Kornimate/medical-research-clean huggingface dataset:
preventive treatment approach of early caries lesions with contemporary methods of remineralization

Conditions: Tooth Decay

Summary: the purpose of this study is to evaluate 1. the additional therapeutic benefit of curodont repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone 2. the tooth gel curodont protect when using it after curodont repair instead of fluoride varnish

objectives: the purpose of this study is to evaluate 1. the additional therapeutic benefit of curodont repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone 2. the tooth gel curodont protect when using it after curodont repair instead of fluoride varnish methods: 90 patients with early occlusal lesions (icdas-ii:2-3) on permanent molars and pre-molars will be allocated in this randomized, controlled, single blinded study to one of the two test groups (test1: curodont™ repair+fluoride varnish; test2: curodont repair+curodont protect) or control (fluoride varnish) group. lesions will be assessed at baseline and recalls after 3, 6 and 12 months regarding caries activity (nyvad), clinical status (icdas-ii) and with diagnodent®. visual analog scale (vas) in addition to the global impression of change questionnaire will also be used for the evaluation of the outcome.

Eligibility criteria:
inclusion criteria: * early occlusal carious lesion which does not require an invasive treatment (icdas-ii scores: 2 and 3) * size and form of the lesion: the lesion must both be fully visible and assessable and accessible * willing and able to attend the on-study visits and to observe good oral hygiene throughout the study * written informed consent before participation in the study exclusion criteria: * evidence of tooth erosion * fluoride varnish application \< 3 months prior to study treatment * history of head and neck illnesses (e.g. head/neck cancer) * any pathology or concomitant medication affecting salivary flow or dry mouth * any metabolic disorders affecting bone turnover * concurrent participation in another clinical trial
pediatric fn definition 2012 bern

Conditions: Cancer in Children/Adolescents; Fever in Neutropenia

Summary: study aims based on prospectively collected information on ear temperatures, anc values, emergency calls and consultations for fever, and on hospitalizations for fn in children and adolescents with cancer * to describe the frequency of episodes of fn, and of other clinically relevant fn-related measures * to compare these frequencies and measures in reality vs. applying bernese standard limits for defining fever (ear temperature ≥39.0°c) * to compare these frequencies and measures applying the bernese standard limit of ≥39.0°c (limitstandard) vs. a range of hypothetically lower limits defining fever (limitlow) * to determine if it would be useful to perform an interventional study on the question of different fever limits, powered to study both efficacy (frequency of fn) and safety (ae in delayed fn diagnosis) * to use the platform of this prospective study to explore if the serum level of cortisol is associated with adverse events in fn hypothesis in children and adolescents with cancer, hypothetically modifying the definitions of fever from ear temperature 39.0°c to lower limits would * increase the rate of fn episodes diagnosed during chemotherapy (primary endpoint). * increase the rate of other clinically important fn-related measures related to chemotherapy exposure time (secondary endpoints 1,2,3) and outcome/treatment-related measures during treatment of fn episodes diagnosed in reality (secondary endpoints 4,5,6). * not relevantly decrease the proportion of fn with ae (secondary endpoint 7).


Eligibility criteria:
inclusion criteria: * \>1 year and ≤17 years at time of recruitment * chemotherapy treatment because of any malignancy for at least 2 months at time of recruitment * written informed consent from patients and/or parents for the study exclusion criteria: * infants ≤1 year old (reason: differences in standard fever limit and method to measure temperature) * denied written informed consent from patients and/or parents for the study
serum 1,25-dihydroxyvitamin d levels in type 2 diabetes mellitus patients with different levels of albuminuria

Conditions: Type 2 Diabetes Mellitus With Diabetic Nephropathy

Summary: diabetic nephropathy(dn)is a major microvascular complication of diabetes.renal injury may be presented with the characteristics of albuminuria, and its main pathological change is glomerular sclerosis. however, both glomerular lesions such as glomerulosclerosis, glomerular basement membrane thickness and tubulointerstitial fibrosis have been found in both type 1 and type 2 diabetic patients with normal urinary albumin excretion rate, moreover the tubular injury may be the primary pathological change in diabetic renal injury not only the secondary change brought on by glomerular injury. thus, if overt urinary albumin exists in t2dm patients, the tubular injury may be severe already. an index which is predominant, sensitive and convenient to be measured should be purposed.it is predicted that insufficient renal 1-alpha hydroxylase may play a critical role in diabetic nephropathy. then the investigators present the presumption that the activity of renal 1-alpha hydroxylase could reflect the degrees of tubulointerstitial injury, using serum 1,25-dihydroxyvitamin d level as an index.


