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Immunosuppression clinical trials

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NCT ID: NCT02833805 Completed - Immunosuppression Clinical Trials

NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia

Start date: September 2016
Phase: Phase 2
Study type: Interventional

Our primary objective is to determine if it is feasible for previously untreated severe aplastic anemia (SAA) patients to be transplanted using non-myeloablative conditioning and post transplantation cyclophosphamide.

NCT ID: NCT02776111 Terminated - Immunosuppression Clinical Trials

Microfluidics and Transcriptomics in Post Solid Organ Transplant Patients

Start date: July 2016
Phase:
Study type: Observational

The field of genomics is an exciting new field being applied in medicine. Its use in treating some cancers, sepsis and burn patients has been very promising. As knowledge of genomics and application of microarrays expands, researchers are developing more intelligent ways to provide individualized care for patients. The plan of this research study is to apply the use of genomics as a tool for transplant in several capacities. This research study is designed to develop methods of isolating relevant cell types via microarray plates, then extracting mRNA samples of those cell types and capturing their genetic profile. This will be done with the blood of up to ten healthy donors. Once this ability has been demonstrated, the next step will be to use these testing in several capacities in transplant patients. The research study plan involves following the genetic profile of 26 kidney transplant patients. One group will be followed prospectively starting at baseline, and then at various set time points. A second group will be sampled with the occurrence of clinical events. These events include viral, bacterial, and fungal infection, WBC < 2.5 or biopsy proven rejection episodes or normal graft function. Thus, the intention of the study is to demonstrate how immunosuppression alters the expression of this genetic expression of these T cells. In doing so, the study will provide a better understanding of the specific and true immunosuppressed state for any given patient.

NCT ID: NCT02547753 Completed - Immunosuppression Clinical Trials

Dental Extractions Among Renal Transplant Recipients

Start date: October 2015
Phase:
Study type: Observational

The literature is rich in studies that explore the type and frequency of oral abnormalities in transplanted recipients, but it is scarce in studies that provide scientific evidence on the risk of complications after invasive interventions on those patients. Within this context, the aim of our study is to evaluate the post-exodontic socket healing in renal transplant recipients compared to a control group and see if some indicators in the population of transplanted people, such complete blood count, serum concentration of immunosuppressive drugs, can help to provide for the host response face a invasive procedures. Therefore, 45 kidney transplant recipients over six months and at least 45 healthy non immunosuppressed adults will be submitted to a maximum of 4 simple dental extractions, always by the same surgeon. Laboratory tests will be performed preoperatively and include: blood count and coagulation - for both groups - and urea, creatinine and serum levels of immunosuppressive drug - only for the study group. Researchers will evaluate the patient in the postoperative 3, 7, 21, and 60 days. The presence, or absence, of post-operative complication and delayed, or not, socket healing will be the results of interest in this study and will be compared between the groups. The data will be evaluated by Pearson's chi-square, Fisher's exact test, Mann-Whitney test, student's T-test and binomial test.

NCT ID: NCT02541916 Completed - Immunosuppression Clinical Trials

Liver Immune Tolerance Marker Utilization Study

LITMUS
Start date: April 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to validate and test a tolerance gene expression profile for the identification of operationally tolerant liver transplant recipients, allowing for the successful withdrawal of immunosuppression without rejection in these patients.

NCT ID: NCT02319876 Recruiting - Sepsis Clinical Trials

Expression of TIM-3 on Lymphocytes in Sepsis

Start date: February 2014
Phase: N/A
Study type: Observational

The current project was designed to examine the express TIM-3 on lymphocytes and monocytes and its role in immunosuppression during sepsis.

NCT ID: NCT02310867 Recruiting - Immunosuppression Clinical Trials

Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Start date: March 2015
Phase: Phase 2
Study type: Interventional

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).

NCT ID: NCT02254668 Recruiting - Immunosuppression Clinical Trials

Intracoronary Analysis of Cardiac Allograft Vasculopathy by Means of Optical Coherence Tomography

OCTandCAV
Start date: December 2013
Phase: Phase 4
Study type: Interventional

Randomized prospective multi-center imaging study which investigates the impact of different immunosuppressive protocols (Everolimus (Certican®) or Mycophenolate mofetil (CellCept®)) on cardiac allograft vasculopathy (CAV) in heart transplanted patients. Maximal intima-thickness will be visualized by optical coherence tomography (OCT) to assess the progression of CAV.

NCT ID: NCT02221843 Terminated - Immunosuppression Clinical Trials

Sunbit UV Measuring Device to Track Sun Behavior

Start date: August 2014
Phase: N/A
Study type: Observational

Sunbit is a new wearable UV dosimeter to measure solar radiation in real time. The purpose of this study is to track sun behavior of patients at high risk for skin cancer, to investigate the feasibility of this prototype in daily life and to investigate the technical accuracy of the Sunbit.

NCT ID: NCT02104479 Enrolling by invitation - Immunosuppression Clinical Trials

Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing

EFFU-ASP
Start date: March 31, 2014
Phase:
Study type: Observational

Diagnostic accuracy of biomarker testing (galactomannan (GM), (1

NCT ID: NCT01978483 Completed - Immunosuppression Clinical Trials

Effect of RANKL Inhibition on UV-induced Immunosuppression

Start date: November 2013
Phase: Phase 1
Study type: Interventional

Ultraviolet (UV) light is part of normal sunlight and has many effects on human skin and health. One of the harmful effects of long-term UV light exposure is that it can cause skin cancer. The mechanism by which UV light causes skin cancer is not entirely understood. One of the ways UV light causes cancer is by modifying DNA molecules in the cells of the skin. Another mechanism involved in cancer formation by UV light is immunosuppression. By this mechanism, UV light inactivates cells of the immune system of the skin. The immune cells are responsible for the detection and destruction of foreign substances and organisms such as bacterias and viruses but they also recognize and destroy cancer cells. UV light is known to prevent cells of the immune system to destroy cancer cells. In laboratory experiments, a medication called denosumab has been shown to diminish the inhibition of ultraviolet-induced suppression of skin immunity. In other words, this medication could block the effect of UV on cells of the immune system and might allow patients taking this drug to be better protected from skin cancer. The objective of this study is to test whether denosumab blocks the immunosuppressive effect of UVB light in healthy subjects. This study is divided into two stages. In the first stage, ten subjects (Cohort 1) will be sensitized to diphenylcyclopropenone (DPCP), a topical sensitizer commonly used for the treatment of alopecia areata and cutaneous warts. By reexposing the subjects to DPCP in incremental doses, dose-response levels of cutaneous hypersensitivity reactions in normal skin will be obtained. This will allow comparison of the normal levels of DPCP-induced cutaneous hypersensitivity (CHS) reaction in non UV-exposed skin (Cohort 1) to the CHS obtained from the two UVB-exposed experimental groups of Cohort 2. In the second stage of the study, 20 subjects (Cohort 2) will be exposed to an immunosuppressive dose of ultraviolet B (UVB) 24 hours prior to DPCP sensitization. This is expected to result in the abolition of CHS upon rechallenge with DPCP. In order to assess whether denosumab can reverse UVB-induced immunosuppression, the subjects will have previously been randomized to receive a single 1mL injection of either 60 mg denosumab (group A; 10 subjects) or 1 mL saline (group B; 10 subjects) two weeks before UVB exposure. CHS reactions elicited by DPCP rechallenge will be compared between the denosumab and saline groups.