Kornimate/medical-research-clean huggingface dataset:
high-dose rosuvastatin preloading for enhanced outcomes in stemi patients undergoing primary pci

Conditions: ST Elevation (STEMI) Myocardial Infarction

Summary: to compare the efficacy of high dose rosuvastatin preloading vs placebo before primary pci in terms of mace at 30 days


Eligibility criteria:
inclusion criteria: * age 18-75 years patients undergoing primary angiography exclusion criteria: * hemodynamically unstable patients. history or clinical evidence of any co-morbidities. taking any medications regularly even statins.
short-term dual antiplatelet and maintenance clopidogrel therapy after drug-eluting stent implantation

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to compare short-term (6-month dual anti platelet therapy(dapt) followed by clopidogrel monotherapy) vs. standard long-term dual antiplatelet strategies (24-month dapt followed by aspirin monotherapy) on clinically relevant bleeding complications (bleeding academic research consortium(barc) type 2, 3, or 5)31 in patients after zotarolimus-eluting stent implantation.


Eligibility criteria:
inclusion criteria: * men or women at least 19 years of age * patients with stable coronary artery disease who were successfully treated with zotarolimus-eluting stents * patients without major bleeding or mace (myocardial infarction, stent thrombosis, stoke, repeat revascularization) within 6 months after zotarolimus-eluting stent placement * the patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site. exclusion criteria: * persistent thrombocytopenia (platelet count \<100,000/µl) * a known intolerance to a study drug (aspirin, clopidogrel) * patients requiring long-term oral anticoagulants or cilostazol * patients presented with acute myocardial infarction (stemi or nstemi) at the time of index procedure * planned cardiac surgery (e.g., cabg, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within 18 months after procedure * bare-metal stent implantation at the time of index procedure * chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible). * a diagnosis of cancer in the past 2 years or current treatment for the active cancer. * any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study. * hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alt or ast \> 3 times upper limit of normal). * history of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s). * unwillingness or inability to comply with the procedures described in this protocol. * patients pregnant or breast-feeding or child-bearing potential.

Keywords: coronary artery disease dual antiplatelet platelet therapy drug eluting stent
treatment of conditions with open label-anecortave acetate sterile suspension ( 15mg.) where lesions do not meet acceptable criteria for standard care.

Conditions: Age-Related Macular Degenerations.; Subfoveal Neovascularization.

Summary: a compassionate method of treatment is offered to patients where lesions do not meet acceptable criteria for standard therapy. visudyne (photodynamic therapy) and laser photocoagulation treatment (a treatment using heat from a fine point laser beam) have not been found to be effective in treating the lesions these patients have. anecortave acetate is an experimental drug that is being tested to prevent the growth of blood vessels under the retina in patients with age-related macular degeneration (amd).

patients will receive a sub-tenon injection of 15mg of anecortave acetate in their study eye with the use of a counter pressure device. patients will then be followed for up to 24 months. the patients will have the option of extending their participation in the study for an additional 24 months. statistical analysis will include comparison of patient follow-up visual acuity and angiographic data.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of patients whose lesions do not meet acceptable criteria for standard of care treatment (pdt or laser). 2. patients must be 18 years of age or older to receive treatment. 3. visual acuity of 20/30 to 20/320 study eye on the etdrs visual acuity chart. 4. visual acuity of 20/800 or better fellow eye on the etdrs visual acuity chart. exclusion criteria: 1. patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions. 2. patients who have undergone intraocular surgery within last 2 months. 3. patient participating in any other investigational drug study. 4. use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication. 5. inability to obtain photographs to document cnv (including difficulty with venous access). 6. patient with significant liver disease or uremia. 7. patient with known adverse reaction to fluorescein and indocyanine green or iodine. 8. patient has a history of any medical condition which would preclude scheduled visits or completion of study. 9. patient has had insertion of scleral buckle in the study eye. 10. patient has received radiation treatment. 11. patient is on anticoagulant therapy with the exception of aspirin. 12. patient is pregnant or nursing.
phase iii study of bkm120/placebo with fulvestrant in postmenopausal patients with hormone receptor positive her2-negative locally advanced or metastatic breast cancer refractory to aromatase inhibitor

Conditions: Breast Cancer

Summary: this study was a multi-center, randomized, double-blind, placebo controlled phase iii study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone receptor-positive (hr-positive), human epidermal growth factor receptor 2-negative (her2-negative), locally advanced or metastatic breast cancer (mbc) whose disease has progressed on or after aromatase inhibitor (ai) treatment.

patients were randomized (1:1) to receive buparlisib (100 mg/day) or placebo with fulvestrant (500 mg); randomization was stratified by pi3k pathway activation status (activated, non-activated, unknown determined in archival tumor tissue) and visceral disease status (present or absent). tumor evaluation was performed 6 weeks after the randomization date and then every 8 weeks until radiological progression (based on response evaluation criteria in solid tumors \[recist\] version 1.1). novartis made the decision not to pursue further development of buparlisib and to terminate the ongoing studies in the program. accordingly, on 19-dec-2016, novartis notified all the investigators about the decision not to pursue further development of buparlisib in breast cancer. as a result, the cbkm120f2302 study was terminated on 19-apr-2019 (last subject last visit).

