Kornimate/medical-research-clean huggingface dataset:
open-label extension study to assess the safety and seizure frequency associated with lacosamide for primary generalized tonic-clonic seizures in subjects with epilepsy

Conditions: Epilepsy

Summary: the purpose is to obtain data on the safety and seizure frequency associated with long-term oral lacosamide for uncontrolled primary generalized tonic-clonic (pgtc) seizures in subjects with idiopathic generalized epilepsy. additionally, to allow subjects who have completed sp0961 (nct01118949) to continue to receive lacosamide.


Eligibility criteria:
inclusion criteria: * subject completed the sp0961 (nct01118949) study * subject is expected to benefit from participation in an open-label extension study with lacosamide, in the opinion of the investigator exclusion criteria: * subject meets the withdrawal criteria for sp0961 (nct01118949) or is experiencing an ongoing serious adverse event (sae)

Keywords: primary generalized tonic-clonic (pgtc) seizures absence seizures myoclonic seizures idiopathic generalized epilepsy (ige)
narrative-based card game in improving spiritual well-being among chinese childhood cancer patients

Conditions: Pediatric Cancer

Summary: cancer as a life-threatening disease can trigger children's unique spiritual needs. unmet spiritual needs can cause low level of spiritual well-being, which is a central component for the overall quality of life (qol) of cancer patients and was inversely associated with depressive symptoms, anxiety and a low level of hope. however, there has been no intervention focused on improving spiritual well-being among childhood cancer patients. evidence from adult cancer patients suggests that narrative intervention can effectively address spiritual needs and improve spiritual well-being, while playing card game can combine an emotionally sensitive topic with an enjoyable activity, providing insight into the development of narrative-based card games for childhood cancer patients. the first objective of this pilot study is to assess the feasibility of narrative-based card game among chinese childhood cancer patients. the second objective is to evaluate the preliminary effects of narrative-based card game intervention on spiritual well-being, hope, anxiety, depressive symptoms, and qol of childhood cancer patients at postintervention and at 1-, and 3-month follow-up postintervention.

a pilot randomized controlled trial will be carried out. a convenience sample of 60 children with cancer will be recruited. subjects who are randomized into the experimental group which will participate the narrative-based card game or into the control group which will play a puke card game only for entertainment purpose, that mimics the time and attention of the intervention. feasibility measures (i.e., the eligibility rate, consent rate, randomization rate etc.) will be collected immediately after the completion of the intervention. also, all subjects will be asked to complete structured questionnaires to assess their spiritual well-being, hope, anxiety, depressive symptoms, and qol at postintervention and at 1-, and 3-month follow-up postintervention.

Eligibility criteria:
inclusion criteria: (1) age 12-17 old (2) diagnosed with any type of cancer and currently undergoing active treatment (3) knowing about their cancer diagnosis, and (4) able to communicate with chinese. - exclusion criteria: (1) those with identified cognitive and/or behavioural problems which affected their verbal communication; (2) those with advanced cancer, including nonresponsive to treatment, stage iv solid tumor that had recurred or progressed as defined, or physician estimated poor prognosis of \<60%. -

Keywords: spiritual well-being intervention childhood cancer patients
sacral neuromodulation as treatment for chronic constipation

Conditions: Chronic Constipation

Summary: the objective of this study is to study if low level laser therapy will do more good than harm for patients with severe chronic refractory constipation. it is a proof of concept study without a placebo arm.

patients will be offered the therapy if high-resolution colonic manometry has shown that coordination between colon motility and recto-anal activity is abnormal and that autonomic nervous system assessment suggests a dysfunction of communication between the spinal cord autonomic nerves and the colon-rectum-anus. the therapy consists of a 3 week treatment with a total of 8 sessions of low level laser therapy. effects will be assessed using symptom and quality of life questionnaires and physiological assessments of colon and pelvic floor function, at 4 weeks and 12 weeks.

Eligibility criteria:
inclusion criteria: * patients with severe chronic refractory constipation * must have undergone high resolution colonic manometry that shows abnormal coordination between colonic motility and ano-rectal function. exclusion criteria: * pregnant patients * known malignancies in the area of treatment * active bleeding in area of treatment * active deep vein thrombosis * when tatoos are present at area of treatment * patients that are light sensitive * patients who take nsaids or steroids.

Keywords: constipation spinal cord injury back pain high-resolution colonic manometry anorectal manometry
risk of radiation-induced cataracts among interventional cardiology staff

Conditions: Cataract

Summary: the goal of the present study is to evaluate the prevalence of radiation-associated lens opacities among interventional cardiology staff members (such as physicians, technicians, and nurses) and determine its association with occupational history. the hypothesis of the study is that interventional cardiology staff will have high prevalence of radiation-induced lens opacities, which will be higher than non-interventional cardiology staff and will correlate with the estimated cumulative lifetime dose.

this is an observational, cross-sectional study to evaluate the prevalence of posterior subcapsular cataract (psc) and its association with prior occupational history of radiation exposure. participants of the society of cardiovascular angiography and interventions 2016 scientific sessions to be held in orlando, fl may 4th to may 7th, will be invited to participate. both interventional cardiology and non-interventional cardiology staff and non-clinical participants will be assessed. written informed consent will be obtained from all participants. they will subsequently be asked to complete a questionnaire on occupational radiation exposure, workplace practices and medical history followed by dilated slit lamp examination using a modified merriam-focht scoring system.

Eligibility criteria:
inclusion criteria: * willing to undergo eye examination * participant at society of cardiovascular angiography and interventions 2016 scientific sessions exclusion criteria: * known pre-existing severe eye disease, such as glaucoma * prior lens surgery * known hypersensitivity to the mydriatic agents * any other conditions that may preclude participation/ performance of slit lamp eye examination/ use of mydriatics, in the opinion of the investigator

Keywords: radiation exposure cardiac catheterization
transformation of somatosensory and visual coordinate systems

Conditions: Stroke

Summary: manipulation of object is a multisensory experience that includes tactile motion between the object and the fingerpad, visual motion elicited by the motion the object and the movement of the hand, and the active motor commend to control upper limb and hand conformation. it remains to be determined how such a complex interaction between touch and vision could be achieved effortlessly. in the present study, we will investigate how the motion information is transformed between touch and vision using the most novel approaches in human psychophysics, neuropsychology and monkey neurophysiology. specifically, we will present tactile motion on primate fingerpads using a recently developed ball stimulator with a design in which we vary the direction of motion with respect to the skin surface and also vary the hand conformation and position. this setup allows us to systematically sample the possible scenarios involving coordinate transformation between the somatosensory and visual systems in conditions that could occur in hand exploration and object manipulation in daily life. we will present these tactile stimuli on normal human subject as well as stroke patients such as patients with spatial hemineglect. finally, we will record from macaque monkeys in cortical areas that are thought to underlie the transformation of coordinates, such as the primary somatosensory cortex and posterior parietal cortex. the results of the present study will contribute to the understanding of multisensory integration and the rehabilitation for patients with impaired use of spatial information.


Eligibility criteria:
for stoke patients inclusion criteria: * stroke patients * stable medical condition * can cooperate in evaluation exclusion criteria: * peripheral neuropathy * limb ambulation

Keywords: coordinate system normal
prognosis analysis of elderly donor liver in liver transplantation

Conditions: Liver Transplantation; Hepatocellular Carcinoma; Survival

Summary: based on the follow-up data of elderly donation after cardiac death(dcd) donor liver transplant recipients from the cltr, a database and official website for national data gathering. patients who met the enrollment criteria were screened for postoperative complications and survival for statistical analysis to understand the prognosis of patients and analyze the risk factors affecting their prognosis.

since the chinese organ donation system was developed in 2015, donation has been the only source of organs for transplantation in china. adult patients (age 18 or older) who underwent lt using grafts from deceased donors between january 1st, 2015, and december 31st, 2018, were retrospectively identified using the cltr, a database and official website for national data gathering. based on the follow-up data of elderly dcd donor liver transplant recipients from the cltr, a database and official website for national data gathering. patients who met the enrollment criteria were screened for postoperative complications and survival for statistical analysis to understand the prognosis of patients and analyze the risk factors affecting their prognosis.

Eligibility criteria:
inclusion criteria: 1. recipient age ≥ 18 years and \< 65 years. 2. donor age ≥ 18 years. exclusion criteria: 1. recipient age \<18 years or ≥65 years. 2. donor age \<18 years. 3. patients who died within 30 days after transplantation. 4. secondary liver transplantation. 5. multiple organ transplantation. 6. patients with incomplete data or failed follow-up.

Keywords: elderly donor liver transplantation donation after cardiac death hepatocellular carcinoma survival
effects of otago exercise program in falls, balance and physical performance in stroke patients

Conditions: Stroke

Summary: this study aims to determine the effects of the otago exercise program (oep) on falls and balance as well as overall physical performance. participants will be divided into two groups; control and intervention group. it is a week-long study, the participants will be assessed through the berg balance scale (bbs), time up and go (tug) and fugl-meyer assessment (fma).

the previous literature suggested that the otago exercise showed significant improvement in terms of fall and balance. most of the studies were conducted on the elderly population but limited studies are available regarding stroke. this study will look at the effect of otago exercise on stroke patients. the otago exercise consists of 17 exercises; strengthening and balancing exercises. the participants will receive otago exercise and routine physiotherapy treatment for six weeks. the participants will go through three assessments; baseline assessment, after 3 weeks assessment and final assessment. for association, a mixed method anova test will be used.

Eligibility criteria:
inclusion criteria: * ischemic or hemorrhagic stroke * medically stable patients with acute to subacute level of stroke recovery (\< 6 month). * patients 40 plus age * berg balance scale \ 20 score * tug test scoring \>20 sec exclusion criteria: * participants having cognition problem or language barrier * physical disability (fracture or amputation) other than stroke * previous surgery 6 weeks * cardiovascular and pulmonary disease

Keywords: stroke cardiovascular attack otago exercise program berg balance scale time up & go test fugl-meyer assessment
annual study to investigate inactivated virosomal influenza vaccine for the 2006/2007 influenza season in europe.

Conditions: Healthy Volunteers

Summary: influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. in europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. the current study is a phase iiia clinical trial with a commercially available virosomal vaccine (invivac®) supplied in pre filled syringes. it is part of the ongoing clinical trial program for invivac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza virosomal vaccine in two groups of healthy subjects: subjects aged \>= 18 and \ = 61 years of age (elderly).


Eligibility criteria:
inclusion criteria: * signed and dated informed consent. * healthy and aged \>= 18 and \ = 61 years of age. * mental health good enough to understand the study and the informed consent form and to fill in the questionnaire." exclusion criteria: * known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. * having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways. * having experienced a documented serious systemic reaction after previous influenza vaccination. * having an auto-immune disorder (e.g. ra, sle, auto-immune thyroid disorders) or other disorders affecting the immune system, taking immunosuppressive medication (such as systemic corticosteroids) including the four weeks preceding the start of the study (date of informed consent), or having a disease in a terminal stage. * having received vaccination against influenza within the previous six months before visit 1. exclusion criteria only for female subjects aged \>=18 and \<=60 years and of childbearing potential: * pregnancy (positive urine pregnancy test on day 1) or breastfeeding. * absence of use of a medically accepted method of birth control (i.e. oral contraceptive, intra uterine device, double barrier method).

Keywords: influenza, vaccine, chmp criteria
management and short term outcome of traumatic wounds in the emergency department

Conditions: Wound Heal

Summary: identify the risk factors for complications as well as study the evolution of wounds sutured in the emergency room towards complications such as superinfections, necrosis, disunity of the stitches linked to inadequate initial care.

all traumatic injuries should be considered contaminated upon presentation to the emergency room. this is why the main objective of this study was to describe the attitude of patients towards their wounds, to identify the risk factors for complications as well as to study the evolution of sutured wounds in the emergency room towards complications such as superinfections, necrosis, disunity of stitches linked to inadequate initial treatment. this is a prospective, observational, monocentric study carried out in the emergency services of the fattouma bourguiba hospital in monastir.

Eligibility criteria:
inclusion criteria: * patients who presented to the ambulatory emergency circuit of the eps fattouma bourguiba monastir having as main reason for consultation an acute suturable wound. exclusion criteria: * wounds requiring surgical treatment * septic wounds * chronic lesions * vascular wounds * patients who did not consent to the protocol.

Keywords: wounds superinfections stitches
a multi-center study to evaluate the safety and efficacy of intravenous infusion of human placenta-derived cells (pda001) for the treatment of adults with moderate-to-severe crohn's disease

Conditions: Crohn's Disease

Summary: the primary objective of the study is to estimate the treatment effect of pda001 (evaluating 3 different pda001 dosings) versus placebo in subjects with moderate-to-severe crohn's disease. the secondary objective of the study is to assess the safety and tolerability of pda001 versus placebo in the above-mentioned patient population.


