mteb/BIRCO-ClinicalTrial-Test huggingface dataset:
The purpose of this study is to determine whether there itraconazole is effective in the treatment of chronic cavitary pulmonary aspergillosis The role of itraconazole is still not clear in the treatment of chronic cavitary pulmonary aspergillosis(CCPA). Some studies have shown a beneficial role of itraconazole in reducing hemoptysis. So the present study is aimed at analyzing the role of itraconazole in CCPA.
Background: - Bronchiectasis is a type of lung condition in which the lungs airways are abnormally stretched and widened. This stretching and widening makes it difficult for mucus and other substances to move out of the lungs, encouraging the growth of bacteria and leading to breathing problems or infection. Bronchiectasis can be caused by genetic disorders or diseases such as tuberculosis or rheumatoid arthritis. Researchers are interested in developing better ways to diagnose and treat a lung problem called idiopathic or unexplained bronchiectasis. Objectives: - To better describe the physical characteristics, radiographic patterns, and airway microbiology of unexplained bronchiectasis and to look for possible genetic links or risk factors. Eligibility: - Individuals at least 18 years of age who have a chronic cough and who have had a CT scan that has revealed signs of bronchiectasis. - Current smokers or those who have smoked for at least 10 years, as well as individuals who have known causes of bronchiectasis or who have had organ transplants, are not eligible to participate. Design: - Participants will have one outpatient clinic visit for evaluation with a physical examination including detailed body size measurements and medical history and for collection of blood samples for routine lab tests and genetic analyses and a chest x-ray if no recent one is available. - Participants will also have tests of lung function, and measurement of a gas called nitric oxide in the nose.
Tuberculosis (TB) remains a leading cause of morbidity and mortality worldwide. The situation for children in this epidemic is complex because they are usually considered less infectious and therefore, not to represent an important public health problem. Uganda ranks among the countries with the highest TB burden with 330/100,000 person-year TB incidence. Up to 16% of new TB infections are estimated to occur in children. Diagnosis of childhood TB is usually based on exposure history and a set of clinical, radiological and biological signs that considered separately have rather low predictive values. There is no consensus on the optimal way to combine these signs. This is even more complex when the child is infected with HIV. The risk of TB infection and disease, and the TB clinical presentation depend on the child's age, the youngest being at highest risk. An important first step in improving the management of childhood TB is to better define the clinical and radiological characteristics of children with suspected TB at first presentation to a health service in an endemic setting; also to document the feasibility and tolerability of TB treatment in this age cohort. This initial descriptive study would help to pave the way for more rigorous studies evaluating novel diagnostics and conducting clinical trials on first and second line TB treatment in children, in the future. The main objective of the study is to improve the diagnosis of TB in children in a setting of high TB and HIV prevalence and to assess the treatment outcomes and tolerance of the new WHO recommended TB drug dosages.
Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL) samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a validated nested PCR assay and a GM ELISA, we prospectively examine BAL samples from hematological patients at high risk of PA.
Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in patients (pts) with hematologic malignancies. As culture-based methods only yield results in a minority of patients, using non-culture-based methods for detection of aspergillosis in clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL) samples with polymerase chain reaction (PCR) is promising, however, the influence of current antifungal drugs on the performance of this diagnostic tool remains controversial. The aim of the trial is to elucidate on the performance of BAL PCR under antifungal treatment. Invasive pulmonary aspergillosis (IPA) remains a major cause for morbidity and mortality in patients (pts) with hematologic malignancies. As culture-based methods only yield results in a minority of patients, using non-culture-based methods for detection of aspergillosis in clinical specimens becomes increasingly important. Analyzing bronchoalveolar lavage (BAL) samples with polymerase chain reaction (PCR) is promising, however, the influence of current antifungal drugs on the performance of this diagnostic tool remains controversial. The aim of the trial is to elucidate on the performance of BAL PCR under antifungal treatment. Patients with high risk of invasive aspergillosis and lung infiltrates are sampled via BAL, the sample is analyzed for fungal DNA by Apsergillus specific PCR. Clinical data including treatment data is assessed and evaluated.
Ventilator associated pneumonia ( VAP) adds burden to the care of the intensive care patients as they may cause the death of the patient or prolong the intensive care stay or complicate the illness in other ways. The risk of infection is dependent on the interplay between bacteria load into the lungs and the immune status. There has been a lot of focus on bacteria load reduction and this includes the use of subglottic suctioning in an attempt to reduce the amount of bacteria that may move into the lungs. The Hi Lo tubes which were designed to allow subglottic suctioning was significantly effective in reducing the incidence of ventilator associated pneumonia compared to normal tubes. A new generation of endotracheal tubes that not only incorporate subglottic suctioning but provide a more snug fit into the tracheal by a new tapering design may be even more useful to provide the solution for bacterial load reduction. Conventional tubes which may furrow on themselves to allow the creation of microchannels may aid microaspiration. The taper guard which has facilities for subglottic suctioning as well as the strategy to reduce furrowing to the minimum may be the answer to the problem of ventilator associated pneumonia. This study is to determine the extent of protection this tube has against ventilator associated pneumonia compared with conventional endotracheal tubes Methodology This will be a prospective randomized trial with 2 treatment groups with 100 patients in each arm. The control group ( Group C) will be intubated with our conventional endotracheal tubes and the test group ( Group T) will be intubated with the special Taper guard tubes with subglottic suctioning and snug fit facilities.
This study aims to see if patient quality of life can be approved after treatment with an injectable medication called ustekinumab for the treatment of generalized psoriasis. The investigators hypothesize that the investigators will see improvement in quality of life. The primary objective of this study is to demonstrate improvement in psoriasis patient quality of life after 36 weeks with ustekinumab through the use of validated dermatologic and non-dermatologic psychometric instruments.
The investigators will collect samples of sputum from healthy volunteers and patients with cystic fibrosis for the purpose of: a) purifying airway mucins for plate-based binding studies and; b) assessment of the effects of carbohydrates on the rheologic properties of the sputum. This study has two hypotheses: 1. Lectins from Pseudomonas aeruginosa and Aspergillus fumigatus bind to airway mucins in a fucose-dependent manner, and this binding can be inhibited by fucosyl glycomimetic compounds. 2. Fucosyl glycomimetics will compete with Pseudomonas aeruginosa lectin (PA-IIL) and Aspergillus fumigatus lectin (AFL) and disrupt lectin-driven mucin cross-linking in CF sputum. Pseudomonas lung infection is a major cause of morbidity and mortality occurring in multiple clinical settings. Patients with cystic fibrosis have lung colonization with Pseudomonas from an early age, and overwhelming pseudomonal lung infection is the most common cause of death in these patients. In addition, Pseudomonas pneumonia is common in immunocompromised patients and in patients intubated for management of respiratory failure. Particularly worrisome is the increasing frequency of P. aeruginosa isolates that are resistant to all or most currently available antibiotics. The mechanism of virulence of P. aeruginosa includes soluble lectins that recognize host oligosaccharides on mucins and the cell glycocalyx. P. aeruginosa has two soluble lectins - LecA, also known as PA-IL and LecB, also known as PA-IIL. PA-IL binds galactose and PA-IIL binds fucose. Notably, PA-IIL binds the fucose containing Lewis a oligosaccharide with very high affinity and the role of PA-IIL in biofilm formation is shown by the absence of biofilm formation in Pseudomonas mutants lacking PA-IIL and by the efficacy of multivalent fucosyl-peptide dendrimers in preventing and disrupting Pseudomonas biofilm formation.
This is a single site, randomized, placebo-controlled, cross-over trial of sub-cutaneous injections of placebo and Stelara™ (ustekinumab) in subjects with scalp psoriasis.The purpose of the study is to assess the effectiveness of Stelara™ (ustekinumab)in the treatment of scalp psoriasis by determining the proportion of subjects who clear or almost clear in scalp specific physician assessments. The study will include approximately 30 subjects.
Aspergillus infection is an infectious complication which frequently occurs in cystic fibrosis. The efficacy of azole therapy in patients with cystic fibrosis with persistent positive sputums for Aspergillus is still unknown. Furthermore, the efficacy of itraconazole and voriconazole in this indication has never been evaluated in a large prospective controlled clinical trial, even though many teams already use it. The ATCF study aims to assess in patients with cystic fibrosis with persistent Aspergillus positive cultures the efficacy of itraconazole and voriconazole on the negativisation of the sputum cultures for Aspergillus. Aspergillus infection is an infectious complication which frequently occurs in cystic fibrosis. The efficacy of azole therapy in patients with cystic fibrosis with persistent positive sputums for Aspergillus is still unknown. Furthermore, the efficacy of itraconazole and voriconazole in this indication has never been evaluated in a large prospective controlled clinical trial, even though many teams already use it. The ATCF study is a prospective, multicenter, randomized, open-label, controlled phase II trial, performed in patients with cystic fibrosis with persistent Aspergillus positive cultures. The primary outcome is to assess the efficacy of itraconazole and voriconazole on the course and outcome of the negativisation of the sputum cultures for Aspergillus on two consecutive cultures. Secondary objectives include the effects of azole therapy on quality of life, FEV1, co-prescription of antibiotic and steroids, plasma concentrations of antifungal agents, speed of negativisation of sputum culture for Aspergillus, outcome of other diagnostic criteria (Aspergillus detection by PCR, precipiting antibodies, total and specific IgE, eosinophilia), and the safety profiles of the two products.
The trial evaluates the overall tolerability of the drug and the efficacy of aerosolised amphotericin B as a lipid complex (ABLC) for primary prophylaxis of invasive pulmonary aspergillosis (IPA) in pediatric patients with acute leukemia undergoing intensive chemotherapy. In recent years the incidence of invasive fungal infection (IFI) especially when caused by filamentous fungi has increased in patients with haematological malignancies and there exists an international consensus on diagnostic criteria. Despite diagnostic and therapeutic progress, invasive aspergillosis remains a major clinical problem of haematological patients, given the still high mortality rates and the huge economic cost of hospitalization of patients, which is attributable to aspergillosis. In addition to the morbidity and mortality rates, these infections interfere with the chemotherapy treatment plan with the risk of compromising the outcome of the antileukemic treatment. In a few uncontrolled studies inhaled amphotericin B deoxycholate showed some benefit in haematological patients, however it was not effective in a large multicenter study with neutropenic patients. Based on the outcome of that clinical trial, the use of aerosolised amphotericin B deoxycholate in neutropenic patients was abandoned for nearly a decade. During this time the use of azole agents as drugs of choice for antifungal prophylaxis in high risk patients was consolidated. However, one of the main problems in the use of triazoles with activity against filamentous fungi (itraconazole, voriconazole, posaconazole) is drug-drug interactions due to their CYP3A4 inhibitory activity.
The aim with study is to provide adjunctive therapy with vitamin D and phenylbutyrate together with standard anti-tuberculosis treatment to significantly improve clinical recovery among patients with untreated, active pulmonary tuberculosis.
ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS
To evaluate and compare the results of conventional and stepwise shock wave lithotripsy treatment modalities in pediatric urinary lithiasis. Between March 2008 and February 2012, 81 patients were randomized and included in this study. Shock wave lithotripsy was performed by using a Dornier Compact Delta instrument. Localizations of radiopaque and non-opaque stones were estimated by using flouroscopy and ultrasonography, respectively. Treatment energy was set on 13 kV in the conventional group. In the stepwise group, treatment energy was initially set on 10 kV and gradually increased up to 13 kV per 250 shocks. The maximum numbers of shocks in both groups were limited to 3000. Patients were followed up with 15 days interval. In each visit, patients were respectively questioned for pain, hematuria and history of stone passage. In case of treatment failure, shock wave lithotripsy was repeated.
Invasive pulmonary aspergillosis (IPA) is difficult to diagnose and remains a cause of high morbidity and mortality in critically ill patients in the ICU. Accepted diagnostic protocols for haemato-oncological patients are not applicable for critically ill patients in ICUs. Definitive discrimination between aspergillic colonisation and IPA often depends on the clinical experience of the treating physician, evaluating clinical signs, co-morbidities, and course of the disease. Life saving treatment with the first line antimycotic Voriconazol (Vfend®) can only be initiated after diagnosis of IPA. In this prospective clinical trial the investigators aim to structure, optimize and fast track the diagnostic pathway of IPA in critically ill patients treated in our ICU-department. Invasive pulmonary aspergillosis (IPA) is difficult to diagnose and remains a cause of high morbidity and mortality in critically ill patients in the ICU. The number of patients with positive Aspergillus culture or galactomannan test in respiratory fluids is increasing every year. In 2007 our Department tested 21 patients positive for Aspergillus, in 2009 it were 49 and last year (2011) the investigators found 59 patients to be positive in our 10 multidisciplinary ICUs. Accepted diagnostic protocols for haemato-oncological patients are not applicable for critically ill patients in ICUs. Halo signs, a typical radiological indication for IPA, can be found in haematological patients, but in patients in the ICU these signs are likely to be masked by pneumonic infiltrations due to ventilator induced lung injury and pneumonia.
This is a trial to determine whether giving a patient a tailored dose of voriconazole is safe and effective. Invasive fungal infections are a major cause of morbidity and mortality in patients with haematological malignancy and haematopoietic stem cell transplantation. Voriconazole is routinely used as a first-line agent for the treatment of invasive aspergillosis, invasive fusariosis and scedosporiosis. Voriconazole has extreme pharmacokinetic variability. Adult patients with a trough concentration of < 1 mg/L have a lower probability of clinical response whereas patients with trough concentrations > 6 mg/L a higher probability of toxicity. Therapeutic drug monitoring for dose adjustment is advocated but there are no algorithms that enable voriconazole dosage to be reliably adjusted to achieve desired trough concentrations in a timely and optimally precise manner. Novel ways to deliver optimised antifungal therapy are urgently required and this trial will evaluate whether giving a patients a tailored dose of voriconazole is safe and effective. Plasma concentrations will be taken in real time and inputted in dose software that will calculate an optimum dose for the required trough concentration of 1-3 mg/L. The software has been developed using data from phase I and III trials of voriconazole.
Patients who have undergone lung transplantation are at an increased risk of developing chest infections due to long-term medication suppressing the immune response. In other chronic lung diseases such as cystic fibrosis (CF) and bronchiectasis, inhaled, nebulised mucolytic medication such as dornase alpha and isotonic saline are often used as part of the management of lung disease characterized by increased or retained secretions. These agents act by making it easier to clear airway secretions, and are currently being used on a case-by-case basis post lung transplantation. To the investigators knowledge, these agents have not been evaluated via robust scientific investigation when used post lung transplant, yet are widely used in routine practice. Patients post lung transplant must be investigated separately as they exhibit differences in physiology that make the clearance of sputum potentially more difficult when compared to other lung diseases. Lower respiratory tract infections are a leading cause of hospital re-admission post lung transplant. Therefore, this highlights the need for a randomized controlled trial. The aim of this study is to assess the efficacy of dornase alpha, compared to isotonic saline, in the management of lower respiratory tract infections post lung transplant. Investigators hypothesize that dornase alpha will be more effective than isotonic saline. The effect of a daily dose of dornase alpha and isotonic saline will be compared over a treatment period of 1 month. Patients admitted to hospital suffering from chest infections characterized by sputum production post lung transplant will be eligible for study inclusion.
In the tests, small sample of clinical study about Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 ( Recombination EC Allergen） healthy adults was carried out. 24 healthy adults were included as study objects, they were randomly divided into four groups of different Recombinant Allergen EC dose (1, 5, 10μg/mL, maximum tolerated dose 20μg/mL, 6 person/dose) for single arm intradermal injection. The main examination items :vital signs (breathing, heart rate, blood pressure, body temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after injection, skin reactivity (redness and/or induration) diameter of injection sites,local reaction ( rash, pain, itching, and skin and mucous membranes ) ,a variety of adverse events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films before and 7 days after intradermal injection . Preliminary evaluation of safety and tolerability of Recombinant Allergen EC applied in humans, which can provide a safe dosage range for phase II clinical study. This clinical study adopts an open, randomized study methods to carry out Recombinant EC Allergen on small sample of healthy adults. 24 healthy adults were included as study objects, they were randomly divided into four groups of different Recombinant EC Allergen dose (1, 5, 10μg/mL, maximum tolerated dose 20μg/mL, 6 person/dose) for single arm intradermal injection, and set up two people as replacement for each group (one male and one female).
The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early approximal carious lesions compared to fluoride. All study participants must have two early approximal carious lesions in need of a treatment but not of an invasive treatment (split-mouth design). One lesion will be treated with Curodont Repair and one with fluoride as control. Study duration is 24 months. For assessment x-ray pictures, Diagnodent Pen and DiagnoCam is used.
The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early approximal carious lesions compared to no treatment. All study participants must have two early approximal carious lesions in need of a treatment but not of an invasive treatment (split-mouth design). One lesion will be treated with Curodont Repair and the other will not undergo a treatment as control. Study duration is 12 months. For assessment x-ray pictures are used.
Pakistan ranks fifth amongst high tuberculosis-(TB) burden countries, where TB persists as a major cause of misery and death. The Diabetes Mellitus-(DM) is also on rise in Pakistan and people suffering from DM are more prone to catch TB as compared to healthy individuals. This concurrence of two outbreaks may further increase the frequency of TB in Pakistan. The TB DM co-occurrence results in various clinical issues as TB in DM patient increases blood glucose, making DM more difficult to treat, while DM raises the risk of treatment failure, relapse and death among TB patients. In addition, both DM and TB usually coexist with micronutrients deficiencies like vitamin D, which has a vital role in immunity, insulin functioning and respiratory health. It has been suggested that the combined supplementation with vitamin D and calcium might be beneficial in improving the glucose metabolism but the current knowledge is very limited. In a resource restrained country with double burden of infectious and non-infectious diseases, an integrated approach with modification of treatment options may benefit in management of these outbreaks. Therefore, this study aims whether vitamin D and calcium supplementation could influence the recovery in patients with TB of lung and DM. Pakistan is going through an epidemiological transition that subjects it to a dual burden of communicable and chronic diseases. According to WHO, Pakistan ranks seventh in diabetes prevalence and fifth amongst high TB burden countries.
This study aimed to evaluate the efficacy and safety of the nature herbal medicine Banlangen granules in patients infected with seasonal influenza A (H1N1,H3N2) and influenza B virus. Inclusion criteria: 1. Patients have confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real time PCR 2. age between 18-65 years old 3. axillary temperature ≥38ºC and with at least two constitutional symptoms (headache, chill, myalgia ，or fatigue) and one respiratory symptom (cough ，sore throat,or coryza) . 4. Illness onset had to be within 36 hours, and informed consent was obtained. Exclusion criteria: 1. age younger than 18 or older than 65 years old. 2. patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung disease by Chest imaging (chest X-ray or CT) . 3. Blood routine screening tests shows numeration of leukocyte 10.0×109/L or Neutrophil percentage ≥80%. 4. Those have got suppurative tonsillitis or cough purulent sputum. 5. Those with underling primary disorders, such as hematological disease, chronic obstructive pulmonary disease（FEV1/FVC＜70％，FEV1/ predicated value＜50％； or respiratory failure or right heart failure）， hepatic disease（ALT or AST≥triple ULN）, renal disease（Serum Creatinine＞2mg/dL）,chronic congestive heart failure( NYHA Ⅲ-IV) 7. Patient is allergic to the study medication(s). 8. Women who are pregnant or may possibly become pregnant or are lactating with a positive urine pregnant test, obesity (abody mass index (BMI) of 25 kg/m2 or more).
