Kornimate/medical-research-clean huggingface dataset:
observational study of tocilizumab in participants with rheumatoid arthritis in australia

Conditions: Rheumatoid Arthritis

Summary: this multi-center, observational study will evaluate the treatment patterns in clinical practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (ra) who have had an inadequate response (or were intolerant to) treatment with non-biological disease-modifying anti-rheumatic drugs (dmards) or with one biological agent. data will be collected from each eligible participant initiated on tocilizumab treatment by their treating physician according to approved label for 6 months from start of treatment.


Eligibility criteria:
inclusion criteria: * severe ra. * inadequate response (or intolerant) to non-biological dmards or one biologic agent * participants initiating treatment with tocilizumab on their physician's decision (in accordance with the local label), including participants who started treatment with tocilizumab within the 8 weeks prior to the enrolment visit. exclusion criteria: * tocilizumab treatment more than 8 weeks prior to the enrolment visit. * previous tocilizumab treatment in a clinical trial or for compassionate use. * enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab. * history of autoimmune disease or any joint inflammatory disease other than ra.
gefitinib (iressa) in combo with chemoradiation in patients with locally advanced head & neck cancer

Conditions: Head and Neck Neoplasms

Summary: to determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3d-crt or imrt) in patients with locally advanced head and neck cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed head and neck cancer * lymph node negative or positive * metastasis negative * chemo- and radiotherapy naïve * who 0-2 * measurable disease by recist * written informed consent exclusion criteria: * severe alcohol abuse * active ild * co-existing chronic gastrointestinal disease(s) * brain metastasis

Keywords: stage iii head and neck cancer stage iv head and neck cancer
maternal and fetal adrenocorticotropic hormone (acth) and leukemia inhibitory factor (lif) and gestational age

Conditions: Abortion, Legal

Summary: in 2010, simamura et al have demonstrated in a rat model that one of the pro-inflammatory cytokine belonging to the interleukin-6 family cytokines, lif, is required for the proliferation of neuronal progenitor cells in the cerebrum. they have shown that maternal lif induces acth from the placenta, which in turn stimulates fetal nucleated red blood cells to secrete lif, leading finally to neurogenesis in the fetus as demonstrated recently in a mouse model, maternal inflammation suppress the physiological maternal- fetal lif-acth-lif signal, result in reduction of acth production from placenta, which lead to a reduction in lif concentration in fetal cerebrospinal fluid (csf) and impaired proliferation of the neural stem/ progenitor cells and poor development of the fetal brain. in the current study, the investigators will take fetal and maternal blood samples of fetuses undergoing termination of pregnancy (top) . maternal samples will be acquired with the routine blood samples before performance of top , fetal blood samples will be acquired from the umbilical vessel after the termination has been completed , the blood samples will be analyzed for levels of lif and acth and checked according to termination pregnancy week, patients electronic files will be checked for relevant demographic and obstetric information.

study protocol: in the current study, the investigators will take fetal and maternal blood samples of fetuses undergoing termination of pregnancy (top) . maternal samples will be acquired with the routine blood samples before performance of top , fetal blood samples will be acquired from the umbilical vessel after the termination has been completed , the blood samples will be analyzed for levels of lif and acth and checked according to termination pregnancy week, patients electronic files will be checked for relevant demographic and obstetric information.

Eligibility criteria:
inclusion criteria: * pregnant women undergoing termination of pregnancy in various gestational weeks. * pregnant women undergoing spontaneous abortion. exclusion criteria: •intrauterine fetal death.
korean post-market registry assessing the clinical use and safety of the lutonix dcb in femoropopliteal arteries

Conditions: Peripheral Artery Disease

Summary: the purpose of the registry is to assess the clinical use and safety of the lutonix drug coated balloon catheter in a heterogeneous patient population in real world clinical practice.

the registry will enroll patients with claudication or critical limb ischemia due to stenotic lesions in femoropopliteal arteries. all subjects meeting protocol criteria will be treated with the lutonix drug coated balloon catheter for approved indications according to the current instructions for use (ifu) and followed clinically for 2 years. total enrollment will be approximately 250 subjects at up to 18 sites. subject follow-up will occur at 1, 6, 12 and 24 months. the primary efficacy endpoint is freedom from target lesion revascularization at 12 months. the primary safety endpoint is freedom at 30 days from the composite endpoint of target vessel revascularization and target lesion revascularization, major amputation and major reintervention of index limb, and device- and procedure-related death.

Eligibility criteria:
inclusion criteria: * ≥19 years of age * rutherford clinical category ≥4 * patient or legally authorized representative is willing to provide informed consent and comply with the required follow-up * stenotic or obstructive vascular lesions in femoropopliteal artery(s) * lesion(s) can be treated with available lutonix drug coated balloon catheter device size matrix per current ifu * at least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is not permitted; treatment of in-flow disease is permitted prior to treatment with the lutonix drug coated pta dilatation catheter) exclusion criteria: * patient is currently participating in an active phase of another investigational drug or device study * inability to take recommended medications as stated in the ifu or non-controllable allergy to contrast * known inadequate distal outflow or planned future (within 30 days) treatment of vascular disease distal to the target lesion

Keywords: femoropopliteal
effect of fertility-sparing therapy of early endometrial cancer

Conditions: Endometrial Cancer; Fertility

Summary: the purpose of this study is to investigate the effect of fertility-sparing therapy of early endometrial cancer.

this is a prospective, multi center, open, randomized, controlled clinical trial. all endometrial cancer (ec) or atypical hyperplasia (ah) patients who met the fertility-sparing indications in the hospitals involved in this study were recruited. then the investigators conducted assessment, treatment and follow up according to the standard procedure. general information, therapeutic regimen, side effects, oncological and pregnant results were collected for risk factors analysis.

Eligibility criteria:
inclusion criteria: * ages of no more than 40 * with a strong desire of fertility preservation * international federation of gynecology and obstetrics (figo) 2009 stage ⅰa grade 1\~2 with lesion confined in endometrium * pathology expression of progestin receptors (prs) and estrogen receptors exclusion criteria: * not eligible for pregnancy or delivery * evidence of suspected extrauterine or distant metastasis * complicated with any other malignancy * severe medical complications * contraindication of oral progestin * uncontrolled epilepsy, central nervous system disease or mental disorder history in patients which influence clinical research compliance judging by the researcher.

Keywords: endometrial cancer atypical hyperplasia fertility-preserving remission time recurrence pregnancy progesterone receptor
patient-reported outcome measurement in heart failure clinic

Conditions: Heart Failure

Summary: this is a randomized study evaluating the effect of routinely collecting a standardized questionnaire of heart failure health status during heart failure clinic visits. participants will be randomized to early or delayed implementation of a validated health-related quality of life survey (the kansas city cardiomyopathy questionnaire). participants randomized to early implementation will be given this 12-question survey at each heart failure clinic visit at the beginning of the study; their heart failure clinician will have access to survey results but will continue to manage participants based on standard treatment practice. patients randomized to delayed implementation will start receiving the survey at each clinic visit one year later. by comparing the health status and treatment rates between early and delayed implementation, this study will determine the impact of standardized health status assessment on patient outcomes and clinician decision-making.


Eligibility criteria:
inclusion criteria: * stanford heart failure clinic visit during enrollment period exclusion criteria: * seen in amyloid clinic

Keywords: quality of life patient-reported outcomes quality of care implementation research
french observatory syndromes tako-tsubo

Conditions: Myocardial Necrosis; Tako Tsubo Syndromes

Summary: tako tsubo syndrome (tts) is characterized by the occurrence in the context of mental or physical stress, a clinical and ecg of acute myocardial infarction without significant coronary artery stenosis, accompanied by a disorder acute, reversible left ventricular who takes on a characteristic apical ballonnisation evoking the image of a japanese octopus trap called tako (octopus) tsubo (jar). pathophysiology of unknown changes immediate life-threatening prognosis is often good in the longer term.


Eligibility criteria:
inclusion criteria: * over 18 * allowed for an array of myocardial necrosis on clinical and electro cardiographic * having a left ventricular ballooning echo cardiography, mri or ventriculographic with normal coronary angiogram. exclusion criteria: * absence of left ventricular ballooning and / or presence of coronary lesions on angiography * refusal by the patient to participate in the observatory

Keywords: left ventricular ballooning
prescribing vs. recommending over-the-counter (protect) analgesics for patients with postoperative pain:

Conditions: Acute Pain; Surgery

Summary: this is a research project in which two standard of care practices will be evaluated to examine the difference in outcomes. the goal is to improve patient care and safety. one group will receive prescriptions for acetaminophen, nonsteroidal anti-inflammatory drugs (nsaids), and magnesium. the other group will receive the recommendation to take acetaminophen, nsaids, and magnesium as over-the-counter drugs in the same dosage as the prescription group. the same doses and routes for non-opioid medications will be used in both groups.


