Evaluation of the safety and potential lipid-lowering effects of oral hydrogen-rich coral calcium (HRCC) capsules in patients with metabolic syndrome: a prospective case series study.

Background: Metabolic syndrome is characterized by a cluster-like occurrence of conditions such as hypertension, hyperglycaemia, elevated low-density lipoprotein (LDL) cholesterol or triglycerides (TG) and high visceral fat. Metabolic syndrome is linked to the build-up of plaque within the artery, which leads to disorders of the circulatory, nervous and immune systems. A variety of treatments target the regulation of these conditions; nevertheless, they remain dominant risk factors for the development of type 2 diabetes (T2DM) and cardiovascular disease (CVD), which affect 26.9% of the US population. Management and intervention strategies for improving cholesterol and/or TG are worthwhile, and recent studies on hydrogen treatment are promising, particularly as molecular hydrogen is easily ingested. This study aimed to investigate the lipid-lowering effects and quality of life (QOL) improvement of hydrogen-rich coral calcium (HRCC) in patients with metabolic syndrome. Methods: The patients, all Taiwanese, were randomly assigned to 3 different doses (low, medium, and high) of HRCC capsules. The primary outcome was the adverse effects/symptoms during this 4-week use of HRCC capsules. The secondary outcome was lipid profile changes. Complete blood count, inflammatory biomarkers, and QOL were also measured before and after the course of HRCC. Results: Sixteen patients with metabolic syndrome completed this study (7 males, 9 females; mean age: 62 years; range: 32-80). No obvious adverse effects were recorded. Only changes in blood TG reached significance. The baseline TG value was 193.19 µL (SD = 107.44), which decreased to 151.75 µL (SD = 45.27) after 4 weeks of HRCC (p = 0.04). QOL showed no significant changes. Conclusion: This study is the first human clinical trial evaluating HRCC capsules in patients with metabolic syndrome. Based on the safety and potential TG-lowering effects of short-term HRCC, further long-term investigations of HRCC are warranted. Clinical trial registration: [ClinicalTrials.gov], identifier [NCT05196295].

The effects of hydrogen treatment in a cigarette smoke solution-induced chronic obstructive pulmonary disease-like changes in an animal model.

Background: Molecular hydrogen, with its antioxidant and anti-inflammatory properties, may be suitable for the prevention and treatment of chronic obstructive pulmonary disease (COPD). This study aims to investigate the therapeutic efficacy of hydrogen-oxygen (H2/O2) treatment in cigarette smoke solution (CSS)-induced COPD-like injury in a female BALB/c mouse model. Methods: Thirty mice were randomly assigned to three groups: Control (n=8), COPD (n=10), and COPD + H2/O2 (n=12). CSS was administered by intraperitoneal (IP) injection twice weekly for 6 weeks during the COPD induction phase. Simultaneously, the COPD + H2/O2 group started received 75 minutes of inhalation therapy (42% H2) delivered by the Oxy-Hydrogen Generator twice daily for 9 weeks. Mice body weights and survival were measured throughout the study period. Neutrophil elastase (NE) activity and lung histopathological changes were also evaluated. Results: The results showed a higher survival rate in the COPD + H2/O2 group compared to the COPD group (100% vs. 80%) during the induction phase. Slight decreases in body weight gains were observed in the COPD and COPD + H2/O2 groups during the first 15 days of the induction phase, but there was no significant difference in mean body weights among the three groups throughout the study period. NE activity was numerically lower in the COPD + H2/O2 group compared to the COPD group. The histopathological evaluation showed significant improvements in the H2/O2-treated mice with respect to mean linear intercept (MLI) and lesion (inflammation and emphysema) scores. Improvements in goblet cell hypertrophy and hyperplasia of airway epithelium were not significant. Conclusions: A 9-week H2/O2 inhalation therapy delivered by the Oxy-Hydrogen Generator to CSS-induced COPD-like injury in mice showed improvement in survival rate, alveolar structural changes, and histopathological lesion scores of the lung.

Prevalence of Cervical Spondylolisthesis in the Sagittal Plane Using Radiographic Imaging in a Pediatric Population: A Cross Sectional Analysis of Vertebral Subluxation.

INTRODUCTION: Cervical Spondylolisthesis (CS) in children is under-studied. This cross-sectional study reports the CS prevalence in children. MATERIALS & METHODS: Subjects were selected from a private practice. Inclusion criteria: 0-17 years of age; documented demographics and health complaints; neutral lateral cervical (NLC) radiographs; and CS. Exclusion criteria: pseudosubluxation. RESULTS: 342 NLC radiographs were analyzed. 73 (21.3%) had CS greater than 2.0 mm. 42 (57.5%) had no musculoskeletal complaints. 8 (2.3%) had the presence of a CS greater than 3.5 mm. 5 (62.5%) had no musculoskeletal complaints. DISCUSSION: Pediatric populations endure various traumas. Pediatric cervical spine biomechanics has an increased risk of upper cervical spine injury. Regular spinal radiographic exams may help identify serious spinal conditions in their pre-symptomatic state. CONCLUSION: CS in pediatric populations is under-studied. CS is present in children and adolescents with and without symptoms.

