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NCT07553000
Randomized clinical trial comparing SAM aluminium splint vs pain relief as usual in patients seeking emergency department care for suspected wrist fractures.
NCT07550790
The K-PROSE study is a randomized clinical investigation evaluating strategies to prevent contrast-induced acute kidney injury (CI-AKI) in patients hospitalized with acute heart failure and moderate renal dysfunction (eGFR 30-75 mL/min/1.73 m²). Patients requiring contrast-enhanced CT imaging are randomized to either standard intravenous saline hydration or a furosemide-based decongestion strategy. Renal function is assessed using serial measurements of creatinine and cystatin C, before and after contrast exposure. By comparing renal outcomes, congestion status, and safety profiles, this study aims to determine whether a decongestion-focused approach provides superior renal protection compared with conventional hydration in high-risk acute heart failure patients.
NCT07478003
BACKGROUND Myocardial reperfusion with the use of primary percutaneous coronary intervention (PCI) including stent implantation is the most efficacious treatment for patients with (STEMI) and improves prognosis significantly. Due to continuous improvements in the treatment, the mortality for patients with STEMI has decreased dramatically, but despite these improvements, the mortality rate seems to have reached a plateau at around 10% within 1 year. In addition, 10% develop clinical heart failure with a per se 50% mortality rate within 5 years. Moreover, congestive heart failure is associated with a highly impaired quality of life due to fatigue dyspnea and reduced exercise capacity. Thus, there is a need for further improvement in the treatment to drive the event rates further down. One such key target is reducing the damage to the heart muscle (infarct size) to preserve the heart function and prevent mortality and heart failure. One major driver of infarct size and mortality is reperfusion injury which may account for up to 50% of the damaged myocardium. Reperfusion injury occurs within the first minutes to hours after the restoration of the blood flow in the occluded artery and reperfusion therapy can therefore be considered a "double-edged sword", since the ischemic injury may additionally be worsened by reperfusion injury. However, the phenomenon of reperfusion injury is not completely understood, and no preventive treatments exist. Multiple pathophysiological factors may contribute to reperfusion injury of which inflammation has been described as a key factor. Inflammation is induced immediately after the onset of acute myocardial ischemia and is subsequently exacerbated following reperfusion. Hence, inflammation per se may drive excessive cardiomyocyte death resulting in decreased contractility and increased infarct size post-STEMI. Moreover, in the course following STEMI and subsequently reperfusion, the myocardium starts healing and scarring resulting in remodelling of the ventricle potentially causing either compensatory hypertrophy or thinning of the myocardium, which may lead to reduced left ventricle ejection fraction (LVEF) and heart failure. Of note, inflammation plays a critical role in ventricular remodeling post-AMI, thus inflammation in relation to reperfusion injury may extend myocardial damage following STEMI. Glucocorticoids are crucial in the regulation of the systemic inflammatory response and may therefore be beneficial in limiting myocardial injury following STEMI. We previously conducted the phase II randomized, placebo-controlled PULSE-MI trial (Nov 2022-Oct 2023) in 742 prehospital STEMI patients, showing pulse-dose glucocorticoid was safe and improved LVEF, infarct size, and microvascular obstruction, with a trend toward lower 3-month mortality. However, as the trial was not powered for clinical outcomes, it remains unproven whether this treatment reduces post-STEMI mortality. Thus, the aim of this prospective, randomized trial is to evaluate the effect of prehospital pulse-dose glucocorticoid on all-cause mortality in patients with STEMI. To reduce the degree of inflammation effectively and adequately, intervention is to be made as soon as possible as close to initiation of ischemia, as recognized from patients' symptom debut, and before revascularization with primary PCI in the prehospital setting since the effect is more pronounced if the treatment is initiated early after the onset of STEMI. In addition to reperfusion induced inflammation, ischemia itself, immediately after occlusion of the artery, induces inflammation. Hence, initiation of the intervention in the ambulance is needed to harvest the potentially beneficial effects of pulse glucocorticoid therapy as soon as possible. Thus, by performing intervention in the pre-hospital setting, the investigators expect that participation in the trial will have the potential to produce a direct clinically relevant benefit for the patient