Kornimate/medical-research-clean huggingface dataset:
deutsches device qualitätsregister

Conditions: Heart Failure

Summary: it is the aim of this register to document the development of therapies by implantation of cardioverter/defibrillators (icds) and/or cardiac resynchronization therapy (crt)-systems.

the possibility of evaluation of successes as well as of the complications of these therapies is needed to make quality management possible. every german center, implanting icds or crt-devices, is encouraged to contribute to this register; data are collected by use of an electronical crf.

Eligibility criteria:
inclusion criteria: * the device register will include all consecutive patients with an intended implantation of an icd / crt. exclusion criteria: * missing signed informed consent

Keywords: heart failure cardiac insufficiency implantable cardioverter/defibrillator cardiac resynchronization therapy icd crt register
safety and tolerability of bion-1301 in adults with relapsed or refractory multiple myeloma (mm)

Conditions: Multiple Myeloma

Summary: this is a phase 1/2 study designed to evaluate the safety and tolerability of bion-1301 in adults with relapsed or refractory multiple myeloma whose disease has progressed after 3 or more prior systemic therapies.

an open-label, multi-center, dose-selection phase 1/2 study (also referred to as adu-cl-16) evaluating bion-1301, a humanized monoclonal antibody directed against april for the treatment of relapsed or refractory mm. this first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and initial clinical activity of bion-1301 administered as a single agent. the study will be conducted in 2 parts. phase 1 is dose escalation and seeks to determine the recommended phase 2 dose (rp2d). once an rp2d is identified, phase 2 of the study will open and continue to evaluate the safety and preliminary efficacy of bion-1301 administered at selected dose level(s). the population for this study will consist of adults with relapsed or refractory mm whose disease has progressed after at least 3 prior systemic therapies. bion-1301 will be administered in 28-day cycles; the dosing interval will be once every two weeks (q2w).

Eligibility criteria:
key inclusion criteria: individuals eligible to participate in this study must meet the following key criteria and additional criteria as specified in the protocol: 1. male or female, aged ≥ 18 years 2. confirmed diagnosis of mm per imwg criteria 3. measurable disease as defined by one or more of the following: * serum m-protein ≥ 0.5 g/dl * urine m-protein ≥ 200 mg/24 hours * serum free light chain (flc) assay: involved flc level ≥ 10 mg/dl provided serum flc ratio is abnormal * in cases where spep is unreliable, serum quantitative immunoglobulin (qiga) ≥ 750 mg/dl (0.75 g/dl) is acceptable 4. relapsed or refractory (rajkumar, 2011) to 3 or more different prior lines of therapy for mm, including immunomodulatory drugs (imids), proteasome inhibitors (pis), chemotherapies, or monoclonal antibodies, and not a candidate for, or intolerant to established therapy known to provide clinical benefit. 5. eastern cooperative oncology group (ecog) performance status of 0 - 1 6. adequate organ and marrow function at screening, as defined by the study protocol. key exclusion criteria: 1. monoclonal gammopathy of undetermined significance (mgus), smoldering myeloma, waldenstrom's macroglobulinemia, or igm myeloma 2. active plasma cell leukemia (˃ 2.0 × 109/l circulating plasma cells by standard differential) 3. poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 4. prior treatment directed to b-cell activating factor (baff; blys), b-cell maturation antigen (bcma;tnfsf17) or transmembrane activator and caml interactor (taci; tnfsf13b), including antibodies or bcma- or taci-directed chimeric antigen receptor (car)-t cell therapy
neuroimaging changes in hereditary ataxia

Conditions: Hereditary Ataxia

Summary: this study aim to investigate the neuroimaging changes of hereditary ataxia patients, especially in the sca3 patients in preclinical or mild stage.


Eligibility criteria:
inclusion criteria: * genetically diagnosed as spinocerebellar ataxia exclusion criteria: * deny to follow-up
chemotherapy-induced lipid profile changes in women with early breast cancer

Conditions: Breast Neoplasms; Lipid Profile; Dyslipidemia

Summary: detection of changes in the lipid profile in early-stage breast cancer patients undergoing neoadjuvant or adjuvant chemotherapy with doxorubicin, cyclophosphamide, and paclitaxel.

despite the development of highly effective antitumor therapies over the past two decades (e.g., targeted therapy, immunotherapy), chemotherapy regimens including anthracyclines, taxanes, and cyclophosphamide continue to represent a fundamental component of treatment algorithms for early breast cancer, particularly in human epidermal growth factor receptor 2 (her2)-positive and triple-negative breast cancer (tnbc). while the cardiotoxicity of anthracyclines is well established and routinely monitored by echocardiography, changes in lipid profiles induced by cytotoxic chemotherapy have primarily been reported in retrospective studies with heterogeneous patient populations and measurement protocols. this prospective, single-center study was designed to evaluate changes in lipid parameters in patients with early-stage breast cancer undergoing neoadjuvant or adjuvant chemotherapy with doxorubicin, cyclophosphamide, and paclitaxel.

