Pergamino, Australia

Efficacy Anda Safety of Etoricoxib With Betamethasone for the Treatment of Acute Gout Arthritis

Researchers will compare the fixed-dose combination of Etoricoxib/Betamethasone versus Etoricoxib in acute gouty arthritis by comparing the level of pain in the affected joint during the 8 days of follow up. The adverse events related to the interventions will be registered during follow up. Participants will: - Be randomized into one of the 2 intervention groups (A or B) - Visit the clinic in 3 occasions (day 0, day 5 of follow up and day 8 of follow up) - In case needed the patient could take 500 mg of acetaminophen, as a rescue medication, previous authorization of de principal investigator

Efficacy and Safety of Etoricoxib/Tizanidine Versus Etoricoxib for Acute Low Back Pain Associated to Muscle Spasm

Researchers will compare the efficacy of a fixed-dose combination of etoricoxib and tizanidine versus etoricoxib alone in the treatment of acute low back pain associated with muscle spasms. Efficacy will be assessed by evaluating the average change in pain among patients who report improvement over the 7-day follow-up period. Adverse events related to the interventions will be recorded throughout the study. Participants will: - Be randomized into one of two intervention groups (Group A or Group B). - Attend three in-person clinic visits: Day 0 (baseline), Day 3, and Day 7 of follow-up. - Receive follow-up phone calls on Days 1 and 5. - Be allowed to take 500 mg of acetaminophen as rescue medication if needed, with prior authorization from the Principal Investigator.

Efficacy and Safety of Celecoxib/Acetaminophen Versus Celecoxib for Diagnosed Osteoarthritis in Acute Exacerbation

Researchers will evaluate the efficacy and safety of a fixed-dose combination of celecoxib and acetaminophen compared to celecoxib monotherapy for the treatment of pain in patients with osteoarthritis experiencing an acute exacerbation over a 6-week follow-up period. Adverse events related to the study interventions will be recorded throughout the follow-up phase. Participants will: Be randomized into one of three intervention groups (A, B, or C). Attend five scheduled clinic visits (Day 0, and Weeks 1, 2, 4, and 6 of follow-up). Be permitted to take 500 mg of naproxen as rescue medication, if needed, with prior authorization from the principal investigator.

Postprandial Metabolome and Metabolic Flexibility

Enrolled subjects are followed every week for one month. At each visit, a questionnaire assesses daily time activity patterns relevant to energy expenditure, general health status, including infectious symptoms, and confirmation of basic social and demographic characteristics. Dietary intake is assessed by a food frequency questionnaire and a multi-step 24-hour dietary recall for quantitative analysis. If symptoms of infection are present, participants are treated with ad-hoc broad antibiotics. Anthropometrics are obtained. Subjects will then be randomized to receive the metabolic challenges in a different order. The procedures will be performed before (fasting; 8-10 hours) and after (postprandial) consumption of the metabolic challenges. Capillary blood samples (40µ) are obtained in the morning after an 8-hour fasting and after test meal consumption. To obtain the capillary blood sample, sterilize the ring finger with alcohol and allow it to dry. Then, puncture the area with a sterile 2 mm long lancet. Once the drop of blood is formed, it is placed directly into the CardioCheck Plus® cassette to determine glucose triglyceride, LDL-cholesterol, HDL-cholesterol, and total cholesterol. A second drop of capillary blood shall be placed on a filter paper (S&S 903) until a circle of filter paper is filled with blood to saturate the paper throughout its thickness. Insulin concentration shall be determined following the protocol for dried blood, which is standardized in the laboratory. Indirect fasting calorimetry is also performed. After the indirect calorimetry, the metabolic and hormonal response to the test meal is performed. Each challenge should be consumed within 15 minutes. After 5 minutes of rest, indirect calorimetry will be postprandially, lasting 30 minutes. Capillary blood shall be obtained at the following times: 15-30-45-60-90 and 120 min after ingestion of food. Nutrient composition of standardized meal and meal example. - High carbohydrate challenge: Energy, 479.6 kcal; Carbohydrate, 83.6%; Lipids, 12.4% and Protein, 4.0% (70 g of hot-Cake, 100 g of mango, 270 ml of peach nectar, and 40 g of strawberry jam) - High lipid challenge: Energy, 1043.4 kcal; Carbohydrate, 4.9%; Lipids, 86.8%, and Protein, 8.3% (60 g of manchego cheese, 25 g of egg, white, dried, 24 g of bacon, 5 ml of oil, 65 g of cream cheese, 70 g of cream, and 16 g of poblano pepper) - High protein challenge: Energy, 441.3 kcal; Carbohydrate, 1.6%; Lipids, 5.1%, and Protein, 93.3% (2 scoop Isopure Zero Carb, 180 g of chicken breast, 20 g of lettuce and 24 g of ham turkey breast) Determination of metabolites in dried blood To determine the concentration of metabolites (amino acids and acyl-carnitines), a circle of 3 mm diameter shall be punched out of the filter paper and placed in a 96-well plate. Add 100 µl of the acyl-carnitine and amino acid standards from the NeoBase PerkinElmer kit. Subsequently, follow the manufacturer's instructions for determining metabolites by liquid chromatography coupled to mass spectrometry (LC-MS). Determination of the respiratory quotient (RQ) To determine the respiratory quotient (RQ= VmaxCO2/ VmaxO2) and lipid and carbohydrate oxidation examinations, the Cardio Coach CO2 Vmax Encore 29 System calorimeter software (Korr, Inc, UT, USA) will be used according to the instructions of the supplier. Examinations are invariably performed in the morning (8:00-9:00 am) in a thermoneutral environment with controlled pressure, humidity, and temperature, with the patient supine but awake. The investigators examine a maximum of two subjects per day. Oxygen consumption and carbon dioxide production were obtained using a canopy and were monitored continuously for 30 minutes. The initial 10 minutes of the measurement are discarded for the calculation to ensure greater data homogeneity. O2 consumption and CO2 production will be recorded continuously for 30 min. VO2 and VCO2 values will be used in the equation proposed by Weir (Energy Expenditure = [3.941(VO2) + 1.11(VCO2)] x 1440 min/day), considered as the standard method [34]. Additionally, one day before the test, subjects are instructed to fast for 8 hours and not engage in physical activity or consume caffeine the day before the exam. All participants will be asked to eat the same dinner the night before each test. Dinner provides 15% of the daily energy intake; 20 g of protein, 7 g of lipids, and 34 g of carbohydrates)

Metabolic Impact on the Mitochondria-gut Microbiota Axis of Failure to Follow Restrictive Dietary Interventions in Subjects Living with Obesity

The study consists of an open-label randomized controlled clinical trial. The selected subjects will be men or women over 18 years of age with a body mass index (BMI) greater than or equal to 30 kg/m2, who meet the selection criteria, the subjects who will be randomly assigned to one of 3 dietary intervention groups. The study consisted of a dietary intervention with a duration of 8 weeks and a follow-up of 24 weeks after dietary intervention. The intervention groups will be as follows: 1. Calorie-restricted diet: Dietary recommendations will be given restricting 30% in energy (kcal) according to their usual diet with normal macronutrient distribution (20-30% protein, 50-60% carbohydrates, 20-30% fats). 2. Intermittent fasting diet: Dietary recommendations will be given according to the energy expenditure determined by indirect calorimetry with normal macronutrient distribution. Intermittent fasting will be used with a time-restricted model of 16:8. For 16 hours, they will not be able to eat or drink calories. In the other 8 hours, they need to adhere to the energy-restricted diet. 3. Ketogenic diet: Recommendation will be given according to the energy expenditure determined by indirect calorimetry, with the following distribution of macronutrients: 20-25% protein, 5-10% carbohydrates, 70-80% fat. Participants with calorie-restriction, intermittent fasting, or ketogenic diet dietary intervention will be provided with a food menu guide for fifteen days. After 8 weeks of the assigned intervention, patients will be provided with general dietary recommendations and will be invited to three more follow-up visits at 8, 16 and 24 weeks post-intervention. In addition, all participants will be provided with general recommendations for a physical activity plan for people living with obesity. To evaluate adherence to treatment, participants will be asked to fill out 2 logbooks every two weeks (1 during the week and 1 for the weekend) in which they must record the type, amount and place where they consumed the food at each feeding time. They will also be called once a week for a 24-hour reminder. Participants on the ketogenic diet will be given test strips to measure ketones in urine.

Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine

Nasal symptom changes will be assessed daily over a 10-day intervention period using the Total Nasal Symptom Score (TNSS) for allergic rhinitis. Patients will complete the first questionnaire during the randomization visit, followed by daily entries each night before bedtime using a patient diary. The final assessment will be completed during the study's end-of-treatment visit. Quality of life, global clinical impression, and patient global assessment will be evaluated during in-person visits conducted at baseline, Day 5, and Day 10. The incidence of adverse events throughout the study will be analyzed by treatment group and reported as frequencies and percentages. Events will be classified according to frequency, seriousness, severity, and their relationship to the investigational product.

