Kornimate/medical-research-clean huggingface dataset:
effects of recombinant human erythropoietin on platelet function in patients with acute myocardial infarction

Conditions: Myocardial Infarction

Summary: the purpose of this study is to see if a naturally-occurring hormone called erythropoietin changes the action of platelets in the blood. patients with heart attacks are treated with medicines to reduce the clotting action of platelets. this study is trying to determine whether erythropoietin alters the clotting action of platelets in patients receiving anti-platelet medicines. it is important to understand the effects of erythropoietin on platelets since preliminary studies in animals suggest that erythropoietin may protect the heart from damage during a heart attack.

anti-apoptotic effects of erythropoietin in experimental myocardial infarction (mi) and ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute mi. before the therapeutic potential of recombinant human erythropoietin (rhuepo) in acute mi can be tested in large clinical trials, more information on the effects of short-term rhuepo on platelet function are needed. accordingly, the current proposal aims to determine the effects of rhuepo (at a dose previously shown not to inhibit the anti-platelet effects of aspirin and clopidogrel in healthy subjects) on platelet function and other safety measures and measure of infarct size in patients with acute coronary syndromes receiving clinically-indicated standard anti-platelet therapy with aspirin, clopidogrel and glycoprotein iib-iiia inhibitors. specific aim 1: to determine the effects of intravenous rhuepo 400 u/kg daily for 3 days vs. placebo on in vivo and in vitro platelet function in patients with acute mi undergoing percutaneous revascularization. specific aim 2: to obtain pilot data to estimate the effects of administration of rhuepo 400 u/kg daily for 3 days vs. placebo on biochemical markers of myocardial infarction size and left ventricular ejection fraction in patients with acute mi undergoing percutaneous revascularization

Eligibility criteria:
inclusion criteria: * age 21-75 years * clinical evidence of acute myocardial infarction (mi) with total or sub-total occlusion on angiogram * status post percutaneous revascularization procedure for acute mi with timi 3 flow * ongoing clinically-indicated treatment with aspirin, thienopyridines exclusion criteria: * hemodynamic instability/shock or severe congestive heart failure * time from onset of chest pain to revascularization procedure \> 16 hours * use of intravenous thrombolytic agents for treatment of mi * known need for additional revascularization procedures

Keywords: platelet function tests erythropoietin myocardial infarction
hemodynamic evaluation using microcirculation for early treatment of septic patients

Conditions: Sepsis; Emergency Care; Microcirculation

Summary: despite early treatment, the deterioration and mortality of sepsis patients remains high. a possible explanation could be persistent tissue hypoperfusion, or undetected in the early phase despite the normalization of macro-hemodynamic parameters. this interventional study evaluates the impact of measuring microcirculation parameters by nurses on patient prognosis through early initiation of vascular filling.

sepsis and its most serious form, septic shock, are a public health problem. sepsis is defined by the presence of organ failure, including acute circulatory failure, which combines hypovolemia, vasoplegia and cardiac dysfunction. vascular filling is therefore a pillar of the management of septic patients to correct hypovolemia and improve perfusion and tissue oxygenation. following numerous studies, the evaluation of peripheral microcirculation is becoming a clinical "trigger" making it possible to identify patients at risk, particularly in emergency department. in a meta-analysis, it has been showed that alterations in microcirculatory perfusion predict deterioration and mortality during severe infections. currently, no interventional study has evaluated the impact of measuring microcirculatory perfusion (peripheral perfusion index and marbling) by nurses on patient prognosis through early initiation of vascular filling. in this study, patients will be assessed hemodynamically using peripheral perfusion index and/or presence of mottling. if peripheral perfusion index \> 3s and/or presence of marbling a first vascular filling test of 500 cc over 30 minutes will be started after a medical control. patient will be followed up 7 days to determine outcome.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. admitted to the emergency department for suspected sepsis for less than 6 hours according to international sepsis-3 definitions (high probability of infection defined by a fever greater than or equal tol to 38.3°c with a suspected infectious source + score news 2 greater than or equal to 2) 3. affiliated to a social security system 4. having agreed to participate in this study exclusion criteria: 1. patient with arterial hypotension (sbp ≤ 100 mmhg) on admission 2. patient having already received a 500ml filling test over 30 minutes 3. patients moribund according to the investigator 4. pregnancy or breastfeeding 5. patient under guardianship, curatorship or safeguard of justice

Keywords: microcirculation septic patient organ dysfunction sepsis peripheral perfusion index emergency unit
effects of massage therapy and kinesthetic stimulation on pre-term infants

Conditions: Prematurity

Summary: the purpose of this study was to determine whether massage with or without physical exercise impacted weight gain or length of hospital stay for premature infants.

premature infants are often cared for in a fashion that minimizes physical activity in order to reduce stress and stress-related complications. previous studies have indicated that massage therapy may increase weight gain and enabled earlier discharge of premature infants. in this study, premature infants were randomly assigned to one of three groups: a: control group b: massage group, 15 minutes twice a day; c: massage and physical exercise group 15 minutes each, twice a day.

Eligibility criteria:
inclusion criteria: * low birth weight, less than 1500 grams * weight of at least 1000 grams at time of entry into study * must be at least one week of age * must have relative medical stability * gestational age between 28-32 weeks exclusion criteria: * infants with major congenital anomaly * those that require mechanical ventilatory support * those that are restricted in their movement or ability to undergo the intervention

Keywords: preterm infants massage physical activity weight gain length of hospital stay nicu
relaxahead for headache patients (phase i)

Conditions: Headache; Migraine; Multiple Sclerosis

Summary: the goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (pmr) for the treatment of headaches. while there are many commercially available electronic diary and mind-body intervention apps for headache, there is little data showing their efficacy. relaxahead app incorporates the electronic pmr that was successfully used in an earlier epilepsy study and beta tested with headache specialist and migraine patient input. it also is an electric headache diary. this 2-arm randomized controlled study will evaluate the feasibility and acceptability of relax for use with headache patients. one arm will be the relax group (the relaxahead app) and the other arm will be a monitored usual care (muc) group (this group receives standard of care and uses the electronic daily symptom reporting diary). the goals are to assess the feasibility and adherence of the relax intervention in persons with headache (aim 1) and to gather exploratory data on the effects of the relax intervention on headache related outcome measures (aim 2).


Eligibility criteria:
inclusion criteria: * meets migraine criteria based on international classification of headache disorders (ichd) 3 beta (based on questions in redcap * 4 or more headache days per month exclusion criteria: * patients who have had cognitive behavioral therapy, biofeedback or other relaxation therapy for migraine in the past year * cognitive deficit or other physical problem with the potential to interfere with behavioral therapy * alcohol or other substance abuse as determined by self-report or prior documentation in the medical record * opioid or barbiturate use 10+ days a month * unable or unwilling to follow a treatment program that relies on written and audio recorded materials * not having a smartphone
transition care model for adolescents with congenital heart disease

Conditions: Congenital Heart Disease

Summary: the primary aim of this study is to assess the effectiveness of a standardized transition care model (tc) on the perceived mental and physical health of adolescents with congenital heart disease (chd). furthermore, the secondary aims of this research are focused on providing a description of the impact of a standardized tc on overall healthcare needs, satisfaction, and engagement. therefore, a prospective, randomized, controlled, single-blind, and multi-center study will be conducted.

congenital heart diseases (chd) are some of the most prevalent and serious birth defects, representing a major global health problem. with a prevalence of 9.1 for 1000 live births, the chd are the leading causes of birth defects associated with morbidity, mortality, and medical expenditures. currently, 1.3 million children live with a chd worldwide (3), and approximately 90% of them can survive into adulthood. in this scenario, the transition from childhood to adulthood is one of the most complex and delicate part of life for chd patients. the multi-disciplinary standardized interventions to educate and support patients with chd, described as "transition clinic" (tc), represent a key element in delivering care for patients during the transition from childhood to adulthood. however, most recent literature focuses on the chd childhood clinical management or the chd adulthood challenges (i.e., guch challenges). thus, the attention to exploring the peculiarities of the transition period from childhood to adulthood in patients with chd is underinvestigated by the lack of experimental studies \[i.e. randomized controlled trial (rct)\] as the published evidence is related to the assessment of effects of the same model on outcomes without a control arm (pre-post test study design).

Eligibility criteria:
inclusion criteria: * adolescent patients (aged between 12 and 18 years) * diagnosis of chd, according to 2018 aha/acc guideline for the management of adults with congenital heart disease * all patients who express the willingness to participate in the study through the signing of the informed consent form and signature of informed consent by patients' parents * moderate and complex chd, according to the classification described by warnes exclusion criteria: * chromosomal abnormalities such as down's syndrome and marfan's syndrome * patients with cognitive impairment (assessed using six item screener, sis): if sis ≤4 * not understanding the italian language * patients in pregnancy * simple chd, according to warnes (2001) (25).

Keywords: congenital heart disease transition care quality of life engagement
evaluation of the clinical performance of reinforced glass ionomer restorations

Conditions: Dental Caries

Summary: this study is conducted to evaluate the clinical performance of class i reinforced glass ionomer restorations (zirconomer improved and equia forte fil)


Eligibility criteria:
inclusion criteria: * normal occlusal relation with normal dentition. * absence of pain from the tooth to be restored. * absence of any active periodontal and pulpal diseases from the tooth to be restored. * medium-sized (buccolingually and mesio-distally) occlusal carious lesions extending into dentin. exclusion criteria: * patients with a history of tooth sensitivity. * patients with bruxism. * defective restorations adjacent or opposing to the tooth. * abutment teeth used for fixed or removable prosthesis. * patients who refused to sign the consent form. * inability to return to recall appointments
lipid emulsion in cardiac valve replacement surgery

Conditions: Ischemic Reperfusion Injury

Summary: myocardial protection has become an essential adjunctive measure in cardiac surgery to bail the myocardium out of ischemia/reperfusion-induced damage during the operation. experimental studies have shown that lipid emulsion infusion just before reperfusion (i.e., intralipid postconditioning (ilpc)) could reduce myocardial infarct sizes, improve cardiac function, and reduce myocardial i/r injuries, despite the interesting experimental findings, the potential clinical usage of lipid emulsion in preventing myocardial i/r injury needs to be further investigated.

the study of myocardial protection has improved aiming to prevent intraoperative myocardial injury, which can lead to ventricular dysfunction, arrhythmias, low cardiac output and other complications, often irreversible ones. nowadays there are numerous methods of myocardial protection during cardiac surgery, but still there is no best myocardial protection technique. despite improved myocardial protection strategies, cardioplegic arrest and ischemia still result in ischemic reperfusion injury during cardiac surgery. many drugs have proved a pharmacological postconditioning effect on the heart at the onset of reflow and had been shown to limit infarction size and decrease the ischemic/reperfusion injury ,postconditioning (poc) has been reported to promote left ventricular functional recovery after global ischemia with cardioplegic arrest on cardiopulmonary bypass in a large animal model smoflipid is a sterile safe lipid emulsion comprised of soybean oil (30%), medium chain triglycerides (30%) olive oil (25%) \& fish oil (15%) that has been associated with decreased oxidative injury, improved liver function and increased antioxidant activity.

Eligibility criteria:
inclusion criteria: * patients undergoing rheumatic valve replacement surgery * elective surgery * age between 18 and 80 years old * left ventricular ejection fraction \> 0.4 exclusion criteria: * emergency and re do surgery, * positive base line ctni or ck-mb, * preoperative treatment with intralipid in the last 1 month. * history of allergy to (peanut, eggs, and soya bean) * implanted pacemaker, * previous myocardial infarction, * diabetic or other metabolic disorders, * significant renal impairment (cr \> 1.5) or on hemodialysis * significant hepatic dysfunction (inr\>2) * drugs interfere as (cyclosporine) * infection (wbc \>12)
autologous stem cells for urinary incontinence: single patient compassionate use

Conditions: Stress Urinary Incontinence

Summary: determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject.

autologous stem cells will be obtained from the subject by needle biopsy, sent to a lab for multiplication and after about 6 weeks time will be injected into the subjects urethra.

Eligibility criteria:
inclusion criteria: * urinary incontinence * failed urinary incontinence (ui) treatments exclusion criteria: - does not meet inclusion criteria, gender and age limit
early detection of relapses in stage iv colorectal cancer patients

Conditions: Metastatic Colorectal Cancer

Summary: this study is a prospective, multicenter, observational study on metastatic, operable colorectal cancer to evaluate the proof of concept of the cfdna analysis for the early detection of recurrences


Eligibility criteria:
inclusion criteria: 1. histological confirmed adenocarcinoma of the colon or rectum with synchronous metastatic disease (localized in liver or in liver and lung) eligible for surgery immediately or after neo-adjuvant treatment. 2. planned primary treatment at one of the redcloud participating hospital centers. 3. evidence of at least one measurable lesion, as per recist 1.1. 4. male or female ≥ 18 years of age at time of informed consent. 5. eastern cooperative oncology group (ecog) performance status 0 or 1. no prior chemotherapy neither for localized nor for metastatic disease. 6. no major comorbidities that would preclude the compliance with the planned therapeutic program as judged by the investigator. 7. life expectancy \> 3 months. 8. availability of biological samples (blood and tumor tissue). 9. patients enrolled in local prospective protocols, in which samples have been collected according redcloud procedures may be included. 10. signed and dated informed consent. exclusion criteria: 1. any physical or medical condition that would contraindicate chemotherapy and/or surgery. 2. any other metastatic site, except for liver and lung metastases 3. transplant recipients 4. known history of human immunodeficiency virus (hiv) infection. note: hiv testing will only be conducted in jurisdictions specifically requiring it. 5. known active hepatitis b or hepatitis c infection. 6. pregnant or lactating women 7. other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ adequately treated

Keywords: liquid biopsy metastatic colorectal cancer early detection of metastases
trial of sk-1404 for nocturia due to nocturnal polyuria in japanese subjects

Conditions: Nocturia Due to Nocturnal Polyuria

Summary: the purpose of this trial is to demonstrate efficacy of sk-1404 against placebo for the treatment of subjects with nocturia due to nocturnal polyuria, during 4 weeks of treatment.


Eligibility criteria:
inclusion criteria: * 5 \> nocturnal voids ≥2 * npi \>0.33 exclusion criteria: * polydipsia * cardiac failure * syndrome of inappropriate antidiuretic hormone secretion * hyponatraemia * uncontrolled diabetes mellitus * uncontrolled hypertension * moderate or severe over-active bladder (oab) * severe benign prostate hyperplasia (bph) * sleep apnoea * interstitial cystitis * stress urinary incontinence * diabetes insipidus * complication or a history of urological cancer
meta-analysis of cell-based cardiac studies: accrue

Conditions: Ischemic Heart Disease

Summary: numerous human cardiac stem cell studies have been published, including relatively small number of patients. meta-analysis of randomized trials have reported safety and a 3-6% increase in global left ventricular performance after intracoronary stem cell therapy in patients with acute myocardial infarction. since most of the studies used different type of stem cells, delivery modes, and patient population, the results are heterogenous, therefore the comparison of the results is biased regarding generalizable conclusions about the effect of treatment. the present comparative meta-analysis is based on individual patient data, and gathers and pools the raw data, and analyzes the clinical outcome, safety and efficacy of the cardiac stem cell therapy.

* background: many clinical trials and meta-analyses presented moderate but significant improvement of the left ventricular ejection fraction (lvef) after intracoronary autologous bone-marrow (bm) or peripheral blood origin stem cells transfer. however, it remains controversial, whether this beneficial effects is comparable with the intramyocardial delivery of the stem cells, or could be maintained during moderate and long term follow-up. the boost trial suggested that cardiac stem cell therapy did not improve lvef at 5-year follow-up. by contrast, balance study showed a long sustained benefit of bm-stem cells treatment. due to these divergent outcomes of the presented trials, the aim of the present meta-analysis is to compare the safety and effectiveness of the cardiac stem cell therapy in different patient population, delivery mode and cell type, to find out, which patients with which therapy mode can have the greatest benefit from cardiac stem cell therapy. * study design: individual patient data meta-analysis * data sources: european centre performing human cardiac stem cell therapy have been contacted calling for participation. * methods: individual data gathering and entering into the database for a pooled analysis. the meta-analysis will be done in line with recommendation from the cochrane collaboration and the quality of reporting of meta-analyses guidelines with review manager 5.0. fixed-effect model will be used.

Eligibility criteria:
inclusion criteria: * patient included in one of the registered cell-based cardiac therapy of the participating center exclusion criteria: * none

Keywords: meta-analysis stem cell cardiac remodeling accrue
is there a link between inflammation and endocrinopathies in turner syndrome?

Conditions: Turner Syndrome

Summary: liver abnormalities are common in turner syndrome. the physiopathology of these abnormalities is unknown for the moment but their potentially serious evolution requires additional explorations.


Eligibility criteria:
inclusion criteria experimental group: * turner syndrome inclusion criteria control group: * healthy subjects
crestal bone level after allogenic bone ring with simultaneous dental implant placement

Conditions: Allogenic Bone Ring

Summary: this trial is aiming to answer a question whether in patients with severely atrophied, distal mandibular regions, the use of allogenic bone rings with simultaneous dental implants, compared to autogenous bone rings, give successful clinical and radiographic outcomes without donor site morbidity


Eligibility criteria:
inclusion criteria: 1. medically free form any systemic diseases that contraindicate the surgical procedures or affect predictable outcomes and non-smoker subjects. 2. atrophic mandibular distal region requiring vertical augmentation. 3. good oral hygiene and healthy keratinized mucosa. exclusion criteria: 1. presence of acute dentoalveolar infection or any pathologic lesions. 2. totally edentulous patients and patients requiring massive reconstruction and augmentation procedures. 3. patients with history of previously failed augmentation procedures, or failed implant placement at the intended augmentation region.
cortical reorganisation in patients with primary headache disorders

Conditions: Migraine Without Aura; Chronic Tension-Type Headache

Summary: primary headache disorders are now accepted as physiological diseases, and advanced imaging-techniques have demonstrated a migraine generator in the brain stem and increased stimulus sensitivity in these patients. the underlying neuronal dysfunctions remain to to clarified and the existing neurophysiological methods have not yet been useful. more sensitive and reliable methods are therefore highly needed. the aims of the study are therefore to develop a sensitive and reliable method to demonstrate a cortical reorganisation and expansion of pain sensitive cortical areas in patients with migraine or tension-type headache.


Eligibility criteria:
inclusion criteria: * clinical diagnosis og migraine without aura or chronic tension-type headache exclusion criteria: * serious somatic or psychiatric diseases including depression * overuse of analgesics * regular intake of opiates or benzodiazepines * intake of prophylactic headache medication * pregnancy
evaluation of transient dyspnea during gadoxetic acid enhanced multiphasic liver mri

Conditions: Dyspnea

Summary: the purpose of this study is to observe transient dyspnea pattern after gd-eob-dtpa administration by obtaining continuous dynamic t1 weighted image data.


Eligibility criteria:
inclusion criteria: * patients who are referred to mr unit for hepatocyte-specific contrast enhanced liver mri using gadoxetic acid, to characterize focal liver lesion or to investigate diffuse liver disease * or, liver living donor candidates * and subjects who sign the informed consent. exclusion criteria: * minors under 18 years old * all contraindication to mri * hypersensitivity to gd * biliary obstruction

Keywords: gadoxetic acid transient dyspnea