Kornimate/medical-research-clean huggingface dataset:
study of methotrexate given to juvenile idiopathic arthritis patients based on pharmacogenomics and pharmacometrics

Conditions: Juvenile Idiopathic Arthritis

Summary: this study will integrate pharmacogenomics and pharmacometrics, to explore an effective concentration of mtxpgn for jia pediatric patients, and set up a population pharmacokinetics model to provide reference for individual administration on jia pediatric patients.

in order to find out "the critical reasons for individual variances in mtx of jia pediatric patients and quantize the influence of these factors", based on early research, this study will integrate pharmacogenomics and pharmacometrics, to explore an effective concentration of mtxpgn for jia pediatric patients, and set up a population pharmacokinetics model to provide reference for individual administration on jia pediatric patients.

Eligibility criteria:
inclusion criteria: * pediatric patients with juvenile idiopathic arthritis * 7.5-10mg/m2 per week per dose of methotrexate * all patients have been treated with methotrexate at least for 3 months exclusion criteria: * co-treated other drugs which can interact with methotrexate

Keywords: methotrexate, juvenile idiopathic arthritis
communicational program "trust" to improve adherence to medications

Conditions: Coronary Artery Disease; Myocardial Infarction; Cardiovascular Diseases

Summary: the trial was designed in such a way as to show that the proposed program "trust" increases the proportion of patients who adhere to therapy in the cohort of those with coronary heart disease for two years after successful revascularization by using thrombolytic or stenting of the coronary arteries against the background of myocardial infarction.

the "trust" program includes a set of measures aimed at increasing the level of adherence to therapy in patients with myocardial infarction. differences in adherence rates between patients enrolled in the program and patients undergoing standard outpatient care will be monitored during the study. the study will be conducted according to the clinical approbation protocol, the principles of good clinical practice (gcp) and regulatory requirements. the developed program is based on the experience of international research studies and includes the following sections: * daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials; * service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (sms, e-mail), as well as calls from contact center operators; * questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. the questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services. information motivating to remain adherence to the therapy is structured as follows: a) greeting and presentation, a reminder of the necessity for therapy, with the support of the patient's trust in prolonging the quality of life by regular use of medications; b) the explanation of the action of the medicine taking into account the peculiarities of ordinary consciousness, warning the patient of the most common mistakes in treatment; c) recommendations for changing lifestyle and explaining their need; d) a reminder of the possibility to contact the attending physician, emotional support and counseling. the establishment of an information and counseling center will allow the patient to be supported throughout the time when the likelihood of giving up therapy and the risk of complications due to failure are most likely.

Eligibility criteria:
inclusion criteria: * signed informed consent * recent acute myocardial infarction within the past 2 months * successful revascularization via coronary stenting or thrombolysis exclusion criteria: * concomitant cardiovascular disorders requiring surgical treatment * coronary revascularization via cabg * patient refused from participating * patient is not available for communication within 2 months

Keywords: adherence to therapy myocardial infarction coronary artery disease communicational program
implementation of prevention and intervention of maternal perinatal depression to strengthen maternal and child health

Conditions: Perinatal Depression

Summary: imprint strengthens maternal and child health by screening, treating and preventing maternal perinatal depression, the most common complication of pregnancy and the child's first 1000 days. it is associated with poor pregnancy outcome and perinatal mortality and has adverse consequences on physical and mental development of the child. yet, only 7-28% of women with perinatal depression worldwide receive appropriate evidence-based care. this is astounding given that the need of investing on mental health is widely recognized and low-intensity interventions not requiring costly mental health professionals have been shown to be effective. imprint improves the effectiveness, reliability, safety, appropriateness, equity and efficiency of routine health care provided for the mother and the child during the child's first 1000 days of life. the investigators 1) have adapted into the gender-, country-, and cultural-context an existing evidence-based, low-intensity pregnancy intervention targeting maternal perinatal depression (online cbt-based therapy) (iloodottaa.fi); 2) test in cluster-randomised trial the short- and long-term efficacy of the intervention in women who report clinically relevant, subthreshold or more severe symptoms in an early pregnancy depression screen; 3) study biological, psychological and social determinants of depressive symptom severity, comorbidities and response to interventions. the study recruits women from 58 antenetal clinics in the cities of helsinki, vantaa, keski-uusimaa, kuopio and lohja and aims at recruiting 500 women to the intervention and 500 women to the control arms.


