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NCT03367572
This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may help lessen nausea and vomiting in patients with breast cancer treated with chemotherapy.
NCT03570801
The purpose of the project is to perform an RCT comparing patient satisfaction and outcome with or without the use of an expert panel. The purpose is also to create a registry to compare the effectiveness of decompression alone versus decompression with fusion for patients with degenerative grade I spondylolisthesis and symptomatic lumbar spinal stenosis. Primary analysis will focus on the patients' improvement from baseline patient-reported outcome questionnaires. In addition, the SLIP II registry aims to (i) develop an algorithm which could identify cases in which surgical experts are likely to recommend one treatment (i.e. \>80% of experts recommend one form of treatment) and (ii) develop a radiology-based machine learning algorithm that would prospectively classify patients as either 'stable' or 'unstable.' In addition to patient reported outcomes, step counts will be collected in order to determine the correlation of step count with patient-reported outcomes (ODI and EQ-5D) and the need for re-operation. This registry portion of the study aims to prospectively collect comparative data for these patients treated with either decompression alone or decompression with fusion.
NCT05946629
Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA. The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.
NCT05890001
The objective of this study is to evaluate the safety of up to 12 months (52 weeks) of once daily oral administration of BLI5100 in patients with non-erosive reflux disease (NERD) or healed erosive esophagitis (EE).
NCT01922440
The main aim of this study is to find out the long-term safety and effectiveness profile of recombinant human parathyroid hormone (1-84) (rhPTH\[1-84\]) treatment in participants with chronic hypoparathyroidism under conditions of routine clinical practice. Participants will be treated according to their clinic's standard practice determined by the treating doctors. Each participant will fill out a study questionnaire during a routine doctor visit.
NCT03745313
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
NCT02140255
The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.
NCT05808634
The objective of this study is to assess safety and efficacy of BA3182 in Advanced Adenocarcinoma
NCT05769582
The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney transplant recipients. This study has an operationally seamless phase II/III design. The phase II part will evaluate the safety of AntiBKV in kidney transplant recipients and establish antiviral proof of concept. The phase II part includes a dose-comparison part to generate additional PK and PD data of AntiBKV. The phase III part will assess the efficacy of AntiBKV in kidney transplant recipients. For both the phase II and phase III parts, participants will be randomized to receive either four doses of AntiBKV or four doses of placebo (every four weeks). In phase II, 60 participants will be first randomized (1:1) to receive either four doses of 1,000 mg of AntiBKV or placebo. In an additional dose-comparison extension, another 30 participants will be enrolled and randomized (1:1:1) to receive either four doses of 1,000 mg AntiBKV, four doses of 500 mg AntiBKV, or placebo. Based on a Day 141 analysis after phase II the sample size for the phase III part of the trial will be defined. Both the phase II and phase III parts will follow identical study assessments and schedules for participants. Eligible participants will receive an intravenous infusion of the investigational medicinal product (IMP) that will be administered four times at a four-week interval. For the first ten participants enrolled in the study, the infusion time will be at least 60 minutes. Provided there are no safety concerns observed with the first ten participants the duration of subsequent infusions will be at least 30 minutes. After administration of the final dose, participants will return as out participants for periodic safety, BKV DNAemia, and PK follow-up assessments until the end of the trial visits, 26 weeks post last IMP application. Regular kidney biopsies will be performed at baseline (prior to infusion) and on Day 141 (8 weeks after full dosing). An additional biopsy will be taken on Day 267 (optional) and if clinically indicated.
NCT06859970
The purpose of this early feasibility study is to evaluate the safety and feasibility of the device for percutaneous shunting of the interatrial septum and improvement of heart failure related symptoms. The primary goal is to determine if the device is safe to use. The findings from this study may be used to refine the intended patient population, the design of the device, or develop a subsequent randomized study.
NCT04770935
Primary Objective: -To characterize the pharmacokinetics (PK) of BIVV001 after a single intravenous (IV) administration, as assessed by factor VIII (FVIII) activity determined by the one-stage activated partial thromboplastin time (aPPT) clotting assay, as well as, BIVV001 capture chromogenic Coatest FVIII activity assay Secondary Objective: -To assess the safety and tolerability of a single IV dose of BIVV001 in adult patients with type 2N and 3 VWD
NCT07057258
The purpose of the study is to learn more about a procedure that may be helpful for the participant's swallowing issues. The investigators are hoping to find out if one type of procedure is the same or better than another type of procedure at improving participant's issues with swallowing. Participants will get one of two procedures. One is called injection laryngoplasty (IL) and injects a gel into the back wall of the participant's airway to prevent food and liquid from falling in. The other procedure is called endoscopic suture repair (ER) and uses sutures to sew together and build up the back wall of the participant's airway to prevent food and liquid from falling in. Participants will be asked to have a number of tests and procedures. These include a modified barium swallow study, in which the participant drinks and eats foods and liquids with barium in them and X-rays are used to assess how the food moves through the participant's body. This will be done before the procedure and 3 months after the procedure. The investigators will also give participants questionnaires to complete before and after the procedure.
NCT06387355
Peripheral artery disease, lack or blood flow to the legs, has a high prevalence in the Veteran population. In patients with severe peripheral artery disease that requires an endovascular or surgical intervention for lower leg revascularization, the long-term mortality of approximately 50% is worse that most cancers. The goal of this study is to develop a management strategy to improve cardiovascular outcomes in this high-risk peripheral artery disease population after lower extremity revascularization.
NCT05749055
The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)
NCT05815342
This is a single arm, multi-center, prospective study that will evaluate the safety and efficacy of the Omnipod 5 Automated Insulin Delivery System in adults with type 2 diabetes requiring insulin therapy.
NCT06056310
The purpose of this study is to evaluate the tolerability and safety of Xevinapant when added to weekly cisplatin-based concurrent chemoradiotherapy (CRT) in the treatment of participants with unresectable locally advanced squamous cell carcinoma of the head and neck, suitable for definitive chemoradiotherapy.
NCT06291922
The goal of this clinical trial is to evaluate the effects of a home-based exercise program using mobile technology on physical activity and capacity, frailty and muscle mass, and quality of life in patients with a newly implanted HeartMate 3 left ventricular assist device (HM3 LVAD). Researchers will compare the effects of an exercise intervention vs. usual care on physical activity and capacity, frailty and muscle mass, and quality of life.
NCT05212233
This is a hypothesis-driven, observational, cross-sectional, multi-site study of the financial difficulties experienced by patients undergoing treatment for multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). It is composed of a patient survey (n=250) (Appendix A), a physician survey (n=100) (Appendix B), and a practice survey completed by each site enrolling patients onto this study (Appendix C). A subset of enrolled patients (n=35) will be invited to participate in an optional second telephone interview (Appendix D). This study will measure the prevalence of patient-reported financial difficulty, specific financial burdens and resources currently available to patients and from practices to assist with patient financial navigation.
NCT05806164
The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI). Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months. Based on patient expert input, there are 2 primary outcomes: Treatment satisfaction and urinary symptom severity. The study will also have a long-term follow-up component (prospective cohort) including 346 participants from the parent trial to describe treatment continuation, treatment efficacy, patient direct costs and other secondary outcomes up to 5 years after treatment.
NCT04284839
The DANCE Trial is a multi-centre, randomized controlled trial comparing the safety of direct oral anticoagulants (DOAC) versus vitamin K antagonists (VKA) in the early period (30 days) after cardiac surgery in patients with atrial fibrillation requiring oral anticoagulation.