Kornimate/medical-research-clean huggingface dataset:
bji inoplex 2 : test for diagnosis of prosthetic infections

Conditions: Bone and Joint Prosthetic Infections

Summary: a national, prospective, open-label, non-interventional, multicentre, controlled study designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder prosthetic removal regardless of whether or not infection is suspected. serological test results will have no impact on the therapeutic approach. study objective: to evaluate the diagnostic performance of an antibody detection kit for the serological diagnosis of bone and joint prosthetic device infections cause by staphylococci, streptococci, propionibacterium acnes (p. acnes) and gram-negative bacteria versus the reference method: the bacterial culture of deep intraoperative samples.


Eligibility criteria:
inclusion criteria: 1. male or female patients 2. patients 18 years of age or older 3. patient with a bone and joint prosthetic device: total hip prosthesis (thp) or total knee prosthesis (tkp) or total shoulder prosthesis (tsp) 4. patients with a revision of a failed prosthesis, regardless of the cause and whether septic or not 5. patients who have not expressed their opposition to the use of their personal medical data and blood samples exclusion criteria: 1. patients already enrolled or clinically reviewed following a relapse 2. patients with several prostheses requiring at least two revisions during the same surgical procedure 3. patients for whom the microbiologist and/or doctor responsible for the care refuses that these patients participate in the study 4. hiv+ patients 5. patients undergoing chemotherapy for a blood disease or solid tumour 6. patients under guardianship or trusteeship 7. patients who are expected to be difficult to monitor (life expectancy less than 1 year, or homeless people, foreigner in transit)

Keywords: staphylococci, streptococci, p acnes and gram-negative bacteria
fully immersive virtual reality applications in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: this study was conducted in children diagnosed with cerebral palsy (cp); it is a prospective randomized clinical study planned to examine the effects of treadmill and bicycle ergometer applications combined with fully immersive virtual reality (tisg) on motor function, balance and walking.

the aim of this study is in children diagnosed with cerebral palsy (cp); it is a comparative study of the effects of treadmill and bicycle ergometer applications combined with total immersive virtual reality (tisg) on motor function, balance and walking. 34 cases diagnosed with cerebral palsy between the ages of 12-18 and attending a rehabilitation center will be included in the study. the sample will be divided into two groups by randomization (ti̇sg combined with treadmill group n = 17, ti̇sg combined with bicycle ergometer group = 17). evaluations will be made before and at the end of treatment. an exercise program that will last 45 minutes twice a week for six weeks will be applied to both study groups. the treadmill combined with ti̇sg group will be given walking training on the treadmill in a virtual environment using virtual reality glasses. the tisg and combined bicycle ergometer group will be given exercise training on the bicycle ergometer in a virtual environment using virtual reality glasses. for both groups, this process will continue in the same order for each exercise in the session. it is assumed that performing the bicycle ergometer in a sitting position makes this exercise safe, easier to perform, and can be performed at different levels of motor function, regardless of the severity of motor impairment. based on this assumption, this study aimed to compare the use of bicycle ergometer combined with tisg with the treadmill combined with tisg in improving functional capacity, balance and walking functions in children with cp.

Eligibility criteria:
inclusion criteria: * being diagnosed with spastic cerebral palsy * being between the ages of 12 - 18 * being at level 1 and 2 according to the gross motor function classification system (gmfss) * being able to understand and speak turkish * not using medical treatment (including botox) in the last six months * no visual or auditory problems that would hinder communication during applications. * having the cognitive skills to adapt to the application and application controls where the intervention is required. exclusion criteria: * presence of secondary orthopedic and neurological problems/problems that are severe enough to affect participation in the study (advanced joint instability, severe scoliosis, nystagmus, etc.). * having a neurodegenerative disease that may cause attacks during virtual reality applications * presence of epilepsy * having undergone lower extremity surgery within the last year * presence of hypersensitivity to visual stimuli * development of vestibular problems with the use of virtual reality devices

Keywords: virtual reality function balance physical therapy
development of predictive biomarkers and novel approached to therapy in breast cancer

Conditions: Breast Cancer

Summary: breast cancer is a common malignancy world-wide, and is the commonest female malignancy in singapore, with rising trends in incidence over the last 2 decades. while there have been improvements in treatment, mortality from breast cancer remains significant. development of biomarkers to predict treatment response and toxicity to anti-cancer agents can rationalize the choice of therapy for the individual patients to optimize treatment outcome and to reduce unnecessary toxicities. development of novel therapies or novel approaches to therapy is also critical to improve the treatment armamentarium in breast cancer. these research strategies will have an significant impact on breast cancer treatment both in singapore as well as globally.


