Kornimate/medical-research-clean huggingface dataset:
non-invasive diagnostics of iron deficiency in surgical patients by measuring zinc protoporphyrin-ix

Conditions: Iron-deficiency; Anemia; Iron Deficiency Anemia

Summary: * in approx. 40% of the incidences anemia is caused by iron deficiency (= id). in turn, preoperative iron-deficiency anemia (= ida) is associated with an increase in morbidity and mortality as well as with the need for a blood transfusion. * a successful preoperative treatment of ida via iron supplementation requires a timely screening of iron deficiency, typically done by analyzing specific blood parameters. this however of course requires drawing a blood sample which further reduces the patients' blood volume and is in many cases stated as an inconvenient procedure. * measured in blood zinc protoporphyrin-ix (= znpp) is an established parameter to detect id. * this study aims to evaluate a prototype device detecting znpp non-invasively in the intact oral mucosa of surgical patients. * results from the non-invasive measurement will be compared to reference measurements of znpp from residual blood samples (hplc analysis) as well as to other parameters including hb level and iron profile (mch \[= mean corpuscular hemoglobin\], mcv \[= mean corpuscular volume\], ferritin, transferrin, transferrin saturation, soluble transferrin receptor, crp).

the non-invasive measurements will be performed using a prototype device based on fluorescence spectroscopical techniques. in brief, light (restricted wavelengths: 407 / 425nm) will be used to excite znpp molecules within the blood of the oral mucosa by means of an optical fibre prob. the outgoing fluorescence emission of the excited molecules will be analyzed using a spectrometer and converted to a znpp value \[unit: µmol/mol heme\] using mathematical transformations as well as spectral fitting. this study compares the diagnostic performance of iron deficiency based on non-invasive measurements of zinc protoporphyrin with results based on standard laboratory procedure (i.e. znpp measured in whole blood sample using hplc) and blood values assessed during clinical routine, respectively. if results of non-invasive and reference measurement techniques yield coinciding results, the non-invasive method could provide an improved mean to detect iron deficiency and thereby to improve treatment of patients suffering from iron deficiency anemia.

Eligibility criteria:
inclusion criteria: * age \> 18 years exclusion criteria: * patients who received a blood transfusion less than 8 weeks before examination * pregnancy

Keywords: iron-deficiency anemia iron-deficiency anemia zinc protoporphyrin
effect of barbed suture fascia closure on incisional hernia in midline laparotomy for gynecological diseases (barbher)

Conditions: Gynecologic Disease

Summary: investigators will compare the incidence of incisional hernia in women who underwent midline laparotomy whose abdominal fascia was closed with barbed suture vs. conventional non-barbed suture.


Eligibility criteria:
inclusion criteria: * anticipating midline laparotomy for gynecologic diseases * ecog performance status 0 - 2 exclusion criteria: * previous or current abdominal incisional hernia * pregnant * previous radiation on abdomen area * allergy to pds or irgacare mp * having disease affecting wound healing such as uncontrolled dm, autoimmune vasculitis, liver cirrhosis, coagulopathy * bmi \> 35 * current or anticipated use of drugs affecting wound healing such as bevacizumab (with 4 week drug free period, bevacizumab user is eligible) * abdominal midline laparotomy within 6 months * surgery for infection control
correlation between the genetic and neuroimaging signatures in newly diagnosed glioblastoma patients before surgery

Conditions: Glioblastoma

Summary: this pilot clinical trial studies the correlation between the genetics and brain images of patients with newly diagnosed glioblastoma before surgery. the genetic characteristics of a tumor are an important way to predict how well it will respond to treatment. imaging, using magnetic resonance imaging (mri), takes detailed pictures of organs inside the body, and may also provide information that helps doctors predict how brain tumors will respond to treatment. if mri can provide doctors with similar information about the tumor as the tumor's genes, it may be able to be used to predict tumor response in patients whose tumors cannot be reached by surgery or biopsy to get tissue samples.

primary objectives: i. determine the correlation between the genetic and neuroimaging signature of glioblastoma. ii. determine the correlation between the neuroimaging signature of glioblastoma and prognosis. outline: patients undergo mri before and after gadolinium contrast administration, including 3-dimensional (3d) volumetric t1-weighted sequence, fluid attenuated inversion recovery (flair) sequence, diffusion weighted imaging, and perfusion mri. tissue samples are also analyzed for the tumor genetic profile.

