Kornimate/medical-research-clean huggingface dataset:
dna diagnostic system for statin safety and efficacy

Conditions: Hypercholesterolemia; Myopathy

Summary: lipitor®, zocor®, and crestor® are statin drugs commonly taken to lower cholesterol and prevent heart disease. statins lower cholesterol by different amounts in different patients and sometimes statins cause muscle pain, cramps, or weakness. this study will examine genetic differences in the blood of patients taking statins to predict both how well the statins lower cholesterol, and whether muscle discomfort occurs. finding such genetic connections is the key to developing genetic tests that might eventually help determine which statin is best for a patient. about 1000 people will be in the study.

statin efficacy in primary and secondary prevention of cardiovascular disease has led to increasingly aggressive usage and dosage of statins. their main clinically relevant safety risk is statin-induced myopathy (sim) evidenced as a constellation of neuromuscular side effects (nmse) that include myalgias (muscle aches, cramps, weakness) and myositis (monitored by elevation of serum creatine kinase \[ck\] activity). nmses are disabling to 3-20% of patients on statins, require alteration of therapy, and reduce compliance. nmses vary in extent between drugs and from patient to patient. we will develop a novel product termed sim phyziotype™ system to provide clinicians with individualized information for each patient on the safest statin drug among atorvastatin, simvastatin, and rosuvastatin, the 3 most prescribed statins. the phyziotype consists of a multi-snp (single nucleotide polymorphism) ensemble that, interpreted with a biomathematical algorithm, predicts drug response. we have developed a prototype phyziotype system incorporating predictive models for myalgia, serum ck activity, and ldlc reduction for atorvastatin and simvastatin patients. we will recruit to obtain 250 patients treated with each drug and use existing clinical records to characterize their nmse and ldlc responses. we will use physiogenomic analysis to identify those snps that differentiate the risk of nmses among the 3 statins and combine them into the sim phyziotype system. this work will also contribute to the pharmacology of sim and unravel new pharmaceutical targets. we will create and validate the sim phyziotype system with clinically useful prediction of nmses and potency for each of the 3 statins. in phase iii a prospective trial is planned for fda approval of the sim phyziotype product.

Eligibility criteria:
inclusion criteria: * receiving, or documented to have received in the past, any of the statins including atorvastatin, simvastatin, rosuvastatin treatment for hypercholesterolemia * chart-documented clinical record of having had, never having had, or possibly having had, statin-associated myopathy exclusion criteria: * never having taken any statin medication

Keywords: single nucleotide polymorphisms, snp, ldl cholesterol, statin myopathy, atorvastatin, simvastatin, rosuvastatin
individualized peep and driving pressure ventilation on postoperative lung complications in robot prostatectomy surgery

Conditions: Lung Collapse

Summary: in the case of robotic prostate cancer surgery under general anesthesia, the surgical posture is extreme trendelenburg. therefore, airway pressure is very high during mechanical ventilation, and there is a possibility of postoperative pulmonary complications. in order to prevent postoperative pulmonary complications, we tried to apply end-tidal pressure suitable for each individual to set the most tidal volume that can reduce the burden on the lungs during the perioperative period.

this study is conducted on patients who are scheduled for prostate surgery under general anesthesia with robot assistance. subjects who consented to the consent form the day before the surgery were conducted with people aged 19 years or older who belonged to the american society of anesthesiologists (asa) class i or ii. in the drive group, the ventilator setting is fixed at tidal volume 6-8ml/kg and respiratory rate 15 breathes/min, and then the recruitment maneuver (rm, alveolar recruitment) is performed within the range that does not cause hemodynamic instability. after that, the peep is gradually raised from 5 cmh2o to 20 cmh2o. driving pressure finds the lowest value. if there is no significant change even when the pressure change raises the peep, select the lowest peep. in the control group, peep is maintained in 5 cmh2o until the end of surgery. the primary outcome of the study is to confirm the presence or absence of postoperative pulmonary complications using chest x-rays, vital signs, and blood tests. it is the individualized peep value as a secondary outcome. the related driving pressure and compliance will also be observed. in addition, anesthesia/surgical time, use of vasopressors, amount of blood loss, amount of fluid, and amount of urine will be measured.

Eligibility criteria:
inclusion criteria: * elective ralp surgery under genenal anesthesia * asa 1-2 * 19 years of age or older * consented to participate in the study exclusion criteria: * do not consent to participate in the study * ≥ bmi 40 kg/m2 * moderate or severe obstructive/restrictive pulmonary disease on pulmonary function tests * preoperative serious cardiovascular disease * required postoperative ventilator care at icu care
ratt vs. vatt for early-stage tets

Conditions: Thymic Epithelial Tumor

Summary: this study is a prospective, multicenter, phase ii randomized controlled trial. we plan to screen 100 eligible thymoma patients for robotic-assisted thoracoscopic thymectomy (ratt) or video-assisted thoracoscopic thymectomy (vatt) at three medical centers in china. the trial was aimed to compare the perioperative outcomes between the two approaches.


