Kornimate/medical-research-clean huggingface dataset:
european non-interventional study on refractory epilepsy with developmental delay

Conditions: Refractory Epilepsy; Development Delay

Summary: this is a multinational, multicentre, non-interventional, retrospective data collection (manual medical chart review).

this is a multinational, multicentre, non-interventional, retrospective data collection (manual medical chart review). the identified local site staff (or trained independent data abstractors, if requested by the site) will review the medical records of all participants meeting the eligibility criteria, who have provided a signed inform consent form (icf) for data collection and analysis. for participants who are less than 18 years of age, in addition to the assent form being signed by the participant, an informed consent would be obtained from parental or legally authorized representative. in line with the retrospective nature of the study: there is no assignment of a participant to a particular therapeutic strategy; no additional diagnostic or monitoring procedures shall be applied to the participants; epidemiological methods shall be used for the analysis of collected data; the prescription of any medication for the treatment of the epileptic syndrome occur before the collection of the data in this study and is clearly separated from the decision to include the participant in the study.

Eligibility criteria:
inclusion criteria: * age ≥2 years * disease history of at least 24 months from date of first seizure * medical history of epilepsy associated with moderate to severe intellectual disability, cognitive developmental delay or cognitive regression * medical history of onset of seizures in early childhood (≤ 8 years) * failure of adequate trials of two tolerated and appropriately chosen and used anti-epileptic drug (aed) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom * ongoing refractory epilepsy * mri and eeg data are available for the participant * participants (or their parents/ legal representative as appropriate) have provided written informed consent / assent form to collect the data specified. exclusion criteria: * normal cognitive development. * any acute symptomatic seizures in participants with underlying developmental delay. * any progressive intellectual and neurological deterioration conditions.

Keywords: observational retrospective
to validate point mini user needs

Conditions: Amputation; Traumatic, Hand; Amputation, Congenital

Summary: the objective of the device feasibility study will be to validate the user needs of the point mini system. this study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss will be asked to perform several tasks. successful completion of a task results in a fulfilled user need. failure to complete a task results in an unfulfilled user need.


Eligibility criteria:
inclusion criteria: * partial hand loss with at least index and/or middle fingers loss at the mcp level * intact thumb with full range of motion * fluent in english * between the ages of 5 and 15 years exclusion criteria: * patients with a residual limb that is unhealed from the amputation surgery * unhealed wounds * significant cognitive deficits as determined upon clinical evaluation * significant neurological deficits as determined upon clinical evaluation * significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation * uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation * serious uncontrolled medical problems as judged by the project therapist
corneal cross-linking and refractive surface ablation in patients with asymmetric corneas

Conditions: Surgical Procedure, Unspecified

Summary: the purpose of this study is to evaluate safety and efficacy of corneal cross-linking and photorefractive keratectomy for refractive correction in patients with bilateral asymmetric topography.

corneal cross-linking (cxl) by the photosensitizer, riboflavin (vitamin b2), and ultraviolet a (uva) light increases corneal rigidity and has been described as an effective method for stabilizing the cornea in patients with progressive keratoconus. the photochemical reaction in this procedure causes the collagen to form additional covalent connections between its fibers, which stabilizes the stromal collagen fibers, improving the collagen's structure and the cornea rigidity. it is a relatively safe procedure with low rates of complications photorefractive keratectomy (prk) it is a traditional technique for refractive surgery. in cases of irregular corneas or re-operation normally the favorite ablation profile chosen is the guided surgery, topography guided or wavefront guided, showing better results. this technique is also relatively safe procedure with low rates of complications. one of the most unwanted complications of this surgery and also rare is corneal ectasia. combining prk and cxl is already done in patients with keratoconus and suspected keratoconus. this combined procedure uses the principle that cxl stiffen the cornea making it possible to reduce corneal thickness with prk without weakening corneal strength. literature show better results, in keratoconus, with simultaneous procedures. guedj et al performed prk in keratoconus suspects and within 5 years he did not found any corneal ectasia.

Eligibility criteria:
inclusion criteria: * bilateral asymmetric topography with inferior steepening * corneal thickness of 440 micra at the thinnest point * inferior-to-superior index (i-s) between 1.0d and 1.4d * maximum keratometric steepness \< 47.00d * stable refraction more than 1 year. exclusion criteria: * forme fruste keratoconus and keratoconus * previous eye surgery * previous eye trauma * confirmed pregnancy

Keywords: refractive surgical procedures photorefractive keratectomy aberrometry
safety assessment of t4090 eye drops in ocular hypertensive or glaucomatous patients.

Conditions: Glaucoma; Ocular Hypertension

Summary: the study purpose is to evaluate the safety of t4090.


Eligibility criteria:
inclusion criteria: * informed consent dated and signed. * both eyes diagnosed open-angle glaucoma or ocular hypertension exclusion criteria: * history of trauma, infection, clinically significant inflammation within the previous 6 months * known or suspected hypersensitivity to one of the components of the investigational medicinal product(s) * pregnancy or breast-feeding
the efficacy and safety of ta1 for sepsis

Conditions: Sepsis

Summary: the purpose of this study is to determine whether thymalfasin is safe and effective in patients who have sepsis

our previous study reported that the 7-day treatment of ta 1 demonstrated positive active effect as to the 28-day all-cause mortality and the augmentation of mhla-dr (monocyte human leukocyte antigen dr) at the secondary endpoint. therefore, we intend to verify this finding through a randomized, double-blind and placebo-controlled clinical trial and the trail will include subjects with impaired immunologic functions.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤85; 2. signed informed consent signed; 3. diagnosed as a sepsis according to the sepsis diagnosis criteria in "surviving sepsis campaign: international guidelines for management of sepsis and septic shock: 2016": at least one acute severe organ dysfunction related to sepsis, and total sofa scores ≥2; 4. infected focus are confirmed or suspected and satisfy at least one of the followings: 1. pathogenic microbes grow in blood or at aseptic locations 2. presence of abscess or partially-infected tissues 3. suspected infection identified by at least one of the following evidences: * leukocytes at normal aseptic locations * organic perforation (confirmed by imaging evidence, examination result or intestinal content leak during drainage) * imaging evidence of pneumonia accompanied by purulent secretion * related syndromes with high infection risk (cholangitis for example) exclusion criteria: 1. history of organ or bone marrow transplantation; 2. acute phase connective tissue diseases (such as rheumatoid diseases, systemic lupus erythematosus) and glomerulonephritis; 3. under pregnancy or in suckling period; 4. presence of hematologic malignancies; 5. the patient has received radiotherapy or chemotherapy within the past 30 days; 6. the patient is inclined to stop or cancel the artificial intervention for sustaining life, in other words, has abandoned treatment; 7. the patient has in the past 30 days received immunosuppressive drugs (tripterygium wilfordii, cellcept, cyclophosphamide, fk506, etc.) or received continuous treatment with prednisolone \>10 mg/day (or the same dose of other hormones); 8. the patient could die of an underlying disease within 28 days or is in end-stage; 9. the patient has undergone cpr in the 72 hours before signing the informed consent and the neuromechanism has not fully recovered (gcs score ≤ 8); 10. the patient has in the past 30 days used thymosin or undergone certain clinical drug or instrument trials which could affect immunity (such as xuebijing, ulinastatin and crrt); 11. the patient has a medical history of allergy or intolerance to thymalfasin; 12. the source of infection cannot be contained, for example: infections that cannot be handled during surgical operations and drainage.

Keywords: thymosin alpha 1; thymalfasin; sepsis; immunodepression
dexmedetomidine for sepsis in icu randomized evaluation trial

Conditions: Sepsis

Summary: background: dexmedetomidine, a highly selective arfa2-adrenergic agonist, is known to be a unique sedative agent which causes less acute tolerance, drug addiction and withdrawal compared with gamma-aminobutyrate (gaba) agonists. dexmedetomidine was approved for short-term icu sedation in 2004 in japan, and it has been used particularly for surgical icu patients. in august 2010 dexmedetomidine was approved in japan for sedation lasting more than 24 hours. recent evidence demonstrated that dexmedetomidine has organ protective effects including neuroprotection, cardioprotection, renal protection, gastrointestinal tract action, and anti-inflammatory action. dexmedetomidine was shown to significantly decrease the infarct size in isolated rat hearts. additionally, dexmedetomidine exhibited a preconditioning effect against ischemic injury in hippocampal slices, and this result was considered an apoptosis suppression effect of dexmedetomidine. aydin c et al reported that dexmedetomidine enhanced the spontaneous contractions of the ileum in peritonitis rats compared with propofol and midazolam. taniguchi and colleagues demonstrated that dexmedetomidine reduced high mortality rates and the plasma cytokine concentrations, interleukin-6 and tumor necrosis factor alpha in endotoxemic rats. a meta-analysis has shown that perioperative alfa2-adrenergic agonists, including dexmedetomidine infusion, decreased cardiovascular events on patients undergoing cardiac surgery. dexmedetomidine treated patients undergoing thoracotomy indicated increase in urine output, reduction in serum creatinine, and the suppression of diuretics in a randomized placebo-controlled double-blind study. septic patients receiving dexmedetomidine had improved 28-day mortality rates compared with septic patients receiving lorazepam in a sub-group analysis of mends randomized controlled trial. these positive effects of dexmedetomidine on the cardiovascular system, neurons, kidneys, gastrointestinal tract action, and an anti-inflammatory action, are expected to improve mortality in septic patients. however, large clinical research studies have not been conducted yet. we designed and conducted the desire trial (dexmedetomidine for sepsis in icu randomized evaluation trial) to test a hypothesis that dexmedetomidine may improve clinical outcome and has these organ protective effects on septic patients. objective: to determine whether dexmedetomidine improves clinical outcome and has organ protective effects on septic patients.


Eligibility criteria:
inclusion criteria: * adult * transferred to icu * anticipation of a need for mechanical ventilation at least 24 hours exclusion criteria: * sever chronic liver disease (child b or c) * acute myocardial infarction, heart disease (nyha 4) * drug dependence, alcoholism * psychological illness, severe cognitive dysfunction * patients who have allergy for dexmedetomidine * attending physician's decision

Keywords: dexmedetomidine sepsis mortality duration of mechanical ventilation organ failure
stress and opioid misuse risk: the role of endogenous opioid and endocannabinoid mechanisms

Conditions: Opioid Use Disorder; Back Pain; Stress

Summary: the purpose of this study is to see how stress influences the effects of opioid pain medications often used to help relieve back pain. the study will help to learn more about how high stress levels could increase risk for pain medication misuse.

the purpose of this project is to advance mechanistic knowledge of how stress impacts differential opioid analgesic responses that enhance risk for opioid use disorder (oud), potentially informing development of data-driven precision pain medicine algorithms to mitigate opioid related risks. the study aims to determine whether subjective and physiological stress-related measures are associated with analgesic and misuse-relevant subjective responses to placebo-controlled oxycodone administration. the study also aims to evaluate associations between stress-related measures and both endogenous opioid (eo) function and endocannabinoid (ec) levels and to test whether eo and ec mechanisms contribute to associations between stress-related measures and oxycodone responses using a mixed between/within-subject design, the study will obtain baseline assessment of stress related markers followed by 3 laboratory sessions with assessment of endocannabinoids, back pain assessment, and exposure to standardized evoked pain stimuli after administration of placebo, naloxone, and oxycodone.

Eligibility criteria:
inclusion criteria: * intact cognitive status and ability to provide informed consent * ability to read and write in english sufficiently to understand and complete study questionnaires (which are only validated in english) * age 18 or older and * presence of persistent daily low back pain of at least three months duration and of at least a 3/10 in average intensity exclusion criteria: * history of renal or hepatic dysfunction * reports of current or past alcohol or substance abuse or treatment for such condition * a reported history of ptsd, psychotic, or bipolar disorders * chronic pain due to malignancy (e.g., cancer) or autoimmune disorders (e.g., rheumatoid arthritis, lupus) * reports of recent benzodiazepine use (confirmed via rapid urine screening prior to each lab session) * any medical conditions (e.g., significant cardiovascular disease) that the study physician feels would contraindicate participation in the lab stressors * reported daily opiate use within the past 6 months, or use of any opioid analgesic medications within 3 days of study participation (confirmed through rapid urine screening prior to each lab session) * pregnancy (females only, to avoid fetal drug exposure - pregnancy tests conducted prior to each lab session to confirm eligibility) * prior allergic reaction/intolerance to oxycodone or its analogs
clinical trial in china for aortic valve stenosis

Conditions: Diseases of Aortic Valve; Aortic Stenosis Disease

Summary: the purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis disease who are at high or prohibitive surgical risk.

this study is a prospective, multicenter, single-arm, clinical study.

