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Showing 1-20 of 385 trials
NCT07668765
Prospective observational cohort study evaluating the early proctologic effects of GLP-1 receptor agonist therapy in morbidly obese patients. Participants will undergo baseline and 3-month anorectal symptom assessment and proctologic examination to evaluate newly developed proctologic diseases and changes in pre-existing symptoms.
NCT07169851
The purpose of this study is to check how well LY35327021 works and how safe it is for controlling nausea and vomiting caused by chemotherapy. Participants who join this study will be in it until all parts are finished, which could take about 2 months.
NCT05413551
This trial is designed to determine whether modifying the dose of isoniazid for individuals according to their n-acetyltransferase 2 (NAT2) genotype could increase the probability of achieving equivalence of area-under-the-curve.
NCT05898464
The purpose of this study is to compare the immunogenicity and safety of recombinant zoster vaccine according to CD4+ T-cell count and age in people living with HIV, and to provide evidence to guide immunization of people living with HIV.
NCT03839784
The research team is creating a foundational infrastructure in order to develop a precision medicine approach for geriatric patients who require surgery with anesthesia. The team plans to build the first of its kind comprehensive database of demographic and risk factor questionnaire responses, biobanked blood specimens, intraoperative electroencephalography (EEG), and inclusive cognitive testing throughout patient interaction starting at the preop appointment until a year later. This will be used to create a predictive model of periooperative neurocognitive disorders.
NCT06965530
Medically tailored groceries (MTG), involving grocery items to be prepared at home, selected by a nutritional professional based on a treatment plan, is a growing approach adopted by healthcare systems to address food insecurity in their patient populations, a leading contribution to health disparities such as poor birth outcomes within pregnant populations. However, transportation and other social needs can often hinder patient uptake of clinic-based approaches. Findings from this study will help to better understand how home delivery of MTGs, with and without supplemental education and support to improve food literacy, behavioral and health outcomes.
NCT07526662
This is a prospective observational cohort study conducted at Beijing Anzhen Hospital. The study aims to establish reference ranges of heart sound and electrocardiogram (ECG) parameters for both mothers and fetuses. It seeks to develop early warning models for maternal adverse cardiac events, fetal congenital heart disease progression, and autoimmune-related fetal heart block, thereby building a comprehensive maternal-fetal integrated risk stratification system.
NCT04965324
Anaesthetic depth and complications after major surgery: an international, randomised controlled trial - The BALANCED trial. In this large, international, randomised controlled trial that enrolled patients aged 60 years and over with significant comorbidity and at increased risk of complications after major surgery, we found no evidence that light general anaesthesia (bispectral index 50) was superior to deep general anaesthesia (bispectral index 35) in reducing 1-year mortality. The BALANCED long term follow up study will look at whether depth of anesthesia affects long term (beyond 1 year) survival. The primary hypothesis is that targetting BIS 50 will result in superior long term survival compared to targetting BIS 35. The two secondary hypotheses are that BIS titration to BIS 50 will 1. reduce local cancer recurrence or metastatic spread and consequently improve long-term survival 2. reduce postoperative delirium and associated cognitive impairment and consequently improve long-term survival Both these mechanisms would be expected to take longer to manifest as reduced survival than 1-year all-cause mortality primary outcome in the Balanced trial. Trials of cancer outcomes often use 5-year survival or similar timeframes to determine evidence of clinical benefit. A steeper cognitive trajectory due to intermediate outcomes such as delirium and cognitive impairment may take longer than 1 year to produce a clinically important difference in survival 30. The 10.6% relative risk reduction seen in the Balanced trial could translate to a statistically and clinically meaningful survival difference in this high-risk population. This population may have 5-year survival of \~80% translating to an absolute survival difference of \~2% potentially (if the \~10% RRR is maintained beyond 1 year). The alternative is that there is no long-term mortality difference which would provide continuing clinical guidance of the safety of current practice in patients who are not at high risk of delirium. This study could provide a rationale for trials in larger populations (such as the total Balanced trial population) or targeted subgroups such as cancer and delirium to provide further mechanistic insights. Long-term survival is an important patient-centred outcome. The mechanisms described above may manifest in longer-term outcomes providing a clear rationale for the current trial.