Improvements in Cervical Spinal Canal Diameter and Neck Disability Following Correction of Cervical Lordosis and Cervical Spondylolistheses Using Chiropractic BioPhysics Technique: A Case Series.

Cervical spondylolisthesis indicates instability of the spine and can lead to pain, radiculopathy, myelopathy and vertebral artery stenosis. Currently degenerative cervical spondylolisthesis is a wait-and-watch condition with no treatment guidelines. A literature review and discussion will be provided. 8 females presented with neck pain, disability, and history of motor vehicle collision. Radiographs revealed abnormal cervical alignment, spinal canal narrowing, and spondylolistheses. After 30 sessions of Chiropractic BioPhysics® care over 12 weeks, patients reported improved symptoms and disabilities. Radiographs revealed improvements in cervical alignment, spondylolistheses, and spinal canal diameter. Motor vehicle collision may cause instability and abnormal alignment of the cervical spine leading to cervical spondylolisthesis. Improving spinal alignment may be an effective treatment to reduce vertebral subluxation and cervical spondylolistheses and improve neck disability as a result of improved spinal alignment.

Innovation and value-driven engineering.

Emerging strategies to simultaneously catalyse rewardable innovation in the field of medical devices and reduce health-care costs could also be applicable in drug development.

The development of a novel cancer immunotherapeutic platform using tumor-targeting mesenchymal stem cells and a protein vaccine.

An ideal anticancer strategy should target only the malignant cells but spare the normal ones. In this regard, we established a platform, consisting of an antigen-delivering vehicle and a protein vaccine, for developing an immunotherapeutic approach with the potential for eliminating various cancer types. Mesenchymal stem cells (MSCs) have been demonstrated capable of targeting tumors and integrating into the stroma. Moreover, we have developed a protein vaccine PE(ΔIII)-E7-KDEL3 which specifically recognized E7 antigen and elicited immunity against cervical cancer. Taking advantage of tumor-homing property of MSCs and PE(ΔIII)-E7-KDEL3, we used E6/E7-immortalized human MSCs (KP-hMSCs) as an E7 antigen-delivering vehicle to test if this protein vaccine could effectively eliminate non-E7-expressing tumor cells. Animals which received combined treatment of KP-hMSCs and PE(ΔIII)-E7-KDEL3 demonstrated a significant inhibition of tumor growth and lung-metastasis when compared to PE(ΔIII)-E7-KDEL3 only and KP-hMSCs only groups. The efficiency of tumor suppression correlated positively to the specific immune response induced by PE(ΔIII)-E7-KDEL3. In addition, this combined treatment inhibited tumor growth via inducing apoptosis. Our findings indicated that KP-hMSCs could be used as a tumor-targeting device and mediate antitumor effect of PE(ΔIII)-E7-KDEL3. We believe this strategy could serve as a platform for developing a universal vaccine for different cancer types.

The case for entrepreneurship in R&D in the pharmaceutical industry.

A lack of entrepreneurial behaviour has often been highlighted as a contributor to the decline in the research and development (R&D) productivity of the pharmaceutical industry. Here, we present an assessment of entrepreneurship in the industry, based on interviews with 26 former and current leaders of R&D departments at major pharmaceutical and biotechnology companies. Factors are highlighted that could be important in promoting entrepreneurial behaviour, which might serve as a catalyst for revitalizing R&D productivity.

The future of drug development: advancing clinical trial design.

Declining pharmaceutical industry productivity is well recognized by drug developers, regulatory authorities and patient groups. A key part of the problem is that clinical studies are increasingly expensive, driven by the rising costs of conducting Phase II and III trials. It is therefore crucial to ensure that these phases of drug development are conducted more efficiently and cost-effectively, and that attrition rates are reduced. In this article, we argue that moving from the traditional clinical development approach based on sequential, distinct phases towards a more integrated view that uses adaptive design tools to increase flexibility and maximize the use of accumulated knowledge could have an important role in achieving these goals. Applications and examples of the use of these tools--such as Bayesian methodologies--in early- and late-stage drug development are discussed, as well as the advantages, challenges and barriers to their more widespread implementation.

Advancing drug innovation for neglected diseases-criteria for lead progression.

The current drug R&D pipeline for most neglected diseases remains weak, and unlikely to support registration of novel drug classes that meet desired target product profiles in the short term. This calls for sustained investment as well as greater emphasis in the risky upstream drug discovery. Access to technologies, resources, and strong management as well as clear compound progression criteria are factors in the successful implementation of any collaborative drug discovery effort. We discuss how some of these factors have impacted drug discovery for tropical diseases within the past four decades, and highlight new opportunities and challenges through the virtual North-South drug discovery network as well as the rationale for greater participation of institutions in developing countries in product innovation. A set of criteria designed to facilitate compound progression from screening hits to drug candidate selection is presented to guide ongoing efforts.

Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers.

The potential to use biomarkers for identifying patients that are more likely to benefit or experience an adverse reaction in response to a given therapy, and thereby better match patients with therapies, is anticipated to have a major effect on both clinical practice and the development of new drugs and diagnostics. In this article, we consider current and emerging examples in which therapies are matched with specific patient population characteristics using clinical biomarkers - which we call stratified medicine - and discuss the implications of this approach to future product development strategies and market structures.