https://repositorio.uca.edu.ar/handle/123456789/655 2026-04-20T04:50:05Z https://repositorio.uca.edu.ar/handle/123456789/19079 Título: Tools for data analysis Autor: Pérez Lloret, Santiago; Enet, Alejandro; Gonzalez Aleman, Gabriela Resumen: What are statistics Good for in human research studies? Studies conducted on human beings may have different objectives and designs, but they all share some common principles. 1 We outline these principles as a cycle, shown in Figure 1. The first step is to obtain a sample from a population. A population is a group of human beings sharing one or more characteristics. In medical research, researchers usually define populations following a disease or a condition. Obtaining the sample is called “sampling”. 2 Researchers will then discuss the study with the potential participants. They will be part of the study sample if they accept to participate and fulfill all inclusion and exclusion criteria. Investigators will perform a series of procedures and assessments and may apply an intervention to the sample of participants. For example, a treatment may be used, and its effects on Parkinson’s Disease motor symptoms may be recorded. Notably, study results only represent the effects of the intervention on the sample of participants. However, researchers are generally interested in “extrapolating” these results to the target population. The “statistical inference” procedure allows for performing such extrapolations. 3 Statistics is the science of collecting, analyzing, and describing data to conclude a particular phenomenon based on a relatively limited sample material. 3 It employs mathematical and probabilistic tools to develop methods and models for data analysis... 2024-01-01T00:00:00Z https://repositorio.uca.edu.ar/handle/123456789/13686 Título: A phase II study of the pineal hormones melatonin and 5-methoxytryptamine plus cannabidiol in association with angiotensin 1-7 in the treatment of advanced solid tumour patients eligible for the only best supportive care Autor: Lissoni, Paolo; Porro, Giorgio; Messina, Giusy; Galli, Carla; Di Fede, Giuseppe; Valentini, Agnese; Simoes-e-Silva, Ana Cristina; Cardinali, Daniel Pedro Resumen: Abstract: The recent advances in the investigation of tumour biology have demonstrated that the human body may produce several molecules provided by a natural anticancer activity without any toxicity, in particular the pineal hormones melatonin (MLT), 5-methoxytryptamine (5-MTT) and pinealine, the endogenous cannabinoids, oxytocin, and angiotensin 1-7 (Ang 1-7). Unfortunately, despite their well confirmed anticancer and non-toxic properties, very few clinical studies have been performed in an attempt to evaluate the potential therapeutic efficacy of the endogenous human anticancer molecules in the treatment of cancer patients, at least of those eligible for the only palliative therapy. Moreover, most studies have been generally limited to the use of the only pineal MLT. The present preliminary study was carried out to evaluate the anticancer efficacy of an oral administration of MLT (100 mg in the dark period) in association with 5-MTT (10 mg in the light period), the cannabinoid agent cannabidiol (CBD) ( 10 mg twice/day) and Ang 1-7 (0.5 mg/twice day) in a group of 14 untreatable advanced or metastatic cancer patients. The clinical response consisted of partial response (PR) in 2/14 (14%), and stable disease (SD) in 8/14 (57%). Then, a disease control (PR + SD) was achieved in 10/14 (71%), whereas the remaining 4/14 (29%) had a progressive disease. Moreover, disease control was associated with a significant increase in lymphocyte-to-monocyte ratio (LMR), by showing that the control of the neoplastic growth is mediated at least in part by an improvement in the antitumor immune status of cancer patients.The treatment was well tolerated in all patients, and in particular no important decline in blood pressure values occurred. On the contrary, a clear improvement in asthenia was obtained in 8/10 (80%) patients with important asthenia prior to study. This preliminary study may suggest that after the failure of the common standard anticancer therapies, the administration of the main endogenous anticancer neuroendocrine molecules, firstly MLT and Ang 1-7, could constitute an alternative approach to cancer patients instead of the simple best supportive care alone. 