NCT07511686
The goal of this observational study is to learn whether statin-related muscle symptoms are linked to problems in fat metabolism in muscle cells, specifically involving acylcarnitines, in adults taking or not taking statins. The main questions it aims to answer are: Do patients with statin-associated muscle symptoms have higher acylcarnitine levels in blood and muscle compared to statin users without symptoms and people not taking statins? Do acylcarnitine levels decrease after stopping or reducing statin treatment in affected patients? Researchers will compare patients with statin-associated muscle symptoms, statin users without symptoms, and individuals not taking statins to see if differences in acylcarnitine levels and muscle metabolism are associated with muscle symptoms. Participants will: Provide blood samples for biochemical tests and acylcarnitine analysis Share information about their health, medications, and lifestyle (Optional) undergo a muscle biopsy to study muscle metabolism Some participants with muscle symptoms will have repeat blood tests and possibly a repeat muscle biopsy after statin dose reduction or discontinuation to track changes over time
NCT07507110
This is a retrospective study from double center: Xuzhou Central Hospital and The First People's Hospital of Yancheng. Acute myocardial infarction (AMI) were screened and AMI complicating with cardiogenic shock were included. This study is to investigate the relationship between red blood cell distribution width-to-albumin ratio (RAR) and major adverse cardiovascular events (MACEs) in acute myocardial infarction complicated with cardiogenic shock (AMI-CS) patients during hospitalization.
NCT07440342
1. The goal of this clinical trial is to learn if transcutaneous electrical acupoint stimulation (TEAS), a non-invasive therapy that applies mild electrical current to specific points on the skin, can help patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) better tolerate the procedure and experience fewer complications related to sedation. It will also test whether TEAS improves procedural success and patient satisfaction. 2. The main questions the study aims to answer are: (1)Does TEAS reduce the incidence of sedation-related adverse events (such as low blood oxygen, low blood pressure, or breathing problems) during ERCP? (2)Does TEAS improve patient comfort and reduce the need for additional sedative medications during the procedure? (3)Does TEAS lead to faster recovery and higher patient and physician satisfaction? 3.Researchers will compare two approaches: 1. Active TEAS: Electrical stimulation at specific points on the legs and arms before and during ERCP. 2. Sham TEAS: Pads placed on the same points but no electrical stimulation delivered (the device appears active). 4.All participants will receive standard conscious sedation with meperidine and diazepam, which is commonly used for ERCP in many centers. Participants will be randomly assigned to one of the two groups. The study will measure sedation-related complications, pain levels, medication requirements, recovery times, and satisfaction scores.
NCT05096338
This is an observational study for patients with prostate cancer that will be treated with Androgen Deprivation Therapy. The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 5 years.
NCT06406114
Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.
NCT07210892
The objective here is to quantify the number of punctures and redirections during routine practice in the anesthesiology department, verify the final angle of incidence and the sac-skin distance by ultrasound, and determine the optimal, maximum, and minimum angles that would have allowed successful punctures. The objective is also to correlate ultrasound and plain X-ray distances, if available. These angles would then be inferred in advance in patients who must undergo spinal anesthesia, assessing whether this prior estimate reduces the number of punctures and redirections.
NCT07469189
We are planning a series of studies in individuals with ulcerative colitis, primary sclerosing cholangitis and pouchitis to determine if hydroxocobalamin is an effective therapy to treat these conditions. For these indications we are submitting INDs to the FDA as well as protocols to the IRB. Hydroxocobalamin, referred to as vitamin B12a has been approved by the FDA for treatment of cyanide toxicity in up to 5 grams intravenously over 15 minutes twice in a brief period. This has been tested and used in intravenous doses as high as 15 grams in a day. We will be utilizing its pharmacokinetic and safety profile to treat several subsets of patients. We are testing this initially in a healthy population to assess tolerability.
NCT07453342
This observational study aims to comprehensively characterize immune-related adverse events (irAEs) occurring during immune checkpoint inhibitor (ICI) therapy in cancer patients and to evaluate the safety and clinical outcomes of ICI rechallenge following irAE resolution. In addition to detailed clinical data collection, the study incorporates biospecimen acquisition, when clinically indicated and feasible, including peripheral blood and organ-specific specimens (e.g., bronchoalveolar lavage fluid for ICI-related pneumonitis, liver biopsy tissue for ICI-related hepatitis, and other relevant clinical specimens). These samples will support exploratory immunologic and molecular analyses to better understand mechanisms underlying irAE development, resolution, and recurrence after rechallenge. This study is designed to generate real-world evidence to improve risk stratification, toxicity management, and decision-making regarding immunotherapy continuation or re-initiation.
