mteb/BIRCO-ClinicalTrial-Test huggingface dataset:
The purpose of this study is to compare the results of preoperative chemotherapy and radiation followed by surgery to surgery followed by postoperative chemotherapy and radiation for esophageal cancer. Patients will be randomized to neo-adjuvant or adjuvant treatment. Quality of life questionnaires will be completed every 2 months up to 1 year.
The purpose of the study is to determine whether the combination of Hycamtin (Topotecan) and Temozolomide is effective in the treatment of relapsed and refractory neuroblastoma and other paediatric solid tumors. Current treatments for malignant paediatric solid tumors involve a combination of chemotherapy, surgery and, in certain cases, radiotherapy. This multidisciplinary approach leads to an overall cure of approximately 70%. Nevertheless, cancer mortality remains the leading cause of disease-related death in children and adolescents between 1 and 19 years. This is due to diseases with a poor prognosis, such as metastatic neuroblastoma, sarcoma in soft tissue and bone and brain tumors. New effective treatments must be found in order to continue to increase the cure rate of children and adolescents treated for cancer, as well as to improve the cured patients' quality of life Neuroblastoma (NB) is a malignant paediatric tumour derived from primordial neural crest cells. This tumor accounts for 8% to 10% of all cancers with a median age of onset of 22 months. The primary tumor may be located in different anatomic sites such as abdomen (65%), thorax (19%), pelvis (2%), and cervix (1%). The strongest prognostic factors are age and stage. Localized NB and those occuring in infants have a 90% survival rate when the biological profile is favorable.
To perform a multiple reader, multiple case (MRMC) observer study assessing the detection performance of VolumeRAD tomosynthesis of the chest in detecting lung nodules. Digital tomosynthesis is a form of limited angle tomography that creates a series of section images using a conventional x-ray tube and generator, a digital detector, and appropriate reconstruction software. It creates section images from a series of projection images acquired as the x-ray tube moves along a prescribed path. Because tomosynthesis can minimize the visual presence of overlying anatomy - the ribs, for example - it has the potential to improve the detection of lesions such as pulmonary nodules when compared with conventional chest radiography. The primary aim of this study is to determine whether the use of VolumeRAD tomosynthesis, in addition to CxR, increases physician accuracy in the detection of lung nodules between 3mm and 20mm in diameter when compared to conventional posterior-anterior (PA) and lateral (LAT) chest radiography (CxR). This aim will be addressed by measuring free-response performance of experienced (with VolumeRAD), blinded expert readers' detection performance. Specifically, we will compare detection performance, as measured by the area under the alternative free response receiver operating characteristic (AFROC) curve, among readers viewing PA and LAT chest X-rays versus VolumeRAD tomosynthesis. The nodule will be the unit of analysis.
The VRI device may provide a complementary diagnostic tool for lung examination and aid the physician in determining whether a chest x-ray should be performed. This study is a prospective, single center study to determine the value of VRI images as an aid in determining whether a chest x ray is necessary to evaluate children presenting with acute respiratory complaints. Study participants will be children, selected from the Emergency Department (ED), who were designated to undergo a PA and Left Lateral CXR because of acute respiratory complaints such as a new respiratory condition, acute cough, onset of shortness of breath, or fever. Patients who meet the study inclusion and exclusion criteria will be enrolled and will be recorded by the VRI device. A technician will perform a CXR on the enrolled patients. The CXR and the VRI will be performed on the same day within 6 hours of each other. VRI readers, who are blinded to the patient's CXR, history, and physical exam, will evaluate the VRI recording. The VRI reader will review the VRI images and, using the lexicon of images supplied by Deep Breeze, determine whether the VRI is normal or abnormal. Certified radiologists will review the patient's CXR and will determine whether the CXR is normal or abnormal based solely on the CXR. The VRI readers determination of normal or abnormal for each subject will be compared to the radiologists determination of normal or abnormal CXR for each subject.
LAY ABSTRACT 1. Statement of the health problem or issue: Of the estimated 24,000 Canadians who will be diagnosed with lung cancer in 2008, 21,000 will die of their disease. Based on this cancer incidence and survival data, the most promising current strategy for improving outcome is screening and early detection. It is suggested that if lesions are discovered at an earlier stage of disease, they will have a higher likelihood of being treatable and therefore, survival will be improved. CT detection of growing small lung nodules, many of which are non-cancerous (benign), raises the possibility of lung cancer and thus causes anxiety in patients and referring clinicians. Unfortunately, confident separation of benign from malignant small lung nodules cannot be reliably achieved using CT or PET criteria. Pathologic diagnosis using needle or excision biopsy is usually required. Excision biopsy removes the entire nodule at one setting and eliminates the sampling error associated with needle biopsy, making it appealing to physicians and patients. To reduce post-operative pain and breathing difficulties, excision biopsy is often performed using minimally invasive surgery (video assisted thoracoscopic surgery, VATS). Finding small pulmonary nodules is often difficult with the minimally invasive camera (VATS) and a bigger incision (thoracotomy) is necessary in more than 60% of our patients. We recently developed a technique of using platinum micro-coils, which are inserted in the lung nodule using CT guidance, to locate the nodule with fluoroscopy and then excise it with VATS.
