Kornimate/medical-research-clean huggingface dataset:
european bifurcation club trial - two-stent versus one-stent technique for large bifurcation lesions

Conditions: Coronary Disease

Summary: this study will examine use of two-stent versus one-stent techniques for patients with large calibre bifurcation lesions including significant side branch disease.

treatment of bifurcation coronary lesions remains a difficult area, in which best practice is yet to be established. prior to the era of drug-eluting stents, the limited data which existed suggested that a strategy of stenting the main vessel, with balloon angioplasty alone of the side-branch if required was superior to stenting both vessels. randomised trials of "all-comer" bifurcation lesions have now established that there is no advantage to systematic dual drug-eluting stent strategies. however, these trials included patients with no disease in the side branch, and small side branch vessels. expert consensus suggests that "large" bifurcations with significant ostial side branch disease still merit a systematic total lesion coverage stent technique. this trial therefore is designed to assess the hypothesis that large true bifurcations with significant side branch ostial disease are more successfully treated with a systematic culotte technique than with the provisional t approach.

Eligibility criteria:
inclusion criteria: * "true" coronary bifurcation lesion (i.e. \>50% lesion in both main vessel and side branch) requiring revascularisation * main vessel ≥ 2.5mm diameter (visual inspection) * side branch ≥ 2.5mm diameter (visual inspection) * side branch ostial lesion ≥5mm length * patient ≥18 years old * females of childbearing potential: -ve pregnancy test exclusion criteria: * acute st elevation myocardial infarction * cardiogenic shock * left main stem lesion of haemodynamic significance * chronic total occlusion of either vessel * additional type c lesions requiring pci * either bifurcation vessel not suitable for stenting * platelet count ≤50 x 109/mm3 * left ventricular ejection fraction ≤20% * patient life expectancy less than 12 months * known allergies to aspirin, clopidogrel, heparin, stainless steel, intravenous contrast (severe), or stent drug elutant * participation in another investigational drug or device study * patient unable to give informed consent

Keywords: stent bifurcation coronary
smoking termination opportunity for inpatients

Conditions: Tobacco Use Disorder

Summary: the smoking termination opportunity for inpatients, (stop) project is designed to capture the opportunity that is provided by admission for acute smoking related illness, to assist patients through withdrawal by use of a combination of: * the new medication champix with * best practice counselling * initiated in an inpatient setting to achieve: * sustained smoking abstinence * reduced hospital bed and health service utilisation * reduced inpatient smoking and craving prior to discharge

a national standard in public hospitals for the management of smoking in patients admitted with smoking related acute illnesses is lacking. where such patients have continued to smoke up until the time of admission, it can be assumed that "primary" prevention has failed. once admitted, there is a vastly under-utilised opportunity, by use of a structured and systematic approach, to intervene with a secondary prevention attempt. this takes advantage of the synergy of: 1. the smoker is a "captive audience" and may be receptive to considering lifestyle factors that have lead to the admission, and 2. best practice medication and counselling can be initiated prior to discharge. if proven to be cost-effective in our analysis, a systematic roll-out of this secondary prevention initiative would be advocated. ie translation of research into practice.

Eligibility criteria:
inclusion criteria: * smoker of at least 10 cigarettes per day on average over the past 12 months * inpatient with an anticipation admission of at least one day * willingness to quit smoking * aged between 20 and 75 years * a plan of discharge to go home * acute hospital admission with cardiovascular, cerebrovascular, peripheral vascular diseases or airways (asthma and/or chronic obstructive pulmonary disease exclusion criteria: * subject preference to use an alternative pharmacotherapy for smoking cessation * respiratory patient being considered for home oxygen * pregnancy * breast feeding * acute or pre-existing severe psychiatric illnesses * past history of psychosis or suicidal ideation * renal impairment with creatinine clearance \<30ml/min

Keywords: cardiovascular diseases peripheral vascular diseases cerebrovascular stroke lung diseases, obstructive asthma tobacco use disorder smoking smoking cessation
high flow nasal cannula therapy for early management of acute hypercapnic cardiogenic pulmonary edema in the emergency department

Conditions: Acute Cardiogenic Pulmonary Edema; Hypercapnic Respiratory Failure

Summary: high flow nasal therapy (hfnt) has not been well evaluated for treating hypercapnia the purpose of this study is to determine whether high flow nasal therapy (hfnt) can decrease hypercapnia and improve respiratory distress parameters in emergency department patients with acute hypercapnic respiratory failure related to cardiogenic pulmonary edema and to compare its efficacy to that of non invasive ventilation.

this is a prospective observational study conducted as a preliminary study to the randomized controlled opticap trial (nct02874339). prospective observational exploratory study including ed patients with a suspected diagnosis of acute hypercapnic respiratory failure related to cardiogenic pulmonary edema who require niv according to the joint recommendations from the french society of anaesthesia and intensive care and the french society for intensive care. patients will receive a 1hr treatment session by either niv or hfnt, depending on the attending ed physician expertise in using hfnt repeat evaluation of arterial blood gases and respiratory parameters and dyspnea will be performed before and after treatment sessions according to current guidelines. improvement in paco2 and other respiratory parameters after 1hr treatment by hfnt will be analysed and compared to that of niv.

Eligibility criteria:
inclusion criteria: a suspected diagnosis of acute cardiogenic pulmonary edema presenting with any of the following criteria: * dyspnea (orthopnea or a worsening of dyspnea according to nyha criteria) * respiratory rate \>20 b/min * bilateral crepitant rales at pulmonary auscultation * pulmonary infiltrate on chest x-ray signs of respiratory failure or any of the following clinical, laboratory or radiology signs: * use of accessory respiratory muscles or paradoxical abdominal movement * cardiomegaly (cardiothoracic ratio \>0.5) * hypertensive crisis * pao2/fio2 ≤ 300 mmhg breathing o2\> 8l/min or pao2 ≤ 63mmhg breathing room air hypercapnia (paco2\>45 mmhg at arterial blood gas analysis) exclusion criteria: * acute exacerbation of chronic obstructive pulmonary disease or associated dyspnea from non cardiac origin * fever (\>38,5°), sepsis or ongoing infection * contra-indication to niv

Keywords: acute cardiogenic pulmonary respiratory failure hypercapnia high flow nasal oxygen non invasive ventilation emergency department
translation, cross-cultural adaptation and turkish validation of the 25-question geriatric locomotive function scale

Conditions: Translation, Cultural Adaptation and Turkish Validation

Summary: 25-question geriatric locomotive function scale (glfs-25) is a patient-reported outcome measure consisting of 25 questions that evaluates locomotive functions and locomotive syndrome risk in elderly individuals. the purpose of this study was to translate and cross-culturally adapt the english version of the glfs-25 into turkish and to investigate the reliability and validity of the translated version of the scale.

aging is an inevitable process that begins after birth and continues until the death of the individual, affecting the person mentally and physically. approximately 21% of elderly individuals requiring care have locomotive organ disorders involving the bone, joint, muscle and nervous system. 25-question geriatric locomotive function scale (glfs-25), developed by japanese researchers in 2012, is a patient-reported outcome measure consisting of 25 questions that evaluates locomotive functions and locomotive syndrome risk in elderly individuals. this scale provides an advantage in terms of locomotive ability and early detection of locomotive syndrome in the elderly. in addition, the scale provides the opportunity to decrease number of needing for hospital care of elderly individuals by early detection of locomotive functions and the risk of locomotive syndrome. before a patient-reported outcome measure can be used in a society other than the one in which it was developed, it must be translated and culturally adapted. the glfs-25 have been translated to different cultural settings and into many languages, including brazilian, iranian and chinese. data obtained from the culturally adapted versions contribute to a better understanding of the tools measurement properties. the studies reported that translated versions of glfs-25 reliable and valid in older adults for functional assessment. therefore, a turkish version of the glfs-25 would likely be that would be helpful in the functional state management and risk factor analyzes for locomotive syndrome of the turkish older adult population. the purpose of this study was to translate and cross-culturally adapt the english version of the glfs-25 into turkish and to investigate the reliability and validity of the translated version of the scale.

Eligibility criteria:
inclusion criteria: * over the age of 65 * who can answer the questionnaire on their own or with the help of their relatives exclusion criteria: * unable to walk without the assistance of another person * having a brain disease or severe cardiovascular, pulmonary or renal disease * having a history of lower extremity and/or spine fractures in the last 6 months * were treated for acute trauma

Keywords: elderly turkish glfs-25 function reliability validity
acute salt sensitivity of blood pressure

Conditions: Blood Pressure

Summary: dietary salt raises blood pressure in certain individuals immediately after ingestion (acute salt sensitivity; ass) while not affecting others. it is hypothesized that ass is a risk factor for hypertension. however, no thresholds or diagnostic guideline is available for ass. this study is the first aim in the main study (hipo cap ditsh study) aimed at determining the threshold or blood pressure cut-offs for ass upon ingesting dietary salt.


Eligibility criteria:
inclusion criteria: * adults aged 18 years and above. normotensive. if hypertensive (should be off antihypertensive medication at least 2 weeks prior to the study) exclusion criteria: * diabetes patients, ill participants

Keywords: salt sensitivity salt acute salt sensitivity blood pressure mean arterial pressure
gd2-sada:177lu-dota complex in patients with solid tumors known to express gd2

Conditions: SCLC; Malignant Melanoma; Sarcoma; High Risk Neuroblastoma

Summary: patients with small cell lung cancer, high risk neuroblastoma, sarcoma and malignant melanoma will be treated with gd2-sada:177lu-dota complex(the imp is a two-step radioimmunotherapy, delivered as two separate products gd2-sada and 177lu-dota) to assess safety and tolerability

a phase 1 dose-escalation single-arm, open-label, non-randomized, multi-center trial of the safety and tolerability of gd2-sada:177lu-dota complex in gd2 expressing solid tumors. the trial is planned as a phase 1 trial with three parts, a, b and c. escalation in this trial will be based on a classical 3+3 trial design. part a is a gd2-sada dose escalation phase, in which patients will receive one treatment cycle. part b is a 177lu-dota dose escalation phase, in which patients will receive up to 2 treatment cycles . part c is a repeated dosing phase where the doses determined in part a and b will be administered. patients will receive repeated treatment cycles with a maximum of 5 cycles.

Eligibility criteria:
inclusion criteria: * signed informed consent from patient, legal guardian(s) and/or adolescents obtained in accordance with local regulations. pediatric patients must provide assent as required by local regulations. * age ≥18 years at the time of informed consent, for high risk neuroblastoma \& sarcoma age ≥16 years of age at time of informed consent/assent * measurable disease according to recist 1.1 * ecog performance status 0-1 * expected survival \&gt;3 months * platelet counts ≥100,000 cells/mm3 * hemoglobin ≥9 g/dl * adequate renal function with serum creatinine ≤1.5 mg/dl or creatinine clearance ≥60ml/min as calculated using the cockcroft-gault equation * patient willing and able to comply with the trial protocol exclusion criteria: * systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks prior to the first planned dosing of the imp per protocol * patients receiving any other investigational therapy for their cancer within 3 weeks prior to the first planned dosing of the imp per protocol * ongoing radiation toxicities from prior rt therapy * patients with a diagnosis of autoimmune diseases or immunodeficiencies or documented infection with human immunodeficiency virus (hiv) or hepatitis b or c virus (active) * prior treatment with anti-gd2 antibody
a study evaluating the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with previously treated estrogen receptor-positive, her2-negative locally advanced or metastatic breast cancer (acelera breast cancer)

Conditions: Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

Summary: this phase ii, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (er)-positive, human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer who have received one or two prior lines of systemic therapy in the locally advanced or metastatic setting.


Eligibility criteria:
inclusion criteria: * women who are postmenopausal or premenopausal/perimenopausal * for women who are premenopausal or perimenopausal and for men: willing to undergo and maintain treatment with approved lhrh agonist therapy for the duration of study treatment * locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent * documented er-positive tumor and her2-negative tumor, assessed locally * disease progression after treatment with one or two lines of systemic therapy (but not more than one prior targeted therapy) in the locally advanced or metastatic setting * measurable disease as defined per recist v.1.1 or bone only disease which must have at least one predominantly lytic bone lesion confirmed by ct or mri which can be followed * eastern cooperative oncology group (ecog) performance status 0-1 * adequate organ function exclusion criteria: * prior treatment with a selective estrogen receptor degrader (serd), with the exception of fulvestrant, if fulvestrant treatment was terminated at least 28 days prior to randomization * treatment with any investigational therapy within 28 days prior to randomization * advanced, symptomatic, visceral spread that is at risk of life-threatening complications * known active uncontrolled or symptomatic cns metastases, carcinomatous meningitis, or leptomeningeal disease * active cardiac disease or history of cardiac dysfunction * pregnant or breastfeeding
adjunctive minocycline in clozapine treated schizophrenia patients

Conditions: Schizophrenia

Summary: schizophrenia is a devastating and costly illness. one-third to one-half of people with schizophrenia do not respond to the most current drugs leaving clozapine as the best alternative for treatment. however, over 60% of people treated with clozapine continue to have persistent symptoms and cognitive impairments. little data is available to support evidence-based recommendations to guide clinicians in treating these patients. preliminary data has suggested that adjunct treatment with minocycline may offer robust symptom improvement in patients with schizophrenia, including those taking clozapine. minocycline has had interesting effects; including suggesting it may have a significant role in treatment of neurologic and psychiatric disorders. minocycline is currently available generically; its side effects are well-described and minimal. the proposed double-blind treatment study seeks to demonstrate that adjunctive minocycline offers patients superior efficacy for persistent positive symptoms, cognitive impairments, and/or other components of schizophrenia pathology. this knowledge could lead to the more effective treatment of patients with schizophrenia. the research itself may lead to a better understanding of the pathophysiology of positive symptoms and cognitive impairments, which could contribute to improved treatments in the future.


Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of schizophrenia or schizoaffective disorder * male or female * age: 18 to 65 years * caucasian or non-caucasian * at least six months of clozapine treatment * clozapine treatment for incomplete symptoms response (evidence of two failed previous trials of antipsychotics) * current dose of 200 mg/day for at least 3 months and a documented clozapine blood level 350 ng/ml prior to study start (maximum clozapine dose of 900 mg/day) * bprs total score of 45 or more on the 18 item version (scale: 1-7) * bprs positive symptom item total score of 8 or more * bprs positive symptom score of 4 or greater on at least one item exclusion criteria: * history of organic brain disease * dsm-iv diagnosis of mental retardation * dsm-iv diagnosis of alcohol or substance dependence within the last six months (except nicotine) * dsm-iv diagnosis of alcohol or substance abuse within the last one month (except nicotine) * pregnancy or lactation * significant renal or liver impairment * previous known hypersensitivity to tetracyclines * current treatment with tetracycline or derivative * current treatment with lamotrigine * treatment with oral contraceptives * current known infection * treatment with cholestyramine or colestipol * treatment with urinary alkalinizers (e.g., sodium lactate, potassium citrate) * treatment with warfarin * abnormal (considered positive) lyme titer

Keywords: schizophrenia cognitive symptoms clozapine
safety and efficacy of aliskiren when added to standardized losartan and optimal antihypertensive therapy in patients with hypertension, type 2 diabetes and proteinuria

Conditions: Diabetic Nephropathy

Summary: study of the efficacy and safety of aliskiren when added to losartan and optimal antihypertensive therapy in patients with hypertension, type 2 diabetes, and kidney disorders to monitor improvement in any of these conditions.


Eligibility criteria:
inclusion criteria: * hypertension * elevated urinary protein levels * confirmed type 2 diabetes exclusion criteria: * certain diseases * uncontrolled diabetes * type 1 diabetes

Keywords: diabetes nephropathy hypertension aliskiren losartan
continuous glucose monitoring in critically ill patients

Conditions: Critical Illness

Summary: the purpose of this study is to determine whether subcutaneous continuous glucose monitoring in critically ill patients is clinically feasible accurate and reliable.

hyperglycemia is is associated with more complications and higher morbidity and mortality in critically ill patients. therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. implementation of intensive insulin therapy increases workload for both physicians and especially for nurses. continuous glucose measurement would facilitate blood glucose control in critically ill patients. numerous studies have shown accuracy of the subcutaneous continuous glucose monitoring derived glucose values compared to blood glucose measurements in diabetics. studies evaluating the subcutaneous continuous glucose monitoring in an inpatient-population especially in an icu-setting are rare. therefore the aim of this study is the prospective evaluation of continuous subcutaneous glucose monitoring in critically ill patients with circulatory shock demanding norepinephrine therapy as compared to critically ill patients without shock.

Eligibility criteria:
inclusion criteria: * admitted patients expected to stay \>48h either with circulatory shock requiring norepinephrine therapy or without circulatory shock. exclusion criteria: * admitted patients expected to stay \<48h

Keywords: critical illness hyperglycemia intensive insulin therapy glucose monitoring shock
prehospital norepinephrine and early mortality in traumatic shock

Conditions: Traumatic Shock; Hemorrhagic Shock; Traumatic Brain Injury; Hypotension and Shock

Summary: the effect of early, prehospital norepinephrine use in patients with traumatic shock on mortality is unknown. recent existing observational evidence from single system data (us, france, japan) are conflicting. the investigators hypothesize that prehospital norepinephrine is associated with decreased mortality when used in patients with traumatic shock.

prehospital hypotension is associated with worse clinical outcomes in patients who sustain traumatic injuries. administration of vasoactive medications, including norepinephrine, is not advocated in north american trauma systems due to the belief that vasopressors will worsen clinical outcomes and increase mortality. however, in european trauma systems prehospital vasopressor administration is included as part of the guidelines for the management of hypotension and hemorrhagic shock. there are multiple physiologic explanations for why prehospital vasopressor administration may be useful in patients with traumatic shock, such as providing adequate blood pressure to maintain vital signs until arrival at the trauma center, allowing adequate organ perfusion in the setting of low blood flow, and supplementing decreased hormone production in the later stages of hemorrhagic shock. the purpose of this retrospective study is to investigate if prehospital norepinephrine administration is associated with decreased mortality in patients with traumatic shock. the investigators will collect patient data from previously collected sources of information and trauma databases from three separate locations: the traumabase consortium in paris, france; trenau trauma database from grenoble, france; and the r adams cowley shock trauma center in baltimore, md, usa. the investigators will perform statistical modeling to propensity score match patients that received prehospital vasopressors with patients that did not receive prehospital vasopressors and assess the association with 24-hour and 28-day mortality.

Eligibility criteria:
inclusion criteria: * age 18-90 years * blunt traumatic mechanism of injury * admitted to the trauma center from the scene of injury * systolic blood pressure during prehospital transport or at admission to the trauma center \<100 mmhg exclusion criteria: * penetrating mechanism of injury * no vital signs at the scene of injury * prehospital cardiac arrest * transferred to the trauma center from another hospital

Keywords: hypotension norepinephrine traumatic shock