Kornimate/medical-research-clean huggingface dataset:
amplification of autologous epidermal cells to repair large area deep wounds

Conditions: Autologous Epidermal Cell Transplantation

Summary: autologous epidermal cell transplantation is based on the principle and technology of skin tissue engineering, and is performed by cutting small pieces of autologous skin from patients, isolating and culturing and expanding them, and then transplanting them to the patient's wounds to repair the damage.

timely wound repair has been a great challenge in the treatment of patients with large deep burns. the current conventional approach is to use autologous skin grafts, such as micro-skin grafts, stamp skin grafts, and mesh skin grafts. since there is very little normal skin left after large deep burns and the expansion of autologous skin grafts is limited (3-15 times), repeated skin grafting procedures are needed to repair the wound gradually, resulting in a long course of disease, scar growth and contracture, which seriously affects the quality of survival and even endangers life. especially for patients with very large deep burns, there is an extreme shortage of normal skin sources, so they face the dilemma of having no rice to cook and unable to repair their wounds. based on the principle and technology of skin tissue engineering, autologous epidermal cell transplantation can provide sufficient skin source for patients with large deep burns by cutting very small pieces of autologous skin (about 2-10 cm2) and expanding them by 1000-5000 times after 2-3 weeks of in vitro culture. autologous epidermal cell membranes combined with a large proportion of expanded autologous dermis (e.g. stamp skin, reticular skin) can significantly shorten the interstitial fusion time, improve the survival rate of autologous dermis transplants, and reduce scar growth after wound healing; autologous epidermal cell membranes combined with allogeneic dermis transplants can repair third-degree burn wounds, thus providing a large number of dermis sources for patients with lack of dermis sources, and has become an important treatment tool for saving the lives of patients with large deep burns. it has become an important treatment tool to save the lives of patients with large deep burns.

Eligibility criteria:
inclusion criteria: * patients with a body surface trauma of 30% tbsa or more and a wound that requires at least 2 weeks to repair as assessed by the clinician exclusion criteria: * patient body surface trauma area less than 30% tbsa

Keywords: autologous epidermal cell transplantation amplification deep wounds
restoring high dimensional hand function to persons with chronic high tetraplegia

Conditions: Spinal Cord Injuries; Tetraplegia; Quadriplegia

Summary: this study is for people who have a paralyzed arm and hand from a spinal cord injury, who have also received a recording electrode array in the brain as part of the braingate study. the study will look at the ability of these participants to control different grasping patterns of the hand, both in virtual reality and in his/her actual hand. movement of the participant's hand is controlled by a functional electrical stimulation (fes) system, which involves small electrodes implanted in the arm, shoulder and hand that use small electrical currents to activate the appropriate muscles.

this work aims to advance brain-computer-interfaces (bcls) to provide severely paralyzed persons a natural way of controlling functional electrical stimulation (fes) neuroprostheses for restoring arm and dexterous hand movements. the prospect of using bci technology for restoring arm and hand movements for reaching and grasping is based on the hypothesis that in a paralyzed human, there is a repeatable and understandable relationship between recordable brain activity and specific aspects of imagined arm movements. many previous studies have attempted to understand the relationships between brain activity and arm and hand movements in able-bodied monkeys. little is known about these same relationships in humans, and specifically within the context of trying to control an fes arm and complex hand system. this study will recruit persons who already have bci and fes systems implanted to take advantage of the possibility of recording high resolution brain activity in human participants. thus, from this study, we aim to gain a better understanding of how brain signals are related to specific aspects of arm and complex hand movements in humans with paralysis. additionally, this study will test novel implementations of complex hand movement restoration in veterans and other persons with chronic hand and arm paralysis.

Eligibility criteria:
inclusion criteria: * cognitively intact (able to follow instructions) * a spinal cord injury resulting in at least partial arm paralysis * participant in braingate2 clinical trial, having already received an intracortical array and demonstrated the ability to use the neural signals to control a cursor on a monitor. exclusion criteria: * profound visual impairments * participant in braingate2 clinical trial with insufficient recordable neural signals (such that the researchers cannot decode a movement intention command signal)

Keywords: brain computer interface electric stimulation
prevention of comorbid depression and obesity in attention-deficit/ hyperactivity disorder

Conditions: Attention-Deficit / Hyperactivity Disorder; Depression; Obesity

Summary: depression and obesity are very common among adolescents and young adults with attention-deficit/ hyperactivity disorder (adhd). however, intervention programmes to prevent these comorbid disorders rarely exist. in a pilot randomized-controlled study we test two newly developed intervention programmes that do not involve medication: bright light therapy and physical exercise. both interventions will be supported by a mobile health application to monitor and feedback intervention success and booster patients' motivation.

