Kornimate/medical-research-clean huggingface dataset:
effects of yoga versus passive modality on pain, disability, salivary cortisol concentrations, brain- derived neurotropic factor, heart rate variability and immune functions among patients with chronic low back pain: a randomized controlled trial

Conditions: Low Back Pain

Summary: this study may clarify a potential promising mechanism and clearest evidence to support the value of yoga as a therapeutic option for reducing chronic low back pain.

low back pain is a common problem, with 70-80% of adults were bothered in their lives, which influence the work and quality of life. yoga is one of the most popular complementary and alternative medicine for back pain, and this mind-body intervention has increasingly chosen to effectively treat chronic pain. this is a parallel-arm randomized controlled trial which will compare the outcomes of participants assigned to the experimental treatment group (yoga, with 36 participants) with those assigned to a passive modality control group for 3 months (12 weeks). each group will receive regular 60-minutes yoga classes or passive modality twice a week. the investigators confer the difference of pain relief and functional life improvement between passive modality and yoga. the latter is expected to have positive effects on chronic low back pain. the effects and possible mechanisms of action responsible for passive modality and yoga on salivary cortisol concentrations, inflammatory cytokines and autonomic nervous tone will be also evaluated. the study's primary endpoints are (1) back pain relief, (2) functional life improved, (3) salivary cortisol concentrations decreased, (4) brain-derived neurotrophic factor improved, (5) heart rate variability improved, and (6) immune function improved significantly among the participants in the experimental group than the control group. this study may clarify a potential promising mechanism and clearest evidence to support the value of yoga as a therapeutic option for reducing chronic low back pain. if the results are positive, clinicians will attain more options for treating patient with chronic low back. furthermore, the positive results from this study will help focus more future in-depth research on the most promising potential mechanism of action identifies.

Eligibility criteria:
inclusion criteria: * patient with idiopathic low back pain of more than 12 weeks. exclusion criteria: * current pregnancy * diagnosis of ankylosing spondylitis, osteoporosis, fibromyalgia, failed back syndrome and other chronic illnesses. * inability to participate yoga exercise regularly. * accept steroid treatment within 3 months. * bmi \> 30

Keywords: low back pain, physical therapy, yoga.
inflammation and oxidative stress of adipose tissue in sleep apnea syndrome

Conditions: Decrease of Inflammation of Adipose Tissue; Sleep Apnea Syndrome

Summary: the main objective of this study is to evaluate the decrease of inflammation of adipose tissue in obese and non-obese patients having a sleep apnea syndrome and treated or not by continuous positive airway pressure (cpap). an interim analysis will be performed when 40 patients will be included.

inflammation of adipose tissue will be evaluated by rt-pcr on mrna of pro and anti-inflammatory cytokines (il-1, il-6, il-4, il-10, il-12, rantes, tnfa, leptin, adiponectin, cd68).

Eligibility criteria:
inclusion criteria: * male between 18 and 70 years old * apnea hypopnea index \> 30/h and \> 5% tst with sao2 \< 90% * patients obese (bmi \> 33kg/m2) or non obese (bmi \< 27kg/m2) exclusion criteria: * female * coronary ischemic disease, past history of cva * chronic pulmonary disease measured by arterial gasometry (pao2 \ 45mmhg) * known hepatic disease * alcohol consumption \> 3 units/day * sleepiness considered to be dangerous by the investigator * patient having an hazardous work regarding to awareness * patient being under anticoagulant, antiplatelet drug or having an active stent or bleeding disorder * patient having an inflammatory syndrome (c-reactive protein \> 10) * any allergy to local anaesthetics * chronic muscle pain * contraindication to mri

Keywords: adipose tissue obese patients inflammation oxidative stress sleep apnea syndrome
a study in male and female adult patients with atopic dermatitis treated with dupilumab in taiwan

Conditions: Atopic Dermatitis

Summary: primary objective: to characterize the use patterns of phototherapy and immunosuppressants prior to dupilumab treatment for adult ad patients, who are eligible for dupilumab reimbursement in taiwan (e.g., used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching). secondary objectives: * to characterize the adult ad patients, who are eligible for dupilumab reimbursement in taiwan, with respect to their a) medical history, b) socio-demographic, c) disease characteristics, d) comorbid with type 2 diseases \[e.g., asthma, chronic rhinosinusitis with nasal polyp (crswnp)\], and e) prior and concomitant treatments of atopic dermatitis * to assess the effectiveness and safety of dupilumab in adult atopic dermatitis patients, who are eligible for dupilumab reimbursement in taiwan * to assess comorbid atopic conditions and effects of dupilumab treatment for comorbid atopic conditions in adult patients, who are eligible for dupilumab reimbursement in taiwan * to evaluate the correlation of patient reported outcome \[atopic dermatitis control tool (adct)\] and physician assessment \[eczema area and severity index (easi)\] from the recruited subjects

1 year

Eligibility criteria:
inclusion criteria: * male or female, 18 years or older at the baseline visit * initiating treatment with dupilumab for ad, who are eligible for dupilumab reimbursement according to the country-specific prescribing information note: patients, who are diagnosed with ad more than 6 months, eczema area and severity index (easi) more than or equals to 20. body surface area (of ad involvement) (bsa) more than or equals to 30% and iga=3-4, may be eligible if they have already initiated treatment with: 1. phototherapy (psoralen + ultraviolet light a (puva) or narrow-band ultraviolet b (nb-uvb) twice a week) more than 3 months, and, 2. two different immunosuppressants (methotrexate, azathioprine, or cyclosporine) more than 3 months respectively before their enrollment in the registry. * provided signed informed consent exclusion criteria: * any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments * patients currently participating in any interventional clinical trial which modifies patient care * patients who have a contraindication to dupilumab according to the country-specific prescribing information the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
gastrodin prevents cognitive decline related to cardiopulmonary bypass

Conditions: Cognitive Decline

Summary: the incidence of cognitive decline related to cpb ranges from 20% to 80%, which may affect length of hospital stay, quality of life, the rehabilitation process, and work performance.however, there is no method to prevent the decline.gastrodin,the active constituent of gastrodia elata, has been widely used for the treatment of paralysis, hemiplegia, headache, vertigo, and alzheimer's disease. gastrodin is safe. no severe side-effect has been observed in the treatment. we postulate that gastrodin would attenuate the causative parameters of cognitive dysfunction related to cpb and would be an effective drug to prevent the decline as a result.

cardiac surgery with cardiopulmonary bypass (cpb) is one of the most frequently performed operations. neurobehavioral disorders, including neuropsychiatric and neuropsychological deficits, are a very frequently reported sequela of valve replacement or coronary artery bypass grafting (cabg) surgery. cpb is associated with significant cerebral morbidity. the incidence of cognitive decline related to cpb ranges from 20% to 80%, which may affect length of hospital stay, quality of life, the rehabilitation process, and work performance. neurocognitive decline can present days to weeks after surgery and may remain a permanent disorder. many pharmacologic strategies have been proposed or investigated for preventing post-cpb cognitive decline, but to our knowledge, none of these drugs has been systematically evaluated for efficacy in preventing post-cpb cognitive decline. the causative parameters of cognitive dysfunction associated with cpb include cerebral ischemia secondary to either microemboli or hypoperfusion, intraoperative cerebrovascular risk factors such as the duration of cpb, inflammatory response, cerebral glutamine release, free radicals, and no release. gastrodia elata, a famous chinese medical herb, has effects on preventing ischemic brain injury, neuronal cell damage or apoptosis, suppressing inflammatory response, inhibiting glutamine receptors and nnos, and scavenging free radicals. gastrodin (4-\[hydroxymethyl\]phenyl-β-d-glucopyranoside), the primary active constituent of gastrodia elata, has been widely used for the treatment of paralysis, hemiplegia, headache, vertigo, and alzheimer's disease. based on its pharmacological effects, we postulated that gastrodin would attenuate the causative parameters of cognitive dysfunction related to cpb and would be an effective drug to prevent the decline as a result.

Eligibility criteria:
inclusion criteria: * adult patients undergo mitral valve replacement surgery. exclusion criteria: * thrombi in left atrium, a history of symptomatic cerebrovascular disease, diabetes, psychiatric illness, renal disease, or active liver disease, less than a seven-grade education, or who cannot read.

Keywords: gastrodin
post-implant performance of the ec-3 iol

Conditions: Cataract

Summary: the purpose of this study is to obtain data on the performance of the ec-3 lens at an interval of two years (and beyond) from subjects who were implanted. the primary aim of the study will be to evaluate the presence, if any, of pco, lens glistening, and other anomalies in the subjects.

anomalies include, but are not limited to: posterior capsule opacification (pco) (pathological condition) - delayed clouding of the lens capsule after cataract surgery. glistenings - fluid-filled micro-vacuoles that form within the intraocular lens (iol) optic when the iol is in an aqueous environment. they may appear to be on the lens surface. artifacts - glares, halos, starbursts and/or shadows caused by iols. fibrosis - the formation of fibrous connective tissue, as in a scar. glare - undesirable sensation produced by brightness that is much greater than that to which the eyes are adapted. causes annoyance, discomfort, or loss in visual performance. halos (symptom) - the appearance of hazy ring(s) around light.

Eligibility criteria:
inclusion criteria: * enrollment in the ec-3 clinical trial * subjects who were implanted with ec-3 iol exclusion criteria: * removal of the ec-3 iol at any time

Keywords: cataract replacement surgery implantation ec-3 iol
year 3 extension for efficacy follow-up in subjects vaccinated in studies rota-028, 029 or 030 (nct00197210)

Conditions: Infections, Rotavirus

Summary: this year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (rv) gastroenteritis (ge) during third year of life in infants previously vaccinated with human rotavirus (hrv) vaccine or placebo in the following schedules: at 3 and 4 months of age in study rota-028; at 2 and 4 months of age in study rota-029 or rota-030. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

note that no new subjects will be recruited in this extension phase studies. the expected total enrolment for the primary studies was as follows: rota-028: 5700 rota-029: 3018 rota-030: 1102

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female between, and including, 6 and 12 weeks of age in hong kong and taiwan or 11 to 17 weeks of age in singapore at the time of the first vaccination according to the country recommendations for the routine vaccination schedules. * written informed consent obtained from the parent or guardian of the subject, prior any study procedure. * free of obvious health problems as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * child is unlikely to remain in the study area for the duration of the study * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * history of allergic disease or reaction likely to be exacerbated by any component of the vaccine. * administration of immunoglobulins and/or blood products since birth or planned administration during the study period. oral intake of immunoglobulins is allowed. * any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator. * first or second degree of consanguinity of parents.

Keywords: rotavirus gastroenteritis human rotavirus vaccine, efficacy, infants
aprotinin versus tranexamic acid in cardiac surgery patients with high-risk for excessive bleeding

Conditions: Cardiac Surgery; Cardiopulmonary Bypass; High Risk Bleeding

Summary: in this before-after multicenter study the authors tested the hypothesis that the prophylactic use of aprotinin compared to tranexamic acid could reduce the proportion of patients presenting severe perioperative bleeding.

perioperative bleeding remains a real challenge for physicians managing cardiac surgical patients. in patients at high risk for excessive bleeding the prophylactic use of antifibrinolytics may be useful. this study propose to compare the efficacity and innocuity of aprotinin and tranexamic acid to reduce the proportion of patient presenting severe peri-operative bleeding according the universal definition of perioperative bleeding (udpb) classification.

Eligibility criteria:
inclusion criteria: patients undergoing cardiac on pump surgery at high risk for bleeding defined by : * aorto-coronary bypasses surgery (2 or more) under dual platelet aggregation therapy (primary or redo) * heart transplant (primary or redo) * infectious endocarditis (primary or redo) * ascending acute aortic dissection (primary or redo) * artificial heart / lvad under cec (primary or redo) * combined surgery, redo * ascending aorta surgery, redo exclusion criteria: * off pump cardiac surgery * patient not meeting the inclusion criteria * patient not receiving antifibrinolytic therapy * patient with absolute contraindication to antifibrinolytics, * patient refusing to give access to their medical chart, * patient not meeting the inclusion criteria * patient protected by the law, under guardianship or trusteeship, * patient deprived of liberty

Keywords: cardiac surgery cardiopulmonary bypass massive peri-operative bleeding antifibrinolytics blood products transfusion
the effect of auditory and motor cognitive distractions on the neural provocation test in subjects with neck pain

Conditions: Chronic Pain

Summary: the main objective of this research is to evaluate the influence of different distraction stimuli on neural mechano-sensitivity tests.


Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 65 years * medical diagnosis of non specific chronic neck pain with more than 6 months of evolution of neck pain exclusion criteria: * patients with rheumatic diseases, cervical hernia, cervical whiplash syndrome, neck surgeries o a history of arthrodesis * systemic diseases * vision, hearing or vestibular problems * severe trauma or a traffic accident that had an impact on the cervical area.
validation of study in respiratory physiology and it interactions

Conditions: Life Experiences; Respiratory Function; Cardiac Function

Summary: the aim of the study was to validate tools of physiological signal processing and interpretation on healthy human volunteers in order to improve the understanding in respiratory physiology and its interactions with heart function, and swallowing.


