Kornimate/medical-research-clean huggingface dataset:
multi-centre post-market data collection

Conditions: Cervical Degenerative Disc Disease

Summary: this is a real world data collection observational study at a single site. there are both prospective and retrospective cohorts. the study will examine the safety and effectiveness of the synergy cervical disc system in patients with degenerative cervical disc disease.


Eligibility criteria:
inclusion criteria: 1. age 21 or above at the time of the surgery. 2. have had (retrospective cohort) or the decision has been made to have (prospective cohort) the synergy disc implanted 3. skeletally mature patients for reconstruction of the disc from c3-c7 following a single or multiple level discectomy for intractable radiculopathy 4. intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: 1. herniated disc and/or osteophyte formation 2. symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (ct, mri, x-rays, etc.) 3. failed a minimum of 6 weeks conservative treatment 5. written informed consent given by subject exclusion criteria: * inclusion criteria: all answers must be yes to be eligible for the study. 1. age 21 or above at the time of the surgery. 2. have had (retrospective cohort) or the decision has been made to have (prospective cohort) the synergy disc implanted 3. skeletally mature patients for reconstruction of the disc from c3-c7 following a single or multiple level discectomy for intractable radiculopathy 4. intractable radiculopathy and/or myelopathy with at least one of the following producing symptomatic nerve root and/or spinal cord compression: 1. herniated disc and/or osteophyte formation 2. symptomatic nerve root and/or spinal cord compression documented by patient history (arm or neck pain and/or neurologic deficit) and imaging (ct, mri, x-rays, etc.) 3. failed a minimum of 6 weeks conservative treatment 5. written informed consent given by subject exclusion criteria: all answers must be no to be eligible for the study. 1. moderate to advanced spondylosis 2. diagnosis of osteoporosis 3. active systemic infection or infection at the operative site 4. pregnancy 5. marked cervical instability on lateral, coronal, or flexion/extension radiographs 6. cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level 7. severe pathology of the facet joints of the involved vertebral bodies 8. previous diagnosis of osteopenia or osteomalacia 9. more than one immobile vertebral level between c1 and t1 from any cause 10. morbid obesity 11. vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)

Keywords: radiculopathy myelopathy disc replacement motion preservation
association between the brain excitability and postoperative delirium in patients undergoing heart valve replacement surgery with cardiopulmonary bypass

Conditions: Brain Excitability; Postoperative Delirium; Cardiac Surgery

Summary: the purpose of this study is to explorethe brain excitability in patients undergoing heart valve replacement surgery with cardiopulmonary bypass and the correlation with postoperative delirium

delirium is the most common surgical patients postoperative complications of brain dysfunction. delirium is a kind of consciousness attention and cognitive function changes of acute brain dysfunction, with volatility and reversibility of postoperative delirium (pod), increased hospital costs and length of hospital stay and mortality rate, and can lower the quality of life, lead to long-term postoperative cognitive dysfunction and dementia. the incidence of postoperative cognitive dysfunction in patients undergoing cardiac valve replacement under cardiopulmonary bypass (cpb) can be as high as 44-53%. however, since the specific mechanism of pod is still not clear, there is still a lack of effective prevention and treatment measures. therefore, early detection and identification are helpful for the early treatment of pod.when brain injury occurs, the levels of excitatory neurotransmitters (glutamate and aspartate) will rise in a short period of time, and the high concentration of glutamate causes excessive intracellular calcium flow, causing cellular calcium overload, and generating excitatory cytotoxic effects. and abnormal electroencephalogram (eeg) is a kind of due to brain excitability/inhibitory amino acid imbalance caused by brain excitability increased result in abnormal discharge mode, can affect cognitive awareness and activities. increased brain excitability is harmful to the potential, should avoid to happen. at present, the relationship between brain excitability and pod is still in exploring. therefore, it is important to clarify the correlation between brain excitability and pod in patients undergoing cardiac valve replacement under cpb for improving the pathogenesis of pod.

Eligibility criteria:
inclusion criteria: 1. asa ⅱ - ⅲ; 2. no cognitive impairment was assessed one day before surgery; 3. patients undergoing elective heart valve replacement under cpb and signed informed consent. exclusion criteria: 1. non-cpb surgery, macrovascular surgery, heart transplantation, correction of congenital heart disease; 2. stroke, schizophrenia, depression, parkinson's disease, epilepsy or dementia; 3. inability to communicate with language impairment or major hearing or visual impairment; 4. liver function child-pugh grade c, severe liver dysfunction; 5. severe renal insufficiency requires preoperative renal replacement therapy; 6. a past history of intraoperative knowledge.

