Kornimate/medical-research-clean huggingface dataset:
a single-center, prospective cohort study on the differentiation of benign and malignant bile duct stenosis based on bile and peripheral blood cfdna methylation profiles

Conditions: Bile Duct Neoplasms; Jaundice, Obstructive; Bile Duct Diseases

Summary: the goal of this observational study is to detect the methylation characteristics of cfdna in the bile and plasma of patients with bile duct stricture. the main question it aims to answer is: can the developed model, using peripheral blood and bile cell-free dna sequencing, work well in screening and classifying unknown biliary stricture? participants will collect approximately 10ml of peripheral blood and 5ml of bile from the patient.


Eligibility criteria:
inclusion criteria: * 1. patients with biliary stricture aged between 18 and 90 years old. * 2. patients scheduled to undergo ercp surgery due to obstructive jaundice or cholangitis. * 3. definite benign or malignant diagnosis: with a pathological diagnosis of benign or malignant disease, or with follow-up data indicating a benign or malignant diagnosis. exclusion criteria: * 1. receive radiotherapy, chemotherapy, or targeted therapy before sampling. * 2. malignant tumors in other parts of the body (not related to biliary stricture). * 3. unable to determine the nature of the biliary stricture. * 4. ineligible for ercp due to systemic conditions or gastrointestinal obstruction. * 5. pregnant or breastfeeding women. * 6. unable to sign the informed consent form.

Keywords: methylation liquid biopsy cell-free nucleic acids cancer diagnosis
study to evaluate immunogenicity, safety, and tolerability of zostavax™ vaccine (zoster vaccine live, v211) administered concomitantly versus nonconcomitantly with quadrivalent influenza virus vaccine (inactivated) in participants ≥50 years of age (v211-062)

Conditions: Herpes Zoster

Summary: the study evaluated immunogenicity, safety, and tolerability of zostavax™ vaccine (v211) administered concomitantly versus nonconcomitantly with quadrivalent influenza virus vaccine (inactivated) in participants ≥50 years of age. the primary hypotheses tested 1) the noninferiority of concomitant versus nonconcomitant vaccination with regard to varicella zoster virus (vzv) geometric mean titer (gmt) antibody responses, 2) the acceptability of geometric mean fold rise in vzv antibody response after concomitant vaccination, and 3) the noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza virus strain-specific gmt antibody responses.


Eligibility criteria:
inclusion criteria: * has history of varicella or residence in a vzv-endemic area for ≥30 years * is male, female not of reproductive potential, or female of reproductive potential and has a negative pregnancy test and agrees to avoid becoming pregnant throughout the study exclusion criteria: * has history of hypersensitivity to any vaccine component * has previously received any varicella or zoster vaccine * has received an influenza vaccine for the 2015-16 season * has history of herpes zoster * has received immunoglobulin, monoclonal antibodies, or any blood products within 5 months before study vaccination * is pregnant or breastfeeding, or expecting to conceive during the study * has used immunosuppressant therapy * has known or suspected immune dysfunction * has experienced guillain-barré syndrome within 6 weeks * has severe thrombocytopenia or any other coagulation disorder
to assess the level of adherence of subjects receiving saizen® via easypod™ in australia

Conditions: Growth Disorders

Summary: this is an australian, multicentre, observational registry to study adherence and long term outcomes of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving saizen® via easypod™.

subjects will be enrolled in a multicenter longitudinal observational registry. parents/subjects will provide their informed consent/assent to upload their data for populationbased analyses and optionally to adhere to a patient adherence support program designed to improve their adherence and, ultimately, clinical outcomes. adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. data will be collected retrospectively and prospectively. this will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: • to assess the level of adherence of subjects receiving saizen® via easypod™ secondary objectives: * to describe the impact of adherence on clinical outcomes for subject receiving saizen® via easypod™ * to identify adherence subject profiling based on age, gender, self injection or not, time on treatment, medical history at time of enrollment * to assess the impact of adherence on insulin-like growth factor 1 (igf1) (above, below or within normal ranges)

Eligibility criteria:
inclusion criteria: * administered growth hormone via the easypod™ electromechanical device according to the saizen® product information * aged between 2 and 18 years * appropriate informed consent/assent provided exclusion criteria: * subjects with mature bone age taking growth hormone (i.e. for taking growth hormone for its metabolic effects) * contra-indications to saizen® as defined in saizen® product information * use of an investigational drug or participation in another interventional clinical trial

Keywords: growth disorders saizen easypod™ growth hormone pediatric subject
enrichment & purging of stem cells in non-hodgkin's lymphoma

Conditions: Lymphoma, Non-Hodgkin

Summary: to evaluate the role of purging the hematopoietic cell graft on outcomes for non-hodgkin's lymphoma.

to study the use of peripheral blood stem cells which have been treated in an effort to remove tumor cells. the researchers hope to learn whether or not this will be more effective in removing the tumor cells as compared to other methods of purging (the removal of cancer cells).

