Clinical Research Directory

Effect of Breathing Exercise on Pain and Quality of Recovery in After Transplantation Patients: A Randomized Controlled Trial

The researchers will fill out the "Patient Introduction Form" for the patients who agreed to participate in the study after obtaining permission from the experimental group with the "Informed Consent Form" the day before the surgery. The breathing exercises will be taught and monitored by the researchers, and the researcher who will implement them is a nurse in the general surgery department. The experimental group will be trained on breathing exercises by the researcher the day before the surgery. The patients will be provided with 1 set (4 breaths) per hour of breathing exercises after the surgery. The patient's vital signs will be monitored before and after the breathing exercise. Patients will not have difficulty during the breathing exercise, and they will be provided with gradual interventions. Pain status will be monitored at 0, 2, 6, 12 and 24 hours during the 24-hour hospital stay. The recovery quality scale will be applied on the 1st and 3rd day after surgery. In the control group, after obtaining permission with the "Informed Consent Form" the day before the surgery, the patients who agreed to participate in the study will fill out the "Patient Introduction Form" by the researchers, and their pain status will be monitored at 0, 2, 6, 12 and 24 hours during the 24-hour hospital stay after the surgery. The recovery quality scale will be applied on the 1st and 3rd day after surgery. No intervention will be made to the patients in the control group, and they will be provided with routine nursing care provided in the hospital.

Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial

This Phase I clinical trial is designed to evaluate the safety, tolerability of XS228 ( iPSC-Derived Motor Neuron Progenitor Cells) in patients with Subacute Spinal Cord Injury

Efficacy of iPSC-Derived Motor Neuron Cells (XS228) in Subacute Spinal Cord Injury: A Phase II Randomized Controlled Trial

Purpose: This clinical trial is studying an investigational cell therapy called XS228-a lab-made stem cell product designed to help repair damaged nerves in the spinal cord. The goal is to see if XS228 is safe and can improve movement, sensation, and function in people with recent spinal cord injuries. Study Treatment: XS228 contains specialized nerve-supporting cells derived from human stem cells. These cells are injected into the spinal fluid (intrathecal administration) in a single dose. Who Can Join? Adults aged 18-65 with a spinal cord injury (thoracic or lumbar level) that occurred 2-12 weeks before enrollment. Participants must have severe but incomplete paralysis (ASIA Impairment Scale Grade A , B or C). Study Plan: Phase II (Main Study): About 60 participants will be randomly assigned to receive either XS228 or a placebo (inactive solution) in a 2:1 ratio. Follow-up: Patients will be monitored for 1 year, with regular check-ups to assess safety, nerve function, and recovery progress. What Researchers Are Looking For: Primary Goal: Measure changes in leg and arm function using the ASIA Motor Score at 6 months. Secondary Goals: Improvement in ASIA Impairment Scale (AIS) grade (e.g., from "complete" to "incomplete" paralysis). Recovery of sensation and bladder/bowel control. Safety (monitoring for side effects like infections or immune reactions). Exploratory Tests: MRI scans and biomarker tests in spinal fluid to see if the treatment helps nerve regrowth. Why This Study Matters: If successful, XS228 could become the first stem cell therapy to promote meaningful recovery in spinal cord injury patients. Currently, no treatments exist to repair nerve damage-this trial aims to change that.

Clinical Study of Venetoclax Combined With Azacitidine as Bridging Therapy Prior to Hematopoietic Stem Cell Transplantation in Patients With Higher-Risk Myelodysplastic Syndromes

A Single-Arm, Prospective Clinical Study of Venetoclax Combined with Azacitidine Followed by Bridging Transplantation in Patients with High-Risk Myelodysplastic Neoplasms with Increased Blasts 2 (MDS-IB2)

Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI

Allotransplants of vascularized composite tissues are subject to chronic vascular rejection, which can lead to graft loss. Currently, no imaging technique allows a reproducible quantitative exploration of the arterial trees of the hand, and therefore a satisfactory monitoring of transplants. Since 2014, flow MRI has been applied to the analysis of small-calibre arteries by the Image Processing Team at the Amiens-Picardie University Hospital. Between 2015 and 2017, several acquisitions were made in 3 patients who received facial allotransplantation, and the team recently developed a flow MRI protocol dedicated to the study of arterial trees in the hand. The main objective is to measure vascular flows of radial, ulnar and interdigital arterial trees in normal (healthy volunteers) and pathological situations (patients with radial forearm flap reconstruction and patients with hand allotransplantation) using the specifically developed flow MRI protocol.

Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors

Allogeneic hematopoietic stem cell transplantation (allo-HSC) is currently one of the only curative treatments for haematological malignancies with a poor prognosis, the realization of which presupposes the identification and availability of a compatible donor. In recent years, haploidentical transplants have been developed, a reliable alternative for patients who do not have 100% compatible donors. The development of haplo-identical transplants leads to an exponential increase in the use of intra-family donation. Intrafamilial donation of hematopoietic stem cells (HSC) has the advantages of lower financial cost and faster availability of the graft, thus avoiding the risk of relapse before the procedure. Nevertheless, intrafamilial donation raises clinical and ethical questions. Indeed, the psychological impact of intra-family donation on the donor cannot be overlooked. Thus, in the context of the development of haplo-identical transplants, measuring the impact of donation on donors (ascendants and descendants) will make it possible to assess the relevance of taking psychosocial aspects into consideration in the choice of donors, to assess the psychological impact of haplo-identical donation and to offer psychological support adapted to donors.