Keywords: brain excitability postoperative delirium abnormal eeg excitatory amino acid heart valve replacement surgery
community translation of the expecting study

Conditions: Pregnancy Related

Summary: the expecting intervention as delivered in prior studies in a clinical setting is described in a previous approved irb submission (protocol 202954). the current project will seek to engage community stakeholders to translate expecting to a community-delivered intervention and to test its acceptability, feasibility, and fidelity in a proof of principle study with 60 expecting mothers.

the aim of this study is to adapt and determine acceptability, feasibility and fidelity of the research- clinic-based expecting intervention with pregnant women with obesity in community settings. specifically, the investigators will show effective application of the replicating effective programs (rep) framework (e.g., fidelity, feasibility, acceptability) to translate the research clinic-based intervention to community settings. rep provides a four-phase process for implementing evidence-based interventions and has demonstrated effective application to translate clinical interventions to community settings. built into the rep framework is the collection of feedback from community stakeholders, iterative piloting of the intervention in the community, and a process for standardizing the intervention across community settings. following adaptation, the updated intervention will be piloted. the pilot study will include 60 expecting women. the investigators will randomize half to receive the community-adapted expecting intervention (intervention, n=30) and half to receive standard of care (control, n=30).

Eligibility criteria:
inclusion criteria: * (a) body mass index \> 30, * (b) singleton pregnancy, * (c) between 11-15 weeks of pregnancy (at enrollment), * (d) sedentary (do not engage in purposeful physical activity plus have sedentary work) * (e) cleared by physician exclusion criteria: * (a) contraindications for exercise (preeclampsia-eclampsia, premature rupture of the membranes, antepartum hemorrhage, placenta previa, multiple gestation and other defined conditions) * (b) illicit drug use.
hip denervation in juvenile idiopathic arthritis with hip arthritis

Conditions: Juvenile Idiopathic Arthritis; Hip Arthritis

Summary: patients having juvenile idiopathic arthritis (according to ilar criteria) with hip arthritis were divided into 3 groups. group 1 received hip denervation and group 2 controlled and received a subcutaneous injection of saline, and group 3 received intra-articular triamcinolone. outcome measures included pain, tenderness, range of motion, solar, hariss score. these outcomes were measured at baseline, 2 weeks, and 16 weeks

the aim of the study is to test the effect of denervation of the active hip in jia and compare it with a placebo without changing systemic treatment during the study. outcome measures included pain, range of motion, solar score, and harris functional score.

Eligibility criteria:
inclusion criteria: * patients with jia with unilateral hip arthritis exclusion criteria: * hip involvement due to other causes including * septic arthritis * other connective tissue diseases * avascular necrosis
effect of upper limb posture on limb volume as expressed in circumference measurement in healthy women and in women with breast cancer related lymphedema

Conditions: Breast Cancer; Lymphedema

Summary: lymphedema is one side effect of breast cancer treatment. measuring the edematous limb enables monitoring changes in the lymphedema and the effect of treatment. circumference measurement using a measuring tape is an inexpensive simple method and therefore useful and widespread in clinical practice. circumference measurement performance varies amongst therapists and lacks uniformity in the literature. to date, the effect of different limb positions on measurement results has not been examined. purpose: the purpose of this study is to describe 1) the effect of position on upper limb volume measurement by using circumference measurement and 2) to examine whether the difference between positions are similar in the upper limbs of the same woman, and 3) between groups of women who are in the intensive phase, in the maintenance phase of lymphedema treatment and women without lymphedema

study design: analytical cross section study population: inclusion criteria: 15 women who have completed breast cancer treatments, with a diagnosis of unilateral arm lymphedema, in the intensive phase of lymphedema treatment; 15 women who have completed breast cancer treatment and are in the maintenance phase of lymph edema treatment and 15 healthy women adjusted in age and bmi. exclusion criteria: active cancer, cardiovascular disorder, wounds or inflammation in the measured upper limb, and illness with fever. research tools: questionnaire to gather personal details, information about the cancer and the lymphedema. plastic, retractable measuring tape with an accuracy of 1 mm. fixed points on the limb are measured according to anatomical landmarks and afterwards the limb volume is calculated using the formula for a truncated cone.