Eligibility criteria:
inclusion criteria: * healthy subject * between 18 and 60 years old exclusion criteria: * patient * person protected by the law

Keywords: swallowing hyperventilation
physical therapy in carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: it is a randomized clinical trial comparing surgical and conservative (physical therapy) treatments for women with carpal tunnel syndrome (cts). the purpose of the study is to determine the efficacy of physical therapy versus endoscopic surgery in pain and disability in women with carpal tunnel syndrome at medium and long-term follow-up periods. we hypothesized that proper physical therapy approach can be equally effective than surgical intervention for improving pain and function in patients with carpal tunnel syndrome.

scientific evidence for the management of cts has exhibited conflicting results. the cochrane review concluded that surgical treatment relieves symptoms significantly better than splinting but further research is needed. a systematic review focused on physical therapy for the management of cts included 6 studies and found weak to strong effect of neural gliding exercises. recent studies have revealed complex nociceptive mechanisms involved in cts which should be carefully considered during the management of these patients. proper physical therapy interventions can modulate nociceptive processes found in cts. we will perform a randomized clinical trial nested within a prospective cohort as our study design to determine if proper physical therapy approach targeted to modulate sensitization processes is equally effective than surgical intervention for improving pain and function in patients with carpal tunnel syndrome.

Eligibility criteria:
inclusion criteria: * pain and paresthesia in the median nerve distribution without extra-median nerve territory symptoms; * increasing symptoms during night; * tinel sign; * phalen sign; * self-reported hand strength deficits. * deficits of sensory and motor nerve conduction of the median nerve according to standardized guidelines of the american association of electrodiagnosis, american academy of neurology, and the american academy of physical medicine and rehabilitation exclusion criteria: * if any sensory/motor deficit in ulnar or radial nerve was present; * previous interventions with surgery or steroid injections; * multiple diagnoses of the upper extremity (i.e., cervical radiculopathy, lateral epicondylalgia); * history of neck, shoulder or arm trauma; * history of a systemic disease causing cts (e.g. diabetes mellitus, or thyroid disease); * history of systemic musculoskeletal conditions (e.g. rheumatoid arthritis, fibromyalgia); * if the patient was actively involved with or seeking litigation at the time of the study; * pregnancy.

Keywords: carpal tunnel physical therapy surgery efficacy
2-year caries clinical study: arginine fluoride-free toothpastes vs. naf toothpaste

Conditions: Dental Caries

Summary: the objective of this study is to evaluate the anticaries efficacy for three dentifrices (1.5% arginine in a calcium base, 8.0% arginine in a calcium base, and 0.32% sodium fluoride in a silica base) in a two-year caries clinical study


Eligibility criteria:
inclusion criteria: * informed consent form signed by parent or legal guardian to permit participation of their child in the study * willingness and ability to use the assigned products according to instructions, availability for all appointments and likelihood of completing the clinical trial. * children ages 10-14 years at baseline. * presence of second molars or evidence of erupting permanent molars. * subjects should be of good general health as evidenced by a review of the medical history. * presence of two or more active caries lesions (icdas scores of 2 or greater) and with a previous caries experience (dmfs ≥ 2). exclusion characteristics * subjects presenting with any of the criteria below will be excluded from the study: * presence of fixed or removable prosthetic appliance or orthodontic treatment involving more than four permanent teeth. * use of medication that could increase the risk of developing dental caries, i.e. medication that reduces saliva flow. * long-term antibiotic therapy. * children with cognitive and/or motor impairment. * severe malocclusion. * presence of severe caries (icdas 5 or 6) on five or more teeth. * evidence of moderate to severe periodontal disease. * participation in any other clinical study within the 30 days preceding the clinical study. * history of allergies or other adverse reactions to arginine, or oral care products, or their ingredients. * pregnant or lactating.

Keywords: fluoride prevention caries icdas dmfs arginine
trans thoracic ultrasound to assess diaphragmatic function in stable copd versus bronchial asthma.

Conditions: Diaphragm

Summary: * assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in copd and bronchial asthma patients. * assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function. * assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator.

* assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in copd and bronchial asthma patients. * assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function (fev1/fvc). * assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator (short acting b2 agonist)

Eligibility criteria:
inclusion criteria: stable patients (not in exacerbation). exclusion criteria: * patients with comorbidities as cardiac, renal or hepatic diseases. * patients who have combined copd and bronchial asthma.