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Showing 1-20 of 2,359 trials
NCT03364296
The FLAG1 study will assess the diagnostic performance of biomarkers Glutathion S-Transferase-π (GST-π) and Peroxyredoxin 1 (PRDX1) to identify cerebral infarction of less than 4,5 hours in a population of patients with neurological deficiency of less than 12 hours.
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).
NCT05853601
Acute kidney injury is a significant complication for infants who experience hypoxic ischemic encephalopathy, being associated with increased rates of death and prolonged hospitalization. This pilot study of theophylline administration soon after birth for the prevention of kidney injury will lay the foundation for the conduct of a larger clinical trial that seeks to identify a theophylline as a novel therapy to prevent kidney injury in thousands of at-risk infants.
NCT05429632
This is a multi-center, randomized, double-blinded, placebo controlled trial.
NCT02390752
Background: \- Some people with cancer have solid tumors. Others have refractory leukemia. This may not go away after treatment. Researchers want to see if a drug called TURALIO(R) can shrink tumors or stop them from growing. Objectives: \- To find the highest safe dose and side effects of TURALIO(R). To see if it helps treat certain types of cancer. Eligibility: \- People ages 3-35 with a solid tumor or leukemia that has returned or not responded to cancer therapies. Design: * Individuals will be screened with: * Medical history * Physical exam * Blood and urine tests * Heart tests * Scans or other tests of the tumor * Individuals will take TURALIO(R) as a capsule once daily for a 28-day cycle. They can do this for up to 2 years. * During the study, participants will have many tests and procedures. They include repeats of the screening tests. Individuals will keep a diary of symptoms. * Individuals with solid tumors will have scans or x-rays. * Individuals with leukemia will have blood tests. They may have a bone marrow sample taken. * Some individuals may have a biopsy. * When finished taking TURALIO(R), individuals will have follow-up visits. They will repeat the screening tests and note side effects.
NCT07383493
The objective of this study is to conduct post-marketing clinical follow-up of four products: NS, NHE, NHG, and PIR. This follow-up will consist of collecting clinical data in real-life conditions to confirm the tolerance, safety, and efficacy of medical devices used in the treatment of acute viral rhinitis, rhinosinusitis, and rhinopharyngitis, while also assessing the benefit/risk ratio of the products.
NCT07636564
This phase II trial tests how well adding revumenib to usual treatment (blinatumomab) compared to usual treatment alone works in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation. Revumenib binds to a protein called menin and keeps it from binding to another protein called KMT2A. This stops or slows the growth of leukemia cells with changes in the KMT2A gene. Blinatumomab binds to CD19, which is found on most B cells (a type of white blood cell) and some types of leukemia cells. It also binds to a protein called CD3, which is found on T cells (another type of white blood cell). This may help the immune system kill cancer cells. In addition to blinatumomab, usual treatment also includes dexamethasone, methotrexate, cyclophosphamide, cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, daunorubicin, vincristine and leucovorin. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Chemotherapy drugs, such as cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Leucovorin is also being studied in the treatment of cancer. It is a type of chemoprotective agent and a type of chemosensitizing agent. Adding revumenib to usual treatment with blinatumomab may be safe, tolerable and more effective than blinatumomab alone in lowering the amount of leukemia in patients with B-ALL or ALAL with the KMT2A translocation.
NCT07637292
The main objective of asthma pharmacological management in adults and teenagers is to maintain long-term control of the disease, including symptom relief, the prevention of exacerbations, the improvement of pulmonary function, the reduction of limitations in daily life and side effects of pharmacological treatments. Dupilumab is a recombinant human monoclonal antibody that inhibits signalling of both IL-4 and IL-13, two Type 2 cytokines involved in inflammatory pathway. Dupixent obtained a European Marketing Authorization in September 2017 and was reimbursed in France from March 5, 2019 in adults with moderate-to-severe atopic dermatitis. On November 10, 2020, the reimbursement of Dupixent was extended to adults and adolescents aged 12 and over as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils (≥ 0.150 g/L) and/or raised fraction of exhaled nitric oxide (FeNO ≥ 20 ppb), who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Lastly, on July 22, 2021, Dupixent was also reimbursed in patients with severe nasal polyposis. Primary objective: To describe the characteristics of patients using dupilumab for severe asthma in a real-world setting. Secondary objectives: * To describe the Health Care Resource Use (HCRU) and associated costs of severe asthmatic patients using dupilumab. * To describe the use of corticosteroids (oral and inhaled) before and after dupilumab initiation. * To study persistence with dupilumab in real-world
NCT01860937
The purpose of this study is to test the safety of giving the patient special cells made from their own blood called "Modified T-cells". The goal is to find a safe dose of modified T-cells for patients whose leukemia has returned to the bone marrow.
NCT02981628
This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.
NCT04848974
This phase Ib/II trial finds out the best dose and effect of cladribine and low dose cytarabine when given in combination with uproleselan in treating patients with treated secondary acute myeloid leukemia. Chemotherapy drugs, such as uproleselan, cladribine, and low dose cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
NCT05453903
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of bleximenib in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of bleximenib in combination with AML directed therapies at the RP2D(s) (dose expansion).
