147 Clinical Trials for Various Conditions
Older Hispanics (age 50+ years) are disproportionately overrepresented on the transplant waitlist, but underrepresented as deceased donors and transplant recipients. This application proposes the formative research to design and empirically test an eLearning module, Promotoras de Donación, to train community health workers (i.e., Promotoras), who already provide culturally and linguistically sensitive services to their communities, to discuss and promote organ donation with older Hispanic women in 3 geographically distinct communities across the U.S. The proposed intervention leverages the established and evidence-based Promotoras program to increase rates of donor designation within Hispanic communities across the U.S. and reduce disparities in access to transplantation for this population.
Investigators will evaluate organ donation educational videos with a 2x3 single blinded Randomized Control Trial (RCT) in partnership with our 26 Latino Owned Barbershops (LOBs). The testimonial video about Uncontrolled Donation after Circulatory Determination of Death (uDCDD) with an uplifting ending will serve as control. Experimental videos may include live uDCDD footage, differing endings, or combinations. Video production will be informed by the entertainment education model and produced with experts including an Academy Award winning filmmaker. The primary outcome is whether participants immediately enroll in the NY State Organ Donor Registry (either online or by our RA mailing in the official form with prepaid postage). Investigators hypothesize that each video will induce differences in registration compared to the control and that there is an interaction effect with video genre and story outcome.
The primary purpose of this 3-phase mixed methods design study is to investigate how presenting content at varying levels of audience specificity (generic, targeted, and tailored) influences organ donor registration behavior among black men using video-based educational programming produced and distributed in partnership with our network of Black Owned Barbershops (BOBs). Investigators have completed a development phase using digital video interviewing to both derive and provide culturally specific content for the videos. This phase of this investigation is a 3 arm randomized control trial (RCT) phase, in which customers will be randomized to receive the generic, targeted, or tailored video programming delivered with iPads, after which an immediate organ donation opportunity will be offered through registration online or with a mailed in application. The final phase of this investigation will be a failure analysis whereby we will interview a subset of participants who registered or failed to register one month after their educational session to ascertain how the programming impacted their decision (Aim 3 - the subject of a future IRB application).
The number of persons actively waiting on the national solid organ waiting list continues to rise while the number donating organs has failed to keep pace. This is a particular problem for some portions of northeastern Ohio where the donation rate is as low as 32%. Adolescents are an important group for organ donation efforts as they have not yet applied for a driver's license and represent the majority of future donors. Yet many organ donation interventions have not targeted adolescents. The investigators propose to utilize existing high school teen summits developed by our Consortium partners to evaluate the effectiveness of existing donation interventions. Together, the investigators will conduct a randomized controlled 2x2 factorial trial to evaluate the independent and combined effects of two donor education interventions on consent for organ donation on the electronic Ohio Donor Registry. One thousand six hundred students over the age of 15.5 years from Cleveland-area high schools will be enrolled.
The purpose of this study is to evaluate the efficacy and generalizability of a communication intervention (Communication Effectively about Donation (CEaD)) for Organ Procurement Organization (OPO) staff requesters and to compare two conditions of delivering the CEaD. The experimental design will test: (1) the overall efficacy of the intervention on timely referral and consent for organ donation and (2) whether a completely autonomous condition (no outside training assistance) is clinically equivalent to the assisted condition (training provided by outside consultants) in terms of the final outcome of consent to donation.
The purpose of this study is to determine the effect of brief organ donation video interventions on consent for organ donation among college and university students. Our hypothesis is that the organ donation video interventions will be superior to lay health websites for increasing organ donation consent.
