Kornimate/medical-research-clean huggingface dataset:
use of midazolam in premedication of pediatric patients

Conditions: Separation, Family; Separation Anxiety

Summary: : the aim of the study is to compare the effect of intranasal and oral midazolam administered for premedication to children of preschool age on hemodynamic parameters, sedation and separation from parents.

patients meeting with anesthesiologists before surgery for assessment and administration of premedication is important in terms of reducing morbidity and mortality linked to surgery and anesthesia. a study reported that 75% of children experience anxiety before surgery. this anxiety and worry observed in the pediatric patient group may cause tachycardia, hypertension and tachypnea due to increased catecholamine levels in the body and may cause aggressive reactions that are difficult to control. additionally, it may make control of postoperative pain more difficult . several drugs are used before anesthesia to resolve surgical anxiety in pediatric patients and facilitate problem-free transfer to the operating room. midazolam is a benzodiazepine group drug, commonly used for preoperative medication for a long time. reasons for it being chosen for premedication are that it ensure sedation and anxiolysis, has rapid onset of effect, and is more amnesic than diazepam . though there are many routes to administer the drug, im and iv routes are painful and frightening for patients. the premedication administration route must be acceptable for the child and not be traumatic. as a result, generally oral and intranasal routes are chosen for sedation of pediatric patients. the aim of this study was to compare the effects of intranasal and oral midazolam, administered for premedication to preschool children, on hemodynamic parameters, sedation level and separation from parents, and in terms of complications. the study was planned as prospective, randomized and single-blind research. after receiving permission from the ethics committee of our hospital (haseki clinical research ethics committee no: 28.05.2009/10), the study included a total of 60 children aged 2-6 years in asa ( physical status classification system) i-ii group, with elective surgery planned under general anesthetic. . patients were allocated to two equal groups with the closed envelope method (group o, n=30, 0.5 mg/kg oral midazolam; group n, n=30, 0.25 mg/kg intranasal midazolam). midazolam was administered 20 minutes before the operation. vital signs and sedation score levels were recorded every 5 minutes. at the end of the 20th minute, the separation from parents score was assessed and recorded. assessments were completed by an anesthesiologist who did not know the method of administration for premedication.

Eligibility criteria:
inclusion criteria: - children 2-6 years old * asa i-ii group * with elective surgery planned under general anesthetic. exclusion criteria: * patients allergic to midazolam * rhinorrhea * respiratory system dysfunction like nasal polyp * neurological or psychiatric disorder

Keywords: midazolam premedication children
lumigan versus cosopt

Conditions: Open-Angle Glaucoma

Summary: to compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed combination given twice daily versus bimatoprost given once every evening in patients with open-angle glaucoma in patients insufficiently controlled on latanoprost monotherapy


Eligibility criteria:
inclusion criteria: * adults with a diagnosis of bilateral open-angle glaucoma including: primary, pigment dispersion or exfoliation in both eyes * on no therapy the intraocular pressure should be 22-29 mm hg inclusive at the 8:00 am measurement * visual acuity should be 20/200 or better in each eye exclusion criteria: * historical failure to respond to topical beta-blockers in a clinically meaningful manner * any contraindication to study medications * any anticipated change, or modification in the 6 weeks prior to visit 1, in systemic hypertensive therapy during the trial
the flapless approach in periodontal regeneration

Conditions: Periodontitis, Adult; Intrabony Periodontal Defect

Summary: the present investigation is designed in order to compare the radiographic and clinical effectiveness of flapless procedure performed alone or in combination with enamel matrix derivatives in the periodontal regenerative treatment of deep intrabony defects in patients with moderate or severe periodontitis. the study will have a follow-up of 12 months.


Eligibility criteria:
inclusion criteria: * diagnosis of periodontitis stage iii or iv; * presence of at least one tooth with ≥6 mm associated with a radiographic intrabony defect ≥3 mm at least 2 months after the completion of non-surgical therapy; * a full-mouth plaque score and full-mouth bleeding score \<15% at the time of the experimental procedure; * signed informed consent. exclusion criteria: * relevant medical disorders contraindicating periodontal surgery or detrimental to periodontal healing; * consumption of drugs known to affect periodontal status; * pregnancy and lactation; * third molars, teeth with furcation involvement or inadequate endodontic treatment and/or prosthetic restoration; * heavy smokers \>10 cigarettes per day.
magnification narrow band imaging colonoscopy for hereditary non-polyposis colorectal cancer surveillance

Conditions: Colorectal Neoplasms, Hereditary Nonpolyposis

Summary: the purpose of this study is to determine whether a new colonoscopic viewing technique called narrow band imaging (nbi)can help doctors detect more patients with at least one pre-cancerous area than conventional colonoscopy using white light alone in patients with genetically inherited high risk for bowel cancer (hnpcc).