Digital Delivery of Person-centered Transitional Care

Advances in medical care have extended the life expectancy of individuals with congenital and pediatric-onset diseases, leading to an increased need for effective transition programs as these individuals move from pediatric to adult healthcare. The STEPSTONES project in Sweden is designed to evaluate the effectiveness of a person-centered transition program to support teenagers with chronic conditions during this transition. The project's innovative digital adaptation, Digi-STEPSTONES, seeks to address challenges related to accessibility and continuity of care by delivering the program remotely. This study will assess the non-inferiority of the digital program compared to traditional, in-person care, focusing on outcomes such as patient empowerment, transition readiness, and quality of life. Additionally, the project will explore the implementation and scalability of the digital transition model across various chronic conditions. Preliminary studies have highlighted the importance of structured, person-centered care in improving empowerment and other outcomes in adolescents with chronic illnesses. The Digi-STEPSTONES project aims to provide crucial evidence for the digital delivery of transition programs, potentially enhancing the accessibility and effectiveness of care for young people with chronic conditions in Sweden.

International (Pediatric) Peritoneal Biobank

Within few years the peritoneal membrane of adult peritoneal dialysis (PD) patients undergoes substantial morphological transformation, including progressive fibrosis, vasculopathy and neoangiogenesis. Ultrafiltration capacity steadily declines and ultimately results in PD failure. In children, peritoneal biopsies demonstrating PD associated alterations have not yet been obtained. They, however, should be particularly informative, since secondary tissue and vascular pathology related to ageing or diabetes is absent. An international, prospective peritoneal membrane biopsy study in children on PD will therefore be performed. Biopsies will be obtained at time of PD catheter insertion, on occasion of intercurrent abdominal surgery (e.g. hernia repair, catheter exchange) and at time of renal transplantation. Quantitative histomorphometry and tissue protein expression analyses will be correlated with time integrated PD treatment modalities and functional characteristics as well as inflammatory and cardiovascular comorbidity surrogate parameter. Blood will be obtained during clinical routine sampling. Biopsies will be obtained during clinically indicated operations, without substantially increasing operation time and associated surgical risks. The detailed histomorphometry of the PD membrane will give additional information, potentially impacting on the individual PD regime. 3/2018: The analyses of the pediatric PD biopsy demonstrated early and major transformation of the peritoneal membrane with neutral pH low GDP fluids, and significant vasculopathy already in children with CKD stage 5, further progressing with PD. The underlying mechanisms are partly understood, only. In view of these major findings and the numerous open questions, collection of biosamples will be continued in children and also in adult PD patients. The following questions will be addressed: Molecular counterparts of peritoneal semi-permeability, solute and water transport (beyond AQP1), pathomechanisms and molecular and functional impact of peritoneal transformation with low and high GDP fluids, and the respective pathomechanisms and molecular and functional impact of vascular disease in CKD and with different PD fluids. The impact of renal transplantation following PD will be assessed in a subgroup of patients with tenckhoff catheter removal several weeks after transplantation and a functioning graft.

Observational Study on the Variation of Ascorbic Acid in Patients Undergoing Solid Organ Transplantation

The objective of this observational clinical study is to evaluate the variations in ascorbic acid during the transplantation phases and how these variations influence the oxidative status and patient outcome. The main questions it aims to answer are: * how many patients arrive at the transplant in a state of hypovitaminosis C? * how does hypovitaminosis C affect the patient's oxidative status? * how does hypovitaminosis C affect the length of stay in intensive care and post-transplant complications?

Transplant Wellness Program

Wellness is defined as the active pursuit of activities, choices and lifestyles that lead to a state of overall health. Prehabilitation, or using rehabilitation in the period before surgery, can improve the pre, during, and post operative experience for the patient. Although exercise as prehabilitation has been well established in organ transplant, the investigators believe a multiphase approach will help to better serve patients and support patient wellness in the long-term. Supporting wellness behaviour change, such as exercise, stress reduction, and sleep, is associated with improved quality of life (QoL), mood, and improvements in well-being. Including behaviour change support in an exercise program can help support transplant patients in long-term positive lifestyle changes. The Transplant Wellness Program (TWP) is an exercise behaviour change program that includes additional wellness components such as nutrition, stress reduction, and sleep programs to support overall health and QoL of transplant patients. Specifically, the TWP will implement physical activity and behaviour change support for patients pre- and post-transplant surgery, addressing functional (frailty, indices of fitness, physical activity levels) and mental (anxiety, stress) outcomes to improve overall QoL. The TWP includes a 12-week exercise program that is delivered either pre-transplant or post-transplant, depending on length of time from study enrollment to transplant surgery. In addition to the exercise intervention, the TWP includes maintenance resources (access to group exercise classes, wellness webinars, group wellness coaching etc.), and wellness behaviour change support. The goal of the TWP is to improve outcomes of participants throughout their transplant journey, as well as reduce health services use. Collected outcomes will include program reach, effectiveness measures such as changes in physical fitness, adoption by healthcare practitioners, implementation of the program, and maintenance. In addition, will also collect health care use measures as the investigators believe the TWP will result in the reduction of several health care use outcomes, such as the number of hospital admissions (including intensive care unit admissions), length of hospital stays and emergency room utilization.