Eligibility criteria:
inclusion criteria: * thymoma was diagnosed by chest enhanced ct or mri (clinical stage: masaoka koga i-ii) with ajcc/uicc tnm grade system (9th edition). the patients whose tumor diameter was not larger than 8 cm; the patients with the estimated survival time should be over 12 months; asa grade：1-2; the patients should have no functional disorders in main organs; the patients should be able to understand our research and sign the informed consent. exclusion criteria: * imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis; patients with myasthenia gravis; patients had undergone a sternotomy; the patients have proved history of congestive heart failure, angina without good control with medicine; ecg-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control; the patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy; female who is positive for serum pregnancy test or during lactation period; the patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation; the patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders; the patients attend other clinical trials.

Keywords: thymic epithelial tumor robot-assisted video-assisted thoracoscopic thymectomy
self-management in young adults with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: type 1 diabetes (t1d) affects 1.6 million americans, and only 14% of young adults age 18-25 years achieve glycemic targets (glycosylated hemoglobin a1c \<7.0%). achieving glycemic targets is associated with reduced risk for both micro-and macrovascular complications, better neurocognitive function, and better diabetes quality of life. in lab studies, sleep deprivation led to impaired glucose tolerance and insulin sensitivity in adults without chronic condition and in one study of adults with t1d. extending sleep in natural environments contributes to improved insulin sensitivity and glucose levels, neurocognition, and psychological symptoms in young adults without chronic conditions. modifiable dimensions of sleep health (appropriate sleep duration, stability, and timing) are associated with better glycemic control in adults with t1d. therefore, improving sleep duration, stability, and timing may be potential therapeutic targets to improve glucoregulation and clinical outcomes (diabetes self-management, neurocognitive function, and symptoms) in this high-risk population. the overall objective is to test and compare the effects of a cognitive-behavioral sleep self-management intervention (sleep extension and consistency in sleep timing) compared to an attention control condition (habitual sleep duration + diabetes self-management education) on improving sleep duration, stability, and timing, and glycemia (glycemic control and glucose variability) in short-sleeping young adults with t1d in a pilot randomized controlled trial.

this is a two-arm randomized controlled trial, with participants assigned to either the sleep self-management arm or the attention control arm (diabetes self-management education). the sleep self-management condition involves an initial 50-minute face-to-face consultation with brief 5-10 minute weekly follow-ups in a format tbd by aim 1 (e.g., call, text, video conference) with 3-week booster sessions in person. the sleep self-management intervention activities are provided in addition to "usual care."

Eligibility criteria:
inclusion criteria: * 1) age range: from 18 to 26 years * 2) diagnosed with t1d for at least 6 months * 3) no other major health problems (e.g., chronic medical condition or major psychiatric illness * 4) not currently participating in any intervention studies * 5) read/speak english * 6) have a most recent a1c or ea1c value ≥ 7%. exclusion criteria: * 1) previous osa diagnosis/high-risk sleep apnea * 2) current pregnancy * 3) night shift workers * 4) habitually sleep \> 7 hours on work or school days.

Keywords: young adult
effects of lateral wedge insoles, knee taping on the management of knee osteoarthritis

Conditions: Medial Compartment Knee Osteoarthritis

Summary: knee osteoarthritis (oa) is a degenerative, progressive and wide spread disease, which may lead the patient to severe outcomes e.g. pain, loss of joint motion, inflexibility, disability and decreases the quality of life (qol). as it affects the adults of older age, therefore should be emphasized.effectiveness of mulligan knee taping, lateral wedge insoles and traditional physical therapy(ultrasound therapy with stretching and strengthening exercises) with home exercises as baseline treatment were assessed through rapa and complete koos questionnaire.

a total of 60 patients with medial compartment 3rd grade knee osteoarthritis were recruited and randomly divided into three groups, 20 in each group.the data was collected through general demographic questionnaire, rapid assessment of physical activity (rapa) to determine physical activity level and knee injury and osteoarthritis outcome score (koos) to determine the level of pain severity, stiffness, functional activities, recreational activities and quality of life for enhancing functional independence while having osteoarthritis. for between-group analysis, one way anova was used and for within-group analysis longitudinal repeated measures analysis of variance (rm-anova) with tukey's multiple comparisons test was used.

Eligibility criteria:
inclusion criteria: * knee oa in the age group of 40-70 year. * knee oa due to aging. * knee oa due to family history exclusion criteria: * knee oa due to trauma. * knee oa due to any knee pathology.