Eligibility criteria:
inclusion criteria: * epds screen result of 10 or more * agreed to be invited for the intervention during the screening phase exclusion criteria: * active suicidality * presence of severe mental disorder * concurrent use of psychotropic medication / concurrently under psychosocial treatment for mental disorder
assessment of body composition via dual-energy x-ray absorptiometry bone densitometry

Conditions: Osteodensitometry

Summary: the main objective of this study is to validate the measurement characteristics of a new bone densitometer, the stratos dr: * via cross calibration to the results of body composition (bc) measurement results to those of a reference device (the "discover a" by hologic) in terms of body fat percentage, lean mass percentage of total body mass and for different subregions (left and right arms, left and right sides, lumbar and thoracic spine, pelvis, left and right legs, head, android area, gynecoid area, visceral region). * and by the evaluation of the reproducibility of the bc measurement results in terms of fat mass and lean mass.

the secondary objective of this study is to cross calibrate the measures of bone mineral content (bmc) and bone mineral density (bmd) from the stratos dr against those of the discovery a on the whole body and its subregions.

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is referred by a doctor for the performance of an osteodensitometry examination. exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection or any kind of guardianship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the subject is suffering from a visually significant scoliosis * the patient is pregnant or breastfeeding * patient weighing over 160 kg * patient having undergone x-ray examination using a contrast medium such as barium in the 7 days preceding the visit * patient who underwent an examination using γ rays in the 15 days preceding the visit
comparison of 2 ventilatory support strategies during coronavirus disease 2019 (covid-19) pneumonia

Conditions: COVID-19

Summary: this retrospective monocentric study compares 2 ventilatory support strategies on outcomes (length of stay, intubation, mortality) in patients admitted in intensive care unit with covid-19 related pneumonia : invasive strategy used during the first period and non-invasive strategies (continuous positive airway pressure, high flow nasal canula, prone position) used during the second period.


Eligibility criteria:
inclusion criteria: * patient with confirmed sars cov2 infection * acute respiratory distress syndrome * patient more than 18 year old exclusion criteria: * intensive care unit admission for extra pulmonary failure * "do not reanimated" order * patient from another intensive care unit * patient objection * judicial protection

Keywords: invasive strategy non-invasive strategy continuous positive airway pressure high flow nasal canula prone position
romiae (rule-out acute myocardial infarction using artificial intelligence electrocardiogram analysis) trial

Conditions: Myocardial Infarction or Chest Pain

Summary: this study is a prospective multicenter observational study for external validation and model advancement of a deep learning based 12-lead electrocardiogram analysis algorithm targeting adult patients presenting to the emergency department with chest pain and acute myocardial infarction equivalent symptoms. about 9,000 adult patients will be enrolled at 20 emergency medical centers in korea. artificial intelligence algorithms are manufactured by medical ai co., ltd. it is an advanced version based on the model developed and published in 2020. it had the diagnostic performance of area under the receiver operating curve 0.901 and 0.951 for acute myocardial infarction and st-segment elevation myocardial infarction, respectively. the primary endpoint is a diagnosis of acute myocardial infarction on the day of the emergency center visit, and the secondary endpoint is a 30-day major adverse cardiac event. from march 2022, patient registration will begin at centers that have been approved by the institutional review board. this is the first prospective multicenter emergency department validation study for a 12-lead electrocardiogram artificial intelligence algorithm to diagnose acute myocardial infarction. this study will give insight into the direction of future development by verifying whether the deep learning algorithm works well for patients visiting the real-world adult emergency medical center.


Eligibility criteria:
inclusion criteria: * adults over 18 years of age with suspected chest pain and acute myocardial infarction * the onset or worsening of the symptom occurs within 24 hours exclusion criteria: * out-of-hospital cardiac arrest (ohca): patients with sustained (\>20 minutes) return-of-spontaneous-circulation are not excluded * patients in whom acute myocardial infarction can be clearly excluded, such as pneumothorax and traumatic chest pain

Keywords: deep learning
cardiobase bern pci registry

Conditions: Myocardial Ischemia

Summary: the aim of the cardiobase bern pci registry is to collect baseline clinical and procedural data as well as to assess the clinical outcomes of all patients undergoing percutaneous coronary intervention (pci) at bern university hospital. all patients undergoing pci with or without stent implantation will be prospectively registered. device use is according to the decision of the treating physician and independent of this registry. at hospital discharge and one year, the following outcomes will be assessed: death, cardiac death, myocardial infarction, stent thrombosis, repeat revascularisation, stent thrombosis, stroke, bleeding, renal failure and vascular complications.

