Kornimate/medical-research-clean huggingface dataset:
mitigation of postoperative delirium in high-risk patients

Conditions: Post-operative Delirium; Decision Support Systems, Clinical; Cognitive Impairment

Summary: among patients with cognitive impairment (ci) that undergo surgery, the risk for developing postoperative delirium (pod) is high (50%) and associated with further morbidity and mortality. yet, 30-40% of pod cases are preventable with perioperative management. this randomized pragmatic clinical trial aims to assess incidence of pod in adult surgical patients with ci, as well as provider adherence to a set of 12 perioperative best practice recommendations for perioperative management. electronic health record (ehr) data will be used to identify patients as high risk for developing pod and clinical decision support (cds) prompts within the ehr will display best practices. cases will be randomized to either the control group, usual care or the intervention which includes the high-risk alert and best practice prompts.


Eligibility criteria:
inclusion criteria: * adult patients with a history of cognitive impairment (ci) undergoing surgery at the mount sinai health system. * attending physicians, resident physicians, and nurse anesthetists at the mount sinai health system receiving cds alerts during ehr system implementation. exclusion criteria: * patients will be excluded if this not their first surgery since study start, if they do not have cognitive impairment based on ehr data, or if the surgery is for organ donation. * there will be no exclusion criteria for providers or historical controls.
intra-arterial albumin in acute ischemic stroke after endovascular treatment for

Conditions: Acute Ischemic Stroke

Summary: stroke is an acute focal injury of the central nervous system caused by cerebral vessels. one in every four people is affected by stroke at different times in life. globally, stroke is the second leading cause of death and third leading cause of disability in adults. we hypothesized that in patients with acute large vessel occlusive ischemic stroke treated with mechanical thrombectomy, the infusion of 20% human serum albumin solution into the revascularization area can exert a stronger neuroprotective effect.

in the previous period, we have conducted a clinical trial on the safety and feasibility of arterial infusion of 20% human serum albumin solution. the results of the study found that after arterial infusion of 20% human serum albumin solution at a dose of 0.6g/kg to the subject's vascularization area, the subjects did not develop significant complications related to albumin solution. there were no serious adverse events associated with arterial infusion of albumin solution in all subjects. after the evaluation of the data safety monitoring board, the clinical study was considered to be the next step, which is to initially explore the effectiveness of 0.6g/kg arterial infusion of 20% human serum albumin solution for neuroprotection of subjects.

Eligibility criteria:
inclusion criteria: 1.male or female, age≥18 and ≤ 80; 2. anterior circulation large vessel occlusion confirmed by cta, mra and dsa; 3. baseline national institute of health stroke scale (nihss) score ≥6； 4. alberta stroke program early ct score (aspects) 6-10; 5. stroke symptoms present to femoral artery or brachial artery puncture within 24 hours； 6. occluded vessel reaches etici level ≥2b after thrombectomy confirmed by dsa；7. informed consent obtained; exclusion criteria: (1) history of congestive heart failure or jugular dilatation, third heart sound, resting tachycardia due to heart failure (\>100 beats/min), hepatomegaly and lower limb edema without obvious cause on admission physical examination; (2) hospitalization for acute myocardial infarction within 3 months; (3) symptoms of acute myocardial infarction or admission electrocardiogram; (4) second or third degree heart block or arrhythmia with hemodynamic instability; (5) acute or chronic renal failure (blood creatinine \> 2.0 mg/dl); (6) severe anemia (hematocrit\<32%); (7) symptoms or ct evidence of subarachnoid hemorrhage; (8) pregnancy; (9) allergy to albumin; (10) admission blood pressure higher than 185/110 mmhg; (11) any chronic lung disease, including chronic obstructive pulmonary disease, bronchiectasis, and other lung diseases that interfere with daily activities; (12) presence of other diseases that may endanger life.

Keywords: acute ischemic stroke albumin intra-arterial thrombectomy neuroprotection
pet-study on the role of the reward system in weight loss after bariatric surgery

Conditions: Obesity

Summary: bariatric surgery (bs) is currently the most effective treatment in severe obesity. however, a considerable percentage of patients undergoing bs fail to lose sufficient weight or regain weight after initial weight loss during long-term follow-up, which may be attributed to personality traits and pathological eating behaviour. previous positron emission tomography (pet) studies have shown reduced dopamine d2 receptor availability in obese patients and upregulation of this availability following successful bs in the brain's reward system. dopamine d2 receptor availability in patients with unsuccessful bs has not been investigated to date.


