Kornimate/medical-research-clean huggingface dataset:
randomized trial of early hemodynamic management of patients following acute spinal cord injury

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to learn more about how participants heal from acute spinal cord injury.

in this study, the investigators will learn about the effect of targeted blood pressure management (tpm) on participants healing from acute spinal cord injury. the investigators want to learn: the effect of two types of tpm on long term motor and sensory outcomes. the effect of two types of tpm on long-term pain and functional independence outcomes. how safe tpm is for participants.

Eligibility criteria:
inclusion criteria: 1. acute traumatic spinal cord injury (sci) involving neurological levels as defined by the asia neurological examination between c0 and t8 (tetraplegia) and resulting in new onset neurological deficits consistent with an asia motor assessment of level a, b or c. 2. subject is 18 years of age or older. exclusion criteria: 1. penetrating sci injury. 2. isolated cauda equina syndrome or injury at bony level th9 or below. 3. pre-existing motor deficit secondary to chronic myelopathy. 4. history of demyelinating disease or central nervous system autoimmune disorder. 5. history within the past six months and/or physical findings on admission of decompensated congestive heart failure (nyha functional class iii or iv, or objective class c or d). 6. acute, evolving or recent (30 days) myocardial infarction. 7. chronic renal failure requiring dialysis. 8. suspected or confirmed pregnancy. 9. severe terminal disease with life expectancy less than 6 months. 10. severe traumatic brain injury at presentation (gcs ≤8) with confirmation of injury on brain imaging. 11. a condition that would preclude the performance of an accurate neurological exam due to a prior diagnosis of alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation. 12. non-english or non-spanish speaking. 13. refusal of consent.
3 months' versus 6 months' anticoagulation in patients with dvt and/or pe

Conditions: Deep Vein Thrombosis; Pulmonary Embolism; Deep Vein Thrombosis With Pulmonary Embolism

Summary: to determine whether 3 months' anticoagulation is as good as or better than 6 months' for the treatment of dvt/pe

multi-centre trial involving 46 hospitals in the united kingdom, with patients entered by 137 consultant physicians. consenting patients were randomised in a central office to either 3 months' or 6 months' anticoagulation. information on progress of the patients was requested by the co-ordinating office at 3 months, 6 months and 12 months. outcomes were measured as death from dvt/pe, non-fatal extensions or recurrences of dvt/pe and major haemorrhages during and after anticoagulation.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or more with suspected or proven dvt/pe whom the clinician intended to anticoagulate. exclusion criteria: * dvt/pe severe enough to require thrombolysis or pulmonary embolectomy. * dvt/pe in the preceding 3 years. * neoplasia diagnosed/treated within previous 3 years. * pregnancy. * known major thrombophilias. * prolonged or continuous immobility or confinement to bed. * previous allergy to heparin or warfarin. * requirement for long-term anticoagulation. * inability to give informed consent.

Keywords: duration of anticoagulation deep vein thrombosis and/or pulmonary embolism
culture system for isolating circulating tumor cells

Conditions: Early Detection of Cancer

Summary: this culture system utilizes the special affinity difference of biomedical material coating for different cells to achieve the effect of isolating cancer cells from the blood sample. the coating of the system has the characteristic that to make the wbcs adhesion, but the cancer cells in the blood sample suspend in the culture medium, which achieves the effect of separating cancer cells from the blood. the supernatant with the cancer cells can further be isolated from the cultural system for related analysis and detection to achieve early diagnosis and screening.


Eligibility criteria:
inclusion criteria: 1. polycythemia patients are between the ages of 20 and 70. 2. willing to sign the consent form under the informed consent. inclusion criteria: exclusion criteria: 1. vulnerable subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.

