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This research aims to evaluate cancer treatment based on HER2 status in Nigerian women with HER2-positive breast cancer. The study focuses on assessing the safety and effectiveness of anti-HER2 therapy given before and after surgery. It specifically looks at how well the treatment works and its safety when combined with chemotherapy. Participants will receive a combination of trastuzumab and pertuzumab PHESGO along with chemotherapy. Initially, all participants get docetaxel injections for 4-6 cycles while receiving trastuzumab and pertuzumab as subcutaneous injections for 52 weeks. Depending on how their cancer responds after this phase, some will undergo surgery and continue receiving pertuzumab and trastuzumab for 36 weeks, possibly with hormone therapy such as tamoxifen, letrozole, or goserelin. Others with less favorable responses will receive trastuzumab emtansine intravenously plus standard chemotherapy. During the study, participants will have regular assessments including ultrasounds to monitor tumor response, laboratory tests, and echocardiograms to check heart function. Researchers will track outcomes like pathological complete response, adverse events, quality of life, and survival over 10 years. The study involves continuous monitoring and follow-up to evaluate treatment effects and safety throughout this period.

Tuberculosis TB is a serious infectious disease caused by Mycobacterium tuberculosis, leading to millions of cases and deaths worldwide, particularly in developing countries like Nigeria. TB mainly affects the lungs and is worsened by HIV infection, making it a top cause of death globally. The trial investigates atorvastatin, a cholesterol-lowering drug, to see if it can improve TB treatment by reducing bacteria and lung damage, building on promising earlier studies that showed atorvastatin was safe and may enhance TB therapy outcomes. The trial is a phase IIC, multicenter, randomized, open-label study comparing four treatment groups three different daily doses of atorvastatin 20mg, 40mg, 60mg given for 16 weeks along with standard 6-month anti-TB therapy, and a control group receiving standard therapy alone. Patients are randomly assigned to one of these groups and followed closely for 12 months after starting treatment. The study aims to evaluate safety, the speed at which TB bacteria clear from sputum, improvement in chest X-rays, and lung function. Participants aged 12 to 65 with active pulmonary TB will undergo screening including medical history, HIV and diabetes testing, sputum cultures, blood tests, lung function, and pregnancy tests for women. During the study, sputum samples, blood tests, chest X-rays, and lung function will be monitored regularly. Researchers will track side effects and measure outcomes like TB disease-free survival and symptom improvement at 6 and 12 months. The long follow-up period allows for detailed assessment of treatment effects and safety.

Researchers are studying how atorvastatin, a drug commonly used to lower cholesterol, behaves in the body when combined with the standard first-line treatment for drug-sensitive pulmonary tuberculosis TB in adults. The goal is to understand the drugs pharmacokineticsthe way it is absorbed, distributed, metabolized, and eliminatedand to develop a model that helps find the best dose of atorvastatin to use alongside TB treatment. This study is a phase 2, randomized trial conducted as a sub-study of the larger ATORTUB trial. Participants will be randomly assigned to one of four groups. Three groups will receive standard anti-TB therapy for 24 weeks combined with daily oral atorvastatin at doses of 20 mg, 40 mg, or 60 mg for the first 16 weeks. The fourth group will receive only the standard anti-TB therapy without atorvastatin. The standard TB treatment includes 8 weeks of rifampicin, isoniazid, pyrazinamide, and ethambutol followed by 16 weeks of rifampicin and isoniazid. This parallel dose comparison aims to identify the optimal atorvastatin dose for future TB treatment studies. Participants will attend several study visits over a total of 52 weeks, including 24 weeks of treatment followed by 6 months of follow-up. At each visit, sputum samples, chest X-rays, lung function tests, and blood samples for pharmacokinetic analyses will be collected. Researchers will measure key drug levels such as area under the curve AUC, peak plasma concentration, and plasma clearance for atorvastatin and TB drugs. The study will also evaluate how these drug levels relate to early bactericidal activity, sputum culture conversion, chest X-ray improvement, and lung function changes. Safety and optimal dosing will be assessed throughout the trial.

Researchers are developing a colonoscopy training program in Nigeria aimed at increasing the number of healthcare providers skilled in colonoscopy to improve early detection and screening of colorectal cancer CRC. This project involves understanding current colonoscopy services and access through surveys, interviews, and geographic analysis, and then comparing the effectiveness of low-fidelity and high-fidelity simulation models for training providers. The study has three main parts first, a needs assessment using surveys, interviews, and GIS technology to identify endoscopy availability and barriers. Second, trained healthcare providers are randomly assigned to learn colonoscopy using either a high-fidelity HF or a locally made low-fidelity LF simulation model. Both groups receive 4-6 hours of adapted lectures and practice with real-time instructor feedback. Finally, participants perform colonoscopies on live patients under supervision to assess skill transfer from simulation to real procedures. During the study, participants complete pre- and post-training assessments of colonoscopy skills and confidence, using validated evaluation tools. The live patient training evaluates procedure times, success rates, and safety, with supervisors intervening if needed. Surveys on satisfaction and confidence are collected at the end. The main outcome is to compare skill improvement between LF and HF trained providers on real patients, with additional goals to assess access to care and costs related to colonoscopy in Nigeria.

Researchers are conducting a case-control study to identify modifiable risk factors for breast and colorectal cancer in Nigeria. The study aims to understand how diet, physical activity, medical history, and lifestyle factors might influence the risk of these cancers. The project builds on the existing ARGO platform, which supports colorectal cancer research in the region. The study will include about 400 patients diagnosed with colorectal or breast cancer as cases, and 400 controls without cancer or gastrointestinal diseases. Controls will be recruited from community mobilization groups and outpatient health centers. Participants will complete a detailed questionnaire about their lifestyle and medical history and undergo body composition assessment using a bioimpedance machine to measure body mass index, fat percentage, and total body water. Participants will provide their information through questionnaires and body composition measurements. Researchers will analyze the data to develop and validate a questionnaire for assessing modifiable risk factors in Sub-Saharan Africa and identify new cancer risk factors in the Nigerian population. The study is observational and involves no treatment intervention, focusing on data collection and analysis over approximately two years.

Researchers are investigating the effectiveness of a structured financial navigation program to reduce financial catastrophe and distress among cancer patients in Nigeria. This trial focuses on newly diagnosed breast, colorectal, or prostate cancer patients, examining if the program can lower the high costs and financial challenges faced by these individuals. The study also evaluates whether the financial navigation program is sustainable and cost-effective for cancer centers in Nigeria. Participants in the financial navigation program will work with a salaried financial navigator who educates them about financial literacy, insurance options, and available charitable payment programs. The navigator also assists with verifying insurance documents, maintaining financial records, and coordinating insurance payments. The trial compares this group to participants receiving routine care without access to the navigators services. The study will enroll 200 patients at two cancer centers and follow them over time to assess financial outcomes. Participants will complete surveys about their demographics, cancer history, socioeconomic status, quality of life, psychological wellbeing, and all costs related to their cancer care. The main outcomes measured include the incidence of financial catastrophe over 12 months and levels of financial distress at 3, 6, and 12 months. Researchers will also monitor cost-related non-adherence to treatment up to 6 months. This detailed monitoring aims to provide insights into how financial navigation may affect cancer care affordability and patient wellbeing in low-resource settings.