Eligibility criteria:
inclusion criteria: * patients who will be undergoing surgery for newly-diagnosed glioblastoma * subtotal, gross total or biopsy patients will be eligible * confirmation of pathology as glioblastoma exclusion criteria: * tissue analysis demonstrating pathology other than glioblastoma * patients with a contraindication to having mr imaging (e.g. pacemaker) or contrast mr administration (e.g. hypersensitivity to gadolinium or renal insufficiency above the institutional threshold for administration of contrast); patients with hypersensitivity to mr contrast may be able to participate if it has been established that premedication will mitigate the hypersensitivity reaction
pharmacokinetics of nebulized amikacin in non invasive ventilated healthy volunteers.

Conditions: Acute Respiratory Insufficiency; Chronic Respiratory Insufficiency; Bronchospasm and Obstruction

Summary: the purpose of the study is to compare the pharmacokinetics of nebulized amikacin administered with three vibrating mesh nebulizers coupled with a single limb circuit bilevel ventilator in healthy volunteers. following our previous in vitro study, our hypotheses are that the pharmacokinetics varies among the devices tested and that a most efficient device can be identified.


Eligibility criteria:
inclusion criteria: * no contraindication of amikacin * written informed consent * negative pregnant test (for women) exclusion criteria: * history of respiratory disease * history of renal disease * history of otological disease

Keywords: non invasive ventilation single limb circuit ventilator bilevel nebulization nebulizer vibrating mesh nebulizer amikacin
the influence of suture method in conjunctival autograft transplantation on postoperative ocular discomfort for primary pterygium

Conditions: the Efficacy and Effect on Patient Comfort of a Hidden-knot Continuous Suture for Pterygium Excision With Conjunctival Autograft

Summary: to evaluate the efficacy and effect on patient comfort of a hidden-knot continuous suture for pterygium excision with conjunctival autograft，compared with two-knot continuous sutures and multi-knot interrupted sutures.


Eligibility criteria:
inclusion criteria: * patients with primary pterygium exclusion criteria: * eye surgery history * acute ocular surface imflamation * patients with coagulation or diabetes mellitus
efficacy of axial stability on improving gait and balance performance in children with dyskinetic cerebral palsy

Conditions: Cerebral Palsy

Summary: the aim of this study will be to evaluate the effect of theratogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy.

the aim of this study will be to evaluate the effect of theratogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy. forty children with dyskinetic cp will be assigned randomly into two groups (a \& b). control group (a) will receive conventional rehabilitation program for postural correction 2 hours/3 sessions weekly/3 successive months. study group (b) will receive conventional rehabilitation program as in group (a) in addition to wearing thera togs soft orthotic undergarment. patients evaluation will be carried out before and after the intervention programs to assess gait and balance performance using noraxons myo pressure plate and biodex balance system.

Eligibility criteria:
inclusion criteria: * the levels of gross motor function will be selected between levels i and ii according to gross motor function classification system (gmfcs); have the ability to walk 10 m independently without an orthosis; should be cognitively competent and able to understand and follow instructions; height will be more than 100 cm to fit with the biodex balance equipment. exclusion criteria: * if participants use an assistive mobility device; gmfcs levels iii, iv, and v; fixed contractures of lower limb musculature; hip dislocation; significant spinal deformities.
retrospective evaluation of adult and pediatric transfusion-dependent patients treated with deferasirox therapy

Conditions: Iron Overload

Summary: iron overload is a leading cause of morbidity and mortality in transfusion-dependent patients. deferasirox is the most promising iron chelator agent in several clinical scenarios. the investigators propose a retrospective study (chart review) to evaluate comprehensive iron overload management in transfusion-dependent patients treated with deferasirox for up to 5-10 years in a real clinical practice setting.


Eligibility criteria:
inclusion criteria: * transfusion- dependent patients (\> 2 years); * ongoing deferasirox therapy during the study period; * ≥ 2 magnetic resonance scans (one at baseline and at least one post baseline - as per clinical need) during study period (this criteria is not mandatory for patients undergoing only the endocrine subanalysis and participating only to the cardiac analysis); * available medical history including relevant clinical and laboratory data (e.g serum ferritin, liver function tests, renal function tests, endocrine parameters ) at baseline before starting deferasirox treatment exclusion criteria: * non transfusion- dependent patients; * other chelation therapy than deferasirox; * absence of complete medical history as above specified

Keywords: iron overload thalassaemia deferasirox magnetic resonance endocrine function
a clinical study to evaluate the long-term safety (12 months) of the combination of aliskiren 300 mg and hydrochlorothiazide 25 mg

Conditions: Hypertension

Summary: the purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with hctz 25 mg.


Eligibility criteria:
inclusion criteria: 1. their successful completion of the cspp100a2302 core study with at least eight months combination treatment of aliskiren 300 mg and hctz 25 mg, i.e., patients who received aliskiren 300 mg and hctz 25 mg at month 4 of the core study and complete the core study. 2. absence of ongoing severe adverse events at visit 10.

Keywords: hypertension aliskiren hydrochlorothiazide
physical and cognitive function - look ahead ancillary study

Conditions: Diabetes; Weight Loss; Physical Function; Cognitive Function

Summary: obesity is associated with physical disability through both direct pathways (e.g., lower extremity pain, insufficient muscle strength) and indirect pathways (obesity-related comorbidities and inflammation). furthermore, diabetes, a major obesity-related health condition, is associated with increased risk of disability and accelerated declines in physical and cognitive function. the investigators preliminary data suggest that intentional weight loss improves physical function, and there is strong circumstantial evidence that it would also benefit cognitive function. to evaluate the role of intentional weight loss on physical and cognitive function, the investigators propose an ancillary study to the on-going look ahead (action for health in diabetes) trial. look ahead is a multi-center, randomized clinical trial to examine the effects of a 4-year lifestyle intervention designed to achieve and maintain weight loss through decreased caloric intake and exercise in overweight or obese men and women aged 45-74 years with type 2 diabetes. the investigators propose to add validated and well-established measures of physical and cognitive performance to the year 8 follow-up visit - during the trial's weight maintenance phase - in \~1000 participants at 4 of the 16 look ahead field sites (colorado, memphis, pennington and pittsburgh). the specific aims of this ancillary study are: 1) to determine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss on physical function; and 2) to determine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss on cognitive function. in addition, the investigators hypothesize that in the intervention group, larger initial weight loss, better weight loss maintenance, and higher physical activity will be associated with better physical and cognitive function. the investigators also hypothesize that in the control group weight loss will be associated with worse physical and cognitive function than in those who are weight stable or who have gained weight. the number of obese older adults is rising rapidly and there are few data to guide an evidence-based clinical response to their management. the results of this study will provide the first direct evidence of the role of long-term intentional weight loss on the maintenance of physical and cognitive function in older obese adults with diabetes. since this study is being done as an ancillary study to an on-going trial it can be done in a timely and cost-efficient manner.


Eligibility criteria:
inclusion criteria: * the only inclusion criterion is that the participant is considered "active" at his/her year 8 or year 9 visit in the main study. exclusion criteria: * the only exclusion criterion is the person is not willing to participate in this ancillary study.
a trial evaluating efficacy and safety of prophylactic administration of concizumab in patients with severe haemophilia a without inhibitors

Conditions: Haemostasis; Haemophilia A

Summary: this trial is conducted in asia, europe and the united states of america (usa). the aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in patients with severe haemophilia a without inhibitors.


Eligibility criteria:
inclusion criteria: - informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine the suitability for the trial - male patients aged 18 years or older at the time of signing informed consent, diagnosed with severe haemophilia a (fviii activity below 1%), based on medical records or results at screening exclusion criteria: - known or suspected hypersensitivity to trial product(s) or related products - known inherited or acquired bleeding disorder other than haemophilia a - presence of inhibitors (neutralising antibodies) to factor viii (equal to or above 0.6 bethesda units) at screening measured by the nijmegen method
classification of heart failure in children

Conditions: Heart Failure

Summary: evaluation of severity of heart failure in children attending cardiology unit, assiut university children hospital

heart failure (hf) has been defined as an abnormality of cardiac structure or function leading to failure of the heart to deliver oxygen at a rate commensurate with the requirements of the metabolizing tissues, despite normal filling pressures (or only at the expense of increased filling pressures). heart failure may result from ventricular pump dysfunction, volume overload with preserved pump function, and pressure overload with preserved pump function.determinations of the degree of heart failure severity are essential for clinical assessment and treatment evaluation. remarkably, no readily applied standardized method of quantifying heart failure severity exists for pediatric patients. although standard index methods from the adult population, such as the new york heart association classification, have been applied to non-infant pediatric populations, none have been validated in children. the nyha classification measures functional capacity, not heart failure severity. the nyha classification is inappropriate for use in pediatrics because functional capacity and responses to heart failure states differ in children compared with adults. children have markedly different cardiac physiology, clinical presentations, and compensatory mechanisms. moreover, the etiologies of heart failure in children are very different from those in adults. for these reasons, ross et al.,developed a scale that is useful for grading heart failure severity in infants from birth to 6 months of age but is not applicable to older children and adolescents (original ross classification). many have since used the "ross classification," including wu et al., who confirmed an incremental rise in pne (plasma norepinephrine) concentrations and progressive down-regulation of β-receptor density in children with increasing ross class. in 1994, the canadian cardiovascular society's consensus conference statement on the "diagnosis and management of heart failure," adopted the ross classification as their official scoring system for children. ross propose an age-based ross classification using the original variables that proved to be sensitive and specific and adding the new evidence-based data. the age ranges of 0-3 months, 4-12 months, 1-3 years, 4-8 years, and 9-18 years were chosen because the variables in the classification are generally stable during these periods but vary between them. the scoring system can be used as a continuous data set for comparison with outcomes, or it can be categorized by points.

