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NCT ID: NCT01678053 Withdrawn - Granuloma Clinical Trials

Efficacy Study of Botulinum Toxin (BOTOX) Injections to Treat Vocal Fold Granulomas

Start date: September 2012
Phase: Phase 2
Study type: Interventional

Vocal process granulomas are inflammatory masses caused in part by vocal trauma that arise in the posterior aspect of the vocal folds and result in throat pain, difficulty swallowing, hoarseness, and globus sensation. Antireflux therapy treats most granulomas, but many are recalcitrant to this therapy or take months to years to resolve. Botulinum toxin injection into the thyroarytenoid muscle has been effectively employed for recalcitrant granuloma, but causes significant voice loss, occasional difficulty swallowing and, in our clinical experience, is associated with significant recurrence. The investigators propose injecting another muscle in the larynx called the interarytenoid muscle with botulinum toxin type A to maintain the benefit of injection with less loss of voice. The investigators have shown the effectiveness of this treatment in a small, retrospective analysis.

NCT ID: NCT01677949 Withdrawn - Clinical trials for Acute Myeloid Leukemia

Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia

Start date: December 2013
Phase: Phase 2
Study type: Interventional

Study Design: This is a two-stage Phase II trial investigating the efficacy of Clofarabine, Cyclophosphamide and Etoposide in acute leukemia patients with detectable minimal residual disease (MRD) prior to allo-HCT. The primary objective is to determine the impact of the study treatment in eliminating the presence of minimal residual disease without causing a significant delay of allo-HCT due to treatment related toxicity. The intent of this study is to allow patients to proceed to transplant (independent of this study) within 42 days of Day 1 of Clofarabine based therapy.

NCT ID: NCT01677650 Withdrawn - Scoliosis Clinical Trials

Pharmacogenomics of Methadone in Spine Fusion Surgery

Start date: March 2014
Phase: Phase 1
Study type: Interventional

The overall objective is to develop a patient oriented research program to efficiently evaluate the effects of pharmacogenetic variants on the dose-response relationships and safety of opioids and non-opioid analgesics. If an opioid regimen can be created that produces excellent opioid analgesia with minimal toxicity related to supratherapeutic opioid concentrations (i.e., ventilatory depression), other non-opioid analgesics (i.e., gabapentin/pregabalin, ketamine, lidocaine, cyclooxygenase inhibitors, etc.) that may decrease preoperative opioid requirements can be more efficiently and safely evaluated. These interventions may limit the opioid related toxicities related to effect site concentrations that are below those required when opioids are the predominant analgesic, such as opioid related ileus. Methadone's slow elimination clearance and limited pharmacokinetic drug-drug interactions make it an attractive perioperative opioid. The first step towards personalized opioid analgesia is to determine the effect of common pharmacogenetic variants that affect either methadone metabolism (CYP2B6) or opioid elimination.

NCT ID: NCT01676454 Withdrawn - Injury Clinical Trials

Serum Vasopressin Levels and Severe Hemorrhagic Shock

Start date: November 2012
Phase:
Study type: Observational

The purpose of this study is to determine if vasopressin is used up by the body during traumatic shock (severe low blood pressure due to trauma).

NCT ID: NCT01675934 Withdrawn - Colonic Neoplasms Clinical Trials

Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes

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

Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in the proximal colon compared to the distal colon. Possible reasons for this include bowel preparation often being worse in the proximal colon as well as flat depressed lesions being more common in the proximal colon. Retroflexion is commonly regarded as standard practice in the rectum, but retroflexion in the proximal colon is not currently routinely performed due to concerns of perforation and possibly because of the increased time required. Proximal colon retroflexion has been shown to be safe and effective without any complications, but data regarding ability to retroflex with certain types of colonoscopes is limited. Endoscopists interchangeably use standard adult colonoscopes or pediatric colonoscopes. Studies have not been performed to comparatively evaluate the success rates of standard adult and pediatric colonoscopes and whether either type of instrument confers a greater polyp detection rate.

NCT ID: NCT01675388 Withdrawn - Clinical trials for Neonatal Respiratory Failure

Hypothermia During ECMO to Decrease Brain Injury

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

Newborn infants with severe respiratory failure are treated with extracorporeal membrane oxygenation (ECMO), a modified form of cardiopulmonary bypass. These infants as at risk for brain injury as a result of hypoxia and blood flow changes in the brain prior to and during ECMO. The investigators propose a clinical trial of a novel treatment (cooling during ECMO) and novel diagnostic tool (advanced MRI techniques) that will lead to improved outcomes, early diagnosis and intervention for brain injury, decreased cost and duration of clinical trials, decrease in the burden of chronic neurologic disease and disability in society, thus improving the health and quality of life of these infants as they progress through childhood into adulthood.

NCT ID: NCT01674868 Withdrawn - Stroke Clinical Trials

Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke

FLAN
Start date: April 2013
Phase: N/A
Study type: Interventional

This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American sample of post-acute stroke patients. This trial will in addition examine the effect of treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial attention, as well as post-stroke fatigue and will evaluate the durability of observed effects. The results of this pilot trial will be used to develop power estimates for a larger trial and to evaluate recruitment and intervention completion rates for subjects in an American post-acute environment. There are two additional substudies: the first will use MRI to assess structural changes at the beginning and end of the intervention; the second will examine the relationship of serum biomarkers of inflammation to the intervention.

NCT ID: NCT01674413 Withdrawn - Crohn's Disease Clinical Trials

Calprotectin-Directed Humira® Maintenance Therapy (CADHUM)

CADHUM
Start date: October 2013
Phase: Phase 3
Study type: Interventional

This is a study that invites adults with Crohn's disease and have been responding well to Adalimumab (Humira ®) for at least 6 months. Patients frequently discontinue maintenance medications in Crohn's disease, particularly when in remission. Patients want to know that they truly need to take a medication, yet they don't want to have flares. The purpose of this study is to see that if we monitor the patient, along with looking at changes in their stool samples, we can safely stop the maintenance medication Adalimumab for up to 48 weeks, or add as-needed dosing only, and keep them in remission.

NCT ID: NCT01672320 Withdrawn - Osteoarthritis Clinical Trials

Outcomes of Robotic Total Hip Arthroplasty

Start date: January 2013
Phase: N/A
Study type: Observational

The objectives of this study are to evaluate the clinical value of robotic-assisted total hip arthroplasty with respect to acetabular cup implantation, and to document the long-term clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be obtained at every study site to evaluate the basic clinical outcomes and post-operative component placement accuracy of each MAKO® THA patient. The hypothesis is that robotic preparation of the acetabulum will significantly reduce the variability and inaccuracy in the component alignment parameters that lead to post-operative complications, including implant failure.

NCT ID: NCT01671735 Withdrawn - Diabetes Clinical Trials

VA Diabetes Prevention: Epidemiology of Pre-Diabetes and Implementation Pilot

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

This study will collect baseline survey data from a NCP funded VA Diabetes Prevention Program (VA DPP) clinical demonstration program at three medical centers on VA DPP participants and VA DPP-eligible VA MOVE! participants to identify baseline participant demographic characteristics; attitudes and beliefs about diet, exercise and weight loss, and psychosocial constructs such as social support; and self-regulation skills that predict 6-month weight loss and program attendance. The data collected will contribute to our knowledge of pre-diabetic Veterans' attitudes and beliefs about diet, exercise and weight loss, to our understanding of how different programs may impact weight loss, and to evidence-based targeting in future clinical implementation projects. It will also provide baseline quality of life data for use in a future cost-effectiveness analysis.