Kornimate/medical-research-clean huggingface dataset:
rct regarding sdm online training and face-to-face sdm training

Conditions: Doctor-Patient-Communication

Summary: cancer patients often report that they are not included in important treatment decisions. numerous studies have shown that a training concerning shared decision making (sdm) for physicians can improve this situation. this does not only lead to a better quality of the doctor-patient interaction, but may have a positive long term impact on treatment adherence, the psychological well-being and the coping abilities of the patients. however, previous experience regarding the implementation of sdm training programs show that it is difficult to recruit physicians for an external sdm group training due to the extensive workload of the physicians. in light of the available evidence on the effectiveness of sdm training and the low motivation by oncologists for traditional sdm group training, this study aims to develop and evaluate a brief sdm intervention. this intervention is disseminated in two different ways which both might be attractive for oncologists. on the one hand an individual face-to-face context-based sdm training is designed and conducted by a trainer at the workplace of the participating oncologists. on the other hand a web-based sdm online training is developed. both sdm interventions are developed on the basis of an sdm manual evaluated in previous studies. this study therefore aims to examine the effectiveness of different disseminations strategies (individualized face-to-face context-based sdm individual training vs. web-based sdm online training) compared to a control group without any training. it will be analyzed which improvements in medical sdm competence can be accomplished by the different sdm trainings. further the effects of the training on sdm knowledge, quality of the doctor-patient interaction and sdm self-efficacy expectation will be evaluated.


Eligibility criteria:
inclusion criteria: 1. oncologists or physicians treating a significant percentage of breast and/or colorectal cancer patients 2. internet access exclusion criteria: * no exclusion criteria
clinical trial to examine the pain relief of ph-797804 alone or with naproxen in subjects with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: ph-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain signalling following nerve injury and inflammation. blocking such mediators may potentially have a therapeutic benefit by reducing pain.


Eligibility criteria:
inclusion criteria: * male or female subjects between, and including, the ages of 18 and 75 years. females must be of non-childbearing potential. * diagnosis of osteoarthritis of the knee based on american college of rheumatology criteria with x-ray confirmation (a kellgren-lawrence x-ray grade of ≥2. exclusion criteria: * history of diseases other than osteoarthritis that may involve the index knee. * other severe pain that impairs the assessment of osteoarthritis of pain. * electrocardiogram abnormalities. * history of gastrointestinal disorders.

Keywords: knee osteoarthritis clinical trial cross-over
slnb after neoadjuvant treatment in node positive patients

Conditions: Sentinel Lymph Node Biopsy; Locoregional Neoplasm Recurrence; Progression, Disease

Summary: from may 2016 till may 2018 all breast cancer patients with operable disease submitted to surgery after neoadjuvant treatment would be divided in four groups considering initially clinical axillary stage, axillary procedure that was done, axillary response to preoperative systemic treatment and pathological axillary stage. in first postoperative year all patients will be monitored for appearance of locoregional and distant recurrence.

from may 2017 slnb after neoadjuvant treatment was introduced in clinical practice for breast cancer patients presenting initially with involved axilla but shifted to clinically negative followed neoadjuvant treatment. this retrospective analysis is designed for period of one year before and one year later to compare the clinical outcomes for this patients in the setting where alnd was performed to the setting where slnb was performed. the main hypothesis was to establish that slnb after neoadjuvant treatment, in initially node positive breast cancer patients that achieve complete clinical remission following neoadjuvant treatment, is reliable alternative to alnd in maintenance of locoregional control of disease. for the purpose of this trial four groups were created and the results would be compared among them. in first postoperative year patients were monitored for the appearance of locoregional and distant recurrence. data were collected individually for each patient and recorded in register. all data are available to all members of investigation team, members of ethic committee and statistician. data collected in this trial would be used for publication.

Eligibility criteria:
inclusion criteria: * operable breast cancer submitted to neoadjuvant treatment in chc rijeka, followed by surgery in period from may 2016 till may 2018 exclusion criteria: * t4 stage * inflammatory breast cancer * m1 stage at the time of diagnose * bilateral disease * multicentric disease * unavailable complete required data

Keywords: breast cancer sentinel lymph node biopsy neoadjuvant chemotherapy locoregional recurrence distant recurrence
exploring novel diagnostic tools for periprosthetic joint infection

Conditions: Prosthesis-Related Infections; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Summary: joint replacement is a valuable surgical intervention that improves quality of life, provides pain relief, and restores function of patients. however, some patients need revision surgery due to failure of the implant, with periprosthetic joint infection (pji) remaining a rare but serious complication following total hip (tha) and knee (tka) arthroplasty. diagnosing pji is a major challenge as no diagnostic test with absolute accuracy exists. the diagnosis is based on a combination of clinical findings, laboratory results from peripheral blood and synovial fluid, microbiological culture, histological evaluation of periprosthetic tissue, and intraoperative findings. however, the preoperative diagnosis can be inconclusive and operative criteria are required for the definitive diagnosis. therefore, novel diagnosing tools for identification of pji are necessary. a recent study using a gene reporter assay, identified biomarkers in synovial fluid that define joint states in patients with osteoarthritis.however, no previous studies have investigated cellular signaling in synovial fluid of patients with pji. with this study we want to explore the potential of a reporter gene assay of synovial fluid in patients with pji and without pji of their tka and tha. also, flow cytometry analysis of biological fluids has recently received increased attention as a potentially valuable method in diagnosing infections. for example, the method is already used to analyze urine samples for urinary tract infections. recently, researchers have now also used this method to screen for the presence of bacteria. the most important limitation of flow cytometry analysis of synovial fluids for bacteria to date is that it is unclear as to which bacteria count value - the cutoff value - represent patients with pji and which represent patients without pji. with this study we want to explore the potential of flow cytometry analysis of synovial fluid in categorizing patients with pji and without pji. our primary objective is to explore the value of synovial fluid analysis using a reporter gene assay and flow cytometry in the detection of a periprosthetic joint infection.


Eligibility criteria:
inclusion criteria: * all patients planned for elective tha or tka revision surgery with revision of one or more fixed components will be eligible to participate in this study. exclusion criteria: * are planned for a revision of single mobile parts only; * have received intravenous and/or oral antibiotics within 2 weeks before the diagnostic workup and/or surgery; * are unable to provide their consent for use of their human tissues for medical research.
clinical study of stent versus direct atherectomy to treat lower limb ischemia

Conditions: Atherosclerosis; Ischemia

Summary: this is a randomized study comparing stent and plaque excision systems in treatment of lower limb (superficial femoral or popliteal artery) ischemia.

this is a randomized study comparing stent and plaque excision systems in treatment of diabetic lower limb (superficial femoral or popliteal artery) ischemia.

Eligibility criteria:
inclusion criteria: provides written informed consent willing to comply with follow-up evaluations at specified times has claudication or rest pain due to peripheral arterial disease disease located within the femoropopliteal artery patient has a de novo or restenotic lesion(s) with \>50% stenosis documented angiographically and no prior stent in the target lesion. patient has symptoms of peripheral arterial disease classified as rutherford category 2 or greater. exclusion criteria: previously implanted stent(s) or stent graft(s) in target leg life expectancy less than 12 months has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure thrombophlebitis, uremia, or deep venous thrombus, within past 30 days. receiving dialysis or immunosuppressant therapy. recent stroke within past 90 days. known allergies to the following: aspirin, clopidogrel bisulfate (plavix®) or ticlopidine (ticlid®), heparin, nitinol (nickel titanium), contrast agent, that cannot be medically managed. tissue loss due to ischemic disease (rutherford/becker category 5 or 6) serum creatinine level \>/= 2.5 mg/dl at time of screening visit known or suspected active infection at the time of the procedure bleeding diathesis patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol. patient is known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser. patient is currently participating in any other investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or future participation in such studies prior to the completion of this study.

