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NCT ID: NCT04732026 Recruiting - Clinical trials for Group B Strep Infection

Serocorrelate of Protection Against GBS (PREPARE WP3)

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

A multicentre, international case-control study to develop a biobank of sera from 150 cases of serotype III GBS disease and associated clinical information from seven countries (Malawi, Uganda, UK, the Netherlands, Italy and France), with 3:1 (450) serotype matched healthy controls.

NCT ID: NCT04730336 Recruiting - Dry Eye Clinical Trials

Assessing the Impact of Tixel Treatment of Periorbital Wrinkles on Dry Eye Symptoms and Signs

Start date: August 9, 2019
Phase: N/A
Study type: Interventional

Pilot study where effect of standard Tixel treatment as used for periorbital wrinkles would be assessed on Dry Eye Disease symptoms and signs

NCT ID: NCT04729777 Recruiting - Clinical trials for Pulmonary Hypertension

Assessment of Cardiac Function Using Combined Cardiovascular Magnetic Resonance and Cardiopulmonary Exercise Testing (CMR-CPET)

CMR-CPET
Start date: March 1, 2019
Phase:
Study type: Observational

What problems limit patients' response to exercise? Using exercise cardiac magnetic resonance imaging to assess the heart's response, with simultaneous measurement of respiratory oxygen and carbon dioxide levels to assess the lung and skeletal muscle responses, to identify the rate-limiting factors affecting different types of patient

NCT ID: NCT04728893 Recruiting - Clinical trials for Hematologic Malignancies

Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

Start date: April 5, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).

NCT ID: NCT04727437 Recruiting - Clinical trials for Subsegmental Pulmonary Embolism Nos

STOPping Anticoagulation for Isolated or Incidental Subsegmental Pulmonary Embolism

STOPAPE
Start date: April 8, 2021
Phase: Phase 3
Study type: Interventional

Pulmonary embolisms (PE) occur when blood clots cause a blockage of the blood supply to the lungs. A small PE located in the subsegmental pulmonary vasculature is identified as a subsegmental PE (SSPE). Anticoagulants are used to treat SSPE and work by preventing new clots from forming whilst the body's own mechanisms break down the clots, however they can also increase the risk of major and potentially life threatening bleeding. More recent observational data of routine care for SSPE showed very high complication rates of anticoagulation but in patients where treatment was withheld, this proved to be a safe strategy in terms of recurrent venous thromboembolism (VTE). Computed tomography pulmonary angiography (CTPA) scans are now able to detect SSPE, however there are concerns that there is an over-diagnosis due to the incorrect interpretation of small artefacts. 1466 patients from approximately 50 sites will be recruited, these sites will consist of hospitals across the United Kingdom (UK). Patients 18 and over with isolated SSPE, confirmed by either CTPA or CT thorax with IV contrast, will be eligible for the trial. Patients will be randomised to either receive standard anticoagulation for at least 3 months (control) or no anticoagulation for at least 3 months (intervention). The participant will receive telephone follow up calls at 4, 12 and 24 weeks following the end of their treatment, and additional data will also be taken from their medical records at these time points. The participant isn't required to be contacted for the 52 week follow up as the data will be extracted from the National Health Service (NHS) Digital collection of Hospital Episode Statistics (HES). In total participation in the study will last 12 months. In addition the cost-effectiveness of no treatment versus treatment with full anticoagulation will be looked at and also improving on radiological diagnosis of SSPE.

