Kornimate/medical-research-clean huggingface dataset:
foundation knee study - retrospective

Conditions: Osteoarthritis; Post-traumatic Arthritis; Inflammatory Tissue Disorders; Arthritis Secondary to Other Diseases; Avascular Necrosis of the Femoral Condyles

Summary: the purpose of this study is to evaluate the use and efficacy of the encore foundation knee system in a group of 200 patients for whom data has already been collected.


Eligibility criteria:
inclusion criteria: * have knee joint disease related to one or more of the following * osteoarthritis * post-traumatic arthritis * inflammatory tissue disorders * arthritis secondary to other diseases * avascular necrosis of the femoral condyles; * skeletal maturity * less than 70 on the knee society score (rating score) * sufficient bone stock, as judged by radiographs, to support primary knee implant * sufficient collateral ligaments to support the device, as judged by physician during stability testing (varus/valgus and flexion/extension) and less than 45 degree varus/valgus deformity and/or 90 degree flexion contracture * patient is likely to be available for evaluation for the duration of the study * able and willing to sign the informed consent and follow study procedures * patient is not pregnant * no infection present * no known materials sensitivity exclusion criteria: * skeletal immaturity * greater than or equal to 70 on preoperative knee society score (rating score) * post-patellectomy * insufficient bone quality which may affect implant stability * insufficient collateral ligaments, as judged by the physician. greater than 45 degree varus/valgus deformity and/or 90 degree flexion contracture. * neurological conditions that might hinder patient's ability to follow study procedures (i.e., any that restrict physical activities such as parkinson's disease, multiple sclerosis, previous stroke which affects lower extremity) * mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and alzheimer's disease) * prisoners * conditions that place excessive demand on the implant (i.e. charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity) * patient is pregnant * infection present * materials sensitivity
effects of restrictive fluid strategy on postoperative oliguric pancreatic surgery patients

Conditions: Fluid Therapy; Postoperative Period; Postoperative Complications; Pancreas Disease; Fluid Overload

Summary: reduced urinary output is a common postoperative issue for patients going through major surgery such as pancreatic surgery. commonly this is treated by increasing fluid administration to the patients and sometimes also diuretics. however, overloading patients with fluid also have several risks and known complications. studies have also shown that a short period of decreased urinary output in the postoperative period do not have an increased incidence of acute renal failure. the aim of our study is to investigate the difference in renal function and postoperative complications associated with fluid overload on these patients that are randomized to either receiving a fluid bolus directly when urinary output decreases or to await for a maximum of four hours to see if urinary output increases spontaneously.

patents after pancreatic surgery will be included in the study. oliguric patients (urine output \<0.5 ml/kg/h) will be randomized to fluid bolus (5ml/kg ringer's acetate in 30 minutes) or no intervention. primary outcome is difference in urine output two hours after the fluid bolus or no intervention.

Eligibility criteria:
inclusion criteria: * patients going through pancreatic surgery. exclusion criteria: * if not oliguric (urinary output \<0,5 mls/kg/h) during their stay in the postoperative department * hemodynamic instability (the need for \>0,1 microgram/kg/min of norepinephrine to keep an acceptable mean arterial pressure based on the patients starting mean arterial pressure). * patients that do not want to be a part of the study. * \<18 years old
the role of unsteady wall shears stress stimuli on human umbilical vein endothelial cells harvested from umbilical cords

Conditions: Vascular Diseases

Summary: the aim of this study is to obtain and test endothelial cells (ec's) from umbilical cords to examine specific properties of these cells which make up the inner lining of blood vessels.

mechanical testing will be performed on the ec's to see how the cells reacts and ultimately how the blood vessel is affected. a central role in the mechanism that defines the nature of vessel remodelling is played by endothelial cells. ec's are extremely sensitive to the frictional forces exerted on a unit of the endothelial area by blood flow. this mechanical stimulus is known as wall shear stress (wss). wss experienced by ec's in-vivo is unsteady due to the unsteady nature of blood flow produced during the cardiac cycle and due to the complex nature of the vascular tree. the extent to which this applies to venous cells and tissue remains unknown and it is the focus of this study.

Eligibility criteria:
inclusion criteria: * patients who are attending the maternity services who are pregnant and due for routine delivery. * aged 18- 40 years. * are willing and capable to voluntarily sign a statement of informed consent to take part in this investigation. * patients due to give birth to twins will be included in this study. women having both "normal" delivery and caesarean section delivery will be included in this study. exclusion criteria: * patients unable to provide informed consent. * patients who are under the age of 18 and over the age of 40 years. * patients who are deemed unsuitable due to any circumstances as deemed appropriate by the consultant. * patients with a blood borne virus (hiv type 1, hiv type 2, hepatitis b, hepatitis c) will be excluded from the study. * patients with diabetes that is not gestational in nature will be excluded from this study. * patients due to deliver triplets or more will be excluded from this study. * patients who deliver their baby before 37 weeks gestation will not have umbilical cord tissue retained for study purposes.

Keywords: endothelial cells
comparing consistency of quantiferon-tb gold plus and quantiferon-tb gold for latent tuberculosis in dialysis population

Conditions: Patients on Dialysis

Summary: in patients receiving long term dialysis, using new generation of quantiferon-tb gold plus can have less result variability in inter-experiment and serial follow up in comparing with quantiferon-tb gold in-tube.

tuberculosis (tb) remains one of the most important infectious diseases worldwide. according to the world health organization (who) estimates, there were 9 million new tb cases and 1.5 million related deaths in 2013. future control strategies include early treatment for preventing transmission and treatment of latent tb infection (ltbi) for reducing reactivation. patients with renal failure undergoing dialysis have increased risk of tb due to attenuated cellular immunity. for instance, their risk of developing active tb in the dialysis population is 7.8-25 times higher than that of the general population. however, tb diagnosis is usually delayed because of frequent extra-pulmonary manifestations. thus, ltbi detection in this specific group is important. positive results of interferon-gamma release assays (igras) and the exclusion of active tb are the current diagnostic bases of ltbi, which is a precursor of tuberculosis reactivation. however, recent reports show a high negative reversion rate of quantiferon gold in-tube (qft-git), a kind of igra, in cohorts of health care workers (33% after 18 weeks) close tb contacts (35% after six months), and patients receiving long-term dialysis (46% after six months). this phenomenon questions the clinical significance of a single positive igra result. increasing the igra threshold or doing serial follow-up to improve specificity have both been suggested but there is no comparison by the risk of tb development. therefore, increasing the accuracy and stability and then improving the rate of negative conversion from positive igra results are very important. currently, new generation of quantiferon-tb gold plus includes two tubes for cd4 and cd8 t cells response, which can indicate tb immune response more specifically. the investigators applied this project to compare the performance of diagnosing ltbi by quantiferon-tb gold plus in comparing quantiferon-tb gold in-tube.

Eligibility criteria:
inclusion criteria: * age ≧ 20 years * receiving long term dialysis exclusion criteria: * having tuberculosis previously

Keywords: latent tuberculosis infection, dialysis
acute pain oscillation in electroencephalographic monitoring under general anaesthesia

Conditions: Pain

Summary: chronic pain is an undesirable condition that impacts predominantly quality of life at all levels. chronic pain might occur in healthy young patients when acute postoperative pain is undertreated and persists in time. there are some indexes in the market to evaluate pain, but they assess mainly parasympathetic activity. hence, it´s a measure of the physiological response to pain, which is still a not well-defined concept. patients under general anesthesia might be experimenting unnoticed pain as there is no direct standard method to measure it in clinical practice. this study aims to detect brain oscillatory activity in the intraoperative setting in four situations; awake-no pain, awake-pain, sleep-no pain, and sleep-pain. pain can be assessed by studying the local and global dynamics of brain activity. a promising upcoming measure of pain could be implemented in clinical practice to detect and treat pain.

