Kornimate/medical-research-clean huggingface dataset:
the neonatal hemorrhagic risk assessment in thrombocytopenia

Conditions: Neonatal Thrombocytopenia; Bleeding

Summary: this is a prospective observational study designed to evaluate immature platelet fraction or immature platelet count and platelet function analyzer-100/200 closure time-adp (in vitro bleeding time) as markers of bleeding risk in thrombocytopenic preterm neonates admitted to the neonatal intensive care unit.

thrombocytopenia is a known risk factor for clinically significant bleeding in neonates. however, there is a poor correlation between degree of thrombocytopenia and bleeding risk. a better marker of bleeding risk suitable for use in neonates could help physicians more accurately determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions, and potentially protecting vulnerable infants from exposure to unnecessary transfusion-related risks. the investigators recently found that the platelet function analyzer (pfa) closure time-collagen/adp (ct-adp) was a better marker of bleeding than the platelet count in preterm neonates. however, the ct-adp requires 0.8 ml blood limiting its potential widespread use. the immature platelet fraction (ipf) is a new laboratory marker measuring the % newly released and more active platelets, measured from the same sample as the platelet count. this is a prospective observational study designed to evaluate ipf as marker of bleeding risk in thrombocytopenic neonates admitted to the neonatal intensive care unit, compared to platelet counts alone. and also, to validate the previously found association between pfa-100/200 ct-adp and bleeding in a bigger cohort, to compare the ipf with the pfa-100/200 ct-adp as bleeding predictors and to assess whether the pfa-100/200 ct-adp combined with the ipf is able to predict bleeding in thrombocytopenic preterm neonates.

Eligibility criteria:
inclusion criteria: * have a gestational age \<32 weeks and a birth weight ≥500 grams; * have a platelet count \<100 x 109/l; and * have a parent/guardian willing to provide written informed consent. exclusion criteria: * are not expected to survive for \>24 hours by the attending neonatologist; * are thought to have a familial thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (associated congenital malformations, platelet morphology).
ultrasound cavitation therapy for cli

Conditions: Peripheral Arterial Disease

Summary: in this study, we will explore how ultrasound exposure of ultrasound contrast agents, which produces beneficial shear-mediated bioeffects, can be used to treat patients with severe non-healing ulcers secondary to peripheral arterial disease (pad). the primary outcome measure is whether ultrasound exposure to microbubble contrast agents in the inflow artery and at the wound site can accelerate wound healing. a secondary outcome measure is whether cavitation-related changes occur in tissue perfusion in the treated limb and wound measured by ultrasound perfusion imaging and skin flow.


Eligibility criteria:
inclusion criteria: * known history of unilateral or bilateral pad diagnosed by reduced ankle-brachial index (\<0.9) or non-compressible vessels * diagnosis of cli (rutherford class iv-vi), and a non-healing ischemic ulcer defined as no change in the prior 3 months. exclusion criteria: * major medical illness other than pad affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure \[nyha class iv\]). * pregnant or lactating females * hypersensitivity to any ultrasound contrast agent or to polyethylene glycol (peg, macrogol). * hemodynamic instability (hypotension with systolic bp \<90 mm hg, need for vasopressors). * expected amputation or revascularization procedure within the ensuing 1 month.
the characterization of small bowel and colonic involvement in patients with seronegative spondyloarthritides

Conditions: Spondyloarthropathies

Summary: up to 60% of patients with seronegative spondyloarthritides have inflammation in the colon or ileum. this is usually asymptomatic, but in 5 to 10% of patients with sa, frank ibd will develop. lesions of the bowel could also be present in the sa patients because of the potential injury posed by the nsaids, a common used medication in this setting. it is the bowel involvement in patients with sa that we propose to characterize, partly because there are scant communicated data in the medical literature, especially regarding small bowel lesions.

the seronegative spondyloarthritides (sa) are a group of disorders that share certain clinical features and an association with the hla-b27 allele, having also overlapping features with inflammatory bowel disease (ibd). up to 60% of patients have inflammation in the colon or ileum. this is usually asymptomatic, but in 5 to 10% of patients with sa, frank ibd will develop. lesions of the bowel could also be present in the sa patients because of the potential injury posed by the nsaids, a common used medication in this setting. on the other hand, biologics used to treat patients with sa are believed to favorably influence the small bowel lesions that are concomitantly present. it is the bowel involvement in patients with sa that we propose to characterize, partly because there are scant communicated data in the medical literature. the design of the proposed study involves performing one full colonoscopic examination (including ileoscopy) followed by one capsule endoscopy examination to the patients with sa. prior to these examination, the patency of the gi tract will be tested using a patency capsule. if the patency of the gi tract is not confirmed, then the capsule endoscopy examination is abandoned. our aim is to explore about 100 patients in three years, thus having a close-to-reality "look" into the presence and extent of bowel involvement in the pool of the patients having sa; and also to characterize the lesions mainly depending on the treatment received, concomitant pathology and the form of the disease. we also aim to identify a relationship between the lesions found at colonoscopy and capsule endoscopy, the purpose being the possibility to predict one having only performed the other. thus, we hope to identify the therapeutic strategies that are most suited in the management of these patients.

