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NCT ID: NCT06064643 Recruiting - Clinical trials for Von Willebrand Diseases

The Lived Experience of People With Von Willebrand Disease

VWD360
Start date: December 8, 2023
Phase:
Study type: Observational

von Willebrand disease (vWD) is reported to be the most common bleeding disorder, with prevalence estimated at 1% of the general population. Despite this, little is known about its natural history, or of the impact it has on affected individuals and their families. The Haemnet vWD360 programme is a mixed-methods, natural history study designed to gain a greater understanding of vWD and its impact on individuals and their families. It comprises both qualitative and quantitative approaches and is designed to include the perspectives of individuals with a diagnosis of any subtype of vWD. The vWD360 study includes three components: - Quantitative cross-sectional survey - Qualitative one-to-one interviews with affected individuals - 30-day bleed diary.

NCT ID: NCT06064474 Completed - Anxiety Clinical Trials

Effects of High Ventilation Breathwork With Retention (HVBR) on Health

Start date: October 13, 2023
Phase: N/A
Study type: Interventional

The investigators are conducting a randomised-controlled trial comparing high ventilation breathwork with retention (HVBR) to a breathwork placebo (paced breathing at 15breaths/min with brief retentions). The metric of 15b/min aligns with guidance from the British Journal of Nursing, Royal College of Physicians and Johns Hopkins Medicine which state that the average, healthy rate should range from: 12-20, 12-18 and 12-16b/min, respectively. The main questions the study attempts to address are: Does HVBR lead to improved state and trait mental health and wellbeing in a general population adult sample? The study will be conducted entirely online through the research platform Prolific, so participant data will be anonymous. The investigators will collect self-reports of mental health and wellbeing before and after the three-week breathwork period, in addition to a follow-up three weeks later. Pre-post intervention and follow-up questionnaires will be completed online via the survey platform Qualtrics which will be linked to Prolific. Data on self-reported adherence to, and credibility/expectancy of, the breathwork will also be collected, along with participants' experiences to gauge the safety and tolerability of the breathwork protocol.

NCT ID: NCT06064461 Not yet recruiting - Myasthenia Gravis Clinical Trials

Vitaccess Real MG Registry

VRMG
Start date: March 2024
Phase:
Study type: Observational

Vitaccess Real MG (VRMG) is a patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life (QoL). The duration of the registry is 10 years from launch, and approximately 600 patients will be recruited in the US and Europe with no defined upper limit. The registry will link relevant patient- and healthcare professional (HCP)-reported data with clinical data from medical records. Patients will be recruited at clinical sites in all participating countries. In the US only, patients can additionally be recruited via community neurologists or direct-to-patient recruitment.

NCT ID: NCT06063967 Recruiting - Crohn's Disease Clinical Trials

A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants. Risankizumab is an approved drug for adults with CD. This study comprises of a Period A and a Period B. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally. Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B. The duration of the study will be approximately 49 weeks.

NCT ID: NCT06063863 Completed - Clinical trials for Retinopathy of Prematurity

Feasibility of Nurse-led Retinal Imaging for Retinopathy of Prematurity Screening Employing the Optos California

N_ORS
Start date: May 10, 2021
Phase: N/A
Study type: Interventional

Retinopathy of prematurity (ROP) is a preventable cause of blindness in babies who are born early i.e. premature. Internationally, there is a shortage of skilled ophthalmologists willing and able to screen for ROP. Even in the UK, not all hospitals have skilled ophthalmologists and premature babies have to travel to other hospitals, often long distances, to have their eyes examined. As a missed examination can lead to sight loss, this is a burden for families and carers of premature babies. To fill this gap, previous studies have explored the use of non-ophthalmologists healthcare workers to increase the workforce screening for ROP. Recently, the Optos ultra-widefield retinal-imaging device (Optos PLC, Dunfermline, Scotland, UK) has been used to help document different stages of ROP in infants. This specialised retinal imaging system uses an internal ellipsoid mirror to capture fundal imaging angles of up to 200 degrees, or more than 80% of the entire retina, in a single image. A single retinal image can be acquired in a quarter of a second and is automatically captured when the infant's pupils are aligned with the Optos imaging device. No contact with the eye is necessary to capture an image of the retina. To date, there are no studies that have validated the Optos as a nurse-led screening tool for ROP. This is a prospective study to determine and validate the feasibility of neonatal nurse-led retinal imagers for ROP screening employing the Optos imaging device. The main purpose of this study will be to test if it is possible for trained nurses to take good images of the back of babies eyes (retina) and if these images can be used by remotely placed ophthalmologists to diagnose and grade ROP. The investigators will compare how good the diagnosis and grading done using Optos images are compared to the current gold standard method (BIO). The investigators will also test how much agreement there is between ophthalmologists in interpreting Optos images by asking two ophthalmologists to grade the images.

