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NCT ID: NCT05287113 Recruiting - Clinical trials for Head and Neck Cancer

Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Start date: November 14, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).

NCT ID: NCT05286788 Recruiting - Clinical trials for Recurrent Adamantinomatous Craniopharyngioma

MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

Start date: April 10, 2023
Phase: Phase 2
Study type: Interventional

MEKTOVI (binimetinib) is an oral, highly selective reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. The biological activity of binimetinib that has been evaluated bith in vitro and in vivo in a wide variety of tumor types In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy.

NCT ID: NCT05283720 Recruiting - Clinical trials for Non-Hodgkin Lymphoma

A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

Start date: June 14, 2022
Phase: Phase 2
Study type: Interventional

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 394 adult participants with NHL will be enrolled in 100 sites globally. In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28-day or 21 day cycles dependent on the arm in combination with the anti-neoplastic agents described below: 1: Oral lenalidomide in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in participants with with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in participants with newly diagnosed treatment-naïve DLBCL; 4: Oral CC-99282 in participants with R/R DLBCL; 5: Oral CC-99282 in participants with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in participants with R/R mantle cell lymphoma (MCL); 6B: Oral ibrutinib, and oral venetoclax in participants with R/R MCL; 7: Oral ibrutinib, and oral venetoclax in participants with newly diagnosed treatment-naïve MCL. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

NCT ID: NCT05282082 Recruiting - Clinical trials for Nosocomial Infection

Carbapenem-resistant Pseudomonas Aeruginosa: the SAMPAN Study.

SAMPAN
Start date: March 1, 2022
Phase:
Study type: Observational

Pseudomonas aeruginosa causes severe infections in hospitalized patients. The worldwide emergence of carbapenem-resistant P. aeruginosa (CR-PA) makes infections by these pathogens almost untreatable. The World Health Organization now ranks CR-PA highest in the list of 'urgent threats'. Information for action to prevent further emergence has to come from insight into sources and transmission routes through smart surveillance. At present, a smart surveillance strategy is not available for CR-PA. The aim of this project is to develop a globally-applicable smart surveillance strategy to guide action against the spread of CR-PA. Since P. aeruginosa prefers moist niches, we will focus on the human-water interface. First, highly-sensitive methods to detect CR-PA in specific environmental and human niches will be developed. Subsequently, CR-PA will be collected in three study sites with increasing prevalences of CR-PA, increasingly warmer climates, and different water situations: Rotterdam (The Netherlands), Rome (Italy), Jakarta (Indonesia). CR-PA will be searched for in a variety of niches in the environment outside and inside the hospital, and in healthy humans and hospitalized patients. Whole genome sequencing will be performed to compare the CR-PA from different sources and identify transmission routes. Our project will provide insight into the relative contribution of the different potential reservoirs of CR-PA to its spread in different settings which will be used for the development of a globally-applicable surveillance strategy for CR-PA to guide preventive actions.

NCT ID: NCT05281380 Recruiting - Quality of Life Clinical Trials

VITAMin Insufficiency in Esophagogastric Neoplasms

VITAMIN
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Rationale: Esophageal cancer and gastric cancer are among the top ten most common cancers worldwide. Both diseases have major impact on the nutritional status of patients and their quality of life. Studies investigating post-operative nutritional status are limited and postoperative identification and treatment of micro- and macronutritional deficiencies are currently lacking in (inter-)national guidelines. Objective: To identify and target vitamin deficiencies after surgery for esophagogastric neoplasms. Study design: Single centre intervention study. Study population: Patients aged 18 years and older that underwent esophagectomy or (sub- )total gastrectomy for esophagogastric neoplasms. Intervention (if applicable): Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy. Main study parameters/endpoints: Baseline micronutrient deficiency measurements and after 6, 12, 24 months supplementation,. Secondary study parameters/ endpoints: Occurrence of exocrine pancreatic insufficiency (n,%), occurrence of diarrhoea (n,%), steatorrhea (n,%), bloating (n,%), time between surgery and start of supplementation (mean in months), quality of life experienced (questionnaires) at baseline and after 6, 12, 24 months supplementation. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this study, no health-related risks are present for participants due to the administration of supplementation that is already used as in clinical practice.

