Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of cyclosporin in nephrotic syndrome

Conditions: Nephrotic Syndrome

Summary: the purpose of this study is to evaluate whether there are differences in the pharmacokinetics of cyclosporine in remission nephrotic syndrome compared to relapsed disease in children.

this is a prospective study on ten children using cyclosporin-a (csa) microemulsion to treat idiopathic nephrotic syndrome (ins), with normal renal function, who achieved complete remission with csa. the objective is to compare the pharmacokinetic (pk) parameters of csa in ins during remission and relapse of the disease. the pk profile of csa was evaluated with the 12-hour area under the time-concentration curve (auc0-12) using seven time-point samples. this procedure was done on each patient during remission and relapse with the same csa dose in mg/kg/day. the auc0-12 was calculated by trapezoidal rule. all pk parameters and the resumed 4-hour area under the time-concentration curve (auc0-4) were correlated with auc0-12. this study is very important because the cyclosporin is a nephrotoxic drug with narrow therapeutic window.

Eligibility criteria:
inclusion criteria: * children with steroid-resistant nephrotic syndrome and steroid-dependent nephrotic syndrome in use of cyclosporine * renal function evaluated by creatinine clearance estimated by stature ≥ 90 ml/min/1.73m2 * cyclosporine trough level (c0) between 50 and 150 ng/ml * complete remission with cyclosporine according to the guidelines of international society of kidney diseases in children exclusion criteria: * renal and hepatic function abnormalities * presence of infectious disease * clinical or histological signs of csa nephrotoxicity and suspicious of non-compliance

Keywords: cyclosporin nephrotic syndrome pharmacokinetics children
improving daily living skills in people with autism spectrum disorder through a personalised serious game

Conditions: Autism Spectrum Disorder

Summary: this study evaluates the efficacy of a rehabilitation intervention for people with autism spectrum disorder through an individualised serious game developed for improving skills related to a specific daily living activity: shopping in a supermarket.

serious games are innovative computer-based interventions to support children and adults with autism spectrum disorder (asd). however, few studies have assessed the efficacy of these interventions in real-life contexts. the present study investigates the generalisation of daily living skills related to shopping activities after a rehabilitation intervention administered via a personalised serious game (shopaut). the underlying hypothesis of this study is that training with an individualised serious game can improve performance in a real-life environment. in order to prove this hypothesis, a small sample of subjects with asd will play an individualised serious game, shopaut, for ten sessions. subjects will undergo real-life experiences in a supermarket pre- and post-virtual training to determine whether there had been a generalisation of skills from the virtual environment to the real environment. improvements in skills and performance in the real shopping activity are evaluated using specific tools. the serious game shopaut is developed integrating an individualised design that provides both the personalisation of the game's scenario, contents, difficulty, and user interface; and the customisation of game modes, player perspectives, and input devices. it is a three-dimensional game that provides a realistic shopping experience where the player can practice and engage with, above all, shopping activities, experiment their problem-solving skills, and take on unexpected events.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of autism spectrum disorder, in keeping with the diagnostic criteria of diagnostic and statistical manual of mental disorders, fifth edition (dsm-v) * chronological age between 8 and 16 years * a rehabilitation plan already underway in accordance with the study's goals * representatives of parental authority who gave informed written consent * native italian speakers exclusion criteria: * no physical impairments * participant to another research protocol * known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities

Keywords: autism serious game
wide-bandwidth open canal hearing aid for better multitalker speech understanding

Conditions: Hearing Impairment

Summary: our goal is to design and build a new hearing aid system, which mitigates the most common complaints that hearing aid users have. these include hearing in multi-talker situations, poor sound quality, unwanted whistling resulting from feedback, and a dislike of the sound of their own voice. current efforts, with limited success, use signal processing methods rather than restoring more closely the normal auditory function. we plan to achieve our goal by reducing to practice three key enabling concepts. the first is to replace the current acoustic transducer with a non-acoustic mechanical output transducer that directly actuates the tympanic membrane (tm). this transducer, called the earlens, floats on the tympanic membrane in a manner similar to the way a contract lens floats on the eye. the second is to increase the output bandwidth of the hearing aid. the third key concept is to place a wide-bandwidth microphone in the ear canal to capture the pinna diffraction cues similarly to the way the normal ear functions. our central hypothesis is that a hearing aid that delivers amplified wide-bandwidth mechanical stimuli, directionally dependent cues, in an open canal configuration will perform better than conventional hearing aids when there are competing talkers in the background. first phase includes verification the capability of the system to deliver sufficient maximum equivalent pressure output (mepo) to treat the degree of hearing loss in the target fitting range.


Eligibility criteria:
inclusion criteria: * hearing loss less than 60 db at any frequency, no conductive hearing loss exclusion criteria: * collapsed ear canal, damaged or repaired middle ear, too much sensory hearing loss

Keywords: hearing loss, eardrum, transducer, hearing in noise
sleep impairment and coping style in diabetes

Conditions: Obesity; Sleep Disorders; Coping Skills

Summary: to examine the effect of sleep impairment on coping style of patients with diabetes

abstract objective: to examine the effect of sleep impairment on coping style of patients with diabetes research design and methods: a total of 105 patients (40 male, 65 female) with diabetes mellitus were recruited from outpatient diabetic clinics in 2011 february. all patients were asked to fill the sociodemographic inquiry, epworth sleepiness scale and coping style inventory.

Eligibility criteria:
inclusion criteria: - patients with diabetes longer than 6 months exclusion criteria: - complications as a congestive heart failure, chronic renal failure

Keywords: sleep impairment, coping style, diabetes mellitus
a trial for subjects with systemic lupus erythematosus who have completed protocol an-sle3321

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the long-term safety of a-623 in subjects with sle.


Eligibility criteria:
inclusion criteria: * completed the treatment period specified in study an-sle3321 or were enrolled in study an-sle3321 prior to november 30, 2010 exclusion criteria: * developed a new medical disease or condition that has made the subject unsuitable for this study in the opinion of the investigator, including interference with written informed consent, study evaluation, completion, and/or procedures * pregnant or nursing * any prior administration of a b-cell modulating therapy other than a-623 * received cyclophosphamide, cyclosporine, anti-tnf alpha therapies, transfusion, plasmapheresis or plasma exchange, iv immunoglobulin, or live vaccines according to listed wash-out periods

Keywords: sle lupus lupus erythematosus, systemic a-623 autoimmune diseases blisibimod
treatment of alcohol-related hepatitis with arginine

Conditions: Alcoholic Hepatitis

Summary: the purpose of this study is to test the effectiveness of the amino acid arginine in reducing liver injury in individuals with alcohol-related hepatitis.

arginine is a naturally occurring amino acid that is also available in pill form. arginine pills have been shown to aid in liver detoxification and fat breakdown in the liver. numerous studies have examined the effects of arginine on the liver. however, few have determined the optimal concentration of arginine that would best prevent injury to the liver this study will provide participants with three concentration levels of arginine to determine which is most effective in reducing liver injury in alcoholic hepatitis patients. this study will last 31 days. participants will be admitted to the general clinical research center for 27 days. participants will be randomly assigned to one of four groups. participants in groups 1, 2, and 3 will have 1%, 2%, or 6% arginine added to their diet in the form of gel capsules. participants in group 4 will receive placebo capsules. participants will be given 24 capsules of different dietary supplements, including the arginine supplements, every day during their hospital stay. participants who are not able to ingest at least 18 capsules per day over 3 days or who are not able to eat the majority of their solid or liquid diet while hospitalized will have a naso-gastric soft feeding tube inserted for food and supplements to be administered. a liver biopsy will be performed on days 3 and 26. the biopsies will involve insertion of a catheter in a neck vein and a small sample of liver tissue will be removed. on days 2 and 25, participants will undergo blood and urine collection. participants will also be infused with nonradioactive leucine to determine the levels of albumin, a protein that is reduced in diseased livers. if participants develop fluid in the abdomen (a condition known as ascites), a small sample of fluid will be extracted from the abdomen twice a day on days 2, 17, and 25. on day 31, participants will return to the research center for additional blood and urine collection.

Eligibility criteria:
inclusion criteria: * diagnosis of alcoholic hepatitis * maddrey's df score less than 33 exclusion criteria: * hepatitis c or b virus infected * hiv infected * history of cancer * hepatic encephalopathy (a condition in which liver failure affects the central nervous system) * kidney failure * a do not resuscitate order (a patient-directed order not to resuscitate in the event that resuscitation is necessary to prevent death) * maddrey's df score of 33 or greater after vitamin k administration during the study * alcohol withdrawal at study entry * active pneumonia at study entry * allergy to iodine * enrollment in any other clinical trials

Keywords: hepatitis liver diseases alcoholism arginine
epi cystic hydatid disease peru

Conditions: E. Granulosus Cystic Hydatid d

Summary: this is a study developed by researchers from the universidad peruana cayetano heredia, the universidad mayor de san marcos and other local and foreign institutions. researchers are performing this research in human beings and animals, in order to determine the best way to understand and eliminate a parasite called echinococcus granulosus (tapeworm). the parasite grows and develops in the dogs´ bowel. the tapeworm produces eggs which are eliminated among the feces and remain in the environment. individuals may accidentally ingest the eggs through contaminated food or drinks and develop a disease called cystic hydatid disease. this disease mainly affects the human lungs and liver. the parasite grows in the shape of a water bag and it can jeopardize human life. it also affects sheep, goats, llamas and alpacas. the study will enroll almost 840 volunteers who are older than 5 years of age. it will last about 3 years.