Eligibility criteria:
inclusion criteria: * cases admitted at pediatric cardiology unit, assiut university with heart failure manifestations. exclusion criteria: * primary liver diseases. * hematological diseases associated with organomegaly.
study of difluprednate ophthalmic emulsion in the treatment of postoperative inflammation

Conditions: Inflammation

Summary: the purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.

the objective is to assess efficacy endpoints in comparison with 0.1% bm ophthalmic solution, prior to investigation of the efficacy and safety of 0.05% dfba ophthalmic emulsion in the treatment of postoperative intraocular inflammation.

Eligibility criteria:
inclusion criteria: * patients undergoing intraocular surgery (cataract surgery, cataract surgery + implantation of intraocular lens, vitreous surgery, cataract surgery + implantation of intraocular lens + vitreous surgery) * patients with anterior chamber cell score ≥2 on the next day of surgery * male and female patients aged ≥20 years (on the day of obtaining informed consent) * patients giving written informed consent prior to initiation of the study exclusion criteria: * patients who did not meet all of the above inclusion criteria * patients receiving systemic administration of any corticosteroid or immunosuppressive drug, or topical application of corticosteroid ophthalmic ointment within 1 week before instillation of the investigational product * patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product (aqueous preparation: within 1 week before instillation of the investigational product, depot preparation: within 2 weeks before instillation of the investigational product) * patients receiving systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme * patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 24 hours before ophthalmic examination prior to instillation of the investigational product (on the next day of surgery) (except instillation of non-steroidal anti-inflammatory ophthalmic solution at 3, 2, 1 and 0.5 hours before surgery) * patients with endogenous uveitis * patients planning to undergo surgery of the contralateral eye during the study period * patients with new intraocular bleeding after surgery * patients receiving gas or silicon oil in the vitreous body * patients with glaucoma or ocular hypertension (iop on the next day of surgery ≥25 mmhg) * patients with superficial punctuate keratopathy or corneal ulcer * patients with any viral, bacterial or fungal keratoconjunctival disease * patients with allergy to any corticosteroid * patients requiring use of contact lens during the study period * women who were or might be pregnant, or lactating women * patients participating in another clinical study within 3 months before initiation of the present study * patients undergoing surgery under systemic anesthesia
pain control for breast cancer patients receiving injection of radioactive tracer

Conditions: Breast Cancer; Sentinel Lymph Node; Breast Neoplasms; Breast Cancer Female

Summary: the purpose of this study is to compare the effectiveness four different pain treatments for the injection of radioactive tracer that women with breast cancer receive for sentinel lymph node biopsies. this study will include women who have been diagnosed with breast cancer and who will be undergoing sentinel lymph node biopsy with a standard injection of radioactive tracer before surgery. a participant's active participation will take place on two separate occasions. in the first occasion, a participant will complete a brief pain assessment on the day of enrollment. the rest of a participant's active participation will take place on one day (the day of surgery) and last approximately 20 minutes, after which active participation will end.

primary objective: to test the effectiveness of four alternative approaches to topical anesthesia on pain associated with radiotracer injection for women diagnosed with breast cancer undergoing sentinel lymph node mapping. secondary objectives: 1. to assess patient satisfaction with pain control modality for radiotracer injection. 2. to identify barriers to implementation of the different pain control interventions.

Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years of age * biopsy proven breast cancer * standard radiotracer injection (intradermal injection in the upper outer quadrant of the involved breast) * radiotracer injection occurs on the same day as sentinel lymph node surgery exclusion criteria: * males * pregnancy * local anesthetic allergy or active use of the following medications: * abametapir (risk x) * conivaptan (risk x) * fusidic acid (risk x) * idelalisib (risk x) * mifepristone (risk d) * stiripentol (risk d) * amiodarone (risk c) * dofetilide (risk c) * dronedarone (risk c) * ibutilide (risk c) * sotalol (risk c) * vernakalant (risk c) * non-english speaking/reading * unable to provide informed consent * unable to participate with surveys * undergoing radiotracer injection the day prior to surgery or intra-operatively at the time of initial surgical scheduling * if patients are initially scheduled for same-day preoperative injection, complete all enrollment procedures (including randomization), and surgery is re-scheduled for a day prior to surgery or for intra-operative injection, they will be excluded if: * randomized to a lidocaine patch arm (arms c or d) * re-scheduled for an intra-operative injection • planned non-standard radiotracer injection site

Keywords: sentinel lymph node biopsy sentinel lymph node mapping radioactive tracer injection nuclear medicine radiocolloid injection