Kornimate/medical-research-clean huggingface dataset:
cardiac deformation: correlation with conventional echocardiographic hemodynamic variables (an intraoperative study)

Conditions: Cardiac Disease

Summary: the aim of this research is to apply cardiac tissue characterization in order to assess left ventricular function in cardiac surgical patients pre and post cardiopulmonary bypass. the procedures to be used include a retrospective review of transesophageal images obtained during conventional intraoperative transesophageal echocardiography (tee) for cardiac surgery, as well as a secondary analysis with tissue doppler. the results will be compared with hemodynamic data obtained from a pulmonary artery catheter (pac).

patients included in this study are between the ages of 18 to 99 years of age, who presented to the operating room for cardiac surgery, and received both a pulmonary artery catheter and a routine intra-operative tee. we will only be looking at patients whose tee images were of good quality. subjects underwent cardiac surgery and received both a pac and a routine tee exam. we will review the data from the pac, the images from the conventional tee exam, and a secondary analysis with tissue doppler. a potential benefit to society is a novel means for assessing left ventricular function. our research will not benefit our subjects directly. there is no additional risk to our subjects beyond the insertion of the pac and the tee probe, which are routinely placed in our patients under-going cardiac surgery.

Eligibility criteria:
inclusion criteria: * male or female patients \>18 years of age patients scheduled for cardiac surgery and will receive both a pulmonary artery catheter and a routine intra-operative tee exclusion criteria: * tee images that are of poor quality

Keywords: cardiac deformation cardiopulmonary bypass tee cardiac surgery left ventricular function pulmonary artery catheter tissue doppler left ventricular function in cardiac surgery
evaluation of the impact of an expert opinion during the management of patients with severe bleeding on oral anticoagulants.

Conditions: Hemorrhage

Summary: the goal of this randomized clinical trial is to evaluate the impact of an expert opinion during the management of patients with severe bleeding on oral anticoagulants. the main question it aims to answer is : • does an expert help of decision during the management of patients with severe bleeding is superior to classic management ? the centers will be randomized in one of the two groups : control group and interventional group. patients will be followed for 3 months. at their inclusion they will be managed in conformity of the randomisation of their center. they will be followed at hour 0 + 6 , h0+24 and at the end of hospitalization. after 3 months, they will be called to assess the occurrence of thrombotic events ou hemorrhage complications. researchers will compare the classic management versus the management with an expert opinion to see if the expert opinion is superior to classic management.


Eligibility criteria:
inclusion criteria: * major patient treated with oral anticoagulants, admitted in an emergency department * for suspected major bleeding defined according to the criteria of the international society of thrombosis and haemostasis * able to give informed consent to participate in research or, in the event of an emergency, to take charge of a reference person * affiliated to a social security scheme. exclusion criteria: * pregnant or breastfeeding women * patient under guardianship, curatorship or safeguard of justice * administration within the last 24 hours of parenteral anticoagulant. * refusal to participate

Keywords: anticoagulants hemorrhage
decreasing agitation in patients with dementia through the use of weighted blankets

Conditions: Dementia

Summary: the purpose of this research study is to determine whether the use of weighted blankets help reduce behavioral and psychological symptoms, including agitation in people with dementia.

the intervention group 1. patient or legally authorized representative (lar) will be asked to sign a consent form and will have the study explained. 2. nursing staff will complete baseline assessments to measure behavioral disturbances using the cmai and cgi and other distressing symptoms using the esas-r. 3. a weighted blanket, based on admission body weight, will be provided to the patient under nursing supervision. 4. for 3 consecutive days after each use of weighted blanket, nursing staff will complete morning assessments to measure behavioral disturbances using the cmai and cgi and other distressing symptoms using the esas-r. 5. at the end of the intervention, nursing staff will complete post-intervention assessments to measure behavioral disturbances using the cmai and cgi and other distressing symptoms using the esas-r. control group: 1. patient or legally authorized representative (lar) will be asked to sign a consent form and will have the study explained. 2. the study team will recruit a group of patients with similar characteristics as described in the inclusion criteria; however, the patient will not receive the weighted blanket, but undergo the same assessments as described in 1-5 (above) and in the schedule of assessments.

Eligibility criteria:
inclusion criteria: * patients admitted on the inpatient geriatric psychiatry unit, complex interventions unit, internal medicine service and/or admitted hospice gip * documented diagnosis of dementia or suspected major neurocognitive disorder. * presence of agitation/aggression symptoms as defined by a minimum aggression score on the cohen-mansfield agitation inventory short version (cmai): patients must score 3, 4, or 5 on at least one question related to aggression (items 1-4). * have a lar able to sign the consent on behalf of the patient. exclusion criteria: * severe pain likely to be exacerbated by use of weighted blanket * inability to remove blanket; * skin burns or open wounds; * admitted on 72 hour hold.

Keywords: agitation dementia inpatient
early intestinal ultrasound in predicting treatment response to filgotinib in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: objective disease assessment in inflammatory bowel diseases at the time of treatment initiation and during follow-up has become gold standard. however, biomarkers, such as c-reactive protein and fecal calprotectin, fail to provide information on disease extent, location or complications. repeated endoscopic assessments are performed to evaluate mucosal response to treatment, though associated costs, availability, invasiveness and patient preference are considerable limitations. recently, intestinal ultrasound (ius) has gained significant momentum as a non-invasive, easily accessible and low-cost alternative for objective assessment. accordingly, the ecco-esgar guideline recognizes ius as a potential tool for the diagnosis and for the monitoring of ibd. our study aim is to evaluate the change in intestinal ultrasound parameters (as measured by b-mode and swe at baseline and week 4) to predict endoscopic response and remission as defined by the follow-up endoscopy and measured by the mayo endoscopic subscore and the uceis during treatment with filgotinib


Eligibility criteria:
inclusion criteria: * ≥18 years of age * endoscopic and/or histological confirmed diagnosis of uc * uc disease extent proximal to the rectum (ie, left-sided colitis or pancolitis) * moderately to severely active uc, defined by an endoscopic mayo score of ≥ 2 * indication for receiving filgotinib treatment exclusion criteria: * pregnancy * inability to give informed consent * proctitis only * ongoing gastroenteritis * (sub)total colectomy * obesity (bmi \>35 kg/m²)
effects and mechanisms of pain neuroscience education in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: this randomized controlled trials study aims, first, to determine the effectiveness of a nurse-led pne program designed by a multidisciplinary team, compared with an active control group on pain intensity, fibromyalgia (fm) severity, pain catastrophizing, and cognitive performance in patients with fm. second, to determine the mediator role of pain catastrophizing in the effects of pne on outcomes of interest. third, to explore pne-induced changes to the brain circuitry using qeeg in patients with fm.

this is a parallel-group, randomized controlled trial (rct). 98 participants who meet the 2016 american college of rheumatology diagnostic criteria for fm will be enrolled. eligible participants who complete the baseline measurements will be randomly allocated to a pne group (n = 49) and a self-management education group (n = 49). primary outcomes include pain severity determined using the brief pain inventory-short form (bpi-sf) and fm severity assessed using the fibromyalgia impact questionnaire-revised (fiqr). secondary outcomes, including pain catastrophizing and sustained attention, will examine using the pain catastrophizing scale (pcs), the psychomotor vigilance test (pvt), and qeeg, respectively. all outcomes will be measured at 3 different time points: (t0: baseline; t1: immediately after the 6-week intervention period; and t2: 3 months after the intervention period). implications: this will be the first-ever rct to examine the effectiveness of a chinese-language pne program and the first study to determine the brain changes after pne using qeeg in patients with fm. once the effectiveness of the pne and its brain mechanisms are supported by evidence from this trial, it will become a game changer in the management of the fm population. if an evidence-based pne platform based on the patented training course is subsequently developed, the product will have great potential for commercialization.

Eligibility criteria:
inclusion criteria: * participants must read and understand chinese language. * according to the 2016 acr diagnostic criteria, participants' pds scores more than or equal to 13 points exclusion criteria: * subjects who have medical history of traumatic brain injury or neurological disorder. * subjects who have present psychopathologic disorder. * subjects who are cancer. * subjects who are pregnancy.

Keywords: fibromyalgia cognitive function disease severity pain catastrophizing pain neuroscience education pain severity quantitative electroencephalography
ohqol with removable partial dentures; a pilot study

Conditions: Missing Teeth; Partial Edentulism

Summary: removable false teeth (called removable partial dentures (rpds)) are commonly made for people with missing teeth. rpds are made out of a framework and the replacement teeth/gum. the framework sits on the teeth and the gums and can be made out of different materials, metal or non-metal, with different properties. the plastic teeth and gum sit on the framework. a common framework material is cobalt chromium, a rigid, non-precious metal alloy. other framework materials include titanium and non-metal materials such as medical grade polyetheretherketone (peek). a review of the literature shows that no research has been reported investigating how different rpd framework materials impact on a person's oral health related quality of life (ohqol). the sensation that different frameworks have in the mouth can be quite varied between people, and it would be relevant to be able to tell patients which type of framework is better tolerated based on research evidence. we hope to conduct an un-blinded randomised crossover pilot trial investigating the difference in patient preference and oral health related quality of life measured by patient centred outcomes in a group of patients due to receive tooth supported removable partial dentures at the charles clifford dental hospital.


Eligibility criteria:
inclusion criteria: adults from age 18 upwards: * with the absence of 3 or more teeth, excluding third molars, per jaw arch, * with or without previous denture wearing experience, and * with a stable oral health in terms of absence of disease activity affecting the periodontium, dental hard tissues (caries), pulp and the structural/aesthetic integrity of restored teeth. exclusion criteria: * patients requiring extensive treatment prior to the provision of a removable partial denture. * patients with active primary disease; caries, periodontal disease or symptoms of pulpal or apical pathology to the remaining teeth. * patients with irreversibly compromised structural/aesthetic integrity of restored teeth that cannot be restored as part of the provision of treatment.
oric-i: optimizing recovery from intensive care: mechanical ventilation and delirium

Conditions: Delirium

Summary: the purpose of this study is to determine if treating delirious intensive care unit patients with haloperidol improves mortality.

intensive care unit delirium is a serious medical condition that is associated with increased morbidity and mortality. in this study, 304 delirious mechanically ventilated subjects will be randomized to haloperidol 5mg iv every 12 hours or placebo to determine if treatment with haloperidol improves short and long-term mortality.

Eligibility criteria:
inclusion criteria: * all adult (\>=18 years of age) mechanically ventilated patients admitted to the medical, surgical, trauma, or cardiothoracic icus of the upmc main campus who are expected by the icu clinical team to require \>24 hours of mechanical ventilation exclusion criteria: * baseline qtc \>480 milliseconds (ms); history of parkinson's disease; pregnancy; history of schizophrenia or neurologic disease that would confound the delirium assessment; deafness or inability to understand english or spanish; extubation prior to enrollment; previously enrolled in this study; patient, family, or attending physician refusal; death before enrollment; treatment with haloperidol within 2 days prior to icu admission; and prisoners.

Keywords: delirium mechanical ventilation intensive care haloperidol
dose confirmation trial of aav5-hfixco-padua

Conditions: Hemophilia B

Summary: this is an open-label, single-dose, single-arm, multi-center trial, with a screening, a treatment + post-treatment follow-up phase, and a long-term follow-up phase. the imp amt-061 is a recombinant adeno-associated viral vector of serotype 5 (aav5) containing the padua variant of a codon-optimized human fix complementary deoxyribonucleic acid (cdna) under the control of a liver-specific promoter. the imp is identified as aav5-hfixco-padua (amt- 061). the pharmaceutical form of amt-061 is a solution for intravenous infusion. the administered dose of amt-061 will be 2 x 10\^13 gc/kg.


Eligibility criteria:
inclusion criteria: 1. male 2. age ≥18 years 3. subjects with congenital hemophilia b classified as severe or moderately severe 4. \>20 previous exposure days of treatment with fix protein exclusion criteria: 1. history of fix inhibitors 2. positive fix inhibitor test at screening 3. select screening laboratory values \> 2 times upper normal limit: 4. positive human immunodeficiency virus (hiv) at screening, not controlled with anti-viral therapy 5. active infection with hepatitis b or c virus at screening 6. history of hepatitis b or c exposure, currently controlled by antiviral therapy

Keywords: hemophilia, gene therapy bleeding factor ix fix viral vector padua
turmeric and curcumin on sebum production

Conditions: Inflammation; Skin

Summary: a noticeably increasing number of patients are asking for naturally based extracts and ingredients as supplementary dermatologic remedies. patients are seeking natural and cost-effective skin care alternatives in place of prescription medications and procedures. our study will evaluate the effects of oral curcumin and turmeric on sebum production in healthy subjects.

turmeric extracts and curcumin have been shown to be safe, even at high doses without significant side-effects. previous clinical studies in other inflammatory skin diseases have shown that a dosage of curcumin at 6,000 mg daily was effective while lower doses were not. in a human phase i clinical trial examining the effects of high dose curcumin in preventing premalignant lesions, even curcumin doses as high as 8,000 mg/day resulted in no toxic effects after 3 months. this study will involve participant ingestion of 6,000 mg/day of turmeric or curcumin to assess how this affects their sebum production. the investigators will also be collecting stool from the study subjects, and examining how the curcumin and turmeric may modulate their gut microbiome. the investigators will specifically be looking to see if curcumin or turmeric have any changes on the gut flora towards bacteria that produce more short chain fatty acids. certain bacteria that make up the microbiome produce short chain fatty acids, such as butyrate and propionate, which have demonstrated anti-inflammatory properties. thus, it would be interesting to see if turmeric or curcumin exert any of its anti-inflammatory effects via modulation of the microbiome.

Eligibility criteria:
inclusion criteria: 1. age 18 to 50 years of age, and 2. subject must be able to read and comprehend study procedures and consent forms. exclusion criteria: 1. subject should be generally healthy and have no smoking history in the past one year, and must have no history of diabetes, metabolic syndrome, known cardiovascular disease, malignancy, kidney disease, or chronic steroid use. 2. those who used topical medications in the past two weeks or systemic antibiotics or oral probiotics within one month of starting the study. 3. subjects who are postmenopausal 4. those who are pregnant or breastfeeding. 5. those that are prisoners or cognitively impaired. 6. those who have a known allergy to black pepper should not participate in this clinical trial, since one of the treatments consists of tablets containing a small amount (1.25mg/tablet) of black pepper. 7. those that are taking angiotensin converting enzyme inhibitor medications or angiotensin receptor blocker medications for any reason.
german multicenter trial for treatment of newly diagnosed acute lymphoblastic leukemia in adults (07/2003)

Conditions: Adult Acute Lymphocytic Leukemia

Summary: the study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. patients with standard risk receive further consolidation and reinduction chemotherapy. in parallel minimal residual disease (mrd) is evaluated. after six months and one year the decision on intensification or discontinuation of therapy is made based on the results of mrd evaluation.


Eligibility criteria:
inclusion criteria: * acute lymphoblastic leukemia (pro-b, common, pre-b, early t, thymic t, mature t) * age 15-65 yrs (\*55-65 years if biologically younger according to general condition) * written informed consent exclusion criteria: * severe comorbidity or leukemia associated complications * late relapse of pediatric all or all as second malignancy * cytostatic pre-treatment * pregnancy * severe psychiatric illness or other circumstances which may compromise cooperation of the patient * participation in other clinical trials interfering with the study therapy

Keywords: all treatment de novo minimal residual disease adult
an open, single-center study to determine the antibody repsonse to gastrimmune and its safety and tolerability in patients with advanced pancreatic carcinoma

Conditions: Pancreatic Cancer

Summary: this study was designed to determine the effect of jaundice on the ability of g17dt to generate antibodies before and after treatment of biliary obstruction due to advanced pancreatic cancer.


Eligibility criteria:
inclusion criteria: * patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent * patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study * male or female patients over 18 years of age * patients with a life expectancy of at least 2 months * patients must have given written informed consent * patients with a karnofsky performance status score of ≥ 50% * patients who would not receive chemotherapy in the period of the extension survival study, except for concomitant gemcitabine ongoing at visit (for extension study) exclusion criteria: * history of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix * concomitant use or anticipated use in the period of the study of radiotherapy * chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study * use in the past month or concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids * females who were pregnant, planning to become pregnant or lactating * patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study * haematological indicators: haemoglobin \<9.5g/dl white blood cell count \<3.5 x 109/l platelets \<100 x 109/l
feasibility of virtual simulation-based diabetes foot care education in patients with diabetes in ethiopia

Conditions: Diabetes Foot Care

Summary: the primary aim of this study is to evaluate the feasibility of virtual simulation-based diabetes foot care education on foot care knowledge and practice/behaviour. research questions the primary question for this study is: • is virtual simulation-based diabetes foot care education a practical and acceptable intervention among patients with diabetes in ethiopia? the secondary questions are: * what is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care knowledge among patients with diabetes mellitus? * what is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care behaviour among patients with diabetes mellitus? * what is the impact of virtual simulation-based diabetes foot care education on diabetes foot self-care efficacy among patients with diabetes mellitus? * what is the impact of virtual simulation-based diabetes foot care education on diabetes foot health-belief among patients with diabetes mellitus?


Eligibility criteria:
inclusion criteria: * adult patients (18 years of age or older). * type ii diabetes mellitus patients who are on diabetes follow-up at university of gondar tertiary referral hospital exclusion criteria: * patients with type 1 diabetes or gestational diabetes * patients who previously attended any form of formal diabetes self management education (dsme) program /documented/ in the past three months. * individuals with documented severe cognitive impairment * individuals with documented visual impairment that diminished their ability to navigate the game * terminally ill individuals * individuals without the ability to read or understand the amharic consent documentation

Keywords: diabetes feasibility acceptability practicability foot-care