Eligibility criteria:
inclusion criteria: female patients with newly diagnosed breast cancer, stage ib-iiib, assigned to receive neoadjuvant or adjuvant chemotherapy. histologically confirmed invasive adenocarcinoma of the breast, including hormone receptor-positive, her2-positive (human epidermal growth factor receptor 2), or triple-negative breast cancer. chemotherapy regimen based on doxorubicin, cyclophosphamide, and paclitaxel. completion of all planned neoadjuvant or adjuvant chemotherapy cycles. availability of complete lipid profile data at all required timepoints. exclusion criteria prior breast cancer treatment (surgery, chemotherapy, radiotherapy, or systemic therapy). ongoing or prior treatment with hypolipidemic (lipid-lowering) medications. incomplete chemotherapy regimen (interrupted or prematurely terminated cycles). presence of distant metastatic disease at diagnosis. missing or incomplete lipid profile data.

Keywords: early-stage breast cancer chemotherapy cardiovascular risk factor
quality of life after enhanced recovery protocol for colorectal surgery

Conditions: Surgery

Summary: the aim of the study is to investigate the quality of life and satisfaction of patient who underwent colorectal surgery using an enhanced recovery protocol when back home. in this retrospective study patients will be telephoned and asked to answer a questionnaire.

since october 1st 2015, our center has been labelled reference center for colorectal surgery using enhanced recovery protocol (erp) by grace (groupe francophone de rehabilitation après chirurgie; a francophone counterpart of eras® society). in case of erp, the quality of life when the patient is at home is not well known. some argue that patient might experience discomfort and lack of autonomy, particularly elderly patient if discharged home too quickly. in this study, the investigators will call our patients introduced in the database of grace to assess the quality of life and patient satisfaction concerning our erp. eight domains will be investigated: information, stress, feelings when discharged home, pain, fatigue, autonomy, feeding problems, and satisfaction. when analyzing the results the investigators will pay a particular attention to elderly patients (age \> 70 yo) to determine whether these experience more difficulties as compared to younger patients.

Eligibility criteria:
inclusion criteria: * all patients included in our grace database exclusion criteria: * no exclusion criteria

Keywords: colorectal surgery enhanced recovery
rapid technique for the detection of intestinal anti-transglutaminase antibodies

Conditions: Coeliac Disease

Summary: intestinal celiac disease (cd)-antibodies have been described as the best marker to reveal progression toward villous atrophy and could become the diagnostic marker to make prompt diagnosis in the wide clinical spectrum of cd reducing the delay in diagnosis and treatment. the introduction of either anti-endomysial antibodies (ema) assay or rapid anti-transglutaminase 2 (tg2) test on supernatant of mechanically lysed biopsy samples in the clinical practice would improve the diagnosis of cd, especially in clinically challenging scenarios. the availability of an accurate test for identifying intestinal cd-antibodies that do not need the culture of intestinal biopsy is less expensive, less time consuming and easier to perform would facilitate the implementation of such technology outside research laboratories, and enable the diagnosis of cd at the end of gastrointestinal endoscopy (gie).


Eligibility criteria:
inclusion criteria: * patients undergoing an elective esophagogastroduodenoscopy (egd) for suspected cd, eosinophilic esophagitis, autoimmune enteropathy, inflammatory bowel disease, gastritis, gastric or duodenal ulcer, gastroesophageal reflux disease. exclusion criteria: * bleeding disorders * patients fulfilling the new espghan guidelines for diagnosing cd (version 2020), for a serology based cd diagnosis * subjects in whom intestinal biopsies are not indicated as part of the diagnostic process.

Keywords: intestinal antibodies rapid test coeliac disease
comparison between bandage contact lens and pressure patching for the erosion area and pain scale in corneal erosion patients

Conditions: Erosion; Cornea, Traumatic

Summary: this research aims to compare between bandage contact lens and pressure patching in reducing size of erosion area and pain scale in corneal erosion patients as well as its complications.

this is a randomized open-label clinical trial in patients with mechanical corneal erosion. subjects were selected to use bandage contact lens (senofilcon a) or pressure patching. all subjects received combination of polymyxin b, neomycin, and gramicidin eye drops and 0,5% tropicamide eye drops. evaluation was done 24 hours after treatment

Eligibility criteria:
inclusion criteria: * aged 17-55 years * onset of corneal erosion \< 48 hours * corneal erosion due to mechanical injury * extensive corneal erosion \> 3 mm2 exclusion criteria: * bilateral corneal erosion * corneal erosion due to chemical or thermal injury * history of systemic analgesic use within 1 week prior to the examination or topical analgesics within 1 hour before the examination * history of systemic or topical antibiotics within 1 week prior to the examination * other abnormalities due to trauma * palpebral or eyelashes position abnormalities * anterior segment infections * tear break-up time \< 7 seconds in the contra lateral eye

