Kornimate/medical-research-clean huggingface dataset:
randomised study evaluating the interest of psychological support of patients waiting for hallux valgus surgery

Conditions: Hallux Valgus Surgery

Summary: catastrophizing is a negative evaluation of events. what surgery concerns, pain catastrophizing is one of the main risks of postoperative pain and / or poor functional recovery. the best survey to evaluate pain catastrophizing is the pcs (pain catastrophizing scale). according to the authors, catastrophizers report more negative pain related thoughts, more emotional distress and more pain than non-catastrophizers. the pcs is a significant predictor of pain intensity and so of poor functional recovery. it is already well known that anxiety and catastrophizing predict postoperative pain. the actual studies focus mainly on functional recovery of knee and hip arthroplasties, but less on pain and functional recovery of hallux valgus surgery. according to several authors, adapted psychological support of preoperative catastrophizing could allow a better postoperative evolution. our hypothesis is that a preoperative psychological consultation of catastrophizing patients is efficient to lower pain catastrophizing in adult patients undergoing a surgical operation for hallux valgus. the first objective is to evaluate the impact of a psychological support of preoperative pain catastrophizing during a hallux valgus surgery.the principal evaluation scale is the pain catastrophizing score before and after surgery. the second objective is to evaluate the pain and functional recovery of pain catastrophizing patients. the criteria of this survey are: anxiety score (usual and actual), pain and function according to the faos (foot and ankle outcome score) pain (analogic visual scale).


Eligibility criteria:
inclusion criteria: * adult over 18 * independent, living in its own home * affiliated at a social security * consent signed * waiting for a hallux valgus surgery. exclusion criteria: * not able to understand french language * patient refusal * under guardianship * under french ame system

Keywords: hallux valgus surgery psychological support
faza pet/mri in cli patients pre and post revascularization

Conditions: Critical Limb Ischemia

Summary: peripheral artery disease is a worldwide problem, leading to high mortality and mobility. critical limb ischemia (cli) is associated with high risk of amputation with the subsequent decreased in life quality. endovascular therapy is now considered the primary treatment option in these patients to improve the vascularity and prevent amputations. in recent years, development of molecular imaging tools are now become available. a recent radio tracer named 18f-fluoroazomycin arabinoside (faza) its an specific marker of hypoxia in the tissues and has been used in multiples studies. this tracer can be used in pet/mr scan providing a potentially power diagnostic tool in patients with cli, allowing in one diagnostic study the evaluation of location and degree of hypoxia in the extremity tissues. this diagnostic tool may offer a better assessment pre and post standard of care endovascular treatment for the patients. moreover, some of the patients treated with endovascular therapy may not have a favorable outcome, without a clear reason explaining this situation. we will try to find some predictor model in the faza pet/mr that can explain the different outcomes and may help clinicians choose the best treatment option in specific cases. thirdly, post processing for optimization of the mr sequences in patients with cli will be performed at the mr component of the pet. there would thus be great clinical interest in developing non-invasive tools that could provide more accurate diagnostic information compared to traditional tests for these patients population.


Eligibility criteria:
inclusion criteria: * age \>= 18 years; * patients with clinical evidence of critical limb ischemia that are candidates for revascularization treatment; * a negative urine or serum pregnancy test in women of child-bearing age; * ability to provide written informed consent to participate in the study. exclusion criteria: * contraindication for mr as per current institutional guidelines; * inability to lie supine for at least 30 minutes; * pregnant or breastfeeding; * unable or unwilling to provide informed consent; * impending amputation within 6 weeks of presentation; * previous metallic hardware in the lower limbs; * unable to have ethanol.
ultra high field magnetic resonance imaging as a biomarker for premotor parkinson's disease

Conditions: Parkinson Disease; REM Sleep Behavior Disorder

Summary: this is a prospective observational study investigating the utility of 7 tesla mri to quantify nigrosome1 signal in a cohort of individuals with recent onset parkinson's disease and in at-risk cohorts at a premotor state of parkinson's disease.


Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease within 1 year of motor symptom onset. idiopathic rem sleep behavior disorder without signs/symptoms of parkinson's disease. age-matched controls. exclusion criteria: * atypical parkinsonism * contraindications for mri
pharmacokinetics of vancomycin in the icu in renal replacement therapy

Conditions: Acute Kidney Injury

Summary: this study is an observational analysis that monitors the effect of different dialysis methods on vancomycin levels when patients are critically ill. no changes are made to therapy based on levels, but levels are checked more frequently than normal. the primary dialysis methods being studied are sled (slow-low efficiency daily) dialysis and intermittent hemodialysis. vancomycin is the only medication being evaluated in this study. this study will provide detailed information on how to dose vancomycin in patients that are on dialysis in the intensive care unit.

the proposed study will evaluate the pharmacokinetics of vancomycin in patients that are on being treated with various types of renal replacement therapy. the renal replacement therapies studied in this trial will be slow-low efficiency daily (sled) dialysis and intermittent hemodialysis. this data will be collected and plotted for vancomycin for each dialysis mechanism utilized and plotted on drug concentration versus time graphs to determine drug clearance in each type of renal replacement therapy. subjects will have blood samples drawn and sent to the laboratory according to the dialysis method studied (9 for sled dialysis and 10 samples for intermittent hemodialysis). serial levels will be drawn prior to the drug being administered and after the drug is infused to assess the clearance and distribution of vancomycin. study drug levels will be drawn from blood that is already available in the laboratory when timing of such samples is appropriate, in order to limit the amount of blood that is drawn from each study subject. a total of 30 milliliters of blood will be collected from each subject for any one study arm they fit into. blood will be collected no more than two times per week and only more than once in a particular patient if their dialysis regimen changes. a single particular subject will only be able to supply blood samples once for each dialysis regimen being studied. this study would allow for the data collection of vancomycin levels at several time points during renal replacement therapy to assess the pharmacokinetic parameters associated with vancomycin dosing in each specialized patient-dialysis combination.

Eligibility criteria:
inclusion criteria: * \> 18 years of age * one of the following types of dialysis modalities implemented: slow-low efficiency daily dialysis intermittent hemodialysis * use of study medication (vancomycin) exclusion criteria: * inability to give informed consent

Keywords: acute kidney injury vancomycin therapy slow-low efficiency daily dialysis intermittent hemodialysis kidney vancomycin hemofiltration
expert guided training versus self learning with virtual patients

Conditions: Educational Problems; Virtual Patient; Emergencies

Summary: virtual patients have increasingly been used in the training of healthcare professionals to enhance critical decision-making skills in emergency patient management education. the aim of this study is to investigate the contribution of the virtual patient simulation used in the education of paramedic students by comparing the effectiveness of self-directed learning with expert-guided learning. additionally, it is believed that the study will be beneficial for educators responsible for program design who are interested in integrating the case-based learning method with virtual patients into their curriculum.

virtual patient-based simulation training is increasingly being used in healthcare and medical education to enhance problem-solving and critical decision-making skills. there are two common approaches in these trainings: instructor-led learning and self-directed learning. in instructor-led virtual patient-based simulation training programs, an experienced subject matter expert guides students through virtual patient simulation activities. the instructor provides feedback, support, and encourages discussion and collaboration among students during the training. this approach is beneficial for students who benefit from structured activities and social support in a group learning environment. however, it can be time-consuming, costly, and may not be suitable for every student. in self-directed learning, the responsibility for learning lies entirely with the student. students are given access to virtual patient simulations and are encouraged to work through the cases independently. this approach may be more suitable for students who are self-motivated, enjoy autonomy, and have the discipline to work independently. it also offers a cost-effective and flexible option. however, in this approach, the feedback and support needed for skill development are limited to the feedback reports generated by the computer-based virtual patient software program. in the literature, studies on the use of virtual patient applications in paramedic students' emergency patient management training are limited. this study aims to contribute to educators who use or plan to use virtual patient simulation by comparing instructor-led virtual patient-based simulation training with self-directed virtual patient-based simulation training to determine which approach is more effective in enhancing students' critical decision-making skills.

Eligibility criteria:
inclusion criteria: volunteer 4th-semester paramedic students from the department of vocational health sciences at the university exclusion criteria: previous experience with the same clinical scenarios

Keywords: virtual patient emergency patient management self directed learning
protein, amino acids & insulin & glucagon secretion in humans

Conditions: Type 2 Diabetes; Metabolic Syndrome

Summary: the purpose of this study is to determine the effect of various foods and/or food substances such as fats or proteins on the blood glucose and insulin concentrations in people with and without type 2 diabetes.

various foods or food substances are given as a test meal. the metabolic response is determined at various times after the administration of the meal (e.g. blood glucose, and other hormones and metabolites).

Eligibility criteria:
inclusion criteria: * subjects with or without type 2 diabetes * c-peptide \> 1.5 ng/ml * able to come to the minneapolis va medical center on several occasions over 2-4 weeks exclusion criteria: * body mass index \> 40 * hematologic abnormalities * liver disease * kidney disease * congestive heart failure * life threatening malignancies

Keywords: glycemic index lobag diet insulin glucagon
safety and immunogenicity of h5n1 adjuvanted, inactivated, split-virion pandemic influenza vaccine in healthy adults

Conditions: Pandemic Influenza; Influenza A Virus Infection; Orthomyxoviridae Infections

Summary: the purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity primary objective: to describe the safety profile and immunogenicity following each injection.


Eligibility criteria:
inclusion criteria : * aged 18 to 40 years on day of inclusion * informed consent form signed * able to attend all scheduled visits and to comply with all trial procedures * for a woman, inability to bear a child or negative urine pregnancy test. exclusion criteria : * participation in another clinical trial in the 4 weeks preceding the first trial vaccination. * planned participation in another clinical trial during the present trial period. * previous participation in a clinical trial involving an investigational flu pandemic vaccine. * vaccination with an influenza vaccine during the past 6 months * any vaccination in the 4 weeks preceding the first trial vaccination * vaccination planned in the 4 weeks following any trial vaccination * breast-feeding. * for a woman of child-bearing potential, the absence of an effective method of contraception or abstinence non observed for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination. * congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy. * known human immunodeficiency virus (hiv), hepatitis b (aghbs) or hepatitis c seropositivity. * known systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances. * thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. * chronic illness at a stage that could interfere with trial conduct or completion. * current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures. * subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * blood or blood-derived products received in the past 3 months. * febrile illness (temperature ≥ 37.5°c) on the day of inclusion. * laboratory abnormalities considered clinically significant upon the investigator's judgment in blood sample taken at screening (for step 1 only)

Keywords: pandemic influenza avian influenza orthomyxoviridae infections a/h5n1
a multi-center trial to determine if curosurf® reduces the duration of mechanical ventilation in very preterm infants

Conditions: Respiratory Distress Syndrome

Summary: the purpose of this study is to see if a medication called curosurf can reduce the length of time that small premature babies with respiratory distress syndrome (immature lungs) or rds, stay on the ventilator, as compared to the standard medication called bles. curosurf is a medication that is already used in other countries around the world but not yet in canada. babies born under 32 weeks of gestation frequently need respiratory support after birth, including being placed on a breathing machine or respirator. the most common reason is respiratory distress syndrome (rds) whereby immature lungs don't produce enough surfactant, a soapy like substance that helps the air sacs open and close. our current standard treatment is a surfactant called bles. curosurf contains more active ingredient per volume therefore the amount is smaller. the investigators hypothesize that babies who receive curosurf will be able to be removed from the ventilator sooner. babies in this study will have a 50/50 chance of receiving either curosurf or bles and the investigators will monitor their progress during their neonatal intensive care unit admission. the study is taking place in canada. the goal is to enroll 88 babies. there are no extra tests (blood tests or x-rays) or return visits to the hospital for the purposes of this study.


Eligibility criteria:
inclusion criteria: 1. infants born between 24+0 and 31+6 weeks gestational age, admitted to the study centers 2. infants with rds requiring intubation and surfactant therapy within 48 hours after birth exclusion criteria: 1. any infant more than 48 hours of age 2. any infant with a pulmonary hemorrhage 3. any infant with life-threatening congenital anomaly or one that is considered non-viable 4. any infant on rescue high frequency ventilation 5. any infant known to require early intubation and ventilation for surgical treatment of a congenital anomaly 6. any infant with anomalies of the upper or lower airway or mandible precluding use of ncpap 7. any infant born after prolonged premature rupture of membranes (\ 28 days prior to delivery) 8. a parent/lar who is incapable of, or unwilling, to give consent 9. participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol 10. any other reason as deemed significant by the investigator

Keywords: prematurity
a study comparing sb4 to enbrel® in subjects with moderate to severe rheumatoid arthritis despite methotrexate therapy

Conditions: Rheumatoid Arthritis

Summary: this is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of sb4 compared to enbrel in subjects with moderate to severe rheumatoid arthritis (ra) despite methotrexate (mtx) therapy. in some countries, after 52 weeks of treatment with either sb4 or enbrel, subjects will be enrolled into an open label extension period. subjects will receive sb4 for an additional 48 weeks.


