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NCT ID: NCT05249426 Active, not recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma (HNSCC)

A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer

Start date: February 25, 2022
Phase: Phase 1
Study type: Interventional

This study is open to adults with head and neck cancer or liver cancer. This is a study for people for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out whether combining different medicines make tumours shrink in people with head and neck cancer or liver cancer. The tested medicines in this study are antibodies that act in different ways against cancer. BI 765063 and ezabenlimab may help the immune system fight cancer (checkpoint inhibitors). Cetuximab blocks growth signals and may prevent the tumour from growing. BI 836880 blocks the formation of new blood vessels that the tumour needs to grow. All participants get BI 765063 and ezabenlimab. One group gets no additional medicine. The other groups get either BI 836880, cetuximab, or chemotherapy. BI 765063, ezabenlimab, and BI 836880 are given as infusions into veins every 3 weeks. Cetuximab is given as an infusion every 1 or 2 weeks. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors monitor the size of the tumour. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05248386 Active, not recruiting - Osteoarthritis Clinical Trials

Efficacy and Safety of RTX-GRT7039 in Adult Subjects With Knee Osteoarthritis

Start date: August 26, 2022
Phase: Phase 3
Study type: Interventional

A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of repeated injections of RTX-GRT7039 versus placebo in patients who have pain associated with osteoarthritis of the knee despite standard of care.

NCT ID: NCT05245071 Active, not recruiting - Clinical trials for Non-squamous Non-small Cell Lung Cancer

Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA

CARMEN-LC06
Start date: June 1, 2022
Phase: Phase 2
Study type: Interventional

This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA). Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated.

NCT ID: NCT05244668 Active, not recruiting - Endometriosis Clinical Trials

Multicenter Validation of the Salivary miRNA Signature of Endometriosis

Start date: December 15, 2021
Phase:
Study type: Observational

ENDOmiARN Salive Test is a multicentre external validation study of a salivary signature of endometriosis carried out in France in Obstetrics and Reproductive Medicine departments, in order to evaluate its performance and discuss its use in clinical practice. The clinical application is to significantly reduce the time to diagnosis and improve the care pathway for endometriosis. The study population is made up of women aged 18 to 43 years with formally diagnosed endometriosis or suspected endometriosis who are already receiving either medical (MAP) or surgical treatment as part of their routine care. The patients concerned by the study are managed without any change in the care pathway, nor any change in the therapeutic indications, nor any change in the diagnostic examinations (imaging or biology) required according to the context, which are carried out in accordance with the HAS recommendations. In this study, the management and follow-up of patients : - Are not imposed by the study: the doctor remains free to make medical prescriptions (treatments and examinations) and to determine the interval between consultation visits, - Are not modified in comparison with the usual follow-up, except for the performance of : - Collection of saliva - Electronic collection of the answers to the questionnaires completed by the patient

NCT ID: NCT05244304 Active, not recruiting - Stargardt Disease 1 Clinical Trials

Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Adolescent Stargardt Disease

DRAGON
Start date: March 28, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this trial is to assesses the efficacy of tinlarebant in slowing the rate of growth of atrophic lesion(s) in adolescent subjects with STGD1

NCT ID: NCT05240131 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study to Investigate the Safety and Efficacy of GB1211 (a Galectin-3 Inhibitor) in Combination With Atezolizumab in Patients With Non-Small Cell Lung Cancer (NSCLC).

Start date: March 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study is an open label study followed by a randomised, double-blind, placebo-controlled, parallel group and an extension study to investigate the safety and efficacy of GB1211 (a galectin-3 inhibitor) in combination with atezolizumab in patients with Non-Small Cell Lung Cancer (NSCLC).

NCT ID: NCT05239728 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)

Start date: March 15, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).

NCT ID: NCT05238974 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants

MELODY
Start date: July 23, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.

NCT ID: NCT05235568 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

VALVOSOFT® Pivotal Study

Start date: June 15, 2022
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis

NCT ID: NCT05233384 Active, not recruiting - Clinical trials for Hereditary Dysfibrinogenemia

Genomics of Fibrin Clot Structure in Patients With Constitutional Dysfibrinogenemia

GENDYSFIB
Start date: July 28, 2022
Phase:
Study type: Observational

Hereditary dysfibrinogenemia results from monoallelic mutation in one of the fibrinogen genes (FGA, FGB, FGG). The spectrum of molecular abnormalities is broad, leading to several subtypes of coagulation disorders with specific biological and clinical features. The correlation between the genotype and the phenotype is poor, and the clinical course of patients, from major bleeding to recurrent thromboses, is unpredictable. Fibrin clot structure is a determinant of the risk of thrombosis in cardiovascular diseases. In all individuals, fibrin networks define the propensity of clot to be more resistant to removal or, on the contrary, susceptible to fragmentation leading to bleeding complications. Besides fibrinogen variants, other relatively common genetic polymorphisms in coagulation and fibrinolytic pathways may affect the fibrin clot structure and therefore act as modifiers of the blood clot function. In this proposal, the investigators will analyze properties (polymerization, fibrinolysis, viscoelastic properties, permeation) and ultrastructure (size, number, packaging, architecture of fibrin fiber by confocal microscopy and scanning electron microscopy) of plasma-based clots in relation to the presence of genetic modifiers (polymorphisms). Polymorphisms will be detected using a whole exome sequencing (WES) in a selected panel of genes of the coagulation and fibrinolytic pathways. The gene panel of 28 genes will include the three fibrinogen genes plus 25 potential modifier genes including F5, F2, PAI-1, PROCR and MTHFR. The overall clot phenotype will be correlated to the presence of prothrombotic polymorphisms and to the patient's clinical phenotype. The investigators plan to include about 100 patients with dysfibrinogenemia. The combination of integrative hemostasis models with genetic dataset will provide a global view of the patient's individual hemostatic profile. This may allow to better predict the clinical outcome and help provide a more personalized therapeutic strategy and precision medicine. In addition, the development of models allowing a reliable global assessment of fibrin clot architecture will be the basis for further research in other acquired diseases involving thrombotic or bleeding events.