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NCT ID: NCT04382131 Recruiting - COVID Clinical Trials

Hypertonic Saline Nasal Irrigation and Gargling in Suspected or Confirmed COVID-19 (ELVIS COVID-19)

Start date: June 23, 2020
Phase: N/A
Study type: Interventional

ELVIS COVID-19 is a pragmatic web-based Bayesian adaptive randomised controlled, parallel group trial of hypertonic saline nasal irrigation and gargling (HSNIG) compared to standard care in participants with clinically suspected or confirmed COVID-19 being managed at home.

NCT ID: NCT04381936 Recruiting - Clinical trials for Severe Acute Respiratory Syndrome

Randomised Evaluation of COVID-19 Therapy

RECOVERY
Start date: March 19, 2020
Phase: Phase 3
Study type: Interventional

RECOVERY is a randomised trial of treatments to prevent death in patients hospitalised with pneumonia. The treatments being investigated are: COVID-19: Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Colchicine, IV Immunoglobulin (children only), Convalescent plasma, Casirivimab+Imdevimab, Tocilizumab, Aspirin, Baricitinib, Empagliflozin, Sotrovimab, Molnupiravir, Paxlovid or Anakinra (children only) Influenza: Baloxavir marboxil, Oseltamivir, Low-dose corticosteroids - Dexamethasone Community-acquired pneumonia: Low-dose corticosteroids - Dexamethasone

NCT ID: NCT04381078 Recruiting - Clinical trials for Cleft Lip and Palate

Methods of Providing Information Prior to an Alveolar Bone Graft

Start date: December 9, 2020
Phase: N/A
Study type: Interventional

Patients born with a cleft of the lip and/or palate may have a gap in the bone in the roof of their mouth and in the area of bone where the teeth develop. These patients require an alveolar bone graft (ABG) to allow the eruption of the maxillary canine teeth amongst other reasons. The optimal time to carry this out is between the ages of nine and eleven. Whilst the patients will have had interventions as infants, this is often the first procedure a child born with a cleft lip and/or palate is likely to comprehend. An audio-visual guide has been developed by the Great Ormond Street Hospital Dental Department for children undergoing an ABG. It explains the reason for the procedure, what the process will involve and advice regarding postoperative care. This study will try ascertain whether providing information to patients and parents in this manner reduces anxiety, improves understanding of why the procedure was undertaken and post-operative care. Children between the ages of eight and twelve ready for this procedure at Great Ormond Street Hospital will be enrolled. They will be allocated into two groups during their assessment appointment. The control will be given standardised verbal and written information, whilst the experimental group will also be given the animation. The level of anxiety and understanding of the procedure will be measured after the intervention/control information and once again when the patient attends for their pre-surgical assessment two to three months later. This study aims to see whether the patient and parent anxiety is reduced and knowledge regarding the procedure is improved when utilising this of kind audio-visual guide for children. This will indicate whether it is worthwhile committing resources to the development of similar animations for other procedures.

NCT ID: NCT04380350 Recruiting - Clinical trials for Intracranial Aneurysm

Trenza Embolization Device for Intrasaccular Aneurysm Treatment

Start date: December 17, 2020
Phase:
Study type: Observational

The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.

NCT ID: NCT04379596 Recruiting - Gastric Cancer Clinical Trials

Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)

DG-03
Start date: June 3, 2020
Phase: Phase 2
Study type: Interventional

DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients. Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or immunotherapy administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing. T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered to HER2-expressing gastric, GEJ and esophageal cancer patients who have not received prior treatment for advanced/metastatic disease will show preliminary evidence of anti-tumour activity and the potential to become a therapeutic option for this patient population.

NCT ID: NCT04376151 Recruiting - Clinical trials for Autism Spectrum Disorder (ASD)

Guided ACT and for Adults With ASD

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

This study aims to investigate the efficacy of guided self-help Acceptance Commitment Therapy (ACT) for adults who have a diagnosis for Autistic Spectrum Disorder (ASD) and are experiencing psychological distress (stress, anxiety or depression). This is a repeated measures design, using a single case experimental design (SCED) over a period of fourteen weeks. Each participant (n=8) with be asked to complete weekly measures and shortened measures every three days, while they read an ACT guided self-help bibliotherapy. For more information about the measures, please see outcome measure section. The ACT guided bibliotherapy will be administered to each participant on a weekly basis, over eight weeks. Participants will be asked to complete outcome measures at two week and at four weeks post intervention.

