Kornimate/medical-research-clean huggingface dataset:
registry of bleeding risk in real world chinese acute coronary syndrome patients-ii

Conditions: Acute Coronary Syndrome; Percutaneous Coronary Intervention; Bleeding

Summary: the present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in acs patients undergoing pci.

acute coronary syndrome (acs) is a group of clinical syndromes characterized by rupture or erosion of coronary atherosclerotic plaques secondary to complete or incomplete thrombus formation. with the development of antithrombotic drugs and percutaneous coronary interventional therapy, bleeding has become one of the major complications for acs patients after pci.moreover,bleeding after pci therapy significantly increased short-term and long-term risk of death. however, there is a lack of data on the risk of bleeding in acs patients treated with pci in the clinical reality world of china. therefore,the present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in acs patients undergoing pci. the present study was designed to observe the incidence of bleeding events and characteristics of bleeding and exploratively analyse bleeding related biomarkers and gene polymorphisms in acs patients undergoing pci. this study will provide sufficient and reliable evidence for the risk of bleeding and the choice of antithrombotic drugs in acs patients undergoing pci in china, and provide a reference for individual antithrombotic therapy after pci.

Eligibility criteria:
inclusion criteria: * age≥18 years, male or female; * confirmed acute coronary syndrome patients; * undergo percutaneous coronary intervention (pci) treatment; * agree to participate in this clinical study and sign a written consent form. exclusion criteria: * acs admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure; * patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements; * pregnant women or lactating women; * investigators consider patients who were not suitable for participation with other reasons

Keywords: acs pci bleeding risk
fight fatigue: a progressive muscle relaxation and walking intervention to reduce fatigue in adults with eskd

Conditions: End Stage Renal Disease on Dialysis

Summary: fight fatigue is evaluating the feasibility and acceptability of a combined progressive muscle relaxation and walking intervention to reduce fatigue for adults with end-stage kidney disease receiving in-center hemodialysis.


Eligibility criteria:
inclusion criteria: * diagnosis of eskd diagnosis and receiving hemodialysis for at least 3 months * can read and speak english * fatigue measured via visual analogue scale, score ≥4 over the last week * able to stand and walk one block * has a cell phone that can receive text messages exclusion criteria: * patient's nephrologist refuses for them to participate * unstable angina * unstable pulmonary disease or pulmonary symptoms that preclude participation * lower-extremity amputation without prosthetic (bka, aka) -orthopedic or neurologic condition that would preclude walking or tensing/releasing of muscles- * cognitive impairment that, in the judgement of the research team, precludes trial participation * participation in the formative phase of the development of fight fatigue

Keywords: fatigue
use of testicular spermatozoa in non-azoospermic patients

Conditions: Male Infertility

Summary: use of testicular spermatozoa in non-azoospermic patients.

the aim of the study is to evaluate the characteristics of couples whose male partner is offered tese after the failure of previous icsi technique performed with ejaculated semen. all couples in a third-level university affiliated centre, between january 2010 and january 2020, whose male partner were diagnosed with any type of oligospermia and underwent tese after icsi from ejaculated semen, were included in the analysis.

Eligibility criteria:
inclusion criteria: * all patients undergone testiscular sperm extraction (tese) after failure of icsi with the use of ejaculated sperm exclusion criteria: * female age \>40 yo
bioequivalence minocycline bioequivalence

Conditions: Skin Infections (Acne)

Summary: the aim of the study is to compare the bioavailability of two medications containing 100 mg of minocycline in capsules to determine bioequivalence. they are minocycline (minocin® is a registered trademark of wyeth holdings corporation), and minocycline (minopac® is a registered trademark of laboratorios dermatologicos darier, s.a. de c.v.). study design is randomized, open, cross-over with two single administrations with two periods and two sequences with a wash-out period of 7 days between the periods. subjects in the study will be 25 healthy male volunteers, 18-55 years, blood samples will be obtained at 0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 48.0, and 72.0 hours after medication administration in each period. plasma minocycline levels will be determined by hplc method with uv detection with previously validated method. minocycline concentration data will be used to calculate cmax, auc0-t, and auc0-inf with winnonlin 5.3 software. the log transformed pharmacokinetics parameters of test and reference medications will be compared calculating ratios and 90% confidence intervals. any adverse event will be reported.


Eligibility criteria:
inclusion criteria: males 18-55 years. healthy based on comprehensive medical history, lab tests, chest x-ray, electrocardiogram, negative tests for hepatitis b and c, and hiv. negative urine doping test. bmi 19-26.5 kg/m2. lab test in normal range +/- 10%. blood pressure 139-90/89-50, heart rate 100-55, respiratory rate 24-17, temperature 37.5-35 °c. non-smoking at least for 10 hrs before study. written informed consent. exclusion criteria: hypersensitivity to study medication or other related drug. history of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic, psychiatric or organic condition. requiring any drug interfering with minocycline pharmacokinetics. exposed to inducers or inhibitors of hepatic enzymes. intake of possible toxic drugs 30 days before study. intake of any drug 14 days or 7 half-lives before study. hospitalization or severe disease 60 days before study. receiving investigational drug out of study center 30 days before study. blood loss or blood donation ≥ 450 ml 60 days before study. recent history of drug abuse including alcohol. intake of xanthine containing products 10 hrs before study. intake of grapefruit juice or hot-spice 10 hrs before study.

