Device clinical trial

PURPOSE: To comprehensively synthesize the existing evidence concerning mHealth interventions for patients with breast cancer (BC). DESIGN: On July 30, 2023, we searched PubMed, PsycINFO, and Google Scholar for articles using the following inclusion criteria: evaluation of mHealth interventions in patients with cancer, at least 30 participants with BC, randomized control trials or prospective pre-post studies, determinants of health (patient-reported outcomes [PROs] and quality of life [QoL]) as primary outcomes, interventions lasting at least 8 weeks, publication after January 2015...

BACKGROUND: The Incentive Spirometer (IS) increases lung volume and improves gas exchange by visually stimulating patients to take slow, deep breaths. It prevents respiratory complications and treats postoperative atelectasis in patients undergoing abdominal, thoracic, and neurosurgical procedures. Its effectiveness has been validated in studies that support improved lung capacities and volumes in individuals with respiratory complications, postoperative thoracic surgery, upper abdominal surgery, and bariatric surgery...

BACKGROUND: Prior studies have found that patients with chronic kidney disease (CKD) have worse outcomes following percutaneous coronary intervention (PCI). There are no data about patients with advanced CKD undergoing Impella-supported high-risk PCI. We, therefore, aimed to evaluate angiographic characteristics and clinical outcomes in patients with CKD who received Impella-supported high-risk PCI as part of the catheter-based ventricular assist device PROTECT III study (A Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2...

Heart failure with preserved ejection fraction (HFpEF) is a clinical syndrome characterised by the presence of diastolic dysfunction and elevated left ventricular filling pressure, in the setting of a left ventricular ejection fraction of at least 50%. Despite the epidemiological prevalence of HFpEF, a prompt diagnosis is challenging and many uncertainties exist. HFpEF is characterised by different phenotypes driven by various cardiac and non-cardiac comorbidities. This is probably the reason why several HFpEF clinical trials in the past did not reach strong outcomes to recommend a single therapy for this syndrome; however, this paradigm has recently changed, and the unmet clinical need for HFpEF treatment found a proper response as a result of a new class of drug, the sodium-glucose cotransporter 2 inhibitors, which beneficially act through the whole spectrum of left ventricular ejection fraction...

BACKGROUND: Representation of diverse study populations in pivotal clinical trials for medical devices and subgroup analyses for demographic groups to explore differences in safety and effectiveness are essential to understanding the benefits and risks in diverse populations. The US Food and Drug Administration (FDA) has taken many steps to improve transparency and subgroup analyses over the past decade, but there has not been a recent evaluation of demographic reporting and subgroup analyses...

BACKGROUND: Clinical practice guidelines recommend oral anticoagulation (OAC) for stroke prevention in selected patients with atrial fibrillation (AF). However, some patients still experience thrombo-embolic events despite adequate anticoagulation. The optimal management of these cases remains uncertain, leading to practice pattern variability. We present a series of three cases illustrating the use of left atrial appendage occlusion (LAAO) as an adjunctive stroke prevention strategy in AF patients with recurrent thrombo-embolic events despite adequate anticoagulation...

Background Quality of Life (QoL) is an essential consideration in healthcare. Numerous studies have examined QoL in India; however, data on QoL following different dietary interventions are lacking. Similarly, the use of technology such as continuous glucose monitoring (CGM) for diabetes care has independently demonstrated improvements in glycemic control; however, its association with QoL remains limited. Purpose The purpose was to study the role of different dietary interventions on QoL and its association with Time in Range (TIR), Time Above Range (TAR), and Time Below Range (TBR) among the Type 2 Diabetes Mellitus (T2DM) population...

BACKGROUND: In patients with locally advanced breast cancer (LABC) receiving neoadjuvant chemotherapy (NAC), quantitative ultrasound (QUS) radiomics can predict final responses early within 4 of 16-18 weeks of treatment. The current study was planned to study the feasibility of a QUS-radiomics model-guided adaptive chemotherapy. METHODS: The phase 2 open-label randomized controlled trial included patients with LABC planned for NAC. Patients were randomly allocated in 1:1 ratio to a standard arm or experimental arm stratified by hormonal receptor status...

BACKGROUND: Extracellular vesicles, or microvesicles, are a large family of membrane-bound fluid-filled sacs that cells release into the extracellular environment. Extracellular microvesicles (EMVs) are essential for cell-to-cell communications that promote wound healing. We hypothesize a correlation between the concentration of EMVs in wound fluid and the percentage of wound healing in treated chronic, nonhealing, wounds. A prospective, multicenter, randomized, single-blind clinical trial was conducted to evaluate EMV concentration in relation to wound healing percentages...

BACKGROUND: Effective teaching methods are needed to improve students' abilities in hand-eye coordination and understanding of cardiac anatomy in echocardiography education. Simulation devices have emerged as innovative teaching tools and exhibited distinctive advantages due to their ability to provide vivid and visual learning experiences. This study aimed to investigate the effect of simulation of sectional human anatomy using ultrasound on students' learning outcomes and satisfaction in echocardiography education...

