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NCT01296022
This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.
NCT04679441
People with cognitive impairments such as Mild Cognitive Impairment (MCI), often experience difficulty performing everyday routine activities. Further, normative age-related changes in cognition often lead to deficits on previously learned skills and impede new learning such as learning of new technology systems. This is of great concern, given population aging, the increasing number of older adults with cognitive impairments, and the continual deployment of new technologies in everyday contexts. The objectives of this SBIR Phase II study is to build on a previous Phase I SBIR project and refine and further evaluate a novel integrated computer-based functional skills assessment and training (CFSAT) program that provides training on everyday tasks critical to independent living (e.g., financial and medication management) with non-impaired older adults (NC) and adults with MCI.
NCT02574481
The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length. Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.
NCT03978741
Study to evaluate the safety and effectiveness of Yoni.Fit for the temporary management of stress urinary incontinence (SUI) in women.
NCT01027000
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and methotrexate after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma.
NCT00841789
The purpose of this study is to determine whether Etanercept (Enbrel) when used in conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with Kawasaki Disease. Funding Source- FDA/OOPD
NCT02800785
For the past 130 years, appendectomy has been the standard treatment for appendicitis. Recent studies from Europe have challenged the notion that surgery is the best option, showing that antibiotics alone can treat appendicitis without a need for appendectomy in as many as 3 out of 4 patients and without safety issues for up to one year of follow up. Despite these results, it remains to be determined if the antibiotic strategy is as good as an appendectomy for the outcomes that most patients care about. The Patient-Centered Outcomes Research Institute (PCORI)-funded Comparison of Outcomes of Drugs and Appendectomy (CODA) trial will be the first American, and largest-ever randomized trial of the issue and its results should help surgeons and patients make more informed healthcare decisions.
NCT04585451
PainQx is conducting a study to collect electroencephalography (EEG) data from 250 people with chronic pain and 50 healthy controls in order to develop algorithms that will objectively assess the level of pain a person is experiencing.
NCT03657043
This trial will study tisotumab vedotin to find out what its side effects are and to see if it works for platinum-resistant ovarian cancer (PROC). It will test different doses of tisotumab vedotin that are given at different times. It will also compare the side effects and ability to treat tumors of these different doses and schedules. In this study, there will be a safety run-in group of approximately 12 patients that will look at a dose-dense treatment schedule. In a dose-dense schedule, smaller doses are given more frequently. In addition to the safety run-in patients, there will be three groups in the study. One group will get tisotumab vedotin once every 3 weeks (21-day cycles). The two other groups will get tisotumab vedotin once a week for 3 weeks followed by 1 week off (28-day cycles).
NCT04929756
Approximately 217 million people worldwide currently suffer from low vision, which impacts a broad range of activities of daily living and is associated with depression and increased mortality. Over half of the patients presenting for low vision services have eye disease that affects the fovea and surrounding macula and leads to central vision loss (CVL). People with CVL are forced to use eccentric vision as a substitute for their impaired fovea, however eye movement control and visual function is impaired with eccentric vision. Recent evidence and preliminary results from the investigators show that rehabilitation methods can help improve oculomotor control and this can lead to improved functional outcomes. The investigators have developed new feedback-based training methods that aim to improve eccentric vision use by patients with CVL. In a series of studies, the investigators examine rehabilitation of fixation control, smooth pursuit eye movements that track moving objects and saccadic eye movements that abruptly change the point of regard. The investigators examine how visual feedback, scotoma awareness methods and hand-eye coordination can improve eccentric vision use. Improvements in oculomotor control are quantified with eye tracking methods and associated changes in visual function are quantified with acuity, contrast sensitivity and reading performance. The proposed research therefore develops and translates state-of-the-art methods in basic science to clinical applications. Accomplishing the proposed aims will provide new and improved methods for rehabilitation strategies for visual impairment. The ultimate goal of this proposal is to maximize the residual visual function of people with low vision and to help them to live independently, thereby improving quality of life and minimizing the economic and social burden of visual impairment.
NCT04445116
This study will examine the feasibility of using an Endeavor™ application as a treatment modality for cognitive impairments in the pediatric MS population. Participants will be asked to undergo a hour-long baseline evaluation, followed by at-home Endeavor™ application sessions. Subjects will complete the User Experience Feedback Form weekly on REDCap and at the end of the study. They will undergo another hour-long follow-up evaluation at the end of the study.
