Kornimate/medical-research-clean huggingface dataset:
effect of mepolizumab on decrease of systemic corticosteroids in patients with severe eosinophilic asthma

Conditions: Asthma; Eosinophilic

Summary: the primary objective of the study is to measure the effect of mepolizumab on declines in oral corticosteroid therapy (prednisolone or prednisone) in patients with severe eosinophilic asthma. asthma is a chronic inflammatory disease of the airways that affects 5 to 10% of adults and children. despite current treatments that are often effective, 10% of patients are not controlled by inhaled therapies. these severe asthma require regular use of systemic corticosteroids in 30 to 40% of cases. in this context, the use of glucocorticoids is associated with many more or less serious adverse effects, but still affecting the patient's quality of life. several treatments have already been proven to save systemic steroids (theophylline, anti-leukotrienes, golimumab ...). on the other hand, none is currently recommended because of a risk / benefit ratio that is too high. mepolizumab is a human monoclonal antibody that binds to and inactivates interleukin 5. it has recently been shown to be effective in reducing the daily dose of oral corticosteroids and in reducing exacerbations in these patients with severe eosinophilic asthma. it also reduces the number of eosinophils in the blood and sputum and improves the quality of life. patients will receive a subcutaneous injection of 100mg mepolizumab every 4 weeks for one year, for a total of 12 injections. in france, this treatment was subject to a temporary authorization for nominative use in severe eosinophilic asthma and is reserved for hospital use. the injections will be done in hdj pneumology chu grenoble alpes and patients will be followed monthly during injections and one month after the end of injections.


Eligibility criteria:
inclusion criteria: * severe eosinophilic asthma * patient on inhaled therapy with inhaled corticosteroid and long-acting bronchodilator for at least 6 months * patient under oral corticosteroid therapy (prednisolone or prednisone) for at least 6 months and unmodified in the last 4 weeks before the first injection * patient able to provide informed and written consent * obtaining the temporary authorization for nominative use for mepolizumab exclusion criteria: * chronic pulmonary pathology other than asthma * active neoplasia * active liver disease * serious and uncontrolled cardiovascular pathology (lvef less than 30%, nyha iv, ...) * other eosinophilic pathology (churg \& strauss syndrome, parasitic infection, ...) * hypersensitivity to mepolizumab or excipient * immunity disorders * patient not affiliated to a social security system

Keywords: asthma mepolizumab corticosteroids
efficacy and safety of diclofenac sodium topical gel 1% compared to placebo in subjects with acute blunt trauma injuries

Conditions: Acute Blunt Soft Tissue Injuries/Contusions

Summary: this study will assess the analgesic efficacy of dsg 1% compared to placebo in the reduction of the pain associated with acute blunt trauma injuries.


Eligibility criteria:
inclusion criteria: * male or female subjects aged 16 years and over fresh impact injury of the upper or lower limbs, not requiring admittance to hospital \& meeting baseline pain intensity level anticipated time between injury and treatment must be ≤ 6 hours exclusion criteria: * pain medication prior to randomization topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated any physical impairment that would influence efficacy assessments, such as peripheral or central neurological disease, significant back pain, painful conditions of the upper or lower extremities other protocol-defined inclusion/exclusion criteria may apply
hill-rom wave for positional obstructive sleep apnea at home

Conditions: Sleep Apnea, Obstructive

Summary: 1. determine the effects of a mattress support (wave 4.3) that promotes the avoidance of supine airway position at home on the apnea-hypopnea index (ahi) in patients with positional obstructive sleep apnea (osa). 2. determine the effects of wave 4.3 on subjective measures of sleepiness and daytime function in patients with positional osa. 3. determine the effects of wave 4.3 on subjective measures of sleep quality in patients with positional osa.

this is a preliminary single-arm study. the study will last up to 4 weeks including the screening period. subjects will sleep using the mattress support at home for two consecutive weeks. outcome measures will include: ahi derived from hsat (primary outcome), oxygen desaturation index (odi), epworth sleepiness scale (ess) score, functional outcomes of sleep questionnaire (fosq), visual analog scale (vas) and questionnaire assessments of sleep quality, and actigraphic sleep measures. subjects will also keep a sleep diary every night for the duration of the study. subjects will be asked about their bed partners' report on snoring and witnessed apneas.

