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NCT ID: NCT03766984 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac

Start date: June 7, 2015
Phase: Phase 1
Study type: Interventional

The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. The study was conducted in healthy participants of both genders.

NCT ID: NCT03761966 Completed - Clinical trials for Correlation of Cytokines and Anthropometry in Pregnancy

Cytokines Profile at the Beginning of Pregnancy

Start date: January 2017
Study type: Observational [Patient Registry]

A mechanism by which obesity could influence the increase in obstetric complications as more weight is gained, apart from oxidative stress (3) would be the changes in the expression profile of T helper (Th) cells. Due to the increase rate of obesity among Mexican women, the aim was to determine if there is some association between the weight changes in pregnancy and the cytokines Interleukin (IL)-10, IL-4, Interferon gamma (IFN-γ) and Tumor Necrosis Factor alpha (TNF-α).

NCT ID: NCT03760770 Recruiting - Keratoconus Clinical Trials

Riboflavin at 4ºC for the Management of Pain After Crosslinking for Keratoconus Patients

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Background: The objective of corneal collagen crosslinking (CXL) is to increase the binding of intrafibrillary and interfibrillary covalent bonds to improve the mechanical stability of the cornea and thus to stop the progression of corneal ectasias. Although the vast majority of studies have described pain after photorefractive keratectomy (PRK), the pathophysiological principle of pain is similar in CXL. From the anatomical point of view, the corneal epithelium is the most densely innervated and sensitive surface of the body, being 300-600 times greater than in the skin. The pain after CXL comes from several routes, the process begins with the epithelial rupture that generates exposure of the nerve endings, induces apoptosis and necrosis of the epithelial cells. Subsequently an inflammatory cascade is initiated in which the different cytokines stimulate the nerve terminals. Inflammatory mediators also activate the ion channels in the nerve membrane, and this process continues until the epithelium heals. Additionally, exposure to UVA rays can also cause nerve damage. The effect of local cold for pain management has already been reported in PRK. By cooling the cornea, the release of chemical mediators and inflammation can be reduced. In the CXL radiation is transformed into several forms of energy: fluorescent radiation, chemical energy and, to a small extent, heat. The CXL process is energetically comparable to photosynthesis, in which the radiation energy is transformed into chemical energy (glucose) with the help of pigments (chlorophyll). The thermal effect is negligible in the photochemical method of CXL. Justification: No method for the control of pain after crosslinking is considered ideal or universally accepted, the importance of this study lies in looking for an additional tool to reduce the most common postoperative complaint in a highly performed procedure worldwide. Hypothesis: The application of riboflavin at 4oC reduces the pain assessment after the CXL. Purpose: to evaluate the effect of the application of riboflavin at 4oC in the assessment of postoperative pain in patients undergoing CXL. Materials and methods: Prospective and interventional clinical study in patients older than 18 years with a diagnosis of keratoconus who underwent CXL, in the cornea and refractive surgery service of the Ophthalmology institute Fundación Conde de Valenciana.

NCT ID: NCT03755947 Not yet recruiting - Clinical trials for B-Cell Chronic Lymphocytic Leukemia

Ibrutinib, Obinutuzumab and Venetoclax for Patients With Chronic Lymphocytic Leukemia

Start date: December 1, 2018
Phase: Phase 2
Study type: Interventional

Background: Chronic Lymphocytic Leukemia (CLL) is the most common leukemia in the occidental countries. Until now, it is considered a chronic disease without a cure. The development of new molecular therapies have showed that the cure may be an option. This protocol propose a triple sequential therapy with three direct therapies for the leukemic cell: an inhibitor of Bruton´s tyrosine kinase (ibrutinib), a second generation monoclonal antibody versus CD20 (obinutuzumab) and a BCL-2 inhibitor (venetoclax) as treatment of first or second line in CLL. Objective: Negativize the minimal residual disease and by this way obtain longer survivals (overall survival and relapse free survival). Design: This is a multicenter, longitudinal, experimental, open, non-randomized and non-comparable study coordinated by the "Grupo Cooperativo de Hemopatías Malignas" situated on Hospital Angeles Lomas in Huixquilucan, México. The study, is a phase II clinical study that will employ three target therapy drugs in sequencing phases. It will start with a BTK inhibitor as induction, later an anti-CD20 will be used for consolidation and it will end with a BH3 analog as maintenance for one year. The primary outcome is the negativization of minimal residual disease.