2021-01-01T00:00:00Z https://repositorio.uca.edu.ar/handle/123456789/13684 Título: A preliminary study of low-dose angiotensin 1-7 plus the pineal hormone melatonin in the treatment of human systemic diseases other than cancer and autoimmune pathologies Autor: Lissoni, Paolo; Porta, Enrica; Rovelli, Franco; Messina, Giusy; Lissoni, Arianna; Porro, Giorgio; Porro, Davide; Di Fede, Giuseppe; Monzon, Alejandra; Sassola, Andrea; Cardinali, Daniel Pedro Resumen: Abstract: The recent advances of the psychoneuroimmunology have demonstrated the existence of a physiological anti-inflammatory antitumor neuroendocrine axis, mainly constituted by the pineal gland through its indole hormone melatonin (MLT) and the ACE2-angiotensin 1-7 (Ang 1-7) system. Moreover, most human systemic diseases, including cancer, autoimmunity, metabolic, cardiovascular, and neurodegenerative pathologies, have appeared to be characterized by an endogenous deficiency in the functionless of the pineal gland and ACEACE2 system. Therefore, the exogenous correction of MLT and Ang 1-7 deficiency could improve the clinical control of human systemic diseases. On these bases, a preliminary study of MLT plus Ang 1-7 was planned in patients suffering from systemic alterations other than cancer and autoimmunity. The study included 33 consecutive patients, whose pathologies were, as follows: cardiovascular pathologies: 9; pulmonary diseases: 7; metabolic syndrome: 7; neurodegenerative pathologies: 10. Both Ang 1-7 and MLT were given orally, at a dose of 0.5 mg/day in the morning for Ang 1-7, and at a dose of 10 mg/day in the evening for MLT. The treatment was well tolerated in all patients, and no-therapy related toxicity occurred. On the contrary, most patients experienced a relief of anxiety and asthenia, and an improvement in both mood and quality of sleep. Moreover, most patients referred an increased diuresis. Blood pressure values progressively became within the normal range in hypertensive patients. On the same way, glucose and cholesterol levels progressively decrease on therapy in diabetic and hypercholesterolemic patients, respectively. Patients with pulmonary disturbance referred an important enhancement in the expectoration, with a following improvement in the respiratory symptomatology. Finally, an apparent improvement in cognitive and motor functions was achieved in patients with neurodegenerative pathologies. These preliminary results would suggest a future medical possibility to treat the human systemicdiseases by simply correcting their endogenous neuroendocrine deficiencies, mainly those involving the functions of the pineal gland and ACE2-Ang1-7 system. 2021-01-01T00:00:00Z https://repositorio.uca.edu.ar/handle/123456789/13682 Título: Melatonin as an add-on treatment of COVID-19 infection : current status Autor: Brown, Gregory M.; Pandi Perumal, Seithikurippu R.; Pupko, Harold; Kennedy, James L.; Cardinali, Daniel Pedro Resumen: Abstract: This brief review was written to provide a perspective on the flurry of reports suggesting that melatonin can be an important add-on therapy for COVID-19. Despite the passage of more than 60 years since its discovery and much evidence representing the contrary, there has been great reluctance to conceive melatonin as anything other than a hormone. Many other body chemicals are known to have multiple roles. Melatonin was first shown to be a hormone derived from the pineal gland, to be actively synthesized there only at night, and to act on targets directly or via the G-proteincoupled receptors (GPCRs) superfamily. It is of note that over 40 years ago, it was also established that melatonin is present, synthesized locally, and acts within the gastrointestinal tract. A wider distribution was then found, including the retina and multiple body tissues. In addition, melatonin is now known to have non-hormonal actions, acting as a free radical scavenger, an antioxidant, and as modulating immunity, dampening down innate tissue responses to invaders while boosting the production of antibodies against them. These actions make it a potentially excellent weapon against infection by the SARS-CoV-2 virus. Early published results support that thesis. Recently, a randomized controlled study reported that low doses of melatonin significantly improved symptoms in hospitalized COVID-19 patients, leading to more rapid discharge with no side effects, while significantly decreasing levels of CRP, proinflammatory cytokines, and modulating dysregulated genes governing cellular and humoral immunity. It is now critical that these trials be repeated, with dose-response studies conducted and safety proven. Numerous randomized controlled trials are ongoing, which should complete those objectives while also allowing for a more thorough evaluation of the mechanisms of action and possible applications to other severe diseases. 2021-01-01T00:00:00Z