Keywords: knee osteoarthritis knee injury and osteoarthritis outcome score rapid assessment of physical activity quality of life traditional physiotherapy
drug-coated balloons and drug-eluting stents in diabetic patients

Conditions: Coronary Heart Disease; Angioplasty, Balloon

Summary: drug-eluting stents (des) have long been recommended as the default device for patients undergoing percutaneous coronary intervention (pci). drug-coated balloon (dcb) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel-coated on the balloon. dcb angioplasty has the following advantages compared to des implantation: firstly, the drug in dcb is uniformly distributed and released, whereas the drug release of des via the stent platform is uneven -85% of the vascular wall is not covered by the stent strut. secondly, there is no alloy in the vessel after dcb angioplasty, while the coronary stent platform and polymer might cause temporal or persistent inflammatory response leading to intimal hyperplasia. finally, there is no metal cage restraining vessel motion after dcb, and the physiological function of coronary arteries would be maintained. currently, dcb constitutes an important treatment option in isr, which is endorsed by the 2018 european society of cardiology guidelines on myocardial revascularization. in addition, some interventional cardiologist has also applied dcb in de novo lesions in their clinical practice. diabetes is associated with worse outcomes after coronary revascularization and has been identified as an independent predictor of adverse events in patients with cardiovascular disease. although some small sample size rcts and observational studies have suggested that the clinical prognosis of dcb is non-inferior to the drug-eluting stent (des), there is still a lack of evidence comparing the dcb versus des for de novo or isr coronary lesions in diabetic patients. the current study aims to compare the long-term efficacy of dcb to des in de novo or isr coronary lesions in diabetic patients.


Eligibility criteria:
inclusion criteria: 1. patients with diabetes mellitus 2. received pci by a drug-coated balloons only strategy or drug-eluting stents only strategy exclusion criteria: 1. under the age of 18 2. unable to give informed consent 3. currently participating in another trial or participants unable to comply to follow-up

Keywords: drug-eluting stents drug-coated balloons diabetic de-novo in-stent stenosis all-comers
markers of platelet activation for identification of late onset sepsis in preterm infants

Conditions: Late-Onset Neonatal Sepsis; Necrotising Enterocolitis; Culture Negative Neonatal Sepsis

Summary: the parent study will examine platelet and endothelial associated proteins in preterm infants being investigated for late onset sepsis (los) to see if infants with fulminant sepsis can be prospectively identified using these markers

infants who are less than 34 weeks corrected gestational age at time of birth will be enrolled prior to any late onset sepsis investigations. at point of clinical concern for the development of late onset sepsis a 0.5-1.3ml sodium citrate sample will be taken. a targeted proteomic analysis using mass spectroscopy and flow cytometry will be performed and compared with the clinical diagnosis of the infant to examine if this can be used prospectively to identify infants with late onset sepsis

Eligibility criteria:
inclusion criteria: * \<34 weeks corrected gestational age at birth * under investigation for late onset neonatal sepsis (sepsis of onset \>72 hours of age) exclusion criteria: * major congenital anomaly * suspicion of an underlying haematological disorder affecting platelets * have received a platelet transfusion prior to sampling

Keywords: sepsis neonatal preterm
a dose-escalation study of ombrabulin in combination with paclitaxel and carboplatin in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the primary objective of the study is to determine the maximum tolerated dose (mtd) based on the incidence of dose limiting toxicity (dlt) and the maximum administered dose (mad) of ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients with advanced solid tumors. secondary objectives: * to assess the overall safety profiles of the combination therapy * to characterize the pharmacokinetic profile of ombrabulin, its active metabolite rpr 258063, paclitaxel, and carboplatin when used in combination * to document the objective tumor response

the duration of the study for each patient will include an up to 4-week screening phase, 21-day study treatment cycles, an end of treatment visit and a follow-up period.

