There are about 5012 clinical studies being (or have been) conducted in Mexico. 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.
Autoimmune ophthalmopathy is clinically evident in one third of Graves' disease cases. In most cases it is mild; however, in 3 to 5% of cases it has a severe presentation. At present, the treatment is directed to identify vision threatening which requires aggressive intervention, usually with glucocorticoids. For mild cases the treatment is limited to the normalization of hyperthyroidism and support measures. Preliminary data show that pentoxifylline and bromocriptine may have a favorable effect in the course of ophthalmopathy by inhibition of the synthesis of TNF-α, VEGF, glycosaminoglycan production, and lymphocyte infiltration. Therefore, the aims of this study were to evaluate the effect of bromocriptine and pentoxifylline on the clinical course and quality of life of patients with mild to moderate ophthalmopathy associated to Graves´disease. Methods. Patients with mild to moderate ophthalmopathy, with less than one year of evolution, and naive to treatment were randomized to receive treatment during 12 months with either 1) bromocriptine (5 mg twice a day) + methimazole (30 mg/day), 2) pentoxifylline (400 mg twice a day) + methimazole (30 mg/day), or 3) methimazole only (30 mg/day). They completed 10 visits to evaluate proptosis and clinical activity score (CAS). In addition, in the first and last visit the quality of life questionnaire specific for Graves' ophthalmopathy(GO-QOL) was applied.
The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need. Primary objective: - To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged >= 50 years who are at risk for CDI and have received at least 1 injection. Secondary Objectives: Efficacy: - To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days. - To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections. Immunogenicity: - To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60. Safety: - To describe the safety profile of all participants who received at least 1 injection.
To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1
THis study is intended to provide contemporary data on the burden of disease in patients 1 to 3 years post-MI, including a description of patient characteristics, current treatment patterns, rate of major CV events, and healthcare resource utilization in a 'real world' patient population at high atherothrombotic risk.
The purpose of the study is to assess if the addition of vildagliptin as add-on therapy improves glucose variability in type 2 diabetes mellitus (T2DM) patients inadequately controlled with insulin, with special emphasis in hypoglycemic episodes measured by continuous glucose monitoring.
Purpose Invasive fungal infections cause significant morbidity and mortality in immunocompromised patients. Amphotericin B deoxycholate (AmB) is a polyene antifungal agent. The broad spectrum of activity contributed to it being considered the gold standard of antifungal therapy despite being associated with high incidences of infusion related adverse events. AmB exerts their antifungal effect binding to ergosterol; a sterol similar to cholesterol found in fungal cell membranes. However AmB also binds to cholesterol molecules in mammalian cell membranes forming intramembranous pores and vacuoles in the distal convoluted tubule of the kidney producing its nephrotoxic effects. Nephrotoxicity is the major adverse effect of AmB, often limiting administrations of full dosage; it's manifested as acute kidney injury, impaired renal concentrating ability, augmented urinary potassium secretion through tubular Na+/K+ ATPase, type-1 renal tubular acidosis, which increases the elimination of potassium, and magnesium wasting. Furthermore potassium depletion potentiates the tubular toxicity of AmB. The management of potassium wasting may be difficult, even high intravenous doses of potassium chloride may not be fully effective in correcting the hypokalemia. It has been probed the use of potassium-sparing diuretics to limit electrolyte wasting in patients treated with AmB. In 1988 Smith et al, demonstrated that amiloride was well tolerated and provided effective control of plasma potassium in patients treated with AmB. This finding was confirmed in 2001 by Bearden et al. However in our country the only available commercial presentation of amiloride also contains hydrochlorothiazide, limiting its use in such patients. Spironolactone acts on the distal renal tubule by competitive inhibition of aldosterone, thereby blocking the exchange between sodium and both potassium and hydrogen in the distal tubules and collecting ducts. These agents produce a sodium diuresis which results in potassium retention. There is only one clinical trial by Ural et al, using spironolactone to prevent hypokalemia in twenty-six neutropenic patients on AmB treatment; they demonstrated that those patients receiving concomitant AmB and spironolactone (100mg bid) had significantly higher plasma potassium levels than those receiving AmB alone (P=0.0027) and required significantly less potassium supplementation to maintain their plasma potassium within the normal range (P=0.022). Renal vasoconstriction appears to play a major role in AmB induced reduction in GFR; recurrent ischemia may lead to structural and tubular damage and permanent nephrotoxic effects. Aldosterone modulates the tone of the renal vasculature. Bobadilla et al have shown in animal models of cytotoxic damage using cyclosporine; that a mineralocorticoid receptor blockade with spironolactone reduces the structural renal damage, and also prevents renal dysfunction due to afferent and efferent vasoconstrictions. This group has also shown that prophylactic treatment with spironolactone completely prevents renal dysfunction and histological signs of tubular injury from ischemia-reperfusion injuries. And also has demonstrated the ability of spironolactone in animal models to protect the kidney after establishing an ischemic insult, when spironolactone was administrated immediately or 3h after the renal ischemic insult had occurred, reducing levels of sensitive biomarkers such as Kim-1 and Hsp70. The investigators' hypothesis is that administration of spironolactone in patients treated with AmB will help to maintain significantly higher plasma potassium levels and will help to reduce potassium and magnesium supplementation. Moreover spironolactone will help to reduce the urinary excretion of potassium. The investigators propose a randomized, double blind, placebo controlled trial approved by the local ethical committee, to compare the efficacy and security of spironolactone to reduce electrolytic derangements in three groups: AmB and placebo, AmB and spironolactone 100mg once a day, AmB and spironolactone 100mg twice a day. The investigators will include 12 patients per group. Researchers will collect daily plasma creatinine, sodium, potassium, BUN and urinary potassium, as well as the values of potassium and magnesium supplements administered orally or parenterally. The researchers will also collect by 7 days urinary levels of NGAL, KIM-1 and Hsp-70 as tubular injury markers.
The purpose of this study is to determine if treatment with celecoxib and pregabalin together would prove to be more effective in relief of pain than treatment with celecoxib alone in people who have chronic low back pain with a probable neuropathic component.
12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with Chronic Idiopathic Constipation.
Study designed to evaluate the safety and efficacy of double staining with brilliant blue G 0.025% as an adjuvant to macular surgery. Patients undergoing surgery for macular hole or epiretinal membrane will be included. Safety will be evaluated by optic coherence tomography, pattern reversal electroretinogram and multifocal electroretinogram.
The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318). Secondary objectives of this study in this study population are as follows: To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon β-1a (Avonex) in Study 205MS301(NCT01064401).