Kornimate/medical-research-clean huggingface dataset:
a study for patients with active rheumatoid arthritis despite ongoing methotrexate therapy

Conditions: Rheumatoid Arthritis

Summary: to assess the efficacy of ly2127399 versus placebo using american college of rheumatology (acr)50 response scale at 24 weeks


Eligibility criteria:
inclusion criteria: * have given written informed consent * women must not be at risk to become pregnant during study participation * diagnosis of rheumatoid arthritis (ra) * current, regular use of methotrexate, at a stable dose * other criteria to be reviewed by study doctor exclusion criteria: * use of excluded medications(reviewed by study doctor) * have not failed biologic tumor necrosis factor-alpha (tnf-α) inhibitor therapy * have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation in the study * evidence of tuberculosis * have systemic inflammatory condition other than ra, such as juvenile ra, crohn's disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy * other criteria to be reviewed by study doctor

Keywords: arthritis
geko™ plaster cast study, deep vein thrombosis (dvt) prophylaxis

Conditions: Deep Vein Thrombosis

Summary: the primary objective of this study is to examine the flow characteristics of deep venous flow in the leg veins using doppler ultrasound imaging and how this flow is modified by the application of a plaster and with a geko™ device in healthy volunteers


Eligibility criteria:
inclusion criteria: 1. be in good general health and fitness. 2. aged between 18 and 65 years. 3. free of significant abnormal findings as determined by medical history (specifically an absence of dvt or haematological disorders or indications), screening physical examination, vital signs (sitting blood pressure, sitting pulse rate, sitting respiratory rate and body temperature) and duplex ultrasound) 4. bmi between 18 and 34 5. no history or signs of drug abuse (including alcohol), licit or illicit. 6. has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the principal investigator during the thirty (30) days preceding the study, and agrees not to use any medications during the course of the study without informing the research team. 7. able to understand the volunteer information sheet and signed the written informed consent forms. 8. able and willing to follow the protocol requirements. exclusion criteria: 1. previous leg fracture. (within the last 12 months) 2. any evidence of organ dysfunction, or any clinically significant deviation from normal in the physical determinations. 3. history or signs of haematological disorders (especially in relation to clotting or coagulation or previous deep or superficial vein thrombosis/pulmonary embolism) or familiar history of such. 4. peripheral arterial disease (abpi\<0.9), clinically significant varicose veins or lower limb ulceration. 5. musculoskeletal disorders (such as pain during exercise of lower limb, rheumatoid or osteoarthritis). 6. neurological disorders,(such as stroke, multiple sclerosis) 7. recent surgery (such as abdominal, gynaecological, hip knee replacement). 8. recent trauma to lower limbs. 9. chronic obesity (bmi index \>34). 10. pregnancy. 11. any medication judged to be significant by the principal investigator. 12. tobacco consumption 13. history of disorders of the gastrointestinal, hepatic, renal, cardiovascular, endocrine, neurological, dermatological, rheumatologic, metabolic (including diabetes), psychiatric, haematological (especially in relation to clotting or coagulation), or systemic disease judged to be significant. 14. a pulse rate of less than 50 beats/minute, a sitting systolic blood pressure \>160 or \ 90 or \<60 mmhg. 15. any significant illness during the four (4) weeks preceding the screening period of the study. 16. any contraindication to blood sampling. 17. donation of blood during the eight (8) weeks preceding the screening period of the study or during the investigation. 18. participation in any clinical study during the 8 weeks preceding the dosing period of the study 19. fitted with a pacemaker or defibrillator

Keywords: deep vein thrombosis
study's care of acute pancreatitis at saint-etienne university hospital.

Conditions: Acute Pancreatitis

Summary: internal medicine units treat patients with undifferentiated or multisystem diseases, with a non-specific organ approach. in some cases, patients with single-organ disease may be admitted to internal medicine wards. acute pancreatitis is the most common gastrointestinal illness requiring acute admission to hospital. it is characterised by local and systemic inflammation of the pancreas corresponding to single-organ disease. for patients with single-organ disease such as acute pancreatitis, it is not known whether admission to internal medicine is as effective as admission to a unit specialising in a specific organ, such as hepato-gastro-enterology.


Eligibility criteria:
inclusion criteria: * adult patient * primary diagnosis of acute pancreatitis in internal medicine and gastroenterology. exclusion criteria: -

Keywords: internal medicine unit efficiency retrospective observational study acute pancreatitis
early detection of severe heart disease in fetuses at high risk of heart disease

Conditions: Heart Diseases

Summary: the main objective of the work is to evaluate, in the french health care system, the performance of early ultrasound screening for severe heart disease between 11 and 14sa in high-risk populations.

numerous studies have shown a link between increased nuchal translucency and heart disease. although high-risk fetal populations are identified between 11 and 13 sa on clinical and biological criteria and by screening ultrasound (echo t1), cardiac morphology analysis is routinely performed only during 2nd trimester fetal morphology ultrasound between 18 and 22 sa (echomorpho-t2) inducing a difficult wait for the couple. the development of increasingly efficient ultrasound probes has made it possible to explore the foetal heart at an earlier stage. international learned societies recommend an early morphological examination with heart-centered slices before 14 weeks in high-risk situations. this practice is not systematic in france and no study has evaluated its feasibility and impact in a french care network.

Eligibility criteria:
inclusion criteria: pregnant women whose fetus is at high risk for congenital heart disease: * nuchal translucency measurement on t1 echo ≥3.5mm * cardiac or extra-cardiac morphological abnormality suspected on the t1 screening echo * first degree family history for the fetus (patient, spouse, 1st children of the couple) of significant congenital cardiopathy (excluding aic, muscular vic or persistent ca). exclusion criteria: * multiple pregnancies * non-emancipated minors, persons unable to express their consent. * lack of affiliation to a social security scheme. * subject in a period of exclusion from another study, * subject under administrative or judicial supervision * subject cannot be contacted in case of emergency
the effect of systane® balance on tear film break up time in dry eye subjects

Conditions: Dry Eye

Summary: the purpose of this study was to evaluate the ability of systane® balance dosed 4 times a day for 30 days to increase non-invasive tear film break up time over baseline, compared to a saline control, in dry eye subjects with lipid deficiency.


Eligibility criteria:
inclusion criteria: * read, sign, and date an information consent; * willing and able to follow instructions and maintain the appointment schedule; * best-corrected visual acuity of 0.6 logmar or better in each eye as assessed at visit 1; * must not have used any topical ocular drops for approximately 24 hours prior to visit 1; * meet protocol-specified criteria for dry eye at visit 1; * other protocol-defined inclusion criteria may apply. exclusion criteria: * history or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past six months; * current punctal occlusion of any type (e.g., collagen plugs, silicon plugs); * history of intolerance or hypersensitivity to any component of the study medications; * history or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye; * use of any concomitant topical ocular medications during the study period; * use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to visit 1; * ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation; * unwilling to discontinue contact lens wear during the study period. contact lens wear must have been discontinued at least one week prior to visit 1. * participation in an investigational drug or device study within 30 days of entering this study; * other protocol-defined exclusion criteria may apply.

Keywords: systane balance dry eye lipid deficiency nitfbut
epimap obstetrics: european practices in the management of accidental dural puncture in obstetrics

Conditions: Post-Dural Puncture Headache

Summary: the aims of epimap obstetrics are: * to identify risk factors for failure of epidural blood patch in the obstetric population for management of post dural puncture headache. * to describe european practices in the management of accidental dural puncture in the obstetric population.

the primary aim of this prospective, international audit of practice is to identify risk factors for failure of epidural blood patch (ebp) in the obstetric population after accidental dural puncture (adp) with an epidural needle. other aims are to describe the epidemiology, management principles, side effects and complications of adp and longer-term effects of adp on patients undergoing obstetric anaesthesia and analgesia. expectation is that this audit of practice will provide important information in understanding the reasons for failure of ebp and subsequently to better manage parturients affected by this debilitating complication. postdural puncture headache (pdph) is the most common serious complication of accidental dural puncture (adp), and feared by every anaesthesiologist. it is associated with significant peri-partum maternal distress, and poor bonding with the baby, which in turn leads to physical disability for the mother and psychological and social implications for the whole family. it is estimated that about 10,000 parturients in europe may have an accidental dural puncture (adp) each year. attitudes and practices in the management of adp are based on small studies, and sometimes driven by experience rather than evidence. although several methods have been described in the literature to treat pdph, one common method used is an epidural blood patch (ebp). this is believed to be successful in about 60-80% of parturients on the first attempt, but results from most studies are based on a small numbers of patients. the reasons and predisposing factors for success and failure of different management strategies, specifically ebp, therefore needs to be investigated and described. large observational studies on post-dural puncture headache in the obstetric population are singularly absent from the literature.

Eligibility criteria:
inclusion criteria: * all women ≥ 18 years old, who develop classical symptoms of post-dural puncture headache after epidural anaesthesia for labour or for caesarean section. exclusion criteria: * post-dural puncture headache following deliberate dural puncture with a spinal needle in women where there was no observed accidental dural puncture with an epidural needle.

Keywords: post-dural puncture headache blood patch, epidural obstetrics european society of anaesthesiology (esa) epidemiology accidental dural puncture (adp) anaesthesia childbirth complication epidural analgesia postdural puncture headache prophylactic epidural blood patch epidural
safety and efficacy study of budesonide (pulmicort®) turbuhaler® in japanese children with bronchial asthma

Conditions: Asthma

Summary: this study will include the patients who are japanese children with bronchial asthma aged 5 years to 15 years old and have completed the phase iii study (study code: d5254c00769) at about 29 centres. to investigate the safety of budesonide turbuhaler® with a daily dose of 100 µg to 800 µg for 54 weeks treatment including the prior 6 weeks phase iii study (study d5254c00769, nct00504062) as compared with conventional therapy in japanese children with bronchial asthma in need of inhaled glucocorticosteroid treatment.


Eligibility criteria:
inclusion criteria: * patient who complete preceding the phase iii study and provide a signed written informed consent by patient's legal representative at visit 1 or 4 weeks prior to visit 1 of the study. a signed written informed assent should also be obtained from the patients themselves as much as possible * when the investigator will obtain the signed written informed consent of phase iii study (d5254c00769) from patient's legal representative, the investigator will also provide the information of this study exclusion criteria: * respiratory infections that, in the opinion of the investigator(s), may affect the efficacy evaluation e.g., lower airways infection such as pneumonia, infection with no available effective antimicrobial drugs or with deep seated mycosis * concurrent serious diseases of liver, kidney, heart or other complications which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study. any clinically relevant abnormal findings in vital sign or physical examination at visit 1 in this study, which in the opinion of the investigator may put the patient at risk because of his/her participation in the study. * pregnant or possible pregnancy or planning to become pregnant during the study period * other subjects who are considered inappropriate to participate in this study judged by the investigator

Keywords: asthma bronchial
effect of various treatment modalities on dendritic vial ulcer

Conditions: Corneal Ulcer

Summary: eye infection is a prevalent problem in primary care and remains a crucial healthcare concern. according to the american academy of ophthalmology (aao), herpes simplex virus (hsv) keratitis (hsk) is the leading cause of infectious blindness worldwide . hsk is defined as a corneal inflammatory condition caused by the hsv infection . the global incidence of herpetic keratitis is estimated at 1.5 million per year, resulting in 40,000 new cases of severe visual impairment associated with corneal scarring and opacification . hsv type i (hsv-1) is by far the most predominant causative pathogen of eye infections\]. hsv-1 is also known for causing orolabial herpes, hsv folliculitis, herpes gladiatorum, herpetic whitlow, and eczema herpeticum . hsv can be transferred to the eye by touching an active lesion and then the eye. the national health and nutrition evaluation revealed a seroprevalence of hsv-1 in 53.9% of 14-49 year olds, and 90% of adults 50 years or older , indicating that the majority of the population has been exposed to this virus thus are at risk of developing hsk. in this study we evaluate the efficacy of different treatment modalities on viral keratitis hsk.


Eligibility criteria:
inclusion criteria: patients with epithelial viral ulcers - exclusion criteria: * patients with stromal keratitis patients with corneal opacity
effect of paroxetine on coat-platelet production in normal volunteers and patients with cardiovascular disease

Conditions: Coronary Artery Disease

Summary: coat-platelets stands for collagen and thrombin stimulated platelets, which are two things in the body that make platelets stick together. these platelets may be important in the initiation of a heart attack (myocardial infarction). a chemical in the body called serotonin maybe responsible for coat-platelet production. paroxetine causes a significant reduction in platelet serotonin and therefore may have value in preventing heart attacks. therefore, the current study is designed to determine whether paroxetine will decrease coat-platelet production in normal volunteers and patients with cardiovascular disease.


Eligibility criteria:
inclusion criteria: * normal volunteers (without heart disease) * patients with heart disease * between ages 18 \& 65 exclusion criteria: * children less than 18 years * adults greater than 65 years * those who can not keep appointments * patients within 2 weeks of a coronary catheterization * patients within 6 months of unstable angina or myocardial infarction * individuals with allergies to paroxetine or similar medications * individuals having adverse events to paroxetine or similar medications * individuals with diagnosis of mania * individuals with a diagnosis of hypomania * individuals with a diagnosis of bipolar disorders * individuals with a diagnosis of depression * individuals with a diagnosis of panic disorders * individuals with a diagnosis of seizure disorders * individuals with a history of suicide attempts * individuals with a diagnosis of hyponatremia * individuals with active bleeding disorders * individuals with a diagnosis of narrow angle glaucoma * individuals with an estimated creatinine clearance of less that 30 ml/min * individuals taking potentially interacting medications
meopa to improve physical therapy results after multilevel surgery

