Enfermedades infecciosas

A continuación se enumeran ensayos clínicos actuales.

Filtrar esta lista de estudios según la ubicación, el estado del estudio y más.

1. A Study Of Larsucosterol In Alcohol-associated Hepatitis

   Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

   The purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90, in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score ≥ 32 and MELD scores 21-30, inclusive.

2. A Study to Evaluate Biomarkers of Fluoroquinolone-induced Mitochondrial Toxicity

   Rochester, Minn.

   The purposes of this study are to determine if patients treated with fluoroquinolone (FQ) antibiotics have depletion of mitochondrial DNA (mtDNA) in buccal swab samples, and whether the degree of depletion correlates with the likelihood of developing FQ-associated toxicity.

   2nd arm - An additional group of patients will be enrolled if they previously received FQ antibiotics. appear to be symptomatic and have a previously collected muscle or nerve biopsy for clinical purposes available for this research study. 

3. A Study To Evaluate Lamprene (Clofazimine) To Treat Non-Tuberculous Mycobacterial (NTM) Infections

   Jacksonville, Fla.

   The purpose of this study is to  evaluate Lamprene (Clofazimine) to treat non-tuberculous mycobacterial (NTM) infections.

4. Sustained Humoral and Cell-Mediated Immunogenicity of COVID-19 Vaccines in Patients With Inflammatory Bowel Disease

   Jacksonville, Fla.

   The purpose of this study is to determine the impact of systemic immunosuppression on sustained antibody COVID-19 concentrations in patients with inflammatory bowel disease (IBD) who received a COVID-19 vaccine.  This observational study will collect blood samples to measure sustained antibody concentrations to evaluate seroprevalence and study immunity  at 6 and 12 months after completion of vaccination.  The primary outcome of this study is to evaluate the immunogenicity of the Covid-19 vaccine in patients with IBD.

5. A Study to Evaluate the QuantiFERON-TB Gold-Plus Test for Blood Detection of Tuberculosis without Symptoms

   Rochester, Minn.

   The purpose of this study is to evaluate the new QFT-Plus assay compared to the QFT-Gold assay and the tuberculin skin test results (as available) for the detection of tuberculosis without symptoms in high-risk patients.

                  

6. Molecular Analysis of Blood for the Detection of Cardiovascular Pathogens

   Rochester, Minn.

   The purpose of this study is to test whether metagenomic shotgun sequencing can identify pathogens causing cardiovascular infections such as infective endocarditis or myocarditis.

7. RLY-2608-201-Ph2 Study Of RLY-2608 In PROS And PIK3CA Driven Malformations

   Rochester, Minn.

   The purpose of this study is to compare the efficacy and safety of RLY-2608 versus placebo in adult, adolescent, and pediatric participants with PROS and malformations driven by PIK3CA mutations, which is preceded by a dose selection and basket design with exploratory single-arm cohorts for various subpopulations of participants.

8. COVID-19 (Coronavirus) Pandemic on Health and Healthcare

   Rochester, Minn.

   The purpose of this study is to identify correlates of healthcare-seeking behavior in patients with ACS and CHF and its association with psychosocial and health outcomes.

9. Adverse effects related to Heplisav-B vaccination in patients with Inflammatory Bowel Disease

   Jacksonville, Fla.

   In this study, we will examine the potential side effects experienced after receiving the new hepatitis B vaccine (Heplisav-B) in patients with ulcerative colitis or Crohn's disease. This new vaccine has been found to be more effective than the existing vaccine Engerix in people without ulcerative colitis or Crohn's disease. It is now the standard of practice vaccine that we use in the Mayo gastroenterology and liver practice. The most common side effects include pain, redness, swelling, fatigue, fever and headache. We would also like to determine if there was any worsening of the patient's underlying inflammatory bowel disease.

   Part 1

   Given these findings and recommendations, members of the Gastroenterology and Infectious Disease department feel that the Heplisav-B vaccine should be the preferred vaccine for patients with IBD and chronic liver disease. In this study, we aim to collect data on patients who receive this vaccine on whether they experience any adverse effects or any worsening of their bowel or liver disease. We also aim to collect data regarding the effectiveness of vaccination by measuring post-vaccination antibody titers at 1 month after vaccination. The goal of this is to confirm that patients have achieved immunity after vaccination. This is consistent with best-practice guidelines and CDC recommendations in immunosuppressed persons.

   Part 2:

   According to the 2022 Center for CDC guidelines for Hepatitis B vaccination in immunocompromised adults, persons found to have antibody titer concentration <10 mIU/ml (indicating non-immunity) after completion of a primary vaccine series should be revaccinated [6]. Accordingly, in the case of non-immunity after the standard 2-dose Heplisav-B series, we aim to give an additional dose of Heplisav-B and re-measure antibody titers at 1 month in order to evaluate effectiveness. This is consistent with best-practice and CDC guidelines in immunosuppressed patients that have not responded to the primary vaccination series. To this point, the CDC guidelines for Hepatitis B vaccination in immunocompromised adults state that a larger vaccine dose or additional vaccine doses may be necessary in this patient population [6]. Immunity to Hepatitis B through vaccination in patients with inflammatory bowel disease and chronic liver disease is crucial due to high risk of morbidity.

   Part 3:

   As a continuation of the above, we aim to perform immunological testing to observing T cell response to Heplisav-B vaccination. The goal is to measure if there are any differences in T cell response depending on certain immunosuppressive medications that the patient is taking for their IBD.

10. Infection Database of Mechanical Circulatory Assist Device Recipients

    Scottsdale/Phoenix, Ariz., Rochester, Minn., Jacksonville, Fla.

    The purpose of this study is to learn more about incidence of infection complications in recipients of mechanical circulatory assist device recipients (MCAD).  Evaluate morbidity and mortality associated with infection complications in MCAD recipients.

A continuación se enumeran ensayos clínicos actuales.

Filtrar esta lista de estudios según la ubicación, el estado del estudio y más.

1. A Study Of Larsucosterol In Alcohol-associated Hepatitis

   Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

   The purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90, in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score ≥ 32 and MELD scores 21-30, inclusive.

2. A Study to Evaluate Biomarkers of Fluoroquinolone-induced Mitochondrial Toxicity

   Rochester, Minn.

   The purposes of this study are to determine if patients treated with fluoroquinolone (FQ) antibiotics have depletion of mitochondrial DNA (mtDNA) in buccal swab samples, and whether the degree of depletion correlates with the likelihood of developing FQ-associated toxicity.

   2nd arm - An additional group of patients will be enrolled if they previously received FQ antibiotics. appear to be symptomatic and have a previously collected muscle or nerve biopsy for clinical purposes available for this research study. 

3. A Study To Evaluate Lamprene (Clofazimine) To Treat Non-Tuberculous Mycobacterial (NTM) Infections

   Jacksonville, Fla.

   The purpose of this study is to  evaluate Lamprene (Clofazimine) to treat non-tuberculous mycobacterial (NTM) infections.

4. Sustained Humoral and Cell-Mediated Immunogenicity of COVID-19 Vaccines in Patients With Inflammatory Bowel Disease

   Jacksonville, Fla.

   The purpose of this study is to determine the impact of systemic immunosuppression on sustained antibody COVID-19 concentrations in patients with inflammatory bowel disease (IBD) who received a COVID-19 vaccine.  This observational study will collect blood samples to measure sustained antibody concentrations to evaluate seroprevalence and study immunity  at 6 and 12 months after completion of vaccination.  The primary outcome of this study is to evaluate the immunogenicity of the Covid-19 vaccine in patients with IBD.

5. A Study to Evaluate the QuantiFERON-TB Gold-Plus Test for Blood Detection of Tuberculosis without Symptoms

   Rochester, Minn.