resulting in reduced all-cause mortality in patients with STEMI. HYPOTHESIS In patients with STEMI undergoing primary PCI, 250 mg methylprednisolone administrated in the pre-hospital setting reduces all-cause mortality. SAMPLE SIZE The primary endpoint is all-cause mortality one year after the last patient has been included. The median follow-up of the trial is expected to be 3 years and minimum follow-up of 1 year. As an estimate based on findings from the PULSE-MI trial and the DANAMI-3 trial, the estimated event rate of in the placebo arm is 9% during follow-up. Glucocorticoid is expected to reduce all-cause mortality corresponding to a hazard ratio of 0.77. To demonstrate the reduction in the primary outcome with an 80% power at a 5% significance level, 2602 patients in each treatment arm is needed, thus 5204 patients in total. The primary analyses will be intention to treat principle
NCT03050268
NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown in the Eligibility Section, you may enroll regardless of the results of your clinical genetic testing. While it is well recognized that hereditary factors contribute to the development of a subset of human cancers, the cause for many cancers remains unknown. The application of next generation sequencing (NGS) technologies has expanded knowledge in the field of hereditary cancer predisposition. Currently, more than 100 cancer predisposing genes have been identified, and it is now estimated that approximately 10% of all cancer patients have an underlying genetic predisposition. The purpose of this protocol is to identify novel cancer predisposing genes and/or genetic variants. For this study, the investigators will establish a Data Registry linked to a Repository of biological samples. Health information, blood samples and occasionally leftover tumor samples will be collected from individuals with familial cancer. The investigators will use NGS approaches to find changes in genes that may be important in the development of familial cancer. The information gained from this study may provide new and better ways to diagnose and care for people with hereditary cancer. PRIMARY OBJECTIVE: * Establish a registry of families with clustering of cancer in which clinical data are linked to a repository of cryopreserved blood cells, germline DNA, and tumor tissues from the proband and other family members. SECONDARY OBJECTIVE: * Identify novel cancer predisposing genes and/or genetic variants in families with clustering of cancer for which the underlying genetic basis is unknown.
NCT07320235
IMAGINE is a two-part trial to evaluate the safety and preliminary efficacy of imetelstat in combination with azacitidine with or without venetoclax in patients with relapsed or refractory AML. The trial will consist of a safety run-in phase (Part A) employing a 3+3 design to monitor dose-limiting toxicities of imetelstat when administered in combination with a fixed dose of azacitidine. Part B will consist of a phase 1b trial employing a BOIN12 design to determine the optimal biological dose of imetelstat, starting at a lower dose level, in combination with azacitidine and venetoclax. Total of up to 36 participants will be accrued over 54 months at Mount Sinai Hospital. Estimated duration of trial is 114 months including recruitment, screening, treatment, and follow-up.
NCT07528807
This observational study aims to investigate the relationship between exercise benefits and barriers, pain beliefs, and activity patterns in individuals experiencing musculoskeletal pain. Participants will complete questionnaires about their pain, exercise habits, and daily activity patterns. The study does not involve any interventions or treatments. The purpose is to better understand how beliefs and perceived barriers influence physical activity in people with musculoskeletal pain, which may help inform future strategies to improve exercise participation and overall well-being.
NCT07431021
The goal of this study is to see if physical activity in high air pollution is worse than rest in high air pollution.
NCT07539610
Evaluation of Sup19 CAR-T cells in cases where previous CD19-targeted therapy has failed or where CD19 Evaluation of Safety and Efficacy in the Treatment of Low-Grade Hematological Malignancies: A Prospective, Single-Arm Clinical Study Research
NCT06455345
This project will evaluate the feasibility of a new fully self-guided online Acceptance and Commitment Therapy (ACT) program entitled Advancing Online Psychology Tools for the Transitional Pain Service (ADOPT-TPS), developed on an online health application platform called Manage My Pain (MMP). The ACT program is designed to teach mindfulness skills and provide psychoeducation about post-surgical pain. The feasibility of the self-guided online program will be compared to a pre-existing psychologist-guided workshop that delivers the same program. It is anticipated that the self-guided online ACT program will be deemed feasible by participants.
