Kornimate/medical-research-clean huggingface dataset:
cross-sectional study to assess prevalence and burden of ckd-associated pruritus in haemodialysis patients

Conditions: Chronic Kidney Disease-associated Pruritus

Summary: vifor international inc. is seeking real-world evidence (rwe) to better understand the epidemiology, patient characteristics, and management of ckd-ap in the real-world clinical setting.

this is a non-interventional, cross-sectional, multicentre, and multinational (european) study. the non-interventional study (nis) design allows the observation of patients in large haemodialysis (hd) centres reflecting routine clinical practice. all decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the full discretion of the treating physician without interference by the sponsor or study protocol. all treatment decisions will follow the real-life treatment behaviour. the census-eu represents a cross-sectional study design of a representative selection of patients undergoing hd at 113 large dialysis centres across 7 countries in europe. prot. v.2.0, 9 may 2023

Eligibility criteria:
inclusion criteria: * male or female adult patients with ckd (≥18 years) receiving hd for at least 3 months prior to signing informed consent * signed informed consent * able and willing to fill in questionnaires exclusion criteria: * patients performing hd at home or both home and centre

Keywords: ckd ckd-ap ckd associated pruritus
investigation of the safety, dosing frequency and anti-scarring potential of two concentrations of intradermal avotermin (juvista)

Conditions: Cicatrix; Wound Healing; Re-epithelialization

Summary: the purpose of this study is to investigate the dosing frequency, wound healing (re-epithelialisation) and anti-scarring effects of one, three and five applications of two concentrations of intradermal rn1001 in healthy male subjects.

subjects were randomised into two cohorts, to receive either 5 ng avotermin doses or 50 ng doses, with a minimum of 21 subjects per cohort. within each cohort subjects were randomised into one of three dosing groups (7 subjects per group). subjects were to receive four 3 mm punch biopsies, two on the upper-inner aspect of each arm. one treatment was randomly allocated to one biopsy on one arm, with the opposite biopsy on the other arm set to receive the same treatment. the other treatment was administered to the other two biopsies (one on each arm. this allowed for control of possible positional effects on healing. three subjects per group received intradermal avotermin to one of the biopsies on each arm and intradermal placebo to the other biopsies. a different three subjects received intradermal avotermin to one of the biopsies on each arm and standard care only to the other biopsies. the final subject per group received intradermal placebo to one of the biopsies on each arm and standard care only to the other biopsy. on day 0 biopsy sites were marked on both arms and following local anaesthesia avotermin, placebo or nothing was injected intradermally into the allocated sites. subjects in dosing frequency group 1 (dfg 1) were dosed only once (day 0), subjects in dfg 2 were dosed three times (day 0, 1 and 2) and subjects in dfg 3 were dosed five times (day 0, 1, 2, 3 and 4). on day 5, all subjects had their punch biopsy wounds on one arm only re-dosed as per day 0 and then excised with a 5 mm surgical ellipse. subjects in dfg2 and dfg3 received further re-dosing on their excised punch biopsies as before, i.e. three doses for dfg2 and five doses for dfg3. subjects returned for a first follow-up at day 14 and then at months 2, 4 and 6 to examine for anti-scarring effects. at month 6 all scars were excised for histological examination.

Eligibility criteria:
inclusion criteria: * healthy, non-caribbean, male subjects aged 18-45 years inclusive * weight between 60-150 kg and a bmi within the permitted range for their height using quetelet's index (15-45 kg/m(squared)) (weight (kg)/height (squared)(m)) * subjects who have a previous history of surgery or minor injury and who have not developed any evidence of hypertrophic or keloid scar formation exclusion criteria: * subjects who have a history or evidence of hypertrophic or keloid scarring * subjects with tattoos or previous scars in the area to be biopsied * subjects who have evidence of any past or present clinically significant disease, particularly coagulation disorders

Keywords: cicatrix scar avotermin juvista rn1001 tgf beta 3
clinical trial of hg146 administered to participants with adenoid cystic carcinoma

Conditions: Adenoid Cystic Carcinoma; Head and Neck Cancer

Summary: this is a phase ii, open-label, non-randomized, multicenter study to evaluate the clinical efficacy and safety of hg146 in participants with recurrent or metastatic adenoid cystic carcinoma. this study is divided into two stages. 40 participants will be enrolled in the first stage. the efficacy and safty data will apply to make go or no go decision. then the second stage will continue to enroll 100 particapants.


