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NCT ID: NCT05421221 Not yet recruiting - COVID-19 Clinical Trials

Olfactory Training in COVID-19 Associated Loss of Smell

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

Olfactory dysfunction (OD) like hyposmia or anosmia has been realized as a common symptom or even cardinal sign of the disease and can be persisting after recovering. There are two different hypotheses on the pathogenesis of OD in past COVID-19: The central hypothesis, which speculates on neurotrophic abilities on olfactory receptors in the neuroepithelium, and the peripheral hypothesis, which speculates on damage of the sensory olfactory epithelium. Potential treatment strategies aim for the unique neural plasticity of the olfactory system and its potential for recovery. Clinical studies and case reports have shown a promising effect of olfactory training (OT) by frequent sniffing and/or exposure to odors 2-4 times a day for several weeks. The main objective of the study is to assess the effects of olfactory training in patients with COVID-19 related OD on: 1. objective olfactory testing with the Sniffin' sticks test (identification and discrimination) (primary endpoint), 2. subjective OD and its impact on the daily life (key secondary endpoint), 3. other clinical scales and questionnaires referring to OD-related mood and quality of life (other secondary endpoint), 4. gender differences in COVID-19 related OD (exploratory endpoint). Approach / methods OT will be performed twice a day with a 4-odor training set for 12 weeks. Effects of OT on COVID-19 related OD will be measured with objective and subjective efficacy variables. The sense of smell is an important function for social relationships and is therefore a challenging clinical problem with few proven therapeutic options. With this new approach, we want to investigate a possible simple treatment for an impedimental symptom of COVID-19, but also learn more about the pathomechanism of post-infectious OD. To our knowledge, this will be the first study comparing patients with COVID-19 associated OD with and without OT in clinical outcomes.

NCT ID: NCT05418725 Not yet recruiting - Atrial Fibrillation Clinical Trials

Ground-Breaking Electroporation-based Intervention for PERSistent Atrial Fibrillation Treatment (BEAT PERS-AF)

Start date: September 2022
Phase: N/A
Study type: Interventional

BEAT AF is a randomized controlled trial aiming to assess the efficacy and the safety of pulsed field energy in persistent AF ablation

NCT ID: NCT05416307 Recruiting - Clinical trials for Secondary Hemophagocytic Lymphohistiocytosis (sHLH)

Evaluation of the Safety and Efficacy of ELA026 in Patients With Secondary Hemophagocytic Lymphohistiocytosis

Start date: May 19, 2022
Phase: Phase 1
Study type: Interventional

Hemophagocytic lymphohistiocytosis is a rare, aggressive and life-threatening syndrome of excessive immune activation. ELA026 is a fully human IgG1 SIRP-directed monoclonal antibody designed to reduce the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, efficacy pharmacokinetics and pharmacodynamics of ELA026 in adult and adolescent patients with secondary hemophagocytic lymphohistiocytosis.

NCT ID: NCT05413278 Not yet recruiting - Clinical trials for Inborn Errors of Metabolism

Targeted Interventions for Successful Transition and Transfer of Adolescents With Inborn Errors of Metabolism to Adult Metabolic Services

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

Main aims of this project are - To assess the baseline status-quo of transition and "fitness for transfer" in terms of information about the adult centre and team, organisational and practical skills (blood sampling and sending, how to make an appointment etc.), disease- and treatment-related knowledge, health-related quality of life (HrQoL), and self-efficacy in adolescnets with inborn errors of metabolism. Biochemical or physical parameters as appropriate for the respective diseases from 12 months before are documented. - To provide targeted, structured intervention modules (using available and, if necessary, adapted materials). - To measure the effects of these interventions on information about adult services short-term (within a month) and to re-assess all other baseline status-quo parameters long-term (6 and 12 months later). Psychological assessments will be complemented by biochemical or physical parameters as appropriate for the respective diseases and indicative for transition success.

NCT ID: NCT05409066 Not yet recruiting - Clinical trials for Follicular Lymphoma (FL)

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

Start date: September 7, 2022
Phase: Phase 3
Study type: Interventional

Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 642 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (intravenous infusion of rituximab up to 5 cycles and oral capsules of lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 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: NCT05406687 Recruiting - Cancer Clinical Trials

Cancer Prevention and Early Detection Among the Homeless Population: The Health Navigator Model

Start date: June 8, 2022
Phase: N/A
Study type: Interventional

Prevention and early detection are key for the decrease of cancer-related mortality. However, socially deprived population groups don't have the privilege of unburdened access to the healthcare system. The EU-funded CANCERLESS project aims to develop an evidence-based, patient-centred innovation that reinforces patients through health education and social support and fosters timely access to primary and secondary prevention services. Based on the combination of the tested Patient Navigator Model and the Patient Empowerment Model, CANCERLESS will develop the Health Navigator Model for Europe, addressed to the underserved population.

NCT ID: NCT05403814 Recruiting - Aging Clinical Trials

Test and Usability of Mixed-reality Screening Tool for Early Detection of Cognitive Declines

Start date: April 25, 2022
Study type: Observational

The aim of this study as part of the SCOBES-AR project is to establish and test a protocol for implementation and usability of mixed reality-enhanced multidisciplinary screening tool for early detection of cognitive impairments in the elderly.

NCT ID: NCT05401773 Recruiting - COVID-19 Clinical Trials

α-synuclein Seeding Activity in the Olfactory Mucosa in COVID-19

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

Loss of the sense of smell is a characteristic feature of COVID-19 and likely related to viral invasion of the olfactory mucosa but is also a prodromal feature of PD. This constellation has kindled concerns that COVID-19 - similar to the Spanish Flu Pandemic in 1918 - might trigger a second wave of post-infectious parkinsonism. The main objective of the study is to probe for the presence of pathological α-synuclein assemblies in the olfactory mucosa of patients with COVID-19.

NCT ID: NCT05398952 Recruiting - POTS Clinical Trials

Post-COVID-19 Outpatient Care and Biomarkers

Start date: April 1, 2021
Study type: Observational [Patient Registry]

The aims of this case-control, non-randomized study including patients with post-COVID-19 persisting symptoms are 1) to establish the large blood biobank, 2) to examine levels of circulating inflammatory biomarkers and different classes of non-coding RNAs (ncRNA), such as selected circRNAs and miRNAs, in plasma and serum samples collected from patients with post- COVID-19, 3) to test the levels of cfDNA in plasma and serum, 4) to define correlation between ncRNAs and cf-DNA with persistent clinical symptoms, and type of symptoms, and 5) to investigate diagnostic and prognostic performances of these circulating biomarkers. Study design. This is a prospective registry including biobank.

NCT ID: NCT05394142 Not yet recruiting - Clinical trials for Polycystic Ovary Syndrome (PCOS)

A Clinical Trial to Evaluate the Efficacy, Tolerability, and Safety of a Fixed Dose Combination of Spironolactone, Pioglitazone & Metformin (SPIOMET) in Polycystic Ovary Syndrome (PCOS)

Start date: May 2022
Phase: Phase 2
Study type: Interventional

This is a multi-centre, multi-national, double-blinded, placebo-controlled, parallel, randomised Phase II clinical trial to evaluate the efficacy, tolerability, and safety of a fixed dose combination of Spironolactone, Pioglitazone and Metformin (SPIOMET) for adolescent girls and young adult women with polycystic ovary syndrome. Study description: Currently, there is no European Medicines Agency /U.S. Food and Drug Administration (FDA)-approved therapy for polycystic ovary syndrome in adolescent girls and young adult women. Oral contraceptives (OCs) are prescribed off-label to approximately 98% of AYAs with PCOS, including those without pregnancy risk. OCs alleviate key symptoms by inducing a pharmacological combination of anovulatory subfertility, regular pseudo-menses, and extreme elevations of sex hormone-binding globulin (SHBG), but OCs do not revert the underlying pathophysiology, and patients remain at risk for post-treatment subfertility and possibly, for lifelong co-morbidities. Given the key role of hepato-visceral fat excess in the pathogenesis of PCOS, the prime aim of the treatment should be to achieve a preferential loss of central fat, which should in turn normalise the entire PCOS phenotype. Recent evidence disclosed that a treatment consisting of a fixed low-dose combination of two insulin sensitisers [pioglitazone (PIO) and metformin (MET), with different modes of action], and one mixed anti-androgen and anti-mineralocorticoid (spironolactone), was superior to an OC in normalising the PCOS phenotype, including ovulation rates and hepato-visceral fat. The study's main goals are to assess the efficacy, tolerability and safety of a new treatment (SPIOMET) for adolescent girls and young adult women with polycistic ovarian syndrome; the comparison (in this order) of each SPIOMET, spironolactone and pioglitazone (SPIO) and PIO over placebo; and in addition, the comparison of SPIOMET over PIO and over SPIO (in this order). Primary Objective: To test the efficacy of SPIOMET in normalising ovulation rate in adolescents and young adult women with PCOS. Secondary Objectives: To test the efficacy of SPIOMET in normalising the endocrine-metabolic status, to describe the drug safety profile and to assess the adherence and subjective acceptability, as well as the quality of life of the participating subjects.