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NCT ID: NCT05688462 Recruiting - Clinical trials for TBI (Traumatic Brain Injury)

Studying Trends of Auto-Regulation in Severe Head Injury in Paediatrics

STARSHIP
Start date: July 1, 2018
Phase:
Study type: Observational [Patient Registry]

Children are known to have devastating impact from traumatic brain injury (TBI). The focus of treatment of severe TBI is to limit secondary insult which can aggravate brain injury and worsen outcome and is supported by monitoring brain pressure (ICP) and arterial pressure (ABP). These pressures, if incorporated in Multi-modality monitoring can be used to interpret state of mechanisms used by brain to maintain normal blood flow. This has been advised to guide management of severe TBI in adults, however, there is limited experience with advanced brain monitoring in children. The investigators propose to study the use of this in children with severe TBI. Children (up to 16 years of age) with a severe TBI are referred to a neurosurgical unit (NSU) and admitted to a paediatric intensive care unit (PICU) as part of usual NHS clinical practice. All patients with a severe TBI require a monitoring wire to be inserted into the brain to read the pressure inside the skull and a similar device in an artery to monitor the blood pressure. These recordings are documented by a PICU nurse at a prescribed frequency. Without interrupting this clinical practice investigators propose to record these values using computer software called ICM+. These recordings will provide real time analysis and a continual recording of important parameters which will provide the study with much needed information on the patterns of pressures in the brain after this injury in children. All patients will be followed up for 12 months to see how well they recover, neuropsychology assessment will be performed by a Neuropsychologist at the recruiting centre using a standardised form.

NCT ID: NCT05688280 Recruiting - Colon Cancer Clinical Trials

Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS

INJECTABL-1
Start date: November 29, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to determine the safety and efficacy of IP-001 for intratumoral injection administration following thermal ablation of a solid tumor.

NCT ID: NCT05687643 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Shear Load In-shoe Plantar Sensing/Strain Analyses and Mapping in Diabetic Foot Ulcers

SLIPSTREAM
Start date: July 1, 2022
Phase:
Study type: Observational

Stain Analysis Mapping of the Plantar surface (STAMP) is a method designed by the University of Leeds to measure 'in-shoe' strain patterns on the plantar surface of the foot. Shear Load Inductive Plantar Sensing (SLIPS) is an insole designed by the University of Leeds to measure plantar shear stress and plantar pressure. This study aims to compare plantar strain using STAMP and plantar shear stress and plantar pressure using SLIPS in two groups of patients with diabetes; high risk patients with a recently healed plantar ulcer and low risk patients (according to the NICE definition).

NCT ID: NCT05687266 Recruiting - NSCLC Clinical Trials

Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

AVANZAR
Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).

NCT ID: NCT05686993 Active, not recruiting - Clinical trials for Primary Aldosteronism

Effect of a Proposed Cav1.3 Inhibitor in Primary Aldosteronism

Start date: May 5, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot, open-label prospective study is to evaluate if the effect of calcium channel blockade on plasma aldosterone levels in people with primary aldosteronism (PA) is due primarily to Cav1.3 blockade. This will be tested by treating participants who have PA with both cinnarizine (Cav1.3 blocker) and nifedipine (Cav1.2 blocker) and evaluating effect on aldosterone levels and blood pressure over a two week course of treatment.

NCT ID: NCT05686941 Recruiting - Clinical trials for Vocal Cord Dysfunction

Is Laryngeal Ultrasound Useful in the Assessment for ILO? A Protocol for a Two-stage Exploratory Pilot Study

Start date: August 24, 2022
Phase:
Study type: Observational

This study is a feasibility study to see if an ultrasound scan of the vocal cords can detect narrowing of the vocal cords as seen in a condition called inducible laryngeal Obstruction (the vocal cords narrow or close on breathing in, which makes it very difficult to breathe).

