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This report provides a summary of sessions on health digitalization, the application of the new European regulations and lessons learnt from COVID-19.In May of 2019, the adeno-associated virus (AAV)-based gene therapy onasemnogene abeparvovec-xioi (Zolgensma) became the second Food and Drug Administration (FDA)-approved gene therapy with designated use for infants diagnosed with spinal muscular atrophy (SMA). The decision came nearly 10 years after results of the first preclinical models were initially reported. While the journey was an arduous one, the approval was an indication of the remarkable success of the first in-human clinical trials. According to the traditional classification system of autosomal recessive SMA, of which there are multiple types with phenotypic variability, SMA type 1 is the most common and most severe and represents 45% of the SMA patient population. Children with SMA type 1 cannot lift their heads without assistance and do not live past their second birthday. With Zolgensma, the first treated children with SMA type 1 have reached 5 years of age and some of them achieved the ability to sit unassisted or even walk. In this article, we review the work that led to FDA approval with emphasis on the development of preclinical and clinical studies.Small cell lung cancer (SCLC) is a rapidly progressive, aggressive metastatic and lethal subtype of lung cancer. Unfortunately, there has been little progress regarding the development of novel treatments for SCLC. However, lurbinectedin, a transcriptional inhibitor, has emerged as a potential novel treatment for cancer. It produces antitumor efficacy by inhibiting oncogenic transcription activity, inducing the accumulation of DNA double-strand breaks and modulating the tumor microenvironment (TME). Data from phase I/II trials indicates that lurbinectedin has significant antitumor efficacy and tolerable adverse effects in SCLC patients. Furthermore, lurbinectedin is efficacious in platinum-sensitive and platinum-resistant SCLC patients and in those with SCLC relapse after second-line treatment. In 2020, the U.S. Food and Drug Administration (FDA) approved lurbinectedin for the treatment of adult patients with metastatic SCLC or for patients that have received platinum-based chemotherapy. In this review, we discuss the molecular profile and the preclinical and clinical studies of lurbinectedin in the treatment of SCLC patients.Hepatocellular carcinoma (HCC) is a worldwide problem, with a high prevalence in nonindustrialized countries and a rising incidence in industrialized countries. Its close association with chronic liver diseases and liver cirrhosis represents a significant challenge in its treatment. Sorafenib, the first front-line systemic treatment for unresectable HCC cases, was approved only in 2007. The role of sorafenib remained largely unchallenged until very recently, with the sole exception of a trial demonstrating the noninferiority of lenvatinib, another tyrosine kinase inhibitor. click here The therapeutic scenario changed dramatically in 2020, when the combination of atezolizumab and bevacizumab proved to be significantly superior to sorafenib and, thus, establishing a new standard of care. In this monograph we provide an update about the safety and efficacy of atezolizumab reported in the clinical trials of HCC, as monotherapy or in combination with other agents.Neurodegeneration plays a significant role in the complex pathology of diabetic retinopathy. Evidence suggests the onset of neurodegeneration occurs early on in the disease, and so a greater understanding of the process is essential for prompt detection and targeted therapies. Neurodegeneration is a common pathway of assorted processes, including activation of inflammatory pathways, reduction of neuroprotective factors, DNA damage, and apoptosis. Oxidative stress and formation of advanced glycation end products amplify these processes and are elevated in the setting of hyperglycemia, hyperlipidemia, and glucose variability. These key pathophysiologic mechanisms are discussed, as well as diagnostic modalities and novel therapeutic avenues, with an emphasis on recent discoveries. The aim of this article is to highlight the crucial role of neurodegeneration in diabetic retinopathy and to review the molecular basis for this neuronal dysfunction, its diagnostic features, and the progress currently made in relevant therapeutic interventions.
Surgical stabilization of the airway through tracheobronchoplasty (TBP) is the current treatment modality for patients with severe symptomatic excessive dynamic airway collapse. However, TBP is associated with increased morbidity and mortality. Bronchoscopic treatment of the posterior membrane using argon plasma coagulation (APC) may be a safer alternative to TBP in highly selected patients. This study aimed to evaluate the effect of APC in the tracheobronchial tree of a sheep animal model.

Two adult sheep were used for this study. Under flexible bronchoscopy, the posterior tracheal membrane was treated with precise APC using different power settings. Chest computed tomography was done at 2 days and bronchoscopy was performed at 30 days following initial procedure, before euthanasia. The airways were assessed for the presence of treatment-related histopathologic changes along with expression of genes associated with fibrosis.

There was no perioperative or postoperative morbidity or mortality. Chest computed tomography showed no signs of pneumomediastinum or pneumothorax. Flexible bronchoscopy showed adequate tracheobronchial tissue healing process, independent of the power settings used. Histologic changes demonstrated an increased extent of fibroblastic collagen deposition in the treated posterior membrane when higher power settings were used. In a similar manner, APC treatment managed to activate fibrosis-associated gene transcription factors, with higher settings achieving a higher level of expression.