Eligibility criteria:
inclusion criteria: * signing of the inform consent * subjects 18 years old or more * patients with spondyloarthropathy as defined by the amor criteria exclusion criteria: * presumed intestinal obstruction * impaired deglutition * cardiac pace-makers present * pregnancy * pelvic or abdominal radiotherapy anytime in the past * major abdominal surgery anytime in the past * major comorbidities which could represent a contraindication to a surgical abdominal intervention

Keywords: seronegative spondyloarthropathies endoscopic capsule examination small bowel and colon lesions nonsteroidal anti-inflammatory drugs anti tnf alpha drugs
study of haemodialysis patients switching from aranesp to biosimilar

Conditions: Anaemia

Summary: the study will obtain data to show insight into clinical outcomes of patients switching from darbepoetin alfa to a epoetin alfa biosimilar.

biosimilars were approved in 2007 by the ema in eu and in 2010 by the tga in australia. this study will look at the retrospective data of patients that have switched from darbepoetin alfa to an approved epoetin alfa biosimilar. data will be collected for the 26 week period prior to switch and a 26 week period post switch to a biosimilar. data to be collected includes haemoglobin measurements, dose requirements, iron use, any transfusions, hospitalisations and other lab values including tsat, ferritin and albumin. data from the study will be published.

Eligibility criteria:
inclusion criteria * patients ≥18 years of age * patients with ckd on haemodialysis and fulfilling the following: * received hd for at least 26 weeks prior to switching from treatment with darbepoetin alfa to treatment with an ema/tga-approved epoetin alfa biosimilar * received darbepoetin alfa treatment i.v. for at least 26 weeks immediately prior to switching to an ema/tga-approved epoetin alfa biosimilar (breaks due to treatment being intentionally withheld are permitted) * switched from darbepoetin alfa treatment to an ema/tga-approved epoetin alfa biosimilar at least 26 weeks prior to enrolment * received at least one dose of an ema/tga-approved epoetin alfa biosimilar after switching from darbepoetin alfa treatment * mean monthly hb 10-12g/dl in the 12 weeks prior to switch * stable darbepoetin alfa dose (i.e. no more than one increment or decrement of pfs) in the 12 weeks prior to switch * patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements exclusion criteria: * treatment with an esa other than darbepoetin alfa during the 12 weeks prior to switch to biosimilar * more than 14 days' cumulative treatment with short-acting esa during weeks 26-13 prior to switch to biosimilar * subject received chemotherapy or major surgery during the 26 weeks prior to switch to biosimilar * subject was enrolled in an interventional device or drug study at any time during the 52-week data observation period or within 30 days prior to commencement of the data observation period.

Keywords: anaemia, chronic kidney disease, switching, aranesp, darbepoetin alfa, epoetin alfa biosimilars, haemodialysis.
knee brace and biomechanical footwear in the treatment of knee osteoarthritis.

Conditions: Osteoarthritis,Knee

Summary: this study investigates the effects of unloader knee brace, biomechanical footwear device and exercise therapy on pain, physical function and quality of life in patients with knee osteoarthritis. the aim is to find more effective treatment strategies to delay or prevent heavy knee replacement surgeries.

the aim of this study is to investigate the effects of exercising, and using a knee brace and exercising, and using of biomechanical footwear device on clinically important symptoms, physical function and quality of life in patients with osteoarthritis of the knee. the hypothesis is that the groups of using knee brace and biomechanical footwear can alleviate pain, improve physical function and quality of life more efficiently, than the group doing home exercises only. the subjects (n = 120) will be randomized into three groups mentioned above, after which they will start to do exercises, or to use a knee brace and do exercises, or to use biomechanical footwear at home according to the instructions for 4 months. physical function, symptoms and quality of life will be measured before and after 4-month intervention. in addition, at 12-month time point follow-up surveys will be addressed with regard to symptoms and quality of life, as well as to cost-effectiveness of the study.

