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Dissociative Disorders clinical trials

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NCT ID: NCT06347302 Recruiting - Clinical trials for Rhegmatogenous Retinal Detachments

Study of Vitreoretinal Molecular Changes During Rhegmatogenous Retinal Detachment

LIPIDRET
Start date: April 25, 2024
Phase: N/A
Study type: Interventional

Retinal detachment is a condition with an estimated incidence of between 9.5 and 18.2 cases per 100,000 individuals. It is an ophthalmological emergency that threatens visual acuity and requires surgery. However, despite satisfactory post-operative anatomical results, vitreoretinal proliferation and photoreceptor death can still have a negative impact on visual prognosis. These complications are still not fully understood. A previous study carried out by the Eye, Nutrition and Cell Signalling team at the CSGA, comparing mouse models of retinal detachment with healthy control retinas, revealed an increase in pro-inflammatory cytokines and a change in retinal lipid abundance in detached retinas. However, these results have yet to be confirmed in humans. Our main hypothesis is that the vitreous content of omega-3 PUFAs and proteins is altered during the onset of retinal detachment, since it reflects both intraocular inflammation and photoreceptor apoptosis. 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.

NCT ID: NCT06145971 Recruiting - Insomnia Clinical Trials

Assessing the Impact of Brief CBTi on Dissociative Seizures: SCED

CBTi 4 DS:SCED
Start date: May 6, 2024
Phase: N/A
Study type: Interventional

Some people experience a temporary change in behaviour and consciousness, that often involves a collapse and/or shaking limb movements. These are referred to as 'Dissociative seizures'. Those who experience such seizures have been found to also display high levels of dissociation, which can be described as a change in your conscious experience and may include gaps in your memory for events. It is thought that people who experience dissociative seizures also often have difficulties with their sleep. Having difficulties with sleep may make these seizures and the amount of dissociation an individual experiences worse. Greater dissociation may be additionally linked to worsening dissociative seizures. A psychological treatment for sleep difficulties called Cognitive Behavioural Therapy for Insomnia (CBTi), has been found to be effective in reducing sleep difficulties. The main questions this study aims to answer are: 1. Does brief CBTi (bCBTi) improve sleep difficulties in those with dissociative seizures? 2. Does bCBTi reduce the frequency of dissociative seizures? 3. Does bCBTi reduce self-reported levels of dissociation in participants? 4. Does improving sleep difficulties lead to improvements in quality of life, mood and anxiety levels? 5. Is bCBTi a feasible intervention to administer in an inpatient setting? This study will investigate whether improving sleep by administering a brief version of CBTi leads to an improvement in levels of dissociation and dissociative seizure frequency. It will also investigate whether brief CBTi is a feasible treatment method for sleep difficulties in an inpatient setting. Participants who have dissociative seizures and sleep difficulties that could be diagnosed as insomnia will be randomly assigned to a baseline phase of 5, 7 or 9 days, where they will fill out daily questionnaires on their sleep, dissociation and number of seizures. They will then begin a 10-day intervention phase where they will attend two sessions of brief CBTi, whilst also completing daily measures. This will allow us to see whether their scores on the sleep and dissociation measures improve when the intervention begins. Participants will be asked to wear an Actiwatch during the night, to gather information on their movement levels during the night. Information on changes in quality of life, mood and anxiety levels following the sleep intervention will also be collected.

NCT ID: NCT06056596 Recruiting - Retinal Detachment Clinical Trials

Lamivudine and Plasma Markers of Inflammation in Retinal Detachment

Start date: January 30, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this clinical trial is to test whether an oral medication (lamivudine) enters the eye and reduces blood markers of inflammation in people who undergo retinal detachment surgery (pars plana vitrectomy). Participants will take the study medication or placebo, and the researchers will measure blood markers of inflammation before and after surgery. The researchers will also measure the amount of medication in the blood and fluid inside the participant's eye (which is collected during surgery).

NCT ID: NCT06054412 Recruiting - Clinical trials for Post Traumatic Stress Disorder

An Adjunctive Neurofeedback Training Program to Enhance Wellness Among Trauma-Exposed Postpartum Mothers

Start date: March 3, 2024
Phase: N/A
Study type: Interventional

The proposed study will collect novel data evaluating the feasibility of the NFB training program delivered in an outpatient mental health setting and its influence on mothers' overall sense of well-being, and further investigate whether enhanced well-being is associated with positive changes in emotion regulation capacities, trauma-related mental health symptoms, parenting behaviors and attitudes, and infant behavioral outcomes (i.e., crying, fussing) among postpartum mothers with a history of childhood trauma and clinically concerning trauma-related mental health symptoms.

NCT ID: NCT06054009 Recruiting - Dissociation Clinical Trials

Dissociation CBT Studies

DisCS
Start date: September 20, 2023
Phase: N/A
Study type: Interventional

Dissociation involves distressing feelings of unreality and disconnection. Evidence suggests it is particularly common amongst people with existing mental health difficulties, where it has been linked with greater clinical severity, poorer treatment response, and increased self-harm and suicidality. However, there are currently no psychological treatments for dissociation that have been developed from a scientific understanding of its underpinning psychological factors. In this project, three studies, each with four participants, will test a different psychological factor. Participants will be: adults (16+ years); on a waiting list for NHS psychological therapy; high scorers on a dissociation questionnaire. Participants will complete assessments before and after treatment, and at a one-month follow-up. The studies follow a 'multiple baseline design', meaning that all four participants for that study will complete their baseline assessment in the same week, and then be randomly allocated to wait either one, two, three, or four weeks before starting the intervention. The intervention will consist of four therapy sessions taking place within a five-week 'window'. Taking part in the research is voluntary. Before deciding whether to participate, we will explain the study and answer any questions. Daily, participants will record a score for their dissociation and the psychological factor being targeted. At baseline, post-therapy, and follow-up, the researchers will also measure their levels of other factors related to dissociation (i.e. those not targeted by the therapy). Additionally, feedback will be requested from participants about the therapy at the end of their involvement, in order to improve it in future. Ultimately, if successful, these interventions could form a pilot therapy for further testing and development. This could mean fewer people struggle with the challenges of dissociation.

