Kornimate/medical-research-clean huggingface dataset:
precision grx post-market study - japan

Conditions: Coronary Artery Disease

Summary: to collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the corpath grx system, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during pci procedures in the first 231 patients treated with the corpath device in japan.

this is a single-arm, open-label, multi-center patient registry in japan of the corpath grx system to examine its performance during pci procedures and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.

Eligibility criteria:
inclusion criteria: 1. age ≥ 20 years; 2. patients with coronary artery disease with clinical indication for pci; 3. patient deemed appropriate for robotic-assisted pci; and 4. the subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, unless the ec has waived informed consent. exclusion criteria: 1. failure/inability/unwillingness to provide informed consent, unless the ec has waived informed consent; or 2. the investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted pci.
radiation-free heart catheterization using mri

Conditions: Aortic Coarctation; Cardiomyopathy; Atrial Septal Defect; Aortic Stenosis; Post Heart Transplant Catheter Procedure; Patent Ductus Arteriosus

Summary: currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. this technology exposes patients to radiation. with this study protocol the investigators will use mri technology to take real-time pictures to navigate catheters throughout heart chambers. mri uses electromagnetic energy; therefore, it does not expose participants to radiation energy.

participants undergo general anesthesia, and vascular access is obtained in the x-ray catheterization lab. next the participant is transferred into the mri scanner where a focused mri examination is performed. catheters are then guided into the heart chambers using real-time mri guidance to perform conventional cardiac catheterization steps. if time allows, additional research mri is performed before the participant is returned to the x-ray catheterization lab. if any mri guided catheterization steps are unsuccessful, the clinically indicated step is performed after the participant returns to the x-ray catheterization lab using conventional x-ray guided pictures.

Eligibility criteria:
inclusion criteria: * undergoing a medically necessary cardiovascular catheterization exclusion criteria: * cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support. * women who are pregnant * women who are nursing and who do not plan to discard breast milk for 24 hours * patients with a contraindication to mri scanning will be excluded. these contraindications include patients with the following devices: 1. central nervous system aneurysm clips 2. implanted neural stimulator 3. implanted cardiac pacemaker or defibrillator which are not mr safe or mr conditional according to the manufacturer 4. cochlear implant 5. ocular foreign body (e.g. metal shavings) 6. implanted insulin pump 7. metal shrapnel or bullet exclusion criteria for gadolinium (contrast agent) 1. renal disease with estimated glomerular filtration rate \< 30 ml/min/1.73 m2 body surface area

Keywords: radiation free cardiac catheterization
the association between glycemic metrics and cardiovascular markers in patients with type 1 diabetes.

Conditions: Type 1 Diabetes

Summary: in this cross-sectioanl study, 90 patients aged \>12 years old with t1dm who are on minimed 780g system will be included.the investigators aim to assesse the association of patients' adherence to mediterranean diet (md) with cgm and insulin metrics, as well as anthropometric measurements, bmi, lipid levels and blood pressure.moreover, markers of endothelial, cardiovascular and liver function will be also assessed and associated with the use of minimed 780g and the adherence to md.

this cross-sectional study will include 90 participants, children adolescents and young adults (12\> years old) with t1d that are on minimed 780g system. participants will be evaluated for adherence to meditteranean diet (md) with predimed questionnaire. hba1c, cgm and insulin metrics, anthropometric measurements, blood pressure and lipid leves will be aso evalutaed. markers of endothelial cardiovascular and liver function will also be assessed.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of type 1 diabetes \>1 year prior to consent date. diagnosis of type 1 diabetes is based on the investigator's judgment; c peptide level and antibody determinations are not required. 2. hba1c \< 12.5% 3. age \>7years at the initiation of the system 4. patients with minimed 780g 5. history of 3 clinic visits in the last year exclusion criteria: diabetic ketoacidosis in the 6 months prior to screening visits
predictive role of red cell distribution width in upper gi bleeding patients

Conditions: Gastrointestinal Hemorrhage

Summary: acute upper-gastrointestinal bleeding (ugib) is a commonly encountered cause of admission in emergency department (ed). early risk stratification allows appropriate therapy that may be helpful to advance the patient's morbidity and mortality. investigators hypothesized that early rdw levels may have an independent, linear relationship with recurrent or massive bleeding in ugib patients.

this is a retrospective clinical study including the ugi patients in ed. all data will be collected through the electrical medical records. the major endpoints are the high risk patients and 30-days mortality which defined cases of including any of one among the death, re-bleeding, and received the intervention (such as blood transfusion, endoscopic therapy and operation). investigators assessed the relationship between initial rdw level and high risk patients and 30-days mortality. in addition, investigators compare the dicrimination power for predicting outcomes between the ugib scoring system and rdw level. univariate and multivariate logistic regression testing and a cox hazard regression model were used to determine the factors associated with outcome variables. in addition, investigators constructed receiver operating characteristic curves, and the areas under the curves and confidence intervals were calculated to compare the discriminatory power for outcomes.

