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Clinical Approvals Research

07:52 EST 18th December 2018 | BioPortfolio

Evaluation of a multidisciplinary training program in magnetic resonance imaging of patients with axial spondyloarthritis: PROGRESSES Project.

To analyze the impact of a multidisciplinary training program in magnetic resonance imaging (MRI) for axial spondyloarthritis in daily clinical practice.

Drawing lessons from the clinical development of antibody-drug conjugates.

The antibody-drug conjugate (ADC) field has seen a remarkable expansion in the number of entrants in clinical studies. Many of these agents employ newer conjugation technologies that have been developed over the last decade that confer various attributes to the ADCs prepared with them, including stability, potency, and homogeneity. In many cases, these new ADCs appear demonstrably superior to earl...

Enzymatic strategies for (near) clinical development of antibody-drug conjugates.

Target-specific killing of tumor cells with antibody-drug conjugates (ADCs) is an elegant concept in the continued fight against cancer. However, despite more than 20 years of clinical development, only four ADC have reached market approval, while at least 50 clinical programs were terminated early. The high attrition rate of ADCs may, at least in part, be attributed to heterogeneity and instabili...

Bispecifics and antibody-drug conjugates: A positive synergy.

Bispecific antibodies (BsAbs) are antibodies with two different paratopes. In the past decade, advances in protein engineering have enabled the development of more than 100 formats of BsAbs. With two BsAbs approved for therapeutic use and more than 60 in clinical trials, this research area has shifted from being effervescent to being a mainstream therapeutic development topic. In parallel, recent ...

Use of pyrrolobenzodiazepines and related covalent-binding DNA-interactive molecules as ADC payloads: Is mechanism related to systemic toxicity?

Antibody-drug conjugates (ADCs) consist of monoclonal antibodies (mAbs) or antibody fragments conjugated to biologically active molecules (usually highly cytotoxic small molecules) through chemical linkers. Although no ADCs containing covalent-binding DNA-interactive payloads have yet been approved (although two containing the DNA-cleaving payload calicheamicin have), of those in clinical trials s...

Amanitins and their development as a payload for antibody-drug conjugates.

Amanitin-based ADCs represent a new class of ADCs using a novel mode of action. This payload introduces a novel mode of action into oncology therapy, the inhibition of RNA Polymerase II. The high potency of the toxin leads to highly efficacious ADCs. The development of the technology around this toxin will be described. These developments support the clinical development of amanitin-based ADCs by ...

Mutation screening of SLC52A3, C19orf12, and TARDBP in Iranian ALS patients.

Mutations in the same gene are sometimes the cause of different clinically diagnosed neurologic disorders; this emphasizes interrelationships between various neurologic diseases. In this light, we screened SLC52A3, which is the cause of Brown-Vialetto-Van Laere syndrome, and C19orf12, which is the cause of neurodegeneration with brain iron accumulation in 60 Iranian amyotrophic lateral sclerosis (...

Genetic alterations of driver genes as independent prognostic factors for disease-free survival in patients with resected non-small cell lung cancer.

This study assessed the associations between the molecular signatures and clinical information in non-small cell lung cancer (NSCLC) patients with postoperative disease-free survival (p-dfs) to identify novel prognostic factors, focusing on associations with driver gene alterations.

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Oral exposure to mite allergens: Sensitizer or tolerogenic?

Preoperative Low-dose and High-dose Pregabalin and Cardiovascular Response to Endotracheal Intubation: A Prospective, Randomized, Single-blind, Controlled Study in China.

A prospective, randomized, single-blind, controlled clinical study was designed to evaluate the efficacy and tolerability of preoperative pregabalin on cardiovascular response to laryngoscopy and endotracheal intubation.

Mid-term clinical outcomes of out-of-hospital cardiac arrest patients treated with targeted temperature management at 34-36 °C versus 32-34 °C.

Targeted temperature management (TTM) in comatose survivors of out-of-hospital cardiac arrest has been associated with improved neurological outcomes. However, the optimal temperature target for TTM remains unclear.

Clinical Cybersecurity Training Through Novel High-Fidelity Simulations.

Cybersecurity risks in health care systems have traditionally been measured in data breaches of protected health information, but compromised medical devices and critical medical infrastructure present risks of disruptions to patient care. The ubiquitous prevalence of connected medical devices and systems may be associated with an increase in these risks.

Rehabilitation of social cognition impairment after traumatic brain injury: A systematic review.

Many studies have described the presence of difficulty processing and generating social behaviour in patients who have suffered a traumatic brain injury (TBI). These difficulties in social cognition (SC) deteriorate personal relationships in the family, at work, or in the community. However, therapeutic programmes aiming to improve SC continue to be an outstanding issue in clinical practice. We pe...

Muscle loss: The new malnutrition challenge in clinical practice.

Recent definitions of malnutrition include low muscle mass within its diagnostic criteria. In fact, malnutrition is one of the main risk factors of skeletal muscle loss contributing to the onset of sarcopenia. However, differences in the screening and diagnosis of skeletal muscle loss, especially as a result of malnutrition in clinical and community settings, still occur mainly as techniques and t...

Mediterranean diet and knee osteoarthritis outcomes: A longitudinal cohort study.

Mediterranean diet has several beneficial effects on health, but data regarding the association between Mediterranean diet and knee osteoarthritis (OA) are limited mainly to cross-sectional studies. We investigated whether higher Mediterranean diet adherence is prospectively associated with lower risk of radiographic OA (ROA), radiographic symptomatic knee OA (SxOA) and pain worsening in North Ame...

Accuracy of Response Assessment Positron Emission Tomography-Computed Tomography Following Definitive Radiotherapy Without Chemotherapy for Head and Neck Squamous Cell Carcinoma.

There are few data to inform on the use of response assessment 2-[fluorine-18]-fluoro-2-deoxy-d-glucose (FDG) positron emission tomography-computed tomography (PET-CT) following radical radiotherapy without chemotherapy for head and neck squamous cell carcinoma (HNSCC). This retrospective study evaluated the accuracy of PET-CT in HNSCC following radical radiotherapy.

Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes.

We performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience.

Influence of limb alignment and prosthetic orientation on patient-reported clinical outcomes in total knee arthroplasty.

The relationship between postoperative limb alignment and clinical outcomes in primary total knee arthroplasty (TKA) is well reported, but the instruments used to evaluate clinical outcomes of TKA are mainly scoring systems from the physician's viewpoint, not patient-reported outcomes. The purpose of this study was to investigate retrospectively the relationship between postoperative limb alignmen...

A 20-year prospective longitudinal MRI study on cervical spine after whiplash injury: Follow-up of a cross-sectional study.

Some patients suffer from long-lasting symptoms after whiplash injury. However, there are few reports on the long-term changes in the cervical spine after whiplash injury using imaging tests. The purpose of this longitudinal study was to determine the changes on MRI of the cervical spine 20 years after whiplash injury, and to examine the relationships between changes in the cervical spine on MRI a...

Clinical and radiographic outcomes of a hybrid fixation revision total knee arthroplasty system at short to mid-term follow-up.

Despite the extensive study of primary arthroplasty, revision surgery is rarely discussed due to the reduced frequency and variability between patients. A new revision knee system was introduced to build off the geometry of a successful knee replacement system. This study seeks to assess the survival, clinical outcomes and radiographic assessment of this revision system at the early to mid-term.

An unusual case of gastrointestinal basidiobolomycosis mimicking colon cancer; literature and review.

Gastrointestinal basidiobolomycosis (GIB), a rare fungal infection associated with high mortality, has been reported worldwide mainly from tropical and subtropical regions of Asia, USA, and Latin America. The clinical manifestations are highly diverse and non-specific depending on the underlying disease, but fever, abdominal pain, weight loss, diarrhea, constipation and chills have been observed. ...

Changing outlook for colorectal liver metastasis resection in the elderly.

This study sought to evaluate the impact of the advancements in clinical care, obtained over the last 20 years, for patients aged 70 and older undergoing liver resection for colorectal liver metastases (CRLM).

Clinical management decisions for adults with prolonged acute cough: Frequency and associated factors.

Uncomplicated episodes of prolonged acute cough are usually viral and self-limited, but despite evidence and recommendations to the contrary, they are often treated with antibiotics.

Reading the palm with MUNIX: A 'reversed split hand' in spinal muscular atrophy.

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