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Filter by:The main goal of this trial is to determine the feasibility of a randomized controlled trial for the Knee Care at Home Programme, rather than the effectiveness, for patients recovering from anterior cruciate ligament reconstruction. Specifically, the trial aims to: (1) assess the feasibility of studying the effectiveness of the Knee Care at Home programme, including patient engagement and satisfaction; and (2) conduct a qualitative assessment to identify barriers and facilitators in the implementation and delivery of the programme.
Spinal muscular atrophy (SMA) is a genetic neurodegenerative disease impacting spinal cord motor neurons, leading to motor and respiratory issues and, ultimately, death. With emerging therapies, a need arises to enhance motor function assessment in severely hypotonic infants (SMA type 1) as traditional scales on examination tables lack completeness due to gravity's influence. The study team has developed a "bath test" to observe infants' motor skills in water, eliminating gravity's effects. This test aims to detect subtle movements using inertial sensors, potentially revealing more active motor neurons in aquatic conditions. It aids in identifying infants with motor improvement potential, even if they show limited mobility outside water, and tracks disease progression and therapy responses. Presently, pediatric neurologists in France use parent-provided bathing videos for evaluations, but these lack standardization and precision. The study aims to establish a standardized evaluation protocol with quantifiable data. The study's key objective is to evaluate severely hypotonic SMA infants using inertial sensors, including accelerometers, gyrometers, and magnetometers. The study will conduct "dry" and "water" assessments using a specially designed bathtub. This method's goal is to quantify water-based movements accurately. Simultaneously, the study seeks to establish semi-quantitative evaluation criteria to create a clinical assessment scale for infant motor function in bathtubs. This scale will aid doctors in therapeutic decisions. The study will not influence the treatment or therapeutic decisions made for the children being tested. Collected data from "dry" and "water" conditions will be statistically analyzed and compared to reference motor assessment scales (e.g., CHOP INTEND and HINE) and electromyography (CMAP-EMG) results, commonly used in diagnosis and monitoring. Blurred video recordings will assist in protocol monitoring and sensor data analysis.
The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases. The trial anticipates enrolling participants to reach a maximum of 24 participants who will receive 1 dose of KYV-101 and will be followed for 2 years.
The goal of this observational study is to learn about the use of equipment to monitor health at home in participants who have non-cystic fibrosis bronchiectasis. The main question[s] it aims to answer are: - How acceptable participants find using home monitoring equipment. - To find out if the data collected from home monitoring can help to detect chest infections (exacerbations) before participants get symptoms they are aware of. Participants will be provided with - - a handheld spirometer to record FEV1 (lung function) - a Fitbit, or other compatible activity monitor, to record activity and heart rate - a saturation monitor that fits painlessly on the end of the finger to record oxygen levels - weighing scales to record weight - a mini freezer and pre-labelled sample containers to store a daily sputum sample. There is enough room in the freezers for samples to be brought to routine clinic visits. We will provide a cool bag and freezer packs for this. A courier collection of the samples can be arranged if necessary. Participants will be encouraged to perform lung function, activity and oxygen levels at least 4 x per week. Participants will be guided through how to set up and use each piece of equipment by the research team. The devices all connect to a smartphone app called Breathe RM (Remote Monitor,) which is free to download, via Bluetooth. Once set up using the home monitoring devices and adding notes to the app should take no more than 15 minutes per day. Participants will be asked to record in the app - - episodes of pulmonary exacerbation that require antibiotic treatment - their coughing and wellness scores daily
CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural lesions in patients with chronic limb-threatening ischemia (CLTI). The primary objective of CALCIO is to understand the effectiveness of IVL in promoting wound healing and preventing amputation. The secondary objectives of CALCIO are to evaluate the immediate effectiveness of the treatment in restoring vessel patency as well as its safety and impact on patients' quality of life.
The primary aim of this study was to investigate the effects of progressive neck motor control exercises on craniocervical pain, posture, function and kinesiophobia in different types of temporomandibular dysfunction. The secondary aim of the study was to examine the differences between the effects of progressive neck motor control exercises on different types of temporomandibular dysfunction.
The goal of this observational study is to compare pulmonary health parameter measurements from the VQm PHM™ to existing clinical measurements. The main questions it aims to answer are: - Confirm the performance of non-invasive pulmonary health parameter shunt fraction value found on the VQm PHM™ when compared to available reference measurements. - Confirm the performance of non-invasive pulmonary health parameter pulmonary blood flow, functional residual capacity and physiological dead space found on the VQm PHM™ when compared to available reference measurements.
Cell-free fetal DNA (cffDNA) is present in the maternal blood from the early first trimester of gestation and makes up 5%-20% of the total circulating cell-free DNA (cfDNA) in maternal plasma. Its presence in maternal plasma has allowed development of noninvasive prenatal diagnosis for single-gene disorders (SGD-NIPD). This can be performed from 9 weeks of amenorrhea and offers an early, safe and accurate definitive diagnosis without the miscarriage risk associated with invasive procedures. One of the major difficulties is distinguishing fetal genotype in the high background of maternal cfDNA, which leads to several technical and analytical challenges. Besides, unlike noninvasive prenatal testing for aneuploidy, NIPD for monogenic diseases represent a smaller market opportunity, and many cases must be provided on a bespoke, patient- or disease-specific basis. As a result, implementation of SGD-NIPD remained sparse, with most testing being delivered in a research setting. The present project aims to take advantage of the unique French collaborative network to make SGD-NIPD possible for theoretically any monogenic disorder and any family.
This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of [225Ac]-FPI-2068, [111In]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC).
The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea. Participants who will receive at least 1 dose of mavacamten will be enrolled.