Eligibility criteria:
inclusion criteria: * moderate or severe knee pain (\>40mm on a vas scale 0-100mm) * radiographic knee osteoarthritis (kellgren-lawrence grades 1-3) * age between 45 and 70 years exclusion criteria: * inflammatory joint disease * acute (\<6 months) knee trauma * arthroscopic surgery in the past six months * a planned knee replacement surgery or other planned surgical treatment of the knee * knee injections in the past 3 months * superficial wounds at the knee area * arterial insufficiency * severe varicosities * impaired vision * postural difficulties * body-mass index (bmi) \>35kg/m2 * fibromyalgia * rheumatoid arthritis or other active rheumatoid inflammatory disease.

Keywords: knee brace biomechanical footwear exercise rct
starting granulocyte colony-stimulating factor at 1 day vs 3 days following chemotherapy in pediatric cancer patients

Conditions: Granulocyte Colony-Stimulating Factor; Chemotherapy-induced Neutropenia; Chemotherapy-Induced Febrile Neutropenia; Pediatric Cancer

Summary: chemotherapy places patients at an increased risk of infection. a medication called granulocyte colony-stimulating factor is given as a daily injection in order to help decrease the risk of infection. the purpose of this study is to determine the best time to begin granulocyte colony-stimulating factor while maintaining the same clinical benefits. the current study aims to fill these research gaps and address the general question: can g-csf safely be given 72 hours following the last day of chemotherapy without increasing the incidence of febrile neutropenia, the duration of neutropenia, or causing increased delays in the next course of chemotherapy.


Eligibility criteria:
inclusion criteria: * pediatric oncology patients will be eligible to participate in this study if they meet the following inclusion criteria: 1. are between the ages of birth and 21 years old 2. is diagnosed with an oncologic disease 3. is being treated at ummc children's cancer clinic 4. will receive g-csf as part of their standard or experimental oncology treatment protocol between january 1, 2019 and december 31, 2019. oncology treatment protocols are typically derived from the children's oncology group standard of care or patients can be enrolled on a children's oncology group treatment study. 5. is within first four courses of chemotherapy treatment exclusion criteria: * patients will be excluded from the current study if: 1. g-csf was added to their oncology treatment protocol due to previous complications but for whom g-csf was not part of their original treatment protocol. 2. are being treated for relapsed disease 3. has clinical evidence of bone marrow involvement
in vivo study of sucrose and liquid oral pediatric medicines of long-term effect on dental biofilm ph

Conditions: Dental Biofilm pH

Summary: the aims of this study were to determine the sucrose and liquid oral pediatric medicines of long-term effect on dental biofilm ph to evaluate the cariogenic potential in vivo.

te study was carried out with 12 subjects that were refrained from brushing their teeth for 28 h and did not eat or drink for at least 3 h prior to each appointment. dental biofilm ph was measured in the cervical and proximal regions of anterior teeth with beetrode-type microelectrode coupled to a potentiometer. the biofilm was submitted nine paediatric medicines a long term and sucrose (negative control). ph measurements were taken at baseline to determine resting plaque ph and at time interval 5, 10, 15, 20, 25 and 30 minutes.

Eligibility criteria:
inclusion criteria: * age 18 to 22 years; * having oral hygiene adequate (ohi\<1.1); * having 20 natural teeth incluing molar; * not havind oral disease. exclusion criteria: * biofilm baseline ph \> 5,5; * not signature consent term; * using orthodontic appliance; * having used medicines last 3 months; * pregant woman.

Keywords: dental caries sucrose oral administration ion concentration of hydrogen pediatric medicines
influence of multi-dimensional wellness program on quality of life

Conditions: Healthy; Physical Disorders; Mental Disorders

Summary: the purpose of this study is to determine whether multi-dimensional wellness program (diet, art and biofield therapy) influences the quality of life for those with different health status in japan.

combination of wellness programs may be one of the best approaches to improve quality of life; however, the effectiveness of a treatment that combines various programs is also yet to be clarified. this study investigated the influence of okada health and wellness program on the quality of life for healthy people and those with illness in japan. okada health and wellness program consists of 3 components: diet, art and biofield therapy.

Eligibility criteria:
inclusion criteria: * those who were interested in practicing the diet program and art therapy established by the moa international corporation. * able to receive okada purifying therapy, a domain of biofield therapy at least once a week. * competent to answer the japanese questionnaires for quality of life * aged 16 years or older exclusion criteria: * those who did not match the inclusion criteria

Keywords: cohort study diet program art therapy laying-on-of-hands quality of life
malnutrition is not a risk factor for free flap failure in the oral cavity

Conditions: Free Flap Reconstruction

Summary: free flap reconstruction consists in replacing tissular defect from one body part by another tissu harvested in a distant site. microsurgery has to be performed to restore vascularization. free flaps are now the gold standard in complex reconstruction. while reliable with a success rate superior to 95 %, a failure takes a heavy burden on the patient. many risk factors have been highlitghted in free flap failure for head and neck microvascular reconstruction. among them, malnutrition is still debated. this is a retrospective cohort study comparing complications occurrence between two groups. one group with normal nutritionnal status, the other with malnutrition. between january 2008 and january 2018, 70 patients who underwent oral cavity reconstruction using free flap were included. this is the first study known to date which uses clinical and biological variables to determine the nutritionnal status. malnutrition is not associated with a higher risk for free flap failure in the oral cavity.