NCT ID: NCT05280548 Recruiting - Fabry Disease Clinical Trials

A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease

CARAT
Start date: May 3, 2022
Phase: Phase 3
Study type: Interventional

This is an 18-month, multicenter, randomized, active-control, parallel-group Phase 3 study, in which participants will be randomized to venglustat versus standard of care therapy (agalsidase alfa, agalsidase beta, or migalastat) to evaluate the effect of venglustat on left ventricular mass index (LVMI) in adult participants with Fabry disease and left ventricular hypertrophy. - Study visits will take place approximately every 3 to 6 months - Participants who complete the randomized period may continue to the long-term extension (LTE) to receive venglustat for up to additional 34 months with the total study duration up to 4.4 years maximum.

NCT ID: NCT05280379 Recruiting - Colon Carcinoma Clinical Trials

Trained Immunity in Thyroid Carcinoma and Colon Carcinoma

Start date: September 19, 2022
Phase:
Study type: Observational

Tumor-related inflammation is one of the hallmarks of cancers in general. Innate immunity specifically is a common denominator which is involved in the pathogenesis of both thyroid carcinoma and colon carcinoma. To improve the patient's outcome and identify novel therapeutic targets, one needs a deeper understanding of the tumor-induced changes in the bone marrow myeloid progenitor cells. Furthermore, treatment of these cells by nanoparticles or other agents that induce a program of 'trained immunity' may be a novel way to re-educate myeloid cells and their bone marrow progenitors in thyroid carcinoma patients. Lastly, the investigators expect that this approach could be effective also in other cancers of which colon carcinoma is here proposed as an additional model. The investigators hypothesize that by exposing myeloid cells or their progenitors to various agents that induce trained immunity (e.g. high-density-lipoprotein-methylene diphosphonate nanoparticles, recombinant and synthetic cytokines), these immune cells will undergo functional reprogramming to induce a tumor-suppressive phenotype. In the future, this could be explored as a novel immunotherapy for tumors that are refractory to conventional treatment.

NCT ID: NCT05280093 Recruiting - Clinical trials for Inappropriate Sinus Tachycardia

HEAL-IST IDE Trial

Start date: May 31, 2022
Phase: N/A
Study type: Interventional

Inappropriate Sinus Tachycardia (IST) is a prevalent and debilitating condition in otherwise healthy younger patients, resulting in significant loss of quality of life, lacking effective treatment options or systematic clinical evidence to support a therapy. The primary objective of this clinical trial is to evaluate the safety and effectiveness of a hybrid sinus node sparing ablation procedure for the treatment of symptomatic drug refractory or drug intolerant IST.

NCT ID: NCT05278793 Recruiting - Pregnancy Related Clinical Trials

The Efficacy of Intermittent Versus Daily Oral Iron Supplementation in Anaemic Pregnant Women.

FER-IDIP
Start date: January 7, 2022
Phase: Phase 4
Study type: Interventional

In this study intermittent dosage of iron supplementation three times a week will be compared to daily dosage in anaemic pregnant women due to iron deficiency.

NCT ID: NCT05274919 Recruiting - Glioma Clinical Trials

Vascular Signature Mapping of Brain Tumor Genotypes

VASIM
Start date: August 16, 2022
Phase:
Study type: Observational [Patient Registry]

A glioma is a primary brain tumor in adults that is characterized by a highly variable, but overall poor survival. The optimal timing of treatment is in part determined by the expected biological behavior of the tumor. At present the expected biological behavior, determined by the tumor genotype, can only be determined by tissue analysis, which requires brain surgery. Non-invasive and improved diagnostic methods are sought to obtain insight into the molecular profile of the tumor and the expected biological behavior to avoid surgery performed solely for diagnostic purposes. Vascularization is an important aspect of the biological behavior of a primary brain tumor. Tumor vascularization characteristics can be assessed by Magnetic Resonance Imaging (MRI), but with the currently available technology this can only be achieved with unacceptably long scan times. In this proposal, the investigators will develop and optimize a novel MRI protocol to gather a large set of quantitative vascularization parameters within an acceptable scan time. The hypothesis is that from such a 'vascular signature' the tumor genotype can be inferred by means of machine learning.