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Hypersensitivity clinical trials

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NCT ID: NCT06138821 Not yet recruiting - Obesity Clinical Trials

ESG vs GLP-1RA vs ESG + GLP-1RA in Patients With Obesity, NAFLD and Advanced Fibrosis: A Randomized Controlled Trial

Start date: July 2024
Phase: Phase 4
Study type: Interventional

Endoscopic bariatric and metabolic therapies (EBMT) are a non-invasive, safe alternative treatment for patients with obesity. Current FDA- approved devices include intragastric balloons (IGB) and suturing devices for endoscopic sleeve gastroplasty (ESG). These gastric interventions work by interfering with how the stomach expands to accept and process a meal, which slows down how fast the stomach empties. ESG, the procedure the investigators are doing in this study, involves endoscopic suturing to reduce the length and width of the stomach so that the patient feels full faster. Semaglutide is a popular medication for weight loss, and has shown significant weight loss with a good safety profile in clinical trials. In this study, the investigators will compare ESG, Semaglutide only, and an ESG + Semaglutide combination, on weight loss for subjects undergoing the procedure with a history of obesity, liver fibrosis and NAFLD. To better understand how these impact obesity and liver fibrosis, the investigators will track weight loss, laboratory values, liver stiffness, and the patients overall liver health. The suturing device used in the ESG procedure and the semaglutide are all approved by the U.S. Food and Drug Administration (FDA) for endoscopic procedures in the upper gastrointestinal tract and medication management of obesity. This is a study that will randomize patients to 1 of 3 different treatment options: ESG only, Semaglutide only or ESG + Semaglutide. The investigators want to see if adding the weight loss medication to the ESG procedure will increase weight loss and how it will impact liver health.

NCT ID: NCT06134271 Not yet recruiting - Clinical trials for Metastatic Hormone-Sensitive Prostate Cancer

Rezvilutamide Plus Abiraterone for Metastatic Hormone-sensitive Prostate Cancer

RASTOM
Start date: November 15, 2023
Phase: Phase 2
Study type: Interventional

This multicenter, prospective, cohort study enrolled patients with metastatic hormone-sensitive prostate cancer who had been treated with other novel endocrine or systemic regimens (excluding patients treated with pre-order chemotherapy alone or bicalutamide); To observe the efficacy and safety of rezvilutamide alone or in combination with abiraterone in hormone-sensitive prostate cancer patients with PSA progression following prior sequence therapy.

NCT ID: NCT06130085 Not yet recruiting - Clinical trials for Cow's Milk Protein Allergy

Partially Hydrolyzed Formula in Cow's Milk Protein Allergy After 6 Months of Elimination

Start date: November 2023
Phase: N/A
Study type: Interventional

For Patients diagnosed as cow milk protein allergy: Elimination of cow's milk products (CMPs) for 6 months. All infants were supplemented with Amino Acid-based Formula (AAF) (Neocate infant®/ Neocate junior®, Dannone Nutricia) for 6 months at start of elimination diet. For mixed milk fed infants (still receiving breast milk with the formula), mothers were encouraged to continue breast-feeding while avoiding all milk and milk products from their own diet. Intervention after completing 6 months of eliminating CMPs. The included patients were randomly assigned to one of (2 groups). 1. Group I (AAF group) n= 50 Infants in this group continued with Amino Acid-based Formula for another 6 months. 2. Group II (pHF group) n= 50 Infants in this group were shifted gradually to Partially-hydrolyzed whey formula (pHF) (Liptomil Plus HA infant formula. for another 6 months with continuation of elimination of cow's milk products. They were followed up for manifestations of intolerance to pHF. Infant who showed manifestations of intolerance were returned to AAF and continued for 6 months with AAF. Final step: Reintoduction of CMPs After 12 months of elimination of CMPs, evaluation of tolerance to whole CMPs was done by oral food challenge (OFC). For infants who were still non-tolerant to CMPs after 12 months of elimination were followed up and re-challenged after 6 months.