the risk for comorbid major depressive disorder and obesity is increased in adolescents and adults with attention-deficit/ hyperactivity disorder (adhd), and adolescent adhd predicts adults major depressive disorder and obesity. nonpharmacological interventions to prevent these comorbidities are urgently needed. bright light therapy (blt) improves day-night rhythm and is an established therapy for major depression in adolescents and adults. exercise prevents and reduces obesity in adolescents and adults and also improves depressive symptoms. interestingly, a reinforcement-based intervention using a mobile health app (m-health) resulted in improved effects on weightloss in obesity. the aim of the current pilot randomized-controlled phase-iia study is to establish feasibility and effect sizes of two kinds of interventions, blt and exercise, in combination with m-health based monitoring and reinforcement in adolescents and young adults aged 14 to 45 years old with adhd, targeting the prevention of depressive symptoms and obesity. in addition, immediate and long-term treatment effects on adhd specific psychopathology, health related quality of life, fitness and body related measures, neurocognitive functions and chronotype are explored. furthermore, saliva samples are taken in a subgroup of adult patients to explore the effects of blt and exercise on concentrations of hormones. this subgroup of adult patients will also participate in an additional neuroimaging study of the reward system in order to explore intervention effects on striatal reward reactivity.

Eligibility criteria:
inclusion criteria: * diagnosis of adhd according to diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria * stable treatment as usual comprising pharmacotherapy, group based or individual cognitive behavioural therapy (not including elements of bright light therapy or exercise) exclusion criteria: * intelligence quotient (iq) below 75 * any severe (comorbid) psychiatric disorder with necessary additional psychopharmaco or daycare/ inpatient therapy beyond treatment as usual * severe medical/ neurological condition not allowing bright light therapy or exercise * history of epilepsy * use of antipsychotics, antiepileptic or photosensitising medication * substance abuse/ dependency

Keywords: attention-deficit / hyperactivity disorder depression obesity prevention bright light therapy exercise mobile healthy system
non-invasive characterization of focal liver lesions in liver cirrhosis

Conditions: Liver Cirrhoses

Summary: this study aims to analyze non-invasive characterization focal liver lesions in patients with liver cirrhosis. the diagnostic accuracy and predictive value of non-invasive methods is studied.

this study aims to analyze non-invasive characterization focal liver lesions in patients with liver cirrhosis. the diagnostic accuracy and predictive value of non-invasive methods is studied. upon diagnosis multiparametric ultrasound imaging of the lesions as well as sarcopenia parameters are performed for characterization of the lesions. for primary endpoint the results are then analyzed with regard to diagnostic accuracy compared to gold standard (ct, mri or histology). for secondary endpoint, predictive value of the non-invasive diagnostics are analyzed with regards to mortality and response to treatment. all work up, treatment and follow up are applied in standard of care fashion.

Eligibility criteria:
inclusion criteria: * all patients with focal liver lesions and liver cirrhosis exclusion criteria: * no consent * under 18 years
gallex 9: safety and tolerability of oral tesaglitazar when added to insulin therapy in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this is a 140-week open-label, multi-center long-term extension study from gallant 9 to monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with type 2 diabetes during up to 140 weeks of treatment. the total duration, including treatment and follow-up, is 143 weeks.


Eligibility criteria:
inclusion criteria: * provision of a written informed consent * men or women who are \>= 18 years of age * female patients: postmenopausal; hysterectomized; or, if of childbearing potential, using a reliable method of birth control. * completed the last two visits of the randomized treatment period in gallant 9 exclusion criteria: * type 1 diabetes * new york heart association heart failure class iii or iv * treatment with chronic insulin * history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin) * history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, or neutropenia (low white blood cells) * creatinine levels of above twice the normal range * creatine kinase of above 3 times the upper limit of normal * previous enrollment in this long-term extension study * any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram which, in the judgment of the investigator, would compromise the patient's safety or successful participation in the clinical study

Keywords: diabetes mellitus, type ii type 2 diabetes mellitus
pct guided antibiotics use in critically ill adult patients in china

Conditions: Sepsis

Summary: procalcitonin (pct) has been widely used in the diagnosis and treatment of bacterial infectious diseases in china. the investigators aim to establish an algorithm based on brahms pct (vidas pct) for patients with severe infections or sepsis in the eicu to reduce antibiotic exposure and verify its validity in the reduction of antibiotic exposure, clinical outcomes and costs saving.

this is a multi-center prospective study that will establish 9 centers. based on preliminary on-site assessments, the centers will be grouped into two arms (soc group and pct group) according to their capacity for daily monitoring of pct. each center will enroll eicu patients with severe infections or sepsis who meet the inclusion and exclusion criteria. a total of 800 patients will be enrolled, with 400 in the pct group and 400 in the soc group. in the pct group, clinicians will prescribe pct tests every day for enrolled patients, with assigning a dedicated person monitoring the daily pct results. once the pct \ 80%, the clinicians will receive a notification and will strictly adhere to guidelines and pct values to adjust antibiotic prescriptions. the soc group will not have any intervention regarding pct prescriptions and antibiotic adjustments. the clinicians in the soc group will prescribe pct at routine frequency (usually once every 2-3 days or even longer) and adjust or discontinue antibiotics according to guidelines and their experiences. the primary and secondary endpoints will be evaluated in both groups. the primary endpoint is the total duration of antibiotic use. the secondary endpoints are the length of eicu stay and the total length of hospital stay.

Eligibility criteria:
inclusion criteria: * age≥18 * suspected or confirmed bacterial patients * stay eicu more than 3 days exclusion criteria: * age under 18 years; * pct concentration throughout the entire hospitalization less than 0.5 ng/ml ; * known pregnancy; expected stay in the eicu less than 3 days; * bone-marrow transplant or chemotherapy-induced neutropenia (\<500 neutrophils per ml); * infections for which long-term antibiotic treatment is strongly recommended (ie, infective endocarditis, osteoarticular infections, anterior mediastinitis after cardiac surgery, hepatic or cerebral abscesses, chronic prostatitis, or infection with mycobacterium tuberculosis, pneumocystis jirovecii, or toxoplasma gondii); * poor chance of survival, defined as a simplified acute physiology score (saps ii) of more than 65 points at screening; and do-not-resuscitate orders

Keywords: pct
effect of light level on stress, anxiety, psychological well-being in pregnant women

Conditions: Stress; Anxiety; Pregnant Women

Summary: to determine the effect of light level on stress, anxiety and psychological well-being in pregnant women. this research was planned as a single-blind, randomized controlled experimental type study by comparing separate groups as experiment-placebo control. data will be collected using the introductory information form, psychological well-being scale, perceived stress scale (asö/psö-14), and state-trait anxiety inventory (stai). the effect of two different amounts of light on pregnant women will be evaluated.

to determine the effect of light level on stress, anxiety and psychological well-being in pregnant women. this research was planned as a single-blind, randomized controlled experimental type study by comparing separate groups as experiment-placebo control. data will be collected using the introductory information form, psychological well-being scale, perceived stress scale (asö/psö-14), and state-trait anxiety inventory (stai). the effect of two different amounts of light on pregnant women will be evaluated.

Eligibility criteria:
inclusion criteria: * being 18 years or older, * being in the last trimester of pregnancy, * volunteering. exclusion criteria: * having any problems that prevent you from communicating
the effect of nn1250 in subjects with type 2 diabetes of different race and/or ethnic origin

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to investigate the pharmacodynamic (effect) and pharmacokinetic (exposure of drug) properties of nn1250 (insulin degludec, ideg) in subjects with type 2 diabetes of different race and/or ethnicity.


Eligibility criteria:
inclusion criteria: * either - black or african american not of hispanic or latino origin or - white of hispanic or latino origin or - white not of hispanic or latino origin * type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months * treated with insulin for at least 3 months, alone or in combination with maximum 2 oral antidiabetic drugs (oads) * body mass index maximum 40.0 kg/m\^2 exclusion criteria: * use of glp-1 receptor agonists (exenatide, liraglutide), thiazolidinediones or dipeptidyl peptidase-4 (dpp-4) inhibitors within 3 months prior to screening * history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening
citrate pharmacokinetics in critically ill liver failure patients receiving crrt

Conditions: Citrate Toxicity; Regional Citrate Anticoagulation; Liver Failure, Acute; Liver Failure, Acute on Chronic; Pharmacokinetic; Continuous Renal Replacement Therapy

Summary: citrate has been proposed as anticoagulation of choice in continuous renal replacement therapy (crrt). however, little is known about the pharmacokinetics (pks) and metabolism of citrate in liver failure patients who require crrt with regional citrate anticoagulation (rca).

this study aimed to evaluate citrate pks, metabolic complications, and clinical outcomes among critically ill acute liver failure (alf) and acute on top chronic liver failure (aclf) patients receiving crrt.

