Search results for "clinical research"
showing 10 items of 474 documents
Periodontal microcirculation in diabetics: An in vivo non-invasive analysis by means of videocapillaroscopy
2012
Summary Background Diabetes mellitus is today considered a society-wide disease of a chronic/degenerative nature. Among the secondary effects of diabetes, the one that interests the dental surgeon most is diabetic parodontopathy. The aim of this study was to underline and objectify microcirculatory variations at a periodontal mucous level in type 2 diabetics. Material/Methods The study enrolled 80 subjects: 40 subjects with a diagnosis of diabetes mellitus type II (18 males and 22 females, between 44 and 85 years of age); and 40 healthy subjects (17 males and 23 females, between 44 and 78 years of age). All the subjects, both diabetic and healthy, were submitted to a videocapillaroscopic ex…
Pharmacokinetics, pharmacodynamics, and safety of moss-aGalactosidase A in patients with Fabry disease.
2019
Moss-aGalactosidase A (moss-aGal) is a moss-derived version of human α-galactosidase developed for enzyme replacement therapy in patients with Fabry disease. It exhibits a homogenous N-glycosylation profile with >90% mannose-terminated glycans. In contrast to mammalian cell produced α-galactosidase, moss-aGal does not rely on mannose-6-phosphate receptor mediated endocytosis but targets the mannose receptor for tissue uptake. We conducted a phase 1 clinical trial with moss-aGal in six patients with confirmed diagnosis of Fabry disease during a 28-day schedule. All patients received a single dose of 0.2 mg/kg moss-aGal by i.v.-infusion. Primary endpoints of the trial were safety and pharmaco…
Soft tissue cell adhesion to titanium abutments after different cleaning procedures: preliminary results of a randomized clinical trial
2013
Objectives: A randomized controlled trial was performed to assess soft tissue cell adhesion to implant titanium abutments subjected to different cleaning procedures and test if plasma cleaning can enhance cell adhesion at an early healing time. Study Design: Eighteen patients with osseointegrated and submerged implants were included. Before re-opening, 18 abutments were divided in 3 groups corresponding to different clinical conditions with different cleaning processes: no treatment (G1), laboratory customization and cleaning by steam (G2), cleaning by plasma of Argon (G3). Abutments were removed after 1 week and scanning electron microscopy was used to analyze cell adhesion to the abutment…
Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF -mutant melanoma (COLUMBUS): a multicentre, open-label, randomis…
2017
Summary Background Combined BRAF-MEK inhibitor therapy is the standard of care for BRAF V600 -mutant advanced melanoma. We investigated encorafenib, a BRAF inhibitor with unique target-binding properties, alone or in combination with the MEK inhibitor binimetinib, versus vemurafenib in patients with advanced BRAF V600 -mutant melanoma. Methods COLUMBUS was conducted as a two-part, randomised, open-label phase 3 study at 162 hospitals in 28 countries. Eligible patients were aged 18 years or older and had histologically confirmed locally advanced (American Joint Committee on Cancer [AJCC] stage IIIB, IIIC, or IV), unresectable or metastatic cutaneous melanoma, or unknown primary melanoma; a B…
Liebowitz Social Anxiety Scale (LSAS): Optimal cut points for remission and response in a German sample
2017
The Liebowitz Social Anxiety Scale (LSAS) is the most frequently used instrument to assess social anxiety disorder (SAD) in clinical research and practice. Both a self-reported (LSAS-SR) and a clinician-administered (LSAS-CA) version are available. The aim of the present study was to define optimal cut-off (OC) scores for remission and response to treatment for the LSAS in a German sample. Data of N = 311 patients with SAD were used who had completed psychotherapeutic treatment within a multicentre randomized controlled trial. Diagnosis of SAD and reduction in symptom severity according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th editi…
Can a meditation app help my sleep? A cross-sectional survey of Calm users
2021
Use of mindfulness mobile apps has become popular, however, there is little information about subscribers’ perceptions of app content and its impact on sleep and mental health. The purpose of this study was to survey subscribers to Calm, a popular mindfulness meditation app, to explore perceived improvements in sleep and mental health, evaluate what components of the app were associated with improvements in sleep and mental health, and determine whether improvements differed based on sleep quality. Calm subscribers who had used a sleep-related component in the last 90 days completed a Web-based investigator-developed survey and the Pittsburgh Sleep Quality Index. The survey included questio…
Diabetic Microagiopathy of Oral Mucosa Depends on Disease Duration and Therapy
2017
Background: Diabetes mellitus is a chronic degenerative systemic disease whose prevalence is increasing. This paper aims to evaluate the effects of diabetic microangiopathy, depending on its duration and the type of treatment administered, by using polarized light videocapillaroscopy of the oral mucosa. Material/Methods: We enrolled 120 subjects: 60 healthy subjects and 60 patients with diabetes mellitus. In turn, patients were divided into 3 subgroups according to the type of diabetes, the duration of the disease, and the type of treatment administered. A videocapillaroscopic examination of the oral mucosa was carried out on the diabetic and healthy subjects. Results: Changes in microcircu…
The Vaccination Concerns in COVID-19 Scale (VaCCS) : Development and validation
2022
Vaccines are highly effective in minimizing serious cases of COVID-19 and pivotal to managing the COVID-19 pandemic. Despite widespread availability, vaccination rates fall short of levels required to bring about widespread immunity, with low rates attributed to vaccine hesitancy. It is therefore important to identify the beliefs and concerns associated with vaccine intentions and uptake. The present study aimed to develop and validate, using the AMEE Guide, the Vaccination Concerns in COVID-19 Scale (VaCCS), a comprehensive measure of beliefs and concerns with respect to COVID-19 vaccines. In the scale development phase, samples of Australian (N = 53) and USA (N = 48) residents completed a…
Prospective Trial of Functional Thyrotropin Receptor Antibodies in Graves Disease
2019
Abstract Context Scarce data exist regarding the relevance of stimulatory (TSAb) and blocking (TBAb) thyrotropin receptor antibodies in the management of Graves disease (GD). Objective To evaluate the clinical utility and predictive value of TSAb/TBAb. Design Prospective 2-year trial. Setting Academic tertiary referral center. Patients One hundred consecutive, untreated, hyperthyroid GD patients. Methods TSAb was reported as percentage of specimen-to-reference ratio (SRR) (cutoff SRR < 140%). Blocking activity was defined as percent inhibition of luciferase expression relative to induction with bovine thyrotropin (TSH, thyroid stimulating hormone) alone (cutoff > 40% inhibitio…
Sexuality in autism: hypersexual and paraphilic behavior in women and men with high-functioning autism spectrum disorder
2017
Like nonaffected adults, individuals with autism spectrum disorders (ASDs) show the entire range of sexual behaviors. However, due to the core symptoms of the disorder spectrum, including deficits in social skills, sensory hypo- and hypersensitivities, and repetitive behaviors, some ASD individuals might develop quantitatively above-average or nonnormative sexual behaviors and interests. After reviewing the relevant literature on sexuality in high-functioning ASD individuals, we present novel findings on the frequency of normal sexual behaviors and those about the assessment of hypersexual and paraphilic fantasies and behaviors in ASD individuals from our own study. Individuals with ASD see…