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NCT ID: NCT05975034 Recruiting - Long COVID Clinical Trials

Investigation of the Use of a Probiotic Supplement in People With Long COVID

Start date: June 12, 2023
Phase: N/A
Study type: Interventional

This study is a double-blinded randomised trial to assess the efficacy of a probiotic supplement in alleviating symptoms in people with Long COVID.

NCT ID: NCT05973851 Recruiting - Clinical trials for Major Depressive Disorder

The Effect of a Six Week Intensified Pharmacological Treatment for Major Depressive Disorder Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

INTENSIFY MDD
Start date: May 31, 2024
Phase: Phase 3
Study type: Interventional

Over 28 million people suffer from current depressive disorder in the European Union. Major depressive disorder (MDD) is one of the most common psychiatric illnesses. The symptoms cause clinically significant distress or impairment in social, occupational, and other important areas of functioning. To treat MDD, there are several antidepressants available and prescribing medication is a process of trial-and-error. Guidelines do not explicitly advise on the order in which antidepressant medication should be prescribed. The choice of antidepressant should be tailored to the patient, while involving the patient in the decision-making process. In general, the choice for the first- and second-line treatment will be a second-generation antidepressant. Recently, esketamine nasal spray (intranasal (IN) administration) was approved for patients with treatment-resistant MDD (TRD). A patient is diagnosed with TRD when having used two antidepressants in sufficient duration and adequate dose without sufficient effect. TRD is associated with a negative impact on quality of life, higher risk for hospitalisations and suicide, comorbidities, poorer social and occupational functioning and a high carer burden. The efficacy of intranasal use of esketamine has been demonstrated in MDD subjects with treatment-resistant symptoms but also in subjects with non-treatment resistant depression, and is approved by the FDA and EMA as a third-line treatment. Besides the registered esketamine nasal spray, which is not available in all countries to all patients because of the high costs, off-label utilization of (es)ketamine infusions (IV) is growing extensively over time to treat TRD. Research conducted so far indicates an unequivocal initial substantial response to (es)ketamine IV in MDD populations, regardless of whether or not patients suffer from treatment resistant MDD. However, until now, there has not been a study investigating this in a sufficiently large population. This may be a unique opportunity to potentially prevent patients progressing into a treatment resistant illness stage. The potential implications of the results of the current study are the prevention of unnecessary trials of ineffective treatments, reducing subject burden substantially, as well as a reduction of healthcare and societal costs.

NCT ID: NCT05973786 Recruiting - Bipolar Depression Clinical Trials

The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

INTENSIFY BD
Start date: May 31, 2024
Phase: Phase 3
Study type: Interventional

Bipolar disorders affect approximately 4.5 million people across the European Union (EU) and are associated with high annual healthcare and societal costs. Bipolar disorder I and II represent disorders that cause extreme fluctuation in a person's mood, energy, and ability to function, in which symptoms of (hypo)mania and depression alternate. The depressive episodes of bipolar disorders are often referred to as bipolar depression (BD). In other words: it is a phase/state of the disorder. For many patients with BD, the depressive polarity is often more pervasive and more debilitating than manic states, with estimates that depressed mood accounts for up to two-thirds of the time spent unwell, even with treatment. The burden of not received an effective treatment for BD is high: more severe psychopathology, higher rates of unemployment, more hospitalisations, lower quality of life, lower cognitive functioning, risk of suicide, comorbidities and poorer social and occupational functioning and thus more carer burden. For BD, the treatment guidelines are very heterogeneous, amongst other reasons because the disease is heterogeneous and treatments should be tailored to the patients. There is no clear treatment algorithm and it cannot yet be predicted which treatment will be effective. Especially the place of adjunctive antidepressants is under debate. Usually, for psychiatric disorders (including bipolar disorder), a patient is considered to be treatment-resistant is two medicinal treatments have been tried (in sufficient duration and dosage) without sufficient success. For BD, there is no consensus on when to consider a patient as treatment-resistant, but the most common definition is after one prior treatment failure. This raises the research question whether adjunctive antidepressants to treat BD should be introduced earlier in the treatment. Additionally, The INTENSIFY trial is part of the larger Horizon 2021 project, with the central goal of paving the way for a shift towards a treatment decision-making process tailored for the individual at risk for treatment resistance. To that end, we aim to establish evidence-based criteria to make decisions of early intense treatment in individuals at risk for treatment resistance across the major psychiatric disorders of schizophrenia, bipolar disorder and major depression.

NCT ID: NCT05973773 Recruiting - Clinical trials for Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation

REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)

REZILIENT3
Start date: June 30, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of zipalertinib in combination with standard first-line platinum-based chemotherapy compared to chemotherapy alone, in patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations.

NCT ID: NCT05973565 Not yet recruiting - Parkinson Disease Clinical Trials

The Effects of a Single Session of Rhythmic Movement Program on Selected Biopsychological Parameters in PD Patients

Start date: October 2024
Phase: N/A
Study type: Interventional

The aim of the present study is to examine the acute effects of a specially designed musicokinetic (MSK) program for patients with Parkinson's disease (PD) on a) anxiety levels b) select kinematic and kinetic parameters, and c) frontal cortex hemodynamic responses, during gait initiation and steady-state walking.

NCT ID: NCT05973539 Recruiting - Clinical trials for Nutritional and Metabolic Diseases

Blood Lipid Responses to Diet

BoLD
Start date: February 15, 2023
Phase: N/A
Study type: Interventional

The macronutrient composition of our diet (proportions of carbohydrates, fats and proteins) strongly influences the way our body stores and utilises substrates (e.g., fats and sugars), which in turn influences our risk of developing cardiometabolic diseases (e.g., coronary artery disease or insulin resistance). The optimal dietary composition to lower the risk of cardiometabolic disease is unknown. In a randomized, parallel design, this study will investigate how the overconsumption of carbohydrates and fats affects blood lipid responses and liver metabolism in adults free from metabolic disease. By genotyping participants, we will also examine the interaction between macronutrient content and an individual's genes on blood lipid responses and liver metabolism.

NCT ID: NCT05972967 Recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

Safety and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria Patients With a Sub-optimal Response to Ravulizumab

Start date: March 27, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of OMS906 for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients who have a sub-optimal response to ravulizumab.

NCT ID: NCT05972551 Recruiting - Clinical trials for Osteogenesis Imperfecta

Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

Start date: April 22, 2024
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.

NCT ID: NCT05972226 Completed - Asthma Clinical Trials

Self-care, Remote Monitoring and Elearning for Children and Young People With Asthma

ASTHMAME
Start date: July 16, 2018
Phase:
Study type: Observational

Asthma is a long-term condition in children, often managed by general practitioners (GPs) in primary care but some children with asthma need hospital treatment and care by experienced paediatricians and nurses. The positive effects of treatment for childhood asthma are well-documented however, less than 50% children take their medications regularly as prescribed. As well as causing poor control of asthma symptoms, failing to take medication as prescribed is a problem that is causing huge cost and wastage to the NHS. Some of the barriers to taking medications as prescribed include people's beliefs about their illness or medications and forgetting or being too busy. These barriers can be addressed by providing education, reminders and incentives. Monitoring medication usage is complex but studies have shown that use of electronic monitoring devices with education does improve the number of asthma attacks. Digital solutions for asthma self-care, including "smart-inhalers" that monitor medication usage and Apps for remote monitoring and self-management are likely to transform health services by providing supported self-management, prioritisation of the more unwell patients and reductions in hospital visits. Asthma + me, a digital self-care solution has been developed by Aseptika Ltd, in consultation with Sheffield Children's Hospital, to support children with asthma. It uses a monitoring device that connects wirelessly to the Asthma +me App and monitors medication usage, providing education tips, reminders and incentives. In this project, 15 children (and their families) will trial Asthma + me with a PUFFClicker and a 3-4 hour education session and report what worked and what didn't using structured interviews and questionnaires. At the same time the investigators will map out the number of patients that could potentially use this solution to self-manage their asthma, with the support of the hospital, until they are ready to be discharged back to their GP.

NCT ID: NCT05972161 Completed - Sleep Apnea Clinical Trials

Measuring Breathing Airflow Using a Heat Sensitive Camera (ThermFlow)

ThermFlow
Start date: October 24, 2017
Phase:
Study type: Observational

ThermPaed is a Sheffield Children's Hospital research collaborative which investigated the clinical diagnostic capabilities of high resolution thermal imaging (HRTI) in paediatrics. This research utilises thermal imaging techniques to detect fractures, arthritic inflammation and infection. ThermPaed proved HRTI has potential in paediatrics and resulted in development of techniques that has led to the current research study. The purpose of this study is to develop HRTI as a non-contact child-friendly means of measuring and monitoring paediatric airflow. Sheffield Children's Hospital Sleep Unit performs 500 sleep studies a year to investigate paediatric sleep-related breathing disorders. 1-6% of children have problems with their breathing during sleep and have breathing pauses called apnoeas. The condition needs accurate diagnosis and treatment to ensure correct blood oxygen levels. During a sleep study a number of physiological parameters are measured. These include heart rate, chest movements, airflow, oxygen levels, body position, snoring, movement and video. A total of 13 sensors are attached to the child whilst awake, and then the child settles to sleep. Airflow parameters are measured by two contact sensorsÍž one measures airflow by temperature and the other measures airflow by pressure. Both sensors are placed in or very close to the nostrils to detect and classify apnoea. Due to their contact nature, these sensors are poorly tolerated. In a recent survey of 100 sleep studies on the sleep unit, 50% children did not allow the sensors to be attached or removed them immediately causing difficulties in interpreting their condition. Breathing generates changes in temperature around nose and mouth which can be detected with HRTI. The investigators will recruit 30 children who are undergoing a sleep study. The investigators will compare airflow measurements from the existing clinical nasal sensors and HRTI to evaluate whether this new technique will provide an accurate non-contact alternative to measure respiration airflow.