A need exists for non-invasive testing to aid in clinical decision-making for CT scan detected lung nodules of indeterminate etiology. The investigators hypothesize that biomarkers detectable in blood, sputum or urine may be useful for guiding clinical decisions in the setting of CT detected lung nodules to determine which nodules are malignant and which are benign. The investigators also hypothesize that these biomarkers will decrease in concentration to the normal range after successful surgical treatment of malignant lung nodules. The Biomarkers for Diagnosis of Lung Nodules Study is a prospective study of a cohort of 500 individuals with lung nodules of indeterminate etiology that are identified by CT scans. Either biopsy or repeat CT scans must be clinically indicated to determine the etiology of the nodule. Patients will be asked to allow investigators access to CT scan images and spirometry data, and provide blood, sputum, urine, and exhaled breath samples over the course of the study. Patients will also be asked to allow investigators to access pathology records if a biopsy or surgical excision of the nodule is clinically indicated.
After an initial screening visit, including an assessment of psychiatric disorders, patients stabilized on antipsychotic medication (aripiprazole or risperidone) for at least 6 weeks and control subjects will undergo an assessment using functional magnetic resonance imaging (fMRI) of the differences of patterns of brain activation during an emotional task This study is: interventional, comparative, open label, multi center, without experimental treatment. Main objective: To evaluate the effect of aripiprazole and risperidone on brain activation during an emotional task of matching patients with schizophrenia, and in reference to control subjects. Secondary Objective: Comparison of emotional subjective and physiological perception in patients with schizophrenia in relation with their treatment. Comparison of brain activation in patients during the emotional induction task based on symptomatic dimensions, personality traits and performance on cognitive and attentional tests, and for insight capacity . Comparison of transcript level of candidate genes in blood mononuclear cells between the study groups and study the interactions between the observed differences in brain imaging and different levels of transcription of these genes.
Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer dogs are trained to distinguish between the BS of patients with lung cancer and healthy individuals (controls). In a prospective, randomized blinded study the dog's ability to differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory airway disease, but no evidence of cancer and iii) healthy individuals is tested. All breath samples (BS) are collected in patients on the basis of radiologic findings before any intervention (bronchoscopy, biopsy or surgery) has been performed. The allocation to study groups is made following diagnostic work up and surgery. Three study groups are defined using the following inclusion and exclusion criteria: - lung cancer: male & female, age 18-80, competent, confirmed lung cancer in diagnostic work up and surgery, no history or present other tumor disease - healthy individual: male & female, age 18-80, competent, no history or present other tumor disease including lung cancer, no pathological lung function tests - chronic obstructive lung disease: male & female, age 18-80, competent, no history or present other tumor disease including lung cancer, pathological lung function tests For each patient, i) history, ii) present medication, iii) lung function tests are documented.
Among the causes of the solitary pulmonary nodule (SPN), benign causes including tuberculosis was noted on 15 to 60 percents in various studies. Although the characteristics of chest imaging is helpful in diagnosis and percutaneous needle biopsy for pulmonary nodule has been represented high diagnostic yield in many reports, but still surgical biopsy has been needed in definite diagnosis of pulmonary nodules in many cases. The aim of this study is to evaluate the usefulness of interferon-gamma release assay in addition to the percutaneous needle biopsy, in diagnosis of pulmonary nodules. Among the patients who failed to diagnosis by percutaneous needle biopsy and needed to have Surgical biopsy, thirty percents of the patients were diagnosed as benign nodules and about six percents were diagnosed as tuberculosis in Seoul National University Hospital during 2007-2008. The investigators want to know whether conducting an interferon-gamma release assay in addition to percutaneous needle biopsy is helpful in diagnosis of lung nodules.
Lung cancer remains the leading cause of mortality from malignant diseases in both men and women worldwide. Following thoracic surgery and pulmonary resection, patients have a surgically induced pneumothorax / hydro-hemothorax and hence tube thoracostomy is necessary to drain the air and effusion. Due to this, patients must undergo post-operative chest x-ray (CXR) evaluations in order to evaluate the chest and make decisions regarding removal of chest tubes (CT) as well as for decisions regarding patient discharge. Thoracic Ultrasound (US) has been shown to be accurate at diagnosing pneumothorax and has been well-studied in the trauma population. To the investigators knowledge, there are currently no centers using thoracic US routinely in the post-operative setting following thoracic surgery. Following thoracic surgery (both open and thoracoscopic) patients have a surgically induced pneumothorax and hence tube thoracostomy is needed to drain the air and effusion. Due to this, patients must undergo post operative chest x-ray (CXR) evaluations in order to evaluate the chest and make decisions regarding removal of chest tubes as well as for decisions regarding patient discharge. Following chest tube removal, most surgeons advocate further CXR evaluation to assure that no pneumothorax was introduced during removal of the tube. Repetitive CXR evaluations are costly, inconvenient, expose the patient and healthcare worker to repetitive radiation, and require time. Surgeon-performed US could be performed as an adjunct to physical examination.
The purpose of this study is to find out what effects an experimental drug, called interleukin 21 or rIL-21, will have on malignant melanoma and whether these effects look promising compared to dacarbazine. In addition, this study will look at the side effects of rIL-21, and some special blood tests will be done to check the level of rIL-21 in the blood. This study will also look at previously removed melanoma tissue to determine which patients might benefit most from this treatment. This research is being done because currently there is no effective treatment for this type of cancer.
Pulmonary nodules are one of the most common thoracic radiographic abnormalities. They are usually found accidentally as discrete well emarginated pulmonary lesions found within the lung parenchyma during a routine chest x-ray. Pulmonary nodules are usually asymptomatic. Most solitary lung nodules are benign; however these nodules can represent early stage lung cancer. The identification of malignant pulmonary nodules is important because they represent a potential form of curable lung malignancy. Every lung nodule should therefore be investigated for the possibility of malignancy. Ultrasound has been beneficial in almost all medical and surgical specialities. The idea of using ultrasound during VATS has emerged from its use in laparoscopic procedures. Few studies have investigated the use intracavitary ultrasound for localizing pulmonary nodules. The sensitivity of ultrasound detecting pulmonary nodules is high (92%). In some studies, ultrasound could detect all pulmonary nodules detected by high resolution CT. It has also been shown to be able to locate nodules not visualized on spiral CT. The use of intracavitary ultrasound has been suggested by many authors as a safe and effective method for localizing hard to find nodules. It is a real time technique with no associated complications, low cost, and has the potential to save operative time. Most importantly, it may be able to prevent conversion of VATS to open operations in cases where nodules are not visualizable or locatable using VATS techniques.
To proof the feasibility and safety of EBUS guided transbronchial cryo biopsies in peripheral lung lesions Solitary pulmonary nodule are a diagnostic dilemma. Nowadays not only the basic tissue diagnosis is necessary, molecular signals are state of the art. Therefore more tissue is necessary. With a cryoprobe the amount of tissue is increased compared to the classical forceps biopsy. Until now, the use of the cryoprobe ism´t show in peripheral lung tissue.
The present investigation is a prospective, multicenter study evaluating craniopharyngioma patients' prognoses following the various currently-practiced therapeutic strategies.Primary goals of the study are to establish quality standards and compare the various therapy strategies with respect to their effectiveness and impact on the quality of life of treated patients. A stratified randomization of two treatment arms will be conducted with respect to timing of postoperative irradiation for the subgroup of patients ≥5 years of age whose tumors are incompletely resected. The researchers will investigate whether an immediate, postoperative irradiation is superior to progression-contingent irradiation based on alterations to quality of life (PEDQOL) from the time randomization is initiated (3rd month post op) to 3 years after randomization. Progression-free survival and overall survival will be examined as closely-related subgoals.Postoperative data will be evaluated via a surveillance study for all complete resection patients as well as for those patients under 5 years of age regardless of their resection grade.
Watchful waiting is non-inferior to surgical repair of asymptomatic and oligosymptomatic incisional hernias in terms of pain and discomfort during normal activities. Incisional hernias are one of the most frequent complications in abdominal surgery. In Germany, 44.000 incisional hernia repairs per year are performed. Incisional hernia repair is not a low risk operation associated with high recurrence rate and high percentage of postoperative pain. Treatment of incisional hernias represents a significant surgical and socioeconomic problem. Until now, surgical treatment is recommended for patients with incisional hernia independent of symptoms due to the risk of an acute incarceration with serious complications. Studies defining the exact indications for incisional hernia repair and describing the natural course of an incisional hernia including the risk of an acute incarceration are not available to date. Randomized controlled trials having been performed in the past few years show that observation is a reasonable option in mildly symptomatic inguinal hernias. In this study, watchful waiting vs. surgical repair of oligosymptomatic incisional hernias are compared in a prospective-randomized setting for the first time. The aim is to determine pain and discomfort, quality of life, patient satisfaction, and the frequency of incarceration. The investigators hypothesize that pain intensity during everyday activities is not different in the compared groups and that incarceration frequency is low. If this was the case, a watchful waiting strategy could be applied in oligosymptomatic incisional hernias and risks and costs for surgery could be saved.
This is an international prospective randomised trial, which will compare two radiotherapy regimens in children and adolescents (aged 4 or 5 years to 21 years inclusive) with carefully staged 'standard risk' medulloblastoma. Patients eligible for the study will be those with non-metastatic medulloblastoma (by imaging and CSF cytology) at diagnosis. Patients randomised to the standard arm will receive conventionally fractionated (once a day) radiotherapy with a dose of 54 Gy to the posterior fossa and 23.4 Gy to the craniospinal axis. The experimental arm will be hyperfractionated (twice a day) radiotherapy (1 Gy b.d.) with a dose of 60 Gy to the posterior fossa with an additional 8 Gy to the tumour bed and 36 Gy to the craniospinal axis. Both groups will receive identical chemotherapy consisting of eight weekly doses of Vincristine given with radiotherapy and 8 courses of CCNU, cisplatin and vincristine following radiotherapy.