Eligibility criteria:
inclusion criteria: this program will recruit mainly cancer patients, predominantly breast cancer patients. the exact inclusion criteria will vary between each individual study. each individual component study will be submitted to dsrb for separate approval, along with the study protocol and patient informed consent sheet. exclusion criteria: the exact exclusion criteria will vary between each individual study. each individual component study will be submitted to dsrb for separate approval, along with the study protocol and patient informed consent sheet.
hamstrings x patellar tendon for acl reconstruction in soccer players - rct

Conditions: Anterior Cruciate Ligament Injuries

Summary: the purpose of this study is to specifically evaluate outcomes of bone-patellar tendon-bone autograft versus hamstring autograft acl reconstruction in soccer players.

a number of techniques for acl reconstruction have been proposed and tested, and most surgeons now prefer autografts with the patellar tendon or semitendinosus tendon. the functional outcome after acl reconstruction with the patellar or semitendinosus tendon has been a recent area of interest. soccer is the most popular sport worldwide with more than 260 million active players, and it is hard to say if patellar tendon or semitendinosus grafts have different outcomes. the purpose of this study was to specifically evaluate outcomes of bone-patellar tendon-bone autograft versus hamstring autograft acl reconstruction in soccer players. the hypothesis of this study was that hamstring autograft acl reconstruction would provide no statistically significant differences in patient-reported outcome scores, postoperative level of sports function, and harvest-site morbidity when compared with patellar tendon autograft .the cincinnati knee rating system (ckrs) was chosen as the primary outcome. as secondary outcome, reruptures. between march 2016 and march 2017, 60 soccer players will be operated. the investigators consider as soccer players those who play more than 4 times a week. once included in the study, they will be randomized in two groups: "hamstring group" and "patellar tendon group". the final clinical evaluation with two years. for both groups, the technique is the same, the fixation of the grafts with metal interference screws. femoral tunnel will be drilled with outside-in technique. the tibial tunnel with conventional 55 degrees guide. both groups of patients will receive the same physical therapy protocol. data will be evaluated with the spss software for windows (version 13.0).

Eligibility criteria:
inclusion criteria: * unilateral acl lesion * skeletally mature patients with closed physis * no previous surgery on the affected knee (except for arthroscopic meniscectomy) * less than 1 year from injury * no associated ligament injuries (except for the medial collateral ligament grade i and ii) * soccer players. exclusion criteria: * morbid obesity * degenerative changes in arthroscopy or image exams * those who play soccer less than 4 times / week

Keywords: acl reconstruction single bundle clinical results soccer players
new york city mobile interventional stroke team

Conditions: Acute Stroke

Summary: endovascular treatment has recently become the recommended therapy for acute stroke after the publication of five randomized trials (mr clean1, escape2, extend ia3, swift prime4, revascat5) in 2015 that demonstrate its efficacy. hospitals need to adapt to these updated stroke care guidelines, and many hospitals are not appropriately equipped for neurointerventional procedures. decreased time to treatment is associated with favorable clinical outcomes, and best practices to optimize workflow between comprehensive stroke centers and secondary hospitals have become an important area of study. this prospective study is being conducted on acute stroke cases within the mount sinai health system from 1 june 2016 up until 31 december 2018. the researchers would like to evaluate how variable methods of interventional service delivery for acute stroke affect clinical measures and outcomes. more specifically, the researchers are conducting this study in order to determine whether outcomes of neurointervention for large vessel occlusion in stroke, for patients presenting to and receiving treatment at a comprehensive stroke center, will be superior to that delivered by a mobilized intervention team at a central satellite hospital. in particular, the hypothesis is that factors affecting outcome include presentation to secondary hospital, delays with transfer including traffic conditions and time of day, and the acquisition of complex imaging within secondary hospitals.


Eligibility criteria:
inclusion criteria: - all patients who consent to the study and present with acute stroke treated with thrombectomy in the mount sinai health system (mount sinai, mount sinai west, mount sinai beth israel, mount sinai st. luke's) from 1 june 2016 - 31 december 2018. exclusion criteria: * if the patient is pregnant * under age 18 * a prisoner. if timing of treatment cannot be captured, patients with these data points will be excluded.

Keywords: embolectomy embolus thrombectomy thrombolysis thrombus mobile interventional neurointervention stroke ischemic acute endovascular cerebrovascular clot stent retriever tissue plasminogen activator drip and ship mothership trip and treat
raltegravir vs. atazanavir in combination with truvada® for the treatment of antiretroviral naïve hiv infected patients

Conditions: HIV Infections

Summary: this is a pilot that will evaluate two regimens for treating hiv infected patients that haven't been on treatment before. hiv/aids patients may have an increased risk of myocardial infarction and antiretroviral therapy used may contribute to this. we will evaluate virological, immunological and cardiovascular effects of two hiv treatment regimens.

we will check blood studies used to evaluate hiv patients response to therapy including cd4 count and hiv viral load test. we will check routine safety labs done on hiv patients and also check homocysteine levels and creatine kinase level. we will evaluate homocysteine and il6 levels at baseline, week 48, and week 96.

Eligibility criteria:
inclusion criteria: * patients must be hiv-1 positive and naïve to hiv therapy. * patients must plan to participate and be available for the trial for the 96-week study period. * patients followed at thomas street clinic. * patients must be over 18 years old. exclusion criteria: * patients must not be pregnant or plan to become pregnant over the 96-week study period. * patients cannot be on a proton pump inhibitor. * patients cannot be undergoing treatment for active tuberculosis. * renal insufficiency with a creatinine clearance \< 50 ml/min/1.73 m2 by the mdrd gfr calculation.

Keywords: raltegravir integrase inhibitor protease inhibitor naive patients hiv disease lipids treatment naïve
study of the safety and efficacy of a caffeine-based antifibrosis cream in patients with breast cancer undergoing radiation therapy

Conditions: Carcinoma Breast

Summary: the purpose of the study is to evaluate whether a caffeine-based cream can reduce the rates of reconstructive complications in patients with tissue expander based reconstruction requiring post-mastectomy radiation therapy when compared to a placebo cream.


Eligibility criteria:
inclusion criteria: * patient has histologically-confirmed carcinoma of breast (all subtypes are permitted) * patient has undergone mastectomy with tissue expander-based reconstruction and require post-mastectomy radiation therapy (pmrt) per the - stage dcis (0) -iii breast cancer, excluding any patients with inflammatory breast cancer at presentation. * patient will receive irradiation of the chest wall. additional fields to treat the regional nodes including the supraclavicular / axillary and/or internal mammary chains is allowed but not required. if a patient requires a boost field to the chest wall, scar and/or nodal region this is allowed. exclusion criteria: * patient with skin changes or inflammatory carcinoma at presentation patient has (ct4b-d) * unhealed wound in the radiation field * patient has allergy to caffeine * patient has systemic lupus erythematosus or scleroderma that increases the risk of radiation dermatitis development * patient will receive concurrent chemotherapy with radiation. (patient is allowed to take concurrent hormonal therapy or trastuzumab) * planned accelerated or hypofractionated fractionation. * previous radiation to the ipsilateral breast or chest wall or thoracic region. * anyone who will require bolus use during radiation (per physician discretion) as this will increase rates of acute toxicity interfering with measurement of the primary study endpoint. * all pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy. pregnant women will be excluded from the study.

Keywords: masectomy
a study evaluating the efficacy and safety of crovalimab versus eculizumab in participants with paroxysmal nocturnal hemoglobinuria (pnh) not previously treated with complement inhibitors

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: a study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with pnh who have not been previously treated with complement inhibitor therapy.


Eligibility criteria:
inclusion criteria: * body weight ≥ 40 kg at screening (pediatric participants with body weight \< 40 kg) * willingness and ability to comply with all study visits and procedures * documented diagnosis of pnh, confirmed by high sensitivity flow cytometry * ldh level ≥ 2x uln at screening (as per local assessment) * vaccination against neisseria meningitidis serotypes a, c, w, and y\< 3 years prior to initiation of study treatment; or, if not previously done, vaccination administered no later than one week after the first drug administration * women of childbearing potential: agreement to remain abstinent or use contraception during the treatment period and for 10.5 months after the final dose of crovalimab or for 3 months after the final dose of eculizumab (or longer if required by the local product label) exclusion criteria: * current or previous treatment with a complement inhibitor * history of allogeneic bone marrow transplantation * history of neisseria meningitidis infection within 6 months prior to screening and up to first study drug administration * history of myelodysplastic syndrome with revised international prognostic scoring system (ipss-r) prognostic risk categories of intermediate, high and very high * pregnant or breastfeeding, or intending to become pregnant during the study, within 10.5 months after the final dose of crovalimab, or 3 months after the final dose of eculizumab (or longer if required by the local product label) * participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever is greater * concurrent disease, treatment, procedure or surgery, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the participant, or would, in the opinion of the investigator, preclude the participant's safe participation in and completion of the study * splenectomy \< 6 months before screening * positive for active hepatitis b and c infection (hbv/hcv) * history of or ongoing cryoglobulinemia at screening
dietary intervention to improve health of cardiovascular patients

Conditions: Cardiovascular Diseases; Heart Diseases; Vascular Diseases

Summary: voed je beter is a randomized, multicenter, controlled trial to examine whether personalized guidance to increase adherence to the dutch dietary guidelines, compared to usual care, improves health of cardiovascular patients who receive regular medical treatment.

voed je beter is a randomized, multicenter, controlled trial to examine whether a personalized intervention to increase adherence to the dutch dietary guidelines, compared to usual clinical care, improves health of cardiovascular patients on top of medical treatment. patients previously diagnosed with cardiovascular disease are randomized into two parallel groups: the intervention or the usual care group. the intervention consists of personalized guidance from a dietician focussing on improving adherence to the dutch dietary guidelines during a period of six months. the control group receives usual clinical care. at baseline, three months, six months, and 12 months measurements will be performed. primary outcome data will be collected at 6 months. after 12 months, additional data will be collected to assess the prolonged effects of the intervention. the primary outcome of interest is the difference in smart risk score between the intervention and usual care group from baseline till six months. secondary outcomes are differences in smart risk score at three months and twelve months; systolic blood pressure, diastolic blood pressure and cardiovascular parameters; diet quality, salt intake, vitamin levels in blood; body weight and waist circumference; renal function; quality of life; sleep; self-efficacy; mental health and medication use. in addition, an economic evaluation is carried out.

Eligibility criteria:
inclusion criteria: * a previously diagnosed cardiovascular disease, including acute coronary disease syndrome, angina pectoris, coronary revascularization, tia, stroke, symptomatic aortic iliofemoral atherosclerosis, aortic aneurysm, intermittent claudication or peripheral revascularization. * over 18 years of age exclusion criteria: * uses medication for treatment of diabetes * a known hereditary form of cardiovascular diseases * chronic kidney disease stage 4 or above (egfr\<30) * participation in another research study of which the outcomes may interfere with the current trial * not able to speak and understand the dutch language * unable/unwilling to comply with the intervention * active treatment for cancer

Keywords: intervention study rct nutrition dietary guidelines dietitian cardiovascular diseases tertiary prevention smart risk score
level of burn out of surgical residents working in government hospitals of lahore

Conditions: Burn Out Syndrome

Summary: the term burnout was coined by psychologist herbert freudenberger in 1974 in an article entitled "staff burnout" in which he discussed job dissatisfaction precipitated by work-related stress. a broadly applicable description defines burnout as a state of mental and physical exhaustion related to work or care giving activities. a long-standing conceptual and operational definition characterized burnout as a triad of emotional exhaustion (emotional over extension and exhaustion), depersonalization (negative, callous, and detached responses to others), and reduced personal accomplishment (feelings of competence and achievement in one's work) in the world health organization international classification of diseases, 10th revision, burnout is defined as a "state of vital exhaustion." although no specific diagnosis of burnout is mentioned in the diagnostic and statistical manual of mental disorders, burnout is a clear syndrome with significant consequences. burnout in health care professionals has gained significant attention over the last several years. given the intense emotional demands of the work environment, clinicians are particularly susceptible to developing burnout above and beyond usual workplace stress. residency training, in particular, can cause a significant degree of burnout, leading to interference with individuals' ability to establish rapport, sort through diagnostic dilemmas, and work though complex treatment decision making. overall, burnout is associated with a variety of negative consequences including depression, risk of medical errors, and negative effects on patient safety. the goal of this review is to provide medical educators and leaders with an overview of the existing factors that contribute to burnout, the impact of burnout, inter specialty variation, and suggestions for interventions to decrease burnout.


Eligibility criteria:
inclusion criteria: * general surgical resident exclusion criteria: * residents of all other specialties * all the general surgical consultants
25-year experience with polytraumatized patients in a level 1 trauma center

Conditions: Polytrauma

Summary: in this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from january 1992 to december 2019. patients with an iss\>16 points, an ais \>3 in one body region and at least 2 different body regions affected were included. possible prognostic factors were evaluated.


Eligibility criteria:
inclusion criteria: * iss \>16 points * ais \>3 in one body region * at least 2 body regions affected exclusion criteria: * patients younger than 18 years of age * isolated traumatic brain injury * minor injuries (ais \<3 or iss \<16 points)