There are about 20 clinical studies being (or have been) conducted in Nicaragua. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This is an initial dose escalation safety and exploratory efficacy study to treat two groups of subjects with critically sized diabetic wounds and diabetic neuropathy using placental-derived stem cells (PDSC) transplanted by injection into soft tissues of the lower limb. Its primary objective is safety assessment and its secondary objective is determining optimum PDSC safe dose. Group 1 will receive implantation of cells in the ulcer, in the ulcer bed, and along the distal arterial vessels that supply blood to the foot. Group 2 will follow the same protocol for the foot but will have an additional dose of cells implanted in the anterior and posterior compartments of the same leg to determine the impact on peripheral neuropathy. Dose escalation and safety will be documented. Exploratory measures of efficacy include: ulcer healing, hemodynamic and anatomical effects on the arteries of the foot, and changes in the sensory perceptions of the foot.
General description of the study This is a prospective, multicenter, expanded access interventional study of subjects recovered from COVID-19 pneumonia to assess their response to intravenous administration of adipose-derived autologous SVF. Primary objective The purpose of this study was to evaluate the safety of single intravenous injections of autologous adipose-derived SVF produced using the GID SVF-2 device system for the treatment of secondary respiratory distress associated with COVID-19. Secondary objective To evaluate the efficacy of the initial treatment with SVF IV.
This is an interventional study to treat 10 patients with a diagnosis of Parkinson's disease with neurological assessment from the Oxford Parkinson's Disease Quotient-39 (PDQ-39) and Movement Disorders Society Universal Parkinson's Disease Rating Scale (MDS-UPDRS), with autologous adipose tissue-derived stromal vascular fraction (SVF) cells by subdermal plane injection into the submuscular aponeurotic fascia of the face. This study assesses: 1) safety and 2) feasibility and 3) exploratory evidence of efficacy.
Spermotrend is a natural based product manufactured by Catalysis Laboratories. Its composition contains different essential elements for spermatogenesis: selenium, zinc and fructose. In addition, it contains L-arginine, natural precursor of nitric oxide that favors vasodilation, and pygeum africanum extract with antioxidant, antiinflammatory, antiandrogenic and antiproliferative action. Its main action resides in the control of oxidative damage to the tissues of the male reproductive system, as well as the control of correct spermatogenesis. Given that sperm quality can be altered by oxidative stress and that male infertility affects more and more people, the prevention and management of this deterioration becomes increasingly important. Therefore, to evaluate Spermotrend as a new therapy for male infertility, the investigators are going to study the safety and efficacy of this treatment in this clinical trial. RESEARCH HYPOTHESIS The treatment with Spermotrend improves the parameters of the spermatogenesis. GENERAL OBJECTIVES To evaluate the effectiveness and the safety level of the natural Spermotrend product in the treatment of male infertility. SPECIFIC OBJECTIVES - Evaluate the increase in sperm motility and concentration. - Identify the improvement in the seminal fluid volume. - Identify the positive changes in the sperm morphology. - Determine how to maintain the semen analysis in a normal range. - Describe the adverse effects. SECONDARY OBJECTIVES - Identify the improvement in urinary symptoms related with benign prostatic hyperplasia. - Identify the improvement in varicocele.
This is an interventional study to treat 18 patients with chronic kidney disease of unknown cause (CKDu), formerly known as Mesoamerican nephropathy (MeN), with autologous adipose tissue-derived stromal vascular fraction (SVF) cells transplanted by intra-arterial injection both kidneys. This study assesses: (1) safety and tolerability, (2) preliminary evidence of efficacy, (3) exploratory evidence of clinical effects.
Given the high recurrence of urolithiasis in patients, the search for less aggressive and preventive treatments is increasingly necessary. Renalof® is presented as an alternative to herbal medicine being a product that, due to its diuretic and demineralization properties of kidney stones, has been widely used in this patient population, disintegrating and eliminating calcium oxalate and struvite stones in a painless in the genitourinary system. With the objective of determining the efficacy of this therapy, an observational, prospective, randomized, single-blind, two-arm study was carried out: treatment group with Renalof® and control group, placebo.
This study investigates nutritional status, at predefined points in therapy, and the association with outcomes in children and adolescents undergoing treatment for cancer in institutions under Asociación de Hemato-Oncología Pediátrica de Centro América (AHOPCA) consortium in Central America. The aim of the study is to examine the effects of the newly-established nutritional program aimed at improving the delivery of nutritional care and outcomes in children undergoing treatment for cancer in Central America.
The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction) test. The study will follow these women through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study.
The purpose is to assess feasibility of rice bran consumption in weaning children and collect pilot data on gut microbiome and metabolome modulation with rice bran intake for diarrheal prevention.
Adolescents in Latin America are at major risk for unwanted pregnancies leading to unsafe abortions and maternal health risks. Mostly, adolescent health programmes tend to focus on unidirectional interventions aiming at a single determinant of adolescents´ sexual and reproductive health. However, evidence exists that a complex health problem should be addressed by an equally nuanced and multipronged response. Knowledge is lacking on how to develop a comprehensive approach to promote adolescents' sexual health. The CERCA study will conduct an implementation based on the hypothesis that a comprehensive strategy of community-embedded interventions helps to improve the sexual health of adolescents. We will test this hypothesis and describe the development, implementation and testing of interventions in three Latin American cities: Cochabamba (Bolivia), Cuenca (Ecuador) and Managua (Nicaragua). The research methodology has been designed based on the methodological frameworks of action research, community based participatory research and intervention mapping. The interventions are complex addressing different target groups (adolescents, parents, authorities and health providers) and focussing on various behaviours that are related to communication about sexuality, information seeking, access to health care and safe sexual intercourse. For the evaluation of effectiveness a randomised and non-randomised controlled study was developed for respectively Managua and the two other cities. Furthermore a process evaluation is conducted. This research will result in a framework that will contribute to the planning of interventions that are effective and responsive to adolescents' sexual health needs.