234 research outputs found

    Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

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    Summary: Platform trials bring the promise of making clinical research more efficient and more patient centric. While their use has become more widespread, including their prominent role during the COVID-19 pandemic response, broader adoption of platform trials has been limited by the lack of experience and tools to navigate the critical upfront planning required to launch such collaborative studies. The European Union-Patient-cEntric clinicAl tRial pLatform (EU-PEARL) initiative has produced new methodologies to expand the use of platform trials with an overarching infrastructure and services embedded into Integrated Research Platforms (IRPs), in collaboration with patient representatives and through consultation with U.S. Food and Drug Administration and European Medicines Agency stakeholders. In this narrative review, we discuss the outlook for platform trials in Europe, including challenges related to infrastructure, design, adaptations, data sharing and regulation. Documents derived from the EU-PEARL project, alongside a literature search including PubMed and relevant grey literature (e.g., guidance from regulatory agencies and health technology agencies) were used as sources for a multi-stage collaborative process through which the 10 more important points based on lessons drawn from the EU-PEARL project were developed and summarised as guidance for the setup of platform trials. We conclude that early involvement of critical stakeholder such as regulatory agencies or patients are critical steps in the implementation and later acceptance of platform trials. Addressing these gaps will be critical for attaining the full potential of platform trials for patients. Funding: Innovative Medicines Initiative 2 Joint Undertaking with support from the European Union’s Horizon 2020 research and innovation programme and EFPIA

    An Approach to Traumatic Brain Injury-Related Hypopituitarism: Overcoming the Pediatric Challenges

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    Traumatic brain injury (TBI)-related hypopituitarism is a rare polymorphic complication of brain injury, with very little data, particularly concerning children and teenagers. This is a comprehensive review of the literature regarding this pathology, starting from a new pediatric case. The research was conducted on PubMed and included publications from the last 22 years. We identified nine original studies on the pediatric population (two case reports and seven studies; only four of these seven were prospective studies). TBI-related hypopituitarism is associated with isolated hormonal deficits ranging from 22.5% to 86% and multiple hormonal deficiencies from 5.9% to 50% in the studied pediatric population. Growth hormone (GH) deficiency is most often found, including the form with late occurrence after TBI; it was described as persistent in half of the studies. Thyroid-stimulating hormone (TSH) deficiency is identified as a distant complication following TBI; in all three studies, we identified this complication was found to be permanent. Adrenocorticotropic hormone (ACTH) deficiency did not relate to a certain type of brain trauma, and it was transient in reported cases. Hyperprolactinemia was the most frequent hormonal finding, also occurring late after injury. Central diabetes insipidus was encountered early post-TBI, typically with a transient pattern and did not relate to a particular type of injury. TBI-related hypopituitarism, although rare in children, should be taken into consideration even after a long time since the trauma. A multidisciplinary approach is needed if the patient is to safely overcome any acute condition

    A Decade of Therapeutic Challenges in Synchronous Gynecological Cancers from the Bucharest Oncological Institute

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    The aim of our study is to present the particularities of a specific subset of gynecological cancer patients in Romania. We present a review of synchronous gynecological neoplasia (SGN) treated in the Bucharest Oncological Institute’s surgery departments over a decade. Between 2012 and 2022, 7419 female patients with genital malignancies were treated. We identified 36 patients with invasive synchronous primary gynecological cancers (0.5%) and 12 cases with one primary gynecological and another primary invasive pelvic cancer (rectal/bladder). All recurrent, metastatic, or metachronous tumors detected were excluded. Demographic data, personal history, presenting symptoms, pathologic findings, staging, treatment, and evolution for each case were recorded. Usually, the most common SGN association is between ovarian and endometrial cancer of endometrioid differentiation (low-grade malignancies with very good prognosis). However, we noticed that, given the particularities of the Romanian medical system, the most frequent association is between cervical and endometrial, followed by cervical and ovarian cancers. Moreover, the cancer stage at diagnosis is more advanced. In countries with low HPV vaccination rate and low adherence to screening programs, SGNs can present as extremely advanced cases and require extensive surgery (such as pelvic exenterations) to achieve radicality. This multimodal treatment in advanced cases with high tumor burden determines a reduction in survival, time until progression, and quality of life

