Kornimate/medical-research-clean huggingface dataset:
a trial to evaluate the efficacy and safety of adjunctive therapy with lacosamide in adults with partial-onset seizures

Conditions: Epilepsy; Partial Onset Seizures

Summary: the purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered lacosamide as adjunctive therapy compared with placebo in japanese and chinese adults with uncontrolled partial-onset seizures with or without secondary generalization.


Eligibility criteria:
inclusion criteria: * subject has had an electroencephalogram (eeg) and a brain computerized tomography (ct) scan or magnetic resonance imaging (mri) exam consistent with a diagnosis of epilepsy with partial-onset seizures according to the international classification of epileptic seizures (1981) * subject must have been observed to have partial-onset seizures for at least the previous 2 years despite prior therapy with at least 2 anti-epileptic drugs (aeds)(concurrently or sequentially) and must have been observed to have on average at least 4 partial-onset seizures per 28 days with a seizure-free phase no longer than 21 days in the 8-week period prior to entry into the baseline period. in the case of simple partial seizures, only those with motor signs will be counted towards meeting the inclusion criterion * subjects must be on a stable dose regimen of at least 1, but no more than 3 aeds (concurrent stable vagus nerve stimulation (vns) is not counted as an aed). the vns must have been in place for at least 6 months prior to study entry. the dosage of concomitant aed therapy and the settings of the vns must be kept constant for a period of at least 4 weeks prior to entry into the baseline period * minimum body weight of 40 kg exclusion criteria: * subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt) or has a suicidal ideation in the past 6 months as indicated by a positive response ("yes") to either question 4 or question 5 of the columbia-suicide severity rating scale (c-ssrs) at screening * subject has a current or previous diagnosis of pseudo-seizures, conversion disorders, or other non-epileptical events that could be confused with seizures * subject has seizures that are uncountable due to clustering (ie, an episode lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished) during the 8-week period prior to visit 1 * subject has a history of primary generalized seizures * subject with a history of status epilepticus within the 12-months period prior to visit 1 * subject who underwent surgery for epilepsy within the 2 years period prior to visit 1 * subjects with cardiac, renal, hepatic, endocrinological dysfunction or psychiatric illness that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol

Keywords: lacosamide epilepsy partial onset seizures
vitamin d3 supplementation to prevent respiratory tract infections

Conditions: Respiratory Tract Infections; Covid19; Flu Like Illness

Summary: the cooper vitamin d3 study is a randomized study investigating whether daily vitamin d3 supplementation can prevent respiratory tract infections, influenza-like illness and covid-19 in hospital workers.

influenza-like illness and covid-19 were added to this summary because the protocol uses respiratory tract infections and influenza-like illness interchangeably. influenza-like illness is more accurate. protocol amendments: protocol title was amended to include covid-19. minimum age was changed from 52 to 18, expanding the sample size. exclusion criteria re vitamin d intake was changed from \>5000 to \>=5000 iu.

Eligibility criteria:
inclusion criteria: * hospital worker * age 18 years or older exclusion criteria: * history of hypercalcemia * history of nephrolithiasis * history of intolerance to vitamin d3 supplements * use of calcium at a dose \> 600 mg/day (individuals using a dose greater than 600 mg of calcium per day will be asked to limit the amount to 600 mg unless they have been directed by their physician to be taking more than 600 mg/day of calcium. if the latter is true the potential subject will be excluded from the study.) * use of vitamin d at a daily dose \> 5000 iu\* * use of aluminum-containing phosphate binders in patients with renal failure * use of calcipotriene * use of digoxin * use of thiazide diuretics if using: * hydrochlorothiazide at a daily dose \> 37.5 mg * indapamide at a daily dose \> 1.25 mg * chlorthalidone at a daily dose \> 12.5 mg * metolazone at a daily dose \> 2.5 mg * methyclothiazide at a daily dose \> 2.5 mg * chlorothiazide at a daily dose \> 250 mg * metolazone at a daily dose \> 0.5 mg * bendroflumethiazide at a daily dose \> 2.5 mg * polythiazide at a daily dose \> 1 mg * hydroflumethiazide at a daily dose \> 25 mg * conditions that are associated with a risk of modified vitamin d metabolism * known allergy to wool * current enrollment in another study * life expectancy \<1 month at time of screening * cognitive impairment precluding the ability to provide informed consent * pregnant or trying to become pregnant * employee is team member on the present study * if potential participants are found to be using vitamin d supplementation upon screening at a daily dose ≤5000 iu/day, they will be eligible for participation by switching to the study dose. if potential participants are taking a multiple vitamin or calcium supplement and there is less than or equal to 800 iu vitamin d in it, they can continue the multivitamin or calcium supplement along with taking the study vitamin d3. total vitamin d cannot exceed 5,800 iu per day combined between any supplements that contain vitamin d. use of vitamin d at a daily dose \> 5000 iu at the direction of a physician will be an exclusion criterion. if a potential subject uses over-the-counter vitamin d not directed by a physician at a daily dose \> 5000 iu they will be eligible to participate by switching to the lower study dose.
comparative study using dermabrasion vs co2 laser & collagen dressing vs vaseline gauze in mktp

