Year 2024
Autori Panagis Galiatsatos - More
Registry of Trials clinicaltrials.gov
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Lower socioeconomic populations continue to remain at high risk for tobacco use and suffer disproportionately from tobacco-related disease. Evidence is lacking of ways to optimally deliver behavioral and pharmaceutical-based cigarette smoking cessation interventions in real-world environments among disadvantaged cohorts where geographic, socioeconomic and technological disparities often undermine the effectiveness of evidence-based smoking cessation efforts. The investigator\'s study focuses on residents of public housing in Baltimore City, a population who face multiple socioeconomic stressors and of whom up to 1/3 are assumed conventional cigarette users. The investigator\'s project uses a partnership between the Housing Authority of Baltimore City (HABC) and Johns Hopkins School of Medicine to enact a remote (off-site) cessation program in two public housing complexes under the management of HABC. The investigator\'s program will institute evidence-based practices in an accessible manner for the residents at both sites. The investigator\'s program\'s key features include the remote recruitment, prescription, delivery and management of evidence-based nicotine pharmacotherapies, and provision of cessation counseling. To assess the feasibility of study design, the investigator\'s project specifically focuses on the following eight elements: a) recruitment of smokers expressing a motivation to reduce or quit smoking, b) Consent process, c) nicotine and non-nicotine pharmacotherapy selection, screening, prescription, delivery, storage management (participation education, side-effecting monitoring), and return of unused drug supplies, d) Administration and perceived utility of motivational interviewing regarding smoking reduction and cessation, e) Delivery of study reimbursement, f) Utility of weekly text reminders of study participation and final endpoint, g) acceptability of outcome measures, h) acceptability and evaluation of joint project oversight with community stakeholders. The project will enroll eighty participants to determine feasibility endpoints. All participants will receive the intervention, as preferred by community partners. Participants will serve as the participants own control, which in turn means that the investigators will compare the intervention\'s effect at an individual level. All participants will be offered over a 4-week period both a long-acting nicotine controller medication (varenicline or nicotine patch) and short-acting medication to address acute urges to smoke (nicotine gum/lozenge). Each week participants will be monitored and receive cessation-directed counseling. If medication questions or concerns arise, patients will have access to 24-hour phone support. The results of the project will be reviewed with participants, community partners and academic team.

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Year 2018
Autori Jan Herman Kuiper, PhD - More
Registry of Trials clinicaltrials.gov
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Osteoarthritis (OA) is a very common disease of the joints, for which in the United Kingdom alone almost 9 million people have sought treatment. This painful disease affects the cartilage and bone inside the joint. Many factors are known to increase the risk of getting osteoarthritis, or the rate at which it gets worse. Very important among these factors is an injury or a defect of the cartilage. It was believed for hundreds of years that cartilage, once injured, does not heal. Research from the past 10 years is now throwing doubt on this old certainty, as researchers who took regular scans of volunteers over time noted that sometimes these defects come and then go. A Japanese group of surgeons decided to look again after a year to see what had happened to these defects, and noted that about half of them had got better! Cartilage defects in human therefore can heal, but nobody knows how this works. For many years, our Center has helped patients who have knee cartilage damage by using the patients\' own cartilage cells to help repair areas of damaged cartilage. This cell therapy starts by taking a piece of cartilage (10 mm) from the patient\'s knee, and this created defect always heals after a year. Thus, our proposal is to use our cell therapy patients as a human experimental model of natural cartilage healing using a wide range of techniques including Magnetic Resonance Imaging (MRI), visual inspection of the joint itself during knee joint surgery, examining biopsies of repair tissue down the microscope and measuring various kinds of molecules researchers think are important. The information gathered from these tests will help bridge the gap in our understanding of the mechanisms involved in the cartilage tissue regeneration.

