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NCT ID: NCT02439957 Terminated - Clinical trials for Kidney Transplant Infection

A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus

Start date: September 2015
Phase: Phase 3
Study type: Interventional

This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral brincidofovir (BCV) versus valganciclovir for the prevention of cytomegalovirus (CMV) disease in CMV-seropositive kidney transplant recipients who received antilymphocyte induction therapy.

NCT ID: NCT02439645 Terminated - Long qt Syndrome Clinical Trials

A Registry to Determine the Clinical and Genetic Risk Factors for Torsade De Pointes

BA-TdP
Start date: October 2013
Phase:
Study type: Observational [Patient Registry]

This is a registry to examine genetic and clinical predictors of torsade de pointes events.

NCT ID: NCT02439346 Terminated - Medical Oncology Clinical Trials

Phase I Dose Escalation and Expansion of Oral BAY 1143269 in Combination With Intravenous Docetaxel

Start date: June 15, 2015
Phase: Phase 1
Study type: Interventional

Determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics (PK), and/or recommended Phase II dose (RP2D) of oral BAY 1143269 given alone or in combination with intravenous (IV) docetaxel in subjects with advanced solid tumors.

NCT ID: NCT02439281 Terminated - Postoperative Pain Clinical Trials

Ropivacaine With Clonidine For Pediatric Rectus Sheath Blocks- The Magic Combination

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

Background: Millions of pediatric patients undergo laparoscopic surgeries every year and many of them suffer significant pain and anxiety. Patient's anxiety correlates with the severity of pain and effective postoperative analgesia is necessary for optimal recovery. Single injections ultrasound guided rectus sheath blocks provide satisfactory postoperative analgesia after pediatric laparoscopic appendectomy, however they are short lived. Searching for a blocking agent that last long enough to outlast pain and has minimal side effects is a difficult task. Using a combination of drugs yielded mixed results. Few pediatric studies showed at best a weak trend in favor of clonidine prolonging analgesia after some blocks, but anxiolytic properties of clonidine were not investigated. This study will compare rectus sheath ropivacaine blocks with ropivacaine and clonidine blocks. Methods: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be double blinded and randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location, and Ropivacaine Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg). Post-operative analgesia will be provided with ketorolac and acetaminophen around the clock, and morphine, or/and oxycodone as needed. The primary aim is to determine if ropivacaine combined with clonidine prolongs duration of paresthesia. The secondary aims are to determine if the use of clonidine decreases anxiety level, prolongs duration of analgesia, and decreases pain severity at umbilicus laparoscopic site, reduces the need for analgesics, improves satisfaction with pain control, and is associated with complications such as oversedation, hypotension, and bradycardia. Conclusions: Every hour of excellent analgesia count and a prolongation of block duration by at least 50% is clinical relevant. The investigators hypothesize that rectus sheath injections with ropivacaine and clonidine offer improved pain management compared to ropivacaine alone.

NCT ID: NCT02438995 Terminated - Clinical trials for Carcinoma, Squamous Cell

Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck

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

This is an open-label, non-randomized, two arm, Phase I research study of superselective intraarterial Cetuximab (Erbitux) with or without radiation therapy for treatment of recurrent unresectable squamous cell carcinoma of the head and neck (HNSCC).

NCT ID: NCT02438917 Terminated - Hepatitis C Clinical Trials

Biomarkers of Liver Fibrosis

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

Chronic liver injury leads to the accumulation of proteins in the liver that form dense scars. Liver scar formation is typically a slow process that leads to major organ damage and loss of function over the course of many years. During scar formation the extracellular matrix in the liver changes. The type and quantity of extracellular collagen and other proteins change during tissue remodeling. Some of these changes can be detected by analyzing factors present in blood. Because of the lengthy time course, changes in the rate of liver scar formation and regression are very difficult measure; however, accurate measurements are needed in order to conduct trials of interventions aimed at preventing scar formation and/or promotion scar regression. Current methods have sub-optimal specificity and selectivity. The long term objective of the study is to identify serum proteins that can be used to accurately estimate rates of liver fibrosis progression and regression. The project focusses on a novel methodology that uses stable isotope labeling with deuterated water, D2O, to tag newly-synthesized proteins. Mass spectroscopy is used to identify individual proteins and to quantify the ratio of labeled protein to total protein. This ratio provides information about the rate of synthesis of the protein of interest. This method will be applied to specimens from patients with hepatitis C virus (HCV) infection who are about to begin HCV treatment. Treatment is known to reduce liver inflammation and collagen content.

NCT ID: NCT02438787 Terminated - Clinical trials for Axial Spondyloarthritis

A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis

Start date: July 31, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of radiographic AxSpA.

NCT ID: NCT02438514 Terminated - Clinical trials for Psychological Stress

Biological Biomarkers in MOMS Partnership

Start date: November 2014
Phase:
Study type: Observational

The investigators propose to evaluate the potential utility of stress-related biomarkers obtained via dried blood spots (DBS) and retinal scans by collecting new data from mothers and children within the New Haven MOMS Partnership, a well-established community-partnered research setting. The proposed research could greatly advance the application of stress-related biomarkers within community-based research by increasing our understanding of how stress, trauma, and depression influence biology in childhood and adulthood, as measured using minimally-invasive approaches.

NCT ID: NCT02438371 Terminated - Preterm Labor Clinical Trials

Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

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

Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor

NCT ID: NCT02438007 Terminated - Prostate Cancer Clinical Trials

A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC

ARMOR3-SV
Start date: June 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).