Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of pitavastatin versus atorvastatin to treat hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: statin is an effective drug to treat hyperlipidemia (hypercholesterolemia), and it rarely leads to hepatic damage to the patients with hepatic disorder. for these patients, intensive monitoring is required.


Eligibility criteria:
inclusion criteria: * patients aged between 25 and 75 * patients who signed informed consent forms of their own volition; * patients who had taken statins for 2 months and longer or whose fasting ldl-c levels, were 130mg/dl and over (friedewald's formula); * patients whose alt levels were 1.25 to 2.5 times higher than the upper limit of normal exclusion criteria: * patients with uncompensated liver cirrhosis. * patients whose total bilirubin levels were over 2 times higher than the upper limit of normal. * patients who had taken antiviral drugs for viral hepatitis. * patients who experienced cerebrovascular diseases or myocardial infarction within 3 months before screening visit or patients with heart failure (nyha class iv). * patients whose triglyceride(tg) levels were 400mg/dl or higher. * patients with uncontrolled hypertension (dbp≧100mmhg) * patients under suspicion of renal dysfunction (serum creatinine≧2.0mg/dl) * patients whose ck levels were over 2.5 times higher than the upper limit of normal. * patients with uncontrolled hypothyroidism although drug treatment (tsh≧uln×1.5) * female patients who were nursing or being pregnant or were planning on becoming pregnant. * patients judged to be unsuitable by investigators.

Keywords: hydroxymethylglutaryl-coa reductase inhibitors hyperlipidemia
sacroiliitis in systemic sclerosis

Conditions: Systemic Sclerosis; Sacroiliitis; Inflammatory Back Pain

Summary: one of the major problems of systemic sclerosis (ssc) patients is suggested to be articular involvement. mostly involved joints in ssc were reported as wrist, carpometacarpal-interphalangeal, foot, knee, hip and shoulder however there have been little knowledge on sacroiliac joint. here the investigators plan a study on the involvement of this joint in ssc.


Eligibility criteria:
inclusion criteria: * patients diagnosed as systemic sclerosis and rheumatoid arthritis and healthy volunteers exclusion criteria: * not giving informed consent
objective brain function assessment of mtbi/concussion in high school athletes

Conditions: Brain Injuries, Traumatic; Concussion, Brain; Concussion, Mild; Concussion, Intermediate; Concussion, Severe

Summary: this study (part 2) is designed to build a database including eeg, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal eeg based algorithm for the identification of concussion and tracking of recovery. in addition, neuroimaging will be conducted at time of injury and following return to play (rtp).

injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. matched controls will be tested following the same schedule as the injured athletes. in addition, the study will include an additional pool of contact and non-contact athletes who are not head injured and will be assessed prior to the season and then after the season has ended. this data will be used to populate a database for the purpose of deriving a multimodal concussion index.

Eligibility criteria:
inclusion criteria: * concussion-injury subjects will be defined as follows: any player who, based on independent clinical impression, is suspected of having suffered a concussion of any severity level, and on whom a routine clinical examination for concussion or head injury would have been conducted prior to implementation of this research protocol according to current standard practice. 1. if loss of consciousness, total duration less than \<20 minutes 2. no evidence of abnormality visible on computerized tomography (ct) of the head related to the traumatic event (note: neuroimaging is not required for enrollment) 3. no hospital admission due to either head injury or collateral injuries for \>24 hours. 4. gcs between 13-15 exclusion criteria: 1. do not speak or read english 2. current cns active prescription medications, with the exception of medications being taken for the treatment of attention deficit disorder (add) 3. skull abnormalities, e.g. metal plate 4. history of brain surgery or neurological disease 5. pregnant women.

Keywords: concussion mild traumatic brain injury sport related concussion
olmesartan as an add-on to amlodipine in hypertension

Conditions: Essential Hypertension

Summary: this study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine alone


Eligibility criteria:
inclusion criteria: * without antihypertensive pre-treatment mean seated bp greater than 160/100 mmhg * pre-treatment with amlodipine 5 or 10 mg: mean seated bp greater than or equal to 140/90 mmhg exclusion criteria: * secondary hypertension * any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs
safety, tolerability, and pharmacokinetics of single doses of apn1125 in healthy normal subjects

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of apn1125 when administered as single doses to healthy adult subjects.

the study will consist of 2 parts: (1) a single dose in healthy adult volunteers, (2) effect of food upon pharmacokinetics of a single dose of apn1125 in healthy adult volunteers.