colorectal cancer is the second commonest cause of cancer death. some people have an inherited defect in the genes which repair dna which results in a very high risk of colorectal (bowel) cancer at a young age. this syndrome is called hereditary non-polyposis colorectal cancer (hnpcc) or lynch syndrome. colonoscopic surveillance of hnpcc patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage, but even with meticulous examination, some precancerous lesions or cancers are missed. precancerous lesions in hnpcc are difficult to see and may be advanced even if as small as a few millimeters. endoscopists have used spraying dye on the lining of bowel (chromoendoscopy) successfully to improve detection of abnormal areas; however this is time consuming and requires extra time and equipment and despite the benefits seen in two studies is not widely used in routine clinical practice in the uk. narrow band imaging (nbi) is a technique that relies on light to improve contrast for the smallest blood vessels in the bowel lining which shows up precancerous areas as they have a richer vascular network. it is sometimes described as "digital chromoendoscopy" as the images produced are similar to chromoendoscopy, but it is much simpler and quicker to use. with magnification it allows assessment of the fine mucosal surace pattern (pit pattern) of lesion which allows an assessment of their likelihood of being precancerous. autofluorescence endoscopy uses short wavelength light and light filters to produce a false colour image of the bowel lining where polyps stand out. these techniques have been used with some success in the oesophagus and stomach but little work is available for the colon. we aim to see if nbi with magnification is better than standard colonoscopy for detecting precancerous areas. this is likely as it produces images similar to chromoendoscopy which is already shown to help. if a potentially precancerous area is found we will use other types of endoscopy, in particular nbi and autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non-cancerous areas.

Eligibility criteria:
inclusion criteria: * patients with hnpcc according to the amsterdam ii criteria * patients over 18 years exclusion criteria: * pregnant patients * unable or unwilling to give consent

Keywords: colonoscopy, narrow band imaging, high definition endoscopy colorectal cancer dysplasia hereditary non-polyposis colorectal cancer lynch syndrome hnpcc
smartstep smartphone pad

Conditions: Peripheral Arterial Disease

Summary: the study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care).

structured exercise therapy is a first line treatment for symptomatic peripheral artery disease, but compliance is poor. coaching programs may help but requires significant resources. smartphone programs may increase the efficiency of such efforts. the study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care) in patients at grady memorial hospital's vascular clinic.

Eligibility criteria:
inclusion criteria: * clinically stable intermittent claudication * able to give informed consent * age 18-89 years and one of the following: * abi \< 0.9 after 10 minutes of rest or * for subjects with an abi of \>1.3 (non-compressible arteries) a toe-brachial index (tbi) of \ 0.9 to 1.0, a reduction of 20% in abi must be measured within 1 minute of treadmill testing. exclusion criteria: life-threatening process including: * sepsis * critical limb ischemia (rutherford class 4-6) * unstable angina * active malignancy with life expectancy \< 6 months * severe nyha class iv heart failure condition other than pad that limits walking before claudication onset this includes, but is not limited to: * severe angina or dyspnea * arthritis * muscle weakness/pain active behavioral conditions such as uncontrolled schizophrenia or illicit drug addiction that, in the opinion of the study team, will interfere with active participation inability to attend study visits

Keywords: smartphone exercise functional capacity
a study in asthmatic children (6 to <12 yrs) comparing single doses of formoterol and foradil® evaluating efficacy

Conditions: Asthma

Summary: this purpose of the study is to investigate the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as symbicort pmdi.

a phase 2, randomized, blinded, 5-period cross-over, placebo and active controlled, multicenter, dose-finding study comparing single doses of formoterol 2.25 µg, 4.5 µg, and 9 µg delivered via symbicort pmdi and foradil® 12 µg evaluating the relative bronchodilating effects and safety in children.

Eligibility criteria:
inclusion criteria: * has a documented clinical diagnosis of asthma for at least 6 months prior to visit 1 * has a fev1 measured at least 6 hours after the last dose of inhaled, short-acting β2-agonist (saba) and at least 48 hours after the last dose of inhaled long-acting β2-agonist of =60% and =85% of predicted normal. * demonstrated reversibility of fev1 of =15% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist exclusion criteria: * has been hospitalized for \>24 hours at least once or required emergency treatment or urgent care visit more than once for an asthma-related condition during the 6 months prior to visit 1 * has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to visit 1.

Keywords: asthmatic children symbicort foradil
comparative study of the efficacy of oral versus intravenous hydration as a preventive measure of contrast-induced nephropathy (cin) in patients with renal insufficiency (ri) grade iii under study conducting computed tomography (ct)

Conditions: Renal Insufficiency

Summary: this study evaluates if oral hydratation is as effective as endovenous hydratation in the prophylaxis of contrast-induced nephropathy in patients renal insufficiency grade iii under study conducting contrasted computed tomography.


Eligibility criteria:
inclusion criteria: * patients of both sexes over 18 years * candidates for a study with computed tomography and intravenous contrast * a glomerular filtration rate between 30 and 45 ml / min including both determinations * they have signed the written informed consent after being informed of the objectives and the nature of the case or be unable to have the authorization or agreement of its exclusion criteria: * refuse to participate in the study * pregnancy or lactation * other risk factors for contrast induced nephropathy: diabetes mellitus type i, have an age of 75 years or above, heart failure (defined by a scale new york heart association 3 or 4), hypotension (defined as systolic blood pressure \<100), being treated with nephrotoxic medications. * any disease or a history that, in the investigator's opinion, could confound the results of the study or pose an additional risk to patient treatment.

Keywords: contrast-induced nephropathy renal insufficiency computed tomography
non-interventional study to describe the clinical management in asthmatic patients (nicma)

Conditions: Asthma

Summary: asthma is a heterogenic chronic disease that affects more than 300 million people worldwide, which it's characterized by acute symptomatic episodes of varying severity, including intermittently inflammation and narrowing of the airways in the lungs. the prevalence in spain it is estimated to be around 5%, according to the european community respiratory survey (ecrhs) and seems to be increased due to a higher rate of asthma diagnosis. in this condition there's substantial proportion of patients with a poor disease control, which conducts to an important negative impact in their health-related quality of life (hrqol) and the need to use health care resources. during the past decades multiple clinical practice guidelines, such as the international global initiative for asthma (gina) and national guidelines as guía española para el manejo del asma (gema) have been launched with the aim of improving quality of care in patients with asthma and reduce the high public burden associated to this disease. however, several studies have concluded that high proportion of patients remain uncontrolled, being in spain estimated around 50%, and there's direct evidence of poor adherence to the guideline's recommendations for asthma management. this evidence raises the need to determine the assistance quality care in asthma population in the influential area of hospital universitario virgen de la victoria through the assistance quality care indicators established by gema guidelines. the aim of this study is to obtain clinical data that allow to assess assistance quality degree in order to find improvement opportunities to achieve a better control of asthmatic patients within this influential area.

a non-interventional, descriptive, cross-sectional and unicentric study, has been designed and will be conducted in a spanish hospital of málaga. the design of the study imposes an only visit to be performed to obtain the patient's signed ic and after signing it (if patient agreed to participate in the study. except for this study visit, the rest of study will be based on electronic medical chart review of approximately 300 asthma patients belonging the influential area of hospital universitario virgen de la victoria. this chart review will be performed by the site investigator or collaborators. the data collection is stated in 6 months, and during this period the investigators will identify and randomly include the patients who meet selection criteria to avoid bias during patient's inclusion.

Eligibility criteria:
inclusion criteria: 1. patient with written informed consent prior to participation. 2. patient female or male ≥ 18 years of age 3. patient with asthma diagnosis more than one year before the study inclusion 4. clinical data available at least 1 year before the study inclusion in the electronic medical records. exclusion criteria: 1. patient's participation in any clinical trial during the year prior to the index date for data collection.

Keywords: asthma clinical management exacerbations
combination chemotherapy in treating patients with advanced cancer of the pancreas

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy in treating patients with advanced cancer of the pancreas.

objectives: i. evaluate tumor response to a trimetrexate, fluorouracil and leucovorin regimen in patients with advanced pancreatic carcinoma. ii. evaluate the toxicities associated with this regimen in patients with metastatic carcinoma of the pancreas. outline: the treatment plan consists of an iv infusion of trimetrexate, followed 24 hours later by iv infusions of leucovorin and fluorouracil. after another 24 hours oral leucovorin will be given every 6 hours for 7 doses. a treatment cycle consists of the regimen repeated weekly for 6 weeks followed by 2 weeks of rest. treatment cycles will be repeated until disease progression or unacceptable toxicity. projected accrual: if 3 or more complete or partial responses are observed in the first 22 patients, an additional 11 patients may be accrued for a maximum of 33.

