Sainte-gemmes, France
Evaluation of the Efficacy of the Watch Your Weight During Holidays Program for the Prevention of Body Weight Gain in Mexican Adults.
Phase
N/ASpan
14 weeksSponsor
Rolando Giovanni Díaz ZavalaHermosillo, Sonora
Recruiting
Healthy Volunteers
Obesity Treatment With a Very Low Energy Diet in Mexican Adults
Phase
N/ASpan
30 weeksSponsor
Universidad de SonoraHermosillo, Sonora
Recruiting
Efficacy of a School-based Obesity Prevention Program in Mexican Schoolchildren: Cluster Randomized Controlled Trial
This is a cluster randomized controlled trial. The study will be conducted in two phases. The first phase will be a 6-month pilot study with a follow-up at 8 months (after the summer holidays) to evaluate the feasibility: of retention, adherence, acceptability, and fidelity (Eldridge et al, 2010). The second will be a definitive study of 6 months with a follow-up at 8 and 12 months to evaluate the efficacy. The study will consist of three parallel, three-arm groups with a 1:1:1 allocation ratio. To perform the protocol of the study, the SPIRIT 2013 guide was followed. The study was approved by the Research Ethics Committee of the University of Sonora Department of Nursing (EPD-007-2022). Fifteen public schools (300 to 450 students) from Hermosillo, Sonora, Mexico will be conveniently invited to participate in the pilot study. The sample size was determined based on the capacity of providing the program and on finding possible positive effects on the variables of interest . The calculation of the sample size is not essential in a pilot study, where its main objective is to know the feasibility of the intervention and information regarding the response variables to later carry out the sample size calculation for a future definitive trial (Eldridge, 2016). Once the informed consent and assent have been signed by the parents and children (respectively), the baseline measurements will be made over 4 weeks. The schools and participants that meet the inclusion/exclusion criteria will be randomly assigned to one of the three arms. 1). Planet Nutrition Program (PNP) implemented by nutrition and physical activity advanced students (studying the last semesters of the degree or who have completed subjects but do not have the degree), 2). PNP implemented by school teachers and 3). a control group. An independent person from the recruitment and the intervention will perform the random allocation of the schools. This will be stratified by socioeconomic level. The random number sequence will be generated using the software "Research Randomizer" https://randomizer.org/. The baseline characteristics will be analyzed among groups, and an ANOVA analysis will be used for the quantitative variables, and a chi-square test for the categorical outcomes in order to assure that groups are similar in all variables. If there are significant differences among groups at baseline, an adjustment will be made in the analysis. To evaluate the differences between groups in the change of the BMI Z-score, body fat, and the other secondary variables at the beginning and at the end of the intervention, a mixed model will be used to consider the effect between groups and within groups. All analyzes will be performed by the intention to treat. If data is not obtained for any reason or subjects were excluded due to a protocol violation, they will be replaced by their baseline measurement. The R studio software will be used to perform the analysis.
Phase
N/ASpan
104 weeksSponsor
Universidad de SonoraHermosillo, Sonora
Recruiting
Healthy Volunteers
Diabetes Training Program for Health Professionals From Hermosillo, Sonora
The study aims to improve knowledge in diabetes through the design and evaluation of a training program in health professionals (doctors, nurses and nutritionists) in primary health care. The hypothesis of the study is that the training program in diabetes aimed doctors, nurses and nutritionists in primary health care will significantly increase knowledge in diabetes.
