View clinical trials related to Acute Disease.
Filter by:The purpose of this study was to evaluate the effect of ION-827359 on forced expiratory volume in 1 second (FEV1) in participants with mild to moderate COPD with CB.
Purpose: The diagnostic approach of patients with acute appendicitis (AA) remains debated. A number of clinical prediction rules (CPRs) exist for diagnosis of AA with variable sensitivity, specificity, and diagnostic accuracy, in different ethnic populations. Among these, the Raja Isteri Pengiran Anak Saleha Appendicitis (RIPASA) score was shown to have a high sensitivity though with a poor specificity. The aim of this study is to modify and validate the RIPASA score in 4 distinct ethnic groups, and to compare the performance of the new score to the original RIPASA and Alvarado scores. Methods: This multicenter, international prospective observational study will be conducted in 6 countries, and will include all eligible patients referred to surgical specialists with acute right iliac fossa pain or suspected AA in the participating centres. Patients will be categorized into 4 ethnic groups based on the country of origin. The modified RIPASA score will be developed in one ethnic group, and along with the original RIPASA and Alvarado scores, will be externally validated in the other 3 ethnic groups. Management of patients will be prospectively evaluated in a standardized manner. The focus of the analysis will be on the performance of the 3 CPRs in different ethnic and gender groups using receiver operating characteristic curve analyses. Discussion: We expect this study to develop a CPR that can assist surgeons and surgical residents to early identify patients with AA in the busy clinical and low-resource settings, and to optimize the diagnostic value of the RIPASA and Alvarado scores in different ethnic and gender groups.
This is a single arm, open-label, phase 1 study, to determine the safety and efficacy of anti-CD123 CAR-T cells in treating patients diagnosed with refractory/relapsed acute leukemia in a dose-escalation way.
[Updated]: To assess the safety and tolerability of ONO-7475 monotherapy in patients with relapsed or refractory acute myeloid leukemia or relapsed or refractory myelodysplastic syndromes and to assess: i) safety and tolerability and ii) preliminary efficacy of the combination of ONO-7475 and venetoclax in patients with relapsed or refractory acute myeloid leukemia.
The purpose of this study is to evaluate the effect of Losartan on cigarette smoke-induced lung injury in smokers and ex-smokers with and without chronic obstructive pulmonary disease (COPD).
This is a phase I study of vincristine, doxorubicin and dexamethasone (modified VXD) plus MLN9708 in adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma, lymphoblastic lymphoma or mixed phenotype acute leukemia.
1.1 Primary Objectives - To determine the feasibility, tolerability, and toxicities of administering the selective CDK 4/6 inhibitor PD 0332991 prior to the combination of ara-C and Mitoxantrone for adults with relapsed and refractory acute leukemias and high risk myelodysplasias (MDS), including primary refractory disease - To determine the direct cytotoxic effects of single agent PD 0332991 on malignant blasts - To determine the maximal tolerated dose (MTD) of PD 0332991 in timed sequential combination with ara-C and Mitoxantrone - To determine if the timed sequential combination of PD 0332991 with ara-C and mitoxantrone can induce clinical responses in adults with relapsed or refractory acute leukemias and high-risk MDS 1.2 Secondary Objectives: - To determine the ability of PD 0332991 to directly induce apoptosis in malignant cell populations in vivo - To obtain pharmacodynamic (PD) data regarding the ability of PD 0332991 to arrest malignant cells in the G 1 phase of cell cycle, followed by synchronized release of those cells into S phase upon discontinuation of PD 0332991 and resultant enhanced ara-C cytotoxicity
The purpose of the international plastic bronchitis registry is to understand the natural course and long term health outcomes of subjects diagnosed with plastic bronchitis due to different types of casts. This provides essential data for identifying best practices and treatments. The secondary aim is to understand the structure of casts and mechanism of their formation.
Lenalidomide is a drug that alters the immune system and it may also be directly toxic to tumor. Therefore, in theory, it may reduce or prevent the growth of cancer cells or directly kill them. We will be studying how lenalidomide can be used to decrease bone marrow blast cells in preparation for a bone transplant.
Study Design: To evaluate the efficacy of the combination of sirolimus and tacrolimus as a graft-versus-host disease prophylaxis, the investigators are going to perform a phase II, multicenter clinical trial after human leukocyte antigen (HLA)-matched, related peripheral blood stem cell transplants (PBSCT) in patients with hematologic malignancies. Total 116 patients will be accrued. Objective: The primary objective is to evaluate the rates of 100 day Grade II-IV acute GVHD. Secondary objectives include the time to neutrophil and platelet engraftment, the incidence of grade III-IV acute GVHD, non-relapse mortality during 100 days after transplant, mucositis severity, all infectious complications including cytomegalovirus (CMV) reactivation, vascular complications (venoocclusive disease of liver; VOD, thrombotic microangiopathy; TMA), disease-free survival, and overall survival at 1 year after transplant. Eligibility Criteria: Eligible patients are between 20 and 60 years of age, have acute leukemia, myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), and adequate organ function. For available sibling donor, a serologic (or higher resolution) 6/6 Class I HLA-A and B and molecular Class II DRB1 must be matched. Treatment Description: Conditioning regimens will vary by center and donor will donate peripheral blood stem cells according to local institutional practices. Peripheral blood stem cells will not be manipulated or T-depleted prior to infusion. Tacrolimus will be administered at 0.05 mg/kg/day intravenously by continuous infusion beginning on day -1 with a target serum concentration of 5 to 10 ng/mL. Sirolimus will be administered as a 6 mg oral loading dose on day -1, followed by a 3 mg/day single dose, with a target serum concentration of 3 to 12 ng/mL. Levels will be monitored weekly during hospitalization and then as clinically indicated. Intravenous tacrolimus will be converted to an oral equivalent dose prior to discharge and both immunosuppressives will be tapered beginning at day +100 after transplantation and eliminated by day +180 when clinically feasible. Accrual Period: The estimated accrual period is three years. Patients will be followed for 100 days post transplantation for evaluation of the primary endpoint, with additional follow-up to two years after transplantation for evaluation of secondary endpoints.