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NCT02047097
The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF). Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.
NCT00946712
This randomized phase III trial studies carboplatin and paclitaxel to compare how well they work with or without bevacizumab and/or cetuximab in treating patients with stage IV or non-small cell lung cancer that has returned after a period of improvement (recurrent). Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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. Bevacizumab may prevent the growth of new blood vessels that tumor needs to grow. Cetuximab may also stop cancer cells from growing by binding and interfering with a protein on the surface of the tumor cell that is needed for tumor growth. It is not yet known whether giving carboplatin and paclitaxel are more effective with or without bevacizumab and/or cetuximab in treating patients with non-small cell lung cancer.
NCT02063464
Background: * Monocytes are a type of white blood cell found in human blood. They help the immune system. Researchers have found that monocytes taken from the blood of healthy people can kill tumor cells. Now they want to know if monocytes taken from the blood of people with ovarian cancer can kill tumor cells. * In addition, native host anti-tumor cell mediated immune mechanisms may play a role in clinical outcome of epithelial ovarian cancer; data indicate that the presence of intra-tumoral CD3+ T-cells was shown to prognosticate improved outcome in advanced ovarian cancer. Furthermore, non-cellular components in the blood, such as exosomes, may influence outcome. Objective: \- To see if monocytes taken from the blood of people with ovarian cancer can kill tumor cells. Eligibility: \- Women 18 years and older with ovarian cancer. Design: * Participants will be screened with: * Medical history and physical exam. * Blood tests. * CT scan of the chest, abdomen, and pelvis and/or an MRI. For these scans, they will lie in a machine that takes pictures of their body. * A small amount of blood (two tubes) will be collected by needle during one visit.
NCT00602459
This randomized phase II trial studies how well fludarabine (fludarabine phosphate) and rituximab with or without lenalidomide or cyclophosphamide work in treating patients with symptomatic chronic lymphocytic leukemia. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Giving fludarabine phosphate and rituximab together with lenalidomide or cyclophosphamide may be an effective treatment for chronic lymphocytic leukemia.
NCT04746976
The primary objective of the study is to characterize the persistence to therapy in participants with relapsing forms of multiple sclerosis (RMS) treated with diroximel fumarate (DRF) in routine clinical practice. The secondary objectives of the study are to assess short-term persistence to treatment; to assess long-term persistence on treatment; to assess the effect of DRF on relapses; to assess the impact of DRF on cognition; to assess the impact of DRF on participant reported outcomes (PROs) and to explore the real-world safety profile of DRF (ie, gastrointestinal \[GI\] tolerability, lymphocyte dynamics, adverse events \[AEs\] leading to discontinuation, and serious adverse events \[SAEs\]).
NCT04631211
This prospective, multicenter, randomized, open-label, Phase 2, parallel, dose ranging, multidose trial will enroll patients into 3 Thrombosomes dose groups and 1 control liquid stored platelets (LSP) group in order to evaluate, in a dose-escalation manner, the safety, and impact on bleeding, and the preliminary effect on coagulation measures of increasing doses of allogeneic Thrombosomes in comparison to standard of care, LSP.
NCT02768701
The purpose of this study is to evaluate pembrolizumab therapy in patients with triple-negative breast cancer (TNBC) who have received at least one prior line of therapy.
NCT04406467
To measure surgical success of open vs closed conjunctiva with Xen implantation.
NCT03536728
A Phase 1 study will be conducted to establish safety and dose level of AMXT 1501 dicaprate alone, and in combination with DFMO, in cancer patients.
NCT04784390
The purpose of this PoC study was to evaluate the potential therapeutic efficacy of binocular video games played on a tablet and to compare the efficacy of binocular video games versus patching in amblyopic patients 4 to 7 years old (Part A) as well as to gain experience with binocular video games in older children population of 8 to12 years old (Part B). Part A and Part B was designed to provide long term data on durability of binocular video games treatment. The study consisted of two parts, Part A: randomized, single masked PoC study in children 4 to 7 years old at Screening, and Part B: open-label substudy in children 8 to 12 year old at Screening.
NCT02700945
The purpose of the Stroke AF study is to compare the incidence of atrial fibrillation (AF) through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ™ Insertable Cardiac Monitor (ICM) (continuous monitoring arm) and standard of care (SoC) medical treatment (control arm) in subjects with a recent ischemic stroke of presumed known origin.
NCT04178967
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.
NCT02245568
The purpose of this study is to provide subjects who have completed participation in a Phase 2 or Phase 3 trial of LMTM continued access to therapy and to evaluate the long-term safety of LMTM.
NCT04163900
NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer. The primary hypotheses are: * The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care * The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care
NCT03916484
AllyQuest (AQ) is a theory-informed smart phone application that supports HIV medication adherence for young men who have sex with men and young transgender women who have sex with men (YMSM/YTW) via behavior change, social support, and game-based mechanics. This study aims to evaluate the feasibility and acceptability of AQ and AQ plus medication adherence counseling in a Sequential Multiple Assignment Randomization Trial.
NCT04432727
The objective of this study is to demonstrate the feasibility of using the Flexitouch Plus with Cellular Connectivity (FT-CC) to monitor device use data to determine if reminders to patients impact compliance, and to identify the impact device compliance has on arm girth, quality of life (QOL), and symptom assessment.
NCT03287960
To demonstrate statistically significant and clinically meaningful effects of setmelanotide on percent body weight change in participants with LEPR deficiency obesity due to rare bi-allelic or loss-of function mutations at the end of 1 year of treatment.
NCT02577523
This is a multicenter, parallel-group, rater-blinded, randomized clinical study in subjects with advanced PD investigating the efficacy, PK, safety and tolerability of continuous SC infusion of 2 dosing regimens of ND0612H, a solution of LD/CD delivered via a pump system as a continuous SC infusion, compared to standard oral LD/CD. After screening, subjects will undergo 1 day of standard oral LD/CD inpatient dosing followed by 2 days of inpatient treatment with 1 of 2 randomly allocated (1:1 randomization ratio) dosing regimens of ND0612H continuous SC infusion. Subjects will then continue on a maintenance dose of the assigned ND0612H dosing regimen for the next 25 days. A safety visit will be performed 4 weeks after the last SC administration of the study drug for a total of about 2.5 months of participation for each subject enrolled into the trial.
NCT03818607
This is a randomized, double-blind, active-controlled phase 3 study of ABP 959 in participants with paroxysmal nocturnal hemoglobinuria.
NCT02837705
The human Prion diseases can be classified into sporadic, acquired and inherited forms. Inherited forms usually manifest in higher age so there have to be factors preventing Prion propagation in young mutation carriers. Antibodies against the flexible tail of Prions have been shown to be protective in mice. The investigators intend to screen mutation carriers and controls for the presence of Prion autoantibodies.