Kornimate/medical-research-clean huggingface dataset:
implementation of actinic keratosis guideline among general practitioners.

Conditions: Actinic Keratoses

Summary: this study investigates 5-fluorouracil cream prescription trends by general practitioners for the treatment of field changes of actinic keratosis over the years 2016-2021. the aim is to analyse whether the publication of the multidisciplinary guideline on suspect skin lesions for general practitioners in 2017 has made an impact in the prescribing behaviour of general practitioners.

actinic keratosis is the most common epithelial precancerous lesion among the caucasian race. with an increase in prevalence worldwide due to an aging population and rise of ultraviolet exposure actinic keratosis are among the most frequently encountered skin lesions in clinical practice. both dermatologists and general practitioners are increasingly confronted with actinic keratosis, entailing to higher healthcare costs and time burden. there are many therapeutic modalities for the treatment of actinic keratosis, depending on multiple factors such as distribution, characteristics, patient preference, side effects, availability and costs. treatment options can be divided into: lesion directed therapy en field directed therapy. both dermatologists and general practitioners can treat actinic keratosis and 5-fluorouracil cream can also be prescribed by general practitioners. the objective of this study was to investigate 5-fluorouracil cream prescription trends by general practitioner for the treatment of field changes of actinic keratosis over the years 2016-2021.

Eligibility criteria:
inclusion criteria: * age \>18 years * diagnosis actinic keratosis (clinical diagnosed or by biopsy) exclusion criteria: * cutaneous malignancy (suspicion) * immunosuppressive co-medication.

Keywords: actinic keratosis general physician 5-fluorouracil cream general practitioner
hf2 registry - hemodynamic frontiers in heart failure registry

Conditions: Heart Failure

Summary: the purpose of the hf2 (hemodynamic frontiers in heart failure) registry is to collect relevant patient-level demographic, clinical, laboratory, and hemodynamic data from patients implanted with pulmonary artery pressure sensor at participating centers to advance scientific knowledge about ambulatory hemodynamics monitoring and hf (heart failure) therapies. the data collected will be used for retrospective studies, quality improvement, identifying research cohorts, and member-initiated research.

longitudinal, multi-center, and non-interventional registry. patients will be identified as eligible for pulmonary artery pressure sensor implant by a heart failure cardiologist from the heart failure clinic. they will consent for device implant and procedure (right heart catheterization) per standard of care. patients may also consent to the registry participation, which is optional. they will be informed that the registry intends to gather data and that they may be approached in the future for additional research based on their data and clinical situation. additionally, patients who underwent pulmonary artery pressure sensor implantation from january 1, 2019, will be identified and consent will be obtained for registry participation, which is optional.

Eligibility criteria:
inclusion criteria: 1. all patients would have been or will be implanted per indications from fda approval/champion trial. these would be patients with nyha (new york heart association) class iii heart failure who had a prior hospitalization. 2. patients who meet the expanded fda indication (bnp elevation without hospitalization or nyha class ii). exclusion criteria: 1. patients less than 18 years of age. 2. pregnant women at the scheduled time of pa pressure sensor implant. 3. patients unable or unwilling to have continuity of care in the heart failure clinic.

Keywords: pulmonary artery (pa) pressure monitor
investigating the safety and clinical performance of seven ivascular devices for endovascular intervention in the popliteal and/or infrapopliteal arteries

Conditions: Peripheral Arterial Disease Below The Knee

Summary: the rationale of this study is to confirm and support the clinical safety and performance of the oceanus 14pro, oceanus 18 and oceanus 35 balloon catheters, the luminor 14m and luminor 18 drug coated balloons, the angiolite btk sirolimus eluting peripheral stent system and the sergeant peripheral support catheter in a real-word population of 143 patients who underwent an endovascular intervention the popliteal and/or infrapopliteal arteries within standard-of-care (soc) where at least 1 of the investigational products from ivascular were used.


Eligibility criteria:
inclusion criteria: 1. corresponding to the ce-mark indications/contra-indications and according to the ifu of the device. 2. patient is \>18 years old. 3. patient understands the nature of the procedure and provides written informed consent prior to enrolment in the study. 4. target lesion(s) is/are located in the popliteal or infrapopliteal arteries 5. patient is eligible for treatment with the oceanus 14pro balloon catheter and/or the oceanus 18 balloon catheter and/or the oceanus 35 balloon catheter and/or the luminor 14m dcb and/or the luminor 18 dcb and/or the angiolite btk sirolimus eluting peripheral stent system and/or the sergeant peripheral support catheter as described in the ifu for each device. exclusion criteria: 1. anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following ifu of the investigational devices. 2. known contraindication and/or allergy to (a component of) an investigational device. 3. pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding. 4. life expectancy of less than 12 months. 5. any planned surgical intervention/procedure within 30 days after the study procedure. 6. any patient considered to be hemodynamically unstable at onset of procedure.
comparison of different intermittent pneumatic compression devices for deep vein thrombosis

