Kornimate/medical-research-clean huggingface dataset:
magnetic seed localisation for nonpalpable breast lesions

Conditions: Oncology; Breast Cancer

Summary: screening programs and advances in imaging have led to more breast lesions being diagnosed at an impalpable stage. multiple localisation techniques for nonpalpable breast lesions have been developed during the past decades. specifically, several alternatives to the golden standard hooked-wire technique have become available, of which magnetic seed localisation is one of the newest approaches. since september 2018, magseed® localisation is the standard of care for localising impalpable breast lesions in uz leuven. in this study, the oncological safety, the clinical safety and surgeon satisfaction of magseed® localisation will be assessed and retrospectively compared to hooked-wire localisation.


Eligibility criteria:
inclusion criteria: * breast conserving surgery with preoperative localisation * minimum 18 years old

Keywords: breast cancer nonpalpable breast lesions hooked-wire localisation magnetic seed localisation
space changes after premature loss of lower first primary molars in children using digital scanning

Conditions: Premature Loss of Primary Molars; Space Maintenance; Dental Arch Development; Pediatric Tooth Extraction

Summary: this prospective split-mouth clinical study aims to evaluate space changes in the mandibular dental arch following premature extraction of the lower first primary molar in children aged 3 to 5.5 years. using digital 3d models, changes in the d space and mandibular arch perimeter will be measured at baseline and 6 months post-extraction. the goal is to determine whether space maintainers are necessary in the primary dentition stage.

premature loss of primary molars in children is a common result of caries or trauma, potentially affecting future occlusion and alignment. this study investigates the space changes that occur after unilateral premature extraction of the mandibular first primary molar before the eruption of the permanent first molar. using a split-mouth design, the contralateral non-extracted side serves as the control. digital impressions will be taken at baseline (day of extraction) and after 6 months. the primary outcome is the change in the d space, and the secondary outcome is the change in the mandibular arch perimeter, both measured using 3d digital software. the study aims to provide evidence for or against the routine use of space maintainers in similar clinical scenarios, potentially reducing unnecessary treatment and improving patient comfort.

Eligibility criteria:
inclusion criteria: * children aged 3 to 5.5 years * mandibular first primary molar indicated for extraction due to extensive decay or hopeless prognosis * contralateral mandibular first primary molar must be intact and free of proximal caries * no eruption of mandibular permanent first molar at the time of enrollment * presence of primary canines and second primary molars * no space maintainers placed * parents/caregivers unable or unwilling to fabricate a space maintainer exclusion criteria: * bilateral premature loss of mandibular first primary molars * contralateral mandibular molar has proximal caries or poor prognosis * children with good prognosis first primary molars (i.e., not needing extraction) * eruption of the mandibular permanent first molar * children who already have space maintainers * uncooperative behavior preventing study participation

Keywords: tooth loss dental arch pediatric dentistry primary dentition
tanshinone in polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: tanshinone was originally isolated from dried roots of salvia miltiorrhiza bunge. in chinese medicine, this herb has been widely prescribed for several pathologies, including diabetes, acne, cardiovascular disease.it has been demonstrated that the therapeutic benefit of cryptotanshinone on prenatally androgenized rats may be mediated by its dual regulation of key molecules during both insulin signaling and androgen synthesis.the purpose of this study is to determine whether tanshinone may prove effective in eradicating polycystic ovary syndrome (pcos) symptomatology.


Eligibility criteria:
inclusion criteria: * presence of pcos diagnosed based on the androgen excess society criteria. all subjects must have hyperandrogenism (hirsutism and/or hyperandrogenemia), ovarian dysfunction (oligoanovulation and/or polycystic ovaries), and exclusion of other androgen excess related disorders. oligomenorrhea is defined as an intermenstrual interval \>35 days or \ 90 days. clinical hyperandrogenism is defined as a ferriman-gallwey (fg) score ≥5 * age of women from 18 to 35 years； * no desire of children within 6 month and use condoms for contraception. exclusion criteria: * use of hormonal drugs or other medications, which can affect the results of the study especially chinese herbal prescriptions in the past 12 weeks； * patients with other androgen excess endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, cushing syndrome, severe insulin resistance, thyroid dysfunction； * patients with history of sever cardiac , pulmonary, hepatic, renal, neurologic disease or mental illness； * pregnancy or lactation.

