Kornimate/medical-research-clean huggingface dataset:
safety and pharmacokinetic study of a recombinant coagulation factor ix albumin fusion protein in subjects with hemophilia b

Conditions: Hemophilia B

Summary: the primary objective of the study is to assess the safety of iv administration of rix-fp. safety will be evaluated by adverse events and laboratory changes over time. the secondary objective of the study is to evaluate the pharmacokinetics parameters, following a single intravenous dose of rix-fp.

this study is comprised of both a rix-fp dose-escalation safety segment (25, 50 and 75 iu/kg of rix-fp), and pk evaluation of rix-fp after a single dose of 50 iu/kg, as well as pk evaluation after a single dose of 50 iu/kg of the previously given factor ix (fix) product (recombinant fix \[rfix\] or plasma derived fix \[pdfix\]) which is used as the reference product.

Eligibility criteria:
inclusion criteria: * male, 12 - 65 years, with body weight ≥ 30 kg and ≤ 120 kg * documented severe hemophilia b (fix activity of ≤ 2%) or tested by the central laboratory at screening * subjects who have received fix products for \> 150 exposure days (eds) (estimated) * no confirmed prior history of fix inhibitor (history of positive fix inhibitor defined as two consecutive positive tests - a confirmatory test on a second, separately drawn sample shortly after the previous positive test) and confirmed no detectable fix inhibitors (negative fix inhibitor defined as \< 0.6 bethesda units \[bu\] by the central laboratory at screening * subjects can be treated on-demand or under prophylactic therapy * signed informed consent/assent exclusion criteria: * known hypersensitivity (allergic reaction or anaphylaxis) to any fix product or hamster protein * any known congenital or acquired coagulation disorder other than congenital fix deficiency * platelet count \< 100,000/µl * immunocompromised (cd4 count \< 200/mm3), (hiv positive subjects may participate in the study and protease inhibitors and antiviral therapy are permitted, at the discretion of the investigator) * currently receiving iv immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment * serum aspartate aminotransferase (ast) or serum alanine aminotransferase (alt) concentration \> 5 times (x) the upper limit of normal (uln) * serum creatinine \> 2 x uln * evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to enrollment * use of an investigational medicinal product (imp) within 30 days prior to the first rix-fp administration * experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to study entry * subject currently on a dose and/or regimen of fix that would preclude participation in the study due to possible increased risk of bleeding because of the requirement to withhold treatment during the pk sampling period * suspected inability (e.g., language problem or mental condition) or unwillingness to comply with study procedures or history of noncompliance
bisphosphonates use after total joint arthroplasty

Conditions: Diphosphonates

Summary: background bisphosphonates has been associated with a decreased risk of revision total joint replacements because of its effects on decreased periprosthetic bone loss and prosthetic migration. however, the results in the early literature are inconsistent and the influence of bisphosphonates on associated complications and subsequent total joint arthroplasty (tja) remains unknown. this study is to investigate the association between the use of bisphosphonates and risk of adverse outcomes after primary tja. materials and methods this matched cohort study utilized national health insurance research database in taiwan to identify patients who underwent primary tja over a 15-year period (january 2000- december 2015 inclusive). study participants were further categorized into two groups: bisphosphonates users and nonusers, using propensity score matching. the kaplan-meier curve analysis and adjusted hazard ratios (ahr) of revision surgery, adverse outcomes of primary surgery and undergoing subsequent tja were calculated using cox regression analysis.


Eligibility criteria:
inclusion criteria: 1. patients who underwent primary total joint arthroplasty during the study period (january 1, 2000 to december 31, 2015). exclusion criteria: 1. patients with total joint arthroplasty before the index date, 2. patients with existing pathologic fracture, nonunion of fracture and partial joint replacement, 3. patients who were lost to follow-up 4. patients \< 40 years old

Keywords: bisphosphonates total joint arthroplasty revision surgery periprosthetic fracture
implant for walking after stroke

Conditions: Stroke; Hemiplegia; Gait, Hemiplegic

Summary: this is a device study that will evaluate the effect of an implanted stimulator on improving walking in stroke survivors. there are two phases in the study: 1) screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) implantation, controller development, and evaluation - this phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months.

the purpose of this study is to evaluate the effects of neural stimulation for improving walking after stroke. participants will undergo surgery to implant a stimulator and electrodes to activate muscles used during walking. the device delivers electrical pulses to the nerves causing the muscles to contract to perform functional movements. the system coordinates assistance based on external sensors. after receiving the implanted device, participants undergo training to use the device to assist walking. evaluations are completed prior to surgery as well after training and at later follow up sessions.