Disc displacement without reduction (DDwoR) can cause pain and limitations in mouth opening, with a significant impact on function. The optimal management strategy for DDwoR is unclear. Treatments include conservative management such as mandibular manipulation, occlusal splints, and patient education/self-management, as well as arthrocentesis, which is a minimally invasive procedure. The aim of this systematic review and meta-analysis was to ascertain whether there is a role for arthrocentesis in the management of DDwoR...

BACKGROUND: There has not been a consensus on the prothesis sizing strategy in type 0 bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR). Modifications to standard annular sizing strategies might be required due to the distinct anatomical characteristics. We have devised a Down Sizing Strategy for TAVR using a self-expanding valve specifically for patients with type 0 bicuspid AS. The primary aim of this study is to compare the safety and efficacy of Down Sizing Strategy with the Standard Annulus Sizing Strategy in TAVR for patients with type 0 bicuspid AS...

OBJECTIVE: Smart sensing has the potential to make psychotherapeutic treatments more effective. It involves the passive analysis and collection of data generated by digital devices. However, acceptance of smart sensing among psychotherapy patients remains unclear. Based on the unified theory of acceptance and use of technology (UTAUT), this study investigated (1) the acceptance toward smart sensing in a sample of psychotherapy patients (2) the effectiveness of an acceptance facilitating intervention (AFI) and (3) the determinants of acceptance...

BACKGROUND: Use of Intra-Aortic Balloon Pump (IABP) in combination with Impella has been described as an alternative strategy for mechanical circulatory support (MCS) in patients with cardiogenic shock (CS). We provide a systematic review aimed to explore the effectiveness of this paired MCS approach. METHODS: We conducted a comprehensive systematic search in MEDLINE, Scopus, and Cochrane databases to identify all studies that investigated dual MCS with IABP and Impella...

In this letter, we propose a miniaturization scheme of inkjet printed ionic sensing electrodes by adding graphene into the ion-selective PVC film not only to reduce the impedance of the ionic liquid layer of the electrode but also to increase the electrode capacitance for the reduction of the response time. Based on the scheme, we present a fully inkjet-printed electrochemical ion-selective sensor comprising a working electrode and reference electrode, which are inkjet-printed Ag NPs/PEDOT:PSS-graphene/PVC-graphene and Ag/AgCl(s) /ionic liquid PVC-graphene layer structures, respectively...

This study tested the usability of a home-based self-administration transcranial direct current stimulation (tDCS) device designed specifically for women's health needs. This is a single center triple blinded clinical usability study for a new wireless, Bluetooth-controlled wearable tDCS device for women's health. The study aims to evaluate the usability and effective blinding of a home-based tDCS system. A total of forty-nine women of reproductive age were randomly allocated (1:1) to receive one session of active tDCS (n = 24) or sham tDCS (n = 25) over the motor and dorsolateral prefrontal cortex...

BACKGROUND: Ankle-foot orthoses (AFOs) are commonly used to overcome mobility limitations related to lower limb musculoskeletal injury. Despite a multitude of AFOs to choose from, there is scant evidence to guide AFO prescription and limited opportunities for AFO users to provide experiential input during the process. To address these limitations in the current prescription process, this study evaluates a novel, user-centered and personalized 'test-drive' strategy using a robotic exoskeleton ('AFO emulator') to emulate commercial AFO mechanical properties (i...

BACKGROUND: Endometrial cancer is one of the most common gynaecological cancers in the world. Rates of endometrial cancer are rising, in part because of rising obesity rates. Endometrial hyperplasia is a precancerous condition in women that can lead to endometrial cancer if left untreated. Endometrial hyperplasia occurs more commonly than endometrial cancer. Progesterone tablets that are currently used to treat women with endometrial hyperplasia are associated with adverse effects in up to 84% of women...

OBJECTIVES: Kidney transplant survival can be improved with better graft surveillance postoperatively. In the quest to explore new technologies, we explored the feasibility of an implantable Doppler probe as a blood flow monitoring device in kidney transplant patients. This qualitative study was embeddedin a feasibility trial and aimed to test the device's clinical acceptability and obtain suggestions for the development of the intervention. Objectives included exploring the experiences of feasibility study participants and identifying barriers to the implementation of implantable Doppler probes in clinical practice...

INTRODUCTION: Adherence counselling with point-of-care (POC) drug-level feedback using a novel tenofovir assay may support pre-exposure prophylaxis (PrEP) adherence; however, perceptions of urine testing and its impact on adherence are not well studied. We qualitatively examined how POC tenofovir testing was experienced by transgender women (TGW) in Uganda. METHODS: Within a cluster randomized trial of peer-delivered HIV self-testing, self-sampling for sexually transmitted infections and PrEP among HIV-negative TGW showing overall low PrEP prevention-effective adherence (NCT04328025), we conducted a nested qualitative sub-study of the urine POC assay among a random sample of 30 TGW (August 2021-February 2022)...