Eligibility criteria:
inclusion criteria: * critically ill alf or aclf adult patients with aki * aged ≥ 18 y old * currently receiving crrt. exclusion criteria: * severe acidosis (ph \ 7.55) * blood transfusion within 24 h prior to the study * use of citrate-containing medications * severe hypocalcemia (serum ionized calcium \< 0.8 mmol/l) * use of heparin as anticoagulation

Keywords: regional citrate anticoagulation liver failure pharmacokinetics crrt cirrhosis
postoperative blood transfusion for frail elderly with hip fracture

Conditions: Hip Fracture

Summary: elderly with hip fractures are often frail and discharged from hospital after few days of hospitalisation. hip fracture surgery is often associated with blood loss, where the patient is at risk of developing anaemia. low haemoglobin level reduces the body's oxygen transport which causes impaired functional ability and strain on vital organs. acute anaemia is worse tolerated in elderly, than in younger patients. therefore this study aims to investigate whether there are effects of an expanded indication for blood transfusion in the frail elderly.

all elderly patients aged 65 and above who are hospitalised from nursing home or sheltered housing facilities to the orthopaedic surgery ward at aarhus university hospital with hip fracture and treated operatively, are eligible for this study. according to sample size calculations 284 patients are needed. informed consent or deputy informed consent, if the patient is cognitively impaired, is needed. inclusion is dependent on a haemoglobin measure between 6 and 7 mmol/l 6 days after surgery at the latest. randomization will be computerised. randomization will determine intervention with blood transfusion and the measurement of haemoglobin is blinded to the patient, relatives, and endpoint assessor. both transfusion groups will receive blood when haemoglobin is less than 6 mmol/l, as recommended by the danish health and medicine authority. geriatric and orthopaedic team (go-team), consisting of following trained specialists: physiotherapist, nurse, and physician, will conduct medical evaluations, including blood transfusions, from admission until 30 days after surgery. the go-team will work on weekdays both at the orthopaedic surgery ward and in the patients home immediately after discharge. in accordance with aarhus blood bank's instructions, blood transfusions are given both under hospitalisation, in the nursing homes and in the sheltered housings. outcomes are functional ability and mortality during 90 days, and overall quality of life (oqol) after 30 days and 1 year. the association between physical recovery and oqol are tested.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hip fracture * surgery treatment * living in nursing homes or sheltered housing facilities * haemoglobin level between 6 and 7 mmol/l latest 6th day after surgery * written consent exclusion criteria: * active cancer * pathological fracture * the patient is against blood transfusion

Keywords: blood transfusion hip fracture elderly geriatrics hospitalization frail elderly
d-ribose for fatigue in subjects with fibromyalgia

Conditions: Fibromyalgia

Summary: to evaluate the safety and to determine the efficacy of d-ribose for the amelioration of fatigue in subjects with fibromyalgia. this is a phase iia, randomized, double-blind, placebo-controlled, multi-center, multiple dose study of d-ribose versus placebo administered at doses of 5 g three times a day (tid) over a 12-week period to subjects who are experiencing fatigue associated with a diagnosis of fibromyalgia.


Eligibility criteria:
major inclusion criteria: * must have a diagnosis of primary fibromyalgia, as defined by the 1990 american college of rheumatology (acr) criteria for the classification of fibromyalgia made at least 6 weeks prior to the pretreatment screening visit; * must have a score of ≥5 on the subject's assessment of fatigue 11-point numerical rating scale (nrs) at the pretreatment screening and baseline visits; * if taking acetaminophen or other non-opioid analgesics, nsaids, fibromyalgia medications, medications to induce sleep, or prednisone ≤ 10 mg (or equivalent dose of other glucocorticoids), must be on stable dose(s) for at least 4 weeks prior to the baseline visit; * must have discontinued any ribose-containing products (including foods, drinks, and supplements) at least 4 weeks prior to the pretreatment baseline visit. major exclusion criteria: * current major depressive episode (mde); * has been diagnosed with any autoimmune disease; * has been diagnosed with type i or type ii diabetes; * has a history of cancer, other than basal cell carcinoma, stage 1 squamous cell carcinoma or cervical carcinoma in situ, that has not been in remission for at least five years prior to the pretreatment screening visit; * has been diagnosed with chronic fatigue syndrome.

Keywords: fibromyalgia fatigue d-ribose