Eligibility criteria:
inclusion criteria: * at least 6-months post stroke * age 21 to 75 years old * able to ambulate, but does not require the assistance of more than one person * walk slower than 0.8m/s during a 10m walk test * lower extremity fugl-meyer motor assessment (fma) \<= 20 * reduced peak hip, knee and/or ankle range of motion during stance or swing phases * modified ashworth scale (mas) \<= 2 at the above joints during passive flexion and extension * innervated and excitable lower extremity and trunk musculature * appropriate body habitus (height and weight within acceptable limits as determined by study physician) * adequate social support and stability * willingness to comply with follow-up procedures * neurologically stable as determined by a physician exclusion criteria: * non-english speaking * significant range of motion limitations (lacking hip extension, etc.) * history of spontaneous fractures or other evidence of excessively low bone density * acute orthopedic problems (severe scoliosis, joint dislocations, etc.) * medical complications (cardiac abnormalities, skin breakdowns, uncontrolled seizures, immunological/pulmonary/renal/circulatory compromise, additional neurologic conditions etc.) * cardiovascular or pulmonary disease * uncontrolled diabetes or hypertension * presence of a demand pacemaker or cardiac defibrillator * pregnancy * complications of stroke that result in an increased risk of falls (apraxia, uncompensated hemineglect, hemianopsia etc.) * significant history of repeated falls * severely impaired cognition and communication * any other medical or psychological condition that would be a contraindication
bone mineral density status in pediatric and adolescent survivors of childhood cancer with history of bone fracture

Conditions: Bone Mineral Density; Childhood Cancer Survivors

Summary: this research study is evaluating bone mineral density in childhood cancer survivors who have a history of bone fracture.

the purpose of this research study is to learn more about the status of bones in children and young-adults who have had bone fractures after treatment for childhood cancer. bone complications including fracture can be important issues for some childhood cancer survivors. in this study we are measuring bone mineral density in children and young adults who have had bone fracture after treatment for childhood cancer. we will measure bone mineral density in two ways. we will use: 1) dual energy x-ray absorptiometry (also known as dxa), and 2) peripheral quantitative computed tomography (also known as pqct).

Eligibility criteria:
inclusion criteria: * history of childhood cancer * age ≥ 8 years and \< 20 years at time of enrollment * ≥ 2 years since completion of cancer-directed therapy for first cancer * received chemotherapy for treatment of childhood cancer * history of bone fracture after the conclusion of chemotherapy\* * not currently receiving cancer-directed therapy * signed written informed consent (by parent if patient is \< 18 years of age, or by patient, if he or she is ≥18 years of age) * patient assent for those ≥10 years of age and \< 18 years of age for whom a parent provides informed consent (\*history of bone fracture will be based on patient/parent report of fracture occurrence and will be confirmed in review of the medical record whenever feasible.) exclusion criteria: * current treatment with bisphosphonates (as of time of enrollment) * current treatment with the anticonvulsant depakote (at time of enrollment) * currently pregnant

Keywords: bone mineral density childhood cancer survivors
assessing how the viscosity of submucosal gel injections helps with endoscopic mucosal resections

Conditions: Gastric Cancer; Colon Cancer

Summary: this is a study to determine how the viscosity (thickness) of an fda approved gel affects the ease in which endoscopic mucosal resections (emr) can be performed.

this is a study to determine how the viscosity (thickness) of an fda approved gel made by cook medical affects the ease in which endoscopic mucosal resections (emr) - a type of endoscopic surgery performed for localised cancer - can be performed when the gel is injected submucosally. the lifting characteristics of the gel will be assessed by height and diameter and ease with which the subsequent emr dissection can be performed. these characteristics would be assessed on excised human stomachs and colon, which are harvested during routine sleeve gastrectomy surgeries or colectomies, in an ex-vivo manner.

Eligibility criteria:
inclusion criteria: * pts undergoing sleeve gastrectomy * pts undergoing colectomy exclusion criteria: * unable to give or understand consent * all of the excised tissue will be needed for diagnostic purposes

Keywords: gastric cancer colon cancer emr biopsy bariatric surgery
wound healing and pain management in partial thickness burns

Conditions: Pain

Summary: the aim of the study is to compare between two advanced wound dressing and conventional dressing for the primary er treatment of superficial partial thickness burns


Eligibility criteria:
inclusion criteria: patients with minor superficial partial thickness burns exclusion criteria: co-morbidities, pregnancy

Keywords: wound healing pain burn
luteal vs follicular surgical oophorectomy and tamoxifen in premenopausal women with metastatic hormone receptor positive breast cancer

Conditions: Breast Cancer

Summary: this study will determine if hormone receptor positive premenopausal metastatic breast cancer patients who undergo removal of the ovaries in mid-luteal versus mid-follicular phase have a longer survival.