Eligibility criteria:
inclusion criteria: 1. males and females ages 18-75 years 2. understand and voluntarily sign an informed consent 3. able to adhere to the study visit schedule and other protocol requirements 4. minimum weight of 50 kg 5. a female of childbearing potential (fcbp)† must have a negative urine pregnancy test at screening (visit 1) and immediately prior to all doses of ip. in addition, sexually active fcbp must agree to use two of the adequate forms of contraception methods for the duration of the study and the follow-up period. a fcbp must agree to have pregnancy tests at least every 4 weeks during the study. males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with fcbp for the duration of the study and the follow-up period. 6. subject must have inflammatory cd 6 months prior to treatment and have confirmation of ongoing disease activity by colonoscopy or (other method) at screening 7. subject must have a cdai score \> 220 and \< 450 as assessed between visit 1 and visit 2 8. the subject must have failed, i.e., had an inadequate response or lost response (recurrence of symptoms) to an agent, or documented intolerance to an agent at any time exclusion criteria: 1. any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study 2. any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study a female of childbearing potential is a sexually mature woman who: 1. has not undergone a hysterectomy or bilateral oophorectomy 2. has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

Keywords: human placenta-derived cells for the treatment of moderate-to-severe crohn's disease
profess - prevention regimen for effectively avoiding second strokes

Conditions: Stroke

Summary: the purpose of the trial is to determine if extended-release dipyridamole + aspirin \[aggrenox, asasa ntin\] is superior to clopidogrel \[plavix\], and if telmisartan \[micardis, gliosartan, kinzal, kinzalm ono, predxal, pritor, samertan, telmisartan\] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one.


Eligibility criteria:
inclusion criteria: male or female subjects 55 year or older who have suffered an ischemic stroke within the past 90 days and who meet all other inclusion criteria. include also patients of ages 50 - 54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at least two of the following additional risk factors: * diabetes mellitus * hypertension (systolic bp ¿ 140 or diastolic bp ¿ 90) * smoker at time of qualifying stroke * obesity (bmi\>30; bmi=weight (kg)/\[height (m)\]2) * previous vascular disease (stroke, mi, or peripheral arterial disease prior to qualifying stroke) * end-organ-damage (retinopathy, lvh, or microalbuminuria) * hyperlipidemia exclusion criteria: hemorrhagic stroke (must be ruled out by imaging);unable to give informed consent; known brain tumor, severe renal or hepatic insufficiency, current active peptic ulcer disease, severe coronary artery disease including unstable angina pectoris or an mi within the previous 3 months,or history of a hemostatic disorder or systemic bleeding ;hyperkalemia;uncorrected volume or sodium depletion; pre-stroke history of dementia;modified rankin score greater than 4;qualifying stroke induced by surgical or cardiovascular procedure;uncontrolled hypertension at entry above 180/110 mmhg (goal bps are lower); sbp 120 mmhg or less for hospitalized patients; currently taking an arb and not able or willing to switch to alternative; required or planned continuing treatment with antithrombotics or anticoagulants including heparin or warfarin or non-study platelet inhibitors; syndrome of asthma, rhinitis and nasal polyps;scheduled for major surgery, carotid endarterectomy, or carotid angioplasty (4 weeks post surgery is allowed);unlikely to be released from hospital following the qualifying stroke or presence of a severe disability likely to lead to being bedridden or demented or a non-vascular disease or condition which makes it unlikely that the patient will survive to the end of the trial; history of thrombocytopenia or neutropenia.
can the electronic nose smell covid-19?

Conditions: SARS-CoV Infection; Covid19

Summary: infection with sars-cov-2 causes corona virus disease (covid-19). the most standard diagnostic method is reverse transcription-polymerase chain reaction (rt-pcr) on a nasopharyngeal and/or an oropharyngeal swab. the high occurrence of false-negative results due to the non-presence of sars-cov-2 in the oropharyngeal environment renders this sampling method not ideal. therefore, a new sampling device is desirable. this proof-of-principle study investigates the possibility to train machine-learning classifiers with an electronic nose (aeonose) to differentiate between covid-19 positive- and negative persons based on volatile organic compounds (vocs) analysis. methods: between april and june 2020, participants were invited for breath analysis when a swab for rt-pcr was collected. if the rt-pcr resulted negative, presence of sars-cov-2 specific antibodies was checked to confirm the negative result. all participants breathed through the aeonose for five minutes. this device contains metal-oxide sensors that change in conductivity upon reaction with vocs in exhaled breath. these conductivity changes are input data for machine-learning and used for pattern recognition. the result is a value between -1 and +1, indicating the infection probability.


Eligibility criteria:
inclusion criteria: * participants of whom an oropharyngeal or nasopharyngeal swab was collected to perform rt-pcr on. exclusion criteria: * participants who were experiencing dyspnea or needed supplemental oxygen.

Keywords: electronic nose volatile organic compounds diagnosis