The number of persons on the national solid organ waiting list continues to increase while the number of donated organs has failed to keep pace. In some portions of northeastern Ohio the donation rate is as low as 32%. There is a positive association between discussing organ donation with a primary care physician and signing a donor card. However, such discussions are rare. The investigators propose a blinded randomized controlled trial to evaluate the effectiveness of two interventions: 1) showing a donation video to patients in primary care settings waiting to see their physician and 2) cueing of primary care providers to have donation discussions with their patients. The study will be conducted throughout Cuyahoga County in at least 10 ambulatory clinics associated with a single county medical system. Nine hundred patients over 15.5 years of age will be enrolled. The investigators hypothesize that patients exposed to the interventions will be 1) more likely to consent to donate organs, 2) more likely to have donation discussions with their primary care providers, and 3) equally satisfied with the time spent with their doctor compared to patients who are not exposed to the interventions.
The purpose of this study is to determine the effect of a 5-minute video intervention regarding organ donation and transplantation on increasing the number of organ donor cards signed in Northeastern Ohio Bureau of Motor Vehicles (OBMV) branches and on willingness to donate organs while living. The investigators hypothesize that persons in the intervention group will sign more donor cards and be more willing to donate organs while living than persons in the control group.
Cytomegalovirus (CMV) is a significant opportunistic pathogen and a major cause of morbidity and mortality in solid organ transplant recipients. CytoGam - Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV), is an immunoglobulin G containing a standardized amount of antibody against CMV. CytoGam is obtained from pooled adult human plasma that has been selected for high anti-CMV titers. This study will evaluate if administration of CytoGam to organ transplant recipients with CMV infection, along with standard of care antiviral medication, leads to faster clearance of CMV from the blood, prevents the development of antiviral resistance, and decreases the rate of recurrence of CMV infection.
This goal of this study is to assess the safety and immunogenicity of recombinant zoster virus in young adult solid organ transplant recipients. In this study, participants will receive the recombinant zoster vaccine. They will be monitored for adverse events and tested for antibody and cellular immunity.
Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. One study compared HD-IIV vs. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase I pediatric study comparing a single dose of HD-IIV vs. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined. The central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher Hemagglutination Inhibition (HAI) geometric mean titers (GMTs) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV.
Long-term graft failure rates continue to be unacceptably high despite the development of immunosuppressive drugs, underscoring the unmet need for robust prognostic biomarkers of allograft injury and failure. While rates of acute rejection (AR) continue to decrease, it remains the strongest predictor of long-term allograft survival, and so having a better understanding of factors predicting AR may contribute to more individualized patient care. Selecting optimum immunosuppressive dosage is another factor in personalizing kidney care. This project will study two areas of individualized kidney care: 1) assessing rejection by surveillance testing utilizing AlloSure, 2) developing an algorithm to select optimum immunosuppressive medication dosage.
This phase IIA study evaluates the effects of calcipotriene plus 5- fluorouracil immunotherapy for skin cancer prevention in organ transplant recipients. Solid organ transplant recipients are at high risk of developing skin cancer. Actinic keratosis (AK), is a premalignant skin lesion that can progress to squamous cell skin cancer. In this study, solid organ transplant recipients with multiple AKs are treated with topical calcipotriene and 5-FU to evaluate how effective this therapy is against AKs and if this could lower their risk of skin cancer. Topical calcipotriene is a form of vitamin D and is used to treat psoriasis. Prior research reported immunomodulatory effects in the skin induced by topical calcipotriene. Topical 5- fluorouracil is a chemotherapy agent and is one of the therapy options for multiple AKs in specific clinical scenarios. Prior research indicates that topical calcipotriene used together with topical 5-FU was more effective in treating multiple AKs than 5-FU alone in individuals with healthy immune system. This study is investigating now if similar beneficial effects can be seen in immunosuppressed individuals who are solid organ transplant recipients.
In solid organ transplant (SOT) the receipt of influenza vaccine in an influenza season is associated with decreased disease severity as demonstrated by the presence of pneumonia and ICU admissions. Different strategies have been assessed to optimize vaccine efficacy and immunogenicity of the influenza vaccine in the solid organ transplant recipient (SOTR). The primary objective of the study is to evaluate the immunogenicity of 2 doses of the high dose influenza vaccine utilizing neutralizing antibody assays. A control group receiving 1 HD influenza vaccine will be included.
This is a research study to test the tolerability and clinical effectiveness of the study drug, Letermovir (LET), when used as secondary prophylaxis following treatment of Cytomegalovirus (CMV) infection and disease in a solid organ transplant recipient. This study is an open label trial in which Letermovir will be prescribed to prevent the recurrence of CMV infection and disease in a solid organ transplant recipient following treatment of CMV infection or disease.
The purpose of this study is to collect data generated by standard clinical practice to determine the short term and long term clinical outcomes of recipients of solid organ transplantation from COVID-19 infected donors and compare it to recipients with organ transplant from COVID-19 negative donors.
The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK) of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT and to identify the optimal dose of maribavir using a 200 milligrams (mg) tablet formulation or powder for oral suspension. The participants will be treated with maribavir for 8 weeks. Participants need to visit their doctor during 12-week follow-up period.
This Expanded Access Protocol will provide access to the IMP ExoFlo for patients who have severe or life-threatening abdominal solid organ transplant rejection or who are evaluated and determined to be at high risk of progression to severe or life-threatening condition related to rejection of an abdominal solid organ transplant, at risk of worsening allograft function, or at risk of complications from current immunosuppressive therapeutic regimens.
Audiovisual teaching aids can play a significant role for the retention of new material and help overcome barriers such as the physical presence or time restrictions of an instructor. In a clinical setting, multimedia health education can offer an advantage over traditional didactic teaching by engaging patients through visual content and unlimited accessibility. A critical factor to long-term survival of solid organ transplant recipients is compliance to post-transplantation medication and follow-up patient care. Transplant pharmacists serve on multidisciplinary care teams as the medication experts that provide discharge education to recipients and caregivers often at the bedside. The adoption of digital multimedia content for patient education can increase engagement of diverse learning styles while simultaneously reducing potential time conflicts in hospital practice. This study contributes to the literature by assessing the effectiveness of discharge education video(s) on patient satisfaction and knowledge levels which are currently limited.
The U.S. Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), published Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV. All such transplants must occur under an institutional review board (IRB) approved research protocol that is compliant with federal regulations governing human subjects research. This is an investigator-initiated, observational prospective study of solid organ transplantation utilizing HIV-positive donors in HIV positive recipients. Stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation will be offered enrollment in the study. Deceased donors (kidney) and living donors (kidney) will be utilized in this protocol. The goal of this research is to increase knowledge about the safety, efficacy, and effectiveness of solid organ transplantation (SOT) utilizing HIV-positive donors in HIV-positive recipients.
A study to evaluate ALVR106; an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets four community acquired respiratory viruses: respiratory syncytial virus (RSV), influenza, human metapneumovirus (hMPV), and/or parainfluenza virus (PIV) following hematopoietic cell transplant (HCT) and solid organ transplant (SOT).
This is an open-label study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) vaccine in adults with a kidney or liver solid organ transplant (SOT) and in healthy adult participants. The primary goal of the study is to evaluate the safety of mRNA-1273 and the serum antibody (Ab) responses obtained 28 days after the last dose of mRNA-1273.
