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NCT ID: NCT02404220 Terminated - Clinical trials for Acute Lymphoblastic Leukemia

Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

Start date: May 6, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety of entospletinib in combination with vincristine (VCR), and dexamethasone (DEX) in adults with previously treated relapsed or refractory B-cell lineage acute lymphoblastic leukemia (ALL). This is a dose escalation study in which after 2 induction cycles participants may be put on maintenance for up to 36 cycles if they have obtained clinical benefit from the treatment.

NCT ID: NCT02403895 Terminated - Clinical trials for Squamous Non Small Cell Lung Cancer

AZD2014 and Weekly Paclitaxel in Squamous NSCLC

Start date: April 15, 2015
Phase: Phase 2
Study type: Interventional

Open--label, phase 2a, multi-centre, single-arm study to assess the efficacy and safety of AZD2014 and weekly paclitaxel in patients with squamous non-small cell lung cancer (NSCLC)

NCT ID: NCT02403622 Terminated - Clinical trials for Clostridium Difficile

Safety of FMT: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection

STOOL
Start date: March 2015
Phase: Phase 2
Study type: Interventional

The overarching objective of this study is to address the knowledge gap regarding the short-term and long-term safety of fecal microbiota transplants (FMT). The design will be a prospective, open-label, multi-center longitudinal cohort study to assess the short- and long-term safety of FMT as well as the clinical resolution of diarrhea among 150 patients with 3 or more episodes of clostridium difficile infection (CDI defined as 3 unformed stools over 24 hours for 2 consecutive days and either a positive stool test for CDI or pseudomembranes on colonoscopy/sigmoidoscopy). Subjects will be adult outpatients referred to one of the study centers after at least three recurrent episodes of CDI and previous treatment with at least one 10-day course of oral vancomycin or fidaxomicin. After FMT by colonoscopy/sigmoidoscopy or enema, patients will be followed prospectively and monitored for clinical resolution and adverse events at: 3 days (telephone), 3 weeks (clinical assessment), 8 weeks (telephone), 6 months (telephone), and 12 months (telephone) after FMT. Subjects who recur will be offered a second FMT by colonoscopy with a different donor. Microbiome analysis will be conducted from stool samples at baseline and each of the 5 follow-up intervals.

NCT ID: NCT02403323 Terminated - Crohn Disease Clinical Trials

Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144

JUNIPER
Start date: June 8, 2015
Phase: Phase 3
Study type: Interventional

This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.

NCT ID: NCT02403297 Terminated - Gingivitis Clinical Trials

Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

Start date: March 2015
Phase: N/A
Study type: Observational

The purpose of this study is to learn if a chair-side testing device will accurately measure levels of a salivary biomarker and thus indicate if a patient has periodontal health, gingivitis or periodontal disease.

NCT ID: NCT02403154 Terminated - Clinical trials for Anterior Pelvic Ring Fractures

Comparison of Subcutaneous INFIX and EXFIX for Anterior Pelvic Ring Fractures Requiring Stabilization

Start date: April 2014
Phase: N/A
Study type: Interventional

The purpose of this research is to compare patient outcomes of two treatment methods that are currently used as standard of care to treat anterior pelvic ring injuries that require stabilization. The two treatment methods are subcutaneous internal fixation (INFIX) and external fixation (EXFIX). Patients will be given the opportunity to opt out of randomization and participate in one of the observational arms. The first observational arm is comprised of those patients who do not want to randomize and they will undergo anterior pelvic ring stabilization according to the treating surgeon's discretion. The second observational arm will be comprised of patients who consent to be in the study but whose pelvic ring fractures do not require any form of anterior pelvic internal fixation based on the treating surgeon's opinion.

NCT ID: NCT02402829 Terminated - Hemophilia A Clinical Trials

A Study Comparing Factor Level and Inhibitor Titer Testing Results Drawn From Central Venous Lines and Venipuncture

CVL#2
Start date: November 2014
Phase:
Study type: Observational

The purpose of this research study is to see if factor levels and inhibitor levels in Hemophilia A and B subjects are accurate when they are drawn from a central venous line (CVL) instead of from a peripheral stick.

NCT ID: NCT02402803 Terminated - Clinical trials for Cardiovascular Diseases

Dried Blood Spot- Statin Pilot Study

DBS
Start date: October 2015
Phase:
Study type: Observational

Cardiovascular disease (CVD) is the number one cause of mortality for men and women in the United States. Dyslipidemia, particularly a high low-density-lipoprotein cholesterol (LDL-C) level, is a well-established cardiovascular risk factor and the current American Heart Association guideline for CVD risk assessment recommends a lipid panel to be checked. In addition, guidelines recommend statin therapy in all patients with clinical atherosclerotic CVD, all patients with LDL-C = 190 mg/dL, patients age 40-75 years with diabetes and LDL-C 70-189 mg/dL, and patients with an estimated 10-year atherosclerotic CVD risk = 7.5%. For all of these patients, a fasting lipid panel should be drawn prior to statin initiation as well as during follow-up to assess medication and lifestyle adherence. These fasting lipid panels are obtained via conventional phlebotomy via venopuncture in an office-based or hospital laboratory setting. However, research protein quantitation with mass spectrometry and enzyme-linked immunosorbent assay (ELISA) are technologies that allow for sensitive quantitation of protein biomarkers and targets, including lipoproteins. Most importantly, multiple reaction monitoring (MRM) mass spectrometry is able to assess samples from a dried blood spot (DBS), whose advantages include minimal volume requirements, ease of sample attainment by finger stick with minimal training required, ease of transport, and sample stability. The purpose of the proposed analysis is to 1) measure changes in CVD biomarkers before and after initiation of statin therapy and 2) compare lipid measurements by conventional phlebotomy blood samples to research protein quantitation measurements in DBS and plasma.

NCT ID: NCT02402738 Terminated - Bipolar Disorder Clinical Trials

Adjunctive Psychotherapy for Perinatal Bipolar Disorder

Start date: April 2014
Phase: N/A
Study type: Interventional

Bipolar disorder (BD) is a serious, disabling, and highly recurrent illness. The perinatal period dramatically increases risk for mood episodes in women with BD, but pregnancy complicates pharmacologic treatment decisions and efficacy. This study will be the first to systematically develop and pilot test an adjunctive psychosocial intervention to assist in treatment of BD during the high-risk perinatal period.

NCT ID: NCT02402348 Terminated - Clinical trials for Cancer of Head and Neck

Pilot Study of Metformin in HNSCC to Investigate the Effects of MF, Tumor Genotype and MF-genotype Interactions, on Tumor Metabolism and Anoikis

Start date: December 2014
Phase: Early Phase 1
Study type: Interventional

The study researchers want to look at the overall effects that Metformin may have on the tumor characteristics of Head and Neck cancer cells as well as the interactions that Metformin has on the growth or death of tumor cells.