    Radiation Hardness of MALTA2 Monolithic CMOS Sensors on Czochralski Substrates

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    MALTA2 is the latest full-scale prototype of the MALTA family of Depleted Monolithic Active Pixel Sensors (DMAPS) produced in Tower Semiconductor 180 nm CMOS technology. In order to comply with the requirements of High Energy Physics (HEP) experiments, various process modifications and front-end changes have been implemented to achieve low power consumption, reduce Random Telegraph Signal (RTS) noise, and optimise the charge collection geometry. Compared to its predecessors, MALTA2 targets the use of a high-resistivity, thick Czochralski (Cz) substrates in order to demonstrate radiation hardness in terms of detection efficiency and timing resolution up to 3E15 1 MeV neq/cm2 with backside metallisation to achieve good propagation of the bias voltage. This manuscript shows the results that were obtained with non-irradiated and irradiated MALTA2 samples on Cz substrates from the CERN SPS test beam campaign from 2021-2023 using the MALTA telescope

    Same Clinical Reality of Spontaneous Rupture of the Common Iliac Artery with Pseudoaneurysm Formation—Comparison of Two Therapeutical Solutions, Endovascular Stent-Graft and Open Surgical Correction, for Two Cases and Review of the Literature

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    The incidence of isolated iliac artery aneurysms is approximately 2% and common iliac artery pseudoaneurysms are even rarer. A pseudoaneurysm is a localized hemorrhage as opposed to an actual aneurysm, which affects the entire vascular wall. They are typically asymptomatic and only detectable accidentally while looking for other causes. If large and symptomatic, they typically exhibit pressure symptoms as a result of the compression of the structures around them. Common symptoms include generalized stomach pain, urological problems, gastrointestinal bleeding, and neurological symptoms such as leg paralysis or sciatica-like back pain. Rarely, they may exhibit hemodynamic instability together with an aneurysm rupture, which has a high fatality rate. Due to the unique presentation, the diagnosis is typically rarely made and there is little experience with treating it. We report two cases of common iliac artery pseudoaneurysm found in two patients who had no notable medical history and who we chose to repair through the endovascular technique in the first case, an approach that has gained more ground for vascular repair worldwide, making it the current go-to method, and for the second case we chose a more traditional approach, through open surgery

    COMPARATIVE STUDY ON THE GUIDANCE OF ORTHODONTIC TREATMENTS THROUGH ARTIFICIAL INTELLIGENCE-BASED SOFTWARE AND CLASSIC SOFTWARE

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    When it comes to guiding orthodontic treatments, our study aims to evaluate the effectiveness and benefits of software powered by artificial intelligence (AI) compared to traditional software. The software underwent a thorough evaluation to assess its performance, adaptability, and verbal communication. According to the findings, the software showed a remarkable ability to process and analyze information, resulting in more accurate planning of orthodontic treatments. Its adaptability has been found to be noteworthy, enabling it to identify and address individual patient conditions and problems with greater precision. With the help of this software, orthodontic treatments can be modified and improved in real time, considering the progress and alterations of the case throughout the treatment. Verbal communication through “speech recognize” AI algorithms contributes significantly to their long-term use and user satisfaction. Creating a comfortable and pleasant environment, this software improves the user experience and strengthens their relationship with technology. Comparatively, the classic software presented a lower level of performance and adaptability, and it was impossible to communicate verbally with the software interface. It is based on fixed rule settings and cannot individualize the orthodontic treatment. On the other hand, it uses standardized planning that can lead to unsatisfactory results or further adjustments. According to the comparative study, the artificial intelligence-based software improved the performance and adaptability of orthodontic treatments. Additionally, it enabled direct verbal communication, eliminating the need for a keyboard and a mouse. They can provide more precise guidance by collecting data and machine learning capabilities. However, it is crucial to consider the cost and security aspects of implementing and using this software in the orthodontic practice

    The Experience of a Single Tertiary Center Regarding Benign and Malignant Tumors in Acromegalic Patients

