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Discover 14,426 clinical trials near Georgia. Find research studies in your area.
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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.
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.
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.
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.
NCT02290028
The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW QP left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in the US. The Sentus OTW QP leads received FDA approval on May 4, 2017. Long-term safety of the BIOTRONIK Sentus OTW QP left ventricular leads will be confirmed during the ongoing post approval phase (US sites only). A protocol update was implemented on September 6, 2019 to transition the long-term follow up for the ongoing Sentus QP Study to a new EP PASSION real-world data methodology.
NCT02489344
Primary Objective: To assess the long-term safety of GZ/SAR402671 in adult male participants with Fabry disease who previously completed study ACT13739 (NCT02489344). Secondary Objective: To assess the long-term effect of GZ/SAR402671 on pharmacodynamic and exploratory efficacy endpoints in adult male participants with Fabry disease who previously completed study ACT13739.
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
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.
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.
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.
NCT04043923
This is a Phase 2b, multi-center, double-blind, randomized, placebo-controlled, parallel-group study of NKT versus placebo in otherwise healthy adults presenting with acute uncomplicated ILI due to influenza or other respiratory viruses in a community setting.
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.
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.
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.
NCT02178969
The purpose of this study is to better understand disease extent and to identify appropriate methodologies to evaluate (dystrophic epidermolysis bullosa) DEB in a quantitative and qualitative manner.
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.
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.
NCT00905060
This phase II trial studies the side effects and how well HSPPC-96 (vitespen) and temozolomide work in treating patients with newly diagnosed glioblastoma multiforme. Vaccines made from a person's tumor cells and heat shock protein peptide may help the body to build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, 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 HSPPC-96 (vitespen) together with temozolomide may kill more tumor cells.
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).
NCT00130312
The purpose of this study is to determine whether sulodexide is effective in slowing or preventing the progression of diabetic kidney disease.