NCT07328620
This study aims to investigate the effects of permissive hypotension, which is routinely used in rhinologic surgeries such as rhinoplasty, septoplasty, and functional endoscopic sinus surgery (FESS), on renal function. Although permissive hypotension has been widely practiced to improve surgical field visibility and reduce intraoperative blood loss, its specific definition is not standardized in the literature. In most studies, maintaining mean arterial pressure (MAP) within the range of 50-65 mmHg is considered permissive hypotension. MAP values below 60 mmHg have been associated with increased risk of cardiac and renal complications. However, in otherwise healthy patients, such episodes are frequently tolerated without clinically apparent renal dysfunction. The kidneys have a strong compensatory reserve capacity, and early tubular injury may not be detected by conventional renal function tests such as serum creatinine. Therefore, the use of more sensitive biomarkers is necessary to detect potential subclinical injury. In this prospective observational study, serum NGAL and cystatin C levels will be measured from routine preoperative and postoperative (12-24 hours) blood samples obtained from adult patients undergoing rhinologic procedures. A ≥25% increase in these biomarkers from baseline will be considered indicative of subclinical acute kidney injury. Additionally, intraoperative hemodynamic data will be monitored, and the duration of MAP \<60 mmHg and MAP \<65 mmHg will be recorded. At the end of the procedure, surgical field conditions will be evaluated using the Boezaart Surgical Field Score. The relationship between these parameters and biomarker changes will be analyzed. The goal of this study is to determine whether early, clinically silent renal injury may occur during permissive hypotension and to provide insight into its potential implications for future renal function. All interventions and blood samplings are part of routine care, and no additional procedures will be performed for research purposes.
NCT05257044
The purpose of this study is to examine the effects of hemp-derived cannabigerol (CBG) on anxiety, stress, mood, and cognition. Further, the severity of various side effects of CBG (sleepiness, dry mouth, dry eyes, increased appetite) will be assessed. As such, the study is focused on better understanding some of the potentially beneficial and detrimental effects of CBG on humans.
NCT07617948
Acute calculous anuria is a urological emergency caused by ureteral stone obstruction in a solitary functioning kidney or bilateral ureteral obstruction. Urgent decompression of the upper urinary tract is required to restore urine drainage and prevent further renal impairment. This prospective randomized double-blind controlled trial will evaluate whether intravesical aminophylline can facilitate urgent retrograde ureteral stenting in adult patients with acute calculous anuria due to ureteral stones. Eligible patients will be randomly assigned to receive either intravesical aminophylline diluted in normal saline or placebo saline before attempted retrograde Double-J ureteral stent placement. The primary outcome is technical success, defined as successful placement of a Double-J ureteral stent across the obstructing stone without the need for percutaneous nephrostomy. Secondary outcomes include stenting time, intraoperative complications, renal function recovery, postoperative pain, analgesic requirement, and the need for alternative drainage.
NCT02583893
This pilot phase II trial studies whether biomarkers (biological molecules) in bone marrow samples can predict treatment response to sirolimus and chemotherapy (mitoxantrone hydrochloride, etoposide, and cytarabine \[MEC\]) in patients with acute myeloid leukemia (AML) that is likely to come back or spread (high-risk). Sirolimus inhibits or blocks the pathway that causes cancer cells to grow. Adding sirolimus to standard chemotherapy may help improve patient response. Studying samples of bone marrow from patients treated with sirolimus in the laboratory may help doctors learn whether sirolimus reverses or turns off that pathway and whether changes in biomarker levels can predict how well patients will respond to treatment.
NCT07604064
This clinical trial is a multicenter, single-arm, open-label study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of olutasidenib administered orally twice daily under fasting conditions for one cycle of 28 days in at least 3 Japanese patients with relapsed or refractory IDH1 mutation-positive AML.
NCT07608328
The Azithromycin to Modify Bronchiectasis Exacerbation Risk (AMBER) trial is a prospective, randomized, double-blind, placebo-controlled, parallel-group clinical trial in adults with clinically and radiologically confirmed non-cystic fibrosis bronchiectasis (NCFB). The trial evaluates whether azithromycin 250 mg orally once daily for 12 months, added to standard bronchiectasis care, reduces the occurrence of at least one bronchiectasis exacerbation during 12-month follow-up compared with matching placebo added to standard bronchiectasis care. Participants will be randomized in a 1:1 allocation ratio to standard care plus matching placebo or standard care plus azithromycin. The primary analysis will follow the intention-to-treat (ITT) principle. The AMBER trial is embedded within the Assiut University bronchiectasis translational research platform and is linked to the Bronchiectasis Assessment of Severity and Exacerbations (BASE) framework and the Bronchiectasis Phenotype Identification Model (BPIM). BASE and BPIM are not used for randomization stratification and will not modify the primary randomized comparison. The locked Version 1.0 methodological disclosure document, protocol, and statistical analysis plan (SAP), primary sample-size source code, and endpoint-level sample-size support matrix are archived in Zenodo: https://doi.org/10.5281/zenodo.20178963. The AMBER public preregistration is also available through the Open Science Framework (OSF) under Digital Object Identifier (DOI) 10.17605/OSF.IO/RE54V.
NCT07586059
This large national cohort study, including over 500,000 patients, where around 5% are treated with continuous renal replacement therapy (CRRT) , aims to evaluate the association between time to initiation of CRRT and intensive care unit (ICU) length of stay (LOS).
NCT06777979
This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells. Primary Objective: To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-positive leukemia. Secondary Objective: To evaluate the anti-leukemic activity of CD19-CD22-CAR T cells.