Kornimate/medical-research-clean huggingface dataset:
posaconazole (mk-5592) intravenous and oral in children (<2 years) with invasive fungal infection (mk-5592-127)

Conditions: Invasive Fungal Infection

Summary: this study aims to estimate the pharmacokinetics (pk) of posaconazole (pos, mk-5592) intravenous (iv) and powder for oral suspension (pfs) formulations in pediatric participants \<2 years of age with invasive fungal infection (ifi).

there are 2 panels in this study. in panel a, pos iv will be evaluated in ≥8 participants. in panel b, both pos iv and pos pfs will be evaluated in ≥14 participants, including ≥6 who are \<3 months of age and ≥5 who transition to the pfs formulation of pos.

Eligibility criteria:
inclusion criteria: * panel a: is undergoing treatment for possible, probable, or proven ifi known or suspected to be cause by fungal pathogens against which pos has demonstrated activity (which can include candidiasis) * panel b: has an investigator-assessed diagnosis of possible, probable, or proven ifi known or suspected to be cause by fungal pathogens against which pos has demonstrated activity (and cannot include candidiasis) * has a central line (eg, central venous catheter, peripherally-inserted central catheter) in place or planned to be in place before beginning iv study intervention. * has a body weight of ≥500 g * the participant (or legally acceptable representative) has provided documented informed consent for the study. exclusion criteria * has received pos within 30 days before day 1 * has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis * has a known hereditary problem of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption * has known or suspected active covid-19 infection * has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study intervention used * has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired qt interval (qt) prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of first dose of study intervention * has received any listed prohibited medications within the specified timeframes before the start of study intervention * has a known hereditary problem of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption (part b) * has suspected/proven invasive candidiasis (part b) * has enrolled previously in the current study and been discontinued * has qtc prolongation at screening \>500 msec * has significant liver dysfunction * is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days
a study of individualized stereotactic body radiation therapy (sbrt) for intrahepatic cancer

Conditions: Liver Cancer; Hepatocellular Cancer

Summary: this is a phase ii trial to characterize the safety and efficacy of individualized stereotactic body radiation therapy (srbt) for patients who have had previous liver treatment or who have primary hepatocellular carcinoma (hcc).

the trial endpoints are toxicity, survival and progression-free survival. dce-mri and plasma biomarkers will also be collected to explore their use as tools for treatment individualization in future trials. during the current trial, an indicator of liver function, indocyanine green (icg), will be used to identify during treatment patients who are at excess risk for radiation-induced liver disease (rild) so that their radiation dose may be reduced. the model used for individualization will be updated as trial data accrue, so this is an adaptive trial of an individualized therapy. the planned accrual is seventy (70) evaluable patients over three years.

Eligibility criteria:
inclusion criteria: * over age 18 * life expectancy of at least 12 weeks * zubrod performance status of ≤2. * biopsy proven hepatocellular carcinoma (hcc) * liver metastases * a discrete hepatic tumor(s) as defined by the barcelona46 criteria - for cirrhotic patients, (1) 2 imaging studies showing hypervascular tumor \> 2cm, or (2) single imaging study showing hypervascular tumor \> 2cm with afp ≥ 400 ng/ml * a discrete hypervascular tumor present on two consecutive imaging studies (ct or mri) with documented growth of \> 1cm in diameter * adequate organ function * women and men not interested in pregnancy * must be recovered from the effects of any prior surgery, radiation therapy, chemotherapy and the effects of radiofrequency ablation (rfa) or transcatheter arterial chemo embolization (tace) * minimum of 6 weeks following their last surgical procedure, radiation and chemotherapy. exclusion criteria: * cannot be eligible for a curative liver resection * uncontrolled ascites clinically evident on physical exam * known allergy to ic-green * known allergy to intravenous iodinated contrast agents * patients with poor venous access * patients with metastatic cancer with normal liver function who have not undergone previous liver directed therapy and a single tumor \< 6 cm in size.
renal manifestations during idiopathic inflammatory myopathies

