Kornimate/medical-research-clean huggingface dataset:
development of a drill guidance system to aid intra-operative surgical drilling

Conditions: Orthopaedic Surgery

Summary: the investigators have developed a camera based drill guidance system to improve the accuracy of surgical drilling. the aim of the study is to assess: accuracy in vivo safety acceptability of use amongst surgeons and theatre staff

this project is a collaboration between the royal united hospitals bath and the department of mechanical engineering at the university of bath in the development of a drill guidance system to aid intra-operative surgical drilling in orthopaedic and trauma surgery. the types of operation will include drilling into bones to place screws or wires to develop a track for passage of a screw, suture or other material. the project has been funded by an national institute for health invention for innovation grant (nihr i4i) over 3 years. the drill guide system (dgs) has been developed so it can be attached to a surgical drill with the overall aim of improving the accuracy of surgical drilling of holes in bones. the drilling will be performed as standard, i.e. as required for any specific operation. the drill guide will be an adjunct to visual observation by the surgeon and fluoroscopy (peri-operative radiographs - x-rays). the surgeon can decide to not use the drill guide if it is considered to be hampering the operation. a camera and computer based system attached to a surgical drill will be used to improve drilling accuracy in an operating theatre the drill guidance system has undergone rigorous testing and various laboratory trials with surgeons and operating staff as part of development of the design. the final prototype will be used as part of a wider clinical trial involving orthopaedic surgeons at the royal united hospitals bath and the great western hospital, swindon (within the nhs) to test the efficacy and value of the system during surgery. the investigators intend to recruit up to 30 surgical patients as part of the trial from two sites. background: it is recognised clinically and in laboratory studies that "freehand" drilling has appreciable inaccuracies. this risks misplacement of screws potentially compromising surgical outcome and increasing the risk of complications. furthermore, inaccurate initial drilling can lead to inaccurate subsequent drilling and so suboptimal positioning of the screw/wire with potential adverse outcomes and increased costs. the screw may be placed and then have to be changed. a new different length screw may be required with the first screw discarded with further costs.

Eligibility criteria:
inclusion criteria: * adults, i.e. 18 years or over; * awaiting orthopaedic or trauma surgery; * have capacity to consent to participate in the study * the proposed operation is deemed to be appropriate by the treating orthopaedic surgeon for use of the dgs exclusion criteria: * children, i.e. \< 18 years of age * the patient is unable to give informed consent; * the surgeon does not feel able to use the dgs * the surgeon does not feel use of the dgs is appropriate for the type of surgery required

Keywords: orthopaedic fracture drill screw wire accuracy
strategies of interruption/reinitiation of antiretroviral therapy in hiv-infected patients with lipodystrophy

Conditions: HIV-Associated Lipodystrophy Syndrome

Summary: aim: to assess the safety on the progression of hiv infection and the efficacy on the evolution of metabolic parameters and body fat of either viral load- or cd4 cell-driven strategies of intermittent treatment in chronically hiv-1-infected persons. design: pilot, prospective, open, randomized, controlled 3-year study. setting and patients: university hospital. patients with viral load \ 450/mm3 for at least the last 3 months. three arms with 50 patients each, that will be randomized either to continue antiretroviral therapy, or to discontinue it as long as either hiv-1 rna be lower than 30000 copies/ml or cd4 cell count be higher than 300/mm3. study end-points: evolution of plasma metabolic parameters, body fat, and bone mineral density; incidence of adverse effects due to antiretroviral therapy and symptoms consistent with acute retroviral syndrome; incidence of virological failure (plasma hiv-1 rna \>200 copies/ml while on therapy), immunological failure (cd4 cell count \<200/mm3 while on therapy), or clinical failure (development of aids-defining illnesses); cost of antiretroviral therapy administered and time free of therapy in the arms assigned to intermittent treatment; and the evolution of t lymphocyte subpopulations and the development of proliferative and cytotoxic responses against hiv.


Eligibility criteria:
inclusion criteria: * hiv-infected patients * on stable antiretroviral therapy * viral load below 200 copies/ml * cd4 above 450 cells/mcl during last 3 months exclusion criteria: * weight variation higher than 10% compared with previous stable weight * active (cdc-c) opportunistic events * major depression or schizophrenia under psychiatric treatment * lack of clinical stability * pregnant women or planning pregnancy

Keywords: lipodystrophy treatment interruption hiv
alogliptin tablets specified drug-use survey "type 2 diabetic patients receiving combination therapy with a hypoglycemic agent (e.g., insulin preparations or rapid-acting insulin secretagogues)"

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this survey is to evaluate the safety and efficacy of long-term use of alogliptin tablets (nesina tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues)\* in addition to dietary/exercise therapy. participants will receive alogliptin as part of routine medical care. \* patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use surveys for alogliptin tablets.

this survey was designed to evaluate the safety and efficacy of long-term use of alogliptin tablets (nesina tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues) in addition to dietary/exercise therapy. participants will receive alogliptin as part of routine medical care. for adults, 25 mg of alogliptin is usually administered orally once daily.

Eligibility criteria:
inclusion criteria: -type 2 diabetic patients meeting the following criteria are included in this survey: patients who have had an inadequate response to the following medications/therapies: • use of one hypoglycemic agent such as insulin preparations and rapid-acting insulin secretagogues, excluding other types of hypoglycemic agents (e.g., α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides)\*, in addition to dietary/exercise therapy \* for use of alogliptin tablets in combination with these agents, a specified drug-use survey is currently ongoing. exclusion criteria: -type 2 diabetic patients who meet any of the following criteria are excluded from this survey: patients with contraindications for alogliptin tablets 1. those with severe ketosis, in a state of diabetic coma or precoma, or with type 1 diabetes mellitus \[quickly rectifying hyperglycemia with administration of intravenous fluid or insulin is essential in these patients; therefore, administration of alogliptin tablets is not appropriate.\] 2. those with severe infections, before or after surgery, or with serious trauma \[controlling blood glucose with an injection of insulin is desirable for these patients; therefore, administration of alogliptin tablets is not appropriate.\] 3. those with a history of hypersensitivity to any of the ingredients of alogliptin tablets

Keywords: pharmacological therapy
high energy formula feeding in infants with congenital heart disease

Conditions: Growth Failure; Neurodevelopmental Disorder

Summary: high energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

infants with congenital heart disease (chd) usually show growth retardation as they can not intake enough calorie due to fluid restriction. we hypothesize that high energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

Eligibility criteria:
inclusion criteria: * infants \>35 weeks of gestational age * infants with chd * i̇nfants fed with formula feeding exclusion criteria: * major congenital abnormalities except chd * infants could not be fed enterally

Keywords: congenital heart disease, growth,neurodevelopment
adaptation and validation of the arabic version of euroqol 5d-5l

Conditions: Validation Study

Summary: the aim of the work is to provide a validated arabic version of euroqol 5d-5l ,so that it would be used as a quality of life assessment tool for egyptian patients specific objectives: 1. cross cultural adaptation of the translated arabic version of euroqol 5d-5l. 2. assessment of the reliability of the translated arabic version of euroqol 5d-5l. 3. testing the validity of the translated version of euroqol 5d-5l.

chronic back pain is one of the most important disabling illnesses. it has a high incidence, high prevalence and high cost to society. one of the most common causes of back pain are degenerative spine diseases which aﬀect all aspects of quality of life (qol) of the patients. they could aﬀect job opportunities, social activities and hinder the patients from performing common daily activities.it was found that many factors could affect quality of life of spine degenerative diseases patients such as sex, age, body mass index (bmi), employment status , living with other family members, smoking, orthopedic disorder in another part of the body (other than spinal disease), history of spinal surgery, and bladder function. comprehensive assessment of these patients should include health related quality of life (hrqol) measures in addition to the objective clinical measures of the diseases. europeans quality of life questionnaire 5 dimensions ,5 levels (eq-5d-5l) is a standardized measure of health status developed by the euroqol group which provides a simple, generic measure of health for clinical and economic appraisal (2).despite being translated and validated in many languages, there is no validated arabic version of eq-5d-5l to measure the quality of life. the objective of this study is to evaluate the reliability and validity of the arabic version of the questionnaire for egyptian patients diagnosed to have spine degenerative diseases.

Eligibility criteria:
inclusion criteria: * patients operated upon for spine degenerative disease coming for follow up in the outpatient clinics. exclusion criteria: * preoperative patients and immediate postoperative patients.
smartrisk stroke prediction by mri of carotid disease

Conditions: Atherosclerotic Disease, Carotid

Summary: atherosclerotic plaque at the carotid artery bifurcation is a major source of stroke. the purpose of this investigation is to determine the ability of the smartrisk software module to predict stroke or stroke-related events due to carotid plaque within a high-risk population. the smartrisk software module operates on magnetic resonance images (mri) of the carotid artery wall.

carotid artery disease (atherosclerosis) is a major cause of stroke that can be treated with carotid endarterectomy surgery (cea) or stenting. subjects with moderate, asymptomatic stenosis (50-79% narrowing) typically do not undergo intervention because the procedural risks outweigh the benefits. however, some of these individuals will have vulnerable plaque that places them at high risk of stroke, but current diagnostic techniques for vulnerable plaque are lacking. recently, vpdiagnostics developed a new module - smartrisk - that stratifies risk of stroke for stenotic (50-79% blockage) atherosclerotic plaque. the smartrisk module uses mri data to compute a risk assessment from a specific atherosclerotic plaque. a continuous risk value is generated and patients with risk values above a prespecified threshold are at elevated risk for cerebrovascular events arising from carotid artery disease. the purpose of this trial is to determine whether the smartrisk module is effective at stratifying risk of a carotid-related cerebrovascular event in subjects with asymptomatic 50-79% carotid stenosis.

Eligibility criteria:
inclusion criteria: * 50-79% stenosis of the carotid artery * age 18 or older * no ischemic neurovascular symptoms within preceding 6 months exclusion criteria: * contraindication to mri (e.g. weight \> 130 kg, pregnancy) * prior or planned carotid endarterectomy or stenting * history of atrial fibrillation * prior neck irradiation

Keywords: carotid artery atherosclerosis stroke transient ischemic attack mri software risk
physiologic tension of the abdominal wall

Conditions: Abdominal Wall Hernia

Summary: restoring the physiologic tension of the abdominal wall is a key concept in abdominal wall reconstruction. yet little is known quantitatively about the normal tension of the abdominal wall. to better understand the ideal tension for abdominal wall reconstruction, the physiologic tension of the abdominal wall needs to be measured. this study aims to measure the tension of the abdominal wall during laparotomy closure.


Eligibility criteria:
inclusion criteria: * patients undergoing laparotomy * patient able to provide informed consent exclusion criteria: * presence of a ventral hernia * patients unable to provide informed consent
safety and immunogenicity of novartis meningococcal b vaccine formulated with omv manufactured at two different sites, in healthy adolescents aged 11-17 years

Conditions: Meningococcal Disease; Meningococcal Meningitis

Summary: the primary objective of this study is to demonstrate the equivalence of rmenb+omv nz lot 1 to rmenb+omv nz lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hsba) geometric mean titers (gmts) against 3 n. meningitidis serogroup b reference strains (h44/76, 5/99, and nz98/254) and as measured by elisa geometric mean concentrations (gmcs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.

novartis will consider this study a success if, at one month following the second vaccination, the two-sided 95% ci of the ratio of the hsba gmts for each of 3 serogroup b reference strains (h44/76, 5/99, and nz98/254) and the two-sided 95% ci of the ratio of the elisa gmcs against vaccine antigen 287-953 are contained within the interval (0.5, 2.0).

Eligibility criteria:
inclusion criteria: * male and female subjects (11-17 years of age inclusive) who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment * who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period) * in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. exclusion criteria: * history of any serogroup b meningococcal vaccination * current or previous, confirmed or suspected disease caused by n. meningitidis * exposure to an individual with any laboratory confirmed n. meningitidis infection within 60 days of enrollment * significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥ 38.0 °c) within the previous day * antibiotic use within 3 days (72 hours) prior to enrollment * pregnancy or nursing (breastfeeding) mothers * females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study. if sexually active the subject must have been using one of the accepted birth control methods for at least 30 days prior to study entry * any serious chronic or progressive disease, known or suspected impairment/alteration of the immune system * receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days * history of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component

Keywords: meningococcal meningitis prevention, vaccination adolescents
d-dimer to improve anticoagulation outcome during ecmo long-term supported

Conditions: Extracorporeal Membrane Oxygenation Complication; Thrombosis; Hemorrhage; Heparin Overdose

Summary: this was a prospective, cohort study.

adult patients receiving ecmo surpport in wuhan asia heart hospital were enrolled by cohort. unfractionated heparin was used for anticoagulation therapy, aptt or anti-xa activity is monitored for dose adjustment. meanwhile, d-dimer is mornitored. if d-dimer levels continue to rise (\>1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; if the d-dimer levels is stable (\<1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding). all patients were followed up the occurrence of endpoints during in-hospital and 30 days after discharge, including bleeding events, thrombotic events and all-cause deaths were recorded.

Eligibility criteria:
inclusion criteria: * adult patients * receiving ecmo surpport for any reason exclusion criteria: * the duration of ecmo surpport was less than 24 hours . * those who had difficulty in compliance or were unavailable for follow-up.

Keywords: d-dimer extracorporeal membrane oxygenation heparin anticoagulant
the real-world treatment satisfaction by gefapixiant in rcc

Conditions: Chronic Cough

Summary: chronic cough has a high global prevalence and it is refractory to such treatments by approximately 20% of patients. gafapixant is a p2x3 receptor antagonist that has demonstrated the reduction of cough in patients with refractory chronic cough(rcc). taste disturbance is the most frequent adverse event by gefapixant (approximately 60-70%). although gefapixant is well-tolerated even if taste disturbance has occurred, the impact of taste disturbance on cough-specific qol remains to be unclear. therefore, the investigator would like to evaluate factors related to treatment satisfaction by gefapixant in rcc patients. the investigator hypothesize that taste disturbance will be associated with the improvement of cough specific qol and treatment satisfaction in rcc patients.

chronic cough has a high global prevalence, but appears to be poorly recognized. most patients respond to specific treatments against causes of chronic cough. meanwhile, cough is refractory to such treatments by approximately 20% of patients and they are regarded as "refractory chronic cough (rcc). gafapixant is a p2x3 receptor antagonist that has demonstrated the reduction of cough in patients with rcc through the inhibition of atp transmission to afferent nerves. according to the cough-1 and cough-2, taste disturbance is the most frequent adverse event by gefapixant, with the incidence of 59.3% in cough-1 and 68.9% in cough-2, respectively. although 45 mg of gefapixant is well-tolerated even if taste disturbance has occurred, the impact of taste disturbance on cough-specific qol remains to be unclear in rcc and ucc. furthermore, both taste disturbance and the improvement of cough by gefapixant would be associated with treatment satisfaction. therefore, the investigator would like to evaluate factors related to treatment satisfaction by gefapixant in rcc patients. the investigator hypothesize that taste disturbance will be associated with the improvement of cough specific qol and treatment satisfaction in rcc patients. furthermore, the investigator would like to evaluate the association of taste disturbance with cough-specific qol in the real-world clinical practice. in addition, there are no biomarkers available that can predict the efficacy of the improvement of cough by gefapixant. the investigator will also explore biomarkers that can be helpful in predicting well response to gefapixant in rcc and ucc patients.

Eligibility criteria:
inclusion criteria: 1. adult patients with rcc and ucc (8 weeks or more). 2. cough is refractory to intensive specific treatments for causes of chronic cough. 3. never smokers and ex-smokers with having smoking history of ≤20 pack-years. exclusion criteria: 1. patients with lung cancer, interstitial lung diseases, bronchiectasis, or respiratory infection such as tuberculosis and acute pneumonia. 2. current smoker, ex-smokers with having smoking history of \>20 pack-years, or those who quit smoking within six months prior to receiving gefapixant. 3. those who are pregnant.

Keywords: chronic cough gefapixiant
usability of the foresee home in intermediate age related macular degeneration (amd) patients

Conditions: Age Related Macular Degeneration

Summary: the study purpose is to demonstrate that the target population can receive a packed foresee home unpack it, install and operate it to an extent that the foresee home can monitor them for changes in the visual field with good specificity. and evaluate the device usage on a small scale, at the subjects' homes before a commercial use.

numerical output of the foresee home, output of the usability parameters provided by the foresee home device, counts of the number of subjects who successfully set up the device and conduct testing sessions.

Eligibility criteria:
inclusion criteria: * capable and willing to sign a consent form and participate in the study * subjects diagnosed as intermediate amd in at least one eye (in case a patient will convert during the study period he will be excluded) * age more than 50 years * va with habitual correction better than 20/60 in the study eye * ability to speak, read and understand instructions in english or hebrew * familiar with computer usage exclusion criteria: * evidence of macular disease other than amd or glaucoma in the study eye * presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, cfp. * any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye * never been tested on the php device * participation in another study with the exclusion of areds study * patients diagnosed with geographic atrophy (ga)

Keywords: hmp, cnv, amd, php, hphp, foresee
an observational study of peginterferon alfa-2a plus ribavirin for hepatitis c virus (hcv) infection in austria

Conditions: Hepatitis C

Summary: this noninterventional, open-label study will observe the safety and tolerability of peginterferon alfa-2a in combination with ribavirin among austrian participants treated for hcv infection according to routine practice.


Eligibility criteria:
inclusion criteria: * ongoing treatment with peginterferon alfa-2a and ribavirin at the discretion of the prescribing physician * hcv infection exclusion criteria: * none specified