Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection
Helicobacter Pylori InfectionThis is an open-label, randomized controlled trial. The aim of the study is to evaluate the efficacy and safety of the Qingre Huashi Granules combined the modified dual therapy (or called high dose dual therapy) for Helicobacter pylori infection specifically in geriatric patients, compared with the bismuth containing quadruple therapy. A total of 160 eligible patients will be enrolled in 4 hospitals. The eradication rate, symptoms, and the adverse events will be recorded and analyzed.
Clinical Trial to Evaluate the Safety of RQ-01 in SARS-CoV-2 Positive Subjects
COVID-19Infectious Disease2 moreThis is a first in human clinical study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of RQ-01. Adult patients who have tested positive for SARS-CoV-2 virus, have mild symptom(s) of COVID-19 disease, and who are at low risk for developing moderate or severe COVID-19 disease are welcome to participate. The main questions this study aims to answer are: What is the safety profile of RQ-01? What is the reduction in SARS-CoV-2 ribonucleic acid (RNA) shedding after administration of RQ-01? How effective is RQ-01 versus placebo in reducing COVID-19 symptoms? After providing informed consent, subjects will be randomized to RQ-01 (high or low dose) or placebo and will be dosed for 3 consecutive days. Throughout the duration of the trial, subjects will participate in the following activities: perform rapid antigen and polymerase chain reaction (PCR) tests for COVID-19, answer questions about their medical history and medications, answer questions about their COVID-19 history and symptoms, conduct a physical exam, have their vitals measured, and have bloodwork done.
Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus
Acquired Immunodeficiency SyndromeBK Virus Infection6 moreThis phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and/or JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and/or JC virus.
Oral Corticosteroids for Post-infectious Cough in Adults
Post-infectious CoughThe purpose of this study is to assess whether a 5-day treatment with orally administered prednisone provides patient-relevant benefits by improving the cough-related QoL of patients with post-infectious cough triggered by an Upper Respiratory Tract Infection (URTI) and seeking care in adult primary care practices. The study aims to describe an efficacy and safety profile for a 5-day prednisone treatment compared to a 5-day course of placebo.
Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent...
Clostridium Difficile Infection RecurrenceClostridium Difficile InfectionThe purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon of the patient with C. diff infection. The goal of this experimental procedure (called fecal microbiota transplantation) is to replenish the good bacteria in the colon that can help prevent C. diff infection from coming back after treatment.
Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)
Clostridioides Difficile InfectionClostridium Difficile Infection2 moreThis is a randomized, double-blind, placebo-controlled trial to determine the optimal dose and safety of oral alanyl-glutamine between 4, 24, and 44 g doses administered for 10 days with standard therapy among first time incident cases of uncomplicated C. difficile infection (CDI) in hospitalized, or outpatient, persons aged 18 or older. Our hypothesis is that alanyl-glutamine supplementation will decrease recurrence and mortality from CDI and these outcomes will be associated with improvement of inflammatory markers and restoration of intestinal microbiota function.
DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With...
HIV InfectionsThis study aims to find out whether treating children and young people living with HIV with two anti HIV medicines, dolutegravir and lamivudine, is safe and as effective as the three-medicine anti-HIV treatments currently used in routine practice.
Treatment of Cytomegalovirus (CMV) Infections With Viral-Specific T Cells
CMV InfectionCytomegalovirus Infections2 moreThe present trial will consist of the treatment of 20 pediatric and adult Hematopoietic Stem Cell Transplantation (HSCT) recipients or immunocompromised participants diagnosed with opportunistic Cytomegalovirus (CMV) infections with virus-specific, antigen-selected T-cells. CMV-specific T-cells will be isolated from donor leukapheresis products using the CliniMACS® Prodigy. Prior studies on transfer of CMV specific T-cells have been shown to be safe and efficacious in the treatment of CMV infections. The main trial objective is to evaluate the feasibility and safety of CMV-specific T-cell transfer in adult and pediatric participants suffering from CMV infections or reactivation following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic therapy). Participants will be followed for one year.
Transplantation Using Hepatitis C Positive Donors, A Safety Trial
Lung Transplant InfectionHeart Transplant Infection3 moreThe success of transplantation is significantly hindered by the lack of sufficient number of available donors. Many potential donor organs cannot be utilized in clinical transplantation because donors have chronic viral infections such as hepatitis C (HCV) infection. This study will test the possibility of safely transplanting organs from HCV-infected donors into HCV-uninfected recipients. Prior to transplantation, recipients will receive an initial dose of highly effective antiviral prophylaxis using approved direct-acting antivirals (DAAs) Glecaprevir/Pibrentasvir (G/P) and they will also receive ezetimibe, a cholesterol-lowering medication that also blocks entry of HCV into liver cells. They will then receive daily dosing of the same medications for 7 days after transplant. The aim of the study is to show that transplantation of organs from HCV+ donors is safe in the era of DAAs. The investigators hypothesize that rates of HCV transmission to recipients will be prevented by the use of DAA prophylaxis and any HCV transmission that does occur will be readily treatable and curable. If successful, the knowledge from this study can have a large impact to patients with end stage organ diseases by providing a large novel source of donors for organ transplantations.
Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery
Infection WoundGastrointestinal Complication3 moreThis international, multicentre, pragmatic, double-blind, placebo-controlled, randomised trial of TxA versus placebo will enrol 3,300 patients throughout Australia and internationally. This is an effectiveness trial - some elements of the trial are deliberately left to the perioperative clinicians' discretion in order to reflect usual practice and maximise generalisability.