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NCT ID: NCT01555684 Withdrawn - Multiple Sclerosis Clinical Trials

Functional Changes Following Percutaneous Venoplasty in Multiple Sclerosis Patients

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

Multiple Sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) that often results in reduced muscle function which produces fatigue, weakness and a decline in daily mobility. Although the underlying cause of the disease is unknown a possible contributory mechanism is chronic cerebrospinal venous insufficiency (CCSVI). Post-mortem studies and magnetic resonance venography have shown a strong relationship between the cerebral venous system and MS cortical plaques. From this a role for CCSVI in MS has been suggested: venous malformations that result in venous hypertension, pressure on the blood brain barrier and subsequent inflammation due to leakage of haemosiderin into the parenchyma. This provokes an immune response which results in neurodegeneration. A procedure known as percutaneous venoplasty whereupon a balloon is inserted and inflated into the jugular vein has been developed to improve this drainage of the CNS, reduce venous hypertension and improve symptoms associated with MS. Although this procedure is widely practiced throughout the world it has yet to be fully accepted as it needs to be supported by evidence based clinical trials. As such NHS National Institute for Health and Clinical Excellence (NICE) recently issued a consultation document to determine more about the procedure's clinical safety and efficacy. A common concern raised is the ability to prevent any possible placebo effect and like any other clinical trial should offer a sham procedure to a matched control group. The difficulty with this option are the ethical issues associated with an invasive sham treatment and also the practical issues of masking a potentially painful treatment such as venoplasty. One option is to have blinded neurological assessment of patients who have either been treated with venoplasty or had no active treatment. Another option is to use dependent measures that are unaffected by motivational or psychological influences which avoids any placebo effect issue. One such dependent measure is motor unit firing behaviour whilst contracting at a submaximal target force. Typically clinicians have used this to manage motor disorder patients but have used cumbersome invasive technology that can only measure a few motor units with limited accuracy. However, De Luca et al recently developed a high density surface electromyographic (HDsEMG) system that can measure 30-40 motor units with 92-97% accuracy. From this it has been proposed as a highly effective tool for evaluating efficacy of therapeutic interventions for upper motoneuron disorders such as MS. Accordingly the investigators propose to use a repeated measures design on an experimental (receiving venoplasty) and control (not receiving venoplasty) MS groups (6 patients in each group) to determine the effect of the treatment on muscular function, mobility and fatigue. This would be combined with independent blinded neurological assessment of the two groups of patients. This design enables us to achieve two aims: 1. Acute neuromuscular response to the treatment 2. Chronic response to the treatment (6 weeks) to determine the effect on muscular function, mobility and fatigue.* Methods - Four (first two to establish baseline variability of measures) repeat visits to the laboratory at University of Stirling to establish neuromuscular measures: 1. HDsEMG pre and post tetanic induced fatigue 2. Muscle fibre conduction velocity as previously described (Hunter et al., 2011) 3. Ultrasound for CCSVI determination on visits 1 and 3 4. DEXA scans for alterations in body composition on visits 2 and 4 - With the use of accelerometers monitor free living activity on days 0-7 and 9-42 (post venoplasty).

NCT ID: NCT01565070 Withdrawn - Knee Osteoarthritis Clinical Trials

Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic

Start date: April 2012
Phase: Phase 3
Study type: Interventional

Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies in the stimulation of A and C fibers by cold and nociceptive stimulation, respectively, which is produced by menthol, apparently through the newly discovered receptor TRPM8 (Transient Receptor Potential melastatin-8) The aim of this study is to investigate if BIOFREEZE ® treatment (Performance Health Inc., Export, PA) improves symptoms associated with moderate knee osteoarthritis, which would decrease the immobility and isolation in older adults.

NCT ID: NCT01577199 Withdrawn - Infertility Clinical Trials

RCT of Low-dose Clomiphene vs. High Dose Gonadotropin Protocol for IVF Poor Responders

CLOVANT
Start date: April 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is compare two commonly-used medication protocols ( low-dose clomiphene citrate and high dose gonadotropin protocols) for the treatment of patients with diminished ovarian reserve (decreased number of eggs remaining in the ovary) undergoing IVF. This research is being done because we do not know if these two medication protocols are equally likely to help a woman become pregnant.

