Kornimate/medical-research-clean huggingface dataset:
beijngfh health cohort study

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: metabolic associated fatty liver disease(mefld) is a major chronic liver disease that can lead to various adverse events, such as liver cancer, cardiovascular disease, and chronic kidney disease. the present community-based cohort study enrolls subjects who take health physical examinations at the sub-center outpatient department, beijing friendship hospital. investigators collect their baseline information, including demographic data, clinical history, physical examination, laboratory results, imageological examination, and so on. follow-up surveys are conducted annually and the information collected is the same as the baseline. the outcome information, including cardiovascular disease, malignancy, liver cirrhosis, liver decompensation, liver transplantation, and all-cause mortality, are obtained by linking to the hospital discharge database and death registration system of beijing. the primary aim of the study is to build a risk-stratified evaluation system for mafld through the cohort.

the present community-based cohort study enrolls subjects who take physical health examinations at the sub-center outpatient department, beijing friendship hospital. after signing the informed consent, their previous health physical examination results, which were recorded in the hospital information system (his) are collected retrospectively. then, investigators collect their baseline information, including demographic data, clinical history, physical examination, laboratory results, image logical examination, and so on. additionally, follow-up surveys will be conducted annually and the information collected is the same as the baseline. the outcome information, including cardiovascular disease, malignancy, liver cirrhosis, liver decompensation, liver transplantation, and all-cause mortality, is obtained from the hospital discharge database and death registration system in beijing. the study's primary aim is to build a risk-stratified evaluation system for mafld through a community population cohort with long-term stable follow-up.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * permanent residents in beijing * signing informed consent exclusion criteria: * no

Keywords: non-alcoholic fatty liver disease cohort studies risk factors
gluten-free diet in patients with primary sclerosing cholangitis (psc)

Conditions: Reduction of Intestinal Inflammatory Activity

Summary: gluten is a protein found in wheat and other cereals as barley and rye. it triggers an inflammatory reaction in the small-bowel of genetically predisposed persons. alpha-amylase/trypsin inhibitors (atis) of wheat seem to be the responsible trigger of this intestinal inflammation. intestinal inflammation is connected to other extra-intestinal autoimmune inflammations like psc (as f.ex. the association of psc with inflammatory bowel disease proves). hypothesis: avoidance of atis through a gluten-free diet will reduce intestinal inflammation and thus also the the inflammatory activity in the liver. proof of hypothesis: * pilot study with n=20 patients with psc * explorative, open-label, mono-centric study * inclusion criteria: age 18-65, diagnosed psc-associated colitis without relevant clinical activity after last coloscopy.


Eligibility criteria:
inclusion criteria: * diagnosed psc-associated colitis without relevant clinical activity after last coloscopy. exclusion criteria: * patients with coeliac disease or wheat allergy * patients with active colitis * patients already on gluten-free diet * liver transplanted patients * patients also diagnosed with autoimmune hepatites (psc-aih overlap) * coloscopy within 2 months before study * endoscopic retrograde cholangiopancreatography (ercp) within 3 months before study * antibiotics within 3 month before study
risk factors and the role of albumin-to-globulin ratio in idiopathic granulomatous mastitis

Conditions: Idiopathic Granulomatous Mastitis

Summary: albumin-to-globulin ratio (agr) is an inflammation-based index that has been shown to have a role in many cancers and inflammatory diseases. idiopathic granulomatous mastitis (igm) is a rare inflammatory disease of the breast with a high recurrence rate. as a relatively new biomarker for inflammatory diseases, agr's role in igm recurrence has never been investigated in the literature. this study primarily investigates the possible risk factors for igm recurrence and whether agr can be used as a predictive factor.

patients diagnosed with igm on pathology reports between january 2016 and march 2021 were enrolled in the study and their medical records were analyzed retrospectively. the patients were divided into two groups: recurrence and non-recurrence. clinical, demographic characteristics, and laboratory parameters were compared. the best cut-off value for significant factors in predicting recurrence was determined by receiver operating characteristic (roc) analysis. univariate and multivariate logistic regression analysis was used to determine the risk factors that are effective in igm recurrence.