Eligibility criteria:
inclusion criteria: * age \>18 years, dm duration \>1 year, all of the patients were predialysis exclusion criteria: * history of liver or kidney disease, malignancy, current pregnancy, extensive dermatologic disease, evidence of metabolic bone disease and hyper-/hypo- thyroidism that would affect mineral metabolism. patients who were taking native or active vitamin d, steroids, phosphate binders, or medications that affect vitamin d metabolism were also excluded.
investigation of the diagnostic role of mirnas in pca and bph

Conditions: Benign Prostate Hypertrophy(BPH); Prostate Cancer (Adenocarcinoma)

Summary: prostate cancer(pca) is the second most common cause of cancer-related death in men after lung cancer. diagnostic methods such as measurement of serum prostate-specific antigen (psa) levels used in the clinic still cannot distinguish between benign conditions and prostate cancer, and biopsy is essential for the diagnosis of prostate cancer. due to the high false-positive rate of psa, many patients are accidentally biopsied, which carries various risks for patients. therefore, there is a need for new diagnostic methods to support psa and the identification of reliable biomarkers for early diagnosis. micrornas (mirnas) are short non-coding rnas that can be detected in body fluids such as urine, blood and serum. in recent years, mirnas have been nominated as reliable biomarkers that help us make an accurate diagnosis in many diseases, such as cancer. although various mirnas have been detected in the sera of prostate cancer patients, there is still little data on which mirnas can be used as biomarkers. in this study, investigators aimed to evaluate the expression levels of mir-107, mir-134-5p, mir-149-5p, mir-370-3p and mir-221 in blood as biomarkers capable of distinguishing pca from benign prostatic hyperplasia (bph) and will prevent unnecessary biopsies. in addition, they aimed to compare some clinical features such as serum psa and gleason score with serum mirna levels and determine the relationship between them.

the present study is a prospective study and consists of three work packages. first, clinical evaluations were made and biopsy samples were taken from patients who applied to the urology clinic, had serum psa levels higher than 4 ng/ml, and were suspected of prostate cancer. then, a pathological examination of the biopsy samples was performed and the patients were grouped into pca and bph. finally, molecular analyses were performed on blood samples obtained from patients and healthy controls and all obtained data were statistically evaluated.

Eligibility criteria:
inclusion criteria: * for all groups, between 40-70 years of age. * prostate cancer group: patients with positive digital rectal examination (dre) results, serum psa level above 4 ng/ml and a confirmed pathological diagnosis of prostate cancer. * bph group: patients with a psa level over 4 ng/ml and a negative dre result who were clinically and pathologically diagnosed with bph. * control: healthy volunteers who applied to the urology outpatient clinic for routine check-ups and whose psa value was below 4 ng/ml. exclusion criteria: * to have undergone drug therapy or surgery for prostate cancer, * to have chronic inflammatory or infectious diseases, * were hospitalized within the past year for a chronic illness, * to have another known malignancy, * being outside the age limit of 40-70.

Keywords: prostate cancer benign prostate hypertrophy(bph) mirna biomarker psa
enable® aortic sutureless bioprosthesis evaluation

Conditions: Aortic Valve Stenosis; Aortic Valve Insufficiency

Summary: the ease enable study is intended to collect additional data on the clinical outcomes of the medtronic enable® aortic bioprosthesis in "real world" patients.

the ease enable study is intended to characterize the clinical performance of the medtronic enable® aortic bioprosthesis in a post-market real-world setting. this is a non-randomized, prospective, non-interventional multi-center post-market release (pmr) study. up to 800 subjects will be enrolled at up to 40 centers in europe. after aortic valve replacement with the enable® aortic bioprosthesis, each patient will have routine follow-up visits at the following intervals: at 30 days post-implant (at 30 days post-implant or prior to hospital discharge, whatever comes first), within 6 months following implantation, 1 year and annually thereafter up to 5 years post-implant.

Eligibility criteria:
inclusion criteria: * patient with aortic valve stenosis, aortic valve insufficiency or a combination of the two. * patient requires replacement of his/her native aortic valve with a bioprosthesis with or without concomitant procedures. * patient is above the minimum age as required by local regulations to be participating in a clinical study. * patient is willing to return to the implant site for follow-up visits. * patient has been adequately informed of this clinical study and is willing to sign the patient data release form. exclusion criteria: * patient requires replacement of two or more valves. * patient who underwent previous aortic valve replacement (avr). * patient with native bicuspid aortic valve. * patient with active endocarditis or other systemic infection. * patient dilatation of the ascending aorta, deformations or irregular aortic annulus or ascending aorta geometry as seen via preoperative imaging.