Keywords: stents atherectomy femoral artery popliteal artery
stopping heavy periods project

Conditions: Abnormal Uterine Bleeding; Abnormal Uterine Bleeding, Ovulatory Dysfunction; Abnormal Uterine Bleeding, Endometrial Hemostatic Dysfunction

Summary: this study is a randomized clinical trial comparing the effectiveness of the levonorgestrel intrauterine system (lng-ius) to combined oral contraceptives (cocs) for improving quality of life among women who report heavy menstrual bleeding.

this study is designed to be conducted within the context of a patient's standard/usual/typical care from their primary gynecologic care provider. we hypothesize that, compared to cocs, the lng-ius will be more effective at improving bleeding-related quality of life at 6 months and one year. to test this hypothesis, we plan to enroll 59 women from several sites who present for gynecologic care and self-report heavy menstrual bleeding into a rct comparing lng-ius to cocs. the eligible study population includes women with heavy menstrual bleeding secondary to ovulatory disorders (aub-o) or endometrial hemostatic disorders (aub-e). women meeting study eligibility will be randomized to receive lng-ius or cocs. main study outcomes will be obtained at 6 weeks, 3 months, 6 months, and 1 year.

Eligibility criteria:
inclusion criteria: * self-reported heavy menstrual bleeding * age 18-51 years * etiology of heavy menstrual bleeding from either ovulatory disorders (aub-o) or endometrial hemostatic disorders (aub-e) exclusion criteria: * plan pregnancy in the next year * menopausal * currently has a copper iud in place * history of ablation or hysterectomy or have any contraindications to cocs or lng-ius
comparison of effects between conventional dose and high dose escitalopram on clinical improvement in patients with obsessive-compulsive disorder

Conditions: Obsessive Compulsive Disorder

Summary: objective: the objective of this study is to compare the effect and safety of conventional dose (20mg) and high dose (40mg) of escitalopram in patients with obsessive-compulsive disorder (ocd). overview of study design: prospective, randomized, active-controlled, double-blind, multi-center, clinical trials study population: patients with ocd efficacy evaluations: y-bocs (d-ybocs), ham-d, ham-a, cgi-s \& -i, gaf, oci-r safety evaluation: adverse events / serious adverse events, uku


Eligibility criteria:
inclusion criteria: 1. man or woman, aged 18 to 65 years, outpatient 2. primary ocd patients diagnosed with dsm-iv-tr, having ocd symptoms for more than six months 3. severity: y-bocs score of \>= 20 at screening and baseline 4. no history or evidences of clinically significant physical problem, or abnormal laboratory findings at screening 5. drug free period of at least 2 weeks before study drug administration (in case of fluoxetine, at least 5 weeks). however, allowed medications in this study could be taken even before study drug administration. exclusion criteria: 1. primary active dsm-iv axis i diagnosis other than ocd 2. history of substance, including alcohol, dependence and psychotic symptoms 3. current depression a. risk of suicidal attempt b. 20-item hamilton depression rating scale (ham-d)(exclude 21th item, obsession) of \>17 at screening or baseline 4. drug allergy a. known or suspected hypersensitivity to escitalopram or citalopram b. history of severe drug allergic reactions or hypersensitivity 5. history of no response to escitalopram or citalopram treatment 6. history of electroconvulsive therapy or received an injectable antipsychotic formulation within 6 months before screening 7. women who are pregnant, planning to become pregnant, or breast-feeding 8. ongoing cognitive behavior therapy (cbt) of ocd 9. hoarding or collecting type 10. unable to perform study protocol as clinically assessed by the investigator (ex, severe personality disorder)
cardiotropic viruses in cardiac surgery patients without clinical evidence of myocarditis or myocarditic sequelae

Conditions: Myocarditis

Summary: myocarditis is mainly caused by cardiotropic viruses. in recent time viruses found in endomyocardial biopsies mainly consist of parvovirus b19 (pvb19) and human herpesvirus 6 (hhv6). a definite causal link between virus-genome detection of pvb19 and/or hhv6 (via pcr techniques)and cardiac inflammation and dysfunction is however still missing. primary objective: to determine the prevalence of pvb19 and hhv6 virus genome in heart muscle biopsies of cardiac surgery patients without clinical evidence of myocarditis or myocarditic sequelae secondary objectives: 1. correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results 2. prognostic value of virus prevalence for the postoperative course primary hypothesis: patients without clinical evidence of myocarditis or myocarditic sequelae demonstrate to a significant lesser extent inflammatory activity and virus genome in their myocardium as compared to patients being clinical suspicious for myocarditis.

prospective monocentric study with to 2 arms study arm: cardiac surgery group, control arm: routine cardiology group minimum of 100 patients included into the study arm inclusion criteria for the study arm: adult patients having cardiac surgery done under use of cardiopulmonary bypass data collection: past medical history, ecg, prior cardiovascular imaging (echo, ventriculography), cardiac magnetic resonance imaging (cmr), serologic studies, work-up of endomyocardial biopsies (histology, molecular-pathology, follow-up cmr.

Eligibility criteria:
inclusion criteria: * cardiac surgery with cardiopulmonary bypass exclusion criteria: * no ability to give informed consent * presence of so far accepted parvovirus/herpesvirus associated comorbidities * contraindications for magnetic resonance

Keywords: myocarditis parvovirus b19 (pvb19) human herpes virus 6 (hhv6) cardiac magnetic resonance tomography (cmr)
influence of fish oil based intravenous fat emulsions on the epidermal barrier function

Conditions: Intestinal Diseases

Summary: the epidermal barrier efficacy is determined by the physicochemical properties of the epidermal lipid matrix, among which ω-6 essential fatty acids (efas) play a key role. inversely, the ω-3 efas are not found in the epidermis. for patients receiving lipid-containing parenteral nutrition (lcpn), the improvement of the epidermal barrier through the infusion of most appropriate intravenous fat emulsions (ivfe) could have many applications in clinical nutrition, mainly limiting water loss in patients receiving long-term lcpn and help in electrolyte and water balance. the objective of this interventional clinical trial is to evaluate the epidermal barrier function in patients receiving long-term lcpn comparing two compositions of ivfe: (i) soybean oil (so)-based ivfe (medialipide) or (ii) fish oil (fo)-containing ivfe (lipidem). epidermal barrier function will be assessed through the transepidermal water loss (tewl) measurement on the skin surface, a validated marker of the epidermal barrier efficacy. the two ivfe (so-based or fo-containing) will be compared using a randomized double blind crossover design, using patients as their own control. each ivfe will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal. patient's epidermal and red blood cell efa profile will be determinate in order to facilitate result interpretation.


Eligibility criteria:
inclusion criteria: * patient with sever chronic intestinal disease requiring long term parenteral nutrition * receiving home lipid containing parenteral nutrition (lcpn), regardless of currently infused intravenous fat emulsion * with a stable dose of lcpn for at least 1 month at recruitment time * administered at least 4 days a week through central venous access, with at least 150 ml of lipid per parenteral nutrition bag with lipid. * age \>18 * being available for 2 medical consultations in a 6 month period * who gave its written informed consent to participate to the study and without legal protection * social security coverage exclusion criteria: * lesser expected parenteral nutrition length than duration for the entire trial * dermatological criteria : history of skin disease (atopic dermatitis, psoriasis) or evolving skin disease, broken or inflamed skin on the tewl measurement site, use of topical creams on the tewl measurement site, skin or systemic allergy (asthma) * contraindication to one of the selected intravenous fat emulsion: severe dyslipidemia; uncontrolled diabetes; sepsis; severe hepatic impairment; major blood clotting disorders; egg protein, soybean, peanut or fish hyper sensibility; serum creatinine clearance \< 30 ml/min

Keywords: intravenous fat emulsions parenteral nutrition skin barrier function essential fatty acids transepidermal water loss
concordance between echocardiographic assessment performed in the initial phase of decompensated cirrhosis with edema and ascites by an expert intensive care physician and a non-expert gastroenterologist

Conditions: Liver Cirrhoses

Summary: the investigators hypothesize that trans-thoracic ultrasound performed by non-specialist gastroenterologists with a standard training by intensive care doctors will give equivalent results to those achieved by experts for a simple evaluation of hemodynamic status.


Eligibility criteria:
inclusion criteria: * patient must be an adult at least 18 years old * patient has known or suspected cirrhosis (diagnosed by biopsy or based on recognized clinical/biological/radiological criteria) * admitted to the gastroenterology service for odematous-ascitic decompensation defined by edema of the lower limbs, and/or ascites, anasarca, associated or not with weight gain. exclusion criteria: * the subject is participating in an interventional study, or is in a period of exclusion determined by a previous study * the subject refuses to sign the consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * patient is pregnant or breastfeeding * patient already participated in the study * patient with cirrhosis admitted for a different decompensation (active digestive hemorrhage or sepsis) * poorly echogenic patient * patient withdraws consent * patient with anasarca of cardiac origin * ultrasound diagnosis of a severe cardiac pathology requiring specialized treatment in intensive care or cardiology (severe cardiac insufficiency, acute pulmonary edema, endocarditis, severe valvulopathy, cardiac tamponade, intracardiac thrombus)
the neurocognitive sub-study of encore1

Conditions: HIV

Summary: the purpose is to investigate whether hiv and hiv medication can affect certain areas of brain function. this study will look at possible changes in brain function including memory, concentration and thought processes to see if there are any differences between the two doses of efavirenz used in the encore1 study and also the level of efavirenz in the blood


Eligibility criteria:
inclusion criteria: * all subjects entering into the main study protocol at participating centres will be eligible to enter this sub-study. exclusion criteria: * existing neurological brain disease * recent (\<6months ) head injury * current major depression or psychosis * current alcohol abuse * intended use of recreational drugs during study period * uncontrolled medical conditions deemed to potentially interfere with cognitive function (e.g. uncontrolled diabetes, pyrexial illness, uraemia etc)
the clinical study of foot function index in adolescent flatfoot

Conditions: Foot Function Index, Flat Foot, Dynamic Plantar Pressure, Reliability, Validity

Summary: using dynamic plantar pressure data during walking, combined with the ffi scores of adolescents, aids doctors and rehabilitation therapists in conducting more accurate, objective, and scientific evaluations of the functional parameters of the foot for appropriate rehabilitation treatment. clinical studies on flat feet mainly focus on imaging diagnosis, gait characteristics, orthopedic insole studies, and different surgical treatment schemes related to flat foot injuries. however, few studies have analyzed the dynamic plantar pressure characteristics of flat feet to guide clinical interventions, as well as the correlation between the subjective perception of ffi and objective biomechanical parameter characteristics to analyze the validity of ffi and elucidate the physiological characteristics of foot diseases. specific purpose of this study therefore, the purpose of our study was to clarify the reliability and validity of the application of the ffi in flatfoot and the correlation between the ffi and dynamic plantar pressure.


Eligibility criteria:
inclusion criteria: 7-18 years old. arch development begins to stabilize around age 7 \[19\]; therefore, preschool children under 7 were excluded. ability to maintain a static standing posture unassisted; bilateral flexible flatfoot (where the heel is valgus and the arch collapses on both sides); no congenital malformation or injury of the lower limbs; normal body mass index (bmi); no previous surgery or corrective treatment for flatfoot problems; and no obvious abnormal gait and posture. exclusion criteria: preschool children under 7 years of age are excluded. ① foot fracture or surgical history in the past six months; ② there are muscular nervous system diseases and syndrome affecting gait and posture, such as knee valgus, knee varus, legs unequal length or scoliosis; ③bmi≥28 kg/m².