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Discover 19,805 clinical trials near Atlanta, Georgia. Find research studies in your area.
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NCT01061736
Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: * reduction of signs and symptoms of rheumatoid arthritis at 24 weeks * inhibition of progression of structural damage at 52 weeks * improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.
NCT01681849
The purpose of this study was to assess the effects of the medication paroxetine on symptoms of posttraumatic stress disorder (PTSD) and the brain in women with a history of PTSD related to childhood abuse. The hypothesis is that paroxetine will result in an improvement in PTSD symptoms accompanied by changes in brain functional response to reminders of childhood trauma.
NCT00856492
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which treatment regimen is more effective in treating women with breast cancer. PURPOSE: This randomized phase II trial is studying paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin, cyclophosphamide, and pegfilgrastim to compare how well they work when given with or without bevacizumab in treating women with inflammatory or locally advanced breast cancer.
NCT01584531
The primary objectives of this study are to determine if rigosertib sodium, given orally in the form of soft gel capsules, is safe and is associated with a reduction in the number of blood transfusion units that are needed in patients with myelodysplastic syndrome (MDS) classified as Low or Intermediate-1 (Int-1) (any cytogenetics) or trisomy 8 Intermediate 2 (Int-2) in the International Prognostic Scoring System (IPSS) who are transfusion-dependent. Rigosertib will be taken on days 1 to 21 of a 21-day cycle.
NCT02642510
The purpose of this study is to evaluate the impact of a structured, DVD educational intervention about what to expect during inpatient treatment of a newly diagnosed cancer. The focus of the study will be newly diagnosed lymphoma and acute leukemia patients and their family members. Outcome variables will be the patient and family member's satisfaction with inpatient teaching and anxiety about inpatient treatment.
NCT00417040
This pilot clinical trial studies how well using the internet to collect symptoms and the ability to carry out daily activities works in patients with enrolled on Cancer and Leukemia Group B (CALGB) studies. A study that evaluates a patient's ability to use a clinic waiting room computer to report their symptoms and their ability to carry out daily activities may help doctors understand a patient's use of a computer to report symptoms.
NCT02465632
This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne vulgaris.
NCT00232505
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving cetuximab together with carboplatin is more effective than giving cetuximab alone in treating metastatic breast cancer. PURPOSE: This randomized phase II trial is studying cetuximab and carboplatin to see how well they work compared with cetuximab alone in treating women with estrogen receptor-negative (ER-), progesterone receptor-negative (PR-) metastatic breast cancer.
NCT01317901
This was a Phase 1 multicenter study of bendamustine, rituximab and TRU-016 (BRT) in subjects with relapsed indolent B-cell lymphoma. This was a multiple-dose escalation study to determine the maximum-tolerated dose (MTD) of TRU-016 given in combination with rituximab and bendamustine and to determine a safe dosing regimen for the combination in up to 12 subjects with relapsed indolent lymphoma. The originally planned Phase 2 portion, an open-label, randomized study to evaluate the efficacy of BRT compared with BR, was not conducted.
NCT01774851
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone
NCT01768572
Primary Objective: To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.
NCT00573560
The CardioKinetix Ventricular Partitioning Device (VPD) is intended to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. By isolating the malfunctioning portion of the left ventricle, it is hypothesized that the left ventricle will pump more effectively.
NCT01967342
Chronic pain is a significant public health problem that affects over 116 million Americans, costs $600 billion annually, and is unequally borne by people in low-income brackets, especially ethnic minorities. Many individuals also have health literacy deficits (difficulty understanding their illness and difficulty navigating the health care system for treatment) putting them at a greater disadvantage. Treatment usually relies on expensive medical interventions that often have negative side-effects. Psychosocial treatments, like Pain Education and Cognitive-Behavioral Therapy (CBT), show promise, but are usually unavailable. Clinicians are poorly equipped to provide psychosocial treatments to patients with low health literacy. CBT has not been adapted and supported for use in individuals with low health literacy, and even educational materials are often poorly adapted for their needs. To address this problem, the PI completed a small trial showing benefits from health literacy-adapted pain education and CBT groups for chronic pain in a population with low income and low health literacy. Patients in both treatments reported lower pain by the end of treatment, and the effects were maintained at one year. Patients in the CBT group also reported less depression. The current study uses a larger sample, and directly compares these psychosocial treatments to medical treatment-as-usual to seek better evidence for or against their widespread use in community settings. Our research questions: 1. In people with chronic pain and low income and/or low literacy, does participating in a health-literacy-adapted psychosocial treatment improve their pain and interference in daily activities due to pain by the end of treatment when compared with a group receiving typical medical care, and are these effects maintained 6 months later? 2. Does participation in the CBT pain management group improve symptoms of depression better than a pain education group by the end of treatment, and are these effects maintained 6 months later? In partnership with a federally qualified health center, we will enroll 294 patients with chronic pain. Main outcomes will be patient-reported pain intensity, pain interference, depression, and perceived change. From an earlier trial, we expect that our participants will be \~75% female and \~70% African American, and will have low literacy and low income (\~60% in the low 15% nationally on word reading, and 90% at or below the poverty threshold).
NCT00607997
This study will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) Injection in patients at least 60 years of age with previously untreated AML
NCT02121210
Primary Objective: To evaluate the immunogenicity of sarilumab administered as monotherapy. Secondary Objectives: * To evaluate the other safety aspects of sarilumab administered as monotherapy. * To assess the exposure of sarilumab administered as monotherapy.
NCT01414595
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies tissue samples from patients with non-small cell lung cancer.
NCT01828593
The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy.
NCT01900431
Primary Objective: To evaluate the efficacy of sarilumab at Week 16 in participants with non-infectious uveitis (NIU). Secondary Objectives: To evaluate the change in best corrected visual acuity (BCVA). To evaluate the safety of subcutaneous sarilumab in participants with NIU. To evaluate the change in macular edema. To evaluate the change in other signs of ocular inflammation. To evaluate the effect on retinal vessel leakage. To evaluate the effect of sarilumab on reducing concomitant immunosuppressant therapy. To evaluate the change in ocular inflammation in the anterior chamber. To evaluate the pharmacokinetics of sarilumab in NIU participants. To evaluate the immunogenicity with anti-drug antibodies (ADA).
NCT01260831
The purpose of this study is to evaluate the impact of Bedside Paediatric Early Warning System (Bedside-PEWS) on early identification of children at risk for near and actual cardiopulmonary arrest, hospital mortality, processes of care and PICU resource utilization.
NCT01277692
This study is a three Part, Phase 1, randomized, dose-escalation, fusion, placebo-controlled, double-blind study to determine the safety, tolerability and Pharmacokinetic (PK) profile of GSK2336805 in healthy subjects and the safety, tolerability, PK, and antiviral profile of GSK2336805 in subjects chronically infected with HCV: i. Single doses in healthy subjects and the effect of food on GSK2336805 PK (Part 1). ii. Repeat doses in healthy subjects (Part 2) iii. Single doses in chronically infected HCV positive subjects (Part 3).