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    Background and Objectives: Acromegaly is a rare disease associated with increased levels of growth hormones (GHs) that stimulates the hepatic production of insulin growth factor-1 (IGF-1). Increased secretion of both GH and IGF-1 activates pathways, such as Janus kinase 2/signal transducer and activator of transcription 5 (JAK2/STAT5), and mitogen-activated protein kinase (MAPK), involved in the development of tumors. Materials and Methods: Given the disputed nature of the topic, we decided to study the prevalence of benign and malignant tumors in our cohort of acromegalic patients. In addition, we aimed to identify risk factors or laboratory parameters associated with the occurrence of tumors in these patients. Results: The study group included 34 patients (9 men (25.7%) and 25 women (74.3%)). No clear relationship between the levels of IGF-1 or GH and tumor development could be demonstrated, but certain risk factors, such as diabetes mellitus (DM) and obesity, were more frequent in patients with tumors. In total, 34 benign tumoral proliferations were identified, the most common being multinodular goiter. Malignant tumors were present only in women (14.70%) and the most frequent type was thyroid carcinoma. Conclusions: DM and obesity might be associated with tumoral proliferation in patients with acromegaly, and findings also present in the general population. In our study we did not find a direct link between acromegaly and tumoral proliferations

    Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

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    Background Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)

    Surgical Strategy for Sternal Closure in Patients with Surgical Myocardial Revascularization Using Mammary Arteries

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    Background: Coronary artery bypass grafting has evolved from all venous grafts to bilateral mammary artery (BIMA) grafting. This was possible due to the long-term patency of the left and right internal mammary demonstrated in angiography studies compared to venous grafts. However, despite higher survival rates when using bilateral mammary arteries, multiple studies report a higher rate of surgical site infections, most notably deep sternal wound infections, a so-called “never event”. Methods: We designed a prospective study between 1 January 2022 and 31 December 2022 and included all patients proposed for total arterial myocardial revascularization in order to investigate the rate of surgical site infections (SSI). Chest closure in all patients was performed using a three-step protocol. The first step refers to sternal closure. If the patient’s BMI is below 35 kg/m2, sternal closure is achieved using the “butterfly” technique with standard steel wires. If the patient’s BMI exceeds 35 kg/m2, we use nitinol clips or hybrid wire cable ties according to the surgeon’s preference for sternal closure. The main advantages of these systems are a larger implant-to-bone contact with a reduced risk of bone fracture. The second step refers to presternal fat closure with two resorbable monofilament sutures in a way that the edges of the skin perfectly align at the end. The third step is skin closure combined with negative pressure wound therapy. Results: This system was applied to 217 patients. A total of 197 patients had bilateral mammary artery grafts. We report only 13 (5.9%) superficial SSI and only one (0.46%) deep SSI. The preoperative risk of major wound infection was 3.9 +/− 2.7. Bilateral mammary artery grafting was not associated with surgical site infection in a univariate analysis. Conclusions: We believe this strategy of sternal wound closure can reduce the incidence of deep surgical site infection when two mammary arteries are used in coronary artery bypass surgery

    Diagnosis and management of colon cancer patients presenting in advanced stages of complications

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    Colorectal cancer is an important health problem with a significant impact on the individual and society. Malignancy (including colorectal cancer) is usually slightly symptomatic in its initial stages. This causes cancer to be discovered in some patients accidentally (either through screening tests in predisposed individuals or during routine investigations for other diseases), while in other patients the colorectal cancer is discovered in late stages, when the symptoms are much more intense due to complications. Unfortunately, such advanced cases of the disease have high rates of morbidity and mortality even with treatment. Current treatment methods are usually complex, interdisciplinary, causing significant suffering (physical, mental) to the individual, while the cost of treatment per patient seems to be extremely high. Until finding therapeutic methods that are effective and accessible to most patients with advanced colorectal cancer, several methods of prophylaxis and early diagnosis should be considered, to reduce as much as possible the devastating impact of this disease. The purpose of this review is to present literature data regarding the current methods of diagnosis and treatment of patients presenting to the doctor with colorectal cancer in advanced stages of complications
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