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NCT ID: NCT05047432 Recruiting - Tracheostomy Clinical Trials

Concordance of Methods to Select Tracheostomy Tube Size for Adults in Intensive Care

COMETS
Start date: November 19, 2021
Phase:
Study type: Observational

This study is part of a larger PhD project. The aim of the overall project is to provide evidence to help healthcare staff choose the best size tracheostomy breathing tube for patients in intensive care. There are no clear guidelines on how to choose the size of tracheostomy tubes currently. The aim of this part of the project is to compare methods of choosing the size tracheostomy tube for patients. Four methods are based on easily recorded physical characteristics of the participants (sex, height, Body Mass Index and shoulder width). A fifth method is based on measurement of the windpipe (trachea). We will recruit patients and staff at the Royal Free London NHS Foundation Trust. We will measure their height, weight and shoulder width, and record their age and sex. We will use ultrasound to measure each participant's trachea. We will calculate the recommended tube size using the five methods above. We will compare how well the first four methods agree with the method based on measurements of the trachea. The results of this study will inform healthcare staff how well the different ways of choosing the size of tube relate to the fit of a tube in the trachea.

NCT ID: NCT05047107 Recruiting - Multiple Myeloma Clinical Trials

Biology and Genetics of Smouldering Myeloma

COSMOS
Start date: April 15, 2021
Phase:
Study type: Observational

Observational clinical trial recruiting Smouldering Myeloma patients (SMM) or potential SMM patients. Study involves collecting blood and bone marrow samples to determine the features of the tumour genome and BM microenvironment, including immune dysfunction that are key drivers of progression from precursor conditions (MGUS and SMM) to MM.

NCT ID: NCT05046496 Recruiting - Clinical trials for Transplant Renal Artery Stenosis

Transplant Renal Artery Stenosis: Observation Versus Stenting

TRASOS
Start date: August 28, 2021
Phase: N/A
Study type: Interventional

Transplant renal artery stenosis (TRAS) is abnormal narrowing of the main blood vessel to the kidney transplant and has historically been considered a surgical complication. In heart transplantation, it has long been recognised that rejection can cause narrowing of the heart's blood vessels, and that this complication is the leading cause of heart transplant failure. It is reasonable to assume that this process may also occur in kidney transplantation, which could contribute to premature transplant failure. However, in kidney transplantation it is also likely that other factors, such as surgical factors, traditional cardiovascular risk factors and immunological factors, contribute to the development of TRAS. Given that the disease processes that cause TRAS are not fully understood, at present there is no consensus among kidney doctors on the best means of treating patients diagnosed with TRAS. The aim of the proposed study is to investigate the involvement of these different processes in the development of TRAS, and investigate the optimal way to diagnose and manage TRAS. At present, there is no standard recommendation for how to treat patients with TRAS. This is partly due to the fact that patients with TRAS may have a broad array of symptoms: Some may have no symptoms, other may have problems with high blood pressure or fluid accumulation, and others may have severe transplant dysfunction. In most transplant centres, patient TRAS and severe symptoms will undergo IADSA and a stent will be placed to open the narrowing. However, it is not clear how best to manage patients with TRAS who have mild to moderate symptoms. We propose to recruit 36 such patients to a clinical study and split them into two groups: One group to undergo IADSA with possible stent placement, and one group to be closely observed. We will then compare transplant function, and other outcomes, after one year between the two groups.