Eligibility criteria:
inclusion criteria: * age over 18 years * diagnosis as upper gastrointestinal bleeding * check rdw when patients visited at emergency department exclusion criteria: * paediatrics * follow up loss * data could not be acquired

Keywords: red cell distribution width risk mortality hemorrhage
rhythm control of af in patients with acute stroke

Conditions: Atrial Fibrillation

Summary: prospective randomized (rhythm control or rate control) objective of study 1. to analyze long term outcome of patients with acute stroke with atrial fibrillation according to the rhythm control 2. to analyze recurrence rate of atrial fibrillation or recurrence stroke in patients with acute stroke according to the rhythm control (by antiarrhythmic drug, cardioversion, catheter ablation)


Eligibility criteria:
inclusion criteria: 1. patients with atrial fibrillation (20\~80 years old) 2. patients with acute stroke within 7 days 3. la diameter \< 55mm 4. patients possible to anticoagulation and anti arrhythmic drug 5. nihss score ≤12 exclusion criteria: 1. hemorrhagic transformation 2. large cerebral lesion or cerebellar lesion (more than 1/3 of mca area and 1/2 of aca area, 1/2 of pca area, 1/2 of cerebellar area) 3. active internal bleeding 4. impossible to anticoagulation or anti arrhythmic drug 5. valvular af (ma\> gii, mechanical valve, mitral valve replacement) 6. lv ejection fraction \< 30% 7. structural cardiac disease 8. catheter ablation history for af, cardiac surgery 9. already prescribed anti arrhythmic drugs 10. with severe medical disease 11. expected survival \< 1year 12. severe alcoholics, drug addiction 14. contraindication to mri 15. pregnancy
study of image-guided sbrt for vertebral metastases

Conditions: Vertebral Metastases

Summary: based on the known efficacy of ablative single dose sbrt and vmat technique in various solid tumors, investigators have designed this study to assess feasibility of sbrt in selected patients with spine metastases.

this is a prospective, phase 2 study. the main objectives are to assess acute and late side effects of single fraction sbrt for selected patients with vertebral metastases and to study the local control of disease in treated sites. the schedule will be 1 fraction of 18 gy delivered in one day with volumetric modulated arc therapy (vmat) and flattening filter-free (fff) beams.

Eligibility criteria:
inclusion criteria: * age ≥ 18years. * who performance status ≤ 2 (ecog - kps). * histologically-proven of primary cancer disease. * metastatic disease in the spine, from c1 to sacrum. a maximum number of 5 sites. each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies. * epidural compression is eligible when there is at least 3 mm gap between the spinal cord and the edge of the epidural lesion, unless patient underwent decompression surgery. * a paraspinal mass ≤ 5 cm. * minimal residual tumor after surgery * metastases in other district of the body are allowed. * informed consent. exclusion criteria: * \> 50% loss of vertebral body height. * prior radiation to the interested spine. * patients for whom an mri of the spine is medically contraindicated. * patients allergic to contrast used in mris or ct scans or who cannot be premedicated for the use of contrast.
self and autobiographical memory in dementia with lewy bodies and alzheimer disease: a behavioral and multimodal neuroimaging study

Conditions: Dementia With Lewy Bodies; Alzheimer Disease; Self; Autobiographical Memory; Insular Cortex

Summary: the present project aims at exploring different components of self-consciousness or 'the self', such as autobiographical memory, self-concept and subjective sense of self, in dementia with lewy bodies (dlb) compared to alzheimer's disease and to normal ageing. anatomical substrates will be studied in multimodal imaging, in terms of volume, anatomical and functional connectivity. we expect to find an alteration of the different components of the self, consecutive to insular dysfunction, a key region within cerebral networks of self-consciousness, which is damaged early in the course of the disease.


Eligibility criteria:
inclusion criteria: inclusion criteria for all participants: * male or female aged between 60 to 80, at the inclusion visit * right-handed * must be affiliated to a social health insurance protection scheme * must be able both to understand the objectives and risks related to the study and to give a dated and signed informed consent * fluency in french * at least 9 years of formal education inclusion criteria for group of dementia with lewy bodies: * subject meeting mckeith et al. criteria (2017) * subject with prodromal dementia with lewy bodies meeting the dsm-v mild cognitive impairment criteria (2013) * subject with prodromal or mild dementia with lewy bodies with an ≤ 20 mmse score * availability of a caregiver for the inclusion visit inclusion criteria for group of alzheimer disease: * subject meeting dubois et al. criteria (2014) * subject with prodromal or mild alzheimer disease with an ≤ 20 mmse score * availability of a caregiver for the inclusion visit inclusion criteria for healthy elderly: * subject must be matched with patients in terms of age, gender and educational level * absence of any cognitive complaint * autonomy must be preserved exclusion criteria: subjects with significant neuropsychiatric comorbidities * abnormal neurological examination * sensory impairment that may significantly interfere with testing * contraindication to mri * claustrophobia * heavy psychotropic drug treatment * excessive and regular consumption of alcohol * subject in period of exclusion (determined by a previous or ongoing study) * inability to give the subject informed information * subject under judicial protection * subject under tutorship or guardianship
volume flow assessment to optimize angioplasty of dysfunctional dialysis access

