Kornimate/medical-research-clean huggingface dataset:
a phase 1 study to evaluate the safety of migalastat hydrochloride given intravenously to healthy volunteers

Conditions: Fabry Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of iv migalastat hcl alone and to determine absolute bioavailability for oral migalastat hcl as compared to iv administered migalastat hcl in healthy volunteers. the data from this study will help us understand how migalastat works in the body and will help us determine what would be an effective dose in future studies with migalastat hydrochloride.


Eligibility criteria:
inclusion criteria: * males and females between 18 and 45 years of age. * body weight range ≥ 50 kg ≤ 100 kg and bmi within the range 18.5 - 29.9 kg/m2. * healthy as determined by a responsible and experienced physician, based on a medial evaluation. * male and female subjects of childbearing potential agree to adhere to the contraception requirements. * capable of giving written informed consent. exclusion criteria: * history of sensitivity to migalastat hcl or related iminosugars (eg, miglitol, miglustat), or other significant drug allergy. * past medical history, or physical examination findings, of clinically significant abnormalities that may put the subject at risk or interfere with outcome variables. * positive pre-study drug/alcohol screen. * pregnant or lactating females. * the subject has participated in a clinical trial and has received an investigational product within 60 days prior to the first dosing day in the current study.

Keywords: fabry disease fabry lysosomal storage disorders lsd amicus migalastat hcl migalastat at1001
genetic evaluation of renal cell carcinoma; predicting biomarkers for renal cell carcinoma

Conditions: Kidney Cancer

Summary: recruitment of participants to the study takes place at the urological department at zealand university hospital, roskilde, feb. 2018-april 2018. 10 people with diagnosis of renal cancer should be recruited in phases 1. subsequently, biological materials from 100 patients with kidney cancer will be used from the national biobank. in phase 3, 10 patients will be recruited for the final gene test.


Eligibility criteria:
inclusion criteria: * patients who have been diagnosed with kidney cancer. exclusion criteria: * patients without signs of malignancy at final histology report. * incapacitated patients.
non-invasive haemodynamic monitoring to predict spinal hypotension during caesarian section

Conditions: Hypotension; Pregnancy Related; Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Summary: spinal anaesthesia for elective caesarean section is associated with maternal hypotension, secondary to alteration of sympathetic tone and hypovolemia, in up to 70% of cases. our objective, in this prospective single-centre observational study, was to assess the ability of change in systolic ejection volume after 45° passive leg raising to predict hypotension after spinal anaesthesia. systolic ejection volum was monitored with non-invasive clearsight device just before elective caesarean section in third trimester pregnant women.


Eligibility criteria:
inclusion criteria: * third trimester pregnant women undergoing elective ceasarean section under spinal anesthesia exclusion criteria: * emergent ceasarean section * eclampsia or pre-eclampsia * undergoing anti-hypertensive treatment * arythmia
vitamin d plasma level and its role in headache

Conditions: Headache

Summary: to date there are conflicting data concerning a correlation between plasma vitamin d levels and headache. the aim of this study was to evaluate plasma vitamin d levels in patients with headache admitted to the center of headache of pugliese ciaccio hospital.

several papers suggest that inflammation is able to induces both headache and low levels of vitamin d. however, to date a correlation between plasma vitamin d levels and headache has not been demonstrated. recently we documented that low levels of vitamin d are related to a low statin efficacy. in this study we will evaluate the plasma levels of vitamin d in patients with headache admitted to the center of headache of pugliese ciaccio hospital. moreover it will be also evaluated: * the correlation between efficacy and safety of drugs used in headache treatment and plasma vitamin d levels. * the role of vitamin d supplementation on both headache symptoms and drug effects. plasma vitamin d levels in patients with headache will be evaluated respect to patients without headache.

Eligibility criteria:
inclusion criteria: * acute or chronic headache diagnosed according to the clinical and radiological criteria of the headache association exclusion criteria: * allergy to drugs, * progressive serious medical conditions (such as cancer, aids or end-stage renal disease) * renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values) * liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range according to the central laboratory definition reference values) * alcohol consumption (\>3 alcoholic beverages daily) * substance abuse * inability to give written informed consent * actual or recent (3-month) treatment with corticosteroids, indomethacin or other antinflammatory drugs. * secondary headache
motivation and executive control in schizophrenia

Conditions: Schizophrenia

Summary: in order to control a behaviour, investigators need to realise goal directed actions and to priories some actions. this control is required in unusual situation. appropriate actions are selected and coordinated according to context and aim. several studies try to draw a model of executive function. recently, koechlin has suggested a three levelled organisation to explain how the prefrontal cortex controls actions. contextual control is useful to answer appropriately with the immediate context. episodic control allows selecting the action according to specific information given before. sensorial control is the automatic response when a stimulus is presented. some diseases like schizophrenia are associated with neurological dysfunction in prefrontal cortex. chambon and al (2008) have identified a dysfunction of contextual control in schizophrenia. as the prefrontal cortex is involved in motivational process, it seems interesting to study potential links between executive function and motivation. a study from kouneiher shows contextual and episodic activation of motivation in healthy population. investigators aim to study the way motivational process are recruited in schizophrenia.