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Year 2020
Autori [No authors listed]
Registry of Trials clinicaltrials.gov
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The role of neoadjuvant chemotherapy (NAC) in breast cancer is well established. In inoperable patients at the time of diagnosis, the goal of NAC is to achieve a pathologic complete response (pCR) which has shown that it improves disease-free survival when compared to those cases with residual tumoral cells. Detection of the presence of residual disease is crucial for surgical planning; the ultimate goal would be to avoid surgery in those patients who achieve a pCR, though nowadays validated techniques with power enough to detect this residual disease are lacking. Currently, several imaging techniques for NAC response assessment are being used (magnetic resonance imaging -MRI-, mammography and ultrasound), with good correlation in partial response, but they lack power in predicting complete pathological response; among them, nowadays the most accurate is MRI. In recent years, the use of the diffusion-enhanced images have been proposed for the quantitative characterization and for helping to improve the specificity of dynamic contrast study. The investigators propose to use a bi-exponential model, IVIM (Intravoxel incoherent motion), which differentiates between microperfusion used by microvascular blood flow from the diffusion of water. Kurtosis (DKI by Diffusion Kurtosis imaging) which quantifies the deviation from the Gaussian pattern and diffusion tensor image (DTI) which provides information on the microstructure and pathophysiology tumor, presenting a statistically significant relationship with tumor cellularity. Preliminary studies have reported promising results for the evaluation of the early response to systemic treatment in breast cancer patients. Its utility for NAC response assessment in these patients will be analysed. Recent studies have evaluated the application of contrast mammography in the assessment of the response to NAC, with MRI-like results. It is a faster and cheaper technique compared to MRI radiological evaluation of the response after NAC through this technique will be assessed and compared its results with the different techniques used in previous studies / in daily practice. Shear wave elastography is a very useful tool for the quantitative assessment of the tissue hardness that is widely used for differentiating benign lesions from malignant ones. Nowadays some studies are investigating its usefulness in the assessment of the radiological evaluation after NAC, with promising results in terms of early evaluation. In this study, the elastography will be performed on pre surgical evaluation and its correlation with pathological anatomy. In order to validate the technique, in those patients with a radiological complete response by all the radiological imaging methods, a stereotactic biopsy will be performed before surgery. After that, a comparison will be done between the results of the pre surgical biopsy and the definitive pathology of the specimen. If the false negative rate of the presurgical assessment including the biopsy are below 5%, patients could spare surgery when there is a complete radiological response. Objectives : To evaluate if patients with complete radiological response after NAC, in this setting can be spared breast surgery. . - To determine if IVIM, KURTOSIS or DTI diffusion sequences in MRI can assess the response to NAC better than conventional sequences and, thus, be able to avoid the use of intravenous contrast in the MRI study in the future. - To determine whether the study of breast elastography with shear wave technology, is more sensitive or specific in the detection of residual tumor after NAC in breast cancer. - To determining whether contrast enhanced mammography helps us to assess the response to NAC in breast cancer, compared to MRI standard practice. The expected results are: False negative rate of pre-surgery biopsy \<5%. Achieve a sensitivity \>80% for the radiological tests in predicting pCR for selected tumoral subtypes (Triple Negative and HER2 enriched tumors). Noninferiority of contrast mammography compared to breast MRI in determining the response to NAC.

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Year 2021
Autori lina Yu - More
Registry of Trials clinicaltrials.gov
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Central venous catheterization technology is a compulsory clinical skill for resident physicians. Because of its difficulty in operation and the possibility of serious complications, teaching this skill is a key and difficult point in clinical teaching in anesthesiology. This skill training has gone through the traditional \"apprentice mode\" teaching to the current video demonstration teaching, bedside feedback teaching, etc.. The attempts of multiple teaching modes are to help low-age resident doctors master the technology as soon as possible, improve the operation success rate, and reduce the incidence of complications. The Department of Anesthesiology in our hospital is a key base for the standardized training of anesthesiologists in China. In recent years, the introduction of video demonstration methods for the central venous catheterization technology of low-age residents has achieved some results. Residents watch the demonstration operation videos specially recorded by the department, and perform operation exercises after passing the pre-operation assessment. The trainees self-reported that the teaching mode increased their confidence in learning this skill. However,in the actual training process, bedside comments (feedback teaching) were also involved, and it was discovered that it could cause panic and dissatisfaction of the patient, which was later improved into the paper-based feedback of the teacher. The video demonstration teaching method was first applied to athletes\' competitive training and was found to be effective in improving athletes\' competitive skills.It was also used in medical education for surgical operation training, such as laparoscopic operation, which also obtained significant results. Feedback, as a method of attracting learners, has long been regarded as an important part of learning in medical education. We used bedside feedback teaching in the early stage, which was criticized by patients. Research has shown that video feedback may not only be superior to traditional verbal feedback methods alone, but it can also avoid problems from patients. When learners watch their own operation videos, video feedback will occur regardless of whether there is guidance from the instructor. Learners can watch these videos individually or with the teacher who can provide guidance at the same time. This teaching method is believed to be helpful for the assessment of skills. The use of video feedback originated from track and field sports learning. A large number of studies have found that video feedback teaching can be used as an effective means of medical communication skills training. Recently, it has also be used in clinical skills teaching. Current studies have confirmed that this teaching method can improve students\' confidence in learning skills, but there is still relatively little research on skill acquisition. In summary, video demonstration teaching and video feedback teaching are both useful in deliberate practice teaching (such as skill operation training). Skills operation training involves targeted repetitive exercises to improve skills, and feedback is the key to strengthening clinical learning. By video demonstrations, learners can observe and analyze the performance of experts (demonstrators) at key decision points under the guidance of the teacher. And video feedback can help promote self-assessment. It shows that the combination of the two may be more conducive to the integration of observational learning, imitation and self-evaluation, and speed up the progress of skill training. This joint teaching has been studied in sports research, while there are few studies in medical education. At present, a small study found that compared with oral feedback, the combined method can achieve better hernia repair skills, and there are recent research reports in peripheral vein indwelling operation training. But whether it is also suitable for the operation training of high-risk skills with greater difficulty coefficient, it needs to be confirmed by further research. This project intends to observe the impact of video demonstration combined with video feedback teaching on the central venous catheterization time of low-age resident physicians, aiming to obtain a better method of central venous catheterization skills training, and to improve the learning confidence of students to better master this skill, improve the success rate of operation, reduce complications, and promote the application.

