Kornimate/medical-research-clean huggingface dataset:
multicenter experience in afib patients treated with oac (craft)

Conditions: Atrial Fibrillation

Summary: according to current guidelines for non-valvular atrial fibrillation treatment, the first line drugs are non-vitamin k oral anticoagulants (noacs), which are preferred over vitamin k antagonists (vkas). however, it is not clearly confirmed, how the success of noacs approval trials (rocket-af (rivaroxaban), re-ly (dabigatran) and aristotle (apixaban) reflects on real-life clinical practice. the aim of this study is to assess treatment of af patients with oral anticoagulants (oacs) in an academic and district hospital, with regard to inclusion/exclusion criteria used in the clinical trials.

atrial fibrillation (af) is a common arrhythmia associated with increased cardiovascular morbidity and mortality. an integral element of management of patients with af is anticoagulation to prevent thromboembolic events. non-vitamin k oral anticoagulants and vitamin k antagonists are two main drugs groups used in treatment. primary objective of the study is to assess the treatment of af patients with oacs (the frequency of prescription of vkas vs noacs), compare the clinical characteristics of the real-life af patients with populations included in the randomized clinical trials (rocket-af, re-ly and aristotle) and population gathered from the university department and the district hospital. secondary objective of the study is to assess the long-term outcomes of patients with af treated with oacs. the craft (multicenter experience in afib patients treated with oac) is a multicenter retrospective analysis of hospital records of patients with af managed in the first department of cardiology of medical university of warsaw and in john paul ii western hospital in grodzisk mazowiecki. gathered data will include demographics, type of af (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics (i.e. blood pressure), laboratory investigations (blood tests, including renal and hepatic function), echocardiographic parameters and concomitant medications. data will be collected from the moment of patient's discharge. each patient will be evaluated regarding to common and new scales assessing risk of thromboembolic (cha2ds2-vasc ) and bleeding (has-bled, hemorr2hages, modifiable and non-modifiable risk factors for bleeding in anticoagulated patients basing on the current guidelines for af treatment) events, as well as samett2r2 score to predict the quality of treatment on oacs.

Eligibility criteria:
inclusion criteria: * paroxysmal, persistent, long-standing persistent or permanent af * valvular or non-valvular af * treatment with oacs (apixaban, dabigatran, rivaroxaban, acenocoumarol, warfarin) exclusion criteria: * lack of oac at hospital discharge

Keywords: atrial fibrillation non-vitamin k oral anticoagulants vitamin k antagonists rocket-af re-ly aristotle
longitudinal follow up of patients with pleural effusion

Conditions: Pleural Effusion, Malignant; Prognosis

Summary: this study aims to evaluate the clinical course of patients diagnosed with pleural effusion and determine various clinical factors and biomarkers associated that can predict the diagnosis and clinical outcome and prognosis of patients with pleural effusion due to specific causes.

patients who presented to seoul national university bundang hospital with pleural effusion would be recruited. pleural fluid and blood samples would be collected. all patients will receive routine diagnostic procedures and medical care and treatments according to the diagnosis; the original cancer if diagnosed with malignant effusion, and managements for pleural effusion control. patients would be observed for the clinical course and prognosis up to 3 years without any interventions caused by this study.

Eligibility criteria:
inclusion criteria: * patients presented with pleural effusion * patients who undergo thoracentesis and fluid analysis for diagnosis and management exclusion criteria: * patients who refuse to be enrolled
a clinical investigation to evaluate efficacy of mepitel ag in partial thickness second degree burns

Conditions: Burns; Wound Healing

Summary: approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% total body surface area (tbsa) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. study site will be from 1-15%. each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. all dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. all dressing changes will be registered in a dressing log. all subjects will be consecutively allocated to a subject code.

see brief summary

Eligibility criteria:
inclusion criteria: * subject with a partial-thickness (superficial, deep or mixed) second degree burn from 1-25% tbsa * study site is from 1-15% bsa * study site is a single, isolated burn area * from 2 years and above * thermal burn injury * signed informed consent/assent form * subjects who are younger than the legal consenting age must in addition to their own assent form have a signature from a legally authorized representative. exclusion criteria: * completely non-exuding or dry wound bed at study site * full thickness \>5% * burn greater than 24 hrs old * burns to face or neck * suspicion of infection of study burn * use of chemical/enzymatic and biological debridement within 7 days of investigation start * chronic steroid use, hx of skin malignancy or chronic papulosquamous disease (e.g. eczema, pemphigus) and hx of steven johnson or tens disease * subject with lung injury or subject being on a ventilator * subject with dermatologic skin disorders or necrotizing processes * subject with insulin dependent diabetes mellitus * electrical, chemical etiology * diagnosed underlying disease(s) (e.g. hiv/aids, cancer and severe anaemia), judged by the investigator to be a potential interference in the treatment * non-compliant subject * subject previously included in this investigation * subject included in other ongoing clinical investigation at present or during the past 30 days.

Keywords: partial-thickness second degree burns mepitel ag silver dressing
do it trial: vitamin d outcomes and interventions in toddlers

Conditions: Respiratory Tract Infections; Asthma; Avitaminosis

Summary: vitamin d can be made in the skin by exposure to sunlight and can be found in certain foods. vitamin d levels are alarmingly low in many north american children. several health issues have been linked with low vitamin d. these include colds caused by viruses and asthma attacks. however, no study has determined whether vitamin d supplementation can reduce the risk of these conditions in young children where they are most common and most severe. the goals of this study are to determine whether wintertime high dose vitamin d supplementation of preschoolers can prevent colds and asthma attacks. the investigators also aim to work out how much money would be saved by the health care system and society if preschoolers were routinely supplemented with vitamin d during the winter. the investigators believe that preschoolers receiving 'high dose' vitamin d supplementation during the wintertime will be less likely to have colds, asthma attacks, and low vitamin d levels and will be less likely to use the medical system and keep their parents away from work.


Eligibility criteria:
inclusion criteria: 1. healthy children by parental report 2. have reached their 1st birthday but not past their 6th birthday 3. present to a target kids! practice for routine primary healthcare prior to viral season (september through november) 4. parents provide informed consent to participate. exclusion criteria: 1. children with gestational age \< 32 weeks 2. children with chronic illness (except for asthma) on parental report which is known to interfere with vitamin d metabolism and increase the risk of respiratory infection 3. children with a sibling participating in the study to reduce clustering effects.

Keywords: vitamin d randomized controlled trial child, preschool dietary supplements respiratory tract infections asthma
a breast cancer treatment decision aid for women aged 70 and older

Conditions: Breast Cancer; Estrogen Receptor Positive Breast Cancer; Node-negative Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Summary: the purpose of this research study is to evaluate a decision aid to help women aged 70 and older decide on treatment for their breast cancer.

the investigators aim to use this information to further refine and evaluate a decision aid to help newly-diagnosed women aged 70 and older with breast cancer understand the risks and benefits of different types of breast cancer treatment. the decision aid (da) was created for women 70 years or older diagnosed with er+, her2-, clinically ln-, 3cm or less breast cancers deciding on breast cancer treatment. the da was designed considering the health literary, cognitive abilities, treatment outcomes, and competing health issues of older women. phase i : - the investigators will obtain and incorporate additional feedback on the da from women 70 years or older who were diagnosed with breast cancer \> 6 months ago, their family members, and clinicians, so that the da can be refined and evaluated by women who were recently treated for breast cancer but not newly diagnosed with breast cancer. phase ii - the investigators plan to test the efficacy of the revised da in a randomized control trial (rct) of 230 diverse women 70 years or older newly diagnosed with er+, ln-, her2-, 3 cm or less breast cancer.

Eligibility criteria:
inclusion criteria: * phase i * patient age ≥ 70 yrs * female patient diagnosed with a first primary er+, her2-, ln-, 3cm or less breast cancer \>6 months ago but \<2 years ago * caregiver age \>21 years * english speaking * phase ii * female patient age ≥ 70 yrs newly diagnosed with a first primary er+, her2-, ln-, 3cm or less breast cancer * women newly diagnosed with breast cancer on the day of surgical consult exclusion criteria: * phase i * patient age \< 70 years * women diagnosed with paget's disease, inflammatory breast cancer or a phyllodes tumor * signs of dementia * score \>10 on the orientation-memory-concentration (omc) test * non-english speaking; * caregiver age \< 21 years * women who do not have capacity to participate. --- before enrolling women in this study, possible participants will be asked 7 questions about the benefits and risks of the study. women that answer 3 or more of these questions incorrectly will be excluded. * phase ii * women with a history of breast cancer (invasive and non-invasive) * diagnosed with paget's disease, inflammatory breast cancer or a phyllodes tumor * signs of dementia * score \>10 on the omc test (indicative of dementia). * women who do not have capacity to participate. --- before enrolling women in this study, possible participants will be asked 7 questions about the benefits and risks of the study. women that answer 3 or more of these questions incorrectly will be excluded.

Keywords: breast cancer estrogen receptor positive breast cancer node-negative breast cancer human epidermal growth factor 2 negative carcinoma of breast
study to evaluate treatment effects associated with the neurostar softstart treatment feature

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the comfort of the neurostar® advanced therapy system regular prescribed tms protocol versus a new feature.

this is a 2 week study to evaluate the new feature an exclusive feature available on the neurostar® advanced therapy system. this feature introduces a series of stepped pulses within each pulse train ramping up the pulse magnitude to the prescribed treatment level. patients will be randomized after consent to receive either the standard dash protocol or the modified dash protocol with the new feature enabled. the subjects will be switched between treatment protocols and asked to complete comfort, and depression questionnaires.

Eligibility criteria:
inclusion criteria: * 1. 22-70 years. * 2. subject qualifies to receive tms therapy with the neurostar advanced therapy system to treat major depressive disorder (mdd) per current fda-cleared treatment guidelines as evaluated by the treating physician. 3. subject has mdd diagnosis according to applicable dsm-iv, dsm-iv-tr, dsm-v, icd-9, or icd-10 criteria. 4. subject failed to respond to at least one prior anti-depressant medication. 5. subject consented to receive tms therapy to treat mdd with his or her physician independent of potential participation in this clinical study. 6. subject must agree not to take analgesic pain medication(s) within 8 hours prior to tms therapy sessions. 7. subject provides written consent to take part in the study. exclusion criteria: * 1. subject satisfies any one or more of the contraindications for tms therapy per current treatment guidelines as determined by the pi. 2. physician intends to treat the subject with an off-label tms therapy or indication. 3. family history of seizures or epilepsy. 4. subject has received prior tms. 5. subject is currently taking analgesic medication or substances which may affect their perception or sensation of pain. 6. known or suspected pregnancy.

Keywords: tms major depressive disorder neurostar tms
cyclophosphamide versus mycophenolate mofetil for the treatment of steroid-dependent nephrotic syndrome in children

Conditions: Idiopathic Nephrotic Syndrome

Summary: idiopathic nephrotic syndrome is steroid-sensitive in more than 90% of cases in children. however 60% of cases are steroid dependent and required treatment with immunosuppressive agent. cyclophosphamide and ciclosporin are used for long time to reduce steroid dependency, but duration of these treatments should be restricted because of gonadotoxicity for cyclophosphamide and nephrotoxicity for ciclosporin. mycophenolate mofetil appears as an alternative treatment without gonadotoxicity and nephrotoxicity. however, contrary to cyclophosphamide, mycophenolate mofetil does not seem to have a residual action so that treatment must be maintained during months or years. the aim of the study is to compare efficacy of cyclophosphamide and mycophenolate mofetil in steroid dependent nephrotic syndrome in children.

aim of the study: comparison of efficacy of cyclophosphamide 148mg/kg in 12 weeks and mycophenolate mofetil 1200mg/m² during 18 months, in children with steroid dependent nephrotic syndrome. the 70 patients will be recruited in the 26 centres of paediatric nephrology in france, included and randomized at the time of a relapse. they will receive the same steroid treatment in the 2 arms. the primary point will be occurrence of a relapse during the 24 months of follow-up. detection of relapse will be done by using dipsticks and confirm by biological dosages (albuminemia and proteinuria/creatininuria ratio). clinical and biological check up will be done every 3 months during all the study.

Eligibility criteria:
inclusion criteria: * children 2 to 16 years old * steroid dependency ≥30mg/m² eod * or steroid dependency ≥15mg/m² eod and occurrence of : at least 2 relapses in 1 year, adverse event of steroid therapy (height rate ≤-1sd, obesity, other complication) or severe complication of nephrotic syndrome (thrombosis, collapse, severe infection,...) * inform consent exclusion criteria: * steroid resistant nephrotic syndrome * prior treatment with cyclophosphamide, mycophenolate mofetil or cyclosporine * absence of contraception in pubescent girls * allergy to cyclophosphamide or mycophenolate mofetil * malignant disease * treatment with other immunosuppressant treatment or with non-steroid anti-inflammatory or anti proteinuric medication (enzyme converse antagonist and angiotensin ii receptor antagonist) * absence of inform consent * participation to other therapeutic trial

Keywords: children mycophenolate mofetil cyclophosphamide idiopathic nephrotic steroid sensitive syndrome
comparison of insulin detemir and nph insulin given once daily in ageing subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of the trial is to compare insulin detemir once daily to nph insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy.

novo nordisk has decided to discontinue the trial as it will not be possible to recruit the required number of patients. the discontinuation is based on an analysis of the significant delay in recruitment of patients which is likely to have a negative impact on the validity of the trial.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * insulin naive * treatment with oral anti-diabetic drugs (oads) for at least 3 months and not achieving therapeutic targets * hba1c between 8% - 10.5% exclusion criteria: * secondary diabetes, mody (maturity onset diabetes of the young) * previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the investigator) * proliferative retinopathy, maculopathy requiring treatment, * hypoglycaemia unawareness as judged by the investigator, recurrent major hypoglycaemia * end stage liver disease (increased liver enzymes 4 fold), end stage renal disease assessed by mdrd (modification of diet in renal disease) less than 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months * acute disease with poor prognosis * history of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol * mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation (patients having a score of less than 15 in a previous mmse (mini-mental state examination) in the last six months) and any conditions as judged by the investigator * legal incapacity or limited legal capacity (patients under guardianship or curatorship) * concomitant medication for alzheimers treatment (memantine, anticholinesterasique treatment) * participation in another clinical trial less than one month before inclusion in this trial * illness requiring repeated hospitalisation * known or suspected allergy to the insulin or any compositional component * anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone) * any other condition that the investigator feels would interfere with trial participation or evaluation of results * terminal illness
continuous quantified eeg in neurointensive care

Conditions: Coma; Traumatic Brain Injury; Subarachnoid Hemorrhage; Ischemic Stroke

Summary: to evaluate the ability of nicu (neurointensive care unit) staff to interpret, before and after a training period, symmetry, sedation level, seizures activities and artefact on continuous ceeg/qeeg (continuous electroencephalography/quantitative electroencephalography) tracings.

using a web based tool, the clinicians of the two study centers will review 24 hours of recording (raw eeg data + derived qeeg variables). the intensivists will evaluate: * simmetry, * sedation level, * seizures activities and * artefact on continuous ceeg/qeeg tracings. the same tracings will be blindly reviewed by a certified neurophysiologist (using the app). the neurophysiologist evaluation will be considered as "reference". the results of the evaluation will be compared (intensivists vs. neurophysiologist) in order to understand if the intensivists are able to adequately identify the pathological findings. the study period will be: * before a formal training * after a formal training by neurophysiologist in order to understand if the training is able to improve the intensivists performance.

Eligibility criteria:
inclusion criteria: intensivists wil evaluate daily qeeg recordings of: * patients in coma after a traumatic/vascular event * admitted to neurointensive care and * recorded with continuous eeg for clinical reasons exclusion criteria: * no eeg recording \> 24 hours

Keywords: continuous eeg
a study to evaluate the effect of a supratherapeutic dose of mk-8189 on the qtc interval in participants with schizophrenia (mk-8189-019)

Conditions: Schizophrenia

Summary: the primary purpose of this study to evaluate the effect of a supratherapeutic dose of 80 mg mk-8189 on the qt interval corrected for heart rate (qtc interval) and to assess the safety and tolerability of multiple once-daily doses of mk-8189 in participants with schizophrenia. the effects of 3 treatment sequences 1) mk-8189 (48 mg \[day 1\] and 80 mg \[day2\]); 2) standard image placebo (day 1) and moxifloxacin 400 mg (day 2); and 3) mk-8189 placebo (day 1 and day 2) were assessed with 5-day washout intervening sequence. participants received all treatments in a counter-balanced order according to 1 of 6 possible treatment sequences. the primary hypothesis is that the administration of an 80 mg mk-8189 dose on day 2 does not prolong the qtc interval to a clinically significant degree. specifically, the true mean difference (mk-8189 - placebo) in qtc change from baseline is less than 10 milliseconds (msec).


Eligibility criteria:
inclusion criteria: * meets diagnostic criteria for schizophrenia or schizoaffective disorder according to the diagnostic and statistical manual of mental disorders (dsm-5) criteria. * is in the non-acute phase of their illness. * has a history of receiving and tolerating antipsychotics medication within the usual dose range employed for schizophrenia. * participants with hypothyroidism, diabetes, high blood pressure, chronic respiratory conditions or other medical conditions could be considered if their condition is stable. exclusion criteria: * history of a primary dsm-5 axis i psychiatric diagnosis other than schizophrenia or schizoaffective disorder per the allowed dsm-5 criteria. * history of intellectual disability, borderline personality disorder, anxiety disorder, or organic brain syndrome. * history of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia (td). * history of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures. * history of cancer. * history or presence of sick sinus syndrome, atrioventricular (av) block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged qtc interval, or conduction abnormalities. * history of risk factors for torsades de pointes (e.g., heart failure/cardiomyopathy or family history of long qt syndrome). * history of frequent syncope, vasovagal episodes, or epileptic seizures. * family history of sudden cardiac death. * has a positive test(s) for hepatitis b surface antigen (hbsag), hepatitis c antibodies or human immunodeficiency virus (hiv). * had major surgery, donated, or lost 1 unit of blood within 4 weeks prior to the pre-study visit.