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Showing 1-11 of 11 trials
NCT07665229
Voice could be considered a new vital sign in the future, being collected in routine care and complement other medical assessments. Vocal biomarkers (VB) are voice characteristics that are specific to a disease or symptom. They can be utilized in clinical practice for remote disease monitoring, screening for diseases, or in clinical research as secondary endpoints to evaluate the efficacy of a treatment or intervention. They can also be used during enhanced consultations to screen for diseases or monitor the progression of a chronic disease, in services to identify at-risk patients, and at home to track patients' symptoms and general health status between consultations. Despite the potential of VB and many progresses, few have reached the stage of use in clinical routine. At LIH, the Deep Digital Phenotyping research lab gained experience in the voice-related research field since 2019, with the implementation of methodological tools to collect and pre-process voice recordings, and with the development of vocal biomarker candidates in several therapeutic domains or symptoms (Type 2 diabetes, fatigue, COVID-19 and Long COVID, respiratory health, mental health, etc.) VB is an early-stage research topic; one needs to accelerate the development, validation and integration of vocal biomarkers for personalized medicine and innovative tools - both for clinical practice and remote patient monitoring. Until now, VB candidates have been developed disease by disease, and there is a lack of data on the influence of concomitant diseases on voice signatures. Therefore, the next vital step to improve vocal biomarkers and assess their specificity is to compare them with both control groups, those without the disease, and those with other diseases. The study is a cohort of adult people attending one of the hospitals in Luxembourg, either for an hospitalization, a consultation, or a simple visit, regardless of their health conditions. Study will be conducted in French, English, German, and Portuguese which are the most frequent languages in Luxembourg. Study participants will be followed up over a 5 years period of time, with on-site study visits in study booths installed in the different hospitals in Luxembourg and at-home monitoring in-between visits, using a smartphone app to collect study data. During both study visits and at-home monitoring voice recordings will be collected together with health data. This will allow to understand how voice evolves with time in a given individual, and to identify VB specific to diseases like diabetes, or to symptoms common to several chronic diseases like fatigue or mental health problems.
NCT07582601
The goal of this observational study is to understand the genetic and molecular risk factors for developing critical illness in adult intensive care unit (ICU) patients in Sweden. The main questions it aims to answer are: Which genetic variants are associated with increased risk of critical illness from conditions such as infections, sepsis, and organ failure? Can circulating proteins and metabolites mediate the effect of genetic risk factors on the severity of illness? Participants will: Provide blood samples at ICU admission and again 3-6 months after discharge Consent to genetic analysis and data linkage with national health registries Have their ICU treatment and outcomes followed using registry and clinical data This study aims to build a national infrastructure for rapid sample collection and analysis that can also support research in future pandemics.
NCT07396285
Gene editing approaches (including but not limited to: CRISPR, LNP, AAV, RNAi etc.) for the medical specialty of interventional genomics require (1) determination of the clinical relevance of genomic variants and (2) systematic evaluation of the 'editability' of those variants. Here, we seek to use in silico and in vitro analyses of genomic, cellular, and clinical data/specimens to (1) identify novel pathogenic variants underlying diseases and (2) examine the specificity and efficacy of various gene editing components across the entire human genomic landscape.
NCT05745688
The purpose of this study is to analyze if there are differences between men and women in the frequency of ignoring "Do not do" recommendations in primary care setting.
NCT04125758
Chronic stress has been shown to impact long-term emotional and physical health. When nearly three-quarters of Americans report stress at levels that exceed what they consider healthy, there is a desperate need to understand factors that contribute to effective stress regulation. This work seeks to develop a measure tied to awareness and acceptance of stress that has shown promise as a predictor of multiple markers of mental and physical well-being, understand how it relates to awareness of the body, and explore whether it can be trained to alleviate suffering and promote well-being. This study aims to 1) Conceptually replicate and extend previous findings linking greater stress-physiology coherence to higher well-being. 2) Assess whether awareness of physiology is associated with stress-physiology coherence. 3) Explore whether stress-physiology coherence can be trained through a brief mindfulness training intervention.
NCT03654417
The purpose of this study is to compare pain control during vulvar biopsy following either (1) application of EMLA (a eutectic mixture of local anesthetics lidocaine 2.5% and prilocaine 2.5%) cream or (2) injection of 1% lidocaine. We hypothesize that lidocaine will provide better biopsy analgesia, but the benefit will be offset by the pain of lidocaine injection compared to EMLA application, thus there will not be a significant difference in highest pain scores between the two groups.