voriconazole is recommended as first-line therapy for invasive pulmonary aspergillosis, however the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis secondary to COPD is not clear. This study aims to investigate the effectiveness and tolerability of intravenous voriconazole for treatment of invasive pulmonary aspergillosis in Chinese patients with COPD, by monitoring changes in clinical symptoms, eradication of aspergillus, improvement of chest imaging as well as record of possible adverse reactions following 2-week intravenous instillation of voriconazole. This is a multiple-center open-label clinical trial to study the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis secondary to COPD in Chinese patients.The primary endpoint is treatment success rate as defined by improvement of symptoms related to invasive pulmonary asperillosis, secondary endpoints include the mortality, the eradication of sputum asperillus and profile of adverse reactions following intravenous instillation of voriconazole.
Essential to laparoscopic operations is adequate visualization. Unfortunately there is no grading system to assess the degree or quality of visualization. The primary objective of the project is to develop a laparoscopic visualization scoring system. We also intend to investigate the effects of neuromuscular blockade agents on visualization. Essential to laparoscopic operations is adequate visualization. Unfortunately there is no grading system to assess the degree or quality of visualization. There are many contributing factors that either assist or hinder the quality. Compared to open surgical procedures, laparoscopic surgical procedures (Laparo-endoscopic Single Site (LESS) and conventional multiport) are associated with less postoperative pain, a lower wound infection rate, shorter length of hospital stays and reduced incidence of late ventral hernia(1). Despite these well documented benefits of laparoscopic procedures, laparoscopy in certain patient populations can be challenging. Preoperative factors that contribute to technical difficulty in performance of laparoscopic procedures include male gender, android body habitus, and body mass index (BMI) greater than 30 kg/m2(2). Men often have an android body habitus, whereby the excess body fat concentrates within the peritoneal cavity, increases intra-abdominal pressure and thus reduces intraoperative laparoscopic visualization. Intra-abdominal pressure measured in morbidly obese patients is 2-3 times higher than in non-obese patients. In addition, android body habitus and high BMI are often associated with an enlarged left lobe of the liver.
This study through the long-term observation followed up for 2 years to find the change of the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the severity of COPD. Evaluate the differences of prognosis between the different oxidative stress level (according to the level of ROMs are divided into higher and normal phenotype). Explore the new oxidative stress evaluation index ROMs application value in COPD. Reactive oxygen metabolites (reactive oxygen metabolites, ROMs) test is a method by measuring the total reactive oxygen metabolites (ROMs) content in blood so as to evaluate the overall level of oxidative stress in the human body .Our previous studies have established the method of detecting ROMs which is suitable for fully automatic biochemical analyser.Our study through the long-term observation followed up for 2 years to find the change of the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the severity of COPD. Evaluate the differences of prognosis between the different oxidative stress level (according to the level of ROMs are divided into higher and normal phenotype). Explore the new oxidative stress evaluation index ROMs application value in COPD.
A single center case-control study with 100 COPD patients will be organized to compare patients with and without bronchiectasis with regard to the presence of Aspergillus in sputum samples, Aspergillus sensitization and vitamin D. Induced sputum samples will be optimized for culture, Aspergillus galatomannan analysis and RT-PCR. This study is part of a larger project in which we assume that chronic respiratory infection by Aspergillus fumigatus and the accompanying immune response play an important role in the development of bronchiectasis in COPD. We suspect that this mechanism is controlled by vitamin D and it fails by suppression of the vitamin D receptor by Aspergillus fumigatus. The present study is designed by the Laboratory of pneumology and will be conducted in collaboration with the Laboratory of clinical bacteriology and mycology of the Catholic University of Leuven.
Background: - Tuberculosis (TB) is a lung infection caused by bacteria. When people with TB cough, they may spread these bacteria. Researchers are looking for new TB medicines. They want to find a faster way to tell if a drug might combat TB. Objective: - To learn the effect of different anti-TB drugs on microbiological, radiographic and immunologic markers in people with TB. Eligibility: - Adults age 18-65 who weigh 30-90 kg and have common TB bacteria that can be treated with common TB medicines. Design: - Participants will be admitted to the hospital for screening. They will have medical history, physical exam, and chest radiograph. They will give blood, urine, and sputum samples. - Participants will be put in 1 of 8 groups. - Participants will get one or a combination of TB medicines daily for about 14 days. - Each day, participants: - Will discuss side effects. - May have a physical exam. - Will spit mucus into a cup. They may breathe in saline water through a nebulizer to make them cough. - Participants will have blood taken 3-4 times during the study - Participants will have 2-3 Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG-PET/CT) scans. FDG is a radioactive sugar molecule which helps measure TB disease in the lungs. It will be injected into a vein.