Conditions: Venous Thrombosis; Deep Vein Thrombosis

Summary: various kinds of intermittent pneumatic compression devices (ipc) with particular ways of compression have been developed and used for prevention of deep vein thrombosis. there are still some controversies about the physiologic properties and clinical impact of numerous issues including the variety of the cuff length, inflation rate, compression sequence, compression-relaxation cycle rate, and pressure generation characteristics. this study is designed to compare clinical efficacies as well as venous hemodynamic improvements between simultaneous bilateral compression with fixed venous refill time versus alternate compression with adjusted refill time


Eligibility criteria:
inclusion criteria: * the patients who undergo total knee replacement arthroplasty exclusion criteria: * (1) chronic superficial or deep venous insufficiency, (2) venous anomalies like duplication of the superficial femoral vein, (3) previous venous thromboembolism history, (4) being under anticoagulation therapy, (5) severe arteriosclerosis obliterans without palpable dorsalis pedis pulse, (6) open fracture, hemorrhagic condition, or extensive dermatitis at lower legs, (7) congestive heart failure. additional exclusion criteria included a documented malignant tumor, because pharmacologic prophylaxis with anticoagulants would be more reasonable in this case.

Keywords: deep vein thrombosis intermittent pneumatic compression venous hemodynamics
pediatric trial investigating the incidence & outcome of veno-occlusive disease with the prophylactic use of defibrotide

Conditions: Hepatic Veno-Occlusive Disease

Summary: the aim of this trial is to evaluate whether the prophylactic use of defibrotide (df) in pediatric patients (age less than 18 years) undergoing stem cell transplantation and who are at high risk of developing hepatic veno-occlusive disease (vod) will have an impact on the incidence and severity of the disease. patients will be randomly assigned to one of two treatment arms: those allocated to the prophylactic arm will receive the study drug (defibrotide) from the day of conditioning onwards. patients allocated to the control arm will receive the study drug (defibrotide) from the day that vod is diagnosed.

comparison/control intervention and duration of the intervention: patients will be assigned randomly to either the defibrotide (df) prophylaxis arm or the control arm. those allocated to the df prophylaxis arm (df 25 mg/kg/d iv in 4 doses) will begin treatment at day of conditioning and stop at day +30 after stem cell transplantation (sct) or upon discharge from inpatient care. there is no dose adjustment for a patient of the study arm who developed vod, they continue with the 25mg/kg/d iv. patients allocated to the control arm receive no prophylactic measures and will start df (25 mg/kg/d iv in 4 doses) beginning at day of diagnosis of veno-occlusive disease (vod) according to modified seattle criteria. treatment will be stopped at complete resolution of symptoms. in both arms patients who developed vod will continue df until: * complete resolution of the ascites and * reversion of the hepatopedal flow (if present) and * normalization of the total and direct bilirubin

Eligibility criteria:
inclusion criteria: * age \<18 years * myeloablative conditioning and autologous or allogeneic stem cell transplantation with at least one of the following risk factors for vod: 1. pre-existing liver disease 2. second myeloablative hsct 3. history of treatment with gemtuzumab ozogamicin (mylotargò, go, cma-676, wyeth) 4. allogeneic hsct for leukemia beyond the second relapse 5. osteopetrosis (op) 6. conditioning with busulfan and melphalan 7. macrophage activating syndromes (mas, like hemophagocytic lymphohistiocytosis, griscelli, chediak-higashi 8. adrenoleukodystrophy (ald) exclusion criteria: * pregnant patients * patients who are transplanted but do not fulfill any of the above mentioned criteria

Keywords: venoocclusive disease pediatric myeloablative conditioning stem cell transplant
biological monitoring of nano sized particles in the airways of asthmatic children

Conditions: Asthma

Summary: background ambient airborne particulate material (pm) is defined according the aerodynamic diameter into coarse, fine, and ultrafine or "nano" sized particles ranging between 2.5-10 µm (coarse), \<2.5 µm (fine), and \<0.1 µm (nano(. many studies have examined particle effect on respiratory health in children, mainly by environmental monitoring of coarse and fine particles. biological assessment of individual exposure to nano sized particles in correlation to adverse health effect was not previously studied. hypothesis individual exposure to nano sized particles in children is associated with reduction in forced expiratory volume at one second.


Eligibility criteria:
inclusion criteria: * age 6-18 years * living in the tel aviv area * referred to the pulmonology lab for respiratory function evaluation exclusion criteria: * exposure to cigarette smoke * respiratory infection in the 4 weeks prior to recruitment and testing

Keywords: asthma reactive airway disease cough air pollution nano particles
a double-dose safety study of an influenza vaccine (multimeric-001)

Conditions: Healthy

Summary: a phase i/ii, randomized, single-blind, placebo-controlled escalating double-dose safety study of an intramuscular universal influenza vaccine (multimeric-001) injected to healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy males and females between 18 and 55 years (inclusive) of age. * non-smoking (by declaration) for a period of at least 6 months. * subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study. * haematology and chemistry values within normal ranges or with no clinical significance * subjects who provide written informed consent to participate in the study exclusion criteria: * known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications. * ongoing flu symptoms or influenza * any clinically significant abnormality upon physical examination or in the clinical laboratory test at screening visit. * treatment with immune immunosuppressant drugs or other immune enhancing drugs. * subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within one year prior to the screening visit. * administration of any vaccine 30 days before the screening visit. * known history of drug or alcohol abuse. * known history of hiv, hepatitis c or b virus (hcv or hbv) * subjects with known guillain barré syndrome in the past * 2 or more hospitalization within the last year prior to screening visit * increased liver enzymes 2.5 times above the upper reference level * known hypersensitivity and/or allergy to any drugs * any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the principal investigator. * subjects who participated in another clinical study within 30 days prior to study entry * subjects who are non-cooperative or unwilling to sign consent form. * pregnant or lactating women at entry to study and those that are unwilling to agree to continue precautions for two months after completion of the study

Keywords: influenza vaccine universal safety
efficacy and safety of vatelizumab in patients with relapsing-remitting multiple sclerosis

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: primary objectives: * to assess the efficacy of vatelizumab compared to placebo as measured by a reduction in new contrast-enhancing lesions (cels) in relapsing remitting multiple sclerosis (rrms) patients. * to evaluate multiple doses of vatelizumab for a dose-response. secondary objectives: * to evaluate the safety and tolerability of vatelizumab compared to placebo. * to evaluate the pharmacokinetics (pk) of vatelizumab.

the duration of study per patient will be up to 108 weeks, including a screening period of up to 4 weeks, a treatment period of 12 weeks and a post-treatment safety follow-up period of up to 92 weeks. patients completing the 12-week treatment period may enter an optional long-term extension study in which all subjects will receive vatelizumab.

Eligibility criteria:
inclusion criteria: diagnosis of relapsing-remitting multiple sclerosis (rrms). at least 1 documented relapse in the past 12 months. at least 1 contrast-enhancing lesion (cel) on magnetic resonance imaging (mri) in the past 12 months and/or at screening. at least 3 t2 lesions on screening mri. exclusion criteria: diagnosis of primary progressive or secondary progressive ms. expanded disability status scale (edss) score \>5.5. relapse within 30 days prior to enrollment. prior immunosuppressive treatment within protocol-specified time periods. prior treatment with natalizumab (tysabri®). history of bleeding/platelet disorders, malignancy, certain infections as defined in the protocol, or any other past or current medical conditions that would adversely affect the patient's participation in the study. pregnancy or breast-feeding. other protocol-defined inclusion/exclusion criteria may apply. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effect of significant ischemic mitral regurgitation on the outcome of st segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention

Conditions: Ischemic Mitral Regurgitation

Summary: the goal of the study is to correlate the effect of ischemic mitral regurgitation on the outcome of stemi patients treated with successful primary pci using clinical data and echocardiography on presentation and during short term follow up after 3 months

* imr is defined as mitral regurgitation (mr) caused by chronic changes of lv structure and function due to ischemic heart disease. it is not a valve disease but represents the valvular consequences of increased tethering forces and reduced closing forces. it is reported in approximately one-fifth of patients following acute myocardial infarction (mi) and one-half of those with congestive heart failure. imr is a frequent complication of coronary artery disease and it worsens the prognosis. * it is important to distinguish between primary mr due to organic disease of one or more components of the mitral valve apparatus and secondary mr which is not a valve disease, but represents lv disease. secondary mr is defined as functional mr, due to lv remodeling by cardiomyopathy or coronary artery disease. in the latter clinical setting, secondary functional mr is called imr. there are some limitations in this definition of functional imr. recent studies have revealed evidence of structural changes in the mitral leaflets in response to tethering on them by lv pathological remodeling. the leaflet adaptation includes enlargement and increased stiffness. * aim of the work : to correlate the effect of ischemic mitral regurgitation on the outcome of stemi patients treated with successful primary pci using clinical data and echocardiography on presentation and during short term follow up after 3 months

Eligibility criteria:
inclusion criteria: 1. subjects with first presentation 2. subjects with acute stemi 3. subjects undergoing primary pci with successful reperfusion 4. subjects with significant imr grade (iii/iv) to (iv/iv) 5. subjects with acute stemi with no or non-significant mr undergoing primary pci undergoing primary pci with successful reperfusion (as control) exclusion criteria: 1. rheumatic mitral regurge 2. valvular mitral regurge 3. imr grade (ii/iv) 4. cardiomyopathies 5. associated other valvular heart diseases

Keywords: ischemic mitral regurgitation primary percutaneous coronary intervention stemi
pet mri in coronary artery disease

Conditions: Coronary Artery Disease

Summary: this study will assess the use of position emission tomography/magnetic resonance imaging (pet/mri) using ultra-small-superparamagnetic particles of iron oxide (uspio) as a contrast agent in patients with coronary artery disease.

positron emission tomography/magnetic resonance imaging (pet/mri) has the potential to provide detailed information on coronary artery anatomy, the presence of coronary artery stenosis, the composition of atherosclerotic plaque using mri tissue characterisation and information about the underlying biological processes using targeted pet tracers. ultra-small-superparamagnetic particles of iron oxide (uspio) have a long blood pool half-life so are an ideal contrast agent for pet/mri imaging. this study will assess the use of pet/mri with uspio in patients with stable coronary artery disease and recent acute myocardial infarction.

Eligibility criteria:
inclusion criteria: * healthy volunteers to undergo mri imaging will be over the age of 18 years and able to provide informed consent. * patients with coronary artery disease to undergo pet/mri will have multi-vessel disease (≥2 vessel coronary artery disease with ≥ 50% cross-sectional luminal stenosis). * able to provide informed consent * over the age of 40 years exclusion criteria: * inability or unwillingness to undergo magnetic resonance imaging or positron emission tomography * renal failure (serum creatinine \>200 umol/l or estimated glomerular filtration rate \<30 ml/min * hepatic failure * pregnancy * inability to provide informed consent * contraindications to undergoing mri scanning * contraindications to contrast agents not included above including evidence of iron overload, known allergy to constituents of the contrast agents, and anaemia not caused by iron deficiency

Keywords: pet/mri ultra-small-superparamagnetic particles
conservative or operative treatment for the shoulder impingement syndrome?

Conditions: Shoulder Impingement Syndrome

Summary: study hypothesis: the impingement syndrome of the rotator cuff is a common cause of shoulder pain for which the most effective treatment is unknown. steroid injections and anti-inflammatory analgetics are considered as effective methods. physiotherapy and acromioplasty are commonly used treatments. hypothesis: arthroscopy and acromioplasty in addition to conservative treatment is equally effective as conservative treatment alone for shoulder impingement syndrome.

the aim of this study was to examine the effectiveness of arthroscopic acromioplasty in the treatment of the shoulder impingement syndrome. nonoperative treatment consisted of information given by a trained physiotherapist. the patients were supervised with a progressive programme to improve the mobility and muscle strength of the shoulder region which was regularly controlled. the exercises aimed at strengthening the stabilising muscles of the glenohumeral joint (m. trapezius, m. deltoides, m. supraspinatus and m. infraspinatus) and activating the decompressive muscles of the the subacromial space (m. teres major and minor, m. subscapularis). the programme lasted for three months. in addition the patients were given advice for daily home exercise. in the surgical group the patients underwent an arthroscopic examination and acromioplasty done by one experienced orthopaedic specialist. postoperatively the patients received similar physiotherapeutical information and training programme than in the conservative treatment group. the follow-up evaluations were performed at 3, 6 and 12 months from the beginning of each treatment in addition at 24 months counted from the randomization. a trained research physiotherapist who was blinded to the treatment group and had not been involved in their treatment performed a standardized assessment of all patients. the range of motion, muscle strengths and neer´s tests were recorded. at each evaluation the patients completed a structured questionnaire.

Eligibility criteria:
inclusion criteria: * a positive clinical neer's test * shoulder pain resistant to rest * shoulder pain resistant to anti-inflammatory drugs * shoulder pain resistant to subacromial steroid injections * shoulder pain resistant to ordinary physiotherapy with a minimum history of three months exclusion criteria: * glenohumeral or acromioclavicular arthritis * glenohumeral instability * total rupture of the rotator cuff * cervical syndrome * adhesive capsulitis * neuropathy of the shoulder region

Keywords: subacromial impingement acromioplasty physiotherapy