Keywords: medtronic enable® aortic bioprosthesis aortic valve stenosis aortic valve insufficiency "real world" patients
genotype-phenotype relationship between cryptogenic cholestasis and familial intrahepatic cholestasis

Conditions: Cholestatic Liver Disease; Intrahepatic Cholestasis; Progressive Familial Intrahepatic Cholestasis; Hepatobiliary Cancer

Summary: genotype-phenotype relationship between adult cryptogenic cholestasis and mutations in genes responsible for progressive familial intrahepatic cholestasis

due to the high number of unsolved cases of adults with cholestatic liver disease, it is crucial to determine the prevalence of pfic gene mutations and gather information on various clinical presentations that often coexist. this will help identify risk factors related to the disease and its progression, ultimately allowing for personalized treatment options for affected patients. this multicenter, retrospective observational study will collect data on patients with cholestatic liver diseases (cclds) from may 2013 until the study begins. diagnoses of pfic/ccld/hbc will be confirmed through imaging studies, excluding other liver disease causes.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of pfic/cclds/hbcs * obtaining informed consent exclusion criteria: * another documented cause of chronic liver disease capable of justifying the clinical phenotype
artificial root-end barriers

Conditions: Dental Cements; Tooth Abnormalities

Summary: this study retrospectively looks to determine the clinical success of proroot mta used as an artificial apical barrier in teeth with immature apices.

the normal development and maturation of a root depends on a vital, healthy pulp. if the pulp becomes necrotic in a tooth with an immature apex, endodontic treatment can be performed using an artificial barrier technique. mineral trioxide aggregate (mta) has become the material of choice to accomplish this procedure, however, few studies have evaluated its clinical success. the purpose of this retrospective study was to determine the clinical success of proroot mta used as an artificial apical barrier. twenty patients were included in this study. after approximately one week of ca(oh)2 treatment, each patient had mta placed as an apical barrier in a tooth with a single canal and open apex followed by placement of a final restoration. patients were recalled and evaluated for clinical signs and symptoms and osseous healing. immediate post-treatment and recall radiographs were evaluated by two endodontists calibrated for use of the periapical index (pai).

Eligibility criteria:
inclusion criteria: * a tooth with a single canal and presence of an open apex by radiograph * ca(oh)2 treatment for at least one week prior to obturation * use of mta to produce an artificial apical barrier * placement of a final restoration * radiographs codumenting pretreatment and immedicate post-treatment conditionof the tooth * patients ages 5-40 years old exclusion criteria: * patients younger than 5 and greater than 40 years old * patients unable to be contacted for recall during the study * patients with a medical condition whose health would be jeopardized by participation in the study

Keywords: mineral trioxide aggregate
a study to evaluate efficacy and safety of epoetin beta (neorecormon®) in anemic participants with breast cancer undergoing chemotherapy

Conditions: Anemia

Summary: this study will evaluate the efficacy and safety of subcutaneous (sc) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.


Eligibility criteria:
inclusion criteria: * adult female participants with histological diagnosis of breast cancer * any type of chemotherapy planned for greater than or equal to (\>/=) 9 weeks * hemoglobin level less than (\<) 11 grams per deciliter (g/dl) * participants able to receive iron supplement, if necessary exclusion criteria: * known or suspected contraindications to epoetin beta * pregnancy or lactation period * diagnosis of anemia only due to iron-deficiency * diagnosis of thalasemic syndromes * epilepsy and/or cerebral metastasis * blood transfusion or treatment with any erythropoietic factor within 4 weeks before study start
real-life observational study of cancer pain management with methadone

Conditions: Cancer Pain

Summary: study rational. methadone is a distinctive opioid because of its pharmacological characteristics and its multiple modes of action, reinforcing its therapeutic value in managing advanced cancer pain, particularly in cases with a neuropathic component. however, the complex pharmacodynamics of methadone makes its prescription sometimes challenging. there is a wide inter-individual variability of its half-life. this long half-life is a valued characteristic for the management of patients treated for an addictive disorder. however, in the context of pain management, it greatly complicates the switch from and to another opioid, accentuating the risk of overdose. this is the reason why lbr, willing to improve his knowledge about methadone in real life clinical practice wants to performe this study. we anticipate that most patients will receive one of the above-described protocols, but we must anticipate that other protocols may be used in clinical practice in the absence of specific recommendations. therefore it is of utmost relevance to describe the safety when initiating treatment with zoryon® during the crucial period from d1 until the day of optimal dosage is determined (dod) as the clinical practice may vary from a practician to another, and then until the routine follow-up visit one month after initiation of the treatment (d28).

to describe the occurrence of overdose and qtc prolongation in patients initiating a treatment with zoryon® for intractable cancer pain not adequately relieved from other level 3 opioids, from the day of instauration (d1) to the day of determination of the optimal dose for the patient (dod: day of optimal dosage (dod): the dosage of zoryon® will be considered optimal after two consecutive days without modification to the posology (usually within the first week) and pain relief for the patient.

Eligibility criteria:
inclusion criteria: * patients with intractable cancer pain inadequately relieved by other opioids (ineffective and/or excessive adverse events) and for whom switching from opioid to zoryon® has been prescribed. * be aged 15 years or older; * suffer from cancer pain; * be treated with a level 3 opioid with inadequate pain relief, i.e., ineffective, excessive adverse effects, or both; * have a prescription to initiate zoryon® treatment. exclusion criteria: * patients participating, or having participated within the previous month, in a clinical trial evaluating a new pain management treatment will be excluded, except for patients participating in the french experimentation of the use of therapeutical cannabis
myleukomap™ genomic survival prediction assay pivotal clinical study

Conditions: Heart Failure

Summary: the myleukomap™ pivotal clinical study will assess the accuracy of myleukomap™, a new molecular blood test, performed within 30 days before scheduled surgical / interventional therapies for heart failure, to determine its effectiveness in improving clinical decision support by providing a quantitative prediction of low, indeterminate, or high risk of death one year after surgical / interventional therapies that is not identified by current diagnostic tools.

the myleukomap™ pivotal clinical study will assess the accuracy of myleukomap™, a new molecular blood test, performed within 30 days before scheduled surgical / interventional therapies for heart failure, to determine its effectiveness in improving clinical decision support by providing a quantitative prediction of low, indeterminate, or high risk of death one year after surgical / interventional therapies that is not identified by current diagnostic tools. patients scheduled for one of 10 different heart failure surgical / interventional therapies will be identified and consented. four clinical parameters will be collected for each patient: age, white blood cell count, blood pressure, and respiratory rate. blood samples will be collected concurrent with a routine preoperative blood draw, and peripheral blood mononuclear cells (pbmc's) will be isolated. the pbmc samples will be shipped to researchdx, irvine, ca, for testing using the myleukomap™ genomic survival prediction assay. patient 1-year postoperative survival/non-survival data will be reported for each patient. the samples will be tested 1-year after the intervention of the last enrolled patient, and the data will be compared to actual patient 1-year survival to determine the survival prediction accuracy of the assay. the investigators anticipate that the assay will better identify those 20% of patients who currently do not achieve 1-year postoperative survival, and who would have better odds of survival by remaining on medical therapy, but who cannot be identified with current tools.

Eligibility criteria:
inclusion criteria: criteria #1: adhf with nyha iii/iv criteria #2: left ventricular ejection fraction (lvef) \ 2+valvular disease severity \& \>low risk society of thoracic surgeons (sts)-score criteria #3: evaluation for interventions including cabg/pci (stratum #1, ischemia), surgical valve replacement/tavr/mitra-clip (stratum #2, overload), vt-ablation/stellate gangliectomy (stratum #3, arrhythmia), or mcs/htx (stratum #4, contractility) - exclusion criteria: criteria #1: no informed consent criteria #2: \<18 years old -
nitrite infusion in islet cell transplantation

Conditions: Diabetes

Summary: this study seeks to investigate the effects of administering nitrite to pancreatic islet cells that have been removed from a patient for autotransplantation.

patients diagnosed with chronic pancreatitis or recurrent acute pancreatitis may acquire insulin-dependent diabetes due to islet cell destruction. therefore, islet cell autotransplantation is the optimal therapeutic approach for many of these patients. islet cell autotransplantation is typically done by excision of the pancreas, followed by isolation of the islet cells and then infusion of these cells into the sinusoids of the liver. isolation of the islet cells occurs in an ischemic and hypoxic environment, resulting in ischemia reperfusion (ir) injury and destruction of islet cells following infusion into the sinusoids. hence, strategies to prevent ir injury and subsequent islet cell destruction, such as the administration of inhaled nitric oxide (no) or sodium nitrite (nano2) could enhance islet cell survival following reperfusion, also decreasing long-term insulin requirement. the purpose of this study is to determine if no administered by infusion in patients undergoing islet cell auto transplantation, will inhibit islet cell destruction, increase diabetes cure rate (decrease the amount of and/or the need for long-term insulin requirement), decrease the ischemic injury (reduces the injury to the islet cells from a decrease in oxygen levels during procurement of the islet cells) during islet cell procurement, and decrease ir injury following islet cell infusion. the primary endpoints of the study are exogenous insulin use, hgba1c levels post-operatively, and blood glucose levels.

Eligibility criteria:
inclusion criteria: * patients greater than or equal to 18 years of age * scheduled to undergo islet cell auto-transplantation by dr. jared white or dr. bart rose * subjects who can provide informed written consent and are willing to do so exclusion criteria: -any patient with liver disease or unsuitable for surgery (as determined by the surgeon)

Keywords: diabetes insulin resistance nitrite pancreatic islet cells autotransplantation ischemia reperfusion injury mitigation cure nitric oxide sodium nitrite islet cell survival pancreas liver