Conditions: Vitiligo; Depigmented Scars; Depigmentation

Summary: the purpose of this study is to: 1. compare two different techniques in the melanocyte keratinocyte transplant procedure: use of carbon dioxide laser versus use of dermabrasion 2. compare two different dressings in the melanocyte keratinocyte transplant procedure: vaseline impregnated gauze versus collagen dressing

the melanocyte keratinocyte transplant procedure (mktp) has been shown to be effective in treating vitiligo and other conditions with depigmented skin. mktp involves the transplantation of melanocytes and keratinocytes from normal skin onto the depigmented skin in order to repigment the skin. both dermabrasion and carbon dioxide lasers have been used effectively in mktp to denude the epithelium. this study will compare the efficacy of these two techniques. the study will also compare the efficacy of two different dressings used in mktp, vaseline impregnated gauze and collagen dressings.

Eligibility criteria:
inclusion criteria: * depigmented patches of skin exclusion criteria: * history of acral vitiligo * unstable vitiligo, defined as new areas of depigmentation or enlarging areas of depigmentation within the last 6 months * history of hypertrophic scarring or keloids * history of koebnerization (new patches of vitiligo at sites of injury or trauma)
analysis of a population in extreme age of life with a hip fracture

Conditions: Hip Fractures

Summary: observational retrospective study of pacients over 95 years admitted in traumatology ward with a osteoporotic hip fracture


Eligibility criteria:
inclusion criteria: * osteoporotic hip fracture exclusion criteria:
a study of fibrocaps™ in surgical bleeding

Conditions: Mild or Moderate Surgical Bleeding

Summary: the purpose of this study is to confirm the superiority of fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis. the investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.


Eligibility criteria:
inclusion criteria: 1. has signed an institutional review board/independent ethics committee (irb/iec)-approved informed consent document 2. is undergoing one of the 4 surgical procedures described 3. is at least 18 years old at time of consent 4. if female and of child-bearing potential, has negative pregnancy test during screening and is not breast-feeding 5. if able to reproduce, agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits when engaging in heterosexual intercourse 6. has not received blood transfusion between screening and study treatment 7. has mild to moderate surgical bleeding 8. does not have intra-operative complications 9. has not used a topical hemostat containing thrombin prior to study treatment 10. has an approximate bleeding site surface area of less than or equal to 100 cm\^2 exclusion criteria: 1. has known antibodies or hypersensitivity to thrombin or other coagulation factors 2. has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required) 3. has known allergy to gelatin sponge 4. is unwilling to receive blood products 5. has liver enzymes appropriate for the study, considering their disease 6. has appropriate level of platelets per liter (plt/l) during screening 7. has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the investigator, or baseline abnormalities during screening that are not explained by current drug treatment (e.g., warfarin, heparin)

Keywords: fibrin sealant thrombin fibrinogen hemostasis
prediction model of long-term cognitive dysfunction and delirium after cardiac surgery

Conditions: Delirium; Cognitive Dysfunction

Summary: delirium is a clinical syndrome caused by normal dysfunction of the brain, characterized by reduced awareness and responsiveness to the environment, as well as orientation disorders, incoherent thinking and memory disorders. delirium indicates poor recovery of cognitive function, decreased ability of daily life, may need to enter nursing homes, and even lead to adverse outcomes such as death. according to a number of clinical studies, middle-aged and elderly people are prone to delirium after undergoing major surgery. delirium occurs in 31 % -40 % of patients over 50 years old after cardiac surgery. compared with patients without postoperative delirium, patients with postoperative delirium had significant cognitive impairment within 1 year after cardiac surgery. the occurrence of delirium suggests that the patient 's brain has become fragile, cognitive function has begun to decline, and the risk of future dementia has increased. secondly, delirium and dementia have overlapping clinical features and common pathogenic mechanisms. some scholars even speculate that delirium and dementia represent different stages of a common process. it is generally believed that the peripheral immune system may be involved in the pathogenesis and progression of dementia through the dysfunctional blood-brain barrier. the activation of microglia and astrocytes leads to the release of chemokines, which can recruit peripheral immune cells to the central nervous system. at the same time, cytokines released by peripheral cells can cross the blood-brain barrier and act on glial cells to change their phenotype. this study is a prospective cohort study of patients aged 65 and over who are about to undergo elective cardiac surgery.cytof can achieve accurate immunophenotyping of cell populations while comprehensively and accurately detecting and analyzing cytokines and signaling pathways. therefore, the detection of peripheral blood biomarkers may effectively predict the risk of long-term cognitive dysfunction and postoperative delirium in patients undergoing cardiac surgery.


