating the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption after haemorrhoidectomy. 222 patients undergoing Ferguson haemorrhoidectomy were randomly assigned to receive either 2% lidocaine gel or a non-anaesthetic lubricant gel control. Pain scores using a visual analog scale (VAS) were assessed at 12 and 24 hours, and 2, 3, and 7 days postoperatively. Analgesic consumption was also measured. **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES **Time Frame:** 1 year ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Pain, Postoperative - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M9570 - Name: Hemorrhoids - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Ancestors - ID: D000000779 - Term: Anesthetics, Local - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000000889 - Term: Anti-Arrhythmia Agents - ID: D000061567 - Term: Voltage-Gated Sodium Channel Blockers - ID: D000026941 - Term: Sodium Channel Blockers - ID: D000049990 - Term: Membrane Transport Modulators - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Antipy - Name: Antipyretics - Abbrev: Analg - Name: Analgesics - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AnArAg - Name: Anti-Arrhythmia Agents - Abbrev: ChanBlk - Name: Channel Blockers - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents ### Intervention Browse Module - Browse Leaves - ID: M2340 - Name: Acetaminophen - Relevance: LOW - As Found: Unknown - ID: M11014 - Name: Lidocaine - Relevance: HIGH - As Found: Solution - ID: M4032 - Name: Analgesics - Relevance: HIGH - As Found: Auditory - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M277 - Name: Celecoxib - Relevance: LOW - As Found: Unknown - ID: M4218 - Name: Anti-Inflammatory Agents, Non-Steroidal - Relevance: LOW - As Found: Unknown - ID: M227681 - Name: Parecoxib - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M4213 - Name: Anti-Arrhythmia Agents - Relevance: LOW - As Found: Unknown - ID: M23177 - Name: Sodium Channel Blockers - Relevance: LOW - As Found: Unknown - ID: M30025 - Name: Diuretics, Potassium Sparing - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000008012 - Term: Lidocaine - ID: D000000700 - Term: Analgesics ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420375 **Acronym:** TURTLE **Brief Title:** Treatment of UC With Novel Therapeutics **Official Title:** Treatment of Ulcerative Colitis With Novel Therapeutics #### Organization Study ID Info **ID:** Unknown (Pending approval 2.0) #### Organization **Class:** OTHER **Full Name:** Brigham and Women's Hospital ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Brigham and Women's Hospital #### Responsible Party **Investigator Affiliation:** Brigham and Women's Hospital **Investigator Full Name:** Joshua Korzenik **Investigator Title:** MD-Director, Brigham and Women's Hospital Crohn's and Colitis Center **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with active mild ulcerative colitis. Participation in this study will take 12 weeks long and the study is structured as a crossover study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 7 study visits, all of which will be conducted at a study site. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool and urine sample for a few lab tests throughout the study. ### Conditions Module **Conditions:** - Ulcerative Colitis Mild - Ulcerative Colitis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** This is a crossover study in which each participant will receive active medication for a period of time and placebo for a period of time. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** This is a double-blinded study. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 18 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In Group 1 of the study, subjects will take oral study drug at 2g twice daily, PO (4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 2 of the study, subjects will take oral study drug at 2g twice daily, PO (4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 2.5g dose of study drug at initiation. In Group 3 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective. **Intervention Names:** - Drug: BRS201 **Label:** Active Comparator: BRS201 Arm **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** In Group 1 of the study, subjects will take oral placebo at 2g twice daily, PO (4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. In Group 2 of the study, subjects will take oral placebo at 2g twice daily, PO (4g daily) with 120mg oral butyrate twice daily (240mg daily) for 4 weeks. Subjects will also receive a one time 100mg dose of cyanocobalamin at initiation. In Group 3 of the study, subjects will repeat the previous conditions of the group that proves to be the most effective. **Intervention Names:** - Drug: Placebo **Label:** Placebo Comparator: Placebo Arm **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Active Comparator: BRS201 Arm **Description:** Groups 1, 2, and 3 will all contain 6 subjects each, with each subject receiving active study drug and placebo in a 2:1 randomized order; 4 will receive active treatment for the first for four weeks followed by placebo for four weeks, while the remaining 2 will receive placebo for four weeks followed by active treatment for four weeks. **Name:** BRS201 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo Comparator: Placebo Arm **Description:** Groups 1, 2, and 3 will all contain 6 subjects each, with each subject receiving active study drug and placebo in a 2:1 randomized order; 4 will receive active treatment for the first for four weeks followed by placebo for four weeks, while the remaining 2 will receive placebo for four weeks followed by active treatment for four weeks. **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The primary endpoint for this study is the capacity of study drug to normalize fecal calprotectin levels from baseline (week 0) compared to end of active treatment (4 weeks). **Measure:** Normalization of fecal calprotectin lab measurements **Time Frame:** 4 weeks #### Secondary Outcomes **Description:** Clinical symptoms assessed by SCCAI which measures patient reported outcomes on a scale of 0 to 19, where a higher score indicates more severe activity and active disease is a score of 5 or more. **Measure:** Simple Clinical Colitis Activity Index (SCCAI) **Time Frame:** 12 weeks **Description:** Correlation between changes in plasma nitrite, nitrate or nitrosothiol levels and fecal calprotectin **Measure:** Plasma nitrite, nitrate, or nitrosothiol **Time Frame:** 8 weeks **Description:** Reduction in fecal calprotectin to \< ULN at the end of active treatment **Measure:** Reduction in fecal calprotectin lab measurements **Time Frame:** 4 weeks **Description:** Change in partial Mayo scores from baseline to end of active treatment. The partial Mayo score measures disease activity on a scale of 0 to 9, where a higher score indicates more severe disease activity and a score of 1 or less indicated remission. **Measure:** Partial Mayo score **Time Frame:** 4 weeks **Description:** Analysis of urine for measurement of thiosulfate, thiocyanate, nitrate and nitrite **Measure:** Measurement of sulfur metabolites in urine **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ability to give consent * Patients with a confirmed diagnosis of UC for \> 3 months * History of ≥ 15 cm of colonic involvement as confirmed by colonoscopy * Disease activity based on calprotectin \> 200 * Allowed medications: mesalamine and sulfasalazine * Total Mayo score of \> 5 * Patients with primary sclerosing cholangitis are eligible to enroll Exclusion Criteria: * History of uncontrolled hypertension with systolic BP \> 140 and systolic BP \> 90 * Chronic kidney disease as defined by GFR \<60mL/min * Impaired hepatic function (transaminases elevated \> 2.5 x ULN) unless due to PSC * Evidence of C. difficile (Negative test result within 1 month is acceptable) * Infectious Colitis or drug induced colitis * Crohn's Disease or Indeterminate colitis * Decompensated liver disease * Patients who are pregnant or breastfeeding * Use of rectal therapies * Patients who have a confirmed malignancy or cancer within 5 years * Congenital or acquired immunodeficiencies * Other comorbidities including: Diabetes mellitus, systemic lupus * High likelihood of colectomy in the next 2 months * Participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trial * Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease * Prohibited medications: Vitamin C, prednisone, immune modulators (including but not limited to azathioprine, 6-mercaptopurine, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, interleukin-10, interleukin-11, and Omvoh or mirikizumab-mrkz) and biologics within the past six weeks including anti-TNF agents within the past six weeks, vedolizumab within the past six weeks, ustekinumab Risankizumab), a JAKi (tofacitinib or upadacitinib), or Velsipity (etrasimod) within the past 6 weeks. (The aim is to treat people who are having disease activity and just on mesalamine.) **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jkorzenik@bwh.harvard.edu **Name:** Joshua Korzenik, MD **Phone:** 617 732-6389 **Role:** CONTACT **Contact 2:** **Email:** sellis13@bwh.harvard.edu **Name:** Siani Ellis **Phone:** 617-396-7703 **Role:** CONTACT #### Locations **Location 1:** **City:** Chestnut Hill **Contacts:** ***Contact 1:*** - **Email:** sellis13@bwh.harvard.edu - **Name:** Siani Ellis - **Phone:** 617-396-7703 - **Role:** CONTACT ***Contact 2:*** - **Email:** smitchell22@bwh.harvard.edu - **Name:** Sophie Mitchell - **Role:** CONTACT ***Contact 3:*** - **Name:** Joshua Korzenik, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Brigham and Women's Hospital **State:** Massachusetts **Zip:** 02467 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000010335 - Term: Pathologic Processes - ID: D000015212 - Term: Inflammatory Bowel Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M17206 - Name: Ulcer - Relevance: HIGH - As Found: Ulcerative - ID: M6320 - Name: Colitis - Relevance: HIGH - As Found: Colitis - ID: M6321 - Name: Colitis, Ulcerative - Relevance: HIGH - As Found: Ulcerative Colitis - 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: M6336 - Name: Colonic Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M17917 - Name: Inflammatory Bowel Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003092 - Term: Colitis - ID: D000003093 - Term: Colitis, Ulcerative - ID: D000014456 - Term: Ulcer ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Hemat - Name: Hematinics - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Vi - Name: Vitamins ### Intervention Browse Module - Browse Leaves - ID: M17548 - Name: Vitamin B 12 - Relevance: LOW - As Found: Unknown - ID: M9934 - Name: Hydroxocobalamin - Relevance: LOW - As Found: Unknown - ID: M6263 - Name: Coal Tar - Relevance: LOW - As Found: Unknown - ID: T451 - Name: Methylcobalamin - Relevance: LOW - As Found: Unknown - ID: T476 - Name: Vitamin B12 - Relevance: LOW - As Found: Unknown - ID: T441 - Name: Cobalamin - Relevance: LOW - As Found: Unknown - ID: T444 - Name: Cyanocobalamin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420362 **Brief Title:** Blood Flow Restriction Training in Basketball Players **Official Title:** Examination of the Effect of Exercise Training With Upper Extremity Blood Flow Restriction on Upper Extremity Muscle Strength and Performance in Basketball Players #### Organization Study ID Info **ID:** 80-23-05 #### Organization **Class:** OTHER **Full Name:** Biruni University ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Biruni University #### Responsible Party **Investigator Affiliation:** Biruni University **Investigator Full Name:** Buket AKINCI **Investigator Title:** Assoc.Prof. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Blood Flow Restrictive Exercises (BFR) provide strength increase with less load than required for traditional muscle strengthening and power. As an alternative for populations that have difficulty training with high loads and speeds, low-intensity BFR training has been shown to improve muscle strength and aerobic parameters and to be safe, even in professional athletes and individuals with chronic diseases in various populations. The aim of our study is to examine the effects of BFR applied to the upper extremity on upper extremity muscle strength and performance in basketball players. **Detailed Description:** Basketball is a demanding sport that requires participants to display a high level of physical fitness and special sporting skills. Basketball requires a high level of anaerobic and aerobic conditioning and is not only a team sport, but also a sport that requires players to demonstrate their individual characteristics. In this regard, it is thought that the determination of performance components based on field tests is a more suitable method for determining the athletic levels of athletes with special needs. BFR, which aims to restrict blood flow to the muscle during exercise, is traditionally known as 'kaatsu'. Blood flow is restricted with a pressure-controlled and monitorable exercise belt produced for BFR. In order for the method to be successful, the tourniquet method must be applied to the proximal region of the extremity, and in this way, less blood flow to the muscle can actually be achieved. With BFR, it is recommended that the external pressure be made sufficient to restrict the arterial oxygen pressure between 40% and 80%, and it is thought that the effects of exercise increase in this hypoxic environment. In this way, it is sufficient to perform the exercises at 20% to 40% of the 1 maximum repetition, not 60-85%, which is normally required for muscle hypertrophy. An ischemic and hypoxic muscle environment during BFR; It has been hypothesized that it is produced to cause high levels of metabolic stress and mechanical tension. Both metabolic stress and mechanical tension have been described as "primary hypertrophy factors" and are theorized to activate other mechanisms for muscle growth. Strength training performed by restricting blood flow plays an important role in muscle hypertrophy by activating the endocrine system. It has been proven that low-intensity blood flow restriction training increases the plasma concentration of growth hormone more than normal exercises. BFR involves low-intensity resistance training and is placed on the proximal portion of the lower or upper extremity muscles to be worked with a bandage or cuff that restricts blood flow, providing appropriate superficial pressure. The aim of this study is to examine the effects of BFR applied to the upper extremity on upper extremity muscle strength and performance in basketball players. ### Conditions Module **Conditions:** - Basketball Players **Keywords:** - bloodflowrestriction - basketball - basketball performance - kaatsu training ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** While the basketball players continue their current basketball training; The 90-minute BFR program will be applied 3 sessions a week for 3 weeks. In the BFR program, biceps curls, triceps curls, shoulder presses, shoulder abduction exercises and sport-specific routine training will be applied. Exercises: 30% of 1 maximum repetition with resistance and 60% of arterial occlusion pressure restricted; Based on previous studies in the literature, the first set will be performed with 30 repetitions and the other three sets with 15 repetitions, a total of 4 sets and a 30-second rest between sets. There will be a 10-minute warm-up exercise before each BFR training and a 10-minute cool-down exercise at the end of the training. **Intervention Names:** - Other: Blood Flow Restriction **Label:** Blood Flow Restriction Training Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Initial evaluations will be made for all participants. Then, they will continue their routine basketball training programs for 3 weeks. **Label:** Routine Training **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Blood Flow Restriction Training Group **Description:** Before BFR training, a repetition maximal (1-RM) test will be determined by selecting a weight with which athletes can perform a maximum of 10 repetitions. The number of repetitions obtained here and the weight lifted will be written into the Brzycki formula, whose validity and reliability has been proven, and 1-TM will be calculated. Brzycki formula; 1-TM = \[100 x (Weight Lifted) / \[(102.78 - 2.78 x (Number of Reps)\] The arterial occlusion pressure of the participants will be measured with a Doppler Ultrasound device by increasing the cuff to the point where the auscultatory pulse of the brachial artery ceases until occlusion occurs in the brachial artery. Then, 60% of this value will be calculated and BFR will be performed during the exercises. **Name:** Blood Flow Restriction **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Bench Press 1RM test will be applied for upper extremity muscle strength. the athlete's 1RM weight will be determined. **Measure:** Bench press test **Time Frame:** Change from Baseline Bench press test at 3 weeks and 6 weeks **Description:** "Jamar (NY 10533)" brand dynamometer, one of the hydraulic measuring instruments, will be used to measure grip force. **Measure:** Hand Grip Strength **Time Frame:** Change from Baseline Hand Grip Strength at 3 weeks and 6 weeks #### Secondary Outcomes **Description:** A 20 m speed test will be applied to evaluate the speed of the participants. Running basketball players will be asked to run the 20-meter track at maximum level after starting. **Measure:** 20 m Sprint Test **Time Frame:** Change from Baseline Bench press test at 3 weeks and 6 weeks **Description:** T test will be applied to evaluate the agility of the participants.The best time of the participants will be recorded. **Measure:** T Agility Test **Time Frame:** Change from Baseline T Agility Test at 3 weeks and 6 weeks **Description:** A shooting test will be applied to evaluate the shooting skills of the athletes. Athletes will be asked to make 2 sets of free throws with 8 repetitions after the "Start" command from the starting position behind the foul (free throw) line. Total scores will be recorded at the end of the test. **Measure:** Free Throw Test **Time Frame:** Change from Baseline Free Throw Test at 3 weeks and 6 weeks **Description:** The modified Borg CR10 scale will be used to evaluate perceived fatigue. **Measure:** Fatigue Assessment **Time Frame:** immediately after each BFR session ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being between the ages of 18-25, * Having been attending training regularly for at least one year, * Having been playing basketball as a licensed player for at least 3 months, * Male athletes, * Volunteering to participate in the study Exclusion Criteria: * Individuals with orthopedic or neurological disabilities that may prevent the exercise test, * Individuals who have had a sports injury in the last 6 months, * Not actively participating in training, * Taking a break from sports * Individuals with inadequate cooperation **Healthy Volunteers:** True **Maximum Age:** 25 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** bakinci@biruni.edu.tr **Name:** Buket AKINCI, Assoc.Prof. **Phone:** +90 212 409 12 12 **Phone Ext:** 1208 **Role:** CONTACT **Contact 2:** **Email:** berdemerdemb@gmail.com **Name:** Busra ERDEM, PT **Phone:** +90 530 084 18 51 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Biruni University **Name:** Buket AKINCI, Assoc.Prof. **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** The data will be shared during the publication process if the journal will ask. **IPD Sharing:** UNDECIDED ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420349 **Brief Title:** NXP800 for the Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma **Official Title:** Phase 1b Study of the Novel GCN2 Kinase Activator NXP800 in Patients With Advanced Cholangiocarcionoma #### Organization Study ID Info **ID:** MC230406 #### Organization **Class:** OTHER **Full Name:** Mayo Clinic #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2024-03613 **Type:** REGISTRY **Domain:** Mayo Clinic in Arizona **ID:** MC230406 **Type:** OTHER **Domain:** Mayo Clinic Institutional Review Board **ID:** 23-012778 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-31 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Mayo Clinic #### 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 phase I trial tests the safety, best dose, and effectiveness of NXP800 in treating patients with cholangiocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). NXP800 inhibits a pathway called the heat shock factor 1 (HSF1) pathway. The inhibition of this pathway inhibits proliferation, migration, survival, and metastasis in susceptible tumor cells. Overexpressed, amplified and/or overactivated in many cancer cells, HSF1 activates a set of genes that play a key role in tumor initiation, progression and metastasis. Inhibiting this pathway may in turn inhibit tumor initiation, progression, and/or metastasis. Giving NXP800 may be safe, tolerable and/or effective in treating patients with advanced or metastatic cholangiocarcinoma. **Detailed Description:** PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose (MTD)/recommended phase 2 dose for heat shock factor 1 pathway inhibitor NXP800 (NXP800). SECONDARY OBJECTIVES: I. To determine the toxicity profile of NXP800. II. To determine the best response for NXP800 using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. III. To estimate the overall survival (OS) for NXP800. IV. To estimate the progression-free survival (PFS) for NXP800. EXPLORATORY OBJECTIVES: I. To evaluate transcriptomic features associated with sensitivity, resistance and pharmacodynamic effect of NXP800 using serial ribonucleic acid-sequencing (RNA-Seq). II. To assess tumor evolution with NXP800 using serial whole genome-sequencing (Seq). III. To assess tumor evolution with NXP800 using serial circulating tumor deoxyribonucleic acid (DNA) (ct-DNA). IV. To estimate tumor marker response using serial CA19-9/carcinoembryonic antigen (CEA). OUTLINE: This is a dose de-escalation study of NXP800 followed by a dose-expansion study. Patients receive NXP800 orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), and/or positron emission tomography (PET) at baseline and on study. Patients may optionally undergo ultrasound-guided liver biopsy and/or collection of blood samples on study and during follow up. After completion of study treatment, patients are followed up every 6 months until progressive disease or death for up to 3 years. ### Conditions Module **Conditions:** - Advanced Cholangiocarcinoma - Metastatic Cholangiocarcinoma - Refractory Cholangiocarcinoma - Stage III Hilar Cholangiocarcinoma AJCC v8 - Stage III Intrahepatic