NCT ID: NCT05045430 Recruiting - Wound Clinical Trials

PMS Study to Confirm the Ongoing Safety and Performance of Silver II Non-woven Dressing in Chronic and Acute Wounds

Start date: July 13, 2022
Phase: N/A
Study type: Interventional

Post Market Surveillance Study to confirm the safety and performance of Silver II Non-Woven Dressing in Chronic and Acute Wounds

NCT ID: NCT05044598 Recruiting - Aniridia Clinical Trials

RAFT - Clinical Trial of RAFT for Aniridia Related Keratopathy

RAFT
Start date: July 28, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The RAFT trial is a first in human trial of a novel cellular therapy called RAFT-OS (Real Architecture for 3D Tissues Ocular Surface) developed and manufactured by Cells for Sight Stem Cell Therapy Research Unit at UCL institute of Ophthalmology. The aim of this seamless phase I/II single-dose, single-arm trial is to investigate if RAFT-OS is a safe and effective alternative treatment for patients with aniridia related keratopathy (ARK) in 21 patients. ARK is a complication of aniridia, which is a genetic eye condition present from birth. RAFT-OS is an artificial tissue, populated with limbal epithelial cells and stromal cells. The source of the adult limbal and stromal cells is from donated human corneas from the NHS blood and Transplant, Tissue and Eye services in Liverpool. Following a Screening visit, participants will commence 10-weeks of immune suppression therapy to prepare for the transplantation of RAFT-OS. The RAFT-OS will be transplanted into the participants worst affected eye. Following surgery, each participant will be assessed at days 1, 7, 14, 21, and 1-month for major or intermediate safety events. Participants will continue to be followed up to 12 months after transplantation and will be required to stay on the immune suppression therapy for the duration of the trial. The trial is conducted at Moorfields Eye Hospital NHS Foundation Trust (MEH), London in the United Kingdom (UK). MEH is a leading provider of eye health services in the UK and is a world-class centre of excellence for ophthalmic research and education. All trial medical assessments and procedures will be performed in an appropriate clinical setting by suitability qualified staff.

NCT ID: NCT05043714 Recruiting - Metastatic Cancer Clinical Trials

Study of NG-641 in Combination With Nivolumab in Metastatic or Advanced Epithelial Tumours

NEBULA
Start date: December 1, 2021
Phase: Phase 1
Study type: Interventional

This is a phase 1a/1b, multicentre, open-label, non-randomized study of NG-641 in combination with nivolumab (or standard of care PD-1 inhibition) in patients with metastatic or advanced epithelial tumours. The purpose is to characterize the safety and tolerability of NG-641 in combination with nivolumab in patients with metastatic or advanced epithelial tumours and to determine the recommended dose of NG-641 in combination with nivolumab for further development in patients with metastatic or advanced epithelial tumours

NCT ID: NCT05043090 Recruiting - Clinical trials for Papillary Renal Cell Carcinoma

Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC

SAMETA
Start date: October 28, 2021
Phase: Phase 3
Study type: Interventional

A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell Carcinoma).

NCT ID: NCT05039619 Recruiting - Lupus Nephritis Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants

POSTERITY
Start date: May 12, 2022
Phase: Phase 2
Study type: Interventional

This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to <12 with LN.

NCT ID: NCT05039515 Recruiting - Clinical trials for Fibrodysplasia Ossificans Progressiva

A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).

FALKON
Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by the presence of bone in soft tissue where bone normally does not exist, known as Heterotopic Ossification (HO). It is often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to abnormal stiffening and immobility (ankyloses) of major joints with cumulative and irreversible loss of movement and disability. This study will evaluate the efficacy of 2 dosing regimens of IPN60130 in inhibiting new HO volume compared with placebo (a dummy treatment) in adult and paediatric participants with FOP. It will be assessed by a scan (provides internal images of the body) called low dose Whole Body Computed Tomography (WBCT), excluding head. Adults and participants 5 years of age or older are also eligible for a sub study to evaluate HO lesions assessed by another type of scan, Fluorine-18-labelled natrium fluoride Positron Emission Tomography-Computed Tomography ([18F]NaF PET-CT ).

NCT ID: NCT05039021 Recruiting - Clinical trials for Adult Gynecological Procedures

A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices

Start date: August 16, 2021
Phase: N/A
Study type: Interventional

This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (general, gynecological, urological, and thoracic surgical procedures). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the HARMONIC 1100 Shears and Generator G11 instructions for use.