Eligibility criteria:
inclusion criteria:- relapsed nhl exclusion criteria:- liver dysfunction
combined behavioral and pharmacological intervention for cardiovascular risk reduction in diabetic patients

Conditions: Diabetes; Hypertension; Dyslipidemia; Coronary Arteriosclerosis

Summary: the purpose of this research is to study whether a multidisciplinary education in diabetes and intervention for cardiac risk reduction in a group setting to modify patient behavior and adjust medications can achieve diabetes guideline goals for glycemia, blood pressure and lipid control.


Eligibility criteria:
inclusion criteria: * all diabetic veterans with a hb-a1c between 7.0- 9.0 % within the last 6 months will be eligible for the study exclusion criteria: * patients without an hb-a1c checked within the last 6 months. * patients who are unable to attend the group sessions, either because of lack of transportation, psychiatric instability (suicidal, psychotic), or organic brain injury that preclude them from diabetes self-care.
feasibility and acceptability of incorporating smartwatches into an exercise is medicine program in older individuals

Conditions: Physical Inactivity; Obesity

Summary: the effects of exercise on prevention and improved control of chronic diseases, reduced mortality, and improved quality of life are well established. exercise has been shown to prevent heart disease, stroke, type 2 diabetes, depression, and certain types of cancers. in addition to prevention, physical activity is included in the standard or care for many chronic diseases and used in treatment. for example, the american diabetes association has identified positive health behaviors like physical activity as foundational in the treatment and management of disease and improving overall quality of life. the ohio state university wexner medical center exercise is medicine program (eim) is a physician referral program that aims to increase physical activity to prevent and reduce complications from chronic disease. the integration of technology among a 65+ population of eim participants provides a novel approach to improving individual's health. thus, our study aims to provide eim participants aged 65+ with smartwatches in the hopes of increasing their overall physical activity levels.


Eligibility criteria:
inclusion criteria: * age 65+ * no healthcare provider-imposed limitations on physical activity * english-speaking exclusion criteria: * symptoms suggestive of coronary artery disease (cad) or congestive heart failure (chf) (i.e. chest pain, dizziness, syncope, excessive dyspnea on exertion) * myocardial infarction within the last 12 months * revascularization within the last 12 months * stroke/transient ischemic attack (tia) within the past 12 months * unstable angina * congestive heart failure (new york heart association (nyha) class ii, iii or iv) * ventricular arrhythmia * clinically significant cardiac valve disease * blood pressure \>160/100 mmhg * uncontrolled seizure disorder * major surgery within the past three months * severe or frequent hypoglycemia * inability to independently manage blood glucose during activity * severe autonomic or peripheral neuropathy * active foot ulcers * unstable retinopathy.
the effect of lullaby and breastmilk smell on preterm newborns

Conditions: Preterm; Infant, Premature, Diseases; Postpartum Depression; Mother-Infant Interaction

Summary: the goal of this clinical trial is to investigate the effect of live lullaby from mother voice, and breast milk smell on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns who are between 35-37 weeks of gestation at the time of the study and the level of pospartum depression of mothers. the main hypothesis are: h0: the live lullaby from mother voice and breast milk smell have no effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns h1: the live lullaby from mother voice has effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns h2: the breast milk smell has effects on pyhsiological parameters, comfort and maternal attachment levels of preterm newborns h3: there is differences between the live lullaby from mother voice and the breast milk smell interventions in terms of preterm newborns' physiological parameters, comfort and maternal attachment levels. h4: the postpartum depression level of mothers in experimental groups (lullaby group and breast milk group) is lower than the control group. participants will be in three groups according to the interventions. the preterm newborns who are going to listen a live lullaby from their mothers' voice will be the first group (lullaby group). the preterms in the second group (breast milk group) are going to smell their mothers' breast milk. the preterms in the third group (control group) are going to recieve rutin nursing care interventions.


Eligibility criteria:
inclusion criteria: * parents' willingness to participate in the study * turkish literate parents * babies between 35-37 weeks of gestation * apgar score of 7 or higher at birth * stability of the baby (near discharge) * having mother's milk exclusion criteria: * parents' reluctance to participate in the study * babies younger than 35 weeks and older than 37 weeks * babies receiving phototherapy * finding a congenital anomaly in infants * apgar score below 7 at birth * being connected to a mechanical ventilator

Keywords: premature infant comfort maternal attachment postpartum depression
intracranial pressure and optic nerve sheath diameter with closed bundle

Conditions: Intra Cerebral Hemorrhage; Subarachnoid Hemorrhage, Aneurysmal; Trauma, Brain; Hypertension Intracranial; Stroke, Ischemic

Summary: the design of the present study will be a multicenter prospective observational protocol. approximately 100 patients will be recruited over the 24-month period with acute brain injury (trauma brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke), who in their acute phase of intensive care unit require placement of a catheter capable of monitoring intracranial pressure (intra parenchymal catheter or external ventricular shunt). in addition to all the intensive care provided by the most recent guidelines, patients will undergo measurement of optic nerve sheath diameter through ultrasonography. at least, three measurements will be performed within the first 3 hours after admission, within the first 24-48 hours, and at each invasive intracranial pressure value greater than 18 cmh2o. those patients with intracranial pressure values greater than 35 mmhg. at the first intracranial pressure measurement, patients with eyeball disease or trauma will be excluded. measurements will be performed following the closed bundle. analysis of the results will include correlation between the invasive pressure values and the mean value of optic nerve sheath diameter measurements in the two projections (sagittal and transverse). in addition, the correlation of the absolute value of invasive pressure detected with the ratio of the optic nerve sheath diameter measurement to the eyeball diameter measured always ultrasound will be sought.


Eligibility criteria:
inclusion criteria: acute brain injury patients with an invasive intra-cranial pressure monitoring - exclusion criteria: patients affected by disease or trauma of eye ball patients or relatives that don't want to participate to the study -

Keywords: optic nerve sheath diameter ultrasonography hypertension intracranial neuro monitoring
the efficacy of lingual aligners in adults.

Conditions: Malocclusion, Angle Class I

Summary: the goal of this clinical trial is to test the effectiveness of lingual aligners in adults. the main question to answer is: - are lingual aligners effective in achieving desired and predicted tooth movements?

the aim of this pilot study is to assess the effectiveness and the accuracy of lingual aligners by evaluating the discrepancy between the predicted and the achieved amounts of tooth movements. also: * patient discomfort and pain * appliance defects * patient compliance * chair and treatment time key inclusion criteria: * adults older than 18 years old * about to undergo orthodontic treatment key exclusion criteria: * patients with tooth extractions or tooth agenesis with space closure * patients with surface enamel defects * pregnant patients * syndromic patients or those with cleft lip and/or palate * patients with metabolic diseases

Eligibility criteria:
inclusion criteria: * adults older than 18 years old * about to undergo orthodontic treatment exclusion criteria: * patients with tooth extractions or tooth agenesis with space closure * patients with surface enamel defects * pregnant patients * syndromic patients or those with cleft lip and/or palate * patients with metabolic diseases
baclofen for the treatment of alcohol dependence

Conditions: Alcohol Dependence

Summary: there is first evidence from preclinical and clinical studies for the efficacy of the selective gaba-b receptor agonist baclofen in the treatment of alcohol dependence. the aim of this trial is to evaluate the efficacy and safety of individually titrated high-dose baclofen for relapse prevention in alcohol-dependent patients.


Eligibility criteria:
inclusion criteria: * diagnosis of alcohol dependence according to icd-10 (international classification of mental and behavioural disorders, 10th revision) and dsm-iv (diagnostic and statistical manual of mental disorders, 4th revision) criteria * an alcohol intake of at least two heavy drinking days per week on average (men ≥ 5 drinks per day; women ≥ 4 drinks per day) and an average overall consumption of 21 drinks per week or more for men and 14 drinks per week or more for women during the 4 weeks before detoxification (one standard drink is equal to 12 g absolute alcohol) * last alcohol consumption within 7-21 days before randomisation * sufficient german language capabilities exclusion criteria: * pregnancy and/or currently breastfeeding * clinical significant medical conditions or observed abnormalities * psychiatric illness undergoing treatment with psychoactive drugs * epilepsy or epileptiform convulsions * addiction to drugs other than nicotine
a 6-week safety and efficacy study of travatan compared to xalcom in subjects with open-angle glaucoma(oag) or ocular hypertension(oht)

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: to compare the safety and iop-lowering efficacy of travatan and xalcom in subjects with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
patients of any race and either sex with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or ocular hypertension.

Keywords: glaucoma poag oag oht
influence of vessel wall calcification on early stent strut healing

Conditions: Coronary Artery Disease

Summary: to assess the influence of superficial calcium on the early endothelialization (1 month) of the struts of the xience skypoint stent (comparing struts with underlying superficial calcium to struts without underlying calcification)

to assess the influence of superficial calcium on the early endothelialization (1 month) of the struts of the xience skypoint stent (comparing struts with underlying superficial calcium to struts without underlying calcificatition by optical coherence tomography.

Eligibility criteria:
inclusion criteria: patients who meet all the following conditions will be included: * patients aged ≥ 18 years old and; * patients with clinical indication for stent implantation and; * patients with oct evaluation that shows the presence of calcified tissue underlying the lumen surface, fulfilling the definition of superficial calcium (the distance from the abluminal point of the calcium to the luminal surface is less than 500 μm, in a perpendicular axis to the vessel luminal surface. when referred to the stent struts it will be assumed that such distance of less than 500 μm will be measured between the centre of the abluminal surface of the strut and the abluminal point of the calcium, in the same perpendicular axis).and; * patients with good quality baseline oct evaluation as judged by the investigators and; * patients who have been briefed on the study characteristics and have given their prior written informed consent. exclusion criteria: * patients who meet, at least, 1 of the following conditions will be excluded: * patients with current st-elevation myocardial infarction (stemi). * patients with non-native lesion: stent restenosis, segment previously treated with drug eluting balloon, arterial or saphenous vein grafts. * patients with contraindication for the 1-month follow-up angiography and oct: * glomerular filtration rate (gfr)\< 30 ml/min/1.72m2 * contrast allergy * baseline post-stent control oct failure, due to tortuosity or any other reason. * patient not candidate for a follow up angiography, due to frailty, non-cardiac disease or whatever other condition considered by the local team.

Keywords: calcification strut coverage optical coherence tomography (oct)
an intervention to reduce inappropriate prescriptions of antibiotics for respiratory infections in general practice

Conditions: Respiratory Tract Infections; Anti-Bacterial Agents

Summary: this study will explore the possible effect of a tailored educational intervention towards general practitioners, in order to improve antibiotic prescriptions for respiratory infections.


Eligibility criteria:
inclusion criteria: * general practitioner * specialist in general practice
a phase 1 study to evaluate safety, tolerability, and pharmacokinetics of vx-407 in healthy participants

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Summary: the purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of vx-407 in healthy participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * a total body weight of greater than (\>) 50 kg * nonsmoker or ex-smoker for at least 3 months before screening key exclusion criteria: * history of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * any condition possibly affecting drug absorption other protocol defined inclusion/exclusion criteria may apply.
comparison study of vasovist® magnetic resonance angiography (mra) and an mra with a conventional extracellular contrast agent with x-ray angiography in patients with peripheral artery disease

Conditions: Peripheral Vascular Diseases

Summary: the particular aim of this study is the comparison of the diagnostic results of mra images upon application of vasovist (gadofosveset), a contrast agent not yet available on the market, with the mra images upon application of a conventional extracellular contrast agent. a catheter angiography, which will be performed as a routine diagnostic procedure for vascular diseases, will serve as an evaluation standard.

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer schering pharma ag, germany. bayer schering pharma ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * patients with a certain circulation disorder (aortoiliac disease fontaine-stage iib / iv) and an indication for the evaluation of the peripheral run-off arteries from the infrarenal aorta to the calves * patients who are scheduled for x-ray angiography and magnetic resonance angiography (mra) of the arteries mentioned above * patients who have had a contrast-enhanced mra examination of the arteries mentioned above using a standard extracellular contrast agent performed within 1 - 7 days prior to the study mra examination exclusion criteria: * less than 18 years of age * women who are pregnant, breast feeding or who are of childbearing potential and have not had a negative urine pregnancy test the same day as the study mra examination * requiring immediate therapy for their vascular disease or in whom conduct of all three angiographic procedures is not possible * not being able to remain lying down for at least 45 - 60 min * patients with a history of serious allergic reactions to any allergen including drugs and contrast agents or with a history of sickle cell disease or other hemolytic anemia * having any contraindication to magnetic resonance imaging (mri) examination or specifically for mra (e.g. pacemaker, recent wound clips, and severe claustrophobia)

Keywords: peripheral artery disease