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NCT ID: NCT01907347 Completed - Clinical trials for Intensive Care Unit Patients

Prognosis Value of Bioimpedance Analysis (BIA) Phase Angle at Admission in Intensive Care Unit (ICU) Patients

PAP
Start date: March 1, 2013
Phase: N/A
Study type: Observational

Critically ill patients feature a loss of fat-free mass (FFM) up to 440 g/day, which is associated with increased morbidity and prolonged recovery. In several clinical conditions, FFM or phase angle (PhA)derived from BIA have been associated with clinical outcome. However, solid data to support this association in ICU patients are lacking. Only one retrospective study of 51 ICU patients with acute respiratory failure correlated loss of active cell mass with mortality. In a pilot study performed in 55 ICU patients, the investigators observed that five kHz BIA PhA was significantly related to SOFA (r=0.38, P=0.03). The relation between PhA and mortality remains to be determined in ICU patients. Classic ICU validated severity scores (e.g. Acute Physiology and Chronic Health Evaluation (APACHE), Sequential Organ Failure Assessment (SOFA), Simplified Acute Physiology Score (SAPS)) and recent nutritional scores have been developed to foresee the clinical outcome of ICU patients. Most of these scores are time consuming and suffer some degree of discriminative power (i.e. APACHE II and SAPS II are not validated in cardiovascular surgery patients). PhA is reflecting intracellular status: altered intracellular water (ICW) to extracellular water (ECW) distribution is suggested by low PhA. PhA measurement does not require anamnestic parameters, body weight, and lab tests. It could easily, accurately and repeatedly measured at bedside. PhA has been correlated with the disease prognosis in HIV infection, hemodialysis, peritoneal dialysis, chronic renal failure and liver cirrhosis patients. These studies suggest that PhA may be useful in determining increased risk of morbidity in the ICU. Computerized tomography (CT) images targeted on the 3rd lumbar vertebrae (L3) could accurately measure FFM13 and predict survival in cancer patients. Body composition evaluation by CT presents great practical significance due to its routine ICU use in the initial diagnosis or follow-up. The usefulness of measuring FFM with L3-targeted CT has never been evaluated in ICU patients. Therefore, the investigators aim to conduct an international multicentre prospective observational study in ICU patients to assess the prognosis value of BIA PhA at admission, and to compare the performances of BIA and L3-targeted CT for FFM measurement.

NCT ID: NCT01906918 Recruiting - Clinical trials for Coronary Artery Disease

Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries

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

Strategies for myocardial protection during open heart surgeries are desired. Several experimental studies have shown beneficial effects of remote ischemic preconditioning (RIPC). The underlying mechanisms are not totally understood. This study intends to evaluate molecular mechanisms involved with RIPC on myocardium of patients underwent open heart surgeries.

NCT ID: NCT01906268 Recruiting - Clinical trials for Generalized Anxiety Disorder

Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants

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

The objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to usual treatment for anxiety disorder patients resistant to antidepressants.

NCT ID: NCT01906242 Completed - Clinical trials for Denture Hygiene Protocol

Hygiene Protocol of Complete Dentures

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

Adequate denture hygiene is important to patient's oral health maintenance in particular because of Candida albicans, responsible for the development of denture stomatitis. The aim of this study is to conduct a randomized controlled trial seeking for the best hygiene protocols to be used in removable denture wearers. The null hypothesis tested is that there will be no difference among the denture hygiene protocols tested.

NCT ID: NCT01905943 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia

Start date: November 4, 2013
Phase: Phase 3
Study type: Interventional

This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator's discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years.

NCT ID: NCT01904292 Completed - Clinical trials for Juvenile Idiopathic Arthritis

A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis

Start date: August 15, 2013
Phase: Phase 1
Study type: Interventional

This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (>=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight <30 kg.

NCT ID: NCT01904279 Completed - Clinical trials for Juvenile Idiopathic Arthritis

A Study of Subcutaneously Administered RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis

Start date: July 2013
Phase: Phase 1
Study type: Interventional

This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics and safety of subcutaneously administered RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis. Patients will receive RoActemra/Actemra subcutaneously every 2 or 3 weeks for 52 weeks.

NCT ID: NCT01904097 Recruiting - Chronic Pain Clinical Trials

Functional Neuroimaging in Fibromyalgia Patients Receiving tDCS

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

The purpose of this study is to evaluate effectiveness and cerebral neuronal ability to adaptation in patients with fibromyalgia who receive pregabalin and transcranial direct current stimulation.

NCT ID: NCT01903980 Completed - Clinical trials for Epipericardial Fat Necrosis

Epipericardial Fat Necrosis: A Misdiagnosed Condition

epipericardial
Start date: June 2013
Phase: N/A
Study type: Observational [Patient Registry]

Epipericardial fat necrosis is a benign and self-limited condition that mainly curses with acute pleuritic chest pain and therefore must be an important differential diagnosis for patients in emergency department (ED). The knowledge of characteristics symptoms and correct management may avoid misdiagnosis or mistakes with other severe conditions like pulmonary embolism, pericarditis or acute coronary disease. Despite the importance of this entity, only fewer than 40 cases have been reported since 1957, when the condition was first described. We have seen a couple of similar cases in our institution during a short period of time, and we suspect that these numbers doesn`t mean the real prevalence of epipericardial fat necrosis, so maybe this condition could be underdiagnosed. Instead, there isn't a study that tried to estimate an incidence of this entity.

NCT ID: NCT01903733 Completed - Clinical trials for Chronic Myeloid Leukemia

Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008

Start date: August 28, 2013
Phase: N/A
Study type: Interventional

The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.