Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics & safety study of clopidogrel 75mg and aspirin 100mg coadministration

Conditions: Atherosclerosis

Summary: the purpose of this study is to compare characteristics and safety after oral administration of g0041(75/100mg) 2 tablets with those of clopidogrel 75mg 2 tablets \& aspirin 100mg 2 capsules coadministration in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * healthy male volunteers between the ages of 20 to 50 years old * weight more than 55kg and within the range of ±20% of ibw * having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination * doctor determines to be suitable as subjects within 3 weeks ago before administration exclusion criteria: * hypersensitivitiy(or history of hypersensitivity) to aspirin and clopidogrel * active liver diseases or exceed 1.5 times the normal range of ast, alt, total bilirubin * exceed the normal range of pt, aptt, bt \& platelet counts under 150,000/㎣ or exceed 350,000/㎣ * creatinine clearance \< 80 ml/min * gastrointestinal diseases or surgeries that affect absorption of drug * congenital galactose intolerance, lactase deficiency and glucose-galactose malabsorption * excessive drinking(exceed 21units/week) * smoking over 10 cigarettes per day

Keywords: clopidogrel aspirin coadministration
post market clinical follow-up of eurostem femoral stem

Conditions: Hip Osteoarthritis; Hip Arthropathy; Hip Arthritis; Hip Necrosis; Hip Fractures; Hip Dysplasia

Summary: eurosstem is intended for use in primary and revision total hip replacement surgery. hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. as part of post market vigilance, euros will collect data on eurostem performances and safety

post market observational study. this study is multicenter, prospective, non comparative.

Eligibility criteria:
inclusion criteria: * patient who received eurostem * patient informed of its participation to the study * patient aged over 18 to date of surgery exclusion criteria: * patient presenting a contraindication to eurostem implantation. * patient who refused to participate to the study * vulnerable subjects
effects of whole-body electrostimulation on patients with chronic kidney disease

Conditions: Renal Insufficiency, Chronic

Summary: chronic kidney disease (ckd) consists of kidney damage, with consequent progressive and irreversible loss of kidney function. in the early stages of the disease, a reduction in circulating levels of the α-klotho protein is already observed, which is related to worsening renal function. therapeutic strategies that increase serum levels of α-klotho may be of great value in the treatment of ckd. electrical stimulation contributes to the reduction of reactive oxygen species, dna damage and improves the effectiveness rate of dialysis, suggesting a systemic effect in patients with terminal ckd. the objective of this study is to evaluate the effects of whole body electrical stimulation on renal function and physical capacity in patients with ckd not dependent on dialysis.

patients with stage iii and iv chronic kidney disease will be randomized into two groups, one group will receive whole-body electrical stimulation and the other group will be a control group (it will only be evaluated and reevaluated at the same times as the intervention group). the intervention group will perform the protocol three times a week, for eight weeks. the following assessments will be conducted pre- and post-intervention: analysis of plasma content of soluble α-klotho and creatinine to assess renal function; measurement of interleukins and tumor necrosis factor by elisa to analyze the inflammatory profile; beta-endorphin measurement by elisa to assess well-being; creatine kinase dosage to assess muscle damage; 10-repetition sit-to-stand test and quadriceps muscle dynamometry to assess lower limb muscle strength; handgrip test with a dynamometer to assess upper limb strength; six-minute walk test to assess functional capacity; application of the euroqol-5d questionnaire for quality of life and the pittsburgh scale to assess sleep quality.