behavioral protocol. letters (vowel and consonant; upper- or lower- case) are presented in several colours into successive blocks. each block included a series of eight letters. each colour required a specific task given by a fixed rule (contextual control) but for some colour, the rule changes sometimes (episodic control). participants are informed that payoffs vary according to their own performance. a frame indicates essay with bonus reward. moreover a dashed frame indicates a low-bonus reward and a solid frame means a high-bonus reward. thus different blocks are designed: low-incentive block and high incentive block. this reward increased from standard to bonus motivation in high-incentive block (contextual motivation) and from low to high according to the type of blocks (episodic motivation) reaction time may be higher in bonus reward patients with schizophrenia are not sensitive to contextual motivation, and therefore patients should behave differently than control in contextual motivation.

Eligibility criteria:
inclusion criteria: * age 18-45 years old * schizophrenia * french native speaker exclusion criteria: * neurological disease * motor or visual deficit * somatic treatment with neurological impact * drug abuse

Keywords: schizophrenia motivation executive control
high frequency rtms treatment for cognitive impairments in chronic schizophrenia patients

Conditions: Schizophrenia

Summary: a randomized, double-blind sham-controlled trial of high frequency rtms treatment for cognitive impairments in 120 chronic schizophrenia patients

objective: this study aimed to evaluate the efficacy of high-frequency repetitive transcranial magnetic stimulation (rtms) over left dorsolateral prefrontal cortex in the treatment of cognitive impairments in 120 chronic patients with schizophrenia. methods: 1. clinical trial: the study consists of 8 weeks of treatment. 2. assessment procedures: 2.1 primary outcome variable-psychopathology: the psychopathology of patients was assessed by three clinical trained staff, who were blind to treatment protocols, using the positive and negative syndrome scale (panss). patients are interviewed at screening, at at baseline, 2 weeks, 4 weeks, 6 weeks and 8 weeks. 2.2 cognitive tests: rbans was used to assess the cognitive function by three psychologists, which is comprised of a total score and 5 age-adjusted index scores for attention, language, delayed and immediate memory and visuospatial/construction. a translated and adapted chinese version of rbans has been evaluated for the test-retest reliability and clinical validity between schizophrenia patients and control subjects. cognitive performance was measured at baseline and at 8-weeks. 2.3 side effects: tess was used to assess the side effect at baseline and every 2 weeks. 2.5 weight gain measurement: weight gain every week

Eligibility criteria:
inclusion criteria: * diagnosis of schizopherenia by two senior psychiatrists * male * right-handed * between 18 and 60 years and han chinese * duration of symptoms at least 60 months * received stable doses of antipsychotic drugs at least 12 months * with unresolved negative symptoms (negative scale of panss ≥20 and positive scale of panss \< 24) exclusion criteria: * a dsm-iv axis i diagnosis other than schizophrenia * documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, huntington's disease, multiple sclerosis * acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension) * severe headache for unknown reasons and cardiovascular diseases, intra-cranial metals, pacemakers, severe and those receiving electroconvulsive therapy in the past 3 months * past history of autoimmune and allergies, hypertension, lung disease, diabetes or cerebrovascular disease), past history of neurological illness (head trauma with loss of consciousness for more than 5 minutes) or family history of epilepsy increasing the risk of seizures * education level less than 5 years by subject report, * receiving or planning to start the psychotherapy during the rtms treatment or past received psychotherapy 6 months before the current study * subjects who suffered from alcohol or illegal drug abuse/dependence

Keywords: schizophrenia rtms
patient-reported effectiveness and safety of etoricoxib in osteoarthritis (oa)(0663-113)

Conditions: Pain

Summary: the purpose of this study is to collect disease burden of oa and the effectiveness and patient satisfaction of treatment by etoricoxib in the normal practice setting.


Eligibility criteria:
inclusion criteria: * must be over 20 years of age, regardless of sex * must have a diagnosis of oa that requiring treatment * patients must have taken an nsaid, cox-2 or opioids on the majority of days during the last 4 weeks before enrollment who are intolerant (due to gastrointestinal adverse events) or inadequately respond to current therapy (vas \>= 40 mm on a pain scale from 0-100 mm) * excluding osteoarthritis, the patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests * must agree to participate voluntarily in the study * must have the capacity to understand and answer the questionnaires used in the study * must agree to return for a follow-up visit with the treating physician four weeks after the initiation of treatment with etoricoxib * patient is willing to sign informed consent form exclusion criteria: * under 20 years of age * severe hepatic insufficiency (child-pugh score \> 9) * advanced renal insufficiency (creatinine clearance \< 30 ml/min) * any contraindication or warning or precaution as mentioned in the approved study drug package insert * gi ulcer with active bleeding present at study enrollment * patient has a recent history of stroke, myocardial infarction or transient ischemic attack (within the previous 2 years)
exposure to the aerobic training stimulus in healthy individuals

Conditions: Healthy

Summary: fitness is an important determinant for health and influenced by using large muscles. muscles respond to training. we want to know if adding arm exercise to leg exercise can provide a better training session for healthy individuals. if the strategy shows promise for healthy people then it might work for people with lung disease who have trouble training because of difficulty breathing. the purpose of this first study is to evaluate, in healthy people, a unique approach to training by determining if adding arm exercise to leg exercise can be endured longer than leg exercise alone.


Eligibility criteria:
inclusion criteria: * healthy individuals exclusion criteria: * orthopedic or neurological condition that might affect the performance of the treadmill, arm or leg cycling * have a symptomatic cardiac disease or undergone a recent surgical procedure that might affect the performance on an exercise test * presence of any chronic respiratory condition
verification of computerized sleep-wake analysis in sleep disorders

Conditions: Sleep-wake Analysis

Summary: objective: computerized sleep staging has been verified in a normal population. this study attempts to investigate and verify the interpretation of this computerized sleep staging program in patients with sleep disorders, and improve the accuracy of actigraphy algorithm for sleep duration and postures. 1. compare the accuracy of computerized sleep-wake analysis with current sleep quality indicators: through actigraphy and heart rate sensors, compare the computerized sleep-wake analysis program with polysomnography, and verify its clinical reliability and validity in sleep disorder patients. 2. establish the sleep posture detection system: through three-axis accelerometer, develop algorithms for position recording and monitoring during sleep, and upgrade its accuracy according to photography. methods: patients ranged from age 20-50 with primary insomnia, periodic limb movement in sleep, simple snores, and obstructive sleep apnea will be enrolled in our study. routine polysomnography will be applied in sleep center at chang gung memorial hospital, taoyuan, as well as sleep-related questionnaires. at the same time, actigraphy and heart rate sensor patch will be used for sleep posture detection and further computerized sleep-wake analysis. results will be verified the consistency by comparison with sleep-wake analysis from polysomnographic data and sleep-related questionnaires.


Eligibility criteria:
inclusion criteria: * age 20-50 * diagnosed as primary insomnia, periodic limb movement in sleep, simple snores, and obstructive sleep apnea exclusion criteria: * arrhythmia * sleep efficiency\<50% * combined other sleep disorders
acute effects of breakfast compared with no breakfast on cognitive function and subjective state in 11-13 year old children

Conditions: Healthy

Summary: this study is a school-based, randomised, controlled, parallel groups trial to examine the acute effect of breakfast (ready-to-eat-cereal and milk) vs. no breakfast on cognitive function and subjective state in 11-13 year old adolescents. it was hypothesised that the consumption of breakfast will have a positive acute effect on cognitive performance and subjective state compared with breakfast omission in 11-13 year olds.

this study is a school-based, randomised, controlled, parallel groups trial to examine the acute effect of breakfast (ready-to-eat-cereal and milk) vs. no breakfast on cognitive function and subjective state in 11-13 year old adolescents. it was hypothesised that the consumption of breakfast will have a positive acute effect on cognitive performance and subjective state compared with breakfast omission in 11-13 year olds. the study sample consisted of males and females aged 11-13 years who were recruited to take part in the study from a uk secondary school. there were two conditions in this parallel groups study: breakfast and no breakfast (fasting). the breakfast intervention consisted of ad libitum intake of ready-to-eat-cereal with milk. cognitive function was assessed at baseline and +70 and +215 minutes post-intervention. the cambridge neuro-psychological test automated battery (cantab; cambridge cognition ltd) was used to assess cognitive function. the battery included: simple reaction time (srt), 5-choice reaction time (5-crt), rapid visual information processing (rvip), and paired associates learning (pal), which measured reaction time, visual-sustained attention, and visual-spatial memory respectively. concomitant ratings of subjective mood, alertness, satiety, and motivation were taken throughout the morning using eight unipolar visual analogue scales

Eligibility criteria:
the inclusion criteria were as follows: aged 11-13 years, willingness to consume rtec with semi-skimmed cow's milk during the study, ability to follow verbal and written instructions in english, and normal vision with appropriate corrective lenses if required. the exclusion criteria were as follows: inability to understand the objective of the cognitive tests or carry out the tests, behavioural difficulties or attention disorders, administration of any psychotropic medication in the month prior to testing or during testing, food allergies or intolerances which prevent consumption of rtec and milk (e.g. coeliac, lactose intolerance), acute illness or feeling unwell within the week prior to testing or during testing, and hearing impairment that precluded the normal use of headphones.

