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Discover 17,836 clinical trials near Boston, Massachusetts. Find research studies in your area.
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NCT00704730
The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). Subjects will be randomized to receive XL184 or placebo in a 2:1 ratio. XL184 is an investigational drug that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration. The Clinical Steering Committee for this study, comprised of study doctors who specialize in medullary thyroid cancer, has provided guidance regarding the design of the study. The committee includes: Douglas Ball, MD, Barry Nelkin, PhD, Martin Schlumberger, MD and Steven Sherman, MD.
NCT03040414
Adolescents and young adults with type 1 diabetes often have a difficult time achieving good glucose control, which is so important in reducing the risk for diabetes complications. Despite the use of multiple daily injections or insulin pumps and glucose sensors, there is still a need for many individuals to further improve glucose levels without causing low blood glucose levels (hypoglycemia) or adding to the daily burden of living with diabetes. Today an insulin pump can receive glucose readings from a continuous glucose monitor and adjust the insulin delivery in an attempt to keep glucose levels in a more optimal range. These systems are called hybrid closed loop (HCL). This means that much of the insulin delivery is automated, yet the patient still interacts regularly with the system, particularly to help determine the insulin dose to deliver to cover a meal. Results of early studies using HCL systems in adolescents and adults with type 1 diabetes are encouraging. The objective of this study is to compare the efficacy and safety of the automated insulin delivery (AID) system with proportional integral-derivative (PID) algorithm (Minimed 670G 3.0 HCL) to an AID system with combined PID and Fuzzy Logic Algorithm (Minimed 670G 4.0 Advanced Hybrid Closed-Loop (AHCL)). The trial will test the hypothesis that the Minimed AHCL can reduce daytime hyperglycemia, currently the biggest challenge for AID systems, without increasing hypoglycemia. Up to 124 adolescents and young adults (ages 14-\<30) will be recruited to test each system for three months in a randomized crossover trial. Investigators will compare how effective each hybrid closed loop system is at preventing high blood glucose readings during the day. The investigators will also evaluate the safety of each system and how participants adjust to the daily use of the technology.
NCT02858076
Although vitreous hemorrhage (VH) from proliferative diabetic retinopathy (PDR) can cause acute and dramatic vision loss for patients with diabetes, there is no current, evidence-based clinical guidance as to what treatment method is most likely to provide the best visual outcomes once intervention is desired. Intravitreous anti-vascular endothelial growth factor (anti-VEGF) therapy alone or vitrectomy combined with intraoperative PRP each provide the opportunity to stabilize or regress retinal neovascularization. However, clinical trials are lacking to elucidate the relative time frame of visual recovery or final visual outcome in prompt vitrectomy compared with initial anti-VEGF treatment. The Diabetic Retinopathy Clinical Research Network Protocol N demonstrated short-term trends consistent with a possible beneficial effect of anti-VEGF treatment in eyes with VH from PDR, including greater visual acuity improvement and reduced rates of recurrent VH as compared with saline injection. It is possible that a study with a longer duration of follow-up with structured anti-VEGF retreatment would demonstrate even greater effectiveness of anti-VEGF for VH to avoid vitrectomy and its attendant adverse events while also improving visual acuity. On the other hand, advances in surgical techniques leading to faster operative times, quicker patient recovery, and reduced complication rates may make prompt vitrectomy a more attractive alternative since it results in the immediate ability to clear hemorrhage and to perform PRP if desired, often as part of one procedure. This proposed study will evaluate the safety and efficacy of two treatment approaches for eyes with VH from PDR: prompt vitrectomy + PRP and intravitreous aflibercept injections.
NCT01838551
The primary objectives of this study are to evaluate the clinical responder rate, defined as the proportion of subjects with normal UFC after 6 months of treatment with COR-003 in the Maintenance Phase without dose increase, and to evaluate the range of effective doses in subjects with various levels of hypercortisolism.
NCT02598050
The purpose of this work is to determine whether preoperative cognitive screening of patients over the age of 65 can be used as predictor of postoperative outcomes in patients undergoing lower extremity surgical procedures. This work is important as it may aid patients, families and physicians about the appropriateness of the surgical procedure and in providing resources to patients who are at the highest risk of adverse outcomes.
NCT02570451
The overall objectives of this study are to improve outcomes of surgical patients 65 years of age or older through risk stratification based on preoperative screening of cognition / mental function. Aim 1 is to determine the prevalence of cognitive impairment among patients 65 years of age or older presenting for elective joint replacement surgery by structured cognitive screening versus standard practice. Aim 2 is to ascertain whether preoperative cognitive impairment in patients 65 years of age or older undergoing elective joint replacement surgery is an independent predictor of adverse postoperative events and/or mortality. Aim 3 is to implement routine structured preoperative cognitive screening of patients 65 years of age or older undergoing elective surgical procedures in a busy preoperative clinic.
NCT02670382
The objective of this study is to provide critical information regarding both common and distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.