Eligibility criteria:
inclusion criteria: * healthy males and females * aged 18 to 65 years, inclusive * body mass index (bmi) of 18 to 32kg/m\^2 inclusive at screening * non-smoker or no tobacco/nicotine usage with 30 days of screening exclusion criteria: * personal or family history of neurological, cardiovascular, renal, hepatic, metabolic, gastrointestinal or endocrine abnormalities * any clinical abnormality in cardiovascular (e.g., blood pressure) or electrocardiogram (ecg) parameters at screening and check-in
recurrent predictive power of circulating tumor cells for non small cell lung cancer patients

Conditions: Lung Cancer Recurrent

Summary: from literature review, circulating tumor cell was demonstrated its possible role in disease relapse. it was rare nit could be identified in all lung cancer patients. in addition, circulating tumor cell usual aggregate to form circulating tumor micro-emboli and caused distant metastases. therefore, circulating tumor cell could play a role in detect disease relapse and appropriate treatment could be given more earlier and further prolong patients' survival. however, the detail clinical significance of circulating tumor still remains unknown. the aim of this study was evaluate the clinical significance, including present timing, numbers, and correlation to disease relapse, of circulating tumor cell in lung cancer patients. the investigators want to clarify the clinical significance between circulating tumor cell and clinical presentation of lung cancer in order to establish new prediction model and improve lung cancer patients' survival.

study subject: inclusion criteria 1. patients with clinical stage 1 to 3a non-small lung cancer 2. patients with a resectable suspicious pulmonary lesion which is difficult for pre-operation tissue prove or refused for pre-operation biopsy 3. received curative intended tumor resection exclusion criteria 1. small cell lung cancer component which identified in pathology 2. patients who presented as stage iiib or iv 3. not received curative intended surgery due to multi-comorbidities 4. patients who presented in tumor seeding or positive resection in pathology confirmation 5. patients who received neoadjuvant therapy data collection: medical record review and blood sampling for circulating tumor cell purification timing of blood sampling: a.pre-operation, post-operation, post-operation day 1, post-operation day 3 b regular opd surveillance (3 month-interval) for 3 years blood sampling: 20 ml blood that withdrawn from a peripheral vein circulating tumor cell purification: two-step procedure 1. cell isolation: centrifugation, isolated karyocyte \> 10 micrometer 2. negative selection: wash out rbc, wbc depletion 3. positive selection: purify circulating tumor cell (karyocyte which presented cd 45 negative, epi-cam positive, diameter greater 10 micrometer result analysis: combine the medical record to analyze the relationship between circulating tumor cells and disease relapse

Eligibility criteria:
inclusion criteria: 1. non-small cell lung cancer patients with stage i to iii 2. patients with resectable suspicious pulmonary malignant lesion 1. no pre-operation diagnosis ( patients refused biopsy or difficult for biopsy) 2. image survey showed clinical stage i to iii exclusion criteria: 1. final pathology coexisted with small cell lung cancer component 2. patients who presented as stage iiib or iv. 3. not received curative intended surgery due to multi-comorbidities. 4. patients who presented in tumor seeding or positive resection in the final pathology 5. patients who received neoadjuvant therapy.
mechanism of thrombocytopenia in infants

Conditions: Thrombocytopenia; Small for Gestational Age (SGA); Preeclampsia

Summary: this research project is studying the causes for low platelet levels in preterm infants. platelets are a component of blood that helps with clotting. the purpose of this study is to determine whether the cause for low platelet levels is the same in infants who are born to mothers with preeclampsia and infants who are small for gestational age.

thrombocytopenia is a common entity in infants who are born to mothers with preeclampsia and in infants who are small for gestational age. there have been several theories to the mechanism underlying thrombocytopenia in these groups of patients. one mechanism suggests that thrombocytopenia in these populations may be secondary to underproduction of platelets. other studies have implied that low platelet levels may be due to endothelial activation causing platelet consumption. this study is being performed to help determine the mechanism causing thrombocytopenia in infants born to mothers with preeclampsia and comparing it to the mechanism of thrombocytopenia in infants who are small for gestational age.

Eligibility criteria:
inclusion criteria: * infants who are less than 34 weeks gestation * infants born to mothers with preeclampsia * infants who are born small for gestational age whose mother did not have preeclampsia exclusion criteria: * infants who are greater than 34 weeks gestation * infants with known congenital anomalies or known congenital infections

Keywords: thrombocytopenia small for gestational age (sga) preeclampsia
evaluation of a sarcopenia prediction model and development and effectiveness of a nursing guidance mobile app

Conditions: Prediction of High-risk Populations for Sarcopenia

Summary: we evaluated a model for the prediction of high-risk populations for sarcopenia in home settings, developed a sarcopenia nursing guidance mobile application, and assessed the effectiveness of this application in influencing sarcopenia-related knowledge and self-care behavior among participants.