A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)

The Effect of Accompaniment by Older Adults on Anesthetic Recovery

Justification: Due to the increase in life expectancy and the growing number of older adults worldwide and in our country, it is important to search for and implement feasible and cost-free measures to improve the quality of medical care, specifically in surgical treatments that impact the reduction of complications, shorten recovery time, and indirectly improve the quality of life for these patients. Feasibility and relevance: - The research question aims to improve the quality of medical care for older adults with a humanistic approach. - In a group of people that will continue to grow, with a longer life expectancy, they will require surgical treatments. - There are no articles evaluating the quality of anesthetic recovery or its impact on their health with accompaniment. - Approximately 222 surgeries are performed in this population every month, making it a frequent occurrence. - It is a measure that does not incur any cost. - It can be applied in any hospital setting. Problem statement: The increase in life expectancy worldwide has led to a larger population of older adults, and Mexico is no exception. Therefore, it is important to establish measures that improve the quality of medical care and reduce complications in this age group, using measures that do not incur any economic costs. Specifically, in the perioperative period, proposing the accompaniment of older adults in the anesthetic recovery area. Research question: Does the accompaniment of older adults improve the quality of anesthetic recovery with a score higher than 122 on the QoR15 (quality of recovery - 15) scale? Hypotheses: Null hypothesis: The accompaniment of older adults in the immediate postoperative period does not improve the quality of anesthetic recovery with a score lower than 121 on the QoR15 scale. Alternative hypothesis: The accompaniment of older adults in the immediate postoperative period improves the quality of anesthetic recovery with a score higher than 122 on the QoR15 scale. Overall objective: - Determine if the accompaniment of older adults improves the quality of anesthetic recovery, classified as good or excellent according to the QoR15 scale with a score of 122 to 150. Specific objectives: - Determine the incidence of anxiety in older adults in the anesthetic recovery area, considering anxiety with a score higher than 22 on the Beck scale. - Determine the presence or absence of delirium in older adults in the perioperative period. - Assess if the accompaniment of older adults reduces the length of stay in the anesthetic recovery area, aiming for a stay of no more than 60 minutes.

Comparison of Two Non-invasive Neuromodulation Techniques as Synergistic Therapy to Cognitive Stimulation in Amnestic Mild Cognitive Impairment (aMCI)

