Kornimate/medical-research-clean huggingface dataset:
post tavi coronary revascularisation guided by myocardial perfusion imaging: a prospective open label pilot study: the revasc-tavi study

Conditions: Severe and Symptomatic Aortic Stenosis; Stable Coronary Disease

Summary: evaluation of a strategy of selected revascularization guided on myocardial ischemia detection after the tavi procedure by using single photon emission computed tomography (spect) myocardial perfusion imaging.

background: percutaneous coronary intervention (pci) is usually proposed to patients with aortic stenosis (as) before transaortic valve implantation (tavi) when significant coronary stenosis is detected on preprocedural coronary angiography. however, the benefit of a systematic revascularisation is unknown and may have specific complications in elderly and frail patients. aims: the investigators proposed a strategy of selected revascularization guided on myocardial ischemia detection after the tavi procedure by using single photon emission computed tomography (spect) myocardial perfusion imaging. methods: this prospective open label clinical trial will include 71 consecutive patients with significant coronary artery disease (cad) defined by one or more significant coronary stenosis in patients admitted for tavi. myocardial spect imaging will be performed in all patients at 1-month follow-up after the tavi procedure. targeted pci will be performed only in patients with significant related ischemia (\> 10 % myocardial perfusion defect). the primary outcome criterion is a composite criterion of feasibility and safety including all causes of death, stroke, major bleedings, major vascular complications, per procedural myocardial infarction, coronary revascularization or rehospitalisation for cardiac cause at 6 month follow-up. hypothesis: an alternative management of cad guided by significant myocardial ischemia detection after tavi could reduce the risk of unnecessary revascularization, the complications and the costs inherent to these procedures and a phase ii trial is requiring to the evaluate this innovative and less invasive strategy.

Eligibility criteria:
inclusion criteria: * patients older than 18 years * severe and symptomatic aortic stenosis defined as a median trans-valvular gradient higher than 40 mmhg and an aortic valve area of less than 1.0 cm2 or 0,6 cm2/m2 on echocardiography associated to significant cad defined by ≥1 stenosis of ≥70% in a major epicardial coronary artery or ≥50% for left main * patients is not candidate for surgical aortic valve replacement after the multidisciplinary heart team decision. exclusion criteria: * recent acute coronary syndrome (within 30 days before randomization), * unprotected left main disease * critical stenosis (\>90%) of left anterior descending artery (lad), * significant angina (ccs class more than 2) * active bleeding, * contraindication for tomographic technetium-99 assessment or dipyridamole injection * previous enrollment in a other study * impossibly to obtain consent

Keywords: tavi aortic stenosis coronary artery disease coronary angiography percutaneous coronary intervention myocardial ischemia spect coronary revascularization
family study of congenital cardiovascular malformations

Conditions: Cardiovascular Diseases; Defect, Congenital Heart; Heart Diseases

Summary: to determine genetic mechanisms responsible for congenital cardiovascular malformations.

background: congenital cardiovascular malformations are a major cause of infant mortality in the united states. in 1985, six defects -- hypoplastic left heart, tetralogy of fallot, truncus arteriosus, transposition of the great arteries, endocardial cushion defect, and ventricular septal defect -- were among the fifteen most frequent causes of premature death due to congenital malformations, accounting for 109,063 years of life lost. this loss of productive life continues in spite of major advances in medical and surgical treatment of congenital cardiovascular malformations. even as successful treatment modalities are developed, the survival to reproductive years without improved understanding of genetic risks produces additional unanswered questions. design narrative: clinical assessment of cases and controls included medical history, pedigree construction, complete evaluation by a pediatric cardiologist, and two-dimensional and doppler echocardiography. first degree relatives of cases and controls underwent clinical-echocardiographic evaluation also. the distribution of cardiac defects for all pedigrees within and among the proband group was delineated. the frequencies of heart defects were compared within and among pedigrees of cases and controls. regressive logistic models of genetic determinants for the malformations were tested. the three participating clinical centers included university of maryland at baltimore, the johns hopkins hospital, and the university of rochester in rochester, new york. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
duration of untreated psychosis (dup) and pathways to care in nordland

Conditions: Schizophrenia and Disorders With Psychotic Features; Affective Psychosis, Bipolar; Psychoses

Summary: during the 1990s, evidence began to emerge of the long duration of untreated illness prior to receiving treatment for patients with psychotic disorders. studies across the world on first episode psychosis have consistently found an average of 1 - 2 years between the onset of psychotic symptoms and the start of treatment. lengthy treatment delay has immediate implications such as unnecessary distress for patients and families, and may also compromise potential recovery when treatment is initiated.by understanding how and why substantial delays occur the investigators may be able to better design interventions to facilitate better earlier treatment. the components of dup can be conceptualised as comprising 3 distinct intervals: help-seeking delay, referral delay and delay in mental health services. in this study the primary aim is to establish the level of dup in nordland, and explore the components of this variable. help-seeking delay will be investigated by interviewing patients presenting at the central mental health hospital in nordland about their psychosis onset and pathways to care. referral delay will be investigated by a questionnaire about the referral pratices among gps in nordland. delays in mental health services will be investigated by focus group interviews with leaders and professionals at the 7 community mental health centers in nordland. this knowledge is believed to be crucial for developing services that can reduce dup and give this patient population earlier access to adequate treatment.


Eligibility criteria:
inclusion criteria: * any patient presenting with a possible psychotic illness (including schizophrenia, affective psychosis and drug-related psychosis, but excluding organic psychosis). * understands and speaks norwegian exclusion criteria: * severe learning disability
descriptive epidemiology of a specialized consultation on adhd in adults at the strasbourg university hospital

Conditions: Attention Deficit and Hyperactivity Disorder

Summary: the main objective of this study is to carry out a descriptive study of the clinical and demographic characteristics of patients having consulted for a specialized opinion about adhd in adults of the psychiatric service of the strasbourg university hospital. the characteristics of patients were collected during the first consultation, by the psychiatrist, and analyzed retrospectively. the secondary objective is to evaluate the evolution at one year in terms of follow-up, maintenance under medical treatment and perceived effects of it. the patients who had a prescription for pharmacological treatment of adhd were contacted between 9 and 15 months after the first consultation and responded to a questionnaire assessing the evolution.


Eligibility criteria:
inclusion criteria: * age \> 18 * having a specialized consultation about adhd in adults in the psychiatric service of the strasbourg university hospital * agree with the use of medical files from the consultation for medical research exclusion criteria: * disgree with the use of medical files from the consultation for medical research

Keywords: attention deficit hyperactivity disorder adult epidemiology evolution treatment
single cohort, 2-period study to assess pharmacokinetics of metformin alone and in combination with ranolazine 500 mg

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the effect of steady-state ranolazine 500 mg bid on the steady state pharmacokinetics (pk) of metformin in subjects with type 2 diabetes mellitus (t2dm).

the primary objective of this study is as follows: • to evaluate the effect of steady-state ranolazine 500 mg twice daily (bid) on the steady state pharmacokinetics (pk) of metformin in subjects with t2dm. the secondary objectives of this study are as follows: * to examine the safety and tolerability of metformin when co administered with ranolazine 500 mg bid at steady-state in subjects with t2dm. * to determine the steady-state pk of ranolazine 500 mg bid in subjects with t2dm receiving metformin.

Eligibility criteria:
inclusion criteria: * males and females, 30 to 65 years old, inclusive * documented history of t2dm * hba1c 6.5%-10%, inclusive * fasting serum glucose ≤ 270 mg/dl at screening * fasting c-peptide ≥ 1 ng/ml at screening * stable metformin monotherapy (metformin ≥ 1500 mg total daily dose for at least 4 weeks prior to screening) * body mass index (bmi) 25 to 40 kg/m2, inclusive, at screening * creatinine clearance \> 80 ml/min at screening * females of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on day -1 and must agree to use highly effective contraception methods from screening throughout the duration of the treatment period and for 14 days following the last dose of study drug exclusion criteria: * type 1 diabetes mellitus (t1dm) * use of insulin therapy \< 3 months prior to screening * history of ketoacidosis, ketosis-prone diabetes, or lactic acidosis * clinically significant complications of diabetes * history of hypoglycemia * any non-insulin antidiabetic therapy (other than metformin) \< 2 months prior to screening * any clinically significant cardiovascular event \< 2 months prior to screening * clinically significant, inadequately controlled, or unstable hypertension * hospitalization \< 2 months prior to screening or major surgery \< 3 months prior to screening * history of gastrointestinal disease or surgery that could impact drug absorption * history of substance of alcohol or substance abuse * positive urine drug screen for drugs of abuse * positive alcohol breath test * any other clinically significant existing medical or psychiatric condition or one requiring further evaluation * treatment with selected medications * hemoglobin \< 12 g/dl for males; or \< 11 g/dl for females at screening * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 2.5x upper limits of normal * clinically significant history of hepatic disease or evidence of hepatic impairment * positive blood screen for hepatitis c or hepatitis b * qtc interval \> 500 msec at screening * females who are pregnant or are breastfeeding

Keywords: metformin ranolazine type 2 diabetes mellitus
topical kb105 for the treatment of tgm1-deficient autosomal recessive congenital ichthyosis (arci)

Conditions: Autosomal Recessive Ichthyosis

Summary: kb105-02 is an intrasubject randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of kb105 in children and adults with autosomal recessive congenital ichthyosis (arci).


Eligibility criteria:
key inclusion criteria: 1. subject, or legally authorized representative, must be willing and able to give informed consent/assent 2. aged ≥6 months 3. a genetically confirmed diagnosis of tgm1-deficient arci 4. clinical diagnosis of lamellar ichthyosis 5. two target areas located on similar anatomical regions with the same scaling severity by iga and scaling severity ≥3 6. subjects taking systemic retinoids must be on a stable regimen for at least 4 weeks and agree to continue to take the medication consistently throughout the study. if the subject prefers to withhold systemic retinoids during the study, then a minimum 4-week washout period is required 7. clinically stable and in good general health key exclusion criteria: 1. subject has a physical condition or other dermatological disorder (e.g., atopic, seborrheic, or contact dermatitis, psoriasis, tinea infections, etc.) which, in the investigator's opinion, might impair evaluation of the target areas or which exposes the subject to unacceptable risk by study participation 2. participation in another clinical study or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer 3. any condition or illness (including a history or current evidence of substance abuse or dependence) that, in the opinion of the investigator, would impact a subject's ability to complete all study-related procedures and/or poses an additional risk to the assessment of safety of kb105 4. women who are pregnant or nursing 5. subject who is unwilling to comply with contraception requirements per protocol 6. subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the investigator
impact of tdcs on emotional processing in major depression

Conditions: Major Depressive Disorder

Summary: background: transcranial direct current stimulation (tdcs) is an innovative treatment for major depression. however, its mechanisms of action are still unclear. major depression is characterized by impaired processing of emotional information, which returns back to normal after successful antidepressant treatment. in this randomized double-blind study, the investigators aim to assess the effect of tdcs on emotional processing in major depression.

methods: 40 subjects with major depression (20 active treatment and 20 placebo) will receive ten 30-minutes sessions of active two milliamps or sham tdcs (anode over left dorsolateral prefrontal cortex and cathode over right dorsolateral prefrontal cortex), twice a day for 5 consecutive days. psychometric assessment of depression (madrs,beck depression inventory , cgi) and a neuropsychological assessment will be conducted before and after the treatment. a facial emotion recognition task and an attentional emotional task with measurement of eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session. the investigators hypothesize that active tdcs will improve emotional processing in major depression, and that this will be observed after 1 and 10 sessions of tdcs. conclusions: studying the impact of transcranial direct current stimulation on emotional processing in major depression could allow to better understand its antidepressant mechanisms

Eligibility criteria:
inclusion criteria: healthy controls: * age between 18 and 65 years * given consent. depressed subjects: * major depressive episode (no psychotic features) according to diagnostic ans statistical of mental disorders number 5 (dsm 5.0.) * age from 18-65 * antidepressant stable for the last 4 weeks * madrs ≥ 20. * given consent exclusion criteria: healthy controls: * psychiatric disorder * addiction except for tobacco addiction * ocular disease (except from refraction disorders), neurologic or cardiac disease. * neuroleptic or anticonvulsivant treatment * presence of a specific contraindication for tdcs (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker) depressed subjects: * other psychiatric disorder except for personality disorders * ocular disease (except from refraction disorders), neurologic or cardiac disease. * neuroleptic or anticonvulsivant treatment * presence of a specific contraindication for tdcs (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)

Keywords: tdcs neuromodulation depression cognition
comparison of two approaches to insulin therapy in patients with type 2 diabetes (ioox)

Conditions: Diabetes Mellitus, Type 2

Summary: a study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes * have been receiving oral antihyperglycemic medications (oam) without insulin including at least two of the following at maximally tolerated doses, and meet the minimum dosing criteria shown: metformin 1500 mg/day, sulfonylurea 1/2 the maximum daily dose, according to package insert, thiazolidinedione (tzd) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. the oams also must be used in accordance with the product label * have a hemoglobin a1c greater than or equal to 7.5% and less than or equal to 12.0%. exclusion criteria: * are taking a tzd dose greater than what is indicated in combination with insulin according to the tzd label. * are taking any other glucose-lowering agents not mentioned in inclusion criterion. * have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks. * have a body mass index greater than 40 kg/m2. * have had more than one episode of severe hypoglycemia in the last24 weeks * are pregnant, intend to be pregnant during the course of the study or are breastfeeding * have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease

Keywords: diabetes type 2
educational intervention to increase select guideline-recommended cardioprotective medications in patients with diabetes

Conditions: Diabetes Mellitus, Type 2; Cardiovascular Diseases

Summary: this is an educational outreach to patients with type 2 diabetes mellitus (t2dm) and atherosclerotic cardiovascular disease (ascvd) and their primary care and specialist providers to improve use of guideline-recommended treatments, specifically sodium-glucose cotransporter 2 inhibitor (sglt2i) and glucagon-like peptide-1 receptor agonist (glp-1 ra) medications.

patients with type 2 diabetes mellitus, a history of atherosclerotic cardiovascular disease, without use of select guideline-recommended medications in the previous year will be identified from administrative claims. primary care providers will be identified, randomly selected and randomized to the intervention arm or control arm. all eligible patients for that provider will be included. the patient's specialist providers (cardiologist and/or endocrinologist, as applicable) will be identified and contacted. the intervention will include a multi-faceted strategy to support providers in the care of their patients by sharing recent guideline-based treatment recommendations and provide patients with information regarding ways to reduce their cardiovascular risk. outreach will occur for all patients and providers randomized for the intervention - there will be no active enrollment or recruitment.

Eligibility criteria:
inclusion criteria: patient * patients with t2dm defined as ≥2 outpatient diagnoses of t2dm in any position on separate days; or ≥1 inpatient diagnosis t2dm in any position; or ≥1 outpatient diagnosis in any position and ≥1 medication claim for t2dm * ≥1 diagnosis code for ascvd (coronary artery disease diagnoses or procedures, cerebrovascular disease, peripheral artery disease of atherosclerotic origin) on any claim type in any position within the 24-month period prior to identification * enrolled in a humana medicare advantage prescription drug plan with ≥12 months pre-identification continuous enrollment (no more than a 31 day gap) as of the identification date and currently enrolled as of the identification date * age 18-85 years at time of identification * patients residing in kentucky (ky), west virginia (wv), pennsylvania (pa), and 6 counties in south new jersey (nj) (burlington, camden, cumberland, gloucester, mercer, salem) (united states) provider * primary care providers of the identified patients exclusion criteria: patients * ≥1 diagnosis or procedure code for end-stage kidney disease, renal transplant, dialysis or kidney failure * any hospice or long-term care residence * ≥1 code for pregnancy/childbirth * patients with any use of sglt2i or glp-1 ra medications in the pre-identification period * patients without an attributed primary care provider * patients on do not contact lists * patients without valid addresses and telephone numbers * patients with ≥1 diagnosis for type 1 diabetes pre-identification primary care providers * providers on do not contact lists * providers without valid fax/mailing address and phone number * providers with \ 50 eligible patients
proteomics research of osteosarcoma

Conditions: Osteosarcoma; Proteomics

Summary: retrospectively collected 400 cases of clinical data and pathological paraffin specimens of osteosarcoma, chondrosarcoma (control) and endogenous chondroma (control) in our hospital from 2008 to 2014, combined with high-pressure cycle-satellite scanning mass spectrometry (pct-swath) molecular typing of osteosarcoma and prediction of targeted therapy, the establishment of a new molecular classification based on proteomics for osteosarcoma to predict the chemotherapy response and recurrence risk of osteosarcoma. clinical osteosarcoma patients include as many types as possible: pre-chemotherapy, post-chemotherapy, recurrence, and metastasis. the study did not involve vulnerable groups, and it was taken as a postoperative wax specimen for patients, which had no health, life and other effects on patients. study application exemption from informed consent.


Eligibility criteria:
inclusion criteria: * all osteosarcoma patients in our hospital * received methotrexate+doxorubicin+cisplatin protocol chemotherapy exclusion criteria: * non-chemotherapy patients * bio-specimen not completed
clinical validation of bbct-hip

Conditions: Osteoporosis

Summary: the clinical study is aimed at assessing the accuracy of the in silico methodology bbct-hip. bbct-hip takes as inputs the subject-specific height and weight, and the ct scan of his femur to predict the risk of fracture for the femur upon falling. in the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. ct scans will be carried out for both groups (no later than 3 months for the fracture group) and bbct-hip run,in order that the risk of fracture will be obtained. first, a transversal study will be performed, where the stratification accuracy of bbct-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. furthermore, the control subjets will be followed up to assess bbct-hip predictive accuracy through a longitudinal study.


Eligibility criteria:
inclusion criteria: * caucasic post-menopausal women resident in emilia-romagna * menopause (\>= 45 years) exclusion criteria: * tumours * not free living * chronic diseases with severe organ failure / endocrine diseases of parathyroid, thyroid, adrenal gland / intestinal malabsorption, osteomalacia / paget bone / rheumatoid arthritis. neurodegenerative diseases * long-term continuous therapy (\>3 months) with corticosteroids and proton pump inhibitors or aromatase inhibitors * previous femur fractures * presence of hip/knee prosthesis only for the fracturegroup: * presence of fixation devices after the fracture * femur fracture due to high energy trauma

Keywords: hip fracture fracture prediction finite element in silico osteoporotic fracture