NCT07142265
Evaluation of clinical outcomes during 12 months after inclisiran initiation in patients after STEMI/non-STEMI in real-world settings in Russia. It is also planned to study the therapy effect on the lipid profile characteristics, its safety, the state of atherosclerotic plaques according to carotid ultrasound, the frequency of hospitalizations and the need for intensive follow-up.
NCT07216443
This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Orca-T is an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons).
NCT04972942
A Phase I trial to determine the safety of targeted immunotherapy with daratumumab (DARA) IV after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) for children, adolescents, and young adults (CAYA) with high risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy). Pre- and post-HCT NGS-MRD studies will be correlated with outcomes in children, adolescents, and young adults with T-ALL undergoing allogeneic HCT and post-HCT DARA treatment. The study will also evaluate T-cell repertoire and immune reconstitution prior to and following DARA post-HCT treatment and correlate with patient outcomes.
NCT07052994
The goal of Phase 1a of this clinical research study is to find the highest tolerable dose of revumenib that can be given in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin to patients who have acute leukemia. The goal of Phase 1b of this clinical research study is to learn if the dose of revumenib in combination with cytarabine, daunorubicin, and gemtuzumab ozogamicin found in Phase 1a can help to control the disease.
NCT04565665
This is a phase I trial followed by a phase II randomized trial. The purpose of phase I study is the feasibility of treating patients with acute respiratory distress syndrome (ARDS) related to COVID-19 infection (COVID-19) with cord blood-derived mesenchymal stem cells (MSC). The purpose of the phase II trial is to compare the effect of MSC with standard of care in these patients. MSCs are a type of stem cells that can be taken from umbilical cord blood and grown into many different cell types that can be used to treat cancer and other diseases. The MSCs being used for infusion in this trial are collected from healthy, unrelated donors and are stored and grown in a laboratory. Giving MSC infusions may help control the symptoms of COVID-19 related ARDS.
NCT04951856
AMUNDSEN-real is a phase IV, international (7 European countries), multicenter, controlled, open label study randomized, in 2 parallel groups of patients with a diagnosis of STEMI or NSTEMI with an indication for PCI, using the PROBE study design (Prospective Randomised Open, Blinded Endpoint). The objective of this study is to demonstrate the superiority of evolocumab versus standard of care in reaching a LDL-C reduction of ≥ 50% from baseline and a LDL-C goal of \<1.4 mmol/L (\<55 mg/dL) at 12 months follow-up on the overall population. The primary clinical objective is to demonstrate the superiority of evolocumab versus standard of care on the composite endpoint of death or any unplanned hospitalization for a CV reason at 12 months. Central randomization uses an IWRS. Stratification is by center and stratum with random block size, generated according to the procedures of the sponsor, by a statistician not involved in the study.
NCT06213168
De novo hypoxemic acute respiratory failure (hARF) is one of the main causes of intensive care unit (ICU) admission. In de novo hARF, intubation is associated with a dramatic increase in mortality rate. Compared to standard oxygen, the use of high-flow oxygen nasal cannula (HFNC) might be beneficial to prevent intubation and mortality, although the results of trials and meta-analyses are conflicting. Even with HFNC, the intubation rate remains high. This is the reason why adjunctive therapies, administered in addition to HFNC are needed. Continuous positive airway pressure (CPAP) is one of these adjunctive therapies. CPAP provides high level of positive end-expiratory pressure that ensures lung recruitment, but without adding inspiratory pressure support, which prevents ventilator induced lung injury. In addition, as opposed to pressure support, CPAP is well tolerated during long periods of time. Therefore, applying CPAP in addition to HFNC may reduce intubation rate and in turn mortality rate. The present trial will evaluate the impact on mortality of a strategy including continuous positive airway pressure plus high flow nasal cannula oxygen therapy versus high flow nasal cannula oxygen therapy alone in patients with de novo acute hypoxemic respiratory failure: a Prospective, Randomized Controlled Trial
NCT07509346
