Kornimate/medical-research-clean huggingface dataset:
positive effects of haematococcus astaxanthin on oxidative stress and lipid profile in overweight and obese adults

Conditions: Healthy; Overweight; Obesity

Summary: the purpose of this study is to determine whether astaxanthin (asx) supplementation will reduce obesity-induced oxidative stress and improve lipid profile in overweight and obese adults.


Eligibility criteria:
inclusion criteria: * subjects with bmi over 25.0 kg/m2 * non-smoker exclusion criteria: * excessive alcohol consumption * pregnant or lactating women * dyslipidemia, hyperglycemia, or other chronic diseases. * subjects who were taking vitamin supplements

Keywords: healthy adults with bmi over 25.0 kg/m2
effects on pain and function of orthopedic manual therapy in patients with painful disc displacement with reduction

Conditions: Temporomandibular Disorder; Manual Therapy

Summary: the objective of this study was to compare the short- and medium-term effects in pain and temporomandibular joint (tmj) and function of implementing a manual therapy (mt) intervention treatment combined with a therapeutic exercise (te) program, versus an isolated te program and a non-intervention in patients with disc displacement with reduction (ddcr) with pain.

study design: the study adopted a single-blind, randomized, controlled clinical trial approach. adults with disc displacement with reduction clinical diagnosis, pain and loss of function were eligible for inclusion. intervention: patients in the study were randomized into three groups, 25 subjects to the manual therapy and therapeutic exercise group, 25 to the therapeutic exercise group and 25 to the no intervention group. subjects were excluded if there was presence of surgical history, dentistry treatment and use of medication. the dependent variables were the presence of clicking, tmj function, cervical disability, pain, and range of motion of the tmj. subjects in every group were assessed after four weeks of intervention and after eight weeks.

Eligibility criteria:
inclusion criteria: * disc displacement with reduction diagnosis according to the research diagnostic criteria for temporomandibular disorders; in the last 30 days, any tmj noise present during the exam or clicking detected with palpation during at least one of three repetitions of jaw opening, closing, protrusion, or laterotrusion movements. * equal or greater than 30 mm on the vas scale * age is greater than or equal to18 years. exclusion criteria: * participants were excluded if they had received interventions of tmj surgery or tmj steroid injections in the previous month, a rheumatoid diagnosis, neurological or psychiatric diseases, or pregnancy.
adolescent menacwy booster study

Conditions: Meningococcal Disease, Invasive

Summary: this study is to confirm non-inferiority of the three menacwy vaccines (menveo, menactra or nimenrix) in adolescents, and to identify whether the number of previous doses of menc influences the response to the menacwy vaccine.

participants will be randomized to receive one of the three doses of licensed menacwy as a booster dose in adolescents. serology will be collect at 3 time points; prior to the booster dose and 1 month and 1 year post-vaccination to measure antibody levels. the participants are healthy students in grades 7-9 who have not received their menacwy vaccine yet and received their routine infant menc vaccines per previous canadian schedules.

Eligibility criteria:
inclusion criteria all the following need to be fulfilled: 1. healthy adolescent 2. previous receipt of appropriate menc vaccine according to the relevant provincial schedule (see above) 3. parent/legal guardian has given informed consent or participant has given consent (if participant demonstrates capacity to consent) 4. participant has given consent (as above) or assent. exclusion criteria the participant may not enter the trial if any of the following apply: 1. has already received any doses of menacwy vaccine at any age 2. previous confirmed or suspected meningococcal disease 3. close contact with an individual with laboratory-confirmed n. meningitidis in prior 12 months 4. previous allergic reaction to a component of any of the 3 vaccines 5. serious chronic or progressive disease 6. confirmed/suspected immunodeficiency 7. receipt of more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone \>0.5ml/kg/day or intravenous glucocorticoid steroid). nasal, topical or inhaled steroids are allowed 8. administration of immunoglobulins within the prior 12 months and/or any blood products planned during the study period 9. pregnancy (based on history from adolescent and parent/legal guardian) 10. any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. temporary exclusion criteria if the adolescent has a temperature ≥ 38°c, then vaccination (and blood sampling if due to occur at same visit) will be postponed until resolution of fever.

Keywords: menacwy neisseria meningitidis adolescents
endothelin concentrations in a population with cardiovascular disease and periodonitis

Conditions: Serum; Disease

Summary: recently, a key role played in the ethiology of periodontitis has been highlighted by a endothelin (et-1). et1 possess the ability to express surface antigens of endothelial and hematopoietic stem cells and to assist in maintaining vascular integrity and the repair mechanism of the endothelium. et originate from bone marrow

the aim of the present study was to investigate the association between et-1 in patients with periodontitis. furthermore, the objective was to determine if the periodontal status influenced et-1 levels.

Eligibility criteria:
inclusion criteria: * presence of at least 16 teeth * cp with a minimum of 40% of sites with a clinical attachment level (cal) ≥2mm and probing depth (pd) ≥4mm; * presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs * presence of ≥40% sites with bleeding on probing (bop) exclusion criteria: * intake of contraceptives * intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study * status of pregnancy or lactation * previous history of excessive drinking * allergy to local anaesthetic * intake of drugs that may potentially determine gingival hyperplasia such as hydantoin, nifedipine, cyclosporin a or similar drugs.
cytarabine in combination with arsenic trioxide vs. cytarabine alone in elderly patients with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the primary objective of this study is to determine whether low-dose cytarabine in combination with arsenic trioxide is more effective than low-dose cytarabine alone in achieving complete remission in elderly patients (≥60 years of age) with acute myeloid leukemia.


Eligibility criteria:
inclusion criteria: * the patient has confirmed acute myeloid leukemia (aml). * the patient is unwilling or unable to tolerate conventional induction chemotherapy. * the patient has no comorbid conditions that would limit life expectancy to less than 3 months. * patient must meet specific laboratory parameters for study inclusion. exclusion criteria: - the patient has had previous cytotoxic chemotherapy for acute myeloid leukemia (aml) or myelodysplastic syndrome (mds). previous treatment with low-dose cytarabine is not permitted. * the patient has a qt interval outside of the protocol-specified range. * the patient has laboratory values outside of protocol-specified ranges. * the patient is concurrently treated with cytotoxic therapy, radiation, or investigational agents. * the patient has uncontrolled, severe cardiovascular or pulmonary disease or other uncontrolled medical condition. * the patient has known central nervous system involvement with aml.

Keywords: acute myeloid leukemia, cytarabine, arsenic trioxide.
bridging animal and human models of exercise-induced visual rehabilitation

Conditions: Vision Disorders

Summary: this study will determine whether blood biomarker changes predict sight-saving benefits of exercise.

investigators of the atlanta va center for visual and neurocognitive rehabilitation (cvnr) find a very high prevalence of blinding diseases in the aging veteran population. there are few treatments for the disorders that threaten our veterans' eyesight. the work proposed here is the first step in determining whether exercise can be used by aging veterans as an inexpensive and self-controlled therapy for vision loss. in order to translate exercise therapy for vision into the clinic, the investigators need to identify biomarkers that can be used to predict visual benefits. though human and animal studies show that aerobic exercise is beneficial to specific central and peripheral nervous system functions, effects on the retina and vision were unknown until the investigators recently discovered that treadmill exercise directly protects retinal neurons in mice undergoing light-induced retinal degeneration (lird). the investigators found that exercise increased levels of brain-derived neurotrophic factor (bdnf) a blood protein in the blood, brain and eyes, whereas treatment of mice with a bdnf inhibitor prevented the protective effects of exercise. for this study, the investigators will assess visual outcomes and serum biomarkers (e.g, bdnf) in 60 subjects age 18-89 before, during, and after aerobic exercise. subjects currently enrolled in a 12-week study (under institutional review board (irb) 56726) examining the effects of aerobic exercise on cognition will have visual testing (erg, visual acuity, contrast sensitivity, and oct) and blood collection prior to, during and after the standardized 12-week aerobic exercise regimen to determine whether circulating biomarker levels and visual outcomes are correlated and whether biomarker levels are altered as predicted in animal studies. this study will determine whether biomarker changes predict sight-saving benefits of exercise. as opposed to surgery or pharmacological treatments, exercise programs provide a means for veterans to exert some control over their visual disease progression and will increase their overall health.

Eligibility criteria:
inclusion criteria: * english speaking * aged 18 to 89 * sedentary as defined by \< 120 min/week of aerobic exercise over prior 3 months * non-demented (mmse 24) exclusion criteria: * severe diabetes requiring insulin * cognitive-executive function deficit (moca \< 26)

Keywords: exercise retinal degeneration neuropharmacology brain-derived neurotrophic factor biometry immunochemistry molecular biology neurosciences ophthalmology
safety and efficacy of levofloxacin combined with intravenous thrombolysis for acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the purpose of this study is to determine the efficacy and safety of levofloxacin combined with intravenous thrombolysis in treating acute ischemic stroke

acute ischemic stroke is a leading cause of disability and mortality. intravenous thrombolysis is a major therapy for acute ischemic stroke, however, nearly half of patients failed to benefit from it. it is necessary to find new interventions combined to intravenous thrombolysis, which promote the efficacy of intravenous thrombolysis. the investigators' previous studies suggested levofloxacin to be a newly identified neuro-protective agent, which could reduce infarct volume and improve neurologic function in animal models. to evaluate the efficacy and safety of levofloxacin combined with intravenous thrombolysis in treating acute ischemic stroke patients, the prospective, multicenter and randomized controlled trial was designed.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years. 2. acute ischemic stroke patients underwent intravenous thrombolysis, treated with ateplase (0.9mg/kg) 3. mrs≤1 before stroke onset, nihss ≥ 5 and ≤ 15，la (nihss) level of consciousness \< 1 exclusion criteria: 1. endovascular treatment 2. patients using glucocorticoids, antiarrhythmic drugs (class i and class iii antiarrhythmic drugs: quinidine, procaine amine, lidocaine, phenytoin sodium, verapamil, etc.), and quinolones within 14 days; 3. patients with other diseases that may aggravate adverse drug reactions, such as ventricular arrhythmias, prolonged qt interval (male: qtc\>430ms, female: qtc\>450ms), severe cardiac insufficiency (nyha functional grade ≥ iii), myasthenia gravis, peripheral neuropathy, seizures, tendon-related diseases, severe immune system-related diseases, hematological diseases, active hepatitis or cirrhosis, serious respiratory diseases; 4. abnormal liver and kidney function: glutamic oxaloacetic transaminase or glutamic pyruvic transaminase exceeds 3 times the upper limit of normal; direct bilirubin or indirect bilirubin more than 3 times the normal upper limit; blood creatinine exceeds 1.1 times the upper limit of normal; creatinine clearance rate≤50ml/min; urea nitrogen≥ 20mg/dl; 5. concurrent infection; 6. fasting blood glucose lower than 3.9 mmol/l; 7. patients with symptomatic intracranial hemorrhage confirmed by clinical signs and imaging before randomization; 8. patients allergy to fluoroquinolones or other antibiotics; 9. patients with a life expectancy less than 3 months or patients unable to complete the study for other reasons; 10. not willing to be followed up or poor treatment compliance; 11. patients who are participating in other clinical studies, or have participated in other clinical studies within 3 months before enrollment, or have participated in this study; 12. other conditions not suitable for enrollment.

Keywords: acute ischemic stroke intravenous thrombolysis levofloxacin
cooperative pain education and self-management: expanding treatment for real-world access (copes extra)

Conditions: Pain, Chronic

Summary: to conduct a superiority trial of copes versus standard veterans health administration (vha) cognitive behavioral therapy chronic pain (cbt-cp)

our prior efficacy trial found that copes was not inferior to in-person cbt-cp and that participants attended, on average, a little over two more treatment weeks in copes than in-person treatment, presumably due to the ease of in-home treatment attendance relative to in-person treatment.

Eligibility criteria:
inclusion criteria: * patients with chronic musculoskeletal pain receiving care in vha. * a pain-related musculoskeletal diagnosis indicated by an ehr identified icd-9 or -10 code. * the presence of chronic pain of at least moderate severity with ehr nrs pain scores ≥ 4 in three separate months for a period of 12 months. * absence of mental illness serious enough to have resulted in an inpatient psychiatric hospitalization in the prior 3 months excluding detoxification of alcohol or drugs. * absence of malignant cancer diagnosis or receipt of hospice or end-of-life palliative care. * ability to participate safely in the walking portion of the intervention as evidenced by patient-reported ability to walk at least one block and absence of diabetic foot ulcers at the time of the enrollment. * absence of significant cognitive impairment as identified by a dementia-related diagnosis. * availability of a touch-tone land-line or cellular telephone and no vision or hearing deficits that would impair participation verified by patient report at the time of the enrollment call. exclusion criteria: * patients not fitting criteria for inclusion.
thoraco-lumbar fascia mobility

Conditions: Low Back Pain

Summary: the purpose of the thoraco-lumbar fascial mobility (tlfm) study is to use ultrasound to measure the movement of connective tissue in the low back area of individuals with chronic low back pain (lasting more than 1 year). this study will compare baseline measurements, measurements after a single high velocity low amplitude spinal manipulation (hvla-sm) and after a course of up to 16 hvla-sm.

the investigators will conduct a single arm pilot (proof-of-concept) clinical trial. approximately 30 participants with self-reported chronic low-back pain (lbp), defined as pain for ≥ 1-year in duration and pain on at least ½ of the days in the past 6-months, will be enrolled. this trial will consist of two separate enrollment phases. phase 1 consists of enrollment at baseline followed by 3 separate ultrasound measurements. phase 1 ends after a 4-week no treatment run-in phase. phase 2 begins twice-weekly hvla-sm treatments to the thoracolumbar region for 8-weeks. two ultrasound imaging evaluations will occur at visit 1 (pre and post-treatment). pre-treatment ultrasound evaluations will be obtained at 4-weeks and 8-weeks. the primary outcome is shear strain (adjacent tissue layer mobility measured with ultrasound) at the level of the lumbar l2-l3 vertebrae bilaterally. ultrasound measures will be obtained with a terason t3000 system using a 12l5 linear array probe with 10 mhz setting. because shear strain may differ between sexes, we will attempt to recruit equal numbers of male and female participants.

