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Filter by:This is an exploratory trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of IMPT-514, an autologous, anti-CD19/CD20 CAR T therapy, administered as an intravenous (IV) infusion, in participants with B cell driven autoimmune diseases, including active, refractory Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV), and Idiopathic Inflammatory Myopathy (IIM).
Background: Allergic fungal rhinosinusitis (AFRS) is a severe type of sinus infection. People with AFRS develop heavy mucus and growths called polyps that apply pressure to the sinuses and block their breathing. Surgery can remove the polyps, but they often grow back. Researchers want to test an approved drug they believe may help people with AFRS. Objective: To test a drug (Dupilumab) in people with AFRS. Eligibility: People aged 18 years or older with suspected AFRS who are scheduled to undergo surgery for nasal polyps. Design: Participants will have several tests before their surgery. They will have imaging scans of their sinuses. They will have an endoscopic exam: A tube with a camera and a light will be inserted into their sinuses. They may give blood and mucus samples. They will have standard treatment with nasal sprays for 2 to 6 weeks before their surgery. Excess nasal tissue removed during the surgery will be collected for research. Then they will begin treatment with the study drug. Dupilumab is injected under the skin. Some participants will receive the study drug. Some will receive a placebo injections. The placebo injections are just like the study drug but contain no medicine. Participants will not know which injections they are getting. All participants will administer the injections to themselves at home. They will do this every 2 weeks for 1 year after the surgery. They will have a clinic visit 16 weeks after surgery. Participants will have follow-up for 12 weeks after treatment ends.
This Phase II clinical study is a prospective, open-label, single-arm trial designed to evaluate the efficacy and safety of combining anti-PD-1 therapy (sintilimab) with thymosin α1 and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or esophagogastric junction (GEJ) adenocarcinoma. The primary objective is to explore the therapeutic efficacy and safety of this combined treatment approach. The secondary objective is to assess its impact on the tumor immune microenvironment in locally advanced gastric cancer. Study Design The study plans to enroll 30 patients who have been pathologically confirmed as HER2-negative and diagnosed with resectable stage III gastric or GEJ adenocarcinoma (Siewert type III and type II without the need for thoracotomy). The study includes multiple steps: Treatment Regimen: Participants will receive three cycles of sintilimab combined with the SOX regimen (oxaliplatin and S-1) and nine weeks of thymosin α1 before surgery. Assessment Points: Tumor response will be evaluated through imaging studies at the end of the second and third cycles of neoadjuvant therapy. Post-treatment surgery is scheduled within 2-6 weeks following the last dose of the third cycle. Pathological Evaluation: Surgical tumor samples will undergo pathological examination, including assessments for pathological complete response (pCR), tumor regression grade (TRG), major pathological response (MPR), overall response rate (ORR), disease control rate (DCR), clinical downstaging rate, and R0 resection rate. Safety Monitoring: Adverse events will be monitored throughout the treatment period to evaluate the safety of the neoadjuvant immunochemotherapy regimen. Follow-up: Patients will be followed up to calculate disease-free survival (DFS) and overall survival (OS). Eligibility Criteria Inclusion Criteria: i, Confirmed diagnosis of HER2-negative gastric or GEJ adenocarcinoma. ii. Clinical stage III, resectable tumors. iii. Adequate organ function and performance status. Exclusion Criteria: i. Prior treatment with immune checkpoint inhibitors. ii. History of autoimmune diseases or other malignancies. iii. Severe comorbidities that could interfere with the study. Goals and Objectives Primary Goal: To determine the effectiveness and safety of combining sintilimab with thymosin α1 and SOX as a neoadjuvant therapy. Secondary Goal: To investigate changes in the tumor immune microenvironment induced by the treatment and their correlation with therapeutic efficacy. Study Implications This study aims to provide critical insights into the potential benefits of integrating immunotherapy with chemotherapy and thymosin α1 in treating locally advanced gastric cancer. By focusing on both efficacy and immune microenvironment alterations, the findings could pave the way for novel neoadjuvant treatment strategies and improve clinical outcomes for gastric cancer patients.
A phase I clinical study of 4th generation chimeric antigen receptor T Cells targeting glypican-3 ( CAR-GPC3 T Cells) in patients with advanced hepatocellular carcinoma.
This study explores the efficacy of Ga-68-PentixaFor PET/CT in detecting, assessing treatment response, and monitoring the risk of aggressiveness in indolent B-cell lymphoma. The background introduces CXCR4 and discusses its role in cancer research. Currently, FDG-PET is the primary imaging tool for lymphoma staging, but it lacks diagnostic accuracy for low-grade lymphomas. Ga-68-PentixaFor PET demonstrates promising detection capabilities across various lymphomas, suggesting its potential as a superior imaging modality for low-grade lymphomas.
The aim of this randomised controlled trial was to investigate the effect of a stress ball on pain, anxiety and physiological parameters in Chronic Obstructive Pulmonary Disease (COPD) patients on non-invasive mechanical ventilation (NIMV).
HS-10504 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targeting EGFR C797S mutation. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10504 in Chinese locally advanced or metastatic NSCLC.
flow restriction training combined with routine rehabilitation training can promote the recovery of lower limb muscle strength on the hemiplegic side of stroke patients, improve the lower limb motor function of patients, and further improve their daily life and walking ability. It provides a new treatment method for stroke patients with hemiplegia that leads to lower limb function loss and activity disorder, and the therapy also has the advantages of simple operation, high safety, good patient compliance and low cost, which is worthy of further clinical research and promotion.
To find the effect of cardiac rehabilitation program with and without progressive resisted exercises on patients after acute stage of PCI with at least 8 weeks history. It is a randomized clinical trial using convenient sampling technique. Randomly assign participants into two groups: An intervention group receiving Delorme progressive resisted exercise along with cardiac rehab and a control group undergoing standard cardiac rehabilitation alone. In Group A, Delorme technique will involve a 10-repetition max of aerobic and resistance exercises along with cardiac rehab. Seven different exercises will be performed in 3 sets of 10-repetition max. The control group will not be performing any type of training but will undergo cardiac rehab alone. Data will be analyzed using t test and SPSS 21 will be used for data collection. Age group will be from ≥70 years with patient undergoing dyspnea along with recent history of primary diseases. Data will be collected from Bethania Hospital, Sialkot through tools like the 6-minute walk test, Rose Angina questionnaire or settle angina questionnaire, quality of life scale (QOLFS), and Modified Borg dyspnea scale.
Additional data on screening for obstructive sleep apnea/hypopnea syndrome (OSAHS) in patients with co-morbidities, such as diabetics and those with chronic respiratory diseases would enable current recommendations to evolve, with a view to promoting the widespread use of simplified techniques for OSAHS screening, particularly in patients with cardiorespiratory co-morbidities. The primary objective of this observational multicentric pilot study is to compare the performance of the Sunrise® medical device with that of ventilatory polygraphy as part of routine screening for OSAHS in diabetic patients followed up in the diabetology department of the Strasbourg University Hospital, and in patients followed up in the pneumology consultation department of Mulhouse Hospital (GHRMSA).