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NCT ID: NCT05605587 Recruiting - MEN1 Gene Mutation Clinical Trials

Leflunomide Treatment for MEN1 Patients - the LUMEN1 Trial

LUMEN1
Start date: May 2, 2023
Phase: N/A
Study type: Interventional

Multiple endocrine neoplasia type 1 (MEN1) is an autosomal dominant disorder due to mutations in the tumor suppressor gene MEN1 with the corresponding gen product menin. MEN1 is characterized by the occurrence of parathyroid, pancreatic islet and anterior pituitary tumors which can release excessive amounts of hormones (= functional active tumors). Other tumors (e.g. carcinoid tumors, adrenocortical tumors, meningiomas, facial angiofibromas, collagenomas, lipomas) have also been described. There is no geno-phenotype correlation but the disease occurs after a second hit of the corresponding gene within the endocrine organ leading to an uncontrolled growth. MEN1-patients have a decreased life expectancy, mainly due to pancreatic neuroendocrine tumors (pNETs) which are often multiple and more aggressive than in non-MEN1 patients. To date, no prophylactic treatment exists to prevent tumor development in this hereditary disease. Leflunomide has been used as a treatment for rheumatoid arthritis for many years. It is a potent inhibitor of the dihydroorotate dehydrogenase (DHODH). According to some preclinical studies, leflunomide showed antineoplastic activities in several malignancies, including prostate, breast, bladder, multiple myeloma, leukemia, and lymphoma. A recent study identified an interaction between MEN1 mutation and DHODH inhibition. In this study, leflunomide selectively killed MEN1 deficient cells in vitro, prevented the occurrence of pancreatic tumor development in xenograft models and led to tumor regression / stabilisation in three MEN1 patients with advanced aggressive pancreatic neuroendocrine tumors. Accordingly, leflunomide could be used as a new treatment option for patients with known MEN1 germline mutation and associated endocrine disease. The aim of this study is, therefore, to evaluate the antitumor effect of leflunomide treatment on MEN1-associated tumors in patients with known MEN1-syndrome.

NCT ID: NCT05605288 Recruiting - Clinical trials for Coronary Artery Disease

Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI

DR-STEMI
Start date: May 23, 2024
Phase: N/A
Study type: Interventional

Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed for undertaking percutaneous coronary angiography and interventions. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.

NCT ID: NCT05603689 Completed - Physical Activity Clinical Trials

Effect of Isocaloric Ketogenic Diet on Physical Performance at High Altitude

ICKD
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

A ketogenic diet (KD) reduces daily carbohydrates (CHOs) ingestion by replacing most calories with fat. KD is of increasing interest among athletes because it may increase their maximal oxygen uptake (VO2max), the principal performance limitation at high altitudes. The investigators examined the tolerance of a 4-week isocaloric KD (ICKD) under simulated hypoxia and the possibility of evaluating ICKD performance benefits with a maximal graded exercise bike test under hypoxia and collected data on the effect of the diet on performance markers and arterial blood gases.

NCT ID: NCT05603676 Not yet recruiting - Hypertension Clinical Trials

Intermittent Hypoxia-hyperoxia Conditioning as a New Therapeutic Intervention to Reduce Hypertension (HyperIHHC)

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

The primary objective of this project is to examine the efficiency of intermittent hypoxia-hyperoxia conditioning (IHHC) protocol to improve vascular health and reduce blood pressure in hypertensive patients (stage 1). The result of the present study will investigate if IHHC could be a therapeutic treatment for hypertensive individuals. The investigation is designed with a placebo intervention (air ambient) and a control group (age-matched healthy participants). The interest of short cycles of intermittent hypoxia-hyperoxia is due to the triggering of the vasodilatory response in a greater extent compared to the pressor mechanisms since the exposure duration remains short. Therefore, it can be hypothesized that control and hypertensive groups achieving IHHC may exhibit a decreased blood pressure compared to the control and hypertensive groups achieving placebo intervention. The control group may show greater change than hypertensive due to higher vascular reserve. The secondary objective of the study is to understand the underlying mechanism of the beneficial effects of IHHC, especially the role of blood hemorheological changes. Based on available literature, it is know that hypoxia induce an increase in blood viscosity. One may hypothesize that with such a short hypoxic dose used during IHHC, only minor change in blood viscosity may occur. However, a slight rise in blood viscosity is known to stimulate NO synthase and then to produce more NO. Hence it could be one of the mechanisms involved in the early vasodilatory response to hypoxia. These findings are in line with the reported higher NO end-product metabolites during exercise in normoxia and hypoxia in subjects who showed a rise in blood viscosity after exercise. The hypothesis is that the magnitude of IHHC beneficial effects is related to change in blood viscosity and its determinants.

