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NCT ID: NCT02148666 Not yet recruiting - Clinical trials for Homing of Stem Cells in the Infarct Area.

Study of Homing of Labelled Stem Cells in Human Heart.

COLT
Start date: August 2014
Phase: N/A
Study type: Observational

One of the challenges of stem cell therapy is to understand the fate of the injected stem cell. By labelling various stem cells with radioisotopes their fate (homing) can be demonstrated. In this study, we will develop and refine the existing techniques of stem cell labelling to various subtypes of stem cells namely- freshly aspirated bone marrow cells, cryopreserved bone marrow cells, g-csf mobilized peripheral blood stem cells and umbilical cord cells. After testing the labelling efficacy and viability, these cells will be injected in to the coronary arteries of patients with myocardial infarction who have undergone a successful revascularization either by angioplasty or thrombolysis. Homing of stem cells will be demonstrated by nuclear scan after the procedure. We are adapting techniques used to label cells for detection of infection and bleeding using nuclear scans for in vivo scanning. Also we are using Technetium instead of FDG which has very little radioactivity allowing us to work with the current cardiac labs with out having to reconstruct the labs with special shielding for radioactive compounds. Real benefit of stem cells then can be explored after demonstrating the proper homing.

NCT ID: NCT02147912 Not yet recruiting - Clinical trials for Depression in Patients With Chronic Obstructive Pulmonary Disease

Evaluation of Depression In Chronic Obstructive Pulmonary Disease

EDIC
Start date: November 2014
Phase: N/A
Study type: Interventional

Background: Several clinical studies show high rates of anxiety and depressive disorders in Chronic Obstructive Pulmonary Disease (COPD), that suggest common underlying pathogenetic mechanisms of COPD and depressive disorders. The aim of this study is to evaluate the effects of aerobic exercise, proposed in the context of pulmonary rehabilitation, in a sample of COPD depressed patients without psychopharmacological treatment, through the correlation of some psychopathological variables and physical/pneumological parameters. Methods: The investigators have designed an observational longitudinal trial. The trial will be prospective 6-weeks randomized clinical study to evaluate the impact of aerobic exercise on depressive symptoms in 154 patient affected by COPD and depression, assessed by Hamilton Depression Rating Scale (HDRS). The investigators will also monitor anxiety, quality of life and neurocognitive function. Outcome measures: The investigators compare the variation of HDRS total score, as primary outcome measure, in two groups (A, B) of COPD depressed patients matched for: COPD status; depressive status; age; gender. Only the participants randomized in study group A will receive a 6-weeks aerobic exercise intervention. Statistical analysis: All tests are two-tailed and a p value 0.05 was considered significant. The difference between the two groups will be evaluated with Student's T test for normally distributed data, and with Mann-Whitney's U test, for those with not normal distribution. The normality of distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations among the variables under evaluation will be assessed by Spearman r correlation. Variables will be compared using the Chi-squared test or Fisher exact test for categorical variables. Discussion: There is a strong correlation between physical activity and mental health. Several data have suggested that aerobic exercise shows significant effects, comparable to pharmacotherapy and to psychotherapy, on reducing depressive symptomatology. The goal of our study is to propose an effective intervention to reduce the risk of severe depression in this special population, evaluating the variation of HDRS total score after the aerobic exercise intervention.

NCT ID: NCT02142088 Not yet recruiting - Clinical trials for Blood Glucose Monitoring in Medical ICU

Comparative Study of GlySure Continuous Intra-vascular Glucose Monitoring and Intermittent Monitoring in Medical ICU

MICU
Start date: June 2014
Phase: N/A
Study type: Interventional

It has been shown that close control of blood glucose levels in the intensive care unit patient has benefits for patient morbidity and mortality rates as well as an impact upon discharge times. GlySure has previously completed an evaluation of its intra-vascular glucose monitoring system in patients in a surgical ICU environment after cardiac surgery. This study seeks to evaluate the same equipment being used in a wider range of patients with a range of underlying conditions who require treatment in medical ICU's. The GlySure device consists of a sensor that is placed into the patient's blood through a central venous catheter. It measures blood glucose levels continuously which allows for more rapid control of blood glucose levels to be achieved as compared to existing methods where blood samples are taken repeatedly every 15 minutes or so. The study is designed to show that the sensor can be used for a protracted period of time, giving accurate results when compared to a reference technique using the i-STAT device. The investigators intend to show that the device performs safely for the required time within the ICU.

NCT ID: NCT02139293 Not yet recruiting - Clinical trials for Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects

Pilot Study - Auricular Vagus Nerve Stimulation Effects on Cardiovascular Parameters

Start date: January 2018
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous system stimulation on cardiovascular parameters and sympathovagal balance in healthy subjects. It is investigated if auricular vagal nerve stimulation affects heart rate variability as well as peripheral local blood perfusion, and if this effect depends on the site of stimulation in the auricle, whereas four distinct stimulation points are tested.