NCT ID: NCT06123780 Not yet recruiting - Clinical trials for Acute Exacerbation COPD

Pattern of Microbial Infection in AECOPD Patients and Its Sensitivity to Antibiotics

Start date: December 1, 2023
Phase:
Study type: Observational

Measurement of bacterial species causing AECOPD and their Sensitivity pattern to antibiotics.

NCT ID: NCT06112873 Not yet recruiting - Food Allergy Clinical Trials

Quality of Life in Food Allergy: Validation of Three Mini-questionnaires

EVAALIM
Start date: November 5, 2023
Phase:
Study type: Observational

The evaluation of the quality of life (QOL) in food allergy (AA) is difficult due to the lack of a currently validated questionnaire. There are only a few tools available to assess the impact of nutritional care on the QOL of the allergic patient . Available questionnaires are poorly adapted to studies dealing with large cohorts where functionality and ease of use are determining factors. The aim of this work will be to develop and validate QOL questionnaires for AA, short and easy to use, also integrating the theme of collective catering in order to assess the evolution of QOL in patients with food allergy. The target population of the questionnaires will be: i) the parents of allergic children 0 to 17 years (15 questions) ii) allergic children aged 8 to 17 years (13 questions) iii) Adults over 18 (14 questions) After receiving an information note, eligible patients or their parents will complete the questionnaires. A total of 200 patients will be recruited for each questionnaire. A statistical evaluation will be carried out using 200 questionnaires for each targeted population in order to validate the psychometric properties of the questionnaire as well as investigate the degree of correlation between the scores of the mini-questionnaire and those obtained using the Europrevall reference questionnaire.

NCT ID: NCT06099990 Not yet recruiting - Clinical trials for High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)

Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)

Start date: October 2023
Phase: Phase 1
Study type: Interventional

This study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free survival(rPFS) based on BICR assessment

NCT ID: NCT06085118 Not yet recruiting - Food Allergy Clinical Trials

Observatory on Cow's Milk Protein Allergy

OLAF
Start date: November 2023
Phase:
Study type: Observational

The purpose of this study is to describe the symptoms and their evolution up to the age of 5 years in a population of newly diagnosed infants with a suspected or confirmed allergy to cow proteins, for whom the doctor prescribed the Pepticate® Syneo® replacement formula as soon as they were diagnosed. The Pepticate® Syneo® product is an advanced protein hydrolyzate, food type intended for special medical purposes. This is a product already available on the market.

NCT ID: NCT06053086 Not yet recruiting - Breast Cancer Clinical Trials

SAHARA-04 : Adaptive Radiotherapy in Hypersensitive Patients and High Locoregional Risk Breast Cancer With ETHOS Technology

SAHARA-04
Start date: October 2023
Phase: N/A
Study type: Interventional

- Prospective, open-label, bi-center study, assessing the clinical outcomes of adaptive breast radiotherapy with ETHOS in hypersensitive patients. - Bi-centric with ETHOS center : ICM (Institut du Cancer de Montpellier) and ISC (Institut Sainte Catherine) Avignon - 500 patients will be included: - COHORTE A = Treatment ETHOS RT :46 evaluable patients with high risk of LRR and bf+ risk - COHORT B = Conventional IMRT : 454 others patients with high risk of LRR and bf- risk

NCT ID: NCT06048315 Not yet recruiting - Lung Cancer Clinical Trials

A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations and Failed EGFR TKIs With the Combination of Enrotinib and Paclitaxel Monoclonal Antibody

Start date: September 2023
Phase: Phase 3
Study type: Interventional

Lung cancer is the second most common malignancy and mortality rate in the world. In the United States and Europe, approximately 10% to 15% of NSCLC patients have epidermal growth factor receptor (EGFR)-sensitive mutations, with higher mutation rates of 30% to 40% in Asia, and objective response rates (ORRs) of 76% to 80% with EGFR Tyrosine Kinase Inhibitor (TKI)-targeted therapy. However, resistance mechanisms such as EGFR, MET, PIK3CA and BRAF gene alterations occur with the development of resistance to EGFR-TKI therapy; Median Progression Free Survival (mPFS) for only 2.8-3.2 months; The median overall survival (mOS) is only 7.5-10.6 months. Due to the variety of mechanisms of resistance to EGFR-TKIs and the limited efficacy of chemotherapy, it is necessary to provide salvage treatment for advanced non-small cell lung cancer that is positive for EGFR-sensitive mutations and has failed EGFR TKIs. Anlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) used to inhibit tumor angiogenesis and proliferative signaling. The main targets of anlotinib include tyrosine kinase vascular endothelial growth factor receptor 1-3 (VEGFr1-3), fibroblast growth factor receptor 1-4 (Fibroblast Growth Factor Receptor 1-4), platelet-β derived growth factor receptor α and β, and stem cell factor receptor. Anlotinib is rapidly absorbed through the intestine, has high bioavailability, a half-life of 5 days, and is convenient for oral administration, which is conducive to improving patient dependence. IN MAY 2018, THE CHINA FOOD AND DRUG ADMINISTRATION APPROVED ANLOTINIB FOR MARKETING, ENTERED THE MEDICAL INSURANCE CATALOG IN OCTOBER OF THE SAME YEAR, AND WAS RECOMMENDED BY THE CHINESE SOCIETY OF CLINICAL ONCOLOGY (CSCO) FOR THE THIRD-LINE TREATMENT OF LUNG CANCER IN 2019. Penpulimab is a humanized immunoglobulin G1 monoclonal antibody (IgG1), which is a class 1 new drug jointly developed by Zhongshan Akeso Biopharmaceutical Co., Ltd. and Chia Tai Tianqing Pharmaceutical Group Co., Ltd., which can specifically bind to PD-1 molecules on the surface of T lymphocytes, thereby blocking the PD-1/PD-L1 pathway that leads to tumor immune tolerance, and reactivating the anti-tumor activity of T lymphocytes to achieve the purpose of treating tumors. A number of preclinical in vitro trials have verified the effect of PEAMPLIMAB in blocking PD-1 pathway, and the results of preclinical pharmacodynamics, animal pharmacokinetics and toxicology have shown that PEAMPLIMAB has good stability, reduced host cell protein residues, and can effectively bind to antigens, and eliminate Fc-mediated effector function, with higher safety. AK105-201 is a multicenter, double-blind, randomized controlled, phase III clinical trial evaluating the efficacy and safety of pianpulimab combined with carboplatin + paclitaxel in the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer, the primary endpoint of the study was PFS, and the secondary endpoint was OS, and the results showed that the mPFS group of pianpulimab and the control group were 7.6m and 4.2m, respectively, and the HR was 0.44, reducing the risk of disease progression by 56%. In the 2022 CSCO guidelines for the diagnosis and treatment of non-small cell lung cancer, peamplimab combined with platinum-containing chemotherapy is recommended as the first-line treatment for stage IV driver-free squamous cell carcinoma Grade II. In advanced patients with EGFR TKIs resistance, pemetrexed chemotherapy has a good efficacy, with a median PFS of 2.83 months and a response rate of 22%. The AK105-203 study is a multicenter phase II clinical study led by Professors Jiao Shun and Bai Li of the Chinese PLA General Hospital of the People's Liberation Army of Anlotinib combined with péamplimab in the first-line treatment of hepatocellular carcinoma, with a median follow-up of 23 months and mPFS of 8.8 months. Therefore, based on the results of the current study on immunosuppressants and antiangiogenic drugs for the treatment of NSCLC, and the current research status in patients with advanced NSCLC who are positive for EGFR-sensitive mutations and have failed EGFR TKIs, we expect to conduct an exploratory clinical study of PD-1 antibody (péamplimab) combined with anlotinib in patients with advanced NSCLC who are positive for EGFR-sensitive mutations and have failed EGFR TKIs, with the aim of evaluating the safety of this combination, It was further investigated whether this combination could further improve the survival benefit of patients with advanced NSCLC.

NCT ID: NCT06015568 Not yet recruiting - Clinical trials for Non-Small Cell Lung Cancer?EGFR Sensitive Mutation

Study of MCLA-129 Combined With Befotertinib in the Treatment of Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation

Start date: September 1, 2023
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerance of MCLA-129 combined with Befotertinib in patients with advanced non-small cell lung cancer with EGFR-sensitive mutations.