APC at high-power settings achieved higher levels of fibroblast collagen deposition at the posterior membrane and higher expression of fibrosis-associated gene transcription factors, when compared with lower settings.
APC at high-power settings achieved higher levels of fibroblast collagen deposition at the posterior membrane and higher expression of fibrosis-associated gene transcription factors, when compared with lower settings.
Autoimmune pulmonary alveolar proteinosis is an ultra-rare pulmonary disease. Whole lung lavage (WLL) is considered the gold standard therapy. We report a protocol for a new modified lavage technique (nMLT) in which controlled repetitive manual hyperinflation (MH) and intermittent chest percussion are used to enhance WLL efficacy.

We included all subjects with autoimmune pulmonary alveolar proteinosis treated with nMLT between 2013 and 2018. nMLT consisted of repetitive MH with intermittent chest percussion every third wash. We reported instilled volume, protein concentration, and optical density using spectrophotometry. Pulmonary function (FVC %predicted and DLCO %predicted) at start of nMLT was recorded. Data are displayed as mean (±SD), median [interquartile range], or number (%). Comparisons within individuals were made using Students t test.

We included 11 subjects (64% male) in whom a total of 67 nMLTs were performed. One nMLT consisted of 15 [12-18] washes. Protein removal was 9.80 [7.52-12.66] g per nMLT. After the first, second, and third cycle of 3 washes, 56% [49% to 61%], 81% [77% to 84%], and 91% [88% to 94%] of the final protein yield was removed, respectively. Optical density was measured 116 times and increased from 1.13 (±0.52) to 1.31 (±0.52) after MH (P<0.001).

Efficacy of WLL seems to be enhanced by applying MH every 3 washes. Our technique of WLL with nMLT could be used to increase the amount of protein recruited while instilling the lung with the smallest volume of fluid as possible.
Efficacy of WLL seems to be enhanced by applying MH every 3 washes. Our technique of WLL with nMLT could be used to increase the amount of protein recruited while instilling the lung with the smallest volume of fluid as possible.
Ado-trastuzumab emtansine (T-DM1) was recently approved for patients with human epidermal growth factor receptor 2 positive (HER2+) early breast cancer (eBC) with residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Cost-effectiveness analysis was conducted to compare T-DM1 versus trastuzumab in the United States.

A Markov cohort-based model tracked clinical and economic outcomes over a lifetime horizon from a US payer perspective. The model included 6 health states invasive disease-free, nonmetastatic (locoregional) recurrence, remission, first-line and second-line metastatic BC and death. Model state transitions were based on statistical extrapolation of the head-to-head KATHERINE study and published sources. Dosing and treatment duration reflected prescribing information and trials. Costs (2019 US dollars) associated with pharmaceutical treatment (wholesale acquisition costs), health state specific care, adverse events, and end-of-life care were included. Health state uti treatment is likely to reduce the overall financial burden of cancer, while simultaneously improving patient outcomes.
Relative to trastuzumab, T-DM1 treatment for patients with HER2+ eBC who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment is likely to reduce the overall financial burden of cancer, while simultaneously improving patient outcomes.
This scoping review summarizes the extent, nature, and type of evidence linking broadly defined maternal cognitions to motor outcomes in infants born preterm. Maternal cognitions are beliefs, perceptions, or psychosocial attributes that inform parenting practices.

Arksey and O'Malley's 5-step method was applied. Thirteen articles between 1980 and November 2019 met inclusion criteria.

Two key themes emerged with infants born preterm (1) quality of the social and physical caregiving environment influence developmental outcomes with implications for motor development; and (2) complex interactions between environmental factors, prematurity-related biomedical risks, and maternal cognitions contribute to eventual motor outcomes.

Further research is needed to understand how maternal cognitions either scaffold or constrain early motor opportunities for infants born preterm and at risk for motor delays.

This review summarizes studies that explore potential links between maternal cognitions and motor development in infants born preterm.
This review summarizes studies that explore potential links between maternal cognitions and motor development in infants born preterm.
To conduct a pilot study to assess the feasibility and effectiveness of an intensive bimanual intervention on upper limb function in children who have undergone hemispherectomy.

Thirteen children received 90 hours of intensive bimanual training (Hand-Arm Bimanual Intensive Therapy, HABIT). The Jebsen-Taylor Test of Hand Function (JTTHF), Box and Block Test (BBT), Assisting Hand Assessment (AHA), ABILHAND-Kids, and Canadian Occupational Performance Measure (COPM) were assessed by a masked clinician twice before, immediately, and 6 months after treatment.

Significant improvements over time were found in the JTTHF, AHA, ABILHAND-Kids, and COPM.

Completion of HABIT was feasible for children with hemispherectomy. Improvement of bimanual function and functional goals can be related to the nature of the activities prioritized in HABIT training.
Completion of HABIT was feasible for children with hemispherectomy. Improvement of bimanual function and functional goals can be related to the nature of the activities prioritized in HABIT training.
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