Eligibility criteria:
inclusion criteria: * bariatric surgery 24-36 months prior to the study * adult (over 18y old) * mentally capable to understand the consequences of the procedure and make his or her own choice without coercion * able to undergo pet and mri, according to the investigator's assessment * native speaking * able to participate in follow-up * written informed consent exclusion criteria: * presence of a dsm-iv axis 1 disorder * the use of drugs that bind to dopamine d2/3 receptors, including various classes of antipsychotics and antidepressants * history of stroke, brain tumor, parkinson's disease or dementia * history of head trauma with loss of consciousness * alcohol or substance abuse in the last 6 months * alcohol consumption 24h prior to pet scanning * smoking or other forms of nicotine intake 12 hours prior to pet scanning * use of anorectic drugs in the last 6 months * current pregnancy * medication for diabetes mellitus * claustrophobia * the presence of implanted metal objects of the type which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field (such as certain implanted devices, shrapnel, ocular metal shavings) * patients with a bodyweight \> 200kg will be excluded to ensure the maximum load of the camera bed of the pet-scanner (227 kg) is not exceeded.

Keywords: obesity reward system pet-scan [11c]-raclopride
validation of patient reported outcome measures for use in hallux valgus

Conditions: Hallux Valgus

Summary: the purpose of the study is to explore whether the mffi is fit for purpose in adults with hallux valgus (hv).


Eligibility criteria:
inclusion criteria: * male or female, of any race and, aged ≥ 18 years * clinical diagnosis of hallux valgus * fluent in reading/speaking us-english to read and understand informed consent form and to participate in the interview exclusion criteria: * participation in another foot-based clinical trial in the last 90 days or in ipsen's clinical trial d-fr-52120-237 * current chronic drug or alcohol abuse problem
population pharmacokinetics of benznidazole in children with chagas disease

Conditions: Chagas Disease

Summary: background: chagas disease is a parasitic infection caused by the trypanosome cruzi. the initial phase of the infection happens mainly in children. up to 10% of infected children die. survivors often develop chronic infection leading to heart disease and other complications in 30% of patients. these complications often result in death or severe handicaps in early adulthood, depriving societies of individuals in their most productive years. there are 20 million people infected in latin america. complications lead to 20,000 deaths every year. treatment during the acute phase with benznidazole leads to a high cure rate. however, there are very few studies of this drug and virtually none in children, even though benznidazole was developed over 30 years ago. hypotheses and specific aims: we hypothesize that the pharmacokinetics of benznidazole in children is different from adults, and that obtaining information on how it is absorbed, distributed and eliminated in children will allow optimization of treatment of chagas disease in this population. this will in turn improve the outlook for children by reducing mortality and long term complications. we aim to study the pharmacokinetics of benznidazole in children receiving the drug for treatment of chagas disease, and to correlate it with treatment effectiveness and incidence of adverse effects. potential impact: this novel knowledge will allow better and more rational approaches to the treatment of chagas disease. it will also set the foundation for further studies that will be able to test improved therapies that may increase treatment response in vulnerable children.


Eligibility criteria:
inclusion criteria: * children 2 - 12 years old of both sexes, with a diagnosis of chagas' disease and eligible for treatment with benznidazole, as per current treatment protocols. * chagas disease diagnostic criteria: at least 2 positive serological tests for trypanosoma cruzi infection (elisa, hemoagglutination, particle agglutination tests). * informed consent signed by the parents, and consent or assent of the patients (according to age and consenting capacity). exclusion criteria: * patients with a history of hypersensitivity to benznidazole or any of the drug excipients * immunocompromised patients * altered hepatic function (increase in ast/alt x3 or bilirubin x3) or altered renal function (increase in creatinine x3) * pregnancy

Keywords: chagas disease pediatrics benznidazole population pharmacokinetics neglected diseases parasitology pediatric clinical pharmacology
a modified tunnel approach in treatment of gingival recession

Conditions: Gingival Recession

Summary: objectives: to clinically evaluate the healing of miller class i and ii isolated gingival recessions treated with the modified tunnel approach (mta) versus the conventional tunnel technique (ctt) in conjunction with subepithelial connective tissue graft (sctg). material and methods: in this split-mouth study, thirty healthy patients exhibiting two isolating anterior miller class i and ii gingival recessions were treated with mta + sctg and ctt + sctg. treatment outcomes were assessed at baseline, 3-months and 6-months postoperatively. the primary outcome was root coverage esthetic scores (res).

various techniques have been suggested for the treatment of isolated mandibular recessions e.g., envelope, coronally advanced flaps double pedicle flap or tunneling procedures combined with laterally positioned pedicle flaps in conjunction with sctg. despite the fact that the mentioned techniques appear to improve root coverage, the success in terms of complete root coverage has high variability and thus it is still unknown which approach may lead to the most predictable outcomes. the limited evidence from the literature points clearly to the clinical importance of developing new concepts for predictable of isolated mandibular recessions. the mta is a dual flap approach; that starts with full thickness flap (avoiding papilla incision) till the level of the mucogingival junction. on reaching the level of the vestibular mucosa, a partial thickness flap is applied to undermine the base of the flap. using this dual approach carries two main advantages: avoidance of severing the gingival blood supply through the full thickness flap, in addition to minimizing the tension on the flap tissue through using the partial thickness flap at the above-mentioned site. in this trial, the mta has been proposed for the surgical treatment of isolated mandibular recessions due to the following advantages: 1) it avoids vertical releasing incisions. 2) it doesn't incise the papilla, which may improve the vascularization of the area plus stabilizing the soft tissue flap. 3) it is suitable to patients with thin gingival biotype.

