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NCT ID: NCT01934192 Terminated - Gastroparesis Clinical Trials

Nutritional Adequacy Therapeutic Enhancement in the Critically Ill. The NUTRIATE Study

Start date: April 4, 2014
Phase: Phase 2
Study type: Interventional

This is a multi-center, parallel group, placebo-controlled and active-compared, randomized study to assess the ability of GSK962040 to enhance the delivery of enteral feed to critically ill subjects that are predisposed to developing feeding intolerance (e.g., percentage of goal volume); enhance gastric emptying in this population; and provide preliminary evidence of the drug's effect on outcomes of therapy (length of stay in the Intensive Care Unit [ICU], time on ventilator, ICU acquired infections, and 60-day mortality). Other aims are evaluation of GSK962040 safety, tolerability and pharmacokinetics upon repeat dosing in a critically ill population. After meeting eligibility criteria, male and female subjects will be randomized to either receive GSK962040 (50 milligram [mg]) once daily (OD) via naso-gastric (NG) or orogastric (OG) feeding tube (oral solution), or placebo by the same route. If subjects develop intolerance to enteral feeding at any point up to Dose 5 of study medication (inclusive), study treatments will switch such that those originally receiving GSK962040 will receive metoclopramide (10 mg, intravenous [iv], every 6 hours) and those subjects originally randomized to receive placebo will receive GSK962040 (50 mg, via NG, OD). Additionally, if subjects develop intolerance prior to any treatment, they will be randomized to receive either GSK962040 (50 mg, via NG, OD) or metoclopramide (10 mg, iv, every 6 hours). The study will consist of a screening/baseline assessment, a treatment period (up to 7 days in duration), and a 4-day post treatment safety follow-up assessment. The duration of each subject's participation in the study from screening to follow-up safety assessment will be up to approximately 2 weeks. In addition, mortality will be assessed 60 days after admission to the ICU.

NCT ID: NCT01933438 Terminated - Clinical trials for Obstetrical Brachial Plexus Palsy

Sup-ER Protocol RCT

Start date: June 2013
Phase: N/A
Study type: Interventional

This study evaluates the ability of a supination and external rotation protocol to improve the arm function and anatomy of children with birth related brachial plexus injuries.

NCT ID: NCT01933308 Terminated - COPD Clinical Trials

Optimization of Pulmonary Rehabilitation Programmes: the OPTION Study

OPTION
Start date: November 2008
Phase: N/A
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) has a profound impact on the lives of individuals who suffer from it. Participants with COPD are often caught in a downward spiral that goes from chronic airflow limitation to invalidity and poor quality of life. Exercise training is considered the key to successful pulmonary rehabilitation (PR) because it is responsible for much of the benefits associated with this intervention. However, despite current guidelines recommend high-intensity exercise training. the optimal exercise training protocol for PR participants has yet to be determined. Aims: The main goal of the proposed research project will be to determine the optimal exercise training protocol in PR. More specifically, the objectives will be to compare the effects of continuous high-intensity training (CT80), continuous training at the ventilatory threshold (CTVT), and interval training (IT) on various PR program outcomes and to compare participant compliance to the three training regimens. Methods: One hundred and twenty subjects will be recruited. Participants who meet the eligibility criteria and accept to participate in the study will be randomized to one of three groups: the CT80 group, the CTVT group, or the IT group. Session duration will be adjusted such that the total amount of work performed per session will be comparable between the three groups. Assessments will be made at baseline (week 0), at program completion (week 12), and one year after program start (year 1). The primary outcome measure will be short-term (12 weeks) change in exercise tolerance, as measured by the endurance time to constant-load cycling. Secondary outcome measures will include: long-term (1 year) change in exercise tolerance; short-term and long-term changes in functional status, psychological status, cognition, and health-related quality of life; average participant compliance to the target intensity throughout the 12-week program; and long-term adherence to exercise recommendations. Relevance: The proposed research will inform clinicians and scientists regarding which of the exercise training protocols currently used in PR is optimal for COPD participants by examining their short-term and long-term impact on physiological, functional, psychological, neuropsychological, behavioural and quality of life outcomes. For COPD participants, our findings have the potential to improve the effectiveness of a key intervention for the management of their disease.

NCT ID: NCT01928043 Terminated - Bipolar Disorder Clinical Trials

Adjunctive Curcumin for Symptomatic Adolescents With Bipolar Disorder: Brain and Body Considerations

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

This study will enroll 30 adolescents with bipolar disorder (BD) who are suffering from symptoms of depression despite already taking a traditional mood-stabilizing medication. Curcumin will be added to their current medications for 8 weeks. During these 8 weeks, their mood symptoms will be assessed regularly. Height, weight, and blood pressure will also be measured repeatedly. Blood tests will be completed before treatment, after 4 weeks of treatment, and at the end of the study. Blood tests will allow us to determine whether changes in inflammation and oxidative stress explain curcumin's effect on mood. Finally, we will use sophisticated technology to measure blood vessel functioning. We have three main predictions: 1. Curcumin will improve mood symptoms without causing physical problems; 2. Curcumin will reduce inflammation and oxidative stress, and these reductions will be linked to improvements in mood; 3. Curcumin will improve blood vessel functioning, and these improvements will be linked to improved inflammation and oxidative stress.

