Kornimate/medical-research-clean huggingface dataset:
evaluation of a flash glucose monitoring system in ambulatory patients with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus

Summary: to evaluate the accuracy of the flash glucose monitoring system (fgm), abbot freestyle libre, used today in clinical practice in sweden in estimating plasma glucose levels. data will be collected in ambulatory patients with type 1 diabetes to determine safety, accuracy, and reliability.


Eligibility criteria:
inclusion criteria: 1. type 1 diabetes 2. adult patients, age 18 or older and \< 75 years 3. written informed consent - exclusion criteria: 1. pregnancy 2. patients with severe cognitive dysfunction or other disease which makes fgm use difficult 3. history of allergic reaction to any of the fgms materials or adhesives in contact with the skin. 4. history of allergic reaction to chlorhexidine or alcohol anti-septic solution. 5. continous glucose monitor (cgm) or fgm usage in the last month 6. abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo) -

Keywords: blood glucose blood glucose self-monitoring
early mobilization of spiral metacarpal fractures compared with operative treatment

Conditions: Fracture

Summary: spiral metacarpal fractures (metacarpal ii-v) can be treated conservatively or with operation. with minimal displacement this fracture is usually treated with immobilisation or early mobilisation. with appreciable displacement especially any malrotation the patient usually is treated with an operation. this usually includes an open reduction of the fracture and fixation with plates and screws or just screws. even if this is an standard procedure both mild and severe complications have been reported. new studies have shown that even displaced fractures can be treated with early mobilization. in those cases the fractures may heal with some shortening but very good function. an advantage of early mobilization is that the patient avoids the risk of an operation and the costs for the treatment are decreased markedly. the study is designed to answer the question if early mobilization is not inferior to operative treatment but with lower costs and without any operation related risks.

the study is designed as an prospective, randomised controlled trial. the patients are divided into two groups (operative and conservative treatment with early mobilisation). the operative group is treated with internal fixation and 2 weeks in a cast. the conservative group is instructed to do a fist to correct any malrotation and to rehabilitate quickly. by this procedure shortening oft he metacarpalfractures is limited by the function of the deep transverse metacarpal ligament connecting the distal parts of the metacarpalbones ii-v. furthermore the participants in the conservative group are allowed to use their hands without any restrictions. a physiotherapist controls that early mobilisation is carried out. the participant will be seen for a follow-up at 1, 6 and 12 weeks and 1 year. radiographs will be performed at 1v and 6v. the finger ranges of motion and pain will be evaluated with every follow-up, dash score, range of motion, pain and grip-strength will be measured after 12v and 1 year. the investigators will measure return to driving, work and sport. complications will be registered continuously for all patients. the overall satisfaction of the patients and the costs for both treatments will be documented as well. the study population is planned to be 21 patients in each group.

Eligibility criteria:
inclusion criteria: * single spiral fractures of metacarpal bone ii-v * fracture line at least twice the length of the diameter of the bone at the level of the fracture * at least 1-2mm displacement of the fracture and/or malrotation * normal hand function before the injury * fracture less than 10 days old exclusion criteria: * multiple metacarpal fractures * open fractures * incompliance or dementia * fracture line not twice the length of the diameter of the bone at the level of the fracture * abnormal hand function before the injury * fracture more than 10 days old

Keywords: early mobilisation metacarpal fracture operation
sacubitril/valsartan in left ventricular assist device recipients

Conditions: Heart Failure

Summary: the primary objective of this prospective randomised study is to assess the safety and tolerability of sacubitril/valsartan compared with standard of care used for treating bp in patients that have been implanted with the heart mate 3 lvad (events of special interest - all cause death, right ventricular failure, bleeding events, deterioration in renal function, hyperkalemia, symptomatic hypotension).