Eligibility criteria:
key inclusion criteria: * locally advanced or metastatic breast cancer * her2-negative and hormone receptor-positive status (common breast cancer classification tests) * postmenopausal woman * a tumor sample must be shipped to a novartis designated laboratory for identification of biomarkers (pi3k activation status) * progression or recurrence of breast cancer while on or after aromatase inhibitor treatment * measurable disease or non measurable disease bone lesions in the absence of measurable disease as per recist 1.1 * adequate bone marrow and organ function defined by laboratory values key exclusion criteria: * previous treatment with pi3k inhibitors, akt inhibitors, mtor inhibitor or fulvestrant * more than one prior chemotherapy line for metastatic disease * symptomatic brain metastases * increasing or chronic treatment (\> 5 days) with corticosteroids or another immunosuppressive agent * active heart (cardiac) disease as defined in the protocol * certain scores on an anxiety and depression mood questionnaires

Keywords: breast cancer hormone receptor positive her2-negative metastatic locally advanced pi3k fulvestrant refractory aromatase inhibitor
study for participants with ulcerative colitis previously enrolled in etrolizumab phase ii/iii studies

Conditions: Ulcerative Colitis

Summary: this two-part, part 1: open-label extension (ole) and part 2: safety monitoring (sm) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (uc) participants previously enrolled in etrolizumab phase ii/iii studies. participants with moderate to severe uc who were enrolled in the phase ii ole study (ga27927 \[nct01461317\]) or the phase iii studies (ga28948 \[nct02163759\], ga28949 \[nct02171429\], ga28950 \[nct02100696\], ga29102 \[nct02165215\], and ga29103 \[nct02136069\]) were included. participants from the phase ii ole study or the phase iii studies who are not eligible or willing to receive etrolizumab in the ole-sm study, and who have completed the 12-week safety follow-up period will be enrolled in part 2. part 1 of ole-sm will continue for up to 9 years after the first participant is enrolled into the study. following part 1, participants will enter part 2 for a period of 92 weeks.


Eligibility criteria:
inclusion criteria: part 1 (open-label extension) - participants previously enrolled in the phase ii ole study or phase iii controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol part 2 (safety monitoring) * participants whose safety follow-up or pml follow-up is not completed within study ga27927 and participants who had their last dose of etrolizumab in july 2016 in study ga27927 and are not eligible or willing to enroll in part 1 (ole) * participants who participated in one of the etrolizumab phase iii studies and are not eligible or willing to enter part 1 (ole) * participants who transfer from part 1 (ole) * completion of the 12-week safety follow-up prior to entering. exclusion criteria: part 1 (open-label extension) * withdrawal of consent from and participant not compliant in the phase ii ole study or any of the phase iii studies * participant who discontinued etrolizumab/etrolizumab placebo prior to week 10 or did not perform the week 10 visit of the phase iii studies ga28948, ga28949, ga29102, and ga29103 * participant who discontinued etrolizumab/etrolizumab placebo prior to week 14 or did not perform the week 14 visit of the phase iii study ga28950 * any new, significant, uncontrolled condition
association of bsmi polymorphisms in vitamin d receptor gene with diabetic kidney disease

Conditions: Diabetic Kidney Disease

Summary: background: diabetic kidney disease (dkd), as one of chronic complication of type 2 diabetes mellitus, is common cause of end stage renal disease (esrd). vitamin d deficiency is known as one of dkd risk factors. recent studies on association between vitamin d deficiency and dkd had shown conflicting results. it may be due to vitamin d receptor gene polymorphisms, which is affected by bsmi, cdx2, apai, foki, and taqi gene. the investigators conducted cross-sectional study to investigate association between bsmi polymorphisms in vitamin d receptor gene with diabetic kidney disease hypothesis: bsmi polymorphisms in vitamin d receptor gene is associated with diabetic kidney disease (dkd)

