Kornimate/medical-research-clean huggingface dataset:
effect of bia 2-093 on the pharmacokinetics of a combined oral contraceptive.

Conditions: Epilepsy

Summary: single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.the volunteers received an oral single-dose of a combined contraceptive containing with an oral once daily dose of 1200 mg of bia 2-093

single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.the volunteers received an oral single-dose of a combined contraceptive containing 30 μg ethinyloestradiol and 150 μg levonorgestrel on two occasions - once as such and once after pre-treatment with an oral once daily dose of 1200 mg of bia 2-093 for 15 days separated by a washout period of at least 3 weeks.

Eligibility criteria:
inclusion criteria: * pre-menopausal female; * able and willing to give written informed consent; * aged 18 to 40 years, inclusive; * not pregnant or breast-feeding; * body mass index (bmi) between 19 and 30 kg/m2, inclusive; * healthy as determined by medical history, physical examination, complete neurological examination, vital signs, and 12-lead ecg; * clinical laboratory tests with clinically acceptable results at screening and admission to the first period; * negative tests for hbsag, anti-hcv ab and hiv-1 and hiv-2 ab at screening; * negative test for drugs of abuse at screening; * non-smoker or smokes less than 10 cigarettes or equivalent per day; * agreed to either practice abstinence or use a double-barrier or intra-uterine device from screening until the follow-up visit; * negative pregnancy test at screening and admission to the first period. exclusion criteria: * had any contra-indication to the use of oral contraceptives; * had experienced notable adverse events while on any oral contraceptive; * had a history of alcoholism or drug abuse; * had a relevant history or presence of respiratory, gastrointestinal, renal, hepatic,haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders; * had acute gastrointestinal symptoms at the time of screening or admission to the first period; * had a significant infection or inflammatory process at the time of screening or admission to the first period; * had a relevant surgical history; * had a relevant family history; * had a history of relevant drug hypersensitivity (e.g., carbamazepine or oxcarbazepine); * had used relevant prescription or over-the-counter medication within 2 weeks ofadmission to the first period; * consumed more than 14 units of alcohol a week; * had participated in any clinical trial within 3 months prior to screening; * had previously received bia 2-093; * had donated or received any blood or blood products within 2 months prior to screening; * was unlikely to co-operate with the requirements of the study.
interactive exoskeleton robot for walking - ankle joint

Conditions: Stroke

Summary: a novel interactive exoskeleton robotic system with embedded force and motion sensors will be developed to facilitate walking of stroke patients with hemiparesis. the robot will synchronise with the gait pattern of the stroke patient to provide assistance in ankle dorsiflexion during swing phase. it is hypothesised that the robot can facilitate stable and longer walking distance for stroke patients with drop foot problem. it can be applied on unilateral side, which is suitable for stroke patients with hemiparesis. the whole system design is lightweight, compact, comfortable, and user-friendly in hospital or at home settings.

in this clinical trial, participated stroke patients will be divided into two groups: robotic group and sham group. stroke patients in both groups will participate in a 20-session gait training program, which includes overground walking and stair climbing exercises. robotic group will walk with the powered ankle robot, which provide ankle dorsiflexion support during swing phase of walking; sham group will walk with the ankle robot with very low assistance level, which provide only tactile feedback but no ankle support in order to evaluate the placebo effect. a series of clinical assessments will be carried out to assess the functional recovery in stroke patients before and after the gait training program.

Eligibility criteria:
inclusion criteria: 1. ischemic or hemorrphagic stroke with drop foot problem. 2. sufficient cognition to follow simple instructions and to understand the content and purpose of the study. (mini-mental state examination \> 21) 3. capable of standing and walking independently for an extended period of time. (functional ambulation category \> 3, berg balance scale \> 40) exclusion criteria: 1. any medical or psychological dysfunctions that would affect their ability to comply with test study protocol, such as lower back pain, neuralgia, rotational vertigo, muscloskeletal disorders, injuries, and pregnancy. 2. any severe contractures in hip, knee, or ankle joint that would preclude passive range of motion in the lower extremity. 3. participation in any therapeutic treatment ("outside therapy") performed with the lower extremity during the planned study, including the baseline and the follow-up.
practical ultrasonographic detection of sarcopenia in patients with long-term gastrectomy

Conditions: Sarcopenia; Gastrectomy

Summary: the investigators aimed to evaluate long-term sarcopenia in patients with total and distal gastrectomy by measuring the anterior thigh muscle with usg, which is a more specific and easy method.

sarcopenia was found to be significantly increased in patients who underwent total, proximal and distal gastrectomy compared to those who did not undergo gastrectomy in the long term. to date, very few studies have investigated the development of sarcopenia in the long term after gastrectomy. in these studies, sarcopenia was usually assessed using bia and dexa. muscle thickness measured by ultrasound has high sensitivity and specificity in determining regional muscle mass. patients who underwent total(n=20) and subtotal gastrectomy(n=35) and patients who did not undergo gastrectomy(n=35) were included in the study. ultrasonographic measurements anterior thigh muscle thickness of the dominant side was measured at the mid-point between the anterior superior iliac spine and the upper border of the patella. transverse measurements were obtained between the outer fascia of rectus femoris muscle and the periosteum of femur. sonographic thigh adjustment ratio (star) was calculated by dividing the anterior thigh muscle thickness (mm) by bmi. functional evaluations grip strength was measured with an electronic hand dynamometer. three repeat measurements were performed from the dominant side and the maximum value was taken for the analyses. chair stand test (cst) was performed while participants were asked to stand up and sit down from a chair - without arm rest, for five times as quick as possible, with their arms crossed over their chests. three measurements were performed and median values were taken for the analyses. diagnosis of sarcopenia the isarcoprm algorithm was used whereby the diagnosis of sarcopenia was established if low muscle mass (i.e. star values \<1.4 for males and \<1.0 for females) was combined with low grip strength (\<32 kg (males) and \<19 kg (females)) and/or increased cst time (≥12 sec).

Eligibility criteria:
inclusion criteria: * who agreed to participate in the study * total or subtotal gastrectomy at least 1 year ago * the control group consisted of patients without gastrectomy with similar exclusion criteria as the patient group exclusion criteria: * rheumatic/neurological diseases * any organ failure, * limitation of mobility * history of major orthopedic surgery, * chemotherapy programs * gastric carcinoma recurrence * parkinson's disease, previous stroke, cerebellar diseases, multiple sclerosis * major depression * those who use any assistive device for walking * people with severe knee, hip and hand osteoarthritis * active malignancies (currently or within the last 1 year receiving radiotherapy/chemotherapy * severe chronic obstructive pulmonary disease * visual impairment and vestibular disorders * pregnancy
a phase iii trial of zd4054 (zibotentan) (endothelin a antagonist) in non-metastatic hormone resistant prostate cancer

Conditions: Prostate Cancer

Summary: enthuse m0 is a large phase iii clinical trial studying the efficacy of zd4054 (zibotentan) in hormone resistant prostate cancer (hrpc). this clinical trial will test if the endothelin a receptor antagonist zd4054 (zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments. zd4054 (zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking endothelin receptor activity. this trial will look at the effects of zd4054 (zibotentan) in hormone resistant prostate cancer (hrpc) patients who have had rising psa after surgical or medical castration but have no evidence of metastases. all patients participating in this clinical trial will receive existing prostate cancer treatments in addition to trial therapy. half the patients will receive zd4054 (zibotentan) , and half the patients will receive placebo in addition to standard prostate cancer therapy. by participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour. no patients will be deprived of standard prostate cancer therapy.


Eligibility criteria:
inclusion criteria: patients who answer true to the following criteria may be eligible to participate in this study. * confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has not spread to the other parts of the body (metastases). patients with lymph node involvement may be eligible if specified criteria is met. * increasing prostate specific antigen (psa), collected within one year of enrollment * currently receiving treatment with surgical or medical castration exclusion criteria: patients who answer true to the following may not be eligible to participate in this study. * currently using opiate based pain killers for cancer related pain * previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). prior targeted cancer therapies are permitted if received during a previous clinical trial * suffering from heart failure or had a myocardial infarction within last 6 months * a history of epilepsy or seizures

Keywords: hormone resistant prostate cancer endothelin a receptor antagonist endothelin a endothelin a antagonist
prenatal iodine supplementation and early childhood neurodevelopment

Conditions: Pregnancy Related; Neurodevelopmental Disorders; Nutrition Disorder, Fetal

Summary: a randomized controlled trial to determine the effect of reducing iodine from vitamin and mineral supplements for pregnant women who have adequate iodine intakes (\>165 μg/d from food alone) on cognitive development of children at 24 months of age.

it is known that severe iodine deficiency during pregnancy leads to profound intellectual disabilities in the child. following results of a 2004 national survey of school-aged children showing that mild iodine deficiency had re-emerged in the south-eastern parts of australia, the australian government mandated the addition of iodine to salt used in bread making to increase population iodine intake. it is also recommended that all pregnant and lactating women take an additional iodine supplement containing 150 µg/d of iodine. since this time, further evidence has emerged from cohort studies that children born to women with high iodine intake (as well as low iodine intake) have poorer neurodevelopmental scores, suggesting that more tailored supplementation may be a better strategy. our poppie trial will determine if limiting iodine supplementation in women who already consume adequate iodine from food, improves cognitive scores in early childhood. a total of 754 pregnant women from around australia who are ≤13 weeks of gestation will be enrolled and randomised to receive a standard prenatal vitamin and mineral supplement with a reduced amount of iodine (20 μg - intervention) or a standard prenatal vitamin and mineral supplement with 200 μg of iodine (control). the control supplement contains a level of iodine to match the amount in most commonly used vitamin and mineral supplements sold in australia. infant neurodevelopment at 24 months of age will be assessed using the bayley-iv and conducted at participating centres or a location convenient to the family.

Eligibility criteria:
inclusion criteria: * pregnant women ≤13 weeks of gestation. * consume greater than 165 µg/d of iodine from food alone based on our validated iodine specific food frequency questionnaire (i-ffq). * english is main language spoken at home as child will need to understand and take instruction in english to participate in the neurodevelopmental assessment. * able to give informed consent. exclusion criteria: * known history of thyroid disease. * previous child diagnosed with thyroid dysfunction. * carrying a fetus with a known or suspected congenital abnormality.

Keywords: iodine supplementation
measurement of arch motion after bunion surgery

Conditions: Hallux Valgus; Instability of the Foot Arch

Summary: this study is an observational "change from baseline" outcome measures design. data is collected for the sake of evaluating treatment (fusion surgery) performed as standard medical care, but the investigator does not assign specific interventions to any participants in this study.

device/fluoroscopy measurements of arch motion and questionnaire data will be acquired on 10 women undergoing surgery for bunion, and 10 controls. surgery will implant hardware to fuse (stabilize) the arch. methods will evaluate the patient's problems associated with bunion and satisfaction with surgery, and assess the effectiveness of surgery in reducing motion of the arch. the hypotheses are that patients treated with surgery will demonstrate improvement in function, and that surgery will reduce motion of the arch postoperatively (posttest measures acquired 6 months after surgery), and in comparison to measures taken on a control group. the data collected will come from a comprehensive examination. methods will include the measurement of arch motion made by an examiner using a device and a fluoroscopic gait examination procedure, and completion of two medical questionnaires. the fluoroscopic acquisition of the digital images will be analyzed across the specified time dimensions of the gait cycle. device and fluoroscopy of measures of arch motion will be made at 2 time points on patients enrolled in this study: presurgery (baseline) and 6 months postsurgery. the questionnaire measurements of self-reported pain and function will be made at 4 time points: presurgery (baseline) and again at 3 months, 6 months, and 12 months postsurgery. outcome measurements will be collected on control subjects at one time point only, on the day of their enrollment into the study. prospective studies have not characterized outcomes in patients receiving this type surgical fusion as part of the corrective treatment for bunion. results have potential to improve surgical treatment outcomes and, improve upon the current methods of fluoroscopic motion analysis.

Eligibility criteria:
inclusion criteria: * age 18 or older. * women. * able to comprehend the risks associated with the study. * able to complete the paperwork required for enrollment. * able to walk without assistance of another individual. exclusion criteria: * pregnancy * history of great toe, forefoot or arch surgery, or severe traumatic injury. * reduced ankle or great toe motion that impairs the ability to walk. * observed evidence of foot deformity other than bunion. * insensate to skin sensation testing which could indicate neuropathy.

Keywords: bunion foot arch instability
nenca study on neurological complications of long covid-19 in children and adolescents; neurophysiological, electroencephalographic and neuroradiological investigation

Conditions: Long Covid-19

Summary: the study seeks to investigate the neurological effects caused by covid-19 in children and adolescents in the 6-16 age group. to do this, neuropsychological scales, an eeg and an mri were used.


