mteb/BIRCO-ClinicalTrial-Test huggingface dataset:
Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and infection. A majority of people with cystic fibrosis have large quantities of bacteria residing in their lungs. One of the most common and harmful bacteria is called Pseudomonas aeruginosa. Patients with cystic fibrosis require frequent therapy with intravenous (I.V.) antibiotics to treat lung infections thought to be caused by Pseudomonas aeruginosa. One of the antibiotics frequently used to treat this bacteria is piperacillin-tazobactam. Piperacillin-tazobactam is thought to be the most effective when there is a constant level of drug in the body. The standard way to administer piperacillin-tazobactam is to give several grams 4 times each day as a 30 minute infusion. An alternative way to give piperacillin-tazobactam is by a continuous infusion; a continuous infusion will make it more likely that drug will remain at a constant level in the body. The objective of this study is to determine if administering piperacillin-tazobactam as a continuous infusion is more effective at treating people having a pulmonary exacerbation of cystic fibrosis than a standard 30 minute infusion, 4 times a day. All patients will receive combination therapy to include piperacillin-tazobactam 400 mg/kg/day (based on piperacillin component, actual body weight) not to exceed 16 grams and tobramycin 12 mg/kg/day extended interval dosing (once daily). Patients randomized to the continuous infusion group will receive a one-time loading dose of 100 mg/kg over 30 minutes followed immediately by initiation of the continuous infusion.
Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death and the only one of the common causes that is still rising. The main effects of the disease are the destruction and inflammation of lung tissue rendering breathing difficult. COPD has significant effects on the quality of life of sufferers and the disease is predicted to be the fifth most common cause of disability in the world by 2020. Patients with COPD are prone to periods of worsening disease symptoms, known as exacerbations, which are often caused by viral and bacterial infections of the lung and current vaccines appear to have little efficacy in limiting these exacerbations. The loss of lung function caused by infectious exacerbations is irreversible and patients who frequently exacerbate experience more rapid disease progression. Nontypeable Haemophilus influenzae (NTHi) is a major bacterial species that colonises the airways and causes exacerbations in COPD. With the development of more sensitive molecular techniques it has been possible to ascertain that it is the acquisition of new strains of NTHi that correlate strongly with exacerbations. However, not all patients with COPD have NTHi in their lungs and the question remains as to why some COPD patients are susceptible to such infections. This study aims to answer this question by comparing the airways of COPD patients who are colonized by NTHi and those who are not to analyse whether the levels of protective antibodies in the lungs and the function of the immune cells in the NTHi colonized airway are reduced.
The primary objective of the study is to determine the percentage of patients with "therapeutic success" at the end of the cycle of antibiotic therapy (10 days), in the two treatment groups (levofloxacin and prulifloxacin). The effect of study treatments will be evaluated on the basis of a score determined in relation to the signs-symptoms of acute exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever) The aim of this study was to examine the effects of the use of fluoroquinolones a class of antibiotics introduced relatively recently, in a particular population of patients with acute exacerbation of COPD, previously treated unsuccessfully with other antibiotics, and hospitalized in Internal Medicine. These patients reflect the reality of patients admitted to Internal Medicine, they are characterized by a high frequency of advanced age, polypathology, with multiple treatments.
COPD (chronic obstructive pulmonary disease) is a long-lasting lung disease usually caused by long-term smoking. COPD can get worse, making people sick enough to need hospitalization. Corticosteroids are very effective and are almost always used, but nobody knows the right dose. High doses may work better but could cause more side effects than low doses. Typical treatment lengths last at least one week. This study will be comparing two common regimens: either 40mg of corticosteroids daily (low dose), or 80mg of corticosteroids daily (high dose). It is unknown which regimen works better.. The goal of the study is to determine whether a high-dose corticosteroid regimen in patients admitted to the hospital with COPD exacerbations is associated with better clinical outcomes and at acceptable risk of adverse effects compared to a low-dose corticosteroid regimen. Our hypothesis is that high-dose corticosteroids is associated with a decreased rate of treatment failure, shorter length of hospital stay, and improved quality of life with similar risk of adverse effects. The study population includes patients ≥ 40 years-old with a ≥ 10 pack-years smoking history and a diagnosis of COPD, emphysema, or chronic bronchitis who present to the emergency room with increased dyspnea, increased sputum, or increased cough that requires admission to the hospital. We will perform a prospective, randomized, double-blinded study to determine if a high-dose corticosteroid regimen, which is already in use in clinical practice, decreases treatment failure compared to a low-dose corticosteroid regimen that is based on national consensus guidelines.