NCT ID: NCT03755843 Completed - Pre-Eclampsia Clinical Trials


Start date: December 1, 2016
Study type: Observational [Patient Registry]

BACKGROUND: A cornerstone of treatment in preeclampsia is to correct the potential hypovolemia with intravascular optimisation, which is usually performed as a fluid challenge. The prediction of fluid responsiveness in these patients, secondary to anatomical and physiological changes associated with pregnancy has not been established. This study aims to evaluate if Passive Leg Raising (PLR) protocol can predict fluid responsiveness in pregnant patients with severe preeclampsia. MATERIALS AND METHODS: in 35 pregnant women diagnosed with preeclampsia with a clinical indication to optimise intravascular volume, . A PLR manoeuvre and a fluid challenge will be performed, and hemodynamic parameters were recorded using Bioreactance technology. Descriptive statistical analyses, Pearson chi-square test, and mean standard deviation (SD) will be calculated. Analysis of proportion was used to calculate probabilistic intersections of the interventions. The area under curve, sensitivity, specificity, positive predictive value and negative predictive value were calculated for a delta of 12. Objective: to evaluate the if passive leg rising protocol identifies fluid responsivness in pregnant patients with preeclampsia

NCT ID: NCT03752762 Not yet recruiting - Obesity, Childhood Clinical Trials

SPOON:Sustained Program for Improving Nutrition - Mexico

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

The primary goal of this study is to assess the impact of an innovative strategy to prevent undernutrition and obesity in early childhood in children 0-24 months in Mexico. This study is designed to evaluate the impact of promoting adequate infant an young child feeding practices and the use of SQ-LNS (Small Quantity Lipid-Based Nutrient Supplements) on the nutritional status of infants and young children. The study will be conducted in peri-urban areas of Tepic, Nayarit in Mexico in conjunction with the Hospital Infantil de México Federico Gómez and the Nayarit Secretariat of Health.

NCT ID: NCT03750539 Active, not recruiting - Cervix Cancer Clinical Trials

Chemotherapy and Pelvic Hypofractionated Radiation Followed by Surgery Cervical Cancer

Start date: November 10, 2017
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the role of hypofractionated in the treatment of locally advanced cervical cancer. The study will be conducted in Honduras and Mexico, and patients will be randomized to a standard fraction (45 Gy in 25 fractions) or hypofractionated (37.5Gy in 15 fractions) followed by surgery. Patients will receive weekly cisplatin with their treatments at 40 mg/m2. Response rate, survival, and toxicity will be evaluated.

NCT ID: NCT03746275 Recruiting - Atherosclerosis Clinical Trials

Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid

Start date: November 13, 2018
Study type: Observational

In this study researchers want to gain more information on treatment patterns of patients treated with Xarelto in combination with acetylsalicylic acid (ASA). Both drugs reduce the risk of blood clots via different pathways. The study will enroll adult patients suffering from coronary artery disease (narrowing or blockage of vessels that supply the heart with blood) or peripheral artery disease (narrowing or blockage of vessels that supply the legs or head with blood). The study will focus on information on when and why physicians are starting to treat patients with Xarelto in addition to ASA, treatment duration, reasons to discontinue treatment and previous therapies. The study will also look into treatment outcomes for patients being treated with a combination of Xarelto and ASA by their physicians.

NCT ID: NCT03743623 Not yet recruiting - Cerebral Palsy Clinical Trials

A Clinical Study to Evaluate Safety and Efficacy of Neurocytotron in Patients With Cerebral Palsy

Start date: December 2018
Phase: N/A
Study type: Interventional

This is a randomized, double-blinded, two-arm, clinical study. This study is expected to last for approximately 6 months, comprised of 4-8 weeks of enrollment period, 28 days of treatment and 3 months of follow up. The enrollment will be completed prior to the beginning of initial treatment. The study will be closed when 48 subjects have completed the study. The enrollment will be randomized 1:1 to Neurocytotron treatment or mock treatment (placebo). Upon the completion of the study period, the placebo group will receive treatment, if the study results show benefits to patients. The placebo group will not receive treatment with Neurocytotron, unless the group assigned to the treatment shows positive results. In the design, the 3-month follow-up period is sufficient because 100% of the patients are current patients of the research centers; therefore, patient safety will be continuously controlled after the study is closed.

NCT ID: NCT03742557 Recruiting - Clinical trials for Treatment Resistant Depression

Evaluation of Schemes of Administration of Intravenous Ketamine in Depression

Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

Mexico, prevalence reported for major depressive disorder (MDD) is of 7.2%. It is currently in the top 5 causes of disability worldwide. One third of patients will not achieve remission after two treatments, being classified as treatment-resistant. In a neurochemical level, evidence shows dysregulation of the excitatory neurotransmitter Glutamate in patients with MDD. Chronic stress has been related to this dysregulation. Ketamine, has shown to regulate glutamatergic neurotransmission, and specially promote the release and production of neurotrophic factors key in the causes of MDD inhibited by glutamate dysregulation), and allow restoration of areas affected. Clinical studies of ketamine in MDD have shown robust, durable , and rapid effects (during the first 4-24 hours), allowing a great opportunity for patients who do not achieve benefits from antidepressants or patients with suicidal ideation . These results have been reported in metaanalysis. To our knowledge, there are no studies using Magnetic Resonance Spectroscopy, in areas related to MDD, after a series of ketamine administrations, which we think may show changes after this chronic administration and explain its antidepressant properties. Goals: Provide clinical evidence of responseas well as a neurological basis or biomarker of response to a series of ketamine infusions.