Eligibility criteria:
inclusion criteria: 1. written informed consent must be obtained before any assessment is performed. 2. ≥18 years of age, male or female 3. recently implanted heartmate 3 lvad recipients, in stable condition and deemed ready for discharge or chronic, stable, ambulatory heartmate 3 lvad carriers implanted within 1 year prior to enrolment 1. current acute decompensated hf (including right ventricular failure) requiring therapy with intravenous diuretics or vasodilators and/or inotropic drugs within the past 48 hours 2. history of hypersensitivity to sacubitril/valsartan or to drugs of similar chemical classes, patients with a known history of angioedema 3. patients with mean blood pressure ≤75 mmhg (systolic blood pressure i.e. doppler opening blood pressure ≤90 mmhg in those pulsatile and measured by doppler method) or symptomatic hypotension 4. egfr \ 5.4 mmol/l (meq/l) at visit 1 6. hemodynamically unstable patients or those with ongoing mcs other than lvad or those with planned biventricular support 7. hemodynamically significant aortic insufficiency in the opinion of the investigator 8. irreversible end-organ dysfunction 9. previous sacubitril/valsartan use while on lvad support 10. acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cv surgery, percutaneous coronary intervention (pci) or carotid angioplasty within 30 days prior to enrolment 11. life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate \>110 bpm at enrolment 12. any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study 13. active infection with hemodynamic compromise 14. hemoglobin (hgb) \ 45 kg/m2 16. congenital heart disease 17. coronary or carotid artery disease or valvular heart disease likely to require surgical or percutaneous intervention within the 6 months after enrolment 18. evidence of hepatic disease as determined by any one of the following: sgot (ast) or sgpt (alt) values exceeding 3x uln, bilirubin \>1.5 mg/dl at visit 1 19. pregnant or nursing (lactating) women and women of child-bearing potential unless they are using highly effective methods of contraception

Keywords: lvad (left ventricular assist device) sacubitril/valsartan heart failure
post marketing surveillance (pms) study of cresemba in korea.

Conditions: Aspergillosis; Mucormycosis

Summary: the purpose of this study is to observe safety and effectiveness of cresemba in patients with invasive aspergillosis or invasive mucormycosis in korea during the post-marketing surveillance period as required by ministry of food and drug safety (mfds).

in compliance with the korean new drug re-examination guidelines, this study aims to collect further observational data on the safety and effectiveness of cresemba for six years after authorization is obtained in at least 600 subjects under routine clinical practice. as the safety and effectiveness results obtained from the clinical development program of cresemba are based on randomized trials using specific inclusion and exclusion criteria, data from the present post-authorization study where cresemba is used in routine clinical practice per approved label is anticipated to provide important information on safety and effectiveness in a real-world population in korea. this non-interventional study is designated as a pms study and is a commitment to mfds.

Eligibility criteria:
inclusion criteria: patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: * patients aged 19 years or older * patients with proven or suspected diagnosis of invasive aspergillosis or invasive mucormycosis. * evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: patients meeting any of the following criteria will not be included in the study: * patients with known hypersensitivity to the active substance of isavuconazole or to any of the excipients. * patients are ineligible as determined by the investigator, such as those with familial short qt syndrome. * patients administrating ketoconazole, high-dose ritonavir (\>200 mg every 12 hours) or strong cyp3a4/5 inducers (e.g. rifampicin, carbamazepine, phenytoin) that cannot be discontinued before administration of cresemba.

Keywords: aspergillosis mucormycosis isavuconazole korean
clinical effectiveness of diode laser as an adjunct in the treatment of periodontitis

Conditions: Periodontitis

Summary: a randomized controlled single-blinded study. the hypothesis of this clinical trial is that disjunctive use of diode laser improve the clinical parameters of periodontists , and there are significant difference between the conventional treatment and diode laser as an adjunct

a total of 240 sites with deep pocket in 30 systemically healthy patients with chronic periodontitis, from subjects attending jordan university of science and technology (just) postgraduate dental clinic (pdc), the age range were (28-55) year, between apr 2017 and oct 2017. those patients were enrolled in a randomized controlled single-blinded study. for each patient, full medical and dental history and periodontal examination were recorded. clinical parameters such as pocket depth (pd), clinical attachment loss (cal), gingival index (gi) and plaque index (pi) were evaluated at the baseline. all patients underwent initial periodontal therapy; srp which was performed using a sonic device and hand instruments and the sites were divided randomly into two groups srp alone and srp with adjunctive diode 810 nm laser in the contralateral sites in the same jaw. the clinical parameters have been re-evaluated at 1, 3 and 6 months to test the effectiveness of (810 nm, 2 w, pulsed mode, for 20 sec) in treatment of cp. diode laser therapy was applied to periodontal pockets in the same day of treatment.

