Journal of Clinical Research

ISSN: 2795-6172

Open Access

Current Issue

Volume 5, Issue 5 (2021)

    Case Report Pages: 1 - 2

    Pallister-Killian Syndrome: The Importance of Clinical Findings

    Gilarte Herrera Cristina Eugenia, Llorente Ruiz Cristina, Miras Aguilar Isabel, Hernández Tienza Fátima, Olteanu Olteanu Filip Camil, Moreno Molinero Ana, De la Torre Sanz Ana, Mazarío Martín Esther and Montes Martín Laura

    Pallister-Killian Syndrome is a rare genetic disease caused by mosaicism for tetrasomy of chromosome 12. It is characterized by dysmorphic phenotype and multiple organs malformation. This syndrome also includes developmental disabilities such as intellectual and motor disability, muscle hypotonia and it is often related with seizures. Here below we present the case of a patient diagnosed in early neonatal period, highlighting the importance of clinical findings which define this syndrome.

    Research Article Pages: 1 - 10

    A Study of the Financial Crisis and its Effect on Psychological Well-Being, Health, Satisfaction, and Financial Incapability

    Paul Thompson and Victor Dulewicz

    This study explores the effect of the financial crisis on the consumer and its impact on psychological well-being and life satisfaction with the core question investigating what effect the financial crisis has on the psychological well-being and life satisfaction of house hold heads in the United Kingdom. The reversed model approach used in the study analysed from two perspectives before and after the financial crisis. One is to investigate the psychological well-being using the general health questionnaire and its effect on health, life satisfaction and financial incapability. The second is to investigate financial incapability and its effect on health, life satisfaction and psychological well-being based on the British Household Panel (1991-2009) and Understanding Society (2010) Surveys. They are two integrated large nationwide panel surveys commissioned by the United Kingdom government as an instrument to measure social and economic indicators at the individual and household level. The result of the analysis indicates that overall life satisfaction and financial incapability are important determinants of psychological well-being. The paper further explores the impact of the financial crisis on a household head before and after the crash. The results suggest that satisfaction with life, health implications, psychological well-being, and financial capability were significantly lower after the financial crisis. In conclusion, the results explain why overall life satisfaction generally affects individuals’ psychological wellbeing and financial capability, and why those with high financial incapability have poor psychological well-being

    Mini Review Pages: 1 - 4

    Deep Vein Thrombosis in Emergency Department: A Simplified Systematic Approach

    Cinzia Nitti, Francesca Riccomi, Lucia Salvi, Susanna Contucci and Aldo Salvi

    Management of patients with Deep Vein Thrombosis (DVT) in the Emergency Department (ED) has dramatically changed over the last 10 years in the absence of a shared management, leading to the need of a shared consensus strategy to standardize the diagnostic and therapeutic approach in acute phase of DVT in a setting where standardization is particularly difficult due to the volume of activity and the number of operators who alternate in the care of the individual patient. We perform a review and comment of a NGT work performed by a panel of 5 Italian experts who developed 21 consensus statements based on available evidence and their clinical experience. Considering the best available evidence and the longstanding clinical experience of 5 Italian EDs’ experts, the management of patients with suspected DVT to ED should be characterized by a standardized diagnostic process, guided by the estimation of pre-test clinical probability with formal and validated Clinical Prediction Rule (CPR), an increase in the number of patients discharged directly from the ED, reserving hospitalization only for high-risk patients and faster and more appropriate use of the wide range of anticoagulant drugs currently available. In conclusion such a guide will standardize the diagnostic and therapeutic approach in acute phase of DVT, limit the number of diagnostic tests performed to exclude or confirm DVT and shorten the stay time of these patients in ED without reducing safety. Indeed, the identification of simple criteria for the definition of high-risk DVT together with availability of DOACs will allow physicians to safely discharge all DVT patients who do not meet these risk criteria, directly from the emergency room.

    Research Article Pages: 1 - 9

    Managing Selection of Sites to Centralized Trials on Stage of Feasibility Based on Calculated Proposed Recruitment

    Svyatoslav Milovanov

    Introduction: Sites where clinical trial will be conducted is the main place in centralized trials in generation data by the patients. Sites without patients lead to absence of clinical trial data and failed of clinical trial. Feasibility stage in selection of sites for conducting of particular clinical trial is emphasis to presence of needed pool of patients. Recruitment of patients in centralized trials is announcing by PI of clinical sites during the feasibility stage. This is subjective decision of investigator based on integral approach like experience, incidence of disease and many other parameters. The objective approach like calculation is apparently needed for calculation of proposed recruitment on the stage of feasibility.

    Materials and methods: Retrospective analysis data of four clinical trials II-III phases, conducted since 2007 to 2017 years.

    Aim: To find out the approach for selecting the trial sites on predictive basis using objective methods on the on the stage of feasibility.

    Statistical analysis: Data had been collected from feasibility questionnaires, open statistical sources.

    Results: It was proposed the formula for evaluation of clinical trial site in perspective of recruitment. Discussion: Selection of sites might be calculated which will decrease the number of failed clinical trials. We called the calculation “Calculated Proposed Patient’s Recruitment”-CPPR».

    Research Article Pages: 1 - 4

    Comparative Study of the Different Modalities of Treatment of Boxer's Fracture

    Amit Kale, Shail Shah, Clevio Desouza, Jaiman Sharma and Chiranjivi Jani

    Introduction: Fifth metacarpal neck fracture is the most common fracture of the hand. It is often related to aggressive, intentional punching Due to intrinsic muscle pull, the metacarpal head angulates volarly. Some of the most common causes of hand injuries are crush/compression injuries, blunt trauma, fall, road traffic accidents, machinery injury, sports related activity, explosions and firearm injuries. A variety of methods and algorithms are available to treat the metacarpal fractures. In our study we have aimed to compare the different modalities of treatment of boxer’s fracture in the form of conservative treatment, k-wire and JESS fixator.

    Materials and methods: This was a prospective study conducted from January 2021 to June 2021. 45 subjects were included in one study and divided into three groups randomly for the different treatment modalities in the form of K wire, JESS fixator and closed reduction with POP slab for boxer’s fracture. Follow up was assessed using DASH score.

    Results: Only 26.6% of the patients in group A as compared to 60% in group B had excellent results. 46.6% of the patients in group C had excellent results. The study revealed a poor outcome in 26.6% of group A, 13.3% of group B and 20% of group C patients.

    Conclusion: From the results, we could conclude that JESS fixator was more effective than other two modalities in the treatment of boxer’s fracture with the emphasis to be provided on regular pin tract dressing.

    Volume 5, Issue 4 (2021)

      Mini Review Pages: 1 - 3

      An Overview of the Nuremburg Code, Declaration of Helsinki and Belmont Report in the Context of Promoting Ethical Global Clinical Trial Conduct

      Veljko Kopjar*

      Globally, clinical trials are widely accepted as the gold standard for determining the safety and efficacy of clinical interventions. As laws and regulations vary by country and by region, standardized guidelines have been developed to promote global adherence to a set of ethical values and benchmarks with the goal of protecting research-subjects from both physical and non-physical harm. Three critical guidelines are: The Nuremburg Code, The Declaration of Helsinki and The Belmont Report. Observance of these guidelines is critical for the successful conduct of a clinical trial not only in terms of ensuring subject safety but also as it relates to promoting data integrity. However, further considerations need to be taken as it relates to artificial intelligence, wearable technologies, social media clinical trial recruitment and other 21st century solutions that are not addressed by the guidelines.

      Review Article Pages: 1 - 5

      Clinical Trial Data Management and Electronic Recruitment Solutions: Impactful Ways to Promote Successful Clinical Trials Using EDC, Mobile Applications and Social Media

      Veljko Kopjar*

      Clinical trials continue to grow in complexity and, in turn, the cost of running a clinical trial is ever-increasing. Improving the Probability of Success (POS) for a clinical trial should be at the forefront of every trial manager’s focus. Delays, whether in terms of missed recruitment targets or data collection inefficiencies, must be proactively addressed in order for trial funds to be budgeted in the most effective manner. Data solutions such as electronic Case Report Forms (eCRFs) or social media subject recruitment tools oftentimes carry high upfront or fixed costs but can lead to faster trials with fewer errors that are more likely to reach recruitment and other milestones.

      Mini Review Article Pages: 1 - 4

      Update on Pheochromocytomas and Paragangliomas

      Xiao-Jun Huang and Xi-Yuan Chen*

      Pheochromocytomas are rare neuroendocrine tumors that originate from chromaffin cells of the adrenal medulla; paragangliomas are tumors originate from extra-adrenal paraganglions, and found in association with sympathetic and parasympathetic nerves. Pheochromocytomas and paragangliomas may cause sympathetic symptoms such as headache, tachycardia, chest pain, paroxysmal hypertension and sweating. If anytime pheochromocytomas and paragangliomas are suspected, a measurement of catecholamine should be taken as well as localization of tumors with imaging examination or functional testing. Pheochromocytomas and paragangliomas are mostly benign tumors, and a small percentage may become malignant and metastasize; hence, early identification leading to complete surgical resection is usually curative and carries a favorable prognosis.

      Mini Review Pages: 1 - 3

      Informed Consent from the Doctrine of the Mature Minor in Biomedical Research

      Anderson Diaz-Perez*

      It is necessary to recognize the child as an active moral subject in making decision process related to his health or his participation in research. The taking of informed consent as a communication process should tend to respect the autonomy and dignity of the child considered mature or not, taking their decisions seriously and not just an assent as a normative principle of mere legal aspect. It describes theoretical elements that can be used as tools to have an approach to the moral development of the child from the principle of responsibility according to the degree of emancipation. The objective is to provide a description of the most relevant aspects about the informed consent process in the mature child and their right to be informed to agree or consent. We searched the databases such as: Proquest, Medline, Lilacs and Pubmed, analyzing 51 articles. It was concluded that the ability to assent or consent of the child considered mature or not should be evaluated under objective parameters and not simply under the perception of the clinician or researcher. Finally, it is necessary to design strategies to promote the autonomy, respect and dignity of the child from the same practices at the time of informed consent.

      Review Article Pages: 1 - 6

      TSEC (Tissue Selective Estrogens Complex) for Women with Postmenopausal Symptoms

      Ikuko Ota*, Yoshiaki Ota and Fuminori Taniguchi

      The hormonal changes associated with menopause accounts for an unpleasant menopause symptom and a rapid decrease in bone mineral density. The former significantly impairs women's quality of life, and the latter causes locomotor disorders as well as osteoporosis in old age. Estrogen-Progestin Therapy (EPT) is useful for reducing menopausal symptoms (vasomotor symptoms (VMS) and vulvar/vaginal atrophy (VVA)) in postmenopausal women, and for preventing osteoporosis. However, EPT has the concerns about adverse effects on the breast, and endometrium such as Abnormal Uterine Bleeding (AUB). The Tissue Selective Estrogen Complex (TSEC) has improved safety and tolerability by combining the Selective Estrogen Receptor Modulators (SERMs), which have an estrogen agonist/antagonist effect on tissue selectivity, with estrogen. Bazedoxifene (BAZ), which has the strongest antagonistic effect on the breast and endometrium as SERM, was used in combination with the Conjugated Estrogen (CE). BAZ with CE has the effect of improving VMS and VVA, which is not found in a bazedoxifene monotherapy, and has prevented osteoporosis by normalizing bone metabolism. In addition, BAZ with CE it is safer for the endometrium and breast compared to EPT. It can be an option as a postmenopausal symptomatic Hormone Therapy (HT). In today's world of extended life expectancy, it is obviously meaningful for the old-aged women with postmenopausal symptoms to alleviate the necessity of the treatment for osteoporosis.

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