Nontuberculous mycobacteria (NTM) are ubiquitous organisms in the environment and are now increasingly being recognized as significant causes of chronic pulmonary infection in immunocompetent individuals (1). The most frequently encountered NTM lung disease worldwide is caused by Mycobacterium avium-intracellular complex (MAC) (2-4). In several studies with chest computed tomography (CT), researchers have demonstrated that the presence of bilateral multifocal bronchiolitis (well-defined small nodules and branching centrilobular nodules, or tree-in-bud pattern) and bronchiectasis distributed mainly in the right middle lobe and lingular segment are indicative of NTM pulmonary infection (7-11). Accordingly, it is believed that radiologic findings of bilateral bronchiolitis and bronchiectasis on chest CT scans specifically suggest NTM pulmonary infection (1). These CT findings, however, may not be specific for NTM pulmonary infection. CT patterns of bronchiectasis and bronchiolitis in the pulmonary infections caused by various NTM organisms have been reported, and these organisms include Mycobacterium kansasii, Mycobacterium xenopi, and rapidly growing mycobacteria such as Mycobacterium abscessus, Mycobacterium fortuitum, and Mycobacterium chelonae (12-14). In addition, not all patients with bronchiectasis and bronchiolitis have NTM pulmonary infection. Two recent studies showed that only about 50% of patients with such CT features have MAC pulmonary infection (9,15). To the best of our knowledge, however, there is no report about the incidence of NTM in patients with bronchiectasis or bronchiolitis in countries with low incidence of TB.
Environmental carcinogens such as polycyclic aromatic hydrocarbons (PAHs) were reviewed as the major risk factors for lung cancer development. In this proposal, the investigators collected fifteen kinds of major PAHs and the investigators would like to perform the following studies: 1. Study the gene expression and subcellular localization of GNMT in the normal-tumor tissue pairs of lung cancer patients. 2. Study the associations of the polymorphisms of GNMT in lung cancer patients and the susceptibility to lung cancer; 3. To assess the allelic loss at GNMT and determined the LOH rate of GNMT in the normal-tumor tissue pairs of lung cancer patients. 4. Study the associations of the copy number variation (CNV) of GNMT and the susceptibility to lung cancer; 5. Study the interaction between GNMT and polycyclic aromatic hydrocarbons (PAHs) in lung cancer cell lines. Multi-functional protein Glycine N-methyltransferase (GNMT, EC2.1.1.20, localized to chromosome 6p12), affects genetic stability by a) regulating the ratio of S-adenosylmethionine (SAM) to S-adenosylhomocystine (SAH) and b) binding to folate. Based on the following observations, GNMT is classified as a tumor susceptibility gene: a) diminished GNMT expression levels in both human hepatocellular carcinoma (HCC) cell lines and tissues; b) genotypic analyses of several human GNMT gene polymorphisms showed a loss of heterozygosity in 36-47% of the genetic markers in HCC tissues and also related to the susceptibility of prostate cancer; c) GNMT binds to environmental carcinogens such as benzo(a)pyrene (BaP) and aflatoxin B1 (AFB1) and protect the liver cells by inhibiting DNA-adduct formation.
The ACRIN 7151 trial will use medical records abstraction data from participants with extracolonic findings (ECFs) reported from the ACRIN 6664 National CT Colonography Trial to: 1) measure incidence of diagnostic imaging, hospitalization, and interventional procedures associated with ECFs reported on computed tomography colonography (CTC), delineated by type of ECF; 2) determine potential predictors of follow-up diagnostic imaging, hospitalization, and interventional procedures, delineated by type of ECF; and 3) evaluate the clinical/pathologic diagnoses associated with indeterminate but potentially significant ECFs. These data can be used to incorporate ECFs into existing models on the cost-effectiveness of CTC in colorectal cancer screening and can potentially be used to develop guidelines for the reporting and management of ECFs. The original ACRIN 6664 National CT Colonography Trial included 15 participating sites and a total study data set of 2531 participants. The target study data set for the ACRIN 7151 trial is 520 participants, assigned to one of three cohorts: an E3/E4 Case Group (n = 141) excluding pulmonary nodules, an E3/E4 Pulmonary Nodules Case Group (n = 119), and an E1 Control Group (n = 260) (see Section 8.6). Medical records will be collected by the site from their institutions and from the primary care provider identified by the participant during the ACRIN 6664 trial. Initial record collection will comprise the six months following CTC for all cohorts.