Patients with abnormalities of the biliary tract (the system that connects the liver to the small intestine and allows bile to flow) are prone to the development of strictures, dilations, or other problems that impede bile flow and promote the formation of gallstones. All of this leads to the development of infections in this anatomical region known as cholangitis. These infections typically require the patient to be admitted to the hospital, either to a general ward or even the ICU. These are, therefore, serious infections that threaten the patient's survival. Unfortunately, one-quarter of these patients experience not just one, but multiple infections of this type over an extended period of time. This condition is called acute recurrent cholangitis (ARC). It is important to note that the antibiotics used to treat these repeated infections lead to the selection of more resistant and virulent bacteria that remain in the intestine for months or years and, in turn, promote the recurrence of these infectious episodes. ARC affects a more vulnerable population, which, combined with the proliferation of resistant bacteria, increases the risk of serious complications and a reduced response to available treatments. Replacing these dangerous gut bacteria with bacteria from healthy donors is a strategy that has proven effective in reducing recurrent urinary tract infections. A similar approach has been successful in patients with chronic vaginal infection (vaginosis). This gut microbiota replacement is currently being investigated for a wide range of diseases affecting various sites, with promising results in some cases. There is strong evidence that this strategy may also be effective in patients with recurrent episodes of cholangitis. The procedure is considered very safe and is subject to strict safety measures to prevent risks to the recipient of these bacteria (requirements similar to those used for blood transfusions). If this strategy proves effective, it could reduce patient suffering and even mortality, as well as save money spent on hospital stays and medications, and contribute to reducing antibiotic use and the emergence of bacterial resistance. Even if no significant clinical benefit is demonstrated in this clinical setting, the information obtained will contribute to increasing knowledge about the role of the fecal microbiota, the technical and scientific aspects of fecal microbiota transplantation, and its potential uses. It should be noted that a patient association called ALBI España (Association for the Fight Against Inflammatory Biliary Diseases) has participated in the study's design and strongly supports this research, which could lead to a reduction in mortality among its patients and a reduction in adverse effects and costs associated with hospital admissions and antibiotic use. In summary, the use of FMT in patients with AC could have a significant impact on treatment effectiveness, reducing new episodes of cholangitis. This would improve patients' quality of life-including their physical, emotional, and social well-being-by reducing hospitalizations and associated complications. Another clear benefit would be the reduction in the proliferation of resistant bacteria and a lower use of antibiotics. The use of TMF would increase the autonomy of the National Health System (SNS) by enabling it to develop and manage non-commercial, non-profit therapies with low production costs, which would guarantee equitable access for patients to an effective and safe therapy.
NCT05554419
This phase II MyeloMATCH treatment trial compares cytarabine versus (vs.) cytarabine and venetoclax vs. liposome-encapsulated daunorubicin-cytarabine and venetoclax vs. azacitidine and venetoclax for treating patients who have residual disease after treatment for acute myeloid leukemia (AML). Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Liposome-encapsulated daunorubicin-cytarabine is a drug formulation that delivers daunorubicin and cytarabine in small spheres called liposomes, which may make the drugs safer or more effective. Azacitidine is a drug that interacts with DNA and leads to the activation of tumor suppressor genes, which are genes that help control cell growth. This study may help the study doctors find out if the different drug combinations are equally effective to the usual approach of cytarabine alone while requiring a shorter duration of treatment. To decide if they are better, the study doctors will be looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to cytarabine alone.
NCT04284787
This phase II trial studies how well azacitidine and venetoclax with or without pembrolizumab work in treating older patients with newly diagnosed acute myeloid leukemia. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving azacitidine and venetoclax with pembrolizumab may increase the rate of deeper/better responses and reduce the chance of the leukemia coming back in patients with newly diagnosed acute myeloid leukemia compared to conventional therapy of azacitidine and venetoclax alone.
NCT07523555
Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies. After central antigen co-expression screening, participants are assigned to the most appropriate active dual-target module: CD19/CD22, CD19/CD20, BCMA/CD19, BCMA/CD38, BCMA/GPRC5D, CD33/CD123, CD33/CLL1, or CD5/CD7. Phase 1 determines safety, dose-limiting toxicities, and the recommended phase 2 dose for each module; phase 2 estimates preliminary antitumor activity, including overall response rate and MRD-negative response. Lymphodepletion with fludarabine/cyclophosphamide precedes infusion. The design is intended to reduce antigen escape by matching disease biology and target co-expression to a rational dual-target strategy.