diabetic kidney disease (dkd) is a common cause of end stage renal disease (esrd). data from indonesian renal registry (2011) revealed that 25% etiology of patients who underwent hemodialysis is dkd. risk factors that are associated with dkd include blood glucose control, hypertension, dyslipidemia, duration of diabetes mellitus, high body mass index (bmi), age, sex, ethnicity, vitamin d deficiency, high sodium diet, high protein diet, and smoking. the roles of vitamin d that are related to kidney are inhibition of renin transcription process, angiotensin ii, renal inflammation process, and albumin excretion, prevention of podocytes damage, glomerulosclerosis process, and transformation from kidney epithelial cell into mesenchymal cell. current studies on association between vitamin d deficiency and dkd had shown conflicting results. it may be related to genetic factor which is vitamin d receptor polymorphisms. the vitamin d receptor polymorphism is affected by cdx2, apai, bsmi, foki, and taqi gene, where asian population is mostly affected by apai, foki, and cdx2. several studies had reported the association between bsmi polymorphisms in vitamin d receptor gene and dkd in various population. zhang, et al (2012) study revealed the association between bsmi polymorphisms in vitamin d receptor gene and dkd in han chinese population, while study from vedralova, et al (2012) in caucasian race showed opposite result. however, the association between bsmi polymorphism in vitamin d receptor gene and dkd has not been investigated in indonesian-malay race. this is a cross-sectional study that investigate the association between bsmi polymorphisms in vitamin d receptor gene and dkd in indonesian-malay race. the investigators collected data about study participants' characteristics, conducted physical examination and laboratory examination, which include bsmi polymorphisms in vitamin d receptor gene.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patient * indonesian-malay race * had signed the informed consent exclusion criteria: * urinary tract infection * pregnant patient * fever * in menstrual period * had undergone hemodialysis or peritoneal dialysis * had used non steroid antiinflammatory drugs (nsaids) * postexercise

Keywords: bsmi diabetic kidney disease polymorphisms vitamin d receptor gene
long term follow-up study at years 2, 3, 4 and 5 where 2 dosing schedules of the combined hepatitis a and b vaccine were compared

Conditions: Hepatitis B; Hepatitis A

Summary: to evaluate the persistence of anti-hepatitis a virus (hav) and anti-hepatitis b surface antigen (hbs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. immune persistence was compared between subjects who received either two dose or three doses of gsk biologicals combined hepatitis a and hepatitis b vaccine. the long-term follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after the primary vaccination of combined hepatitis a and b vaccine to assess antibody persistence. no additional subjects will be recruited during the long term follow-up period.

Eligibility criteria:
inclusion criteria: * participation in primary study * written informed consent obtained before each long term follow up visit.

Keywords: combined hepatitis a and b vaccine twinrix™
cosmetic outcomes and patient satisfaction after facial laceration repair in the emergency department

Conditions: Facial Lacerations

Summary: facial lacerations are commonly treated in the emergency department. the nature of the injury leads to a great deal of concern about the long-term cosmetic appearance of the wounds. research questions 1. what is the association between wound characteristics, wound management in the ed, patient satisfaction in the ed, and patient-rated cosmetic appearance of sutured wounds? 2. is there a difference noted among ed providers with different levels of training? 3. is there an association between initial satisfaction scores and wound outcome? 4. is there an association between short term and long term wound scores? design this is a non-randomized, prospective, observational study of patients who present to the ed seeking treatment for facial laceration repair.


Eligibility criteria:
inclusion criteria: * families presenting to the ed for repair of facial laceration will be approached for study inclusion if: * their child seeking treatment is less than 18 years of age * the laceration was sustained less than 12 hours prior to presentation to children's ed * they speak english exclusion criteria: * families presenting to the ed for repair of facial laceration will be excluded from study participation if they: * are medically complex children * have a history of pre-existing coagulopathy or collagen vascular disease * have a history of immunodeficiency or diabetes mellitus * are suspected of non-accidental trauma * have wounds that could be approximated by tissue adhesives * have animal or human bites * have gross contamination * have puncture wounds * have lacerations of tendon/nerve/cartilage * have scalp lacerations * do not speak english

Keywords: laceration emergency cosmetic outcomes patient satisfaction suture
cyclophosphamide, doxorubicin, vincristine w/ irinotecan and temozolomide in ewings sarcoma