NCT ID: NCT04373668 Recruiting - Dementia Clinical Trials

NightCAP: Reducing Hypnotic Drug Use and Improving Night-time Care

NightCAP
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Dementia is a devastating condition characterised by progressive loss of cognition leading to loss of independence and eventually death. One major unmet need, which remains a critical challenge for care provision, is the management of night-time care and sleep-related symptoms in people with dementia living in care homes. The causes and impacts of sleep disturbances in people with dementia in care homes are complex and multi-faceted, indicating the need of a whole-systems approach to the issue. It will require a tailored, person-centred approach which accounts for the environmental, personal and clinical factors contributing to the symptoms. The aim of this study is to evaluate the NightCAP intervention to improve treatment of sleep disturbance in people with dementia in care homes, with the goal of reducing sleep disturbance behaviour and reducing the use of hypnotic drugs. This will provide robust evidence to support guidance on night time care and improving hypnotic drug prescribing, both of which are major unmet needs in the care of people with dementia.

NCT ID: NCT04372953 Recruiting - Preterm Birth Clinical Trials

Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).

POLAR
Start date: May 4, 2021
Phase: N/A
Study type: Interventional

Premature babies often need help immediately after birth to open their lungs to air, start breathing and keep their hearts beating. Opening their lungs can be difficult, and once open the under-developed lungs of premature babies will often collapse again between each breath. To prevent this nearly all premature babies receive some form of mechanical respiratory support to aid breathing. Common to all types of respiratory support is the delivery of a treatment called positive end-expiratory pressure, or PEEP. PEEP gives air, or a mixture of air and oxygen, to the lung between each breath to keep the lungs open and stop them collapsing. Currently, clinicians do not have enough evidence on the right amount, or level, of PEEP to give at birth. As a result, doctors around the world give different amounts (or levels) of PEEP to premature babies at birth. In this study, the Investigators will look at 2 different approaches to PEEP to help premature babies during their first breaths at birth. At the moment, the Investigators do not know if one is better than the other. One is to give the same PEEP level to the lungs. The others is to give a high PEEP level at birth when the lungs are hardest to open and then decrease the PEEP later once the lungs are opened and the baby is breathing. Very premature babies have a risk of long-term lung disease (chronic lung disease). The more breathing support a premature baby needs, the more likely the risk of developing chronic lung disease. The Investigators want to find out whether one method of opening the baby's lungs at birth results in them needing less breathing support. This research has been initiated by a group of doctors from Australia, the Netherlands and the USA, all who look after premature babies.

NCT ID: NCT04370769 Recruiting - Pregnancy Related Clinical Trials

PREDICT: Thinking About Pregnancy Risk in Women With Kidney Disease

PREDICT_RP
Start date: October 16, 2020
Phase:
Study type: Observational

Currently, there is no robust evidence about how women with Chronic Kidney Disease (CKD) perceive pregnancy risk. The aims of this research are to understand women with CKD's perception of risk in pregnancy. In order to provide appropriate pre-pregnancy and antenatal counselling including accurate presentation of risk of pregnancy outcomes, it is important to establish how do women with CKD perceive their risk in pregnancy. In addition, to facilitate discussion about pregnancy for women with CKD, it is critical to understand key psychosocial factors influencing their risk perceptions. This study will be conducted in two phases. In phase one, risk perceptions in women with CKD who are contemplating pregnancy will be quantitatively measured with potential influencing psychosocial factors including their illness perceptions, quality of life, anxiety, depression and perceived social support. Demographic, pregnancy-intentions, medical and pregnancy histories will also be collected. Phase one findings will establish to what extent do women with CKD perceive their pregnancy risk. In phase two, perception of risk, pregnancy intention and behaviour, will be qualitatively explored in women with CKD who perceive high and low degrees of risk. This sub-study will facilitate understanding about which factors and experiences impact risk perception and their relationship with pregnancy intentions and behaviour.

NCT ID: NCT04370366 Recruiting - Meniere Disease Clinical Trials

Imaging of Endolymphatic Hydrops at 7T MRI

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

Imaging endolymphatic hydrops with 7T Sodium Imaging and 1.5 T gadolinium enhanced imaging: a comparison of diagnostic outcomes with 3T MRI Duration of study 24 months Study design Prospective cohort study Number of patients 16 patients 1. To evaluate whether imaging both 1.5T and 3T have an equivalent performance in terms of diagnosing MD ears with delayed post gadolinium enhanced MRI (applying quantitative and semi-quantitative analysis) 2. To compare the diagnostic performance of Sodium Imaging at 7T (applying semi-quantitative analysis) with that of delayed post gadolinium enhanced 3T MRI in distinguishing symptomatic from asymptomatic Meniere's Disease (MD) ears.