Kornimate/medical-research-clean huggingface dataset:
a multiple dose study of safety, tolerability, pharmacokinetics, and pharmacodynamics of abt-288 in stable subjects with schizophrenia

Conditions: Schizophrenia

Summary: evaluate the safety, tolerability and pharmacokinetics of abt-288 in order to determine the maximum tolerated dose of abt-288 in stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.


Eligibility criteria:
inclusion criteria: * subject has signed informed consent; * current dsm-iv-tr diagnosis of schizophrenia; * clinically stable on the same single second-generation antipsychotic for the past 8 weeks; * meets study-specific panss criteria; * willing and able to cooperate with cognitive testing * females are not pregnant, not breast-feeding; * females are post-menopausal or surgically sterile or practicing birth control; * males are surgically sterile or agree to be sexually inactive or use barrier method of birth control exclusion criteria: * subject has a substance dependence disorder that has not been in sustained remission for at least 1 year; * diagnosis of schizoaffective disorder; * bipolar disorder, manic episode, dementia, ocd, or drug-induced psychosis or current major depressive disorder; * diagnoses with mental retardation; acute psychosis hospitalization within past 6 months; * current clozapine treatment; suicidal ideation or behavior; * bmi of 39 or greater; current homicidal or violent ideation; * medical or cns condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse; * positive hepatitis or hiv test result; * recent clinically significant illness/infection or surgery; * recent blood product transfusion, donation or loss of 5 ml/kg of blood; * visual, hearing or communication disability
gentamicin in preventing post endoscopic retrograde cholangiopancreatography (ercp) cholangitis in non-calculus stenting

Conditions: Cholangitis

Summary: cholangitis is the most prevalent infectious complication of ercp. stenting of biliary strictures and stenosis is one of important risk factors for post-ercp cholangitis. adding antibiotics to contrast media has proposed in some studies for prevention of cholangitis but remains controversial. in this study we compare effect of adding gentamicin versus placebo in preventing cholangitis in patients who undergone endoscopic stenting for non-calculus strictures and stenosis.


Eligibility criteria:
inclusion criteria: * patients with non-calculus biliary obstruction who need palliative treatment exclusion criteria: * fever (\> 37.8 celsius) * leukocytosis (wbc \> 10,000 /mm3) * not candidate for surgical cure of obstruction

Keywords: cholangitis; cholangiopancreatography, endoscopic retrograde; stents; cholestasis
the effects of ezetimibe on coronary plaque volume in patients with acute coronary syndrome

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to assess the effects of ezetimibe on coronary plaque volume in patients with acute coronary syndrome.

previous studies reported that administration of statins in patients with coronary artery disease resulted in significant reduction of low-density lipoprotein cholesterol(ldl-c) and regression of coronary plaque volume, and a decrease in the level of ldl-c through statin treatment positively correlates with a reduction in the volume of plaques. administration of ezetimibe in addition to statin has been shown to be more effective at reducing ldl-c levels compared with statin monotherapy. however, the effects of ezetimib on coronary plaque volume remain unclear. in this study, the investigators assess the effect of ezetimibe on coronary plaque volume and tissue composition in patients with acute coronary syndrome.

Eligibility criteria:
inclusion criteria: 1. patients who have been diagnosed as acute coronary syndrome, and successful percutaneous coronary intervention (pci) were performed with intravascular ultrasound (ivus) guidance. 2. patients having coronary plaques (≧ 500 µm in thickness or % plaque of 20% or more at ≧ 5 mm distal or proximal to the previously treated area in the same branch of coronary artery. exclusion criteria: 1. patients with bypass graft or in-stent restenosis at the site of pci. 2. patients who received pci in the past on the lesion where the evaluation of coronary plaque volume is planned. 3. patients who had plaques in a non-culprit site and might receive pci during the treatment period. 4. patients receiving lipid-lowering drugs (statins, fibrates, probucol, nicotinic acid or cholesterol absorption inhibitors). 5. patients with familial hypercholesterolemia. 6. patients with cardiogenic shock. 7. patients receiving cyclosporine. 8. patients with any allergy to ezetimibe. 9. patients with hepatobiliary disorders. 10. pregnant women, women suspected of being pregnant, or lactating women. 11. patients with renal disorders or undergoing dialysis. 12. patients who are ineligible in the opinion of the investigator.
biomarkers in pain and pain treatment

Conditions: Chronic Pain; Inflammation

Summary: the goal of this research project is to explore if levels of inflammation predict levels of comorbid mood disorders and treatment success in chronic pain patients. more knowledge in this respect will advance our understanding of chronic pain and comorbid syndromes, and facilitate subgroupings of patients based on the presence and/or level of low-grade inflammation. this research is an important step towards finding an explanation to why treatment effects following behavioral interventions differ across individuals, and generate new hypothesis regarding novel treatment approaches. the specific aims are: 1) to explore if baseline levels of inflammatory biomarkers predict the effects of behavioral intervention and 2) to investigate if baseline levels of inflammatory biomarkers are associated with psychological co-morbidity (e.g. depression, anxiety and fatigue) in patients with chronic pain.


Eligibility criteria:
inclusion criteria: 1. referred to a specialist clinic within pain management 2. equal to or older than 18 years 3. chronic pain (\> 6 months) 4. the pain is refractory 5. the pain results in significant functional limitations 6. stable medication in the last 2 months and no planned changes in medication (except possibly discontinuation or lowering of current dose) exclusion criteria: 1. spontaneous improvement can be expected (without treatment) 2. psychiatric comorbidity a) is deemed to be the main reason for the restrictions, or b) should be promptly evaluated and possibly treated, or c) may adversely affect the treatment given in the context of the study 3. significant risk of suicide 4. poor teamwork, defined as repeated missed appointments during the assessment / investigation phase 5. language difficulties (swedish)

Keywords: psychoneuroimmunology
samples from leukemia patients and their donors to identify specific antigens

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this project is to develop a process to identify highly personalized antigens that are uniquely expressed by the patient's own leukemia cells that can be used for cellular immune therapy.

it is well known that tumor cells and leukemia cells express different surface structures (called antigens) that can serve as targets for cancer cell destruction by the immune system. effective immune therapies are characterized by high specificity and low toxicity. one of the major obstacles impeding the use of these therapies as standard of care is the identification of good target antigens. in acute myeloid leukemia (aml) there is major patient to patient variation in leukemia antigens, so there is no universal aml cell target. rather, each patient has a unique array of potential cell targets. thanks to the rapid progress of new dna/rna sequencing technologies, the identification of these unique, patient-specific leukemia cell antigen-targets is now possible. the purpose of this project is to develop a process to identify highly personalized antigens that are uniquely expressed by the patient's own leukemia cells that can be used for cellular immune therapy.

Eligibility criteria:
inclusion criteria: * diagnosis of aml with plan to receive a bone marrow transplant exclusion criteria: * na

Keywords: acute leukemia acute myeloid leukemia aml
the value of pancreatic stone protein in predicting acute appendicitis

Conditions: Appendicitis; Abdominal Pain; Abdominal Sepsis

Summary: psp (pancreatic stone protein) is a compound naturally produced mainly in the pancreas and the gut. there is evidence from experimental and clinical trials that the levels of psp in the blood rise in the presence of inflammation or infection. what is not yet well known about psp is whether it is superior to other established blood tests (e.g. wbc or crp) in predicting appendicitis in patients that present at the emergency room with abdominal pain and a clinical suspicion of appendicitis.

interim analysis will be performed once 123 patients are recruited. a power analysis will be performed and the sample size re-calculated based on the actual and precise data collected. at interim analysis, the external data monitoring committee will decide upon the continuation or discontinuation of the trial, as well the potential need to modify the sample size. if any changes are suggested by the external data monitoring committee, the principal investigators will decide on the feasibility of the potential changes and submit a formal addendum to the ethics committee. no changes will be made to the protocol or study design unless first approved by the ethics committee. any changes to the protocol approved by the ethics committee will be updated at clinicaltrials.gov

Eligibility criteria:
inclusion criteria: * age \>18 years of age (subject to the current ethics approval protocol, may change) * clinical suspicion of appendicitis as the primary or differential diagnoses * patients able to provide informed consent exclusion criteria: * age \<18 years of age (subject to the current ethics approval protocol, may change) * abdominal discomfort without tenderness or rebound or clinical suspicion of appendicitis * pregnancy * patients with impaired consciousness * patients not able to provide informed consent * patients that will receive an appendicectomy as part of another elective procedure

Keywords: pancreatic stone protein abdominal pain acute appendicitis alvarado score appendectomy sensitivity and specificity
videothoracoscopic (vats) vs. robotic approach for lobectomy or anatomical segmentectomy

Conditions: Lung Cancer

Summary: this is a prospective, randomized, multicenter study on 300 patients (150 vats lobectomies and 150 robotic lobectomies) affected by early stage (i-ii) lung cancer. the expected recruitment is one year and two year follow up. surgeons should have a minimum of 30 major lung resections performed using one of the two techniques for participation in the study. each participating centers should have the possibility to offer both techniques (robotics and vats). the primary end point is a combination of conversion and complication rate. the presence of at least one of the two events is considered a failure. considering the rate of failure of 35% in the vats arm, we want to see a failure rate not over 20% in the robot arm, so with a power of 80% and an alpha error of 5%, we need a total of 300 patients.


Eligibility criteria:
inclusion criteria: * age older than 18 years old * known or suspected lung cancers * patients in clinical stage t1-t2, n0-n1 candidate to surgery lobectomy or anatomical segmentectomy * asa-1-2-3 exclusion criteria: * clinical stage \>ii * severe heart disease * alcohol abuse * renal impairment (creatinine \>2.5) * presence of serious comorbidities

Keywords: lung cancer, video-assisted thoracoscopic surgery, robotic-assisted thoracoscopic surgery
validation of a self-questionnaire in french on the use of the upper limbs in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is an inflammatory and demyelinating disease of the central nervous system that causes disability in young adults. this disability can take many forms depending on the neurological systems affected: disability walking, cognitive impairment or disability in the upper limbs. the development of validated measurement tools for these different disabilities is essential for the follow-up of patients in clinical routine and for the evaluation of new therapies.

a specific self-questionnaire for patients with ms has recently been developed and validated in english and dutch: "the arm function in multiple sclerosis questionnaire (amsq)". the questionnaire groups 31 items and was created from questionnaires developed for other pathologies. the dutch team that developed this questionnaire combines biostatisticians and neurologists, experts in the development and validation of disability measurement tools. this study aims to validate the french version of amsq questionnaire. this study is carried out in collaboration with the amsterdam team, which has carried out the methodology and will conduct the statistical analysis.

Eligibility criteria:
inclusion criteria: * patient with ms according to the diagnostic criteria of 2010 * age ≥18 years * patients seen in consultation at the sep reference center in rennes exclusion criteria: * other neurological or rheumatological pathology hindering the use of the upper limbs * inability to understand * minors * major persons subject to legal protection (legal safeguards, guardianship) * persons deprived of their liberty

Keywords: multiple sclerosis self-questionnaire measurement tools
diagnostic and prognostic biomarkers of sepsis

Conditions: Sepsis

Summary: this study aims to evaluate sepsis biomarkers as soluble triggering receptor expressed on myeloid cells 1 (strem-1) and soluble urokinase plasminogen activator receptor (supar) in diagnosis of sepsis in comparison to the traditional blood culture and c-reactive protein (crp) and to evaluate the prognostic value of these biomarkers in comparison to sequential organ failure assessment score (sofa score), acute physiology and chronic health evaluation ii ( apachi score), 28 day mortality.

sepsis is usually diagnosed in patients have clinically suspected infections with systemic inflammatory response syndrome (sirs) manifestations. patients with sirs as those with trauma or stroke have the same classic infection signs such as fever and elevated leukocytic count, as long as the microbiological diagnosis is the ultimate diagnostic method, but it has poor sensitivity with delayed results. new biomarkers such as strem-1 and supar can be used for rapid diagnosis of sepsis and differentiating it from non infectious inflammatory syndromes. also these soluble biomarkers can be used for predicting the prognosis of sepsis patients

Eligibility criteria:
inclusion criteria: * temperature of \>38oc * heart rate of \>90 beats/min * respiratory rate of \>20 breaths/min * partial pressure of arterial carbon dioxide (paco2) of \<32 mmhg * white blood cell (wbc) count of \>12,000 cells/mm3 exclusion criteria: * hiv patients * patients with neutropenia \<1000 cells/mm3 * \<18 years of age.

Keywords: strem-1 supar crp
an assessment of rapid streptococcal tests in community clinics in israel

Conditions: Pharyngitis; Streptococcus Pyogenes Infection; Streptococcus Pyogenes Identification

Summary: there is a large over-use of antibiotics in family medicine, especially in upper respiratory tract infections. this study is designed to determine if the use of rapid streptococcal tests in primary care clinics can lower the rate of antibiotic use while not missing bacterial infections.

pharyngitis is a clinical diagnosis which requires antibiotic treatment only if caused by group a streptococcus (gas). however, it is impossible to identify by clinical signs alone those patients whose symptoms are caused by this pathogen. diagnosis demands a throat culture, which requires at least 24 hours to rule in infection and 48 hours to rule it out. rapid streptococcal tests (rst) based on antigen identification have been in use for over 10 years. these allow determination of the presence of gas within 10 minutes using tests designed for point of care use. while the specificity of these tests is generally reported as high (90-95%), the sensitivity is quoted at between 60% and 90% , depending on author affiliation, place of testing and type of test. various protocols have been put forward, these combine clinical signs (centor criteria) with rst or throat cultures in order to lower antibiotic over-use. these protocols are often under-used by primary physicians, even when rsts are available. clalit health services, the largest hmo in israel, has decided to evaluate all the rsts available in the country in community clinic settings in order to determine the feasibility of adopting these tests to improve clinical care. the sensitivity, specificity and ease-of-use will be assessed in 25 clinics in various settings (urban and rural). gold standard will be a standard throat culture processed in the district laboratory. the effect of point-of-care testing will be estimated by requiring physicians to decide on antibiotic use before receiving the result of the rst. (they will be free to change this decision after the test). clinics were selected by number of throat cultures sent in previous years. the number of patients was determined using the positivity rates of 2005. the results of this study will enable us to estimate the benefit and cost of adopting rsts, and to determine in which situations they will be most efficacious.

Eligibility criteria:
inclusion criteria: * sore throat * at least two centor criteria: * fever \> 38 deg c or history of fever * enlarged cervical lymph nodes * tonsillar exudate * lack of cough * age 3-14 years exclusion criteria: * antibiotic treatment in preceding 7 days * no informed consent

Keywords: pharyngitis community infections rapid testing group a streptococcus
crystalline lens tilt evaluation using swept-source optical coherence tomography

Conditions: Cataract Surgery

Summary: the goal of this retrospective study is to quantify the physiological lens tilt of the phakic eye. the main question it aims to answer is: -what influence does misalignment or tilting of iols have on visual quality? preoperative biometry data are compared with anterior segement oct data. measurements were obtained using high-resolution swept-source optical coherence tomography. the influence of biometric measurements on tilt is analyzed.

the human (crystalline or phakic) lens is located in the capsular bag which is attached to zonules. zonules are fibres, that hold the lens in place. in the course of life, an opacification on the lens occurs, which is called cataract. to replace the cloudy lens, cataract surgery is being performed and an artificial intraocular lens (iol) is implanted in the eye, after the phakic lens is removed. misalignment or tilting of iols can result in reduction of visual quality, therefore prediction of the position may be beneficial. modern optical coherence tomography (oct) devices already provide profound information about phakic lens tilt. still there is little data on the values that influence the tilt of the crystalline lens. before each cataract surgery, each eye is measured using biometry (iol master 700). however, a statement about the tilt cannot be made on the basis of the results of iol master 700. for this purpose, an anterior segment oct is required (casia 2). in this study, preoperative biometry data are compared with anterior segment oct data. a statistical analysis will then be performed to identify the biometric parameters that can predict phakic lens tilt.

Eligibility criteria:
inclusion criteria: * planned cataract surgery in one or both eyes * minimum age of 21 years exclusion criteria: * opacities of the refracting media * measurement error in the context of preliminary investigation * pseudophakia

Keywords: cataract casia2 iol master700
identifying patients in risk of post-operative complications using pacu discharge criteria

Conditions: Complication,Postoperative; Post-Op Complication

Summary: in the postoperative care unit surgical patients are monitored closely to ensure safe condition before transfer to the ward. this study will aim to identify patients in risk of complications on the ward using the national postanesthesia care unit (pacu) discharge criteria, a modified aldretes score. secondary to identify patients in risk of micro events as detected by continuous monitoring of vital signs on the ward.

patients undergoing esophageal resection and pancreaticoduodenectomy are at high risk of developing complications after surgery. described patient groups are monitored for at least 24 hours in pacu before returning to the ward. in denmark physiological parameters are assessed in the pacu every hour until discharge using the dasaim discharge criteria (a modified aldrete score). the pacu discharge score is calculated on parameters including sedation, respiratory rate, saturation, systolic blood pressure, puls, physical capability (if epidural or spinal anesthesia), pain in rest, nausea, diuresis and temperature. each parameter is given a score between 0 and 3. 0 describes no problem and 3 describes a severe problem. the investigators will investigate the predictive value of the pacu discharge criteria and interventions in the pacu setting, to identify patients at risk of developing postoperative complications. secondary outcome is micro events on the ward. patients vital signs are monitored continuously from pacu discharge until the 5th postoperative day. micro events are defined as deviations of vital parameters from normal range.

Eligibility criteria:
inclusion criteria: * elective surgery * pancreaticoduodenectomy (kjlc30) * transthoracic esophageal resection without interposition (kjcc10) exclusion criteria: * patients not expected to be able to cooperate * patients not cognitive well (mini mental state examination \< 24) * pacemaker * patients with allergies including band aid, plastic and silicone

Keywords: pacu postoperative care unit continous monitoring pacu discharge criteria
neurological complications - pulmonary transplant

Conditions: Cognitive Dysfunctions

Summary: a monocentric prospective open study to evaluate the frequency and nature of cognitive complications in the 3rd month post pulmonary transplant.


Eligibility criteria:
inclusion criteria: * patients more than 18 years of age. * enregistered in lung transplant waiting list * have given their agreement to be enrolled in the study exclusion criteria: * patients had a previous lung transplant * patients with insufficient level of french language that may affect the comprehension and answering the psychometric test

Keywords: pulmonary transplant
prevention of the progression of coronary calcification with use of spironolactone in peritoneal dialysis patients

Conditions: Coronary Artery Calcification; Vascular Calcification

Summary: vascular calcification is a frequent complication in dialysis patients and is strongly associated with mortality. its pathogenesis is complex and involves a series of markers that act on the vascular microenvironment. there is evidence that aldosterone is one of the biomarkers and may have a role in osteoinductive pathways.the aim of this study was to evaluate the effect of spironolactone, an inhibitor of mineralocorticoid receptor, in the progression of coronary calcification in patients undergoing peritoneal dialysis.


Eligibility criteria:
inclusion criteria: * coronary calcium score \> 30 agatston unit * peritoneal dialysis for at least 6 months exclusion criteria: * use of spironolactone in the last 3 months * mean serum potassium \> 6 meq/l in the last 3 months * cardiac revascularization surgeries * arrhythmias * pregnancy

Keywords: vascular calcification coronary calcification peritoneal dialysis spironolactone