Eligibility criteria:
inclusion criteria: * diagnosed as having ra according to the revised 1987 acr criteria for at least 6 months but not exceeding 15 years prior to screening * have moderate to severe active disease despite mtx therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (esr, westergren) ≥ 28 mm/h or serum c-reactive protein ≥ 1.0 mg/dl * must have been treated with mtx for at least 6 months prior to randomisation and on a stable dose of mtx 10-25 mg/week given at least 4 weeks prior to screening * female subjects who are not pregnant or nursing at screening and who are not planning to become pregnant from screening until 2 months after the last dose of investigational product exclusion criteria: * have been treated previously with any biological agents including any tumour necrosis factor inhibitor * have a known hypersensitivity to human immunoglobulin proteins or other components of enbrel or sb4 * have a positive serological test for hepatitis b or hepatitis c or have a known history of infection with human immunodeficiency virus * have a current diagnosis of active tuberculosis * have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to randomisation. * have any of the following conditions 1. other inflammatory or rheumatic diseases. 2. history of any malignancy within the previous 5 years prior to screening 3. history of lymphoproliferative disease including lymphoma. 4. history of congestive heart failure 5. physical incapacitation (acr functional class iv or wheelchair-/bed-bound). 6. history of demyelinating disorders.

Keywords: rheumatoid arthritis etanercept biosimilar
brown fat activity and bariatric surgery

Conditions: Obesity

Summary: the mechanisms of bariatric surgery-induced weight loss go beyond reductions in calorie intake and may involve several other pathways. recently, brown adipose tissue (bat) has been added as another potential player. activation of bat results in enhanced energy expenditure and promotes weight loss. here, the investigators will study the effects of bariatric surgery on bat function by pet/ct studies and molecular analyses of adipose biopsies. the investigators will explore different pathways that may affect bat activation in this patient population.


Eligibility criteria:
inclusion criteria: * age 20 - 50 years * body mass index (bmi) 35 - 55kg/m2 exclusion criteria: * endocrine disease (except hyperlipidemia and substituted hypothyroidism or type 2 diabetes with fasting glucose concentrations \<120mg/dl), kidney disease, inflammatory bowel disease, autoimmune or rheumatologic diseases that require immunosuppressive treatment, active oncologic disease, heart failure. * medication for any of the above mentioned conditions. * antibiotic treatment in the past three months * pregnancy

Keywords: bat bariatric surgery energy metabolism
energy specific far infrared radiation treatment for erectile dysfunction

Conditions: Erectile Dysfunction

Summary: a preliminary study to determine the possibility of using far infrared (fir) radiation to treat impotency.

erectile dysfunction is characterized by the regular or repeated inability to obtain or maintain an erection. erection depends on a complex interaction of psychological, neural, vascular and endocrine factors. we are proposing a non-drug and a non-invasive radiation treatment for the enhancement of erection.

Eligibility criteria:
inclusion criteria: * persons with erection challenges exclusion criteria: * none

Keywords: impotence male impotence male sexual impotence
effects of low dose aspirin pre-treatment on platelet activation undergoing off-pump coronary artery bypass surgery

Conditions: Coronary Artery Disease

Summary: platelet activation after off pump coronary artery bypass (opcab) surgery may affect thrombus formation. the purpose of this study is to assess the effects of preoperative continuation of aspirin on platelet activation after off pump coronary artery bypass surgery.

patients undergoing opcab surgery will be randomized to continue preoperative aspirin or discontinue aspirin before surgery. platelet activation can be evaluated by measuring platelet p-selectin using flowcytometry. in this study, we will compare platelet-activated markers and conventional coagulation tests.

Eligibility criteria:
inclusion criteria: * age : 20-80 * elective opcab * informed consent exclusion criteria: * coagulation disorder * emergency operation, re-operation * co-existing valvular disease * less than 6 months after cerebral vascular accident * heparin induced thrombocytopenia * heparin resistance * menstrual phase * preoperative cardiopulmonary bypass, continuous veno-veno hemofiltration, intra-aortic balloon pump application * less than 12 months after myocardiac infarction * less than 10 days after unstable angina * less than 30 days after percutaneous coronary intervention * less than 6 wks after bare metal stent insertion * less than 12 months after drug eluting stent insertion

Keywords: preoperative aspirin use platelet activation off pump coronary artery bypass