Conditions: Inflammatory Myopathy

Summary: there are currently no recommendations regarding treatments for idiopathic inflammatory myopathies (iim) due to the difficulty in conducting high-powered randomized controlled trials. generally speaking, corticosteroids constitute one of the cornerstones of treatment and are, with some exceptions, always used at least in the initial phase of the disease. in general, this involves oral corticosteroid therapy initiated between 0.5 and 1.5 mg/kg/day followed by a gradual decrease after 4 to 6 weeks of treatment. it is generally necessary to introduce immunosuppressive treatment early with the aim of avoiding corticosteroids. the most commonly used as first-line treatment and having shown effectiveness in observational studies are methotrexate, azathioprine, mycophenolate mofetil and calcineurin inhibitors. in general, rituximab is reserved for severe forms refractory to several first-line immunosuppressants, and has shown some effectiveness during a randomized study. likewise, cyclophosphamide is only considered in the most severe forms, generally rapidly progressive interstitial lung damage. more recently, janus kinase inhibitors have been evaluated in several open-label and small-number studies, showing interesting effectiveness, particularly for refractory forms, as shown in this recent review of the literature. immunoglobulins are the only treatment that has shown superiority compared to placebo in good quality randomized controlled studies. however, due to their cost and difficulty of access, they should be reserved for the severe form, particularly in cases of dysphagia, or refractory form. apart from these medicinal treatments, it is necessary to add all the non-drug measures which are an integral part of the management of iim. performing regular physical activity helps prevent muscle loss and also has a beneficial effect on other comorbidities often present in patients and aggravated by corticosteroid therapy, such as cardiovascular risk factors, osteoporosis and resistance to 'insulin.


Eligibility criteria:
inclusion criteria: * major subject (≥ 18 years old) * inflammatory myopathy defined by the acr/eular 2017 criteria * kidney biopsy performed * supported at the strasbourg university hospital during the period from january 1, 1990 to may 1, 2023. * subject who has not expressed opposition to the reuse of their data for scientific research purposes. it is the responsibility of the investigator to verify the absence of opposition in the patient's medical file. exclusion criteria: * subject having expressed opposition to participating in the study * known etiology of renal damage excluding inflammatory myopathy.

Keywords: inflammatory myopathy idiopathic inflammatory myopathy renal biopsy, guided kidney aspiration biopsy
coronary ct angiography evaluation for clinical outcomes: an international multicenter registry (confirm)

Conditions: Atherosclerosis; Coronary Artery Disease; Cardiovascular Disease

Summary: the confirm study was developed to examine the prognostic value of cardiac computed tomographic angiography (ccta) findings for prediction of future adverse cardiac events related to coronary artery disease (cad) in a large, international patient population. the purpose of this multicenter registry is to correlate coronary and non-coronary cardiac findings by ccta with demographic and clinical data for refinement of risk stratification of individuals with suspected or known cad.

coronary computed tomographic angiography (ccta) of 64-detector rows or greater represents a novel noninvasive anatomic method for evaluation of patients with suspected coronary artery disease (cad). early studies suggest a potential for prognostic risk assessment by ccta findings but were limited by small patient cohorts or single centers. the confirm registry is a large, prospective, multinational dynamic observational study of patients undergoing ccta. the primary aim of confirm is to determine the prognostic value of ccta findings for the prediction of future adverse cad events. the confirm registry currently represents 27,125 consecutive patients at 12 cluster sites in 6 countries in north america, europe, and asia. confirm sites were chosen on the basis of adequate ccta volume, site ccta proficiency, and local demographic characteristics and medical facilities to ensure a broad-based sample of patients. patients comprising the present confirm cohort include those with suspected but without known cad, with known cad, or asymptomatic persons undergoing cad evaluation. a data dictionary comprising a wide array of demographic, clinical, and ccta findings was developed by the confirm investigators and is uniformly used for all patients. patients are followed up after ccta performance to identify adverse cad events, including death, myocardial infarction, unstable angina, target vessel revascularization, and cad-related hospitalization.