this is a pilot study of the presence of neural oscillations during acute pain while awake and in the anesthetized patient with neurophysiological monitoring during a neurosurgery surgical intervention analyzed by electroencephalography. after the patient's consent, the electroencephalogram is placed in the awake patient and a small painful stimulus is performed based on the channeling of a second venous access. in turn, a recording of the eeg waves is made in order to identify similar neuronal waves during the surgical procedure once the patient is under general anesthesia. the reason for this intervention is to have a baseline record of each patient without interfering with the oscillations of the different drugs used during total intravenous anesthesia used in these procedures. normally, after general anesthesia, between 3 and 6 electrodes would be placed on the scalp and 10 electrodes would be placed to carry out this work. after the intervention, a telephone survey will be carried out on postoperative pain at 3 months and a year.

Eligibility criteria:
inclusion criteria: * adult patients that undergo schedule neurosurgery with neurophysiological monitorisation. * american society of anaesthesiologist physical status (asa) i-iv. exclusion criteria: * pregnancy * obstructive hydrocephaly with or with a derivative catheter. * patients with neurostimulator * emergency surgery.
open label extension of isis 301012 (mipomersen) to treat familial hypercholesterolemia

Conditions: Lipid Metabolism, Inborn Errors; Hypercholesterolemia, Autosomal Dominant; Hyperlipidemias; Metabolic Diseases; Hyperlipoproteinemia Type II; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Metabolic Disorder; Congenital Abnormalities; Hypercholesterolemia; Hyperlipoproteinemias; Dyslipidemias; Lipid Metabolism Disorders

Summary: the purpose of this study is to evaluate the safety and efficacy of extended dosing of mipomersen in patients with familial hypercholesterolemia on lipid-lowering therapy who have completed either the 301012-cs8 (nct00280995) or 301012-cs9 (nct00281008) clinical drug trials.

familial hypercholesterolemia (fh) is an autosomal dominant metabolic disorder characterized by markedly elevated low density lipoprotein (ldl), premature onset of atherosclerosis, and development of xanthomata. there are two distinct subpopulations that have a high unmet medical need due to the lack of alternative therapy: homozygotes, who have two defective ldl receptor (ldl-r) genes, and heterozygotes with a history of cardiovascular disease (cvd) on maximally tolerated therapy. treatment for fh is directed at lowering plasma levels of ldl-c. mipomersen is an antisense drug targeted to human apolipoprotein b (apob), the principal apolipoprotein of atherogenic ldl-c and its metabolic precursor, very low density lipoprotein (vldl). mipomersen is complimentary to the coding region of the messenger ribonucleic acid (mrna) for apo-b. inhibition of apo-b would be expected to impair vldl synthesis and result in lowered levels of ldl-c. in early clinical trials, mipomersen has been shown to reduce levels of ldl-c to recommended target levels in some participants. this was an open-label extension study, which consisted of a ≤2-week screening period, up to 3 years of treatment with mipomersen, and a 24-week post-treatment follow-up period. patients who participated in cohorts a, b, or c in study 301012-cs9 were randomized in a 1:1 ratio to mipomersen 200 mg once a week (qw) or 200 mg mipomersen every other week (qow) for up to 3 years. patients randomized to mipomersen 200 mg qow were allowed to receive mipomersen 200 mg qw at the investigator's discretion after the first 52 weeks of the treatment period. patients who participated in study 301012-cs8 or cohort d of study 301012-cs9 received 200 mg mipomersen qw for up to 3 years.

Eligibility criteria:
inclusion criteria: - satisfactory completion of dosing and week 7 or week 15 assessments (depending on the treatment and dose received) in their initial study (protocol 301012-cs8 (nct00280995) or 301012-cs9 (nct00281008)). exclusion criteria: - have a new condition or worsening of existing condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with patient's participation in or completion of the study.

Keywords: familial hypercholesterolemia heterozygous familial hypercholesterolemia homozygous familial hypercholesterolemia isis 301012 mipomersen open label extension
clinical assessment of patients with high bone mass due to mutation in lrp5

Conditions: Osteopetrosis

Summary: the aim of the study is to describe patients with a high bone mass phenotype due to a mutation in the low density lipoprotein l receptor 5 gene (lrp5) and compare them with age and sex matched controls. moreover, bone density and microarchitecture as well as markers of bone metabolism are evaluated

cases and controls are closely matched on age and sex and evaluated cross-sectionally. dual x-ray absorptiometry (dxa) and high resolution peripheral quantitative computed tomography (hr-pqct) are used in order to evaluate bone density as well as microarchitecture. bone turnover markers and body composition are also measured.

Eligibility criteria:
inclusion criteria: * lrp5 mutation/adoi exclusion criteria: * pregnancy

Keywords: low density lipoprotein receptor 5 high bone mass autosomal dominant osteopetrosis type i bone turnover markers
the effect of remote ischemic preconditioning in aortic valve replacement surgery

Conditions: Aortic Valve Stenosis; Cardiopulmonary Bypass

Summary: the study objective is to verify if a non-invasive remote ischemic preconditioning procedure (blood pressure cuff on the arm) is cardioprotective when applied before an aortic valve replacement surgery.


Eligibility criteria:
inclusion criteria: * planned isolated aortic valve replacement (stenosis based) * age ≥ 18 years exclusion criteria: * pregnancy * left ventricular dysfunction (lvef\< 50%) * myocardial infarct (\< 7days) * coronary artery disease (documented with \>50% stenosis) * coronary artery bypass grafting * chronic renal insufficiency (creatinine \>175 mmol/l or dialysis) * endocarditis * sternotomy redo * deep vein thrombosis to the compressed limb * emergency procedure * tavi procedure * planned off pump coronary artery bypass * maze procedure

Keywords: remote ischemic preconditioning myocardial infarction cardiac surgery
a multiple dose of hl237 in healthy male subject

Conditions: Rheumatoid Arthritis

Summary: hl237 is a new autoimmune therapeutic agent for rheumatoid arthritis, including the basic structure of biguanide in metformin, an existing diabetes drug. the immune modulating activity of hl237 was demonstrated in animal model. hl237 is a stat3 inhibitor and stat3 is well known for an important regulator inhibiting th17 cells and activating treg cells. therefore, when stat3 activity is inhibited, it is expected to be able to treat autoimmune diseases such as rheumatoid arthritis. this is the first repeated administration clinical trial performed for the development of hl237 and is intended to evaluate the safety, tolerability and pharmacokinetics of each dose group.

doses are increased sequentially from low-capacity groups, and within six weeks after the last dose of the last subject in the ongoing dose phase, if available pharmacokinetic data are judged acceptable under review by investigators, sponsor and safety review committees, then proceed to the next dose stage.

Eligibility criteria:
inclusion criteria: * a healthy adult male aged 20 years or older and 45 years old at the time of the screening test * those who weigh more than 55kg but weigh less than ± 20% of ideal body weight * proper contraception during the clinical trial period * after hearing the detailed explanation of the clinical trial, those who decide to participate voluntarily and write agreement exclusion criteria: * clinically significant, a person with a history of neurological, psychiatric, malignant, cardiovascular, respiratory, kidney, endocrine, hematologic, digestive or central disease * a person with a history of gastrointestinal disorders that may affect the absorption of pharmaceuticals for clinical trials (crohn's disease, ulcers, etc.) or gastrointestinal surgery (except for simple cecal surgery or hernia surgery) * a person with a history of hypersensitivity or clinically significant hypersensitivity to the clinical trial drug or additives * a person judged to be inappropriate for the subject by health screening (history of disease, physical examination, vital signs, electrocardiogram, laboratory test, etc.)
study and analysis of micafungin for non-albican candidemia: efficacy, risk factor and clinical manifestation

Conditions: Non-albicans Candidemia

Summary: this study is a retrospective research in order to compare and analysis the risk factor, clinical manifestation and efficacy of albicans candidemia by pulling medical records. we hope that this retrospective research will let us understand the method of treatment and prevention of albicans candidemia in order to improve the quality of healthcare.


