Kornimate/medical-research-clean huggingface dataset:
pcb for long de novo lesions of main coronary arteries (d-lesion long trial)

Conditions: Stable Angina Pectoris; Unstable Angina Pectoris

Summary: this study evaluates the efficacy and safety of paclitaxel-coated balloon catheter in patients with diffuse long de novo lesions of main coronary arteries.

paclitaxel-coated balloon catheter is a new device in coronary disease, it can inhibit the proliferation of smooth muscle of coronary vessels by transitory contaction, without residual implantation. more and more evidences have shown its efficacy and safety in diffuse small coronary disease, bifurcation disease and in-stent restenosis. but there are still seldom evidences in de novo lesions of main coronary arteries. pcb has used in some subgroup of many study but confused with in-stent renstenosis or small coronary disease. the investigators designed this study to evaluate the efficacy and safety of paclitaxel-coated balloon catheter in patients with diffuse long de novo lesions of main coronary arteries.

Eligibility criteria:
inclusion criteria: 1. a diagnosis of stable angina or unstable angina in hospitalized patients. objective clinical evidence of ischemia (ect, exercise ecg, ecg st-t changes) with cag proven one vessel lesion（a lesion length of ≥ 20mm)； 2. a lesion diameter stenosis \>75% as evaluated by qca with a reference diameter of ≥ 2.75 mm and ≤ 3.5 mm . 3. a willingness or ability to provide informed consent，a willingness to receive telephone followed-up at postoperative 1 month, 3 month, 6 month, and an angiographic follow up at postoperative 9 month. 4. a willingness to receive dcb angioplast or des implantation. exclusion criteria: 1. patients with acute myocardial infarction within 30 days； 2. a previous history of severe valvular heart disease,severe hepatic and renal insufficiency；severe cardiac dysfunction with ef≤40%； 3. advanced cancer with a life expectancy of \<12 months； 4. patients with abnormal coagulation function, contraindications for antiplatelet drugs or unable to tolerate antiplatelet therapy; 5. pregnant and lactating patients； 6. multiple vessels involvement or multiple lesions requiring intervention treatment,left main artery lesions and coronary artery bypass graft lesions； 7. stent restenosis 8. thrombotic disease，severe calcified lesions（judged by the operator， cag showed class 2 or more severe calcified lesions），spontaneous dissection or ulcerative lesion，coronary ostial lesions (the lesion included should be an interval of greater than 3mm from the ostial of rca or lad)， severe angulated lesions（\>45°） 9. diameter of collateral vessel≥ 2.25 mm requiring interventional therapy,type 1 coronary lesions（patients with diameter of collateral vessel\< 2.25 mm， who were not treated with dcb dilatation were also eligible）.

Keywords: drug-coated balloon main coronary artery de novo lesion
feeding study in vlbw premature infants

Conditions: VLBW - Very Low Birth Weight Infant

Summary: a multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk


Eligibility criteria:
inclusion criteria: * clinically and metabolically stable * birth weight 700 g to less than or equal to 1,250 g * appropriate birth weight for gestational age * 24 0/7 to 32 0/7 weeks' gestational age at birth * exclusively fed human milk * signed informed consent and authorization to use and/or disclose phi exclusion criteria: * metabolic or chronic disease * 5-minute apgar score \<4 * major surgery * ventilator dependent * fluid restriction * grade iii or iv intraventricular hemorrhage (ivh)
translation, cultural adaptation and validation of the creole versions of the eq-5d and the sf-36 questionnaires in patients with type ii diabetes in reunion island, martinique and guadeloupe