Cholangiocarcinoma AJCC v8 - Stage IV Hilar Cholangiocarcinoma AJCC v8 - Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients receive NXP800 PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or PET at baseline and on study. Patients may optionally undergo ultrasound-guided liver biopsy and/or collection of blood samples on study and during follow up. **Intervention Names:** - Procedure: Biospecimen Collection - Procedure: Computed Tomography - Biological: Heat Shock Factor 1 Pathway Inhibitor NXP800 - Procedure: Magnetic Resonance Imaging - Procedure: Positron Emission Tomography - Procedure: Ultrasound-Guided Biopsy **Label:** Treatment (NXP800) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment (NXP800) **Description:** Undergo collection of blood samples **Name:** Biospecimen Collection **Other Names:** - Biological Sample Collection - Biospecimen Collected - Specimen Collection **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Treatment (NXP800) **Description:** Undergo CT **Name:** Computed Tomography **Other Names:** - CAT - CAT Scan - Computed Axial Tomography - Computerized Axial Tomography - Computerized axial tomography (procedure) - Computerized Tomography - Computerized Tomography (CT) scan - CT - CT Scan - tomography **Type:** PROCEDURE #### Intervention 3 **Arm Group Labels:** - Treatment (NXP800) **Description:** Given PO **Name:** Heat Shock Factor 1 Pathway Inhibitor NXP800 **Other Names:** - CCT 361814 - CCT-361814 - CCT361814 - HSF1 Pathway Inhibitor NXP800 - NXP-800 - NXP800 - VK2019 **Type:** BIOLOGICAL #### Intervention 4 **Arm Group Labels:** - Treatment (NXP800) **Description:** Undergo MRI **Name:** Magnetic Resonance Imaging **Other Names:** - Magnetic Resonance - Magnetic Resonance Imaging (MRI) - Magnetic resonance imaging (procedure) - Magnetic Resonance Imaging Scan - Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance - MR - MR Imaging - MRI - MRI Scan - MRIs - NMR Imaging - NMRI - Nuclear Magnetic Resonance Imaging - sMRI - Structural MRI **Type:** PROCEDURE #### Intervention 5 **Arm Group Labels:** - Treatment (NXP800) **Description:** Undergo PET **Name:** Positron Emission Tomography **Other Names:** - Medical Imaging, Positron Emission Tomography - PET - PET Scan - Positron emission tomography (procedure) - Positron Emission Tomography Scan - Positron-Emission Tomography - proton magnetic resonance spectroscopic imaging - PT **Type:** PROCEDURE #### Intervention 6 **Arm Group Labels:** - Treatment (NXP800) **Description:** Undergo ultrasound-guided liver biopsy **Name:** Ultrasound-Guided Biopsy **Other Names:** - Ultrasound Biopsy - Ultrasound Guided Biopsy **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients. **Measure:** Maximum tolerated dose (MTD) **Time Frame:** Up to 12 months **Description:** Recommended phase 2 dose is based on MTD (Outcome 1). **Measure:** Recommended phase 2 dose **Time Frame:** Up to 12 months #### Secondary Outcomes **Description:** Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses. The grade 3+ adverse events will also be described and summarized in a similar fashion. **Measure:** Incidence of adverse events **Time Frame:** Up to 30 days after the administration of the last dose of study drug **Description:** Best response is defined to be the best objective status recorded. The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. The Response Evaluation Criteria in Solid Tumors 1.1 criteria will be used for tumor evaluation and patients will be re-evaluated every 8 weeks. Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population (overall and by dose level). The number of responses may indicate further evaluation for specific tumor types in a phase II setting. **Measure:** Best response **Time Frame:** Up to 3 years **Description:** OS will be estimated using the Kaplan-Meier method. The median OS and corresponding 95% confidence interval (by Brookmeyer and Crowley) will be reported. **Measure:** Overall survival (OS) **Time Frame:** Up to 3 years **Description:** PFS will be estimated using the Kaplan-Meier method. The median PFS and corresponding 95% confidence interval (by Brookmeyer and Crowley) will be reported. **Measure:** Progression-free survival (PFS) **Time Frame:** Up to 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 years * Histologically/cytologically confirmed biliary tract cancer * Advanced or metastatic disease that is refractory to gemcitabine or fluoropyrimidine based therapy, or if there is intolerance to these regimens * Measurable disease by RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Anticipated life expectancy of \> 12 weeks * Hemoglobin ≥ 9.0 g/dL (obtained ≤ 14 days prior to registration) * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 14 days prior to registration) * Platelet count ≥ 100,000/mm\^3 (obtained ≤ 14 days prior to registration) * Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration) * Alanine aminotransferase (ALT) ≤ 2.5 x ULN (obtained ≤ 14 days prior to registration) * Total bilirubin ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration) * Serum creatinine ≤ 1.5 x ULN (obtained ≤ 14 days prior to registration) * Provide written informed consent * Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Willing to use a highly effective method of contraception from the first dose of study medication through 180 days after the last dose of study medication, for persons of childbearing potential or persons able to father a child only * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) Exclusion Criteria: * Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown: * Pregnant persons. * Nursing persons. * Persons of childbearing potential who are unwilling to employ adequate contraception * Systemic anti-neoplastic therapy or radiation therapy ≤ 14 days prior to registration * Major surgical procedure ≤ 28 days prior to registration * Ongoing therapy related events \> grade 2 * Presence of another primary malignancy not in remission * New York Heart Classification 3 or greater heart failure * QT/corrected QT (QTc) interval \> 470 ms using Fredericia's QT correction formula * Uncontrolled brain metastatic disease * Uncontrolled infection * Any other comorbidities within the opinion of the investigator interfere with the investigation of the protocol * Usage of drugs that strongly inhibit or induce CYP3A4 ≤ 7 days prior to registration and for the duration of NXP800 dosing. Drugs that are low, medium, or other inhibitors of CYP3A4 are not prohibited and should be used with caution. Drugs that inhibit BCRP are not prohibited but should be used with caution, since NXP800 was found to be a BCRP substrate * Usage of seville oranges, grapefruit or grapefruit juice or products ≤ 7 days prior to registration and for the duration of NXP800 dosing * Unwillingness to follow study related procedures * Inability to provide informed consent **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mayocliniccancerstudies@mayo.edu **Name:** Clinical Trials Referral Office **Phone:** 855-776-0015 **Role:** CONTACT #### Locations **Location 1:** **City:** Scottsdale **Contacts:** ***Contact 1:*** - **Email:** mayocliniccancerstudies@mayo.edu - **Name:** Clinical Trials Referral Office - **Phone:** 855-776-0015 - **Role:** CONTACT ***Contact 2:*** - **Name:** Mitesh J. Borad, M.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Mayo Clinic in Arizona **State:** Arizona **Zip:** 85259 #### Overall Officials **Official 1:** **Affiliation:** Mayo Clinic **Name:** Mitesh J. Borad, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** Mayo Clinic Clinical Trials **URL:** https://www.mayo.edu/research/clinical-trials ## Derived Section ### Condition Browse Module - Ancestors - ID: D000000230 - Term: Adenocarcinoma - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M20426 - Name: Cholangiocarcinoma - Relevance: HIGH - As Found: Cholangiocarcinoma - ID: M20430 - Name: Klatskin Tumor - Relevance: HIGH - As Found: Hilar Cholangiocarcinoma - ID: M3585 - Name: Adenocarcinoma - Relevance: LOW - As Found: Unknown - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T755 - Name: Bile Duct Cancer - Relevance: HIGH - As Found: Cholangiocarcinoma - ID: T3241 - Name: Klatskin Tumor - Relevance: HIGH - As Found: Hilar Cholangiocarcinoma - ID: T3096 - Name: Intrahepatic Cholangiocarcinoma - Relevance: HIGH - As Found: Intrahepatic Cholangiocarcinoma ### Condition Browse Module - Meshes - ID: D000018281 - Term: Cholangiocarcinoma - ID: D000018285 - Term: Klatskin Tumor ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420336 **Brief Title:** QL vs LAI for Palatoplasty **Official Title:** Quadratus Lumborum Block for Pain Control in Unilateral Anterior Iliac Bone Graft Harvesting for Pediatric Patients Undergoing Palatoplasty: a Prospective Randomized Control Trial #### Organization Study ID Info **ID:** Pro00136697 #### Organization **Class:** OTHER **Full Name:** Medical University of South Carolina ### Status Module #### Completion Date **Date:** 2026-07-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Medical University of South Carolina #### Responsible Party **Investigator Affiliation:** Medical University of South Carolina **Investigator Full Name:** Nicole McCoy **Investigator Title:** Assistant Professor-Faculty **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study will consist of patients ages 6-18 who are undergoing a surgery on the hard or soft palate of the mouth (palatoplasty), with removal of bone from the front of the hip (anterior iliac bone graft harvesting). The patients will be randomized to receive either a unilateral QL block by an anesthesiologist, or local anesthetic infiltration at the surgical incision by the surgeon. The primary aim will be assessing post-operative pain in the first 48 hours after surgery. Secondary outcomes will include pain medication use in the first 48 hours after surgery, block resolution time, and evaluating any complications associated with the QL block or local anesthetic infiltration. ### Conditions Module **Conditions:** - Post-operative Pain - Opioid Use - Cleft Palate ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 46 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After induction of anesthesia and securement of appropriate airway device, the patient will be placed in position for the QL block. Using ultrasound guidance, the pediatric anesthesiology attending will perform unilateral QL block on the side of the anterior iliac bone graft harvest. The dose will be 0.2% ropivacaine, 1 mL per kilogram to a max of 20 mL with an additive of dexamethasone 4 mg. Ultrasonography will be used to identify external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A 50 mm-150 mm block needle will be advanced under ultrasound guidance. Ropivacaine will be injected slowly with frequent aspiration to rule out incorrect needle placement. The anesthetic is deposited at the lateral edge of the QL after penetrating the transversus abdominus aponeurosis. Injection will continue to be observed with real time US guidance. **Intervention Names:** - Procedure: Quadratus lumborum block **Label:** Quadratus lumborum block **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Patient will undergo induction of anesthesia as deemed appropriate by the attending pediatric anesthesiologist assigned to the case. After induction of anesthesia and securement of appropriate airway device the patient will be turned over to the surgical team to proceed with the operation. The surgeon will proceed with usual injection of local anesthetic as their standard of care; this medication will be charted by the circulating nurse in the Medication Administration Record with local anesthetic type and amount. At the conclusion of the procedure, to maintain the blind, the patient will have a bandage placed where the QL block would have been performed. **Intervention Names:** - Procedure: Local anesthetic infiltration **Label:** Local anesthetic infiltration **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Quadratus lumborum block **Description:** After induction of anesthesia and securement of appropriate airway device, the patient will be placed in position for the QL block. Using ultrasound guidance, the pediatric anesthesiology attending will perform unilateral QL block on the side of the anterior iliac bone graft harvest. The dose will be 0.2% ropivacaine, 1 mL per kilogram to a max of 20 mL with an additive of dexamethasone 4 mg. Ultrasonography will be used to identify external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A 50 mm-150 mm block needle will be advanced under ultrasound guidance. Ropivacaine will be injected slowly with frequent aspiration to rule out incorrect needle placement. The anesthetic is deposited at the lateral edge of the QL after penetrating the transversus abdominus aponeurosis. Injection will continue to be observed with real time US guidance. **Name:** Quadratus lumborum block **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Local anesthetic infiltration **Description:** After induction of anesthesia and securement of appropriate airway device the patient will be turned over to the surgical team to proceed with the operation. The surgeon will proceed with usual injection of local anesthetic as their standard of care; this medication will be charted by the circulating nurse in the Medication Administration Record with local anesthetic type and amount. At the conclusion of the procedure, to maintain the blind, the patient will have a bandage placed where the QL block would have been performed. **Name:** Local anesthetic infiltration **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Using the Wong-Baker FACES Pain Rating Scale, patients will report their average pain from 0 hours post-op through 48-hours post-op at various intervals. In the Post-Anesthesia Recovery Unit, pain scores will be evaluated every 15 minutes as clinically able, until discharged from the PACU. On Post-Op Day 1 at 9:00 am, pains average pain score from discharge to PACU to midnight will be reported. At approximately 24-hours after surgery ends, pain scores from midnight to 23-hours post-op will be reported, then at the 48-hour post-op mark, pain scores from 24-hr post op to 48-hour post-op time will be recorded. **Measure:** Pain Scores **Time Frame:** 0-48 hours after surgery ends #### Secondary Outcomes **Description:** Subjects will report the date and time that resolution of numbness over operative hip occurs or feeling of pain in operative hip returns. **Measure:** Time to block resolution **Time Frame:** up to 7 days after surgery ends **Description:** Total morphine milligram equivalents (MME) will be calculated from pre-op to 48-hours after surgery ends. **Measure:** Opioid Consumption up to 48 hours after surgery ends **Time Frame:** From the pre-operative phase up to 48 hours after surgery ends **Description:** Complications associated with study participation will be evaluated. **Measure:** Number of complications associated with each intervention **Time Frame:** From the time the intervention is administered up to 48-hours after surgery ends. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria * Patients undergoing palatoplasty with autologous bone graft from the anterior iliac crest. * Ages 6-18 years of age * Planned admission post-op * ASA Status Range: 1-3 Exclusion Criteria * Contraindication to QL blocks or LAI which may include: * overlying infection skin at the block needle insertion site * coagulopathies * known bleeding disorders * Allergy to local anesthetic * Cognitive or developmental impairment that would limit ability to report pain. * Non-English Speaking/Writing * Subjects or their parent/guardian unable or choose to not give informed consent/assent. **Maximum Age:** 18 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** nitchie@musc.edu **Name:** Haley Nitchie, MHA **Phone:** 843-792-1869 **Role:** CONTACT #### Locations **Location 1:** **City:** Charleston **Contacts:** ***Contact 1:*** - **Email:** nitchie@musc.edu - **Name:** Haley Nitchie, MHA - **Phone:** 843-792-1869 - **Role:** CONTACT **Country:** United States **Facility:** Medical University of South Carolina **State:** South Carolina **Zip:** 29425 #### Overall Officials **Official 1:** **Affiliation:** Medical University of South Carolina **Name:** Nicole McCoy, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000007569 - Term: Jaw Abnormalities - ID: D000007571 - Term: Jaw Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000019767 - Term: Maxillofacial Abnormalities - ID: D000019465 - Term: Craniofacial Abnormalities - ID: D000009139 - Term: Musculoskeletal Abnormalities - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000009056 - Term: Mouth Abnormalities - ID: D000009059 - Term: Mouth Diseases - ID: D000018640 - Term: Stomatognathic System Abnormalities - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Post Operative Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M6207 - Name: Cleft Palate - Relevance: HIGH - As Found: Cleft Palate - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M10599 - Name: Jaw Abnormalities - Relevance: LOW - As Found: Unknown - ID: M10601 - Name: Jaw Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M21671 - Name: Maxillofacial Abnormalities - Relevance: LOW - As Found: Unknown - ID: M21420 - Name: Craniofacial Abnormalities - Relevance: LOW - As Found: Unknown - ID: M12096 - Name: Musculoskeletal Abnormalities - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M12016 - Name: Mouth Abnormalities - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M20727 - Name: Stomatognathic System Abnormalities - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002972 - Term: Cleft Palate - ID: D000010149 - Term: Pain, Postoperative ### Intervention Browse Module - Ancestors - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: AnEm - Name: Antiemetics - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M7102 - Name: Dexamethasone - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: HIGH - As Found: Process - ID: M1700 - Name: Ropivacaine - Relevance: LOW - As Found: Unknown - ID: M4109 - Name: Anesthetics, Local - Relevance: HIGH - As Found: Influenza Vaccine - ID: M235549 - Name: Dexamethasone acetate - Relevance: LOW - As Found: Unknown - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000000777 - Term: Anesthetics - ID: D000000779 - Term: Anesthetics, Local ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420323 **Brief Title:** NovoX®Cup as Primary Dressing After Breast Reduction **Official Title:** NovoX® Cup as Primary Dressing After Breast Reduction: an Intra-individual Comparison Between Standard of Care and Oxygen-enriched Olive Oil Bra Cup #### Organization Study ID Info **ID:** NOVOX CUP #### Organization **Class:** INDUSTRY **Full Name:** MOSS S.p.A. ### Status Module #### Completion Date **Date:** 2025-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** MOSS S.p.A. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Breast reduction is one of the most frequently performed plastic surgeries. Studies have shown that breast reduction surgery significantly improves the patients' suffering and leads to a better health-related quality of life.However, as in every surgery, there can be complications. Wound disorders, such as open wounds and skin loss account for the most commonly encountered postoperative complications. NovoX® Cup is a new single-use wound dressing that is shaped cupular in order to tightly adapt to the breast anatomy. It is internally coated with oxygen-enriched oil releasing reactive oxygen species and is free from active pharmaceutical ingredients. It is intended, among other indications, for the use in surgical wounds after oncological breast surgery, breast reconstruction and cosmetic breast surgery. In two studies, a total of 140 patients (surgical wounds after breast augmentation-mastopexy, mammary lesions) were treated successfully with NovoX® Cup and no product-related adverse events were reported.The claimed advantages sound promising but an advantage compared to established wound dressings such as sterile strips or tapes has still to be investigated. The aim of the following study is to compare the outcomes (postoperative complications, scar quality and patients' satisfaction) of breast reduction and application of the wound dressing NovoX® Cup in comparison to already established wound closure systems 2 weeks and 3 months after surgery. ### Conditions Module **Conditions:** - Wound Healing Disorder - Post-Surgical Complication - Mammaplasty **Keywords:** - Surgical wounds - Breast surgery - Plastic surgery - Oxygen-enriched oil - Dressing - Wound healing - Scar quality - postoperative complications - Breast reduction ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patient gets treated with NovoX® Cup for 2 weeks. **Intervention Names:** - Device: Treatment with NovoX® Cup **Label:** Treatment with NovoX® Cup **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patient gets treated with Omnistrip® for 2 weeks. **Intervention Names:** - Device: Treatment with Omnistrip® **Label:** Treatment with Omnistrip® **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment with NovoX® Cup **Description:** NovoX® Cup treatment **Name:** Treatment with NovoX® Cup **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Treatment with Omnistrip® **Description:** Omnistrip® treatment **Name:** Treatment with Omnistrip® **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** scar quality measured through VSS scale (total scores 0 to 13), higher scores indicate worse scar outcome **Measure:** Scar quality (Vancouver Scar Scale, VSS) **Time Frame:** 2 weeks and 3 months after surgery. **Description:** scar quality measured through POSAS scale (total scores 6 to 60), higher scores indicate worse scar outcome **Measure:** Scar quality (Patient and Observer Scar Assessment Scale, POSAS) **Time Frame:** 2 weeks and 3 months after surgery. **Description:** occurrence of wound healing disorders (yes/no) **Measure:** Wound healing disorder **Time Frame:** 2-weeks and 3 months post-surgery #### Secondary Outcomes **Description:** Pain evaluated with Numerical Scale Rating (NRS score 0 to 10) higher score indicates worse pain **Measure:** Pain (Numerical Scale Rating NRS) **Time Frame:** before surgery, 2-weeks and 3 months post-surgery **Description:** Clavien-Dindo-Classification (CDC grade I to V) of surgical complications, higher grade indicates higher severity of the complications **Measure:** Surgical Complications (Clavien-Dindo-Classification CDC) **Time Frame:** 3 months post-surgery **Description:** Breast-Q® questionnaire satisfaction with outcome (scores 0 - 100 for each breast), higher score indicates greater satisfaction **Measure:** Breast-Q® Outcome **Time Frame:** before