Eligibility criteria:
inclusion criteria: * age ≥ 65 years * patients undergoing elective cardiac surgery with cardiopulmonary bypass * sign informed consent exclusion criteria: * serious dementia, encephalopathy, mental illness or other neurological diseases * patients who could not take neurocognitive tests due to other reasons ( such as language, hearing or visual impairment ) * patients with stage 3 or 4 malignant tumors, and patients with pancreatic cancer, gallbladder cancer, cholangiocarcinoma and other tumors with high malignancy and expected survival time less than 1 year * american society of anesthesiologists ( asa ) classification iv or v patients
partial breast irradiation with interstitial high dose rate brachytherapy

Conditions: Breast Cancer

Summary: partial breast irradiation (pbi) is becoming more widespread in the treatment of early breast cancer in patients at low risk of relapse as pathological and clinical findings have demonstrated that most breast cancer recurrences after bcs occur close to the tumour bed. in our phase ii prospective study pbi is administered with high-dose-rate brachytherapy in patients with low-risk early-stage breast cancer. patients receive 4 gy twice a day for 4 days (total dose 32 gy).

patients included in our phase ii trial of pbi with interstitial hdr brachytherapy are at low-risk of relapse. implants are positioned during surgery or postoperatively, within 12 weeks. treatment schedule is 4 gy twice a day, with a time relapse of at least 6 hours between each fraction, for four days, for a total dose 32 gy. before post-operative implantation, all patients undergo a breast computed tomography (ct) scan to visualize and expand the excision cavity and obtain the planning target volume (ptv), i.e. the lumpectomy cavity plus a margin of 1-2 cm around it. through virtual simulation with a 3d treatment planning system (tps), we define the implant catheter position. after implantation, in all patients a breast ct scan checked implant geometry. on ct images transferred to a tps the surgical cavity is outlined and expanded, the ptv defined, and inactive and active source lengths measured.ct-based 3d software is used to identify and reconstruct the catheters, outline and expand the surgical cavity and obtain the ptv. dwell positions are activated for each catheter, and inactive and active lengths defined.prescribed dose was 85% of the basal dose. dwell weights are optimised in the basal points applying the volume and distance method and best values were chosen independently of strategy. a dose-volume histogram that records the volume covered by 100% and 150% of the prescribed dose (v100 and v150) was obtained for each patient. dhi, defined as v150 - v100/ v100 (7), is recognized as the most suitable quality index.

Eligibility criteria:
inclusion criteria: * age \> or = 40 years * ecog performance status 0-2 * t dimensions ≤ 2.5 cm * negative surgical margins * negative axillary lymph nodes * suitable breast anatomy for implantation exclusion criteria: * age \< 40 years * ecog performance status \> 2 * t dimensions \> 2.5 * positive surgical margins * positive axillary lymph node * infiltrating lobular histology * significant areas of lobular carcinoma in situ * paget's disease of the nipple * extensive intraductal component (eic) * lymphovascular invasion * multifocality (n) skin infiltration

Keywords: early stage breast cancer
the effectiveness of montelukast on atopic dermatitis in koreans

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to assess the clinical effectiveness of montelukast in children (2\~6 years old) with atopic dermatitis and identify the pathophysiologic background of montelukast on the role of modulating the atopic dermatitis measured by urinary leukotriene 4 (lte4) and eosinophil protein x(edn).

leukotriene b4 (ltb4) and the cysteinyl-leukotrienes ltc4, ltd4 and lte4 are potent proinflammatory mediators derived from arachidonic acid through the 5- lipoxygenase pathway. they are secreted from eosinophils and other inflammatory cells such as mast cells and macrophages. the primary action of leukotrienes includes contraction of human airway muscle, chemotaxis, and increased vascular permeability, with secondary effects of inhibiting allergen-induced early and late responses. several in vivo and in vitro studies suggest a role for cysteinyl leukotrienes in the pathogenesis of atopic dermatitis and there is a rationale for the use of pharmacological agents to antagonize their effects in the treatment of atopic dermatitis. levels of lte4 measured in urine (urinary-lte4) may be a useful measure of whole-body cysteinyl-leukotriene production in vivo, because that lte4 is a stable urinary metabolite of ltc4 and ltd4. urinary-lte4 has been measured in individuals with atopic dermatitis, but in small-scale studies, and the results are conflicting.

Eligibility criteria:
inclusion criteria: * the ages of 2 to 6 years old, 54 children with moderate to severe atopic dermatitis diagnosed by the criteria of haniffin and rajka were included in the study. * volunteer children with moderate to severe atopic dermatitis were recruited from the pediatric allergy and respiratory center of the soonchunhyang university hospital (seoul, korea). at the time of recruitment, written consent was obtained. the ethical committee at the soonchunhyang university hospital approved the trial. * volunteers who agreed by their parents. * the severity of their disease was assessed by modified scorad index. exclusion criteria: * too severe atopic dermatitis defined as the sum of scores is 80 and above by scorad index. * a history of liver disease; allergy to montelukast or cross-reacting medication; use of phenobarbital, phenytoin or rifampicin. * patients on systemic steroids, immune-suppression or korean herbal medicine during the previous 6 weeks.

Keywords: atopic dermatitis montelukast
symbicort usage in asthma treatment and impact of a new therapeutic strategy on compliance and asthma control in france

Conditions: Asthma

Summary: descriptive pharmacoepidemiological study on the use of symbicort turbuhaler in the treatment of asthma in france and impact of a new therapeutic strategy on the compliance and control of asthma


Eligibility criteria:
inclusion criteria: * asthmatic patients treated for this disease with symbicort turbuhaler * patients monitored for asthma by the doctor for at least 12 months * patients seen in outpatient care at the baseline visit * patients agreeing to participate in the study exclusion criteria: * patients with any chronic lower respiratory disease other than asthma * patients receiving anti-ige agents in the last 4 months * patients receiving desensitisation treatment outside of the maintenance phase * patients deemed to be unable to respond to the study for linguistic or cognitive reasons

Keywords: symbicort turbuhaler asthma cohort study france
network interventions to reduce disparities in living kidney donation

Conditions: End-stage Renal Disease

Summary: for this current phase of the larger project, the investigators will survey transplant candidates as well as the participants family and friends to understand the barriers to volunteering and evaluation. this project will examine how network characteristics are associated with eventual living donor kidney transplant outcomes and test the efficacy of evidence-based interventions designed to assist kidney transplant candidates in participant donor search on a multi-center scale.

the overall goal is to understand the process and assist participants who do not receive unsolicited offers to be evaluated as a living kidney donor in initiating and effectively conducting these critical conversations with participants kin and friends. in the search intervention, based on what they can tell investigators about the number, type, perceived health, perceived relationship, and potential willingness to donate, as well as analyses of data from the national health and nutrition examination survey (nhanes) investigators will counsel them on which members of participants family and friendship networks appear most biomedically promising as donors among the subset of these individuals that participants have not ruled out for known medical or perceived relationship reasons. in the rhetorical intervention, investigators will test non-coercive, promising verbal scripts that have proven promising in preliminary tests in vignette experiments in online and phone surveys. aim 1: survey transplant candidates about their social network and transplant-related attitudes, knowledge, and characteristics; and randomize participants into one of two interventions or a control group. aim 2: send network member participants a survey that measures potential donor attributes that are hypothesized to influence donation decisions, such as medical contraindications, blood type, health insurance status, and barriers to living donation. aim 3: test whether participant social networks and interventions affect donation outcomes using medical records and follow-ups provided by penn and uab. investigators will create the first predictive model of potential donor evaluation and actual donation. this information is critical to improve clinical practice and efforts to ethically influence the living donor search process.

Eligibility criteria:
inclusion criteria: * are kt candidates at the university of pennsylvania or university of alabama-birmingham or were identified by kt candidate from the university of pennsylvania or university of alabama-birmingham as a network member * are adults aged 18 or older * are able and willing to consent to participation in the survey exclusion criteria: * person is not a kt candidate at university of pennsylvania or university of alabama-birmingham or was not identified by kt candidate from university of pennsylvania or university of alabama-birmingham as a network member * individuals who are not yet 18 * participant does not speak english
validation of nicom device to measure stoke volume variation

Conditions: Anesthesia

Summary: the purpose of this study is to evaluate the ability of nicom (noninvasive cardiac output monitor) to detect stroke volume variation induced by leg raising or fluid expansion during surgery


Eligibility criteria:
inclusion criteria: * patients undergoing general anesthesia with an expected duration exceeding two hours * gastrointestinal surgery, urological or gynecological surgery. exclusion criteria: * difficulty of venous access. * contraindication for the use of oesophageal doppler * contraindication for the use of nicom * contraindication for the use of bispectral index * pregnant or lactating women