Mild Cognitive Impairment can be described as an intermediate stage between intact cognition and dementia, this study has become a global priority due to alarming changes in the population pyramid that place the world population at a higher risk of developing dementia. The global prevalence of MCI is between 15-20% in people over 60 years old. In 2012, a prevalence of MCI of 3.2% was found in Mexico City, which encourages the researchers to study this phenomenon to achieve early detection and create interventions that could delay the onset of dementia and even prevent it. Symptomatology is distinguished by deficits in one or more cognitive domains through formal tests applied repeatedly; the individual can manifest symptoms directly by identifying as different from a previous state and/or being corroborated by an informant. The amnestic cognitive impairment (aMCI) occurs when the cognitive failure is limited only to the domain of episodic memory. Generally, there is a slight functional impairment for complex tasks, but the basic and instrumental activities of daily life must be preserved. Behavioral and psychological symptoms (BPSD) can occur. Apathy, anxiety, and depression present in patients with mild cognitive impairment may represent an increased risk of dementia and in many cases, can be the first symptoms to appear. The evaluation is essential because BPSD are often controllable with treatment and appears in up to 77% of patients with MCI. Despite the need to stop the progression to dementia, a MCI treatment is currently nonspecific, focused on associated events, with pharmacological and non-pharmacological measures aimed to reduce cognitive and neuropsychiatric symptoms. Therapeutic methods that promote neuroplasticity, for instance, cognitive stimulation (CS) and non-invasive neuromodulatory techniques such as Repetitive Transcranial Magnetic Stimulation (rTMS) and Transcranial Direct Current Stimulation (tDCS), optimize performance by stimulating the neural network distributed around a dysfunctional circuit, interacting with brain plasticity, and inducing or increasing compensatory mechanisms. This phenomenon could add to the cognitive reserve and interfere with the temporal evolution of the symptoms. Thereby, the rTMS and tDCS have been suggested as a possible treatment in aMCI. These non-invasive alternatives (rTMS and tDCS) have shown efficacy as a treatment in other disorders, but evidence is required on the efficacy, tolerability, and viability of the application in patients with amnesic MCI as well as the time that the effect of its application remains, which creates the need of further studies with maintenance phases. In this project, the researchers propose a clinical trial for participants with risk of developing dementia using rTMS and tDCS added to CS in an effectiveness comparison using strict placebo control methods which will only be used with rTMS and tDCS, not with CS. The non-invasive neuromodulating techniques will be applied as a treatment alternative to be able to compare the techniques with CS alone, taking into account clinical and neuropsychological evaluations in addition to: 1) the known clinical risk factors (physical activity, comorbidities treatment, etc.) that allow to characterize patients; 2) characterize the participants with genetic biomarkers using the APOE4, CR1, COMT, TREM2 and ABCA7 genotype; 3) document the biological effects related to neurogenesis from olfactory epithelial neural progenitor cells isolated before and after treatment. In addition to the documentation of soluble factors secreted by olfactory epithelial neural progenitor cells, what is relevant to the knowledge of the influence of peripheral serum on microglia. This is crucial role in inflammation. The evaluations will be performed at different time points such as: Baseline (T0), after first phase of treatment (T1=15 sessions/week of tDCS+CS), after maintenance (T2=12 sessions/week of tDCS+CS), and follow-up phase (T3=1 year after treatment); 4) use hippocampal volume, cortical thickness of the medial temporal cortex and parietal cortex using structural magnetic resonance imaging and the default mode network using functional magnetic resonance imaging at rest as a biomarker of response to treatment and 5) associate the response to treatment with changes in Motor Evoked Potential (MEP) amplitude to generate a response-to-treatment biomarker with neuromodulators in MCI and changes in electroencephalogram (EEG). Among the current limitations on knowledge of this disease, many studies use biomarkers to predict MCI or progression to dementia, and although most biomarkers are reported to be valuable in this setting, few are compared with each other, so this is currently difficult to understand the relative importance of the different biomarkers when used together. For this reason, the present project could be a contribution in the short and long term to detect changes that may or may not be related to each other and generate multiple lines of research. Population aging will continue to increase and therefore there will be a greater number of people with aMCI. Currently, there is no treatment that prevents the progression of aMCI to AD, so the trend is to make earlier interventions. aMCI is a condition of opportunity because the cognitive reserve of the patients has not been exhausted, so developing studies with innovative treatments and few side effects that can change the evolution over time is important. To that end, understanding the etiology of this progression and designig treatments that delay or definitively stop aMCI are of importance to preserve the functionality of individuals with this condition. Clinical trials with rTMS and tDCS carried out in aMCI have already shown favorable results regarding episodic memory, semantic memory, and speed of information processing. This trial will be able to contribute to the already reported findings that allow to identify better therapeutic approaches that support the standardization of the application of neuromodulatory techniques. Besides, the possible additive effect of neuromodulatory techniques and CS is well known, but no studies are comparing between diferent interventions with each other. The genetic characterization will be obtained, an experimental biomarker of secretion proteins from olfactory epithelial neural progenitor cells together with the analysis of the neurogenic process occurring in the olfactory epithelium will be generated, an experimental biomarker of serum and the effects soluble factors contained in serum on microglia will be generated, neuroimaging and produce neurophysiological measures considered as possible neuroplasticity biomarkers (MEPs and EEG) associated with the response to non-pharmacological treatment will be recorded and evaluated if the parameters are related to clinical and cognitive characteristics. With this therapeutic approach where non-invasive neuromodulatory techniques are combined with CS, the aim is to improve the quality of care for patients with aMCI, considering that neuromodulation alternatives can delay the process of deterioration in each patient admitted. The hypotheses in this study are: 1) The combined application of non-invasive neuromodulation techniques with cognitive stimulation will significantly improve the cognitive performance of patients with aMCI, compared to the single application of non-invasive neuromodulation techniques or cognitive stimulation alone. 2) There will be differences in the protein expression in the olfactory epithelial neural progenitor cells of patients with aMCI who are treated with some non-invasive neuromodulation techniques and those who only receive cognitive stimulation. 3) The soluble factors in the serum of patients with aMCI before and after treatment will differentially modulate microglia. 4) There will be differences in brain morphology such as cortical thickness and surface area, white matter integrity, as well as structural connectivity between different brain areas before and after treatment with non-invasive stimulation techniques. 5) There will be differences in the amplitude and latency of the MEP as well as changes in EEG of patients with aMCI who are treated with one of the non-invasive neuromodulation techniques and patients who only receive CS.

Associative Peripheral Stimulation for Reduction of Motor Impairment During Acute Period of Stroke Recovery