Eligibility criteria:
inclusion criteria: * above 20 years old * hospital patients * albicans candidemia patients exclusion criteria: * pregnant patients or patients under 16 years old * liver cirrhosis and child c

Keywords: non-albicans candidemia
individualized lifestyle intervention for obesity management based on obesity phenotypes

Conditions: Obesity

Summary: the purpose of this protocol is to define an "individualized diet" approach based on obesity related phenotypes (pathophysiology obesity classification), which would increase weight loss, adherence, and weight loss maintenance.


Eligibility criteria:
inclusion criteria: * adults with obesity (bmi \>30kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and uncontrolled life-threatening comorbidities (i.e. unstable angina). * age: 18-65 years. * gender: men or women. exclusion criteria: * weight change greater than 3% in the previous 3 months (weight stable). * history of bariatric surgery including lap band and bariatric endoscopy. * significant untreated psychiatric dysfunction including binge eating disorders and bulimia. * current use of anti-obesity pharmacotherapy, medications known to affect weight (e.g., corticosteroids) or glp-1 agonist/analog for t2dm * a positive score on the audit-c questionnaire as judged by an investigator. * patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence
a prospective cohort study on the serum kisspeptin levels throughout pregnancy in pcos

Conditions: Polycystic Ovary Syndrome; Pregnancy Complications

Summary: the current study aims to investigate the dynamic serum kisspeptin levels throughout pregnancy and to explore its predictive value for gdm in pcos.

the current prospective cohort study aims to investigate the dynamic serum kisspeptin levels in the patients with polycystic ovary syndrome (pcos) at different trimesters of pregnancy, to analyze the associations between serum kisspeptin, insulin, glucose and testosterone, and to explore the predictive value of kisspeptin for gdm and other complications in pcos patients.

Eligibility criteria:
inclusion criteria: * age between 18 and 40 years old * women diagnosed as pcos who register for prenatal check ups in the obstetrics outpatient department of hospitals during early pregnancy.(the diagnostic criteria for pcos are based on the 2003 rotterdam diagnostic criteria (any two out of the three key characteristics of pcos: oligo-amenorrhea, hyperandrogenism, and polycystic-appearing ovarian morphology on ultrasonography) . exclusion criteria: * all other diseases with ovulation disorders or hyperandrogenism

Keywords: polycystic ovary syndrome pregnancy complications kisspeptin gestational diabetes mellitus insulin resistance
a prospective study investigating the use of relaxation prior to medical procedures.

Conditions: Pain; Anxiety

Summary: the primary aim is to investigate the efficacy of buddhify relaxation therapy in reducing the stress and anxiety levels of patients. the secondary aim is to investigate the effect of prior stress and anxiety levels on the perceived pain level of undergoing a medical procedure, reported post-procedure.

undergoing medical procedures is reported to cause stress and anxiety among many individuals.this can trigger the sympathetic nervous response, including decreased skin temperature, increased pulse, and increased blood pressure. while evolutionary advantageous, this response has deleterious effects on the healing process. heightened stress levels can also trigger an increased release of cortisol, a naturally produced steroid hormone known to hinder the immune response. in response to high levels of stress, a patient's tolerance for pain decreases and the perceived pain level increases. relaxation techniques can assist in reducing the stress and anxiety levels of a patient, which allows for lower perceived pain and more rapid healing. many relaxation techniques exist, including acupuncture, child life intervention, breathing therapy and guided imagery. buddhify, a mobile application, incorporates breathing therapy and audio-guided imagery into brief relaxation sessions, with the goal of reducing the stress and anxiety levels of the user. this application presents a convenient option for patients to use prior to undergoing a procedure. if proven to be effective, this application could be more widely used to help reduce the stress level, anxiety level and subsequent perceived pain level of patients, ultimately improving their healing reaction.

Eligibility criteria:
inclusion criteria: * patients aged 14 and older undergoing an invasive procedure by dr. gianmichel corrado at the division of sports medicine of boston children's hospital. exclusion criteria:

Keywords: buddhify stress anxiety relaxation technique