Clinical research

Schizophrenia is a chronic, severe, and disabling brain disease. About one-third of all patients with schizophrenia do not respond adequately to drug treatment. Advances in neuroscience and clinical research have led to the introduction of a novel generation of compounds with neuroprotective properties. Despite numerous animal studies with promising neuroprotective agents, no successful strategy for neuroprotection from functional psychoses has been successfully demonstrated. There are two main targets for neuroprotective therapy: (1) neurodegenerative processes in schizophrenia (e.g. apoptosis, excitotoxicity, oxidative stress, stress sensitization, and alteration of neurosteroids); and (2) phenotypic presentations of illness including psychopathological symptoms, significant decline in cognition, psychosocial functioning and in health related quality of life (HRQL). In this chapter substantial information about clinical trials with neurosteroids, vitamins, and some herbal supplements with neuroprotective properties in schizophrenia is presented. Neurosteroids such as pregnenolone (PREG), dehydroepiandrosterone (DHEA) and their sulfates (PREGS and DHEAS) are reported to have a modulatory effect on neuronal excitability and synaptic plasticity. In addition, vitamins and herbal supplements are important for regular cell function, growth and development. As a rule, vitamins promote the activity of enzymes to improve their efficiency and in this role they are called coenzymes. The herbal supplements are active antioxidants with neuroptective properties. The authors hope that neuroprotective strategies will pave the way to the next generation of antipsychotic, sedative and mood stabilizer medications. The clinical effects of neuroprotective agents clearly merit further clinical trials for the treatment of mental disorders.

Surgical site infection (SSI) is one of the most common infections associated with health care, but its importance as a global health priority is not fully understood. We quantified the burden of SSI after gastrointestinal surgery in countries in all parts of the world. This international, prospective, multicentre cohort study included consecutive patients undergoing elective or emergency gastrointestinal resection within 2-week time periods at any health-care facility in any country. Countries with participating centres were stratified into high-income, middle-income, and low-income groups according to the UN's Human Development Index (HDI). Data variables from the GlobalSurg 1 study and other studies that have been found to affect the likelihood of SSI were entered into risk adjustment models. The primary outcome measure was the 30-day SSI incidence (defined by US Centers for Disease Control and Prevention criteria for superficial and deep incisional SSI). Relationships with e...

MSC (Avemar) is a medical nutriment of which preclinical and observational clinical studies suggested an antimetastatic activity with no toxicity. This open-label cohort trial has compared anticancer treatments plus MSC (9 g once daily) vs anticancer treatments alone in colorectal patients, enrolled from three oncosurgical centres; cohort allocation was on the basis of patients' choice. Sixty-six colorectal cancer patients received MSC supplement for more than 6 months and 104 patients served as controls (anticancer therapies alone): no statistical difference was noted in the time from diagnosis to the last visit between the two groups. End-point analysis revealed that progression-related events were significantly less frequent in the MSC group (new recurrences: 3.0 vs 17.3%, P<0.01; new metastases: 7.6 vs 23.1%, P<0.01; deaths: 12.1 vs 31.7%, P<0.01). Survival analysis showed significant improvements in the MSC group regarding progression-free (P=0.0184) and overall su...

Translational medicine has made impact and have come to be accepted (Dai, et al., 2013) as a
global medical strategy for improving Medicare such that, funding of translational medicine
globally has increased, it is treated with priority and many institutes for translational studies have
been established, (Zhang, 2012). Demonstrating this critical significance of translational
medicine to modern medical practice is the emphasis by the World Medical Association (WMA
Ethics Manual, 2009), that ‘physicians must know how to interpret research results and apply
them to patients’.
However, as noted by Zerhouni, (2007) and Qian et al., (2012), a lot remains to be understood
and lessons need to be learned on the best strategies for translational medicine which may not be
unconnected with observed issues of clinical research bottlenecks. Mankoff, et al., (2004), had
earlier identified “three major obstacles to effective translational medicine”. The first two
revolves around the subject of clinical research; – “the challenge of translating basic science
discoveries into clinical studies”, and “the translation of clinical studies into medical practice and
health care policy”. This second issues hinges on the core challenges of the practical conduct of
clinical research. Sung, et al., (2003) opined that the two “translational blocks can be removed
only by the collaborative efforts of multiple system stakeholders”

Since fetal alcohol syndrome was first described over 35 years ago, considerable progress has been made in the delineation of the neurocognitive profile in children with prenatal alcohol exposure. Preclinical investigators have made impressive strides in elucidating the mechanisms of alcohol teratogenesis and in testing the effectiveness of pharmacological agents and dietary supplementation in the amelioration of alcohol-induced deficits. Despite these

There are many challenges to transporting evidence-based treatments from laboratories into real-world settings. However, if we hope to make our evidence-based treatments accessible and available to children and usable by community professionals, effectiveness research is imperative. We argue that schools represent an ideal real world setting in which to conduct such research. The goals of this paper are to present

Despite the widespread acceptance of quality of life (QOL) as the ideal guideline in healthcare and clinical research, serious conceptual and methodological problems continue to plague this area. In an attempt to remedy this situation, we propose seven criteria that a quality-of-life concept must meet to provide a sound basis for investigation by questionnaire. The seven criteria or desiderata are: (1) an explicit definition of quality of life; (2) a coherent philosophy of human life from which the definition is derived; (3) a theory that operationalizes the philosophy by specifying unambiguous, nonoverlapping, and jointly exhaustive questionnaire items; (4) response alternatives that permit a fraction-scale interpretation; (5) technical checks of reproducibility; (6) meaningfulness to investigators, respondents, and users; and (7) an overall aesthetic appeal of the questionnaire. These criteria have guided the design of a validated 5-item generic, global quality-of-life questionnai...