Conditions: Bone Cancer; Ewing's Sarcoma

Summary: the outcome of patients with metastatic ewings sarcoma is poor with current standard of care chemotherapy, with less than 30% survival. based on recent encouraging pediatric literature we have designed this trial to improve the outcome of patients with metastatic ewings sarcoma using irinotecan and temozolomide in addition to standard chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of metastatic ewing's sarcoma. * patients must have measurable disease defined as lesions that can be measured by medical imaging techniques such as ct or mri. ascites, pleural fluid, bone marrow disease, lesions seen on scan will not be considered measurable. * patients must have metastatic disease. * age 13 years or older * life expectancy of at least 3 months. * ecog performance status of \<= 3. * normal hepatic function (direct bilirubin \<1.5mg/dl, sgot or sgpt \<3x upper limit of normal). * left ventricular ejection fraction of at least 50%. * adequate renal function: creatinine clearance \>= 50 ml/min or serum creatinine \< 1.5 x uln for age. * adequate bone marrow reserve (defined as an absolute peripheral granulocyte count of \>=1500/mm3, platelet count of \>=75,000/mm3); unless bone marrow infiltrated with metastatic ewing's sarcoma; anc \>= 500 and platelet \>= 50,000 mm3. * ability to understand and willing to sign a written informed consent document. * patients of childbearing potential must agree to use an effective method of contraception. exclusion criteria: * no prior chemotherapy for ewing's sarcoma; no prior doxorubicin, temozolomide or irinotecan. * known hypersensitivity to any of the components of the protocol drugs. * clinically significant unrelated systemic illness (such as serious infections requiring active systemic intravenous antibiotic therapy; cardiovascular disease \[congestive heart failure, recent myocardial infarction, unstable angina, inadequately controlled hypertension\]. * no prior history of chronic diarrhea, bowel obstruction, crohn's disease or ulcerative colitis. * pregnant or nursing woman are not included in the study. * hiv-positive patients will be excluded from the study due to risk of infection or other serious side effects. * other medical, psychiatric or social condition incompatible with study treatment.
hybrid closure of congenital heart disease

Conditions: Pediatric Ventricular Septal Defects

Summary: ventricular septal defect (vsd) is one of the most common pediatric congenital malformations. in recent years, in view of the rapid rise of transthoracic minimally invasive hybrid closure for pediatric vsd in the clinical practice, precision assessment of perioperative its effectiveness and safety has already become an important issue that must be solved. on the basis of echocardiography, integrating with characteristics associated critical care, the investigators focus on precision assessment of perioperative effectiveness and safety of transthoracic hybrid closure for pediatric vsd, compared with conventional surgical sternotomy repair with cardiopulmonary bypass (cpb).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of perimembranous ventricular septal defect, muscular ventricular septal defect, doubly committed subarterial vsd by transesophageal echocardiogram (tee) with vsd size 5-12mm; * no significant aortic insufficiency or aortic valve prolapse. exclusion criteria: * confirmed pulmonary hypertension (systolic pulmonary arterial pressure \>75mmhg or pulmonary vascular resistance \>8.0 wood u/m2); * more than mild degree of aortic regurgitation and obvious aortic valve prolapse; * preoperative congestive heart failure; * other coexisting cardiac anomalies; * infective endocarditis.
safety and tolerability of vk2809 in patients with primary hypercholesterolemia and non-alcoholic fatty liver disease

Conditions: Hyperlipidemia; NAFLD

Summary: this study will investigate the efficacy, safety, and tolerability of vk2809 in lowering ldl-c and liver fat content in patients with primary hypercholesterolemia and fatty liver disease. the primary efficacy endpoint is percent change from baseline ldl-c at the end of the treatment period (week 12). secondary endpoints include effects on liver fat content and other liver and lipid markers, as well as effects on safety and tolerability, and pharmacokinetic (pk) measurements.


Eligibility criteria:
inclusion criteria: 1. minimum of 10% liver fat as assessed by mri - proton density fat fraction 2. fasting serum ldl-c \>130 mg/dl at screening, \>110 mg/dl on lipid lowering medications 3. any one of the following: 1. triglycerides ≥150 mg/dl or receiving prescription medication for elevated triglycerides. 2. systolic blood pressure \>130 mmhg or diastolic blood pressure ≥85 mmhg or receiving prescription medication for hypertension. 3. waist circumference \>40 inches (men) or \>35 inches (women) 4. body mass index (bmi) 18.50 - 40.00 kg/m2 inclusive at screening 5. provide a personally-signed and dated informed consent document exclusion criteria: 1. females of childbearing potential and males unwilling to use barrier birth control method (condom) throughout the study 2. resting 12-lead ecg showing qtc \>450 msec, any tachyarrhythmia or morphology change, or any other clinically significant abnormality 3. cardiovascular event requiring hospitalization in the past year 4. history or presence of thyroid disorder 5. history of malignancy in past 5 years 6. ldl-c ≥190 mg/dl or familial hypercholesterolemia 7. significant hepatic or renal function test abnormalities