Eligibility criteria:
inclusion criteria: * healthy patients having periodontitis in at least two quadrants each quadrant should have at least 4 sites with pd \>4mm. * both male and female patients. * patient who are ready to cooperate with diode laser treatment. * patient who can comply with 3 visits for follow up (three times). exclusion criteria: * subjects with systemic diseases that may interfere with wound healing (such as diabetes) or any systemic disease that complicates the treatment. * pregnant women and breast feeding. * smokers, alcohol or drug dependent. * patients who received any form of periodontal treatment within the last 6 months. * patients who are currently taking or were on antibiotic treatment within the last 6 months. * presence of faulty restoration at teeth involved in the disease. * teeth indicated for extraction at sites that will be part of the study. * patient under 18 years of age.
local wound anesthesia in spine surgery

Conditions: Surgical Wound; Orthopedic Disorder of Spine

Summary: prospective, randomized, double-blinded, trial regarding the effect of local wound infiltration at the end of spine surgery; randomizing 1:1:1 between nacl, ropivacain, levobupivacaine combined with tramadol

subcutaneous local wound injections with nacl, ropivacain or levobupivacaine combined with tramadol will be performed in a randomized, double-blinded manner at the end of spine surgery. pain control, dosage of analgesics used, analgesics reduction compared to preoperative, wound healing problems and clinical outcome socres will be assessed up to 6 weeks after surgery

Eligibility criteria:
inclusion criteria: * informed consent * age ≥ 18 years * elective spine surgery with any technique * at least 6 weeks of scheduled follow-up from hospitalization exclusion criteria: * documented decline for data inclusion * allergy to any of the drugs used * \<50kg total body weight * vertebro- or kyphoplasty * pregnancy and breast feeding * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
postural orientation in the use of school backpacks

Conditions: Backpain; Prevention; Physical Therapy

Summary: this study will examine the effects of postural orientation in the use of school backpacks among elementary school students.


Eligibility criteria:
inclusion criteria: * children from seven to ten years of age. studing in private elementary school.
randomized controlled clinical trial of cinnamon to lower hemoglobin a1c

Conditions: Diabetes

Summary: this study will randomize diabetics with hemoglobin a1c greater than 7.0 to receive either cinnamon plus usual care or usual care alone. hemoglobin a1c will be measured at intake and after 90 days.

as the worldwide incidence of diabetes increases, the search for dietary adjuncts to treat this life-altering disease becomes far ranging. cinnamon is purported to be a natural insulin sensitizer without any known adverse events. both in vitro and in vivo animal studies have shown that cinnamon is an insulin sensitizer1. several compounds within cinnamon have been identified as possible sources of this sensitization process. to-date, three small randomized trials studying cinnamon in human diabetics have been published. khan et al. reported that fasting serum glucose could be reduced by 18-29% after 40 days of supplementation with 1, 3, or 6 g of cinnamon (cinnamomum cassia) in type 2 diabetics. 2 this study had several limitations that included failure to measure hemoglobin a1c, all patients were pakistani, and no power analysis was documented. vanschoonbeek, et al.3 report a small rct of postmenopausal women with well-controlled type 2 diabetes which showed no change in hba1c or fasting glucose. once again no power analysis is reported. mang et al. 4 conducted a rct of type 2 diabetics treated with aqueous extract of cinnamon for 4 months. they report a 15% decrease in fasting glucose and no change in hba1c over the duration of this trial. subjects had hba1c less than 7% and again no power analysis was included in this study. this study will address whether cinnamon at the dose of 1g daily in addition to usual care lowers hemoglobin a1c compared to usual care. power analysis indicates that 63 per group are needed and we will recruit 70 patients.