Background: Many people around the world get tuberculosis (TB) and non-tuberculous mycobacteria (NTM) infections. Sometimes medicine that treats these infections does not get to where the bacteria are in the lungs. Researchers want to find a way to tell if enough medicine is getting to where it is needed in the lungs. They will look at how much medicine is in your sputum (what you cough up) compared to how much is in your blood. They will also investigate a new test to quickly figure out what medicines are likely to treat TB effectively. Objective: To determine the relationship between the concentration of TB drugs in plasma and sputum over time. Eligibility: People ages 18 and older who have TB or NTM infection that is suspected to be drug resistant. They must be taking TB or NTM medicines. Design: Participants will be screened with medical history. Participants will be in the study for 2 8 days. Participants will give 3 or more sputum samples over at least 2 different days. They will cough sputum into a cup. Participants will have blood drawn 4 times a day on 2 different days. This study will support two avenues of research, pharmacokinetics (PK) of drugs used to treat tuberculosis and resistance to those drugs that has been developed by the pathogen. Given the high inter-individual variability in TB drug exposure, therapeutic drug monitoring would be of value to adjust the drug dose in TB patients in order to improve clinical outcome and minimize toxicity.
The study aims to asses the ability of cell tests based on the analysis of the anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic fibrosis. In addition, the study will evaluate the contribution of biological classification of aspergillosis according to criteria recently proposed by Baxter et al. compared to the classification used in clinical practice in the hospital of Montpellier.
To compare parenteral versus inhaled pentamidine in patients with documented Pneumocystis carinii pneumonia (PCP) with AIDS.
This study is using a standardized method to assess respiratory function in SCI in order to determine the association between level of SCI with chronic respiratory symptoms, measures of pulmonary function, and respiratory illness, both cross-sectionally and longitudinally. Primary Objectives: Determine the association between level of spinal cord injury (SCI) with chronic respiratory symptoms, measures of pulmonary function, and respiratory illness, both cross-sectionally and longitudinally. Intervention: None Study Abstract: This study is using a standardized method to assess respiratory function in SCI in order to determine the association between level of SCI with chronic respiratory symptoms, measures of pulmonary function, and respiratory illness, both cross-sectionally and longitudinally. A community-based mail survey was made of 1147 subjects (42% response rate; 2 mailings, n=485). Additional subjects injured >1 year ago underwent testing at the West Roxbury VAMC (FVC, FEV1, TLC and subdivisions, maximal inspiratory and expiratory pressures (MIP/MEP), and completed a health questionnaire based on the ATS DL-78 respiratory questionnaire. Between 10/94-9/98, a cross-sectional cohort of 361 subjects with chronic SCI were tested. Multiple logistic regression was used to examine predictors of respiratory symptoms and chest illness determined from the questionnaire. From the community-based mail survey, SCI with complete cervical injury (CC) the odds reporting ?any wheeze? relative to lower SCI levels (odds ratio (95%CI)) was 3.34 (1.75-6.40), p<0.001, and for ?persistent wheeze?
The objective of this study is to demonstrate the safety and efficacy of IC14 in the treatment of hospitalized patients with community-acquired pneumonia and sepsis.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Combining chemotherapy and radiation therapy with gefitinib before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase I/II trial to compare the effectiveness of neoadjuvant chemoradiotherapy with or without gefitinib in treating patients who are undergoing surgery for stage III non-small cell lung cancer. OBJECTIVES: Phase I: - Determine the tolerability and toxicity of gefitinib in combination with chest radiotherapy in patients with stage IIIA or stage IIIB non-small cell lung cancer. Phase II: - Compare the pathologic response (complete response and rate of downstaging) in patients treated with neoadjuvant chemoradiotherapy with vs without gefitinib. - Compare the feasibility and toxicity profile of these regimens in these patients. - Compare the resection rates, time to progression, and overall survival of patients treated with these regimens. - Correlate the percent decline in the fludeoxyglucose F 18 standardized uptake value as measured by position emission tomography with pathologic response at resection, time to progression, and overall survival in patients treated with these regimens. OUTLINE: - Phase I: This is an open-label, nonrandomized study.