NCT ID: NCT04726137 Recruiting - Clinical trials for Sars-Cov2 Antibodies in Children and Adolescents Living With HIV

European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) SARS-CoV-2 Antibody Study Protocol. Covid-19

SARS-Cov2
Start date: October 14, 2020
Phase:
Study type: Observational

Scientific knowledge about the COVID-19 pandemic and the virus that is causing it (SARS-CoV-2) is developing rapidly, and the investigators have a clearer idea of the population groups who are at higher risk of becoming infected, having serious illness, and dying. However, less is known about COVID-19 in children, adolescents and young adults living with HIV. It is not yet known whether, or how, HIV affects people's risk of being infected with the virus or becoming ill. This study aims to find out whether children and adolescents living with HIV have had the COVID-19 virus, even if they did not have symptoms and did not realise it at the time. When a person is infected with a virus, their immune system fights the infection. As a result, they produce proteins called antibodies, and it may take a few weeks for enough antibodies to be made to be detected by a blood test. These antibodies may help protect the person from getting the same infection again. This study wants to find out how many children and adolescents living with HIV across Europe and South Africa have antibodies to the COVID-19 virus. It wants to see if the proportion with antibodies is different in younger children compared to older adolescents and young adults, and whether it varies between different countries. Children and adolescents with HIV regularly attend hospital outpatient appointments, and during these appointments blood samples may be taken to monitor their health. This study will invite these patients to be tested for antibodies to the COVID-19 virus during their routine visit. The participants will be asked a few short questions about COVID-19 diagnoses in their household and other risk factors for exposure to the virus, and it will collect information on their HIV, medications and any other illnesses they may have. At their next routine clinic visit, approximately 6 months later, it will test them again for antibodies. Testing twice will let see how the percentage of children, adolescents and young adults with antibodies to the COVID-19 virus has changed over time. In South Africa, HIV-uninfected adolescents from a similar socioeconomic background to those living with HIV and recruited to the study will be invited to join this study, which will allow us to compare the prevalence of antibodies across the two groups. The information from this study will help scientists and healthcare workers care for children, adolescents and young adults living with HIV during the ongoing COVID-19 epidemic in the best possible way. Participants may be given their test results, together with information about what the result means, depending on the usual practice within their clinic.

NCT ID: NCT04724889 Recruiting - Stroke Clinical Trials

Predictors of Atrial Fibrillation in Patients Undergoing Implantable Loop Recorder Implant

Start date: August 1, 2019
Phase:
Study type: Observational

Implantable Loop Recorders (ILR) are small devices the size of a memory stick, which are implanted to investigate stroke, palpitations and fainting episodes. They monitor the heart constantly and detect abnormalities such as slow or fast heart beats and an irregular heartbeat called Atrial Fibrillation (AF). Stroke is a life threatening condition and no cause is identified for over 30% of strokes. AF is a predominant risk factor for stroke. About 30% of patients with stroke are found to have AF when they are monitored with an ILR. Unfortunately not every patient with a stroke can have an ILR; one of the prohibiting factors is cost. Therefore, there is an urgent unmet clinical need to rationalise the use of ILRs and prioritise their implantation in those patients that have most to gain and therefore achieving cost-effectiveness and improving patient care. In order to achieve the above, identifying parameters that can predict the presence of underlying AF is very important. Studies have shown that special factors including patient's other medical problems, family history, factors on paper recording of the electrical activity of the heart, heart monitors and ultrasound scan of the heart can be useful in predicting AF. Also certain blood molecules have been investigated as potential predictors of AF. The aim of this study is to look at all the above factors and combine them in order to determine whether these factors can predict the presence of AF. Identify predictors of AF will allow doctors to identify patients at different risk of having AF and use the ILR in all possible patients that might need it.

