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NCT ID: NCT02431260 Terminated - Clinical trials for Solid Tumors and Hematologic Malignancy

An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies

Start date: April 14, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment groups also had an intra-patient dose titration (Part 2).

NCT ID: NCT02431169 Terminated - Clinical trials for Non-Small Cell Lung Cancer

Genomic Landscape of EGFR Mutant NSCLC Prior to Erlotinib and at the Time of Disease Progression

Start date: April 30, 2015
Phase:
Study type: Observational

The investigators propose to conduct a pilot feasibility study of single agent erlotinib in patients with metastatic EGFR mutant adenocarcinoma of the lung with up to one prior treatment with the sole purpose of characterizing the genomic landscape before erlotinib and at the time of disease progression. The logistics of obtaining adequate quality fresh tissue specimens for sequencing studies before therapy and at the time of disease progression in patients with advanced lung cancer are complex and a thorough understanding of the practical challenges in conducting a study like this is crucial. The current proposal will include exome and transcriptome sequencing from blood collected at baseline along with tumor samples obtained prior to starting erlotinib and at the time of disease progression (a total of two tissue samples and one blood sample per patient). If carried out successfully, the proposed strategy very likely will lead to a larger and adequately powered study to understand fully evolving molecular changes due to clonal selection under treatment pressure. The pace of progress in the field of sequencing technology currently underway is only likely to accelerate in the near future yielding richer and highly content-rich information. Moreover, it is likely that genomic information from DNA sequencing and transcriptome will be supplemented by analyses of translatomes and proteomes. The investigators plan to sequence paired tumor specimens from 20 patients with EGFR mutant adenocarcinoma of the lung before treatment with erlotinib and at the time of disease progression following treatment with erlotinib. As the investigators expect some drop off (due to unexpected clinical events precluding a second biopsy at the time of disease progression, poor specimen quality and early discontinuation of therapy for non-progression), the investigators will enroll 40 patients in this trial to get 20-paired specimens.

NCT ID: NCT02430818 Terminated - Acute Pain Clinical Trials

Comparing Ketamine and Morphine in the Treatment of Acute Fracture Pain

Start date: April 2015
Phase: N/A
Study type: Interventional

Opioid pain medications such as morphine and dilaudid are commonly used in emergency departments to treat pain in patients. Physicians are familiar with the side effects of these medications; the most concerning of which is slowing or stopping a patient's breathing, as well as dangerously lowering their blood pressure. An alternative medication is ketamine. This medication is also commonly used in the emergency department, although it is typically used to help sedate patients for uncomfortable procedures. Ketamine has also been used for pain control, but in a much lower dosage that does not sedate patients. When used for analgesia, it has typically been administered in combination with opioid pain medications. To date, there is no study that looks at the effectiveness and safety of using a low dose ketamine alone in comparison to the use of morphine. The purpose of this study is to measure how well low-dose ketamine treats pain compared to morphine and to look at how often serious side effects are seen with each medication.

NCT ID: NCT02430532 Terminated - Clinical trials for Multiple Sclerosis, Secondary Progressive

BG00012 and Disability Progression in Secondary Progressive Multiple Sclerosis (SPMS)

INSPIRE
Start date: May 2015
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to investigate whether treatment with BG00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with SPMS; The secondary objective of the study is to assess the effect of BG00012 compared with placebo on patient-reported outcomes, brain atrophy, and cognitive function.

NCT ID: NCT02430389 Terminated - Surgery Clinical Trials

Effect of Remifentanil on Hemodynamic Stability During Placement of a Mayfield Head Fixation Device for Craniotomy

Start date: July 2012
Phase: N/A
Study type: Interventional

To identify a better method using a combination of routine anesthetic drugs to improve hemodynamic stability during Mayfield head pinning for craniotomy surgery.

