Clinical Research Directory

Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care PAPAYA III

The overall objective of the study is to evaluate and analyze major and minor incidents during airway management in adults under anaesthesia care at all study sites. The patient characteristics, type of airway management is recorded and if airway management-related incidents occur, they are analyzed in more detail to improve patient safety in the future.

Impact of SCFA Supplementation on Gut Microbiome Composition of Kidney Transplant Recipients

This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of high-dose short-chain fatty acid (SCFA) supplementation on the gut microbiome and host metabolome in stable kidney transplant recipients. Participants will be randomly assigned to receive either 1000 mg of sodium butyrate per day or placebo for a duration of 12 weeks. Comprehensive profiling of the serum and urinary metabolome, along with analysis of the gut microbiome composition and diversity, will be conducted at three time points: baseline, after the intervention period (week 12). The biochemical parameters and the level of tacrolimus will be also examined.

CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation

The investigators' overall objective is to assess the incidence of critical events related to tracheal intubation at all international study sites. Furthermore, the study will investigate the used intubation techniques and identify possible improvement measures to increase patient safety.

Amino Acid Infusion in Kidney Transplant Recipients

The study addresses the impact of amino acid infusion in the early post-transplant period on graft function and the incidence of post-transplant complications.

ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery

The purpose of this prospective trial is to investigate ABM/P-15 bone graft versus traditional bone graft in patients undergoing surgery for Adult Spinal Deformity (ASD) in order to provide better clinical results through faster bone healing, no additional surgeries, fewer complications and thereby increase health-related quality of life. Main hypotheses: 1. The use of ABM/P-15 bone graft is superior to traditional bone graft treatment regarding the incidence of additional surgeries following index surgery for ASD Secondary hypotheses: 2. The investigators expect non-inferiority in patient reported outcome measures in the ABM/P-15 bone graft group compared to the control group 3. The investigators expect non-inferiority in the postoperative fusion rates (bone healing) evaluated on CT scans in the ABM/P-15 bone graft group compared to the control group 4. The investigators expect non-inferiority in postoperative incidence of asymptomatic pseudarthrosis in the ABM/P-15 bone graft group compared to the control group 5. The investigators expect non-inferiority in perioperative complications in ABM/P-15 bone graft group compared to the control group 6. The investigators expect the use of ABM/P-15 bone graft to be cost-efficient compared to the traditional treatment in the control group

Electroacupuncture for Preventing Adverse Events of Cancer Immunotherapy

This study aims to investigate the preventive effects of electroacupuncture on immune-related adverse events (irAEs) in patients with malignant solid tumors at the neoadjuvant stage, locally advanced, unresectable, or metastatic stages, who are receiving immune checkpoint inhibitors (ICIs) monotherapy, ICIs combined with anti-angiogenic agents, or ICIs combined with chemotherapy. The study will evaluate the efficacy, safety and mechanisms of electroacupuncture in preventing irAEs in a multicenter setting.

Study of the Association Between Fatigue Experienced by Patients and the Specific Side Effects of CART Cells, During the First Month After Administration for Non-Hodgkin's Lymphoma

The incidence of cancer in 2023 is estimated at 433136 cases, according to INCa. Haemopathies account for 12% of these new cases of cancer cases of cancer, and around two-thirds are lymphoid haemopathies, in particular lymphomas. There are many treatments available for lymphoma. However, the arrival in France in 2018 of immunotherapy treatments such as CAR-T Cells have changed the paradigm of treatment options for certain non-Hodgkin's lymphomas. In these treatments can have both short-term and long-term adverse effects and long-term adverse effects. During hospitalisation for the administration of CAR-T Cells, acute side effects include CRS and ICANS. There is also another complication very specific to this treatment that has been observed in patients: cytopenias. This is despite the fact that one of the symptoms frequently mentioned and felt by patients during the first month after month after treatment is fatigue. Despite numerous studies on the prevalence of fatigue, healthcare professionals often underestimate this symptom. Nurses, and in particular the advanced practice nurse have a crucial role to play in assessing fatigue. The EORTC scale QLQ-FA12 is a multidimensional scale which assesses the physical emotional and cognitive dimensions of fatigue. The theory of symptom management, which was developed in 1994 by the California College of Nursing in San Francisco, is a relevant framework for understanding fatigue in patients. This theory places the patient's experience at the centre of care. This holistic approach provides a detailed framework for understanding this symptom. "According to the theoretical model, measuring the symptom is an important step and characterising it is an essential element in better targeting the actions to be taken". Although CAR-T Cell therapy is innovative and allows long-term remissions, it is important to evaluate and understand how patients live with this treatment. To our knowledge, few studies have been carried out on quality of life, particularly regarding fatigue, following the first month of CAR-T Cell administration. The research question we will address in this study is: "Is there an association between the side effects of CAR-T Cell treatment and the state of fatigue in patients receiving this treatment for non-Hodgkin's lymphoma during the first month?"

The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization

Ultrasound-guided oocyte retrieval (OR) is a short, but oftentimes painful procedure, during which the follicles are punctured trans-vaginally to obtain oocytes for in vitro fertilization (IVF). Conscious sedation is the most commonly used method of pain relief, yet several studies have shown that more than half of women report moderate to high levels of pain and up to 7% of women report extreme or unacceptable levels of pain during OR. Adjuvant virtual reality (VR) therapy has been explored to reduce psychological stress during dental procedures, burn wound care, colonoscopy, as well as other minor procedures. Hence, the purpose of this study is to evaluate the use of VR technology during IVF treatment, particularly with respect to tolerability, patient satisfaction, and pain reduction during oocyte retrieval.

Studying the Senescent T Cell Features and Its Relationship with the Chemotherapy Efficacy in Young TNBC

The goal of this observational study is to learn about the features of senescent T lymphocytes induced by chemotherapy and its relationship with the efficacy of neoadjuvant chemotherapy in young triple-negative breast cancer (TNBC) patients. The main questions it aims to answer are: * What are the senescent features of peripheral T lymphocytes in young TNBC patients receiving neoadjuvant chemotherapy and the relationship with the efficacy of neoadjuvant chemotherapy? * What is the relationship between senescent T cells and adverse events, DFS and tumor infiltrating lymphocytes? 1. Participants will receive 6 cycles of docetaxel + adriamycin/epirubicin + cyclophosphamide (TEC/TAC) neoadjuvant chemotherapy, and radical mastectomy after chemotherapy. 2.5ml peripheral venous blood will be collected before chemotherapy, after 2 cycles of chemotherapy, before surgery, and six months after surgery. 3.Clinicopathological data, chemotherapy-related adverse events and prognostic information of patients should be collected during the study.

Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS

The PreDECESS trial is a prospective study where that will evaluate a new method taking care of premature infants in gestational weeks 30+0 to 34+6 at birth. The new method includes delayed cord clamping and early skin-to-skin contact with a parent. Two populations of infants with their parents will be compared. Infants taken care of in the traditional way before the new method is introduced, and infants taken care of with the new method when it is being introduced. Primary question: Does delayed cord clamping and early skin-to skin contact (SSC) lead to better bonding between parents and their infants? Secondary questions: Are there any potential adverse effects with delayed cord clamping and early skin-to skin contact (SSC)? Is there a difference in infants level of bilirubin, haemoglobin or proBNP? Is there a difference in infants growth? Is there a difference in infants neurological development? Is there a difference in infants and parents level of stress? Is there a difference in mothers production of breastmilk, frequency of breastfeeding or experience of breastfeeding? Is there a difference in parents mood? How do parents of preterm infants experience giving birth of their preterm baby before and after the introduction of the new method?