View clinical trials related to Syndrome.
Filter by:This study aims to determine how infrared spectroscopy compares to continuous compartment pressure monitoring in the detection of compartment syndrome. Individuals meeting the study eligibility criteria will be identified at time of admission by the receiving Trauma and Orthopaedics Registrar who will be trained in the study design and protocols. Eligible individuals will be approached about participating in the study either at time of admission or shortly afterwards, either by the chief investigator or another doctor trained in the research protocol. Where the individual is unconscious or otherwise incapacitated, which is likely in many major trauma victims, inclusion in the study will be discussed with the patient's legal representative and/or family. The consent process for the study will consist of having the study protocol explained by either the chief investigator, or another doctor trained in the study design. Patients will be allowed to read a participant information sheet, and permitted as much time as they require to decide if they wish to participate in the study. Verbal and written consent will be taken using a study specific consent form. In the case of incapacitated patients, the study design will be explained to their relatives' legal representatives as appropriate and advice sought from them as to whether they know of any reason why the patient might object to participate in the study. Upon regain capacity consent will be sought from the patient for storage and analysis of their study data. Once consented, the patient will undergo monitoring with both continuous compartment pressures, and NIRS measurements. Recordings for both techniques will be taken each hour, as part of the patients normal observations, from the point of consent until 24 hours after their first operation. Where patients do not have an operation the total duration of monitoring will be 24 hours. The measurements will be taken by nursing staff who have received training in both techniques. The procedure for each technique is described below: 1. Continuous compartment pressures will be recorded in the broken leg, in case of tibial fractures, in all other patients fitting the inclusion criteria measurements will be taken from both legs (as both legs are at risk of compartment syndrome). Compartment pressures will be recorded using a slit catheter technique. Insertion of the slit catheter will be performed by either the chief investigator or Orthopaedic Registrar who will have been trained in the technique. The slit catheter is inserted using a sterile technique - the skin over the front outer part of the leg is cleaned and a catheter inserted into the anterior muscle compartment at this point. The catheter should be sited at the approximate midpoint of the leg, although this can be adjusted up or down if this would lead to insertion into a fracture site. The catheter is secured with a sterile dressing and connected to a monitor from which recordings can be taken, the catheter can be left in place for the duration of the study with no need to re-site it unless it stops recording accurately. At the same time as compartment pressure measurements are taken the patient's blood pressure will be monitored and the 'Perfusion Pressure' for the leg calculated, where: Perfusion pressure = diastolic blood pressure - leg compartment pressure 2. NIRS measurements will be taken with an the INVOS system, produced by Somentics. These measurements will be taken from both legs, the affected leg and other other leg used as a control for comparison. Where both legs are at risk measurements will be taken from both legs and the midpoint of the forearm used as a control. The INVOS probe is a small adhesive patch that is stuck to the skin. The probe is sterile and will be attached using the same sterile technique as the compartment pressure catheter. Where the overlying skin is hairy the hair overlying the area for the probe should be clipped before attaching the probe, to ensure adequate adhesion and accurate readings. The probe is to be sited just below the compartment pressure catheter, although if there is an underlying haematoma (blood clot), then the probe should be positioned so at to avoid this but still remaining over the front outer part of the leg. This technique conforms with the manufacturers recommended use of the equipment and is similar protocol to previous studies. At the end of the monitoring period both measuring devices are removed. If the patient has developed compartment syndrome during this period and required an operation, the NIRS probe and compartment pressure catheter will be replaced for a further 12 hours of monitoring to monitor the changes post-operatively and ensure compartment pressures stay low.
RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood leukemia who have undergone stem cell transplant may help doctors learn more about the disease and the long-term effects of leukemia treatment. It may also help improve the quality of life for future cancer survivors. PURPOSE: This clinical trial is studying metabolic syndrome in adolescent and young adult survivors of childhood leukemia who have undergone stem cell transplant.
The purpose of this study is to analyze income variables in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, and to analyze the effect of short vs. long Cognitive Behaviour Therapy.
RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood cancer may help doctors learn more about the disease. PURPOSE: This clinical trial is studying metabolic syndrome in survivors of childhood cancer and in their healthy sisters and brothers.
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously. A new formulation of idursulfase, idursulfase-IT, that differs from that of the intravenous (IV) formulation, Elaprase, has been developed to be suitable for delivery into the cerebrospinal fluid (CSF) via intrathecal administration. This Phase I/II study is designed to obtain necessary safety and exposure data, as well as secondary and exploratory outcome measures, to be interpreted and used in the design of subsequent clinical trials.