Eligibility criteria:
disease characteristics: histologically proven advanced pancreatic cancer with metastatic disease bidimensionally measurable disease patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: at least 12 weeks hematopoietic: platelet count at least 100,000/mm3 absolute granulocyte count at least 1,500/mm3 hemoglobin at least 9 g/dl hepatic: bilirubin no greater than 2.0 mg/dl sgot, sgpt and alkaline phosphatase less than 3 times upper limit of normal serum albumin at least 3.0 g/dl renal: serum creatinine no greater than 1.5 mg/dl other: not eligible for higher priority protocol no prior malignancy within 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix not pregnant or nursing fertile patients must use effective birth control no underlying medical condition precluding treatment prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior or concurrent chemotherapy endocrine therapy: not specified radiotherapy: no concurrent radiotherapy no prior radiotherapy to only site(s) of measurable disease fully recovered from therapy surgery: fully recovered from prior surgery

Keywords: stage iv pancreatic cancer
premature ventricular contractions (pvcs) and blood pressure control

Conditions: Ventricular Premature Complexes; Blood Pressure

Summary: the purpose of this study is to determine if reduction in premature ventricular contraction (pvc) burden results in a decrease in blood pressure, sympathetic outflow, plasma catecholamines and an improvement in baroreflex gain. flecainide will be used for pvc suppression in a randomized, double-blinded, crossover fashion.


Eligibility criteria:
inclusion criteria: * frequent symptomatic premature ventricular contractions (pvcs) (\>10% of total qrss on a 24-hour holter) * willingness to participate in research exclusion criteria: * age \> 65 years old * pacemaker implantation * implantable cardioverter defibrillator implantation requiring pacing * sick sinus syndrome * atrio-ventricular (av) block * left ventricular dysfunction defined as left ventricular ejection fraction \< 50% * history of myocardial infarction or coronary artery disease * severe left ventricular hypertrophy (wall thickness \> 1.5 cm by echocardiography performed within 3 months from enrollment) * severe liver dysfunction * creatinine clearance of 35 ml/min/1.73 square meters or less * pregnancy * known hypersensitivity to the drug * qrs duration \> 120 ms * recent change in blood pressure medication within 30 days of enrollment
comparison of electronic calipers to conventional calipers and x-ray measurement of spinal tilt

Conditions: Lower Back Pain

Summary: the objective is to compare the accuracy and reproducibility of measurements taken with electronic calipers and conventional calipers. using both calipers, reproducibility will be determined by comparing results from a number of practitioners and accuracy will be determined by comparing results with those obtained from x-rays.

participants will have 2 spinal measurements, one at the shoulder and one at the hip, taken by electronic calipers and conventional calipers with different individual research staff. up to 5 individual research staff will take the 2 spinal measurements on each participant. this will be done to compare variation of measurements between individual operators. the accuracy of the spinal measurements, obtained with electronic and conventional calipers will be compared to the results obtained from x-rays taken of shoulder and hip areas. only one x-ray of the shoulder and one x-ray of the hip will be taken of each participant. x-rays represent the clinically accepted standard of obtaining spinal measurements. the data will analyzed statistically to determine sources of variation among the methods of spinal measurement described above.

Eligibility criteria:
inclusion criteria must be able to have shoulder and hip measurements for spinal tilt exclusion criteria: not able to have shoulder and and hip measurements for spinal tilt.
berberine effects on clinical symptoms and metabolic disturbance in patients with schizophrenia

Conditions: Schizophrenia; Therapeutics

Summary: the study was a 8-week, randomized, double-blind, placebo-controlled trial. berberine (300 mg，three times a day), as an adjuvant therapy has been used on the basis of the second-generation antipsychotics（sgas） monotherapy. all participants were randomly divided into two groups.any sga + berberine (bbr) or any sga +placebo.positive and negative syndrome scale (panss) has been used for psychiatric symptoms.the treatment emergent symptom scale(tess) has been used for evaluate adverse effects.glucose and lipid profile, inflammatory factors，adiponectin，leptin were obtained at 0, 4,8 weeks.

glucose and lipid profile:fasting blood samples for fasting blood glucose(fbg),insulin, hemoglobin a1c(hba1c), total cholesterol(tc), low-density lipoprotein cholesterol(ldl-c),high-density lipoprotein cholesterol(hdl-c), triglycerides (tg),apolipoprotein a(apoa),apolipoprotein b(apob),lipoprotein-a(lp-a) . inflammatory factors:c-reaction protein(crp),interleukine-1 beta(il-1β), interleukine-6 (il-6), tumor necrosis factor-α (tnf-α).

Eligibility criteria:
inclusion criteria: * individuals who aged 18 to 65 years * meet the diagnosis of schizophrenia according to dsm-iv * monotherapy of atypical antipsychotics for 4 weeks or more * at least 60 for positive and negative syndrome scale (panss) * female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential * sign the informed consent form exclusion criteria: * individuals who with diagnosis of other psychiatric disorders except schizophrenia according to dsm-iv * refused to provide informed consent * significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases * currently on anti-inflammatory or immunosuppressant medication including oral steroids and history of chronic infection (including tuberculosis, hiv and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition.

Keywords: schizophrenia；berberine；symptoms；inflammation