NCT02787213
Prospective multicenter observational study to further develop and validate a preterm birth risk predictor, using a preterm cutoff at 37 0/7 weeks gestation and at 35 0/7 weeks gestation. A single maternal peripheral blood sample will be collected for analysis. Data related to potential risk factors for preterm birth will be obtained through maternal interview and review of medical records. Subjects will be followed through the delivery process to assess the course of pregnancy, labor, and to document any related maternal complications. Neonatal outcomes will be gathered from the medical record for up to 28 days of life or discharge, whichever occurs first.
NCT03863964
Postpartum hemorrhage (PPH) accounts for 20-25 percent of maternal deaths worldwide. Tranexamic Acid (TXA) is an antifibrinolytic agent that has been shown to reduce the estimated blood loss after delivery and is recommended by the World Health Organization for PPH treatment. However, dosing in studies ranges from 0.5g to 4g and the optimal dose of TXA in the pregnant population has not been established. Further, the effect of TXA on global coagulation assessed by rotational thromboelastometry (ROTEM®) has not been elucidated. The primary aim of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of TXA administered after delivery in patients at risk for PPH.
NCT01857193
Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to characterize the safety and tolerability of the combinations of everolimus + exemestane + LEE011 and LEE011 + exemestane in patients with ER+ HER2- advanced breast cancer Dose Expansion part of the study: To characterize the safety and tolerability of the triplet combination of LEE011 + everolimus + exemestane in patients naïve or refractory to CDK4/6 inhibitor based therapy, and the safety and tolerability of the doublet combination of LEE011 + exemestane in patients refractory to CDK4/6 inhibitor based therapy (except patients treated with prior LEE011 are not allowed in Group 3).
NCT03061175
This pilot randomized clinical trial studies how well a web-based decision aid works in improving informed decisions in patients with stage 0-IIIA breast cancer considering contralateral prophylactic mastectomy (CPM). A web-based decision aid (DA) may help doctors determine how patients make decisions about whether or not to have contralateral prophylactic mastectomy.
NCT03742024
This is a multi-center registry that will prospectively collect regulatory compliant data from children and adolescents with migraine. This study will enroll approximately 200 participants from approximately 20 sites and will examine migraine symptoms, therapeutics used, and biomarkers associated with migraine.
NCT02452866
This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.
NCT01201356
The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.
NCT01887717
This is a two-arm, open-label, prospective, multi-center, randomized, active-controlled clinical trial to assess efficacy and safety of TheraSphere in comparison to standard of care therapy (sorafenib) in the treatment of participants with inoperable liver cancer and blockage of the portal vein.
NCT03419403
The objective of this study was to evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who were being treated with depatuxizumab mafodotin (ABT-414).
NCT01569698
Limited prospective data is available to compare morbidity and mortality between renal replacement modalities in pediatric acute renal failure. In the absence of clear standard of care, the choice of the extra renal replacement therapy modality is subject to clinical judgement, practical aspects, and costs. This study will supply important data about usual modalities of pediatric acute extra renal replacement therapy and their impact on patient outcome and renal recovery. An obvious next step will be to conduct a randomized controlled trial comparing the different strategies.
NCT02903069
This study is for newly diagnosed WHO Grade IV malignant glioma patients to determine whether an investigational drug known as marizomib (MRZ) will improve the treatment of newly diagnosed glioblastoma patients by delaying the growth of the cancer, reducing the size of the tumor, and/or improving survival. Marizomib (MRZ) is being added to standard-of-care treatments of radiotherapy (RT), temozolomide (TMZ), and Optune.
NCT04239391
The main purpose is to determine the safety of Triferic iron administered via dialysate and intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is a global, multi- center, open-label study.
NCT02518906
Specialized treatment of personality disorders (PD) in youth has been neglected for a long time, because these disorders were not diagnosed before the age of 18. Since 2013 the age threshold has been dropped in the Diagnostic and Statistical Manual (DSM)-5, and such change is also announced for the International Classification of Diseases (ICD)-11. There is broad consensus from both scientific evidence and clinical experience that specialized early interventions in adolescents with PD are urgently needed. In the last decades a number of specialized psychotherapeutic treatment programs have been developed. Despite their conceptual differences, many of the treatment models have shown significant effects in the treatment of PD in adults. However, the treatment of adolescents with PD remains difficult and further enhancement and development of treatments is needed. Given the different therapeutic approaches available, the present project aims to go beyond the comparison of integral therapeutic models in the classical outcome study design. While outcome research is important to build on the evidence of the effectiveness of an intervention, it contributes little to its understanding and refinement. The aim of the present multi-center project is to compare two therapeutic methods used in routine care: * Adolescent Identity Treatment (AIT) * Dialectic Behavioral Treatment for Adolescents (DBT-A) Treatments will be performed at different study centers and compared using the same measures of outcome. The main outcome will be psychosocial functioning. Additionally, the psychotherapy process will be investigated to explore specific and unspecific mechanisms of the therapeutic process, its outcome and mediators.
