Journal of Clinical Research

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.

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.

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.

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.

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.