Kornimate/medical-research-clean huggingface dataset:
pinless-navigated versus conventional total knee arthroplasty

Conditions: Arthropathy of Knee

Summary: the success of total knee arthroplasty depends on a number of factors including pre-operative range of movement, obesity, medical comorbidities, prosthesis design, preparation and implantation of the prosthesis, soft tissue balancing, as well as implants alignment. optimal placement of the implants within 3° of the mechanical axis of the lower limb has been proven to reduce wear and early implant failure. compared to conventional techniques, computer-aided navigation total knee arthroplasty has been widely used in the last decade and have been proven to improve the accuracy of prosthesis placement and lower limb alignment by reducing the number of outliers with more than 3° deviation from the mechanical axis. however, its use also involves a steep learning curve, high initial capital cost and longer duration of surgery. traditional computer-navigated tka using optical tracking systems also requires fixation of the femoral and tibial reference arrays to bone using anchoring pins. complications reported with the use of these pins include either femoral or tibial fracture, pin site pain, pin site infection and osteomyelitis. the investigators study aims to investigate the accuracy of a new pinless navigation system for tka that will avoid these complications.

the duration of surgery and length of hospital stay were recorded for all patients. three radiographic measurements were recorded on the coronal films: 1) hip-knee-ankle angle (hka), the angle formed by the mechanical axis of the femur (line between the centre of the femoral head and the centre of the knee) and the mechanical axis of the tibia (line between the centre of the talus and the centre of the knee); 2) coronal femoral-component angle (cfa), the angle formed by the femoral component and the mechanical axis of the femur; 3) coronal tibia-component angle (cta), the angle formed by the tibia base plate and the mechanical axis of the tibia. the post-operative radiographic measurements were compared with the intra-operative readings from the pinless navigation system. the accepted values used in our study for normal alignment were: 1) 0° ± 3° varus/valgus for hka; 2) perpendicular (± 3°) to the mechanical axis of the femur; 3) perpendicular (± 3°) to the mechanical axis of the tibia.

Eligibility criteria:
inclusion criteria: * patients between the ages of 45 and 90 diagnosed with osteoarthritis of the knee and scheduled for unilateral total knee replacement. exclusion criteria: * patients coming for revision total knee arthroplasty * patients diagnosed with inflammatory arthritis

Keywords: total knee replacement, computer-assisted surgery
a multicentre trial to compare two articulating bearing surfaces as used in cementless primary hip arthroplasty

Conditions: Osteoarthritis

Summary: the aim of this study is to demonstrate the non-inferiority of the ceramic-on-metal articulation using large diameter bearings (38mm to 60mm) compared to the metal on metal articulation using the same cup in regards to the composite clinical success (ccs) rate at 2 years postoperatively (delta = 10% minimum clinically significant difference in rates).

this multicentre randomised controlled trial will compare the clinical outcome of the ceramic-on-metal articulation against a metal-on-metal articulation using the same recap acetabular cup. the metal ion release will be evaluated at predetermined postoperative intervals during the first 36 months. a trial will be conducted as a clinical trial in accordance with the medical devices directive 93/42/eec (2002). a total of 150 patients have to be recruited from the south african centre (2 groups) the initial study assessment period will be 48 months; 24 months recruitment and 24 months follow-up. the follow-up reviews will be at 6 weeks, 6 months, 1 year, 2 years and 3 years. a 5 year and 10 year clinical review will also be carried out with all patients. an assessment of incidences of adverse events and metal ion release concentrations will be made when all patients are at 6 months postoperatively.

Eligibility criteria:
inclusion criteria: * primary total hip replacement * patient with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of osteoarthritis,avascular necrosis, legg perthes, rheumatoid arthritis, diastrophic variant, fracture of the pelvis, fused hip, slipped capital epiphysis, subcapital fractures, traumatic arthritis * patients preoperative harris hip score \< 80 points * patients with limited co-morbidity - asa i - iii * patients with normal urea and electrolyte levels and creatinine levels * patients must be able to understand instructions and be willing to return for follow-up * patients willing to provide blood and urine samples for metal ion analysis at follow-up exclusion criteria: * patient preoperative harris hip score \> 80 points * pre-existing metal implants * patients with significant co-morbidity - assa iv - v * dementia and inability to understand and follow instructions * neurological conditions affecting movement * women younger than 45 years old * presence of symptomatic arthritis in other lower limb joints * patients requiring smaller than 38mm and larger than 60mm diameter femoral heads * patients taking nsaids and / all drugs that will affect bone metabolism
remote preconditioning and myocardial protection

Conditions: Congenital Heart Disease

Summary: remote ischemic preconditioning (ripc) of the myocardium by limb ischemia/reperfusion may mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.

the investigators will test if ripc will be associated with differential effects depending on background anesthesia. specifically, the investigators hypothesized that ripc during sevoflurane anesthesia attenuates myocardial injury in patients undergoing congenital cardiac defects repair surgery and that effects may be different during propofol anesthesia.

Eligibility criteria:
inclusion criteria: * pediatric scheduled for cardiac surgery requiring the cardioplegic arrest and cardiopulmonary bypass exclusion criteria: * previous cardiac surgery * urgent or emergent cases * patient with the following diseases diabetes mellitus ,hypertension ,renal failure, hepatic and pulmonary diseases

Keywords: remote ischemic preconditioning sevoflurane total intravenous anesthetic
the no-tie technique using the harmonic scalpel in total thyroidectomy with central neck dissection: a prospective randomized study

Conditions: Hemorrhage; Hypocalcemia; Vocal Cord Palsy

Summary: to investigate the safety and efficacy of the no-tie technique using the harmonic scalpel (hs) in terms of the operating time and complications in total thyroidectomy with central neck dissection (cnd). recently, the hs has been used as an alternative to conventional hand-tied ligation for hemostasis in thyroid surgery, which is a time-consuming procedure. very limited data have been published on evidence of its safety in total thyroidectomy accompanied by cnd without supplementary hand-tied ligation.


Eligibility criteria:
inclusion criteria: * patients with total thyroidectomy plus central neck dissection * if primary tumor size was more than 1 cm in papillary thyroid cancer * there was any evidence of lymph node enlargement in paratracheal lymph node group preoperatively or intraoperatively * patients who underwent minimal resection of the surrounding soft tissues, including the sternothyroid or sternohyoid muscle, for extracapsular extension of thyroid cancer exclusion criteria: * patients who required lateral compartment neck dissection or mediastinal dissection for preexisting lymph node metastasis * patients had clinical or laboratory indicators of coagulation disorders * patients with preexisiting vocal cord palsy, fixation of the tumor to the recurrent laryngeal nerve requiring trnasection of the nerve * patients with massive extracapsular extension to the surrounding soft tissues.

Keywords: thyroidectomy central neck dissection harmonic scalpel perioperative complications
controlled crossover study of aionx antimicrobial surface for the prevention of healthcare-associated infections

Conditions: Healthcare Associated Infection

Summary: this is a controlled open label efficacy study of aionx antimicrobial surface for the prevention of healthcare-associated infections.

the study is an open label controlled efficacy trial of aionx patented antimicrobial surface for the prevention of healthcare-associated infections (hais). it will take place at penn state hershey. half of the single occupancy rooms of the 5th and 7th floor will be assigned to contain the antimicrobial surface at five locations: bed rails, overbed table, door handles, counter, and arm rests of bedside chair. the remaining rooms will serve as controls. data on hais will be gathered for all the patients admitted to the rooms during the duration of the study. after 45 days the rooms will be flipped so that test rooms become controls and control rooms become test rooms. the duration of the study will be for a minimum of 90 days.

Eligibility criteria:
inclusion criteria: * admission to a single occupancy room in a participating floor at hershey medical center exclusion criteria: * refusal to participate in the study.
adapting and adopting highly specialized pediatric eating disorder treatment to virtual care: implementation research for the covid-19 context and beyond

Conditions: Anorexia Nervosa

Summary: the covid-19 pandemic has had detrimental effects on mental health. individuals with eating disorders (eds) are no exception, exhibiting increased symptoms and exacerbated feelings of isolation and anxiety. across canada, in-person outpatient services have been quickly replaced with virtual care, yet practitioners and patients have noted substantial challenges in adapting ed-related care virtually. given the success of our previous research on family-based treatment (fbt) for eds, as well as the rapid transition to virtual care during covid-19, there is an urgent need to adapt fbt to virtual formats and adopt it in the ed network. using a multi-site case study with a mixed method pre/post design, this study aims to examine the implementation of virtual fbt (vfbt) as well as its impact within six ed programs in ontario, building on the investigator's previous work, and further developing capacity in the system. the investigator will develop implementation teams at each site and provide a virtual training workshop on vfbt, with ongoing consultation during initial implementation. the investigator proposes to examine implementation success by studying fidelity to vfbt, as well as team and patient/family experience with virtual care, and patient outcomes. these findings for virtual care will not only be important in the covid-19 context but are also vital in the north, where access to specialized services is extremely limited.


Eligibility criteria:
inclusion criteria: * youth must be under 18 years of age in order to participate * youth must have a diagnosis of anorexia nervosa in order to participate * must have the capacity to write, speak, and understand english * must have access to a computer and the internet. exclusion criteria: * individuals 18 years of age and older are unable to participate * youth without a diagnosis of anorexia nervosa are unable to participate * individuals who cannot write, speak and understand english are unable to participate * individuals who do not have access to a computer and the internet are unable to participate

Keywords: anorexia nervosa youth adolescents eating disorders family-based treatment
myoinositol, l-arginine and chromium with letrozole for ovulation induction in polycystic ovarian syndrome patients

Conditions: Polycystic Ovary Syndrome

Summary: the aim of the study is to compare and assess the efficacy of combined letrozole with myoinositol, chromium, or l-arginine in infertile women with pcos. this study will help in the investigation of alternative therapeutic modalities for fertility improvement in polycystic ovarian syndrome

d prospective study trial. we will recruit patients diagnosed with pcos according to rotterdam criteria of pcos and who present to outpatient clinics at beni-suef university hospital. infertile women will be randomized to receive letrozole (2.5 mg for 5 days from 3rd day of patients' menstrual cycle) combination with myoinositol, chromium or l-arginine

Eligibility criteria:
inclusion criteria: * primary or secondary infertility associated with pcos as defined by the revised rotterdam criteria * normal values of the following laboratory tests: thyroid function, prolactin level, and husband's sperm analysis and hysterosalpingography exclusion criteria: 1. patients with a history of systemic diseases such as liver, kidney, cardiovascular, diabetes (type i or ii) or malignancy. 2. patients who consumed myoinositol, metformin, sglt2 or drugs effecting insulin secretion or clomiphene citrate in the previous 2 months. 3. use of hormonal medications, lipid-lowering agents (statins, etc.), anti-obesity drugs or medications for weight loss in the previous 2 months. 4. patients with hormonal disorders such as hyperprolactinemia, hypo or hyperthyroidism or cushing syndrome. 5. presence of hypersensitivity to any of the study medications.

Keywords: polycystic ovary syndrome letrazole myoinositol l-arginine chromium
long-term safety of tezepelumab in japanese subjects with inadequately controlled severe asthma

Conditions: Severe Asthma

Summary: this is an open-label, single arm study designed to evaluate the safety of tezepelumab administered subcutaneously every 4 weeks in japanese adult and adolescent subjects with inadequately controlled severe asthma.

this is open-label, single arm study designed to evaluate the safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma on medium to high-dose ics and at least one additional asthma controller medication with or without ocs. approximately 66 subjects will be dosed in japan. subjects will receive tezepelumab administered via subcutaneous injection at the study site, over a 52-week treatment period. the study also includes a post-treatment follow-up period of 12 weeks.

Eligibility criteria:
inclusion criteria: age. 12-80 documented physician-diagnosed asthma for at least 12 months subjects who have received a physician-prescribed asthma controller medication with medium or high dose ics for at least 12 months. documented treatment with a total daily dose of either medium or high dose ics (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months. at least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months. documented history of at least 1 asthma exacerbation events within 12 months. acq-6 score ≥1.5 at screening or on day of registration. exclusion criteria: pulmonary disease other than asthma. history of cancer. history of a clinically significant infection. current smokers or subjects with smoking history ≥10 pack-yrs. history of chronic alcohol or drug abuse within 12 months. hepatitis b, c or hiv. pregnant or breastfeeding. history of anaphylaxis following any biologic therapy. subject randomized in the current study or previous tezepelumab studies

Keywords: asthma uncontrolled asthma severe uncontrolled asthma
lyske trial (danish) groin trial

Conditions: Groin Injuries in Football Players

Summary: to examine the effect of a specific training programme towards groin injuries in male footbal players. to evaluate the effect on other football related injuries as well. to examine any possible relations between various possible predictors such as experience, age, hypermobility and others, and the risk of sustaining inujries during football.


Eligibility criteria:
inclusion criteria: male adult football players playing in the participating clubs in the study period - exclusion criteria: * under 18 years groin injury at the start of the study

Keywords: groin injury football prevention traing programme cluster randomized study
effect of teach-back method in angiography

Conditions: Healthy; Angiography

Summary: this study aims to evaluate the effect of discharge training with teach-back method on anxiety, fear of death and knowledge level in patients undergoing coronary angiography. h1: the training given with the teach-back method decreases the anxiety level of coronary angiography patient. h2: the training given with the teach-back method decreases the fear of death level of coronary angiography patient. h3: the training given with the teach-back method increases the knowledge level of coronary angiography patient.

teach-back technique is an effective educational method that enables a person to rephrase what he/she has learnt in his/her own words to show that he/she understands. there is no study evaluating the effect of discharge training with teach-back method on anxiety, fear of death and knowledge level in patients undergoing coronary angiography. in addition, in this study, anxiety, fear of death and knowledge levels of the patients before and after the training will be discussed and will guide future studies. discharge education to be given with the teach-back method will increase the level of knowledge of the patients and enable them to return to their normal lives. at the end of the study, the participants will be asked about their satisfaction level with the teach-back method. according to the results of the study, it is expected that the use of the teach-back method will increase in the education given to patients.

Eligibility criteria:
inclusion criteria: * to have the ability to communicate verbally, * volunteering to participate in the research, * to be 18 years of age or older. exclusion criteria: * lack of verbal communication skills, * not volunteering to participate in the research, * being under 18 years old.

Keywords: angiography teach-back anxiety fear of death knowledge level education
ketorolac for acute vaso-occlusive crisis in pediatric sickle cell disease

Conditions: Sickle Cell Disease; Sickle Cell Crisis; Veno-occlusive Disease

Summary: pediatric patients who present with acute vaso-occlusive pain crisis may have equivalent pain reduction scores at lower dosing of intravenous ketorolac compared to standard dosing of 0.5 mg/kg/dose iv (\ 16yo max 30mg) x 1 dose.

sickle cell disease is characterized by a point mutation that causes red cell polymerization and clinically results in pain events, called vaso-occlusive crises (voc), and end organ damage. voc is the most common reason for hospital admissions and er visits in the scd population. ketorolac is an nsaid class medication widely used for pain. ketorolac reversibly inhibits cyclooxygenase-1 and cyclooxygenase-2 and inhibits the formation of prostaglandins and thromboxane. specifically, in the scd pediatric population, ketorolac was shown to provide adequate pain relief without the need for additional iv analgesics in 50% of patients presenting to the emergency department with voc. despite its potential benefits, adverse effects from ketorolac at standard dosing include gastrointestinal hemorrhage, nephrotoxicity and drug-drug interactions, some of which are dose-dependent. patients with scd may be particularly vulnerable to acute kidney injury from nephrotoxic medications given the propensity for chronic kidney disease from ongoing anemia, hemolysis and inflammation. a retrospective review in hospitalized patients with scd who received at least one dose of ketorolac found that higher doses of ketorolac was a risk factor for acute kidney injury. in addition, a case report on a pediatric patient with scd showed irreversible renal failure and bleeding complications after administration of ketorolac, despite adequate hydration. the american society of hematology guidelines for management of acute and chronic pain in patients with sickle cell disease recommend a short course of nsaids in addition to opioids for acute pain management based on very low certainty of evidence. several adult studies have suggested that the efficacy of ketorolac analgesia at 10mg is equivalent to higher doses (15mg-90mg) for treatment of various pain syndromes in the ed setting, post-operative and cancer pain. however, these studies excluded patients with scd whose pain mechanism and pain thresholds may differ from these populations. the investigators propose a prospective, randomized, double blind clinical trial that will take place in the dcmc emergency department and children's blood and cancer center hematology outpatient clinic.

Eligibility criteria:
inclusion criteria: * pediatric patients with sickle cell disease (any genotype) who present to dcmc emergency department or outpatient hematology clinic with acute pain. exclusion criteria: * patients receiving nsaid medication \<6 hours from presentation * known kidney injury * sickle nephropathy * bleeding concerns * allergy to nsaid medication * chronic pain patient * hemodynamic instability as defined by the treating provider
bci training for social cognition and error monitoring in asd

Conditions: Autism Spectrum Disorder (ASD)

Summary: social cognition seems to develop atypically in autism, particularly in processes such as faces perception, joint attention and social information processing. in this sense, and using an emotional paradigm of facial expressions (efp) with a brain-computer interface (bci) based on electroencephalography (eeg), the investigators intend to evaluate its effectiveness as a medical device in autism spectrum disorder (asd), namely: improving 1) social skills and 2) reducing generalized anxiety, 3) improve error monitoring, and consequently verify 4) an increase in motivation. to this end, the investigators will test a gamified intervention (efp), using personalized feedback in real time. in this gamified interface, there is an artificial agent that learns rules through reinforcement learning using the evoked potentials from the participant as they observe the agent's right or wrong actions. the hypothesis is that this approach allows, during the gamified task (efp), not only the agent/interface to learn, but also the participant through operant conditioning and implicit scrutiny of errors, which makes it particularly interesting for disorders in which error monitoring processes are compromised, as in asd.


Eligibility criteria:
inclusion criteria: * participant is able and willing to give written informed consent/assent * previous diagnosis of autism spectrum disorder by a qualified clinician according to gold-standard instruments * aged between 16 and 55 years old * normal or corrected-to-normal vision exclusion criteria: * global intelligence quotient \<70 * dermatological diseases of the scalp * concurrent neurofeedback therapy * concomitant medication without a stable dosage for at least 4 weeks * history of seizures and/or epilepsy