Eligibility criteria:
inclusion criteria: * signed informed consent form (icf) and able to comply with study. * age ≥18 years, gender unlimited. * recurrent or metastatic adenoid cystic carcinoma with evidence of disease progression (imaging progression or clinical evidence of progression) within one year of histological or cytological diagnosis. * estimated survival \>12 weeks, as determined by the investigator. * the united states eastern cancer consortium (ecog) physical status score 0-1. * has adequate organ function. * at least 1 measurable tumor lesion according to recistv1.1 criteria. exclusion criteria: * symptomatic central nervous system (cns) metastases that have required steroids within 4 weeks prior to first dose of study treatment. * received prior therapies targeting hdac. * chemotherapy was received within 21 days before the first administration of the study treatment, and anti-tumor therapy such as radiotherapy, biotherapy, targeted therapy, and immunotherapy was received within 28 days before the first administration of the study treatment \[small molecule targeted drugs, chinese medicines with anti-tumor indications, and local palliative radiotherapy were 14 times before the first administration of the study drug. * used strong cyp3a4 inhibitors or inducers within 7 days before the first use of the investigational drug. * major surgery or major injury \<=28 days before the first dose of study treatment,or anticipated major surgery during the study. * prior allogeneic bone marrow transplantation or other solid organ transplantation * active infection requiring systemic treatment. * current or past presence of other malignancies (other than adequately treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the cervix), unless radical treatment has been performed and there is no evidence of recurrence and metastasis in the last 5 years. * a person is known to be allergic to any active ingredient or excipient of the investigational drug. * pregnant or lactating women. * patients with drug abuse or chronic alcohol abuse that may affect the evaluation of the test results.

Keywords: hg146 hg146cn201
effect of blood pressure measurement in different positions on blood pressure values and anxiety levels in pregnant women with preeclampsia

Conditions: Preeclampsia; Blood Pressure Check (Hypertension Screening)

Summary: aim: this study examined the effects of blood pressure measurement in different positions on diastolic and systolic blood pressure values and anxiety levels in pregnant women diagnosed with preeclampsia. method: the study was conducted between march and june 2024 as a pre-test post-test quasi-experimental study with 96 pregnant women diagnosed with preeclampsia in the perinatology department of a training and research hospital. participants were divided into three groups and their blood pressures were measured in the left lateral, right lateral and semi-fowler positions. data were collected using an introductory information form and the state anxiety scale.

aim: this study examined the effects of blood pressure measurement in different positions on diastolic and systolic blood pressure values and anxiety levels in pregnant women diagnosed with preeclampsia. method: the study was conducted between march and june 2024 as a pre-test post-test quasi-experimental study with 96 pregnant women diagnosed with preeclampsia in the perinatology department of a training and research hospital. participants were divided into three groups and their blood pressures were measured in the left lateral, right lateral and semi-fowler positions. data were collected using an introductory information form and the state anxiety scale.

Eligibility criteria:
inclusion criteria: * being primigravida (first pregnancy), * being in the third trimester of pregnancy, * being between the ages of 18-45, * being diagnosed with preeclampsia, * having an arm circumference of less than 36 cm, * having a history of hospitalization of at least 24 hours (in order to minimize anxiety, uncertainty, lack of information and disorientation related to hospitalization). exclusion criteria: * • presence of a physical disability that would make it difficult to perform the positions included in the study (e.g. loss of extremity), * presence of decompensated disease (e.g. eclampsia, pulmonary edema), * presence of a history of cardiological disease, * diagnosis of obstructive sleep apnea, * presence of additional risk factors other than preeclampsia (e.g. threat of premature birth, placental anomalies).