Eligibility criteria:
inclusion criteria: * anticipated to be prescribed and use an opioid medication to treat acute pain after elective outpatient surgery exclusion criteria: * contraindications to taking acetaminophen or nsaids * significant analgesic medication use before surgery * inability to receive emails or phone calls for follow up assessment * patients who have reoperation, another surgery, or experience complications within 14 days after surgery

Keywords: medications after surgery surveys acetaminophen nsaids opioids elective outpatient surgery magnesium
the effect of different low-level tragus stimulation parameters on autonomic nervous system function

Conditions: Atrial Fibrillation; Heart Failure, Diastolic

Summary: low level transcutaneous vagus nerve stimulation (llts) involves delivery of electrical impulses transcutaneously at the auricular branch of vagus nerve and it has been shown to have anti-inflammatory and anti-arrhythmic effects. in previous studies from our laboratory, we found that llts significantly suppressed atrial fibrillation (af) inducibility and decreased af duration. the anti-arrhythmic effects of llts were similar to those delivered to the cervical vn trunk. llts for just one hour significantly shortened the af duration and decreased inflammatory cytokines. we have also shown that llts leads to favorable heart rate variability (hrv) changes and cardiac mechanics in patients with diastolic dysfunction. these results support the use of llts as a novel non-pharmacological, non-ablative treatment modality for af and possibly other inflammatory conditions. however, the optimal stimulation parameters of llts remain to be determined. in this study, we aim to examine the effect of 2 different frequencies (5hz and 20hz) and 2 different amplitudes (50% below the pain threshold and 1ma below the pain threshold) of llts on heart rate variability with deep breathing (hrvdb), mental arithmetic stress test (mast), frequency domain measures of heart rate variability (hrv) and brain stem evoked potentials (bsevp) in healthy volunteers and patients with af or heart failure with preserved ejection fraction (hfpef). hrv is a marker of vagus nerve activity and can be easily measured by software calculating the distance between consecutive r waves on the ecg. bsevp are a surrogate for the central projections of the vagus nerve. patients will be randomized into 4 groups in a 2x2 factorial design. llts will be delivered through a transcutaneous electrical nerve stimulation (tens) device for 15 minutes. hrvdb, hrv and bsevp will be measured before and after llts and compared.


Eligibility criteria:
inclusion criteria: 1. male and female patients older than 21 year old 2. healthy volunteers free from diagnosis of af, heart failure, coronary artery disease or diseases that affect the autonomic nervous system. 3. patients with paroxysmal atrial fibrillation 4. patients with heart failure with preserved ejection fraction (hfpef) exclusion criteria: 1. recent (\<6 months) stroke 2. recent (\<6 months) myocardial infarction 3. heart failure (nyha class iii or iv) 4. left ventricular ejection fraction \<50% 5. recurrent vaso-vagal syncopal episodes 6. unilateral or bilateral vagotomy 7. pregnancy or breast feeding 8. uncontrolled diabetes or hypertension 9. inability or unwillingness to understand and/or sign informed consent 10. any serious disease that affects autonomic nervous system function 11. any medications that affect autonomic nervous system function
effect of small versus large epidural needles on postdural puncture headache study

Conditions: Post-Dural Puncture Headache

Summary: the purpose of this study is to determine the effect of 19g versus =\>18g traditional tuohy-type epidural needles on the incidence and severity of postdural puncture headache (pdph).

a headache is the most significant complication of dural puncture during epidural placement. this complication leads to longer hospital stays and many repeated visits to hospital for management. women suffering from severe postdural puncture headache (pdph) are often bedridden and unable to care for themselves or their babies.the efficacy of epidural blood patch as a "gold standard" therapy is over-estimated by the earlier, poor quality studies. the prevalence of dural puncture during epidural anesthesia using current techniques ranges from 0.03 to 6% in the literature. of these patients, 70 to 80% will suffer from moderate to severe pdph. avoidance of dural puncture is always the goal. however, complete avoidance is unlikely using current techniques of needle placement. this study proposes another method of prevention (i.e., reducing the gauge of the epidural needles if it is shown to be suitable for continuous infusion in adults). most of the risk factors for developing pdph cannot be changed (e.g., younger age, female sex, low body mass index, history of migraines). however, epidural needle gauge is a modifiable risk factor. evidence suggests that the use of smaller gauge epidural needles, like spinal needles, have the potential to reduce the incidence and severity of pdph.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists status 1 to 2 * must have provided written informed consent = or \< 6cm cervical dilation * fetus 37 to 42 weeks gestation * must be able to read and write english well enough to provide written informed consent exclusion criteria: * bmi = or \> 40 * multiple gestation pregnancy * known contraindications to use of epidural analgesia * pregnancy-induced hypertension * investigator concern for maternal or neonatal welfare * receipt of spinal or epidural anesthesia within 14 days of labour epidural request * women with chronic headaches (defined as headaches that occur 15 or more days per month for more than 3 months) * already participated in study * history of narcotic abuse