Eligibility criteria:
inclusion criteria: 1. age ≥ 65; 2. patients with symptomatic aortic valve regurgitation diseases, and new york heart association (nyha) ≥ ii; 3. subject must have society of thoracic surgeons (sts) score ≥8% or have been evaluated as inoperable by the surgical team \[defined as rate of death #50% within 30 d post-surgery or accompanied with irreversible occasions of other factors prevent surgeries (such as heavily calcified (porcelain) ascending aorta, weakness, chest malformation, liver dysfunction, pulmonary dysfunction and so on ); (note: age of inoperable patients can be expanded to ≥ 50); 4. aortic valve anatomy is suitable for tavr evaluated by the investigators; 5. patients who can sign informed consent form, and are willing to accept relevant examinations and clinical follow-ups. exclusion criteria: 1. active endocarditis; 2. acute myocardial infarction or coronary revascularization occurred within 1 month before procedure; 3. cerebrovascular accident (cva) occurred within 30 days before procedure; 4. the echocardiogram indicates the presence of mass, thrombus or vegetation in left ventricle and left atrium; 5. hypertrophic obstructive cardiomyopathy; 6. other valve diseases that need interventions; 7. previous aortic valve implantation (mechanical or biological); 8. allergic to nickel-titanium alloys or contrast agents or cattle-originated products; 9. known allergy or contraindication to all anticoagulation, or anticoagulation can not be used during the tavr; 10. in presence one of the following (from selection to the day of procedure index): a other diseases that may shorten life expectancy to less than 12 months (recurrent or metastatic cancer, congestive heart failure); b drug abuse (such as cocaine, heroin and so on); c planned additional operations that may result in incompliance or data confusion; 11. stenosis of common carotid artery, internal carotid artery or vertebral artery #70%; 12. severe left ventricular dysfunction, left ventricular ejection fraction (lvef) \<20%; 13. hepatic encephalopathy or acute active hepatitis; 14. receiving hemodialysis; 15. bleeding tendency or history of coagulopathy or refuse to receive transfusion; 16. active gastrointestinal (gi) ulcer or bleeding; 17. severe dementia; 18. patients who need emergency surgery for any reason; 19. patients are participating in other drugs or medical devices clinical trial; 20. pregnant or plan to be pregnant, or are taking estrogen or estrogen-like drugs (women suspected of pregnancy must have a negative serum or urine test for human villous gonadotropin prior to enrollment in the study); 21. other inappropriate occasions according to the investigators.
cognitive-behavioral intervention to increase tummy time practice and maintain healthy weight in infants

Conditions: Obesity/therapy; Prevention and Control

Summary: childhood obesity is a serious health problem worldwide evidenced by its high prevalence, specifically for the age group called the first 1000 days of life. this condition has serious consequences on the health of infants who suffer from it, being a precursor for the development of diseases such as diabetes and hypertension. for this reason, international organizations have proposed physical activity as a priority component for the prevention of childhood obesity. the objective of this study is to evaluate the preliminary effect of an intervention based on social cognitive theory aimed at mexican mothers with children under six months of age to increase the practice of tummy time and maintain the healthy weight of the infant compared to usual care. the methodology will be a pilot randomized clinical trial with randomization to the experimental group and control group, the intervention will be with a single-blind approach and repeated measurements. a non-probabilistic sampling will be used for convenience and the sample will be 144 participants who will be dyads of mothers and children who are in the immediate postpartum hospitalized in a second-level hospital in mexico.


Eligibility criteria:
inclusion criteria: * mother-child dyads that are in the postpartum * mothers who declare that they know how to read and write in spanish * have an electronic device (cell phone, tablet or computer), * have an internet connection. * have the social network whatsapp® * agree to participate voluntarily evidenced by informed consent will be considered exclusion criteria: * women who report having received information about tt one month before the intervention. * women who are actively participating in programs related to early stimulation * who declare that they have a premature infant born before 37 sdg, * who has a low birth weight \&lt;2,500g, * who has a medical condition or complication at birth that impacts their physical mobility and * who has chronic health problems or congenital anomalies.

Keywords: infants prone position health behavior mothers
metabolic syndrome, inflammation, and risk of cognitive decline

Conditions: Cognitive Decline

Summary: the purpose of this study is to determine if the metabolic syndrome is a risk factor for cognitive decline and if this association is modified by inflammation.

the metabolic syndrome is a clustering of several commonly occurring disorders that include abdominal obesity, high triglycerides, low hdl cholesterol, high blood pressure, and insulin resistance. this study was conducted to determine if, as hypothesized, the presence of the metabolic syndrome is associated with more cognitive decline and greater risk of developing cognitive impairment, and whether this risk is affected by the level of inflammatory markers in the blood. this 5-year prospective observational study was conducted from 1997 to 2002 at community clinics in two locations. a total of 2632 black and white participants, aged 70 to 79 years, were recruited from the 3075 participants in the health, aging and body composition (abc) study conducted during the same period. participants were screened for presence of metabolic syndrome, cognitive status, inflammatory markers, and a clinic examination was administered, when the study began and at the year 3 and 5 follow-up visits.

Eligibility criteria:
inclusion criteria: * aged 70 to 79 * white or black * community-dwelling in memphis, tn or pittsburgh, pa vicinity * well-functioning (no difficulty in walking a quarter of a mile or going up 10 steps without resting) exclusion criteria: * any difficulty with activities of daily living * clinical dementia * inability to communicate with interviewer * intention of moving out of vicinity in the next year * active treatment for cancer in the previous 3 years * participation in a trial involving a lifestyle intervention

Keywords: metabolic syndrome alzheimer's disease cognitive impairment inflammation