Dublin 9

Researchers are evaluating blood-brain barrier BBB disruption in adults newly diagnosed with glioblastoma multiforme who are undergoing surgical tumor removal. This prospective study aims to understand how BBB integrity relates to tumor biology, neurological function, and treatment outcomes by using advanced imaging, blood tests, cognitive assessments, and molecular analysis of tumor tissue. The study includes serial assessments before surgery, after surgery, and following radiotherapy. Participants will undergo a comprehensive diagnostic evaluation involving advanced 3-Tesla MRI scans with and without contrast, blood sampling for biomarkers linked to BBB disruption and neuronal injury, neurocognitive tests such as the Repeatable Battery for the Assessment of Neuropsychological Status RBANS and Reading the Mind in the Eyes Test RMET, and collection of tumor tissue during routine surgical resection for immunohistochemical and transcriptional analyses. Assessments are scheduled before surgery, shortly after surgery, at 72 hours, 4 weeks post-surgery, and 4 weeks after completing radiotherapy. During the study, participants will provide clinical and demographic information and complete neurocognitive evaluations at multiple time points. Blood samples will be collected at several intervals to measure specific biomarkers, and MRI scans will assess BBB changes. Tumor tissue analysis will help characterize BBB disruption. The main outcomes include serum biomarkers of BBB damage and neuronal injury, MRI measures of BBB integrity, tissue characterization, and neurocognitive function. The study duration extends to the study completion date, and participants are monitored throughout these defined time points.

Researchers are evaluating epoetin alfa, a medication related to erythropoiesis stimulating agents, in critically ill trauma patients who require mechanical ventilation in intensive care units ICUs. This phase III, randomized, double-blind trial aims to see if epoetin alfa can reduce death rates and severe disability six months after injury. The study involves 2500 patients admitted to ICUs with primary trauma diagnoses from centers in Australia, New Zealand, Europe, and Saudi Arabia. Participants will receive either epoetin alfa 40,000 IU or a placebo sodium chloride 0.9% by subcutaneous injection on Study Days 1 and 8 while in the ICU. Treatment is administered during their ICU stay, and patients are randomly assigned to one of these two groups. The study is designed to compare the effects of epoetin alfa against placebo in this critically ill population. During the study, patients will be monitored for survival and disability outcomes using tools like the World Health Organization Disability Assessment Schedule WHODAS 2.0 at six months. Other outcomes include mortality at different time points and thrombotic vascular events. Data on clinical status, adverse events, and safety will also be collected. The total participation length includes ICU stay and follow-up assessments up to six months after injury.

Breast cancer is the most common cancer affecting women worldwide, and this research focuses on improving follow-up care after treatment for early-stage breast cancer. The study aims to find out if reducing hospital visits during follow-up, while continuing regular mammograms, can keep patients safe and well cared for. It compares two follow-up schedules to see if fewer visits might reduce stress and be more convenient without compromising patient health. Participants are randomly assigned to one of two groups. One group follows the usual schedule with hospital visits every 6 to 12 months for five years, along with annual mammograms. The other group has hospital visits only for the first two years after treatment but continues yearly mammograms for the full five years. Both groups complete yearly questionnaires about their quality of life and experience with follow-up care. Throughout the five-year follow-up, participants will attend scheduled visits or participate by phone for questionnaires. Researchers will monitor health through questionnaires, mammogram results, and medical records to assess quality of life and breast cancer recurrence. No extra tests or treatments are required. The study measures health-related quality of life with the EQ-5D-5L questionnaire at multiple time points and tracks cancer recurrence with mammograms and clinical outcomes.

Researchers are evaluating the differences in patient-reported outcomes between robotic-assisted and conventional open nipple-sparing mastectomy NSM in women undergoing immediate breast reconstruction. This trial focuses on women with breast cancer or those at high risk, including genetic mutation carriers and those with ductal carcinoma in situ or early invasive breast cancer. The study aims to determine if the minimally invasive robotic approach offers better cosmetic results, body image, and satisfaction compared to the traditional open surgery. Both implant-based and autologous DIEP flap reconstructions are included to enhance the relevance of the findings. Participants will be randomly assigned to one of two treatment groups within separate reconstruction cohorts. One group receives robotic-assisted NSM using a single-port robotic system through a single axillary incision, performed at a central surgical hub. The other group undergoes standard open NSM through a conventional incision at either local or central sites depending on reconstruction needs. Immediate breast reconstruction follows the assigned NSM technique, either implant-based or DIEP flap. This multicenter study uses a hub-and-spoke model to provide access to robotic surgery while maintaining oncological safety. During the study, participants will be followed for up to 12 months postoperatively. Researchers will collect patient-reported outcomes using validated tools such as the Breast-Q, Hopwood Body Image Scale, and Aesthetic Item Scale to assess satisfaction, body image, and aesthetic results. Blinded assessors will evaluate aesthetic outcomes to reduce bias. Eligibility is carefully determined by clinical and radiological criteria to ensure appropriate candidates for NSM. The study also monitors safety and recovery, aiming to guide future patient care and surgical decision-making in breast cancer treatment.

Breast-conserving surgery is a common treatment for early-stage breast cancer or ductal carcinoma in situ DCIS, aiming to remove the tumor completely with a clear margin of healthy tissue. If cancer cells are found at the edge of the removed tissue, a second surgery may be needed, which can delay treatment and increase anxiety and costs. This study compares the current standard imaging method using two-dimensional 2D specimen mammography with a newer three-dimensional 3D digital breast tomosynthesis technique performed during surgery to see if it improves margin assessment. Participants undergoing breast-conserving surgery will be randomly assigned to either standard 2D specimen mammography performed in the radiology department or 3D digital breast tomosynthesis performed directly in the operating theatre using the Mozart system. In both groups, the surgeon will review images during surgery to decide if more tissue needs removal. The study does not change standard surgical care or postoperative management. During the study, participants will have intraoperative imaging to assess tumor margins. Researchers will monitor outcomes such as the rate of positive margins on final pathology, need for additional surgery, operating time, and workflow efficiency. Follow-up will include reviewing the final histopathology reports and assessing surgery-related metrics. The study aims to determine if intraoperative 3D imaging improves surgical results and reduces the need for a second surgery.

Oesophageal cancer patients undergoing minimally invasive or robotic-assisted oesophagectomy are being studied to evaluate whether using medium-chain triglyceride MCT based enteral feeding can reduce the risk of chyle leak, a complication involving lymphatic fluid leakage that can prolong hospital stay and require further treatment. This trial compares MCT feeds with standard long-chain triglyceride feeds in a controlled setting to better understand their preventive role for chylothorax after surgery. Participants will be randomly assigned to one of two groups one receives standard jejunostomy feeding with Nutrison Protein Plus starting on postoperative day 1, and the other receives MCT-based jejunostomy feeding with Nutrison Peptisorb starting the same day. Both groups follow the same feeding escalation protocol. This single-centre trial aims to enroll 160 patients, with outcomes assessed up to 90 days post-surgery. During the study, participants will have their chest drain output monitored and undergo clinical and biochemical assessments for chyle leak on postoperative days 1, 3, and 5. Researchers will evaluate chylothorax incidence, re-intervention needs, and length of hospital stay. The trial includes safety monitoring and intends to analyze results on an intention-to-treat basis, with participant involvement spanning the immediate postoperative period and follow-up for complications.

This research evaluates the best order for taking mammography images in women who have had breast cancer and are undergoing routine surveillance. It focuses on women treated with breast-conserving surgery within the past five years. The study aims to compare patient-reported pain and satisfaction across different mammography view sequences, while also assessing image quality, compression force, and breast thickness. Participants are randomly assigned to one of four groups, each following a different sequence for taking mediolateral oblique MLO and craniocaudal CC views of both treated and untreated breasts. No additional imaging is done beyond standard surveillance mammography. The study plans to enroll 400 women at a single center over 2.5 years. During the mammography visit, pain is measured before and after the procedure using a visual analog scale, and satisfaction is collected afterward via a questionnaire. Two radiologists will later review images to score quality. Compression force, breast thickness, radiation dose, and procedure duration are also recorded. The study uses an intention-to-treat approach and monitors participants during the same visit for outcomes.

Urinary incontinence often occurs after radical prostatectomy and can greatly affect quality of life. This trial examines whether a structured pre-operative education program combined with direct referral to pelvic floor physiotherapy can reduce urinary incontinence after surgery compared to the usual care. The study is a single-centre, parallel-group randomized controlled trial involving men scheduled for radical prostatectomy at Beaumont Hospital. Participants are randomly assigned to one of two groups. The standard care group receives an educational video and a recommendation for physiotherapy, but patients must initiate their own referral. The intervention group receives a one-to-one education session led by an Advanced Nurse Practitioner, a scheduled follow-up call 7 to 10 days after surgery, and direct referral to supervised pelvic floor physiotherapy. Follow-up visits take place at 6 weeks and 3 months after surgery. During the study, participants will track their urinary pad use over 7 days, and researchers will measure the average number of pads used per day at 3 months. Other assessments include the time it takes to regain continence, quality of life surveys, physiotherapy adherence, and any complications within 90 days after surgery. The total participation involves observation and follow-up for at least 3 months post-operatively.

HER2-positive metastatic breast cancer has a high risk of spreading to the brain, which can cause serious symptoms like headaches, seizures, and cognitive changes. Although treatments targeting HER2 have improved control of cancer outside the brain, brain involvement remains a major concern. This study evaluates whether it is possible and acceptable to recruit patients and randomly assign them to routine brain MRI surveillance or standard care without routine brain imaging. Participants will receive a baseline contrast-enhanced brain MRI. Those without brain metastases on this scan will be randomly assigned to one of two groups one undergoes brain MRI surveillance at 6 and 12 months, and the other receives no routine brain imaging unless symptoms develop. If brain metastases are found at any time, treatment follows standard clinical practice. The study will follow participants for 14 months from the baseline scan. During the study, participants will be monitored for the development of brain metastases, symptoms related to brain involvement, treatments directed at brain metastases like surgery or radiotherapy, changes in systemic cancer therapy, and survival. Researchers will assess how many eligible patients agree to participate and be randomized. This information will help decide if a larger trial on brain surveillance in this patient group is feasible.

This trial focuses on women undergoing mastectomy for breast cancer who are candidates for Deep Inferior Epigastric Perforator DIEP flap reconstruction. Researchers are evaluating whether a structured post-operative exercise program improves physical fitness and recovery after this type of breast reconstruction, which is preferred for its cosmetic outcomes and suitability for patients who may need radiotherapy. The study also aims to assess how exercise affects quality of life, psychological health, and body image after surgery. Participants are randomly assigned to either a 12-week individualized exercise program or to receive standard post-operative care without a formal exercise plan. The exercise program follows ACSM oncology guidelines and includes aerobic, resistance, and flexibility training delivered in person or via Zoom. The program begins after surgery and is designed to improve strength and overall recovery compared to usual care. Throughout the study, participants are assessed at baseline, 6 months, and 12 months after surgery. Assessments include cardiorespiratory fitness, limb strength, body composition measures such as BMI, fat, muscle, and bone mass, and quality of life questionnaires. Researchers will also monitor post-operative complications, hospital stay length, adherence to the exercise program, psychological effects, and health economics. The total study duration extends up to one year postoperatively to evaluate long-term recovery.