Eligibility criteria:
inclusion criteria: * type 2 diabetics greater tahn 18 years of age exclusion criteria: * allergy to cinnamon pregnancy

Keywords: cinnamon diabetes hemoglobin a1c
cellular immunotherapy for viral induced cancer - ebv positive lymphomas

Conditions: Hodgkin Lymphoma; Lymphoma, Large B-Cell, Diffuse; Post-transplant Lymphoproliferative Disorder

Summary: to investigate the efficacy of autologous epstein-barr virus (ebv)-specific t cells for the treatment of ebv positive diffuse large b cell lymphoma (dlbcl), hodgkin lymphoma (hl) and post-transplant lymphoproliferative disease (ptld) after failing first line treatment.


Eligibility criteria:
inclusion criteria: 1. the study will include three primary cohorts, with any of the following ebv+ diseases: cohort a - dlbcl, 1) in first or subsequent relapse, not eligible for autologous transplantation following salvage therapy or 2) relapse following autologous transplantation. cohort b - hl, brentuximab vedotin (bv) treatment failure or unable to tolerate bv. cohort c - ptld, rituximab treatment failure. 2. presence of active lymphoma or active ptld, based on imaging performed within the previous 3 months. 3. tumor positive for ebv encoded rna (eber) based on report from certified laboratory. 4. absolute lymphocyte count (alc) \>500/µl 5. male or female ≥ 12 years of age 6. weight ≥ 35 kg 7. eastern cooperative oncology group (ecog) performance score 0-2, inclusively or lansky score ≥ 60, as age appropriate 8. able to understand and comply with the requirements of the study and to provide written informed consent or age appropriate assent for pediatric patients. exclusion criteria: 1. known central nervous system (cns) lymphoma 2. primary refractory hl or dlbcl 3. bulky disease 4. relapse or progression following previous autologous ebv specific t cell treatment. 5. use of systemic corticosteroids \> 0.5 mg/kg/day prednisolone or equivalent does of alternative corticosteroid within 10 days prior to obtaining 200 ml starting material 6. positive for hiv, hepatitis b, hepatitis c, syphilis or human t cell leukemia virus (htlv). 7. patient is pregnant or lactating 8. systemic fungal, bacterial, viral or other infection that is not controlled 9. prior allogeneic hematopoietic stem cell transplantation (allo hsct) 10. known history of primary immunodeficiency

Keywords: epstein-barr virus dlbcl ptld ebv civic hl t cell
anticoagulants comparative benefit-risk ratio in real life

Conditions: Atrial Fibrillation

Summary: the study is an analysis using the french national health insurance database, six months after the beginning of noac launch in the nvaf indication. the aim is to compare the one-year, two-year and three-year benefit-risk (major bleeding, arterial thrombotic events, myocardial infarction (mi), death) between patients starting a noac and patients starting a vka for nvaf in 2013


Eligibility criteria:
inclusion criteria: patients with nvaf with a first reimbursed dispensation of pradaxa®, xarelto®, or vka in 2013, with no other identified indication for anticoagulation; without any vka or noac (pradaxa®, xarelto®, or eliquis®) reimbursed dispensation for the last 3 years before the first reimbursed dispensation of pradaxa®, xarelto®, or vka exclusion criteria: none
health mobile cognitive stimulation in alcohol use disorder

Conditions: Alcohol-Induced Disorders, Nervous System; Alcohol Dependence

Summary: the consequences of alcohol dependence are severe and may range from physical diseases to neuropsychological deficits in several cognitive domains. alcohol abuse has also been related to brain dysfunction specifically in the prefrontal cortex. to assess these deficits and the application of a novel approach of cognitive stimulation to alcoholics, we have carried out a neuropsychological intervention program with mobile health technology. patients diagnosed with alcohol dependence syndrome were submitted to cognitive stimulation during four weeks in a three-day/week basis.


