Kornimate/medical-research-clean huggingface dataset:
a clinical study to evaluate symbicort turbuhaler used 'as needed' in adults and adolescents with asthma

Conditions: Asthma

Summary: the purpose of this study is to test if symbicort (budesonide/formoterol) turbuhaler is effective in treating asthma when used 'as needed' in patients with milder asthma. the efficacy of symbicort 'as needed' will be compared with pulmicort (budesonide) turbuhaler twice daily plus terbutaline turbuhaler 'as needed'

a 52-week, double-blind, randomised, multi-centre, phase iii, parallel-group study in patients 12 years and older with asthma, evaluating the efficacy and safety of symbicort (budesonide/formoterol) turbuhaler 160/4.5 μg 'as needed' compared with pulmicort (budesonide) turbuhaler 200 μg twice daily plus terbutaline turbuhaler 0.4 mg 'as needed'

Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedures. for patients under-age, signed informed consent from both the patient and the patient's parent/legal guardian is required 2. male or female, ≥12 years of age 3. documented diagnosis of asthma for at least 6 months prior to visit 1 4. patients who are in need of gina step 2 treatment 5. patients treated with a short acting inhaled bronchodilator(s) only should have pre-bronchodilator fev1 ≥ 60 % of predicted normal (pn) and post-bronchodilator fev1 ≥ 80 % pn 6. patients treated with low stable dose of ics or leukotriene antagonists in addition to short acting inhaled bronchodilator(s) should have pre-bronchodilator fev1 ≥80 % pn 7. patients should have reversible airway obstruction 8. to be randomized patients must have used bricanyl turbuhaler as needed on at least 3 separate days during the last week of the run in period exclusion criteria: 1. patient has a history of life-threatening asthma including intubation and intensive care unit admission 2. patient has had an asthma worsening requiring change in treatment other than short acting inhaled bronchodilator(s) within 30 days prior to visit 1 and from visit 1 until randomization 3. patient has required treatment with oral, rectal or parenteral gcs within 30 days and/or depot parenteral gcs within 12 weeks prior to visit 1 4. current or previous smoker with a smoking history of ≥ 10 pack years 5. pregnancy, breast-feeding or planned pregnancy during the study
comparative study of gene-activated bone substitute and autobone in treatment of long bone nonunions

Conditions: Non Union Fracture; Non-Union of Ankle Joint Without Infection

Summary: the study is aimed to compare the effectiveness of "histograft" bone substitute (gene-activated bone substitute based on octacalcium phosphate and plasmid dna encoding vegfa gene) mixed with shredded autobone and pure shredded auto bone harvested from iliac crest in treatment of patients with long bone nonunions

an open-label randomized controlled clinical trial, two cohorts. patients who met the inclusion criteria are planned to be enrolled into the trial. upon enrollment, all patients will undergo screening, a set of clinical examination, instrumental investigations and laboratory tests, including ct of the affected bone with the assessment of nonunion. all patients enrolled in the study will be subjected to bone reconstructive surgery with nonunion excision and bone grafting with either investigational bone substitute mixed with shredded autobone (in a ratio of 50/50) harvested during the surgery or pure shredded autobone from iliac crest. the clinical study results will be evaluated at the time points of 1, 15, 45, 90, 180 days with clinical examination, instrumental investigations and laboratory tests. control ct will be carried out for the primary outcome measure at 90, 180, 360 days after surgery.

Eligibility criteria:
inclusion criteria: * traumatic isolated closed or open gustilo i and ii, iiia and iiib humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture with a status of atrophic, oligotrophic or normotrophic non-union; * signed voluntary informed consent exclusion criteria: * hypertrophic non-union; * disability or unwillingness to give a voluntary informed consent or follow requirements of the clinical trial; * segmental bone loss requiring specific therapy (bone transport, vascularized graft, large structural allograft, megaprosthesis, etc); * other fractures causing interference with weight bearing; * visceral injuries or diseases interfering with callus formation (severe cranioencephalic trauma, etc.); * unrecovered vascular or neural injury; * infection of any location and aetiology; * pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control; * malignant tumour (past history or concurrent disease); * history of bone harvesting on iliac crest contraindicating new iliac crest bone graft harvesting or bone marrow collection; * conditions limiting study compliance (e.g., dementia, psycho-neurological diseases, drug addiction, and alcoholism); * medication affecting bone turnover (oral bisphosphonates, pth, sodium fluoride, strontium ranelate, calcitonin, testosterone, systemic cortico- or anabolic steroids)

Keywords: nonunion gene-activated matrix bone grafting bone substitute vegf octacalcium phosphate
rate control in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to compare the effect of metoprolol, verapamil, diltiazem and carvedilol on ventricular rate, working capacity and quality of life in patients with chronic atrial fibrillation.

this is a randomised, single blinded, cross-over study comparing the efficacy of metoprolol 100 mg o.d., verapamil 240 mg o.d., diltiazem 360 mg o.d. and carvedilol 25 mg o.d. in reducing ventricular rate in atrial fibrillation. a total of 60 patients will be included, with a minimum of 20 women.patients will receive each of the drug regimens in a random sequence. each regimen will be administered for 3 weeks, ensuring that steady-state drug concentration will be attained and to provide an adequate washout of the previous treatment. following each regimen, exercise ecg and holter registration will be performed and patients will undergo laboratory evaluation and complete qol-forms. they will then be started on the next randomly assigned treatment regimen, until the entire sequence of treatment schedules is completed.

Eligibility criteria:
inclusion criteria: * persistent or permanent atrial fibrillation with ventricular rate \> 80/min at rest and/or \> 100/min average at daytime. * male or female, age \> 18. exclusion criteria: * hypersensitivity or contraindication to metoprolol, verapamil, diltiazem or carvedilol. * coronary heart disease or heart failure * systolic blood pressure \< 100 mmhg * av-conduction disturbance * severe hepatic or renal dysfunction * thyrotoxicosis * ongoing treatment with digitalis * pregnancy or lactation

Keywords: atrial fibrillation
accuracy of non-contact thermometry

Conditions: Hypothermia

Summary: subjects will be admitted to hospital the evening prior, or the morning of surgery, whereupon they will undergo standard admission processes, including pre-operative assessment by the anaesthetist assigned to that list (one of the two study authors). the anaesthetist will then explain the study again, reiterating the potential risks and benefits of the study to the patient themselves, and to the population as a whole. consent will be sought at this point. patients will be transferred to theatre, anaesthetised and operated on as per normal practice. inclusive of this, in accordance with nice guidelines, patients will have a nasal or oesophageal doppler probe inserted to accurately measure core temperature. at this point, patients enrolled in the study will have temperature measurements taken every minute from the oesophageal probe and non-contact thermometers. if the patients requested it previously, they will be informed of the results of the study at a later date. statistics will then be carried out on the data to compare accuracy of the two novel methods to the oesophageal probe.


Eligibility criteria:
inclusion criteria: * participants will be patients undergoing elective gynaecological, vascular or urological surgery at the royal sussex county hospital, and as such will be seen at a pre-operative assessment clinic as part of their normal work up for theatre. exclusion criteria: - lacking mental capacity not speaking english malignancy in medical history undergoing open abdominal surgery
peripheral endothelial function in copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of the study is to assess the peripheral endothelial function in adult copd (chronic obstructive pulmonary disease) patients and the relationship between the peripheral endothelial function and the pulmonary function.

the primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). the pulmonary function will be assessed by the measures of the fev1 (forced expiratory volume in one second), the forced vital capacity (fvc) and the expiratory flow between 25% and 75% (fef25-75%). the relationship between these parameters of the pulmonary function and the peripheral endothelial function will be analyzed. in addition, a relationship between peripheral endothelial function and the severity of copd (classification according to gold (global initiative for chronic obstructive lung disease) 2010 and gold 2011 and the copd assessment test, the cardiovascular risk factors (score index) and the smoker status will be also assessed.

