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Showing 1-20 of 73 trials
NCT06262776
The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are: 1. Are there differences in vaccination immunological responses in transplant patients on different immunosuppression regimens? 2. Are there differences in vaccination immunological responses between transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination.
NCT07479511
This prospective observational study investigates the effects of intermittent hypoxic conditioning and real high-altitude exposure in lung transplant recipients compared with healthy controls. The study includes an eight-week home-based preparatory phase during which participants use a normobaric hypoxic tent with reduced oxygen concentration. Prior to this phase, all participants receive standardized training on the safe use of the equipment. During the preparatory period, daily vital parameters, including heart rate, oxygen saturation, and heart rate variability, are recorded using a sports watch and a pulse oximeter. Symptoms, adverse events, and subjective well-being are documented daily in an electronic diary. All data are transmitted to the study team via encrypted electronic systems, allowing continuous remote monitoring. At the end of the preparatory phase, participants undergo a clinical evaluation to confirm fitness for the expedition phase. The expedition phase consists of a monitored ascent of Aconcagua (6,971 meters). Before departure, all participants are required to attend a comprehensive safety, protection, and first aid training conducted jointly by the study team and professional expedition providers. The expedition is planned and led by an experienced international expedition company in cooperation with a local provider specializing in high-altitude mountaineering. The expedition includes arrival in Mendoza, preparatory procedures such as equipment checks and permits, followed by a staged ascent to base camp. Subsequent days involve rest periods and acclimatization hikes with the establishment of progressively higher camps. A summit attempt is planned after sufficient acclimatization, followed by descent to high camp. A weather-dependent buffer period is included before the final descent to the valley and return to Mendoza, where the expedition concludes. Total study participation is expected to last approximately 15 weeks, including about eight weeks of home-based preparation and approximately three weeks at altitude. A final follow-up examination is conducted 2 to 4 weeks after completion of the expedition, marking the end of study participation.
NCT07269041
This clinical trial is being conducted to help liver transplant recipients safely discontinue toxic immunosuppressive drugs years after surgery. Lifelong use of these drugs is the current standard, but they come with life-threatening side effects. UCLA has pioneered this "Delayed Tolerance" approach, achieving success in numerous kidney recipients now living drug-free. The process uses a conditioning regimen followed by donor stem cell infusion to retrain the immune system to accept the liver as "self."
NCT06879106
The study aims to analyze the effects of Mindfulness-Based Cognitive Therapy (MBCT) on the motivation levels and compliance with immunosuppressive therapy of post-liver transplant recipients. H1-0: MBCT has no effect on the compliance of recipients to immunosuppressive therapy after liver transplantation. H1-1: MBCT has an effect on the compliance of recipients to immunosuppressive therapy after liver transplantation. H2-0: MBCT has no effect on increasing the motivation of recipients after liver transplantation. H2-1: MBCT has an effect on increasing the motivation of recipients after liver transplantation.
NCT05756036
To seek an association between Torque Teno Virus DNA titres resulting from under or over-immunosuppression in a kidney allograft recipient, Graft rejection, both cell-mediated rejection and antibody-mediated rejection, donor-specific antibodies (DSA), the incidence of BK viraemia and BK nephropathy, CMV infection or diseases and PCP infection and the number of circulating NK, B and T lymphocyte subtypes.
NCT06694740
The vast majority of serious clinical situations leading to intensive care (septic shock, polytrauma, acute cerebral aggression, major surgery) are characterized by significant systemic inflammation. Recently, the existence of a common immune response pattern to acute aggression has been demonstrated, and with it the existence of a phenomenon known as post-aggressive immunosuppression (PAIS).
NCT06970964
This study aims to evaluate whether a fermented milk drink containing the probiotic strain Lacticaseibacillus paracasei strain Shirota (LCS), commonly found in Yakult®, can help reduce upper respiratory symptoms in triathletes before and after competition. Athletes often experience cold-like symptoms due to physical stress, intense training, and immune system challenges. The study investigates whether daily consumption of this probiotic drink can help improve immune response and reduce the incidence or severity of symptoms such as sore throat, nasal congestion, or coughing. This is a randomized, double-blind, placebo-controlled, parallel-group study involving healthy adult triathletes. Participants will be randomly assigned to receive either the probiotic drink or a placebo for a specific period before and after a triathlon event. Symptoms and health markers will be tracked through questionnaires and biological samples. The goal is to explore whether probiotic supplementation can provide practical, non-pharmacological support for athletes' immune health and well-being during intense physical activity.
NCT04786067
The purpose of the study is to identify kidney transplant patients that can be transitioned from multi-drug immunosuppression therapy to Belatacept monotherapy, using cell free DNA and gene expression as markers of immune quiescence. The primary objective will be to determine if donor derived-cell free DNA (AlloSure) can be utilized to facilitate Belatacept monotherapy, and to determine if Belatacept is safe and effective as immunosuppression in kidney transplant recipients. The secondary objective is to determine the utility of AlloMap as a predictor of immune quiescence and tolerance of immunosuppressive de-escalation to Belatacept monotherapy, and to evaluate the performance of iBox in predicting adverse outcomes in patients transitioned to Belatacept monotherapy
NCT07206277
Following Liver transplantation, recipients remain on life long immunosuppression. Prolonged exposure to immunosuppression is associated with side effects and complications including kidney dysfunction, diabetes, heart disease and cancer risk. Therefore studies are looking at safe ways to reduce or stop immunosuppression. An individual without autoimmune liver disease (these patients are at higher risk of rejection), without history of rejection, with normal blood tests (liver biochemistry, liver function, etc.) can be eligible for minimization of immunosuppression. A recent study showed use of fibroscan (an Ultrasound, which provides information on liver stiffness (diseased liver is hard while a normal liver is soft) and fat content) provides more objective information to help investigators select individuals who will tolerate immunosuppression minimization. Our goal is to see if use of fibroscan allows the investigators to safely minimize immunosuppression in eligible individuals. The secondary aims are to assess benefit on kidney function, heart disease and risk factors for heart disease.
NCT04104438
This is a study to help understand how well new combinations of immunosuppressive medications (medications that weaken your immune system to prevent your body from rejecting the transplanted liver) work compared to standard immunosuppressive medications after your liver transplant. Also the study will assess how safe the new combination of immunosuppressive medicines are and if there are any changes in how your kidneys work after taking these medicines.
NCT06972069
This is an open-label, single-institution study to assess the safety and the efficacy of the Sip-Tego regimen for the induction of donor-specific immunologic unresponsiveness to a renal allograft. The investigators propose to treat 6 adult subjects in end-stage renal disease (ESRD) who do not demonstrate evidence of prior sensitization.
NCT02310867
The purpose of this study is to determine the safety and efficacy of hand transplantation as a treatment for patients with loss of limb below the elbow, The study will focus on patients who have had loss of limb. The primary endpoint is the ability to use the tranplanted limb in activities of daily living at 18 months following transplantation measured by a quantitative functional test. Study activities include several study visits over 18 months and include; demographics, medical history, vital signs, psychosocial evaluation, urine, blood test, chest x-ray, bone density scans, and biopsies. Subjects who are 18-65 and willing to travel to site and have loss of limb will be included in study evaluation. Risks of the study include risk of rejection and infection after being transplanted. Additional risk are associated with procedures that include blood draws, biopsies, x-rays, and potential loss of confidentiality. All patient data will be kept electronically and in accordance with the requirements of Duke University. In addition to the experimental data, this database includes recipient and donor demographics and transplant relevant medical history, range of motion, sensation, and immunosuppressive medications. Data will be recorded and reported in accordance with the standards required by the United Network for Organ Sharing (UNOS).
NCT05732922
This project assesses feasibility of providing medically vulnerable rural patients with Medical-Self-Assessment-Boxes containing equipment to use at home during telephone and video consultations (telemedicine) with GPs and other healthcare professionals. COVID-19 has caused an upsurge in primary care telemedicine which the investigators believe can be sustained and optimized to make things better for medically vulnerable rural patients beyond the pandemic. The investigators will achieve this by equipping the participants to self-measure and report key clinical measurements (e.g. blood pressure, temperature, oxygen levels) during telemedicine consultations. Before conducting a major evaluation of the Medical-Self-Assessment-Box for medically vulnerable rural patients the investigators must establish three things: First, to show the investigators can issue a Medical-Self-Assessment-Box to medically vulnerable rural patients and enable them to use it properly. Second, to determine that patients can use the Medical-Self-Assessment-Box effectively during telemedicine consultations. Third, to show that it is possible to measure how well the Medical-Self-Assessment-Box is working by counting how often the boxes are being used and whether use is appropriate and helpful. The knowledge gained will provide the investigators with the information needed to develop a funding proposal to evaluate Medical-Self-Assessment-Boxes for medically vulnerable rural patients in the whole of the UK.
NCT05060991
Immunocompromised individuals, such as solid organ transplant (SOT) recipients are at high risk of COVID-19 associated complications and mortality. Retrospective studies so far have shown that a majority of SOT recipients did not develop appreciable anti-spike antibody response after a first, second, or even third dose of mRNA vaccine. Treatment with antimetabolites was associated with poor vaccine response. The goal of this study is 1) examine whether transient immunosuppression reduction improves the immune response to a third dose of SARS-CoV-2 mRNA vaccine in kidney transplant recipients and 2) to assess the safety of immunosuppression reduction before and after third dose SARS-CoV-2 mRNA vaccination.
NCT05814432
Phase III trial evaluating the safety and efficacy of a single high dose (10 mg/kg) of liposomal amphotericin B for disseminated histoplasmosis in AIDS patients, in comparison to standard therapy (3 mg/kg of liposomal amphotericin B for two weeks) (INDUCTION trial).