NCT03297281
Benign prostatic hyperplasia (BPH) is a very common pathology of the aging man with an incidence that rises from 40% in men aged 50 to 60 years to 90% in men over 80 years. Studies such as the MTOPS (the Medical Therapy of Prostatic Symptoms) study show that more than half of the patients recruited had an aggravation of their disease over time either by an increase in symptoms or by the appearance of complications such as acute retention of urine. For benign symptomatic prostate hypertrophy, apart from any complication, first-line treatment is now a medical treatment. For patients who respond poorly to medical treatment or who have complications related to benign prostatic hypertrophy, the treatment becomes surgical. The reference treatment is endoscopic prostate resection (TURP). It is mainly to improve the safety of hemostasis in patients older and older and at significant surgical risk that new "minimally invasive" surgical techniques have emerged. Thus, lasers have been developed and are currently used as an alternative to the TURP. Used in clinical practice since 2000, prostatic photosensitive vaporization (PVP) relies on the absorption of a 532nm (green) wavelength laser beam by the oxyhemoglobin contained in richly vascularized prostate tissue. Given the aging of the population, more and more patients are being treated with oral anticoagulants (Anti Vitamin K (AVK) or direct oral anticoagulants (DOACs)). Today there are about 1.4 million people on oral anticoagulants, 40% of whom are over 80 years of age. The peri-operative management of the AVK is currently based on the recommendations published by the FHA (French Health Authority) in 2008. Concerning the perioperative management of DOACs, the perioperative haemostasis interest group (GIHP) made proposals updated in September 2015. Numerous studies published in the literature have concluded the feasibility of prostate removal surgery by PVP with greenlight laser without relay (or interruption) of AVK or DOACs because of the properties of hemostasis. But the levels of evidence for these studies remain low. No study has focused on rigorously assessing the perioperative hemorrhagic risk associated with OAC therapy in patients eligible for PVP, and this is the originality of this study. This study is a multicenter prospective randomized study whose objective is to show that the PVP performed in patients with OAC is not associated with an increase in perioperative hemorrhagic risk.
NCT06180876
Remimazolam is a novel benzodiazepine with ultra-short onset and offset of its effect. It can be used for general anesthesia. However, classical benzodiazepine such as midazolam was reported to increase the risk of postoperative delirium. Thus, the investigators aim to investigate the effect of remimazolam general anesthesia on postoperative delirium in elderly patients.
NCT06832371
This observational, multicenter, retrospective and prospective study aims to evaluate the effect of lomitapide treatment on Major Adverse Cardiovascular Events (MACE) in patients with Homozygous Familial Hypercholesterolemia (HoFH). HoFH is a rare genetic disorder characterized by extremely high levels of LDL cholesterol (LDL-C), leading to an increased risk of early cardiovascular diseases. Lomitapide is an approved medication that lowers LDL-C levels by inhibiting microsomal triglyceride transfer protein (MTP). The study will collect data from patients who have been treated with lomitapide for at least 12 months and will compare the incidence of MACE during the first three years of treatment with the three years before treatment initiation. The study includes data collection from multiple lipid centers across Europe. The primary objective is to assess the impact of lomitapide on MACE, while secondary objectives include evaluating changes in lipid profiles, liver function tests, and lipid-lowering treatments.
NCT05763069
High-risk pregnancies often require long-term hospitalization or outpatient maternal and/or fetal monitoring, placing a burden on patients, hospital resources and society. The demand for intensified pregnancy surveillance and interventions is increasing, due to the increased prevalence of risk factors like obesity and advanced maternal age, as well as altered guidelines resulting in increasing labor induction rates.The main aims of the HOME study (Home monitoring of pregnancies at risk) are to assess if home monitoring of selected high-risk pregnancies for maternal and fetal wellbeing is feasible, safe (in a clinical trial), cost-efficient, and simultaneously empowers the users.