Eligibility criteria:
inclusion criteria: * • 18-75 years of age * willing and able to give informed consent * able to speak and understand english * previous sleep study prior to enrollment done based on previous clinical evaluation by the subject's treating physician in the course of usual clinical care: 1. overall ahi 5-40 events/hr. 2. at least 10% time spent in the supine and 10% time in the non-supine positions. 3. apoc i and apoc ii 4. central respiratory events \< 50% of the total number of apneas and hypopneas * using at least a queen-sized mattress when sleeping at home * patients who meet the above criteria who have been prescribed cpap or dental device but are non-adherent to treatment will be enrolled in the study. cpap non-adherence will be defined as average nightly use \< 4hrs/night based on a download of the cpap machine, or self- acknowledged discontinuation or non-regular of cpap use. exclusion criteria: * • incapable of giving informed consent * under the age of 18 * active titration of medication * pregnancy, lactation (will be screened with urine pregnancy test) * self-reported substance abuse (current) * excessive alcohol consumption * excessive alcohol use is defined as: * more than 3 glasses of wine a day * more than 3 beers a day * more than 60 ml of hard liquor a day * use of home oxygen * presence of severe daytime sleepiness defined as an epworth sleepiness scale score \> 16 or a prior history of falling asleep while driving * presence of cardiac pacemaker or automatic implantable cardioverter-defibrillator (aicd). * unstable medical problem such as uncontrolled hypertension. * body mass index (bmi) \>45 kg/m2 * any other clinically significant condition that, in the opinion of the investigators, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data.

Keywords: positional therapy
vitamin k to slow progression of cardiovascular disease risk in hemodialysis patients

Conditions: Cardiovascular Diseases; Chronic Kidney Disease Stage 3; Chronic Kidney Disease Stage 4; Chronic Kidney Disease Stage 5; Vitamin K Deficiency; Hemodialysis

Summary: the life span of adults with end-stage renal disease is reduced, and cardiovascular disease (cvd) accounts for approximately half the deaths among those undergoing hemodialysis (hd). vascular calcification is a key process in the development of atherosclerotic and arteriosclerotic cvd, and contributes significantly to the greater mortality rates and cvd events in hd patients. recently, there has been growing interest in the vitamin k-dependent matrix gla protein (mgp) and its role in inhibiting vascular calcification. animal studies have revealed that the vitamin k-dependent protein mgp may reduce the progression of vascular calcification, possibly by means of improving vascular function. the relationship between mgp and vitamin k lies in the fact that inactive matrix gla protein requires vitamin k to carboxylate it for its activation. currently, data in hd patients are scant and equivocal on the effects of vitamin k supplementation on cvd risk outcomes. therefore, the purpose of this 8-week randomized, placebo-controlled, double-blind clinical trial is to determine whether daily vitamin k supplementation can favorably alter measurements of endothelial function and arterial stiffness in hd patients.


Eligibility criteria:
inclusion criteria: * chronic kidney disease stages 3 to 5 * receiving hemodialysis treatment for at least 3 months * subject understands the study protocol and agrees to comply with it * informed consent documents signed by subject exclusion criteria: * using vitamin supplements containing vitamin k * history of metabolic gastrointestinal diseases * subjects presenting chronic degenerative and/or inflammatory diseases * receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics) * subjects receiving corticosteroid * use of anticoagulants * history of soy allergy * have an unstable medical condition, such as having a life expectancy of less than 6 months in the judgment of the investigator * known sensitivity, intolerance, or other adverse response to study drugs which would prevent compliance with study medication * subjects who have participated in a clinical study more recently than one month before the current study

Keywords: arterial stiffness endothelial function vitamin k
a nested case-control study on the secondary prevention of ischemic stroke and tia by hypertension health education protocol (hhep): the post-stroke preventive trial

Conditions: To Investigate the Relationship Between the Adherence of HHEP After ISTIA and Stroke Recurrence or Cardiovascular Events.

Summary: patients with a diagnosis of ischemic stroke or tia (istia), who are treated at hospital are asked to participate in our pre specified hypertension health education protocol (hhep) after discharge from our hospital.hhep was used as secondary prevention treatments of stroke and cardiovascular diseases. hhep consists of several items such as controlling the patient's hypertension level, monitoring the adherece of antihypertensive agents, reducing risk factors of hytertension like tobacco smoking, obesity, and motivating the patient to physical activity and to a healthy diet. patients will receive visits by a study nurse with the aim of supervising, monitoring, and recording the adherence of hhep. the patients will be classified as different adherence level at the end of the study according to their adherence condition. this study is aimed at testing the hypothesis that controlling hypertension and its risk factors was more effective than those do not receive hhep in reducing the recurrence of stroke and cardiovascular diseases.


Eligibility criteria:
inclusion criteria: participants were eligible for this observational cohort study if they were age 18 years or older; hospitalized for a primary diagnosis of acute ischemic stroke or transient ischemic attack (tia) and concurrently diagnosed as hypertension; provided consent to participate, and their data can be collected from medical record system of our hospital. exclusion criteria: we will exclude people who are onset of symptoms 3 months after their ischemic stroke or tia; the stroke events occurred before the baseline survey were identified from the hospital discharge register retrospectively and excluded from the analyses.
study of the ability of a new technique to effectively diagnose movement disorders

Conditions: Functional Movement Disorder

Summary: sante fe is an investigation of a new technique to distinguish between different types of movement disorders, specifically organic versus functional, by observing changes in involuntary movements in two different situations.

this study involves a short, one-time visit. subjects will be asked to undergo a brief neurological examination while being video taped in two different scenarios. the severity of the abnormal movement will be analyzed and compared among subjects with functional (fmd) versus organic movement disorders (orgmd).