Eligibility criteria:
inclusion criteria: * except for chronic periodontitis, our patients were systemically free * two mandibular miller class i or ii recession sites * at least 2 mm attached gingiva. * at least 3 mm depth of recession. exclusion criteria: * systemic diseases. * smokers or formal smokers * pregnant or lactating females * history of antibiotic therapy at the last 6 months * patients who are not willing to follow the study protocol

Keywords: gingival recession tunnel technique miller class i and ii
the effect of virtual reality exercises on balance in children with brain tumors

Conditions: Postural Balance

Summary: 30 patients with brain tumor will be included in the study between the ages of 6 and 18 who have undergone surgery. patients included in the study will be randomly assigned to two groups. the study group will be included in the nintendo wii fit plus balance game exercise program under the supervision of a physiotherapist for 2 days per week for 8 weeks. the control group will be taken to the conventional exercise program under the supervision of a physiotherapist for 2 days a week, 1 hour a day. the assessments will be made before the exercise program begins and at the end of the 8th week. patients' physical measurements were assessed by anthropometric evaluations, muscle strength measurement, pain visual analogue scale, walking observational walking analysis, balanced pediatric functional range test, timed up and go (tug) and one foot standing test and nintendo wii fit plus balance assessment, functional capacity 2 min. with walking test, fatigue with pedsql multidimensional fatigue scale, daily life activities will be evaluated with weefim.

in our pediatric rehabilitation policlinic we have seen that these children has problems in balance and coordination from cause muscle weakness and cerebral-sensory-proprioceptive problems. we have evaluated with all parameters belong the physiotherapy and rehabilitation measurements and then planning this study with study protocol.

Eligibility criteria:
inclusion criteria: * 6-18 years of children * brain tumor exclusion criteria: * have any conditions with exercises * neurological and musculoskeletal disorders

Keywords: balance brain tumor virtual reality
comparison of safety, immuno- and reactogenicity of mpl-adjuvanted recombinant hepatitis b vaccine to that of engerix™-b

Conditions: Hepatitis B

Summary: the purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis b vaccine to that of engerix™-b when administered at 0, 2 months with a booster at month 12 if necessary

at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * between 18 and 40 years old. * written informed consent will have been obtained from the subjects. * good physical condition as established by physical examination and history taking at the time of entry. * female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry exclusion criteria: * pregnancy or lactation. * positive titres for anti hepatitis b antibodies * any vaccination against hepatitis b in the past. * any previous administration of mpl. * elevated serum liver enzymes. * history of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. * axillary temperature \> 37.5°c at the time of injection. * any acute disease at the moment of entry. * chronic alcohol consumption. * any treatment with immunosuppressive or immunostimulant therapy. * any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study. * history of allergic disease likely to be stimulated by any component of the vaccine. * simultaneous administration of any other vaccine(s). * administration of any immunoglobulin during the study period. * simultaneous participation in any other clinical trial

Keywords: hepatitis b engerix™-b adjuvanted recombinant hepatitis b vaccine
corneal epithelial autograft for lscd

Conditions: Limbal Stem Cell Deficiency

Summary: the purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial autograft is more effective than limbal conjunctival autograft for ocular surface reconstruction in patients with limbal stem cell deficiency (lscd).


