Kornimate/medical-research-clean huggingface dataset:
weaning of norepinephrine guided by the dynamic arterial compliance in cardiac surgery post operative.

Conditions: Vasoplegic Syndrome

Summary: after cardiac surgery, vasoplegic syndrome is a hemodynamic state characterized by profound hypotension associated with a decrease in systemic vascular resistance. the care of this disease is based on the intravenous administration of a vasopressor, usually norepinephrine. during the recovery phase, weaning of norepinephrine, is an important step in which any lack of preload (blood volume) initial or secondary can be, and increase tissue malperfusion.


Eligibility criteria:
inclusion criteria: * major patient ≥ 18 years * patient operated a cardiac surgery for myocardial revascularization (cabg surgery) or surgical correction of valvular or combined surgery (cabg and valve disease) or surgery the ascending aorta and cardiac surgery with vasoplegic syndrome treated by norepinephrine * signed consent * affiliation to social assurance exclusion criteria: * permanent atrial fibrillation * treatment with dobutamine and/or epinephrine * pregnant woman * patient under guardianship or private public law * internal pacemaker * hypothermia * patient refusal
treatment of antipsychotic-associated obesity with a glp-1 analogue

Conditions: Obesity; Metabolic Syndrome X; Drug-induced Obesity; Schizophrenia

Summary: to examine if 3 months of treatment with a glp-1 (glucagon-like-peptide-1) analogue can induce weight loss in obese, non-diabetic patients with a diagnosis within the schizophrenic spectrum. the investigators will also examine possible associations between glp-1 treatment and peripheral metabolic parameters such as change in body fat and hba1c. moreover, the glp-1 analogue treatment will be associated with the effects/changes on cognition and subjective quality of life. possible cerebral effects (pro-cognitive) of the glp-1 analogue treatment will associated and correlated with changes in the brain, functional magnetic resonance imaging (fmri).

the primary endpoint is weight loss after 3 months of treatment with the glp-1 analogue exenatide (bydureon®). secondary endpoints comprise both physiological/metabolic parameters and cognitive measurements: * metabolic endpoints include amongst others: changes in body fat (dexa-scan) and changes of the hba1c(average blood glucose levels), cholesterol and triglycerides. moreover physiological effects will be examined eg possible effect on central/peripheral bloodpressure and heart rate. * cerebral endpoints will be investigated via functional magnetic resonance imaging (fmri); including potential neuroprotective effects of exenatide. the main focus is potential hippocampal volume changes and potential changes in cerebral blood flow. functional mri will provide this data and the images will be correlated to both cognitive tests and questionnaires. * cognitive endpoints comprise potential improvements in cognition with focus on specific memory tests (bacs, dart and rey's complex figure) and possible improvements in subjective quality of life (questionnaires).

Eligibility criteria:
inclusion criteria: * age: 18 - 65 years * diagnosis of the schizophrenia spectrum (icd-10: f20.x, f25.x)both in-patients and out-patients will be included * current and unchanged treatment with at least one antipsychotic drug (fga and/or sga and/or depot treatment) * bmi ≥30 kg/m2 * hba1c \< 6,5 % exclusion criteria: * substance dependence (icd-10: f1x.2 (apart from nicotine addiction f17.2)) * diabetes or hba1c ≥6.5% * contraindications to mri (metal implants, pacemakers, severe claustrophobia, ≥150 kg (max. bed weight in the mri scanner)) * previous head trauma with a loss of consciousness for more than 5 minutes * pregnancy (screened by urine human chorionic gonadotropin (hcg),lactation or no acceptance to use effective contraception during the intervention period * severe somatic disease, including inflammatory bowel disease and chronic ketoacidosis * allergy to exenatide * coercive measures according the danish law of psychiatry * conditions that according to sponsor are not congruous with participation in the study

Keywords: obesity the metabolic syndrome/disturbances drug-induced adipositas schizophrenia glp-1 analogue cerebral effects
a trial of the safety and efficacy of sep-363856 in the treatment of adults with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this is a phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial of the safety and efficacy of flexible doses of sep-363856 as adjunctive therapy in the treatment of adults with major depressive disorder (mdd)


Eligibility criteria:
inclusion criteria: * male and female subjects between 18-65 years of age, with a primary diagnosis of major depressive disorder and in a current major depressive episode * current major depressive episode must be at least 8 weeks and no longer than 2 years in duration * history of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode exclusion criteria: * subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode * subjects with a lifetime history of schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, major or mild neurocognitive disorder, neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent/ follow study directions/ or otherwise safely participate in the study, borderline or antisocial personality disorder. * subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia). * sexually active subjects, who could become pregnant, not agreeing to practice 2 sponsor approved methods of birth control or remain abstinent during the trial and for 30 days (females) or 90 days (males) after last dose of study drug.

Keywords: mdd sep-363856 antidepressant therapy adt depression depressive disorder major mood disorders mental disorders
a dietary intervention to modify breast milk content in obese lactating women

Conditions: Effect of Diet on Breast Milk Composition

Summary: this study is a nutrition research study designed to look at how healthy meals can influence the content of breast milk. moms will be provided with meals that follow a mediterranean diet pattern for 4 weeks. the goal of the study is to see if breast milk content changes over the 4 week period. the infants of the moms will also be included in the study to measure any changes in growth.


Eligibility criteria:
inclusion criteria: * ≤4.5 months postpartum * bmi 30 - 50 kg/m2 * ≥ 18 years of age * singleton pregnancy * exclusive breastfeeding and plans to exclusively breastfeed for at least 6 months postpartum * mother has a breast pump * mother is willing to collect breast milk for a 24 hour period. exclusion criteria: * pre-existing conditions (e.g. diabetes, hypertension, heart disease) * use of recreational drugs, tobacco, or alcohol * use of medications or supplements for which breastfeeding is contraindicated * child has internal metal which may be an nmr safety concern

Keywords: breast milk mediterranean diet
gelsemium sempervirens in anticipatory anxiety

Conditions: Anxiety

Summary: to evaluate the effectiveness of gelsemium sempervirens 5ch et 15ch on anticipatory provoked anxiety, in healthy volunteers.

state-anxiety can appear during banal events without objective harrowing factors. it is preponderant in particular situations as exams and competitive examination for example, and may be responsible of failures, notably at school. particularly, a form of anxiety said anticipatory (largely named nerves) is focused on a coming performance. this anticipative anxiety, maximal before the beginning of the test, disappears during this test to let place to relief. even if phenomenon of habituation exists, it can be responsible of social and professional failures. numerous therapeutics exists to fight against anxiety, non medicinal first but the resort to drugs are sometime necessary. the reference is the class of benzodiazepines. many patients try non conventional medicines, like homeopathy. gelsemium sempervirens would be active on sensible et emotional persons, reducing anxiety in some situations. a large used of gelsemium sempervirens is the case of a situation of provoked stress in particular exam. that is the reason why the drug is particularly intended to a population of young adults who don't want to use " traditional " tranquillizing. but this drug, largely used, has never showed his effectiveness on provoked anxiety, in biomedical research. that is why we proposed in this study to compare the effectiveness of gelsemium sempervirens 5ch, gelsemium sempervirens 15ch and placebo, in a situation of provoked anxiety in young adult healthy volunteers.

Eligibility criteria:
inclusion criteria: * man or woman, * age between 18 et 40 ans, * affiliated to a regime of social security or equivalent exclusion criteria: * medical history of psychiatric disease relevant of psychoses, * medical history of hospitalisation in psychiatric environment, * psychotropic substance of the class of antidepressants, antipsychotics and normothymics), in the year before inclusion, * taking, even punctual of psychotropics substances of the class of benzodiazepines and related, in the month before inclusion, * taking, even punctual of psychotropics substances of the class of anxiolytics non benzodiazepines, in the month before inclusion: meprobamate, hydroxyzine, buspirone, captodiamine, pregabalin, etifoxine, * taking, even punctual of substances of the class of the sedatives divers, in the month before inclusion: phytotherapy, homeopathy, sedatives with brome, mineral elements, * taking, even punctual of substances of the class of antihistamine with hypnotic aim, in the month before inclusion, * taking, even punctual of propanolol in the month before inclusion * known addiction, * handicap incompatible with the stress test : blindness, partially sighted, daltonism, dementia, language troubles, * pregnancy, parturient and nursing woman, * person private of freedom by judicial or administrative decision, person under measure of legal protection, * allergy to one of the constituents

Keywords: stress provoked healthy volunteers gelsemium homeopathy
wt1 for the detection of minimal residual disease

Conditions: Leukemia; Cancer

Summary: the purpose of this study is to determine if wt1 is an adequate measurement of minimal residual disease in leukemic patients.

patients with acute leukemia may have a large number of leukemic cells at the time that leukemia is evident clinically. at the time that we determine that a patient is in complete remission (cr) the patient may still have leukemic cells present in smaller quantities. one of the most important factors in the successful treatment of patients with leukemia is the ability to determine if the eradication of leukemia has been achieved. the determination of minimal residual disease may be important in the determination of the therapy that a given patient will receive as determined by the level of residual disease. wt1 gene function and expression. the wt1 gene is a candidate gene for wilms tumor, which is thought to arise as a result from inactivation of both alleles of the wt1 gene located at chromosome 11p13. the wt1 gene has been considered a tumor suppressor gene because intragenic deletions or mutations are found in tumors, germline mutations have been found in-patients with leukemia, and mediates growth suppression of wilms tumor cells expressing a wt1 splicing variant.

Eligibility criteria:
inclusion criteria: * age less than 21 years of age. * patients with the following diseases: acute lymphoblastic leukemia (all) at the time of diagnoses or relapse, acute non-lymphoblastic leukemia (anll) at diagnosis or after relapse and chronic myelogenous leukemia in chronic or accelerated phase. * patients will be eligible for any of the available treatment protocols or protocols for stem cell transplantation, regardless of the source of stem cells. * patients or legal guardians will sign an institutional review board (irb) approved informed consent. * patients will have venous access or peripheral vein for sampling.

Keywords: leukemia acute lymphocytic leukemia chronic myelogenous leukemia acute myelogenous leukemia
improved prostate cancer diagnosis - combination of rapid prebiopsy magnetic resonance imaging and biomarkers

Conditions: Prostate Cancer

Summary: this study will enroll 200 men with clinical suspicion of prostate cancer due to higher serum level of psa than 2.5 ng/ml or abnormal digital rectal examination. anatomical magnetic resonance imaging (mri) and diffusion weighted imaging (dwi) at 3 tesla (t) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer. targeted trus guided biopsy based on mri findings will be performed in addition to routine twelve core trus biopsy. moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.

specific aims of the current study are as follows: i) to determine the sensitivity, specificity and accuracy of a novel rapid anatomical mri and dwi at 3t magnetic field for the detection of prostate cancer in correlation with systematic trus guided biopsy ii) to determine the sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer iii) to develop statistical model for diagnosis of prostate cancer incorporating findings of a novel rapid mri/dwi and selected biomarkers iv) to assess the applicability of trus guided prostate biopsy based on mri finding in patient with no previous prostate biopsy v) to develop and validate an imaging protocol which will become the standard protocol for prostate imaging at medical imaging centre of southwest finland (vskk) / tyks, turku, finland.

Eligibility criteria:
inclusion criteria: * age: 40 to 85 years * language spoken: finnish * clinical suspicion of prostate cancer, based on: serum level of psa from 2,5 ng/ml to 25 ng/ml in two following measurements and/or abnormal digital rectal examination * mental status: patients must be able to understand the meaning of the study * informed consent: the patient must sign the appropriate ethics committee (ec) approved informed consent documents in the presence of the designated staff exclusion criteria: * previous prostate biopsies * previous diagnosis of prostate carcinoma * previous prostate surgeries, e.g. turp (transurethral prostatic resection) * symptomatic of acute prostatitis * contraindications for mri (cardiac pacemaker, intracranial clips etc) * uncontrolled serious infection * claustrophobia * any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist

Keywords: prostate cancer magnetic resonance imaging
topical 0.4% ketorolac and vitreoretinal surgery

Conditions: Surgery

Summary: to determine whether use of topical 0.4% ketorolac has any effect on pupil size during vitreoretinal surgery.

other outcomes will be to assess postoperative pain and inflammation and visual acuity.

Eligibility criteria:
inclusion criteria: * age of 18, routine elective vitrectomy exclusion criteria: * history of trauma, uveitis, prior intraocular surgery within 3 months, requirement of mechanical pupil dilation, prior inclusion of other eye

Keywords: vitreoretinal surgery, ketorolac, acular, mydriasis
comparison of the hoya surgical optics (hso) isert 251 posterior chamber aspheric aphakic intraocular lens to historical / literature controls.

Conditions: Aphakia; Cataract

Summary: the purpose of this multi-center clinical trail is to determine the safety and efficacy of the isert 251 for the correction of aphakia.

this study evaluated the safety and effectiveness of the hoya surgical optics isert model 251 iol following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. results from this prospective, multicenter clinical trial will be used to support a pma supplement for the isert® 251 iol.

Eligibility criteria:
inclusion criteria: * have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber iol implantation is indicated * have clear intraocular media * have potential best corrected visual acuity of 20/40 or better * have preoperative best spectacle-corrected visual acuity of 20/40 or worse exclusion criteria: * have ocular pathology or abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period * are monocular * have current ocular infection * are taking systemic steroids or other anti-metabolites * have previous retinal detachment in the operative eye or expect to require retinal laser treatment during the course of the study eligibility criteria not complete. contact hoya surgical optics, inc. for more information.

Keywords: intraocular lens iol cataract hoya surgical optics ocular visual acuity
arthrocentesis study

Conditions: Periprosthetic Joint Infection; Septic Arthritis

Summary: the purpose of this study is to analyze pre- and intra-operative joint aspirates of native joints and joints with suspicion of periprosthetic joint infection (pji) of the hip, knee and shoulder acquired in clinical routine. joint aspirates are then analyzed with new diagnostic methods (microcalorimetry, pcr, alpha-defensin, etc.). diagnostic speed and accuracy of these methods is compared to standard diagnostic methods in clinical routine, such as blood cultures of joint aspirates, cell count/differential, intra-operative tissue culture and histology and sonication.

in this study, joint aspirate of patients that undergo joint aspiration in the context of routine pre- and intra-operative clinical diagnosis of a hip, knee or shoulder joint is collected. routine joint punctures at our clinic are regularly performed in the emergency room, in the outpatient clinic and intra-operatively during diagnostic and revision surgery. a minimum of 5 ml aspiration fluid was required for inclusion in this study. empty or diluted aspirations were excluded. joint aspirations are performed by orthopaedic surgeons with an 18-gauge needle according to standardized aseptic technique. intraoperative punctures are performed prior to arthrotomy. a minimum of 1ml of joint aspirate is immediately transferred to a native study vial for our study, a native vial for gram stain and culture and a native vial for polarization microscopy, respectively. a minimum of 1 ml joint aspirate is transferred to an ethylenediaminetetraacetic acid (edta) vial for the determination of leucocyte count. finally, a minimum of 1 ml is inoculated into a paediatric blood culture bottle. standard microbiological methods are performed in an external laboratory that routinely collaborates with our clinic. leucocyte count is performed automatically with the mentioned edta vial. polarization microscopy is performed at our pathohistological department in order to detect crystals and signs of infection in joint aspirate. if written informational consent has been signed by the patient, the study vial is immediately transported to our internal laboratory for analysis with new diagnostic methods (microcalorimetry, pcr, etc.). when an immediate transportation was not feasible, the vial is stored in a cooling fridge at +3° c until transportation was possible. each case is individually reviewed and classified by an experienced infectiologist taking the case's clinical history and laboratory results into account.

Eligibility criteria:
inclusion criteria: * adult of 18 or more years * written consent to participate in study * suspicion of septic arthritis or periprosthetic joint infection * joint aspirate minimum of 5 ml exclusion criteria: * is not able to understand the aim or purpose of this study * empty joint aspirate

Keywords: periprosthetic joint infection septic arthritis
stem cell transplant and zoledronic acid improve outcome in previously untreated patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: assess the impact in outcome of the use of zoledronic acid in multiple myeloma.

assess if the use of zoledronic acid can improve outcome in patients with multiple myeloma whose are treated with cytoreductive therapy and stem cell transplant.

Eligibility criteria:
inclusion criteria: diagnosis of multiple myeloma no previous treatment symptomatic high risk (iss) or stage iii ( durie-salmon) no severe comorbidities - exclusion criteria: pregnancy hiv + refuse treatment -

Keywords: multiple myeloma stem cell transplant zoledronic acid
patient centred communication intervention

Conditions: Aphasia; Stroke

Summary: the most frequent consequence of a stroke is a communication impairment. when patients cannot articulate their needs, frustration and agitation are frequent responses, often resulting in poor optimization of post-stroke function. staff's lack of knowledge of communication strategies exacerbates the problem. a key component of patient-centred care is the ability of staff to communicate in such a way that allows them to understand the patient's needs. members of our team developed the patient-centred communication intervention (pcci) targeting registered and unregulated staff caring for complex continuing care (ccc) patients with communication impairments post stroke. the purpose of the study is to examine if the pcci results in improved patients' quality of life and in improved staff attitudes and skills in caring for patients with communication impairments.


Eligibility criteria:
patients: inclusion criteria * diagnosis of stroke related to cerebral infarct * presence of a communication impairment * ability to speak and understand english before the stroke * ability to consent exclusion criteria: * global aphasia or severe wernicke's aphasia staff: inclusion criteria * directly involved in providing care * employed full or part-time * ability to consent * ability to speak and write english * work with patients who have communication impairments exclusion criteria * unwilling to provide informed consent

Keywords: stroke communication impairments nurse-patient communication patient-centred care