Keywords: circulating tumor cells,wbcs adhesion, biomedical materials
graft patency analysis of the right coronary artery system

Conditions: Coronary Artery Disease

Summary: the ideal grafts for the right coronary artery system in coronary artery bypass surgery remain controversial. the objective of this study is to compare the long-term patency of a right gastroepiploic artery and a saphenous vein graft used for revascularization of the right coronary artery system in off pump coronary artery bypass surgery and to analyze the long-term clinical outcomes. total 224 patients will be enrolled according to the randomization protocol. check list 1. laboratories 2. quantitative coronary analysis (preoperative) 3. major adverse cardiac and cerebrovascular event 4. coronary ct (coronary angiography if needed) at discharge, 1, 5, 10 years postoperatively 5. echocardiogram 5. cardiac enzyme

the ideal bypass conduit for the right coronary artery remains a subject of intense controversy. a variety of grafts and configurations are used: the right gastroepiploic artery,the right internal thoracic artery in situ or in a y-graft configuration,the free radial artery implanted into the aorta or the left internal thoracic artery, and the saphenous vein graft. the influence of the type of graft to the right coronary artery system on clinical results remains poorly documented, and the complementary conduit of choice to this system has yet to be determined. no superior long-term patency rate for any of these grafts to the rca has been clearly established. we have used a saphenous vein and a right gastroepiploic artery for the right coronary artery system.

Eligibility criteria:
inclusion criteria: * angiographic evidence of severe coronary stenosis on the right coronary territory * elective surgery * isolated off pump cabg * age \ 5 years * preoperative rgea diameter \> 1.5mm * normal left ventricular function exclusion criteria: * history of upper abdomen surgery * history of upper gi bleeding * active gastric or duodenal ulcer * body mass index \> 35kg/m2 * redo surgery * presence of varicose vein * contraindication for cabg such as malignancy or liver cirrhosis * other configuration than rgea to rca territory or svg to rca territory

Keywords: opcab
transcranial direct current stimulation as an augmenting intervention for major depression

Conditions: Major Depressive Disorder

Summary: transcranial direct current stimulation (tdcs) is a noninvasive method to activate or de-activate neurons in superficial regions of the brain through the induction of weak electric currents in the brain tissue delivered by two scalp electrodes. initial studies have shown tdcs to be effective for treating major depressive disorder (mdd), although there are negative trials in the specialized literature. one reason for these discrepant results might be that the duration of tdcs treatment in clinical trials to date (up to 2 weeks) is still insufficient to produce consistent clinical improvements. thus, we intend to assess, in a sample of outpatients with mdd, whether a 3-week adjunctive course of active tdcs over the left dorsolateral prefrontal cortex is associated with a significant clinical improvement when compared to sham tdcs. the investigators hypothesize that subjects receiving active tdcs will present with significantly higher response and remission rates at weeks 3.


Eligibility criteria:
inclusion criteria: * presence of a current major depressive disorder (according to the diagnostic and statistical manual, fourth edition, text revision \[dsm-iv-tr\]) * baseline score ≥ 13 on the qids-c * stable medication regimen (\> 4 weeks) exclusion criteria: * psychotic features in the current episode * lifetime history of psychotic disorders and/or bipolar i or ii disorders * substance or alcohol abuse/dependence in the past 6 months * lifetime history of a major neurological disease (e.g., parkinson's, stroke) * uncontrolled medical disease (e.g., cardiovascular, renal) * pregnancy and/or lactation * presence of a specific contraindication for tdcs (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)

Keywords: major depression transcranial direct current stimulation randomized, sham-controlled trial tdcs
the pharmacokinetics/pharmacodynamics of high-dose daptomycin in patients with septic shock

Conditions: Septic Shock

Summary: the first objective of this study was to characterize the pharmacokinetics and pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the second objective is to identify the optimal dosing scheme for daptomycin among patients with septic shock and to enhance therapeutic outcomes.

daptomycin is a novel lipopeptide exhibiting concentration-dependent bactericidal activity against multidrug-resistant gram-positive pathogens, including methicillin-resistant staphylococcus aureus (mrsa). in recent years, daptomycin plays an important role in the treatment of septic shock. the pharmacokinetics of daptomycin is significant changed in patients with septic shock, it is proved that the recent dosage regiment comes with a low blood drug concentration and unsatisfactory outcome. although the high-dose daptomycin shows safety and effectiveness in the treatment of critically ill patient, but still the pharmacokinetics and pharmacodynamics data is scant. so the purposes of this study is to characterize the pharmacokinetics and pharmacodynamics of daptomycin with a daily dose of 12mg/kg in septic shock patient; the second objective is to identify the optimal dosing scheme for daptomycin among patients with septic shock and to enhance therapeutic outcomes.

Eligibility criteria:
inclusion criteria: * ≥18 years and ≤75 years * confirmed or suspected bloodstream and soft tissue infections caused by a grampositive organism exclusion criteria: * known hypersensitivity to daptomycin or product excipients * documented or suspected pneumonia caused by a grampositive organism * infection with a daptomycin-resistant organism * presence or history of rhabdomyolysis * signs or symptoms of myopathy with an elevation of creatine phosphokinase concentrations 6.pregnancy or breast-feeding
vasomotor reactivity in cerebral small vessel disease and new approach to treat lacunar stroke

Conditions: Cerebrovascular Accident; Hypercholesterolemia

Summary: the main purpose of this study is to evaluate the efficacy of atorvastatin treatment during 3 months (80mg/day) on cerebral vasoreactivity (cvr) in lacunar patients.


Eligibility criteria:
inclusion criteria: * clinically defined lacunar syndrome 3 months before inclusion * small deep infarct on diffusion mri (diffusion weighted imaging) * no atherothrombotic, cardio-embolic, or other rarer cause. exclusion criteria: * patients with past coronary event * contra-indication for assessment of vasomotor reactivity * patients being on statin therapy at the time of brain infarction * contra-indication for statin therapy * patient still under statin therapy
a trial of lu ag13909 in participants with congenital adrenal hyperplasia

Conditions: Congenital Adrenal Hyperplasia

Summary: this trial will evaluate the effects of different doses of lu ag13909 in adult participants with congenital adrenal hyperplasia, also called cah. cah is a rare genetic disorder that affects a person's ability to produce certain hormones. the main goals of this trial are to learn about the safety and tolerability of lu ag13909, how lu ag13909 behaves in the body, and how the body responds to lu ag13909.


Eligibility criteria:
inclusion criteria: parts a and b: * confirmed diagnosis of 21-hydroxylase deficiency cah (based on a pathogenic cyp21a2 variant and/or elevated 17-ohp). * morning (pre-glucocorticoid \[gc\] replacement dose) blood concentrations of 17-ohp \>4-times upper limit of normal (uln). * body mass index (bmi) ≥18.5 kilograms (kg)/square meter (m\^2) (minimum 50 kg) and ≤40 kg/m\^2. * stable gc replacement therapy for ≥1 month prior to the screening visit. * for the salt-wasting form of cah, the participant must have been on a stable dose of mineralocorticoid replacement for ≥3 months prior to the screening visit. * apart from cah, the participant is generally healthy in the opinion of the investigator and based on medical history, physical examination, vital signs, ecgs, and the results of the safety laboratory tests. part c: * confirmed diagnosis of 21-hydroxylase deficiency cah (based on a pathogenic cyp21a2 variant and/or elevated 17-ohp). * for cohort c1 only: morning (pre-gc replacement dose) blood concentrations of androgens (a4) \> uln for age and sex. * for cohort c2 only: morning (pre-gc replacement dose) blood concentrations of androgens (a4) ≤ uln for age and sex and the participant is treated with high doses of gc. * stable gc replacement therapy for ≥1 month prior to the screening visit. * for the salt-wasting form of cah, the participant must have been on a stable dose of mineralocorticoid replacement for ≥1 month prior to the screening visit. exclusion criteria: * the participant is pregnant or breastfeeding. * the participant has a clinically significant abnormal laboratory value, electrocardiogram (ecg) parameter, or vital signs value, or other safety findings at the screening visit that indicate a potential risk for the participant if enrolled, in the opinion of the investigator. * the participant has a history of known hypersensitivity or intolerance to lu ag13909 or its excipients. part c only: * the participant has received at least one dose of lu ag13909 in part a or part b. other inclusion and exclusion criteria may apply.
neonatal sepsis workup for high risk newborns - evaluation of need and ways to prevent

Conditions: Neonatal Sepsis

Summary: sepsis is a significant cause of morbidity and mortality among newborns. due to strict criteria and in order to diagnose and prevent early-onset group b streptococcal (eogbs) sepsis, many infants undergo a sepsis workup due to risk factors alone, even though they are asymptomatic. our goal is to evaluate the number of newborns that undergo sepsis workup due to risk factors alone, to determine the number of newborns having positive blood cultures, and to establish ways to reduce the number of asymptomatic infants undergoing sepsis workup.


Eligibility criteria:
inclusion criteria: term newborns with blood cultures taken from them the first 48 hrs exclusion criteria: * preterm newborns * septic/ill appearing newborns * newborns requiring admission to nicu

Keywords: early onset gbs sepsis prevention maternal risk factors
thyroid associated orbitopathy treatment by methotrexate against triamcinolone periocular injections

Conditions: Thyroid Associated Orbitopathy

Summary: the study objective is to investigate the efficacy and safety of periocular injections of methotrexate in management of patients with active moderate to severe thyroid associated orbitopathy in comparison to periocular injections of triamcinolone acetonide.

recruited subjects will be randomized such that one orbit receives 3 periocular injections of methotrexate and the contralateral orbit receives 3 periocular injections of triamcinolone acetonide at day 0, week 3 and week 6. all study subjects will be followed up for 6 months where outcome measures are assessed at 2 weeks, 1month, 3 months and 6 months after last injection

Eligibility criteria:
inclusion criteria: 1. bilateral moderate to severe thyroid associated orbitopathy. 2. clinical activity score (cas) ≥ 3. 3. duration of thyroid associated orbitopathy \< 2 years exclusion criteria: 1. sight threatening thyroid associated orbitopathy (dysthyroid optic neuropathy or exposure keratopathy) in any eye. 2. glaucoma patients or those known to be steroid responders 3. presence of orbital infections or any infection in nearby structures as paranasal sinusitis or dental abscess 4. pregnancy 5. previous orbital or lid surgeries 6. history of steroid therapy (oral, intravenous or periocular) or other immunosuppressive therapy within the previous 3 months

Keywords: thyroid associated orbitopathy grave's orbitopathy periocular injections methotrexate triamcinolone
a study on the efficacy and safety of multi-focal scleral contact lens

Conditions: High Myopia

Summary: the rigid scleral contact lens with optical multi-focal design adopted in this study can focus the light in part of the optical area on the front of the retina to form myopic defocus, in order to delay the axial changes in children and adolescents with ultra-high myopia. in this study, rgp was used as a control, and a multicenter, randomized, controlled trial was conducted to verify the safety and effectiveness of multifocal scleral contact lenses for the correction of ultra-high myopia in children and adolescents.


Eligibility criteria:
inclusion criteria: 1. be able to understand and sign the informed consent when accompanied by parents or guardians. 2. age from 8 years old to15 years old. 3. the equivalent spherical lens of both eyes after ciliary muscle paralysis is -5.00d to -20.00d, the astigmatism is ≤-3.50d. 4. willing to wear hard contact lenses, and able to wear only the hard contact lenses provided by the study as required and ensure adequate wearing duration. (6) best corrected visual acuity of both eyes ≥ 0.8. exclusion criteria: (1) allergic or intolerant to rigid contact lens or its care products or ciliary muscle paralysis drugs. strabismus and/or amblyopia. (3) those who have worn hard contact lenses in the past 30 days are using atropine, defocus frame lens, bifocal lens or progressive lens, acupuncture, etc. for myopia treatment. (4) any clinically significant active eye disease, such as glaucoma, uveitis, chorioretinitis, central retinal artery or vein occlusion, and so on. (5) patients with systemic diseases that may affect the wearing of hard contact lenses, such as hyperthyroidism, diabetes, mental illness, and so on. (6) are using drugs that affect their eye health. (7) history of eye injury or surgery. (8) incapacitated or unable to follow the visitor as required. (9) other conditions not suitable for inclusion as judged by the investigator.