Eligibility criteria:
all consecutive patients at cluster sites meeting all inclusion criteria undergoing ccta of 64-detector rows or greater will be included within the confirm registry. inclusion criteria: 1. age \> 18 years 2. evaluation by ccta with 64-detector rows or greater for cad evaluation as part of standard of care 3. interpretable ccta 4. prospective data collection for cad risk factors. exclusion criteria: no explicit patient exclusion criteria are defined.

Keywords: coronary artery disease cad atherosclerosis myocardial infarction mi confirm coronary computed tomographic angiography ccta
depression and health outcomes in refractory epilepsy

Conditions: Depression; Epilepsy

Summary: to define the benefits of antidepressant treatment or cognitive behavior therapy on mood, function, and quality of life in persons with depression and refractory epilepsy.

this randomized clinical trial will be conducted to compare the drug sertraline to cognitive behavioral therapy on symptoms of depression, antiepileptic medication compliance, seizure frequency, and quality of life outcomes in persons with depression and a seizure disorder or epilepsy. approximately 140 persons will be enrolled in this study over a period of five years. individual participation will last approximately 16 weeks. study participants will be chosen randomly to receive either the study medication (sertraline) or cognitive behavior therapy for 16 weeks. sertraline is approved by the food and drug administration (fda). subjects who receive cognitive behavior therapy will be provided with a one-hour individual session with a licensed clinical psychologist each week for 15 weeks. all study participants will attend scheduled clinic visits every 4 weeks for 16 weeks.

Eligibility criteria:
inclusion: * must have a seizure disorder. * must meet the dsm-iv criteria for major depression. * must be willing to provide written informed consent. * must be age 21 to 75 years old. * must be compliant, cooperative, reliable, and able to follow instructions, and to visit the clinic on schedule. exclusion: * have active suicidal or homicidal ideation. * have current alcohol or other substance abuse disorders or a history of bipolar depression or any psychotic disorder. * are pregnant or lactating. * are known to be hypersensitive to sertraline. * have a progressive central nervous system disorder (such as a tumor or multiple sclerosis), or severe hepatic or renal disease (serum creatinine \>3 mg/dl). * currently taking an antidepressant medication or seeing a therapist regularly.

Keywords: depression epilepsy seizures
multimodal imaging in rectal cancer & pancreatic cancer

Conditions: Rectal Cancer; Pancreatic Cancer

Summary: most digestive cancers show (over)expression of the tumour marker carcinoembryonic antigen (cea). therefore, interest in cea-targeting tracers has increased over the past years. cea-targeting tracers can be used for preoperative, intra-operative and postoperative imaging purposes. this study focusses on both preoperative and intraoperative multimodal imaging and image-guided surgery in patients with rectal cancer or pancreatic cancer.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of rectal cancer where a (beyond) tme resection is planned for or clinical suspicion of pdac * scheduled for surgical resection * age over 18 years * signed informed consent exclusion criteria: * any medical condition present that in the opinion of the investigator will affect patients' clinical status * administration of a radionuclide within 10 physical half-lives prior to study enrollment * pregnancy or lactation * known cea negative tumor: if a patient had a primary tumor which did not express cea determined immunohistochemically on the resection specimen of a prior operation or biopsy.
decidual stromal cells as treatment for acute graft versus host disease, a phase 1-2 study

Conditions: Graft vs Host Disease

Summary: the purpose of this study is to evaluate safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. the hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.

patients with gvhd grade 2-4, will receive decidual stromal cells at approximately 1-2x10\^6 cells/kg at one or more occasions dependent on clinical response.

Eligibility criteria:
inclusion criteria: * acute graft versus host disease grade 2-4. * are on calcineurin inhibitor and high dose corticosteroids. exclusion criteria: none.