surgery, 2 weeks and 3 months post-surgery **Description:** Breast-Q® questionnaire satisfaction with breasts (scores 0 - 100 for each breast), higher score indicates greater satisfaction **Measure:** Breast-Q® breasts **Time Frame:** before surgery, 2 weeks and 3 months post-surgery **Description:** Breast-Q® questionnaire satisfaction with nipples (scores 0 - 100 for each breast), higher score indicates greater satisfaction **Measure:** Breast-Q® nipples **Time Frame:** before surgery, 2 weeks and 3 months post-surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Written informed consent * Female patients 18 years and older * Patient able to give informed consent * Patients undergoing bilateral breast reduction Exclusion Criteria: * Absent informed consent * Patients from protected groups and those who are not personally able to give consent. * Patients younger than 18 years * Pregnancy (pregnancy test before enrollment) and breastfeeding women * Former radiation of the breast(s) * Former surgery at the operation site * Skin abnormalities in the operation area (e.g. burn scars) * Participation in other clinical trials during this study * Active malignant disease * Breast cancer history * Radiation or chemotherapy during the study period or up to 6 months before possible enrollment * Immune disease **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** mcolombo@moss-info.it **Name:** Maurizio Colombo, Ph.D. **Phone:** +39 345 9070415 **Role:** CONTACT #### Locations **Location 1:** **City:** Graz **Contacts:** ***Contact 1:*** - **Email:** Lars.kamolz@medunigraz.at - **Name:** Lars-Peter Kamolz, Prof. - **Phone:** +43 316 385 14685 - **Role:** CONTACT ***Contact 2:*** - **Name:** Lars P. Kamolz, Prof. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Andrzej Hecker, Dr.med.univ. - **Role:** SUB_INVESTIGATOR ***Contact 4:*** - **Name:** Maximilian Moshammer, Dr.med.univ. - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Anna-Lisa Pignet, Dr.med.univ. - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Marlies Schellnegger, Dr.med.univ. - **Role:** SUB_INVESTIGATOR **Country:** Austria **Facility:** Division of Plastic, Aesthetic & Reconstructive Surgery, Department of Surgery, Medical University of Graz **Zip:** A-8036 #### Overall Officials **Official 1:** **Affiliation:** Medical University of Graz, Austria **Name:** Lars-Peter Kamolz, Prof. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M6160 - Name: Cicatrix - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M1112 - Name: Surgical Wound - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T242 - Name: Olive - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420310 **Acronym:** Pest-PD **Brief Title:** Pesticides and Parkinson´s Disease **Official Title:** Prevalence of Preclinical and Prodromal Parkinson´s Disease in Subjects Exposed to Pesticides #### Organization Study ID Info **ID:** GRS 2682/A1/2023 #### Organization **Class:** OTHER **Full Name:** Hospital Universitario de Burgos ### Status Module #### Completion Date **Date:** 2028-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospital Universitario de Burgos #### Responsible Party **Investigator Affiliation:** Hospital Universitario de Burgos **Investigator Full Name:** Esther Cubo **Investigator Title:** MD, PhD **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 project is to study whether people exposed to pesticides have a higher risk of developing PD. We will perform an epidemiological study determining the presence of pesticides in urine and comparing signs traditionally associated with PD in early forms. **Detailed Description:** Within different risk factors, pesticide exposure increases the risk of developing Parkinson's disease (PD) through epigenetic mechanisms by modifying the expression of genes related to PD and secondary mitochondrial dysfunction.We will conduct a cross-sectional prevalence study with cases (exposed to pesticides) and controls (not exposed to pesticides), randomly selecting 130 individuals in each group. Pesticide exposure will be determined through questionnaires.We will study the prevalence of preclinical and prodromal PD based on pesticide exposure, stratified by age and gender in the exposed, and non-exposed groups. Preclinical and prodromal PD will be assessed using: biological biomarkers and prodromal PD signs. Multivariate analyses will be employed to determine the risk of presenting early PD, adjusting for different clinical covariates. The results of this study will allow us to understand the early mechanisms associated with neurodegeneration and pesticides exposure. ### Conditions Module **Conditions:** - Pesticide-Induced Parkinsonism ### Design Module #### Bio Spec **Description:** Blood samples from cases and controls **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 260 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 3 Years ### Arms Interventions Module #### Arm Group 1 **Description:** Subjects exposed to pesticides **Intervention Names:** - Other: exposure to pesticides **Label:** Cases #### Arm Group 2 **Description:** Subjects without any exposure to pesticides **Intervention Names:** - Other: exposure to pesticides **Label:** Controls ### Interventions #### Intervention 1 **Arm Group Labels:** - Cases - Controls **Description:** based on work exposures to pesticides **Name:** exposure to pesticides **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Early non motor symptoms **Measure:** Prodromal PD **Time Frame:** over the last year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Farmers exposed to pesticides for cases * No work exposure to pesticides for controls Exclusion Criteria: * Subjects without signed consent form * Neurological significant conditions **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 45 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** Subjects not diagnosed with PD living in Burgos region ### Contacts Locations Module #### Locations **Location 1:** **City:** Burgos **Contacts:** ***Contact 1:*** - **Email:** mcubo@saludcastillayleon.es - **Name:** Esther Cubo, MD - **Phone:** +34947256533 - **Role:** CONTACT **Country:** Spain **Facility:** Hospital Universitario de Burgos **Status:** RECRUITING **Zip:** 09006 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001480 - Term: Basal Ganglia Diseases - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000009069 - Term: Movement Disorders - ID: D000080874 - Term: Synucleinopathies - ID: D000019636 - Term: Neurodegenerative Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases ### Condition Browse Module - Browse Leaves - ID: M13213 - Name: Parkinson Disease - Relevance: HIGH - As Found: Parkinson's Disease - ID: M22494 - Name: Parkinsonian Disorders - Relevance: HIGH - As Found: Parkinsonism - ID: M25603 - Name: Ganglion Cysts - Relevance: LOW - As Found: Unknown - ID: M16358 - Name: Synovial Cyst - Relevance: LOW - As Found: Unknown - ID: M4774 - Name: Basal Ganglia Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12029 - Name: Movement Disorders - Relevance: LOW - As Found: Unknown - ID: M2217 - Name: Synucleinopathies - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010300 - Term: Parkinson Disease - ID: D000020734 - Term: Parkinsonian Disorders ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420297 **Brief Title:** OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome **Official Title:** A Long-term, Open-label Extension Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome #### Organization Study ID Info **ID:** ACP-101-303 #### Organization **Class:** INDUSTRY **Full Name:** ACADIA Pharmaceuticals Inc. #### Secondary ID Infos **ID:** 2023-506201-19-00 **Type:** CTIS ### Status Module #### Completion Date **Date:** 2029-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2029-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-11 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** ACADIA Pharmaceuticals Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** To evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS **Detailed Description:** This is a long-term, OLE study to evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS. Subjects who complete the antecedent double-blind study (ACP-101-302) will be invited to participate in the present study. ### Conditions Module **Conditions:** - Hyperphagia in Prader-Willi Syndrome **Keywords:** - Opel-label extension - safety - tolerability ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 160 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Carbetocin nasal spray 3.2 mg three times daily (TID) **Intervention Names:** - Drug: Carbetocin **Label:** Drug: Carbetocin **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Drug: Carbetocin **Description:** Carbetocin nasal spray 3.2 mg three times daily (TID) **Name:** Carbetocin **Other Names:** - ACP-101 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Treatment-emergent adverse events (TEAEs) and device incidents or device malfunctions, TEAEs leading to discontinuation, TEAEs related to study drug, TEAEs by maximum severity, fatal TEAEs, treatment-emergent SAEs, and treatment-emergent SAEs related to study drug will all be summarized for all subjects as well as by previous treatment group. **Measure:** Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), withdrawals due to adverse events (AEs), potentially clinically important changes in other safety assessments, device incidents or device malfunctions **Time Frame:** Baseline to 36 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Has completed the Week12/EOT visit of the antecedent, Study ACP-101-302 * Met all entry criteria for the antecedent study * May benefit from long-term treatment with open-label carbetocin in the judgment of the Investigator. * Lives with a caregiver who understands and is willing and able to adhere to study-related procedures and is willing to participate in all study visits. Exclusion Criteria: * History of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. A history of febrile seizures is not exclusionary. * Active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder * History of suicide attempt or inpatient psychiatric hospitalization * Has a clinically significant abnormality in vital signs at Baseline * Has an average QTcF interval of \>450 ms on the Baseline ECG performed before the first dose of carbetocin is given in the present study (i.e., the ECG performed at the EOT visit of the antecedent study) * Has developed a clinically significant ECG finding during the antecedent study * Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met. **Maximum Age:** 30 Years **Minimum Age:** 5 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Nashville **Country:** United States **Facility:** Vanderbilt Clinical Research Center **State:** Tennessee **Zip:** 37232 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000008607 - Term: Intellectual Disability - ID: D000019954 - Term: Neurobehavioral Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000000015 - Term: Abnormalities, Multiple - ID: D000000013 - Term: Congenital Abnormalities - ID: D000025063 - Term: Chromosome Disorders - ID: D000030342 - Term: Genetic Diseases, Inborn - ID: D000096803 - Term: Imprinting Disorders - ID: D000009765 - Term: Obesity - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - 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: BC10 - Name: Nervous