Keywords: polycystic ovary syndrome cryptotanshinone
study to compare the efficacy and safety of pitavastatin and simvastatin

Conditions: Hypercholesterolemia; Dyslipidemia

Summary: the purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.


Eligibility criteria:
inclusion criteria: * males and females (18-75 years) * must have been following a restrictive diet * diagnosis of primary hypercholesterolemia or combined dyslipidemia exclusion criteria: * homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia; * conditions which may cause secondary dyslipidemia. * uncontrolled diabetes mellitus (by hemoglobin a1c \[hba1c\] \> 8%) * abnormal serum creatine kinase (ck) above the pre-specified level * abnormal pancreatic, liver or renal function * significant heart disease

Keywords: hypercholesterolemia kowa dyslipidemia pitavastatin nk-104 primary hypercholesterolemia or combined dyslipidemia
efficacy and safety of telmisartan compared with losartan

Conditions: Diabetic Nephropathies; Hypertension

Summary: a study to evaluate the efficacy and safety of telmisartan compared with losartan in patients with diabetic nephropathy and hypertension

a multi-center, randomized, open-label, active comparator-controlled, phase 4 clinical trial to evaluate the efficacy and safety of telmisartan compared with losartan in patients with diabetic nephropathy and hypertension

Eligibility criteria:
inclusion criteria: * male of female subjects aged ≥19 or \<75 * type ii diabetes mellitus subjects who have been taken medicine * subjects who have voluntarily decided to participate in this clinical trial and signed icf exclusion criteria: * subjects with type i diabetes mellitus * subjects with primary hyper-aldosteronism * subjects with a history of drug or alcohol abuse or suspected patient within 1 year as of the time of screening * pregnant women, lactating women, or subjects who do not agree to use appropriate contraception during the clinical trial period * subjects who received other clinical trial drugs within 28 days of screening visit * subjects who are unable to participate in this clinical trial at the discretion of the investigator.
health system methods to improve nursing retention amidst ongoing covid-19 pandemic: a mixed method study

Conditions: Motivational Factors for Nurse Retention; Nurse Well-being

Summary: this study is a mixed-method exploratory study with the aim to determine an objective compensation or mechanism of support from a healthcare system standpoint to aid in retention of nursing staff amidst the ongoing covid-19 pandemic. it will include semi-structured qualitative interviews of current and prior nursing staff from the trauma/surgical floor, progressive care unit, and icu, in addition to trauma/surgical unit and system administrators; the second portion of the study will include a quantitative survey distributed via email to current nurses on the trauma/surgical floor, progressive care unit, and icu to assess ranked priority of additional mechanisms of support to improve intention of retention.


Eligibility criteria:
inclusion criteria: * registered nurses on the trauma/surgical floor, surgical progressive care unit, or surgical icu who are currently working or who have worked bedside in the past 24 months * adult hospital administrative staff exclusion criteria: * non-registered nurses (ie. cnas, lpns) * rns without clinical bedside experience in the past 24 months * rns working on other units beside the trauma/surgical floor, surgical progressive care unit, or surgical icu
usefulness of early warning systems in detecting early clinical deterioration after intensive care discharge

Conditions: Early Clinical Deterioration; Early Warning Score

Summary: the vitalpac early warning score (views) scoring system, developed by prytherch et al., is an early warning system that aims to predict the first 24-hour mortality in emergency patients. national early warning score (news) is another early warning scoring system recommended by the royal college of physicians in london to detect early clinical deterioration in hospitalized patients. the aim of this study was to determine the early clinical deterioration after icu and hence the rate of admission to intensive care and to evaluate whether these two scoring systems can be used to determine early clinical deterioration in intensive care early discharge.


Eligibility criteria:
inclusion criteria: * over 18 years, * discharged from the icu and returned within 24 hours exclusion criteria: * under 18 years old, postoperative patients, pregnant women
this study aim is to compare the effect of oral methyl prednisolone on different radiological patterns of hypersensitivity pneumonitis as it was found that not all patients get satisfying therapeutic effect after taking corticosteroids.

Conditions: Hypersensitivity Pneumonitis

Summary: the aim of this work is to compare the effect of oral methyl prednisolone on different radiological patterns of hypersensitivity pneumonitis and to evaluate the patient's clinical and functional status after taking the required dose of methyl prednisolone. not all hypersensitivity pneumonitis patients get the same therapeutic effect after taking corticosteroid so by comparing the effect of methyl prednisolone on patients with different radiological pattern we will be able to select the patient who really need to take corticosteroid and who don't so we will protect the patient who doesn't need to take oral corticosteroids from its numerous side effects all patients will undergo the following assessment before and after taking 0.5 mg/kg/day of methyl prednisolone for 8 weeks : high resolution ct (hrct) of chest , chest x-ray , spirometry, 6 minute walk test to evaluate the patient's functional status and oximetry to measure percentage of oxygen in blood

hypersensitivity pneumonitis patients will be divided in two groups : non- fibrotic hypersensitivity pneumonitis patients ( nfhp) and fibrotic hypersensitivity pneumonitis patients ( fhp), based on hrct findings. all patients will undergo the following assessment at the beginning of the study: high resolution ct (hrct) of chest , spirometry to assess forced expiratory volume in 1 second (fev1), forced vital capacity (fvc) and fev1 to fvc ratio , 6minute walk test , oximetry to measure percentage of oxygen in blood. then all patients took methyl prednisolone 0.5mg/kg /day orally for 8 weeks . during the treatment period pulmonary spirometry will be done every 2 weeks and 6 minute walk test will be done every 4 weeks as follow up at the end of the treatment period all these assessments will be repeated to compared the patients functional and clinical statues before and after taking methylprednisolone.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of hypersensitivity pneumonitis. 2. adults (older than 18 years). 3. having history of exposure to allergen 4. steroid naïve patients - exclusion criteria: 1. patients with respiratory co-morbidities. 2. patients with other type of interstitial lung diseases. 3. patients already taking steroids. 4. pregnant or nursing female -
attenuated sox as first-line treatment in elderly patients with relapsed or metastatic gastric cancer

Conditions: Elderly; S-1; Oxaliplatin; First-Line; Gastric Cancer

Summary: stomach cancer is the most common malignant disease and the second most common cause of cancer-related deaths in the korea. the elderly are primarily affected by the disease with most gastric cancer-related deaths occuring in patients aged 65 years or older. systemic chemotherapy improves the quantity and quality of life in patients with gastric cancer when compared with best supportive care. however, elderly cancer patients often present with concomitant co-morbidities and age-associated physiologic problems that make the selection of optimal treatment difficult. there is also uncertainty about the use of systemic palliative chemotherapy in elderly patients because of under representation of this age group in clinical trials. therefore, this phase ii trial was planned to investigate efficacy and toxicities of combination chemotherapy with attenuated dose of s-1 and oxaliplatin (attenuated sox)in patients with elderly agc

treatment scheme * s-1 60mg/m2/day (d1-14) oxaliplatin: 85mg/m2 + 5dw 250ml miv over 2-hours each cycle is repeated every 3 weeks response evaluation will be performed every 2 cycles repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * age : more than 70 to 80 and ecog ps 0-2 * age : more than 65 to less than 70 and ecog ps 2 * histological or pathologically confirmed adenocarinoma * relapsed or metastatic adenocarcinoma of stomach * no previous chemotherapy except adjuvant chemotherapy completed at least 12 months before enrollment * at least more than one measurable lesion on recist criteria * no radiation history for the target lesion * an estimated life expectancy of more than 3 months * ability for adequate oral intake * adequate bm function: defined as wbc≥4000/μl, anc ≥1500/μl, plt≥100,000/μl. * adequate renal function: defined as creatinine \<1.5mg/dl. * adequate hepatic function: defined as total bilirubin \< 2.0mg/dl, sgot/sgpt \< normal x 3. * written informed consent exclusion criteria: * symptomatic brain metastasis or meningeal metastasis. * double primary cancer * medical history of other cancer within 5 years * g-i bleeding or intestinal obstruction (other condition that can't have the oral intake) * hypersensitivity to the 5-fu or oxaliplatin * active infectious disease that need to treat systemically * serious medical or psychologic condition: newly developed ami ( within 6ms)...

Keywords: elderly s-1 oxaliplatin relapsed or metastatic gastric cancer
impact of information strategy based on booklet on anxiety in family in icu

Conditions: Anxiety; Depression; Post-traumatic Stress Disorders

Summary: anxiety and depression are symptoms frequently met in icu patients and relatives. risk factors are known: disease severity, age, gender. another risk factor is lack of information from the medical staff and nurses. anxiety and depression can be measured by the hospital anxiety and depression scale (hads). other scales are used in the psychiatric field : the impact event score - revisited (ies-r) is relevant to detect post-traumatic stress disorder (ptsd), the short form health survey (sf-36) is an assessment of life quality. in the following study, the investigators will evaluate the impact of a "brochure" as complement of oral information on anxiety developed by relatives and family of icu patients. the medical and surgical icu is composed by two different units (different medical and nurse team, different location in the same hospital) of 12 beds on one side, 14 beds on the other side. during a year, in the first unit, the investigators will use the booklet as support and complement of oral information : "booklet arm". the information process will be as usual in the other unit : "control arm". during the second year, the booklet will be used in the second unit while the first unit will return to the usual oral information (cross-over). for each included patient, one relative or family member is pointed to be the referring family member or "referent". this "referent" receives the hads questionnaire at day 3 after admission, at day of discharge if the patient is alive, at one month after discharge. the ies-r questionnaire is delivered at discharge of the living patient and at day 30. the sf-36 questionnaire is given to the "referent" and the living patient at day 30. the day 30 questionnaires are send by mail at the "referent" address.


Eligibility criteria:
inclusion criteria: * all patients admitted in icu whose previsible length of stay is over 3 days. exclusion criteria: * admitted patient without organ failure * family member or patient who can't speak and/or read french * family who didn't show off within the first week of hospitalization

Keywords: anxiety depression post-traumatic stress disorders quality of life family icu
immunogenicity and safety of tetanus, diphtheria and mono component acellular pertussis (tdap) vaccine in comparison to tetanus and diphtheria (td) vaccine when given as booster vaccinations to adults

Conditions: Healthy

Summary: the clinical trial is a phase iii, double-blind, randomised, controlled, multi-centre, clinical trial, on the immunogenicity and safety of tdap vaccine in comparison to td vaccine when given as a booster vaccination to adults who were vaccinated with d, t and wp vaccine according to the danish vaccination programme in their childhood. healthy, adult, female or male volunteers, who completed primary vaccination with diphtheria (d), tetanus (t) and whole cell pertussis vaccine (wp), typically during their childhood, is the target population.


Eligibility criteria:
inclusion criteria: 1. healthy female or male adult of ≥ 18 years of age 2. completed primary vaccination with diphtheria (d), tetanus (t) and whole cell pertussis (wp) vaccines in denmark 3. signed informed consent 4. prepared to grant authorised persons access to medical records 5. likely to comply with instructions exclusion criteria: 1. congenital or acquired immunodeficiency or progressive neurologic disease 2. uncontrolled epilepsy or progressive encephalopathy 3. previous experience of serious adverse reaction(s) after vaccinations with diphtheria-, tetanus- acellular or whole cell pertussis- vaccines 4. vaccinated with any diphtheria, tetanus or pertussis toxoid containing vaccine within 5 years before inclusion 5. vaccinated with any tetanus toxoid, diphtheria toxoid or diphtheria crm197 protein conjugated vaccine within 5 years before inclusion 6. known tetanus-, diphtheria- or pertussis disease/infection within 5 years before inclusion 7. known hypersensitivity or history of allergic reactions to any of the active or inactive constituents of the tdap or td vaccines 8. vaccinated with a live or inactivated vaccine within 1 month before inclusion 9. administration of immune modulating drugs (such as immunoglobulin, systemic corticosteroids, blood products, azathioprine, cyclosporine, infliximab) within 3 months before inclusion 10. administration of any investigational drug product or vaccine within 1 month before inclusion 11. females if pregnant or breastfeeding or not willing to use contraception during the trial

Keywords: immunisation, active
complications related to activity after pediatric both bone fractures: exploring the effects of activity on fracture displacement

Conditions: Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)

Summary: the goal of this randomized clinical study is to understand the effect of activity on the re-displacement of pediatric forearm fractures in patients ages 8-18 years old excluding those with known metabolic bone disease or obvious refracture. the main questions the study aims to answer are: does increased activity lead to increased re-displacement rates during the treatment of pediatric forearm fractures? are there complications associated with increased levels of activity during the treatment of pediatric forearm fractures (skin irritation, need for re-casting, operation)? do activity restrictions provided for pediatric forearm fractures influence patient activity levels? participants will be randomized into activity-restricted vs activity-limited (no contact sports). some patients will be provided an actigraph activity tracker to monitor patient activity. every patient will complete a validated activity survey (paq) to assess activity at each follow-up appointment. activity data and any complications will be recorded from time of initial presentation to cast removal.


Eligibility criteria:
inclusion criteria: * isolated distal radius metaphyseal fx (with or without ulna styloid) * distal third (\<4 cm from physis) radius and ulna fracture (i.e. without obvious physeal involvement) * insolated radial shaft fracture (diaphyseal) * radial and ulna shaft fracture (diaphyseal) exclusion criteria: * initial presentation \>7 days from the time of injury * pathologic fracture * any patient with metabolic bone disease (ex. osteoporosis, skeletal dysplasias) * any patient with known bone fragility condition (ex. osteogenesis imperfecta) * if operative treatment is required at initial presentation
effects of cardiovascular health education program on community-dwelling older adults at risk of ascvd

Conditions: Cardiovascular Diseases; Healthy Lifestyle; Health Education

Summary: despite older adults being exposed to an increased risk of atherosclerotic cardiovascular disease (ascvd), they are generally underrepresented in cardiovascular prevention programmes. the aim of this study is to assess the feasibility of implementing an integrated exercise and cardiovascular health education programme (he programme) on older adults at risk of ascvd.

the study is a two-arm pilot randomized controlled trial. (1) the control group will receive a basic lifestyle modification talk and governmental education leaflets. (2) the experimental group will receive an integrated exercise and health education programme (he programme) based on self-efficacy theory. physical activity level, exercise self-efficacy and ascvd risk profile including blood pressure, cardiac endurance, and anthropometric outcomes will be investigated via physiological assessments, medical history-taking or questionnaires at baseline, week 6, and week 12. meanwhile, study feasibility will be primarily evaluated in terms of programme acceptability, intervention integrity, recruitment rate and retention rate throughout the process and at week 12.

Eligibility criteria:
inclusion criteria: * chinese adults ≧60 years old * having at least one ascvd risk factor * pass the cardiovascular fitness evaluation * able to write and read chinese, and communicate in cantonese; * possess a mobile phone and able to make use of the phone in reading sms exclusion criteria: * visually impaired, hearing impaired, or suffer from cognitive, psychiatric, or muscular disorder * having a history of attending similar cardiovascular prevention program * having a previous history of coronary heart disease or stroke

Keywords: older adults physical activity atherosclerotic cardiovascular disease lifestyle modification health education