NCT ID: NCT02135055 Not yet recruiting - Sepsis Clinical Trials

Effect of Midazolam on Inflammatory Response and Organ Function in Mechanically Ventilated Sepsis Patients With Different Immune Status

Start date: May 2014
Phase: Phase 4
Study type: Interventional

ICU patients always experience all kinds of pain, discomfort and sleep disturbance,especially the sepsis patients. Appropriate sedation and analgesia is must,the newest sepsis guideline strongly recommend that mechanically ventilated sepsis patients need sedation therapy. Recent studies show than immune dysfunction dose have an important effect on the occurrence and development of sepsis. When the body suffer from the pathogenic microorganism attacking and sepsis, it activate the systemic inflammatory response (SIRS) and compensatory anti-inflammatory response syndrome (CARS). When it is out of balance between SIRS and CARS, the inflammatory response, immune paralysis or immune dysfunction occurs and the mixed anti-inflammatory response syndrome (MARS) exists, and then the multiple organ dysfunction. So, immune dysfunction is thought to be the key factors on the development of the sepsis. Some studies show that the sedation drug such as midazolam, propofol, dexmedetomidine could suppress the inflammatory response effectively and then modulate the immune function. Several recent studies show that midazolam has the immunoregulation effect and trend of suppress the inflammatory response, but the result is controversy, the possibly reason is the different immune status. Now there is the guideline about the different immune status: the normal immune function means that the value of mHLA-DR is more than 15000 monoclonal antibody; moderate-sever immune suppression means that the value of mHLA-DR is in the range of 5000 and 15000 monoclonal antibody; the immune paralysis means that the value of mHLA-DR is less than 5000 monoclonal antibody. The purpose of the study is to explore the effect of midazolam to inflammatory response and organ function at mechanically ventilated sepsis patients who have different immune status.

NCT ID: NCT02133677 Not yet recruiting - Clinical trials for Lung Cancer and Breast Cancer Patients With Brain Metastases

A Phase II Multi-center Pilot Study of Concurrent Temozolomide and Whole Brain Irradiation in Lung Cancer and Breast Cancer Patients With Brain Metastases

Start date: May 2014
Phase: Phase 2
Study type: Interventional

Brain metastasis (BM) is among the most feared complications in cancer because even small tumors may cause incapacitating neurologic symptoms. It is observed in more than 50% of patients with lung cancer and 15% to 25% of patients with breast cancer. Temozolomide (TMZ) is an oral alkylating agent that crosses blood-brain barrier (BBB). This pilot study aims to evaluate the efficacy, safety and tolerability of whole-brain radiotherapy (WBRT) plus concomitant TMZ in lung cancer and breast cancer patients with BM.

NCT ID: NCT02127827 Not yet recruiting - Clinical trials for To Demonstrate That the Closed Loop System Can be Used Safely Over a Few Consecutive Days.

Multiday Fully Closed Loop Insulin Delivery in Monitored Outpatient Conditions

Start date: May 2014
Phase: N/A
Study type: Interventional

Insulin replacement therapy is absolutely required for patients with Type 1 diabetes. The insulin pump provides for continuous subcutaneous insulin infusion (CSII), which can approximate the insulin release patterns of the normal pancreas. Timely and accurate knowledge of ambient glucose levels is important for insulin dose adjustments. Typically, glucose values are measured volitionally, several times a day, using capillary "fingerstick" samples. In addition, glucose in the interstitial fluid can be measured automatically and continuously using implantable glucose oxidase-based sensors. Recent study showed that this continuous measurement of glucose levels allows for a fully automated "closed-loop" insulin replacement therapy which requires an algorithm that receives glucose data, calculates an appropriate insulin dose, and directs the pump to deliver the insulin dose.The need for development of a closed-loop insulin replacement system that integrates insulin delivery, glucose measurement, and control subsystems will present several challenges to biomedical engineers.

NCT ID: NCT02126098 Not yet recruiting - Clinical trials for Microscopic Polyangiitis

Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis

Start date: May 2014
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to observe the clinical manifestation, Lab findings including chest CT scans, pathological findings and outcomes in chinese patients with pulminary vasculitis.

NCT ID: NCT02124226 Not yet recruiting - Clinical trials for Low Dose Methotrexate in Severe Chronic Asthma

Low-dose Methotrexate for Change in Global Initiative for Asthma Step 5 Medications in Chronic Severe Asthma

Start date: December 2021
Phase: Phase 3
Study type: Interventional

Patients with chronic severe asthma (CSA) have a crippling disease and current available treatments are not satisfactory. Thus, management of CSA remains a major unmet need. Although the evidence from existing randomized controlled trials fails to support a definite role for immunomodulatory drugs in these patients due to major methodologic drawbacks, findings with low-dose methotrexate (MTX) are encouraging. However, larger and well designed clinical trials are required to establish the beneficial role of MTX in CSA and for the detection of the key characteristics of those who are going to respond to this drug. This study will be the first multi-centre RCT investigating the role of an add-on immunological modifier as a clinically useful therapeutic strategy in patients with well-phenotyped chronic severe asthma. As such, this study does not overlap with any other research currently ongoing.

NCT ID: NCT02124187 Not yet recruiting - Clinical trials for Tobacco Smoking in Depressed Patients

Smoking Cessation And Reduction in Depression

scarid
Start date: December 2022
Phase: N/A
Study type: Interventional

It is well established in studies across several countries that tobacco smoking is more prevalent among depressed patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in depressed smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population. We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in depressed smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product. Outcome measures: A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit ("reducers"). Abstinence from smoking will be calculated at each study visit ("quitters"). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders".