Kornimate/medical-research-clean huggingface dataset:
lci-hem-spec-001: tissue collection for genetic analysis of acute myelogenous leukemia

Conditions: Leukemia, Myelogenous, Acute

Summary: the purpose of this study is to obtain high quality specimens for molecular studies for the identification and characterization of genetic mutations involved in the pathogenesis of familial myeloid malignancies. specimens obtained will be de-identified, linked to basic clinical data, and sent to washington university (division of oncology, st. louis, mo) for molecular analyses. some specimens sent to washington university may also be used for quality control analyses.

this is a specimen collection study for patients receiving standard of care treatment for aml. specimens collected will be 1) bone marrow biopsy and aspiration, 2) peripheral blood, 3) skin punch biopsy, and 4) oral rinse. collection of these specimens will be at timepoints determined by the patient's standard of care and their physician investigator.

Eligibility criteria:
inclusion criteria * patients must have a diagnosis of acute myelogenous leukemia. * family members of patients with acute myelogenous leukemia may be enrolled. * informed consent must be provided by the patient or his/her legal guardian in accord with the practices of levine cancer institute and atrium health. exclusion criteria * known infection with hepatitis b or c, htlv, or hiv.
study evaluating orally administered amg 900 in adult subjects with acute myeloid leukemia

Conditions: Cancer; Hematologic Malignancies; Leukemia; Myeloid Leukemia

Summary: this study of amg 900 will be conducted in two parts: dose escalation and dose expansion. the dose escalation part of the study is aimed at evaluating the safety, tolerability and pk (pharmacokinetics) of oral amg 900 in subjects with acute myeloid leukemia. up to 93 subjects may be enrolled in dose escalation. the dose expansion part of the study will consist of 20 subjects with acute myeloid leukemia. the dose of amg 900 will be dependent upon data from the dose escalation part of the study.


Eligibility criteria:
inclusion criteria: * men or women ≥ 18 years old * pathologically documented, definitively diagnosed aml that has failed standard treatments or for which no standard therapy is available or the subject refuses standard therapy * must consent to undergo bone marrow biopsies per schedule of assessments exclusion criteria: * white blood cell greater than 20,000 ul * history of or active central nervous system leukemia * prior allogeneic bone marrow transplant * subject will not be available for protocol-required study visits or procedures other inclusion/ exclusion criteria may apply to qualify for enrollment

Keywords: amgen phase 1 clinical trial aurora kinase inhibitor open label oncology hematology
study to compare the effect of valsartan vs atenolol on pro-thrombotic state in hypertensive patients.

Conditions: Hypertension

Summary: a study to compare the effects of diovan or atenolol taken for 12 weeks on platelet function of patients who have mild to moderately severe hypertension


Eligibility criteria:
inclusion criteria: * male or female, aged between 18 - 75 years of age inclusively. * mild to moderate hypertension (msdbp \>= 95 and \>= 110 mmhg and / or mssbp \>140mm hg) at visit 1, requiring pharmacological intervention. for newly diagnosed patients, hypertensive blood pressure values must be noted on at least two successive examinations prior to entry into the study. in addition, patients must require therapy despite having been following dietary \& lifestyle advice for at least 3 months. * written informed consent to participate in the study, prior to any study procedures. * ability to communicate and comply with all study requirements exclusion criteria: * o uncontrolled hypertension defined as seated blood pressure of either systolic bp \>180 mmhg and/or diastolic bp \>110mmhg. * clinically significant laboratory abnormalities that may interfere with the assessment of safety and/or efficacy of the study drug * patients with severe medical condition(s) that in the view of the investigator may prohibit participation in the study * renal artery stenosis * diabetes mellitus * any condition resulting from or leading to platelet or clotting abnormalities (eg. hemophilia, von willebrand's disease). * history of a vascular event or intervention (e.g. mi, ptca or cabg) within 6 months preceding the study. * history of clinically significant angina, lvh, transient ischemic attack, stroke, intermittent claudication, deep vein thrombosis (dvt), pulmonary embolism or peripheral vascular disease. * uncontrolled atrial fibrillation (\>100 b.p.m. at rest) or other conditions which may require anti-aggregant or anti-vitamin k therapies. * clinical evidence of congestive heart failure. * evidence of second or third degree heart block or sick sinus syndrome.

Keywords: hypertension valsartan
evaluation of pet scan timing relative to av-45 injection time

Conditions: Alzheimer's Disease

Summary: this study will re-read 10-minute positron emission tomography (pet) scans acquired in previous clinical studies of av-45 at 30 and 50 minutes after injection and compare the results.


Eligibility criteria:
eligibility for subjects scans to be used in this study is determined by subject's eligibility/enrollment in study a01(nct01565291) or a03(nct01565330). inclusion criteria (ad group): * greater than 50 years of age * probable ad according to the national institute of neurological and communication disorders and stroke-alzheimer's disease and related disorders association (nincds-adrda) criteria * mild/moderate dementia as evidenced by a mini-mental state examination (mmse) score ranging from 10 to 24, boundaries included, at screening * history of cognitive decline gradual in onset and progressive over a period of at least 6 months inclusion criteria (a01\[nct01565291\] healthy volunteer group): * 50 years of age, inclusive * mmse of 29 or greater inclusion criteria (a03\[nct01565330\] healthy volunteer group): * 35 to 55 years of age, inclusive * mmse of 29 or greater exclusion criteria (both groups): * neurodegenerative disorders other than ad, including, but not limited to parkinson's disease, pick's disease, fronto-temporal dementia, huntington's chorea, down syndrome, creutzfeldt-jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy * diagnosis of other dementing / neurodegenerative disease * diagnosis of mixed dementia * cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation * clinically significant infarct or possible multi-infarct dementia as defined by the nincds criteria * evidence on screening mri or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of ad pathology) * clinically significant psychiatric disease * history of epilepsy or convulsions * clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances * current clinically significant cardiovascular disease * received investigational medication within the last 30 days

Keywords: amyloid imaging positron emission tomography 18f-av-45 florbetapir f 18 diagnostic imaging
evaluation of the introduction of a colorectal bundle in left sided colorectal resections

Conditions: Colorectal Disorders; Surgery--Complications; Colorectal Cancer; Anastomotic Leak; Complication of Surgical Procedure

Summary: the complication rate in colorectal surgery is high and shows a large variance depending on the patient and the treating surgeon. the primary aim of the presented study is to evaluate the introduction of a colorectal bundle to reduce the complication rate in left sided colorectal resections. the colorectal bundle is a catalog of measures consisting of several items these are for example preoperative risk stratification, antibiotic and mechanical bowel preparation and preoperative showering. the primary endpoint will be the complication rate measured as the comprehensive clinical index (cci) within 30 days. investigators will include patients that undergo elective or emergency left sided colorectal surgery.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * patients undergoing any left sided emergency or elective colorectal resections * patients should have given or will give a general consent exclusion criteria: * no general consent given * unable to provide informed general consent * vulnerable patients (age \< 18 years or patients with severe dementia) * the intervention is a reoperation within 30 days of primary operation exclusion criteria for an antibiotic decontamination subgroup: * known allergy to one of the applied antibiotic regimes * active bacterial infection requiring systemic antibiotics * iv or oral antibiotics in past 7 days prior to the planned decontamination * terminal kidney disease * unable to take antibiotic decontamination medication * pregnancy or breastfeeding * emergency or expedited surgery
dispensing overnight study in lenses

Conditions: Myopia

Summary: the purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping.

the purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping. physiological changes will be monitored and subjective ratings collected.

Eligibility criteria:
inclusion criteria: 1. has had an oculo-visual examination in the last 2 years. 2. is between 18-45 years old and has full legal capacity to volunteer. 3. has read and understood the information consent letter 4. is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits. 5. is correctable with the prescription of the available lenses (-1.00 to -4.00 ds in 0.50d step). 6. is correctable to at least 20/40 distance visual acuity with contact lenses in each eye. 7. is a current soft contact lens wearer (both daily wear and extended wear experience allowed). 8. has refractive astigmatism of \<= 1.00 diopters 9. has clear corneas and ocular clinical findings considered to be "normal". exclusion criteria: 1. has any systemic disease affecting ocular health. 2. is using any systemic or topical medications that will affect ocular health. 3. has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses. 4. has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities. 5. has limbal injection, bulbar injection or corneal staining that, in the investigator's opinion, is clinically significant. 6. has never worn contact lenses before. 7. has corneal distortion resulting from rigid lens wear. 8. is aphakic. 9. has undergone corneal refractive surgery. 10. is participating in any other type of clinical or research study.
observational study of the remodelling process following myocardial infarct

Conditions: Heart Failure; Myocardial Infarct

Summary: this study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in patients 3 years following a myocardial infarction.

a multinational trial compared losartan vs. captopril in 5477 postinfarction patients with symptoms of heart failure and/or evidence of left ventricular dysfunction. the trial was terminated in 2002 and the results of the main trial have been published. in this trial, a collagen and neurohumoral substudy was performed to assess the importance of collagen turnover in this population. a total of 235 patients were included from 18 centres. blood was taken at randomisation, 1 month, 1 year and 2 years. the present study will recruit surviving patients among the 119 individuals that were randomised to the neurohumoral substudy at the stavanger university hospital. the study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in these patients about 3 years following the index myocardial infarction. the data collected at the 3-year follow-up visit will be compared to data from the initial study.

Eligibility criteria:
inclusion criteria: * participation in the previous neurohormonal substudy of the optimaal trial * willingness to participate in the present study and ability to understand and sign the written informed consent exclusion criteria: * myocardial infarction within 3 months of visit 1. * significant primary valve disease, confirmed by echo cardiography, * autoimmune disease likely to cause an increase in collagen turnover * active cancer disease * immunosuppressive treatment, * significantly reduced liver function * contraindications for performing a cardiac mri scan (including claustrophobia, implanted ferromagnetic devices or known allergic reactions to omniscan™). * inability to cooperate during the 1 month follow up period.

Keywords: left ventricle remodelling collagen markers neurohormones cardiac mri
tailored hospital-based risk reduction to impede vascular events after stroke

Conditions: Stroke

Summary: the purpose of this study is to determine whether a culturally-sensitive multipronged post-discharge intervention can significantly reduce blood pressure, enhance achievement of guideline recommended targets for risk factor control, and lower recurrent vascular events in a low-income and middle-income (lmic). the study will have 2 phases - a qualitative phase (phase 1) lasting less than one year involving development of the intervention through focus group methodologies and structured interviews, and a clinical trial phase (phase 2)lasting 3 years involving a randomized trial testing the efficacy of the intervention.

this research seeks to develop an effective and sustainable way of reducing the devastating and deadly impact of stroke in a low-income region of the world with poor medical infrastructure. it will do so by focusing on improving the treatment of the condition most closely tied to stroke, hypertension, using novel methods that incorporate the input of the local community. if successful, the strategy could serve as a ready model to be adapted by decision-makers in other under-resourced areas for lessening the burden of stroke(and other major public health challenges).

Eligibility criteria:
phase 1: inclusion criteria: age ≥ 18 years stroke within one year access to mobile phone. exclusion criteria: any medical condition that would limit participation in follow up assessments, severe cognitive impairment/dementia (mmse ≤24) severe global disability (modified rankin score ≥ 3).
comparison of vaginal axis on mri in alternative apical prolapse surgeries to sacrocolpopexy

Conditions: Pelvic Organ Prolapse

Summary: sacrocolpopexy remains the preeminent modality in addressing apical prolapse surgically. nevertheless, amplified morbidity rates within cohorts characterized by obesity and advanced age constrain the advantages conferred by the procedure. recent years have witnessed a proliferation of inquiries appraising the efficacy of laparoscopic lateral suspension, pectopexy, and sacrospinous ligament fixation interventions, which have, over time, garnered extensive clinical application, in relation to recurrence rates. a multitude of investigations have been undertaken to delineate the optimal vaginal axis. in the present investigation, we have delineated a research protocol aimed at scrutinizing these alternative surgical modalities with regard to their impact on the vaginal axis.

the study objective pertains to the assessment of vaginal axis in patients undergoing apical prolapse surgery, whether they have undergone hysterectomy or not. the investigation is designed to test the null hypothesis by means of a comparative analysis of preoperative and postoperative magnetic resonance imaging images capturing the vaginal axis. this examination will be conducted on patients slated to receive lateral mesh suspension, pectopexy, and sacrospinous ligament fixation procedures for the correction of apical prolapse.

