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Filter by:This study is designed to test if the medical-education-community collaborated intervention can reduce the symptoms of children with Attention deficit hyperactivity disorder (ADHD) compared to routine clinical care. Investigators will also evaluate if the intervention will positively affect organizational skills and academic achievement compared to controls.
This phase I trial investigates the side effects and effectiveness of chemotherapy followed by a donor (allogeneic) stem cell transplant when given to patients with high grade brain cancer. Chemotherapy drugs, such as fludarabine, thiotepa, etoposide, melphalan, and rabbit anti-thymocyte globulin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells.
Evaluate the safety and efficacy of microcurrent stimulation therapy for patients with dry age-related macular degeneration.
In the last 20 years, atrial fibrillation has become one of the leading healthcare burden in Europe and other developed countries. With an ever-increasing prevalence and incidence, atrial fibrillation is expected to remain a significant problem in the near future. Due to numerous detrimental effects atrial fibrillation has on the patient's health, having an efficient and safe treatment is crucial for managing the problem. The gold standard for an atrial fibrillation treatment is a catheter ablation. In typical catheter ablation procedure, triggers in pulmonary veins are addressed with a pulmonary vein isolation- offering a high long-term success rate in patients with paroxysmal atrial fibrillation. However, the same cannot be said for persistent and longstanding persistent atrial fibrillation. Studies have shown that efficiency of catheter ablation for persistent and longstanding persistent atrial fibrillation, including multiple procedures per patient, ranges around 50 %. It is postulated that extrapulmonary vein triggers, such as foci located in the posterior wall of the left atrium, play an important role in initiating and maintaining persistent and longstanding persistent atrial fibrillation. In the past, to address this issue, a convergent procedure was developed. In convergent procedure an epicardial ablation of posterior wall is performed through a subxyphoid window. Next, an endocardial ablation with an ablation catheter is performed to isolate pulmonary veins. Because the epicardial lesions are applied in the opposite direction and not towards the esophagus, ablation of posterior wall can safely be performed. The procedure offers a high long-term success rate (85%) in patients with persistent and longstanding persistent atrial fibrillation. However, due to higher associated invasiveness, the convergent procedure carries a higher risk of complications compared with catheter ablation (4 % vs 9 %). With advancements in ablation catheter technology, such as continuous force measurement at the tip of the catheter, the depth and volume of the lesion can be estimated. This information greatly increases the reliability of lesion formation. The operator can thus effectively apply lesions to the posterior wall of the left atrium more safely in regards to the collateral damage to the esophagus. The objectives of the study are: - To compare procedural, safety and efficiency profile of convergent procedure with catheter ablation procedure, both targeting pulmonary veins triggers and triggers located in the posterior wall of the left atrium. - To compare long-term success rate of convergent procedure with catheter ablation procedure, both targeting pulmonary veins triggers and triggers located in the posterior wall of the left atrium.
Covid-19 also primarily affects endothelium that line up the alveoli. The resulting hypoxemia may differ from "typical" Acute Respiratory Distress Syndrome (ARDS) due to maldistribution of perfusion related to the ventilation. Thus, pathophysiology of Covid-19 ARDS is different, which requires different interventions than typical ARDS. The investigators will assess whether extravascular lung water index and permeability of the alveolar capillary differs from typical ARDS with transpulmonary thermodilution (TPTD) technique. Extravascular Lung Water Index (EVLWI) and Pulmonary Vascular Permeability Index (PVPI) will be compared.
There is no current accepted and predictably effective ablative therapy for patients with recurrent paroxysmal atrial fibrillation after prior pulmonary vein isolation (PVI). This study will compare redo PVI with hybrid epicardial ablation incorporating posterior wall isolation and LAA clip, and redo PVI.
This is a multicenter, Phase 2a, randomized, double-blind, placebo-controlled pilot study to assess the biological activity, safety and pharmacokinetics of PU-AD compared to placebo in ALS. It will be conducted in approximately 20 sites in the US. Approximately 30 subjects will be enrolled in this study; subjects will be randomized 3:2 to receive either PU-AD 30 mg or matching placebo qd, added onto any current stable background treatment.
The purpose of this research is to replace one of participants' outpatient chimeric antigen receptor T-cell (CAR-T) therapy follow up visits with a virtual or "telemedicine" visit. The telemedicine visit will use an electronic tablet with a camera and a microphone that allows participants to communicate with their physicians and nurses. Participants will be provided with the necessary equipment to complete these visits.
This phase Ib trial investigates the side effects of the combination of nivolumab and ipilimumab, and to see how well they work in treating patients with cancers that have come back (relapsed) or does not respond to treatment (refractory) and have an increased number of genetic changes. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tumor mutational burden (TMB) is the total amount of genetic changes or "mutations" found in tumor cells. Some studies in adults with cancer have shown that patients with a higher TMB (an increased number of genetic changes) are more likely to respond to immunotherapy drugs. There is also evidence that nivolumab and ipilimumab can shrink or stabilize cancer in adult patients with cancer. This study is being done to help doctors learn if the combination of nivolumab and ipilimumab can help children, adolescents, and young adults patients live longer.
The objective of this trial is to assess anti-tumour activity of BI 754091 as monotherapy and of BI 754091 in combination with BI 836880 in patients with unresectable or metastatic squamous cell carcinoma of the anal canal who progressed on or after chemotherapy.