Eligibility criteria:
inclusion criteria were being a member of the public, aged ≥20 years and \<80 years, and having experience using mobile devices or smartphones. exclusion criteria were not belonging to a high-risk population for sarcopenia and/or being unable to use the application platform.

Keywords: artificial intelligence, nursing, nursing guidance mobile application, prediction model, sarcopenia
clinical study to evaluate the anti-adhesion efficacy and safety of megashield®-sp in comparison with guardix-sp plus after spine surgery

Conditions: Herniation, Disc

Summary: this study is interventional, parallel, double-blinded, randomized study. subjects aged 20 to 70 years who had a lumbar discectomy or laminectomy, megashield-sp® and guardix-sp plus will be applied.

to evaluate preventing adhesion, the study group is compared with megashield®-sp or guardix-sp plus after lumbar discectomy or laminectomy. afterwards, they visit at 2 weeks, 12 weeks to conduct examinations and assess questionnaires.

Eligibility criteria:
inclusion criteria: * patients aged 20 to 70 years. * patient diagnosed with single-level lumbar disc herniation and scheduled to perform lumbar discectomy, or patients diagnosed with single-level spinal stenosis and scheduled to perform laminectomy. * patients who voluntarily decide to participate in the study and voluntarily agree in writing to the informed consent form. exclusion criteria: * patients diagnosed with multi-level lumbar disc herniation or lumbar disectomy ,far lateral lumbar disc herniation(flldh). * patient diagnosed with spinal cord disease * patient who needs spinal fusion * patient who has previous experience in spinal surgery * patient diagnosed with a serious liver or kidney disease * patients with lymph fluid or blood clotting disorder or taking antithrombotic or antiplatelet agents * patients with uncontrolled diabetes that may affect surgery or postoperative progress according to the investigator's judgment, * patients with immunocompromised or autoimmune diseases such as rheumatoid arthritis or systemic erythematosus lupus, and severe systemic immune disease * patients with infectious diseases or healing disorders that can interfere with the normal healing process after surgery * patients who received steroid epidural injections within 2 weeks from the date of screening or who took oral steroids within 24 hours * patients who participated in other clinical trials within 30 days from the date of screening * patients who are unable to take mri scans * pregnant or lactating women * patients who are not eligible for clinical trials according to the investigator's judgement * patients with a history of hypersensitivity to the main and other components of the investigational device * patients who are scheduled to receive myelogram or lumbar puncture within 24 hours from the application of the investigational device

Keywords: disc herniation laminectomy anti-adhesion disc resection megashield megashield-sp
ankaferd blood stopper for hemostasis after transradial coronary angiography

Conditions: Radial Artery Injury; Hematoma; Bleed

Summary: in 2008 goker et al, introduced ankaferd blood stopper (abs) as a new hemostatic drug. recently, abs has been shown to produce local hemostasis by implementing topically after major arterial vessel injury. reducing the compression time during patent hemostasis by facilitating hemostasis may decrease rao. to test this hypothesis the investigators planned a three arm randomized study to evaluate the safety and efficacy of ankaferd blood stopper in adjunct to short-time compression, compared to either short-time compression with conventional sterile gauzes or with a tr band after transradial diagnostic procedures.


Eligibility criteria:
inclusion criteria: * all consecutive patients undergoing transradial elective diagnostic coronary procedures between november 2016 and november 2017 at the catheterization laboratory of acibadem university kocaeli hospital were considered to be enrolled in the study. exclusion criteria: * the only exclusion criteria were an abnormal barbeau's test before puncture and failure to provide written informed consent.
study of remodulin® in pediatric pulmonary hypertension with single ventricular physiology after fontan surgery

Conditions: Pulmonary Hypertension

Summary: the aim of this study is to determine the safety and efficiency of remodulin®（treprostinil injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (ph) after fontan operation with univentricular physiology.

ph is a significant contributor to the postoperative morbidity and mortality of congenital heart disease, especially after fontan operation with univentricular physiology. mild increase of pulmonary vascular resistance may lead to failure of fontan circulation. remodulin® has been approved for the treatment of adults with ph, but little is known about the effects in children with ph after fontan operation. the study aim is to determine the safety and efficiency of remodulin® to reduce the pulmonary arterial pressure and prevent ph in children after fontan operation. meanwhile pharmacokinetics of the drug were checked with or without the peritoneal dialysis.

Eligibility criteria:
inclusion criteria: after fontan procedure, the criteria should be met 1. mpap greater than 15 mmhg 2. tpg greater than 6 mmhg (exclude the obstruction of cavopulmonary anastomosis) exclusion criteria: after fontan surgery : 1. severe arrhythmia led to low cardiac output 2. platelets smaller than 50,000\*109/l and obvious bleeding

Keywords: remodulin® pulmonary vascular resistance univentricular physiology
pain control after total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: patients are randomized to receive pain control after total knee arthroplasty with either a regional pain catheter or a local intraarticular pain catheter. pain, analgetic use and mobility is asessed.