Traditional methodological clinical and instrumental diagnostics of the lacrimal gland for the study of glandular architecture and functions are limited and include analysis of tear constituents, evaluation of apparent diffusion coefficients in magnetic resonance imaging and histopathological evaluation of lacrimal gland biopsy specimens. Confocal microscopy is a new emerging technology which is useful as a supplementary diagnostic tool for in vivo assessment of anterior-segment disorders.The use of in vivo confocal microscopy in a comparative study of the microscopic morphology of the salivary/lacrimal glands have not been reported up to date. In this study, we employ laser scanning confocal microscopy to evaluate the morphological changes of the salivary/lacrimal glands in patients with primary Sjögren's syndrome and compare the results with those of healthy control subjects.
In this placebo controlled study the safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome was investigated. The purpose of this study is to determine whether Cernilton is safe and effective in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome.
Sacral nerve stimulation (SNS) has become a well-established treatment for patients with fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood but recent studies have shown that the motility of the whole colon is modulated during the stimulation. This modulation of the colonic motility could be a potential mechanism of an action to relieve the symptoms in patients with IBS. Twenty eight patients with IBS will be enrolled in the study. They have to meet the ROME III criteria, and also satisfy the criteria for implantation of a neurostimulator. After a post implantation period where the programming of the neurostimulator is optimised, the patient is randomized in a double blinded design to receive either ON-OFF or OFF-ON stimulation in a 2-month period. At the end of each period (ON/OFF) the patient will be examined with Magnet Tracking System (MTS) for motility and with impedance planimetry including thermal stimulation (circulating water)for multimodal sensory testing of the rectum. This is based on the study hypothesis that the motility of the small intestine and the colon is changed in IBS patients according to their subtype (Diarrhoea-IBS, Constipation-IBS and Disordered bowel habit-IBS) compared to healthy persons. And that SNS will affect the motility of the small intestine and the colon in IBS patients as well as SNS will affect the perception of pain/discomfort in the rectum in IBS patients. The effect of ON-OFF-sacral nerve stimulation on the IBS patients and thereby their IBS symptoms will also be evaluated by an IBS score (GSRS-IBS)and on quality of life by an IBS Impact Scale (IBS-IS) as well as the significance of placebo effect in the treatment of patients with IBS with SNS will be evaluated.
This study aims to investigate the anti-nociceptive biogenic amine (serotonin [5-hydroxytryptamine; 5-HT], norepinephrine [NE], dopamine [DA], and their metabolites) status, and serum levels of cytokines, BDNF and BH4 in Thai fibromyalgia syndrome (FMS) patients compared with a representative Thai population. The efficacy and the tolerability of mirtazapine as monotherapy for FMS will also be assessed. In addition, proof of concept of the indoleamine 2,3-dioxygenase (IDO) activity in FMS will be conducted. The study will be divided into three parts. In part I, FMS patients of Thai ethnicity will be examined to determine the blood and/or urinary level of anti-nociceptive biogenic amines, cytokines, BDNF and BH4 by comparison with the demographically matched, but unrelated, healthy normal controls (HNC). In part II, the FMS subjects from part I study will be randomized to blinded therapy with mirtazapine or identical appearing placebo. There will be three treatment groups (N=1:1:1) to accommodate two dosages of mirtazapine (15 mg, 30mg) and placebo given before bedtime. Pill counts at baseline and at follow-up visits will document compliance. Standard outcome instruments (translated and validated in Thai language) will be used at baseline and at each of the follow-up visits. The co-primary outcome variable will be the changes in the pain visual analog scale (PVAS) score and pain responders (>= 30% PVAS reduction). Secondary clinical outcome variables of interest will include depression, insomnia, anxiety, physical function, morning stiffness, patient global assessment of disease status, patient global impression of change, fibromyalgia impact questionnaire (FIQ, quality of life and adverse experience. The changes of biogenic amine and IGF-1 concentrations in blood and/or urine with the treatment will be examined as the secondary biochemical measures. In part III, the IDO activity of depressed FMS, non-depressed FMS and HNC will be compared. Moreover, the effect of mirtazapine treatment on the IDO activity in depressed and non-depressed FMS patients will be assessed. Study hypothesis 1. Anti-nociceptive biogenic amine levels in Thai FMS patients are lower than in Thai healthy normal control. 2. Higher IDO activity could be observed in FMS patients. 3. Higher cytokines could be observed in FMS patients. 4. Higher BDNF could be observed in FMS patients. 5. Lower BH4 could be observed in FMS patients. 6. Mirtazapine is effective in FMS treatment.
A new device for interstitial cystitis is compared to inactive control to determine if it is safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.