NCT ID: NCT01927757 Terminated - Clinical trials for Moderate to Severe Rheumatoid Arthritis

Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab

ROCkIES
Start date: May 6, 2013
Phase: Phase 4
Study type: Interventional

To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their first biologic agent.

NCT ID: NCT01924039 Terminated - Psychosis Clinical Trials

Brief Motivational Enhancement Therapy for Concurrent Disorders

Start date: June 2013
Phase: N/A
Study type: Interventional

The investigators are proposing a project that will examine the effectiveness of brief motivational enhancement therapy in a population with concurrent psychotic disorders and substance use disorders. This study will represent an emerging line of inquiry, as best practice interventions with this concurrent disordered (CD) populations are yet to be established.

NCT ID: NCT01921114 Terminated - Clinical trials for Patients Indicated for a PICC for Any Medical Condition

The PROOF Study: The PICC Related Obstruction Of Flow Study

PROOF
Start date: October 2013
Phase: N/A
Study type: Interventional

The main purpose of this study is to confirm whether the AngioDynamics BioFlo™ Peripherally Inserted Central Catheter (PICC) is associated with less formation of blood clots compared to another commercially available PICC.

NCT ID: NCT01912261 Terminated - Fatigue Clinical Trials

Effects of Oral Iron on Postoperative Fatigue Upon Coronary Artery Bypass Graft Patients

Start date: December 16, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to examine how an oral iron supplement (Feramax®) influences fatigue during early postoperative recovery (at three months) among CABG patients and, the effects on recovery outcomes (e.g. quality of life, functional capacity, anemia, and medication adherence). It is hypothesized that CABG surgery patients receiving oral iron (Feramax®) 150mg orally (once a day therapy) will have a 15% reduction in POF (measured by the Identity Consequence Fatigue Scale (ICFS)), compared to patients receiving a placebo.

NCT ID: NCT01911377 Terminated - Neuropathic Pain Clinical Trials

Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MS

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

This study will examine the efficacy of Botulinum Toxin Type A ("Botox") in treating Allodynic-type neuropathic pain in people with spinal cord injury or multiple sclerosis. Neuropathic pain is pain initiated or caused by injury to or disease of the nervous system, and is common in spinal cord injury patients or people with multiple sclerosis. Allodynia is a type of neuropathic pain caused by something that normally would not cause pain, such as light touch, pressure from clothing, or bed sheets brushing against the skin. Botox has been used to treat the muscle overactivity that causes spasticity in spinal cord injured patients. It has been noticed to exert some analgesic(pain relieving) effect, and has recently been studied as a treatment for neuropathic pain. We want to see if Botox, injected intradermally, will relieve the symptoms of allodynic-type neuropathic pain. 24 volunteers are to be enrolled, with 16 receiving active treatment, and 8 "controls" receiving placebo.

NCT ID: NCT01911182 Terminated - Clinical trials for Apnea of Prematurity

Inhalation of Low Concentration of CO2 in Preterm Infants Not Responding to Caffeine for the Treatment of Apnea

Start date: October 2011
Phase: Phase 2/Phase 3
Study type: Interventional

In premature infants, apnea of prematurity is one of their major clinical problems. Caffeine is currently a worldwide therapy to reduce the number and severity of these apneas. This practice has shown to be safe on cognitive and neurodevelopmental outcomes at 18 to 21 months of age. However, caffeine is not 100% effective, and may have little effect on hypoxemia and bradycardia. Infants with intractable apneas unresponsive to caffeine treatment may require endotracheal intubation and mechanical ventilation. This procedure is invasive and has been associated with complications and increased risk for chronic lung disease and adverse neurodevelopmental outcome. Therefore, an alternative treatment modality would be preferable if it would prevent the infants from requiring endotracheal intubation. The investigators have been testing the overall hypothesis that small concentrations of inhaled CO2 (~1%) are effective in treating apnea of prematurity. The investigators have completed three studies in preterm infants showing that inhalation of low concentration of CO2, in infants not on caffeine, regularize breathing and decrease apneas significantly. The effects of inhalation of CO2 in infants already on caffeine, are unknown. The hypothesis to be tested is that inhalation of low concentration CO2 (1%) will significantly reduce apnea in infants treated with caffeine. The investigators have three specific aims in this proposal. 1) the investigators want to know if the apnea rate (number of apneas of ≥5 seconds/hour) is decreased with CO2 inhalation in preterm infants already on caffeine for the treatment of apnea of prematurity; 2) the investigators want to know whether inhalation of CO2 can make breathing more regular with less apneic time and whether it decreases prolonged apneas (>20 seconds) in infants already on caffeine for the treatment of apnea of prematurity; 3) the investigators want to assess the effect of inhalation of low concentration of CO2 on the regional oxygen saturation of the brain measured by near-infrared spectroscopy (NIRS) during apneas. This is to see whether CO2, by protecting cerebral blood flow, minimizes the decrease in cerebral oxygenation during apneas. This study entails a new and possibly more physiological method of treating apneas of prematurity that can be added to the present treatment of caffeine. These two treatments together, could minimize the number and severity of apneas and possibly decrease the need for mechanical ventilation in preterm infants.