This study will evaluate the use of RightBio Metrics' RightSpot device used to determine if there is proper placement of a nasogastric or orogastric tube. Primary objective: To assess the level of accuracy of the RightSpot pH Indicator in determining correct placement of NG/OG tubes as compared to the gold standard of CXR in Emergency Department & ICU patients. Hypothesis 1: In greater than 90% of the cases, RightSpot pH Indicator will be successful in confirming the placement of NG/OG tubes by demonstrating a pH of 4.5 or less in patients with CXR proven tube placement. Hypothesis 2: The time to confirmation of NG/OG tube placement will be significantly less using the RightSpot pH Indicator than using CXR. The time will be calculated by the start time consisting of the time that the NG/OG tube was placed until the end time, which will be when the device pH Indicator testing is performed. The time to confirmation using the gold standard of a CXR will begin when the NG/OG tube is placed and end when the CXR is available on PACS (picture archiving and communication system). Secondary objective: To determine via subgroup analysis whether gross blood in the stomach, presence of acid-reducing medications, or trauma affects the accuracy of NG/OG placement determination by the RightSpot pH Indicator.
The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer. A statistically significant result will indicate that patients with a high ProLung Test result have a greater risk of developing lung cancer than patients with a low test result. There are three Specific Aims of this study: 1. Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with a diagnosis. 2. Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive patient diagnosis. 3. Assess the safety and tolerability of the ProLung Test procedures. Study Design This Study consists of two distinct phases, Stabilization and Validation. The Study will collect data from multiple sites (3 to 12), and each site may enroll patients and collect data for the Stabilization and Validation Phases with a minimum of three sites for the Validation Phase.
Background - Symptomatic undifferentiated hypotension represents a negative prognostic factor and the strongest predictor of in-hospital mortality. - Misdiagnosis may lead to delayed or incorrect treatment of some life-threatening conditions. Aim - The aim of the study is to evaluate the feasibility and accuracy of a new bedside ultrasound method that consists in the focused imaging of the thorax, abdomen and leg veins, in emergency. Methods - Hypotensive (<100 mm/Hg) patients presenting to our emergency department, complaining of at least one of the neurologic, respiratory and cutaneous signs and symptoms of inadequate tissue perfusion, are prospectively studied by ultrasound-focused assessment of the heart, lungs, inferior vena cava, peritoneum, aorta and leg deep veins. - On the basis of physical examination and ultrasound results, the operator declares the diagnostic hypothesis without influencing the attending physician and the following diagnostic procedure (which includes ultrasound, when needed). - The diagnostic hypothesis is compared with the final diagnosis, obtained after the hospital route and discussed by a panel of three blinded experts (one radiologist, one cardiologist and one emergency physician). - The statistical agreement is calculated by the k of Cohen with p-value, confidence intervals and raw agreement (Ra).
Background - Assessment of the percentage of lung collapse is crucial in the therapeutic decision-making of pneumothorax. - The methods normally used to this purpose are radiological. Computerized tomography scan (CT) is highly accurate because it allows the exact evaluation of the volume of the air layer. However, in clinical practice assessment of the volume of pneumothorax mainly relies on the measurement of the inter-pleural distance at conventional chest radiography (CXR). This latter method is inaccurate. - Lung ultrasound is a new method highly accurate in the first diagnosis of pneumothorax, with a sensitivity superior to CXR and similar to CT in case of traumatic pneumothorax. - The scientific community is actually debating about the usefulness of lung ultrasound in the quantification of pneumothorax []. Lung ultrasound can assess the superficial extension of the pneumothorax, but cannot evaluate its volume. Aim - Main purpose of the study is to compare measurement of the superficial extension of pneumothorax on the chest wall obtained by lung ultrasound, to the evaluation of the air volume performed by CT in patients with pneumothorax. - The main hypothesis of the study is that the cut-off between small (<11% of lung collapse) and large (>11% of lung collapse) pneumothorax can be identified by a lung ultrasound evaluation of the superficial extension of pneumothorax. - Second purpose of the study is to compare the accuracies of lung ultrasound and CXR in predicting the volume of pneumothorax assessed by CT. - Secondary hypothesis is that lung ultrasound demonstrates greater accuracy in the prediction of volume of pneumothorax and percentage of lung collapse.
Chemotherapy is often used to help shrink the cancer temporarily and may improve survival for patients with incurable pancreas cancer that has spread to other organs. In Canada, the gemcitabine chemotherapy is used to treat pancreas cancer that has spread. The combination of oxaliplatin with other chemotherapies, including 5-fluorouracil, leucovorin, and irinotecan has also been studied and has benefit for patients with advanced pancreas cancer. To date, there is no test that can be done on a patient's tumour to tell if chemotherapy will work in pancreatic cancer. Human equilibrative nucleoside transporter 1 (hENT1) has been shown to be a possible predictor that gemcitabine may or may not work but this needs to be proven in a randomized study where patients get treated with gemcitabine or a different kind of chemotherapy while their tumours get tested for hENT1. This study is being done because we want to prove that hENT1 can predict if gemcitabine will work in advanced pancreas cancer and if it can, we also would like to show that a different chemotherapy combination called FOLFOX (a combination of 5-fluorouracil, leucovorin, and oxaliplatin) will be helpful for patients whose tumours don't have hENT1. Pre-clinical and retrospective clinical data indicates hENT1 may be a predictive and prognostic biomarker for gemcitabine (Gem) efficacy. To ultimately prove its use as a biomarker, a prospective randomized study with hENT1 stratification is required.