Conditions: Diabetes Mellitus, Type 2

Summary: the evaluation of quality of life in health is particularly important for measuring the impact of the chronic diseases. the scales of measure constitute the main measurement tool in clinical trials because of their psychometrics properties and of their ease of use. among these scales, the 36-item short form survey (sf-36) and the euroqol five dimensions questionnaire ( eq-5d) were widely validated in various populations, of which the population of the diabetics patients. both scales have validated versions in french. in the antilles and in reunion island, diabetes is a frequent pathology and is the subject of many clinical and epidemiological trials. one of the difficulties encountered during the implementation of these studies is the absence of measurement tools validated for these populations. investigators thus suggest, within a common workgroup uniting guadeloupe, martinique and reunion island, adapting and validating these scales according to an identical procedure in creole from guadeloupe, from martinique and from reunion island and validating the french versions of these scales in their populations of type ii diabetics patients.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age * type ii diabetes diagnosed more than 1 year ago * creole speaking * living on the island for more than 5 years * agreed and signed the informed consent form exclusion criteria: * not able to understand and follow the instructions * patients with proven cognitive issues which do not make possible to complete questionnaire * patients with current acute and serious complications associated with diabetes * medical history of stroke with physical or neurological damage * patients already involved in the study

Keywords: validation of questionnaire quality of life
a retrospective and multicenter survey to investigate the dosage, efficacy and safety of sertraline in posttraumatic stress disorder patients

Conditions: Posttraumatic Stress Disorder

Summary: this is a multicenter retrospective study to investigate the dosage regimens of sertraline in the treatment of posttraumatic stress disorder (ptsd) under current medical practice and the efficacy and safety of this drug in patients with ptsd. data will be collected from the medical records of patients with ptsd.

patients with ptsd who have been dosed with sertraline from july 2006 (i.e., the start of marketing of this drug in japan) or later to before contracting with each investigational site.

Eligibility criteria:
inclusion criteria: * patients with ptsd who have been dosed with sertraline since july 2006 or later. * patients must be japanese. * patients should be started before the conclusion of a contract with each investigational site. exclusion criteria: * not applicable.

Keywords: retrospective sertraline posttraumatic stress disorder
white study: which decision after a first venous thromboembolism?

Conditions: Venous Thromboembolism

Summary: the white study is a multicenter, multinational, investigators-initiated, observational, prospective study conducted in a consecutive series of ambulatory patients who had completed the recommended or practicable period of anticoagulation after a first-ever episode of venous thromboembolism (vte) the general aim of the study is to evaluate the distribution of decisions and of the reasons guiding the physician's decision on the modality to manage the secondary prevention of vte in patients treated for a first-ever episode of vte, after the initial 3-12 months of anticoagulant therapy.

the white study is an international, non-profit, multicenter, observational, prospective and no profit study 3,200 subjects having experienced a first-ever episode of dvt of the lower limbs and/or pe, receive anticoagulation therapy for a period as recommended by international and/or local practice guidelines will be enrolled across all the countries participating to the study. when this recommended period expires, the attending physician has to decide whether to continue with anticoagulation, switch to anti-thrombotic of another class, or stop any prophylactic pharmacological treatment. the primary objective of the study is the evaluation of the distribution of decisions and of the reasons guiding the physician's decision on the modality to manage the secondary prevention of vte in patients treated for a first-ever episode of vte, after the initial 3-12 months of anticoagulation therapy. the secondary objective is the collection of data during the follow-up: the frequency of thromboembolic complications, of bleeding complications, or death from any cause.

Eligibility criteria:
inclusion criteria: 1. subjects who provided a written informed consent and authorization for disclosure of protected health information; 2. male and female adult or elderly patients of any ethnicity having had a first-ever event of provoked or unprovoked dvt of the lower limbs and/or pe and treated with oral anticoagulant 3. for whom the center is in possession of all the data relevant to the index event; 4. having a permanent reference contact. exclusion criteria: 1. subjects \<18 years old; 2. subjects unable or unwilling to issue the written informed consent; 3. subjects for whom the information relevant to the index event are incomplete or inaccessible to the investigator; 4. subject in whom the index event was a dvt not of the lower limbs; 5. subjects with life expectancy of less than 2 years; 6. subjects participating in any other clinical study, regardless of its nature; 7. subjects considered, by the attending physician, unable to comply with the study procedures.

