Witbank (emalahleni), South Africa

Difficult Airway in the Bariatric Patient: the BARINTUBE Cohort Study

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.

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.

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.

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

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.

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.

Behavioral Activation Therapy for Medical Students With Symptoms of Depression in Two Cities of Mexico

Safety and Effectiveness of the Opira AIOL in Comparison to Commercial IOLs in Patients Undergoing Cataract Surgery

This is a prospective, multicenter clinical study comparing the safety and performance of the Opira accommodative IOL, a commercial monofocal IOL, and a commercial multifocal IOL. Eligible patients with bilateral cataracts will undergo cataract surgery implanting one of three study lenses, and will be followed postoperatively for 24 months

A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy