Kornimate/medical-research-clean huggingface dataset:
dose ranging study of bococizumab (pf-04950615; rn316) in hypercholesterolemic japanese subjects

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to evaluate the low density lipoprotein cholesterol (ldl-c) lowering effect of bococizumab (pf-04950615;rn316) administered subcutaneously at every two weeks (q14d) in hypercholesterolemic japanese subjects whose ldl-c is not controlled by a stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose ldl-c is not controlled.


Eligibility criteria:
inclusion criteria: * subjects whose ldl-c is not controlled by a stable dose of atorvastatin (population a). * subjects who are naïve to a treatment by lipid lowering drug and whose ldl-c is not controlled (population b). exclusion criteria: * severe acute or chronic medical or psychiatric condition or laboratory abnormality. * pregnant females; breastfeeding females; males and females of childbearing potential; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception. * subjects who were administered or prior exposed to pf-04950615 and/or anti-body targeting pcsk9.

Keywords: pf-04950615 japan
effect of lidocaine 1% and 2% in the tube cuff on postoperative sore throat and cough

Conditions: Postoperative Sore Throat; Postoperative Cough

Summary: comparing the effect of different methods of endotracheal tube cuff inflation on the occurrence of a postoperative sore throat and cough (air vs lidocaine 1% vs lidocaine 2%).

eligible patients undergoing general anesthesia will be randomized and assigned to three groups: group a: endotracheal tube cuff inflation with air group b: endotracheal tube cuff inflation with lidocaine 1% group c: endotracheal tube cuff inflation with lidocaine 2% the induction of anesthesia will be made following a preoxygenation with a facial mask with 100% oxygen. it consists on the intravenous injection of sufentanil 5 mcg or fentanyl 50mcg, lidocaine 1mg/kg, propofol 2.5mg/kg, rocuronium 0.6mg/kg or cisatracurium 0.15mg/kg. maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention). the intubation is made by a n° 7.5 tube in men and a n° 7 tube in women. cuff inflation will be done upon placement of the endotracheal tube. the cuff's pressure will be monitored at several intervals of the intervention and kept \< or = 20 centimeter of water (cmh2o). the volume of lidocaine used will never exceed 5 mg / kg for the patient to be protected from the local toxicity of the local anesthetic in case of accidental rupture of the balloon. all patients will receive paracetamol every 6 hours for the first 24 hours after the end of surgery.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * american society of anesthesiologists classification (asa) category 1 or 2 * high pressure, low volume endotracheal tube - (lo-pro) exclusion criteria: * ear nose and throat and cranial surgery * ear nose and throat pathologies * asthma and bronchial hyperreactivity * chronic cough * diabetes * cognitive disorders * swallowing disorders * corticotherapy during the last week * allergy to lidocaine * urgent surgery * nasogastric, oro-gastric * ventral position * more than 2 intubation attempts * continuous intravenous infusion of lidocaine intraoperatively.

Keywords: lidocaine 1% lidocaine 2% endotracheal tube cuff cuff inflation postoperative sore throat postoperative cough general anesthesia endotracheal intubation
prospective assessment project of airway management-related incidents in adult anaesthesia care papaya iii

Conditions: Airway Complication of Anesthesia; Adverse Events

Summary: the overall objective of the study is to evaluate and analyze major and minor incidents during airway management in adults under anaesthesia care at all study sites. the patient characteristics, type of airway management is recorded and if airway management-related incidents occur, they are analyzed in more detail to improve patient safety in the future.

it is a prospective observational cross-sectional european multi-centre study collecting health-related patient data on anaesthetic airway management over three months. this detects the incidence and nature of local airway management problems and assesses how they are solved. this will enable the investigators to identify generalisable interventions and recommendations to further improve patients' airway management to improve patient safety. during the observational period, the anaesthesia staff in charge will fill out a screening questionnaire for airway management for every patient undergoing anaesthesia care with airway management. the investigators will extract the characteristics from the local anaesthesia record system for all patients. if no event arises, there are no further requirements. if an event occurs, the anaesthesia provider will fill out an additional form asking for more details on what happened.

Eligibility criteria:
inclusion criteria: * all adult patients requiring airway management under anaesthesia care for elective, semi-elective, urgent or emergency diagnostic procedures or interventions. airway management includes awake and asleep tracheal intubation, insertion of supraglottic airway devices, and face mask ventilation. * patients older than 18 years of age * informed consent given or general consent in place, according to local ethics committee requirements. exclusion criteria: * refusal to give consent or withdrawal of consent. * patients \<18 years.

Keywords: intubation, intratracheal anesthesiology difficult airway critical events
effectiveness study of vilazodone to treat depression and to discover genetic markers associated with response

Conditions: Depressive Disorder, Major

Summary: this study is designed to determine the safety and effectiveness of vilazodone for major depressive disorder and to discover genetic markers associated with response. this study will enroll approximately 400 patients.

this randomized, double-blind, placebo-controlled, multicenter, 8-week, clinical trial is designed to assess the efficacy and safety of vilazodone and to discover genetic markers of treatment response associated with vilazodone use in adult patients diagnosed with mdd by the dsm-iv-tr criteria. this study will enroll approximately 400 patients.

Eligibility criteria:
inclusion criteria: * male or female patients 18-65 years of age, inclusive. * a diagnosis of mdd, single episode or recurrent, according to dsm-iv-tr (296.2/296.3) with a current major depressive episode of less than two year's duration with a minimum duration of at least 4 weeks. * ham-d score ≥ 22. * ham-d item 1 (depressed mood) score ≥ 2. * patients must be able to provide written informed consent to participate before beginning any trial related activities. * patients must be able to speak, read and understand english and possess the ability to respond to questions and follow simple instructions. exclusion criteria: * a current (or within 6 months prior to the screening visit) axis i disorder of post traumatic stress disorder, eating disorder, obsessive compulsive disorder (generalized anxiety disorder, social phobia or simple phobia will be allowed). * a history of schizophrenia, schizoaffective disorder or bipolar i or ii disorder (with a history of hypomanic or manic episodes). * dsm-iv-tr criteria for substance abuse (alcohol or drugs) within 3 months prior to screening visit or substance dependence within 6 months prior to the screening visit. * criteria for any of the following dsm-iv-tr mdd specifiers: \[a\] with catatonic features; \[b\] with postpartum onset; \[c\] with seasonal pattern.

Keywords: depression. genetics, pharmacogenetics
multicenter trial of daily chlorhexidine bathing to reduce nosocomial infections

Conditions: Nosocomial Bacteremia; MRSA Colonization; MRSA Infection; VRE Colonization; VRE Infection

Summary: to determine if daily bathing with chlorhexidine impregnated washcloths will reduce the incidence of mrsa and vre within an intensive care unit (icu) or ward setting.

this is a cluster randomized, crossover-controlled trial with wards as the units of randomization. the trial will predominantly take place in icu's but may include any acute care ward that has active surveillance for mrsa and or vre in place (i.e., bone marrow transplant units, oncology wards, etc.) units will be randomly assigned to utilize two bathing routines in a random order. each bathing routine will be utilized on all admitted patients to the unit for a six month study period for a total study duration of 12 months. the two bathing routines will include either the use of the comfort® bath washcloth system (control) or the use of 2% chlorhexidine gluconate cloth. randomized units will either start with 2% chlorhexidine gluconate cloth for six months and then switch to comfort™ bath washcloth for the remaining six month period or the reverse order. data collection will include all surveillance and clinical cultures for mrsa and or vre and all bloodstream infections.

Eligibility criteria:
inclusion criteria: * all patients admitted to study units during the proposed study interval are eligible for inclusion in the study exclusion criteria: * patients with known allergies to chlorhexidine gluconate or any other ingredients in the product * patients with burns that include a high percentage of disrupted body surface area * use in patients undergoing lumbar punctures or contact with the meninges * patients with large open skin wounds; and * children less than 18 years old

Keywords: mrsa vre bsi
quantiferon-cmv test in a prediction for colic cytomegalovirus reactivation during ulcerative colitis

Conditions: Cytomegalovirus Infections

Summary: cytomegalovirus (cmv) infection impairs evolution of ulcerative colitis (uc) leading to more severe and resistant to immunosuppressive therapies flare-up. cytomegalovirus (cmv) reactivation is assessed by the quantification of the cytomegalovirus (cmv) deoxyribonucleic acid (dna) load by real-time pcr (qpcr) in colonic biopsies; this assay is invasive and costly. the quantiferon-cytomegalovirus (qf-cmv) assay measures the immune response against cytomegalovirus (cmv) in a blood specimen.

this study aim to evaluate the performances of this new assay to predict the risk of cytomegalovirus (cmv) reactivation in the colon of uc patients. a new algorithm for the care of ulcerative colitis (uc) patients that could be used in all centers, even those without molecular biology lab, could be proposed: in case of a positive quantiferon-cytomegalovirus (qf-cmv) assay, the immune response protects the patient against cytomegalovirus (cmv) reactivation and intensification of immunosuppressive therapies should be proposed; at the opposite, a negative quantiferon-cytomegalovirus (qf-cmv) assay will invite to biopsy in order to detect cytomegalovirus (cmv) replication and to treat with ganciclovir when appropriate. this algorithm will preserve invasive biopsies in absence of cytomegalovirus (cmv) tissue reactivation.

Eligibility criteria:
inclusion criteria: * patient with seropositive for cytomegalovirus (cmv) (igg+) * patient requiring hospitalization for flare of ulcerative colitis (uc) with mayo score \> 5 and an endoscopic subscore ≥ 2 * social security affiliation * signed informed consent exclusion criteria: * wardship patient and curatorial patient * patient unable to understand or sign the protocol * colectomy total or partial

Keywords: immune response against quantiferon-cytomegalovirus (qf-cmv) ulcerative colitis (uc) cytomegalovirus (cmv) quantitative polymerasechainreaction (qpcr) immunohistochemistry (ihc)
perioperative assessment of right ventricular function and venous return in patients with epithelial ovarian cancer undergoing cytoreductive surgery (gyn right) - pilot study

Conditions: Right Ventricular Function and Venous Return

Summary: in this prospective, observational study the investigators assess the perioperative course of right ventricular function in combination with the venous return in patients undergoing major non-cardiac surgery. the study aims to investigate if patients undergoing major non-cardiac surgery develop an impairment of right ventricular function and/or venous return. furthermore, the study evaluates if an impairment of right ventricular function and/or venous return is associated to left ventricular function, arterial side of the circulation and to postoperative clinical outcome.


Eligibility criteria:
inclusion criteria: * offered patient information and written informed consent * female patients aged greater than or equal to 18 years for cytoreductive surgery of a primary epithelial ovarian tumour 1. patient group 1: female patients with \> 500 ml ascites in the preoperative sonographic examination 2. patient group 2: female patients aged \> 70 years and at least one of the following secondary diagnoses: * status post stent placement due to coronary heart disease respectively status post-myocardial infarction * existing arterial hypertension for more than 5 years * chronic heart failure (new york heart association (nyha) class ii-iii) * peripheral arterial disease exclusion criteria: * patients aged less than 18 years * persons without the capacity to consent * inability of german language use * lacking willingness to save and hand out data within the study * accommodation in an institution due to an official or judicial order * (unclear) history of alcohol or substances disabuse * coworker of the charité * advanced disease of the oesophagus or upper respiratory tract at the beginning of hospitalization * operation in the area of the oesophagus or nasopharynx within the last two months before participation in the study * neurological or psychiatric disease at the beginning of hospitalization * chf (congestive heart failure) according to (new york heart association) classification - nyha class iv at the beginning of hospitalization * american society of anesthesiologists (asa) classification greater than iv * renal insufficiency (dependency of haemodialysis) at the beginning of hospitalization * pulmonary oedema in thorax x-ray at the beginning of hospitalization * history of intracranial hemorrhage within one year before participation in the study * conditions following venous thrombosis within the last three years before study inclusion * known allergies or hypersensitivity on colloidal, starch or gelatine infusion solutions * diabetes mellitus with signs of severe neuropathy * known atrial fibrillation * participation in an interventional clinical trial during the study period; exception: assignment to adjuvant therapy study during this study is allowed.
inhaled hypertonic saline for bronchiolitis

Conditions: Bronchiolitis

Summary: study design: this randomized, double blind, controlled, multi-centre study will occur in the emergency department, hospital-based urgent care centre or paediatric outpatient clinics (collectively "ed") of 3 general hospitals in ontario and 1 in british columbia.

children under age 2 years presenting for unscheduled care to the ed with a diagnosis of moderately severe bronchiolitis (as defined by inclusion/exclusion criteria below) will be approached for entry into the study. recruitment will only occur when research assistants are on duty, is projected to include regular working hours monday-friday as a minimum and will continue until the calculated sample size has been obtained (anticipated 12 months). initial routine assessment by the ed staff will identify potential subjects and research assistants will be notified to apply the inclusion/exclusion criteria and obtain informed consent if appropriate. recruited subjects will be randomized to receive treatment in a double blind fashion with inhalation of nebulized study solution containing either 7% hypertonic saline (hs, study group) or 0.9% saline (ns, control group). each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) added by the ed staff. each participant will remain on the same allocation throughout the protocol and receive 3 consecutive 4ml doses of the assigned study solution with salbutamol over a 1-hour period.

Eligibility criteria:
inclusion criteria: 1. age under 2 years 2. history of viral upper respiratory infection within previous 7 days 3. wheezing or crackles detected on chest auscultation 4. respiratory distress assessment instrument (rdai) score of 4 or greater or oxygen saturation (sao2) of 94% or less in room air. exclusion criteria: history of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), down syndrome, gestational age under 34 weeks. severe illness at presentation as defined by any of the following respiratory rate greater than 80/min sao2 less than 88% in room air need for assisted ventilation use of nebulized hs within previous 12 hours previous enrollment in this study.

Keywords: infant bronchiolitis hypertonic saline
investigating fe 202158 as potential primary treatment in patients with early septic shock

Conditions: Septic Shock

Summary: the purpose of this trial is to investigate the potential of fe 202158 as a treatment which can stabilize blood pressure for treatment of patients in early septic shock.


Eligibility criteria:
inclusion criteria: * signed informed consent form by the patient or a legal representative according to local regulations' * man or women 18 years of age or older * body weight below 115 kg for male patients and 100 kg for female patients * proven or suspected infection * septic shock, i.e. vasodilatory hypotension requiring vasopressor support * willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from informed consent to one week after the end of infusion of study medication exclusion criteria: * present or a history within the last 6 months of symptoms of acute coronary syndrome (myocardial infarction or unstable angina) * known or suspected endocarditis * hypovolaemia suspected on clinical grounds, e.g. cold extremities with delayed capillary filling, low cardiac filling pressure, marked systolic or pulse pressure variation or positive leg raising test * known or suspected cardiac failure * known or suspected infection with (hiv)-1, hiv-2, hepatitis b, or hepatitis c * pregnancy or breastfeeding * any cause of hypotension other than early septic shock * use of vasopressin or terlipressin within 7 days prior to start of imp infusion * proven or suspected acute mesenteric ischemia, as judged by the investigator * known episode of septic shock within 1 month prior to screening * death anticipated within 24 hours, or due to the underlying disease within 3 months * known past or current 2nd and 3rd degree av-block without a well functioning pacemaker * brain injury within current hospitalisation * present hospitalisation with burn injury * symptomatic peripheral vascular disease including raynaud's syndrome * previously included in this trial * intake of an investigational medicinal product (imp) within the last 3 months (or longer if judged by the investigator to possibly influence the outcome of the current study) * known participation in another interventional clinical trial * considered by the investigator to be unsuitable to participate in the trial for any other reason
characteristics of pts initiating spiriva respimat in asthma

Conditions: Asthma

Summary: this study is a cross-sectional, non-interventional study based on existing data (nised).

the uk cprd data will be used to assess the characteristics of asthma patients who were prescribed ics/laba fdc before the index date and who initiated spiriva respimat, or received a higher dose of ics/laba fdc, or initiated ltra, or switched to a new ics/laba fdc in the uk during the study period (september 2014-december 2017) enabling to assess potential channeling of prescribing to different patient populations.

Eligibility criteria:
inclusion criteria: * aged 18 years and above at the index date * at least 12 months of continuous registration prior to the index date in a practice contributing up to standard (uts) data to the clinical practice research database (cprd) * had a diagnosis of asthma before the index date * being treated with inhaled corticosteroids/long-acting beta agonists (ics laba fdc) before the index date (at least one prescription within 3 months before the index date) * patients who were new users of spiriva respimat, or ltra, or patients who were prescribed a higher dose of ics/laba fdc, or patients who switched to a new ics/laba fdc from the previous ics/laba fdc exclusion criteria: * patients who were prescribed other long-acting muscarinic antagonists (lama) any time before or on the index date * in the primary analysis, patients who were diagnosed with copd before or on the index date will be excluded from the study. in a sensitivity analysis, patients who had both asthma and copd diagnoses will be included in the study
a self-efficacy intervention to reduce injecting risk behaviour and hepatitis c reinfection rates

Conditions: Hepatitis C

Summary: the study evaluates the use of implementation intentions to increase self-efficacy and reduce injecting risk behaviour in a sample of injecting drug users on treatment for hepatitis c (hcv). the overall aim is to reduce hcv reinfection rates. the primary objective is to identify lower injecting risk behaviour scores in patients on treatment for hepatitis c receiving the psychosocial intervention compared to the same patient group assigned to the control group.

the intervention will entail completing a volitional help sheet.this will create implementation intentions, which are self-regulatory strategies taking the form of "if-then" plans (i.e. situation-solution plan). injecting risk behaviour scores and self-efficacy scores will be analysed for differences between intervention and control groups. to control for contact-time with the researchers, participants in the control group will spend approximately 20 minutes with the researcher exploring zimbardo's time perspective constructs (ztpi, zimbardo \& boyd, 1999) and completing the short zimbardo's time perspective inventory (orosz et al. 2017). the inventory was selected because the cognitive processes involved in accessing time constructs will also be activated in the intervention group for the planning of coping strategies and goal achievement during future injecting risk situations. the study also aims: * to assess the variability in injecting risk behaviour as explained by subjective norms, social connectedness and group identification constructs; * to assess the variability in intervention effectiveness as explained by changes in mental health, illness perception subjective norms, social connectedness, and group identification.

Eligibility criteria:
inclusion criteria: * male or female. (over 18 years of age); * chronic hcv positive infection; * current illicit drug use established through participants' self-report; * current hcv treatment provided by the nhs; * informed consent, agreeing to study and monitoring criteria; * english-speaking. exclusion criteria: * inability to provide informed consent; * aggressive or violent behaviour; * not currently receiving hcv treatment; * inability to communicate in english.

Keywords: behavioural medicine health psychology psychosocial intervention people who inject drugs