System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M14099 - Name: Prader-Willi Syndrome - Relevance: HIGH - As Found: Prader-Willi Syndrome - ID: M10014 - Name: Hyperphagia - Relevance: HIGH - As Found: Hyperphagia - ID: M11589 - Name: Intellectual Disability - 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: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M14 - Name: Abnormalities, Multiple - Relevance: LOW - As Found: Unknown - ID: M23023 - Name: Chromosome Disorders - Relevance: LOW - As Found: Unknown - ID: M23686 - Name: Genetic Diseases, Inborn - Relevance: LOW - As Found: Unknown - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M25307 - Name: Overnutrition - Relevance: LOW - As Found: Unknown - ID: M12684 - Name: Nutrition Disorders - Relevance: LOW - As Found: Unknown - ID: M15622 - Name: Signs and Symptoms, Digestive - Relevance: LOW - As Found: Unknown - ID: T4665 - Name: Prader-Willi Syndrome - Relevance: HIGH - As Found: Prader-Willi Syndrome ### Condition Browse Module - Meshes - ID: D000011218 - Term: Prader-Willi Syndrome - ID: D000013577 - Term: Syndrome - ID: D000006963 - Term: Hyperphagia ### Intervention Browse Module - Ancestors - ID: D000010120 - Term: Oxytocics - ID: D000012102 - Term: Reproductive Control Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M205821 - Name: Carbetocin - Relevance: HIGH - As Found: Acute Respiratory Distress ### Intervention Browse Module - Meshes - ID: C000020731 - Term: Carbetocin ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420284 **Brief Title:** Immunological Parameters Between MRONJ Stages **Official Title:** Characterization of Immunological Parameters in Different Clinical Stages of Medication-Related Osteonecrosis of the Jaw #### Organization Study ID Info **ID:** MU_DHF_MI_01 #### Organization **Class:** OTHER **Full Name:** Marmara University ### Status Module #### Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-02-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Marmara University #### Responsible Party **Investigator Affiliation:** Marmara University **Investigator Full Name:** Ferit Bayram **Investigator Title:** Assist. Prof. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to conduct a detailed analysis of the immunological response profiles that emerge at different clinical stages of medication-related osteonecrosis of the jaw (MRONJ). The research seeks to understand how these responses influence the pathogenesis, staging, and treatment of MRONJ. Throughout the study, cytokine levels, inflammation markers, and other immunological parameters observed at various stages will be comprehensively assessed. The results of these analyses are expected to provide insights into how stage-specific immunological variables could play a role in the diagnosis and treatment of MRONJ. ### Conditions Module **Conditions:** - Medication-Related Osteonecrosis of Jaw ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 42 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants in this group are receiving antiresorptive/antiangiogenic therapy and exhibit nonspecific symptoms but no exposed bone. This stage is considered a precursor stage, where the risk of developing MRONJ is present but not yet visible through exposed bone. **Label:** MRONJ Stage 0 #### Arm Group 2 **Description:** Individuals in this group are on antiresorptive/antiangiogenic therapy and show exposed bone without any symptoms. This stage represents the early manifestation of MRONJ, characterized by visible bone changes without associated pain or infection. **Label:** MRONJ Stage I #### Arm Group 3 **Description:** This group includes patients treated with antiresorptive/antiangiogenic agents, who have exposed bone accompanied by symptoms such as pain or infection but without extensive bone involvement. This stage indicates a progression in the severity of MRONJ. **Label:** MRONJ Stage II #### Arm Group 4 **Description:** Participants are undergoing antiresorptive/antiangiogenic treatment and exhibit exposed bone with symptoms, where the exposed bone extends beyond the alveolar bone, indicating advanced disease with significant bone and surrounding tissue involvement. **Label:** MRONJ Stage III #### Arm Group 5 **Description:** This group consists of individuals receiving antiresorptive/antiangiogenic therapy who do not yet show any exposed bone or symptoms. They are considered at risk for developing MRONJ and are monitored for any potential progression. **Label:** At-Risk Group #### Arm Group 6 **Description:** This control group comprises individuals who have not received antiresorptive/antiangiogenic therapy and show no signs of exposed bone or symptoms. This group serves to provide baseline data for comparing immunological parameters against those receiving treatment. **Label:** Healthy Control Group ### Outcomes Module #### Primary Outcomes **Description:** This outcome evaluates the proliferation capacity of peripheral blood mononuclear cells (PBMCs) isolated from the study participants. This analysis will help quantify and understand the dynamics of lymphocyte activation and proliferation in response to different clinical stages of MRONJ and potentially identify immunological differences that could inform therapeutic strategies. **Measure:** Lymphocyte Proliferation Analysis **Time Frame:** Baseline **Description:** This outcome assesses apoptosis in lymphocytes isolated from the peripheral blood of participants included in the study. This analysis aims to quantify apoptotic processes in lymphocytes, offering insights into cell death mechanisms under varying conditions of culture and potentially relating these mechanisms to the immunopathology of MRONJ. **Measure:** Apoptosis Analysis in Lymphocytes **Time Frame:** Baseline **Description:** This outcome measures the levels of specific cytokines as indicators of immunological response in MRONJ at different disease stages. The cytokines to be analyzed include IL-17, IL-2, IL-4, IL-6, IL-10, TNF-α, and IFN-γ. **Measure:** Cytokine Profile Analysis **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Individuals aged 18 and over * Both male and female participants * Individuals who apply to the Oral and Maxillofacial Surgery Clinic at Marmara University Faculty of Dentistry due to medication-related osteonecrosis of the jaw during the study period * Individuals or their legal representatives who have provided written consent to participate in the study Exclusion Criteria: * Non-drug-related osteonecrosis/osteomyelitis * Osteoradionecrosis * Metastasis to the oral region * Individuals who have not given written consent to participate in the study **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:** The study population for this research comprises adults aged 18 and older, both male and female, who present with medication-related osteonecrosis of the jaw (MRONJ) at the Oral and Maxillofacial Surgery Clinic of Marmara University Faculty of Dentistry. All participants must have provided written informed consent either personally or through a legal representative to be included in the study. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** ferit.bayram@marmara.edu.tr **Name:** Ferit Bayram, PhD **Phone:** 00902167775000 **Role:** CONTACT #### Locations **Location 1:** **City:** Istanbul **Contacts:** ***Contact 1:*** - **Email:** ferit.bayram@marmara.edu.tr - **Name:** Ferit Bayram, Ph. D. - **Phone:** 2167775074 - **Role:** CONTACT ***Contact 2:*** - **Name:** Tunç Akkoç, Prof. Dr. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Gül Emren, DDS - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Zeynep Tunca - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 5:*** - **Name:** Sabriye Senem Kılıç - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Turkey **Facility:** Marmara University School of Dentistry **Status:** RECRUITING **Zip:** 34854 #### Overall Officials **Official 1:** **Affiliation:** Marmara University Faculty of Dentistry **Name:** Ferit Bayram, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Ruggiero SL, Dodson TB, Aghaloo T, Carlson ER, Ward BB, Kademani D. American Association of Oral and Maxillofacial Surgeons' Position Paper on Medication-Related Osteonecrosis of the Jaws-2022 Update. J Oral Maxillofac Surg. 2022 May;80(5):920-943. doi: 10.1016/j.joms.2022.02.008. Epub 2022 Feb 21. **PMID:** 35300956 #### See Also Links **Label:** AAOMS MRONJ staging **URL:** https://www.aaoms.org/docs/govt_affairs/advocacy_white_papers/mronj_position_paper.pdf ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009336 - Term: Necrosis - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12943 - Name: Osteonecrosis - Relevance: HIGH - As Found: Osteonecrosis - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010020 - Term: Osteonecrosis ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M22318 - Name: Angiogenesis Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420271 **Acronym:** EtABeta **Brief Title:** Effects of Cerebellar tACS-iTBS in Ataxia **Official Title:** Effects of Combined Transcranial Electrical and Magnetic Stimulation of Cerebellum on Balance Function in Ataxia Patients #### Organization Study ID Info **ID:** 80/SL/23 #### Organization **Class:** OTHER **Full Name:** I.R.C.C.S. Fondazione Santa Lucia ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** I.R.C.C.S. Fondazione Santa Lucia #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Ataxia refers to a group of neurological disorders characterized by impaired coordination and balance due to dysfunction in the cerebellum or its connections. Traditional therapeutic approaches for ataxia have shown limited efficacy, prompting researchers to explore alternative interventions. Non-invasive brain stimulation (NIBS) techniques, such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and intermittent theta burst stimulation (iTBS), have emerged as potential therapeutic options. The aim of this study is to investigate the combined effect of tACS-iTBS on balance functions in ataxia disorders. ### Conditions Module **Conditions:** - Ataxia **Keywords:** - Non Invasive Brain Stimulation - Transcranial Magnetic Stimulation - Intermittent Theta Burst Stimulation - Transcranial Electrical Stimulation - Transcranial Alternating Current Stimulation - Exergaming ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** A randomized cross-over design will be used. A 3-weeks wash-out period will be observed between the two conditions (real and sham). ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 10 sessions of real 5Hz tACS with real iTBS + exergaming biofeedback, 5 times per weeks for two weeks. **Intervention Names:** - Device: Real (real iTBS/tACS + exergaming) **Label:** Real **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** 10 sessions of sham 5Hz tACS with sham iTBS + exergaming biofeedback, 5 times per weeks for two weeks. **Intervention Names:** - Device: Sham (sham iTBS/tACS + exergaming) **Label:** Sham **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Real **Description:** Stimulation will be applied to the cerebellum. The tACS session duration will be 190 seconds with a frequency of 5 Hz coupled with iTBS (coil positioned tangentially with respect to the scalp)(600 pulses consisting of bursts of 3 stimuli at 50 Hz, repeated at intervals of 200ms, with an intensity of 80% of active motor threshold -AMT-) (Huang et al., 2005) for a total duration of 190 seconds. The exergaming will be performed with an adaptive system, comprising a force platform connected to a computer. The system is designed to enhance standard balance rehabilitation programs by guiding the user's performance of prescribed physical exercises through a video interface. Patients will perform 3 different exercises (10 minutes of training for a total of 30 minutes): 1) latero-lateral load shift; 2) antero posterior load shift; 3) omnidirectional displacement (combined latero-lateral and antero-posterior loading). **Name:** Real (real iTBS/tACS + exergaming) **Other Names:** - real iTBS/tACS + exergaming **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Sham **Description:** Stimulation will be applied to the cerebellum. The tACS session duration will be 10 seconds with a frequency of 5 Hz coupled with sham iTBS (coil positioned perpendicularly with respect to the scalp)(600 pulses consisting of bursts of 3 stimuli at 50 Hz, repeated at intervals of 200ms, with an intensity of 80% of active motor threshold -AMT-) (Huang et al., 2005) for a total duration of 190 seconds. The exergaming will be performed with an adaptive system, comprising a force platform connected to a computer. The system is designed to enhance standard balance rehabilitation programs by guiding the user's performance of prescribed physical exercises through a video interface. Patients will perform 3 different exercises (10 minutes of training for a total of 30 minutes): 1) latero-lateral load shift; 2) antero posterior load shift; 3) omnidirectional displacement (combined latero-lateral and antero-posterior loading). **Name:** Sham (sham iTBS/tACS + exergaming) **Other Names:** - sham iTBS/tACS + exergaming **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** SARA is a clinical scale developed to assess a range of different impairments in cerebellar ataxia. The scale is made up of 8 items related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test. Score ranges from 0 to 40 where 40 indicates severe ataxia. **Measure:** Change in the Scale for the Assessment and Rating of Ataxia (SARA) **Time Frame:** Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2) **Description:** MICARS was developed to quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Score ranges from 0 to 120 where 120 indicates severe ataxia. **Measure:** Changes in the Modified International Cooperative Ataxia Rating Scale (MICARS) **Time Frame:** Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2) #### Secondary Outcomes **Description:** SF-36 is an outcome measure instrument that is often used, well-researched, self-reported measure of health. Scores range from 0 to 100 for each domain, where 100 indicates a more favorable health-state. **Measure:** Changes in the Short Form-36 Health Survey (SF-36) **Time Frame:** Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2) **Description:** Instrumented postural stability will be assessed using a 75 cm (length x width) static force platform (PlatformBPM 120, Physical Support Italia, Italy). The signals will be amplified and acquired using dedicated software (Physical Gait Software Vv. 2.66, Physical SupportItalia, Italy). The length of the center of pressure (CoP) trajectory (mm) will be measured as indicator of the postural stability. An increase in the length of CoP indicates a severe impairment in postural control. **Measure:** Changes in postural control **Time Frame:** Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2) **Description:** Twenty Motor evoked potentials (MEPs) will be collected from left and right primary motor cortex with single pulses of transcranial magnetic stimulation (TMS) set at 1 mV. An increase in the MEPs amplitude indicates an improvement in cortico-spinal activity. **Measure:** Changes in cortico-spinal excitability **Time Frame:** Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2) **Description:** CBI will be performed with two Magstim figure-of-eight coils (70 mm diameter), one placed over the primary motor cortex and the other centered over the contralateral cerebellar hemisphere, 3 cm lateral to the Inion with an upward current induced to the brain. For each CBI evaluation, we will record 20 TMS test stimuli (TS) over the M1 that were set at intensity to elicit an MEP ∼1 mV. In half of these trials, selected randomly, a TMS conditioning stimulus (CS) was delivered over the contralateral cerebellar hemisphere 5 ms prior to the TS at an intensity of 120% of the resting motor threshold (RMT). Thus, a total of 20 TS and 20 CS + TS pulses will be administered. CBI will be calculated as the ratio of the mean MEP amplitude in the CS + TS relative to TS. An increase in CBI indicates higher connectivity between the cerebellum and primary motor cortex. **Measure:** Change in Cerebellar Brain Inibition (CBI) **Time Frame:** Baseline (1), 2 weeks from baseline (1), Baseline (2), 2 weeks from baseline (2) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Confirmed diagnosis of ataxia based on clinical assessment and/or neuroimaging findings. 2. Stable medication regimen for at least four weeks prior to the study. 3. Sufficient cognitive ability to understand and comply with study instructions. Exclusion Criteria: 1. History of seizures. 2. Severe general impairment or concomitant diseases. 3. Intracranial metal implants. 4. Cardiac pacemaker. 5. Pregnancy status. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** g.koch@hsantalucia.it **Name:** Giacomo Koch, Prof. **Phone:** 0651501181 **Role:** CONTACT **Contact 2:** **Email:** v.pezzopane@hsantalucia.it **Name:** Valentina Pezzopane, MSc **Phone:** 0651501181 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Roma La Sapienza **Name:** Danny Spampinato, PhD **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** IRCCS Santa Lucia Foundation **Name:** Alex Martino Cinnera, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Spampinato D, Avci E, Rothwell J, Rocchi L. Frequency-dependent modulation of cerebellar excitability during the application of non-invasive alternating current stimulation. Brain Stimul. 2021 Mar-Apr;14(2):277-283. doi: 10.1016/j.brs.2021.01.007. Epub 2021 Jan 20. **PMID:** 33482375 **Citation:** Libri I, Cantoni V, Benussi A, Rivolta J, Ferrari C, Fancellu R, Synofzik M, Alberici A, Padovani A, Borroni B. Comparing Cerebellar tDCS and Cerebellar tACS in Neurodegenerative Ataxias Using Wearable Sensors: A Randomized, Double-Blind, Sham-Controlled, Triple-Crossover Trial. Cerebellum. 2024 Apr;23(2):570-578. doi: 10.1007/s12311-023-01578-6. Epub 2023 Jun 22. **PMID:** 37349632 **Citation:** Guerra A, Suppa A, Bologna M, D'Onofrio V, Bianchini E, Brown P, Di Lazzaro V, Berardelli A. Boosting the LTP-like plasticity effect of intermittent theta-burst stimulation using gamma transcranial alternating current stimulation. Brain Stimul. 2018 Jul-Aug;11(4):734-742. doi: 10.1016/j.brs.2018.03.015. Epub 2018 Mar 24. **PMID:** 29615367 **Citation:** Gong C, Long Y, Peng XM, Hu H, Chen J, Xiao L, Zhong YB, Wang MY, Luo Y. Efficacy and safety of noninvasive brain stimulation for patients with cerebellar ataxia: a systematic review and meta-analysis of randomized controlled trials. J Neurol. 2023 Oct;270(10):4782-4799. doi: 10.1007/s00415-023-11799-8. Epub 2023 Jul 17. **PMID:** 37460852 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020820 - Term: Dyskinesias - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000002526 - Term: Cerebellar Diseases - ID: D000001927 - Term: Brain Diseases - 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: M4565 - Name: Ataxia - Relevance: HIGH - As Found: Ataxia - ID: M5773 - Name: Cerebellar Ataxia - Relevance: HIGH - As Found: Ataxia - ID: M22574 - Name: Dyskinesias - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M5775 - Name: Cerebellar Diseases - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001259 - Term: Ataxia - ID: D000002524 - Term: Cerebellar Ataxia ### Intervention Browse Module - Browse Branches - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M16974 - Name: Triamcinolone - Relevance: LOW - As Found: Unknown - ID: M16975 - Name: Triamcinolone Acetonide - Relevance: LOW - As Found: Unknown - ID: M237966 - Name: Triamcinolone hexacetonide - Relevance: LOW - As Found: Unknown - ID: M209573 - Name: Triamcinolone diacetate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420258 **Brief Title:** Deeper Intubation Make Effects on Cervical Esophageal ESD **Official Title:** A Study on the Effectiveness and Safety of Intratracheal Deep Intubation Compared to Traditional Tracheal Intubation in Endoscopic Submucosal Dissection for Early Esophageal Cancer in the Cervical Esophagus: A Randomized Controlled Trial. #### Organization Study ID Info **ID:** K2023-10-008 #### Organization **Class:** OTHER **Full Name:** Fujian Provincial Hospital ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2022-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fujian Provincial Hospital #### Responsible Party **Investigator Affiliation:** Fujian Provincial Hospital **Investigator Full Name:** Wei Liang **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:** To compare the efficacy and safety of intratracheal deep intubation with traditional intubation in endoscopic submucosal dissection for early esophageal cancer in the cervical esophagus, and to follow up and assess their short-term clinical outcomes. **Detailed Description:** Forty patients with early esophageal cancer in the cervical esophagus scheduled for endoscopic submucosal dissection will be included. They will be randomly divided into two groups using sealed envelopes: approximately 20 patients in the intratracheal deep intubation group and 20 patients in the traditional intubation group. By comparing the operation time, perioperative complications, postoperative short-term complications, and other outcomes, we aim to elucidate the effectiveness and safety of deep intubation in endoscopic submucosal dissection for early esophageal cancer in the cervical esophagus. ### Conditions Module **Conditions:** - Carcinoma in Situ of Cervical Part of Esophagus **Keywords:** - Deep tracheal intubation - Cervical esophageal cancer - ESD ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Masking Description:** Each group allocation will be sealed in an opaque envelope with a code written on the outside. These sealed envelopes will be handed over to the researchers. When a study participant meets the inclusion and exclusion criteria upon entry into the study, they will be assigned a number. Subsequently, the corresponding envelope with the assigned number will be opened, and the intervention will be carried out according to the group allocation specified in the envelope. The treatment plan for each research participant will be determined by the generated random sequence. **Who Masked:** - PARTICIPANT - CARE_PROVIDER **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** After general anesthesia, endotracheal intubation was conducted using an ultrafine endoscope (GIF-XP260NS, Olympus Corp., Japan), which allows observation of the exact position and avoids blindness caused by laryngoscopy. To prevent balloon compression of the CE after inflating, the endotracheal intubation tube was inserted above the tracheal carina, roughly the upper thoracic esophagus **Intervention Names:** - Procedure: Deeper endotracheal intubation **Label:** Deeper endotracheal intubation **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** Conventional endotracheal intubation **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Deeper endotracheal intubation **Description:** After general anesthesia, endotracheal intubation was conducted using an ultrafine endoscope (GIF-XP260NS, Olympus Corp., Japan), which allows observation of the exact position and avoids blindness caused by laryngoscopy. To prevent balloon compression of the CE after inflating, the endotracheal intubation tube was inserted above the tracheal carina, roughly the upper thoracic esophagus. **Name:** Deeper endotracheal intubation **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Measure:** the rate of complete resection and postoperative stricture **Time Frame:** Seven days and three months after ESD procedure #### Secondary Outcomes **Measure:** ESD procedural time and other procedure-related complications **Time Frame:** During procedures and just after ESD procedure. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. The lesions mainly involve superficial esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia (HGIN) in the cervical esophagus; 2. There is no evidence of regional lymph node or distant metastasis on endoscopic ultrasound (EUS) or CT/MRI imaging; 3. Participants have a thorough understanding of this study and voluntarily sign the informed consent form. Exclusion Criteria: * 1. Patients who have received radiotherapy or chemotherapy before endoscopic submucosal dissection surgery; 2. Patients with severe comorbidities who are not suitable for endoscopic submucosal dissection surgery. **Maximum Age:** 80 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** 454202013@qq.com **Name:** Yanqin Xu, MD **Phone:** +86 13599382136 **Role:** CONTACT **Contact 2:** **Email:** fjsllw@163.com **Name:** Wei Liang, MD **Phone:** +86 18120888996 **Role:** CONTACT #### Locations **Location 1:** **City:** Fuzhou **Contacts:** ***Contact 1:*** - **Email:** fjsllw@163.com - **Name:** Wei Liang, MD - **Phone:** +86 18120888996 - **Role:** CONTACT **Country:** China **Facility:** Fujian Provintial Hospital **State:** Fujian **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** Fujian Provintial Hospital **Name:** Wei Liang, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M8088 - Name: Esophageal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5535 - Name: Carcinoma in Situ - Relevance: HIGH - As Found: Carcinoma in Situ - 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: T2141 - Name: Esophageal Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002278 - Term: Carcinoma in Situ ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31

## Protocol Section ### Identification Module **NCT ID:** NCT06420245 **Acronym:** REBOUND **Brief Title:** Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management **Official Title:** A Prospective, Post-market Randomized Controlled Trial (RCT) to Demonstrate the Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer (DFU) Wound Management #### Organization Study ID Info **ID:** LEGACYMED-001 #### Organization **Class:** INDUSTRY **Full Name:** Legacy Medical Consultants ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-18 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Legacy Medical Consultants #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if use of Orion TM, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot ulcers. The main question it aims to answer is the incidence of complete wound closure at the end of 12 weeks of treatment. Researchers will compare the outcomes between a group of people treated with standard wound care and another group treated with standard wound care in addition to the amniotic membrane allograft to see if the amniotic membrane allograft improves patient outcomes. Participants will visit their doctor weekly over a 12 week period, as per standard diabetic foot ulcer treatment procedures, and fill out a questionnaire measuring quality of life. **Detailed Description:** Lower extremity diabetic ulcers are a common complication affecting millions of people in the United States. The purpose of this study is to evaluate the clinical utility of Orion TM, a dual-layer amniotic membrane allograft, versus standard wound care in the management of diabetic foot ulcers. Amniotic membrane allografts are confirmed by the FDA Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the PHS Act as defined in 21 CFR Part 1271 for the management of diabetic foot ulcers. Investigators hypothesize that the group of participants who receive amniotic membrane allografts in addition to standard wound care will experience a faster rate and higher incidence of complete wound closure compared to standard wound care alone. For only partially healed wounds, investigators anticipate a statistically significant reduction in the size of the ulcer and improved quality of life for participants in the experimental arm compared to standard wound care alone. ### Conditions Module **Conditions:** - Diabetic Foot Ulcer **Keywords:** - amniotic membrane allograft ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - INVESTIGATOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Standard wound care procedures **Intervention Names:** - Procedure: Standard of Care (SOC) **Label:** Standard of Care (SOC) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Application of Orion TM amniotic membrane allograft in addition to standard wound care for DFUs **Intervention Names:** - Device: Orion TM Amniotic Membrane Allograft - Procedure: Standard of Care (SOC) **Label:** Amniotic Membrane plus Standard of Care **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Amniotic Membrane plus Standard of Care **Description:** The intervention is a sterile allograft made from dehydrated extracellular matrix, designed to promote wound healing by providing a reliable and protective wound covering. Amniotic membranes are hypothesized to promote healing in open wounds by serving as a scaffold to support native tissue ingrowth, encouraging angiogenesis, and limiting microbial spread. **Name:** Orion TM Amniotic Membrane Allograft **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Amniotic Membrane plus Standard of Care - Standard of Care (SOC) **Description:** Standard wound care entails surgical debridement to remove all necrotic tissue, screening for infection and probing of the wound for bone, application of a collagen alginate primary dressing, and off-loading using a removable diabetic offloading cam-walker. **Name:** Standard of Care (SOC) **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Percentage of enrolled study participants demonstrating 100% re-epithelialization of the index wound without leaking exudate at 12 weeks post-randomization. **Measure:** Incidence of Complete Wound Closure **Time Frame:** 12 weeks after randomization into study arm following a 4-week run-in period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subject age is between 50-80 years old 2. Presence of Wagner 1 DFU extending at least through the dermis provided it was below the aspect of the medial malleolus, and if multiple Wagner 1 DFUs present, then the largest ulcer was evaluated as the index ulcer in the study with other ulcers being more than 2 cm from the index 3. Index ulcer duration ≥4 weeks prior to the study screening but \<52 weeks as of the date of consent 4. Index ulcer area \>1.0 cm2 and \<25 cm2 at screening visit and first treatment visits 5. Index ulcer offloaded for ≥14 days prior to randomization 6. Affected foot had adequate circulation (defined as a dorsal transcutaneous oximetry measurement (TCOM) or a skin perfusion pressure measurement of ≥30 mmHg, OR an ankle brachial index (ABI) of ≥0.7 and ≤1.3 within 3 months of screening, OR arterial Doppler with a minimum of biphasic flow in the dorsalis pedis and posterior tibial vessels at the level of the ankle, OR a toe brachial index (TBI) of \>0.6) 7. Women of childbearing potential complied with contraception use and pregnancy tests for the study duration 8. Demonstration of understanding and willingness to participate in the study, ability to comply with the weekly visits and follow-up, and provided written informed consent. 9. Meets screening criteria 30 days following first run-in visit. Exclusion Criteria: 1. Index ulcer deemed to be caused by a medical condition other than diabetes 2. Index ulcer is potentially or confirmed by biopsy to be cancerous 3. Subject is afflicted with Raynaud's disease 4. Arterial ischemia is a potential cause of foot ulcerations 5. Presence of active osteomyelitis or bone infection as verified by x-ray within 30 days prior to randomization 6. An infected foot ulcer on the index foot requiring use of antibiotics; 7. Subject exhibits poor metabolic control (HbA1c ≥ 12.0) within 90 days of randomization 8. Participation in an investigational device or drug study currently or within 30 days of screening 9. More than 2 weeks of treatment with immunosuppressants, including systemic corticosteroids and/or topical steroids applied to the index ulcer surface within 1 month prior to screening, or are anticipated during study participation; 10. Treated with cytotoxic chemotherapy within one month prior to screening, or is anticipated during study participation 11. Index ulcer site has undergone radiation therapy 12. Presence of any condition which would seriously compromise the subject's ability to complete this study 13. Known history of poor adherence to medical therapy and/or clinic appointments 14. Subject is taking a selective COX-2 inhibitor 15. Subject has serum creatinine \> 3.0 mg/dL within 120 days of randomization 16. Subject is non-ambulatory 17. Failure to meet screening criteria within 30 days of first run-in visit, including index ulcer reduced in area by 20% or more after 28 days of SOC during the run-in period. **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** jennifer@legacymedicalconsultants.com **Name:** Jennifer Linksy **Phone:** 813-600-9290 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000003925 - Term: Diabetic Angiopathies - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000007871 - Term: Leg Ulcer - ID: D000012883 - Term: Skin Ulcer - ID: D000012871 - Term: Skin Diseases - ID: D000048909 - Term: Diabetes Complications - ID: D000003920 - Term: Diabetes Mellitus - ID: D000004700 - Term: Endocrine System Diseases - ID: D000003929 - Term: Diabetic Neuropathies - ID: D000005534 - Term: Foot Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M17206 - Name: Ulcer - Relevance: HIGH - As Found: Ulcer - ID: M19933 - Name: Diabetic Foot - Relevance: HIGH - As Found: Diabetic Foot - ID: M18919 - Name: Foot Ulcer - Relevance: HIGH - As Found: Foot Ulcer - ID: M7120 - Name: Diabetic Angiopathies - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M10883 - Name: Leg Ulcer - Relevance: LOW - As Found: Unknown - ID: M15686 - Name: Skin Ulcer - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M7115 - Name: Diabetes Mellitus - Relevance: LOW - As Found: Unknown - ID: M26004 - Name: Diabetes Complications - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M7124 - Name: Diabetic Neuropathies - Relevance: LOW - As Found: Unknown - ID: M8658 - Name: Foot Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000017719 - Term: Diabetic Foot - ID: D000016523 - Term: Foot Ulcer - ID: D000014456 - Term: Ulcer ### Misc Info Module - Version Holder: 2024-05-31