background percutaneous coronary intervention (pci) is the most frequently medical intervention performed worldwide. coronary heart disease (cad) remains the leading cause of death, although advances in the management of acute myocardial infarction (mi) have reduced in-hospital mortality from 16% in the mid-1980s to around 4 to 6%. several breakthroughs have accounted for improvement of cardiovascular outcomes, including the use and further improvement of coronary stents and antiplatelet therapy. regarding stents, bare metal stents were first introduced but associated with a high risk of restenosis, something which was successfully addressed by the introduction of drug-eluting stents. all benefits and shortcomings of newly introduced devices and drug therapies are evaluated in large randomized controlled trials (rct). registries provide useful insights into novel associations that cannot be addressed by rct. the aim of the cardiobase bern pci registry is to collect baseline clinical and procedural data as well as to assess the clinical outcomes of all patients undergoing percutaneous coronary intervention at bern university hospital. all patients undergoing pci with or without stent implantation will be prospectively registered. device use is according to the decision of the treating physician and independent of this registry. objective prospectively collect baseline clinical, procedural and clinical outcomes at discharge and one year in order to assess the safety and efficacy of pci at bern university hospital. methods ecgs of all patients will be analyzed and a correlation with clinical outcome data performed. outcomes will be compared in different clinical subgroups. the impact of stent devices implanted and the anti-platelet therapy regimen on cardiovascular outcomes will be assessed.

Eligibility criteria:
inclusion criteria: * patient above 18 years of age * undergoing pci at bern university hospital * written informed consent exclusion criteria * no informed consent

Keywords: percutaneous coronary intervention registries
safety and efficacy of a hypoglossal nerve implant for the treatment of obstructive sleep apnea (osa)

Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders; Signs and Symptoms, Respiratory; Syndrome, Obstructive Sleep Apnea

Summary: the objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 system for the treatment of obstructive sleep apnea (osa).


Eligibility criteria:
inclusion criteria: * moderate to severe obstructive sleep apnea (ahi 15 to 60). * cannot or will not tolerate cpap treatment. * body mass index (bmi) between 25 and 40 * able to read, understand, sign and date the written informed consent form

Keywords: obstructive sleep apnea, neurostimulation, hypoglossal nerve
compliance with american diabetes association treatment guidelines for adult ketoacidosis

Conditions: Diabetic Ketoacidosis

Summary: at this time, saint mary's medical center is currently in the process of implementing a standardized diabetic ketoacidosis (dka) protocol. the first main goal of this project will be to evaluate patient outcomes to determine the effects of treating patients without a standardized protocol and to establish a baseline on how patients are being treating with dka. the final goal of the project will be to compare outcomes of those patients not placed on the protocol to those that were treated using smmc newly implemented dka protocol. the overall goal of this project is to determine the benefit of an institutional dka protocol.


Eligibility criteria:
inclusion criteria: * admitted to st. mary's medical center with dka * \>/= 18 years of age exclusion criteria: * \< 18 years of age

Keywords: acidosis, diabetic diabetic acidosis diabetic ketosis ketoacidosis, diabetic ketosis, diabetic
nuwiq dosing and outcomes in the management of women/girls with haemophilia a needing fviii treatment for surgery

Conditions: Hemophilia A

Summary: recombinant factor viii for the prevention of bleeding in women/girls with haemophilia a undergoing major surgery

female patients with mild to moderate haemophilia a will often need fviii concentrates to provide haemostatic cover during major surgery. this prospective, open-label, non-controlled, single-arm, multinational, multicentre study aims to evaluate the overall perioperative haemostatic efficacy of nuwiq in women/girls over 12 with haemophilia a undergoing major surgery requiring fviii treatment

Eligibility criteria:
inclusion criteria: 1. women/girls with haemophilia a (fviii:c ≥1-\<40%) according to medical history 2. at least 12 years of age 3. scheduled to undergo major elective surgery requiring fviii treatment 4. freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations exclusion criteria: 1. coagulation disorder other than haemophilia a 2. present or past fviii inhibitor (≥0.6 bethesda units \[bu\]/ml) 3. severe liver or kidney disease (alanine aminotransferase \[alt\] and/or aspartate aminotransferase \[ast\] levels \>5 times the upper limit of normal; or creatinine \>120 μmol/l) 4. known hypersensitivity to nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188) 5. pregnancy 6. already had surgery in this study 7. current participation in another interventional clinical trial 8. treatment with any investigational medicinal product (imp) within 30 days prior to screening visit
comparative results of conservatively and surgically treated adolescents with triplane and juvenile tillaux ankle fractures after skeletal maturity

Conditions: Ankle Injuries

Summary: triplane and juvenile tillaux fractures of the ankle are well known in adolescent pediatric population. it is widely accepted, that optimal treatment for displaced fractures is close or open reduction and fixation with screws under general anesthesia and under intraoperative fluoroscopy control. usually a small degree of displacement (up to 2mm) is expected to be healed without any sequences. until now, no evidence of ankle function and pain after skeletal maturity or long follow-up was published. more than that, no comparative study between operative and no operative treatment of mild and borderline displaced fractures were published. the purpose of this study is to evaluate functional and radiographic results of operatively and conservatively treated patients after they reach skeletal maturity.


Eligibility criteria:
inclusion criteria: * sign informed consent. exclusion criteria: * pregnancy * unwillingness to sign the informed consent.
effects of ospemifene on pelvic vascularity and blood flow

Conditions: Menopause

Summary: subjects will be randomized in a ratio of 1:1 to receive either 60 mg of ospemifene (osphena, shionogi, florham, nj) or placebo tablet. placebo tablets will be identical in appearance and packaging will be identical for the two pills. the participants will be instructed to take one tablet in the morning with food for twelve weeks. basic demographic information will be obtained on all participants. all women will undergo a pelvic examination, and questionnaires regarding pelvic floor dysfunction and sexual function before and three months after treatment. 3-d ultrasound with doppler blood flow analysis will be performed before the patient is started on the treatment. 3 months after treatment, the 3-d ultrasound with doppler blood flow analysis will be repeated. four areas will be measured: 1. the urethra in exactly the same section at the same level with the same setups. 2. 3 and 9 o'clock position 3. 6 o'clock position 4. clitoral blood flow doppler blood flow will be visualized using the doppler color mode of the ultrasound machine and will be applied for the assessment of the vascularity pattern. additionally, we will record a film with the use of color doppler in a video file. the transducer will be immobilized at one selected section and record a ten seconds of film. this film will be further analyzed in special software called pixel flux after the examination. dr. pawel wieczorek and dr. magdalena wozniak will read these deidentified video files in a randomized fashion based on their previous research experience with similar video interpretations of pelvic color doppler imaging \[8-11\].


Eligibility criteria:
inclusion criteria: * female gender * available for reliable follow up * able to complete study assessment * mammogram within the last year * menopausal (at least 12 months since last spontaneous menstrual bleeding) exclusion criteria: * age \<18 years * dementia or inability to follow instructions * prior pelvic floor radiation * history of uterine, ovarian, fallopian tube, breast, or colon cancer * current use or use within the last 6 months of estrogen (vaginal, oral, transdermal, compounded) * current use of alternative medicines including black cohosh, evening primrose, dong quai, or chasteberry * known prothrombotic mutations such as factor v leiden, prothrombin mutation, protein c or protein s deficiency * history of or current thrombophelbitis or venous thromboembolic disorders * currently using fluconazole or rifampin
phase ii study of recombinant relaxin for progressive systemic sclerosis

Conditions: Systemic Sclerosis

Summary: objectives: i. determine whether parenteral relaxin improves skin tightness, raynaud's phenomenon, digital morbidity, and digital ulcers in a patient with progressive systemic sclerosis (scleroderma). ii. determine whether relaxin decreases collagen production by fibroblasts in vivo and cultured from skin biopsies.

protocol outline: this is a compassionate use study. the patient is treated with subcutaneous injections of recombinant relaxin for approximately 12 months. if clinically indicated, therapy may be extended.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * progressive systemic sclerosis (scleroderma) * no pregnant or nursing women

Keywords: arthritis & connective tissue diseases rare disease systemic sclerosis
safety and efficacy pilot study of azasite® (azithromycin) in subjects with blepharitis

Conditions: Blepharitis

Summary: the purpose of this study is to evaluate the safety and efficacy of azasite® ophthalmic solution, 1% on signs and symptoms of blepharitis.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe chronic blepharitis * if female of childbearing potential, are non-pregnant and non-lactating exclusion criteria: * had ocular surface surgery (lasik, refractive, etc.) within the past year * unwilling to discontinue the use of contact lenses during the study * have glaucoma * unable or unwilling to withhold the use of lid scrubs during the study * have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance * currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation