Kornimate/medical-research-clean huggingface dataset:
bone age assessment in children using ultrasound compared to wrist x-ray

Conditions: Short Stature; Growth Disorders

Summary: bone age assessment in children is based on the interpretation of hand x-ray scans according to greulich and pyle (gp) standard atlas and frequently used for evaluating growth and puberty in children and adolescents. to address the disadvantage of repeated irradiation, the need for specialized radiation centers, heavy equipment and subjective reading a new device, sonicbone was developed. sonicbone utilizes a quantitative ultrasonographic technology of ultrasonic (us) waves, propagating along a measured bone distance. the aim of the study is to evaluate an ultrasound based device, sonicbone, compared to the current method in children. the investigators will be compared the us assessment to available bone age x-ray that exists in the medical files of the patients. the investigators will not do bone age x-ray scans especially for the current study.

bone age assessment in children is based on the interpretation of hand x-ray scans according to greulich and pyle standard atlas and frequently used for evaluating growth and puberty in children and adolescents. to address the disadvantage of repeated irradiation, the need for specialized radiation centers, heavy equipment and subjective reading a new device, sonicbone was developed. sonicbone utilizes a quantitative ultrasonographic technology of ultrasonic (us) waves, propagating along a measured bone distance. the aim of the study is to evaluate the ultrasound based device, sonicbone, and to compare it to the current method used in children. the sonicbone device (rishon lezion, israel) is a small (50cm x 25cm x 25cm), portable, bone sonometer, which measures two parameters: 1. speed of propagation through bone (speed-of-sound, sos, m/sec) of inaudible high frequency waves of a short ultrasound pulse; and 2. attenuation (atn; the decay rate) of the sound wave by the bone as a function of the distance it travels between a transmitter probe and a receiver probe15. the hand is measured by: 1- wrist (w), measuring sos and atn at the distal radius and ulna secondary ossification centers of the epiphyses; 2-metacarpals (mc), measuring sos and atn at the distal metacarpal epiphyses; and 3- phalange (p), measuring sos and atn along the bent proximal third phalanx shaft, growth plate and epiphysis. the average of those 3 readings is define as the child's bone age by sonicbone. all ultrasonic examinations will be conducted at the pediatric endocrinology clinic, by a trained technician. x-ray scans will be evaluated independently by a pediatric endocrinologist according to the gp atlas.

Eligibility criteria:
inclusion criteria: * children 3.5-18 years old refered to the endocrine pediatric clinic due to short stature or other growth abnormalities exclusion criteria: * children with bone disease * children who within the last year took medications which might change bone metabolism or mineralization

Keywords: bone age, height prediction growth
randomized study of physiological vs right ventricular pacing in patients with normal ventricular function post tavi

Conditions: Transcatheter Aortic Valve Implantation; Physiological Pacing; Right Ventricular Pacing; AV Block; Preserved Left Ventricular Systolic Function

Summary: single-center randomized trial in patients with pacing indication (av block) after tavi (transfemoral aortic valve implantation) and lvef\> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.

there is currently no evidence of the best mode of definitive pacing after tavi in patients with preserved systolic ventricular function and av block. through this study, investigators intend to elucidate the best post tavi pacing strategy, comparing the effect of right apical pacing vs. physiological pacing on the evolution of both echocardiographic and clinical parameters. investigators will include 24 patients without ventricular dysfunction (lvef\> 50%) and with av block pacing indication after tavi. patients will be randomized to 2 types of pacing (parallel randomized trial): physiological or right ventricular pacing (conventional). phys-tavi trial will analyze the following parameters in the 2 groups: survival; nyha class; distance in the 6-minute walking test; hospital admissions; left ventricular function; echocardiographic asynchrony (strain and flash septal); ntprobnp; and quality of life/symptoms with the kansas city cardiomyopathy questionnaire test (kccq-12) clinical, and echocardiographic follow-up will be performed for 1 year. inclusion of 24 more patients to those already included in the context of phystavi i (nct04482816). exploratory trial.

Eligibility criteria:
inclusion criteria: * successful implantation of tavi according to varc-3 criteria. * indication of cardiac pacing due to av block according to esc guidelines. * lvef\> 50%. * the patient must indicate their acceptance to participate in the study by signing an informed consent document. exclusion criteria: * ventricular dysfunction: lvef \<50%. * transapical tavi. * participating currently in a clinical investigation that includes an active treatment. * patients with left bundle branch block but without indication of pacing (av block). * life expectancy \<12 months.
comparing the effects of insulin glargine on blood glucose between needle-free jet injection and insulin pen

Conditions: Type 2 Diabetes

Summary: to comparing the blood sugar improvement and patient sensibility of insulin glargine injected with needle-free jet injector and conventional insulin pen

compared with conventional pen, needle-free jet injection of insulin has faster flow rate and larger area of local subcutaneous absorption. the aim of this study was to investigate the effects of subcutaneous insulin glargine injection with needle-free jet injection and conventional pen on blood glucose profile and safety in type 2 diabetic patients.

Eligibility criteria:
inclusion criteria: * volunteer to participate and be able to sign informed consent prior to the trial. * patients with type 2 diabetes, aged 18-80 years old, meeting who1999 diagnostic criteria, have not used any hypoglycemic drugs. the dosage of insulin glargine (4-35 units) combined with oral medicationis, stable for more than 2 months. * no acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc. * subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise. exclusion criteria: * patients with insulin allergy. * impaired liver and kidney function with alt 2.5 times higher than the upper limit of normal value;serum creatinine was 1.3 times higher than the upper limit of normal. * drug abuse and alcohol dependence in the past 5 years. * systemic hormone therapy was used in the last three months. * patients with poor compliance and irregular diet and exercise. * patients with pregnancy, lactation or pregnancy intention. * any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Keywords: needle-free jet injection insulin glargine
clinical relevance of anti-neutrophil cytoplasm antibody (anca)in hospitalized patients

Conditions: ANCA-related Vasculitis

Summary: laboratory testing of anti-neutrophil cytoplasm antibody (anca) is used to confirm diagnosis of patients who have a high level of suspicion for anca-related vasculitis. in these patients the specificity and sensitivity to the anca test is very high. this study hopes to prove that when this lab test is performed on blood of patients who do not have a high level of suspicion for anca-related vasculitis, the sensitivity and specificity is reduced and there are many false positive results. because of this, it should not be used as a screening test for a more general patient population.


Eligibility criteria:
inclusion criteria: * blood samples sent for anca lab test exclusion criteria: * patients with anca vasculitis * patients with known malignancy
tri staple technology stapler used in gastric bypass

Conditions: Sleep Apnea; Hypertension; Hyperlipidemia; Coronary Artery Disease; Gastroesophageal Reflux Disease; Osteoarthritis; Diabetes

Summary: the objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the endo gia™ stapler with endo gia™ sulu with tri-staple™ technology when used in a gastric bypass procedure.


Eligibility criteria:
inclusion criteria: * the patient must be 18-65 years of age. * the patient has a bmi of 40-60 kg/m2, or 35-40 kg/m2 with one or more of following comorbidities: sleep apnea, hypertension, hyperlipidemia, coronary artery disease, gastro esophageal reflux disease, osteoarthritis, and diabetes and eligible for gastric bypass. * the patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent. exclusion criteria: * the procedure is needed as revision bariatric surgery or the patient has had prior gastric surgery (nissen fundoplication, hiatal hernia, etc) * the patient is pregnant. * the patient has an active or history of, infection at the operative site. * the patient is unable or unwilling to comply with the study requirements, follow-up schedule, or to give valid informed consent. * patient has an abdominal ventral hernia requiring mesh repair * the patient has a history of clinically significant liver disease * the patient has a history of drug or alcohol abuse within 2 years of enrollment * the patient has a history of venous thrombosis or pulmonary embolism * the patient has a history of coagulopathy

Keywords: gastric bypass gastric bypass surgery
foot reflexology and pain and ankle brachial index and walking impairement

Conditions: Peripheral Arterial Disease

Summary: this randomized controlled study aimed to determine the effect of foot reflexology on pain, walking impairement and ankle brachial index level in patients with peripheral artery disease

patients with pah may experience pain in the legs, cramps, pain or aching symptoms (claudication) in the hip, thigh or leg calf, along with compulsive movements such as walking. reflexology is reported to have effects such as protecting the tissue integrity of the feet, increasing skin turgor, reducing neuropathic pain and increasing peripheral blood flow. for this reason, this study aimed to determine the effect of foot reflexology on pain, walking impairement and ankle brachial index level in patients with peripheral artery disease.

Eligibility criteria:
inclusion criteria: * adult patients over 18 years of age with pah; * no fractures or open wounds in both lower extremities; * absence of unilateral or bilateral amputation of the lower extremities exclusion criteria: * having an acute infection with fever; * requiring an acute surgical condition * undergoing femoral-popliteal bypass surgery * having a verbal communication problem such as alzheimer's or dementia
study evaluating etanercept for the treatment of refractory heel enthesitis in spondylarthropathy

Conditions: Spondylarthropathies, Enthesitis

Summary: to assess the efficacy and safety of etanercept in patients with spondylarthropathy and refractory heel enthesitis.


Eligibility criteria:
inclusion criteria * spondylarthropathy * heel enthesitis refractory to standard treatment * between 18 and 70 years of age * the patient global assessment of the disease activity (measured by a 100 mm vas) must be \>40 in the last 48 hours exclusion criteria * use of \> 1 local steroid injection within 2 weeks of screening * prior exposure to any tnf-inhibitor, including etanercept * dose of nsaids changed within two weeks of study drug evaluation

Keywords: refractory heel enthesitis in spondylarthropathy spondylarthropathy refractory heel enthesitis
study to investigate the efficacy and safety of sofosbuvir/velpatasvir fixed-dose combination for 12 weeks in adults with chronic hcv infection and compensated cirrhosis

Conditions: Hepatitis C Virus Infection

Summary: the primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (sof/vel) fixed-dose combination (fdc) in adults with chronic hepatitis c virus (hcv) infection and compensated cirrhosis.


Eligibility criteria:
key inclusion criteria: * chronic hcv-infected males and non-pregnant/non-lactating females * treatment-naïve or treatment-experienced individuals * compensated cirrhosis at screening note: other protocol defined inclusion/exclusion criteria may apply.
efficacy study of evt 201 to treat insomnia

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the purpose of this study is to determine whether a compound known as evt 201 is effective in treating people diagnosed with primary insomnia ( difficulty sleeping with no other significant contributing factor, such as depression).


Eligibility criteria:
inclusion criteria: * must have a diagnosis of primary insomnia * over the last three months, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours * must be able to attend the sleep center for two consecutive nights on four occasions over a two month period * must be willing and able to complete a sleep diary and questionnaires exclusion criteria: * must not have a clinically significant or unstable medical condition that may interfere with sleep * must not have a major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder * must not be currently using any medication know to affect sleep e.g. hypnotics, anxiolytics,antidepressants, antihistamines, anticonvulsants * must not intentionally nap 3 (or more) times per week * must not smoke more than 10 cigarettes per day and /or be able not to smoke without distress or discomfort for the duration of visits to the sleep laboratory ( i.e. approximately 12 hours)
a monocentric study to investigate a new low dose oral gut cleansing solution

Conditions: Colorectal Cancer

Summary: a first study at one centre, with a new oral gut cleansing solution, nrl994, in patients who were going to have a colonoscopy. the study was to find out how well the new "low dose bowel prep" (ldbp) worked, and whether it was safe to use.

a pilot monocentric, open phase i study to investigate the efficacy and safety of a new oral gut cleansing solution nrl994 in patients submitted to colonoscopy. the study was carried out as an open, uncontrolled investigation in a group of 36 in-patients scheduled for colonoscopy. patients were enrolled one or two days prior to the endoscopic procedure. gut cleansing started in the evening prior to the intervention when the first dose of ldbp was taken; bowel preparation was continued in the morning of the day of colonoscopy when the second dose was taken. a patient's participation in the study ended after completion of the endoscopic procedure. a dose of nrl994 was diluted in 1000 ml of water and consisted of 100 g peg 3350, 7.5 g sodium sulphate, 4.7 g ascorbic acid, 5.9 g sodium ascorbate, 46 mmol sodium chloride, and 12.46 mmol potassium chloride. the product was flavoured with lemon flavour (2.015 g), anhydrous citric acid (1.565 g), and potassium acesulfame (0.35 g). each dose of one litre had to be swallowed within one hour, followed by 500 ml of additional clear fluid.

Eligibility criteria:
inclusion criteria: * written informed consent must be obtained prior to inclusion * male or female * inpatients 18 to 60 years old with indication for complete colonoscopy * willing and able to complete the entire procedure and to comply with study instructions * females of childbearing potential must employ an adequate method of contraception. exclusion criteria: * ileus * intestinal obstruction or perforation. * toxic megacolon. * history of any colonic surgery. * cardiac insufficiency (nyha grad iii and iv). * ischemic cardio vascular disease. * renal insufficiency (creatinine above 1.4 mg/100 ml). * cirrhosis of liver (child b or c). * known hypersensitivity to polyethylene glycols and/or vitamin c. * concurrent participation in an investigational drug study or participation within 30 days of study entry. * females who are pregnant, nursing or planning a pregnancy. females of child bearing potential not using reliable methods of contraception. * subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly. * abnormal laboratory values (clinically significant) for sodium, potassium, chloride, creatinine and hematocrit * untreated or uncontrolled arterial hypertension (max. \> 170 mmhg and min \> 100 mmgh).
vytorin treating uncontrolled lipids (vytul) study (0653a-122)

Conditions: Cardiovascular Diseases; Diabetes Mellitus

Summary: to compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.


Eligibility criteria:
inclusion criteria: * greater than 18 years of age * treated for at least the last 3 months with a daily dose of atorvastatin 40 mg * existing coronary heart disease and cholesterol \> 4.0 mmol/l exclusion criteria: * uncontrolled diabetes * elevated liver function tests * elevated creatine kinase (ck) * triglycerides (tg) \> 4.5 mmol/l * drug or alcohol dependency within 6 months prior to visit 1 * woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study * woman of childbearing potential not using an acceptable method of birth control * women who are pregnant or breast feeding
comparison of duodenoscope with single-use distal cover and the conventional reusable duodenoscope

Conditions: Biliary Disease; Pancreatic Disease; Choledocholithiasis; Biliary Obstruction; Biliary Tract Neoplasms; Pancreatic Neoplasms

Summary: the purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing endoscopic retrograde cholangiopancreatography (ercp) using two types of currently available endoscopes. these are (1) duodenoscope with a single-use distal cover or (2) a conventional reusable duodenoscope.

the risks associated with the ercp procedure will be explained to patients who meets the eligibility criteria. consenting patients will be randomized to undergo endoscopic retrograde cholangiopancreatography (ercp) using either (1) a duodenoscope with a single-use distal cover or (2) a conventional reusable duodenoscope. assessments will be made during, and immediately after the procedure, then patients will be called after 1 week, 1 month, and 3 months after the procedure to get information about adverse events.

Eligibility criteria:
inclusion criteria: * patients undergoing ercp for biliary and pancreatic conditions * age \> 18 years old exclusion criteria: * vulnerable patient groups including pregnant women * patients who are unable to consent * patients with known cholangitis * patients with known carbapenem-resistant enterobacteriaceae (cre) or any other multi-drug resistant organisms (mdro) infection * surgically altered anatomy except for billroth i

Keywords: ercp duodenoscope duodenoscope with single-use distal cover
opals cardiac arrest database (ocad)

Conditions: Cardiac Arrest

Summary: to provide the infrastructure to answer prehospital research questions posed by scientists at academic health science centers and policy makers at multiple levels of government.

to provide the infrastructure to answer prehospital research questions posed by scientists at academic health science centers and policy makers at multiple levels of government

Eligibility criteria:
inclusion criteria: * ages 16 years and above exclusion criteria: under 16 yrs

Keywords: cardiac arrest
efficacy and safety of lanreotide 120 milligram (mg) as a palliative treatment of clinical symptoms associated with malignant intestinal obstruction in inoperable patients

Conditions: Malignant Intestinal Obstruction

Summary: the primary objective of this study is to assess the efficacy of lanreotide 120 mg for the relief of clinical symptoms due to malignant bowel obstruction in inoperable patients. this effect will be evaluated by the percentage of responder patients 7 and 14 days after one administration of lanreotide 120 mg. (a responder patient will be defined either as a patient experiencing \< or= 1 vomiting episode per day during at least three consecutive days or as a patient in whom ngt has been removed without any vomiting recurrence during at least three consecutive days) the total number of visits will depend on the clinical situation, 5 visits are obligatory: day(d)-3/-0,day 1,day 7,day 14,day 28 inclusion visit (d-3/-0): eligibility, pic, obstruction history, clinical exam, vital signs, diary cards, vas scale, cc medication, blood sample visit d1: injection visit d7/d14/28: clinical exam, nutrition procedure, result of biochemical analyse, adverse events, cc medication in between the visits, the patient will keep and fill out his diary and vas scale


Eligibility criteria:
inclusion criteria: * pic * \>= 18 years at time of enrolment * diagnosis of a digestive obstruction of malignant origin * diagnosis of peritoneal carcinomatosis confirmed by a ct scan within the previous 3 months * inoperability as decided after surgical consultation exclusion criteria: * operable obstruction * bowel obstruction that can be explained by a non malignant cause * signs of bowel obstruction * prior treatment with somatostatin analogues within the previous 60 days * known hypersensitivity to any of the test materials or related compounds * previous enrolment in this study

Keywords: malignant intestinal obstruction in inoperable patients