Eligibility criteria:
inclusion criteria: * age between 6 years and 16 years and 11 months * symptomatology compatible with long neurological covid, specifically: persistence or appearance of new neurological signs/symptoms (e.g. fatigue, headache, sleep disturbance, cognitive dysfunction, memory difficulties, emotional or mood disorders, vertigo cognitive dysfunction, memory difficulties, emotional or mood disorders, dizziness, dysautonomia, movement disorders movement disorders, ataxia, tremor, epilepsy, muscle weakness, myalgia, hyposmia, hypogeusia hearing loss or tinnitus and/or sensorimotor deficits such as hypoesthesia, dysesthesia) after three months after established sars-cov-2 infection, as well as persistence of these symptoms for at least two months, in the absence of a clear aetiology. * signature of the appropriate informed consent by caregiver(s) and patient(s) exclusion criteria: * poor knowledge of the italian language or other limitation of verbal communication that compromises the subject's ability to perform neuropsychological tests * need for sedation to perform brain mri 7 tesla * neurological or neuropsychiatric disorder diagnosed prior to covid-19 diagnosis * caregiver's failure to sign consent

Keywords: covid-19
the use of fibroscan to assess liver fibrosis in patients with cardiac pacemakers

Conditions: Liver Cirrhosis

Summary: this study is designed to determine if the fibroscan (echosens, paris), a non-invasive, ultrasound-based device used to estimate fibrosis in patients with chronic liver disease, interferes with implanted cardiac pacemaker and/or implantable cardioverter-defibrillators. recruitment consists of a total of 200 outpatients undergoing routine pacemaker interrogation at a teaching-hospital pacemaker clinic.

assessment of liver fibrosis in patients with chronic liver diseases provides staging and prognostic information critical in establishing treatment priorities. the gold standard evaluation of liver fibrosis is hampered by the invasive nature of liver biopsies. fibroscan is a non-invasive alternative that has been extensively validated in chronic hepatitis c, chronic hepatitis b, alcoholic liver disease, and non- alcoholic fatty liver disease patients. to avoid unknown risks of potential interaction, the manufacturer have advised against the use of the device in patients with active implantable medical device including cardiac pacemaker and/or implantable cardioverter-defibrillators(icd). review of the literature showed that these two population have been specifically excluded in all previously reported studies. at the time of writing, no specific reports have demonstrated either safety or potential harm of the fibroscan in patients with pacemaker/icd. given the proven benefit of the fibroscan in chronic liver disease and the current policy of excluding patients with pacemaker/icd in clinical practice, this study aims to formally evaluate the safe use of the fibroscan in this population within the controlled environment of a pacemaker lab.

Eligibility criteria:
inclusion criteria: -any outpatient undergoing routine pacemaker interrogation at pacemaker clinic exclusion criteria: * pregnancy * bmi\>35 * person with active implantable medical devices other than cardiac pacemaker and/or icd * person who are unable to tolerate lying flat for the fibroscan examination.
covid-19 biorepository

Conditions: Covid-19; SARS-CoV 2; Coronavirus; COVID

Summary: establish a covid-19 biorepository to aid in developing our knowledge of the disease.

while sars-cov-2 has some similarities to the sars-cov pathogen that led to an epidemic in 2002 and 2003, there is much about the epidemiology, pathogenesis, clinical presentation, diagnosis, and treatment of the novel virus that remains unknown.3 additional research is needed to explore the nature of the virus, its spectrum of disease, and potential therapies to combat its spread. the aim of this project will be to establish a biorepository of blood samples from patients infected with sars-cov-2 that can then be used by investigators to expand our understanding of covid-19 and its treatment and, in turn, improve patient outcomes. the covid-19 biorepository will accomplish the following specific aims: 1. establish a collection of biospecimens from patients with covid-19. 2. establish a link between biospecimens and longitudinal individual patient data, which will be collected and stored in redcap. 3. provide biospecimens and unique patient data to researchers investigating covid-19. separate irb approval will be needed for these studies.

Eligibility criteria:
inclusion criteria: * the participant is a patient at tukhs or has agreed to participate in a study approved by the kumc human research protection program (hrpp). * the participant has a diagnosis of covid-19 confirmed by covid-19 pcr. * patient is 18 years of age or older. exclusion criteria: * participant declines to participate (living patients only) * participant or healthcare surrogate is unable to provide informed consent (living patients only)