Eligibility criteria:
inclusion criteria: * indication to total knee arthroplasty * signed informed consent exclusion criteria: * chronic pain * allergy against local anaesthetics * not understanding study or questionnaires

Keywords: total knee arthroplasty total knee replacement outcome results pain
adjunctive benefit of xenograft plus a membrane during sinus crestal approach

Conditions: Edentulous Jaw

Summary: patients in need for implant-supported restoration in maxillary posterior sites with insufficient residual bone height will be randomly allocated to two different arms. crestal sinus lift with simultaneous implant placement will be performed in both groups. control group: crestal sinus lift with no adjunctive biomaterial; test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; six months after implant placement, implants will be loaded with definitive screw-retained prostheses. six months later, patients will be recalled for clinical and radiographic assessment.

patients in need for implant-supported restoration in maxillary posterior sites with bone deficiencies will be randomly allocated to two different arms. full-mouth periodontal chart and standardized radiographs will be evaluated at the time of inclusion. crestal sinus lift with simultaneous implant placement will be performed in both groups. control group: crestal sinus lift with no adjunctive biomaterial; the healing abutment in this group is made up of peek (poly-ether-ether-ketone). test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; the healing abutment in this group is made up of titanium; resonance frequency analysis will be performed at the time of implant placement and at 1, 3, 6 months of follow-up. both healing abutment will be undersized: this characteristic will allow to harvest a 1mm-wide biopsy of the transmucosal tract at the end of the healing phase (6 months). six months after implant placement, impression will be taken and implants loaded with definitive screw-retained prostheses. six months later, patients will be recalled for clinical and radiographic assessment.

Eligibility criteria:
inclusion criteria: * more than 18 years old * edentulous in posterior maxilla * patient in need of sinus augmentation procedure * residual bone height greater than 3mm exclusion criteria: * systemic chronic diseases affecting osseointegration * contraindication for implant therapy * less than 18 years * uncontrolled periodontitis * smoker (more than 10 cig/day)

Keywords: dental implant sinus lift maxillary atrophy biomaterials
scoliosis shared decision making

Conditions: Scoliosis

Summary: analysis of video encounters between providers, patients, and families will be used to develop a shared decision making tool for patients deciding between surgery and observation for scoliosis treatment.

for patients and parents who are considering scoliosis surgery, a video recording of the encounter will be obtained during their routine clinical visit to discuss surgery/options. this video will then be sent to the shared decision making group at mayo clinic, rochester, minnesota to run analysis of the data (shared decision making national resource center, knowledge and evaluation research unit, mayo clinic). investigators will follow the patient's electronic medical records for 2 years after their decision of treatment option. no outcome forms will be specifically collected as part of the study, as outcomes forms are currently being collected clinically on all scoliosis patients. based off of the initial video recordings, the first visual prototype of the shared decision making tool for scoliosis has been developed. this prototype of the shared decision making tool will be now be used to help test it's efficiency.

Eligibility criteria:
inclusion criteria: * scoliosis curve \>40 degrees, \< 65 degrees * risser score \> 2 * age \> 13 years exclusion criteria: * risser score of 0 or 1 * non-ambulatory scoliosis patients * ages 12 year and under
effects of mechanical ventilation on the diaphragm in covid-19 intensive care patients. a post-mortem pathology study

Conditions: Diaphragm Injury; Pathology; COVID-19 Acute Respiratory Distress Syndrome; Ventilation Therapy; Complications

Summary: the diaphragm is the fundamental muscle of the respiratory system. the diaphragmatic dysfunction is present in 60% of critical patients at hospital admission and up to 80% after prolonged mechanical ventilation and difficult weaning. risk factors associated with diaphragm dysfunction and atrophy are sepsis, trauma, sedatives, steroids, and muscle relaxants. the main pathology characteristics of diaphragm biopsies of mechanically ventilated patients are atrophy and a reduction in contractility, determining an impact on the clinical outcome. shi et al. found a higher section area of the diaphragm muscle fiber in biopsies of post mortem covid-19 patients versus negative patients, independently from days of mechanical ventilation. the hypothesis of our study is to identify different clusters of pathological presentation in post-mortem covid-19 mechanically ventilated patients.


Eligibility criteria:
inclusion criteria: * patients deceased in the intensive care unit positive to sars-cov-2 and mechanically ventilated * post-mortem examination of the diaphragm exclusion criteria: * patients with a terminal disease and a prognosis of less than 48 hours at admission.