Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the effect of dapagliflozin with and without saxagliptin on albuminuria, and to investigate the effect of dapagliflozin and saxagliptin on hba1c in patients with type 2 diabetes and ckd

Conditions: Type 2 Diabetes Mellitus, CKD and Albuminuria

Summary: the purpose of this clinical research study is to determine whether dapagliflozin alone or in combination with saxagliptin can decrease albuminuria and improve glycemic control in patients with type 2 diabetes, albuminuria and renal impairment (ckd). the study is planned to randomize a total of 450 patients (150 patients per treatment arm)


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * female or male aged ≥18 years * history of type 2 diabetes mellitus for more than 12 months * hba1c≥7.0% and ≤11.0% * stable antidiabetic treatment during the last 12 weeks up to randomization * egfr 25-75 ml/minute/1.73m2, inclusive * micro or macroalbuminuria (uacr 30 - 3500 mg/g) * treatment with ace inhibitor or an arb for at least 3 months prior to screening * body mass index between 20 and 45 kg/m2 exclusion criteria: * any of the following cv/vascular diseases within 3 month prior to signing the consent at visit 1: * myocardial infarction * cardiac surgery or revascularization (cabg/ptca) * unstable angina * unstable hf * new york heart association (nyha) class iii-iv * transient ischemic attack (tia) or significant cerebrovascular disease * unstable or previously undiagnosed arrhythmia * significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 3x uln * total bilirubin (tb) \>2 mg/dl (34.2 μmol/l) * history of acute kidney injury requiring renal replacement therapy (dialysis or ultrafiltration) or any biopsy or imaging verifying intercurrent kidney disease other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis * ongoing treatment with a sglt2 inhibitor, glp-1 agonist or dpp4 inhibitors * any condition which, in the judgment of the investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient or patient suspected or with confirmed poor protocol or medication compliance
effects of secondhand smoke on flight attendant health

Conditions: Cardiopulmonary Disease

Summary: this is a study on a population of flight attendants who were exposed to occupational secondhand tobacco smoke (shs). this research will examine associations between flight attendant shs exposure and development of respiratory illnesses, reproductive problems, and cardiovascular diseases.

the main hypothesis of this study is that exposure to the secondhand tobacco smoke (shs) in the confined workspace of commercial aircraft prior to the ban of cigarette smoking is responsible for long-term damage on the health of nonsmoking flight attendants. we will compare the data collected from our pre-ban flight attendant participants to age-matched, nonsmoking controls from the nhanes (national health and nutrition examination survey) database. the results of our study should permit us to determine if shs exposure is the cause of long-term increased cardiovascular morbidity and risk, as well as increased susceptibility to respiratory illnesses.

Eligibility criteria:
inclusion criteria: 1. never smoker flight attendants who began working for airlines before the smoking ban on aircrafts went into effect. never smoker is defined as those with history of tobacco use of less than 100 cigarettes in their lifetime. 2. shs exposure for at least 1 year while working with the airlines. exclusion criteria: 1. less than 1 year of occupational exposure to shs 2. smoking more than 100 cigarettes over a lifetime

Keywords: secondhand smoke flight attendants lung function cardiac function reproductive health
amino acid composition reduces frequency of common cold. results of a controlled completely masked trial

Conditions: to Improve the Effectiveness of a Amino Acid Dietary Supplement in Chronic Pharyngeal Infections vs Placebo

Summary: the purpose of this study is to investigate the effectiveness of a dietary supplement with high dosage of amino acids and vitamins in the treatment of acute and chronic infection of pharyngeal area known as common cold. t


Eligibility criteria:
inclusion criteria: men and women with at least two episodes of common cold and infection of ear, nose and pharyngeal area. exclusion criteria: * people with severe infection like pneumonia, patients expecting an in-patient treatment during the trial, pregnant or breast feeding and people not able to understand the procedure of the treatment

Keywords: amino acids immune system vitamins chronic infection common cold ear nose throat
use of coils during percutaneous coronary intervention

Conditions: Percutaneous Coronary Intervention (PCI); Coronary Artery Disease

Summary: use of coils during percutaneous coronary interventions (pci) is sometimes life-saving and useful althought currently off-label and with unknown clinical outcomes. the study aims to report and compare in-hospital and long-term outcomes of patients undergoing coils implantation for treating coronary perforation or closing coronary aneurysms/fistulas.

background. use of coils during percutaneous coronary interventions (pci) is sometimes life-saving and useful althought currently off-label and with unknown clinical outcomes objectives. to report and compare in-hospital and long-term outcomes of patients undergoing coils implantation for treating coronary perforation or closing coronary aneurysms/fistulas. methods. among 245.652 pcis performed in 17 high-volume european centers, patients treated with coils will be identified. the primary outcome was technical success, defined as the successful sealing coronary perforation or aneurysm/fistulas and procedural success defined as technical success without in-hospital major cardiovascular events (mace). long-term mace and mortality were also reported

