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We therefore wish to demonstrate that the protein and PUFA contents of the vitreous humour are different between eyes with retinal detachment and eyes not affected by retinal detachment after macular surgery (epiretinal membrane or macular hole). We would like to show that the vitreous PUFA content is lower in the macular surgery group due to the absence of photoreceptor apoptosis and the absence of dehiscence causing communication between the subretinal space (photoreceptors whose membranes are very rich in PUFAs) and the vitreous space. We also hope to identify changes in the protein composition of vitreous fluid in patients with retinal detachment, with overexpression of proteins involved in inflammation pathways.
In addition, we hypothesise that retinal omega-3 PUFA content is a factor influencing retino-vitreal proliferation and functional and anatomical recovery from retinal detachment. To this end, we will study the correlation between retinal PUFA-3 content and the clinical presentation and postoperative course of retinal detachment.
Finally, with the aim of identifying a serum marker for the prognostic evaluation of retinal detachment, we will use as a candidate a biomarker of retinal omega-3 PUFA content that we have developed in an Age-Related Macular Degeneration (AMD) model. We will analyse the correlation between this biomarker and levels of omega-3 PUFAs measured directly in the retina.
To do this, we will analyse intraoperative samples of vitreous humour, sub-retinal fluid and retinal fluid from patients undergoing vitrectomy for retinal detachment in the Ophthalmology Department of the Dijon University Hospital. A group of control patients will consist of patients operated on by vitrectomy for macular surgery (epiretinal membrane or macular hole) for whom a vitreous humour sample will also be taken.
Clinical information on the characteristics of the retinal detachment will be collected. During the consultation, the patient will be questioned about any history of dyslipidaemia and any current treatment, including the use of lipid-enriched food supplements. Post-operative follow-up with prospective collection of clinical and paraclinical data on anatomical and functional evolution will be carried out up to 6 months after the occurrence of retinal detachment.
A blood sample will be taken to establish a lipid profile in all patients. We will thus gain a better understanding of the changes in lipid and protein content in the vitreous humour, sub-retinal fluid and retina, and the demonstration of a link between the initial presentation and the postoperative anatomical and functional evolution of retinal detachment. This will provide a better understanding of the lipid-dependent mechanisms linked to inflammation and photoreceptor degeneration during retinal detachment, and will ultimately make it possible to develop new therapeutic strategies to improve visual prognosis. conditions: Rhegmatogenous Retinal Detachments studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 160 type: ESTIMATED name: Blood sampling name: vitreous sampling name: Sub-retinal fluid sampling name: Retinal tissue sampling measure: Molecular content of fatty acids and proteins in the vitreous humour of eyes operated on for retinal detachment and eyes operated on for macular surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Dijon Bourgogne city: Dijon zip: 21000 country: France name: Petra EID role: CONTACT phone: 0380295173 phoneExt: +33 email: [email protected] lat: 47.31667 lon: 5.01667 hasResults: False
<|newrecord|> nctId: NCT06347289 id: CHSD_0024_REA briefTitle: Refusal of Organ Donation: a Study of Psychological, Anthropological and Cultural Factors overallStatus: COMPLETED date: 2022-01-01 date: 2023-04-30 date: 2024-03-29 date: 2024-04-04 date: 2024-04-04 name: Centre Hospitalier de Saint-Denis class: OTHER name: Agence de La Biomédecine briefSummary: The Hospital of Saint Denis (HSD) has been involved for several years in the dynamics of organ donation. In spite of the evolution of the practices of coordination of the collection of samples, the rate of refusal of organ donation is increasing in our hospital, contrary to the rest of France.
Based on hypotheses derived from psychological and anthropological perspectives, this survey will provide first-hand information on the personal, family and cultural issues related to organ donation. It will be a question of identifying and locating individual and collective representations concerning death, its definition, and the associated symbols and rites. Based on the collection of these representations, we will be able to propose hypotheses of a psychological, social and anthropological nature on resistance to organ donation. conditions: Psychology conditions: Anthropology conditions: Refusal, Organ Donation studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ACTUAL measure: Demographic information measure: Demographic information measure: Demographic information measure: Demographic information sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hopitalier de Saint-Denis city: Saint-Denis state: Seine Saint Denis zip: 93200 country: France lat: 48.93326 lon: 2.36666 hasResults: False
<|newrecord|> nctId: NCT06347276 id: 2023-RW320-08 briefTitle: Cerebral Microembolization Associated With PFO Closure overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: China National Center for Cardiovascular Diseases class: OTHER_GOV briefSummary: This study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of PFO or ASD, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within PFO. conditions: Thrombosis Cardiac studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: PFO occluder; ASD occluder measure: De novo cerebral microembolization sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chaowu Yan status: RECRUITING city: Beijing state: Beijing zip: 100037 country: China name: Chaowu Yan, PhD and MD role: CONTACT phone: +861088398408 email: [email protected] name: Chaowu Yan, PhD and MD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06347263 id: PER 332 briefTitle: Clinical and Radiographic Evaluation of Using the Entire Papilla Preservation Technique With and Without Autogenous Bone Graft and Injectable Platelet Rich Fibrin in Treatment of Periodontal Intraosseous Defects overallStatus: RECRUITING date: 2024-04 date: 2025-04 date: 2025-04-30 date: 2024-04-04 date: 2024-04-04 name: Cairo University class: OTHER briefSummary: The goal of this Clinical trial is to evaluate the clinical and radiographic outcomes of using entire papilla preservation technique with and without autogenous bone and injectable platelet rich fibrin in treatment of isolated Intrabony defects in patients with stage III periodontitis. conditions: Isolated Intrabony Periodontal Defects in Patients With Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Blinding of the operator and patient is not applicable.
- Outcome assessor (primary and secondary outcomes) \& biostatistician will be blinded whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Entire papilla preservation technique measure: Clinical attachment level (CAL) gain change from baseline to 12 months measure: Linear bone fill change from baseline to 12 months sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of dentistry, Cairo University status: RECRUITING city: Cairo zip: 3753450 country: Egypt name: Nesma M Shemias, Ass Lecturer role: CONTACT email: [email protected] name: Manal M Hosny, Professor role: CONTACT email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06347250 id: SGB-Bulbar Palsy briefTitle: A Nerve Block Therapy for Bulbar Palsy Pharyngeal Dysphagia overallStatus: COMPLETED date: 2022-01-01 date: 2023-05-02 date: 2023-05-31 date: 2024-04-04 date: 2024-04-04 name: Babujinaya Cela class: OTHER_GOV briefSummary: This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group or the control group. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function. conditions: Bulbar Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 122 type: ACTUAL name: Nerve Block name: Lidocaine Hydrochloride name: routine therapy name: placebo block measure: The Functional Oral Intake Scale measure: Yale Pharyngeal Residue Severity Rating Scale measure: penetration-aspiration scale measure: Video fluoroscopic swallowing study measure: The Swallowing Quality of Life Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ZhenD No.1 Hos. city: Zhenzhou country: China lat: 32.28034 lon: 119.16999 hasResults: False
<|newrecord|> nctId: NCT06347237 id: NL84429.078.23 briefTitle: PsA Digital Phenotyping and Inflammation Drivers Study acronym: PDPID overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2025-12 date: 2024-04-04 date: 2024-04-04 name: Jolanda Luime class: OTHER name: University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences name: Aristotle University of Thessaloniki - Hipokrateion Hospital Thessaloniki name: Portuguese Society of Rheumatology - The Rheumatic Diseases Portuguese Registry (Reuma.pt) briefSummary: The goal of this observational study is to develop and internally validate a machine learning model for detecting flare using a digital biomarker and a machine learning model for predicting flare, in patients with psoriatic arthritis. The main questions it aims to answer are:
* In patients with psoriatic arthritis, is a digital biomarker capable of detecting a flare as compared to clinical defined flare by the rheumatologist?
* In patients with psoriatic arthritis, what factors trigger a psoriatic arthritis flare ?
Participants will be requested to:
* Install app on their phone
* Use a smartwatch
* Complete questionnaires
* Collect biological material conditions: Psoriatic Arthritis conditions: Flare Up, Symptom conditions: Psoriatic Arthritis Aggravated studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Absence of flare in patients measure: Minimal disease Activity (MDA) measure: Psoriatic Arthritis Disease Activity Score (PASDAS) measure: Disease Activity Psoriatic Arthritis (DAPSA) measure: Psoriatic Arthritis Impact of Disease (PsAID) measure: Morning stiffness measure: Keystroke dynamics measure: Screen time measure: Accelerometer data measure: Gyroscope sensor data measure: Steps count measure: Physical activity intensity and categories measure: Motion measure: Distance measure: Pulse Ox measure: Respiration measure: Body battery measure: Stress (digital) measure: Heart rate measure: Beat-to-beat intervals measure: Sleeping time measure: Sleeping type measure: Hand and feet photos measure: Hand and body movements videos measure: Medical history measure: Joint count measure: Enthesitis measure: Body surface area measure: Weight measure: Height measure: Abdominal circumference measure: ClASsification criteria for Psoriatic ARthritis (CASPAR) score measure: Demographics measure: VAS Pain measure: HAQ questionnaire measure: VAS patient global measure: PSAID questionnaire measure: SF-36 questionnaire measure: EQ5d questionnaire measure: Work Productivity and Activity Impairment (WPAI) questionnaire measure: Health care questionnaire measure: Patient Health Questionnaire (PHQ9) questionnaire measure: Perceived Stress Scale (PSS) measure: Global Rating of Change (GRoC) Scale measure: Life events questionnaire measure: Digital literacy questionnaire measure: Inflammatory blood marker measure: Genetic variants measure: Gut microbiome measure: Stress (cortisol levels) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06347224 id: BCFC-BCS-VIRTUAL2024 briefTitle: Both Column Fixation Corridor in Pelvic Surgery overallStatus: COMPLETED date: 2023-10-01 date: 2024-02-01 date: 2024-03-01 date: 2024-04-04 date: 2024-04-04 name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital class: OTHER_GOV briefSummary: The concepts of the Both Column Fixation Corridor (BCFC) and Both Column Screws (BCS) have emerged as innovative approaches in orthopedic surgery yet have not been extensively explored in the literature. This study aims to evaluate the feasibility and potential advantages of this novel screw fixation technique, thereby filling the existing gap in knowledge and establishing standards for its application. conditions: Acetabular Fractures studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 400 type: ACTUAL name: Virtual placement of lag screws in both columns of the acetabulum on 3D pelvic CT models. measure: Successful Visualization of Both Column Fixation Corridor (BCFC) and Placement of Both Column Screws (BCS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bakırköy Dr. Sadi Konuk Education and Research Hospital, Department of Orthopedics and Traumatology city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<|newrecord|> nctId: NCT06347211 id: Attikon Hospital briefTitle: "Hypotension Probability Indicator" in TAVI/MitraClip for Hypotension Management overallStatus: RECRUITING date: 2024-01-10 date: 2026-01-10 date: 2026-01-10 date: 2024-04-04 date: 2024-04-05 name: Attikon Hospital class: OTHER briefSummary: The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension. conditions: Hypotension During Surgery conditions: Prevention of Hypotension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Acumen IQ sensor with Hemosphere monitor incorporating the HPI algorithm measure: TWA hypotension (measured with Acumen IQ sensor) measure: Incidence of hypotension measure: Time spent in hypotension measure: Treatment choice (drugs/fluids) measure: Diagnostic guidance protocol deviations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Attikon Hospital status: RECRUITING city: Athens zip: 12462 country: Greece name: Orestis Milionis role: CONTACT phone: +306948333359 email: [email protected] name: Orestis Milionis role: PRINCIPAL_INVESTIGATOR name: Tatiana Sidiropoulou role: PRINCIPAL_INVESTIGATOR lat: 37.97945 lon: 23.71622 hasResults: False
<|newrecord|> nctId: NCT06347198 id: 20230807-02 briefTitle: Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer overallStatus: RECRUITING date: 2024-04-10 date: 2024-12-01 date: 2025-05-01 date: 2024-04-04 date: 2024-04-04 name: Wuhan Union Hospital, China class: OTHER name: Huazhong University of Science and Technology briefSummary: This is a single-center exploratory clinical study to explore the efficacy and safety of Oral Inulin in Combination With Fruquintinib Plus Sintilimab as Third- or Further-line Treatment in Metastatic Colorectal Cancer. conditions: Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Fruquintinib name: Sintilimab name: Inulin measure: Intestinal microbiota diversity, abundance and taxonomic information measure: adverse events measure: Objective remission rate (ORR) measure: Overall survival (OS) measure: Progression-free survival (PFS) measure: Disease control rate (DCR) measure: Duration of remission (DOR) measure: Concentration of various serum metabolites measure: Concentration of various plasma Cytokine Changes measure: Frequency of peripheral blood lymphocyte measure: Correlation between dietary fiber intake and progression-free survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Min Jin status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Min Jin role: CONTACT phone: 18807108606 email: [email protected] lat: 30.58333 lon: 114.26667 hasResults: False
<|newrecord|> nctId: NCT06347185 id: EORTC-2236-HNCG-QLG briefTitle: Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study acronym: SupCare overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-04 date: 2028-12 date: 2024-04-04 date: 2024-04-04 name: European Organisation for Research and Treatment of Cancer - EORTC class: NETWORK briefSummary: This is a late phase II, prospective, multicenter randomized study, to assess the value of early palliative care integrated with the standard oncologic care in patients with Recurrent Metastatic (RM) Head and Neck Cancer (HNC) proposed to first line palliative systemic treatment.
The study randomizes patients in a 1:1 fashion to standard oncologic care, in which the palliative care is requested as needed (reactive approach) or to early palliative care integrated with the standard oncologic care (proactive approach).
Standard of Care: the oncologist will be the main referral of the patient, deciding the therapeutic approach, the assessments requested, in terms of type of exams and timing and the need of possible further support from other expertise. The oncologist will base the choices also upon the results of the Liverpool Head and Neck Patient Concern Inventory (PCI-H\&N) and the patient's preferences. At the end of the first oncological visit, the physician will be asked to predict the survival of the patient.
Integrated approach: Besides the Oncology visit, patient will have the palliative care expert visit and follow up. The oncologist will define the therapeutic approach and the assessments requested, in terms of type of exams and timing. The palliative care clinician and the oncologist will judge the burden of symptoms and together they will propose the suggested interventions to relief the symptoms, with a particular attention to a validated instrument (the PCI-H\&N) and patient priority questionnaire's results.
Stratification Factors
* Institution
* Performance Status (PS) (0 vs 1-2)
* Presence of any caregiver at home
* Type of treatment (Immunotherapy alone vs any other combination)
Study duration: the total study duration is estimated at 36 months, with a total accrual time estimated to be 24 months from first patient in (FPI) and with an additional follow-up period of 12 months.
End of study occurs when all patients have completed their end of study visit and the study is mature for all analyses defined in the protocol and the database has been cleaned and frozen for these analyses. conditions: Head and Neck Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 160 type: ESTIMATED name: Early palliative care, integrated with the standard oncologic care (proactive approach) name: Palliative care requested as needed, integrated with the standard oncologic care (reactive approach) measure: Change from baseline in emotional functioning and pain scores according to Item List (IL) 250 questionnaire at 15 weeks. measure: Change from baseline in emotional functioning and pain scores according to Item List 250 (IL250) questionnaire at 6 weeks, 24 weeks and 52 weeks. measure: Change from baseline in the selected Health Related Quality of Life (HRQoL) scales from the Item List 250 (IL250) questionnaire at 6 weeks, 15 weeks, 24 weeks and 52 weeks measure: Number of unplanned visits to emergency room or specialist visits measure: Hospitalization due to treatment toxicities or tumour signs/symptoms, as evaluated by number of admissions and duration measure: Identification of the rate of patients starting a new systemic treatment in the last three months of life measure: Rate of patients receiving systemic treatment in the last month of life measure: Rate of patients with a tracheostomy performed in the last 3 months of life measure: Rate of patients with gastrostomy performed in the last 3 months of life measure: Caregiver/family members' satisfaction (FAMcare questionnaire) at 15 weeks measure: Overall Survival (OS) measure: Prediction error of survival (defined as the difference between actual survival (AS) of patients and clinician prediction of survival (CPS)) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06347172 id: 2024p000278 id: U54AG063546 type: NIH link: https://reporter.nih.gov/quickSearch/U54AG063546 briefTitle: Deprescribing in Patients Living With Dementia With Caregiver and Provider Nudges overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-11-15 date: 2025-01-15 date: 2024-04-04 date: 2024-04-04 name: Brigham and Women's Hospital class: OTHER name: Brown University name: National Institute on Aging (NIA) briefSummary: The objectives of this study are to demonstrate the feasibility of implementing a deprescribing nudge intervention using pragmatic methods, confirm that outcomes can be feasibly measured and evaluated at scale in a subsequent embedded pragmatic clinical trial (ePCT), and explore representativeness of persons living with dementia and care partners identified. conditions: Alzheimer Disease conditions: Mild Cognitive Impairment conditions: Dementia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 360 type: ESTIMATED name: Nudge Intervention measure: Composite of the percentage of eligible PCPs or their PLWD/care partners who view or click on information measure: Number of nudges that fire as intended: Fidelity measure: Discontinuation or prescribed reduction in medication sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06347159 id: EDG-7500-102 briefTitle: A Study of EDG-7500 in Adult Patients With Obstructive Hypertrophic Cardiomyopathy (CIRRUS-HCM) overallStatus: RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-04-04 date: 2024-04-04 name: Edgewise Therapeutics, Inc. class: INDUSTRY briefSummary: This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 either as a single or multiple dose in adult patients with obstructive hypertrophic cardiomyopathy. conditions: Hypertrophic Cardiomyopathy studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: EDG-7500 name: EDG-7500 measure: Incidence of treatment-emergent adverse events measure: Change from baseline in left ventricular outflow tract (LVOT) gradient measure: Pharmacokinetic parameters of EDG-7500 as measured by maximum plasma concentration (Cmax) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine) status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Edgewise Therapeutics, Inc. role: CONTACT lat: 39.95233 lon: -75.16379 hasResults: False
<|newrecord|> nctId: NCT06347146 id: R01HD112323 type: NIH link: https://reporter.nih.gov/quickSearch/R01HD112323 id: R01HD112323 type: NIH link: https://reporter.nih.gov/quickSearch/R01HD112323 briefTitle: Bridges2Scale: Testing Implementation Strategies overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-03-31 date: 2028-07-31 date: 2024-04-04 date: 2024-04-04 name: Washington University School of Medicine class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: The goal of this clinical trial is to compare two multifaceted strategies (standard vs enhanced) for scaling Bridges in a two-arm Hybrid III effectiveness-implementation cluster randomized controlled trial (RCT) in adolescent and youths affected by AIDS \[AYaAIDS\] (ages 13-17 years) from 48 schools in the Greater Masaka region of Uganda. The main aims of the clinical trial are: Aim 1. Compare the implementation effectiveness of the standard implementation strategy vs. an enhanced implementation strategy. The investigators will assess fidelity to Bridges (primary implementation outcome) and sustainment of Bridges (exploratory implementation outcome).
Aim 2. Determine the clinical effectiveness of Bridges implemented via a standard vs. enhanced implementation strategy. Aim 3: Explore implementation processes, mechanisms, and determinants. Aim 4. Compare the cost and cost-effectiveness of the two implementation strategies. Using an activity-based ingredients approach, the investigators will examine how much each strategy costs to achieve a unit of effect. conditions: HIV/AIDS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 1440 type: ESTIMATED name: Financial Literacy Training (FLT) workshops name: Mentorship name: Income Generation Activity (IGA) name: Youth Development Accounts (YDA) measure: Intervention Fidelity measure: HIV prevalence measure: Sexual risk-taking behavior measure: Economic stability measure: School attainment measure: Depressive Symptoms measure: Proportion of adolescents living with HIV who are virally suppressed measure: Proportion of HIV negative adolescents who use PrEP measure: Hopelessness measure: Self-Esteem measure: Self-concept sex: ALL minimumAge: 13 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
<|newrecord|> nctId: NCT06347133 id: AROAPOC3-3009 id: 2023-509302-30 type: EUDRACT_NUMBER briefTitle: Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia acronym: MUIR-3 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-07 date: 2026-10 date: 2024-04-04 date: 2024-04-04 name: Arrowhead Pharmaceuticals class: INDUSTRY briefSummary: This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo and be evaluated for efficacy and safety. conditions: Hypertriglyceridemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1328 type: ESTIMATED name: Plozasiran Injection name: Placebo measure: Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo measure: Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo measure: Proportion of Participants who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo measure: Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment measure: Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment measure: Change from Baseline in Hemoglobin A1c (HbA1c) During the Treatment Period Compared to Placebo measure: Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo measure: Change from Baseline in C-peptide During the Treatment Period Compared to Placebo measure: Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo measure: Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo measure: Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo measure: Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo measure: Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 measure: Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06347120 id: PI2024_843_0011 briefTitle: Place of Nasogastric Tube in Uncomplicated Adhesive Small Bowel Obstruction acronym: BOWNTI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-03 date: 2027-04 date: 2024-04-04 date: 2024-04-18 name: Centre Hospitalier Universitaire, Amiens class: OTHER name: Centre Hospitalier de Beauvais name: CHU de Rouen - Accueil name: Hospital Avicenne name: Centre Hospitalier Universitaire Dijon name: University Hospital, Limoges name: Saint Antoine University Hospital name: Centre Hospitalier Universitaire de Besancon name: Hôpital Cochin name: University Hospital, Toulouse name: CH Abbeville name: University Hospital, Angers briefSummary: Acute adhesive Small Bowel Obstruction (ASBO) is a public health issue: this is the 3rd cause of hospitalization in Digestive Surgery Departments, 20-30% of patients will be operated, the mortality rate per episode is 3%, the duration of hospitalization is 8 days (up to 16 if resection), and it is associated with a tremendous health care expenses.
The working group on ASBO of the World Society of Emergency Surgery suggested two distinct approaches for the management of acute ASBO: non-operative management (NOM) which concerning around 85% of patients and operative management (OM) :
* OM: if there is clinical signs of strangulation, peritonitis, bowel ischemia, or if IV CT Scan shows sign of ischemia, strangulation, peritonitis, or if the occlusion persists for more than 72 hours;
* NOM in all other cases, including nasogastric tube (NGT), intravenous administration of fluids, and clinical and biochemical monitoring for 72h.
NGT is an old concept first describe for treatment of ASBO based on several studies made on the dog where he proved efficacy of NGT by aspirating gas in the stomach favorising venous decompression and survival of patients. Since, NGT became one of the pillars of NOM.
However NGT is quite bad tolerated by patients (ranked the most painful hospital procedure), some of them refuse it, others put off after the beginning of the treatment and one of the most frequent complications of NGT is pneumonia, which is quite surprising when the first argument for its insertion is to avoid inhalation pneumonia.
Four specific retrospectives studies showed that absence of NGT is possible in 20 to 80% of included patients and was associated with a decrease: in transit recovery time; in complications rate (including rates of pneumonia); in length of stay (LOS); without an increased risk of surgery or resection. 20-87% (a total of 922 patients) were managed successfully conservatively without NGT with a reduction LOS of 2-6 days compared with NGT. But none of this series focused on the patient relief as an endpoint. A retrospective critical analysis of our own management (January - December 2019, n=96) found that: only 17% of patients had a NGT during the IV CTscan, the presence of the NGT did not influence neither gastric volume nor the rate of full stomach, and gastric volume did not influence patient management.
To summarize, the investigators therefore know that the insertion of a NGT is painful, does not relieve all patients, and has an unquantified therapeutic effect on the evolution of ASBO. That is why it is pertinent, in 2023, to question the useless of NGT in the treatment of ASBO, in selected patients. This study would be the first randomized controlled trial to focus on the absence of NGT for the NOM of patients with ASBO. The results of this study could lead to a change in the surgical practice. The absence of NGT in ASBO management appears to be an innovative practice, in rupture with the current practice. This is a part of the simplification of patients'care suffering from ASBO. conditions: Small Bowel Obstruction Adhesion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 504 type: ESTIMATED name: nasogastric tube name: NOM without NGT insertion measure: Decrease of complication rate in patient without NGT group compared to control group measure: aspiration pneumonia rate in both patient groups sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amiens Universitary Hospital city: Amiens country: France name: jean marc Regimbeau, Pr role: CONTACT phone: +33 3 22 08 89 05 email: [email protected] name: charles sabbagh, Pr role: SUB_INVESTIGATOR name: Aiham Ghazali, Pr role: SUB_INVESTIGATOR name: Thierry Yzet, Pr role: SUB_INVESTIGATOR name: François Mauvais, MD role: PRINCIPAL_INVESTIGATOR name: Lilian Schwarz, MD role: PRINCIPAL_INVESTIGATOR name: Christophe Tresallet, MD role: PRINCIPAL_INVESTIGATOR name: Pablo Ortega deballon, MD role: PRINCIPAL_INVESTIGATOR name: Muriel Mathonnet, MD role: PRINCIPAL_INVESTIGATOR name: Jérémie Lefevre, MD role: PRINCIPAL_INVESTIGATOR name: Zaher Lakkis, MD role: PRINCIPAL_INVESTIGATOR name: David Fuks, MD role: PRINCIPAL_INVESTIGATOR name: Fabrice Muscari, MD role: PRINCIPAL_INVESTIGATOR name: Corina Iederan, MD role: PRINCIPAL_INVESTIGATOR name: Aurelien Venara, MD role: PRINCIPAL_INVESTIGATOR lat: 49.9 lon: 2.3 hasResults: False
<|newrecord|> nctId: NCT06347107 id: S67215 briefTitle: Robotic Subretinal tPA Injection Study acronym: RoTIS overallStatus: RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-04-04 date: 2024-04-04 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: DORC Dutch Ophthalmic Research Center International BV briefSummary: In the RoTIS study, the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery. The surgical devices used during this procedure will be the following:
* The robotic stabilizer (prototype - FAMHP approval received)
* 41G subretinal needle (CE marked - used within label)
* Inicio micro-injection system (CE marked - used within label) The Inicio system mounted with the 41G needle will be held by the robot, and guided by the surgeon towards the required position. When the tip of the needle is in the desired subretinal position, the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained, with a maximal duration of up to 3 minutes.
As performed routinely, the surgical view through the microscope will be video-recorded and while the injection is being administered, the built-in iOCT of the Artevo surgical microscope (Zeiss, Oberkochen, Germany) will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review. conditions: Subretinal Hemorrhage conditions: Age-Related Macular Degeneration studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Investigator-initiated, academic, mono-center, prospective, interventional case study primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Robotic subretinal tPA injection measure: Percentage of patients with succesful subretinal insertion of the robot-held 41G needle measure: Percentage of patients with stable subretinal position of the needle for at least 3 minutes. measure: Device-related adverse events measure: Functional outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Leuven status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Peter Stalmans, MD PhD role: CONTACT email: [email protected] name: Ivo De Clerck, MD role: CONTACT email: [email protected] name: Ivo De Clerck, MD role: SUB_INVESTIGATOR name: Peter Stalmans, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False
<|newrecord|> nctId: NCT06347094 id: 610/2023/SPER/UNIPR briefTitle: Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols acronym: PRE-CARE-DIET overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2025-12-31 date: 2025-12-31 date: 2024-04-04 date: 2024-04-04 name: University of Parma class: OTHER name: Azienda Ospedaliero-Universitaria di Parma name: University of Milan name: Foundation for Liver Research name: National Research Council, Spain briefSummary: This chronic study aims at assessing whether the effects of a personalized, plant-based diet rich in (poly)phenols on cardiometabolic health depend on the capability to metabolize dietary (poly)phenols, creating predictive models able to explain, at individual level, the cardiometabolic response. This study presents an observational part, for targeted recruitment and volunteers characterization, and an experimental part for the dietary and deep phenotyping. conditions: Individual Variability in (Poly)Phenol Metabolism conditions: Cardiometabolic Health conditions: Personalized Dietary Intervention conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Metabotypes will also be masked to participants and investigators, while the dietary treatment will not. whoMasked: OUTCOMES_ASSESSOR count: 330 type: ESTIMATED name: Personalized Dietary Plan name: Oral (Poly)phenol Challenge Test (OPCT) name: General Dietary Advice measure: Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation measure: Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation-Older Persons measure: Anthropometric measurements: weight, height and body mass index measure: Anthropometric measurements: waist and hip circumferences detection measure: Body composition: bioelectrical impedance analysis measure: Blood pressure measure: Heart rate measure: Biomarkers of cardiometabolic health: hematochemical and urine analysis measure: Biomarkers of cardiometabolic health: alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase measure: Biomarkers of cardiometabolic health: homocysteine measure: Biomarkers of cardiometabolic health: insulin measure: Biomarkers of cardiometabolic health: glycated hemoglobin and glycated albumin measure: Biomarkers of cardiometabolic health: quantitative insulin-sensitivity check index measure: Biomarkers of cardiometabolic health: homeostasis model assessment beta-cell function measure: Biomarkers of cardiometabolic health: homeostasis model assessment of insulin resistance measure: Inflammatory status measure: Risk prediction scores: Framingham General Cardiovascular Risk Score - 10-years measure: Risk prediction scores: Framingham General Cardiovascular Risk Score - 30-years measure: Risk prediction scores: Hard Coronary Heart Disease - 10-years risk measure: Risk prediction scores: First Coronary Heart Disease - 2-years risk measure: Risk prediction scores: Framingham Heart Study for Diabetes measure: Risk prediction scores: Framingham Heart Study for Hypertension measure: Risk prediction scores: Framingham Heart Study for Stroke measure: Risk prediction scores: Framingham Heart Study for Fatty Liver Disease measure: Risk prediction scores: Atherosclerotic Cardiovascular Disease measure: Risk prediction scores: QRESEARCH risk estimator version 3 measure: Risk prediction scores: QDiabetes Score measure: Risk prediction scores: Finnish Diabetes Risk Score measure: Risk prediction scores: Cuore Project - Calculating the individual risk score measure: Evaluation of adherence to healthy and sustainable dietary models: the Healthy Eating Index measure: Evaluation of adherence to healthy and sustainable dietary models: Italian Mediterranean Index measure: Evaluation of adherence to healthy and sustainable dietary models: Greek Mediterranean Index measure: Evaluation of adherence to healthy and sustainable dietary models: DASH Index measure: Evaluation of adherence to Mediterranean diet measure: Nutritional and energy assessment: LARN measure: Nutritional and energy assessment: EPIC measure: Dietary intake assessment of plant bioactive compounds and dietary components related to gut microbiome measure: Lifestyle factors assessment: general information measure: Lifestyle factors assessment: sleep quality (PSQI) measure: Lifestyle factors assessment: sleep quality (ESS) measure: Lifestyle factors assessment: sleep quality (ISI) measure: Lifestyle factors assessment: physical activity (IPAQ) measure: Lifestyle factors assessment: state of health (BDI) measure: Lifestyle factors assessment: state of health (SF-36) measure: (Poly)phenol metabolites and changes in the prevalence of aggregate phenolic metabotypes measure: Other plant bioactive metabolites measure: Food/gut/host-derived metabolites measure: Biomarkers of food intake and of healthy dietary patterns measure: Untargeted metabolomics measure: Genetic differences measure: Gut microbiota composition measure: Oral microbiota composition measure: Biomarkers of adipose tissue function measure: Biomarkers of food intake regulation sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Parma - Plesso Biotecnologico Integrato city: Parma state: PR zip: 43125 country: Italy name: Pedro M Mena Parreño, PhD role: CONTACT phone: +39 0521 903970 email: [email protected] name: Joana M Santos Rebelo, MSc role: CONTACT phone: +39 0521902043 email: [email protected] name: Pedro M Mena Parreño, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.79935 lon: 10.32618 facility: Azienda Ospedaliero-Universitaria di Parma city: Parma state: PR zip: 43126 country: Italy name: Riccardo Bonadonna, MD role: CONTACT phone: +39 0521 033307 email: [email protected] lat: 44.79935 lon: 10.32618 hasResults: False
<|newrecord|> nctId: NCT06347081 id: P.T.REC/012/00449 briefTitle: Effect of Nd-YAG Laser on Hypertrophic Scar acronym: Nd-YAG overallStatus: COMPLETED date: 2022-05-01 date: 2024-02-28 date: 2024-02-28 date: 2024-04-04 date: 2024-04-04 name: Cairo University class: OTHER briefSummary: A hypertrophic scar is a serious health concern in the industrialized world. Two groups of patients were treated with standard medical care. The experimental group received additional laser therapy. scar assessment was measured immediately before treatment, after 3, and 7 months.
T test for comparison before-treatment between the control and study groups. ANOVA with repeated measures test for comparison among other measures. conditions: Hypertrophic Scar studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: one treatment one control group primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Nd- YAG laser at 532nm wavelength measure: hypertrophic scar maturation measure: hypertrophic scar volume sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Physical Therapy city: Cairo zip: 12613 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06347068 id: LCCC2128-ATL briefTitle: Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2028-05 date: 2024-04-04 date: 2024-04-23 name: UNC Lineberger Comprehensive Cancer Center class: OTHER name: Bellicum Pharmaceuticals briefSummary: This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed/refractory triple-negative breast cancer (TNBC). conditions: Breast Cancer conditions: Relapse conditions: Resistant Cancer conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: iC9-CAR.B7-H3 T Cell Therapy name: cyclophosphamide name: fludarabine measure: Toxicity: NCI-CTCAE measure: Toxicity: Cytokine Release Syndrome (CRS) measure: Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS) measure: The recommended phase 2 dose (RP2D) NCI-CTCAE v5. measure: The recommended phase 2 dose (RP2D) CRS Grading measure: The recommended phase 2 dose (RP2D) measure: Objective response rate measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Duration of Response (DOR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of North Carolina city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Catherine Cheng role: CONTACT phone: 919-445-4208 email: [email protected] name: E. Claire Dees, MD, MSc role: SUB_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
<|newrecord|> nctId: NCT06347055 id: 403690 briefTitle: NeuroControl of Nicotine Dependence overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2030-03-25 date: 2030-04-30 date: 2024-04-04 date: 2024-04-08 name: University of Missouri-Columbia class: OTHER briefSummary: The purpose of the study is to examine the effects of continuous theta burst stimulation (cTBS) on different forms of cognitive control in adults who smoke cigarettes, and to determine if the location where cTBS is delivered may help smokers reduce or quit smoking. Participation in the study will take 3-weeks over 4 visits, with a total time commitment of approximately 12 hours. conditions: Nicotine Dependence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Repetitive Transcranial Magnetic Stimulation (rTMS) measure: Acute effects of cTBS on cognitive control measure: Exploratory: Acute effects of cTBS on fMRI brain response measure: Safety and Tolerability sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06347042 id: 012/004897 briefTitle: Effect of Qigong on Sleep Quality in Fibromyalgia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-06 date: 2024-04-04 date: 2024-04-04 name: Cairo University class: OTHER briefSummary: This study aims to determine any significant efficacy of qigong exercise on sleep quality and heart rate variability in patients with fibromyalgia. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: qigong exercise + routine medical treatment +Anti-inflammatory diet name: routine medical treatment +Anti-inflammatory diet only measure: Sleep quality measure: Heart Rate variability measure: Quality of Life o measure the quality of life of patients with problems found fibromyalgia. measure: pain self-administered questionnaire measure: Fatigue :prevalence and severity of fatigue measure: Depression and Anxiety assess Depression and Anxiety sex: FEMALE minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Physical therapy Cairo University city: Cairo state: Giza country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06347029 id: Endothelial dysfunction briefTitle: Evaluation of Endothelial Dysfunction Using the "Flow Mediated Dilation" Test in a Population of Chronic Renal Failure Patients at Different Stages, and Evaluation of the Role of Antiphospholipid Antibodies overallStatus: RECRUITING date: 2023-10-17 date: 2024-12-31 date: 2024-12-31 date: 2024-04-04 date: 2024-04-04 name: Brugmann University Hospital class: OTHER briefSummary: The vascular endothelium is an organ in its own right, playing, among other things, a primordial role in the control of vascular tone. This vascular tone is ensured by pro-dilator mediators (nitric oxide (NO), prostacyclins (PGI2)), or vasoconstrictors (endothelin, thromboxane A2 or PGH2).Uremic toxin accumulation in chronic kidney disease (CKD) is a well-known factor in endothelial dysfunction, often associated with higher cardiovascular risk. This association is also present for terminal chronic kidney disease characterized by the need to resort to an extra-renal purification technique (in-center hemodialysis (HD), daily home hemodialysis (HDQ), peritoneal dialysis) or to resort to renal transplantation.
For HD to be effective, it is essential that the blood flow rate passing through the dialyzer is greater than 300ml/min. This imperative requires that any hemodialysis patient have specific vascular access (dialysis catheter or arteriovenous fistula (AVF)) to ensure these flow rates. The vascular access of choice is the arteriovenous fistula , because it is associated with a lower risk of infection and lower morbidity and mortality. Making an arteriovenous fistula consists of surgically creating an anastomosis between a vein and an artery.
Complications of arteriovenous fistula are common. Arteriovenous fistula maturation may be delayed (maturation delay) or even absent. Drainage veins and/or anastomoses can also be the site of stenosis or thrombosis. The pathophysiology of these complications is complex and multifactorial. Among the risk factors for these complications (delay or absence of maturation, stenosis thrombosis), the positivity of antiphospholipid antibodies (aPL) can be cited, as well as endothelial dysfunction.
Antiphospholipid syndrome (APS) is an autoimmune disease causing a thrombotic phenotype. This is an acquired thrombophilia. In the general population, the prevalence of antiphospholipid antibodies is around 0.5%; this prevalence is far from rare in hemodialysis, since it represents up to 37% in dialysis patients. In a retrospective study carried out at Brugmann University Hospital in 2023 , on 115 patients with AVF and in whom aPL dosages were available, the prevalence of persistent positivity (2 positive dosages spaced more than 12 weeks apart) was 21%.
Interestingly, a third of the cohort presented an antibody profile that did not allow them to be classified according to the classification criteria in force. This group corresponds to patients with a single positive dosage, either not recontrolled or recontrolled negative. This group was called Fluctuating. This fluctuating group was associated with arteriovenous fistula complications in a 2019 study.
Endothelial dysfunction is also implicated in the pathophysiology of APS. In clinical practice, the "flow mediated dilation" (FMD) test makes it possible to assess endothelial dysfunction in vivo. It involves the phenomenon of post-occlusive hyperemia which is mainly linked to NO and endothelium-dependent vasodilation. In the brachial artery, NO is the sole mediator of FMD. Endothelial dysfunction according to FMD has been described in populations with advanced chronic kidney disease, as well as patients with cardiovascular diseases. Hemodialysis patients with delayed/absence of arteriovenous fistula maturation have more pathological FMDs compared to dialysis patients without fistula problems. However, the additive role of aPL in this different population has not been studied in terms of endothelial dysfunction by FMD.
The objective of this study is to evaluate the weight of antiphospholipid biology on endothelial dysfunction in hemodialysis patients, using the FMD test.
1. Compare endothelial dysfunction by FMD according to the stage of chronic kidney disease and in comparison to a control group without chronic kidney disease.