Eligibility criteria:
inclusion criteria: * every consenting patients undergoing free flap reconstruction of the oral cavity exclusion criteria: * unable to give consent
extended resection after positive intraoperative pathology in gastric cancer surgery

Conditions: Gastric Cancer

Summary: of 737 consecutive patients undergoing (sub)total gastrectomy for gastric or gej adenocarcinoma, 679 cases with curative intent surgery between 05/1996 and 03/2019 were included. patients were categorized into: i) r0 without further resection (direct r0), ii) r0 after positive ioc and extension of resection (converted r0) and iii) r1.

this retrospective cohort study was performed at our tertiary referral center at the university hospital of cologne, germany. since 1st may 1996 medical charts of patients who undergo surgery for gastric or gej adenocarcinomas are collected in a department internal database for research analyses (chairman since 05/2016 cj bruns, from 5/1996-4/2016 ah hölscher). in this study, patients undergoing curative surgery between 1st may 1996 and 31st march 2019 with (sub)total gastrectomy for gastric or gej adenocarcinoma were included. palliative resections and resections with transthoracic esophagectomy and gastric pull-up were excluded. demographics, perioperative treatment, survival and clinicopathologic data were obtained. medical records were reviewed and complications were categorized according to clavien-dindo classification. depending on iocs, extended resection and final pathology report a treatment flow-chart was created (figure 1): patients were grouped on a) ioc received (yes/no), b) ioc positive (yes/no), c) extended resection (yes/no), d) second ioc (ioc2; yes/no), e) ioc2 positive (yes/no) and final pathology results (r0/r1). the decision to perform ioc and to carry out extended resection in case of positive ioc was at the discretion of the treating surgeon. patients were then categorized into 3 subgroups according to final r status: r0 after extended resection (i.e. converted r0), r0 without extended resection (i.e. direct r0) and r1.

Eligibility criteria:
inclusion criteria: * older than 18 years * tumor resection via total gastrectomy and subtotal esophagectomy exclusion criteria: * no additional other solid or hematological neoplasias in the medical history * pregnancy * surgical procedures in palliative intention

Keywords: excision margin; prognosis; gastric cancer; resection
the asian transcatheter aortic valve replacement registry

Conditions: Aortic Valve Stenosis; Aortic Diseases

Summary: the purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (tavr) in the asian pacific population

this registry changes to tp-tavr registry(nct03826264). some subjects moved to tp-tavr registry and continue to 10-year follow-up.

Eligibility criteria:
inclusion criteria: * patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses * the patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethics committee of the respective clinical site

Keywords: transcatheter aortic valve replacement asian pacific asian
predicting relapse after cocaine inpatient cessation

Conditions: Cocaine Dependence; Cocaine Use Disorder

Summary: can brain mri at entry of cocaine inpatient cessation attempt predict relapse during a three month follow-up ? hypothesis : white matter losses in the prefrontal cortex are associated with relapse to cocaine use.

a multivariate model using mri parameters, craving score, impulsivity score, and neuropsychological testing results will be tested to predict relapse or continuous abstinence three month after cocaine inpatient cessation attempt.

Eligibility criteria:
inclusion criteria: * cocaine dependent patient requiring inpatient cessation * 18 years old and older * giving his/her consent to come back for visits up to three months * having a social insurance exclusion criteria: * minor * under guardianship * restraint hospitalization * contraindication to brain mri * pregnant women

Keywords: cocaine dependence abstinence prediction model humans mri cognitive impulsivity craving
an epidemiological study on winter sports injury in chinese population

Conditions: Sports Injury

Summary: the aims of the study are to describe the injury patterns among recreational skiers and snowboarders in china and to provide primary data to guide the reconstruction of regional healthcare facilities to deal with the increasing number of participants in snow sports.

a retrospective study was performed in ski resorts in chongli, china. 5000-10000 injured skiers and snowboarders will be recruited. data of all injury patients in the resort clinic will be collected. patients' information, including sex, age, equipment, skill level and injured body part, will be analysed.

Eligibility criteria:
inclusion criteria: * skiing and snowboarding injuries exclusion criteria: * skiing and snowboarding visitors without injuries