Eligibility criteria:
inclusion criteria: * the patients with a pathologically confirmed diagnosis of granulomatous mastitis * patients over the age of 18 * female patients exclusion criteria: * male patients * secondary granulomatous mastitis etiologies (tuberculous mastitis and wegener's granulomatosis) * patients who do not have enough follow-up information * patients with missing data

Keywords: idiopathic granulomatous mastitis recurrence albumin-to-globulin ratio risk factors
lumen-apposing metal stent with or without coaxial plastic stent for treatment of walled-off pancreatic necrosis

Conditions: Pancreatitis, Acute Necrotizing; Walled Off Necrosis

Summary: a prospective randomized cohort study to compare whether the placement of a double-pigtail plastic stent (dps) within a lumen-apposing metal stent (lams) may improve the efficacy and safety of endoscopic ultrasound guided transmural drainage of walled-off pancreatic necrosis (won) and thus prevent potential adverse events related to lams insertion.

the aim of the study is to compare endoscopic ultrasound guided transmural drainage using lumen-apposing metal stent with (1.) or without (2.) coaxial plastic stent in the management of walled-off pancreatic necrosis. the usage of lams has been evaluated as a safe and effective method for the drainage of walled-off pancreatic necrosis in various studies. however, complications such as bleeding, infection due to stent obstruction, stent migration, or buried stent syndrome have been reported. a preventive measure to minimize adverse events related to lams insertion by means of placing an anchoring dps through the lams have been suggested but there has been no prospective randomized study to assess the utility of such measure to date. the study is to be conducted at a tertiary institution with an expertise in treating hepato-pancreato-biliary diseases. the main timeframe of the study is 3 weeks following lams insertion with or without dps. all lams will be extracted 3 weeks after the initial procedure. the extraction will be preceded by a ct scan of the abdomen to assess whether the dps needs to be left in place/ inserted in patients with incomplete resolution of the collection. in addition, material from the collection will be collected for cultivation at every endoscopic intervention to assess colonization by microbial flora over time. all patients will be closely followed with clinical, laboratory, and radiological assessment for 12 months in total. our experience has shown failure of the (2.) method in 70 % of patients so far. assuming a clinically significant difference to be a reduction to 40 % in failed patients using the (1) method, the required study population size was calculated to 62 patients (31 in both arms) by power analysis (at standard alpha and beta values). the final number was set to 70 as a safety measure.

Eligibility criteria:
inclusion criteria: * walled-off pancreatic necrosis (won) indicated for endoscopical drainage * signed informed consent form exclusion criteria: * patient disagreement with the study * types of collections other than won * drainage with stents other than lams * previous attempts at drainage of won * severe coagulopathy or thrombocytopenia

Keywords: walled off necrosis acute pancreatitis necrotizing pancreatitis endoscopic drainage lumen apposing metal stents double pigtail plastic stent
assessment of the quality of life of multiple sclerosis patients treated with ofatumumab in real-life in france

Conditions: Multiple Sclerosis (MS)

Summary: sepros is a non-interventional study, based on primary data collection of ms adult patients who initiated ofatumumab as per neurologist practice and regardless of the study protocol.

this is a non-interventional, prospective (primary data), multicenter study conducted in metropolitan france. the primary objective of this study is to describe the quality of life of ms patients after initiation of treatment with ofatumumab. in order to form a representative sample of ms patients taking into account the terms of care in france, free or practicing neurologists in healthcare institutions (public or private) in different regions of france will be selected to participate in this study. the study will enroll adult patients with ms who initiated ofatumumab according to the physician's advice and independently of the study. patients will be followed from initiation of ofatumumab either until (i) 12 months (± 1month) after initiation of ofatumumab (end of study), or until (ii) discontinuation of treatment with ofatumumab prior to the completion of the 12-month follow-up (early termination); whichever occurs first (end of study or early termination).

Eligibility criteria:
inclusion criteria: 1. male or female, 18 years of age or older 2. patient with confirmed ms diagnosis 3. patient initiating treatment with ofatumumab for the first time 4. patient for which the decision to initiate treatment with ofatumumab was made by the doctor (investigator) in accordance with his/her usual practices independently of the study 5. patient not opposed to participation in this study 6. patient willing and able to complete patient questionnaires exclusion criteria: 1. patient treated with ofatumumab in the context of a clinical trial

Keywords: ms multiple sclerosis nis ofatumumab kesimpta qol pro
a study comparing standard treatments in people with non-muscle invasive bladder cancer (nmibc)

Conditions: Non-Muscle Invasive Bladder Cancer

Summary: the purpose of this study is to compare the effectiveness of different fda-approved/nccn-recommended drug treatments for nmibc. in particular, the fda-approved drug nadofaragene firadenovec will be compared to usual care with other nccn-recommended standard treatments for nmibc (gemcitabine with or without docetaxel, mitomycin, re-treatment with bcg, or pembrolizumab).