Keywords: stem cell transplantation decidual stromal cells
prophylactic cranial irradiation (pci) vs observation in stage iii nsclc

Conditions: Non Small Cell Lung Cancer (NSCLC); Radical Treatment; Stage III Non-Small Cell Lung Cancer

Summary: for patients with stage iii non-small cell lung cancer, which is radically treated, we will investigate whether prophylactic cranial irradiation (pci) should become standard of care to prevent brain metastases.

for this group of patients, brain metastases are one of the major sites of tumor failure. radical therapy of symptomatic brain metastases is seldom possible and only very rarely, long term survival can be achieved. pci has shown to reduce the incidence of brain metastases in patients with non-small cell lung cancer to the same extent as in limited disease small-cell lung cancer. however, the exact value of pci in stage iii nsclc patient, treated with contemporary chemo-radiation schedule with or without surgery, remains unsettled. therefore this study is launched, in order to investigate whether pci should become the standard of care in patients with stage iii nsclc who are treated with curative intention.

Eligibility criteria:
inclusion criteria: * uicc stage iiia or iiib (without malignant pleural of pericardial effusion) non-small cell lung cancer (histology or cytology) * whole body fdg-pet-scan before start of therapy available: no distant metastases * ct or mri of the brain before the start of radical therapy available: no brain metastases * platinum-based chemotherapy is mandatory * radical local therapy: concurrent of sequential chemotherapy (platinum-based) and radiotherapy with or without surgery * radiotherapy dose without surgery at least a biological equivalent of 60gy * no prior cranial irradiation * patients must sign a study-specific informed consent at the time of registration exclusion criteria: * the opposite of the above
ultrasound guided serratus anterior plane block in ed patients with rib fractures

Conditions: Rib Fractures; Pain Acute; Regional Anesthesia; Opioid Use

Summary: the goal of this clinical trial is to test the effectiveness of the serratus anterior plane block in patients with rib fractures. the main questions it aims to answer are: * determine if ug-sapb results in an improved pain, incentive spirometry, and cough ability (pic) score when compared to usual care over the first five hours. * evaluate if ug-sapb results in fewer opioid medications administered when compared to usual care over the first 24 hours. participants will undergo the serratus anterior plane. researchers will compare this to usual care to see if this intervention improves pulmonary function and reduces opioid requirements for ed patients with rib fractures.


Eligibility criteria:
inclusion criteria: * radiology confirmed anterior or lateral rib fractures either on x-ray or chest computed tomography ct * pain score of 5/10. * patients must be able to verbalize how much pain they are having on an 11-point numeric rating pain scale * perform an incentive spirometry and be able to cough on command exclusion criteria: * isolated rib fractures that do not include ribs t3-t9 * penetrating trauma, pregnancy * requiring immediate surgical or procedural intervention * known allergy to amide-type local anesthetics * have a painful distracting injury

Keywords: rib fractures regional anesthesia opioid use acute pain
effects of pulmonary rehabilitation on cognitive function in patients with severe to very severe chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease is a leading cause of mortality worldwide. it is a systemic disease which includes pulmonary, cardiac, muscular, digestive and cognitive impairments. pulmonary rehabilitation is a symptomatic treatment to reduce dyspnea and functional incapacity. however, it effects on cognitive dysfunction are not well known. the aim of this study is to assess the effects of a comprehensive pulmonary rehabilitation program on cognitive dysfunction in patients with severe to very severe chronic obstructive pulmonary disease using the montreal cognitive assessment tool.