Corticosteroid treatment in diabetic patients admitted for COPD exacerbation are expected to significantly increase hemoglobin A1C levels HbA1C levels were evaluated in diabetic patients with COPD exacerbation on admission to the hospital and 3-months later. Demographic, clinical, laboratory variables and total steroid dose were documented. Age- and sex-matched group of diabetic patients with COPD who were admitted for other reasons, were asked to participate as a control group. Mann-Whitney and Chi square/Fischer's exact tests were used to compare between the parameters of the two groups. Wilcoxon signed rank test was used to compare between HbA1C levels at baseline and 3 months later. Multi-variate linear regression analysis was used to find predictors for increase in HbA1C levels in the patients' group.
Bronchiectasis is clinically characterized by irreversible dilation of the bronchi and bronchioles leading to persistent cough, purulent sputum, and airway ﬂow limitation, which may be accompanied by recurrent exacerbations.It has been increasingly recognized that respiratory viruses are mainly responsible for acute exacerbation of chronic pulmonary diseases, i.e. asthma, chronic obstructive pulmonary disease and cystic fibrosis. However,little is known about the roles of viral infection in driving exacerbations of bronchiectasis.This study aims to identify the frequency of common viral infections and determine the roles that viruses play in acute exacerbations of bronchiectasis. Bronchiectasis is a chronic airway disease characterised by a vicious cycle of persistent bacterial colonization,inflammation and progressive tissue destruction.Patients with bronchiectasis frequently developed acute exacerbations characterised by acute worsening requiring changes in concomitant use of medication,with attendant adverse effects on their morbidity and health-related quality of life. The detailed pathogenesis of exacerbations of bronchiectasis, however, remains poorly understood. Recent data suggested that airway infection and inflammation are important drivers of exacerbations,therefore the imbalance between chronic bacterial infection and host immune response may result in bronchiectasis exacerbations. Viral infection may be an important factor that leads to this events.It has been established that respiratory viruses are mainly responsible for the exacerbations of other chronic respiratory diseases, i.e. asthma, COPD and cystic fibosis. However, the data regarding prospective studies that sought to investigate the roles of viruses in acute exacerbation of bronchiectasis are lacking.
To identify whether home monitoring of multiple physiological parameters and biomarkers in sputum could provide advanced warning of an infective exacerbation or treatment failure before changes in patient-reported symptoms. 1. To determine if longitudinal profiling of sputum from Cystic Fibrosis patients allow accurate prediction of exacerbations in a study of a larger group and can we confirm the 7+ day early warning system works in this larger group. 2. Is one biomarker sufficient to predict exacerbations - what is the accuracy? Are two or more biomarkers required to achieve an accuracy of greater than 95%? 3. Can we now accurately determine how many hospital bed days a home testing/wellness monitoring device would save? What is the business case for healthcare providers to adopt our future test for home use? We estimate a 50% saving. Can this be confirmed? 4. When used in the clinic, how many hospital days would our test save through faster determination of treatment efficacy? What is the business case for adopting our future test as a point of care test on the ward in Cystic Fibrosis centres? Could this be the new revolutionary tool that we anticipate? 5. We forecast a 50% reduction in costs to treat Cystic Fibrosis patients in disease severity bands 2-A to 5. Can we provide evidence for this to support further investment?
The ultimate goal is to reduce unnecessary antibiotic prescriptions which drive the development of antibiotic resistance in the community. The primary objective of ABACOPD is to demonstrate in a sufficiently sized clinical study that there is no relevant increase in the "failure-rate" for patients with acute moderate exacerbations of COPD (AE-COPD) treated with placebo instead of antibiotic treatment both on top of standard of care. A patient is classified as treatment failure if additional antibiotic therapy is required during treatment period or until the test of cure visit (TOC at day 30, primary endpoint).
Title: Pro-to-COLD, Procalcitonin to Chronic Obstructive Lung Disease, COLD: Chronic Obstructive Lung Disease, Regarding: Patients hospitalized with suspected acute exacerbation of COPD + / - pneumonia. Background: Patients with COPD exacerbation often get antibiotics. There is considerable criticism of this, many of these patients are not bacterially infected and the antibiotics overconsumption can lead to resistance development and side effects. The purpose: To show that one can reduce the consumption of antibiotics among patients hospitalized for worsening of COPD disease in a population of Danish COPD patients by giving antibiotics depending on the value of the biomarker procalcitonin measured in the blood. A sub-objective is a validation study of mini VIDAS ® / Biomérieux equipment to the current gold standard in measuring procalcitonin, Kryptor/ BRAHMS. Subjects: All patients with confirmed/suspected COPD admitted with COPD exacerbation to the Acute Admissions Unit/ Pulmonary dept. in weekdays. Participants must be adults and be of age and there must be a signed informed consent. Method: 1) Controlled (Quasi-randomized): Even and uneven (concealed) digit of patient´s danish personal identification number, not last digit (gender-fixed) (CPR-number). Even = procalcitonin-guided, Uneven = Control. 2) Collect and analyze procalcitonin (PCT)-samples of patients in the PCT group at admission and then every 2 day. Samples analyzed throughout the week: Vital Status looked up 28 days after inclusion.