NCT ID: NCT06063824 Not yet recruiting - Mental Health Clinical Trials

Feasibility & Acceptability of One-Session MOL Therapy in Primary Care

FAOMTPC
Start date: October 2023
Phase: N/A
Study type: Interventional

People sometimes wait a long time for psychological therapy and could have this sooner if they had only one session. This is because they may only require one session to meet their needs if this is provided quickly (Cannistrà et al., 2020) and may therefore require less therapy overall, and if they can access this, then services can run more efficiently, and overall capacity of services to offer therapy can increase. Some therapies are hard to deliver in one session. But the method of levels (MOL) was conceived to be highly flexible with respect to session length and number of sessions, and this makes it easier to use in one-off sessions. It is designed to help people focus on problems they describe as being most relevant to them and to find their own solutions. We want to know if we can give one session of MOL to people seeking help from their GP. We want to see if they find it helpful. So we need to find out if they want and attend the session and if they tell us about it. This will help us decide whether to run a larger study exploring whether one session of MOL can help meet the goals of people seeking GP support. This could tell us whether MOL could help reduce waiting times. We will ask people using GP surgeries if they want to participate. They will be offered one session of MOL with their usual support. We will ask them to complete questionnaires to see if they found the therapy helpful. We will note how many participate, attend sessions, and complete questionnaires. We will check whether participants liked having MOL and will interview 10-12 of them to learn about what they thought. The research will be funded by The University of Manchester.

NCT ID: NCT06063551 Recruiting - Childhood Cancer Clinical Trials

Cryopreservation of Prepubertal Testicular Tissue for Preservation of Fertility in Young Boys With Cancer

Start date: April 1, 2016
Phase: N/A
Study type: Interventional

Prepubertal boys treated for cancer are at risk of infertility as a result of their treatment. At present there are no options to preserve fertility in these boys. With informed consent, the investigators aim to cryopreserve (freeze) testis tissue biopsies taken from boys undergoing cancer therapy with a high risk of infertility. A portion of cryopreserved tissue will be securely stored, which in the future may be used to restore fertility in the patients. A second portion of the tissue will be used for laboratory work aimed at understanding the conditions required for development of the germ cells. Patients will be recruited from the Oncology Department at the Royal Hospital for Children and Young People (RHCYP) in Edinburgh. Tissue will be obtained from prepubertal patients with cancer who are about to undergo treatment with a high risk (>80%) of infertility. Informed consent will be obtained from the patients legal guardian (and patient if applicable) for the procedure and subsequent use of tissue. A testis biopsy from one testis will be performed and if possible will coincide with a planned routine procedure requiring general anaesthetic in order to avoid the need for additional anaesthesia. The procedure will take place at RHCYP during the initial assessment and prior to the commencement of cancer treatment and will not result in delay of treatment. Tissue will be assessed for the presence of sperm for storage using existing methods. In addition, tissue will be cryopreserved by Tissue and Cells Directorate, SNBTS in Edinburgh. The tissue will be stored for up to 55 years in accordance with current legislation (HFEA Act as amended 2005). Research will be carried out at the MRC Centre for Reproductive Health in accordance with Human Tissue (Scotland) Act 2006.

NCT ID: NCT06062784 Completed - Aging Clinical Trials

Bedside Tests of Cardiorespiratory Fitness

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

A study of 64 older adults over the age of 65y to assess the utility of patient characteristics and bedside measures of physical function and muscle size to predict cardiorespiratory fitness.

NCT ID: NCT06062732 Recruiting - Violence Clinical Trials

Face It Evaluation

Start date: September 2023
Phase: N/A
Study type: Interventional

This project is a pilot evaluation randomised controlled trial of Face It, a school-based intervention designed and implemented by Khulisa. Face It is specifically designed for young people at risk of offending, exploitation and school exclusion. The programme builds self-awareness and encourages pupils to reflect on the root causes and triggers of their disruptive or challenging behaviour. Khulisa believes that early intervention breaks the school to prison pipeline, which is exacerbated by exclusion, enabling young people to choose a safe and crime-free future. The intervention is delivered over 6 weeks, including an intensive 5-day programme of activities, and pre-programme and post-programme group and 1:1 sessions. Each programme is tailored to participants' needs and uses art, storytelling, 1:1 and group experiential techniques, delivered by trained dramatherapists. The randomised controlled trial will test the programme's feasibility, acceptability, evaluability, mechanisms and outcomes, to determine whether the trial should proceed to a full-scale efficacy trial through quantitative and qualitative data collection.

NCT ID: NCT06060951 Not yet recruiting - Clinical trials for Kidney Failure, Chronic

Relating Abdominal Complications With Peritoneal Pressure Estimation and Reporting

RAPPER
Start date: October 1, 2023
Phase:
Study type: Observational

This is a prospective observational study in people treated with peritoneal dialysis for kidney failure to investigate whether estimated intraperitoneal pressure (eIPP) is correlated with non-infectious PD-related complications in end-stage renal failure patients. It looks to understand how both peritoneal dialysis complications (including fluid leaks and hernias) along with gastrointestinal symptoms are associated with eIPP in people treated with PD.