Durango Durango, Mexico
Difficult Airway in the Bariatric Patient: the BARINTUBE Cohort Study
Phase
N/ASpan
59 weeksSponsor
: Manuel Alberto Guerrero GutierrezTijuana, Baja California
Recruiting
Mama Empoderada: Adapting a Novel Mental Health Prevention Intervention for Migrant Mothers With Young Children
The goal of this randomized controlled trial is to adapt and pilot-test a novel mental health prevention intervention for migrant mothers with young children in a humanitarian setting. This pilot trial will adapt 'Mama Empoderada' [Mom Power] - a theory-based, trauma-informed, culturally-tailored group intervention to promote mental health and positive parenting among mothers with young children (0-5 years) for the first time. Aims are to: 1. Conduct a pilot study of the adapted intervention to determine acceptability and estimate effect sizes on symptoms of depression, anxiety, and parenting stress; and 2. Explore which theory-based mechanisms of action predict changes in symptoms of depression, anxiety, and parenting stress, and identify factors associated with differential intervention response. The intervention group will receive trauma-informed group and individual sessions on parenting, linkage to resources (e.g., food, shelter), social support, and resilience. The control group will receive standard of care programming. Both groups will complete baseline and exit surveys, as well as follow-up surveys at 2-, 4- and 6- months post-intervention.
Phase
N/ASpan
97 weeksSponsor
San Diego State UniversityTijuana, Baja California
Recruiting
Healthy Volunteers
A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event.
Phase
3Span
211 weeksSponsor
AstraZenecaTijuana
Recruiting
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
Phase
3Span
387 weeksSponsor
GlaxoSmithKlineTijuana
Recruiting
Early Postoperative Complications in Patients Undergoing Bariatric Surgery
This study, conducted in specialised high-volume bariatric surgery centres in Tijuana, Baja California, Mexico, aimed to analyze the outcomes of various bariatric surgery procedures. It include patients who underwent surgeries like sleeve gastrectomy, gastric bypass, and others. The surgeries were performed by five specialized surgeons with assistance from ten bariatric surgery subspecialists. The researchers reviewed electronic medical records and excluded patients with incomplete information. Postoperative complications requiring additional medical or surgical interventions were noted. Statistical analysis was conducted using SPSS software, focusing on descriptive measures like frequencies, percentages, means, and standard deviations.
Phase
N/ASpan
40 weeksSponsor
Instituto Mexicano del Seguro SocialTijuana, Baja California
Recruiting
Healthy Volunteers
A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity
The study will include a screening period of up to 5 weeks. The primary endpoint will be at Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed approximately 4 weeks after end of treatment.
Phase
2Span
163 weeksSponsor
Eli Lilly and CompanyTijuana, Baja California
Recruiting
Carotid Doppler Peak Velocity Variation in Liposuction Fluid Management
The research will involve 50 female participants who have undergone liposuction and will be divided into two groups. Group 1: Fluid administration will be determined by the intraoperative fluid ratio. This ratio is calculated by dividing the sum of subcutaneous infiltration and intravenous fluid by the total aspirate volume. Depending on the aspiration volume, it will be maintained at 1-1.4. Group 2: Participants will be given a fluid maintenance rate of 1.5 ml/kg/h. To determine fluid responsiveness, the carotid artery peak velocity variation (ΔVPeak-CA) will be measured before, during, and after the procedure. If the ΔVPeak-CA goes above 15%, the patient will receive a fluid bolus of lactated ringer solution at a rate of 4-6 ml/kg over 10-15 minutes, and the team will re-measure fluid responsiveness 10 minutes after each ΔVPeaK-CA. During the examination, a single cardiothoracic anesthesiologist will use a 13-6 MHz linear probe (Fujifilm Sonosite M-Turbo) to measure the peak velocity of the carotid artery on the left side. The sample volume will be positioned at the center of the lumen, 2 cm from the bulb, and a pulsed wave Doppler examination will be conducted. To measure the ΔVPeak-CA, the investigators will calculate the maximum and minimum values during one respiratory cycle. This will be done by using the formula: 100x (maximum peak velocity - minimum peak velocity) / [(maximum peak velocity + minimum peak velocity)/2]. Surgical technique The superwet tumescence technique will be the only method utilized for infiltration during the procedure. All participants will undergo power-assisted liposuction, and a single surgeon will operate. The wetting solution will contain 1000cc of normal saline and 2mg of epinephrine in a 1:500,000 ratio. The total Infiltration volume will depend on the patient. The total amount of aspiration will depend on the patient and surgery plan and can vary between 2500 to 5000 ml During the surgical procedure, the investigators will monitor vital signs such as blood pressure, heart rate, temperature, oxygen levels, and urine output. Additionally, the investigators will track the amount of fluids given and removed, and the volume of blood aspirated. Following surgery, participants will be hospitalized for 24 hours. During this time, the investigators will closely monitor the plethysmography variability index (PVI) in both groups. If the PVI exceeds 15%, participants will receive a ringer lactate fluid bolus of 4-6 ml/kg. Additionally, the investigators will keep track of their urine output, total fluid intake, and vital signs