Keywords: preeclampsia blood pressure hypertension anxiety position
prognostic impact of myocardial longitudinal strain in asymptomatic aortic stenosis: a meta-analysis

Conditions: Aortic Valve Stenosis; Asymptomatic Conditions; Left Ventricular Function

Summary: in patients with asymptomatic aortic stenosis (as), the prognostic value of reduced left ventricular (lv) ejection fraction is well known. consequently, there is class i indication for surgery in these patients when lv ejection fraction \ 50%, a reduced lv global longitudinal strain, as assessed using speckle tracking imaging with transthoracic echocardiography, may be an accurate marker to identify early subclinical lv dysfunction and thus, to improve the risk stratification, the management and the timing of surgery. several mono-centric observational small studies recently reported results emphasizing the role of lv global longitudinal strain in as patients. therefore, a meta-analysis may be conducted and may provide meaningful data. the investigators hypothesized that lv global longitudinal strain is a determinant of outcome in asymptomatic patients with as and preserved lv ejection fraction.


Eligibility criteria:
inclusion criteria: * studies selected in pubmed, embase, ovid, and google scholar, published between 2005 and 2015 without language restriction according to the following criteria: "aortic stenosis" and "longitudinal strain" exclusion criteria: * studies reporting global longitudinal strain derived from vvi and not speckle tracking analysis. * studies with cohort of patients with aortic valve replacement indication
abemaciclib (ly2835219) plus fulvestrant compared to placebo plus fulvestrant in previously treated breast cancer

Conditions: Breast Neoplasm; Neoplasm Metastasis

Summary: this study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (hr+), human epidermal growth factor receptor 2-negative (her2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a cdk4/6 inhibitor and endocrine therapy. participation could last up to 5 years, depending on how you and your tumor respond.


Eligibility criteria:
inclusion criteria: * have a diagnosis of hr+, her2- locally advanced or metastatic breast cancer * have radiologic evidence of disease progression or recurrence either * on treatment with a cdk4/6 inhibitor with aromatase inhibitor (ai) as initial therapy for advanced disease, or * on/after treatment with a cdk4/6 inhibitor plus endocrine therapy (et) administered as adjuvant therapy for early stage breast cancer * must be deemed appropriate for treatment with et * if female, have a postmenopausal status by natural or surgical means or by ovarian function suppression * have response evaluable criteria in solid tumors (recist) evaluable disease (measurable disease and/or nonmeasurable disease) * have a performance status of 0 or 1 on the eastern cooperative oncology group scale (oken et al. 1982) * have adequate renal, hematologic, and hepatic organ function * must be able to swallow capsules/tablets exclusion criteria: * have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis * have symptomatic or untreated central nervous system metastasis * have received any systemic therapy between disease recurrence/progression and study screening * have received more than 1 line of therapy for advanced or metastatic disease. * have received prior chemotherapy for metastatic breast cancer (mbc) * have received prior treatment with fulvestrant, any investigational estrogen receptor (er)-directed therapy (including selective er degraders \[serds\] and non-serds), any phosphatidylinositol 3-kinase (pi3k)-, mammalian target of rapamycin (mtor)-, or protein kinase b (akt)-inhibitor
corneal asphericity adjustment (q adjustment) in myopic and hyperopic patients undergoing refractive correction with excimer laser

Conditions: Myopia; Hyperopia

Summary: to study the postoperative results in myopic and hyperopic eyes treated with two different laser ablation algorithms (std and f-cat), both fda approved.


Eligibility criteria:
inclusion criteria: * myopic and hyperopic eyes eligible for lasik or prk refractive correction * central corneal thickness more than 500 micrometers exclusion criteria: * topographies of less than 55% of successful total sampled area and eyes exhibiting asphericity variations, in either the horizontal or the vertical axis, greater than 0.2 * corneal scarring * cataract surgery * corneal ulceration * topographical abnormalities

Keywords: laser ablation algorithms excimer laser refractive correction corneal asphericity adjustment
high-flow nasal cannula oxygen therapy for ischemic stroke patients with dysphagia and obstructive sleep apnea

Conditions: Cerebral Infarction; Sleep Apnea, Obstructive; Deglutition Disorders

Summary: high flow nasal cannula (hfnc) ventilation therapy was found to improve the severity of obstructive sleep apnea in non-stroke subjects. the investigators hypothesized that hfnc might be effective in stroke patients with dysphagia who needed nasogastric tube feeding and can not receive continuous positive airway pressure ventilation for obstructive sleep apnea.


Eligibility criteria:
inclusion criteria: * ischemic stroke patients with dysphagia and obstructive sleep apnea who need nasogastric tube feedings exclusion criteria: * congestive heart failure, unconsciousness, chronic obstructive pulmonary disease, intracranial hemorrhage or malignancy, and unstable medical and neurological conditions * central sleep apnea
retrospective assessment of the morphology of acetabular defects: a 3d reconstruction approach

Conditions: Hip Arthrosis; Hip Injuries

Summary: in this study, we aim to develop a statistical shape model and use it to reconstruct the shape of acetabula with severe defects (paprosky 3a-3b). this will allow us to visualise and assess the morphology of the missing bone. in future studies we will use the obtained results to improve the design of acetabular implants for revision surgery.


Eligibility criteria:
trainings dataset for statistical shape model: * patients where a bilateral ct of the hip was performed with unilateral pathologies. * we aim to include an equal amount of scans from each gender and varying ages. dataset of defect acetabula used for reconstruction: * patients who received a ct scan of the hip after removal of a primary/revision implant (e.g. patients where debridement was performed due to infection.) * patients where the defect can be classified as a paprosky 3a or 3b defect.

Keywords: hip revision surgery
can dipyridamole induce protection against ischemia and reperfusion injury in patients undergoing elective coronary artery bypass grafting (cabg)?

Conditions: Cardiovascular Disease; Ischemic Heart Disease

Summary: rationale: due to western lifestyle human coronary arteries are prone to develop atherosclerotic plaques. hence the heart is an important target organ for atherothrombotic complications: myocardial ischemia, arrhythmias, myocardial infarction and heart failure. to alleviate symptoms and decrease mortality in these patients, myocardial revascularisation is recommended. coronary artery bypass grafting (cabg) is indicated in patients with severe atherosclerotic disease of all three coronary arteries or the left main stem coronary artery. cardiac ischemia and reperfusion injury during cabg is inevitable and jointly accountable for complications that occur after cabg (e.g. death, myocardial infarction, arrhythmias, stroke, or renal complications). dipyridamole has been shown to reduce ischemia reperfusion injury in healthy volunteers using an intermediate endpoint and may prevent cardiovascular death or event in secondary prevention after cerebrovascular disease. the investigators hypothesise that oral pre-treatment with dipyridamole can increase cardiac tissue tolerance against ischemia and reperfusion injury due to cabg. the investigators expect lower troponin-i release in patients who were pretreated with dipyridamole. objective: to study the effect of oral pretreatment with dipyridamole on high sensitivity (hs)-troponin-i release after cabg. secondary objectives are whether oral pretreatment with dipyridamole reduces postoperative cabg arrhythmias, prolonged inotropic support, and duration of intensive care-stay. further secondary endpoints are the effects of dipyridamole pretreatment on renal injury and post-ischemic recovery of contractile function (measured ex-vivo). hypothesis: the investigators hypothesize that oral pre-treatment with dipyridamole can increase cardiac tissue tolerance against ischemia and reperfusion injury. the investigators expect lower hs-troponin-i release in patients who were pretreated with dipyridamole. additionally the investigators expect the incidence of arrhythmias, need for prolonged inotropic support (longer than 24 hours postoperative) to be decreased in pretreated patients.


Eligibility criteria:
inclusion criteria: * acceptation for cabg in runmc * informed consent exclusion criteria: * recent myocardial infarction (stemi or non-stemi), during two weeks prior to inclusion * asthma * use of insulin * use of sulfonylurea derivates (e.g. glibenclamide, tolbutamide, gliclazide, glimepiride) * use of metformin * use of oral corticosteroids * use of dipyridamole * use of clopidogrel within 8 days prior to scheduled cabg surgery * chronic use of non steroid anti-inflammatory drugs (nsaids) * off-pump surgery

Keywords: ischemia reperfusion injury cabg dipyridamole hs-troponin-i
hedia exercise algorithm - hexa study.

Conditions: Diabetes

Summary: a randomised controlled crossover pilot study to evaluate safety and efficacy of a digital insulin bolus calculator with a physical activity module

hedia diabetes assistant is a software device intended to monitor blood glucose and to support in the decision making of the optimal bolus insulin dose for management of insulin-dependent diabetes by providing the user with an indicative bolus insulin dose. this study has been designed to investigate the safety and efficacy of a digital insulin bolus calculator with a physical activity module that provides guidance on insulin reduction to patients with type 1 diabetes mellitus prior to and after exercise, based on exercise duration and intensity compared with the patients' habitual diabetes management.

Eligibility criteria:
inclusion criteria: * signed informed consent. * ability to understand, speak and read danish fluently. * diagnosis of type 1 diabetes mellitus for ≥12 months. * age between ≥18 and \<60 years. * minimum one measurement of hba1c between 6.0 to 8.6 % (42 to 70 mmol/mol) within the last four months. if several measurements, then it is the latest one that counts. * body mass index (bmi) between ≥18.5 and \<30 kg/m2. * ability to use an apple® (ios version 13 and up) or android® (android version 8.0 and up) smartphone. * treated with the same pen-based insulin regimen with basal insulin (insulin glargine, degludec, or detemir) and meal time insulin (insulin aspart, lispro, glulisine) for at least the three preceding months. * patients who can perform 45 min. of exercise at moderate intensity on an ergometer bike (investigator assessment). * if female participants of childbearing potential; willing to have a pregnancy test performed and to use a highly effective method of contraception. exclusion criteria: * already using hedia diabetes assistant. * use of human insulin or premixed insulin. * blood pressure \> 180/105 mmhg. * treatment with sodium-glucose transporter 2-inhibitors, glucagon-like peptide 1 receptor agonists, or glucocorticoids. * job situation entailing night shifts. * fever. * a mental state impeding compliance with the protocol. * expected non-compliance with the protocol at the discretion of the principal investigator. * pregnancy. * breast-feeding. * dialysis therapy or egfr \< 60 ml/min. * patients diagnosed with claudicatio intermittens, heart failure, ischaemic heart disease or stroke. * patients prescribed with beta blockers. * abuse of alcohol or drugs in the past two years. * on-going participation, or participation within the last 3 months, in an organised clinical study in which participants received study medication (investigator assessment). * surgery scheduled for the study duration period. * an episode of diabetic ketoacidosis or severe hypoglycaemia requiring third-party assistance within the preceding 6 months. * known gastroparesis.
surgery or chemoradiation for esophageal cancer

Conditions: Esophageal Cancers

Summary: the aim of this study is to compare outcomes in patients with operable squamous carcinoma of the esophagus who have received either surgery or definitive chemoradiation (crt).


Eligibility criteria:
inclusion criteria: * eligible patients had mid or lower thoracic esophageal cancers that were confirmed on histology to be a squamous cell carcinoma deemed to be resectable. exclusion criteria: * the investigators excluded those patients who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve. * those patients who were older than 75 years or who had a serious premorbid condition or a poor physical status that compromised a thoracotomy were also excluded.

Keywords: squamous cell carcinoma esophagectomy chemoradiotherapy chemoradiation squamous cell carcinomas of the esophagus
evaluation of effectiveness and safety of aortic valve replacement in routine clinical practice

Conditions: Aortic Valve Disease; Aortic Valve Stenosis

Summary: this study evaluated effectiveness and safety of aortic valve replacement in real-world clinical practice.


Eligibility criteria:
inclusion criteria: * age 19 and more * patient with aortic valve replacement exclusion criteria: * combined with mitral stenosis requiring surgery or aorta stenosis * acute bacterial endocarditis within 1 month of valve replacement

Keywords: tavr savr tavi conventional avr sutureless avr