Eligibility criteria:
inclusion criteria: * female with genital prolapse exclusion criteria: * patients who had pouch of douglas obliteration * patients with enterocele * patients who have any congenital or acquired anatomic and reproductive anomaly

Keywords: pelvic organ prolapse apical prolapse pectopexy sacrospinous ligament fixation lateral suspension
accuracy and primary stability in immediate implant placement: dynamic navigation versus freehand

Conditions: Tooth Diseases

Summary: prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. dynamic navigation has been reported better implant positioning. however, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. patients will then be followed up one year after delivery of the crown to assess additional parameters.

prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. dynamic navigation has been reported better implant positioning. however, dynamic navigation's application to immediate implant placement has not been studied, and its exact role is still needed to be investigated further. besides, implant insertion angle may influence primary stability, which is a prerequisite in achieving osseointegration, while dynamic navigation can precisely control angle and position. therefore, the investigators designed a randomized controlled clinical trial study to verify the clinical efficacy of dynamic navigation and freehand in immediate implant placement. patients will then be followed up one year after delivery of the crown to assess additional parameters. these will include the assessment of soft tissue inflammation, cytokine concentrations, microbiome, stability of the buccal bone plate.

Eligibility criteria:
inclusion criteria: 1. ≥18 years old and in good health; 2. the maxillary incisor that cannot be retained due to non-periodontitis; 3. the buccal bone plate is complete; 4. no acute infection; 5. the extraction socket have at least 3-5 mm apical bone. exclusion criteria: 1. general contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids); 2. treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy); 3. periodontitis history or uncontrolled periodontitis. bleeding of probing (bop) positive site ≥ 10%, or probing depth (pd) ≥ 4mm; 4. heavy smokers or previous heavy smoking history (quit smoking time \ 20 cigarettes per day); 5. refuse to participate in this trial.
a study to assess the safety of a potential new drug in comparison to the standard practice of dosing with warfarin for non-valvular atrial fibrillation

Conditions: Atrial Fibrillation; Thromboembolism

Summary: this study is to assess the safety of a potential new drug du-176b for the prevention of stroke/systemic embolic event (see) in individuals with non-valvular atrial fibrillation (af). the duration is 3 months of treatment and a 30 day follow-up visit.


Eligibility criteria:
inclusion criteria: 1. male or female, 18 to 80 years old. 2. able to provide written informed consent. 3. persistent non-valvular af supported by abnormal electrocardiogram (ecg) 4. a congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (chads2) index score of at least 2 exclusion criteria: 1. subjects with mitral valve disease or previous valvular heart surgery 2. known contraindication to any anticoagulant including vitamin k antagonists such as warfarin 3. known or suspected hereditary or acquired bleeding or coagulation disorder

Keywords: anti-coagulant non-valvular venous thromboembolism prevention of blood clots atrial fibrillation non-valvular atrial fibrillation
potential biomarkers of the severity of endothelial damage in end-stage chronic kidney failure

Conditions: End-stage Chronic Kidney Failure

Summary: the principal objective of this study is to qualify markers of oxidative stress in inflammatory cells (monocytes) in patients with stage 3 kidney failure (diabetic or not), and patients with end-stage kidney failure (diabetic or not), who require dialysis. the evaluation of these markers will be done by the activation and localization of proteins implicated in vascular tone and oxidative stress in monocytes, correlated with the distribution of cholesterol sphingomyelin within planar rafts and caveolae. the aim is to describe their evolution under treatment, which could lead to interventional studies.


Eligibility criteria:
inclusion criteria: * patient who have been informed about the research * patients with national health insurance cover * patients aged between 18 and 75 years * patients with stage 3 kidney failure (30 ml/min \< cl creat \< 59 ml/min) diabetic or not * patients with stage 5 kidney failure (cl creat \< 15 ml/mn) diabetic or not and requiring dialysis. exclusion criteria: * patients under guardianship * pregnant or breast-feeding women * infection (including peritonitis in peritoneal dialysis, infection of the catheter insertion site), * neoplastic disease, * systemic diseases in flare, * patients positive for human immunodeficience virus (hiv), * patients on immunosuppressants * patients taking antioxidants (selenium, vitamin c and/or e) * patient on statins