Eligibility criteria:
inclusion criteria: * patients with coronary artery perforation or coronary artery fistula/aneurysm suitable treating with coils embolization exclusion criteria: * patients without coronary artery disease suitable of coils treatment

Keywords: coils coronary artery perforation coronary fistulas coronary aneurysm
prospective trial: myocardial injury after noncardiac surgery (mins) following radical prostatectomy

Conditions: Myocardial Injury

Summary: the aim of this study is to prospectively analyse the rate of mins in the standardised radical prostatectomy patient clientele at the martini-clinic and to identify risk factors. pre- and postoperative troponin levels are determined (1st and 2nd postoperative day). the patient's height, weight, age and cardiovascular risk factors (including determination of the revised cardiac risk index) are recorded in the medical history as well as previous medical and interventional cardiological therapy. furthermore, the prostate carcinoma-associated tumour and surgical parameters are determined. clinically significant cardiovascular events during the inpatient stay are also described. finally, a description of the rate of events, a check for correlation with the revised cardiac risk index and an identification of risk factors are carried out.

primary endpoint: acute myocardial injury, defined as a postoperative troponin concentration above the 99th percentile sex-specific upper reference limit with a) an increase of ≥ 50% from baseline if the baseline troponin i or t concentration was below the 99th percentile sex-specific upper reference limit or with b) an increase of ≥ 20% from baseline if the baseline troponin i or t concentration was above the 99th percentile sex-specific upper reference limit. percentile or with b) an increase of ≥ 20 % compared to the initial value if the initial troponin i or t concentration was above the sex-specific upper reference limit of the 99th percentile. secondary endpoints: 1. recording the frequency of acute myocardial damage without or with clinical findings typical of ischaemia. 2. frequency of cardiovascular events during hospitalisation. cardiovascular events are defined as follows: non-fatal cardiac arrest, heart failure, interventional coronary angiography, coronary artery bypass surgery, new-onset atrial fibrillation, stroke, pulmonary artery embolism, deep vein thrombosis of leg or arm. 3. correlation between the level of postoperative troponin increase and the occurrence of cardiovascular events during hospitalisation. 4. predictive value of the revised cardiac risk index for the occurrence of acute myocardial damage. 5. differences in the incidence of acute myocardial damage in open radical prostatectomies versus minimally invasive radical prostatectomies. furthermore, the included patients are followed up for 24 months and questioned about cardiovascular events.

Eligibility criteria:
inclusion criteria: * consent form signed * patients with a biopsy-proven prostate carcinoma * planned orp or rarp exclusion criteria: * no exclusion of patients who fulfil the above inclusion criteria

Keywords: mins myocardial injury after noncardiac surgery radical prostatectomy prostate cancer complication clavien-dindo myocardial infarction revised cardiac risk index
complex cutaneous leishmaniasis healing study in algeria

Conditions: Cutaneous Leishmaniases

Summary: this study evaluates the effect of clean wound management and dressing on complex zoonotic cutaneous leishmaniasis caused by l. major in the mena region (algeria). the patients will participate in the wound dressing themselves. the objective is to determine the amount of patients that can avoid systemic chemotherapy with pentavalent antimony which is compulsory for patients with complex cl lesions. in algeria, this requires expensive hospital care because of the eventual toxic side effects of sb(v).

the investigator initiated, non-interventional leiclean trial with 100 cl patients presenting complex cl lesions, normally in need of a systemic an in-door treatment with meglumine antimoniate and in risk of systemic antimony toxicity (see inclusion criteria!) during the cl season of 2017/18 is part of the renewed cooperation treaty between the ipa and wm e. v. and originates from encouraging compassionate use observations after topical leiclean treatment authorized by the algerian ministry of health in december 2015. the study will be carried out in the zcl region of m'sila and bou saada. the german regulation authority, bfarm, has granted a special approval according to §11 mpg (german regulation for medical devices) to the new filmogenic gel dressing leiprotect®. the patients with complex cutaneous leishmaniasis (giemsa and pcr confirmed) elected for indoor treatment with systemic antimony treatment are given the option for a leiclean treatment of their lesions; they are instructed on hand hygiene and leiprotect® dressing of their lesions which they carry out themselves at home during seven days. on day eight they come for lesion cleansing and photographic monitoring before they start another weekly leiclean cycle. the patients can at any time opt for a conventional systemic chemotherapeutic treatment in a hospital if they are not satisfied with their healing progress. however, if the doctor realizes that after two months the hygienic wound management results in inadequate healing, he can also order hospital for the patients. the doctor will allow the patients to visualise their healing progress over the course of the trial through digital images on the computer. after complete epithelisation of the lesions, the patients come for controls at monthly intervals up to a period of five months to check for eventual lesion relapses. the costs of the leiclean outdoor treatment will be evaluated and compared to the already known hospital costs per patient for a three-week systemic indoor sb(v) treatment.

