Kornimate/medical-research-clean huggingface dataset:
safety and aesthetic outcomes of breast conserving surgery with peri-areolar incision approach

Conditions: Breast Cancer

Summary: cosmetic result after breast-conserving surgery (bcs) would impose great effect upon patient's quality of life. although peri-areolar incision has been widely used in benign breast tumor excision, mastopexy procedures and skin-sparing mastectomy with primary reconstruction, the actual safety and aesthetic outcome of the peri-areolar incision approach in bcs for cancer patients has not been established by randomized, controlled trials. this trial was design to compare the safety and aesthetic outcomes of breast conserving surgery between peri-areolar incision approach and traditional methods.

the trial aims to determine whether bcs with the peri-areolar approach: 1) is safe in terms of the rates of recurrence and metastasis; 2) can improve the post-operative aesthetic score and qol score.

Eligibility criteria:
inclusion criteria: * patients desire for breast conserving surgery; * fulfills criteria for breast conserving surgery; * the maximum diameter of the tumor should be less than the semi-perimeter of the areola and that the proximal margin of tumor should be at least 1 cm away from the areola; * patients suitable to receive bcs with either the peri-areolar incision or the traditional incision were included; exclusion criteria: * patients not suitable for breast conserving surgery; * skin or sub-cutaneous tumor invasion as definite contra-indication of skin-sparing; * male or bilateral breast cancers who might bring up bias in deciding aesthetic outcomes and expenditure; * patients who were supposed to benefit from a certain kind of incision were also excluded at the researcher's discretion.

Keywords: breast cancer breast conserving surgery peri-areolar incision
the incidence of treatment-requiring retinopathy of prematurity in greece

Conditions: Retinopathy of Prematurity

Summary: a prospective observational study of the incidence of treatment-requiring rop (tr-rop), at a national level, in greece.

the purpose of this observational study is to prospectively collect data on rop cases necessitating treatment at a national level. each and every rop screening unit in greece (collaborating centers) report their new tr-rop cases, their demographics and treatment characteristics, monthly, for a 12-month period. a reminder email is sent to avoid under-reporting due to neglect. data are collected by the responsible party and will be analyzed together with national registry data on all preterm births in the same 12-month period.

Eligibility criteria:
inclusion criteria: * preterm infants undergoing screening for rop, who developed tr-rop and were treated for rop in one or two eyes. exclusion criteria: * none.

Keywords: retinopathy of prematurity rop treatment
the detection of heat stress by assessing individual body responses to heat (heat strain) in young and healthy non-athlete participants

Conditions: Heat Stress

Summary: • this study investigates and compares the within and in-between variances of the body responses to different heat stressors in a controlled lab-setting. the participants will be exposed to different heat sources while a variety of physiological heat strain reactions such as heartrate, sweat rate, and core body temperature are recorded using on- and in-body devices. for the participant monitoring during the study, medical grade devices such as a certified ecg and a swallowable sensor-pill to continuously monitor the core body temperature will be applied. a one-for-all wearable device is additionally applied for physiological validation. further, sweat will be collected to assess (i) the local sweat rate and (ii) the appearance of different heat stress associated molecular markers in this non-invasively collectable biofluid. as a secondary aim, a model will be developed that will enable to predict the different heat stress sources out of the heat strain measurements.


Eligibility criteria:
inclusion criteria: * healthy participant, able to give consent * age 18-40 years * non-athlete (\<4h sport/week) * bmi\<30 (non-obese) * german speaking, or fluent in german exclusion criteria: * pregnancy (urine pregnancy test), and breastfeeding * regular medication intake (excluding birth control pill) * intake of drugs and/or daily alcohol consumption * fever or symptoms of an acute infection (cough, shortness of breath, sore throat, taste loss) * active smoking or history of smoking \<9 months ago * mobility impairment * traveled (\ 6 days * any chronic conditions such as: high blood pressure, diabetes mellitus, immuno-deficiencies, sweat disorders such as anhidrosis * color blindness (stroop test) * weight \<40 kg (e-celsius pill) * diverticulum or obstructions of the gastrointestinal tract (including motility disorders, swallowing disorders) as well as major abdominal surgery (e-celsius pill) * need of exposure to strong electromagnetic fields during study participation, above all mri examinations (e-celsius pill)