rationale: previous research suggests that women who have their ovaries removed as part of their treatment for breast cancer may live longer if the ovarian surgery is performed during the luteal phase (last 14 days of the menstrual cycle) rather than the follicular phase (the first 14 days of the menstrual cycle). the current study will evaluate this important research question in premenopausal women with metastatic hormone receptor-positive breast cancer who will be treated with surgery and tamoxifen. purpose: the purpose of this research is to find out if premenopausal women with breast cancer that has spread to other parts of the body live longer if their ovaries are removed during the second half of the menstrual cycle. this study will compare how long women live if they have their ovaries removed during the first half of their menstrual cycle (follicular phase) to how long women live if they have their ovaries removed during the second half of their menstrual cycle (luteal phase). tamoxifen will also be given to study participants. treatment: study participants will have tests performed in advance of surgery to remove their ovaries. surgery will be performed within four weeks of these tests. the exact day will be determined by the study participant's menstrual history and by a process called randomization, which is a random decision making process to determine if each study participant will have their surgery during the first or second half of their menstrual cycle. on the day of surgery, blood will be taken immediately prior to surgery and three hours after surgery for hormone tests. after the surgery, study participants will be given tamoxifen in oral pills for daily consumption. study participants will be asked to return to the hospital every two months for tests and distribution of additional tamoxifen tablets. treatments will be discontinued for disease progression or unacceptable adverse effects.

Eligibility criteria:
inclusion criteria: * estrogen receptor or progesterone receptor positive breast cancer * premenopausal with regular menstrual cycles exclusion criteria: * current oral contraceptives

Keywords: metastatic secondary hormone receptor-positive breast cancer
perioperative anxiety in children

Conditions: Nurse's Role

Summary: the study was conducted to evaluate the effect of preoperative patient education given by three different methods on the level of perioperative anxiety in children aged 4-7 years. the research was carried out between 1 june - 31 november 2021 at tekirdag namık kemal university health practice and research center, department of pediatric surgery. a total of 66 patients, 22 patients in each group, who met the inclusion criteria and were included in the stratified randomization method, were included in the planned quasi-experimental study. research data were obtained by using the "patient diagnosis form" and the "anxiety scale in preschool children" administered before and after the surgery.

pre-operative patient education was given to the children in the first experimental group by the service nurse. the children in the second experimental group were given pre-operative patient education by the service nurse, in addition, patient visits were provided by the operating room nurse and the operating room environment was explained through play. the children in the third experimental group were given pre-operative patient education by the service nurse, after which they listened to the mother's voice recording and loving words until they went to the operating room. it was determined that 69.7% of the mothers of the children participating in the study were 30 years and older, 81.8% were married, 37.9% were undergraduate graduates, and 51.5% were unemployed. the general anxiety disorder levels of those who had no previous surgery experience were found significantly higher than those who had previous surgery experience (p\<0.05). in terms of affecting the anxiety level, there was a significant difference between the preoperative methods (p\<0.05). it was determined that the education given by both the service nurse and the operating room nurse together was more effective than other methods in reducing the anxiety levels of children, and there was a statistically significant difference between them. (p\<0.05)

Eligibility criteria:
inclusion criteria: * planned elective surgery related to pediatric surgery, * having no problems in communicating, * volunteer to participate in the research * children aged 4-7 years exclusion criteria: * children scheduled for emergency surgery

Keywords: anxiety child sick surgical nursing
a comparison between clobetasol propionate 0.05% (clobex®) spray and clobetasol propionate 0.05% (olux®) foam

Conditions: Psoriasis

Summary: the primary objective of this study is to evaluate the efficacy and safety of clobetasol propionate 0.05% (clobex®) spray compared to clobetasol propionate 0.05% (olux®) foam.

same as above.

