Kornimate/medical-research-clean huggingface dataset:
power of growth - digitally assisted intervention for the early childhood educators' self-efficacy teamwork and children's behavioral challenges.

Conditions: ECE Teachers Self Efficacy; Team Work; Positive Pedagogy; Behavior Problems

Summary: this is an rct study investigating the efficacy of digital intervention focusing on enhancing positive directing skills for teams of early childhood education (ece) professionals. the aims are to study 1) changes in the eces' self-assessed self-efficacy experience in the intervention group compared to the control group; 2) changes in the behavioral challenges of the children in the eces' groups assessed by the parents in the intervention group compared to the control group; and 3) changes in the eces' guidance methods in the intervention group compared to the control group. we will also study changes in the wellbeing of eces and teamwork in both treatment groups. the sample size will consist of approximately 64 teams of eces. hence, altogether there will be approximately 200 study subjects. the intervention is aimed at ece teams and its goal is to strengthen and unify the team positive guidance practices in children's groups. the intervention includes self-learning material and teams online coaching in which the entire team participates simultaneously. the self-material includes 360 videos of everyday situations in the daycare and videos can be watched with vr glasses. the participants practice the skills systematically with their group of children. the duration of the intervention is approximately 12 weeks and team coaching are carried out approximately every two weeks.


Eligibility criteria:
inclusion criteria: participant is working in a daycare centre team that is participating to the study. sufficient knowledge in finnish language. exclusion criteria: -

Keywords: ece self efficacy team work positive pedagogy behavior problems
effect of pioglitazone on endothelial function in premenopausal women with uncomplicated systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: the present study aims to investigate the effect of pioglitazone (30 mg/day) on endothelial function in premenopausal women with sle (systemic lupus erythematosus). patients with hypertension, endocrine, hepatic or renal diseases will not be included, or pregnant /breast feeding women. this is a randomized, double blind, placebo controlled study.

sle (systemic lupus erythematosus) is characterized by accelerated atherosclerosis. the risk of suffering an acute myocardial infarction among premenopausal women with sle is 50 times higher than control women of the same age. insulin resistance and hyperinsulinemia are frequent in sle. lipid metabolism in sle, as in other insulin resistant states, is characterized by high triglycerides, low hdl-cholesterol, normal ldl cholesterol (or slightly increased) and an increase in ldl's susceptibility to oxidation. all these alterations can produce endothelial dysfunction which is present in sle patients. pioglitazone is a ppar (peroxisome proliferator activated receptor) gamma agonist that can potentially improve insulin resistance, with a positive effect on the lipid profile (lowering of triglycerides, and a discrete increase in hdl-c) and improve endothelial function. patients will be randomized to receive either placebo or pioglitazone 30 mg/day during a period of 12 weeks. endothelial function will be assessed by positron emission tomography (pet).

Eligibility criteria:
inclusion criteria: * eligible participants were premenopausal women with sle * older than 18 years * attending the outpatient rheumatology clinic at three mexico city community tertiary care hospitals exclusion criteria: * menopause * diabetes * thyroid dysfunction * neurological * hepatic * renal or liver disease * personal history of high blood pressure * chd (coronary heart disease) * cerebrovascular events * chronic or acute infections * malignancy * nor history of chronic drugs or alcohol abuse * smoking * pregnancy or breast-feeding * intake of hormones or lipid-regulating drugs

Keywords: lupus hdl particles endothelial function pioglitazone
treatment of hyperprolactinemia with the non-ergoline dopamine agonist ropinirole

Conditions: Hyperprolactinemia; Prolactinoma

Summary: the purpose of this study is to evaluate the use of the non-ergoline dopamine agonist ropinirole for the treatment of hyperprolactinemia in patients with idiopathic hyperprolactinemia and prolactinomas.

treatment of prolactin secreting pituitary tumors with traditional ergot dopamine agonist drugs can be limited by medication side effects, pharmacologic resistance, and by concerns regarding the potential risk of cardiac valve disease. the overall goal of this project is therefore to evaluate, for the first time, the efficacy and tolerability of the selective d2/d3 receptor non-ergot dopamine agonist ropinirole for the treatment of prolactinomas. this proposal will establish the pharmacologic profile of this medication when used to treat hyperprolactinemia in patients with prolactinomas and will determine the impact of long-term ropinirole administration on critical clinical parameters including serum prolactin levels, gonadal function, and tumor regression, in order to establish ropinirole's utility as a new, clinically efficacious, safer and more tolerable therapeutic option for the treatment of prolactinomas that may prove particularly useful in patients with underlying cardiac valve disease and in those with resistance or intolerance to ergot dopamine agonists.

Eligibility criteria:
inclusion criteria: * ages 18-70 years * prolactin level (prl) ≥2 times upper limit of normal * pituitary adenomas on mri ≤ 1.5cm in greatest diameter and ≥ 5mm from the optic chiasm * normal renal and liver function * agrees to barrier contraception if pre-menopausal exclusion criteria: * use of medications known to interfere with prl secretion and prl and ropinirole (rop) metabolism * use of another dopamine agonist during the 4 weeks prior * pituitary stalk compression on mri * history of visual field abnormalities or previous radiation * untreated hypothyroidism * consumption of \> 2 alcoholic drinks per day * pregnancy

Keywords: ropinirole hyperprolactinemia prolactin
effect of electromagnetic field in lumbar disc prolapse patients

Conditions: Lumbar Disc Herniation

Summary: to investigate the effect of electromagnetic field therapy on sciatica and postural control in lumbar disc prolapse patients background: lumbar disc prolapse is a clinical condition resulting from compression of lumbar nerve roots resulting in decreased postural control and alleviating sciatic pain pulsed electromagnetic field (pemf) therapy is an easy, non-invasive, safe, and relatively new treatment method that is used with growing interest in physical and rehabilitation medicine. historically, the benefits from magnetotherapy have been reported for patients with musculoskeletal and neurological disorders

thirty-four patients with lumbar disc prolapse the patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks. the evaluation methods by visual analogue scale for pain (vas-p), ) multidirectional reach test, mcgill pain questionnaire, time up and go test and oswestry low back pain disability questionnaire

Eligibility criteria:
inclusion criteria: 1. age ranging from 30:45 2. sciatica due to lumbar disc prolapse mild to moderate disc prolapse according to magnetic resonance image (mri). 3. body mass index (18.5 to 29.9) kg/m2. exclusion criteria: * the patients will be excluded if they have one of the followings: 1. lumbar myelopathy. 2. patients with previous spinal surgery. 3. inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis 4. any other neurological or musculoskeletal disorders of the spine or upper extremity. 5. patient with cardiopulmonary disease or diabetes mellitus
etiological diagnosis of urinary stone in chinese children

Conditions: Urinary Stone

Summary: the incidence of nephrolithiasis in children has been reported to increase by approximately 6-10% annually, and the incidence is currently 50 per 100,000 children with high recurrent rate. investigators aimed to determine the metabolic risk factors in chinese children through metabolic evaluation. in order to identify diagnostic criteria of hypocitraturia and hyperoxaluria in western country wether adapt to chinese children, investigators aim to determine normal urine levels of oxalate and citrate in children without kidney stone.

investigators aimed to determine the metabolic risk factors in 200 chinese children with urinary stones through metabolic evaluation. in order to identify diagnostic criteria of hypocitraturia and hyperoxaluria in western country wether adapt to chinese children, investigators aim to determine normal urine levels of oxalate and citrate in children without kidney stone.

Eligibility criteria:
inclusion criteria: * children with urinary stones exclusion criteria: * anatomic urinary system abnormality, vesicoureteral reflux, urinary tract infection (temperature \>38°c and/or positive urine culture), solitary kidney, and renal insufficiency

Keywords: children renal stone metabolic evaluation mutational analysis
age-related hearing loss and lexical disorders

Conditions: Alzheimer Disease; Presbycusis; Lexical Syntactic Disorder

Summary: in france, alzheimer's disease accounts for 70 to 80% of the causes of neurocognitive disorders, i.e. 600,000 to 800,000 patients. it is a neurodegenerative pathology that causes evolutionary cognitive dysfunction, mainly affecting memory functions. the inability to name familiar objects (lack of the word) is one of the most commonly noted symptoms at an early stage of the disease. presbyacusis, or age-related hearing loss, is the most common sensory deficit in the elderly which is manifested socially by a progressive discomfort of verbal communication. presbyacusis remains underdiagnosed and undertreated: 2/3 of the patients are not using hearing aid. in recent years, a link between neurocognitive disorders and hearing loss has been shown by investigating general cognition. in this study, the investigators are investigating lexical disorders.


Eligibility criteria:
inclusion criteria: * \> 65 years old * french mother tongue * good vision with or without correction * alzheimer's or related disease (15 \<mini-mental state examination\<25) * affiliate or beneficiary of a social security * informed consent exclusion criteria: * cognitive disorders related to another pathology (cerebrovascular accident, head trauma, epilepsy ...) * protected patient (under guardianship) or person deprived of liberty by judicial or administrative decision
study of the touch® trapezo-metacarpal prosthesis

Conditions: Complications Due to Internal Joint Prosthesis; Thumb Osteoarthritis

Summary: prospective observational study of implanted patients with a new orthopaedic implant: the touch trapezo-metacarpal prosthesis

prospective observational study of implanted patients with a new orthopaedic implant: the touch double mobility trapezo-metacarpal prosthesis, 15 years follow up.

Eligibility criteria:
inclusion criteria: • patients implanted with the touch® prosthesis by one of the three investigating surgeons exclusion criteria: * patient not in capacity to understand the study * patient not in capacity to consent to the study
central and peripheral adiposity and iron absorption

Conditions: Adiposity; Iron-deficiency

Summary: adiposity is a state of sub-clinical inflammation, thus hepcidin is increased in adiposity, often leading to iron deficiency in this population group. central adiposity is generally considered having a greater negative effect on health compared to peripheral adiposity. whether this can be also seen in hepcidin and thereby in iron absorption is uncertain.


Eligibility criteria:
inclusion criteria: * either normal-weight (bmi 18-25kg/m2) or overweight/obese (bmi 28-50kg/m2) with either central or peripheral fat deposits based on dexa exclusion criteria: * iron supplement or antibiotic intake within 2 weeks before study start * diagnosed chronic disease or gastrointestinal disorders * regular use of medication (except contraceptives) * pregnancy * lactation * smoking * blood donation or surgery within the last 4 months.
to evaluate the effect of liraglutide versus glimepiride (amaryl®) on haemoglobin a1c

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in north america (the united states of america (usa) and mexico). the trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. the trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. the total duration of the treatment period is planned to be 260 weeks (5 years).


Eligibility criteria:
inclusion criteria: * type 2 diabetes * ttreatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months * diet/exercise treated subjects with hba1c between 7.0% and 11%, inclusive * oad (oral anti-diabetic drug) treated subjects with hba1c between 7.0% and 10%, inclusive * body mass index (bmi) less than or equal to 45 kg/m\^2 exclusion criteria: * treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness * treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound) * any serious medical condition
safety and efficacy of mbi 226 2.5% and 5.0% topical acne solutions in the treatment of acne

Conditions: Acne Vulgaris; Acne; Propionibacterium Acnes

Summary: this study investigates the safety and efficacy of mbi 226 2.5% and 5.0% acne solutions, applied topically for six weeks, in the treatment of acne.


Eligibility criteria:
inclusion criteria: * males and females, ages 13 and up, exhibiting high levels of facial p. acnes * presence of inflammatory and non-inflammatory lesions exclusion criteria: * acne conglobata, acne fulminans, or secondary acne (chlorine, drug-induced acne, etc.) * active facial cysts

Keywords: acne acne vulgaris mbi 226 propionibacterium acnes lesion counts lesions inflammatory non-inflammatory topical
a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of jnj-38431055 in healthy male volunteers

Conditions: Diabetes Mellitus, Type 2

Summary: this will be a single center study conducted in two parts. part 1 will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of jnj-38431055 in healthy male volunteers. part 2 will assess the effect of food on the pharmacokinetics of jnj-38431055.

the study includes 2 parts and will be conducted at a single center. part 1 is a randomized (study drug assigned by chance), double-blind (neither the volunteer or investigator knows the name of the assigned study drug), placebo-controlled (placebo is a substance that looks the same as jnj-38431055 but contains no jnj-38431055), single ascending dose study. in part 1, study drug (i.e., jnj-38431055 or placebo) will be administered orally as single doses on day 1 or three treatment periods. in part 1, for each volunteer, the study will consist of a screening evaluation visit, 3 periods of double-blind treatment, and a final, follow-up examination. the total study duration for each volunteer will be approximately 9 weeks. part 2 is a randomized, open-label, 2-period crossover study to evaluate the effect of administering jnj-38431055 together with food on the pharmacokinetics of jnj-38431055, as compared to administration in the fasting condition. in part 2, study drug (jnj-38431055 will be administered orally as single doses on day 1 or two treatment periods. there will be at least 7 days between doses. in part 1, study drug (i.e., jnj-38431055 or placebo) will be administered orally as single doses on day 1 of three treatment periods. in part 2, study drug (jnj-38431055) will be administered orally as single doses on day 1 of two treatment periods.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.5 and 29.9 kg/m2 (inclusive) * healthy on the basis of physical examination including medical history, vital signs, 12-lead ecg, and all other screening lab tests performed * volunteers must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study exclusion criteria: * history of, or currently active, illness or medical condition or disorder that the investigator considers to be clinically significant * smoker or tobacco user within the past 6 months * history of recent major surgery (within 6 months of study start) * positive test for alcohol and/or drugs of abuse * psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements * any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements.

Keywords: diabetes mellitus, type 2
covid19 oral vaccine consisting of bacillus subtilis spores

Conditions: COVID-19 Pneumonia

Summary: this is a study trial to assess the effectiveness of the immune response stimulated by the genetically engineered bacillus subtilis which express and display spike protein of the sars-cov2 on the spore coat.

bacillus subtilis is regarded as safe organism by the food and drug administration and it is presented in most food sources. preliminary experiments have shown that the genetically engineered bacillus subtilis can express and display receptor binding domain of spike protein of the sars-cov2 on its spore coat, thus successfully inducing the secretion of cytokines of human cells in vitro. previous experiments also successfully demonstrated that a increased detection of neutralizing igg and igm levels in mice and human after oral administrated with the bacillus subtilis. this suggests that the transgenic spores of bacillus subtilis have successfully activated the immune system, producing high-affinity neutralizing antibodies and memory b cells. furthermore, no adverse effects were shown in all the mices. the engineered bacillus subtilis will be further studied in a human trial through oral administration to test its safety and the immune effect resulted in human bodys.

Eligibility criteria:
inclusion criteria: * healthy * age over 12 years * the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial); * participant vaccinated with covid-19 over 6 months * anti-sars cov 2 neutralizing antibody is negative in serum. exclusion criteria: * pregnant women * history of covid-19 infection or showing covid-19 infection symptoms * having had contact to people with known covid-19 infection in the last 14 days * having fever (\> 37.4oc in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea. positive real time rt-pcr covid-19 test. * persons with autoimmune diseases * allergic diathesis or any clinically significant allergic disease (i.e. asthma) * any condition that might impair the immune response * recent or current immunosuppressive medication * any other vaccine application 5 months before the first dose

Keywords: covid-19 vaccine reaction bacillus subtilis
perfected: caring for patients with hip-fracture & memory difficulties

Conditions: Dementia; Hip Fractures

Summary: this qualitative study is part of the 5-year long (2013-18) perfected (peri-operative enhanced recovery hip-fracture care of patients with dementia) national institute for health research (nihr) funded research programme. perfected's overall aim is to develop and pilot an evidence-based intervention to improve the hospital care of patients living with dementia who have fractured their hip. the findings from this particular study will support perfected's other activities by exploring stakeholder (lay and professional) views of the hospital care experiences of hip-fracture patients who are experiencing memory difficulties. best practices and priorities, including attention to cost-consequences will be explored. semi-structured interviews will be conducted with 15-30 hip-fracture patients with mild memory difficulties recently discharged from acute hospitals in norwich, nottingham and bradford. equal attention will be given to those patients discharged directly home and those discharged to community hospitals for further rehabilitation. interviews will be conducted with 15-30 recognised carers of hip-fracture patients with moderate/severe memory difficulties who have recently been discharged from acute hospitals in the same three regions. semi-structured interviews will also be carried out with a nominated dementia lead in each region. finally, in each region, small focus groups, face-to-face or telephone interviews will be conducted, with clinical staff of various grades and professions, hospital managers and with nhs commissioners. this study will enable a range of topics and perspectives to be explored and potential components for perfected's intervention to be identified. as part of perfected's on-going commitment to public patient involvement (ppi), lay researchers will be trained to assist in interviewing recognised carers of hip-fracture patients with moderate/severe memory difficulties. interviews and focus groups will be recorded, transcribed and analysed thematically. resulting data will address the pre-defined aims of the current study and feed into findings reported across the whole of work package 1 of perfected.


Eligibility criteria:
inclusion criteria: * a hip-fracture patient recently discharged (within a month) from an acute hospital in one of the study locations. * 60 years or older * having some memory difficulties as recognised by a relevant member of their care team - supported by an amt score of 5-8 if required * has the cognitive ability to engage with a research interview as determined by a relevant member of their care team exclusion criteria: * lacks mental capacity