Eligibility criteria:
inclusion criteria: * patients diagnosed with ckd (≥ 3 months) in stages 3-4 (gfr between 59 and 15 ml/min/1.73m2); * age between 18 and 80 years old; * functional capacity ≥ 300 meters in the six-minute walk test. exclusion criteria: * cognitive dysfunction that prevents assessments from being carried out or inability to understand and sign the informed consent form; * intolerance to electrical stimulator and/or changes in skin sensitivity; * skin injuries or burns where the electrodes are positioned; * patients with stroke sequelae; * recent acute myocardial infarction (two months); * uncontrolled hypertension (sbp\>230 mmhg and dbp\>120 mmhg); * new york heart association grade iv heart failure or decompensated; * unstable angina or arrhythmia; * artificial cardiac pacemaker or implantable cardioverter defibrillator; * peripheral vascular changes in the lower limbs such as deep vein thrombosis; * disabling osteoarticular or musculoskeletal disease; * uncontrolled diabetes (glycemia \> 300mg/dl); * patients with cancer and/or undergoing oncological treatment; * epilepsy; * hemophilia; * chronic obstructive pulmonary disease; * grade ii obesity (bmi≥35).
effectiveness of atmx in treating adolescents with adhd and sud

Conditions: Attention Deficit Disorder With Hyperactivity; Substance-Related Disorders

Summary: adolescents with attention deficit hyperactivity disorder (adhd) often develop substance use disorders (sud). the purpose of this study is to evaluate the effectiveness of atomoxetine in treating adolescents dually diagnosed with adhd and sud.

high rates of adhd have been reported in adolescents with sud. in addition, untreated adhd is a risk factor for developing sud. atomoxetine is a norepinephrine reuptake inhibitor, and is currently used to treat adolescents with adhd. the purpose of this trial is to evaluate the efficacy of atomoxetine in treating adolescents dually diagnosed with adhd and sud. this study will last up to 18 weeks. participants will receive six treatments of manual-driven, cognitive behavioral therapy for substance abuse over at 6 or earlier weeks. participants and their parents will partake in therapy sessions. subjects who have completed at least 2 weeks of cbt will be eligible to enter the controlled trial, at which point participants will be randomly assigned to receive either atomoxetine or placebo, which they will take once daily for 12 weeks. at the week 12 study visit, participants will be assessed for symptoms of adhd and sud.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of adhd * current or recent (within the three months prior to study entry) sud, including marijuana and alcohol abuse * adhd cgi-s score of greater to or equal to 4 exclusion criteria: * any unstable medical condition * recent history of intravenous drug use or cocaine dependence * currently abusing ecstasy, cocaine, gamma-hydroxybutyrate, methamphetamine, amphetamine, opioids, phencyclidine, or benzodiazepine * mental retardation or organic brain syndrome * currently psychotic or history of bipolar disorder * currently taking any psychotropic or anti-substance abuse disorder medications * current dsm-iv diagnosis of major depression, depressive disorder, or anorexia * pregnant or breastfeeding
scs as an option for chronic low back and/or leg pain instead of surgery

Conditions: Chronic Pain

Summary: to evaluate the safety and effectiveness of spinal cord stimulation (scs) with multiple modalities compared to conventional medical management (cmm) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the boston scientific wavewriter scs systems.


Eligibility criteria:
key inclusion criteria: * chronic low back pain, with or without leg pain, for at least 6 months * received at least 90 days of documented pain management care to address the primary pain complaint, prior to screening (e.g. medication, physical therapy) * if female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at screening * subject signed a valid, irb-approved informed consent form (icf) provided in english key exclusion criteria: * primary pain complaint of vascular origin (e.g. peripheral vascular disease) * require implantation of lead(s) in the cervical epidural space * significant cognitive impairment at screening that, in the opinion of the investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity * previous failed spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

Keywords: spinal cord stimulation
prospective cohort study for analyzing the effect of gastric cancer surgery to the metabolic syndrome and insulin resistance

