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NCT03893825
The primary objective of the study is to evaluate the long-term safety and tolerability of TV-46000. The primary safety and tolerability endpoint is the frequency of all adverse events, including serious adverse events. For new participants, the total duration of participant participation in the study is planned to be up to 80 weeks (including a screening period of up to 4 weeks, a 12-week oral conversion/stabilization stage \[Stage 1\], a 56-week double-blind maintenance stage \[Stage 2\], and a follow-up period \[8 weeks\]). For roll-over participants, the total duration of participant participation in the study is planned to be up to 64 weeks (including up to 56 weeks in the maintenance stage \[Stage 2\] and a follow-up period \[8 weeks\]). Participants who started Stage 2 who relapse or meet 1 or more of the withdrawal criteria should be invited to perform the Early Termination visit as soon as possible within 4 weeks of the last injection. Participants who withdraw from the study before completing the 56-week maintenance stage will have follow-up procedures and assessments performed at their follow-up visits. During the follow-up period, participants will be treated according to the investigator's judgment. All participants will be treated with active drug.
NCT01610557
Background: * Diabetic macular edema is a common eye complication of diabetes. It causes the blood vessels in the retina at the back of the eye to leak, causing swelling. The macula is the center part of the retina that is important for seeing fine details and for tasks such as reading, driving, or sewing. Swelling of the macula leads to vision loss and possible blindness. Inflammation may play a role in diabetic macular edema. It is also possible that there is a problem with the blood vessels and the blood supply to cells of the retina. * A chemical in the body called vascular endothelial growth factor (VEGF) is important in the formation of blood vessels in the body. Lowering VEGF levels may help treat diabetic macular edema by reducing abnormal leaking blood vessels in the eye. Drugs that can lower or block VEGF include ranibizumab and bevacizumab. Both drugs have been shown to help treat diabetic macular edema. Researchers want to see if one of the drugs works better than the other. Objective: To compare the effectiveness of ranibizumab and bevacizumab injections for diabetic macular edema. Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least one eye. Design: * Participants will be screened with a physical exam and medical history. A full eye exam will be performed. Blood and urine samples will be collected. * One eye will be selected as the study eye to receive treatment. If both eyes are affected, both eyes may be enrolled in the study and receive different drug treatments. * The main part of the study will last for 9 months. At each study visit, participants will have physical exams and eye exams. They will answer questions about their health and any side effects from the drugs. * Participants will be assigned to one of four groups. Two groups will have two series of ranibizumab and one series of bevacizumab shots. The other two groups will have two series of bevacizumab and one series of ranibizumab shots. A series is three eye injections of the same drug every 4 weeks. The injections will be given at these study visits. The series order will vary for the different groups. * After 9 months, participants will continue to have additional study visits. If the treatment seems to be successful, the study doctor may increase the time between visits. Study injections may be given as needed every 4 weeks for up to 3 years. * Participants may have laser treatments in a study eye if needed. After being in the study for 1 year, they may also have steroid injections or other treatments as directed for the macular edema.
NCT04916223
Therapeutic massage is the most common non-traditional treatment option offered to improve quality of life, provide comfort and decrease pain in hospice and palliative care settings outside the hospital. Three systematic reviews of data in general pain, surgical and cancer populations found massage to be effective for treating pain versus active comparators. Given the remarkable negative impact on QOL experienced by patients hospitalized with a serious progressive illness, a nationwide opioid crisis in the setting of public concern for untreated pain, and patient demand for integrative therapies, we wish to investigate non-traditional methods of supporting patients in pain and providing clinicians with viable alternatives. Unfortunately, very little is known about optimal delivery of massage interventions in the hospital setting, including dosing parameters such as time and frequency We conducted a single center comparative effectiveness study to evaluate therapeutic massage "dosing" to improve self-reported quality-of-life in hospitalized patients receiving palliative care consultation.
NCT04400435
The purpose of this research is to prospectively test and validate the single-lead Low EF algorithm in outpatients in order to test the performance of a single-lead ECG based algorithm to identify people with decreased left ventricular EF.
NCT01998633
HLH, HLH-related disorders, Chronic Granulomatous (CGD), HIGM1, Immune dysregulation, polyendocrinopathy, enteropathy, and X-linked inheritance (IPEX) and severe LAD-I represent primary immune disorders that are typically fatal without Hematopoietic Cell Transplant (HCT). However, transplant is often complicated by inflammation, infection and other co-morbidities. In addition, these disorders have been shown to be cured with partial chimerism, making them an ideal target for the use of reduced intensity approaches, where a portion of patients may not achieve full donor chimerism, but instead achieve stable mixed chimerism. Reduced-intensity conditioning strategies have demonstrated improved survival with decreased Treatment Related Mortality (TRM) in institutional series for patients with HLH (Cooper et al., 2006; Marsh et al., 2010; Marsh et al., 2011). However, graft loss and unstable chimerism remain challenges. An institutional case series from Cincinnati Children's Hospital demonstrated full or high-level chimerism and improved durable engraftment using intermediate (Day -14) timing alemtuzumab (Marsh et al., 2013b). This study aims to test the efficacy of the Intermediate RIC strategy in a prospective multi-center study including HLH as well as other primary immunodeficiencies where allogeneic transplant with RIC has been shown to be feasible and stable chimerism is curative.