NCT ID: NCT01579396 Withdrawn - Acute Kidney Injury Clinical Trials

High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery

HICOSIRS
Start date: April 2012
Phase: N/A
Study type: Interventional

A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with incidence of "systemic inflammatory response syndrome" (SIRS) and associated increased risk for acute kidney injury (AKI). Hypothesis: The high cut off dialyzer (septeX) can increase the postoperative IL-6/Il-10 ratio.

NCT ID: NCT01582685 Withdrawn - Breast Cancer Clinical Trials

Exercise in Breast Cancer Survivors

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

The investigators hypothesize that exercise in postmenopausal breast cancer survivors will result in an increase in the plasma concentrations of angiostatic factors and a decrease in the plasma concentrations of angiogenic factors. Exercise is expected to result in a circulating angiostatic phenotype that inhibits adipose tissue mass, growth of breast cancer tumor, growth of microscopic residual disease after breast cancer resection, decreases rates of local-regional recurrence, decreases rates of distant recurrence, and increases survival.

NCT ID: NCT01583205 Withdrawn - ALS Clinical Trials

Coping Effectiveness Training for ALS

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

The investigators propose to adapt and pilot test a behavioral intervention for recently diagnosed patients with Amyotrophic Lateral Sclerosis (ALS), and/or a family care partner. ALS fatal neurodegenerative disease, the diagnosis of which can have a devastating impact on patients and their families. Our eight session intervention is derived from Coping Effectiveness Training, a manualized intervention based on stress and coping theory. It is designed to strengthen coping skills and alleviate distress following diagnosis. Participants (patients and/or care partners) will be recruited from the Eleanor and Lou Gehrig MDA/ALS Research Center, Columbia University. The main outcomes are changes in distress level, depression and anxiety symptoms, and coping self-efficacy. Once the investigators gain preliminary experience with the manual, get some sense of feasibility and acceptance, and learn about patient and care partner reactions, the investigators will be better able to prepare a grant application seeking NIH support for the development of the intervention, with the eventual goal of a multisite randomized controlled trial (RCT).

NCT ID: NCT01586884 Withdrawn - Heart Failure Clinical Trials

Study to Determine the Safety and Feasibility of Utilizing the CD Leycom Pressure/Conductance Catheter to Determine Optimal LV Pacing Site

Start date: April 2012
Phase: Phase 1
Study type: Interventional

It is hypothesized that it is both safe and feasible to use an interventional approach to LV lead placement (placing the LV lead guided by acute hemodynamic measurements), and that the LV lead can be placed in a position that is superior to the initial empiric lateral wall LV lead location in less than 30 minutes without significant risk to patients. The time from RV capture to LV activation correlates with the optimal pacing site based on stroke volume & dP/dt measurements.

NCT ID: NCT01588314 Withdrawn - Neuropathic Pain Clinical Trials

Safety and Efficacy of Gabapentin for Neuropathic Pain in Fabry Disease

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

The purpose of this study is to determine efficacy of gabapentin vs. placebo at controlling peripheral neuropathic pain in patients with Fabry disease, and reducing their use of opioid analgesics. The investigators are conducting a randomized, double-blind, placebo controlled, single center, cross-over study. The primary endpoint is percent reduction in patients' use of hydrocodone-acetaminophen.

NCT ID: NCT01589718 Withdrawn - Clinical trials for Proliferative Diabetic Retinopathy

A Study of the Safety, Tolerability, and Efficacy of IVT Pre-op 0.3mg Pegaptanib Sodium Versus Sham, for Management of Tractional Retinal Detachment and Vitreous Hemorrhage With Proliferative Diabetic Retinopathy

No-Crunch01
Start date: April 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess whether preoperative pegaptanib sodium safely improves vitreous hemorrhage prior to surgical intervention and to evaluate the stability of pre-existing tractional retinal detachment.

NCT ID: NCT01591759 Withdrawn - Clinical trials for Traumatic Brain Injury

A Pilot Trial of Citicoline in Individuals With Mild Traumatic Brain Injury (mTBI)

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

This investigation will explore the impact of 8 weeks of citicoline treatment on cognitive function, clinical state and substance use in 40 individuals with mild traumatic brain injury (mTBI).