Conditions: Gastric Cancer With Metabolic Syndrome or Metabolic Disease

Summary: gastric cancer is still one of the most common malignance in korea. because of the popularity of regular check ups, early detection of gastric cancer has increased, consequently, the survival of the patients also has increased. in this reason, the interest of outcomes after gastrectomy for gastric cancer move survival only to quality of life of these patients. although the definition of metabolic syndrome is various, but it is normally accepted as a state that insulin resistance or glucose intolerance combined with hypertension or hyperlipidemia or obesity. metabolic syndrome is a worldwide health problem, and the treatment is modification of life style, weight loss and medication. however, in most of the patients metabolic syndrome is considered not curable disease. recent studies have shown that some bariatric surgery offers not only control the overweight but also metabolic syndrome. the exact mechanism is still unknown but decreased gastric volume and intestinal bypass itself seemed to play an important role to improve metabolic syndrome over just decreased weight. for treating gastric cancer, gastrectomy is essential and the extent of gastrectomy is varied subtotal and total gastrectomy according to the location of tumor. also, reconstruction type is varied gastroduodenostomy and roux-en-y gastrojejunostomy after subtotal gastrectomy, esophagojejunostomy after total gastrectomy. this kind of operation for gastric cancer lead decreased gastric volume and/or intestinal bypass, which means this operation could lead similar effect of bariatric surgery. already, there have been several retrospective reports that metabolic syndrome or diabetes was improved after gastrectomy for gastric cancer but no prospective study about this subject yet in korea. the purpose of this study is that evaluating the degree of improvement of metabolic syndrome after gastrectomy for gastric cancer, and analyze the differences between the type of operation.


Eligibility criteria:
inclusion criteria: 1. gastric cancer, 2. in plan for gastrectomy for gastric cancer 3. ages between 20 to 85 years old 4. assign in consent exclusion criteria: 1. vulnerable subject (pregnant, be devoid of mental capacity, soldiers, or medical students) 2. had low performance scale due to severe cardiovascular disease.

Keywords: metabolic syndrome insulin resistance gastric cancer
multicenter, randomized, open-label study to assess whether treatment with mycophenolate sodium (mps) allows higher dose optimization versus mycophenolate mofetil (mmf) leading to a dose reduction of tacrolimus. maximiza study.

Conditions: Prophilaxis of Acute Rejection in Patients Receiving a Renal Allograft

Summary: multicenter, randomized, open-label study to assess whether treatment with mycophenolate sodium (mps) allows higher dose optimization versus mycophenolate mofetil (mmf) leading to a dose reduction of tacrolimus. maximiza study.


Eligibility criteria:
inclusion criteria 1. renal transplant recipients ≥ 1 year and ≤ 5 years prior1 to inclusion in the study. 2. patients who were receiving an immunosuppressive regimen including mmf ≤1000 mg/day and ≥ 250 mg/day 4 and prograf®1 or advagraf®6 (levels ≥7 ng/ml). 3. patients who had been receiving the current maintenance immunosuppressive regimen with stable doses of mmf for at least the past 3 months.2 4. patients included must have had prograf® or advagraf® levels ≥ 7ng/ml4 for at least one month prior to inclusion in the trial.2 5. patients with low immunological risk, in the investigator's opinion. 6. patients with an estimated glomerular filtration rate based on the mdrd formula of \> 30 ml/min x 1.73 m2.1 7. patients over 18 years of age.1 8. patients who were able to understand the study information and give written informed consent. 9. patients who were able to meet all study requirements, including completing questionnaires and attending study visits. exclusion criteria 1. patients with gi symptoms known or assumed not to be caused by mycophenolic acid (mpa) treatment (e.g. oral bisphosphonate-induced infectious diarrhoea). 2. patients with chronic inflammatory bowel disease. 3. diabetic patients. 4. acute rejection \< 1 month prior to inclusion in the study. 5. patients with leukopenia (\< 3500 cells/mm3) or thrombocytopenia (\< 100,000 cells/mm3). 6. women of childbearing potential who were planning to become pregnant, were pregnant and/or breastfeeding, or who did not wish to use effective contraception \[hormonal contraceptives (implantation, patches, oral) and double-barrier methods (any double combination of: iud, male or female condoms with spermicidal gel, diaphragm, contraceptive sponge, cervical cap)\]. 7. presence of psychiatric illness (such as schizophrenia, major depression) that, in the investigator's opinion, could interfere with study requirements. 8. patients who were undergoing surgery for an acute condition or who were hospitalised. 9. any other medical condition that, in the investigator's opinion based on blood counts or chart review, could interfere with completion of the study, including but not limited to visual problems or cognitive impairment. 10. patients who were receiving or had received any investigational medicinal product during the 30 days prior to inclusion in the study.
validation of a health-related symptom index for persons diagnosed with and either treated or monitored for anal high-grade squamous intraepithelial lesions (hsil)

Conditions: Anal High-Grade Squamous Intraepithelial Lesions

Summary: the purpose of this study is to finalize development of a questionnaire that measures health-related symptoms and concerns for persons diagnosed with, and either treated or monitored for, anal pre-cancer lesions.