Eligibility criteria:
inclusion criteria: * age \> 18years; * chronic obstructive pulmonary disease stade iii to iv; * referred for pulmonary rehabilitation. non inclusion criteria: * pregnancy or likely to be; * history of psychiatric, neuro-vascular, cognitive disease or cranial trauma; * active alcoholism; * guardianship; * hospitalisation for acute exacerbation of chronic obstructive pulmonary disease in the previous 4 weeks; exclusion criteria: * interruption of the pulmonary rehabilitation program \> 15 days; * disruption of the training before the 18th session; * less than 18 sessions in four month.
pain and smoking study

Conditions: Smoking; Pain; Smoking Cessation

Summary: this purpose of this study is to test the telephone delivery of a cognitive behavioral intervention (cbi), for smoking cessation among veteran smokers with chronic pain

veterans with chronic pain represent an important population in which to focus smoking cessation efforts. smoking cessation among patients with chronic medical illnesses substantially decreases morbidity and mortality; yet, many patients (\>50%) with chronic pain continue to smoke. this study aims to test the telephone delivery of a cognitive behavioral intervention (cbi), for smoking cessation among veteran smokers with chronic pain. proposed is a randomized comparative effectiveness trial with a two-group design in which 370 veteran smokers with chronic pain will be randomized to either: 1) smoking cessation plus cbi (smk-cbi), an intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain and a tele-medicine clinic for accessing nicotine replacement therapy (nrt), or 2) smoking cessation telephone counseling control (smk control), a contact-equivalent control that provides standard smoking cessation telephone counseling and a tele-medicine clinic for accessing nrt.

Eligibility criteria:
inclusion criteria: * veterans enrolled at va connecticut or va central western massachusetts * current cigarette smokers * willing to make quit attempt in next 30 days * pain intensity 4 or greater on scale 0-10, self-reported exclusion criteria: * non-english speaking * no access to telephone/lack of telephone access * severely impaired hearing * active diagnosis * terminal illness * refusal to provide informed consent * enrolled in concurrent smoking cessation programs/research

Keywords: smoking cigarette smoking veterans tobacco use pain
egg ingestion in adults with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: we propose a prospective, randomized, single-blind controlled crossover study to assess the effects of daily egg inclusion versus egg exclusion, on glycemic control, anthropometric measures, and overall diet quality in adults with type 2 diabetes.

hypothesis inclusion of eggs in the diets of individuals with type 2 diabetes mellitus will improve glycemic control, anthropometric measures and overall diet quality. restriction of dietary cholesterol, and thus the avoidance or restriction of egg intake, is routinely recommended to patients at increased risk for cvd, including those with diabetes. however, the relative importance of dietary cholesterol to serum lipids and the role of egg ingestion in cardiovascular risk are increasingly suspect. further, the exclusion of eggs from the diet may lead to increased consumption of high-glycemic carbohydrate foods of particular potential harm to individuals with diabetes. the examination of how food-specific recommendations translate into effects on other food choices and overall diet quality, and in turn health effects, is a neglected area of research. eggs provide a complete profile of amino acids and an array of micronutrients, and are low in total fat. although epidemiological and clinical studies largely suggest a lack of association between egg intake and harmful effects, the evidence is somewhat more ambiguous with regard to glycemic control for diabetes, or the risk for cvd among individuals with diabetes. our own prior work shows no adverse effects of egg ingestion in healthy adults, hyperlipidemic adults, or adults with established coronary artery disease. as a satiating and protein-rich food, eggs have potential to foster calorie and weight control, and to reduce the dietary glycemic load, offering potential advantages in type 2 diabetes.

Eligibility criteria:
inclusion criteria: * males age greater than 35 years; * post-menopausal females not currently on hormone replacement therapy; * non-smokers; * clinical diagnosis of type 2 diabetes mellitus for at least 1 year but no more than 5 years; * 6.5% ≤ hba1c ≤8.0% (5) bmi between 25 and 40 kg/m². exclusion criteria: * failure to meet inclusion criteria; * anticipated inability to complete study protocol for any reason; * current eating disorder; * use of antihyperglycemic, lipid-lowering or antihypertensive medications unless stable on medication for at least 3 months; * use of glucocorticoids, antineoplastic agents, psychoactive agents, or nutraceuticals; * regular use of fiber supplements; * restricted diets (i.e., vegetarian, vegan, gluten free); * known allergy to eggs.

Keywords: type 2 diabetes egg glycemic control insulin sensitivity diet quality