Eligibility criteria:
inclusion criteria: * 21 years of age or older * being treated for high-grade nmibc (tis, ta, or t1) with one of the participating treating urologists at msk * one or more prior induction course of bcg at any point in time and judgment by the treating urologist that bcg has failed °any amount of maintenance bcg is allowed * in the previous 12 months, receipt of at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for nmibc treatment °an intravesical agent can include bcg or any other nmibc treatment * in the opinion of the treating urologist, there is no contraindication to treatment with nadofaragene firadenovec (i.e. hypersensitivity to ifna, severe immunosuppression) and there is uncertainty over whether nadofaragene is better than "best usual care" exclusion criteria: * opting for treatment with radical cystectomy * currently enrolled in a clinical trial of an experimental therapy for nmibc * prior exposure to nadofaragene firadenovec
breath analysis in children by new point-of-care instruments

Conditions: Asthma; Cystic Fibrosis

Summary: in this study new hand-held devices for measuring exhaled breath will be tested in children with asthma, cf, and healthy controls. main objectives will be feasibility and discriminative value of these techniques.

rationale: assessment of volatile organic compounds (vocs) is a new recently developed non-invasive technique to assess airway inflammation. the non-invasive character makes it highly suitable for use in (preschool) children. however, the analysis of vocs by gas chromatography mass spectrometry technique (gc-ms), the gold standard, is expensive and time consuming. therefore, new hand-held devices (such as electronic noses (enoses) and ion mobility spectrometer techniques) have been developed. however, these new point-of-care instruments have not been studied in children. objectives: 1) to test whether new point-of-care instruments for the measurement of vocs in exhaled breath are feasible for use in children aged 6 to 16 years; 2) to explore whether these techniques can differentiate between healthy children, asthmatic children and children with cystic fibrosis (cf). study design: cross-sectional study design. several vocs tests will be performed in all participants.besides, fraction of exhaled nitric oxide (feno) and inflammatory markers in exhaled breath condensate (ebc) will be measured. study population: three groups of children aged 6 to 16 years: 20 healthy children, 20 children with doctor's diagnosed asthma, 20 children with cf. main study parameters/endpoints: each technique will be evaluated for its use and feasibility in children. for each technique, voc profiles between study groups will be evaluated for its discriminative power.

Eligibility criteria:
inclusion criteria: * children aged 6 to 16 years * healthy group: see exclusion criteria * asthma group: doctor's diagnosed asthma * cystic fibrosis group: a diagnosis of cystic fibrosis, confirmed by a sweat test or genetic analysis exclusion criteria * recent course of prednisone or antibiotics (\< 1 month before test) * passive smoking * other chronic inflammatory disease (e.g. inflammatory bowel disease, rheumatic disease, auto-immune disease) * healthy children: * no current or history of respiratory symptoms * no current or history of allergic rhinitis

Keywords: paediatrics breath analysis volatile organic compounds respiratory diseases
robot-assisted versus standard laparoscopic approach for the surgical treatment of deep infiltrating endometriosis

Conditions: Endometriosis

Summary: deep infiltrating endometriosis (die) is a severe form of endometriosis in which lesions affect retroperitoneal tissue and pelvic organs wall. it is often a cause of significant pain (dysmenorrhea, dysuria, dyspnea, dyspareunia and chronic pelvic pain) and infertility, drastically reducing patients' quality of life. surgical therapy with complete removal of endometriotic lesions is often necessary when the disease is resistant to medical therapy. the minimally invasive surgical approach has proved to be the most advantageous. over time, there has been a growing use in the gynecological field of robot-assisted laparoscopic surgery. several clinical cases and retrospective studies on robotic surgery for die have highlighted favorable surgical outcomes, with the exception of operative times, compared to standard laparoscopic approach. however, a randomized control studies comparing surgical outcomes and postoperative pelvic organs function in women with die submitted to robotic-assisted or conventional laparoscopy is missing. in order to analyze the real impact of robotic advances the present study sought to assess surgical outcomes and urinary, bowel and sexual functions in women with die requiring minimally invasive surgery through robot-assisted or conventional lps approach.

patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of deep endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study. patients are divided into 2 groups: group a: standard laparoscopic approach group b: robot-assisted approach after surgery, patients will be included in the post-operative follow-up, as usual in our clinical practice.

Eligibility criteria:
inclusion criteria: * diagnosis of deep endometriosis based on clinical and transvaginal/transabdominal ultrasound examinations and, when necessary, magnetic resonance * patients with indication for removal of endometriosic lesions by standard and robot-assisted laparoscopy * obtaining informed consent exclusion criteria: * contraindications for removal of endometriosic lesions by standard and robot-assisted laparoscopy * cardiovascular problems * hepatic insufficiency * psychiatric diseases * history of oncologic disease

Keywords: endometriosis robot-assisted surgery standard laparoscopic surgery
the spinus i study: spinal fusion for a single level spect/ct positive lumbar degenerative disc disease

Conditions: Degenerative Disc Disease; Back Pain, Low

Summary: the aim of the present study is to find out whether fusion of a sinlge level spect/ct positive degenerative disc disease leads to a significant improvement of pain and disability.