Eligibility criteria:
inclusion criteria: * consented to the anchor trial as per self-report and by providing a valid referral code on the information sheet provided by the referring site. both men and women from the anchor trial will be recruited to this study. * english fluent as we are only validating this measure in english at this time * at least one month post-treatment for anal hsil as per self-report, or if the person is in the anchor trial observation arm, then at least one month post- randomization. * within two weeks post initial-treatment for anal hsil on anchor study or within two weeks post-randomization to anchor study as per self-report. notes: * anchor participants who are randomized to the treatment arm must have completed initial treatment and are within two weeks of initial treatment completion. * anchor participants who were treated initially with topical treatment are only eligible within two weeks after the last topical treatment application. * anchor participants who were treated initially with both topical and ablation treatments are eligible within two weeks of completing both treatments. * anchor participants who are randomized to the active monitoring arm are eligible if they are within two weeks of randomization exclusion criteria: * has a scheduled anchor follow-up appointment in the next two weeks as per self report. the purpose of this exclusion criterion is to minimize the impact on a participant's responses to a post-test evaluation the potential occurrence of an interim diagnosis or treatment event, or anxiety related to an upcoming medical follow-up.

Keywords: health-related symptom index anchor( anal cancer hsil (high grade squamous intraepithelial lesions) outcomes research study)
apixaban in the prevention of stroke and systemic embolism in patients with atrial fibrillation in real-life setting in france sniiram study

Conditions: Anticoagulation

Summary: the purpose of this study is to evaluate the apixaban use in the prevention of stroke and systemic embolism in patients with atrial fibrillation in real-life setting in france, data from sniiram (french data base).


Eligibility criteria:
inclusion criteria: * patient meeting inclusion criteria of the french système national d'information inter-régimes de l'assurance maladie (sniir-am)/programme de médicalisation des systèmes d'information (pmsi) claim databases (patient insured by the french national health insurance general scheme stricto sensu (apart from local mutualist sections) * patients with at least one reimbursement of ac treatment (acenocoumarol, warfarine and fluidione for vka treatments, apixaban, dabigatran or rivaroxaban for new oral anticoagulants (noacs)) treatments during the inclusion period * patients initiated with a new ac treatment during the inclusion period, either ac naive or not * patients aged 18 or older at their first anticoagulant initiation during the inclusion period * patient diagnosed with non-valvular atrial fibrillation (af)
comparison of the efficacy of peng block in combination with lfcn block and wound infiltration

Conditions: Postoperative Pain

Summary: the ultrasound-guided approach for the blockade of articular branches of femoral and obturator nerves, pericapsular nerve group (peng) block, is an effective method for postoperative analgesia in hip surgeries.

the ultrasound-guided approach for the blockade of articular branches of femoral and obturator nerves, pericapsular nerve group (peng) block, is an effective method for postoperative analgesia in hip surgeries. however, it fails to provide cutaneous analgesia on the anterolateral surgical incisional site. this study compares the effects of wound infiltration and lateral femoral nerve blocks in combination with peng blocks for postoperative pain in patients undergoing total hip arthroplasty for coxarthrosis.