Conditions: Cerebral Palsy; Spastic Diplegia; Quadriplegia; Hemiplegia

Summary: children with cerebral palsy commonly undergo "multilevel surgery", meaning several lower limb combined procedures performed during the same surgical intervention. the aim of this type of surgery is to correct all deformities together in order to restore near to normal anatomy and muscular function. it is very important to be able to obtain good range of motion after surgery, in order to consolidate surgical results. during the first days after the operation, children are sore and it may be difficult to realize adequate physical therapy. in order to palliate this situation, meopa gaz is used during rehab sessions. good results have been obtained so far but no study is available to demonstrate these results. the goal of our research is to prove that there is a benefit in using meopa postoperatively in these patients.

the study is a randomized, single blinded, controlled clinical trial. it consist of two groups of patients: one group will receive meopa (fda approval-"amm" in france, 2003) and the other will receive medical air. results, in terms of articular range of motion, will be compared between groups after five sessions of rehab. the following items will be evaluated: degree of pain, measured by a pain scale; joint rom; number of sessions to obtain the desired results; parents, patients and caregivers satisfaction. patients aging from 6 to 20 years will be included if they meet selection criteria. inclusions are confirmed before the first session starts. at this time, informed consent is to be signed by patients or parents and the clinical epidemiology unit will assign a study number to the patient. all patients get morphine therapy before the rehab session; a new dose is administrated 10 minutes later if pain is higher than 4/10; ten minutes later, if pain is still over 4/10, meopa (or medical air) will be administrated. if this is not enough to diminish pain, the session will be interrupted. five physical therapy sessions are provided after surgery, during inpatient time. knee rom will be measured by goniometry and will be the measure of reference to evaluate the influence of meopa. two types of pain scale will be used: analogical scale from 1 to 10 and faces scale (fps-r) for small children. for security reasons, the person who administrates de gaz will be informed of the nature of the product (meopa or medical air), the bottle will be masked and the therapist won't know what kind of product is being administrated.

Eligibility criteria:
inclusion criteria: * multilevel surgery * spastic cerebral palsy exclusion criteria: * patient not being able to walk

Keywords: meopa spasticity multilevel surgery cerebral palsy children
effect of parathyroid hormone (pth) and weight-bearing on bone in spinal cord injury (sci)

Conditions: Osteoporosis; Bone Loss; Spinal Cord Injury

Summary: individuals with spinal cord injury sustain significant loss of bone mass in their lower extremities (20-40% or more). this study evaluates the ability of pth and weight-bearing, two interventions that build bone, to increase bone mass in this population.

this pilot project aims to evaluate pth with weight-bearing in a group of individuals with chronic sci and loss of bone mass in their lower extremities. a convenience sample of 12 people with sci will be enrolled into a 6 month study assessing the effects of a weight-bearing regime plus daily pth (forteo 20ug sc) on bmd and bone markers. subjects will be evaluated at 3 and 6 months after initiating treatment with measurement of bone density as well as bone markers of formation and resorption. an optional extension to 12 months will be offered to all subjects.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years 2. complete sci - total loss of motor function below level of lesion 3. capable of positioning to have dexa performed 4. capable of undertaking the weight-bearing exercise regime 5. capable of reading and understanding informed consent document 6. able to self-administer pth or have someone in the family who can do so 7. t score \<-2.5 or z score \<-1.5 on evaluation of total hip bmd 8. no known endocrinopathies 9. normal tsh levels 10. normal 25-oh vitamin d levels 11. normal calcium levels 12. normal renal function (creatinine \<2.0mg/dl) 13. able to return for all follow-up visits exclusion criteria: 1. surgical or other intervention resulting in metal or anatomy precluding obtaining dexa and/or mri measurements 2. other medical conditions that in the opinion of the investigator would preclude the subject from completing the study 3. history of malignancy 4. history of radiation therapy 5. unable to self-administer pth or have it administered 6. elevated liver function tests \>2x normal 7. for males, significantly abnormal free testosterone levels 8. currently being prescribed anti-convulsants 9. currently being prescribed glucocorticoids, other than inhaled glucocorticoids 10. currently being prescribed any bone-active agents, including any bisphosphonate, raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or strontium-containing compounds. 11. no previous history of bisphosphonate use 12. no previous use of other bone-specific agents during past 2 years