Primary graft dysfunction (PGD) is the most common cause of early morbidity and mortality following lung transplant and is characterized by acute lung injury and capillary leak leading to an increase in extravascular lung water index (ELWI) and impaired graft function. PGD has many features in common with acute respiratory distress syndrome (ARDS). PGD may be life-threatening and can also lead to impaired long term lung function. In ARDS, a restrictive fluid strategy has been associated with an improvement in lung function and outcomes. Accurate methods of evaluating, quantifying and guiding the hemodynamic / fluid management and limiting the extent of ELWI that accumulates in the setting of PGD are lacking. Using transpulmonary thermodilution to estimate ELWI and the pulmonary permeability index (PPI) represents a novel approach to fluid management, which has been used in patients with ARDS, but to date not in the transplant setting. To determine if these measurements may better guide the management of lung transplant patients, the investigators first wish to establish whether these methods are able to predict the onset of clinical pulmonary edema earlier, whether they correlated with traditional markers of PGD, and whether they may be useful for predicting outcomes. AIM 1: The investigators will evaluate the correlation between ELWI and current surrogates of pulmonary edema in lung transplant patients with and without Primary Graft Dysfunction (PGD) AIM 2: The investigators will correlate the use of ELWI and PPI to determine the presence and severity of PGD.
Background: Improving implantation rates in ICSI cycles has been the focus of research in recent decades. Because success rates is not satisfactory enough especially when transferring good embryos to the uterine cavity and pregnancy does not occur. Trying to improve endometrial receptivity, the investigators have thought about stem cell therapy as stem cells have played a pivotal role in regenerative medicine in many pathologies as myocardial infarction, Diabetes Mellitus and spinal cord injuries. Garget and Healy reported in 2011 treatment of a case with Asherman's syndrome by administration of bone marrow stem cells in the uterine cavity. Endometrial growth and improved vascularity has been observed by ultrasound follow-up and Doppler study of endometrial blood flow. Endometrial regeneration has been enough to support pregnancy through successful IVF trial. The investigators have succeeded in previous work to isolate MSC from placental tissue and differentiate it to endometrium-like cells. The investigators compared the differentiation ability of placental derived mesenchymal stem cells (MSC) and Wharton Jelly derived MSC to differentiate to endometrium under 3 different culture conditions: endometrium conditioned medium (ECM), follicular fluid (FF) conditioned medium and medium containing both. The investigators found that placental MSC has better differentiating ability to endometrium especially under culture conditions containing both ECM and FF as evidenced by prominent appearance of glandular pattern and expression of progesterone receptors in differentiated cells. Therefore the investigators need to direct this study and test the effect of placental derived MSC in improving implantation rates in patients with recurrent implantation failure, unresponsive endometrium to ovulation induction drugs or with endometrial atrophy or advanced maternal age planning for ICSI trial.
The primary objective of this study is to determine if lung ultrasound (LUS) can replace chest x-ray (CXR) when evaluating patients with possible pneumonia. Specifically, we are looking for an overall reduction of CXR when LUS is used first. Our null hypothesis is that LUS cannot replace CXR for diagnosing pneumonia. Our alternate hypothesis is that LUS can replace CXR for diagnosing pneumonia. Our secondary objectives include: (1) a comparison of unscheduled healthcare visits after the index Emergency Department (ED) visit between those subjects who undergo CXR first and those who undergo LUS first, (2) an evaluation of the rate of antibiotic use between the two groups, (3) a comparison of the admission rates, and (4) a comparison of the length of stay in the Emergency Department between the two groups. Background - Ultrasound is now widely accepted as a diagnostic tool for use in the emergency department, as supported by the American College of Emergency Physicians position statement in 2001 (revised in 2008). Evidence-based guidelines for point-of-care lung ultrasound have recently been published (Volpicelli et al 2012). Lichtenstein et al (2004) performed bedside LUS on 117 critically ill patients to evaluate for alveolar consolidation and compared these findings with CT, the gold standard. Sensitivity of ultrasound was 90% and specificity 98%, indicating that US is a feasible imaging modality for the lungs.