Phase
N/ASpan
68 weeksSponsor
Centro de Investigación en Alimentación y Desarrollo A.C.Hermosillo, Sonora
Recruiting
Healthy Volunteers
Evaluation of the Plant-based Approaches to Stop Obesity Diet for the Treatment of Overweight and Obesity
Phase
N/ASpan
147 weeksSponsor
Universidad de SonoraHermosillo, Sonora
Recruiting
CONVALESCENT PLASMA FOR ILL PATIENTS BY COVID-19
Specific objectives 1. Show the efficacy and safety of fresh plasma in different doses in severe cases and in very severe cases. 2. Assess whether fresh plasma can overcome negative prognostic factors in very severe ill patients with COVID-19 infection. These factors are age, high SOFA score, and high D-dimer. 3. To evaluate the titration of antiCOVID-19 antibodies and if its quantification is related to the therapeutic response. The responses to drug treatments that exist in our country such as hydroxychloroquine ± azithromycin, lopinavir / ritonavir and tocilizumab (anti-IL-6) are very heterogeneous, with high cost and diverse and serious adverse events in some cases. Absent randomized-controlled studies and case series or small cohort studies have not been shown to be more effective than supportive treatments in these patients. One more factor is that intubated patients cannot swallow and these medications are for oral posology; the only way to administer is through a nasogastric tube, so we cannot assure that its absorption is as expected and that the blood levels do not reach therapeutic levels. Therefore, we propose a treatment that in the first instance is in our hands, which has already proven to be effective in infection with highly pathogenic viruses such as Ebola virus, Lassar fever and other coronavirus infections (SARS1 in 2003, MERS 2012). With regard to convalescent plasma, two studies have recently been published, a series of 5 and another of 10 cases, seriously ill and with no response to the mentioned therapies (hydroxychloroquine ± azithromycin and lopinavir / ritonavir, among others). The outcomes in this series of cases have been reported satisfactory in most with few minimal adverse events (rash). Since the convalescent plasma dose is very ambiguous in the case-series reported, we will try to find this dose. Therefore, in this initial phase, we divided it into two severity groups: 1. . Severe ill group, convalescent plasma dose on day 0, evaluation on day +3 and if you continue with the clinic and laboratories, a second dose of plasma may be administered. Always watching the safety always (early and late transfusion reactions). Clinical evaluation (including oxygenation) as well as laboratory (days +6, +9, +12, +15, +18, +21 to find the necessary dose for response. The patients will be evaluated and if they meet the response points, the minimum effective plasma dose will be recommended for phase 2. 2. . Very severe ill group, convalescent plasma dose day 0, with evaluation on day +3, will add another dose of plasma if there is no improvement clinic or laboratory, reevaluate day +6 and if required, apply another dose of plasma if there will be not clinical or laboratory improvement. Always watching security. It is reassessed clinically (including respiratory parameters) on days +9, +12, +15, +18 and +21, to find the minimal dose necessary. This sequential treatment will help reduce the risk of water overload and also assess the presence of transfusion lung injury syndrome or TRALI. A second phase, the dose and safety of treatment will be evaluated. In the second phase , both early and late or B will be evaluated as follows: to. Sever ill cases: plasma will be applied according to the dose you will find in phase 1b. Security and response will be evaluated in this phase. b. Very sever ill cases: Plasma will be applied according to the dose you will find in phase 1b and the safety and response phase will be evaluated. It will also be open (the study will not be blinded), it will not be randomized, and it will be controlled only by the severity of the patient and their characteristics of the disease (severe vs. very severe), as well as being controlled by the amount of infusion of plasma (minimum effective dose). SECURITY ANALYSIS The security analysis will be between the researchers in the group and another externak group. They will analyze the first 5 patients in each group (severe and very severe), the main objective for security analysis is going to be mortality related directly to plasma infusion. Subsequently, every 20 patients in each group for phase 2 will be analyzed for safety and response.
Phase
1/2Span
33 weeksSponsor
Instituto de Seguridad y Servicios Sociales de los Trabajadores del EstadoHermosillo, Sonora
Recruiting
A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)
Phase
3Span
265 weeksSponsor
Eli Lilly and CompanyHermosillo, Sonora
Recruiting
Hermosillo, Sonora
Recruiting
ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack
Phase
3Span
115 weeksSponsor
Novo Nordisk A/SHermosillo, Sonora
Recruiting