NCT ID: NCT05686824 Completed - Clinical trials for Retention/Attrition of Midwives

Midwifery Retention Project

Start date: April 1, 2023
Phase:
Study type: Observational

The NHS is experiencing a significant workforce crisis across the service; with currently >130, 000 vacancies, therefore, national efforts to improve recruitment and retention are a priority. In maternity services, there are currently 2,500 WTE midwife vacancies and over three-quarters of Heads of Midwifery cite it is 'increasingly difficult' to fill these vacancies . A vital component of a sustainable workforce and safe maternity care is retaining newly qualified midwives (where attrition is currently high) and experienced midwives already working within the service. However, data repeatedly demonstrate dissatisfaction and intentions to leave the midwifery profession. Recognising the importance of retention, NSHEI allocated a one-off lump sum of £50,000 to each hospital Trust to specifically employ midwives to support retention efforts. However, to date, research has not captured contemporary midwifery attrition and retention insights with this role in place. Therefore, the purpose of this study is to capture, analyse and disseminate localised data from one NHS Trust to inform future local, regional and national retention projects. Specifically, this study aims to explore the views of midwives and student midwives at Torbay and South Devon NHS Foundation Trust regarding intentions to stay or leave either their current workplace and/or the profession. These subtle but salient differences are important as some may prefer to work elsewhere but remain in midwifery, conversely, others may be satisfied with their workplace but intend to leave the profession. We will also gather insights regarding the retention midwife role, their work to date and potential impact. We will gather the data via documentary review, a survey aimed at midwives and student midwives and 10-15 individual interviews. Using these insights, we will identify recommendations for the local, regional and national workstreams to inform future retention work.

NCT ID: NCT05686551 Recruiting - Huntington Disease Clinical Trials

GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington's Disease.

Start date: February 3, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease.

NCT ID: NCT05686070 Recruiting - Clinical trials for Acute Non-cardioembolic Ischemic Stroke

A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic Stroke or After a High-risk Transient Ischemic Attack, a So-called Mini Stroke

OCEANIC-STROKE
Start date: January 26, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had: - an acute stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or - TIA/mini-stroke with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Acute ischemic strokes or TIA/mini-stroke result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together. Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting). The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care without increasing the risk of bleeding. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or TIA/mini-stroke when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health. Dependent on the treatment group, the participants will either take asundexian or placebo once a day for at least 3 months up to 31 months. Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned. During the study, the study team will: - Check vital signs such as blood pressure and heart rate - Examine the participants' heart health using an electrocardiogram (ECG) - Take blood samples - Ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.

NCT ID: NCT05685810 Active, not recruiting - Obesity Clinical Trials

Genetic Determinants of Kidney Disease in People of African Ancestry With HIV

GEN-AFRICA
Start date: May 1, 2018
Phase:
Study type: Observational [Patient Registry]

Black ethnicity is a major risk factor for chronic kidney disease [CKD] in people with HIV infection, suggesting that genetic factors are an important determinant of kidney disease progression in this population. The Gen-Africa study was established in 2018 to allow the study of genetic and clinical risk factors for CKD in people with HIV in the UK. Just over 3000 people across 15 sites were enrolled between May 2018 and January 2020. Demographic and clinical information was collected, and biological samples (buffy coats, plasma and urine) obtained. Cross-sectional analyses have revealed that participants of West-African ancestry are at higher risk of CKD and end-stage kidney disease [ESKD], and that genetic variants in the apolipoprotein L1 (APOL1) gene and sickle cell trait (SCT) are predictors of CKD and ESKD. The pathogenesis of APOL1- and SCT-associated CKD is incompletely understood, and additional, longitudinal data will be collected to improve understanding of the contribution of demographic, traditional CKD (diabetes, hypertension, obesity/metabolic syndrome, cardiovascular disease) and HIV (immuno-virological and hepatitis B/C co-infection status, antiretroviral medications) risk factors as well as additional genetic and epigenetic markers.