The purpose of this study is to investigate the role of endothelial dysfunction in chronic obstructive pulmonary disease. Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death in developed countries. Acute exacerbations and cardiovascular diseases are the major causes of morbidity and mortality in COPD patients. According to the frequency of exacerbations, phenotype "frequent exacerbator" is defined and characterised with severe clinical course and was recognised as an increased risk for cardiovascular mortality. Recent studies considered that systemic inflammation plays a key role in the pathogenesis of COPD and endothelial dysfunction is a suspected link between increased cardiovascular mortality and systemic inflammation in COPD patients. Endothelial dysfunction is assessed by determining flow mediated dilatation index (FMD index) or plasma markers. Previous studies have suggested the presence of endothelial dysfunction in COPD patients, as well as the deterioration of endothelial function during exacerbations of COPD. This study will, for the first time, systematically explore endothelial dysfunction in two phenotypically distinct groups of COPD patients with simultaneous assessment of endothelial function flow mediated dilatation index (FMD index) and plasma markers.
The purpose of this pilot study is to determine whether early treatment of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) with a combination therapy, Salmeterol + Fluticasone Propionate (SFP - Advair) will reduce the use of prednisone, known as the conventional treatment. Primary objective: To determine whether early treatment with combination therapy (SFP) can reduce the use of prednisone (the conventional treatment) in the event of an AECOPD. Secondary objectives: - To evaluate the feasibility of this treatment approach and to provide pilot data (needed for a larger multi-centre clinical trial; - To evaluate the feasibility and need of assessment during and after exacerbation onset, health-related quality of life and physical activity; - To evaluate the safety of this approach; this is in terms of the delay in starting prednisone and an unfavourable outcome (ER visits and/or hospitalization). BACKGROUND Acute exacerbations of COPD (AECOPD) are of major importance since they are associated with adverse effects on morbidity, health status, and costs. Conventional treatment includes the use of antibiotics and oral corticosteroids (OCS). However, OCS is associated with significant side effects. This is of considerable importance since exacerbation occurs on average 2 to 4 times per year in COPD patients. Alternative treatment such as high dose inhaled corticosteroids has also been shown to be effective in the treatment of AECOPD.
- Chronic Obstructive Pulmonary Disease (COPD) is characterized by lung hyperinflation and flow limitation. These physiopathological modifications are secondary to loss of elastic recoil and bronchial obstruction due to emphysema. - The cornerstone of COPD treatment is represented by inhaled beta-2 agonists and anticholinergics. The molecules of the latter classes can be characterized by short lasting action (few hours), long acting action (12 hours) or ultra long acting duration of action (24 hours). - For years the only anticholinergic (or antimuscarinic) drug other than those used by aerosol, was Tiotropium Bromide. Recently two new antimuscarinic agents have been launched on the market: glycopyrronium bromide (once daily) and aclidinium (twice daily). - The Single Breath Nitrogen Test is capable of identifying the pulmonary closing volume. The part of the curve that reflects lung ventilation inhomogeneity is the slope of phase III - For COPD patients, the most important characteristic for an inhalatory drug is a prompt action in order to give a quick relief from respiratory symptoms, in particular dyspnoea. - The objective of this study is to study the acute action of glycopyrronium and aclidinium in terms of reduction of hyperinflation, pulmonary specific resistances, lung volume distribution and dyspnoea at rest in severe COPD patients. - To our knowledge no study has explored these aspects before. Chronic Obstructive Pulmonary Disease (COPD) is a disease characterized by progressive and evolutionary physiopathological changes that are responsible for the developing of respiratory symptoms, disability, poor quality of life and morbidity.
Chronic obstructive pulmonary disease (COPD) is characterized by pulmonary and systemic inflammation. The effect of inhaled corticosteroids (IC) on inflammation in COPD is controversial. Physical exercise produces a systemic inflammatory response, both in the healthy individual and in the COPD patient (Rabinovitch et al ERJ 2003; van Helvoort et al Respir Med 2005; Davidson WJ et al. J Appl Physiol). Nevertheless, although it has been described that some of the systemic biomarkers related with COPD (Protein C-Reactive (PCR), interleukin [IL]-8) are associated with a lower tolerance to exercise in COPD patients (García-Río et al. Respir Res 2010), the role of IC on systemic inflammation triggered by exercise in COPD patients remains unknown. This study explores the hypothesis that the inflammatory response induced by exercise in COPD patients could be with IC treatment.
Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of chronic obstructive pulmonary disease is one of the most important causes of death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD exacerbations. In clinical practice for the treatment of acute exacerbation of COPD， antibiotic application is still controversial. Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified. Patients meet the criteria account for the minority in the real world. Therefore, it is still not clear whether most patients benefit from the recommended treatment. In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed. The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world. Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of COPD is one of the most important causes of death in patients with COPD. The global strategy for the diagnosis, management, and prevention of COPD recommends systemic corticosteroids therapy in COPD exacerbations as it can shorten recovery time, reduce treatment failure, improve lung function and arterial hypoxemia.
The objective of this study is to investigate molecular, cytological and genetic features of occupational chronic obstructive pulmonary disease (COPD) in conditions of different occupational exposures. In order to achieve this goal serum pro-inflammatory cytokines and standard inflammation markers level, hemostasis, cytological analysis of bronchoalveolar lavage and associations of single nucleotide polymorphisms (SNPs) rs1800470 transforming growing factor β1 (TGF β1) gene, rs1828591 hedgehog interacting protein (HHIP) gene, rs4129267 interleukin 6 receptor (IL-6R) gene, rs1051730 nicotinic acetylcholine receptor 3 (CHRNA3) gene with COPD in subjects exposed to silica dust and in those exposed to polycyclic aromatic hydrocarbons exhaust will be investigated. The relationship between genotype and phenotype characteristics, such as an inflammation activity, assessed by C-reactive protein (hsCRP) and tumor necrosis factor-α (TNF α) serum concentration, in different occupational COPD groups will be studied. The hypothesis is that the mechanisms underlying disease development and progression are different due to environmental risk factor that reflex in differs in disease attributes - molecular biomarkers, cytology results and genetic susceptibility between COPD due to dust, COPD due to chemicals and COPD in smokers therefore COPD can be subdivided into ecological phenotypes according to environmental risk factor. Study rationale: The main risk factors of COPD are tobacco smoking, biomass smoking and occupational factors. Tobacco smoking is well-known risk factor so tobacco induced COPD is completely established.
* Hypothesis: There is an underdiagnosis of pneumonia in COPD (Chronic Obstructive Pulmonary Disease) exacerbations which could be demonstrated by performing low-dose chest CT. Differences in the inflammatory profile in sputum and blood in patients with and without pneumonia can be seen. * Objective: To assess the degree of underdiagnosis of pneumonia in COPD exacerbations, using chest low-dose CT and to compare clinical and inflammatory differences in blood and sputum between patients with and without pneumonia. *Material and Methods: Prospective observational study including 75 patients with the diagnosis of COPD at the time of an exacerbation and with criteria for a respiratory tract infection. At the time of inclusion clinical features, blood and sputum analysis, chest X-ray and chest low-dose CT are performed. The investigators divide the patients into two groups according to the existence of pneumonia and the inflammatory pattern in blood (inflammatory markers) and sputum (cell populations and inflammatory markers) is compared between the two branches.
This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of Community Acquired Bacterial Pneumonia. This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of CABP. Adult patients who meet all inclusion and none of the exclusion criteria will be randomized to one of the two treatment arms. Dosing will commence on Day 1, and all patients will receive a minimum of 10 days of therapy. Patients will be assessed on Day 1, Day 4-5, Day 7, Day 14 (End of Therapy, EOT), and Day 28 (Follow up).
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Its prevalence is in progression and COPD is expected to become the fourth leading cause of death by 2030. COPD is characterized by periods of stability interspersed with acute infectious/inflammatory flare-ups, also called acute exacerbations, during which patients deteriorate, sometimes to the point of requiring immediate medical assistance. Although most patients eventually recover, repeated episodes of exacerbations may accelerate COPD progression. Exacerbations may further compromise the integrity of limb muscles by promoting further loss in muscle mass and strength. The overall objective of this substudy is to elucidate how an acute COPD exacerbation may affect limb muscles. Focusing our attention during exacerbations, a period of aggravated systemic inflammation, should be more rewarding in terms of understanding the link between inflammation burst and muscle disease in COPD. We have recently acquired experimental data supporting a role for the ubiquitin proteasome pathway in the worsening of limb muscle structure and function during an acute exacerbation, providing a solid framework for this investigation. The overall objective of this proposal is to substantiate these preliminary findings and elucidate how systemic inflammation during acute COPD exacerbation may affect limb muscles. Ultimately, our research could open new therapeutic avenues to minimize the systemic consequences of an acute exacerbation.
The objective of this study is to investigate molecular, cytological and genetic features of occupational chronic obstructive pulmonary disease (COPD) in conditions of different occupational exposures. In order to achieve this goal serum pro-inflammatory cytokines and standard inflammation markers level, hemostasis, cytological analysis of bronchoalveolar lavage fluid and association of single nucleotide polymorphisms (SNPs) rs1800470 transforming growing factor β1 (TGF β1) gene, rs1828591 hedgehog interacting protein (HHIP) gene, rs4129267 interleukin 6 receptor (IL-6R) gene, rs1051730 nicotinic acetylcholine receptor 3 (CHRNA3) gene with COPD in subjects exposed to silica dust and in those exposed to polycyclic aromatic hydrocarbons exhaust will be investigated. The relationship between genotype and phenotype characteristics, such as an inflammation activity, assessed by C-reactive protein (hsCRP) and tumor necrosis factor alpha (TNF α) serum concentration, in different occupational COPD groups will be studied. The hypothesis is that the mechanisms underlying disease development and progression are different due to environmental risk factor that reflex in differs in disease attributes - molecular biomarkers, cytology results and genetic susceptibility between COPD due to dust, COPD due to chemicals and COPD in smokers therefore COPD can be subdivided into ecological phenotypes according to environmental risk factor. Study rationale: The main risk factors of COPD are tobacco smoking, biomass smoking and occupational factors. Tobacco smoking is well-known risk factor so tobacco induced COPD is completely established.
This is a randomised, double-blind, parallel-group, multi-centre study evaluating 15 milligram (mg) twice daily/ Bi-daily (BID) of losmapimod versus placebo, in addition to standard of care (SoC). The primary objective of this study is to explore the therapeutic potential of losmapimod as a treatment to reduce the rate of exacerbations in the subset of participants with moderate-to-severe COPD who are at high risk of exacerbation, having experienced two or more moderate/severe exacerbations in the preceding 12 months, and who have <=2% of blood eosinophils at screening. As secondary objectives safety, effects on lung function, quality of life, pharmacokinetic (PK), biomarkers of both disease and inflammation shall be evaluated. The duration of the treatment period is variable but will be at least 26 weeks and up to a maximum of 52 weeks, with the end of study date being established once the final participant has been randomized. The purpose of the variable dosing regimen is to enable participants to remain in the study for a longer duration, as it is anticipated that this will increase the likelihood of observing exacerbation events without increasing the overall study duration. It will also enable safety data on dosing periods beyond 6 months to be generated. Approximately 200 participants in a 1:1 ratio between losmapimod and placebo will be randomized to the study. Sample size re-estimation will be performed during the course of the study to potentially increase the sample size up to a maximum of 600 participants.
Head and neck cancers usually occur in patients who have a history of long tobacco use. Chronic obstructive pulmonary disease (COPD) is a chronic progressive disease of the airways and lung parenchyma that is also associated with exposure to tobacco. COPD and head & neck cancer share a common environmental risk factor in cigarette smoke exposure. the investigators hypothesize that patients with chronic lung disease related to smoking have a higher risk to develop cancer in the head and neck. The investigators designed a study to assess the prevalence of cancer and pre-cancer disease in the head & neck in patients with chronic lung disease. the investigators will examine patients with and without a history of smoking and chronic lung disease in order to determine the prevalence of head and neck cancer in the different groups. The patients who will be included in the study will undergo comprehensive evaluation of their lung function and voice performance. This study is a joint effort of the Pulmonology Institute and the Department of Otolaryngology, Head & Neck Surgery in Israel and the Netherlands.
Background Chronic obstructive pulmonary disease (COPD) is a major public health issue with no curative treatment. In Switzerland estimated 5-7% of the total population are suffering from this chronic disease. According to current guidelines corticosteroids are part of treatment of acute exacerbations in COPD patients. Several studies suggest that corticosteroids accelerate the recovery of forced expiratory volume in 1 second (FEV1), decrease duration of hospitalization, reduce treatment failure rate and improve clinical outcome. The additional therapeutic benefit on FEV1-recovery tough seems only to last for three to five days. The investigators recently published a hospital-based study showing that in patients presenting to emergency departments with acute exacerbation of COPD, a short five day treatment with systemic steroids was not inferior to a conventional 14 day treatment with regard to re-exacerbation. Cumulative corticosteroid dose could be reduced in this trial. To the investigators knowledge no data is available about the minimal necessary corticosteroid dose in an outpatient treatment setting so far. Aim The primary aim of this study is to investigate in an outpatient setting, whether a three day treatment with orally administered systemic corticosteroids is non-inferior to a five day treatment in acute exacerbation of COPD and if total glucocorticoid exposure can be reduced by shorter therapy. Hypothesis The investigators postulate, that in an outpatient setting, where generally less severe exacerbations are being treated, a three day treatment duration of systemic corticosteroids should be non-inferior to a five day treatment duration with regard to treatment benefits but decrease cumulative corticosteroid exposure.
This study will collect sputum samples from healthy smokers, COPD smokers and COPD ex-smokers to analyse biomarkers of inflammation
MISSION is a new and novel way of delivering highly specialised Chronic Obstructive Pulmonary Disease (COPD) care and has the potential to change the way COPD care across the UK is delivered as well as services for other long term health conditions. The MISSION model has been piloted in asthma which is the subject of an ongoing research study. This is the first model of this type in COPD and the current research study aims to evaluate the outcomes of the project. This will be done in several different ways. The study is a mixed methods evaluation of the new service comparing outcomes before and after the clinic using retrospective data analysis and prospective qualitative interview. The study will be conducted at Portsmouth Hospitals NHS Trust and will recruit patients who attend MISSION COPD clinics as well as staff who attended MISSION clinics in a professional capacity. The purpose of the study is to evaluate in detail the clinical and health economic outcomes from the MISSION COPD project. MISSION COPD is a quality improvement project funded by the Health Foundation, Foundation with additional funding from Pfizer, to trial an innovative way of finding and assessing patients with COPD and also case finding new diagnoses of COPD. MISSION-COPD will allow swift early specialist multi-disciplinary interventions in primary care to diagnose and treat those at greatest risk, consistent with the NHS England '5-year Forward View' calling for removal of traditional primary and secondary care barriers.
This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP).
Chronic obstructive pulmonary disease (COPD) and gastric ulcer both get infected via or from the oropharyngeal tissues and have antibiotics in their treatment regimen of both diseases. This proposal suggests that the oral microbiome, in particularly dental plaque, is a plausible source of reinfection of COPD and gastric ulcer. Subjects with COPD or gastric ulcer are randomized to an adjunctive dental cleaning or no dental treatment. Both groups undergo the regular treatment for their respective diseases. Both groups have a full dental examination and have salivary microbiota as well as dental plaque harvested. The primary outcome variables is COPD exacerbations and new gastric ulcer event, and the secondary outcome variable re-colonization of the stomach and lung. Given that the study shows that additional dental cleaning does have an impact on reinfection of gastric ulcer and COPD it implies that dental cleaning should be subsidized when treating these diseases. This would have a significant impact on restricting antibiotic resistance as both H. pylori infections and COPD are treated with antibiotics. Both diseases also cause personal suffering and consequently disables the person to work, which causes financial consequences, and of course healthcare expenses. Recurrent chronic obstructive pulmonary disease (COPD) exacerbations and Helicobacter pylori infected gastric ulcers cause pain and discomfort, healthcare resources and an increased usage of antibiotics. COPD and gastric ulcer have two things in common - (i) they are infected via or from the oropharyngeal tissues and (ii) antibiotics is included in the treatment regimen of both diseases.
This observational study aims to characterize the patient population and describe multiple sclerosis exacerbation recovery, treatment patterns and safety outcomes in patients with multiple sclerosis experiencing exacerbations treated with H.P. Acthar® Gel (Acthar Gel) in standard practice in the United States.
The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by filgrastim in normal donors.
To assess the efficacy and safety of Tenecteplase versus Placebo in normotensive patients with sub-massive Pulmonary Embolism and Right Ventricular Dysfunction (RVD) all receiving unfractionated heparin (UFH) In patients with major acute PE thrombolysis has been shown to be life saving (22). Recent registries showed the beneficial effect of thrombolysis also in patients with PE not associated with shock or hypotension (4-23). In these patients thrombolytic treatment has been shown to obtain an improvement of 37% in lung perfusion, detected by lung scan, with respect to an improvement of 18.8% obtained by heparin treatment (24). In a different trial, rt-PA resulted in a faster and greater improvement of pulmonary artery hypertension than heparin treatment (25). Indeed, PE has a wide spectrum of severity at presentation and it is conceivable that the use of more aggressive treatments should be reserved to patients at high risk for adverse outcome. Hence, the search started of prognostic factors of adverse outcome in patients with pulmonary embolism. RVD has been associated with early adverse outcome (PE recurrence and mortality) in patients with acute PE (26-28; 3). In-hospital mortality in PE patients with and without echocardiographic RVD has been found to be 18.4% and 5.7%, respectively (3). Ribeiro et al. found a higher mortality in patients with PE and severe RVD: in-hospital mortality was 7.9% in the overall population with respect to 14.3% in patients with severe RVD (5).
The aim of this study is to establish the additional effectiveness and costs of routine thoraco-abdominal computed tomography (CT) in blunt trauma patients versus conventional radiological imaging and to determine which clinical parameters predict a high additional value of routine thoraco-abdominal CT. The technological advances in computed tomography (CT), with faster image acquisition resulting in higher resolution, result in making CT a more widely and intensively used imaging modality in trauma patient care. Thoraco-abdominal CT in addition appears to have additional diagnostic value compared to conventional radiography, especially in severely injured trauma patients. Nowadays, both clinical data and conventional radiology are used to determine which patient should undergo body CT scanning. Currently there are no widely accepted guidelines for the use of a "standard" TRAuma CT (TRACT). Although many retrospective and several prospective cohort studies have been published on this topic, the data are not sufficient to sustain evidence-based practice in decision-making. The aim of this study is, to establish the additional effectiveness and costs of routine thoraco-abdominal CT in blunt trauma patients versus conventional radiological imaging and to determine which clinical parameters predict a high additional value of routine thoraco-abdominal CT. Consecutive trauma patients, who are at least 16 years old and are suffering from severe injuries, undergo a standard trauma CT of the cervical spine, the thorax and abdomen after clinical evaluation and conventional radiological workup.
Immune thrombocytopenic purpura (ITP) is an autoimmune disorder characterized thrombocytopenia. Splenectomy is the standard treatment for patients who fails the first-line treatment: corticosteroid. Rituximab, has recently emerged as a promising treatment for ITP. The aim of the study is to determine whether early treatment with Rituximab can result in durable remissions, and consequently, lead to the avoidance of splenectomy in a significant number of patients. ITP is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading to premature platelet destruction and persistent thrombocytopenia often resulting in bleeding. The goal of treatment is to raise the platelet count to a hemostatically safe level. Treatment with corticosteroids rarely results in durable responses, and most of the patients will ultimately require a second-line treatment. Splenectomy results in a high rate of sustained remissions. However, the procedure is invasive and is associated with considerable short and long term morbidity and mortality. Rituximab, a chimeric anti-CD20 antibody with a B-cell depleting effect, has recently emerged as a promising treatment for ITP. The study aims to determine whether early treatment with Rituximab can result in durable remissions, and consequently, avoidance of splenectomy in a clinical significant number of patients. The main objective of this study is to assess the rate of treatment failure (splenectomy or meeting criteria for splenectomy after week 12) at 1.5-year in a prospective, randomized, placebo-controlled, double-blind, multi-centre
Effect of nicotine patch as an adjutant for acute pain after surgery. This is a dose finding trial for nicotine patches as analgesics. Doses used are 5mg/ 10mg/ 15mg or placebo. Primary outcome variable is reported pain score (VAS), secondary is morphine PCA utilization, nausea, sedation, and hemodynamic changes.
The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive screening tool for pancreatic cancer in a high-risk population. Pancreatic cancer is the fourth most common cause of cancer death in the US. Because patients with pancreatic cancer rarely presents with disease specific symptoms until late in the course of the disease, identifying and developing surveillance strategies for early detection of asymptomatic pancreatic cancer is critical. EUS and fine needle aspirate (FNA) are currently the most accurate non-operative methods of establishing the presence or absence of pancreatic cancer. The CT findings of pancreatic cancer include an attenuation difference between the pancreatic mass and the surrounding pancreatic parenchyma, pancreatic ductal dilation and cutoff, disruption of the normal fatty marbling of the pancreatic parenchyma, rounding of the inferior margin of the posterior head of the pancreas, atrophy of the proximal gland, and signs of locally advanced or distant disease. In a case-controlled retrospective review of pancreatic cancers missed at CT prior to clinical presentation at the Mayo Clinic, Gangi et al found that CT findings definite or suspicious for pancreatic cancer were present in 50% of scans obtained up to 18 months before the clinical diagnosis of pancreatic cancer. Pancreatic duct dilation and cutoff were early CT findings indicating tumor presence, and were associated with near-perfect and substantial interobserver agreement. Consequently, early pancreatic neoplasms likely result in at least partial occlusion of the duct, leading to subsequent ductal dilation.
Background: Midline incisional hernia is reported from 0,5 to 11% after abdominal operations. Primary repair without mesh reinforcement is almost abandoned because of high recurrence rates (24 to 46%). Use of prosthetic mesh in incisional hernia repair lowered the recurrence rates under 10%. Recurrence rate alone is not the main quality criterion for incisional hernia repair anymore. Large series and meta-analyses confirmed the value of laparoscopic repair as at least equal if not better compared with open repair. Discomfort, pain, diminished quality of life and body image alteration influences functional well being. No baseline information exists in any of these fields treating pre- or post-operative phases in patients with incisional hernia. Respiratory functions and medico-economic evaluation are other rarely investigated fields that we consider in our trial. The objective of this study is to analyse the functional outcome status of patients after laparoscopic incisional hernia repair compared to open repair. Methods: A randomized controlled non-blinded clinical trial is designed to compare laparoscopic incisional hernia mesh repair with open repair on post operative pain, health related quality of life outcomes, body image and cosmetic measurements, respiratory functions, recurrence rates, and cost. Volunteers will be recruited in Geneva University Hospital, department of surgery, visceral surgery unit. Eligibility criteria is male patient aged over 18 years, with reducible incisional hernia who are candidates for elective surgery and medically fit for general anesthesia.30 patients will be enrolled for each group.
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated and nonheated chemotherapy drugs after surgery may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of hyperthermic intraperitoneal oxaliplatin followed by intraperitoneal leucovorin and fluorouracil in treating patients with peritoneal cancer. OBJECTIVES: Primary - To determine the safety and optimal dose of hyperthermic intraperitoneal oxaliplatin when administered during cytoreductive surgery and followed by intraperitoneal leucovorin calcium and fluorouracil in patients with peritoneal malignancies. Secondary - To determine the outcome of cytoreductive surgery in these patients. - To determine the time to disease progression and pattern of failure in patients treated with this regimen. - To determine the 1 and 5 year survival in patients treated with this regimen. - To compare quality-of-life pre- and post-surgery in these patients. - To characterize total- and free-platinum pharmacokinetics in the plasma and total platinum in the intraperitoneal space at baseline, during, and after hyperthermic intraperitoneal chemotherapy (HIPC). - To assess for the presence of genetic polymorphisms in the XDP and XRCC1 DNA repair genes. - To assess tumor and normal tissue concentrations for total platinum obtained at baseline and immediately after HIPC.
The purpose of this ascending-dose research study is to determine whether the administration of ARC1779 Injection improves subject's health profile by protecting the brain, heart, and kidney from damage due to formation of small blood clots in blood vessels. It will also determine the safety of ARC1779 Injection, how ARC1779 Injection enters and leaves the blood and tissue over time, and its effect on laboratory tests related to blood clotting, heart and brain function, and other body systems.
ABSTRACT Background: Although there are some comparative studies between laparoscopy and hand-assisted laparoscopic splenectomy (HALS) in splenomegaly cases, there is no study of the differences between HALS and open splenectomy (OS). Our aim was to compare the HALS and OS techniques in splenomegaly cases. Methods: This prospective study included 27 patients undergoing splenectomy for splenic disorders at the Department of General Surgery, Istanbul Medical Faculty between February 2007 and October 2007. OS was performed on 14 patients, and HALS was performed in the other 13 patients. Key words: HALS, open splenectomy, splenomegaly The advent of laparoscopic surgery, increasing experience in its performance and advances in techniques and surgical devices have all greatly influenced general surgery. The usefulness of laparoscopic surgery has already been well proven in cholecystectomy, esophageal antireflux surgery, and splenectomy for benign diseases (1). Laparoscopy is also now gaining recognition for procedures accompanied by lymph node dissection, such as gastric and colorectal surgery (2, 3). The development of hand-assisted laparoscopic surgery (HALS) has also brought about improvements in regard to various disadvantages that have previously been associated with laparoscopic surgery, including lack of tactile sensation feedback, poor depth perception, lack of quick access in the event of unexpected hemorrhage, and difficulties with intracorporal suturing. Such improvements have enabled the performance of advanced laparoscopic surgery (4).
Splenic/portal vein thrombosis is an alarming complication of splenectomy. Retrospective studies in the literature have shown the incidence of symptomatic splenic/portal vein thrombosis to be between 0.7% (Rattner et al., 1993) to 8% (Winslow et al., 2002). This is a single-center, prospective, randomized study in subjects undergoing laparoscopic splenectomy. All participants will receive one dose of pre-operative low molecular weight heparin (Lovenox®) subcutaneously, 2 hours prior to surgery. Participants will be randomized pre-operatively to treatment or control group however the treatment allocation will not be revealed until the surgery is complete. Postoperatively, those assigned to the treatment group will receive 40 mg of Lovenox® subcutaneously once a day for 21 days; those in the control group will not. Patients with severe renal impairment will receive an adjusted dose of Lovenox® (30 mg subcutaneous dose daily). All patients will have a baseline abdominal Doppler ultrasound preoperatively and a second one done at 14 to 28 days post surgery to monitor for the presence of portal vein and/or splenic vein thrombosis. They will also have their lipase and liver function tests checked to correlate with the imaging findings.
This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.