Eligibility criteria:
inclusion criteria: * 15 women who have completed breast cancer treatments, with a diagnosis of unilateral arm lymphedema, in the intensive phase of lymphedema treatment; * 15 women who have completed breast cancer treatment and are in the maintenance phase of lymph edema treatment and * 15 healthy women adjusted in age and bmi. exclusion criteria: * active cancer, * cardiovascular disorder, * wounds or inflammation in the measured upper limb, and * illness with fever.
intervention with weighted blankets for children with adhd and sleep problems: implementation and effectiveness

Conditions: ADHD; Sleep Disturbances; Sleep; Sleep Problems

Summary: the aim is to study a sleep intervention with weighted blankets in children with adhd and sleep problems regarding 1) short- and long-term effects on sleep and health-related outcomes in comparison with standard treatment (melatonin), 2) barriers and facilitators to implementation in routine clinical practice, and 3) health-economic outcomes.


Eligibility criteria:
inclusion criteria: * children diagnosed with adhd (dsm-5) and sleep problems (defined by screening instrument). * being a patient at child and adolescent mental health service (camhs) in region halland, sweden.

Keywords: implementation sleep intervention weighted blankets children with adhd sleep problems
the impact of crt on renal function

Conditions: Chronic Kidney Diseases; Chronic Heart Failure

Summary: the study is observational, prospective, including patients undergoing crt-d / crt-p implantation in the department of cardiology. in the current project, the researchers assumed that the improvement in cardiac function obtained in patients qualified according to the esc / ptk guidelines for resynchronization therapy may improve renal function in a prospective 12-month follow-up. in addition, it is planned to take into account the possibility of temporary deterioration of kidney function, which may occur immediately after implantation of the resynchronization device due to the nephrotoxic effect of the contrast agent.


Eligibility criteria:
inclusion criteria: adult patients with heart failure who had met the criteria for crt implantation according to european society of cardiology guidelines for the treatment of heart failure exclusion criteria: * no written consent to participate in the study * no indications for cr implantation * current infection * children * pregnant women

Keywords: chronic cardio-renal syndrome biomarkers
rapid urinary tract infection diagnosis and real-time antimicrobial stewardship decision support

Conditions: Urinary Tract Infections

Summary: the study aims to assess the accuracy and impact of rapid diagnosis and rapid diagnosis decision support on different aspects of antibiotic consumption when implemented alone or together.

this interventional study in two centers compares two groups with each other and with a pre-intervention control group. in group 1 rapid techniques for handling urine cultures will be the only intervention. in group 2 rapid diagnostics will be supplemented with real-time antimicrobial stewardship decision support (rads). in each center two departments will be involved. urine samples present at the laboratory at opening on weekdays will be screened using urine flow cytometry and microscopy of centrifuged gram stained urine. samples found positive for significant mono microbial bacteriuria will be investigated further by using direct automated phenotypic identification and antimicrobial susceptibility determination and screened for inclusion in the interventional study. in one of the centers, rapid techniques will be coupled to real-time antimicrobial stewardship decision support (rads). rads will be given by telephone to a designated clinician with the aim of: 1. switch to active treatment if non-working empirical treatment 2. de-escalate broad spectrum empiric treatment when feasible 3. promote early intravenous to per oral switch 4. shorten treatment duration

Eligibility criteria:
inclusion criteria: * urine sample present at the laboratory weekdays * at least 11 ml of urine in sample * admitted to surgical or medical ward. * urine sample taken on admission to hospital. * rapid diagnostics suggesting mono microbial growth of \> 100.000 microbes/ml urine. * clinical and laboratory signs/symptoms of urinary tract infection at time of sample delivery. exclusion criteria: * other simultaneous infections that warrant systemic antimicrobial therapy or surgery.

Keywords: diagnostic accuracy anti-bacterial agents decision support systems, clinical
autonomic nervous activity in women with gestational diabetes

Conditions: Gestational Diabetes

Summary: through complex hormonal pathways, insulin resistance can lead to the activation of the sympathetic nervous system, and vice versa. schobel et al. showed that in pe patients, mus-cle sympathetic nerve activity (msna) is increased compared with normotensive pregnant and non-pregnant women. studies assessing heart-rate variability and plasma noradrenalin concentrations also suggest increased sympathetic activity in pe. it has been hypothesized that sympathetic over-activity is a precursor of pe, normally compensated for by vasodilating mechanisms, but resulting in pe when the mechanisms fail. in addition to sympathetic activity, various markers of inflamma-tion are also associated with reduced insulin sensitivity, suggesting that chronic sub-clinical inflamma-tion could be part of the insulin resistance syndrome. the role of sympathetic over-activity and inflammatory markers in gestational diabetes has not been investigated


Eligibility criteria:
inclusion criteria: * clinical diagnosis of gestational diabetes (ogtt) with or without bp \> 140/90. * pregnant control with normal ogtt- exclusion criteria: * smoking * uncontrolled hypertension * diabetes * medication affecting sympathetic activity

Keywords: inflammatory factors coagulation factors sympathetic activity
pediatric nasal mask usability study

Conditions: Obstructive Sleep Apnea

Summary: the purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (osa) in a pediatric population.

obstructive sleep apnea (osa) is a condition in which there is partial or complete collapse of the upper airway during sleep. features of osa include snoring to upper airway resistance, which could be mild to severe. while osa has been studied extensively in an adult population, research indicates that osa is prevalent in a pediatric population as well, though the options for treatment are not as varied as that for the adult population. the study seeks to determine if a mask made for a pediatric population effectively treats their osa.

Eligibility criteria:
inclusion criteria: * 2-7 years of age * diagnosis of osa * current pap therapy user * current nasal mask user exclusion criteria: * recent sinus surgery * allergies to mask material * current seasonal allergies that could interfere with therapy * history of clinically significant epistaxis in past 6 months * upper airway surgery less than 60 days before study entry
immune failure in critical therapy (infect) study

Conditions: Sepsis; Septic Shock

Summary: patients admitted to intensive care units (icu) are at high risk of developing secondary infections, and this is in part due to dysfunction or failure of their 'germ killing' functions (the immune system). our group has recently identified three signatures of immune system failure which can be readily detected on a blood sample, and importantly, appear to predict the chances of developing secondary infection. such a test would have major benefits for the management of patients in intensive care if it can be translated into a test usable in everyday clinical practice. this study aims to validate our original findings in a cohort of patients from multiple icus, using a test which will be suitable for everyday clinical practice, and thus take the next step towards developing a market-ready test. study hypothesis: measurement of neutrophil cd88, monocyte hla-dr and percentage tregs will accurately predict the risk of nosocomial infection.


Eligibility criteria:
inclusion criteria: * age \>16 (\>18 in england) * requiring level 3 care (i.e. requiring invasive support of respiratory system alone, or two or more other organ systems (haemofiltration, inotropes/vasopressors) * predicted to remain in icu for at least 48 hours, exclusion criteria: * not expected to survive for a further 24 hours * known or suspected icu-acquired infection at time of screening (non-icu acquired nosocomial infection - i.e. non-icu healthcare associated infection is not and exclusion) * known inborn errors of immune function * immunosuppression (corticosteroids up to 400mg hydrocortisone equivalent daily dose permitted) * hiv infection * pregnancy * previously enrolled in the study

Keywords: sepsis septic shock critical care immune dysfunction inflammatory markers neutrophil monocyte tregs
online question-answering and conventional consultation with a dermatologist

Conditions: Skin Diseases

Summary: comparison of online question-answering system and conventional consultation for dermatological questions: * same diagnosis? * same information, which had been collected? * same recommendations about treatment? * what were the relevant differences of the two?

mainly, icd codes and dermatological diagnosis codes according to the aad will be used.

Eligibility criteria:
inclusion criteria: - a conventional dermatological consultation after a question in the online question-answering system. exclusion criteria: -power of veto after information of patient
phase ii study of neoadjuvant weekly paclitaxel and carboplatin followed by dose dense epirubicin and cyclophosphamide in stage ii and iii triple negative breast cancer

Conditions: Breast Cancer

Summary: this is a prospective belgian, multi-center, open-label, single-arm phase ii study of weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (auc=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus long acting gcsf at day 2) administrated preoperatively in locally advanced operable stage ii and iii triple negative breast cancer to evaluate tumor response in the breast and the axilla.


Eligibility criteria:
inclusion criteria: * stage ii-iii operable triple negative (er and pr \ 18. for patients aged 65 or older the g8 geriatric screening test should be \> 14 (on a total of 17). * baseline mammography, us. mr of the breast on clinical indication. * fna of suspicious axillary lymph node is indicated * pre-treatment sn biopsy is indicated in clinical n0 * measurable loco-regional disease * adequate bone marrow function, defined as * absolute neutrophil count(anc) \>1500\*109/l * platelet count \>100.000\*109/l * adequate liver function defined as * serum(total) bilirubin \<1.5\*upper limit of normal(uln), unless the patient has documented gilbert's syndrome * ast and/or alt \<2.5\*uln * alkaline phosphatase \<2.5\*uln * normal cardiac function measured by ultrasound with a left ventricular function \> 55% * creatinine clearance \> 40 ml/min according to local laboratory standard (mdrd, cdk-epi, cockroft-gault, or other established formula to calculate renal function) exclusion criteria: * t4d breast tumor * bilateral breast cancer * other invasive cancer in the past except for a localized squamous cell cancer or basal cell of the skin or an in situ squamous cell cancer of the cervix. * pregnant or lactating patients