Keywords: mechanical corneal erosion bandage contact lens pressure patching erosion area pain scale
hospitalization at home of elderly patients with exacerbated copd

Conditions: COPD Exacerbation

Summary: aim of the study was to evaluate the efficacy of hospital-at-home treatment compared with inpatient care in selected elderly patients with acute exacerbation of chronic obstructive pulmonary disease (copd).

a total of 104 patients with an exacerbation of chronic obstructive pulmonary disease (copd) selected from the emergency department (ed) of the hospital were randomized to home treatment from a geriatric home hospitalization service (ghhs) or to general medical ward (gmw). the sample size estimation was performed according to the increasing 1-year (june 2002-may 2003) incidence of copd exacerbation in hospital at home. on this basis, al least 100 patients needed to be included in the study to allow to detect a 20% difference in the endpoint hospital iatrogenic diseases, with a statistical significance  = 0.05 and a power 1-  = 0.8 using a two-sided test. this study is considered a single-blind study because patients were aware of the treatment assignment while physicians and nurses evaluating patients were blinded to the patient's allocation. in the ed all patients underwent baseline standard clinical evaluation; blood tests (blood cell count, routine biochemical tests and arterial blood gas tensions); pulse oximetry; 12-lead electrocardiography; chest radiographs and hand-held spirometry (spirhometer, cosmed, italy). further investigations (including pneumologist's assessment) were performed when required, according to the clinical judgement of the ed physician. only patients with a copd exacerbation evaluated in ed for at least 12-24 hours and with stable clinical conditions were considered elegible to be included in the study. additional exclusion criteria were: 1) living outside the hospital catchment area; 2) absence of family and social support; 3) absence of informed consent; 4) necessity of intensive monitoring or mechanical ventilation; 5) history of dementia; 6) severe renal or hepatic failure; 7) cancer. patients fullfilling inclusion criteria were informed about the nature of the study and asked to give their informed consent. extensive information was also provided to patients' relatives to obtain their collaboration. patients fullfilling the inclusion criteria and having none of the criteria for exclusion were randomised, using a set of computer-generated random numbers, in a 1:1 ratio either to the treatment group (home-based hospitalization (ghhs)) or to the control group (conventional care (gmw)), using blinded sealed envelopes. intention-to-treat analysis was used.

Eligibility criteria:
inclusion criteria: * exacerbation of copd * age \>= 75 years * living in hospital catchment area * informed consent * adequate social or familial support exclusion criteria: * patients requiring assisted ventilation or intensive monitoring * history of dementia * severe renal or hepatic failure * cancer

Keywords: frail elderly hospital at home
pilot study of the effectiveness of probiotics and lactitol for the decolonization of oxa-48 (carbapenemase) producing klebsiella pneumoniae among rectal carriers

Conditions: Bacterial Colonization

Summary: the combination of lactitol and probiotics (lactobacillus acidophilus and lactobacillus biphidus) administered orally is an effective strategy of intestinal decolonization of enterobacter produced oxa-48-type carbapenemase. the purpose of this study is to determine the effectiveness of lactitol and probiotics for the intestinal decolonization of people who carried klebsiella pneumoniae produced oxa-48-type carbapenemase.


Eligibility criteria:
inclusion criteria: * men and women over 18 years old * have signed the informed consent to participate. * have evidence of intestinal colonization by kp-oxa-48 during the period of screening. * start of intestinal colonization by kp-oxa-48, \> 6 months of starting treatment. * absence of exclusion criteria exclusion criteria: * be hospitalized for an acute process at the time of inclusion. * take antibiotics (oral , intramuscular or intravenous ) at the time of inclusion. * having diarrhea in the two weeks prior to the inclusion. * baseline electrolyte abnormalities requiring supplementation : hypokalemia (k \<3 meq / l), hypomagnesemia (mg \<1.8 meq / l ), hypocalcemia (ca \< 8mg/dl ) * suffering from digestive diseases : crohn's disease, ulcerative colitis , celiac disease, irritable bowel syndrome , intestinal resection, colostomies. * neutropenia ( neutrophil count \< 1.00 x 10 3 / ul ) or other situations of severe immunosuppression , including continued use of systemic steroids (at least 1mg/kg/day of prednisone or equivalent for more than 1 month) and other forms of pharmacological immunosuppression deemed by the investigator. * diabetes mellitus poorly controlled ( hga1c \> 8 mmol / mol ). * taking antisecretory inhibitors, proton pump or anti -h2. * advanced chronic renal failure (gfr \< 30 ml / min) * being a carrier of endovascular prosthetic devices, including long-term central catheters. * having significant valvulopathy on the opinion of the investigator. * surgical intervention of gastrointestinal tract in the last three months. * treatment with systemic corticosteroids or immunosuppressive. * allergy or intolerance to lactose or lactitol or infloran .

Keywords: sdd (selective digestive decolonization) oxa 48 carbapenemase probiotics
is there any relation between pain and stone location in retrograde intrarenal surgery?

Conditions: Nephrolithiasis

Summary: we want to serach the relationship between the pain degree and stone localisation in kidney in retrograde intrarenal surgery


Eligibility criteria:
inclusion criteria: * patients undergoing rirs age between 18 and 90 years exclusion criteria: * patients who have congenital urogenital abnormalities 2)patients who have previous surgery history

Keywords: pain, rirs, kidney
a prospective cohort study of metabolic associated fatty liver disease in china

Conditions: Metabolic Associated Fatty Liver Disease

Summary: metabolic dysfunction-associated fatty liver disease (mafld) is a new concept proposed in 2020. unlike non-alcoholic fatter liver disease (nafld), the diagnosis of mafld requires the presence any of the following 3 metabolic risks, including overweight/obesity, presence of diabetes mellitus, and evidence of metabolic dysregulation. however, there are patients that have hepatic steatosis but no metabolic risk, who thus do not meet the diagnostic criteria of mafld. besides, there are patients with both mafld and other liver diseases. the clinical features and the management of these patients remain unclear. thus, further histopathological and clinical study is required to elucidate and compare the characteristics of mafld and nafld. here, in this single-center, prospective clinical study, investigators are planning to establish a long-term follow-up cohort of patients with either mafld or nafld. in order to understand the risk of developing liver-related complications and important extra-hepatic outcomes (e.g. cardiovascular disease), and also to better elucidate the risk of disease progression in "lean" nafld individuals without any metabolic dysregulation and mafld individuals with dual or multiple causes. ultimately, investigators aim to improve the diagnosis of mafld and improve patients' outcomes.

the study is divided into 2 parts: firstly, it contains a cross-sectional study to collect the clinical data of the patients with fatty liver. the clinical features of this population will be analysed. secondly, the study will collect the plasma, urine and stool samples of the patients in this cohort. and then a long-term follow-up of these patients will be carried out. investigators wish to find out biomarkers that can detail patient stratification and predict the prognosis of the disease.

Eligibility criteria:
inclusion criteria: * diagnosed as hepatic steatosis in adults (fulfill at least one of the followings): 1. liver ultrasound shows liver parenchymal hyperechoic or "bright liver" 2. controlled attenuation-parameter (cap) ≥248db/m 3. hepatic steatosis diagnosed by ct/mri/mrs 4. mri-based proton-density fat fraction (mri-pdff) shows liver fat content\>8% 5. fatty liver confirmed by liver histology. exclusion criteria: 1. diagnosed with hepatocellular carcinoma or other malignancy (in accordance with the appropriate diagnostic criteria); 2. during pregnancy; 3. patients with history of liver transplantation; 4. patients with serious cardiovascular and cerebrovascular events (such as acute myocardial infarction, cerebral infarction, cerebral hemorrhage, etc.).

Keywords: metabolic associated fatty liver disease metabolic nonalcoholic fatty liver disease (nafld) non-mr-nafld
tinnitus and arterial hypertension

Conditions: Tinnitus; Hearing Loss; Arterial Hypertension

Summary: many authors link tinnitus to arterial hypertension. the aim of this study is to establish a possible relationship between them, analyze the severity of tinnitus related to arterial hypertension and analyze a possible influence of ototoxic drugs used to treat arterial hypertension

arterial hypertension has been cited as a possible tinnitus etiology. vascular abnormalities associated with it may account for cochlear and central nervous system. however, a relationship between tinnitus and arterial hypertension has never been established. the aim of this study is to analyze this relationship, comparing groups with and without arterial hypertension and the incidence of tinnitus amongst them. inclusion and exclusion criteria try to isolate arterial hypertension as the main etiological factor, as much as possible. presbycusis, noise exposure, metabolical diseases and genetic factors will be ruled out. a comparison will be performed inside the arterial hypertension group between subgroups that use or not ototoxic medications, such as furosemide and beta-blockers

Eligibility criteria:
inclusion criteria: * age between 40 and 50 * arterial hypertension for group 1 * at least 5 years standing arterial hypertension exclusion criteria: * chronic noise exposure * metabolic diseases * family antecedents of hearing loss (except for presbycusis) * pregnant women * use of ototoxic drugs (except for anti-hypertensives)

Keywords: tinnitus hearing loss arterial hypertension ototoxicity