NCT ID: NCT04723836 Recruiting - Pregnancy Clinical Trials

Optimal Nutrition for Prevention of Hypertension in Pregnancy

OptiPREG
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the role of the 677C→T polymorphism in the methylenetetrahydrofolate reductase (MTHFR) gene on blood pressure (BP) during pregnancy, and to examine the effect of intervention with riboflavin, alone or in combination with 5-methyltetrahydrofolate (5-MTHF), as a non-drug approach for managing BP in pregnancy in women with the variant TT genotype. In addition, we aim to examine the effect of maternal supplementation with riboflavin, alone or combined with 5-MTHF, on BP in the offspring in early infancy. Study design: A double-blind randomized controlled trial in pregnant women will be conducted. Women with a singleton pregnancy who are in their first trimester will be recruited from antenatal clinics in Northern Ireland and the Republic of Ireland. Women interested in the study will provide informed consent, complete a screening questionnaire and will provide a buccal swab to collect DNA to screen for the MTHFR 677C→T polymorphism. Women with multiple pregnancies, a previous NTD-affected pregnancy and those who are taking medication interfering with B-vitamin metabolism will be excluded from participation in the study. At approximately the 16th gestational week (GW), those with the variant TT genotype and age-matched heterozygous women (CT genotype) will be randomised to receive riboflavin (5 mg/day) alone, or in combination with 5-MTHF (400µg/day), or placebo, until the end of pregnancy. A non-fasting blood sample will be collected for biomarker assessment of B-vitamin status and other relevant variables from each participant before intervention and at the 36th GW. At the same time points, anthropometric and BP measurements will be taken. Women will also complete a health and lifestyle questionnaire and a 4-day dietary record. Samples of cord blood, umbilical cord and placenta will be collected after delivery and anthropometric parameters of the newborns will be retrieved postpartum. Maternal and infant BP will be measured 2-4 months after birth. In parallel with the intervention trial, age-matched pregnant women who do not carry the variant gene (CC genotype) and have not been randomized to treatment, will be monitored in order to control for any changes associated with normal pregnancy in the study outcome measurements. In the pilot phase, the feasibility and acceptability of the study procedures and treatment will be evaluated for clarification of the sample size and refinement of the study protocol.

NCT ID: NCT04723316 Recruiting - Cancer Clinical Trials

Tumour Characterisation to Guide Experimental Targeted Therapy - National

Start date: June 30, 2021
Phase:
Study type: Observational

The primary aim of TARGET National is to establish a national framework to offer molecular profiling of circulating tumour DNA and/or tumour tissue (optional) to patients with advanced solid cancers referred to any of the Experimental Cancer Medicine Centres (ECMCs) across the UK, in order to help decision making for allocation to molecularly targeted experimental cancer treatments. Patients will be allocated treatment using a national Molecular Tumour Board to find the most suited therapies based on their molecular profiling results. This study aims to recruit up to 6,000 patients with advanced solid tumours across 5 years and proposes to collect blood samples, archival tumour tissue and fresh tissue (optional) The data may also be used for future development of predictive cancer biological markers, the design of clinical trials involving new or existing drugs, discovery of new genetic targets and exploring how resistance to specific anticancer agents arises in patients to help improve future cancer treatment management.

NCT ID: NCT04722237 Recruiting - Quality of Life Clinical Trials

Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing

ACT NOW
Start date: March 18, 2021
Phase: N/A
Study type: Interventional

Background. Survivors of childhood brain tumours have the poorest health-related quality of life of all cancer survivors due to the multiple physical and psychological sequelae of brain tumours and their treatment. Remotely delivered Acceptance and Commitment Therapy (ACT) may be a suitable and accessible psychological intervention to support young people who have survived brain tumours. Aims. This study aims to assess the feasibility and acceptability of remotely delivered ACT to improve quality of life among young brain tumour survivors. Method. This study is a two-arm, parallel group, randomised controlled trial comparing ACT with waitlist control. Participants will be aged 11-24 years and survivors of brain tumours who have completed cancer treatment. Participants will be randomised to receive 12 weeks of ACT either immediately or after a 12-week wait. The durability of treatment effects will be assessed by further follow-up assessments at 24-, 36- and 48- weeks. The DNA-v model of ACT will be employed, which is a developmentally appropriate model for young people. Feasibility will be assessed using the proportion of those showing interest who consent to the trial and complete the intervention. A range of clinical outcome measures will also assess physical and mental health, everyday functioning, quality of life and service usage. Acceptability will be assessed using participant evaluations of the intervention, alongside qualitative interviews and treatment diaries analysed thematically. Discussion. This study will provide an initial assessment of the value of remotely delivered ACT in supporting recovery and coping for young people after brain tumour treatment.