Eligibility criteria:
inclusion criteria: * subject has giemsa and pcr proven l.major cutaneous leishmaniasis * subject has complex zoonotic cutaneous leishmaniasis or sb(v) incompatibility * subject gives voluntary consent exclusion criteria: * immune deficiencies, skin tumours, allergy to 1,2-propylene glycol (rare)

Keywords: complex zoonotic medical device
efficacy study of mupirocin on infection after coronary artery bypass grafting

Conditions: Surgical Site Infections

Summary: the hypothesis is that application of mupirocin to the nose before and after coronary artery bypass grafting surgery will reduce the incidence of surgical site infections.

mupirocin applied to the nares is effective in eradicating nasal carriage of staphylococcus species. abundant evidence has documented that a majority of gram positive surgical site infections share bacterial phenotypes identical with nasal phage types. conflicting literature exists regarding the efficacy of mupirocin in reducing the incidence of surgical site infections. a randomized prospective double-blind placebo-controlled trial is needed to help settle this question in the setting of coronary artery bypass grafting surgery where surgical site infections carry significant morbidity, cost, and mortality.

Eligibility criteria:
inclusion criteria: * adults \>18 years old undergoing coronary artery bypass grafting surgery (cabg) with or without concomitant cardiac valve surgery or other cardiac surgery, * median sternotomy wound * capable of informed consent exclusion criteria: * allergy to mupirocin or components * pregnant or lactating females * emergency surgery * pre-existing ongoing infection

Keywords: mupirocin surgical site infections coronary artery bypass grafting
pancreatic calcium handling in islet beta cells in patients with type 1 diabetes mellitus

Conditions: Type 1 Diabetes

Summary: approximately 400,000 people are living with type 1 diabetes mellitus (t1dm) in the united kingdom: one of the highest rates in the world. it is characterised by autoimmune loss of pancreatic beta cell mass leading to metabolic dysregulation, requiring lifelong insulin therapy. it is now recognised that there are micro-secretors of insulin and that preservation of insulin secretion in these cases is associated with decreased complications. therefore, recent research has focussed on using immunomodulation to preserve pancreatic beta cell mass. evaluation of novel therapies for t1dm requires reliable methods to measure beta-cell function, which is unattainable using traditional non-invasive imaging techniques. a new approach is manganese-enhanced magnetic resonance imaging (memri). this proof-of-concept study was designed to investigate whether memri can be used as a measure of beta-cell function in people with t1dm.


Eligibility criteria:
inclusion criteria: * age \>18 years * no regular medications * no known significant medical conditions exclusion criteria: * inability to consent * renal failure (egfr \<30 ml/min/1.73 m2) * standard mri contraindications * pregnancy or breast feeding
investigation of thenar muscles morphometric parameters in patients with tmc oa

Conditions: Thumb Osteoarthritis; Muscle Atrophy or Weakness

Summary: in this study, investigators aimed to investigate the morphometric parameters tenar muscles and joint configuration in patients with trapeziometacarpal osteoarthritis (tmc oa) osteoarthritis stages, thenar muscle parameters, radial subluxation rate, functional level and hand dexterity.

patients diagnosed with trapeziometacarpal osteoarthritis and healthy subjects will be included in the study. thickness and cross-sectional area measurements of the thenar muscles of the patient and healthy volunteers will be performed by using shimadzu sdu 1200-pro ultrasound system with an 8-10 mhz linear probe. to improve the image quality and to avoid muscle compression, water immersion ultrasonography will be preferred and the hands will be positioned in a water-filled plastic container. the thenar muscles will be imaged in hands of each subject. in this study, poster-anterior radiographic imaging will be performed. the osteoarthritis stage will be determined on the radiographic image. three different measurements will be performed on radiography: radial subluxation of the first metacarpal base (rs), articular width (aw) of the first metacarpal, and the distance between the ulnar articular facet of the trapezium and the ulnar edge of the metacarpal (u). rs / aw ratio will be calculated. because tmc oa caused pain and affect performance, especially during grip activities in the osteoarthritis and control groups will be tested. grip strength will also be measured.

Eligibility criteria:
inclusion criteria: * patients with trapeziometacarpal osteoarthritis who were between 35 and 75 years exclusion criteria: * patient with de'quervain tenosynovitis, trigger finger, entrapment neuropathy and who had undergone hand surgery were excluded.

Keywords: thumb trapeziometacarpal osteoarthritis muscle thickness muscle cross sectional area hand function hand dexterity pain pinch strength
a research study in children with a low level of hormone to grow. treatment is somapacitan once a week compared to norditropin® once a day (real4)

Conditions: Growth Hormone Deficiency in Children

Summary: the study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and norditropin® given once a day (the medicine doctors can already prescribe). researchers will test to see how well somapacitan works. the study will also test if somapacitan is safe. participants will either get somapacitan or norditropin® - which treatment participants get, is decided by chance. both participants and the study doctor will know which treatment participants get. the study will last for 4 years. participants will attend 19 clinic visits and have 1 phone call with the study doctor.


Eligibility criteria:
inclusion criteria: * prepubertal children: a) boys: age more than or equal to 2 years and 26 weeks and less than 11.0 years at screening. testis volume less than 4 ml. b) girls: age more than or equal to 2 years and 26 weeks and less than 10.0 years at screening. tanner stage 1 for breast development (no palpable glandular breast tissue) * confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of less than or equal to 10.0 ng/ml using the world health organisation (who) international somatropin 98/574 standard * impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of center for disease control and prevention * impaired height velocity, defined as annualised height velocity below the 25th percentile for chronological age and gender according to the standards of prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening * insulin-like growth factor-i (igf-i) less than -1.0 sds at screening, compared to age and gender normalized range measured at central laboratory * no prior exposure to growth hormone therapy or igf-i treatment exclusion criteria: * any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements * current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening * children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening * diagnosis of attention deficit hyperactivity disorder * concomitant administration of other treatments that may have an effect on growth, e.g. but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder * prior history or presence of malignancy including intracranial tumours
pain out: improvement in postoperative pain outcome

Conditions: Post-operative Pain

Summary: pain out is a multi-national, non-interventional registry and benchmark project, assessing and analysing clinical and patient-reported outcome data of postoperative pain.

pain out offers a large registry as well as a system for benchmarking and feedback of outcome quality and decision support in acute pain conditions. it collects demographic, clinical and outcome data, using a validated assessment tool available in multiple languages. the registry part of the project aims at performing population-based research. furthermore, its infrastructure allows for the conduct of prospective studies comparing the effectiveness of processes of care. the benchmark part of the project provides the medical community with a unique, user-friendly system to improve treatment of patients with postoperative pain. a web-based information system, featuring two main functions, was developed: 1. a feedback and benchmarking system which provides participating sites with continuously updating data and analyses about the quality of care they provide compared to other institutions and allows identification of best clinical practice. 2. a knowledge library which provides clinicians with easily accessible and regularly updated summaries of evidence-based recommendations tailored to specific post-operative situations. pain out is leading and overseeing sub-projects in mexico, china, a number of european countries. additional countries will join over time. the sub-projects are scheduled to take place over a period of two years. the design is an uncontrolled pre- post-study, in which approximately 10 hospitals from each country participate. the project consists of collecting data (processes and patient reported outcomes) at baseline from 1-3 wards in participating hospitals; analyzing of the findings, selecting and implementing measures for change in practice; carrying out another round of data collection; summerizing the findings and discussing options for further work.

Eligibility criteria:
inclusion criteria: * \>= 18 years or \>= 4 years for sub-project quipsi/pain outinfant * patient is post-op day 1 * patient is at least 6 hours on the ward * patient has given consent exclusion criteria: * patient cannot communicate * patient is cognitively impaired * patient is asleep * patient is too ill * patient does not want to fill in the questionnaire

Keywords: post-operative pain paitent reported outcomes quality improvement
clinical risk assessment of cognitive function in systemic autoimmune diseases

Conditions: Systemic Sclerosis; Systemic Lupus Erythematosus; Myopathies, Inflammatory; Rheumatoid Arthritis; Healthy

Summary: objectives: systemic autoimmune diseases are chronic diseases characterized by chronic inflammation, vasculopathy, and autoimmune phenomena. several organ involvements are typical, including the central nervous system. formerly published investigations emphasize a mild cognitive impairment affecting attention, memory, and complicated solution tasks. however, these symptoms significantly impact patients' routines and quality of life. the study examined the associations between cognitive impairment and clinical parameters regarding systemic autoimmune diseases. methods: general clinical data, some serum biomarkers including ccl-18, ykl-40, comp, vegf, galectin-3, and pentraxin as well as results of functional, quality of life, and neuropsychological measures, the mini-mental state examination (mmse), the digit span forward-backward, the trail making a, b and the digit symbol tests all were administered.


Eligibility criteria:
inclusion criteria: * systemic autoimmune diseases * healthy individuals - as controls exclusion criteria: * diseases of the central nervous system * presence of pregnancy