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Filter by:Phase 1b open-label study to evaluate the safety of selected TIL (TBio-4101) delivered after lymphodepleting chemotherapy and followed by intravenous (IV) bolus aldesleukin (IL-2) and pembrolizumab for patients with advanced HNSCC who have initially progressed on pembrolizumab or pembrolizumab/platinum chemotherapy.
The goal of this prospective, cross-sectional study is to test the strength of the soleus muscle in participants who have a ACL tear confirmed by MRI. Previous studies have shown that the soleus muscle, which one of the muscles situated in the calf, decreases mechanical loading on the ACL. Therefore, we aim to test soleus muscle strength using a seated plantar flexor test. The main questions we aim to answer are: - Do patients with ACL tears demonstrate inter-limb soleus strength asymmetry (>10%) - Do patients with ACL tears have soleus muscle weakness compared with uninjured (normative) participants? - Do changes in soleus strength values correlate with patient reported outcomes and stability, as measured by the IKDC questionnaire? To achieve this the VALD force frame will be used as the testing device for plantar flexor strength testing. This device records the force generated by the movement. This will be repeated three times on each leg as part of the testing procedure. Furthermore, as part of the testing procedure participants will be required to fill out an IKDC form to assess their knee stability. Interrater reliability of the force frame will be investigated. Further data from participants without ACL tears will be used to compare results. Thus allowing us to see if people with ACL tears have a weakness in the soleus muscle.
The goal of this observational study is to investigate the prevalence of joint complaints in nursing home residents with and without dementia. Primary objective: Number of tender or swollen joints. Secondary objectives: 1. Only when it is possible for the nursing home resident to provide us this information: how nursing home residents themselves assess the severity of their joint complaints that day (at that time). If the nursing home resident cannot answer this question (reliably), we use the Pain Assessment Checklist for Seniors with Severe Dementia (PACSLAC-D). 2. Investigate mobility limitations among nursing home residents. 3. To understand whether an accurate (differential) diagnosis for the joint complaints is reported in the electronic files. During the study, a standard physical examination of the musculoskeletal system will performed. Nursing home residents allocated in group 1 (no dementia) also provide an answer on 3 non-incriminating questions (severity of joint complaints, pain in general and general health). Nursing home residents allocated in group 2 (dementia) answer, if possible, 1 non-incriminating question (pain in joints at that moment). These question(s) and the physical examination are also widely used in daily clinical practice. No further incriminating questions or questionnaires will be administered. If the nursing home resident cannot answer this question (reliably), we use the PACSLAC-D.
This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves. The research will be conducted as a multicenter observational study, involving several centers worldwide, and will have a one-year follow-up period (with a possible extension to 5 years). The primary aim is to determine the proportion of MMVD among patients evaluated for valvular heart disease. Secondary aims include the evaluation of the epidemiologic distribution of clinical, biological, and cardiovascular imaging characteristics at baseline, management strategies, and their impact on prognosis. The study will also evaluate clinical outcomes such as mortality, hospitalization for heart failure, and changes in echocardiographic parameters. This research aims to provide valuable insights into the diagnosis, management, and prognosis of MMVD, addressing an important knowledge gap in this area.
A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy
This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120 to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors. Dose-Escalation part is planned to establish the MTD or RD for Dose-Expansion part, while Dose-Expansion part is designed to assess potential efficacy of BH3120 when administered at the RD to subjects in indication-specific expansion cohorts.
To assess sensory processing anomalies in neurotypical children, children with autism spectrum disorder, and attention-deficit hyperactivity disorder, particularly within the vibrotactile and auditory sensory modalities.
Loss of skeletal muscle mass (atrophy) and strength in the lower limb are consequences of elective knee surgery as result of prolonged disuse from limb immobilization and impaired mobility, as well as pathophysiological trauma. The highest rates of skeletal muscle mass and strength loss occur during the 2-week post-surgery period, considered the early phase of outpatient recovery. Alternative to resistance exercise and pharmacology, nutritional intervention represents one strategy to combat skeletal muscle disuse atrophy. Essential amino acids (EAA) and omega-3 fatty acids are known to independently potentiate rates of skeletal muscle protein synthesis and attenuate skeletal muscle atrophy in humans. However, the combined actions these nutritional strategies on skeletal muscle have not been explored in a pathophysiological context, such as surgery. With the ultimate goal to test the efficacy of the combined nutritional strategy to attenuate skeletal muscle disuse atrophy in the future, the aim of this present pilot study is to explore the feasibility of recruitment and retention of anterior cruciate ligament reconstruction (ACLR) outpatients from a single centre across 18 months for a 6-week nutritional intervention. Participants will consume either an intervention of omega-3 fatty acids and EAAs, or a placebo control of safflower oil and non-essential amino acids (NEAA), for 4 weeks before and 2 weeks after elective ACLR surgery. Furthermore, this pilot will characterize secondary outcomes of skeletal muscle mass, strength, and power, and integrated rates of muscle protein synthesis, as well as report participant adherence to protocols and incidence of adverse events.
Acute myeloid leukemia (AML) accounts for about 15% to 20% of childhood leukemia, but the death rate accounts for about 50%. About 20-30% of children with AML did not achieve complete response (CR) after 2 induction treatments, and about 30% of children with CR had relapse within 3 years (including recurrence after hematopoietic stem cell transplantation).Relapsed/refractory (R/R) AML is a major cause of treatment failure and refractory survival. Reinduction chemotherapy for R/R-AML to obtain CR again, followed by hematopoietic stem cell transplantation, is the current treatment. At present, there is no recognized reinduction protocol, and the reinduction remission rate of R/R-AML varies greatly among different treatment regimens, ranging from 23 to 81%. Current guidelines recommend a new combination chemotherapy regimen consisting of new drugs without cross-resistance. This method selects sensitive chemotherapeutic drugs, and then forms a new combination chemotherapy regimen according to the characteristics of drugs, which is the choice of R/R-AML reinduction therapy.This study intends to conduct a clinical study on the individualized treatment of R/R AML patients through in vitro drug sensitivity test combined with patient transcriptomic characteristics.
This project aims to quantify and evaluate rates of non-adherence and barriers to medication adherence in pediatric patients with CRMO followed at Seattle Children's Hospital's robust CRMO program, which is the only clinical program in the Washington, Wyoming, Alaska, Montana, Idaho (WWAMI) region. This will be a stepped-wedge cluster-randomized trial, in which participants will be randomly assigned to one of two groups -- one which receives educational materials at the end of their first clinic visit, and the other which receives educational materials at the end of their second clinic visit. All participants will be given baseline surveys at the start of their first clinic visit, as well as follow-up surveys at the start of their second and third clinic visits. These surveys aim to evaluate rates of non-adherence and qualitative barriers to adherence, as well as efficacy of educational interventions in improving adherence rates.