this is a 3 year study of approximately 840 male and female subjects aged 5 years old and above to be conducted in a peruvian highland community in lima, peru in order to described the dynamic and associated risk factors to both human infection and cystic hydatid disease (chd). the purpose is to determine the prevalence and incidence of both infection and disease in human population, to assess the proportion of seroconversion (positive to negative) through follow-up of the same indiviuals every year and to identify risk factors related to human infection and disease by using baseline questionnaire (e.g. husbandry practices and education level). echinococcal infection is prevalent in regions of the world where dogs are used to care for large herds (lima, peru). this study involves collection of 5 ml of blood every year for 3 years. in addition, cxr and abdominal us will also be performed. signs and symptoms of hydatid disease depend on the organ involved (lungs and liver) and the size of the cyst. at this time, the best therapeutic approach is surgical intervention preceded by careful radiological evaluation plus adjuvant chemotherapy. the mortality rate post surgery is 1-4% and for those patients who refuse to have surgery, 60%. despite the presence of current methods of control, the parasite prevalence appears to be increasing worldwide therefore this study will obtain data to implement a control program to eradicate this zoonosis.

Eligibility criteria:
inclusion criteria: 1. living in study area (cooperative tupac amaru). 2. older than five-years old exclusion criteria: 1. pregnant woman (only for chest x-ray procedure).

Keywords: hydatid disease, echinococcus granulosus, tapeworm
effects of assisted sit-up exercise vs swiss ball pikes on postpartum low back pain.

Conditions: Postpartum Disorder; Lumbar Pain Syndrome; Activation, Patient

Summary: the aim of this study is to evaluate and compare the effectiveness of assisted sit-up exercise and swiss ball pikes on the treatment of pain and disability of postpartum low back pain. the current study will compare the use of assisted sit-up exercise and swiss ball pikes. the current study is novel in a way that there is limited literature about treating postpartum low back pain with physical strengthening exercises. these two methods will be employed to see if they improve ranges along with accompanying pain and disability.

this study will be a randomized clinical trial. subjects with postpartum low back pain meeting the predetermined inclusion and exclusion criteria will divide into two groups. pre-assessment will be done using the numeric pain rating scale \& roland-morris questionnaire as subjective measurements. subjects in one group will be treated with assisted sit-up exercise and the other will be treated with swiss ball pikes. each subject will receive a total of 12 treatment sessions, with 2 treatment sessions per week. post-treatment reading for numeric pain rating scale and roland-morris questionnaire will be recorded after the end of the 4th, 8th, and 12th treatment session.

Eligibility criteria:
inclusion criteria: * age 20 to 40 years. * back pain without leg pain for at least three months postpartum period. * pain intensity of numeric pain rating scale ranges between 6 to 10. * intensity of pain limited daily work activities. exclusion criteria: * any kind of infection, malignancy, inflammation, and structural deformity present in the lumbar and pelvic region. * neurologic signs * trauma history of the lumbar and pelvic region * any lumber or abdominal surgery * pregnancy.
the future of revascularization using a bioprotec graft

Conditions: Peripheral Artery Disease

Summary: the main purpose of this study is the rate assessment of rescued limbs, one year after a bioprotec vascular graft.

the bioprotec grafts are controverted: they are useful in some cases, but they are known as frequently broken or thrombosed. however they are always posed in a complicated situations, in a fragile patients who have ever had many of revascularizations or in an infectious state (which is supportive of the pseudoaneurysm and thrombosis) despite the frequent use of this graft in france, the results have never been published.

Eligibility criteria:
inclusion criteria: * ≥ eighteen years old. * critical ischemia (phase 4-6 of rutherford): no saphenous equipment for the vascular reconstruction; at least one leg axis permeable. exclusion criteria: * pregnant woman. * patient with an acute ischemia. * patient with an exceeded ischemia.

Keywords: peripheral artery disease revascularization graft vein artery limb amputation
transcranial direct current stimulation (tdcs) in the treatment of drug-naïve obsessive-compulsive disorder(ocd)

Conditions: Obsessive-Compulsive Disorder

Summary: this study will evaluate the possible therapeutic effects of transcranial direct current stimulation (tdcs) in drug-naïve obsessive-compulsive disorder (ocd) patients, and the underlying neural mechanism by magnetic resonance imaging (mri),transcranial magnetic stimulation and electroencephalography (tms-eeg).

the purpose of this study is to examine the efficacy of tdcs over orbitofrontal cortex (ofc) in treatment of drug-naïve ocd patients. 60 drug-naïve ocd patients will be randomized into two groups (i.e. active or sham stimulation). tdcs stimulation will be performed once a day, five times a week, for two weeks. the investigators will assess symptom severity before and after two weeks of tdcs. through the study, yale-brown obsessive compulsive scale（y-bocs）, the obsessive compulsive inventory-revised (oci-r), the beck depression inventory (bdi), the beck anxiety inventory (bai), perceived stress scale (pss), pittsburgh sleep quality index (psqi)and side-effect questionnaire will be obtained by a trained investigator. the patients will also receive mri scan and tms-eeg.