Eligibility criteria:
inclusion criteria: 1. unilateral lscd secondary to ocular burns, with the duration of disease of at least 24 months at the time of screening visit; 2. presence of superficial neo-vascularization affecting at least 2 cornea quadrants and involving central cornea; 3. informed consent signed by patient or legal guardian. having the ability to comply with study assessments for the full duration of the study. exclusion criteria: 1. lscd of mild degree, with less than 2 quadrants of neo-vessel invasion and without central cornea involvement; 2. lscd by ocular surface disorders other than pterygium; 3. eyelids malposition; 4. the center corneal thickness\ 150µm; 5. high myopia with a spherical equivalent of -15.0 d or less; 6. corneal or ocular surface infection within 30 days prior to study entry; 7. ocular surface malignancy; 8. uncontrolled diabetes with most recent hemoglobin a1c greater than 8.5%; 9. renal failure with creatinine clearance\< 25ml/min; 10. alanine aminotransferase \> 40iu/l, or aspartate aminotransferase \> 40iu/l; 11. platelet levels \ 450,000 per microliter; 12. hemoglobin \< 12.0 g/dl (male) or \< 11.0 g/dl (female); 13. prothrombin time \> 16s and activated partial thrombin time \> 35s in patients not accepting anticoagulant therapy; an international normalized ratio greater than 3 in patients accepting anticoagulant therapy; 14. pregnancy (positive test) or lactation; 15. participation in another simultaneous medical investigation or clinical trial; 16. severe cicatricial eye disease; conjunctival scarring with fornix shortening; 17. ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases; 18. severe dry eye disease as determined by schirmer's test \< 2mm at least in one eye; 19. any medical or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent; 20. signs of current infection, including fever and treatment with antibiotics; 21. active immunological diseases; 22. history of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.
electroclinical effect of steroid in patients with benign childhood epilepsy with centrotemporal spikes

Conditions: Benign Childhood Epilepsy With Centrotemporal Spikes

Summary: benign epilepsy with centro-temporal spikes is the most common type of focal epilepsy in children. it is known to be age-dependent and presumably genetic. age of onset ranges from one to fourteen years and it represents fifteen percent to twenty five percent of epilepsy in children under 15 years of age.

generally, benign epilepsy with centro-temporal spikes is characterized by infrequent focal sensorimotor seizures in the face during sleep, which may secondarily generalize, along with spike-wave discharges, reflecting nonlesional cortical excitability from rolandic regions. the prognosis is usually considered to be excellent. over the past years, however, some investigators have questioned whether benign epilepsy with centro-temporal spikes is indeed benign, considering the variety of different presentations associated with the disorder.it is not uncommon for benign epilepsy with centro-temporal spikes to be associated with neuropsychological deficits, such as linguistic, cognitive, and behavioral impairment. in particular, reading difficulties and speech/language disorders are more common in children with benign epilepsy with centro-temporal spikes than in healthy controls.various neuropsychological deficits seem to be very dependent on the spike index, as well as the predominant localization of epileptiform discharges.furthermore, the frequency of epileptiform discharges is closely related not only to the degree of neuropsychological deficits, but also to an atypical evolution of benign epilepsy with centro-temporal spikes. the high comorbid prevalence of attention deficit hyperactivity disorder and epilepsy suggests that there is a bidirectional relationship between these disorders .cognitive impairment and attention problems are particularly crucial issues in children with epilepsy who are in a vigorous phase of neurodevelopment. resolution of continuous spike-and-wave during sleep had been achieved with conventional antiepileptic drugs including ethosuximide, valproic acid, levetiracetam, and sulthiame. when these agents fail to normalize the eeg, a trial with second-line agents such as steroids or high-dose diazepam is attempted.

Eligibility criteria:
inclusion criteria: * history and eeg findings of benign epilepsy with centrotemporal spikes exclusion criteria: * genetic disorders. * metabolic or neurodegenerative disease. * gross motor delay.
follow-up safety and efficacy evaluation on subjects who completed pneumostem® phase-ii clinical trial

Conditions: Bronchopulmonary Dysplasia

Summary: this is a follow-up study to investigate the long-term safety and efficacy of pneumostem® versus placebo, for the treatment of bpd in premature infants. subjects who participated in and completed the initial stage of the phase ii trial (nct01828957) will be followed-up until 60 months of corrected age.

subjects who completed the initial stage of the phase ii clinical trial will be followed-up at 7 additional visits: corrected age of 6, 12,18, 24, 36, 48, and 60 months.

Eligibility criteria:
inclusion criteria: * subject who completed the safety and efficacy evaluations in pneumostem phase ii clinical trial * subject with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial exclusion criteria: * subject whose parent or legal representative does not agree to participate in the study * subject who is considered inappropriate to participate in the study by the investigator

Keywords: human umbilical cord blood derived mesenchymal stem cells bronchopulmonary dysplasia premature infants
placebo effect in the treatment of atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the study is initiated in the indication of atopic dermatitis to study the impact of placebo in the treatment of pruritus. classical conditioning and expectation via instructions/anticipation maintain the effect of placebo.


Eligibility criteria:
inclusion criteria: * scorad-score \< 50 points * basic experimental pruritus \>= 3 points on a numeric rating scale * no acute eczema on their forearms * no systemic treatments for skin diseases for at least four weeks * no topical treatment on their arms for at least two weeks exclusion criteria: * intake of antihistamines * pregnancy and lactation * serious dysfunctions of the liver, kidneys or thyroid * prostatic hyperplasia * patients with tumors, major cardiovascular diseases, immunosuppression * glaucoma