Conditions: Dialysis Access Malfunction

Summary: this is a multicenter, prospective study investigating a new concept of intra-procedural percutaneous duplex ultrasound (dus) volume flow-guided balloon angioplasty for the quantification and optimization of endovascular treatment outcomes of dysfunctional autologous arteriovenous fistulae (avf).

this is a prospective, multi-center, single-arm observational clinical trial investigating a new functional index of success of endovascular treatment of dysfunctional avf assessed with intraprocedural percutaneous dus. the study will include 100 consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional avf. exclusion criteria will be (i) patients with arteriovenous synthetic grafts. (ii) immature afvs not previously used for hemodialysis (at least once). patients' demographical data, dialysis access history, and procedural details will be recorded. intraprocedural volume flow measurements will be obtained just prior to the procedure and after final balloon dilation, before sheath removal. clinical follow-up will be set at 6 months after the index procedure. all dus measurements will be performed using the same imaging protocol. the study's primary endpoints will be (i) the quantification of angioplasty outcome using dus volume flow analysis before sheath insertion and at the end of the procedure before sheath removal and (ii) to assess the correlation between volume flow at the end of the procedure and clinically driven re-intervention-free rate at defined as the rate of reintervention due to dysfunction recurrence of the treated avf. secondary endpoints will be (i) to assess the correlation between volume flow and clinical success defined as high-quality dialysis for a period of at least one month and (ii) identification of independent predictors of re-intervention-free rate.

Eligibility criteria:
inclusion criteria: * consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional avf * signed consent form * agree to the study protocol exclusion criteria: * patients with arteriovenous synthetic grafts * patients with contraindication to antiplatelet therapy * immature afvs, not previously used for at least one dialysis session.

Keywords: percutaneous transluminal angioplasty volume-flow measurement autologous arteriovenous fistula dialysis access interventional radiology
real-world treatment patterns of endocrine based therapy among patients with hormone receptor-positive/human epidermal growth factor receptor-2-negative (hr+/her2-) advanced breast cancer: an analysis of administrative claims data in japan

Conditions: Breast Cancer

Summary: this is a retrospective observational study focusing on patients diagnosed with advanced breast cancer(abc) in japan using de-identified claim data from medical data vision (mdv) database. the primary objective of this study is to describe patient demographics, treatment patterns and treatment duration of palbociclib, and subsequent treatment patterns and treatment duration after palbociclib-based therapy among abc patients in japan the secondary objective of the study is to describe patient demographics, treatment patterns of abc patients and treatment duration of endocrine therapy, and subsequent treatment patterns and treatment duration after endocrine therapy among abc patients in japan.


Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer based on international statistical classification of diseases and related health problems 10th revision (international statistical classification of diseases and related health problems \[icd-10\]) (c50.xx) * received at least one prescription of endocrine therapy drugs * diagnosis of secondary malignant neoplasm based on icd-10 (c77.x, c78.x, c79.x ) exclusion criteria: -received a prescription of anti-her2 therapy (trastuzumab, trastuzumab emtansine, pertuzumab, and lapatinib tosilate hydrate)

Keywords: advanced breast cancer hormone receptor positive (hr+) human epidermal growth factor receptor 2 negative (her2-)
optimizing patient selection for surgery using pathologic analysis following neoadjuvant therapy in locally advanced rectal cancer

Conditions: Locally Advanced Rectal Cancer (LARC)

Summary: this interventional, non-randomized, prospective trial aims to evaluate the role of endoscopic resection following neoadjuvant treatment in patients with locally advanced rectal cancer. phase i focuses on assessing the feasibility, safety and efficacy of endoscopic resection of residual scar or superficial residual neoplastic tissue following neoadjuvant treatment. phase ii explores the potential of this approach to guide patient selection for total mesorectal excision and to serve as a definitive treatment option for those with limited residual disease.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * signed informed consent * patients diagnosed with locally advanced rectal cancer showing complete or near-complete clinical response after neoadjuvant therapy without evidence of invasive disease (\>t2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan. * patients diagnosed with locally advanced rectal cancer showing incomplete response with presence of superficial residual lesions, without invasive features on endoscopic evaluation, without evidence of invasive disease (\>t2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan. * without previous medical history of rectal cancer or rectal surgery exclusion criteria: * previous medical history of rectal cancer * previous rectal surgery

Keywords: locally advanced rectal cancer neoadjuvant endoscopic resection endoscopic submucosal dissection endoscopic intermuscular dissection feasibility safety
study to assess csl787 in non-cystic fibrosis bronchiectasis (ncfb)

Conditions: Noncystic Fibrosis Bronchiectasis (NCFB)

Summary: this study is a prospective, multicenter, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd) and exploratory efficacy of nebulized csl787 after administrations of single (sad) ascending doses in healthy subjects and multiple (mad) ascending doses in subjects with ncfb.


Eligibility criteria:
inclusion criteria: * male or female, aged ≥ 18 years at the time of providing written informed consent for part a (sad) only: * healthy and free of medical conditions that could in the opinion of the investigator affect's the subject's participation in the study or the interpretation of results. for part b (mad) only: * diagnosis of ncfb made by a respiratory physician, confirmed per ct showing bronchial wall dilatation with or without bronchial wall thickening, with a fev1 ≥ 40% of the predicted value regarding age, height, gender, ethnicity, and fev1 ≥ 1 l (pre-bronchodilator values) at the screening visit. * no antibiotic use within 1 month before the screening visit. * presence of one or more of the following bacteria (h. influenzae, p. aeruginosa, m. catarrhalis, s. pneumoniae, members of enterobacterales family or s. aureus) in the sputum culture at the screening visit. * has been fully vaccinated against covid-19 (as per country recommendations) at least 7 days prior to day 1 exclusion criteria: * evidence of a clinically significant medical condition, disorder, or disease, including but not limited to any of the following: hepatic (hepatitis, cirrhosis); biliary; renal; cardiac; bronchopulmonary; vascular; hematologic; gastrointestinal; allergy; endocrine / metabolic (diabetes, thyroid disorders, adrenal disease); neurologic; psychiatric; immunodeficiency; cancer. * history of chronic respiratory disease (eg, copd or bronchiectasis) or current asthma with regular treatment including occasional use of an inhaler for exercise induced asthma. * current moderate-severe allergic disease (eg, allergic rhinitis) with regular treatment. * diagnosis of cystic fibrosis, mycobacterial disease, connective tissue disease, or alpha-1 antitrypsin deficiency as underlying disease for bronchiectasis. * oral/parenteral corticosteroid 28 days before the screening visit until eos visit. use of long acting bronchodilators (long acting muscarinic antagonists (lama) and / or long acting beta2 agonists (laba) and/or inhaled corticosteroids that have been at a stable dose for at least 3 months before the screening visit is permitted; inhalation with hypertonic saline solution is permitted up to and including day -1. * any systemic or inhaled antibiotic for acute pulmonary exacerbation within 1 month before the screening visit until eos visit.
bioequivalence study of fluoxetine hydrochloride delayed-release capsules 90 mg of dr. reddy's under fed condition

Conditions: Healthy

Summary: the purpose of this study is to asses the bioequivalence study of fluoxetine hydrochloride delayed-release capsules, 90 mg and prozac ® weekly under fed conditions.

a randomized, open label, two treatment, two period, two sequence, single dose, crossover bioequivalence study of fluoxetine hydrochloride delayed-release capsules 90 mg of dr. reddy's laboratories limited, generics, india and prozac®weekly 90 mg delayed release capsules of eli lilly and company, usa in healthy adult human subjects under fed conditions.

Eligibility criteria:
inclusion criteria: * healthy human subjects between 18-50 years of age (inclusive), weighing as per the standard height and weight chart of life insurance corporation of india (11 underweight and overweight min. \& max. chart). * subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study. * subjects whose screening laboratory values are within normal limits or considered by the physician/principal investigator to be of no clinical significance. * informed consent given in written form according to section 11.3 of the protocol. * female subjects * of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies,diaphragm, intrauterine device, or abstinence. * postmenopausal for at least i year. * surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject) exclusion criteria: * cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. * alcohol dependence, alcohol abuse, i.e., regular use of more than 2 units of alcohol or 10 units per week or a history of alcoholism (one unit of alcohol equals 1/2 1 of beer 200 ml wine or 50 ml (of spirits) within last 6 months or recovered alcoholics , or drug abuse within past 1 year. * moderate to heavy smoking (\> 10 cigarettes/day) or consumption of tobacco products. * history of difficulty in swallowing capsules. * clinically significant illness within 4 weeks before the start of the study. * asthma, urticaria or other allergic type reactions after taking any medication. * positive urine drug screening, human immunodeficiency virus, hepatitis b \& c tests. * any history of hypersensitivity to fluoxetine.

Keywords: bioequivalence crossover fluoxetine hydrochloride