Eligibility criteria:
inclusion criteria: * copd : fev1/fvc \< 70% * smokers or ex-smokers ( ≥ 10 pack-years) * no copd exacerbation in the last three months * no history of asthma and no respiratory allergy exclusion criteria: * pregnant or nursing women * treatment with pulmonary vasodilators * patients with a significant acute disease. a significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial.

Keywords: endothelial function copd pulmonary function
efficacy of brock string therapy post concussion

Conditions: Concussion, Brain; Near Point Convergence

Summary: the purpose of the proposed study is to evaluate the efficacy of brock string therapy prescribed in the acute stage of concussion recovery can improve clinical outcomes among patients with receded near point of convergence (npc). aim 1: determine if participants receiving the brock string have more significant improvements in npc measurements at follow up 7-10 days post injury. aim 2: determine if participants receiving the brock string 1) improve on computerized neurocognitive test scores from initial visit (\<48 hours post injury) to follow up visit (7-10 days post injury) compared to control participants, and 2) have reduced recovery time (i.e., days from injury until return to play) compared to control participants.

receded near point of convergence (npc) is a common oculomotor deficit associated with numerous vision diagnoses, including convergence and accommodative insufficiencies, following sport-related concussion (src). researchers have found associations with worse neurocognitive test scores, higher post-concussion symptom burden, and longer recovery among patients with receded npc relative to concussion patients with normal npc. although oculomotor dysfunction may resolve spontaneously or improves with vision therapy exercises in the post-acute phase of recovery, it is unclear if early intervention can improve recovery outcomes. the brock string is a cost effective and practical vision therapy exercise for congenital convergence insufficiency (ci), and initial research supports effectiveness with src patients who have receded npc in the subacute phase of recovery (e.g., weeks to months post injury). early vision therapy intervention may be efficacious in improving recovery times and reduce healthcare costs by eliminating later therapies for chronic deficits.

Eligibility criteria:
inclusion criteria: * athletes who sustained a concussion during organized sport within past 48 hours * ages 12-20 * at least one npc measurement \>10 centimeters at initial clinic evaluation. exclusion criteria: * lack of access to a smart phone to receive text message prompts * vestibular disorder * seizure disorder * history of traumatic brain injury with imaging findings or brain surgery * history of 3+ concussions\\ * concussion within the past 6 months * history of developmental or intellectual disability * history of substance abuse * patients will also be excluded from recruitment if the treating clinician feels the potential participant would be unable to tolerate brock string therapy due to severe symptoms

Keywords: brock string sport-concussion concussion therapy receded near point of convergence
responsiveness to dalfampridine-er treatment among multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: ampyra (dalfampridine-er) was approved by the fda (2010) for improving walking speed in persons with multiple sclerosis. this project seeks to determine if there are other benefits to taking dalfampridine besides an increase in walking speed. this is strictly an observational study and research staff will not be involved in any decisions to stop or start taking the medication.

subjects will be evaluated before starting medication, throughout a 14week period after starting d-er as well as at 12 and 18months following the start date of medication regardless of if they stayed on medication or not.

Eligibility criteria:
inclusion criteria: * confirmed clinical diagnosis of ms by mcdonald criteria * prescribed ampyra (dalfampridine) as part of usual care, but have not yet started taking the medication before baseline visit * receive ms care at the mandell ms center * cognitively able to understand directions and complete protocol (score of 22 or greater on the mmse) * 18 years of age or older exclusion criteria: * already began to take drug prior to baseline research visit * not planning to continue care at mandell center for at least 14 weeks after initiation of therapy * unwilling or unable to complete assessments

Keywords: multiple sclerosis dalfampridine-er walking speed
iris-biofreedom cohort in the iris-des registry

Conditions: Coronary Stenosis

Summary: the objective of this study is to evaluate effectiveness and safety of biofreedom™ family stent in the "real world" daily practice as compared with other drug-eluting stents.

biofreedom™ family stent means that biofreedom stent, biofreedom ultra and the other stents with names starting with biofreedom.

Eligibility criteria:
inclusion criteria: * age 19 and more * patient with biofreedom™ family stent * written consent exclusion criteria: * intervention with biofreedom™ family stent and other drug eluting stent at the same time * life-expectancy less than 1 year * cardiac shock

Keywords: biofreedom drug eluting stent coronary artery disease
preoperative relaxation and intensified patient surgery education in patients undergoing colorectal surgery

Conditions: Gastrointestinal Diseases

Summary: this study aims to test the effects of a preoperative relaxation intervention and an intensified surgery patient education on pre- and postoperative wellbeing and health in patients undergoing colorectal surgery.

a former pilot study has shown that a preoperative relaxation program was effective in reducing preoperative anxiety. however the intervention was biased by concurrent pre-surgery education. therefore this study aims to test the effects of a preoperative relaxation intervention and an intensified surgery patient education on pre- and postoperative wellbeing and health in patients undergoing colorectal surgery using a factorial design.

Eligibility criteria:
inclusion criteria: * referral for colorectal surgery * preoperative anxiety at least 4/10 points on a numeric rating scale * physical and mental capability to participant * written informed consent exclusion criteria: * emergency surgery * known malignoma * severe comorbidity * severe psychological disorders * immunosuppression * coagulation disorders

Keywords: colorectal surgery
a study for lymphocele and lymphorrhea control following inguinal and axillary radical lymph node dissection

Conditions: Lymph Node Dissection; Lymphoedema; Lymphocoele

Summary: patients undergoing groin or axillary radical lymph node dissection (rlnd) or completion lymph node dissection (clnd, after positive sentinel lymph node biopsy (slnb) for melanoma or breast cancer were randomized in a controlled trial for surgical dissection technique. harmonic scalpel dissection were compared with classic dissection in term of lymphocoele and oedema.

the aim of the present study was to assess the value of uss in rlnd in groin and axilla in a homogenous group of patients. in a tertiary academic centre, patients undergoing groin or axillary rlnd or clnd after positive slnb for melanoma, skin cancer, sarcoma or breast cancer were enrolled in a randomized controlled trial for surgical dissection technique. the study was reviewed and accepted by the local ethical committee. patients were older than 18 years and gave an informed consent. all patients with a past medical history of contralateral lymph node dissection or other cause of lymphedema (previous trauma, deep venous thrombosis, radiotherapy, etc.) were excluded. patients undergoing both iliac and inguinal lymph node dissections were excluded as well. no patients had distant or in transit metastasis. patients were randomly assigned using sealed numbered envelopes to one of two arms of the study in a 1: 1 ratio. in the first group the dissection was conducted with uss (harmonic focus ®, ethicon endo-surgery (europe) gmbh) exclusively. in the control group the lymphadenectomy was performed using ligation and monopolar electrocautery. all patients were operated by a dedicated team headed by a single surgeon.

Eligibility criteria:
inclusion criteria: * all adult patients undergoing groin or axillary radical lymph node dissection (rlnd) or completion lymph node dissection (clnd), after positive sentinel lymph node biopsy (slnb) for melanoma or breast cancer were included. exclusion criteria: * patient with a past medical history of contralateral lymph node dissection or other cause for lymphedema (trauma, deep venous thrombosis, radiotherapy, etc.) were excluded.
neutrophil phenotypic profiling and surgical site infections in surgical patients

Conditions: Surgical Site Infection

Summary: surgical site infections (ssis) are one of the major hospital acquired infections and responsible for the most cost among the hospital acquired infections. the objective of this study is to assess the neutrophil functional profiles and their associations with ssis.


Eligibility criteria:
inclusion criteria: * scheduled for an elective open gastrointestinal surgical procedure or spine fusion surgery exclusion criteria: * on chronic immunosuppressive drugs such as chronic corticosteroid use * preexisting immunodeficiency diseases
prevention of catheter-associated urinary tract infection in incontinence and reconstructive pelvic surgery patients

Conditions: Catheter-Associated Urinary Tract Infection

Summary: the study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. women will be given an antibiotic or placebo at the time of catheter removal. the investigators hypothesize that prophylactic antibiotics will reduce the rate of infection.


