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Found 21 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating treatments for patients with clinically node positive breast cancer who undergo upfront surgery. The study aims to compare tailored axillary surgery (TAS) combined with axillary radiotherapy (ART) against the standard axillary lymph node dissection (ALND) to see which approach results in better arm-related quality of life and fewer cases of lymphedema two years after treatment. This trial addresses the concern that ALND, while standard, can cause significant harm and morbidity, and seeks to determine if TAS plus ART can reduce this burden. Participants are randomly assigned to receive either ALND, which involves surgical removal of lymphatic tissue in the armpit area, or the combination of TAS and ART. TAS targets positive lymph nodes more selectively than ALND and removes fewer nodes, while ART involves radiation treatment to the axillary region. The trial is conducted in the upfront surgery setting, with prior clipping of the most suspicious axillary lymph node to aid in treatment precision. During the study, participants will complete quality of life questionnaires and be closely monitored for the development of lymphedema over two years following randomization. The main outcomes measured are changes in arm-related quality of life and the occurrence of lymphedema. Safety and treatment effects will be tracked through regular follow-up visits, with the overall goal of improving patient well-being and reducing treatment-related side effects.
Actively Recruiting
This research investigates the best approach for treating low-risk patients with isolated subsegmental pulmonary embolism (SSPE), a condition where small blood clots block tiny arteries in the lungs. The study aims to clarify whether SSPE truly requires anticoagulant treatment or if careful monitoring without medication is a safe option. Currently, many patients receive anticoagulants, which can increase bleeding risk, but some evidence suggests that avoiding these drugs might be safe in selected patients without other complications. Participants are randomly assigned to receive either the anticoagulant drug rivaroxaban or a placebo, allowing comparison between clinical surveillance without anticoagulation and standard anticoagulation treatment. This phase 4, multicenter trial evaluates outcomes over a 90-day period following randomization. During the study, researchers monitor participants for recurrent venous thromboembolism and assess safety outcomes related to bleeding. Participants provide informed consent and are followed closely to observe any clots returning or adverse events. The total follow-up is at least 90 days to determine the efficacy and safety of withholding anticoagulation in this specific patient group.
Actively Recruiting
Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.
Actively Recruiting
Researchers are collecting real-world data from cancer patients who are treated with radiotherapy. This study aims to support radiotherapy research and provide evidence on how radiation oncology fits into a multidisciplinary cancer treatment approach. It is a prospective, open-ended, non-interventional, and non-therapeutic multi-cohort study. Participants included in this study are those planned to receive radiotherapy as part of their cancer treatment. The study involves observing and collecting data without introducing any new treatments or interventions. It includes patients aged 12 years and older with pathologically confirmed cancer who have consented to participate. During the study, researchers will monitor and record the number of patients treated with radiotherapy over a five-year period. There are no additional interventions or treatments given; the focus is on gathering information to better understand radiotherapy's role in cancer care. Participation duration varies as the study is open-ended and ongoing.
Actively Recruiting
Researchers are evaluating the effectiveness of early minimally invasive image-guided endoscopic hematoma evacuation combined with the best medical treatment compared to best medical treatment alone in patients with spontaneous supratentorial intracerebral hemorrhage (SSICH). SSICH is a serious type of stroke with poor prognosis, where nearly half of patients die within one year. This randomized controlled trial aims to improve functional outcomes at 6 months after treatment through this new surgical approach. The study compares two groups: one receiving the current best medical treatment (BMT), which includes strict blood pressure control, seizure management, and intensive care monitoring, and the other receiving BMT plus early minimally invasive image-guided endoscopic hematoma evacuation performed within 6 to 24 hours after symptom onset. The surgery uses advanced neuro-navigation and endoscopic systems to carefully remove the hematoma. The procedure is conducted in specialized operating theaters equipped with imaging and neuronavigation tools. Participants will have six visits in total, four during the hospital stay and two follow-ups within routine clinical care. Assessments include neurological scales such as Glasgow Coma Scale (GCS), modified Rankin Scale (mRS), and National Institute of Health Stroke Scale (NIHSS). Imaging with CT scans and blood sampling occur before intervention, immediately after surgery, and during follow-up. Patient satisfaction, cognition, and quality of life will also be evaluated. The primary outcome is the functional status measured by mRS at 6 months after treatment.