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Year 2024
Autori Hunter-Barnett S , Viney M - More
Giornale Parasitology
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Year 2021
Autori Anna S Bratt, PhD - More
Registry of Trials clinicaltrials.gov
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Reactions to severe stress is one of the most common causes of sick leave in Sweden. Previous research has shown that compassion interventions for staff can affect work-related stress by increased self-care, better self-awareness and an increased healthy attitude, however, Swedish studies on the subject are scarce. Compassion is a motivation to reduce suffering in oneself and others characterized by a warm, understanding, and respectful attitude. In addition to beneficial effects for the staff, a compassion-oriented approach, has shown to improve the relationship between patient and staff, increase patient satisfaction with care and reduce patient anxiety and stress. As a result of the covid-19 pandemic, healthcare professionals have been exposed to difficult physical and mental work conditions that cause feelings of stress and inadequacy. In the long run, increased stress can cause fatigue and increased number of sick leaves. This can in turn contribute to increased stress for the staff who remain working and difficulties to recruit new staff, which make the situation worse. There is a lack of interventions for staff aimed at preventing stress-related health issues, enabling recovery and reduce mental suffering linked to a stressful work situations. The aim of this study is to find a method that help healthcare providers cope with stress of conscience in relation to stressful work situations, particularly during the current covid-19 pandemic. A five week internet-based compassion course of five modules will be conducted and evaluated with the aim of exploring whether the course contributes to reduce stress of conscience and work-related stress, and increases the levels of professional quality of life and self-compassion among healthcare professionals. The internet-based compassion course will be compared with: one group that is on a waiting list for ten weeks and then receives an internet-based general stress management course and one group that participate in the general stress management course.

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Year 2021
Autori David Maahs, MD - More
Registry of Trials clinicaltrials.gov
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This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening. Seropositive subjects (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative subjects will be discontinued from study participation (screen failures). Subjects who meet Visit 1 protocol enrollment criteria will be enrolled.

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Year 2021
Autori [No authors listed]
Registry of Trials clinicaltrials.gov
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A Multi-center Randomized Control Single Cross-over Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema. To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD) in a multi-centered setting to evaluate volume, quality of life, safety, adherence, and preference.

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Year 2021
Autori Jianfeng Zhou, PhD, MD - More
Registry of Trials clinicaltrials.gov
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Current treatments for relapsed/refractory hematopoietic malignancies such as B-cell lymphomas (BCLs) and peripheral T-cell lymphomas (PTCLs) are far from satisfactory. CD5 is widely expressed in multiple subtypes of BCLs and PTCLs but rarely found in normal tissues except certain types of lymphocytes. Chimeric antigen receptor (CAR) T cells against CD5 offer another potential therapeutic option for patients with relapsed/refractory CD5 positive hematopoietic malignancies. In the current study, the safety and efficacy of a novel CAR T cell therapy, termed CT125A cells, are evaluated in patients with relapsed/refractory CD5+ hematopoietic malignancies. The endogenous CD5 in CT125A cells is knocked out via CRISPR/Cas9 genome editing technology to prevent fratricide during CAR T cells manufacturing.

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Year 2021
Registry of Trials clinicaltrials.gov
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There exist very few effective treatments that ease the intelligibility burden of dysarthria, and all of these require cognitive and physical effort on the part of the speaker to achieve and maintain gains. Therefore, individuals with intelligibility deficits whose cognitive and physical impairments limit their ability to modify their speech are currently not viable treatment candidates. This constitutes a significant health disparity that disproportionately affects those clinical populations with developmental, cognitive, and/or significant neuromuscular impairment. To address this critical gap in current dysarthria management, the weight of behavioral change is shifted from the speaker to the listener. While a novel concept for dysarthria management, the idea is firmly rooted in the field of psycholinguistics and supported by a programmatic body of research showing that listener-targeted perceptual training paradigms (wherein listeners are familiarized with the degraded speech signal and provided with an orthographic transcription of what the speaker is saying) result in statistically and clinically significant intelligibility gains in dysarthria. Further, preliminary evidence suggests that these intelligibility outcomes may be influenced by hypothesis-driven speaker parameters, such as acoustic predictability of speech rhythm cues, and listener parameters, such as expertise in rhythm perception. A requisite next step to bringing listener-targeted perceptual training closer to clinical implementation, and the overarching goal of this clinical trial, is the systematic and rigorous analysis of the speaker and listener parameters, and their interactions, that modulate, and in some cases optimize, perceptual training benefits of intelligibility improvement. To achieve this aim, an existing database of dysarthric speech (20 speakers with dysarthria) and a large cohort of listeners (n = 400) across two well-established testing sites, Utah State University and Florida State University are utilized. Thus, the key deliverable resulting from this work will be explanatory models that account for the unique and joint contributions of speaker and listener parameters on the magnitude of intelligibility improvement following perceptual training with dysarthric speech.

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