A study for patients with confirmed locally advanced or metastatic Transitional Cell Carcinoma of the bladder or upper urinary tracts who have developed progressive disease within 12 months of their platinum based chemotherapy. The study aims to compare the overall response rate of cabazitaxel treatment versus best supportive care including single agent chemotherapy. Bladder cancer was the 9th most common cause of cancer worldwide in 2002. About 70% of patients have superficial tumour and 30% have invasive tumour at diagnosis. Patients with superficial tumour are treated by surgery, which is the only curative treatment. However, about 50% of these patients will relapse, and cannot be cured by local treatment in the majority of cases. The survival of untreated metastatic patients does not exceed 3 to 6 months, and systemic chemotherapy increases overall survival of patients with unresectable disease. However, the overall survival of patients with advanced disease treated with chemotherapy remains short (14 months), which reflects a substantial unmet medical need for more effective therapy in this very poor prognosis disease. Cabazitaxel is a new taxane, taxanes have demonstrated activity in advanced bladder cancer, and are among the most active new cytotoxic agents to be assessed in transitional cell carcinoma. Cabazitaxel has demonstrated activity in cell lines with acquired resistance to doxorubicin, vincristine, vinblastine, paclitaxel, and docetaxel. This is a randomised, open-label, parallel-group phase 2 study of cabazitaxel versus best supportive care (including chemotherapy).
The cerebral oxygen saturation is assessed by means of near-infrared spectometry in parturients undergoing cesarean delivery under spinal anesthesia. The investigators hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation.
This study aims to shed light on the theoretical concept of mental flexibility and its manifestation in adolescents following frontal lobe damage, and to develop a test battery for young Hebrew speakers.
This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for lung cancer. PRIMARY OBJECTIVES: I. To determine whether screening with chest x-ray can reduce mortality from lung cancer in women and men aged 55-74 at entry. SECONDARY OBJECTIVES: I. To assess screening variables, other than mortality, for each of the interventions including sensitivity, specificity, and positive predictive value. II. To assess the incidence, stage, and survival of cancer cases. III. To investigate the mortality predictive value of biologic and/or prognostic characterizations of tumor tissue as intermediate endpoints. IV. To conduct biomolecular and genetic research into factors associated with cancer carcinogenesis and promotion, as well as the early detection of these factors. OUTLINE: Participants in the overall PLCO study are stratified by screening center, gender, and age (55-59 vs 60-64 vs 65-69 vs 70-74). Participants are randomized to 1 of 2 arms (control vs screening). ARM I (Control): Participants receive standard medical care. Participants complete a Diet History Questionnaire (DHQ) at baseline. ARM II (Lung Screening): Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years.
Lung cancer is the number one cancer killer in the USA. Early stage lung cancer is asymptomatic. Most patients with lung cancer are usually symptomatic at diagnosis and already have advanced stage disease. Low dose CT screening (LDCT) for high risk individuals has recently been shown to decrease lung cancer mortality by 20%. However, 4 out of 5 lung cancer deaths are not prevented with LDCT screening alone. In this trial, the addition of a blood biomarker test is being combined with early LDCT to determine if screening with combination may result in detection of more lung cancer at an earlier stage of disease.The study will also assess if the blood test is able to detect lung cancers in high risk individuals when the LDCT is negative for cancer. There will be health-economic costs included in the final analysis of study data.
The study aims to determine if there are defining EBUS and confocal endoscopy features as well as exhaled alveolar gas VOC that can discriminate malignant pulmonary nodules or masses from benign etiology, thereby obviating unnecessary thoracotomy. Directly sampled alveolar gas VOC from patients with lung cancer will be compared against exhaled breath VOC for signature compounds that may complement CT in screening the population at risk. AIMS 1. To improve diagnostic yield of pulmonary nodule or mass by using combined approach of navigation bronchoscopy and EBUS. 2. To determine if characteristic features of EBUS and confocal microendoscopy exist as well as VOC patterns in alveolar and exhaled gas that can aid in discriminating malignant pulmonary nodule or mass from benign etiology by correlating with pathology. 3. To identify VOC patterns specific for lung cancer by correlating VOC from directly sampled alveolar gas and exhaled breath with pathology. Exhaled breath VOC signature may complement CT in screening population at risk.
This clinical trial studies biomarker differences in samples from patients with undifferentiated sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Prospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Patients from ARST0332 study Sampling Method: Non-Probability Sample PRIMARY OBJECTIVES: I. To determine what proportion of unclassifiable sarcomas are unclassifiable because the initial evaluation was not sufficiently comprehensive versus what proportion can be regarded as "true" undifferentiated sarcoma when a comprehensive assessment has been performed. II. To develop formal diagnostic criteria for establishing the diagnosis of undifferentiated sarcoma. III. To determine whether undifferentiated sarcoma can be subdivided into separate and distinct pathologic entities that are distinguishable by light microscopy, immunohistochemistry, single nucleotide polymorphism (SNP) array profiling, or clinical features. IV. To determine whether undifferentiated sarcomas with specific "actionable mutations" can be identified based on their histologic appearance, immunohistochemical staining characteristics, or SNP array profiling features. OUTLINE: Tissue samples are analyzed for loss of heterozygosity (LOH) and SNP array profiling using microarray and immunohistochemistry.