Keywords: deep vein thrombosis anticoagulant treatment lower limbs pulmonary embolism oral anticoagulant treatment
in vivo confocal endomicroscopy of the brain

Conditions: Brain Neoplasms

Summary: the purpose of the study is to test the feasibility of obtaining interpretable in vivo endomicroscopy images which can be compared with traditional histopathology. hypothesis: that a rigid confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables differentiation of tumour tissue from normal adjacent brain tissue.

confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. it is already in clinical use in the fields of gastroenterological endoscopy, laparoscopy, dermatology, gynecology and respiratory medicine. this study represents the first time that confocal endomicroscopy will be evaluated for intraoperative imaging in neurosurgery. the procedure involves a small endoscope which is placed gently into contact with the brain, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. the captured confocal images will be compared with corresponding histology (tissue that is being removed as part of the indicated neurosurgical procedure). the images will be visually compared among each other and with histology images to detect possible clinically relevant information.

Eligibility criteria:
inclusion criteria: * all patients with neurosurgical pathology requiring surgery in which tumor resection might be evaluated by using biopsy. exclusion criteria: * pregnant women * inability to give informed consent * history of allergy to fluorescein * patients on beta-blockers or ace inhibitors

Keywords: pathology microscopy, confocal microscopy, fluorescence intraoperative procedures
intensive glycemic management and outcomes following liver transplantation

Conditions: Hospital Hyperglycemia; Post-transplant Hyperglycemia

Summary: most people develop high blood sugars following liver transplant that requires treatment with insulin in the hospital, even if they don't have diabetes, due to stress and use of steroid medications. high blood sugar levels can be treated with a hormone that the body makes called insulin. this study is being done to determine if maintaining normal blood sugar levels after transplant for as long as needed while in the hospital results in a lesser incidence of death, infections, transplanted liver rejection or failure or need for rehospitalization within 90 days after transplant.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * undergoing liver transplant or combined liver-kidney transplant exclusion criteria: * unable to grant informed consent or comply with study procedure * allergic to any of the excipients in insulin

Keywords: liver transplant high blood sugars hospital hyperglycemia post-transplant hyperglycemia post liver transplant post liver-kidney transplant
hepatitis c among opioid addicts in opioid maintenance treatment in zurich, switzerland

Conditions: Hepatitis C, Chronic; Substance Abuse Treatment Centers; Opioid-Related Disorders

Summary: hepatitis c viral infection is common among opioid addicts in zurich, switzerland. the majority undergoes a maintenance treatment with methadone, heroin or buprenorphine. while stabilized by an opioid maintenance treatment (omt)chronic hepatitis c can be treated with pegylated interferon plus ribavirin. as not sufficiently known, the results are comparable to the results of the treatment of nonaddicts. our crossectional study investigates how many patients undergoing omt are adequately investigated concerning hepatitis c. if not, why are they not adequately investigated and treated? representative data are collected in the local clinics and medical practices involved in omt in the kanton of zurich. the patients files are revised and the involved doctors are asked through a structured interview.

www.seidenberg.ch/hepcop.pdf

Eligibility criteria:
inclusion criteria: * medical practices and clinics involved in opioid maintenance treatment in the kanton of zurich, switzerland

Keywords: hepatitis c opioid maintenance treatment methadone buprenorphine heroin interferon, pegylated
an early warning model of unfavorable outcomes following endovascular interventional treatment of intracranial aneurysm