Researchers are studying triple negative breast cancer TNBC, an aggressive type of breast cancer that affects more Black women and younger age groups. This cancer lacks targeted treatments, so chemotherapy remains the main systemic therapy, though resistance often develops quickly. The study aims to evaluate the response rate to a standard chemotherapy regimen and explore if blood levels of microRNA and circulating tumor DNA can indicate treatment failure early in Nigerian women with TNBC. Participants will receive a sequence of chemotherapy drugs Epirubicin and Cyclophosphamide every three weeks for four cycles, followed by Paclitaxel and Carboplatin every three weeks for four cycles. Blood samples will be collected before, during, and after treatment to measure microRNA and tumor DNA levels. Tumor response will be assessed by ultrasound using RECIST criteria, and treatment side effects will be graded using CTCAE guidelines. Quality of life will be monitored with the EORTC questionnaire. During the study, patients will undergo clinical evaluations, imaging, blood tests, and quality of life assessments. The main outcomes include the proportion of patients achieving complete response after chemotherapy and the incidence of treatment-related side effects, monitored up to five years. Secondary measures include disease-free survival at 2, 5, and 10 years, and changes in quality of life. Total participation may last up to 10 years for long-term monitoring of outcomes and side effects.

Researchers are investigating the effects of pre-operative mouthwash and varying oxygen levels during surgery on the rates of pneumonia and surgical site infections in patients undergoing major abdominal surgery. This trial focuses on patients in low and middle-income countries, where postoperative complications are more common and often more severe. The study aims to find ways to reduce these serious complications, which can cause pain, disability, and increased healthcare costs. Participants will be randomly assigned to one of four groups pre-operative chlorhexidine mouthwash combined with high oxygen levels 80-100% FiO2, no mouthwash with high oxygen levels, mouthwash with low oxygen levels 21-30% FiO2, or no mouthwash with low oxygen levels. Treatments are given around the time of surgery, with oxygen delivered during the operation and mouthwash used before surgery. The study includes an internal pilot phase lasting six months to check recruitment and compliance, followed by a larger trial aiming to enroll nearly 13,000 participants. During the study, researchers will monitor participants for up to 30 days after surgery, assessing rates of pneumonia and surgical site infections using CDC definitions. They will also track other outcomes like mortality, repeat surgeries, hospital stay length, return to normal activities, critical care admissions, and healthcare resource use. Follow-up includes evaluating patient recovery and safety, with all data collected to understand how these interventions impact surgical outcomes in these settings.

Researchers are evaluating the effect of an intravenous lidocaine infusion during breast cancer surgery to reduce the development of persistent pain three months after surgery. This international Phase III randomized controlled trial involves 1,602 patients undergoing various types of breast cancer surgery, including lumpectomy and mastectomy, and aims to compare lidocaine infusion with a placebo treatment. The study is designed to prevent long-term pain outcomes following surgery and improve patient quality of life. Participants are randomly assigned to receive either an intravenous lidocaine infusion or a placebo saline infusion during surgery. The lidocaine group receives a 1.5 mgkg bolus at the start of anesthesia, followed by a 2.0 mgkghour infusion until surgery ends and up to 30 minutes into recovery. The placebo group receives a matching saline infusion under the same conditions. Study medications are blinded and prepared in syringes to ensure unbiased treatment. Patients are monitored closely during surgery and recovery. After surgery, participants are followed up during the first three days and then at three and twelve months to assess their pain levels, use of pain medication, physical and emotional functioning, and overall quality of life. Researchers also monitor for neuropathic pain, cancer recurrence, adverse events, and cost effectiveness of the intervention. These assessments help measure the impact of lidocaine on preventing persistent pain and improving recovery over the year following surgery.

This clinical trial investigates whether intravenous prophylactic antibiotics and antimicrobial-coated sutures can reduce surgical site infections in children undergoing open groin surgeries. It aims to compare no antibiotic use, intravenous prophylactic antibiotics, and antimicrobial-coated sutures to see which approach may better prevent infections after surgery. Participants will be randomly assigned on the day of surgery to one of three groups one receiving a placebo injection with non-coated sutures, another receiving intravenous prophylactic antibiotics with non-coated sutures, and a third receiving a placebo injection with antimicrobial-coated sutures. The study is double blinded and controlled to ensure unbiased results. During the study, children will have their surgical wounds examined at clinic visits on postoperative days 5, 13, and 30 to check for signs of infection. The main outcome measured is the occurrence of surgical site infection within 30 days after surgery. This monitoring follows CDC guidelines to ensure consistent assessment of wound healing and infection status.