Keywords: heat strain wearable sweat analysis
evaluation of adherence to clinical treatment of glaucoma

Conditions: Glaucoma; Drugs

Summary: evaluation of adherence to clinical treatment of glaucoma in patients of a reference ophthalmological hospital in goiânia using morisky adhesion scale as a validated questionary.


Eligibility criteria:
inclusion criteria: have glaucoma diagnosed - exclusion criteria: not having glaucoma diagnosed -
low protein diet in patients with collagen vi related myopathies

Conditions: Bethlem Myopathy; Ullrich Congenital Muscular Dystrophy

Summary: * this is a 2 stage exploratory study with a 3-month observational phase on the natural course, followed by a 12-month, open-label, non-comparative, single-arm, phase ii pilot study on the efficacy, safety and tolerability of a low-protein diet (lpd) in 8 adult patients with bethlem myopathy (bm) and ullrich congenital muscular dystrophy (ucmd). * objective of this trial is to test the effect of a normocaloric lpd to reactivate autophagy in bm/ucmd patients. the primary end point of the study will be the change in muscle biopsy of beclin 1, a marker of autophagy, at 1 year of lpd treatment when compared to baseline. * the rationale rests on our discoveries that (i) mitochondrial dysfunction mediated by inappropriate opening of the ptp plays a key role in collagen vi myopathies; (ii) defective autophagy with impaired removal of defective mitochondria amplifies the defect; and (iii) reactivation of autophagy with a low-protein diet or treatment with cyclosporine a, the mitochondrial ptp inhibitor, cured co6a1-/- mice, hinting at a common target among all beneficial treatments - namely autophagy. * specific aims of this project are to (i) study the modifications of clinical, nutritional and laboratory parameters in a cohort of patients with bm/ucmd during a 3-month observational period before starting the lpd treatment; (ii) assess the effect of a normocaloric lpd in correcting defective autophagy in muscle of patients; (iii) test if new non-invasive biomarkers of activation of autophagy examined in the blood are mirroring the effect of lpd in the muscle biopsy; (iv) assess the clinical efficacy and safety of the lpd with an innovative combination of complementary measures of the nutritional status in patients. * the anticipated output is defining and validating a therapeutic nutritional approach in autophagy upregulation for bm/ucmd.


Eligibility criteria:
inclusion criteria: * males or females aged ≥18 years. * women of childbearing age must have a negative pregnancy test and must use adequate contraception during the study. * clinical and molecular diagnosis of bethlem myopathy or ullrich congenital muscular dystrophy. * no previous treatment with csa within 6 months prior to the start of the study. * willing and able to adhere to the study visit schedule and other protocol requirements. * written informed consent signed. exclusion criteria: * current or history of liver or renal disease. * pregnant or breast-feeding women. * any serious internal medicine condition interfering with the study.

Keywords: bethlem myopathy ullrich congenital muscular dystrophy low protein diet autophagy pilot clinical trial
retrospective study for recurrent nasal polyposis

Conditions: Nasal Polyps

Summary: a retrospective study for patients with recurrent nasal polypi operated at otorhinolaryngology department, sohag university hospital will be carried out.

a retrospective study for patients with recurrent nasal polypi operated at otorhinolaryngology department, sohag university hospital will be carried out. all available information about these patients will be retrieved from our department data base including full personal history, medical history and type of surgery performed with operative details.. missed patients due to any reason will be excluded from the study during. complete information about patients' symptoms, onset, progression, severity and duration of recurrence after surgery will be taken from our department data base. associated factors will be evaluated from data base (asthma, allergy, smoking, samter's triad, cystic fibrosis, fungal sinusitis, immune status, etc.).

Eligibility criteria:
inclusion criteria: all patients with recurrent nasal polypi will be include in our study regardless their age and sex. exclusion criteria: * exclusion criteria: patients with nasal polyps due to underlying neoplasm will be excluded from our study. also, those with fresh polyps or missed patients during follow up due to any reason are not candidates for our research.
xiyanping injection for the treatment of new coronavirus infected pneumonia

Conditions: 2019 Novel Coronavirus Pneumonia

Summary: the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of xiyanping injection in patients with 2019-ncov pneumonia.


Eligibility criteria:
inclusion criteria: 1. laboratory examination (rt-pcr) confirms the infection 2019-ncov, which meets the diagnostic criteria for pneumonia (common type) in the new coronavirus infection pneumonia diagnosis and treatment program (trial version 6); 2. the patient has a complete hospitalization record that can be used for research. exclusion criteria: - subjects who meet any of the following criteria cannot be enrolled: 1. suffering from diseases that need to be distinguished from pneumonia infected with new coronavirus, such as tuberculosis, bacterial or viral pneumonia other than new coronavirus pneumonia, hospital-acquired pneumonia, and other pathogenic microorganisms pneumonia; 2. people with basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory tract malformations, abnormal lung development, aspiration pneumonia, and lung malignant tumors; 3. according to the judgment of the investigator, the previous or current disease may affect the patient's participation in the trial or the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine disease; presently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (hiv) infection, or blood system, or splenectomy, organ transplantation, etc; 4. pneumonia diagnosed with severe, critically re-associated coronavirus infection or requiring mechanical ventilation or systemic anti-hormonal therapy; 5. used chinese patent medicines with similar efficacy as xiyanping injection during the treatment. 6. the investigator judges that the relevant test or data is missing during the treatment process, which affects the research evaluation or analyst.
juggerknot with broadband pmcf study

Conditions: Shoulder Injuries; Hip Injuries; Foot Injury; Ankle Injuries; Knee Injuries

Summary: the purpose of the study is to collect post-market clinical follow-up data, which is needed to confirm the safety and performance of the juggerknot device and meet existing eu regulatory requirements.


Eligibility criteria:
inclusion criteria: 1. undergoing soft tissue fixation of the shoulder, knee, foot/ankle, elbow, or hip where the juggerknot with broadband anchor is indicated; 2. male or non-pregnant female ≥ 18 years of age; 3. willing to provide informed consent and comply with the required follow-up period. exclusion criteria: 1. infection where implantation of the device would be compromised; 2. conditions including blood supply limitations and insufficient quantity or quality of bone or soft tissue; 3. known allergy to one of the juggerknot with broadband components; 4. mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions or patients who are otherwise unwilling or incapable of doing so.

Keywords: soft tissue fixation
spo2 comparison between commercial smartwatch and medical-grade pulse oximeter during hypoxia

Conditions: Hypoxia; Pulse Oximetry

Summary: the aim of the project is to experimentally compare spo2 measured on a wrist by commercial smartwach and on a finger measured by a medical-grade pulse oximeter in healthy humans during gradual desaturation in the range of 60-100% spo2 and simultaneously during a step change from the hypoxic phase to the recovery phase (return to physiological values).

the newest models of smartwatches measure peripheral blood oxygen saturation (spo2) and the technology is rapidly improving. the results of individual studies on the accuracy of spo2 measurement using smartwatches from different brands are still inconclusive. the study aims to compare the measurement of peripheral blood oxygen saturation using the latest smartwatch with a medical-grade pulse oximeter under the condition of normobaric hypoxia. spo2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. the agreement of the measurements of both devices will be evaluated.

Eligibility criteria:
inclusion criteria: * passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure, blood oxygen saturation and medical history exclusion criteria: * pregnancy * severe cardiovascular conditions * severe asthma or other severe respiratory conditions * injury to the upper limbs or hands that could affect the peripheral perfusion * diabetes * hypotension or hypertension
a validation study of sodium hyaluronate in patients with periarthritis of shoulder

Conditions: Periarthritis

Summary: alge as a positive control drug, in patients with periarthritis of shoulder, in a double-blind, controlled manner to study the safety and treatment of sodium hyaluronate

aerzhi as a positive control drug, in patients with periarthritis of shoulder, in a double-blind, controlled manner to study the safety and treatment of sodium hyaluronate. once a week, continuous treatment for 5 weeks

Eligibility criteria:
inclusion criteria: 1. based on clinical symptoms and range of motion (rom) limitation: abduction is not more than 135 degrees, external rotation is not more than 20 degrees or the maximum internal rotation arrives at the first lumbar spinous process (the tip of the patient can touch) to diagnose the patients with periarthritis of shoulder 2. signs and symptoms were repeated for 12 weeks or more at the time of signing informed consent (12 weeks or more) 3. at zeroth weeks, according to the pain assessment scale (nrs, range: 0-10), the subjects' self rating pain score was no less than 5 points 4. fully informed consent signed voluntarily informed consent exclusion criteria: 1. lead to other diseases of shoulder disorders, such as acute rotator cuff tear, calcific tendinitis. if the diagnosis is necessary, the mri scan is performed 2. patients who are not suitable for medical treatment (e.g. patients with surgical indications) 3. patients who received opioids before the first study of the drug 4. patients who received the following or more treatment within 2 weeks before the first use of the drug(bilateral or unilateral shoulder joint movement therapy/treatment of periarthritis of shoulder with proprietary chinese medicine) 5. patients who received the following or more treatment within 4 weeks before the first use of the drug(corticosteroids were injected locally or bilaterally on either side of the shoulder or on the other side of the shoulder (bilateral or unilateral shoulder joint);oral corticosteroids, suppositories or intravenous preparations for the treatment of glucocorticoids) 6. treatment of shoulder joint (bilateral or unilateral) with hyaluronic acid injection within 24 weeks before the first study of the drug 7. it is diagnosed as rheumatic disease 8. patients unable to assess their clinical manifestations 9. skin disease or skin infection around the injection site can cause the risk of injection infection 10. severe heart disease, renal failure, hematologic diseases, or diabetes mellitus 11. there is a history of hypersensitivity to any component in the research drug (imp)
dolutegravir pharmacokinetics among hiv/tb coinfected children receiving standard and high-dose rifampicin

Conditions: Pediatric HIV Infection; Tuberculosis Infection

Summary: tuberculosis (tb) is the leading cause of death among children with hiv, yet insufficient data are available on the pharmacokinetics of newer hiv/tb cotreatment strategies in children. current who-recommended rifampicin dosages result in low concentrations in most children, and high-dose rifampicin may improve outcomes and shorten treatment duration. yet the impact of high-dose rifampicin on dolutegravir exposures has not been examined in children. this study aims to evaluate the safety and pharmacokinetics of dolutegravir twice daily among hiv/tb coinfected children receiving standard-dose and high-dose rifampicin.

this study is a prospective, single-arm, open-label, intensive and sparse pharmacokinetic (pk) and safety study to evaluate steady-state dolutegravir (dtg) concentrations among 20 hiv/tb coinfected children 4 weeks to \<6 years of age requiring concurrent tb treatment. ten patients will be recruited into each of two age cohorts: 4 weeks to \<2 years and ≥2 years to \<6 years. children will be recruited from two large pediatric hiv clinics in nigeria. children in this study will receive hiv/tb cotreatment that is considered standard of care consisting of dtg twice daily during rifampicin (rif)-containing tb treatment. for this portion of the study, the primary intervention is additional blood sampling for drug concentration determination and biomarker assessment. additionally, during a two week period (study weeks 20-21), the rif dose will be increased from standard-dose to high-dose rif, during which two-way pk and toxicity monitoring will occur. clinical and laboratory monitoring for toxicity during hiv/tb cotreatment is consistent with routine care. pk sampling for drug concentration determination will occur at three time points during the 48-week study. specifically, pk sampling will occur at week-20 to evaluate dtg twice daily during standard-dose rif, week-22 to evaluate dtg twice daily during high-dose rif, and at week-30 to evaluate dtg once daily after tb treatment is complete. additionally, the endogenous biomarker of cyp3a4 activity, 4-beta-hydroxycholesterol to cholesterol ratio, will be evaluated to advance understanding of underlying mechanisms of drug action. blood sampling to quantify this biomarker will occur at either 4 (among art-experienced children) or 5 (art-naive) time points during the 48-week study.

Eligibility criteria:
inclusion criteria: * art-naïve or art-experienced hiv-infected children between 4 weeks and \<6 years of age * active tb diagnosis * weight of at least 3 kilograms * consent of the parent or legal guardian exclusion criteria: * baseline labs with evidence of ≥grade 3 abnormalities: alt, total bilirubin, absolute neutrophil count (anc), platelets, or creatinine * suspected tb meningitis or presenting with acute respiratory distress or decompensation * receipt of a medication that has drug-drug interactions with dolutegravir or rifampicin

Keywords: pharmacokinetic dolutegravir rifampicin
a follow-up programme for patients using symbicort smart in normal clinical practice

Conditions: Bronchial Asthma

Summary: this patient follow-up programme was designed to describe the extent of symbicort use in patients prescribed symbicort as maintenance and reliever therapy in routine clinical practice in comparison with the already documented use of symbicort as maintenance and reliever therapy in clinical therapies


Eligibility criteria:
inclusion criteria: * asthma patients prescribed symbicort as maintenance and reliever therapy, according to the label, before inclusion in this programme * signed and dated informed consent(icf) * for patients under-age, signed and dated icf form from both the patient and the patient's parent/legal guardian is required exclusion criteria: * involvement in the planning and conduct of the programme (applies to both astrazeneca staff or staff at the investigational site)

Keywords: asthma bronchial symbicort
atorvastatin pre-treatment study in asian patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: this present study is specifically designed to examine the efficacy and safety of a high pre-treatment dose of atorvastatin in asian patients with nste-acs in china and the republic of korea, by using a treatment paradigm similar to that employed in the armyda-acs study.


Eligibility criteria:
inclusion criteria: * non-st elevated acs; ldl-c \> 80 mg/dl exclusion criteria: * st elevated acute myocardial infarction; previously or currently treated with atorvastatin or other statins

Keywords: asia lipitor pre-treatment in acute coronary syndrome
post-stroke fatigue, inflammation, tdcs

Conditions: Stroke; Fatigue; Chronic Stroke; Stroke Sequelae

Summary: fatigue is a common condition after an individual has a stroke. while the negative impacts of post-stroke fatigue are well known, the knowledge of the causes of post-stroke fatigue and effective treatments for post-stroke fatigue are lacking. this small study will investigate the possible benefits of transcranial direct current stimulation (tdcs), which uses small electrical currents supplied by a 9-volt battery, on post-stroke fatigue and investigate tdcs' possible anti-inflammatory effects.


Eligibility criteria:
inclusion criteria: * men and women of any race or ethnicity * 35-80 years of age * 6+ months post-stroke * have clinically present fatigue for 6 months * able to walk 10m unassisted exclusion criteria: * absolute contraindications to mri, tms (transcranial magnetic stimulation), or tdcs (e.g., implanted metal devices, history of seizure, and surgical clips or staples) * inability to understand and provide written informed consent * multiple strokes on opposite hemispheres * diagnosed comorbid neurological conditions (e.g. multiple sclerosis, parkinson's disease, and dementia) * severe hypertension * cerebellar or brainstem strokes/lesions * concurrent depression and/or anxiety disorders