Eligibility criteria:
inclusion criteria: * age: 18-50 years old; * dsm-5 criteria for ocd; * y-bocs total score \> or = 16, discontinued medication for at least 8 weeks before tdcs stimulation. * \>or＝9 years education exclusion criteria: * any axis i psychiatric disorder comorbidity * the inability to receive tdcs because of metallic implants, or history of seizures，or 3.history of head injury, or history of neurosurgery. * participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body. * any current significant medical condition. * serious suicide risk
drug eluting balloon angioplasty versus everolimus platinum chrome stent

Conditions: Percutaneous Coronary Intervention (PCI); Coronary Artery Disease (CAD); De Novo Stenosis

Summary: randomized, open-label, single-center, non-inferiority clinical trial to compare late lumen loss (lll) at 12 months in tunisian population undergoing coronary percutaneous intervention between drug eluting balloon treated group and everolimus platinum chrome stent treated group.

drug eluting stents (des) leave a permanent metal implant that interferes with vasomotion, endothelial function and vascular remodeling. the rigid structure and the pharmacological properties of des could overcome acute complications related to balloon dilation and late complications related to in-stent restenosis. however, they do not restore normal arterial function after the procedure. drug eluting balloons (deb) offer an alternative to the implantation of a durable material. they release a transient antiproliferative drug. they promise potential advantages over des as: * an ad integrum restitution of the endothelium and its vasomotor properties. * a reduction of late thrombosis risk. * the possibility of grafting on the treated segment. * avoid the problems of side-branch trapped in the treatment of bifurcations. * improve the profitability of non-invasive imaging (coroscanner, magnetic resonance imaging) during patient follow-up. deb is validated for the treatment of in-stent restenosis, especially focal and on small caliber arteries. the use of deb in de novo lesions has been the subject of several studies. this therapeutic option should be evaluated in the tunisian context the aim of this clinical trial is to compare the results of angioplasty by deb (sequent please) versus last generation des: coronary stent system in platinum chromium alloy with everolimus elution (promus premier and promus elite) the primary endpoint: late lumen loss at 12 months. the secondary endpoint: the major cardiovascular event rate (mace).

Eligibility criteria:
inclusion criteria: * patients with silent ischemia, stable angina, unstable angina, or non-q wave myocardial infarction. * a de novo lesion on a never treated native artery. * a reference artery diameter between 2 mm and 4 mm. non-inclusion criteria * patients with stemi in the acute phase or presenting a cardiogenic shock. * patients with an allergy or a contraindication to double anti-platelet aggregation. * pre-menopausal patients not using regularly an oral contraceptives or breast-feeding . * patients with severe comorbidity or with an estimated survival of less than 12 months. * dissected lesions or spontaneous dissections other than grade a or b requiring des angioplasty. * in-stent restenosis. * thrombotic lesions. exclusion criteria: * none

Keywords: risk assessment metals coronary artery disease treatment outcome drug-eluting stents angioplasty, balloon, coronary randomized controlled trials as topic coronary restenosis
observational study of total ankle arthroplasty and tibiotalar arthrodesis

Conditions: Arthritis

Summary: in case of severe ankle arthritis, the two common surgical treatments are tibiotalar arthrodesis and total ankle arthroplasty. few studies have compared these treatments and it remains difficult to determine which operation is the better solution for end stage ankle arthritis. the purpose of the present study is to analyze patient's outcome after each type of ankle surgery and to describe the decision making process.


Eligibility criteria:
inclusion criteria: * patient with isolated symptomatic end-stage ankle arthritis who needs a tibiotalar arthrodesis or a mobile-bearing total ankle arthroplasty * patient receiving ce marked medical devices and planned to be operated in compliance with their respective instructions for use * patient aged between 40 and 75 years old exclusion criteria: * patient who already had before his inclusion in this study a tibiotalar arthrodesis or a total ankle arthroplasty in the same ankle * patient with planned or existing arthrodesis of adjacent joints (subtalar, talonavicular and calcaneaocuboid joint) * patient with ankle deformity \> 20° (weight bearing x-rays) * patient with history of infection of the ankle joint (positive culture) or current infection of the ankle joint (positive culture) * patient with neuropathy or with a history of diabetes mellitus for more than 15 years * patient with avascular necrosis of the talus \>25% * patient already included in the study for the other ankle