   The purpose of this study is to evaluate the new QFT-Plus assay compared to the QFT-Gold assay and the tuberculin skin test results (as available) for the detection of tuberculosis without symptoms in high-risk patients.

                  

6. Molecular Analysis of Blood for the Detection of Cardiovascular Pathogens

   Rochester, Minn.

   The purpose of this study is to test whether metagenomic shotgun sequencing can identify pathogens causing cardiovascular infections such as infective endocarditis or myocarditis.

7. RLY-2608-201-Ph2 Study Of RLY-2608 In PROS And PIK3CA Driven Malformations

   Rochester, Minn.

   The purpose of this study is to compare the efficacy and safety of RLY-2608 versus placebo in adult, adolescent, and pediatric participants with PROS and malformations driven by PIK3CA mutations, which is preceded by a dose selection and basket design with exploratory single-arm cohorts for various subpopulations of participants.

8. COVID-19 (Coronavirus) Pandemic on Health and Healthcare

   Rochester, Minn.

   The purpose of this study is to identify correlates of healthcare-seeking behavior in patients with ACS and CHF and its association with psychosocial and health outcomes.

9. Adverse effects related to Heplisav-B vaccination in patients with Inflammatory Bowel Disease

   Jacksonville, Fla.

   In this study, we will examine the potential side effects experienced after receiving the new hepatitis B vaccine (Heplisav-B) in patients with ulcerative colitis or Crohn's disease. This new vaccine has been found to be more effective than the existing vaccine Engerix in people without ulcerative colitis or Crohn's disease. It is now the standard of practice vaccine that we use in the Mayo gastroenterology and liver practice. The most common side effects include pain, redness, swelling, fatigue, fever and headache. We would also like to determine if there was any worsening of the patient's underlying inflammatory bowel disease.

   Part 1

   Given these findings and recommendations, members of the Gastroenterology and Infectious Disease department feel that the Heplisav-B vaccine should be the preferred vaccine for patients with IBD and chronic liver disease. In this study, we aim to collect data on patients who receive this vaccine on whether they experience any adverse effects or any worsening of their bowel or liver disease. We also aim to collect data regarding the effectiveness of vaccination by measuring post-vaccination antibody titers at 1 month after vaccination. The goal of this is to confirm that patients have achieved immunity after vaccination. This is consistent with best-practice guidelines and CDC recommendations in immunosuppressed persons.

   Part 2:

   According to the 2022 Center for CDC guidelines for Hepatitis B vaccination in immunocompromised adults, persons found to have antibody titer concentration <10 mIU/ml (indicating non-immunity) after completion of a primary vaccine series should be revaccinated [6]. Accordingly, in the case of non-immunity after the standard 2-dose Heplisav-B series, we aim to give an additional dose of Heplisav-B and re-measure antibody titers at 1 month in order to evaluate effectiveness. This is consistent with best-practice and CDC guidelines in immunosuppressed patients that have not responded to the primary vaccination series. To this point, the CDC guidelines for Hepatitis B vaccination in immunocompromised adults state that a larger vaccine dose or additional vaccine doses may be necessary in this patient population [6]. Immunity to Hepatitis B through vaccination in patients with inflammatory bowel disease and chronic liver disease is crucial due to high risk of morbidity.

   Part 3:

   As a continuation of the above, we aim to perform immunological testing to observing T cell response to Heplisav-B vaccination. The goal is to measure if there are any differences in T cell response depending on certain immunosuppressive medications that the patient is taking for their IBD.

10. Infection Database of Mechanical Circulatory Assist Device Recipients

    Scottsdale/Phoenix, Ariz., Rochester, Minn., Jacksonville, Fla.

    The purpose of this study is to learn more about incidence of infection complications in recipients of mechanical circulatory assist device recipients (MCAD).  Evaluate morbidity and mortality associated with infection complications in MCAD recipients.