Keywords: high myopia children and adolescents defocus scleral contact lens
effectiveness and safety of once or twice daily mometasone nasal spray versus amoxicillin versus placebo for treatment of acute rhinosinusitis (study p02683)

Conditions: Acute Rhinosinusitis

Summary: this study was conducted to compare the effectiveness and safety of mometasone nasal spray once daily or twice daily with amoxicillin or with placebo in treating the signs and symptoms of acute rhinosinusitis. patients received mometasone nasal spray 2 sprays per nostril once daily, 2 sprays per nostril twice daily, amoxicillin 500 mg three times a day, or placebo three times a day. patients on nasal spray were treated for 15 days and patients on amoxicillin or placebo were treated for 10 days. all patients were followed-up with a 14-day no-treatment observation period.


Eligibility criteria:
inclusion criteria: subjects must: * have been diagnosed with acute rhinosinusitis * have had signs and symptoms of rhinosinusitis for at least 7 but not more than 28 days prior to baseline * have had a major symptom score \>=5 and \<=12 at the screening and baseline, and no more than 3 of the 5 major individual symptoms were to be rated as "severe" * be \>=12 years old * be in good health overall and normal laboratory tests * not be pregnant, intending to become pregnant or intending to impregnate. exclusion criteria: subjects who: * have a history of chronic rhinosinusitis or who had undergone sinus or nasal surgery for chronic rhinosinusitis in the 6 months prior to screening * have fever \>=101°f and/or persistent severe unilateral facial pain/tooth pain; and/or orbital or peri-orbital facial swelling; and/or dental involvement; and/or worsening symptoms after initial improvement * have a history of symptomatic seasonal allergic rhinitis who were exposed to allergenic pollens * have asthma with fev1\<65% of predicted volume in the past 3 months or who have had an exacerbation within the past 30 days * have nasal polyps, kartagener's syndrome, and otitis or atrophic rhinitis * have certain comorbid conditions or contraindications to certain drug therapies
study of the molecular genetics of menstrual migraine

Conditions: Migraine

Summary: the investigators hypothesize that genes that play a role in menstrual migraine can be identified using a well characterised migraine population and a comprehensive genome-wide association scan approach. the aim of the study is to identify genes, genetic regions, and the effect of hormones on expression profiles in women with menstrual migraine compared to a control population with no personal or first-degree family history of migraine. in this case control study, saliva samples will be taken from 300 cases and 300 controls for dna analysis. blood samples from 30 cases and 30 controls will be taken during the follicular phase as well as the luteal phase of the menstrual cycle for ribonucleic acid (rna) analysis.


Eligibility criteria:
inclusion criteria: all cases and controls must: * be over 18 years * caucasian * provide written, informed consent * clearly understand and be able to comply with all the trial procedures, as required * not have taken part in trials of any investigational products within the previous 4 weeks dna study: * cases must have at least a 12-month current or past history of menstrual migraine rna study: * cases must have at least a 12-month current history of menstrual migraine * cases must have kept at least three months of headache diary data in advance of visit in order to confirm diagnosis * controls must still be having menstrual periods exclusion criteria: dna study: * cases and controls must not have smoked, chewed gum or consumed any food or drink in the 30 minutes prior to sample collection rna study: * cases and controls will not be eligible for participation if they have: * polycystic ovarian syndrome; * taken any hormones or drugs in the previous three months that may affect normal hormone activity (e.g., hormonal contraceptives, hormone replacement therapy, dietary supplements such as isoflavones); * donated or lost a significant amount of blood (\> 550 ml) within the previous 12 weeks * additionally, controls must not have a personal or family history in any first-degree relative of current or past migraine

Keywords: menstruation migraine menstrual migraine genetics