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NCT ID: NCT03323034 Active, not recruiting - Clinical trials for Refractory Malignant Solid Neoplasm

Pevonedistat, Irinotecan, and Temozolomide in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphoma

Start date: January 11, 2018
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of pevonedistat when given together with irinotecan hydrochloride and temozolomide in treating patients with solid tumors, central nervous system (CNS) tumors, or lymphoma that have come back after a period of improvement (recurrent) or that do not respond to treatment (refractory). Pevonedistat and irinotecan may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, 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. Giving pevonedistat, irinotecan hydrochloride, and temozolomide may work better in treating patients with solid tumors, central nervous system (CNS) tumors, or lymphoma compared to irinotecan and temozolomide alone.

NCT ID: NCT03322774 Active, not recruiting - Clinical trials for Major Depressive Disorder

Sleep To Reduce Incident Depression Effectively

STRIDE
Start date: March 9, 2018
Phase: N/A
Study type: Interventional

This project will assess the effectiveness of a stepped-care model (i.e. digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) followed by face-to-face CBT-I) in improving severity of insomnia and sleep outcomes in an insomnia cohort. This project will also investigate the effectiveness of this stepped-care model in prevention of major depressive disorder, and will test rumination as a mediator of treatment response.

NCT ID: NCT03322449 Active, not recruiting - Inflammation Clinical Trials

APOA2 Gene, Diet, Inflammation and Gut Health

Start date: October 13, 2017
Phase: N/A
Study type: Interventional

Nutrients and chemicals in food are able to regulate expression of genetic elements. Gene-nutrient interaction in response to unhealthy diets can increase an individual's risk, shifting the individual from health toward the development of chronic disease. The apolipoprotein A2 (APOA2) gene may either put individuals at risk for or protect from obesity in the presence of certain fats in food. The main purpose of this four-week study is to examine diet induced gene-nutrient interaction, with a focus on gut health, gut microbiota and inflammation in individuals who have either the CC or the TT form within a specific variant of the APOA2 Gene. The (2) one-week study diets, one plant based and the other animal based are separated by a (1) week return to your regular habitual without probiotic or prebiotic food products.

NCT ID: NCT03321799 Active, not recruiting - Infection, Drainage Clinical Trials

Comparison of Negative Pressure Wound Therapy vs. Conventional Dressings for Prevention of Wound Complications After Revision THA

Start date: April 28, 2017
Phase: Phase 1
Study type: Interventional

Wound complications and surgical site infections following revision total joint arthroplasty result in significant morbidity and cost. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revision total hip arthroplasty when treated with negative pressure wound therapy (NPWT) versus sterile dressings. The investigators hypothesize that the rate of wound complications, infections, and subsequent procedures in patients undergoing revision THA treatment will demonstrate a statistically and clinically relevant decrease when using NPWT versus sterile dressing.

NCT ID: NCT03321643 Active, not recruiting - Clinical trials for Refractory Diffuse Large B-Cell Lymphoma

Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma

Start date: September 18, 2018
Phase: Phase 1
Study type: Interventional

This pilot phase I trial studies the side effects of atezolizumab, gemcitabine, oxaliplatin, and rituximab and to see how well they work in treating patients with transformed diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving atezolizumab, gemcitabine, oxaliplatin, and rituximab may work better in treating patients with transformed diffuse large B-cell lymphoma.

NCT ID: NCT03320330 Active, not recruiting - Clinical trials for Refractory Malignant Solid Neoplasm

Pepinemab in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors

Start date: January 31, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and best dose of pepinemab and to see how well it works in treating younger patients with solid tumors that have come back after treatment, or do not respond to treatment. Immunotherapy with monoclonal antibodies, such as pepinemab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT03319667 Active, not recruiting - Plasma Cell Myeloma Clinical Trials

Clinical Benefit of SAR650984, Bortezomib, Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant

IMROZ
Start date: December 7, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: -To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant. Secondary Objectives: - To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd)) arms: - Complete response (CR) rate, as defined by the International Myeloma Working Group (IMWG) criteria. - Minimal residual disease (MRD) negativity rate in patients with CR. - Very good partial response or better rate, as defined by the IMWG criteria. - Overall survival (OS). - To evaluate the overall response rate (ORR) as per IMWG criteria. - To evaluate the time to progression (TTP) overall and by MRD status. - To evaluate PFS by MRD status. - To evaluate the duration of response (DOR) overall and by MRD status. - To evaluate time to first response (TT1R). - To evaluate time to best response (TTBR). - To evaluate progression-free survival on next line of therapy (PFS2). - To evaluate the sustained MRD negativity >12 months rate. - To evaluate safety. - To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only). - To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (IVRd and crossover arms). - To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.

NCT ID: NCT03319628 Active, not recruiting - Clinical trials for Non Small Cell Lung Cancer Metastatic

First-in-Human Study of XMT-1536 in Cancers Likely to Express NaPi2b

Start date: December 12, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

First-in-human, Phase 1b/2 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks. Patients with tumor types likely to express NaPi2b were enrolled in dose escalation. Patients with platinum-resistant ovarian cancer and non-small cell lung cancer (adenocarcinoma subtype) were enrolled in the expansion segment of this study. Patients with platinum-resistant, high-grade serous ovarian cancer were enrolled in the UPLIFT segment of this study. In addition to safety assessments, the pharmacokinetics of the drug were assessed along with ADC activity. A QTc sub-study was added for the UPLIFT cohort for a sub-set of sites.

NCT ID: NCT03319485 Active, not recruiting - Parkinson Disease Clinical Trials

ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease

Start date: February 9, 2018
Phase: N/A
Study type: Interventional

Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.

NCT ID: NCT03318094 Active, not recruiting - Healthy Clinical Trials

Role of Sympathetic Vasoconstriction on Insulin-Mediated Microvascular Recruitment and Glucose Uptake in Obesity

Start date: October 24, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to better understand the contribution of sympathetic vasoconstriction to impaired insulin-mediated vasodilation and subsequently insulin-mediated glucose uptake. The investigators will test the hypothesis that removal of sympathetic vasoconstriction can result in improvement in insulin-mediated vasodilation and subsequently sensitivity to insulin-mediated glucose uptake.