Although the notions that kidney transplantation is the treatment of choice for patients with end-stage renal disease and that simultaneous kidney and pancreas transplant is the only treatment able to restore euglycemia in patients with type 1 diabetes and selected patients with type 2 diabetes, are now consolidated, rates of transplantation remain low among potential candidates with high levels of preformed anti-HLA antibodies. Most of the data comes from the experience in kidney transplant but can be easily translated to pancreas transplant. Approximately 30% of patients on the transplant waiting list have evidence of sensitization in the form of alloantibodies, generated from exposure to previous transplants, blood transfusions, pregnancy, or other events. The presence of a panel-reactive antibody level of at least 80% (i.e. a high level of sensitization) creates difficulty in finding matched kidneys from compatible donors, leading to lower rates of transplantation in highly sensitized candidates compared to non-sensitized; the longer waiting times translates in an increased mortality rate. Despite the development of desensitization strategies and the advancement in immunosuppression protocols, it is apparent that transplanting these patients carries an increased risk of acute antibody mediated rejection; 25%-50% of transplants will have an early acute antibody mediated rejection . Most of these rejections can be successfully treated, but a high rate of transplant glomerulopathy and chronic antibody mediated rejection (AMR) leading to accelerated allograft failure is common.
In this open-label, multicenter, Phase II study, the investigators propose to evaluate the efficacy of ruxolitinib, an orally administered inhibitor of JAK1/2, in solid organ transplant recipients with advanced cSCC. In a safety lead-in of 6 patients, subjects will receive ruxolitinib 15mg twice daily (BID). After 4 weeks, if dose-limiting toxicities (DLT) are observed in 1 or fewer patients, the study will enter stage 1 of the Simon two-stage design where all subsequent patients will receive a starting dose of ruxolitinib 15mg BID. If more than 1 DLTs are observed, another cohort of 6 patients will be treated at a dose of 10mg BID. If less than 2 DLTs are observed at the new dose of 10mg, then the study will proceed to stage I using this dose; otherwise the study will stop.
This clinical trial aims to investigate the efficacy of Calcipotriol ointment combined with 5-FU cream in Organ Transplant Recipients (OTRs) to determine if it can stimulate the immune cells against actinic keratoses precancerous skin lesions after transplantation and prevent cutaneous squamous cell carcinoma (SCC) in long-term.
2.1. Study Objectives * Primary Objective(s) * Identify the incidence and risk of CDI within one year after kidney, liver, and/or pancreas transplant * Secondary Objective(s) * Identify the risk factors for recurrent CDI post-transplant in patients who were diagnosed with a CDI within one year prior to Solid Organ Transplant * Evaluate the impact of CDI on graft survival following Solid Organ Transplant
In solid organ transplant recipients, poor adherence to immunosuppressant medications carries the risk of graft rejection (needing a new transplant), post-transplant complications, and increased healthcare costs. Additionally, nonadherence to immunosuppressant medications is imperative to short- and long-term outcomes. The rate of nonadherence in this population varies vastly. Because of lacking objective and accurate nonadherence measurements, both to immunosuppressant drugs and medical indications, the true implications and prevalence of nonadherence is not yet well understood. Therefore, investigators believe that mobile health (mHealth) technology has the potential to allow clinicians and researchers to more comprehensively address and understand nonadherence in solid organ transplant recipients. The aim of this study is to conduct a randomized control trial to compare medication adherence among liver and kidney transplant patients who use the mHealth system against controls who do not.
This study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient.
This Phase 1B/2 study is a multicenter, open-label, study of RP1 to investigate the (a) objective response rate, in addition to (b) safety and tolerability of RP1 for the treatment of advanced cutaneous malignancies in up to 65 evaluable organ transplant recipients. This will include patients with either previous renal, hepatic, heart, lung, or other solid organ transplantation or hematopoietic cell transplant and experiencing subsequent documented locally advanced or metastatic cutaneous malignancies. The study will enroll a total of 65 evaluable patients. Patients will participate up to approximately 3 years including a 28-day screening period, up to approximately 1 year treatment period, and a 2-year follow-up period.
The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to treat viral infections that may happen after solid organ transplant (SOT). VSTs are cells specially designed to fight viral infections that may happen after a solid organ transplant. These cells are created from a blood sample collected from the study participant. Solid organ transplant and the use of immunosuppressive medications reduces the body's ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. Reduction of immunosuppression may put the organ at risk of rejection. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study the investigators are trying to find a better way to treat these infections and minimize complications.