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NCT00610935
The purpose of this study is to determine the safety and effectivess of a single intramuscular injection of peramivir for the treatment of subjects with acute, uncomplicated influenza.
NCT01652157
This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of the large intestine). Patients will be followed at their regular clinical care visits over a 10-year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information.
NCT01596595
Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the pulse generator 4-SITE Header.
NCT04332991
ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.
NCT03719378
Purpose: Evidence-based guidelines on optimal perioperative fluid management have not been established in patients undergoing orthopaedic surgery. Recent randomized trials in major abdominal surgery suggest that large amounts of IV fluid may increase morbidity and hospital stay. This study will investigate the effects of two regimens of intraoperative fluid management ("traditional" vs. "oral") with physiologic and patient function as primary outcome measures after surgery.
NCT02404805
The investigator believes simeprevir concentrations are unchanged when administered in combination with dolutegravir relative to administration alone. The investigator believes dolutegravir concentrations are unchanged when administered in combination with simeprevir. Additionally, the investigator believes simeprevir and dolutegravir are safe when administered alone and in combination.
NCT01127529
The overall objective is to collect and assess data on the treatment, safety, and treatment outcomes of subjects prescribed, receiving and participating in the Ceprotin treatment registry.
NCT03510728
Large scale surveys indicate that approximately 68% of college students drink alcohol every month and 40% of college students engage in heavy episodic drinking. Despite prevention/intervention efforts, problematic alcohol consumption among college students continues to result in an estimated 1,800 deaths and 600,000 injuries annually, and epidemiological studies demonstrate no appreciable decrease in risk among college students. The purpose of the proposed research is to improve extant college-drinking interventions by advancing the dissemination methodology and the intervention content (Specific Aim 1). As a methodological improvement, rapid advances in mobile computing makes ecological momentary interventions (EMIs) increasingly feasible. EMIs refer to interventions that can be delivered multiple times and "in the moment". EMIs can optimize the timing and location of the intervention while also increasing the dose of the intervention. To improve the intervention content, the researchers will examine protective behavioral strategies (PBS) to reduce alcohol problems, not just alcohol use. PBS are behaviors that one can engage in immediately prior to, during, and immediately following alcohol use that limit alcohol use and/or alcohol-related harm. Research suggests that PBS use can protect individuals from alcohol problems above and beyond its effect on reducing alcohol use. The primary purpose of this research is to provide a more powerful test of a PBS intervention's effects on alcohol-related consequences by using a technology-based intervention methodology (i.e., EMI). Participants will be randomized into to a fully crossed, 3 (Standard BMI, BMI with a PBS component, control) X 2 (PBS-based EMI, Ecological Assessment Only) design. These 6 conditions will answer several critically important research questions (Specific Aim 2): a) does the addition of a PBS component improve the efficacy of a standard BMI, b) does a PBS-based EMI improve efficacy over the standard, single session BMI, c) does the combination of motivation-based intervention (BMI) with a skills-based intervention (EMI) yield even greater decreases in consequences (i.e., moderation). A final purpose of this research is to examine PBS norms, PBS perceived effectiveness, and motivation to change PBS use as novel mediators of the improved interventions. Results can be used to disseminate more effective college drinking interventions that are cheaper and more efficacious.
NCT02369159
This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of pediatric subjects with acute uncomplicated influenza.
NCT01054443
The primary objective of this study was to assess the efficacy of 3 dose levels of lusutrombopag (0.5 mg, 0.75 mg, and 1.0 mg) and placebo on platelet count.
