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Filter by:This study is primarily aimed to investigate whether PROs can be improved after the initiation of BGF pMDI in real world clinical settings. While the study is 12-weeks in duration, the initial 4-week period will be used to assess immediate onset of benefits while the full study length will serve to demonstrate durability in response. Study design: This is a 12-week, multi-center, prospective observational study in which a total number of 107 patients will be enrolled. Adult outpatients with COPD without asthma history and who initiate on BGF pMDI as decided by the physicians in their routine clinical care will be consecutively invited for this study. Investigators (physicians) make screening their patients prior to the study entry and make informed consent explanation at their usual visit timing to the all eligible patients. After fulfilling eligibility criteria at study entry, the patients are enrolled in the study and the investigators will follow up the patients as in routine clinical practice and collect the data at baseline, at week 4 and week 12. Data Source(s): The study sites will be selected where BGF pMDI is used as a treatment option for COPD patients. Investigators participating in the study evaluate lung function (i.e., spirometry) for COPD patients in a daily practice Statistical Analysis: All data including patient characteristics at baseline will be summarized using appropriate descriptive statistics. Where applicable, changes from baseline at each timepoint will also be summarized using descriptive statistics. A comprehensive statistical analysis plan (SAP) including more details will be prepared prior to the database lock.
The objective of this study is to determine the effects of the ketogenic diet on the frequency of non-epileptic seizures in patients with functional neurological symptoms disorder compared to a healthy diet.
The purpose of this study is to assess the safety and effectiveness in the real-world setting among participants who are treated with Azacitidine in accordance with the China Product Label.
An obstetric anal sphincter injury (OASI) occurs during the final stage of a vaginal delivery. This tissue laceration, even if adequately sutured, poses a substantial threat to bowel continence in women.1,2 In a recent register-based study we showed that following an OASI at the first birth, the risk of a repeat injury almost tripled and that the long-term prevalence of fecal incontinence (FI) doubled in women with 1 OASI and tripled in those with 2 consecutive OASIs, in comparison with nulliparous women not affected by childbirth.3 Most OASIs occur seemingly by chance in the absence of known risk markers, and there is still no prediction model that is of use to avoid OASI in the clinical setting.4 Therefore, these injuries are often excused as inevitable and impossible to foresee. The aim of this study is to develop and validate prediction models for the risk of an OASI in high- and low-risk scenarios.
This study will assess whether a modification in the default dose and frequency (the first option a provider sees) during electronic prescribing of a high-risk drug can impact prescribing behavior and subsequent changes in average dose for the targeted high-risk drug, when prescribed to a hospitalized patient aged ≥65 years. In this cluster randomized crossover (CRXO) trial we will randomize a non-intrusive "nudge" intervention, which involves modifying the default dose for high-risk drugs when prescribed electronically to hospitalized patients aged ≥65 years. The CRXO trial involves 10 sites in an urban health system: five sites will start the trial under the intervention/control during a first time period (T1) after which they switch intervention/control status (T2). The primary outcome is prescription rate of a lower default dose (i.e. the geriatric standard) for 8 high-risk drugs. This study will inform the effectiveness of EHR-based "nudge" interventions to reduce inappropriate prescribing of high-risk drugs for elderly patients. Analyses ongoing, expected to finalize spring 2023
Purpose: This study aims to investigate the demonstrability of increased inflammation and neurodegeneration in multiple sclerosis (MS) patients in relapse period compared to MS patients in remission by cross-sectional analysis of in-vivo corneal confocal microscopy (IVCM), and to evaluate the alternations with a second IVCM administered at least 6 months after the relapse period. Methods: This prospective, non-randomized-controlled, cross-sectional study included 58 MS patients which were grouped regarding the presence of relapse (MS-Relapse group [n=27] and MS-Control group [n=31]), and age-sex matched 30 healthy controls (HC). The corneal nerve fiber density (CNFD), the corneal nerve branch density (CNBD), the corneal nerve fiber length (CNFL), and dendritic cell (DC) density were evaluated in all MS patients and HCs by IVCM. If the patients in the MS-relapse group did not have an attack within 6 months, the same parameters were evaluated with the second IVCM. The patients with a history of optic neuritis or trigeminal symptoms were excluded.
This between-subject, longitudinal pilot study in healthy college students aims to explore the acceptability and preliminary outcomes of two novel and complementary interventions that may improve stress and sleep: transcutaneous vagus nerve stimulation (tVNS) and a mobile mindfulness intervention.
The Er:YAG laser possesses specific characteristics allowing to be used in non-surgical periodontal treatment. The aim of the resent study was to evaluate the long-term clinical effectiveness of Er:YAG laser monotherapy in the treatment of moderate chronic periodontitis and to compare it with conventional hand instrumentation. MATERIALS AND METHODS: 451 teeth (1,099 periodontal pockets) from 30 patients with moderate chronic periodontitis (initial probing pocket depth 4 to 6 mm) were allocated for subgingival scaling and root planing in two groups - hand instrumentation (control) and Er:YAG laser instrumentation with 100mJ/15Hz (test). Using a computerized periodontal probe, patients were examined for probing pocket depth (PPD), gingival recession (GR), clinical attachment level (CAL), bleeding on probing (BOP), plaque presence (FMPS) at baseline, one, three, six and 12 months after instrumentation.
The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis.
High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems. It is a heterogeneous group of premature infants born under thirty-seven weeks of age, with infants with low birth weight, term or developmental retardation for various reasons. Therefore, preterm infants with low birth weight can survive with a neurological sequelae such as cerebral palsy (CP), epilepsy, hearing and vision loss, mental retardation, speech and speech problems, and learning difficulties. The clinical diagnosis of CP, which can be observed in high-risk infants, is based on the combination of some neuroimaging and neurological examinations and assesments like neonatal imaging, general movements (GMs) and Hammersmith Infant Neurological Examination (HINE).