NCT00582062
We are undertaking a study of patients with gastric or pancreatic cancer. A common place for cancer to return after surgery for gastric or pancreatic cancer is the inside lining of the abdomen, called "peritoneal metastasis". At the time of surgery, washing the abdomen with a mild salt solution may reveal free cancer cells in the abdomen which could develop into peritoneal metastasis. Recently, surgeons here at Memorial Sloan-Kettering have found that patients who have these cells develop peritoneal metastases and are better treated with chemotherapy rather than surgery. Sometimes, though, these cells might be present but cannot be found by using current techniques. We are trying to figure out a better way to find these free cancer cells. This could improve our treatment of patients with gastric and pancreatic cancer. We need "negative control" population to which we can compare the peritoneal washings of these cancer patients.
NCT05681689
This is a multi-center, non-randomized, open label study. Subjects will be enrolled if they are deemed eligible given the inclusion criteria. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Subjects will be exposed to non-radioactive 13C-Urea with citric acid, and may submit a stool sample or undergo endoscopy for Rapid Urease Test and Histology samples. Center(s) will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus UBT System. Treating physician will either prescribe a H. pylori Stool Antigen Test through P4 Diagnostics, along with another Urea Breath Test using Breath ID, or patient will undergo Endoscopy to provide a composite reference method consisting of Rapid Urease Test and Histology. These will act as the comparators to the PyloPlus Urea Breath Test System.
NCT02907944
Tobacco, alcohol and opioid use disorders threaten the health of HIV-infected patients. What if evidence-based counseling and medication treatments for tobacco, alcohol and opioid use disorders (herein refered to as addiction treatments) were routinely provided in HIV clinics? Implementation Facilitation is an established strategy to increase the uptake of evidence-based treatments. Our goal is to evaluate the impact of Implementation Facilitation on the use of addiction treatments in four large HIV clinics. The purpose of the WHAT-IF study is: Aim 1. Among key stakeholders, to use quantitative and qualitative (mixed) methods to identify the site-specific evidence, context and facilitation-related barriers and facilitators to the integration of addiction treatments to help tailor an Implementation Facilitation for each clinic. Aim 2. To evaluate the impact of Implementation Facilitation on: 2a: Organizational readiness to deliver addiction treatments 2b: Provider readiness to deliver addiction treatments 2c: Provision of addiction treatments 2d: Changes in organizational models of care used to deliver addiction treatments Aim 3. To evaluate the impact of Implementation Facilitation on antiretroviral therapy receipt, HIV viral suppression, VACS Index, and retention in HIV care among patients eligible for addiction treatment.
NCT04090853
Open-label, baseline-controlled, multi-center study evaluating a 1064 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks.
NCT05848219
This was a retrospective cohort study using the MarketScan health care administrative claim databases: Truven Health Analytics' MarketScan Commercial Claims and Encounters; MarketScan Medicare Supplement and Coordination of Benefit. We conducted this analysis using the most recent available data from the MarketScan database at the time of analysis, which was 01 June 2018 to 31 December 2020. We initiated this analysis from 01 June 2018 as encorafenib + binimetinib (enco/bini) was approved for patients with unresectable or metastatic melanoma with BRAF mutation at this time.
NCT02376829
To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.
NCT04648215
This feasibility study's aim is to determine the effectiveness of lavender oil aromatherapy on quality and duration of sleep in hospitalized adult patients
NCT03020797
This is a pilot trial to test perampanel (Fycompa; Eisai, Inc.) in ALS patients. The investigators will focus on safety and preliminary signs of efficacy. Perampanel is approved by the FDA for treatment of seizures in patients with epilepsy. In this study, perampanel will be used off-label for adults with ALS at an oral medication dose on the low end of the recommended dose range for epilepsy. This study will consist of two treatments arms: perampanel and matching placebo randomized at a 1:1 ratio. Subjects will receive medication for 9 months.
NCT03510884
Primary Objective: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in participants with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age on optimal stable daily dose of statin therapy ± other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins. Secondary Objectives: * To evaluate the efficacy of alirocumab versus placebo on LDL-C levels. * To evaluate the effects of alirocumab versus placebo on other lipid parameters. * To evaluate the safety and tolerability of alirocumab in comparison with placebo. * To evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment. * To evaluate the development of anti-alirocumab antibodies.