Eligibility criteria:
inclusion criteria: * subjects must have a clinical diagnosis of moderate to severe plaque psoriasis, defined as 3%-20% of the body surface area involved exclusion criteria: * subjects who have surface area involvement too large that would require more than 50 grams per week of clobex® spray or more than 50 grams per week of olux® foam * subjects whose psoriasis involves the scalp, face or groin * subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis
a retrospective study of biomarkers in non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is: 1. to characterize the types and frequency of molecular alterations to the epidermal growth factor receptor (egfr) pathway, fgfr4 and eml-alk in asian patients with non-small cell lung cancer 2. to identify candidate biomarkers of importance in the egfr and estrogen pathways most, if not all, human malignancies including lung cancer are caused by somatic alterations of the genome, leading to activation of oncogenes or inactivation of tumor suppressor genes and their resultant oncogenic effects. in addition to mutations, increased chromosomal copy number (by amplification or polysomy) and dna methylation are other mechanisms of oncogene activation and tumour suppressor gene inactivation respectively. little is known about the relationship between these oncogenes of the egfr family and the recently described oncogenes fgfr4 and fusion gene eml4-alk. recent data suggests molecularly defined subgroups of non-small cell lung cancer (nsclc) exist and can be used to predict for sensitivity to targeted agents (erlotinib or gefitinib) or cytotoxic chemotherapy (pemetrexate, gemcitabine, platinum agents). the findings that estrogen receptors are present in lung tumours and that estrogen can stimulate growth and proliferation of lung cancers in vitro and in vivo are provocative. further studies to evaluate the role of estrogens and other sex hormones in lung cancer are warranted. a further understanding of the molecular indicators of lung cancer prognosis and treatment prediction would improve drug development and patient treatment selection. archived paraffin-embedded and fresh frozen nsclc tumor tissue will be obtained via the department of pathology and the national university tissue repository respectively. clinico-pathological characteristics will be obtained from the case records, pathology and tissue repository. dna will be isolated using standard techniques. sequencing of genes in the egfr signaling pathway: egfr, kras, erbb2, erbb3, met, pi3k, and braf as well as fgfr4. unstained slides from the paraffin-embedded tissue will be obtained and subjected to fluoresce in vitro hybridization (fish) for breakpoints in the eml4 and alk genes as previously described. for cases that have been snap-frozen, rna will be extracted and eml4-alk fusions will be confirmed using rt-pcr and pre-specified primers. to analyse the expression of proteins of putative relevance to egfr function (such as egfr, erbb2, erbb3, akt, met, stat, erk, mapk, cyclin d1, c/ebpa), downstream effects of egfr: cell proliferation (ki-67), angiogenesis (cd34, vegf-a), apoptosis (bcl-2), metastasis, and hormonal influence (oestrogen and progesterone receptors, aromatase), tma technology will be utilised. the status of the tumor suppressor genes pten and c/ebpa will be analysed.


Eligibility criteria:
inclusion criteria: * nil exclusion criteria: * nil
a biochip for rapid diagnosis of complicated urinary tract infection

Conditions: Urinary Tract Infections; Bladder, Neurogenic

Summary: the purpose of this proposal is clinical validation of an electrochemical biochip for rapid pathogen identification and antibiotic susceptibility determination.

point-of-care identification of pathogens and determination of antibiotic susceptibility will significantly improve the clinical management of urinary tract infection. we have previously developed a biochip based on microfabrication technology capable of rapid detection of pathogens. the specific objectives of the current proposal are: 1) determination of microbial constituents in spinal cord injury (sci) patients and development of additional species-specific probes against these pathogens; 2) development of a rapid antibiotic susceptibility and molecular pyuria assay using the electrochemical biochip; and 3) clinical validation of the biochip as a diagnostic test for urinary tract infection. within a single protocol, two non-interventional studies were conducted at different time points to achieve the aforementioned objectives. sensitivity and specificity of the electrochemical biosensor based assay was demonstrated in each study.

Eligibility criteria:
inclusion criteria: * patients suspected or at risk for complicated urinary tract infections exclusion criteria: * gross contamination of urine samples at the time of collection

Keywords: rna, ribosomal, 16s biosensing techniques microchip analytical procedures
large scale demonstrator, webportal diabetes

Conditions: Diabetes Mellitus Type 2

Summary: rationale: accounting for the growth, aging and detrimental life style changes in the dutch population, the investigators expect further growth of number of known diabetes patients. the economic burden with this increase will be enormous, the healthcare system is under increasing pressure to provide better but more time efficient service to more people with limited human resources. the investigators hypothesize that, by increasing the patients self-management by offering remote care services, this reduction of the individual caseload can be achieved. objective: primary objective is to test the hypothesis that the consistent use of a web portal and its educational content and the possibility to review personal diabetes related data for type 2 diabetes patients (t2dm) in the primary care setting, will result in an improvement quality of life. study design and methods: in this prospective observational cohort study the investigators examine the effect of the voluntarily use of a web portal and its educational content. the primary end point is health related quality of life. we predefined a clinically relevant difference of 0.074 in the eq-5d index score. secondary endpoints are diabetes-related distress and well being and a selection of clinical measurements, number of contacts with health care provider and the amount of prescribed medication. the participants are being followed for 1-year and the data will be collected at baseline, after 6 months and 12 months.


Eligibility criteria:
inclusion criteria: * a diagnosis of type 2 diabetes mellitus, as registered in the primary care system under the diagnosis t90.2, and where the gp is defined as the main care giver * aged 18 years or older exclusion criteria: cohort study: * none intervention study: * mental retardation or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past * insufficient knowledge of the dutch language to understand the requirements of the study and/or the questions posed in the questionnaires * life expectancy \< 1 year due to malignancies or other terminal illnesses * cognitive impairment, including dementia, that interferes with trial participation * any condition that the investigator and/or coordinating investigator feels would interfere with trial participation or evaluation of results