NCT02232659
The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is approved by the U.S. Food and Drug Administration (FDA) for use as a bridge to transplant for patients at risk of imminent (about to happen) death from irreversible biventricular heart failure. The purpose of this research study is to evaluate whether the TAH-t can support patients with life-threatening irreversible biventricular heart failure who are not eligible for transplantation. The TAH-t, when used for patients who are not eligible for transplant, is considered to be an investigational (not approved by FDA) use. This use is called destination therapy (DT). Nineteen (19) patients with life-threatening, biventricular failure who are not eligible for cardiac transplant will be enrolled in the Primary Arm of the study and followed for up to six months post-TAH-t implant. Safety will be evaluated by reviewing the adverse events that are experienced by the enrolled subjects and comparing them to previous experience of TAH-t patients who were waiting for a heart transplant. Since approximately 74% of patients with this condition would not be expected to live beyond six months, the benefit of the TAH-t for DT will be confirmed based on survival to six months without experiencing permanent disabling stroke-related deficits. After the six month follow-up visit, patients will continue to be followed under the study for up to five (5) years postTAH-t implant \[every six months for up to two years while supported with the TAH-t implant and then annually for another three years\]. Up to an additional 19 patients may be enrolled in the Secondary Arm of the study to further characterize the use of the TAH-t for DT in a broader patient population. Follow-up would be the same for patients enrolled in both arms of the study.
NCT03875482
The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.
NCT01707394
CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis
NCT03923478
Phase 1B randomized, double-blind, placebo-controlled, two-cohort clinical trial of ABI-M201 in adult subjects with mildly-to-moderately active Ulcerative Colitis(UC) and ongoing treatment with mesalamine.
NCT03481725
Postoperative pain is usually treated with opioids that have undesirable and sometimes dangerous side effects (e.g., vomiting and respiratory depression)-and yet over 80% of patients still experience inadequate pain relief. A novel, non-pharmacologic analgesic technique-percutaneous peripheral nerve stimulation (PNS)- holds extraordinary potential to greatly reduce or obviate opioid requirements and concurrently improve analgesia following painful surgery. This technique involves inserting an insulated electric lead adjacent to a target nerve through a needle prior to surgery using ultrasound guidance. Following surgery, a tiny electric current is delivered to the nerve resulting in potent pain control without any cognitive or adverse systemic side effects whatsoever. The electrical pulse generator (stimulator) is so small it is simply affixed to the patient's skin. The leads are already cleared by the US Food and Drug Administration to treat acute (postoperative) pain for up to 60 days; and, since percutaneous PNS may be provided on an outpatient basis, the technique holds the promise of providing potent analgesia outlasting the pain of surgery-in other words, the possibility of a painless, opioid-free recovery following surgery. The current project is a multicenter, randomized, double-masked, placebo-controlled, parallel-arm clinical pilot study to (1) determine the feasibility and optimize the protocol of a planned definitive clinical trial; and (2) estimate the treatment effect of percutaneous PNS on pain and opioid consumption following moderate-to-severely painful ambulatory surgery compared with usual and customary opioid-based analgesia. This will allow determination of the required sample size for a subsequent definitive multicenter clinical trial. Combined, the pilot study and definitive trial have a strong potential to dramatically reduce or obviate postoperative opioid requirements and their resultant negative effects on both individuals and society; while concurrently improving analgesia, increasing the ability to function in daily life, decreasing the risk of transition from acute to chronic pain, and improving quality of life.
NCT03360006
This is an open-label, Phase 1, dose-escalation (Segment 1) and expansion (Segment 2) study to determine the maximum tolerated dose (MTD) and/or the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-744 in participants with relapsed/refractory Acute Myeloid Leukemia (AML).
NCT01757067
Premature ventricular contractions (PVC) are a very common irregular heart beat (arrhythmias) even in patients without heart disease. Frequent PVCs are thought to occur in about 1-4% of the general population. Many patients with PVCs complain about skipping of their heart (palpitations), shortness of breath and feeling tired. In some patients PVCs may also result in weakening of the heart muscle (heart failure), which might be reversible with suppression of the PVCs.
NCT03888365
This is an observational, multicenter, single-day, Phase 2 study. This study will include a 14-day Screening Period and Study Day 1 clinic visit. Participants will be required to perform an activity to induce symptoms of PAH, and participants' severity of self-reported symptoms of PAH will be measured from pre-activity, immediately after the activity, and through the 30-minute recovery. Participants will be asked about their PAH symptoms using 3 PGI-S questions that address their overall PAH symptoms, shortness of breath, and physical fatigue.
NCT01963650
The purpose of this study is evaluate the natural course of disease progression related to gross motor function in children with metachromatic leukodystrophy (MLD).
NCT02578901
The purpose of this study is to evaluate the usefulness of antifibrinolytic therapy with tranexamic acid (TXA) in preventing bleeding in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy.