Kornimate/medical-research-clean huggingface dataset:
study on the impact of desk and chair adaptation intervention on the occurrence and development of myopia in primary school students

Conditions: Axial Length, Eye; Myopia; Myopia Progression

Summary: this study is a randomized controlled trial of a desk and chair adaptation intervention involving primary school students and their parents or primary caregivers. we compared the myopia status of students in the intervention and control groups before and after the intervention to confirm the effect of the desk and chair adaptation intervention on the development of myopia in students.

in this study, two pilot schools in anhui province were selected , and all students were examined by ophthalmologists, and their heights and the heights of their desks and chairs were measured in order to investigate the association between desk and chair adaptations and myopia. one of the elementary school was randomly selected for a one-year desk and chair adaptation intervention to compare the occurrence of myopia and axial growth of the students before and after the intervention in the two schools. translated with deepl.com (free version)

Eligibility criteria:
inclusion criteria: * students and their families were informed and voluntarily participated in the study, with parents signing the informed consent form. * able to cooperate with eye examinations and questionnaires. exclusion criteria: * communication barriers, unable to cooperate. * strabismus, amblyopia, or any other ocular or systemic diseases that may affect refractive development. * children currently using orthokeratology lenses or rigid contact lenses. * using other interventions (such as acupuncture, massage, medication, ear acupuncture, etc.) to control myopia, apart from school eye exercises.
"the length of cervical collar treatment for traumatic sub-axial fractures"

Conditions: Collar Treatment of Stable Subaxial Spine Fractures

Summary: most fractures of the cervical spine are considered stable and treated with a rigid cervical collar. however no studies have to date been published addressing the length of treatment. there seems to be a significant dissimilarity between hospitals within and between countries with the length of collar treatment varying from 6 to 12 weeks. at the neurosurgical department at oslo university hospital, ullevål the standard length of treatment for a stable cervical fracture is 12 weeks. this study seeks to establish whether 6 weeks of collar treatment for a specific subtype of stable fractures in the cervical spine is sufficient.

the investigators will include 150 patients with a stable cervical fractures of vertebra c3-c7 with a subaxial cervical spine injury severity (slic) score 1-3 and randomize them in to two similar groups. one group will be treated with a cervical collar for 6 weeks and the other group will be treated for 12 weeks. there will be a clinical check up and a ct scan at 1, 6, 12 and 26 weeks after the initial injury. the investigators will compare the results between the two groups when it comes to fracture healing (ct based), level of function, pain and the length of sick leave with a total of 6 months of follow up.

Eligibility criteria:
inclusion criteria: * patients with a newly diagnosed (within 5 days of injury) fracture in vertebra c3-c7 with slic score 1-3 * patients must be abel to give their consent to participate in the study exclusion criteria: * unstable cervical fractures in need of surgery * slic score \>3 * fractures of the spinous process and the transverse process in the cervical spine * stable fractures in in the c3-c7 vertebra combined with fractures of the c0-c2 vertebra * pathological fractures in the cervical spine
efficacy and safety of a herbal medicinal product (dry extract bno 1016) in patients with acute rhinosinusitis

Conditions: Acute Rhinosinusitis

Summary: the purpose of this study is to determine whether the dry extract bno 1016 is effective and safe in the treatment of acute rhinosinusitis in adults.

the aim of this clinical study is to investigate the efficacy of a 15-days treatment with the herbal medicinal product bno 1016 for therapy of acute rhinosinusitis in adult patients. due to the considerable morbidity and the diminished quality of life experienced by people afflicted with acute rhinosinusitis an important aim of the treatment is to reduce the severity of rhinosinusitis symptoms and the duration of the disease. by grading the severity of the disease on the basis of the 5 main rhinosinusitis symptoms the investigator will assess the efficacy of the treatment.

Eligibility criteria:
inclusion criteria: diagnosis of acute rhinosinusitis * characterized by a major symptom score (mss) ≥ 8 and ≤ 12 points (minimum 0, maximum 15 points) * individual score for facial pain/pressure ≥ 1 (mild) and ≤ 2 (moderate) * confirmed by ultrasonography of paranasal sinuses * with presence of symptoms ≤ 3 days prior to inclusion exclusion criteria: * chronic rhinosinusitis * polyposis nasi * anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation/airflow * acute symptoms of a known allergic rhinitis * patients with asthma who have a history of exacerbations within 30 days prior to study inclusion * signs or symptoms of fulminant bacterial sinusitis * odontogenic sinusitis

Keywords: bno 1016, acute rhinosinusitis
comparison of eprosartan/hct versus enalapril/hct in hypertensives with type ii diabetes

Conditions: Hypertension; Type 2 Diabetes

Summary: this study is to demonstrate the superiority of combination of eprosartan/hctz versus ramipril/hctz.


Eligibility criteria:
inclusion criteria: * essential hypertension, * diabetes type 2 exclusion criteria: * severe cardiovascular disease, * grade 3 hypertension, * secondary hypertension, * abnormal liver enzymes

Keywords: comparator trial hypertension diabetes blood pressure
outcome of a cohort of patients fitted with a syme type prosthesis in the context of a hindfoot amputation with distal support

Conditions: Amputation, Surgical; Walking, Difficulty

Summary: the purpose of this study is to see outcome of patients with syme prothesis in order to comment the handfoot amputation.


Eligibility criteria:
inclusion criteria: * syme or pirogoff or atct or arthrodesized chopart type amputation * age \> 18 years old, * first fitting or renewal of syme type prosthesis delivered to irma between january 2008 and december 2018 exclusion criteria: * refusal documented in the file that the data be used for scientific purposes, * congenital etiology of the condition.

Keywords: amputation prothesis outcome
evaluating the efficacy and safety of empagliflozin addition to insulin and oral antidiabetic medication (oad) regimen in poorly controlled type 2 diabetes and obese patient

Conditions: Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Empagliflozin

Summary: the primary aim of this study is to assess the impact of incorporating empagliflozin, an oral sodium-glucose co-transporter 2 (sglt2) inhibitor, into the existing therapeutic regimen of insulin+metformin+dipeptidyl peptidase 4 (dpp-4) inhibitors in poorly controlled type 2 diabetes mellitus (t2dm) patients. the study seeks to evaluate its effect on achieving glycemic goals in this patient population.


Eligibility criteria:
inclusion criteria: * patients aged 35 years or older, diagnosed with type 2 diabetes mellitus, * specifically, individuals with a documented hba1c level equal to or exceeding 8.5% over the course of the last six months or more are considered eligible candidates. * these patients should currently be undergoing treatment involving a combination of insulin and either metformin or sitagliptin. exclusion criteria: * patients with a history of recurrent urinary tract infections * those who are currently pregnant are excluded from participation in the study. * patients with an estimated glomerular filtration rate (egfr) exceeding 40 ml/min/1.73m², * furthermore, individuals with other concurrent medical conditions, and those who are unable to provide informed consent for the study, have also been excluded.

Keywords: insulin resistance type 2 diabetes overweight add-on therapy glycemic control
safety and efficacy evaluation of topical al-60371 otic suspension, 0.3% in the treatment of acute otitis externa

Conditions: Acute Otitis Externa

Summary: the purpose of this study was to demonstrate superiority of al-60371 relative to vehicle based on clinical cures at test-of-cure (toc) for the treatment of acute otitis externa (aoe).

participants or legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear medication use, and impact of ear pain on sleep and other daily activities.

Eligibility criteria:
inclusion criteria: * at least 6 months of age. * clinical diagnosis of acute otitis externa (aoe) based on clinical observation and of presumed bacterial origin in at least one ear. * combined numerical score of ≥4 in at least one affected ear at the day 1 exam for tenderness, erythema, and edema. * agree to refrain from water immersion of the ears during the conduct of the entire study. * other protocol-defined inclusion criteria may apply. exclusion criteria: * duration of signs or symptoms of aoe greater than 28 days in the affected ear(s) as reported by patient or parent/guardian. * presence of a tympanostomy tube or perforated tympanic membrane in the affected ear(s). * clinically diagnosed otic disease other than aoe (eg, malignant otitis externa) in the affected ear(s). * known or suspected ear infection of yeast, fungal or mycobacterial origin in the affected ear(s). * prior otologic surgery within 6 months of study entry in the affected ear(s). * known or suspected allergy or hypersensitivity to quinolones or other ingredients present in the medications to be used in the study. * patients who use ear plugs, head phones or ear buds and are unwilling to discontinue their use during the study period. * other protocol-defined exclusion criteria may apply.

Keywords: acute otitis externa
adjunctive anti-seizure medication (asm) real world evidence (rwe) study

Conditions: Epilepsy

Summary: the purpose of this study is to describe the effectiveness of the adjunctive asm treatment on the clinical response, safety profile and quality of life of patients affected by focal onset seizures in a real-world setting.

the aim of the study is to assess the effectiveness and safety of adjunctive therapy in a real-world setting of patients affected by focal-onset seizures who are eligible to start the treatment with asm as adjunctive therapy according to the physician's judgment.

Eligibility criteria:
inclusion criteria: * male and female patients of any ethnic origin ≥18 years old at baseline. * patients with diagnosis of focal-onset seizures with or without secondary generalization. * patients should have been eligible to start treatment with asm as adjunctive therapy according to the physician's judgement prior to the inclusion. * patients should have clinical history of treatment failure with at least 2 asms. * patients using their seizure diary as part of their standard of care for at least 3 months prior to -the study entry (diary can be paper or electronic, filled in by patient and/or family members). * written informed consent (including data privacy consent) signed by the patient, legal guardian, or legally authorized representative prior to entering the study in accordance with the ich gcp guidelines exclusion criteria: * patients who meet any of the contraindications to the administration of adjunctive asms according to their approved smpc. * progressive neurological disease, including degenerative cns diseases and progressive tumors. * patients with unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified assessments (e.g., in the judgement of the investigator, pose an appreciable risk for suicide, including suicidal behavior and ideation within 6 months prior to enrollment, current psychotic disorder, acute mania). * evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator could affect the participant's safety or interfere with study assessments. * patients with substance abuse or dependence (except for caffeine and nicotine). * patients participating in any pharmacological or nonpharmacological interventional study within 30 days prior to baseline.

Keywords: epilepsy focal-onset seizure cenobamate adjunctive therapy
influence of exceptional patient characteristics on everolimus exposure

Conditions: Breast Neoplasms

Summary: a study to determine whether everolimus pharmacokinetics in elderly and obese patients is different compared to control patients. furthermore the investigators will investigate the relation between metabolic response assessed with \[18f\] fluorodeoxyglucose-positron emission tomography (fdg-pet) and everolimus exposure and clinical benefit. the investigators will explore whether dose escalation in patients who are hypothetically underexposed will result in an increase in metabolic response.


Eligibility criteria:
inclusion criteria: * adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy. * histological or cytological confirmation of estrogen-receptor positive (er+) breast cancer * postmenopausal women * radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment. * progression following a non-steroidal aromatase inhibitor * falling into one of the following categories * elderly patients (age ≥ 70 years and bmi \< 30 kg/m2); or * obese patients (bmi ≥ 30 kg/m2 and age \< 70 years); or * control patients (bmi \< 30 kg/m2 and age \< 70 years); * serum aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 5 x uln * adequate renal function: calculated creatinine clearance, as estimated by gfr using the mdrd formula, is ≥ 30ml/min/1.73m2 * performance status ecog 0 - 2 (karnofsky index: 60 - 100) * patient is willing and able to sign the informed consent form prior to screening evaluations exclusion criteria: * patients aged ≥ 70 years and bmi ≥ 30 kg/m2 * her2-overexpressing patients by local laboratory testing (ihc 3+ staining or in situ hybridization positive). * previous treatment with exemestane or mtor inhibitors. except for the treatment with exemestane in the adjuvant setting. * known hypersensitivity to mtor inhibitors, e.g. sirolimus (rapamycin). * patients with a known history of hiv seropositivity. * any severe and / or uncontrolled medical conditions such as: * unstable angina pectoris, serious uncontrolled cardiac arrhythmia * patients with severe hepatic impairment (child-pugh a/b/c) * uncontrolled diabetes mellitus * impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome) * patients who test positive for hepatitis b or c * patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme cyp3a within the last 5 days prior to enrollment * history of non-compliance to medical regimens * patients unwilling to or unable to comply with the protocol

Keywords: breast neoplasms everolimus pharmacokinetics elderly patients obese patients
fluid collections management in severe acute pancreatitis

Conditions: Acute Pancreatitis; Acute Pancreatic Fluid Collection

Summary: acute fluid collections is common in patients with severe acute pancreatitis (sap). but the treatment for this is controversial. in this study, the investigators aim to evaluate the different effects of three different treatment protocols which is repeated aspiration, continuous catheter drainage and conservative treatment. the investigators suppose repeated aspiration could not only solve acute fluid collections, but also lower the rate of pancreatic infection.


Eligibility criteria:
inclusion criteria: * symptoms and signs of acute pancreatitis according to atlanta criteria and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination * ct density \< 30hu * within 7 days from the onset of the disease * available approach for percutaneous penetrate exclusion criteria: * pregnant pancreatitis * receiving surgery or aspiration before;need of early surgery * infected fluid collection

Keywords: severe acute pancreatitis acute fluid collection catheter drainage repeated aspiration
use of oxygen hoods in patients failing on conventional high-flow oxygen delivery systems, effects on oxygenation in hypoxic covid-19 patients. prospective cohort study.

Conditions: COVID -19; Respiratory Failure; Hypoxia

Summary: to determine whether the use of oxygen hoods as compared to conventional high-flow oxygen delivery systems, and the effects on oxygenation, mechanical ventilation and mortality rates in hypoxic patients with covid-19.

to determine whether oxygen hoods improve o2-saturation (sao2), and how they effect length of hospitalization, and in-hospital mechanical ventilation and mortality rates in covid-19 patients when compared to conventional high-flow oxygen delivery systems. oxy-hemoglobin saturation is continuously measured by pulse-oximetry including immediately before and after oxygen hood placement, and will be measured in controls. comparison/control group the control cohort includes covid-19 patients presenting for treatment prior to 4/3/20 when hyperbaric oxygen hoods were not available. patients maintained on, or those failing on conventional o2- delivery systems and subsequently receiving mechanical ventilation will be studied. all patients included must have tested positive using pcr swabs and/or been diagnosed based on clinical/laboratory standard diagnostic criteria. medical management will include evolving treatment regimens and other standard medical treatments widely used at time of study in all hypoxic covid-19 patients. prognostic/confounding covariates are to be collected through electronic medical record (emr) chart review and compared between intervention and control cohorts. including: age, body mass index (bmi), gender, chronic lung disease - copd, asthma (cld), cardiovascular disease - cad, chf, chronic dysrhythmia (cvd), chronic kidney disease (ckd), immunosuppression - history of cancer, immunosuppressive medication, hiv (immunosuppression), diabetes mellitus (dm), and pertinent lab markers. routine follow-up evaluation is maintained until final in-hospital outcomes are known including: 1. oxygen difference pre/post-hood (sao2 difference, %) 2. intubation/mv status (intubated) 3. survival/mortality (expired) 4. hospital length of stay (los, days) randomization/blinding randomization is not possible as it is unethical to deny a hypoxic patient an alternative approved means of oxygenation for patients failing on conventional oxygen delivery systems. no blinding of participants or investigators.

Eligibility criteria:
inclusion criteria * hospital census is reviewed for all patients seen in the emergency department admitted with covid -19 diagnosis and experiencing hypoxia requiring supplemental high-flow oxygen delivery or who have required mechanical ventilation. * consent (native language services provided). * no limitations/restrictions on age, sex, race/ethnicity, comorbidities, pregnancy status, dnr/dni status. exclusion criteria * sao2 \> 90% on conventional high-flow o2-delivery system. * confinement anxiety post-oxygen hood placement with request for removal.
physiological factors that influence maintenance of lifestyle changes and weight loss - a longitudinal study

Conditions: Obesity; Overweight

Summary: in denmark and the western world, there is an increasing prevalence of obesity probably due to a combination of inadequate daily physical activity and a high energy intake. one approach to achieve weight loss and change life style is to participate in an intensive supervised prolonged life style modification course. the immediate effect is often positive, but over time the overall effect is limited as the majority will not maintain weight loss and a changed life style. the purpose of this study is therefore to characterize the physiological factors that determine/influence the capacity to maintain weight loss and a healthy lifestyle after a prolonged lifestyle intervention. we have the following research questions: 1. are there physiological traits and characteristics that mediate better adherence to lifestyle changes and weight loss? 2. does the adaptation in muscle oxidative capacity after lifestyle intervention predict success in maintaining weight loss and lifestyle changes 3, 12 and 39 months after intervention? 3. how does gender and age influence the capacity to maintain the lifestyle induced adaptation in muscle and adipose tissue and maintaining weight loss? the study design is a longitudinal intervention and will be based on a lifestyle intervention, as it is practiced in a real life setting at ubberup folk high school.


Eligibility criteria:
inclusion criteria: * participants at ubberup folk high school exclusion criteria: * previous gastric bypass surgery or gastric banding * bmi\<25

Keywords: lifestyle intervention body weight body composition weight loss maintenance physical activity
cinical trial to explore the efficacy of statin/choline fenofibrate combination therapy vs statin monotherapy in patients with inadequately controlled tg despite receiving statin monotherapy

Conditions: Dyslipidemias

Summary: a multi-center, randomized, double-blind, parallel phase ⅳ study to explore the efficacy of statin/choline fenofibrate combination therapy vs statin monotherapy in patients with inadequately controlled tg despite receiving statin monotherapy


Eligibility criteria:
inclusion criteria: * both male and female who are over 19-year-old * 200mg/dl≤tg\<500mg/dl * desired value of ldl-c 1. very high risk \< 70 2. high risk \< 100 3. moderate risk \<130 4. low risk \< 160 exclusion criteria: * patient who is going to have an operation during this study * patient who has allergy or hypersensitivity of fenofibrate * patient who has abnormal ecg
peri-operative oral triiodothyronine replacement therapy to decrease the risk of transient atrial fibrillation after off-pump coronary artery bypass surgery

Conditions: Non-thyroidal Illness Syndrome

Summary: this study is planned to medicate oral t3(liothyronine)to the patients who are planned to have opcab(off- pump coronary bypass graft surgery. the aim of this study was to assess the effects of oral triiodothyronine (t3) therapy on postoperative thyroid hormone concentrations, hemodynamic variables and outcomes in patients undergoing opcab in a randomized, controlled trial.


Eligibility criteria:
inclusion criteria: * patients who are undergoing off-pump coronary artery bypass graft exclusion criteria: * no normal sinus rhythm, * history of thyroid disease * abnormal thyroid hormone * renal dysfunction * hepatic dysfunction * lvef \<30% * recent mi * active infection 1\~15