NCT04640896
To achieve appropriate exposure for an anterior neck surgery (for example an Anterior Cervical Discectomy and Fusion or ACDF), patients are positioned supine with their neck extended. Due to being in this position, patients frequently complain of posterior neck stiffness and pain postoperatively in addition to the anterior incisional pain. This posterior cervical pain can be classified as myofascial pain. Cervical myofascial pain is thought to be the result of overuse or trauma to the supporting muscles of the neck and shoulders. Trigger point injections are one of the methods used to treat myofascial pain. The trigger point injection procedure is where a physician (typically an anesthesiologist) performs an exam of the patient neck and upper back and finds areas of point tenderness. The physician will then inject a small amount of numbing medication (such as bupivacaine) into the muscle or tissue in that area. Trigger point injections have been shown to be superior to botox injections or dry needling, and equivalent to physical therapy. However, these studies were performed on patients with chronic neck pain. There are no studies evaluating the effectiveness of trigger point injections on post anterior cervical surgery patients. At our institution, trigger point injections with local anesthetic are used as part of a multimodal pain control regimen for post-anterior cervical surgery patients. Our hypothesis is if the addition of trigger point injections to standard of care multi-modal post-operative pain control will decrease patients' myofascial pain, and thereby decrease the amount of narcotic pain medication used.
NCT03051477
This study will seek to determine the safety and toxicity profile as well as the maximum tolerated dose of Helixor® M in patients with advanced solid tumors.
NCT04823052
This study is to investigate the safety, tolerability and efficacy of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in males with Fragile X Syndrome (FXS) with confirmed full FMR1 mutation treated over a 10 week period in an outpatient setting.
NCT02081248
The study has two parts: (1) Randomized Study to evaluate the effectiveness of ETRIC, and (2) Evaluation Study to understand barriers to implementation of ETRIC.
NCT02402309
This is a multi-center, randomized, double-blind, vehicle-controlled, parallel-group study designed to evaluate the safety, pharmacokinetic (PK), and exploratory activity of topically-applied NS2 dermatologic cream administered once-daily (QD) to subjects with ichthyosis secondary to Sjögren- Larsson Syndrome (SLS). NS2 is expected to trap fatty aldehydes that are pathogenic in SLS patients, and thereby diminish the lipid-aldehyde adduct formation that likely results in ichthyosis associated with SLS, and potentially reduce the mild dermal inflammation characteristic of SLS.
NCT04672980
This is an open-label, multicenter, multiple-ascending dose, FIH, Phase 1 study of RTX-321 for the treatment of patients that are HLA-A\*02:01 positive with persistent, recurrent, or metastatic, unresectable, HPV 16+ cancers.
NCT01081912
The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.
NCT00864227
A bone marrow transplant, which is a type of stem cell transplant, is a treatment option for people with leukemia or lymphoma. Recently, stem cell transplants using umbilical cord blood have become a treatment option for people with these types of cancers. This study will evaluate the effectiveness of a stem cell transplant using umbilical cord blood, along with lower doses of chemotherapy, to treat people with leukemia or lymphoma.
NCT03241186
This is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered Day 1 of a 21-day cycle in Cycles 1-4 and then nivolumab 480 mg will be administered Day 1 of a 28-day cycle for Cycles 5-15 (maximum of 15) or until disease recurrence or intolerance before completion of 15 cycles.
NCT05245539
The purpose of this trial is to characterize the effects of 2 oral doses (over 8 weeks total) of CVL-231 on ambulatory blood pressure and heart rate in patients with stable schizophrenia.
NCT03833128
The purpose of this Phase 1b study is to assess REN001 safety in subjects with fatty acid oxidation disorders.
NCT03809481
An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)
NCT03811912
This study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.
NCT00543712
This is a multicenter, open-label, Phase II trial designed to evaluate the efficacy and safety of PRO95780 when given as a single agent in patients with advanced chondrosarcoma. Up to 90 patients with confirmed chondrosarcoma will be enrolled.
NCT02848781
The current standard of care for ventricular tachycardia (VT) includes the use of medicine called anti-arrhythmic drugs (AADs) and Implantable Cardioverter Defibrillator (ICD) therapy. These treatments are used to terminate the irregular heartbeats and bring the heart back to a normal rhythm. Catheter ablation is a procedure used to eliminate (damage) the heart cells causing the arrhythmia. Patients eligible for this may benefit from an ablation procedure in addition to an ICD to treat their VT condition or risk of developing VT. This study aims to show that treating VT with catheter ablation, if performed preemptively at the time of ICD implantation, will reduce subsequent recurrent VT, ICD shocks, and lead to improved survival.