This was a study involving the emergency department and outpatient clinics of the David Grant United States Air Force (USAF) Medical Center, a tertiary care facility. Patients 18 years of age or older with acute respiratory tract symptoms and positive chest radiographs from October 1, 2004 through May 31, 2005 were included as positive cases. Controls were randomly selected from a review of negative chest radiograph reports with a clinical history of an acute respiratory illness over the same time period. Equivocal radiographs were treated as positive cases. Patients were excluded if they were under the age of 18 or in suspected cases of hospital-acquired or aspiration pneumonia. The six clinical indicators included cough, sputum production, temperature, heart rate, respiratory rate, and findings on physical examination. Abnormal vital signs were defined as temperature of 100.5 degrees Fahrenheit (38 degrees Celsius) or greater, heart rate greater than or equal to 100 beats per minute, and respiratory rate greater than 20 breaths per minute. Positive physical examination findings consisted of the presence of crackles, decreased breath sounds, dullness to percussion, egophony, or rhonchi.
This is a multinational, double-blind, placebo-controlled trial designed to assess whether iseganan, applied topically to the oral cavity, can prevent ventilator-associated pneumonia among patients who are intubated and mechanically ventilated and survive for up to 14 days. Patients will be randomized and receive their first dose of Study Drug within 24 hours of oral/nasal intubation and the initiation of mechanical ventilation. The Study Period will begin with the first administration of Study Drug (Study Day 1). Three mL of Study Drug (9 mg iseganan or matching placebo) will be applied to all visible surfaces in the oral cavity and the oral portion of the endotracheal tube (for non-tracheostomy patients) every 4 hours through Study Day 14, or until the diagnosis of microbiologically-confirmed pneumonia (based on central laboratory results) or extubation, whichever occurs first. All patients will be evaluated for clinically defined pneumonia at least once daily and, if diagnosed, blood specimens will be collected and cultured, and a bronchoscopic alveolar lavage (BAL) specimen (for intubated patients) or a respiratory secretion specimen (for extubated patients) will be obtained PRIOR to initiating or changing any systemic antimicrobial therapy.
Nursing home residents are frequently transferred to hospital for management of pneumonia. This often leads to hospital related complications and is a burden on the acute care health system. The purpose of this study is to assess whether managing residents with pneumonia and lower respiratory tract infection on site in the nursing home can reduce hospital admissions and can reduce complications and improve quality of life for residents. We have randomized residents with nursing home acquired pneumonia to on-site management, using a clinical pathway, versus usual care. We conducted a cluster-randomized controlled trial where nursing homes were randomized to either use of a clinical pathway or usual care for management of nursing home acquired pneumonia. The clinical pathway included chest radiographs performed on-site in the nursing home by a mobile x-ray unit, use of hypodermocylysis (subcutaneous infusion) for re-hydration, administration of an oral antimicrobials, and use of pulse oximetry to assess oxygenation. The main outcomes were hospital admission rate and length of stay. Secondary outcomes included health related quality of life, rates of both infectious and non-infectious complications within four weeks of onset of symptoms; mortality rate of residents with pneumonia (death from all causes within 30 days of onset of symptoms. Time to stabilization of vital signs, as well as functional status at four weeks, were assessed.
This study was designed to determine whether taking daily doxycycline during an outbreak of Mycoplasma pneumoniae could prevent a person from getting infected and interrupt ongoing disease transmission during an outbreak. Doxycycline is a treatment for Mycoplasma pneumoniae, but it is not certain that the drug could prevent disease if used prophylactically.
The purpose of this study is to develop a scoring system to allow doctors to accurately identify children on a mechanical ventilator who have bacterial pneumonia. Currently this diagnosis is very difficult to make, resulting in the overuse of antibiotics and the promotion of antibiotic-resistant bacteria in the pediatric intensive care unit (ICU). Four ICUs at 3 children's hospitals will participate. Study participants will include 150 children, ages 2 months to 17 years old who require mechanical ventilation, and in whom the bedside health care providers suspect bacterial pneumonia. Bacteria will be studied by sampling lung fluid through the breathing tube less than 12 hours after starting antibiotics, using a procedure known as "non-bronchoscopic-bronchoalveolar lavage (NB-BAL)." Participants may be involved in study related procedures for up to 31 days. The primary objective of this prospective cohort study is to derive a clinical score for predicting the absence of bacterial pulmonary infection in children requiring mechanical ventilation. This study is in preparation for designing an interventional trial whose aim will be to reduce antibiotic use in the pediatric intensive care unit (ICU) and thereby reduce the incidence of acquisition of antibiotic resistant bacteria. Secondary study objectives are to: define key characteristics of bacterial pulmonary infection in children requiring mechanical ventilation: demographics, microbiology, and predisposing factors; and assess the duration and number of antibiotics used for the treatment of pneumonia in this study population and to further assess the amount of antimicrobial therapy that could potentially be avoided in patients with a low probability of bacterial pneumonia as determined by the scoring system.
The hypothesis is that community-acquired pneumonia is usually a monomicrobial infection. Therefore, early detection of the etiology allows to select the most active, narrow-spectrum, and cheap, and less toxic antibiotic agent. In community-acquired pneumonia, identification of the etiologic agent has theoretically important advantages. For individual patients, it facilitates the administration of a targeted, narrow-spectrum antibiotic therapy that may improve the efficacy of treatment, and reduces risks of antibiotic-related toxicity. For the community, microbiologic results contribute to understanding the local microbial epidemiology of community-acquired pneumonia and the antimicrobial resistance patterns of pathogens, information that is essential in the instauration or modification of empiric treatment regimens. Guidelines recommend that all admitted patients with community-acquired pneumonia should have a collection of two sets of blood cultures, a good quality sputum sample for Gram stain and culture, a sample of pleural fuid if present and, for severe patients, an urine sample for antigen detection. In contrast, several prospective studies (usually without include urinary tests) concluded that these microbiological studies have limited value in the management of patients admitted with community-acquired pneumonia. In addition, microbiological studies could provide erroneous or incomplete information. Thus, investigations has showed false-positive results from pneumococcal antigen detection in urine caused by a frequent persistence of positivity after infection or a nasopharyngeal or bronchial colonization. Other authors suggested that community-acquired pneumonia is a polymicrobial infection; consequently, despite the detection of a true microorganism, treatment needs to be also addressed against other potential pathogenic agents.
Pneumonia in general and CAP in particular is considered as one of the most common bacterial infections, associated with high rates of morbidity and mortality and is highly significant economically since all respiratory infections, and pneumonia especially, cause about 80% of antimicrobials use in the community. The high frequency of respiratory infections and the excessive use of antimicrobials are major contributors to the development of pathogens resistant to antimicrobials. In addition, in CAP almost all patients are treated empirically, without identification of causing pathogen. Aim of study: To identify common pathogens causing CAP in hospitalized patients in north Israel. Pneumonia in general and CAP in particular is considered as one of the most common bacterial infections, associated with high rates of morbidity and mortality. CAP is highly significant economically since all respiratory infections, and pneumonia especially, cause about 80% of antimicrobials use in the community. The high frequency of respiratory infections and the excessive use of antimicrobials are major contributors to the development of pathogens resistant to antimicrobials. In addition, in CAP almost all patients are treated empirically, without identification of causing pathogen. CAP is divided to two principal groups: Bacterial CAP and Atypical CAP. Since pathogens are different, treatment approach is also different. The main obstacle is absence of adequate diagnostic immediate and cheap tools to enable identifying pathogen and hence treatment is not always appropriate.
The purpose of this study was to determine the effect of aerosolized antibiotics on respiratory infection in mechanically ventilated patients.We hypothesize that aerosolized antibiotics , which achieve high drug concentrations in the airway, would more effectively treat respiratory infection, decrease the need for systemic antibiotics and decrease antibiotic resistance. In patients requiring mechanical ventilation, signs of respiratory infection often persist despite treatment with powerful antibiotics given through the patient's vein. In this trial, patients with purulent secretions were assigned aerosolized antibiotics or placebo by a randomizing protocol. Neither the patients or their doctors knew what the patient was receiving.Need for a systemic antibiotic was determined by the clinical physician. Comparisons were made between placebo and study drug for their effects on pneumonia, respiratory signs of infection, ability to wean patients from the ventilator, systemic(given in the vein) antibiotic use and the development of organisms that were resistant to antibiotics.
It is known that individuals with spinal cord injury are at increased risk for respiratory tract infections like pneumonia. Part of this risk is due to weakened chest and abdominal muscles that are vital to deep breathing and the ability to cough. The purpose of this study is to look at the effectiveness of two different treatments in preventing pneumonia and other respiratory problems in persons with SCI. This is a randomized controlled trial investigating the effectiveness of two different treatments. Participants will be randomly assigned to one of the two treatment groups. They will not be told the details of the other intervention since this could influence or change their activities during the study.
The aim of the study is to investigate the bacterial causes in community acquired pneumonia in adults admitted to hospital in two counties in Norway and to look at possible factors that makes the patients susceptible to pneumonia. In Norway there is little knowledge of which bacterias that causes pneumonia in patients admitted to hospital. There are also few registered cases of Legionnaires disease every year, compared to our neighbour countries. Therefore 500 patients with community acquired pneumonia admitted to Telemark hospital and Ostfold hospital in Norway will be tested by urin antigen test for the detection of Legionella pneumophila serogroup 1 and Streptococcus pneumoniae. We will also perform routine bacterial culture of sputum and culture on medium for isolation of Legionella species. A throat swab from the patients will be tested for Mycoplasma pneumoniae, Chlamydophila pneumoniae and Bordetella pertussis using PCR-techniques. Legionella-serology will also be performed. In addition all the included patients are invited to fill in a questionnaire in order to look for risk factors for developing community acquired pneumonia.