NCT ID: NCT05603247 Active, not recruiting - Clinical trials for Acute Myocardial Infarction

The SWISSHEART Failure Network (SHFN)

Swissheart
Start date: November 1, 2021
Phase:
Study type: Observational

A retrospective cohort study will be conducted on patients who were hospitalized at the University Hospital Basel (USB), University Hospital Bern (Inselspital), University Hospital Geneva (HUG) and the University Hospital Zurich (USZ) with the diagnosis of AMI and/or AHF. Baseline data will be collected in the hospital during treatment will be complemented by a short outcome evaluation.

NCT ID: NCT05602272 Recruiting - Gastroparesis Clinical Trials

Respiratory and Hemodynamic Implications of Endoscopic Myotomy of the Esophagus and Stomach

Start date: November 1, 2022
Phase:
Study type: Observational

The goal of this observational study is to learn about hemodynamic and respiratory repercussions during general anesthesia in patients with achalasia or gastroparesis who underwent an endoscopic treatment such as a peroral endoscopic myotomy (POEM) or gastric (GPOEM). The main questions it aims to answer are: - Are there predictable elements reliable to this study-population for the occurrence of adverse events/complications? - Is there a correlation between the value (percutaneous puncture) of the intra-abdominal pressure and the variations of the patient's respiratory and hemodynamic parameters in the event of a pneumoperitoneum complication? Participants will be treated with the usual standard of care for this procedure and no additional or specific therapy will be planned for this study.

NCT ID: NCT05602077 Recruiting - Elbow Fracture Clinical Trials

Accuracy of Sonography in Elbow Trauma

SONOELB
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

X-rays (XR) are today the standard modality for the diagnosis of bone fractures in the lower or upper limbs in the emergency room. Point-of-care ultrasound (POCUS) is an alternative with some obvious advantages especially in the emergency room setting: It does not require the patient to fix the bone of interest in a stable position, allows observing the bone and joints under movement by the patient, can be performed at bedside, and avoids the exposure to radiation. The advances in ultrasound technology has increased the interest in using POCUS as an alternative to XR in recent years. POCUS is used routinely prior to XR at the ORTHO-NOTFALL of the Merian Iselin Klinik Basel (MIK) in patients with suspicion for an indirect elbow trauma. It is the aim of this project to use this constellation in order to contribute to a systematic comparison of the value of the two modalities with the long-term aim to establish POCUS as the first-line diagnostic tool. As a fist project, the SONOELB study was initiated. This study aims at a comparison of the diagnostic accuracy between XR and POCUS using CT as reference. The project started in October 2022 and aims at enrolling 130 patients until March 2025. The project is financially supported by the Merian Iselin Science Research PLC.

NCT ID: NCT05601973 Recruiting - Clinical trials for Non Small Cell Lung Cancer

AMAZE-lung: Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-generation EGFR-TKI

AMAZE-lung
Start date: March 27, 2023
Phase: Phase 2
Study type: Interventional

AMAZE-lung is a multicenter single-arm phase II trial. The protocol treatment consists of amivantamab, lazertinib and bevacizumab (Zirabev®), given in a three-weekly regimen. The primary objective of the trial is to assess the efficacy of amivantamab and bevacizumab added to continued treatment with the third-generation EGFR-TKI lazertinib, in patients with EGFR-mutant advanced NSCLC, who have been previously treated with a third-generation EGFR-TKI in order to provide data on treatment effect and sample size required for a future phase III trial. In addition, the safety of the treatment combination will be evaluated.

NCT ID: NCT05601882 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Level Up
Start date: November 28, 2022
Phase: Phase 3
Study type: Interventional

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed. Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment period 1 and a 16-week treatment period 2. During period 1, participants are randomly assigned in 1 of 2 groups, called treatment arms to receive upadacitinib Dose A or dupilumab. In Period 2, participants will receive upadacitinib Dose A or Dose B. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide. Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label for 32 weeks and followed for 30 days. 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05601453 Recruiting - Clinical trials for Aortic Valve Stenosis

The ReTAVI Prospective Observational Registry

Start date: September 5, 2023
Phase:
Study type: Observational [Patient Registry]

Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger & lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure. The evidence on redo-TAVI (where a transcatheter heart valve [THV] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations. Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year.