Eligibility criteria:
inclusion criteria: * patients with advanced solid tumor for which the combination paclitaxel and carboplatin is potentially effective such as lung cancer, epithelial ovarian cancer. * patients who have signed and dated an institutional review board (irb)-approved patient informed consent form prior to study enrollment or performance of any study-specific procedures. exclusion criteria: * less than 20 or above 75 years of age ecog performance status ≥2. * patients with more than 1 line of previous chemotherapy for advanced or metastatic disease (adjuvant/neoadjuvant and targeted agents \[eg gefitinib\] excluded) * concurrent treatment with any other anticancer therapy (except palliative radiotherapy), * women of childbearing potential who does not agree with contraception. * washout period of less than 28 days from prior anticancer therapies * symptomatic brain metastases and carcinomatous leptomeningitis. * other serious illness or medical conditions * current peripheral neuropathy ≥grade 2 and ototoxicity, * absolute neutrophils counts\ upper normal limits of the institutional norms. - alt/ast \>1.5 times the upper normal limits of the institutional norms. - ap\>2.5 times the upper normal limits of the institutional norms. * medical history of myocardial infarction, angina pectoris, congestive heart failure, coronary artery bypass graft , arrhythmia , stroke or history of arterial or venous thrombo-embolism within the past 180 days requiring anticoagulants. * patient with a lvef \<50% by echocardiography. * patient with uncontrolled hypertension and patient with organ damage related to hypertension such as left ventricular hypertrophy or grade 2 ocular fundoscopic changes or kidney impairment. * hypertension defined as systolic bp \>140 mmhg or diastolic bp \>90 mmhg on two repeated measurements at 30 minutes interval. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
the effect of exercises of different intensity applied after total knee arthroplasty on exercise-induced hypoalgesia

Conditions: Knee Osteoarthritis; Pain, Acute

Summary: the aim of this study was to investigate whether exercise-induced hypoalgesia (eih) is present following exercise in patient after total knee arthroplasty (tka) and if so, if it changes with exercise intensity. a repeated measures and single-blinded randomized study were done. thirty-eight patients 24 hours after tka were randomly assigned to either low intensity exercises (lie) group or high intensity exercises (hie) group. an exercise programs lasted for five days during the hospitalization period. pain severity was assessed by visual analog scale (vas) (0-10 mm). pressure pain thresholds (ppts) were measured over quadriceps and biceps brachii and muscles immediately before and after exercise.

background: the aim of this study was to investigate whether exercise-induced hypoalgesia (eih) is present following exercise in patient after total knee arthroplasty (tka) and if so, if it changes with exercise intensity. methods : a repeated measures and single-blinded randomized study were done. thirty-eight patients 24 hours after tka were randomly assigned to either low intensity exercises (lie) group or high intensity exercises (hie) group. an exercise programs lasted for five days during the hospitalization period. pain severity was assessed by visual analog scale (vas) (0-10 mm). pressure pain thresholds (ppts) were measured over quadriceps and biceps brachii and muscles immediately before and after exercise.

Eligibility criteria:
inclusion criteria: * patients had undergone primary unilateral total knee replacement surgery * patients hospitalized for at least seven days were enrolled in this study. exclusion criteria: * medically stable patients who used glucocorticoids or strong analgesic drugs * patients had post-traumatic oa, rheumatoid arthritis (ra), psoriatic arthritis, cognitive, hearing and visual problems patients were diagnosed chronic pain condition were excluded from the study.

Keywords: total knee arthroplasty exercises intensity pressure pain threshold exercise-induced hypoalgesia
non-invasive neurostimulation for the relief of symptoms associated with migraine

Conditions: Migraine

Summary: the purpose of this pilot study is to assess feasibility and clarify the design of future study(ies) to support marketing approval of the gammacore™ device for the treatment and/or prevention of migraine symptoms.


Eligibility criteria:
inclusion criteria: * is between the ages of 18 and 55 years. * has been previously diagnosed as suffering from migraine, in accordance with the ichd-2 classification criteria (2nd), with or without aura. * experiences at least 2 migraines per month, but less than 15 headache days per month (over the last 3 months). * has age of onset of migraine less than 50 years old. * is able to give written informed consent exclusion criteria: * has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma. * has a lesion (including lymphadenopathy) at the gammacore™ treatment site. * has known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of tia or cva), congestive heart failure (chf), coronary artery disease or recent myocardial infarction. * has a history or baseline ecg that identifies the presence of a clinically significant unstable cardiac arrhythmia, second degree heart block type ii, history of ventricular tachycardia or ventricular fibrillation, or known cardiac syndromes that may be associated with increased risk of sudden death in otherwise healthy people. * has had a previous bilateral or right cervical vagotomy. * has a clinically significant irregular heart rate or rhythm. * has uncontrolled high blood pressure. * is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant. * has a history of carotid endarterectomy or vascular neck surgery on the right side. * has been implanted with metal cervical spine hardware or has a metallic implant near the gammacore™ stimulation site. * has a recent or repeated history of syncope. * has a recent or repeated history of seizure. * has a history or suspicion of narcotic abuse. * takes medication for acute headaches more than 10 days per month. * is pregnant, nursing, thinking of becoming pregnant in the next 3 months, or of childbearing years and is unwilling to use an accepted form of birth control. * is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days. * belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner). * is a relative of or an employee of the investigator or the clinical study site.

Keywords: vagus nerve stimulation vagal nerve stimulation nvns vns migraine non invasive gammacore