Actively Recruiting
Researchers are evaluating the effectiveness of fecal microbiota transplantation (FMT) following standard antibiotic treatment (vancomycin or fidaxomicin) compared to standard antibiotic treatment alone in adults with a first episode or first recurrence of Clostridioides difficile infection (CDI). This phase III, multicenter, randomized, open-label trial focuses on preventing further CDI recurrences, which can cause significant health problems and reduced quality of life. Although FMT is recommended for multiple recurrences, its use for first episodes or first recurrences has not been previously studied. Participants will be assigned to one of two groups. The experimental group receives standard antibiotic treatment for 10 days followed by FMT capsules administered orally over two consecutive days; those with severe CDI receive an additional second FMT over the next two days. The control group continues with the standard antibiotic treatment for 10 days without FMT. The FMT capsules contain feces from healthy donors and are produced under strict conditions. Participants will be monitored for clinical cure rates eight weeks after completing treatment and followed for up to 12 months. Assessments include clinical evaluation of CDI symptoms and recurrence. Researchers will compare outcomes between the groups to determine if adding FMT reduces CDI recurrence risk. Safety and adherence to the treatment protocols will also be tracked throughout the study period.
Actively Recruiting
This research focuses on children with focal cerebral arteriopathy (FCA) and stroke, a rare but serious condition caused by inflammation in blood vessel walls triggered by infection. It aims to evaluate if combining high dose steroids with standard aspirin treatment leads to better and faster recovery, improved clinical outcomes, and fewer stroke recurrences compared to aspirin alone. This trial is a phase 3 multicenter randomized controlled study conducted in over 20 hospitals across several countries, addressing a top research priority identified by pediatric stroke experts and parents. Participants will be randomly assigned to one of two groups: one receiving standard care including aspirin plus high dose steroids, and the other receiving standard care with aspirin only. The steroid treatment involves intravenous methylprednisolone for 3 days followed by oral prednisolone tapering over 4 weeks at specified doses. Standard care will be consistent across centers and all treatments will begin within 48 hours of diagnosis and no later than 96 hours after stroke onset. During the study, children will be monitored at 1, 3, 6, and 12 months with clinical assessments and MRI/MRA scans at 1, (3), and 6 months. Researchers will measure changes in the severity of arteriopathy, clinical outcomes, and stroke recurrence. The primary outcome is the change in Focal Cerebral Arteriopathy Severity Score (FCASS) from baseline to 1 month. The study will last 48 months and follow strict clinical and ethical guidelines.
Actively Recruiting
Healthy Volunteer
Magnesium sulfate is regularly used during anesthesia, for instance for the reduction of postoperative pain. It reduces the liberation of acetylcholine at the neuromuscular junction. At high plasma concentrations it can induce muscle weakness, flaccid paralysis and in cases of intoxication lead to respiratory arrest. It enhances the effect of muscle relaxants. Volatiles anesthetics influence neuromuscular transmission. They inhibit postsynaptic nicotinic acetylcholine receptors by causing open channel block, receptor desensitization and reducing exocytosis from pre-synaptic vesicles at the neuromuscular junction. The ranking order of these effects of volatile anesthetics on neuromuscular transmission is: desflurane \> sevoflurane \> isoflurane, depending on their blood-gas and tissue-gas solubility index. Magnesium given intravenously during volatile anesthesia induces effects on neuromuscular transmission similar to that of neuromuscular blocking agents. This effect has never been investigated and quantified systematically and prospectively. Propofol, an intravenous anesthetic, has very little effects on neuromuscular transmission. Therefore magnesium given intravenously during total intravenous anesthesia with propofol has no or only very little effect on neuromuscular transmission. The primary objective of the study is to quantify the effect of a perfusion of intravenous magnesium on neuromuscular transmission measured by accelerometry with theTetraGraph device in patients undergoing general anesthesia with volatile anesthetics (desflurane, sevoflurane and isoflurane) as compared to intravenous anesthesia with propofol. The investigators expect a following rank order of the effect: desflurane \> sevoflurane \> isoflurane \> propofol.
