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NCT ID: NCT04351698 Recruiting - Anemia, Sickle Cell Clinical Trials

SMILES: Study of Montelukast in Sickle Cell Disease

SMILES
Start date: October 16, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Sickle cell disease (SCD) is a genetic blood condition causing long term health problems including pain and brain problems which affect quality of life. These may be made worse if patients have low night-time oxygen levels when the upper airways close repeatedly during the night (obstructive sleep apnoea). This is associated with increased pain, poorer concentration and increased kidney problems. Montelukast, widely used in the treatment of Asthma, has been shown to improve symptoms of obstructive sleep apnoea in patients without sickle cell anaemia. Investigators think this treatment could be useful in patients with sickle cell disease too. Early intervention with Montelukast could help prevent deterioration in concentration and thinking skills. The aim of this trial is to see whether young children with sickle cell disease randomised (randomise: the same as tossing a coin and not knowing whether it will come up heads or tails) to Montelukast treatment have better thinking skills compared with people randomised to placebo (tablet with no active medical ingredients - i.e. "sugar pill"). This means that the child could be on Montelukast treatment or he/she might be on placebo tablets.

NCT ID: NCT04351555 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

NeoADAURA
Start date: December 16, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer

NCT ID: NCT04350294 Recruiting - Clinical trials for Mental Disorders, Severe

Measuring Development of Brain Responses to Vocal Sounds in Babies of Mums With Mental Illness

CAPRI-Voc
Start date: September 1, 2017
Phase:
Study type: Observational

CAPRI-Voc examines the differences in how speech and environmental sounds are processed in the infant brain as they grow from 9 to 12 months. The main aim of our research is to see whether serious mental illness or other factors influence this development in children. This means we are looking for new mums and their infants who have not experienced mental illness.

NCT ID: NCT04342143 Recruiting - Stroke Clinical Trials

Reliability and Validity of the Vicorder Device When Measuring Pulse Wave Velocity Within Chronic Stroke Patients

Start date: March 1, 2020
Phase:
Study type: Observational

Stroke is a major global health problem and main cause of disability worldwide. Blood pressure control is important for good health in stroke patients. Measuring central blood pressure (the blood pressure which is found in the heart) and measuring the stiffness of your arteries will give practitioners, clinicians and researcher's important information over and above what is usually obtained from peripheral blood pressure in the arm. The most validated and most recognisable equipment for central blood pressure and arterial stiffness is the SphygmoCor XCEL. However, the Doppler Ultrasound is used more often in population-based studies and has been shown to be a precise and accurate measurement. Although these devices are validated, they both require a highly skilled operator and are quite time-consuming. As such, it is important to explore less operator dependent and time consuming devices, such as the Vicorder, as this could be essential for researchers and clinicians.Therefore, this study will investigate whether the Vicorder device is valid and reliable when measuring these outcomes and if so could be implemented in large research studies and potenially be used by clinicians.

NCT ID: NCT04338776 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

Comparing UroLift Experience Against Rezūm

CLEAR
Start date: January 22, 2021
Phase: N/A
Study type: Interventional

C.L.E.A.R. Study is poised to compare the patient experience post procedure, including catheterization needs as well as retreatment and BPH medication rates following treatment with either the UroLift® System or Rezūm™ System through 12 months.

NCT ID: NCT04337450 Recruiting - HIV Infections Clinical Trials

DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children With HIV Infection Aged 2 to <15 Years Old

D3 (Penta21)
Start date: April 22, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to find out whether treating children and young people living with HIV with two anti HIV medicines, dolutegravir and lamivudine, is safe and as effective as the three-medicine anti-HIV treatments currently used in routine practice.

NCT ID: NCT04337151 Recruiting - MAGEC Rod Clinical Trials

Blood Titanium Analysis of Patients With MAGEC Spine Rods in the COVID-19 Environment

Start date: April 2020
Phase:
Study type: Observational

Magnetic Expansion Control (MAGEC) growth rods are used in the surgical treatment of children with scoliosis; the primary constituent metal alloy in these is titanium. Since June 2019, the manufacturer has released two Urgent Field Safety Notices (FSN) relating to known issues with the function of the rods that increase the risk of early failure and unplanned revisions. The UK MHRA has issued two similar Medical Device Alerts (MDA) with the most recent MDA issued on 1st April 2020, stating that (1) MAGEC rods must not be implanted in the UK until further notice and (2) all patients already implanted with this device should be followed up as soon as is possible. At the time of writing, hospitals across the world are facing incredible challenges in dealing with the COVID-19 pandemic. Due to this, virtually all planned clinic visits for MAGEC rod patients and X-ray appointments have been postponed to help reduce the risk of the virus spreading. Recent retrieval studies have shown that mechanical wear and corrosion of these rods is common, with a risk that the debris generated is released into surrounding tissue. This wear and corrosion is thought to be the primary cause of implant failures and the underlying implant factors leading to the issuing of FSNs and MDAs. Whilst titanium is known to be highly biocompatible, the baseline and toxic levels of this alloy in biological fluids are poorly understood. Additionally, a better understanding of blood titanium levels in patients with MAGEC rods may enable this to become a biomarker of wear and corrosion of the rods. This may help surgeons identify earlier those patients who may develop implant related problems. Furthermore, in the current COVID-19 environment, a blood test to measure titanium levels may be one of the most suitable ways in which to continue patient monitoring (and identify those at greatest risk of implant related issues), in the absence of regular clinic visits. Previous work from the RNOH involved a similar study investigating patients with titanium hip implants.

NCT ID: NCT04336722 Recruiting - Biliary Atresia Clinical Trials

Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

Start date: July 8, 2020
Phase: Phase 3
Study type: Interventional

Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.

NCT ID: NCT04336241 Recruiting - Cancer Clinical Trials

Study of RP2 Monotherapy and RP2 in Combination With Nivolumab in Patients With Solid Tumors

Start date: October 17, 2019
Phase: Phase 1
Study type: Interventional

RP2-001-18 is a Phase 1, multicenter, open label, single agent dose escalation and combination treatment study of RP2 in adult subjects with advanced solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

NCT ID: NCT04335032 Recruiting - SARS-CoV-2 Clinical Trials

EPA-FFA to Treat Hospitalised Patients With COVID-19 (SARS-CoV-2)

Start date: January 8, 2021
Phase: Phase 3
Study type: Interventional

This is an double-blind, randomized, placebo controlled phase III study in hospitalized subjects with confirmed SARS-CoV-2.