The purpose of this institutional protocol is to offer SBRT to selected patients in a controlled environment to refine treatment techniques (including dose/fractionation schedules) and standardize follow-up. SBRT has been in clinical use for over a decade in some institutions and the available data suggest that it can be used safely and with good results. This study will see how effective Stereotactic Body Radiation Therapy is for treating tumours in the lung and how often people have side effects. Radiation therapy is usually given once a day, often for a few weeks. In this study, study participants will receive high doses of radiation treatment to tumours in the lung for 3 to 10 treatment sessions over a total of about 1 to 2 weeks. Several reports indicate that this therapy might shrink tumours and control the cancer for extended periods of time. Although specialists started to treat patients with SBRT over 10 years ago, it is still used in relatively few cancer centres. SBRT is an adaptation of the principles and experience gained from stereotactic brain RT. SBRT was developed in the early 90s at the Karolinska Institute in Stockholm, Sweden, and is used as an accepted alternative of treatment for patients with early stage lung cancer in many centers in Japan and a number of centers in Germany,USA and elsewhere. It is also now being used for patients who have lung metastases and extra-thoracic disease (primary or metastatic).
This is a phase II protocol to determine the safety and feasibility of Intraoperative CT fluoroscopy guidance for lung resection for small nodules. This is a phase II protocol to determine the safety and feasibility of image guided CT marking for resection of small lung nodules. This is relevant because many such nodules are hard to localize for minimally invasive lung resection. It is hoped that this technology using fluoro CT capability available now in most operating room will improve safety and reliability of thoracic surgery.
The primary objective was to determine the tolerability of a new inhaled formulation of interferon beta-1a when given as a single dose, when given once per week for 4 weeks, and compared with standard intramuscular (IM) AVONEX® when given as a single dose. The additional objectives were: To determine the pharmacokinetic (PK) properties of a new inhaled formulation of interferon beta-1a, using an anti-viral cytopathic effect (CPE) assay for human interferon-beta, when given as a single dose, when given once per week for 4 weeks, and compared with standard IM AVONEX® when given as a single dose. To determine the pharmacodynamic (PD) properties of a new inhaled formulation of interferon beta-1a, as measured by serum neopterin and 2-microglobulin, when given as a single dose, when given once per week for 4 weeks, and compared with standard IM AVONEX® when given as a single dose.
The primary objective of this study is to determine the response rate, duration of response,progression-free survival and overall survival of subjects with advanced melanoma treated with TH-302. Hypoxia is an independent marker of a poor prognosis for subjects with metastatic melanoma (Simonetti 2012, Lartigau 1997). Hypoxic melanoma cells are more likely to exhibit a stem-cell like phenotype with an associated increased propensity for invasion, angiogenesis, and metastasis formation compared to normoxic cells. Moreover, this phenotype is also associated with treatment resistance. TH-302, a hypoxia activated prodrug (HAP), was designed to target the hypoxic nature of tumours while having a minimal effect on normoxic tissue. TH-302 belongs to a class of alkylating agents that have significant experimental and clinical activity (Brock 1989). Preclinical data support the hypothesis that TH-302 targets hypoxic regions of tumours and is also able to kill tumour cells in normoxic regions as a result of cytotoxin diffusion, leading to significant effects on tumour growth (Meng 2011). TH-302 has been investigated in over 700 subjects with solid tumours or hematologic malignancies, including subjects with metastatic melanoma. In this subset a disease control rate of 63% (3 subjects with partial responses and 9 subjects with stable disease out of a total of 19) was observed in an early phase clinical trial of TH-302 (Weber 2010). Predictive biomarkers for response and toxicity have yet to be identified for subjects with advanced melanoma treated with TH-302.
The purpose of this study is to prospectively evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema. This is a prospective single arm study to evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.
The primary objective of this study was to determine the maximum tolerated dose (MTD) of BIBF 1120 in patients with solid tumours by the monitoring of drug-related adverse events. Secondary objectives were the evaluation of safety, efficacy, pharmacokinetics, and pharmacodynamics.
A small proportion of patients with lung cancer present with a solitary pulmonary nodule (SPN). This is an important group of patients because if it is lung cancer, presentation as a SPN represents early disease, which following surgery has a high 5 year survival rate. However as not all SPNs are lung cancer it would be unethical to biopsy every case. Clinical guidelines recommend that SPNs should undergo an initial (FDG)-PET/CT scan, which may give more information about the SPN and may indicate if it is likely to be lung cancer. However in many cases it does not and current practice is to monitor the SPN with a series of CT scans over 2 years to look for changes or growth which may/ but not always indicate lung cancer. If no changes are observed over 2 years the SPN is considered not lung cancer. This is both expensive for the National Health Service (NHS) and worrying for the patient in terms of monitoring CT costs and delayed treatment due to length of time to diagnosis. This study examines the diagnostic capacity of using a different CT scan. Dynamic Contrast Enhanced -CT(DCE-CT). DCE-CT and FDG-PET/CT scans give different information about the SPN and the investigators will look to see if information from either scan or combined information from both scans may be better in the diagnosis of early stage lung cancer.