Actively Recruiting
Researchers are conducting the REALITY study to collect both short- and long-term safety and effectiveness data on people implanted with Abbott's neurostimulation systems for chronic pain. This prospective, open-label, multi-center study includes a broad range of participants to reflect real-world use and aims to enroll up to 2,000 subjects across up to 100 centers. Enrollment is planned to be completed within 7 years, with an overall study duration of 13 years including follow-up and close out. Participants will receive market-approved Abbott neurostimulation devices, specifically spinal cord stimulation (SCS) or dorsal root ganglion stimulation (DRG) systems. Individuals scheduled to receive implantation within 60 days of the baseline visit can join the study. The study does not randomize or compare treatments but monitors the implanted devices over time to gather safety and performance information. During the study, participants will be followed for up to 5 years after implantation with regular assessments to track device- and procedure-related adverse events, deaths, and device deficiencies. These safety outcomes will be measured at multiple time points including baseline, the permanent implant procedure, and every six months up to five years. The study also involves collecting data on patient experience and device performance throughout this period.
Actively Recruiting
Femara (letrozole) is an extensively investigated, marketed aromatase inhibitor (AI) widely used as treatment in the maintenance phase of estrogen-receptor (ER) positive breast cancer, as it inhibit the synthesis of estrogens. Estrogen is a well known driver of cancer growth in ER-positive tumors and a high percentage of the epithelial ovarian cancers express ER as well. Of which low grade ovarian cancers demonstrates the highest level of expression, supporting our strategy of a sub-group analysis (LOGOS). Therefore, letrozole in this study be investigated prospectively and evaluated as maintenance therapy after standard surgical and chemotherapy treatment in comparison to placebo (which is the current standard maintenance treatment) in subjects with primary, ER-positive low or high grade serous or endometrioid epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) of FIGO Stage II-IV, whose cancer has not progressed by the end of the platinum-based chemotherapy. The objectives are to evaluate the letrozole maintenance treatment compared to placebo in terms of * progression-free survival (PFS; primary endpoint) * overall survival (OS) * quality-adjusted progression free survival (QAPFS) * time to first subsequent treatment (TFST) * quality-adjusted time without symptoms of toxicity (Q-TWiST) * health related quality of life (QoL) assessed by EQ-5D-5L, FACT-ES and FACT-O questionnaires Methods: 540 for this study eligible subjects are 1:1 allocated in this randomized, controlled, double-blinded, multi-centre study to either the test (letrozole) or control (placebo) group. The maximum maintenance treatment duration is 5 years or until symptoms of toxicity or progression of underlying disease. Health and health-related quality of life will continuously be assessed at study entry and during routine recalls which are scheduled every 12 weeks for the first 2 years, followed by every 24 weeks for the next 3 years. Procedures performed to assess the participants' health are the same as are performed during the regular routine ovarian cancer follow-up visits: blood tests, physical as well as gynaecological examinations and may include imaging. In addition, the participants are asked to complete during the study quality of life (QoL) specific questionnaires and wear an activity tracker for one week just before the scheduled visits. These assessments will be used for the evaluation of letrozole's efficacy and burden in comparison to the standard maintenance treatment. Survival follow-up data after the mainentance treatment duration of 5 years (study end) are obtained for up to another 7 years.
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