Phase
N/ASpan
59 weeksSponsor
TJ Plast Advanced Center for Plastic SurgeryTijuana, Baja California
Recruiting
Healthy Volunteers
Pilot Study of Neoantigen Peptides and Leukine for the Treatment of Neoplasms
Rationale: Cancer cells express unique peptide antigens recognized by CD8+ cytotoxic T lymphocytes (CTL), which are typically 8-10 amino acids long and are presented in association with Class I MHC molecules. The peptides recognized by helper (CD4+) T-cells are presented in association with Class II MHC molecules and are usually longer (13-18 amino acids in length), although peptide elution studies have indicated no apparent restriction on peptide length. Selected peptides can induce circulating T cell responses in most patients, and that vaccination with a mixture of peptides is immunogenic in up to 100% of patients. The magnitude of T cell responses sometimes is substantial, with 1-5% of circulating CD8 T cells reactive to single antigens. T cell responses to vaccines may be durable for months or years, but are at least as likely to be transient, sometimes declining even while still receiving vaccines. However, T cells induced by vaccination can recognize and lyse cancerous cells expressing the relevant protein and MHC, and peptide vaccines induce promising immunogenicity. Though MHC-restriction of individual peptides limits their use to a subset of patients, there are mixtures of a dozen peptides restricted by HLA-A1, A2, A3, or A11 can be prepared as a stable mixture and can induce immune responses in 85% of patients with cancer who express one or more of those MHC molecules, without negative effects from competition among the peptides. Other experience supports the ability to induce T cell responses to multiple peptides when vaccinating with peptide mixtures. Since antigenic peptides are easily degraded by proteases in the body, it is difficult for the receptors expressed on the immune cells to identify antigen epitopes, and they do not generate a strong immune response to pathogens. An epitope-based vaccine with a reasonable design is composed of epitope peptide/s, and a delivery system. For multi-epitope vaccines, since the traditional carriers and adjuvants are associated with poor efficacy, vaccine designs with built-in adjuvants have been proposed. Therefore, a built-in adjuvant exhibiting both the functions of a transmission system and a traditional adjuvant, is constructed within the vaccine to improve the immunogenicity of epitope peptides by stimulating the innate immune response required for an adaptive immune response. To achieve this goal, the epitopes are regularly fused with adjuvant proteins or displayed on the surface of some particular biomaterials (e.g., liposomes, gold nanoparticles, and poly(lactic-co-glycolic acid) (PLGA)) and the immunogenicity of the epitopes are significantly increased by this immune complex. Leukine is the first and only FDA-approved GM-CSF that supports the survival, growth, and activation of neutrophils, monocytes, macrophages, and myeloid-derived dendritic cells. It boosts and stimulate T cells, promoting tissue repair and wound healing, mediating defense against fungal and bacterial pathogens, and producing anti- and pro-inflammatory cytokines, it also improves dendritic cell activity, which is responsible for antigen presentation and immune response regulation. This symbiotic activity potentiates the action of the peptide vaccine. Study design: This research is a pilot clinical trial using a personalized neoantigen peptide vaccine. Approximately 100 patients with cancer and whose sequencing studies show the presence of neoantigens will receive the personalized multi-peptide vaccine. Peptide vaccines will be given with the addition of Leukine (Sargramostim 250 mcg/m2/dose) by intradermal injection (~0.5 mg of each peptide) in the arm every week for 4 weeks and once every month thereafter for 5 months; the treatment will be discontinued if disease progresses or if there is deterioration of the patient's general condition. All patients will give written informed consent; their data will be coded and fully anonymized. The study was approved by the Ethics Committee of the Regenerative Medicine Institute and conformed to the ethical guidelines of the Declaration of Helsinki.
Phase
1Span
215 weeksSponsor
Instituto de Medicina RegenerativaTijuana, Baja California
Recruiting
ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation
Phase
3Span
231 weeksSponsor
Novo Nordisk A/STijuana, Baja California
Recruiting
Behavioral Activation Therapy for Medical Students With Symptoms of Depression in Two Cities of Mexico
Phase
N/ASpan
53 weeksSponsor
Universidad Autonoma de Baja CaliforniaTijuana, Baja California
Recruiting
Healthy Volunteers