Kornimate/medical-research-clean huggingface dataset:
does treatment with montelukast improve symptoms of atopic dermatitis in children?

Conditions: Dermatitis, Atopic

Summary: an open-label (outcome assessor blinded) prospective crossover cohort study of children 6-16 years assessing effects of montelukast on moderate to severe atopic dermatitis.

an open-label, prospective cohort study with two arms over 16 weeks comprising 8 weeks of treatment with montelukast and 8 weeks without treatment of montelukast. all patients will be followed from recruitment to the study end date. study population 62 patients aged 6-16 years old with moderate to severe atopic dermatitis recruited from the royal children's hospital and box hill hospital dermatology clinics having already previously received eczema education (scorad \>25) study product oral tablet montelukast dose regimen for patients 6-8 years old - 4mg montelukast once daily for patients 9-13 years old - 5mg montelukast once daily for patients 14-16 years old - 10mg montelukast once daily evaluation criteria primary objective measurement: mean change in scorad index at 8 weeks patients will be randomized into 2 arms: arm 1 treated with montelukast therapy over 8 weeks followed by no montelukast therapy for 8 weeks. arm 2 followed for 8 weeks without montelukast therapy followed by 8 weeks with montelukast therapy. assessment schedule clinical assessment will be conducted at baseline (week 0), and reviewed every 4 weeks over 16 weeks with a safety follow-up visit 2 weeks after the treatment ends (week 18). at the first clinic visit, demographic data, medical history and baseline scorad and cdlqi will be recorded. cdlqi will be completed by the participants. participants with scorad \<25 are considered to have mild disease and will not be included in the study. suitable participants will be prescribed oral montelukast as an adjunct to their standard topical therapy (corticosteroids, emollients) or immunosuppressive therapy. adverse effects, scorad (assessed by a blinded assessor) and cdlqi will be assessed at each review. data will be analyzed based on intention-to-treat. paired data on scorad and cdlqi will be analyzed. a p value \<0.05 will be considered statistically significant. a 30% improvement in scorad and cdlqi scores will be considered clinically significant.

Eligibility criteria:
inclusion criteria: - patients aged 6-16 years old with moderate to severe atopic dermatitis (scorad \>25) despite topical therapy (corticosteroids and emollients) for at least 2 months patients aged 6-16 years old with moderate to severe atopic dermatitis (scorad \>25) despite immunosuppressive therapy (azathioprine, cyclosporine, methotrexate) for at least 2 months exclusion criteria: - patients with mild atopic dermatitis (scorad \<25) patients who have received phototherapy in the past 8 weeks patients with history of sensitivity to leukotriene receptor antagonists
acoart scb sfa: sirolimus coated balloon catheter in the treatment of femoropopliteal artery stenosis

Conditions: Peripheral Artery Disease

Summary: a prospective randomized trial designed to compare the efficacy and safety of sirolimus coated balloon (scb) versus paclitaxel coated balloon (dcb) in the treatment of femoropopliteal artery stenosis


Eligibility criteria:
inclusion criteria: * age ≥18 years old and ≤80 years old * had lower extremity arterial occlusive diseases, and rutherford classification is 2-5 * sfa and/or popliteal artery had severe stenosis (stenosis degree ≥70%) or occlusion. * the length of target lesion less than 20 cm * subject (or legal guardian) understands the study requirements and procedures and provides written informed consent before any study tests or procedures are performed exclusion criteria: * the plasma creatinine level is higher than 150 umol/l * thrombolysis or thrombectomy is required * there are more than 2 lesion need to treat in the target vessel. * the patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks. * the target lesion had residual stenosis\>30% or flow-limit dissection after pre-dilatation. * the patient had outflow less than 1 vessel * the lesion located in a stent. * patient has a known allergy to aspirin, clopidogrel, heparin, paclitaxel, sirolimus or contrast medium that cannot be adequately pre-medicated. * women who are pregnant or breast-feeding. * the subjects have participated in other drug property studies or device studies that have not yet completed the main end point. * patient has life expectancy of less than 12 months. * the investigator think the patient is not suitable for participation in the clinical trial.

Keywords: drug eluting balloon catheter peripheral artery disease
use of nmoabs for the treatment of covid-19 in patients with hm.

Conditions: Covid19; Hematological Malignancy

Summary: this is a multicenter retrospective, non-interventional observational study to evaluate the efficacy of nmoabs in hm patients.

this is a multicenter retrospective, non-interventional observational study. the participating centres will retrospectively review all episodes of sars-cov-2 infection occurring in hms identified at their institutions from february 2020 to may 2021 and treated with nmoabs, to evaluate their efficacy.

Eligibility criteria:
inclusion criteria: * all patients must meet all the following criteria for study entry: 1. age equal to or greater than 18 years of age. 2. diagnosis of hm (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative disorders) at any stage/status. 3. third generation rapid molecular or antigen test positive for sars-cov-2 from february 2020 until may 2021 4. treatment with anti sars cov 2 nmoabs approved by aifa 5. not hospitalized for covid-19 at the time of nmoabs administration 6. not on oxygen therapy at the time of nmoabs administration 7. at least one of the following symptoms for no more than 10 days: * fever * cough * anosmia * ageusia / dysgeusia * pharyngodynia * asthenia * headache * nausea * diarrhea * myalgia * dyspnea * tachypnea 8. signed written informed consent according to ich/eu/gcp and national local laws (if applicable). exclusion criteria: * 1. hematological diseases, other than hm. 2. not tested positive for sars-cov-2 3. patients in disease remission "off therapy" for more than 6 months 4. immune plasma treatment in the previous two months

Keywords: neutralizing monoclonal antibodies
use of nutrigenomic models for the personalized treatment with medical foods in obese people

Conditions: Obesity; Dyslipidemia

Summary: the nutrigen project will be using nutrigenomic methods to determine the effectiveness of treatments with specific dietary foods, on the basis of genetic risk predisposition (genetic signature) of obese individuals.

nutrigen project specific aim 1. establishing a genetic signature model, involved in the donation of methyl groups and unsaturated omega-6/3 fatty acids metabolism, with a high predictive value for classification of dyslipidemia and insulin resistance in obese subjects. 1. establishing a genetic signature model in obese adults with dyslipidemia. 2. establishing a genetic signature model in obese children with insulin resistance. c. establishing a correlation between blood/plasma concentrations of the relevant metabolites, genetic signatures and dyslipidemia profile of adults, and respectively a profile for insulin resistance in obese children. nutrigen project specific aim 2. determining the efficacy of a dietary food specific treatment, which is also correlated with a genetic signature (nutrigenomics), based on the correlations defined in objective 1: 1. implementation of a treatment with dietary foods (for adults), in the presence/absence of other already prescribed treatments; 2. implementation of a treatment with dietary foods (for children), in the presence/absence of other already prescribed treatments.

Eligibility criteria:
inclusion criteria: * adults: between 18 and 70 years old; obesity present as defined by body mass index (bmi) ≥30 kg/m2 and by abdominal circumference ≥84 cm (women), and ≥90 cm (men); dyslipidemia present as defined by: serum cholesterol ≥200 mg/dl, hdlc ≤50 mg/dl (women) or ≤40 mg/dl (men), serum triglycerides ≥150 mg/dl, or present treatment for dyslipidemia (e.g. statins, fibrates, omega-3 fatty acids, cholestyramine, ezetimibe). * children: age between 7 and 18 years old; bmi \>+2sd who reference exclusion criteria: * adults: diagnosed for any type of cancer, or medical history of cancer; any auto-immune disease; any psychiatric disorder; blood coagulation disorders; history of drug abuse; alcohol abuse evaluated using audit-c. * children: the above exclusion criteria for adults; familial hypercholesterolemia; endocrine-induced obesity (cushing syndrome, hypothyroidism, growth hormone deficit), hypothalamus-induced obesity (babinski-fröhlich syndrome), genetic syndromes (prader-willi, achondroplasia, bardet-biedl, fanconi, turner, etc.); deposition diseases (glycogenosis, lipomatosis); personal history for: convulsive disorders, nephrotic syndrome, or asthma that necessitated corticoid treatment.

Keywords: nutrigenetics medical foods obesity children adults
low molecular weight heparin vs unfractionated heparin at cardiac surgery

Conditions: Coronary Disease; Coronary Artery Bypass Grafting

Summary: because the impairment of platelet function may cause excess peri-operative bleeding, pre-operative aspirin discontinuation and heparin bridging are common at cardiac surgery. we aimed to evaluate the impact of a low-molecular-weight-heparin (lmwh), enoxaparin, and unfractionated heparin (ufh) on coagulation parameters and peri-operative bleeding in patients undergoing elective coronary artery bypass grafting (cabg) surgery after aspirin discontinuation. the specific hypothesis of this study was that a 12 h interval is sufficient not to cause excess peri-operative bleeding, and is therefore an optimal compromise between antithrombotic efficacy and haemorrhagic safety.

since lmwh provide many pharmacokinetic advantages compared with ufh, and since they are a valid substitution for ufh in a number of settings, such as non-st elevation acute coronary syndromes and prevention of venous thromboembolism, lmwh may provide a useful bridge to revascularization after aspirin discontinuation in patients undergoing cabg surgery. obstacles to the spreading of this practice are mainly the absence of solid evidence of equivalence (or superiority) as to efficacy in this setting, and the proof of equal safety, namely the absence of excess bleeding because some studies have suggested an increased number of haemorrhagic complications after lmwh, particularly with the use of higher doses. this might here be a problem, as patients are here generally at high risk of thrombotic events and for this reason need higher doses than for prevention of venous thromboembolism.

Eligibility criteria:
inclusion criteria: * patients aged 35-75 years with 3-vessel coronary artery disease (cad) * candidates to elective cabg exclusion criteria: * other additional (valve, carotid, etc.) simultaneous surgery required, * off-pump surgery, * any altered liver and kidney laboratory parameters, * a history of any haemorrhagic disorders, * platelet count \ 450.000/μl, * treatment with ticlopidine or clopidogrel in the last month.

Keywords: unfractionated heparin enoxaparin low molecular weight heparin bypass surgery bleeding
clinical evaluation of flortaucipir f 18

Conditions: Alzheimer's Disease; Traumatic Brain Injury; Depression

Summary: this study is designed to expand the database of flortaucipir f 18 safety and tau binding as measured by pet imaging and to provide standardized conditions for flortaucipir pet use, data collection and analysis to facilitate companion studies including, but not limited to, longitudinal studies of aging, depression, and traumatic brain injury.


Eligibility criteria:
subjects should meet inclusion and exclusion criteria for the companion protocol in addition to the criteria below. inclusion criteria: * subjects who have a historical volumetric magnetic resonance imaging (mri) as part of the companion study exclusion criteria: * have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances * have a screening electrocardiogram with a corrected qt interval (qtc) \> 450 msec if male or qtc \> 470 msec if female * have a history of additional risk factors for torsades de pointes (tdp) or are taking drugs known to cause qt-prolongation. patients with a prolonged qtc interval in the setting of intraventricular conduction block may be enrolled with sponsor approval * have a history of drug or alcohol dependence within the last year, or prior prolonged history of dependence unless approved by the sponsor * are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception * have a history of relevant severe drug allergy or hypersensitivity * are patients who have received an investigational medication within 30 days prior to the planned imaging session for this study * are patients with current clinically significant unstable medical comorbidities * are patients who have received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study
bioimpedance of diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: the bipped study seeks to determine whether wound healing, in particular diabetic foot ulcers, can be monitored using electrical bioimpedance analysis (bia). bia measures the resistance of biological tissue to the passage of a very small electric current applied with electrodes. different types of tissue, due to cell structure, hydration and vascularization, have specific electrical characteristics. the bipped study aims to provide experimental data for the development of a bia sensor for monitoring of wound healing in chronic wounds.


Eligibility criteria:
inclusion criteria: * diabetic patient (type 1 or 2) with diabetic foot ulcer or lower limb ulcer * written informed consent signed * insured by the french national health insurance scheme exclusion criteria: * wound in the similar position on the other limb * people under legal protection * unilateral limb oedema * contra-indication to impedancemetry : pregnancy, patient with a pacemaker, neurostimulator or any other implanted electrical device, metallic prostheses * patients participating to other protocols involving foot ulcers measurement, if it interfers with the current protocol.

Keywords: diabetic foot ulcer
biological therapy in patients with inflammatory bowel disease

Conditions: Quality of Life

Summary: inflammatory bowel disease (ibd) is characterised by chronic, relapsing inflammation of the intestinal mucosa and an inability to down regulate the inflammatory immune response once activated. ibd encompasses ulcerative colitis (uc), crohn's disease (cd) and indeterminate colitis which is not clearly diagnosed as uc or cd. the peak age of onset of ibd is 15 to 30 years, with a second smaller peak occurring between 50 and 70 years of age

the incidence of ibd is rapidly increasing in newly industrialized countries strongly implicating environmental factors. the pathogenesis of ibd is not fully understood, but key influences are thought to include genetics, environmental factors, immune response, and gut microbiota.it is recognised that the availability of vitamin d is important in regulating gut mucosal immunity; with studies suggesting that vitamin d may affect gut epithelial integrity, innate immune barrier function, and the development and function of t cells the predominant symptoms of ibd are diarrhea, abdominal pain, gastrointestinal bleeding, weight loss, malnutrition and fatigue which can substantially impact a patient's quality of life (qol), largely due to the psychosocial impact of symptoms. a survey of ibd outpatients found that concerns about loss of bowel control, producing unpleasant odours, achieving their full potential in the workplace, feeling dirty or smelly, and issues with sexual relationships, ranked highly for both uc and cd

Eligibility criteria:
inclusion criteria: - any patient who is above age of 18 years old and diagnosed to have ibd (uc and/or cd) and eligible for biological therapy will be recruited in the study. exclusion criteria: * patients with ibd who aren't eligible to biological therapy * pregnant patients with ibd * patients with ibd who are under age of 18 years old * patient's refusal
transient urinary incontinence after holmium laser enucleation of the prostate (holep)

Conditions: Prostatic Hyperplasia; Incontinence

Summary: in men, urinary incontinence (ui) is relatively uncommon, and usually associated with some forms of prostate surgery. thus, one of the risks of surgery for benign prostate hyperplasia (bph) is postoperative ui. the guidelines of the american urological association for bph treatment indicate that ui (2\~5%) is relevant complications after transurethral prostatectomy (turp). rassweiler et al., based on a review of publications stated that early ui may occur in up to 30-40% of patients after turp. rigatti et al. reported that early postoperative urgency ui occurred in 38.6% (turp) and 44% (holmium laser enucleation of the prostate; holep) of surgically treated patients at 1-month after the surgery. recently, the follow-up data for patients treated with holep showed that transient stress ui developed in up to 44% after holep. although this alternative surgical treatment such as holep can be performed safely with minimal complications, patients often face debilitating ui during the postoperative period before any improvement in micturition parameters occurs. although this symptom ameliorates within a relatively short time, it usually cause significant stress and anxiety to the patient as far as their durations is concerned. in addition to its economic cost, ui is a distressing condition that has major impacts on a patient's quality of life. social withdrawal, isolation, and depression occur in some patients. because this problem is usually temporary, there has been little attempt at addressing the issue. therefore, there has been no research devoted specifically to transient de novo ui associated with holep. 1. the aim of the present study was following: 1. to investigate the incidence of transient de novo ui after holep for bph 2. determine the predictors of early postoperative transient de novo ui.


Eligibility criteria:
inclusion criteria: * age older than 50 years * presence of moderate or severe luts (international prostate symptom score \[ipss\] greater than 8)or maximum flow rate of less than 10 ml/s exclusion criteria: * previous prostate surgery * urethral stricture * prostate carcinoma * neurogenic bladder disease
effects of breathing exercises on pain, range of motion and neck disability in patients with cervical spondylosis

Conditions: Cervical Spondylosis

Summary: a randomized controlled trial was conducted on 72 diagnosed patients with cervical spondylosis at university of lahore teaching hospital. the study was completed within 9 months after the approval of synopsis. patients who fulfill the inclusion criteria were identified by individual physiotherapist and were enrolled for particular study. informed written consent was be taken by the patients and were randomly allocated into two groups. the total numbers of sessions were 12 (3 sessions per week). the study was single blinded. the assessor was unaware of the treatment given to both groups. control group received only routine physical therapy. this includes thermotherapy, trans-cutaneous electrical nerve stimulation, neck isometrics and stretching that includes 12 sessions and three times per week. experimental group received routine physical therapy along with breathing exercises. this includes thermotherapy, trans-cutaneous electrical nerve stimulation, neck isometrics and stretching that includes 12 sessions and three times per week. baseline data was collected before first treatment then after 4th, 8th and 12th session. the outcome measures were neck pain, rom, neck disability and quality of life and were analyzed by using spss 26 and then results and conclusion were drawn.


Eligibility criteria:
inclusion criteria: * diagnosed patients with cervical spondylosis * both male and female * age from 40-60 years exclusion criteria: * any deformity of spine * any surgery of spine * tumor * trauma \& fracture * cervical radiculopathy * respiratory diseases
aortic valve replacement with trifecta(tm)

Conditions: Aortic Valve Insufficiency; Regurgitation, Aortic Valve; Aortic Valve Incompetence; Aortic Valve Stenosis

Summary: the purpose of this study is to confirm the clinical safety and effectiveness of the trifecta valve.

the clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the trifecta valve.

Eligibility criteria:
inclusion criteria: * requires aortic valve replacement (heart surgery such as bypass is allowed at the same time). * legal age. * signed informed consent prior to surgery. * willing to complete all follow-up requirements. exclusion criteria: * pregnant or nursing women. * have already had a valve replaced other than the aortic valve. * needs another valve replaced. * cannot return for required follow-up visits. * have active endocarditis. * acute preoperative neurological event (such as a stroke). * renal dialysis. * history of substance abuse within one year, or a prison inmate. * participating in another study. * life expectancy less than two years.

Keywords: aortic valve heart valve tissue valve bioprosthesis valve disorder valve disease cardiac surgery aortic valve stenosis aortic valve regurgitation
comparison of the clinical efficacy of the lingual brackets and labial brackets in the leveling phase

Conditions: Irregular Teeth

Summary: this aim study aims to compare clinical effectiveness of customized lingual brackets and conventional labial brackets in alignment period in a sample of class i malocclusion patients treated on a nonextraction basis.

the study included 20 patients who presented with class i malocclusion and scheduled for orthodontic treatment without tooth extraction. the patients were randomly assigned for treatment with customized lingual brackets or with conventional labial brackets. during the alignment period 0.012 inch (t1) , 0.014 inch(t2), 0.016 inch (t3)niti arch wires were performed respectively and the control visits were scheduled by 6-weeks intervals. in all sessions, digital models were obtained by intra-oral scanning device after removal of arch wire, which then analyzed by software. in order to analyze change in t0 (pretreatment), t1, t2 and t3; little's irregularity index, distance between canine teeth, distance between first premolar teeth, distance between second premolar teeth, distance between first molar teeth and arch length measurements were performed on digital models.

Eligibility criteria:
inclusion criteria: * class i malocclusion * completed permanent dentition * crowding ≥ 6 mm exclusion criteria: * tooth loss or extraction except third molars * having cross bite * having genetic or hormonal disorder * using a chronic drug * previous orthodontic treatment and prosthetic restoration * inappropriate oral hygiene and periodontal diseases

Keywords: customized lingual brackets lingual orthodontics digital model
change in heart rate variability prior to tachyarrhythmia in icd implanted patients

Conditions: Ventricular Tachyarrhythmia

Summary: to investigate changes in hrv during the time before a spontaneous episode of ventricular tachyarrhythmia.


Eligibility criteria:
inclusion criteria: * s/p lexos vr/-t,dr/-t implantation * signed patient informed consent exclusion criteria: * caf * life expectancy\<6 months * impending heart transplant * persistent recurring tachycardia * rhythm disturbances that preclude a meaningful hrv analysis * participation in another study.

Keywords: icd icd implanted patients