Biostatistics is the application of statistical techniques to biological data obtained prospectively and/or retrospectively. Statistics plays critical analytical role in biomedical research. It is the bases for building clear inference from the data collected in a biomedical evaluation and without which it would be impossible to declare an outcome from any clinical trial. This critical role of biostatistics in biomedical research was noted by Cadarso-Suárez, and González-Manteiga, (2007), who stated that “the discipline of biostatistics is nowadays a fundamental scientific component of biomedical, public health and health services research” and pointed out traditional and emerging areas of application as “clinical trials research, observational studies, physiology, imaging, and genomics”. At the same time, misuse of biostatistics has resulted in several misleading outcomes and several workers have progressively noted the many statistical errors and shortcomings found in a large numb...

Cancer and venous access (CAVA) trial has highlighted some issues and problems from the different departments linked to this clinical trial. This clinical service review attempted to reflect on this problems and offered some insights as to how address these problems.

Abstract: To determine the histological changes induced by the human therapeutic dose of 5-Fluorouracil (5-FU) and study the histological effects of a single intraperitoneal injection of one tenth, three tenths and five tenths 5-FU LD50 on liver and kidney of healthy mice and to show if these changes are irreversible or not after stopping the treatment. For testing the effects of the drug human therapeutic regime, 18 mice were allocated in six cages (3 mice each); one acted as a control and five acted as a treated group. Treated group received the following treatment through intraperitoneal injection, an initial dose (12 mg/kg 5-FU) was injected intraperitoneally for three consecutive days and a maintenance dose (15 mg/kg 5-FU) was injected intraperitoneally once a week for three weeks. For testing effects of a single intraperitoneal injection of one tenth, three tenths and five tenths 5-FU LD50, the mice were randomized into four groups (one control group and three treated groups) 10 mice each. The treated groups received 50, 150 and 250 mg/kg 5-FU through intraperitoneal injection, respectively. The human therapeutic regime induced histological change only in liver. The treated groups received 50, 150 and 250 mg/kg 5-FU, fatty degeneration and portal area inflammatory cells infiltration were noticed after one week. Liver multinucleated giant cells were detected only in histological sections of mice that received 150 mg/kg. The 250
mg/kg 5-FU induced liver apoptosis. Kidney tubular necrosis was induced by a single injection of 150 and 250 mg/kg 5-FU. The 5-FU human therapeutic regime induced no histological changes in the mice studied organs except for the liver. It induced liver focal necrosis and hydropic degeneration. While, the liver hydropic degeneration disappeared later on, the liver focal necrosis persisted. Using higher doses induced histological change to the liver and the kidney and these pathological changes persisted.

Abstract
Background and objectives: Recent studies have shown an association between prolactin (Prl) levels and body weight, with
increased prevalence of obesity in patients with prolactinomas and weight loss associated with hyperprolactinemia. However, data
on variations in body weight associated with different degrees of hyperprolactinemia remain scarce. This study aimed to evaluate
the prevalence of obesity and overweight in patients with hyperprolactinemia of various causes and correlate Prl levels with body
mass index (BMI).
Methods: Medical records of patients with hyperprolactinemia were retrospectively reviewed. Patients were classified according to
BMI as normal weight (19.0-24.9), overweight (25-29.9), and class I (30-34.9), class II (35-39.9) and class III (> 40) obesity. Disease
etiology was divided into microprolactinoma, macroprolactinoma, and other causes for analysis.
Results: Of 138 eligible patients, 52.9% had micro or macroprolactinoma and 65.2% were overweight or obese. Mean patient age
was 36.2±13.6 years. Obesity was more prevalent in patients with macroprolactinoma (50%), and overweight in patients with other
causes of hyperprolactinemia (37.9%), with no statistical difference between groups. Prl levels were higher in macroprolactinomas,
with a statistically significant difference (p<0.001) compared to microprolactinomas and other causes of hyperprolactinemia. Prl
was also significantly higher in microprolactinomas than in other causes of hyperprolactinemia (p<0.001).
Conclusions: Prevalence of obesity was significantly high in hyperprolactinemic patients, regardless of the degree of obesity and
the cause of hyperprolactinemia. It is important to monitor BMI in patients with elevated Prl levels to introduce measures aiming
to maintain an ideal weight and reduce associated comorbidities.
Keywords: Body weight, hyperprolactinemia, obesity, overweight, prolactinoma