NCT01236287
Voclosporin is an investigational medication previously studied to prevent acute rejection in patients who receive a kidney transplant. This study is a compassionate release program where subjects previously participating in the study entitled A Phase 2B, Randomized, Multicenter, Open-Label, Concentration Controlled, Safety Study of ISA247 and Tacrolimus (Prograf®) in denovo Renal Transplant Patients (ISA05-01)" may be eligible to continue to receive voclosporin despite the Phase 2B study being terminated by the sponsor. Under the compassionate release program, subjects previously taking voclosporin may continue to receive the study medication until the drug is FDA-approved and commercially available in the United States. Voclosporin was approved by the FDA in January 2021 for the treatment of active lupus nephritis. The sponsor (now called Aurinia Pharma, U.S.) is willing to continue to provide voclosporin (commercial supply) for the one subject remaining in this special access protocol.
NCT05459181
This is an unblinded, randomized, controlled, two-arm interventional research study enrolling patients who are undergoing heart transplantation. The aim of the study is to determine whether patients at low risk of rejection can safely reduce the doses of their post-transplant immunosuppression medications using a combination of tests that include donor-specific antibodies (DSA), histology (looking at tissue from the donor heart), donor-derived cell-free DNA (AlloSure), and gene expression profiling (AlloMap). Eligible participants will be randomized in a 1:1 ratio into the HeartCare immune-optimization (intervention) arm or the corresponding observational (control) arm. AlloSure and AlloMap are the components of the HeartCare panel developed by CareDx.
NCT04521790
Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents. Clinical presentations are multiple, including chest-pain, heart failure and a broad spectrum of arrhythmias. In turn, outcome is largely unpredictable, ranging from mild self-limiting disease, to chronic stage and progressive evolution towards dilated cardiomyopathy, to rapid adverse outcome in fulminant forms. Subsequently, myocarditis is often underdiagnosed and undertreated, and optimal diagnostic and therapeutic strategies are still to be defined. This study, both retrospective and prospective, originally single-center and subsequently upgraded to multicenter, aims at answering multiple questions about myocarditis, with special attention to its arrhythmic manifestations. 1. Optimal diagnostic workflow is still to be defined. In fact, although endomyocardial biopsy (EMB) is still the diagnostic gold standard, especially for aetiology identification, it is an invasive technique. Furthermore, it may lack sensitivity because of sampling errors. By converse, modern imaging techniques - cardiac magnetic resonance (CMR) in particular - have been proposed as alternative or complementary diagnostic tool in inflammatory heart disease. Other noninvasive diagnostic techniques, like delayed-enhanced CT (DECT) scan or position emission tomography (PET) scan, are under investigation. 2. Biomarkers to identify myocarditis aetiology, predisposition, prognosis and response to treatment are still to be defined. 3. Arrhythmic myocarditis is largely underdiagnosed and uninvestigated. Importantly, myocarditis presenting with arrhythmias requires specific diagnostic, prognostic and therapeutic considerations. At the group leader hospital, which is an international referral center for ventricular arrhythmias management and ablation, a relevant number of patients with unexplained arrhythmias had myocarditis as underlying aetiology. The experience of a dedicated third-level center is going to be shared with other centers, to considerably improve knowledge and management of arrhythmic myocarditis. 4. The role of CMR, as well as alternative noninvasive imaging techniques, in defining myocarditis healing is a relevant issue. In particular, optimal timing for follow-up diagnostic reassessment is still to be defined, in patients with myocarditis at different inflammatory stages, either with or without aetiology-dependent treatment. 5. Uniformly-designed studies are lacking, to compare myocarditis among different patient subgroups, differing by variables like: clinical presentations, myocarditis stage, associated cardiac or extra-cardiac diseases, aetiology-based treatment, associated arrhythmic manifestations, diagnostic workup, and devices or ablation treatment.
NCT06342505
The goal of this study is to measure concentrations of the drug tacrolimus in both whole blood and within T lymphocytes. It will also learn on the correlation between the concentration in T lymphocytes and the effects of the drug. The main questions are: (i) What is the ratio between the tacrolimus concentration within T lymphocytes and in whole blood?; (ii) What is the correlation between tacrolimus concentrations and the effects of the drug? Participants will: * Receive standard clinical care; * Undergo two extra venipunctures for the collection of blood.
NCT04360772
Corticotherapy is widely used in auto-immune diseases. If induced immunosuppression by corticosteroids is well admitted, it's currently not possible to determine individual risk of infection. Thus, the development of new biomarkers able to reflect immunological status under immunosuppressive treatments is needed. It would help identifying patients who would benefit from adapted treatment protocols or infectious prophylaxis. In this field, the mHLA-DR (monocyte Human Leukocyte Antigen-DR) has shown encouraging results. However, it has never been used in patients treated by immunosuppressive therapies. The investigators aim to describe changes induced by corticosteroids in mHLA-DR expression in vivo. To achieve this goal, the investigators will measure mHLA-DR before treatment, after 1 months, 3 months and 6 months of treatment. Finally, the investigators will look for correlation between the level of expression of mHLA-DR and the cumulated dose of corticosteroids administered.