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NCT02102022
Phase 1: Assessment of safety and tolerability of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in advanced GI malignancies. Phase 2: Assessment of the objective response rate (ORR), measured by RECIST 1.1 criteria as assessed by blinded independent central review (BICR).
NCT01047683
The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.
NCT03227029
The purpose of this study was to evaluate the infectivity, safety, and immunogenicity of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 when delivered as nose drops to RSV-seronegative infants 6 to 24 months of age. This study was a companion study to Center for Immunization Research (CIR) 321.
NCT02519777
People infected with HIV often have cognitive dysfunction even if they are on antiretroviral therapy (ART) and have undetectable viral loads. The study evaluated if the addition of maraviroc (MVC) and dolutegravir (DTG) (which are two antiretroviral \[ARV\] medications) to participants' existing ART regimens improved participants' neurocognitive performance.
NCT03768284
This study will ascertain approximately 150 subjects, which will include pediatric psoriasis patients diagnosed before age 12, parents not affected by psoriasis, and if a family history is indicated, up to third-degree family members. Saliva (or buccal swabs in the case of infants) will be obtained for DNA isolation.
NCT02901717
This is a Phase 3, multi-center, randomized, open-label, assess-blind study to determine the efficacy and safety of MLT, a novel antibiotic lock therapy that combines minocycline with edetate disodium in 25% ethanol solution as an adjuctive therapy for the treatment of catheter-related or central line associated bloodstream infection (CRBSI/CLABSI). Approximately 144 subjects who have been diagnosed with CRBSI/CLABSI and who meet all necessary criteria for the study will be randomized in a 1:1 ratio to 1 of 2 treatment arms: * MLT Arm: Mino-Lok therapy; or * Control Arm: Antibiotic lock (±heparin). The antibiotic lock (ALT) should be comprised of the best available therapy at the sites based on standard institutional practices or recommendations from the Infectious Diseases Society of America (IDSA) guidelines.
NCT04426058
Complete motorsparing protocol (CMP) has been developed to try to minimize the motor nerve block that is created when using Facia iliaca nerve block. The blocks performed in the (CMP) are the cluneal nerve block, Pericapsular nerve group block and lateral femoral cutaneous block. On the clinical trial, the investigators will randomize the participants that meet criteria to CMP or Fascia iliaca Block and compare the amount of opioid needed post op during 24 hours and their pain scores.
NCT03049735
The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
NCT01844232
Clinical protocol OS440-3003 is a multicenter, open-label, non-randomized, uncontrolled, dose escalation study to evaluate the safety and tolerability of Arbaclofen Extended Release Tablets over 1 year in Multiple Sclerosis (MS) subjects with spasticity. All subjects in this study will receive arbaclofen in the extended release tablet formulation.
NCT03628066
This study will look at the safety and effectiveness of the combination of palbociclib and letrozole and ovarian suppression for premenopausal patients who have ER-positive/HER2-negative breast cancer that has not yet been treated.
NCT03373786
This is a Phase 1, open-label, multi-center study of the safety, pharmacodynamics, and pharmacokinetics of RG-012 administered to subjects with Alport syndrome.
NCT00605215
The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6 milligrams (mg) with the effect of placebo capsules (capsules that contain no active medication) as well as with the effect of an existing Multiple Sclerosis (MS) injectable drug: Interferon β-1a (Avonex®).
NCT03102047
This study is being done to look at the safety and response to the investigational drug durvalumab (MEDI4736) following chemo-radiation therapy for patients with MSS stage II to IV rectal cancer. Durvalumab recognizes specific proteins on the surface of cancer cells and triggers the immune system to destroy the cancer cells. The chemoRT portion of the treatment will be completed just before the course of durvalumab is initiated. In order to learn more about certain characteristics of rectal cancer tumors, this study includes special research tests using samples from diagnostic tumors, a tissue sample from tumors removed during surgery, fresh tumor samples from an area where the cancer has recurred, and blood samples.
NCT03205163
The primary purpose was to assess the safety and tolerability of a single intravenous (IV) administration of BIVV001 in adult previously treated patients (PTPs) with severe hemophilia A.
NCT01227616
The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.
NCT04103385
Background: Interoception is defined as the "sense of the physiological condition of the entire body" and is crucial for recognizing emotions and sensations (e.g., hunger, temperature, pain) and responding accordingly. The investigator's lab has conducted several independent studies and two pilot studies that support the hypothesis that disrupted interoception leads one to be disconnected from the body, and thus more able to harm the body should one desire to do so. Research suggests that interoceptive deficits may not only differentiate those who are thinking about suicide from those who engage in suicidal behavior, but it may also provide information about who is at imminent risk for suicidal behavior. The identification of novel, short-term risk factors, like interoceptive deficits, allows for the development of new treatment applications for suicide, which is important for several reasons: 1) suicide rates have increased in recent years, especially among military populations, and 2) existing treatment approaches are often ineffective, lengthy, expensive, or impractical for large-scale dissemination. This project evaluates a novel, brief intervention for interoceptive deficits and suicidal behavior with the potential to be acceptable and feasible for a military population.
NCT00126672
This research study is evaluating a drug called rapamycin as a possible treatment for the lumps (or tumors) that form in the kidneys, called angiomyolipomas, in people who have either TSC or LAM. Kidney angiomyolipomas are tumors that are made up of blood vessels, muscle and fat. Rapamycin has been approved to treat other diseases, but it is investigational for treating kidney angiomyolipomas. Investigational means that it is being as a possible treatment for kidney angiomyolipomas but is not currently approved by the U.S. Food and Drug Administration (FDA) for treating this disease.
NCT03372720
This randomized pilot trial studies how well fractional carbon dioxide (CO2) laser therapy works in minimizing genitourinary syndrome of menopause (GSM) in gynecological cancer survivors. Fractional CO2 laser therapy may reduce symptoms of GSM in survivors of gynecologic cancers.
NCT03414736
Primary Objectives: * Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and severity of gastrointestinal (GI) adverse events (AEs). * Six-month safety extension period: To assess the safety and tolerability of SAR425899 after 6 months treatment at the maximum dose that was individually well tolerated during the main part of the study in terms of the relative and absolute frequency and severity of GI AEs. Secondary Objectives: Main study and 6-month study extension period: To assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic pharmacotherapy: * The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose (FPG), and hemoglobin A1c (HbA1c). * Safety and tolerability.
NCT04828590
DEEPVESSEL FFR is a medical device that is designed to extract three- dimensional coronary tree structures and generate computed tomography-derived fraction flow reserve (FFR) values from coronary CT angiogram images. The primary objective of this multi-center clinical validation study is to validate the clinical performance of DEEPVESSEL FFR in identifying patients with myocardial ischemia due to significant obstructive coronary artery diseases.