Keywords: cognition
efficacy and safety of tenomir in lateral epicondylitis

Conditions: Tennis Elbow

Summary: this study is testing a drug called tenomir that is being developed for the treatment of tennis elbow (lateral epicondylitis). the study drug is a new compound that works by improving the quality of the collagen which helps repair damage to the elbow. the study drug is being developed in the hope of providing a more reliable treatment than those currently available and can be given at the time of first diagnosis, so that recovery can begin as soon as possible. the study drug has been tested in humans in an earlier study, and appeared to be safe and well-tolerated. this study aims to test the study drug in a larger number of participants.

tenomir a chemically synthesised mimic of microrna-29a (mir29a) which has improved stability, activity and cellular uptake while being non-immunogenic, has been created to restore mir29a levels back to pre-injury levels. tenomir is unique in directly targeting the key changes in collagen production associated with tendinopathy. unlike other therapies, tenomir has a well-defined mode-of-action that is supported by a wealth of scientific data. moreover, treatment with tenomir does not require invasive biopsies and can be delivered at the point of initial diagnosis initiating recovery at the very earliest time. this is a global multicentre study which will test tenomir in a larger population, to follow on from the previous phase 1b study in which tenomir appeared to be both safe and well-tolerated.

Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria. 1. subject has a clinical diagnosis of lateral epicondylitis. 2. aside from lateral epicondylitis, the subject is otherwise healthy as determined by a responsible physician, based on medical history, physical examinations, concomitant medication, vital signs, 12-lead ecgs and clinical laboratory evaluations. laboratory values may be retested once at the discretion of the investigator. 3. subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion (as confirmed by tenderness at lateral epicondyle and positive pick up back of chair sign). 4. subject's symptoms have persisted for at least 6 weeks to 9 months, despite conservative treatment that includes 1 or combinations of: 1. physical therapy 2. splinting 3. nsaids exclusion criteria: subjects with any of the following will be excluded from study participation: 1. subject has undergone previous corticosteroid injection therapy to the affected elbow in less than 6 months prior to enrolment. 2. subjects unwilling or unable to discontinue use of pain medication (opiate or nsaid) from at least 1 week prior to investigational medicinal product (imp) administration. 3. subject has received previous platelet-rich plasma (prp) injection to the affected elbow. 4. subject uses or has recent use of medications known to affect the skeleton (e.g., glucocorticoid usage \>5 mg/day, fluoroquinolone antibiotics). 5. subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis.
selective ultrasound screening for ddh 1991-2006

Conditions: Developmental Dysplasia of the Hip

Summary: early treatment is considered essential for developmental dysplasia of the hip (ddh), but the choice of screening strategy is debated. the investigators evaluated the effect of a selective ultrasound (us) screening programme. all infants born in a defined region during 1991-2006 with increased risk of ddh, i.e. clinical hip instability, breech presentation, congenital foot deformities or a family history of ddh, were subjected to us screening at age one to three days. severe sonographic dysplasia and/or dislocatable/dislocated hips were treated with abduction splints. mild dysplasia and/or pathological instability, i.e. not dislocatable/dislocated hips were followed clinically and sonographically until spontaneous resolution, or until treatment became necessary. the minimum observation period was 5,5 years.

of 81564 newborns, 11539 (14,1%) were identified as at risk, of which 11190 (58% girls) were included for further analyses. of the 81564 infants, 2433 (3•0%) received early treatment; 1882 (2,3%) from birth and 551 (0,7%) after six weeks or more of clinical and sonographic surveillance. another 2700 (3,3%) normalised spontaneously after watchful waiting from birth. twenty-six infants (0,32 per 1000, 92% girls, two from the risk group) presented with late subluxated/dislocated hips (after one month of age). another 126 (1,5 per 1000, 83% girls, one from the risk group) were treated after isolated late residual dysplasia. thirty-one children (0,38 per 1000) had surgical treatment before age five years. avascular necrosis was diagnosed in seven of all children treated (0.27%), four after early and three after late treatment. interpretation the first 16 years of a standardised selective us screening programme for ddh resulted in acceptable rates of early treatment and us follow-ups, and low rates of late subluxated/dislocated hips compared to similar studies.

Eligibility criteria:
inclusion criteria: * born at haukeland university hospital january 1991-december 2006 exclusion criteria: * children with ddh due to neuromuscular syndromes were excluded.

Keywords: developmental dysplasia of the hip, ddh, avascular necrosis, late detected cases