Conditions: Intracranial Aneurysm

Summary: endovascular treatment has become one of the primary treatment methods for intracranial aneurysms. the unfavorable outcomes during follow-up included aneurysm recurrence and long-term incomplete-occlusion, which would bring a high risk of rebleeding and retreatment. previous studies have tried to predict the outcomes of aneurysms following endovascular treatment based on aneurysm characteristics including morphology, embolization packing degree, etc, but the conclusion was inconsistent. hemodynamics of aneurysms and parent artery played a greater role in predicting outcomes following endovascular treatments. investigators also found that the outcomes were determined by many factors, in which the demography, clinical indicators, treatment methods, and material selection can not be ignored, and the mechanism of unfavorable imaging outcomes should be explored using large samples of clinical cases and numerous variable parameters. the pre-experiment of investigators confirmed that artificial intelligence technology can meet the calculation requirements for deep mining and analysis of large sample data. this study aims to use the deep learning model to identify relevant risk factors and weights, establish a stable and accurate prediction model, then incorporate the prospective study to verify the model. the results will be very helpful in accurately predicting the adverse outcomes such as recurrence and long-term non-occlusion after endovascular treatment and help to improve the therapeutic strategy and avoid risk factors. besides, the occurrence of ischemic or hemorrhagic complications during follow-up may affect the final follow-up outcome, so the analysis was included as one of the outcome events to evaluate the prognosis after intervention.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of intracranial aneurysm； * endovascular intervention was performed； * the age is more than 18 years and less than 80 years; * at least one follow-up of imaging data must be digital subtraction angiography with a time interval of 12 months or more; * the quality of image data can satisfy morphological measurement and hemodynamic calculation; * the patient family members were informed and consented to participate in the study. exclusion criteria: * dynamic aneurysms with cerebrovascular malformation; * dissecting, fusiform or thrombotic aneurysms; * follow-up images were not digital subtraction angiography or data quality can not meet the hydrodynamic analysis.

Keywords: unfavorable imaging outcome artificial intelligent prediction model deep learning
acceptability and tolerance study of a plant-based tube feed

Conditions: Nutrition Disorders

Summary: this is a single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a 7-day period with a plant based tube feed.

enterally fed adults who are assessed by the health care professional/dietitian as requiring an adult plant- based high-energy, enteral formula will be recruited. data from 15 participants are required in order to submit an application to the uk advisory committee on borderline substances (acbs) for product registration

Eligibility criteria:
inclusion criteria: * patients 16 years and over and adults requiring a plant- based enteral tube feed (taking 50% or more of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition * patients well-established and stable on current polymeric enteral tube feed. * willingly given, written, informed consent from patient exclusion criteria: * inability to comply with the study protocol, in the opinion of the investigator * under 16 years of age * patients on total parenteral nutrition * known food allergies to any ingredients including patients who have an allergy to milk protein e.g ige and non- mediated as product contains traces of milk and allergy to peanuts due to the pea protein * patients with significant renal or hepatic impairment * participation in another interventional study within 2 weeks of this study. * patients with known or suspected ileus or mechanical bowel obstruction
intraoperative superior hypogastric plexus block for pain relief during cesarean-section

Conditions: Superior Hypogastric Plexus Block

Summary: purpose: to evaluate the efficacy of superior hypogastric plexus block for pain relief after cesarean section

superior hypogastric plexus block(shpb) for pain relief is routinely implemented in cesarean section operations at h.s.u kocaeli derince education and research hospital. the implementation of this procedure depends on the clinical situation of the patient, the preference of the surgeon and the anesthesiologist, the course of the operation, and whether the patient wishes or not. superior hypogastric plexus block is performed with 0.25 % bupivacaine 30 ml injected under peritoneum above promontorium. this is a prospective case-control study. the sample consisted of 60 women having cesarean-section with general anesthesia at h.s.u kocaeli derince education and research hospital divided into two groups: the first group having superior hypogastric plexus block for pain relief and the control group not having superior hypogastric plexus block. all participants signed an informed consent and the study was approved by the ethics committee of kocaeli university ( kugokaek 2017/270). the sample size was calculated with g power 3.1 program. with ki-square goodness-of-fit test α:0.05 ,power 95% ,effect size 0.5 total sample size was calculated 52, including 26 in case group and 26 in control group. women having cesarean-section with spinal anesthesia, women with known bupivacaine allergy, women with anxiety-depression disorder, women with known fibromyalgia were not enrolled to the study. age, bmi(body mass index), education status, vas (visual analog scale) scores ,the amount of analgesic used and the hour of gas extraction and bowel movement will be recorded.

Eligibility criteria:
inclusion criteria: * pregnant women having cesarean-section operation at h.s.u kocaeli derince education and research hospital with general anesthesia, * women agree to participate in the study, * literate women. exclusion criteria: * women having cesarean-section with spinal anesthesia, * women with known bupivacaine and nsaids allergy, * women with anxiety-depression disorder, * women with known fibromyalgia. * insufficient ability to understand information in turkish

Keywords: nerve blockade hypogastric plexus cesarean section
survival among patients with pancreatic cancer depending on surgical resection rate

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: the primary aim of this population-based study is to investigate how a high resection rate of pancreaticoduodenectomy affects overall survival among patients aged ≥70 years with pancreatic ductal adenocarcinoma. the secondary aim is to determine if a high resection rate of pancreaticoduodenectomy increases perioperative morbidity.


Eligibility criteria:
inclusion criteria: * diagnosed between 1 january 2010 and 31 december 2018 * registered in the swedish national registry for tumours in the pancreatic and periampullary region * either a diagnosis of pancreatic ductal adenocarcinoma of the pancreatic head or having been resected with pancreaticoduodenectomy exclusion criteria: * none

Keywords: pancreaticoduodenectomy
cone-beam vs multidetector computed tomography (ct) for arthrography of the wrist, ankle, elbow and knee

Conditions: Cartilage Ulceration of the Distal Joints

Summary: conebeam scanner (cbct) is a widely technique used for dental and maxillofacial imaging. patients can be set up in a sitting or a laying position in the, newtom 5g cbct allowing for an analysis of the limbs distal joints. our hypothesis is that the cone-beam scanner could detect and characterize chondral lesions the cartilage similarly to a multidetector ct (mdct). 100 patients over 18 years requiring arthroscanner of the wrist, ankle, elbow or knee will be enrolled the primary endpoint based on the ability of cone-beam scanner to detect cartilage lesions. secondary endpoints will concern the depiction of the joint lesions, quality of the images, tolerability of the exams and inter- intra-operator reproducibility. after arthrography, patients will have a mdct considered as the reference exam, and a cbct on a randomized order. exams will be anonymized and read twice by two trained radiologists with 3-6 week intervals. the inter-observer agreement for the diagnosis of cartilage lesion type between the two techniques will be evaluated by a kappa coefficient. the evaluation of diagnostic performance will be achieved by studying the sensitivity, specificity, negative predictive value and positive predictive value, and its likelihood ratio. kappa test will be performed to evaluate the consistency of the depiction of the lesions. a student t test will be performed for paired data if distributions are normal, a wilcoxon test if not. to assess patient's tolerance, the percentages of (painful, not painful) will be calculated for each technique and will be compared using the chi2 test (or fisher's exact test if the chi can not apply).


Eligibility criteria:
inclusion criteria: * patient age 18 years old or above, weight ≤ 160 kg * patient require knee or ankle or elbow or wrist arthroscanner * french spoken an read * free and informed consent signed * being affiliated to a french social security system or similar. exclusion criteria: * patients already included in the arcobe study * patient with severe pain and reduced spontaneous mobility that could prevent proper positioning for the cone-beam * lack of effective contraception (risk of pregnancy) or pregnancy proven data on interrogations * patient on protection of the court, under supervision or trusteeship * inability to express a consent * patients already enrolled in a study with a conflict of interest with this study.

Keywords: arthroscanner cone-beam computed tomodensitometry