Eligibility criteria:
inclusion: 1. adults between 21 and 65 years 2. lbp of ≥ 1-yr duration with at least ½ of days with pain over the prior 6-months 3. able to understand study procedures and willing to sign informed consent document 4. willing to forgo any manual therapy for lbp for the initial 4-week study period 5. willing to forgo any manual therapy for lbp other than study treatments during the 8-week treatment period 6. able to tolerate and safely receive study procedures exclusion criteria: 1. chiropractic care or other manual therapy for at least 90 days prior to baseline visit 2. unable to visualize necessary tissue layers using musculoskeletal ultrasound 3. weight above 350 lbs 4. unable to tolerate or safely receive study procedures 5. need for referral 6. unable or unwilling to comply with study procedures 7. current or planned pregnancy (self-reported) within the study timeframe 8. any prior surgery to the thoracolumbar region 9. needing a proxy 10. connective tissue disorder such as marfan and ehlers-danlos syndrome

Keywords: back pain ultrasound fascia
adherence in the childhood asthma management program

Conditions: Asthma; Lung Diseases

Summary: to evaluate three adherence promoting interventions within the childhood asthma management program (camp), an eight center clinical trial that compared pediatric asthma therapies in children five to twelve years old.

background: the success of any therapeutic intervention, whether preventive or curative, is ultimately dependent on the individual's adherence to treatment. unfortunately, the failure of a large percentage of patients to adhere to prescribed medical regimens is a widely recognized and well documented phenomenon. it has been estimated that as many as 50 percent of patients do not take their prescribed medications, and of those remaining, less than two-thirds take their medication as prescribed. the study was part of a two grant initiative, "evaluation of adherence interventions in clinical trials", developed by the behavioral medicine branch staff and the clinical trials branch staff and by members of the clinical applications and prevention advisory committee behavioral medicine and prevention working groups. the initiative, jointly sponsored by the nhlbi and the national center for nursing research (ncnr), was released in september 1991 and awarded in september 1992. design narrative: all participants medication adherence was measured by self-report, canister weighing, and with the nebulizer chronolog, a microprocessor-based monitor of inhaler adherence that recorded the date and time of each inhaler use. the subjects were assigned to one of three adherence treatment groups; a control condition, an informed condition, and a feedback condition. adherence outcomes were analyzed with respect to treatment assignment, as well as camp measures of asthma morbidity, pulmonary function, medication side effects, psychosocial development, and quality of life. cost-effectiveness analyses were also conducted. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
cohort of ischemic stroke patients

Conditions: Ischemic Stroke

Summary: ischemic stroke is the first cause of acquired disability of the adult, the second cause of dementia and the third cause of death in the industrialized countries, what constitutes à major public health issue. stroke is characterized by a cerebral parenchymal lesion due to an ischemic mechanism (85% of the cases) or hemorrhagic mechanism (15%). for a long time, the only approved treatment was the intravenous thrombolysis (rt-pa). recently, thrombectomy has proven its superiority in this pathology. cohorts of patients with stroke are rare but can be very valuable by their clinical, laboratory and imaging well documented. they are the source of new hypotheses for research or interventions as well as the quality of care assessment tool. the main objective of this project is to identify new markers: biological and imaging, treatment response and prognosis after ischemic stroke. secondary objectives of the hibiscus-stroke cohort are to establish a clinical database, completed by biological samples and by imaging data that can be used in the following areas: * descriptive epidemiology of ischemic stroke and cerebral reperfusion, * pharmacoepidemiology and treatments observatory: safety, efficacy, indication of treatment in real life, costs * assessment of the long-term effect of the treatment on the occurrence of disability, stroke recurrence and death, * quality of life and personal, familial, professional and social consequences of stroke, * research of new diagnostic and prognostic biomarkers, * research projects.


Eligibility criteria:
inclusion criteria: * age\> 18 years * ischemic stroke confirmed by mri * proximal arterial occlusion (ica or m1) * eligible for thrombolysis and/or thrombectomy exclusion criteria: * patients residing\> 50 km from the pierre wertheimer hospital (lyon, france) * inability to perform the first sample (h0) * patient with progressive or uncontrolled cancer. * refusal to participate in the study or to sign the consent * lack of medical social coverage * deprivation of civil rights

Keywords: ischemic stroke, stroke, bio-collection, imaging markers, biomarkers, clinical outcomes