chronic back pain (cbp) is a very common clinical problem. it is dominantly caused by degenerative changes, while specific causes such as tumor, trauma or inflammatory conditions are relatively rare. back pain may be a concomitant symptom of lumbar disc herniation or spinal canal stenosis and is a typical symptom of spondylolisthesis. magnetic resonance imaging (mri) plays a key role in the diagnosis, showing in detail the soft structures, vertebral bodies (modic changes, mc) or signs of facet arthropathy. on the other hand, it also proves a number of clinically silent findings. degenerative disc disease (ddd) or facet osteoarthritis are most often considered to be a pain generator. the problem, however, is that both entities are very common in the general population without a painful correlate, and there is still controversy in the literature about their role in the genesis of cbp. radionuclide bone scintigraphy with single photon emission computed tomography (spect) provides functional imaging and is used to detect microcalcification due to increased osteoblastic activity. in the absence of other pathology the foci of increased osteoblastic activity reflex areas of mechanical stress and degenerative change in the skeleton. there is growing evidence about the relationship between ddd, facet arthropathy, and spect positivity. although these findings have been recently confirmed by surgical studies, the evidence about the effect of surgical treatment of spect positive lumbar degeneration is still weak due to the small number of operated patients. the aim of the present study is to define a possible correlation between degenerative changes of the lumbar spine and positivity on spect/ct imaging. patients with a single level spect+ ddd will undergo spinal fusion of the involved segment. postoperative improvement will be measured by odi (oswestry disability index) and pain vas (visual analogue scale) in 6 and 24 months follow-up period.

Eligibility criteria:
inclusion criteria: * lower back pain (in extension +/- pain in buttocks, groin, thigh) without radicular pain * symptoms \> 6 months after failure of conservative management in the primary care setting * mri signs of degenerative disc disease or facet arthropathy * one-level positivity on lumbar spect/ct exclusion criteria: * other spinal pathology (tumours, congenital defects, spondylolysis or spondylolisthesis) * intolerance of spect examination * pregnancy
safety study evaluating intravenous infusions of tigecycline to treat acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to determine whether tigecycline is safe and which dosage is most effective in the treatment of patients with acute myeloid leukemia.

relapsed and refractory hematologic malignancies have poor responses to standard therapy and are associated with a poor prognosis. for example, relapsed acute myeloid leukemia (aml) is a highly aggressive and resistant disease, particularly when associated with first complete response (cr) duration of less than 12 months. thus, there is an urgent need for new agents in relapsed and refractory hematologic malignancies such as acute leukemia. in elderly patients, where the tolerance of aggressive induction therapy is often poor and curative options such as bone marrow transplantation hsct are not available, the need for effective non-aggressive drug regimens for aml is even greater. tigecycline is a glycylcycline derivative of tetracycline. tigecycline is currently indicated for the treatment of complicated skin and skin structure infections, and complicated intra-abdominal infections. this clinical trial is a phase i dose escalation study of tigecycline in patients with relapsed or refractory aml or those with newly diagnosed disease not eligible for induction chemotherapy.

Eligibility criteria:
inclusion criteria: * age \>18 years * diagnosis of relapsed or refractory aml for which all potentially curative or standard salvage therapy options have been exhausted; or aml without prior treatment who are not eligible for induction chemotherapy as defined as age \> or equal to 80 or age \> 70 with poor risk cytogenetics (3 or more abnormalities, -5/del(5q), 3q abnormalities, or -7) or stable co-morbidities that would preclude induction chemotherapy such as lvef less than 40% and/or dlco less than 60% expected * ecog 0-2 performance status * biochemical values within the following range * serum creatinine \<2x upper limit of normal * total bilirubin \<1.5x upper limit of normal * ast and alt \<2x upper limit of normal * recovery from non-hematologic toxicity from prior chemotherapy * able and willing to provide informed consent exclusion criteria: * allergy to tetracycline or minocycline * uncontrolled intercurrent illness such as uncontrolled diabetes or active uncontrolled infection * active systemic bacterial, fungal, or viral infection * concomitant use of linezolid or chloramphenicol that are known to inhibit mitochondrial protein synthesis * pregnant or breast feeding * known active cns involvement with aml * neurologic symptoms related to uncontrolled illnesses or unexplained causes * psychiatric illness that would limit compliance with study * receiving systemic chemotherapy other than hydroxyurea to control circulating blast counts. concomitant hydroxyurea is permitted, but only in the first cycle of therapy * prior therapy with tigecycline as an anti-cancer therapy or any use of the drug in the last month * use of other investigational anti-leukemic therapy within 14 days of registration

Keywords: aml