Keywords: parturient obstetrics pregnancy labour labor headache epidural analgesia anesthesia anaesthesia
efficacy of irbesartan/hydrochlorothiazide versus valsartan/hydrochlorothiazide in mild to moderate hypertension

Conditions: Hypertension

Summary: the primary objective is to compare the efficacy of irbesartan/hydrochlorothiazide 300/25mg against valsartan/hydrochlorothiazide 160/25mg in reducing mean systolic blood pressure (sbp) as measured by home blood pressure monitoring (hbpm) after 24 weeks compared with baseline. the secondary objectives are: * to compare the percentage of patients with normal blood pressure as measured by hbpm and at the doctor's office at weeks 16 and 24 * to compare the differences in mean diastolic blood pressure (dbp), mean morning and evening sbp and dbp evaluated by hbpm at weeks 16 and 24 * to compare the difference in mean sbp evaluated by hbpm at week 16 * to compare the differences in mean sbp and dbp evaluated at the doctor's office at weeks 16 and 24 * to determine the incidence and severity of adverse events


Eligibility criteria:
inclusion criteria: * established essential hypertension, untreated or treated but uncontrolled with treatment: * office sbp ≥ 160 mmhg for untreated patients * office sbp ≥ 140 mmhg for patients already treated with an antihypertensive drug. * previous antihypertensive therapy must have been implemented for a minimum of 4 weeks and must be either monotherapy or one of the following permitted combination drugs: * ace inhibitor / calcium channel blocker * beta blocker / calcium channel blocker * beta blocker / low dose diuretic * ace inhibitor / low dose diuretic exclusion criteria: * sbp ≥ 180 mmhg and/or dbp ≥ 110 mmhg evaluated at doctor's office at visit 1 * known or suspected causes of secondary hypertension * patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, a renal transplant or only has one functioning kidney * type 1 diabetes mellitus * significant cardiovascular, neurological, endocrine, renal, metabolic, or gastrointestinal disease, a malignancy or any other diseases considered by the investigator to make participation in the study not in the best interest of the subject * known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin ii receptor antagonist or any combination of the drugs used * known contraindications to any of the study drugs * concomitant use of any other antihypertensive treatment * use of any of the investigational products for this study within the 3 months prior to the study * inability to obtain a valid hbpm recording i.e., obesity, arm circumference \> 32 cm or arrhythmia * administration of any other investigational drug in the last 30 days before enrolment and during the course of the study * pregnant or breast-feeding women * women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
cardiovascular evaluation of patients with high cholesterol and normal volunteers

Conditions: Homozygous Familial Hypercholesterolemic

Summary: homozygous familial hypercholesterolemia is a rare inherited disease of metabolism. it occurs in less than 1 in 1 million people within the united states. patients with the disease are typically children and young adults who develop heart disease early in life. children less than age 5 years with this disease have suffered heart attacks and death. the normal process that removes cholesterol particles from the blood stream does not work in patients with this disease. it causes cholesterol to build-up in the arteries and leads to hardening of the arteries (atherosclerosis). the goal of this study is to detect and measure atherosclerosis in these patients before it becomes permanent and potentially life threatening. patients with this disease can participate in this study. researchers plan to evaluate patients with homozygous familial hypercholesterolemia using new and standard methods for detecting atherosclerosis. researchers plan to use information gathered during this study to develop new, promising treatments such as liver transplantation and gene therapy....

familial hypercholesterolemia is an autosomal co-dominant disorder resulting in abnormal ldl receptor function, profoundly elevated concentrations of low density lipoproteins, accelerated atherosclerosis and death by early adulthood. this disease is heterogeneous in both the degree of ldl receptor dysfunction as well as the age of death. liver transplantation has been demonstrated to virtually normalize plasma lipoprotein concentrations in homozygous fh and the recent cloning of a functional ldl receptor gene holds promise in the definitive treatment of this condition. we propose performing longitudinal sequential cardiologic studies utilizing noninvasive techniques in homozygous patients with well-characterized ldl receptor defects. sequential cardiovascular study of these patients will not only characterize the progression of atherosclerosis heart disease in this disease, it may also permit the identification of individuals with would be likely to benefit from liver transplantation and/or genetic engineering.

Eligibility criteria:
* inclusion criteria: fasting cholesterol greater than 500 mg/dl, low density lipoprotein cholesterol greater than 400 mg/dl, and triglycerides less than mg/dl. family history of hypercholesterolemia and/or cardiovascular disease before the age of 60 years. tendinous and tuberous xanthomas. arcus corneae before the age of 30.

Keywords: dyslipoproteinemia hypercholesterolemia atherosclerosis natural history