NCT01266304
The overall objective of this study is to develop and test an efficient self-report instrument to measure Complementary and Alternative Medicine(CAM)-relevant contextual factors important in healing. The initial phase of the study involves developing and refining an item bank. During the initial 'item bank development' phase, the investigators will run focus groups and cognitive interviews with individuals who participate in CAM and conventional medicine interventions. The current protocol in ClinicalTrials.gov pertains only to the initial phase of the study involving focus groups and cognitive interviews. The next step of instrument development is called Calibration, and will involve administering the revised item bank to an internet sample and to persons who receive services in a CAM clinic and a conventional primary care setting. The items will be calibrated using item response theory and classical test theory. This will result in a computerized adaptive testing version of the instrument, as well as a static short form of the instrument. The final phase of the project will involve conducting initial validation studies of the instrument. The instrument will be called the Healing Encounters and Attitudes List (HEAL). The investigators will evaluate the convergent, discriminant, and predictive validity of the HEAL in a sample of 200 persons with chronic low back pain who are receiving physical therapy, chiropractic care, or mindfulness-based stress reduction. For convergent validity, the HEAL is expected to display moderate to large correlations with measures of similar constructs. The HEAL is expected to correlate modestly with self-report measures of general psychosocial functioning, in support of discriminant validity. Finally, HEAL score should account for a significant proportion of the variance in treatment outcome, supporting predictive validity.
NCT02639845
The purpose of this study is to determine if an eye drop video monitoring device can accurately assess (as compared to a patient's own log or a proprietary software) the exact amount and time of eye drop delivery to a patient's eye. It is our belief that the experimental device will help patients to be more compliant by: 1) providing a viewable format so patients can see what is happening when they are applying their drops 2) providing greater accuracy to doctors regarding when and how much medication was used 3) providing greater accuracy to doctors and patients regarding how much medication was actually delivered to a patients eye.
NCT02311127
Peripherally inserted central catheters (PICCs ) are used for the administration of intravenous fluids and for blood sampling. PICCs may remain in place for weeks to months and are safeguarded from migration or accidental dislodgement by securement devices. Different types of these devices are available. StatLock® (C.R. Bard) is a stabilization device with an adhesive anchor pad. The catheter wings of the PICC must be placed over the posts then the system is closed with "gull-wings" . StatLock® has to be changed weekly. Healthcare providers have to pay attention to prevent accidental catheter dislodgement during the renewal procedure. SecurAcath® (Interrad Medical) is a new securement device to the European market. The device uses a small subcutaneous anchor to secure the PICC. One of the advantages compared to adhesive stabilization devices, is a reduction in maintenance time by simplifying dressing changes and subsequently staff time. It is described that nurses report that care is left undone due to low staffing levels. Therefore, investigation of nursing time savings with the support of technology is imperative. SecurAcath® remains in place for life of the PICC and therefore has the potential to reduce the time for dressing change as there is no need for weekly device change. The objective of this study is to measure nursing time for dressing change and explore inserting and removal issues and patient experiences.
NCT02044770
The primary objective of this clinical study is to describe the initial clinical experience with ENSEAL® G2 Articulating Tissue Sealer in laparoscopic colectomy, quantifying and/or qualifying how its articulation feature enables optimization of vessel sealing through improved access, approach, and visibility. This is an observational study of device usage being conducted to report initial experience with the ENSEAL ART device. It is not intended as hypothesis testing.
NCT01614353
"Patients can easily be overwhelmed, confused and many times don't fully understand their need for new medications, or when the dosages are to be administered" (patient research partner quote). The long-term goal of this study is to refine medication science by developing patient-centered assessment, monitoring and management guidelines for patients and health professionals. The objective is to advance knowledge about the medication-taking perspectives, experiences, and behaviors of older adults with multiple chronic medical conditions (MCMC) to inform future research related to patient-centered medication prescribing, monitoring and management. This pilot study addresses the following PCORI interest area: "evaluating methods that can be used to assess the patient perspective when researching behaviors and choices within the patient's control that may influence outcomes." The rationale that underlies the proposed study is that medication-taking practices are wholly within patients' control, and are foundational to reducing complications and improving outcomes for those with MCMC. To meet the overall objective of this application, the following specific aims will be pursued: 1) identify perceptions and behaviors surrounding the medication-taking process of older adults with MCMC; and 2) generate an interpretation of the meaning of medication-taking among older adults with MCMC. To achieve these aims, data will be obtained in "real time" from patients (N=30) receiving a new prescription using smart phone technology. The smart phones will include prompts to help participants record thoughts about medication use throughout the day for 30 days. Findings from electronic diaries will be logged, analyzed and qualitatively analyzed. Some patients (n=15) will provide in-depth hermeneutic interviews to provide rich descriptions and interpretive commentary about the experience of receiving a new medication prescription. The objective is to uncover previously unidentified areas of common experience in older persons with multiple chronic conditions who have received a new prescription. Common experiences and patterns of influences, that are often surprising or unexpected, will be categorized and assessed. The expected outcomes of this pilot study are improved knowledge of medication-taking perceptions, experiences, and practices of older adults with MCMC-knowledge that is critical to advance patient-centered medication science.