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Filter by:Porto-sinusoidal vascular disorder (PSVD) is considered a rare cause of portal hypertension (PH), resulting from specific histological alterations that essentially affect the small portal branches and sinusoids, in the absence of cirrhosis. In recent years, the recognition and importance of PSVD has increased, notably due to the widespread use of transient elastography (TE). However, the definitive diagnosis of PSVD can only be established through liver biopsy. Recent data show that PSVD should be suspected in patients with PH and TE ≤ 20 kPa and liver biopsy should be considered in this context. The investigators hypothesize that hepatic venous pressure gradient (HVPG) and magnetic resonance liver elastography (MRE) may help in the selection of liver biopsy candidates for the diagnosis of PSVD. The primary objective of the study is to describe HVPG and MRE values and liver biopsy findings in patients with PH and TE ≤ 20 kPa. The search for serum markers that can distinguish these patients from those with cirrhotic portal hypertension without the need for liver biopsy will also be the object of this study. 50 patients will be included, prospectively and retrospectively, in a comparative study between diagnostic methods, with a cross-sectional design.
Determine the usability of an interface and its accessories to provide non-invasive respiratory therapy to neonates and infants.
This is a phase 3, multicentri, randomised, open label study. The purpose is to investigate the safety and efficacy of stereotactic body radiation therapy (SBRT) combined with transarterial chemoembolization (TACE) and lenvatinib (LEN) in the treatment of advanced hepatocellular carcinoma with portal vein tumor thrombus.
Final results from TITAN trial showed that apalutamide plus ADT improved OS in a population of patients with metastatic hormone sensitive prostate cancer (mHSPC), if compared to ADT alone. However, stereotactic body radiotherapy (SBRT) showed to improve outcomes of oligometastatic patients if compared to systemic therapy alone within modern randomized trial, including a mixed cohort of different pathologies. However, there are no trials specifically exploring the benefit offered by SBRT in oligometastatic mHSPC treated with Apalutamide if compared to Apalutamide alone associated to Androgen deprivation therapy. Thus, a randomized trial was designed to test specifically the hypotesis that SBRT will improve outcome in a selected population of oligometastatic mHSPC treated with Apalutamide and ADT, undergoing baseline staging according to local reimbursability.
This phase II trial tests the safety, best dose, and effectiveness of inhaled aerosolized sargramostim in combination with standard immunotherapy (nivolumab) for the treatment of patients with melanoma that has spread from where it first started (primary site) to the lung (metastatic to the lung). Sargramostim works to stimulate the immune system by prompting the bone marrow to produce more white blood cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. In this study, an aerosolized form of sargramostim is inhaled using a device called a nebulizer, which can deliver the drug directly to the lungs. Inhalation of aerosolized sargramostim in combination with nivolumab may be more effective at treating patients melanoma metastatic to the lung.
Rationale: Diabetes mellitus is a chronic disease that is often associated with long-term macrovascular and microvascular complications and decreased life expectancy. Approximately 70% of patients with type 2 diabetes mellitus (DM2) are overweight or obese. Weight loss benefits several aspects of DM2, such as improved glycemic control, increased insulin sensitivity and reduced fasting insulin. Interventions for weight loss in patients with DM2 include diet, exercise, but also pharmacotherapy and bariatric surgery. Bariatric surgery is indicated at a body mass index (BMI) > 35 kg/m², in combination with other comorbidities. It is associated with better glycemic control and more weight reduction, compared to intensive medical treatment alone. For patients with not adequately controlled DM2 who are not eligible for surgery (i.e., BMI of < 35 kg/m²), there is a therapeutic gap, which could be filled by one of the currently available endoscopic therapies aiming to reduce weight. One of these therapies is endoscopic sutured gastroplasty (ESG), performed with the endomina device (EndoTools Therapeutics S.A.). There is however a paucity of data showing the effect of ESG on metabolic comorbidities including DM2. We hypothesize that ESG with the endomina device will improve glycemic control in patients with DM2 and obesity. Objective: To evaluate the efficacy of ESG with the endomina device on glycemic control, in obese insulin treated type 2 diabetic patients. Study design: This is a prospective, randomized controlled trial. Study population: 58 subjects (29 in each group) with a BMI between 30 and 40 kg/m² and DM2, treated with insulin therapy. Intervention (if applicable): The intervention group will receive ESG performed with the endomina device. The control group will receive standard diabetic care. Main study parameters/endpoints: The primary endpoint is the proportion of patients with a clinically relevant reduction of insulin dose. Secondary endpoints include among others reduction in HbA1c, remission of diabetes, weight loss, quality of life and (serious) adverse events. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: An ESG with the endomina device is known to have only minor adverse events (transient abdominal cramps, nausea, vomiting), and a serious adverse event rate of <1% (no surgical intervention needed, no mortality).
The aim of this study is to characterize the efficacy of percutaneous tenotomy (PUT) using TENEX®, a device used for the treatment of various tendinopathies. In this study an ultrasound (US) is performed to guide the partial release of gluteus medius and minimus and Iliotibial band tendons in patients diagnosed with refractory Greater Trochanteric Pain Syndrome (GTPS) vs control. The study team hypothesizes that PUT can improve the pain level and function for individuals suffering with GTPS. The study will assess walking, standing, and side-lying tolerance, as well as medication utilization. The investigator team predicts that this percutaneous outpatient procedure can decrease pain and medication utilization while increasing mobility.
Project Summary: The prevalence of preterm birth ranges from 5% to 18% across 184 countries, and an estimated 15 million infants are born preterm globally. These infants with an immature immune system and gastrointestinal tract are at risk of complications of premature birth, which is the leading cause of neonatal death. According to researcher hypothesis for this study, there is role of probiotics in promoting food tolerance and reducing the incidence and severity of Necrotizing Enterocolitis (NEC) and death related to NEC in pre-term VLBW infants. In the current study, we will examine the effects of probiotics in premature infants and figure out the optimal intervention through randomized controlled trial (RCT). A prospective, masked, randomized single blinded controlled trial will be conducted in the neonatal intensive care unit (NICU) of Services Hospital Lahore. In this trial the treatment group will receive the probiotics during their first month of life, and the control group will receive no treatment. Primary outcome will be the incidence of death or NEC (≥ stage 2). Death is included as a primary outcome because it is a competing variable of NEC. The x2 test will be used to analyze the categorical data, along with Fisher's exact test when applicable. The Student's t test will be used for continuous data. A logistic regression model will be used to analyze the treatment effects on the primary and secondary outcome variables (death, NEC, and sepsis). Values will be expressed for mean and standard deviation. Statistical significance is set at P-value of 0.05. The objective of this study is to confirm the evidence and to get the more reliable and authentic results regarding the more effective treatment of NEC in preterm neonates. In this way, the researcher shall be able to improve the outcome of premature births and to reduce the complications by increasing the cure rate. Similarly, it will help the researcher to improve knowledge for better management of NEC in neonates.
The purpose of this clinical trial is to determine whether different types of ventilator settings during surgery change the relationship between the pressures in the lungs and the function of the heart. In this study, patients will be randomly assigned (like flipping a coin) to receive either standard or individualized (research) lung protective ventilator settings. Before surgery, patients will be given an 8-item verbal questionnaire about any respiratory symptoms. After patients are asleep for surgery, an ultrasound probe will be inserted into the esophagus (food pipe) and stomach to examine the heart and lungs and take ultrasound pictures. The ultrasound probe is then removed. Next, a small balloon catheter (a narrow tube smaller in diameter than a pencil lead) will be placed in the esophagus, where it will be used to measure the pressures in the chest and lungs. For patients who are assigned to standard ventilator settings, the ventilator settings and pressures during surgery will be recorded. For patients assigned to individualized (research) ventilator settings, the pressures from the balloon catheter will be used to adjust the ventilator settings every 30 minutes during surgery. A second ultrasound pictures of the heart and lungs will be obtained at the point at which the patient is placed into the Trendelenburg position. At the end of surgery and before the patient is awake, the balloon catheter will be removed, the ultrasound probe will be inserted, a third set of ultrasound pictures of the heart and lungs will be obtained, and the ultrasound probe then removed. Patients will be telephoned 30 days after surgery to ask about their recovery. The 8-item respiratory symptom questionnaire will be repeated at this time.
The optimal treatment for oligometastatic prostate cancer (OMPC) is still on its way. Accumulating evidence has proven the safety and feasibility of radical prostatectomy and local or metastasis-directed radiotherapy for oligometastatic patients. The aim of this trial is to compare the safety and feasibility outcomes of metastasis-directed neoadjuvant radiotherapy (naRT) and neoadjuvant androgen deprivation therapy (naADT) followed by robotic-assisted radical prostatectomy (RARP) to ADT combined with abiraterone for treating OMPC.