Eligibility criteria:
inclusion criteria: * requires catheterization \>24h hours following incontinence or pelvic reconstructive surgery exclusion criteria: * receipt of antibiotics for either prophylaxis or treatment of a known infection during the postoperative hospitalization * allergy to sulfonamides or trimethoprim * non-english speaking * pregnancy * breast feeding * severe renal impairment (creatinine clearance \<30) * patients taking dofetilide, methenamine, procaine, warfarin, procainamide, methotrexate.

Keywords: catheter urinary tract infection
collateral circulation in acute ischemic stroke with large vessel occlusion

Conditions: Stroke, Ischemic; Stroke, Acute; Collateral Circulation, Any Site

Summary: prospective multicenter study of consecutive patients with acute ischemic stroke and large intracranial vessel occlusion in which a thorough and systematic evaluation of all variables that may be related to the degree of collateral circulation is performed.

introduction. in patients with an acute ischemic stroke due to a large-vessel intracranial occlusion (lvo), the status of the colateral circulation (cc) is related to clinical outcome and to the success of mechanical thrombectomy. however, cc is highly variable from patient to patient. methods. an observational, prospective, multicenter study of 700 consecutive patients with acute ischemic stroke and a lvo. factors to be evaluated: 1) modifiable: vascular risk factors, blood analysis, prior medications, vital constants (with emphasis on continuous blood pressure monitoring), head position, metrics (time to admission, computed tomography (ct), groin puncture, end of procedure), 2) non-modifiable: age, sex, completeness of circle of willis, etiology, type of mechanical thrombectomy, plasma biomarkers, genetic/epigenetic factors (a discovery phase with gwas study and a replication phase). cc grade will be assessed by the asitn/sir collateral score from ct-angiography (cta) and the digital substraction angiography (dsa, when performed). statistics: bivariate analyses and a logistic regression to predict cc grade (poor versus good) and cc persistence comparing cta with dsa (4 possibilities: poor-poor, poor-good, good-poor, good-good). expected results. our study may find markers of the cc status, facilitate the design of clinical trials to improve cc grade, may find new therapeutic targets and new treatments to enhance the beneficial effects of mechanical thrombectomy.

Eligibility criteria:
inclusion criteria: * patients with acute ischemic stroke. * large vessel occlusion of an intracranial internal artery: m1, m2 or tica. (terminal intracranial carotid artery), as demonstrated by cta. * cta performed within the first 24 hours after stroke onset. patients with wake-up stroke are included. * a previous modified rankin scale score of 0 to 3. * the patient or a legal representative signs a written consent to participate. exclusion criteria: * more than 24 hours from last been known to be well. * occlusion of other arterial segments (vertebrobasilar circulation, a1, p1, m3, m4). * age below 18 years.

Keywords: collateral circulation ischemic stroke large vessel occlusion
effect of 4 weeks of shuttle run training on insulin sensitivity in sedentary men

Conditions: Insulin Resistance; Obesity; Metabolic Syndrome

Summary: a number of studies have shown that short duration, high intensity interval training can improve health-related outcomes, such as insulin sensitivity and cardiorespiratory fitness. however, these often use specialized equipment, such as cycle ergometers, which makes it difficult to roll these interventions out for wide-scale use in the general population. this study aims evaluate the effects of a high intensity shuttle running intervention on insulin sensitivity, fitness and related cardiometabolic risk factors in men who are currently inactive. participants will be randomized into intervention (4 weeks of shuttle running) and control groups. we hypothesize that the shuttle running programme will result in improved insulin sensitivity, fitness and increased fat oxidation at rest compared with the control group.


Eligibility criteria:
inclusion criteria: * male * 18-40 years * undertaking \< 1 hour per week of planned exercise exclusion criteria: * bmi \> 35 kg/m2 * blood pressure \> 160/90 mm hg (on anti-hypertensive medication) * history of established coronary heart disease * family history of early cardiac death (\<40 years)

Keywords: physical activity exercise insulin resistance high intensity interval training fat oxidation fitness lipids blood pressure