Eligibility criteria:
inclusion criteria: only patients that scored higher than the cutoff values for their age on the mini mental examination test and with no clinical scores on the symptoms checklist revised were included in the study. exclusion criteria: patients with dependency from substances other than alcohol or with history of previous neurological disorders were excluded from the study. patients were also screened for minimal computer literacy; no patients were excluded due to lack of this criterion.

Keywords: alcohol dependence cognitive therapy executive function mobile health recovery of function rehabilitation
assessment of cognitive and functional impairment in older patients after ercp

Conditions: Cognitive Impairment

Summary: endoscopic retrograde cholangiopancreatography (ercp) is an interventional endoscopy procedure utilized in the therapeutic management of pancreatobiliary diseases including gallstones, bile duct strictures, leaks and infections, pancreatitis, and cancers of the bile duct or pancreas. ercp is classified as a high risk procedure. potential adverse events directly attributable to the technical aspects of ercp include pancreatitis, hemorrhage, infection, and bowel wall perforation. other potential adverse events of ercp may be less apparent and/or unknown, such as risk of neurocognitive dysfunction. overall, neurocognitive dysfunction after medical procedures impacts quality of life, functional disability, depression, and caregiver and societal burden. the prevalence of postoperative neurocognitive dysfunction and disability following interventional endoscopy procedures such as ercp has not been reported. this prospective observational study is designed to assess the prevalence of cognitive impairment and functional disability after ercp and endoscopic ultrasound (eus) procedures in older patients, and to assess whether specific patient and/or procedural factors are associated with increased risk of adverse outcomes.


Eligibility criteria:
inclusion criteria: * adults aged 60 years or older * scheduled to undergo outpatient ercp and/or eus at vanderbilt university medical center (vumc) exclusion criteria: * age \<60 years * inpatient status at the time of ercp/eus * documented history of dementia * inability to provide informed consent for study participation, implying baseline neurocognitive dysfunction * blind, deaf, or unable to speak english, as these conditions would preclude our ability to perform assessments. * no access to a telephone to permit pre-procedure and 3 month post-procedure neurocognitive assessment
study of mar001 in adults with metabolic dysfunction

Conditions: Hypertriglyceridemia

Summary: the purpose of this study is to evaluate the safety and tolerability of multiple doses of mar001in adult volunteers with metabolic dysfunction.


Eligibility criteria:
inclusion criteria: * willingness to provide informed consent and comply with the intervention * women of childbearing potential and men agreeing to use an appropriate method of contraception for the duration of the study * evidence of metabolic dysfunction at screening (triglyceride levels \> 2.8 mmol/l) exclusion criteria: * any condition which in the opinion of the investigator prevents the participant from complying with study procedures or prevents the participant from completing the study or interferes with the interpretation of study results * pregnant or breastfeeding mothers * terminal illness with expected survival of less than 1 year note: additional inclusion/exclusion criteria may apply, per protocol
prospective study of mammaprint in patients with an intermediate recurrence score

Conditions: Hormone Receptor Positive Malignant Neoplasm of Breast

Summary: this is a prospective study that will assess the impact of mammaprint on chemotherapy + endocrine versus endocrine alone treatment decisions in patients with an oncotype intermediate score.

the frequency of chemotherapy + endocrine versus endocrine alone decisions in oncotype dx intermediate score patients will be calculated before and after receiving the mammaprint result.

Eligibility criteria:
inclusion criteria: * women with histologically proven invasive stage i-ii, node negative, hormone receptor positive, her2 negative breast cancer, who received an oncotype dx intermediate score (18-30) * ≥ 18 years of age at time of consent * written informed consent exclusion criteria: * insufficient tissue remaining for mammaprint ffpe * tumor sample shipped to agendia with ≤ 30% tumor cells or that fails qa or qc criteria * women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy