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NCT ID: NCT05767814 Recruiting - Clinical trials for Rheumatoid Arthritis

Optimization of Psoriatic and Seronegative Rheumatoid Arthritis Patients Selection and Treatment Outcomes of Biologic Therapies.

Start date: October 3, 2019
Phase:
Study type: Observational

Different classes of biological targeted therapies (b-DMARDs) are available for psoriatic arthritis (PsA) and seronegative rheumatoid arthritis (RA) (TNF inhibitors, anti-IL23, anti-IL17). A variable percentage of subjects, however, does not respond the first b-DMARD. Musculoskeletal ultrasound (US) and synovial tissue analysis could provide useful information on the top of clinical variables to predict response. The primary aim of this project is to create a global single-cell RNA sequencing atlas of PsA synovitis and to evaluate the predictive value of clinical, US and synovial variables (inflammatory cells and synovial tissue-single cell signature) on disease trajectory outcome and treatment response. Patients with PsA or seronegative RA at different disease stages will be enrolled. Clinical and US examination will be performed at baseline, 3, 6 and 12 months, while synovial biopsy at baseline and 6 months. The optimal combination of clinical, US and synovial variables to stratify treatment response will be developed. The sensitivity to change of US and synovial variables and their evaluation in patients achieving clinical remission will also be considered as secondary aims. The expected results will help the optimisation of treatment strategies in patients with PsA and seronegative RA.

NCT ID: NCT05767346 Recruiting - Clinical trials for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM

MAPLE-HCM
Start date: June 19, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction

NCT ID: NCT05767034 Recruiting - Clinical trials for Polymyalgia Rheumatica

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

REPLENISH
Start date: March 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.

NCT ID: NCT05767021 Recruiting - Ulcerative Colitis Clinical Trials

A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis

LUCENT-URGE
Start date: May 17, 2023
Phase: Phase 3
Study type: Interventional

A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.

NCT ID: NCT05765786 Recruiting - High Blood Pressure Clinical Trials

Diagnosing Variable Primary Aldosteronism.

Start date: February 24, 2023
Phase:
Study type: Observational

The goal of this observational study is to see if there is a cyclical or exaggerated diurnal variation in aldosterone production in people with Primary Aldosteronism.

NCT ID: NCT05765734 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of TAS3351 in NSCLC Patients With EGFRmt

TAS3351
Start date: May 3, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human, open label, Phase 1/2 study to investigate the safety and efficacy of TAS3351 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.

NCT ID: NCT05764473 Recruiting - Menopause Clinical Trials

Diet, Cardiometabolic Risk (CM) and Menopause Symptoms

Start date: March 14, 2023
Phase: N/A
Study type: Interventional

This research will explore the question 'What impact do the Mediterranean Diet (MedDiet) and the Heart UK Ultimate Cholesterol Lowering Plan (UCLP) Menopause have on cardiometabolic risk factors and the frequency and severity of menopause symptoms? This is a randomised cross-over parallel trial of 12 weeks duration. Participants are women undergoing or having completed the menopause transition.

NCT ID: NCT05764252 Recruiting - Epilepsy Clinical Trials

A Prospective Diagnostic Belief Updating Study to verIfy the Utility of BioEP in First Seizure Clinics.

PRISTINE
Start date: August 23, 2023
Phase: N/A
Study type: Interventional

The goal of this belief updating study is to assess the utility of BioEP as a complementary support tool in aiding clinical decision making in adults in first seizure clinics. The main outcomes we shall measure are: - Clinicians' perception of seizure probability. - Clinicians' decision to recommend commencing or deferring ASM (anti-seizure medications) - Clinicians' decision to refer for additional investigations/services. Participants will consent to have their EEG (that is taken at their routine care) to be used in the study. There is not extra burden to the participants taking part in the study.

NCT ID: NCT05763121 Recruiting - Asthma Clinical Trials

A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.

EXHALE-2
Start date: January 30, 2023
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.

NCT ID: NCT05762770 Recruiting - Infertility Clinical Trials

A Trial of Sperm Injection (PICSI) on Miscarriage Rates in Assisted Conception

PICSI
Start date: March 27, 2023
Phase: N/A
Study type: Interventional

Physiological intracytoplasmic sperm injection (PICSI) is a technique used to select healthy, mature sperm for use in infertility treatment based on their physiological ability to bind to hyaluronan (HA), a natural compound found in the body. The relationship between sperm and hyaluronan can be used a marker of sperm maturity and optimal fertilising potentialÍž this principle can be observed in vitro using a PICSI sperm selection device. The PICSI Dish contains microdots of hyaluronan, which only mature sperm bind to and these are selected by the embryologist prior to use in the intracytoplasmic sperm injection (ICSI) procedure. Recurrent miscarriages following infertility treatment are mainly idiopathic, but can be linked with increased chromosomal abnormalities. PICSI has been shown to result in better embryo development and reduced chromosomal abnormalities, due to selection of mature sperm with low DNA damage. Therefore, PICSI may be a useful tool for reducing the rate of miscarriage following infertility treatment. The recent HABSelect study investigated treatment outcomes following PICSI, and whilst they concluded no effect on livebirth rate, they found a significant association in their secondary analysis between PICSI and reduced miscarriage rate compared to ICSI. The implications of the HABSelect study deserve to be explored further with miscarriage rate assessed as a primary outcome measure. This proof-of-concept randomised-controlled-trial aims to investigate whether PICSI shows some promise that would merit evaluation in a fully-powered trial to assess its efficacy as an advanced sperm selection method for the reduction of miscarriage rate. Eligible study participants will be patients undergoing fertility treatment using ICSI, who have provided consent for PICSI. Patients will be randomly allocated to two groups: the control group will receive ICSI according to standard protocol, and the intervention group will have additional sperm selection by HA-binding in a PICSI dish.