NCT ID: NCT02429934 Terminated - Clinical trials for Systemic Lupus Erythematosus Arthritis

Abatacept for SLE Arthritis (IM101-330)

Start date: October 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This research trial is for patients who have been diagnosed with systemic lupus erythematosus (SLE) with swollen, tender joints (which is called inflammatory polyarthritis) because of the SLE. The purpose of this clinical research study is to evaluate the safety and effectiveness of treatment with abatacept (Abatacept) 125mg injected subcutaneously (under the skin) weekly for 16 weeks versus placebo injections(a substance with no active ingredients and therefore may have no treatment benefit) in subjects with SLE and inflammatory polyarthritis. The effectiveness will be assessed primarily by the number of swollen, tender joints (called a joint count) at each of study visits. Study Medication Abatacept is approved in the U.S. for treating rheumatoid arthritis by prescription and has not been approved by the U.S. Food and Drug Administration for treating SLE yet. In this study, subjects will receive treatment with either abatacept or placebo once a week for 16 weeks (a total of 16 injections).

NCT ID: NCT02429804 Terminated - Clinical trials for Metastatic Prostate Carcinoma

NaF/FDG PET/MRI in Measuring Response to Radium Ra 223 Dichloride in Patients With Metastatic Hormone-Resistant Prostate Cancer

Start date: April 2015
Phase: Phase 1
Study type: Interventional

This pilot clinical trial studies combined fluorine F 18 sodium fluoride (NaF)/ fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and magnetic resonance imaging (MRI) in measuring response to a drug, radium Ra 223 dichloride (Ra-223), in treating patients with prostate cancer that has not responded to hormone therapy and has spread to other parts of the body. Combining NaF/FDG in a simultaneous PET/MRI scan may help doctors accurately measure how well patients respond to treatment with radium Ra 223 dichloride.

NCT ID: NCT02429583 Terminated - Clinical trials for Hepatitis C Infection

Effects of Persistent Innate Immune Activation on Vaccine Efficacy

Start date: May 8, 2015
Phase: Phase 4
Study type: Interventional

This study will investigate the effects of chronic HCV infection and corresponding innate immune activation on the immune response to HBV vaccination. We will recruit chronic HCV patients and healthy control patients for HBV vaccination. We will use RNA Sequencing (RNA-Seq), a relatively new technology for simultaneously measuring the expression of all genes, to determine patients' innate immune status, and learn how this innate immune signature is related to HBV vaccine response. We will then explore the mechanisms by which chronic HCV infection affects different immune cells and functions that are known to be important for an effective HBV vaccine response. These studies will enhance our understanding of the immune effects of chronic viral infection, establish factors that determine effective vaccine responses, and help guide vaccination strategies for HCV patients and other individuals with chronic inflammatory disease.

NCT ID: NCT02429401 Terminated - Alcohol Consumption Clinical Trials

Culturally Adapted Brief Intervention for Heavy Drinking Hispanic Men

Project Valor
Start date: August 2015
Phase: N/A
Study type: Interventional

In this comparative-effectiveness study, investigators will recruit 400 English-speaking, Spanish-speaking, or bilingual heavy-drinking Mexican-origin men admitted to a community hospital for medical treatment of an alcohol-related injury or heavy drinking. Participants will be randomized to receive a culturally adapted brief motivational intervention (CA-BMI) or a non-adapted brief motivational intervention (NA-BMI). The primary outcomes of interest include alcohol use, alcohol problems, and treatment utilization. Secondary outcomes include therapeutic alliance ratings and social support. Telephone follow-up assessments will be completed at 3, 6, and 12 months post-treatment.

NCT ID: NCT02428309 Terminated - Clinical trials for Lupus Erythematosus, Systemic

Autologous Polyclonal Tregs for Lupus

Start date: August 27, 2015
Phase: Phase 1
Study type: Interventional

The primary purpose of this Phase 1 study is to evaluate the safety, tolerability, and effect of 3 different doses of Treg therapy in adults with skin (cutaneous) involvement of their lupus. Targeting cutaneous disease offers the ability to control background therapy, readily detect clinical effects, and perform research analyses not only in blood but also skin. Safety, disease activity, and mechanism of Tregs will be evaluated. The intent is to support dose selection for a future larger efficacy trial in lupus.