Eligibility criteria:
inclusion criteria: 1. patients with a clinical diagnosis of functional movement disorder (e.g. functional tremor, functional dystonia, functional myoclonus) based on fahn-williams criteria or orgmd (e.g. parkinson disease, essential tremor, cervical dystonia) evaluated by a fellowship-trained movement disorder neurologist at cleveland clinic 2. patients with mild to severe involuntary movement as a result of the movement disorder, visible for video-recording. exclusion criteria: 1. significant cognitive impairment that prevents proper informed consent 2. patients whose movement disorders cannot be captured on video

Keywords: functional movement disorder functional neurological disorder fmd psychogenic movement disorder movement disorders
theophylline for treatment of pseudohypoparathyroidism

Conditions: Pseudohypoparathyroidism; Pseudohypoparathyroidism Type 1a; Albright Hereditary Osteodystrophy

Summary: pseudohypoparathyroidism is a genetic disorder with limited treatment options, characterized by early-onset obesity, short stature, hormone resistance and cognitive impairment. this phase 2 clinical trial will test the efficacy of theophylline, a phosphodiesterase inhibitor, in pseudohypoparathyroidism. we hypothesize that theophylline will cause weight loss, improve glucose tolerance and decrease hormone resistance in children and young adults.

trial objectives 1. the primary objective of this study is to evaluate the long-term safety of theophylline in patients with php. 2. the secondary objectives of this study are to evaluate changes in bmi, hormone resistance and epiphyseal closure associated with theophylline treatment of patients with php. study design the proposed study is a single center, 24-month open label extension clinical trial for patients with php who complete the randomized clinical trial.

Eligibility criteria:
inclusion criteria: * 1. successful completion of the randomized clinical trial "phase 2 study of theophylline treatment of pseudohypoparathyroidism ind 133103 (11/1/2016)". exclusion criteria: 1. history of a seizure disorder unrelated to hypocalcemia 2. history of a cardiac arrhythmia (not including bradycardia) 3. hepatic insufficiency including cirrhosis and acute hepatitis (ast or alt \>3x upper limit of normal) 4. congestive heart failure 5. current cigarette use or alcohol abuse 6. pregnancy or intention to become pregnant during the next year 7. active peptic ulcer disease 8. current use of medications known to effect theophylline levels 9. history of hypersensitivity to theophylline or other medication components 10. unable to comply with study procedures in the opinion of the investigator
botulinum toxin type a injection to prevent keloid recurrence

Conditions: Scar Keloid

Summary: the prospective, split-scar, double-blind, randomized controlled study will enroll the patients who are older than 20 years with progressive keloid lesion which is symmetric. botulinum toxin a will be injected into half of each keloid revision wound immediately after skin closure. the scars will be assessed at 1-year follow-up with vancouver scar scale (vss), patient and observer scar assessment scale (posas), and the cutometer.

continuous variables will be reported as the mean ± standard deviation(sd). each aspect of the vss score, posas score, and the cutometer parameters of each scar half between the bta and control groups will be analyzed longitudinally using the paired t test. the interrater consistency will be evaluated using the spearman rho. all analyses will be performed with ibm spss version 23.0 (ibm corp., redmond, wash.). a value of p \< 0.05 is considered to indicate statistical significance. the sample size was calculated based on the results of the investigators' aforementioned study published in 2019. thirty patients underwent keloid revision and then received radiation therapy based on our treatment protocol. the postoperative vancouver scar scale score was 4.15 ± 1.74. if treatment could improve vss score by 1, which was considered clinically significant, approximately 26 patients would have been necessary to provide a result with a real significance (using the same sd and considering the standard α error of 0.05 and a power of 0.8). assuming a 20% non-compliance rate for follow-up evaluation, the sample size was increased to 32 patients.

Eligibility criteria:
inclusion criteria: * adult (20 years or older) * progressive keloid lesion that is bilaterally symmetric, mandibular area, anterior chest or suprapubic area, for example * at least 4 cm in length * repeated or uncontrolled recurrence, and unendurable symptoms with poor response to conservative modalities * valid written informed consent provided for surgery and trial inclusion exclusion criteria: * allergy to botulinum toxin * previous botulinum toxin injection at the lesion within 6 months before enrollment * myasthenia gravis * focal infection signs * pregnant or breastfeeding woman

Keywords: keloid botulinum toxin type a radiotherapy
doxorubicin plus estramustine in treating patients with metastatic prostate cancer

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i trial to study the effectiveness of doxorubicin plus estramustine in treating patients with metastatic recurrent prostate cancer that does not respond to hormone therapy.

objectives: i. estimate the maximum tolerated dose of weekly intravenous doxorubicin (dox) that can be given in combination with oral estramustine (em) in patients with metastatic prostate cancer refractory to treatment with hormonal agents. ii. assess the frequency of expression of the multidrug resistance phenotype in biopsy specimens from these patients. iii. assess the response to dox/em in these patients. outline: 2-drug combination chemotherapy. doxorubicin, dox, nsc-123127; estramustine, em, nsc-89199. projected accrual: three to 18 patients will be entered.

Eligibility criteria:
disease characteristics: biopsy proven metastatic prostate cancer biopsy requirement waived at principal investigator's discretion if new disease site technically inaccessible and psa elevated recurrent disease following orchiectomy, estrogen, or gonadotropin-releasing hormone agonist therapy if previously irradiated: progressive disease outside prior radiotherapy field required no brain metastases patient characteristics: age: 18 and over performance status: not specified hematopoietic: not specified hepatic: bilirubin no greater than 1.5 mg/dl alt/ast less than 3 times greater than normal renal: not specified cardiovascular: left ventricular ejection fraction at least 45% no nyha class iii/iv status no unstable angina other: no crohn's disease, ulcerative colitis, or other inflammatory bowel syndrome prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior doxorubicin or estramustine endocrine therapy: see disease characteristics at least 30 days since flutamide estrogen or gonadotropin-releasing hormone agonists discontinued prior to treatment radiotherapy: at least 6 weeks since radiotherapy surgery: not specified

Keywords: recurrent prostate cancer
rhythmic auditory stimulation on neural activity during finger-tapping in pd patients

Conditions: Acoustic Stimulation; Parkinson Disease; Electroencephalography

Summary: introduction bradykinesia (i.e., slow movements) is one of the most prominent symptoms of parkinson's disease (pd) and has a negative impact on quality of life. rhythmic auditory stimulation (ras), a widely used and promising treatment technique, has been shown to effectively improve gait speed in pd patients. however, only few studies have explored effects and neural mechanisms of ras on upper-limb movements. the investigators will conduct two studies to investigate effects and mechanisms of ras on upper-limb movements in pd patients. the purpose of this study is to examine real-time neural activity when patients with pd and healthy controls listen to ras and execute finger-tapping task simultaneously. methods and analysis this study will recruit patients with pd and healthy controls. electroencephalography (eeg) will be used under six conditions related to a finger-tapping task. two-way repeated measures analysis of variance will be performed to investigate the group and condition effects on neural mechanisms. study significance this study will offer evidence on ras effects and mechanisms by investigating the changes in upper-limb movements and neural mechanisms during auditory-motor entrainment. results from this study will provide a solid foundation for further research and clinical applications of ras.


Eligibility criteria:
inclusion criteria: * (a) idiopathic pd diagnosed by a neurologist based on the movement disorders society clinical diagnostic criteria; * (b) the hoehn and yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability; * (c) a score of montreal cognitive assessment (moca) is equal to or higher than 21 to ensure that they understand experimental instructions; * (d) a score of edinburgh handedness inventory is above 60 to ensure that they are right-handed; * (e) types and doses of medications remain unchanged in the past month right before participation. * age- and sex-matched healthy controls who filled the criteria (c) and (d) will be recruited from communities. exclusion criteria: * the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.

Keywords: acoustic stimulation parkinson disease movement electroencephalography
the beta cell responsiveness to glucose-dependent insulinotropic polypeptide (gip) with and without sulfonylurea in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the investigators hypothesize that the impaired insulinotropic effect of the incretin hormone gip may be due to inadequate sensitization and atp induced closure of beta cell k-atp channels. by closing the channels through the use of sulfonylurea (su) we hope to restore the insulinotropic effect of gip.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus diagnosed according to who criteria * diet and/or metformin treatment * hba1c \> 7,0% for metformin treated patients * hba1c \> 7,5% for diet treated patients * age: 18 years or older * 25 \> bmi \> 40 kg/m2 * signed informed consent * sufficient birth control in case of child bearing capacity exclusion criteria: * proliferative retinopathy * diabetic nephropathy with s-creatinine \> 130 microm and/or macroalbuminuria * liver disease (alat \> 2 x normal value) * cad (nyha group iii or iv) * positive screening for islet-cell and/or gad-65 autoantibodies * type 1 diabetes i first degree relatives * gastrointestinal surgery with intestinal resection * anemia * pregnancy and/or breastfeeding

Keywords: type 2 diabetes mellitus glucose dependent insulinotropic polypeptide sulfonylurea compounds insulin secretion sulfonylurea receptor subunit-sur1 impaired incretin effect