Kornimate/medical-research-clean huggingface dataset:
comparison of cross pin configurations in supracondylar humerus fracture treatment: 2 pins versus 3 pins

Conditions: Supracondylar Humerus Fracture

Summary: the objective of this prospective randomized controlled trial is to evaluate and compare the outcome of the 2wire vs 3 wire crossed pin configurations in the management of supracondylar humeral fractures in children.

fortyfive children with supracondylar humeral fractures were randomly divided into two groups. one group was treated with 2 crossed pins and the other group with 3 crossed pins. the mean age was 6.04±2.49 (1-12).. the follow-up period was 5 years, with no patients lost to follow up. intervention: twentytwo patients were managed by 2 crossed and 23 by 3 crossed pin method. all surgeries were performed by the same surgeon. main outcome measurements: postoperative stability, ulnar nerve injury, range of motions, and pin tract infections were evaluated.

Eligibility criteria:
inclusion criteria: * the inclusion criteria was children with closed extension type iii of supracondylar fracture of humerus. exclusion criteria: * patients with type i and type ii injuries, flexion type injuries, open fractures and patients above the age of 12 years were excluded from the study.
tailored intervention to improve medication adherence in patients with hypertension

Conditions: Hypertension

Summary: patients with hypertension have an increased risk of stroke and myocardial infarction. however, poor adherence to treatment with antihypertensives and lipid-lowering agents occurs frequently within this patient group. the purpose of this study is to investigate whether a complex tailored intervention in a hospital setting will lead to increased medication adherence and fewer cardiovascular events when compared to a usual care group. interventions focus on motivational interviewing, medication review and telephone follow up.


Eligibility criteria:
inclusion criteria: age: 18 years or older * patients receiving ambulatory treatment for hypertension in a hospital setting * the patient or a carer usually dispenses the patient's medications * patient lives in the southern region of denmark * written consent exclusion criteria: * lives in a care home or institution * receive dose dispensed medicine from a pharmacy * medicine is dispensed by a nurse in the patient's home * correctional mental health patients

Keywords: hypertension medication adherence motivational interviewing
clinical evaluation of two daily disposable lenses in neophytes

Conditions: Myopia

Summary: the purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).


Eligibility criteria:
inclusion criteria: * no previous contact lens experience or attempts to try contact lenses (neophytes). * currently wearing spectacles or needing vision correction in both eyes. * no older than 45 years of age. * able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters. * interested in wearing contact lenses. * willing to wear study lenses for at least 8 hours/day, at least 5 days/week. * other protocol-defined inclusion/exclusion criteria may apply. exclusion criteria: * eye injury or surgery within twelve weeks prior to enrollment. * pre-existing ocular irritation that would preclude contact lens fitting. * previous corneal or refractive surgery. * currently enrolled in any clinical trial. * other protocol-defined inclusion/exclusion criteria may apply.
nasal findings in reactive airway diseases

Conditions: Reactive Airway Disease; Wheezing

Summary: reactive airway diseases is a common respiratory diseases affecting 1-18% of the population in different countries. it carries a significant burden to children, their families, the healthcare system and the overall community.the purpose of the study is to delineate the prevalence of abnormal nasal finding in wheezy children and evaluate the role of the endoscopic examination of the nose in evaluation and management of a wheezy child.patients and methods:the study will be conducted as a prospective case series including all children having chest wheezes, aged from two years to eighteen years, attending emergency unit of assuit university children hospital

reactive airway diseases is a common respiratory diseases affecting 1-18% of the population in different countries. the worldwide increasing incidence of asthma continues to make it a global health problem . it is one of the major causes of hospitalization among children younger than 15 years of age . it carries a significant burden to children, their families, the healthcare system and the overall community. when combined with shortness of breath, chest tightness and/or cough, it is a bronchial asthma . pediatric wheeze be triggered by upper respiratory tract infections . the adenoids are a prominent contributor to chronic rhinitis in the pediatric population. clinical control of chronic rhinosinusitis may be important to optimize the control of difficult-to-treat asthma. however, the relationship between chronic rhinosinusitis and asthma in children remains largely descriptive .

Eligibility criteria:
inclusion criteria: * all children having chest wheezes, aged from two years to eighteen years, attending emergency unit of assiut university pediatric hospital, during the period 1⁄6∕2017 to 1∕6⁄2018. they will be examined in otolaryngology department, assiut university hospital exclusion criteria: * refusal of endoscopic nasal examination by care givers.and patients with definite diagnosis of wheeze (bronchiolitis,pneumonia)

Keywords: delineate the prevalence of abnormal nasal finding in wheezy child
pharmacokinetics (pk) and metabolism of fty720 in patients with severe renal impairment and healthy matched subjects.

Conditions: Renal Insufficiency

Summary: the purpose of this study is to compare the pharmacokinetics of fty720 and its metabolites in patients with severe renal insufficiency and in matched, healthy volunteers. this study will allow a better understanding of the effects of renal insufficiency on the disposition of fty720.


Eligibility criteria:
inclusion criteria: healthy subjects: * subjects must have a calculated glomerular filtration rate (gfr) by cockcroft-gault equation ≥80 ml/min. severe renal impaired patients: * patients not on dialysis with severe renal failure with a creatinine clearance \< 30 ml/min as determined by cockcroft-gault equation. * renal function should have been stable within the 3 months prior to study start. * patients with diabetes and/or hypertension who are in otherwise in good health may be included. however patients with diabetes must not have clinical evidence of gastropathy or enteropathy. exclusion criteria: all subjects/patients: * history of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study * history of retinal macular edema. * history of any significant cardiovascular events such as myocardia infarction, valvular disease, angina, ischemic heart disease, dilated cardiomyopathy, dysrhythmia. * history of immunocompromise, including a positive hiv (elisa and western blot) test result. severe renal impaired patients: * use of any highly potent cyp3a4 inhibitor (e.g. erythromycin, ketoconazole, itraconazole) within 2 weeks prior to dosing. * use of beta blocker therapy within two (2) weeks prior to dosing. other protocol-defined inclusion/exclusion criteria may apply

Keywords: fty720, pharmacokinetics, renal insufficiency
a prospective trial of enavogliflozin to evaluate cardio-renal outcome in type 2 diabetes mellitus patients

Conditions: Diabetes Mellitus, Type 2; Cardiovascular Diseases; Kidney Diseases

Summary: the novel sodium-glucose cotransporter-2 (sglt2) inhibitor, enavogliflozin, effectively reduces glycated hemoglobin (hba1c) levels and body weight without increasing the risk of serious adverse events. however, its long-term clinical benefits concerning cardiovascular and renal outcomes have yet to be thoroughly studied. this study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. eligible participants are adults aged 19 or older with type 2 diabetes who have a history of, or are at risk for, cardiovascular disease. a total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other sglt2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. the primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular and renal events. this trial aims to determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with type 2 diabetes and cardiovascular risk factors. it will also clarify role of enavogliflozin in preventing vascular complications in this patient population.

the envelop study aims to assess cardiorenal outcomes following enavogliflozin administration compared with dapagliflozin or empagliflozin in korean patients with type 2 diabetes, representing the first large-scale sglt2 inhibitor outcome study targeting this population.

Eligibility criteria:
inclusion criteria: 1. male and female adults aged 19 years and older at screening 2. subjects diagnosed with t2d at screening 3. subjects on treatment with or requiring treatment with enavogliflozin, dapagliflozin, or empagliflozin within the scope of label and reimbursement criteria exclusion criteria: 1. subjects with different types of diabetes mellitus other than t2d 2. subjects with moderate to severe hepatic impairment 3. subjects with contraindications to sglt-2 inhibitors, i.e., kidney function disorders with estimated glomerular filtration (egfr) \<60 ml/min/1.73 m2, end stage renal disease (esrd), or on dialysis 4. subjects with major comorbidities 5. subjects with a history of hypersensitivity to enavogliflozin, dapagliflozin, or empagliflozin and any of its components 6. pregnant or breastfeeding women
a 12-week extension trial to evaluate the safety and tolerability of brexpiprazole in the treatment of subjects with agitation associated with dementia of the alzheimer's type

Conditions: Alzheimer's Disease

Summary: active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the alzheimer's type (aad).


Eligibility criteria:
inclusion criteria: * participants must have participated in the 331-14-213 study. * participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior. exclusion criteria: * participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.

Keywords: agitation
is the use of drain for thyroid surgery realistic?

Conditions: Goiter

Summary: background : the use of suction drains in thyroid surgery is common practice in order to avoid haematoma or seroma, as well as to identify promptly the onset of haemorrhaging that might compromise the patient's airway. the aim of this study to determine the effects of routine drainage compared to no drainage in thyroidectomy patients. study design : total of 400 patients who undergoing total thyroidectomy or lobectomy for thyroidal disorders will be randomly allocated to be drained or not. postoperative ultrasonographic (usg) neck examination will be performed for all patients on postoperative 24th hour by the same ultrasonologist each time. postoperative pain, complications and hospital stay will be recorded. the statistical analysis will be performed and p\<0,05 will be accepted as an important statistical value (spss 16.0 for windows).

patients will include in the study will randomly allocate to drain and non-drain group on the basis of computer generated random number table. patients with substernal goitre or non differentiated cancer will exclude from the study. according to the thyroidal disorder, total thyroidectomy or lobectomy plus isthmectomy will be performed. the operating time will be defined as the time from the first incision to the last suture's placement. 4/0 polypropylene sutures will be used subcutaneously for wound closure. in the drain group a closed suction drain with negative pressure (hemovac®) was brought out through a separate wound.

Eligibility criteria:
inclusion criteria: * all patients required thyroidectomy exclusion criteria: * patients with substernal goitre or non differentiated cancer

Keywords: thyroidectomy drain use
a study of tl-895 with standard available treatment versus standard available treatment for the treatment of covid-19 in patients with cancer

Conditions: COVID-19; Sars-CoV2; Cancer; Solid Tumor; Carcinoma; Blood Cancer

Summary: this study evaluates tl-895, a tyrosine kinase inhibitor (tki). this is a study comprising a phase 1 safety assessment. tl-895 open-label will be administered orally at an assigned dose continuously in 7-day cycles for 2 cycles. up to 3 dose levels will be evaluated. only phase 1 of the study was enrolled and the study did not proceed into phase 2.


Eligibility criteria:
inclusion criteria: * known diagnosis of active cancer that is not considered cured or disease free. * confirmed covid-19 infection as per world health organization (who) criteria with suspected pneumonia requiring hospitalization and oxygen saturation \< 94% on room air or requires supplemental oxygen. * adequate hematological, hepatic and renal function as would be medically expected of a cancer patient population. * able to swallow and absorb oral medications. exclusion criteria: * current active treatment with medications contraindicated for receipt of investigational product. * require chemotherapy or urgent systemic therapy for active cancer that cannot be withheld. * no remaining available therapies for advanced or metastatic malignancies. * participation in another clinical study with therapeutic intent for covid-19 * require artificial ventilation at screening. * life expectancy less than 6 months. * medical conditions that make it unsafe to receive investigational product (for example, heart attack in the last 6 mos, unstable angina, uncontrolled arrhythmia, heart failure class 3/4, qtc interval \> 480 msec; known bleeding disorders, stroke or intracranial hemorrhage in the last 6 mos; active hbv, hcv or history of hiv; gi malabsorption syndrome, small bowel resection, poorly controlled ibs; untreated/actively progressing known cns lesions). * receipt of radiation therapy to the lung or mediastinum for treatment of covid-19

Keywords: tki tyrosine kinase inhibitor
cue-based tactile stimulation and infant stress reactivity

Conditions: Premature; Infant, Light-for-dates

Summary: the present study is an examination of cue-directed tactile stimulation (ctds), administered by mothers and nicu nurses, on infant and maternal stress reactivity, infant immune system functioning, maternal parenting cognitions, and parenting competence.

the overarching aim of this study is to assess the effects of a program of mother-delivered, cue-based infant massage on stress reactivity in the mother-infant dyad, and on other measures of mother-infant functioning. the study has several interrelated objectives: 1. to evaluate the short-term effects of infant massage intervention on infant and maternal stress reactivity from assays of maternal and infant salivary cortisol, and cortisol levels in mothers' breast milk. 2. to examine the impact of mother-delivered infant massage on the development of infant resistance to infectious pathogens and antibody-based protective immunity in response to routine scheduled vaccinations, and to examine if the degree of immunity is mediated by infant stress reactivity. 3. to examine the impact of mother-delivered infant massage, and of changes in stress reactivity in response to massage, on infant physiological functioning (vagal tone, heart rate variability), infant physical development (weight, height, and head circumference), mothers' perception of infant temperament and infant state regulation, parenting self-efficacy, symptoms of depression and anxiety, and mother-infant interaction. 4. to examine associations between cortisol levels in mothers' saliva, mothers' breast milk, and infants' saliva. establishing such linkages would support recent animal data suggesting that infant glucocorticoid levels can be affected by glucocorticoid levels transferred to the infant in mother's milk. 5. to examine whether a single nucleotide polymorphism (snp) in three candidate genes (mu opioid receptor, brain-derived neurotropic factor, and vasopressin v1b receptor), each associated with hypothalamic-pituitary-adrenal axis (hpa) functioning, moderates the effects of infant massage on stress-related outcomes.

Eligibility criteria:
exclusion criteria: * the following babies will be excluded: * with any chromosomal abnormality * with congenital heart disease * with any surgical intervention * with intraventricular hemorrhages greater than grade ii * if mother dies during delivery

Keywords: prematurity massage stress parenting infancy sleep intervention
influence of social determinants of health on the management of hcc in the french national cohort study chief

Conditions: Hepatocellular Carcinoma

Summary: with 8,000 related deaths per year, hcc is one of the most dangerous cancers in france. the main reason for the poor prognosis of hcc is most often a diagnosis at an advanced stage ineligible for curative treatment. in the field of oncology, low participation to screening is closely linked to socioeconomic status (e.g. level of education, income, employment). in hcc, the socioeconomic status is linked to incidence, overall survival and treatment allocation in us, uk and australia. this suggests that the social environment should be taken into account when designing interventions and policies that allows facilitating the medical pathways for patients with hcc with the ultimate goal of improving the overall prognosis. however, the studies assessing the impact of social determinants on the management of hcc in france are limited. bryère at al. reported that the highest incidence and the worst prognosis of hcc were observed in the most disadvantaged populations in france. to date, there is no available data concerning the influence of social determinants on: implementation of surveillance programs of hcc, stage of disease at the time of diagnosis or treatment allocation. this data is essential for better understanding the geographic disparities observed in france and for developing the strategies to remedy them. chief is a multicenter longitudinal observational study of patients with hcc (clinicaltrials.gov identifier: nct04348838), that will collect the exhaustive data including patient and tumor characteristics, diagnostic circumstances and modalities, care pathway from diagnostic imaging to referral to expert center, treatment allocation and implementation, and 5-year follow up including recurrent assessment of quality of life. social-chief is an ancillary study to the chief cohort (approved by chief scientific committee). the population of this study will consist in a subset of patients from the chief prospectively included or already recruited who accept to participate in this study. the data collected in chief will be retrieved from the chief main database and additional data about social determinants will be specifically investigated by self-administrated questionnaires. the results obtained will provide a better understanding of the influence of social determinants on health trajectories of hcc patients. these data will be essential in recommending new health policies and in designing innovative intervention studies to address social disparities.


Eligibility criteria:
inclusion criteria: * patients already included in the french national chief cohort who accept to participate in the social-chief study. exclusion criteria: * patients included in chief cohort who opposed to participate in the social-chief study.

Keywords: hepatocellular carcinoma primary liver cancer social determinants of health
clinical study of imaging and endoplant-related mechanical complications after long segment fixation and fusion of degenerative lumbar scoliosis (dls)

Conditions: Degenerative Scoliosis

Summary: there is a high probability of mechanical complications in patients with degenerative lumbar scoliosis after long segment fixation and fusion, and there are few studies on distal borderline kyphosis deformity/failure. this study was designed to retrospectively analyze the patients with degenerative lumbar scoliosis (dls) who underwent posterior selective decompression and long segment fixation and fusion surgery in the lumbar spine department of our hospital from april 2009 to may 2016. patients' basic data, surgical data and preoperative, immediate postoperative and follow-up imaging data were collected to study the incidence of distal mechanical complications, risk factors and their relationship with clinical symptom scores in dls patients undergoing posterior selective decompression and long segment fixation and fusion. it has guiding significance for clinical operation decision making.


Eligibility criteria:
inclusion criteria: * age ≥45 years old; * the number of fixed vertebral bodies ≥5, and the upper instrumented vertebra (uiv) is located in the thoracolumbar segment; * third generation total pedicle screw internal fixation system; * follow-up time ≥24 months; * complete clinical and imaging data. exclusion criteria: * idiopathic scoliosis, neuromuscular scoliosis, non-structural scoliosis, spinal tumors, spinal tuberculosis, ankylosing spondylitis, humman's disease, history of spinal surgery, history of spinal trauma, and history of hip surgery
motivational interviewing to acutely admitted psychiatric patients with comorbid substance use

Conditions: Substance-Related Disorders

Summary: the purpose for this study is to determine whether 2x45 minutes motivational interviewing given during hospital stay to acutely admitted psychiatric patients with substance use problems, can reduce substance use after discharge.

the aims of the study are in a randomized controlled trial to compare the effects of 2 x 45 minutes motivational interviewing and standard treatment with standard treatment alone.all patients acutely admitted to østmarka psychiatric hospital are evaluated for substance use, and all patients with substance use that give their consent to participate are randomized to motivational interviewing and standard treatment or standard treatment alone. substance use and function will be followed for two years.admittances to hospital and contacts with primary health care for five years.

Eligibility criteria:
inclusion criteria: * substance use * acutely admitted to psychiatric hospital exclusion criteria: * dementia * serious brain damage * not speaking norwegian or english

Keywords: motivational interviewing substance abuse acuteley admitted psychiatric patients emergency services, psychiatric