NCT ID: NCT05943652 Recruiting - Parkinson Disease Clinical Trials

Observational Study on "Functional Overlay" in Patients With Movement Disorders

Start date: January 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about functional neurological disorders in patients with common non-functional movement disorders ("functional overlay"). The main questions it aims to answer are: - What is the frequency of functional neurological disorders in patients with non-functional movement disorders (functional overlay)? - What are the characteristics of functional neurological disorders in patients with non-functional movement disorders? Participants will be examined clinically and electrophysiologically, the examinations consist of: - a neurological examination - neuropsychological testing - electrophysiological tremor diagnostic - questionnaires about psychological, biological and social risk factors Researchers will compare patients with functional motor disorders to patients wit non-functional movement disorders to see if they differ from each other regarding the functional symptoms.

NCT ID: NCT05863312 Recruiting - Retinal Detachment Clinical Trials

REtinal Detachment Outcomes Study

REDOS
Start date: September 26, 2023
Phase: N/A
Study type: Interventional

Background: Few large randomized controlled trials provide strong evidence to guide surgical repair of primary rhegmatogenous retinal detachment (RRD) repair. The purpose of this factorial, single-blind, randomized controlled trial is to analyze and compare the surgical outcomes, functional visual outcomes, complications, and quality of life associated with RRD repair using (A) pars plana vitrectomy only (PPV) or PPV with scleral buckle (PPV-SB) and (B) sulfur hexafluoride gas (SF6) or perfluoropropane gas (C3F8) tamponade. Methods: Eligible patients with moderately complex RRD will be randomized 1:1 to PPV or PPV-SB and 1:1 to SF6 or C3F8 gas tamponade. Approximately 560 patients will be recruited to be able to detect a difference of around 10% in SSAS rate between groups. Patients will be followed using multimodal imaging and quality of life questionnaires before and after the surgical repair until 1 year postoperative. The primary outcome will be single surgery anatomic success (SSAS), defined as absence of reoperation for recurrent RRD in the operating room. Secondary outcomes will be pinhole visual acuity (PHVA) at 8-10 weeks and 6 months, final best-corrected visual acuity (BCVA), final retina status (i.e., attached or detached), time to onset of RRD recurrence, severity and number of complications, and questionnaire results. Discussion: This will be the first 2 × 2 factorial randomized controlled trial examining repair techniques in primary RRD. It will also be the first randomized controlled trial to compare gas tamponade between the two most common agents. Notably, it will be adequately powered to detect a clinically significant effect size. The use of multimodal imaging will also be a novel aspect of this study, allowing us to compare head-to-head the impact of adding an SB to the retina's recovery after RRD repair and of differing gas tamponades. Until now, the treatment of RRD has been largely guided by pragmatic retrospective cohort studies. There is a lack of strong evidence guiding therapeutic decisions and this trial will address (1) whether supplemental SB is justified and (2) whether longer duration gas tamponade with C3F8 is necessary.

NCT ID: NCT05822570 Recruiting - Clinical trials for Liver Transplantation

Oxygen Dissociation Curve in Patients Undergoing Orthotopic Liver Transplantation

Start date: May 1, 2023
Phase:
Study type: Observational

Hemoglobin (Hb) is the molecule responsible for the transport of oxygen (O2) to the tissues in mammals. The p50 and the Hill coefficient (HC) best describe the ODC. The interaction between Hb and O2 can be influenced by many agents and conditions like temperature, pH, pCO2 and 2,3-diphosphoglycerate (2,3-DPG). During liver transplantation numerous profound physiological changes occur, linked to the different stages of the surgical procedure. Previous studies in humans and animals undergoing liver transplantation have shown that while the ODC seems preserved during preparation and the anhepatic phase, a left shift of the ODC occurs after reperfusion . This left shift of the ODC could imply a decreased release of oxygen to the tissues, probably worsening hemodynamic instability. With this pilot study the investigator aim to measure ODCs at baseline and at different stages during orthotopic liver transplantation in patients in order to get deeper understanding of oxygen delivery and supply during liver transplantation surgery.

NCT ID: NCT05746637 Recruiting - Clinical trials for Conversion Disorder in Children

The Complexity of the Diagnostic Pathway of Children With a Functional Neurological Symptomatology Disorder

TC-HPaS
Start date: December 6, 2022
Phase:
Study type: Observational

The goal of this qualitative and quantitative cross-sectional observational study is to describe the complexity of the diagnostic pathway for Functional Neurological Symptomatology Disorder (TSNF) in children and adolescents based on the experience of the different protagonists of care (parents, adolescents, caregivers). The main question[s] it aims to answer are: - How do the various stakeholders experiences the care pathway for children and adolescents with a diagnosis of TSNF - What are their expectations regarding the diagnosis and management of TSNF Participants will be enrolled in interviews in which they will describe their experience. Parents will also answer a lifestyle questionnaire.

NCT ID: NCT05620901 Recruiting - Coats' Disease Clinical Trials

DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia

Start date: February 1, 2023
Phase: Early Phase 1
Study type: Interventional

The Tender Study is a prospective, open-label, single-center, randomized, investigator-initiated clinical study seeks to investigate the safety and efficacy of the DEXTENZA insert in pediatric patients following retinal surgery or laser treatment under anesthesia.