Eligibility criteria:
inclusion criteria: * coxarthrosis * total hip replacement * patients agreed to receive peng block * lfcn or wound infiltration performed combined with peng blocks exclusion criteria: * other kinds of hip surgeries * total hip replacement performed for other indications * patients refused to receive peng block

Keywords: coxarthrosis regional anesthesia total hip replacement
gsp as an novel indicator for residual liver function in patients with fatty liver

Conditions: Galactose Single Point (GSP), Residual Liver Function

Summary: the primary objective is to determine the galactose single point (gsp) cutoff values to discriminate subjects with different hepatic function. the secondary objective is to analyze the correlations between gsp and other hepatic function assessment methods among this trial subjects.

nonalcoholic fatty liver disease (nafld) is the most common chronic liver disease, including the potential for progression to nonalcoholic steatohepatitis (nash), followed by fibrosis and ultimately cirrhosis. the gold standard to evaluate fibrosis in patients with nafld is liver biopsy. the investigators aimed to evaluate the clinical utility of using the galactose single point (gsp) test which recommended by the us fda to quantitatively measure liver function in patients with nafld.

Eligibility criteria:
inclusion criteria: subject must fulfill all of the following criteria to be eligible for the study: 1. male or female with age between 20-80. 2. ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires. exclusion criteria: any of the following criteria will disqualify the subject from participation: 1. history of serious allergic reaction to galactose and have galactosemia. 2. history of receiving total gastrectomy, subtotal gastrectomy, celiac disease, or small intestinal resection. 3. history of diabetes mellitus. 4. subjects are children or handicapped people. 5. subjects with any other reasons considered by the investigator not in the condition to enter into the trial.

Keywords: gsp galactose single point (gsp)
dlbs1442 for the treatment of pain in patients suspected endometriosis

Conditions: Endometrioma; Visual Analogue Pain Scale: Moderate or Severe Pain

Summary: this is a 3-arm, prospective, randomized, double-blind, and controlled study of dlbs1442 for the treatment of pain in patients suspected endometriosis. it is hypothesized that the reduction of the composite-pain intensity (as measured by vas) from baseline to the end of study (week 8th) resulting from administration of dlbs1442, regardless of the dosage regimen, is significantly greater than that of control. in addition, the administration of dlbs1442 at higher dose also results in significantly greater reduction than that of dlbs1442 at lower dose and of control.

there will be three groups of treatment by dosage regimen in this study. eligible subjects will be randomized to receive any of the following regimens: 1) dlbs1442 at a dose of 3 x 100 mg daily, or 2) dlbs1442 at a dose of 3 x 200 mg daily; or 3) mefenamic acid at a dose of 3 x 500 mg daily. dlbs1442 will be taken every day along the study period (8 weeks), while mefenamic acid will only be taken for five (5) days during the menstrual period, i.e. day 1st to day 5th of menstrual period. study treatment will be given at a standardized starting point for all subjects, i.e. on the first day of their respective menstrual periods. clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and every 4-week interval throughout the study period.

Eligibility criteria:
inclusion criteria: * signed informed consent before any trial related activities * female of 18 - 50 years of age * subjects suspected with cystic endometriosis or adenomyosis confirmed by transvaginal ultrasonography (or transrectal ultrasonography for unmarried subjects) * presence of moderate or severe pain as shown by vas score of at least 4 on at least one of the following pain: menstrual pain (dysmenorrhea), dyspareunia, non-menstrual pelvic pain, dysuria, dyschezia * occurrence of at least 3 last sequential menstrual cycles of 21 - 35 days duration prior to screening exclusion criteria: * pregnancy * patients with infertility who are willing to be pregnant * using hormonal contraception or other forms of hormonal therapy within the last 30 days * being under therapy with systemic corticosteroids on a chronic or regular basis within the last 90 days * history or presence of suspected malignancy abnormalities * history of surgical treatment for endometriosis within 3 months prior to screening * history of hysterectomy or oophorectomy * presence of clinical signs of sexually transmitted disease * presence of unexplained uterine or cervical bleeding * impaired liver function: serum alt \> 2.5 times upper limit of normal * impaired renal function: serum creatinine \>= 1.5 times upper limit of normal * known or suspected allergy to similar products

Keywords: dlbs1442 endometriosis pain visual analogue scale endometriosis health profile (ehp-30tm)