Kornimate/medical-research-clean huggingface dataset:
pain perception is attenuated in patients with painless myocardial infarction

Conditions: Myocardial Infarction; Myocardial Ischemia

Summary: to explore whether reduced systemic pain perception in response to painful stimuli and personality pain related variables characterizes silent mi patients.

objective: silent myocardial infarction (mi) is an event of severe myocardial ischemia without pain experience. the lack of pain alarm leads to increased morbidity and mortality, because the patients do not sick timely medical treatment. this study aims to explore whether reduced systemic pain perception in response to painful stimuli and personality pain related variables characterizes silent mi patients. methods: level of chest pain intensity was assessed by visual analogue scale (vas), range from 0 (no pain) to 100 (maximal pain). heat pain threshold, magnitude estimation of supra-threshold painful stimuli at 47ºc as well as pain catastrophizing scores were assessed in 90 acute mi patients (mean age 66±12.1, range 33-79) with chest pain (n=65) and without pain symptoms(n=25). all stimuli were performed by thermal sensory analysis (tsa) and applied to the right forearm. results: the demographic variables, history of ischemic heart, risk factors for coronary artery disease, st-t segment changes on ecg and troponin levels were similar in both groups. greater intensity of chest pain vas scores was inversely correlated with lower pain threshold (r= -0.417, p\<0.001), and directly associated with higher pain scores in response to the heat pain (r=0.354, p=0.002). patients with painful mi demonstrated lower pain threshold (41.9±3.6 vs. 44.9±3.8, p=0.001), higher vas scores in response to the supra-threshold painful stimuli (50.2 ±21.8 vs. 27.0±25.2, p=0.002), and higher catastrophizing level (10.6±12.0 vs. 5.4±8.8, p=0.032). chest pain complaint was not related to st-t changes as well as concomitant diseases. conclusions: this study suggests that reduced systemic pain perception as well as cognitive personality variables play an important role in the etiology of silent mi.

Eligibility criteria:
inclusion criteria:all patients with painless or painful myocardial infarction - exclusion criteria:patients who can't give informed concent or couldn't cooperate -

Keywords: therma,pain, silent myocardial ischemia, catastrophizing
the sentry clinical study

Conditions: Pulmonary Embolism; Deep Vein Thrombosis

Summary: the sentry bioconvertible inferior vena cava (ivc) filter has been developed to provide temporary protection against pulmonary embolism (pe).

pulmonary embolism (pe) is a prevalent disease with a significant morbidity and mortality. the estimated annual incidence is 1.45 per 1,000 patients, which translates to 1,350,000 cases per year in the united states. it is estimated that pe results in more than 200,000 deaths per year. currently there are two types of commercially available ivc filters utilized to prevent pe; permanent and retrievable. both types of filters have documented limitations, such as tilting, migration, fracture, embolization and late deep vein thrombosis (dvt). retrievable filters were developed to avert some of the late consequences of permanent filter, but in practice there is low success with eventual removal. in a series of 37 clinical studies, with a total of 6,834 patients the mean retrieval rate was 34%. there are numerous design features of the sentry ivc filter that are intended to improve on the limitations of available ivc filters and obviate the need for retrieval.

Eligibility criteria:
inclusion criteria: 1. \> 18 years of age 2. fully informed subject who has executed an institutional review board (irb) or ethics committee (ec) approved informed consent 3. willing and able to comply with follow-up visit requirements 4. requirement of transient pe protection of \< 60 days 5. documented or high risk of pe or dvt 6. inability to use anti-coagulation due to contraindication, failure, complication or risk of injury from pharmacotherapy 7. ivc diameter compatible with filter diameter 8. ivc length adequate for filter placement exclusion criteria: 1. intellectual impairment preventing understanding involvement in a clinical study 2. hypersensitivity to device components 3. impaired renal function defined as a serum creatinine level of \> 2.0 mg/dl 4. active systemic infection 5. life expectancy \< 12 months 6. malignancy extending pe risk \> 60 days 7. pregnant or plans to become pregnant during study follow-up period 8. participating in another investigational trial that has not reached its primary endpoint 9. known hypercoaguable state 10. inherited or acquired hemostatic disorder 11. history or presence of a caval stent or filter 12. inability to gain femoral or jugular access 13. duplicated or left sided ivc 14. renal vein thrombosis or ivc thrombosis extending to the renal veins 15. jugular and femoral vein irregularity, stenosis or aneurysm that would interfere with successful device delivery 16. spinal irregularity that may interfere with successful device delivery 17. occlusive or free-floating thrombus in the ivc 18. contrast allergy that cannot be adequately pre-medicated
coronary artery disease (cad) in postmenopausal women

Conditions: Postmenopausal Women; Stable Angina Pectoris

Summary: aim of this study is the determination of a valid procedure for ischemia diagnositc in postmenopausal women.

in order to investigate which ischemia diagnostic presents which sensitivity and specificity for postmenopausal women, 100 consecutive patients presenting to our abmulance with stable angina pectoris and indication for myocardial szintigraphy will be enrolled in this study. an addidional stress-echocardiography and stress-mri will be performed in this patients before they will reiceve their again routine coronay angiography. the different methods for ischemia diagnostic will be compared in order to determine the most valid method for this specific population.

Eligibility criteria:
inclusion criteria: * postmenopausal women presenting to the hospital with stable angina pectoris complaints and an indication for myocardial szintigraphy exclusion criteria: * cabg * pacemaker or other metal implants * chronic bronchitis * asthma bronchiale * arterial hypotension

Keywords: coronary artery disease ischemia diagnostic
quantifying the benefits of supervised vs. unsupervised pre-habilitation for patients with acute acl tears

Conditions: Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Injuries

Summary: although the success of physical therapy following surgery has been well-documented and validated in patients undergoing anterior cruciate ligament reconstruction (aclr) procedures, more recent studies have demonstrated that patient outcomes are the most favorable when surgery is delayed approximately 4 weeks until after the patient has completed a preoperative physical therapy program, or "pre-habilitation." the ultimate goal of pre-habilitation is to regain full range of motion in the knee and reach approximately 80% of pre-injury quadricep strength. however, extra physical therapy can stress both time and resources. thus, we propose a home-based, self-guided pre-habilitation program. we hypothesize that patients participating in self-guided pre-habilitation will experience the same benefits as patients in a traditional office-based physical therapy program.


Eligibility criteria:
inclusion criteria: * skeletal maturity * acute acl rupture occurring no longer than 4 weeks prior to presentation * ability to participate in a pre-habilitation program * nature of the injury allows adequate time for pre-habilitation * ability to speak, read, and understand english * willing and able to provide informed consent exclusion criteria: * any injuries requiring immediate surgical intervention * ipsilateral meniscus tear that preventing participation in a pre-habilitation program * ipsilateral mcl tears grade iii * ipsilateral pcl tears (any grade) * concomitant lcl injuries * concomitant posterolateral corner injuries * inflammatory arthritis * prior acl rupture/reconstruction * anyone unable to participate in a stretching/strengthening program
prevention of vascular access graft failure in patients with chronic renal failure requiring hemodialysis

Conditions: Hyperplasia; Chronic Renal Failure

Summary: the purpose of this study is to determine the effect of recipient vein pretreatment of edifoligide (e2f decoy), compared to placebo, on graft/recipient vein stenosis in polytetrafluoroethylene (ptfe) vascular access grafts placed for hemodialysis at 6 months after enrollment.


Eligibility criteria:
inclusion criteria: * be scheduled to undergo placement of a new straight or loop arm ptfe arteriovenous hemodialysis access graft or a vectragraft® (thoratec, inc.) * be currently receiving chronic dialysis or be expected to begin hemodialysis within 4 weeks of placement of the index ptfe graft * have undergone an assessment of patency (such as venography) of central veins if any of the following conditions have occurred on the ipsilateral arm intended for graft placement: presence of collateral veins, upper extremity edema or increased size (relative to the contralateral arm), history of subclavian catheter, transvenous pacemaker, or history of trauma or surgery that may have involved the neck or chest veins * be \> 18 and \<80 years old * have a documented negative serum pregnancy test (for all women of childbearing potential) * be using an acceptable method of birth control if of reproductive potential and agree to continue using the birth control for at least 3 months following the graft procedure * have agreed to participate voluntarily and have signed and dated an irb/ec approved, patient informed consent form exclusion criteria: * have an intended recipient vein \>6 mm or \<3 mm in diameter * have a history of three or more previous ptfe grafts * have uncorrected central vein (including the subclavian vein) stenosis * have markedly diminished arterial pulses in the access location (unless adequate flow has been documented by arteriography or doppler ultrasound) * anticipate receipt of a renal transplant within 6 months of enrollment into this study * have anticipated use of the index ptfe graft \<14 days after enrollment (this does not apply to vectragraft®) * have a known allergy to iodinated contrast * have a known hypercoagulable state (e.g., antithrombin iii deficiency; antiphospholipid or anticardiolipin antibodies; factor v leiden; circulating lupus anticoagulant; current, active, heparin-induced thrombocytopenia; protein c or s deficiency; or a history of recurrent deep venous thrombosis not related to av access) * have been in another investigational (i.e., nonapproved) drug or device study within the previous 30 days or prior participation in another clinical study with e2f decoy * have been previously enrolled in this study for an earlier access graft * have any comorbid, nonrenal condition that makes 6-month survival questionable (e.g., end-stage cancer, advanced heart failure) * have a known or suspected history of drug or alcohol abuse within the previous 6 months * have a known allergy to any component of the investigational product (drug or device), including latex

Keywords: edifoligide e2f decoy chronic renal failure hemodialysis av graft neointimal hyperplasia
transabdominal gastric contrast ultrasound

Conditions: Transabdominal Gastric Contrast Ultrasound

Summary: in this study, the clinical data of patients diagnosed with gastric cancer who were ready for surgery were examined by contrast-enhanced ultrasonography and gastric-enhanced ct before surgery. based on the results of postoperative pathological examinations, the diagnostic accuracy of gastric filling contrast-enhanced ultrasonography and gastric contrast-enhanced ct in different stages of gastric cancer was compared and analyzed. provide better guidance for follow-up clinical practice.


Eligibility criteria:
inclusion criteria: 1. age: 18\~80 years old, male or female; 2. diagnosed with gastric cancer by histology or cytology; 3. no distant multiple metastasis; 4. ecog score 0-2; 5. heart, lung, liver and kidney function can tolerate surgery; 6. patients and their families can understand and be willing to participate in this clinical study, and sign the informed consent. exclusion criteria: 1. previous history of malignant tumor or recent diagnosis combined with other malignant tumors; 2. patients with gastrointestinal perforation, gastrointestinal bleeding, etc. requiring emergency surgery; 3. patients with previous gastroduodenal surgery; 4. preoperative neoadjuvant therapy; 5. patients and their families refuse surgical treatment; 6. asa grade ≥ iv and/or ecog performance status score \> 2; 7. patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases who cannot tolerate surgery; 8. have a history of serious mental illness; 9. pregnant or lactating women; 10. patients with other clinical and laboratory conditions considered by the researchers should not participate in this trial.
dental office prevention strategies for children

Conditions: Dental Plaque

Summary: the overall goal of this study is to improve the standard of care in treating young children who often suffer from chronic caries (dental decay). current standard of care for children under 12 years old includes a dental cleaning and fluoride treatment. often this dental cleaning includes a 'dental prophylaxis' with a pumice based paste delivered by a small rubber-like cup that rotates on a slow-speed dental handpiece. the procedure of this dental prophylaxis removes the gross levels of plaque around the supragingival tooth surfaces. after this prophylaxis, a fluoride treatment is delivered. the national maternal and child oral health resource center at georgetown university has published (bertness j, holt k) an extensive publication proving that 5% sodium fluoride varnish has become the 'standard of care' for fluoride treatment in children. this study includes this fluoride standard of care. prior to the administration of this standard of care fluoride treatment, a separate step of cleansing the tooth after the dental prophylaxis is added. this study uses a cleansing procedure of 10% povidone iodine (pi) cleansing prior to fluoride varnish (fv) application. the primary aims of this study are: 1. to measure the changes in overall plaque levels after using a 10% povidone iodine (pi) cleansing prior to fluoride varnish (fv) application. 2. to measure the short term changes in the oral microbial ecology of dental plaque after 10% povidone iodine (pi) cleansing prior to fluoride varnish (fv) application.


Eligibility criteria:
inclusion criteria: * inclusion criteria: ages 6-12 years age. recent history (\< 24 months) of childhood caries, weight ≥ 15 kg, and current dental radiographic films within standard of care practices. at this time, we are looking for longitudinal changes within this cohort and are not using condition-matched controls. exclusion criteria: * exclusion criteria: weight \<15 kg; iodine or seafood allergy; hypersensitivity to fluoride varnish; antibiotics within the past 3 months; thyroid disease; significant past or current medical problem history, especially conditions that may affect salivary flow, dietary intake patterns, or routine oral hygiene.

Keywords: children, plaque
combination natural health product in children with attention deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: attention deficit/hyperactivity disorder (adhd) is a chronic neurobehavioural disorder often diagnosed in childhood years. complementary/alternative treatments including natural health products (nhps) are used by children with adhd despite limited information on their safety or usefulness. some evidence suggests children with adhd have a greater need for zinc, magnesium, vitamin b6 and vitamin c. this study will supplement a small number of children diagnosed with adhd with therapeutic levels of these nutrients over 10 weeks to get a better understanding of the safety and possible benefit of using these nutrients to treat symptoms associated with adhd.

the is an open-label study. children diagnosed with adhd will be provided with a weight-based dose of a chewable natural health product containing zinc, magnesium, vitamin b6 and vitamin c for 10 weeks with an additional follow-up post intervention at 20 weeks. severity of adhd symptoms will be measured at baseline, week 5 and week 10 using the connor-3 parent and snap-iv validated questionnaires. nutritional status will be monitored at baseline and week 10 for changes in serum zinc and erythrocyte magnesium. children will be monitored for any adverse reactions that may occur using the investigational product.following the informed consent process, participants will undergo a structured psychiatric interview prior to enrollment and will have 4 30 minute study visits and 2 10 minute telephone calls throughout the study. blood samples will be taken 2 times with the use of a topical anesthetic to decrease sensation during the blood draw. once enrolled, children can withdraw from the study at any time if assent to participate is withdrawn.

Eligibility criteria:
inclusion criteria: * male and female children age 6-12 diagnosed with adhd of any subtype according to dsm-iv criteria. a structured diagnostic interview (kiddie sads present and lifetime version) will be conducted to confirm diagnosis of adhd and assess for comorbid mental health disorders. * primary caregiver (parent or guardian) has given informed consent; child participant gives ongoing assent throughout the study. exclusion criteria: * changes to participants' adhd medication within 6 weeks of study onset. * diagnosis of additional mental health disorder using the kiddie sads. * diagnosis of cancer. * antibiotic use for periods greater than 2 weeks within the 10 weeks prior to the study * diagnosis of type 1 diabetes and insulin use * low serum ferritin/iron deficiency (\<30 ng/ml)

Keywords: attention deficit disorder pediatrics attention impulsivity complementary therapies
effect of cannabis on simulated and actual driving in healthy subjects

Conditions: Healthy

Summary: assess the effect of cigarette smoking of tobacco with or without addition of resin cannabis on driving performance in healthy volunteers in simulated driving in marseille and toulouse, and in real world driving to bordeaux. multicenter study of phase 1, randomized, double-blind, cross plan, carried out in healthy male volunteers.

* to compare performance data driving with the data self-assessed on the ability to drive, and the level of sleepiness and fatigue * to measure the effects of distractive task on driving performance, consisting of a conversation with co-driver of the real or simulated vehicle (a series of difficult questions involving reflection) * to validate the (known) effects of cannabis * to adapt equipment and standardize methods for the pharmacological studies evaluating other types of substances having an impact on driving (antihistamines, antidepressants, antiparkinsonian ...) and other populations of subjects (men versus women, young versus elderly, healthy versus sick ...) * to compare data obtained under conditions of simulated driving and actual driving situation, under identical experimental conditions (volunteers, narcotic substance, experimental) and measure the degree of ecological validity of the simulation of driving

Eligibility criteria:
inclusion criteria: * weight +/- 10% of ideal weight * tobacco smoker moderate * having already smoked of the cannabis (less 1 time per month) * not consuming in a way exaggerated by some coffee, tea or cola * not having acute or chronic pathologies * normal electrocardiogram * not taking a drug interfering with the study * not presenting disorder of sleeping * having a driving license for at least 3 years and driving more 3000 km per year * normal acuteness or corrected visual acuteness and normal vision of colors * reachable and available during the study * no nausea or vomit during using of a driving simulator * having a national insurance scheme * volunteer exclusion criteria: * women * weight deviating of 10% of ideal weight * consuming moreover 5 cup of caffeine drinks * drinking alcohol regularly * acute or chronic pathologies interfering with the study * abnormal electrocardiogram * asthmatic * dependence present or spent in a psychotropic substance * presenting an anxious or depressive syndrome * circadian typology (horne et ostberg) * positive control in the cannabis in urines the day of the balance assessment of inclusion * positive control in alcohol the day of the balance assessment of inclusion * participating in another clinical study * having collected an upper total amount of compensations allowances * deprived of freedom further to a court or administrative order * risk of not observance * duration average of sleep of 3 nights previous every session lower than 80 % of the average duration of sleep which the volunteer thinks of needing to be in shape

Keywords: social circumstances
the safety and utility of skin testing with xolair® (omalizumab) and placebo omalizumab (formulation excipients)

Conditions: Healthy; Asthma

Summary: this study enrolled 30 healthy volunteers and 30 patients with atopic asthma, for a total of 60 subjects. the study examined the tolerability of omalizumab and omalizumab excipients in two successive cohorts of subjects, healthy volunteers and patients with allergic asthma without prior exposure to omalizumab, according to a skin test protocol, consisting of a prick skin test and/or intradermal test.


Eligibility criteria:
inclusion criteria: * (applicable to healthy subjects only) healthy subjects not taking any regular prescription medication, without history of allergy, and considered healthy by the physician * (applicable to asthma patients only) patients with atopic asthma diagnosed by a physician with asthma and history of positive skin test(s) * physical examination findings within normal limits * body mass index (bmi) between 18 and 30, inclusive exclusion criteria: * pregnancy and lactation * current or previous treatment with a biologic agent (e.g., monoclonal antibody) * concurrent disease or condition that would interfere, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to individuals in this study * history or symptoms of significant psychiatric disease, including but not limited to, depression, schizophrenia, etc. * history of drug abuse * participation in an investigational drug or device trial within the last 30 days prior to screening

Keywords: xolair asthma skin tests