Keywords: minocycline mexico acne bioequivalence
safety and tolerability of vildagliptin versus sitagliptin in patients with type 2 diabetes and severe renal insufficiency

Conditions: Diabetes Mellitus, Type 2

Summary: this clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(t2dm) and severe renal insufficiency (glomerular filtration rate (gfr) \< 30 ml/min) for a period of 24 weeks.


Eligibility criteria:
inclusion criteria * history t2 dm * severe renal impairment exclusion criteria * glucose ≥ 270 mg/dl (≥15 mmol/l) * patients undergoing any method of dialysis * treatment with therapy other than sulfonylureas, tzds ,insulin, and metiglinides

Keywords: type 2 diabetes, vildagliptin
vx-770 for the treatment of chronic bronchitis

Conditions: Chronic Bronchitis

Summary: this research study will test how well a new drug affects bronchiectasis or chronic bronchitis. the new drug, ivacaftor (kalydeco), is a drug that has recently been approved by the u.s. food and drug administration (fda) for patients with a lung disease called cystic fibrosis (cf). it has not been approved for use in patients with bronchiectasis or chronic bronchitis.

the study is an open label study of orally-administered ivacaftor in subjects with chronic bronchitis and/or bronchiectasis. subjects will be administered the study drug ivacaftor 150 mg twice daily (bid). the study drug is commercially available and will be purchased by the participant.

Eligibility criteria:
inclusion criteria: * male or female age 18 years * a clinical diagnosis of bronchiectasis and/or chronic bronchitis in the investigators opinion * exhibit symptoms of chronic bronchitis as defined by the medical research council * fev1 percent predicted greater than 40 percent post bronchodilator * clinically stable in the last 4 weeks with no evidence of exacerbation * weight of 40 kg to120 kg * willingness to use at least one form of acceptable birth control including abstinence, condom with spermicide, or hormonal contraceptives * willing to monitor blood glucose if known history of diabetes mellitus requiring insulin or medical therapy * element of cftr dysfunction, as defined by sweat chloride exclusion * daytime use of oxygen therapy * documented history of drug abuse within the last year * subjects should not have a pulmonary exacerbation or changes in therapy for pulmonary disease within 28 days before receiving the first dose of study drug. * cirrhosis or elevated liver transaminases \> 3x uln * gfr \< 50 estimated by cockroft-gault * any illness or abnormal lab finding that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject. * pregnant or breastfeeding * subjects taking any inhibitors or inducers of cyp3a4, including certain herbal medications and grapefruit juice. (excluded medications and foods including the drugs and foods are provided in the appendix document) * uncontrolled diabetes * clinically significant arrhythmias or conduction abnormalities that in the opinion of the investigator that affect patient safety
identification of non-responders to levothyroxine therapy

Conditions: Hypothyroidism; Biomarkers; Endocrine System Diseases

Summary: the purpose of this study is to assess differential effects of t4 and t3 on cell and tissue level

15-20% of the patients with hypothyroidism remain symptomatic, despite adequate thyroxine substitution. endocrinologists are split in their opinion on combination therapy with t4 and t3 on patients with poorly regulated hypothyroidism. there are no objective means, by which to identify individuals who would benefit from combination therapy. the purpose of this study is to assess differential effects of t4 and t3 on body temperature, metabolism, muscle strength and brain function. the main aim is to try to identify biomarkers reflecting different effects of t4 and t3 on cell and tissue level.

Eligibility criteria:
inclusion criteria: * poorly regulated hypothyroidism * female aged between 18 and 65 years * written informed consent obtained from the patient according to national regulations exclusion criteria: * cardiovascular disease * chronic liver disease * chronic kidney disease * any other endocrinological disease * use of beta blockers * pregnant or lactating females * hormonal substitution other than t3 and t4 * known psychiatric disease

Keywords: thyroxine triiodothyronine
coreg cr, blood vessel stiffness and blood vessel function

Conditions: Endothelial Function; Diabetes Mellitus; Hypertension

Summary: we are comparing the blood pressure-lowering effects of two marketed medications, coreg cr and toprol xl. although both drugs reduce blood pressure by blocking the action of noradrenaline on beta-receptors in the blood vessels, coreg cr also blocks alpha-receptors, which may provide added blood pressure-lowering. in addition, coreg cr may have anti-oxidant actions. cells which line blood vessels (termed "endothelial cells") make nitric oxide (no), which relaxes the muscle cells encircling the blood vessels, causing a reduction in blood pressure. when body cells use oxygen, they normally produce "free radicals", which can destroy no,leading to high blood pressure, heart damage and worsenimg of diabetes. antioxidants remove free radicals and prevent or repair this damage. in this study we will measure endothelial cell function, blood vessel wall stiffness, no in exhaled breath, and blood levels of substances which reflect no production and destruction to determine if a pure beta-blocker (toprol xl) differs from an alpha/beta blocker (coreg cr) in these effects. we will also examine the mechanism by which such differences might occur.

the following techniques will be used: endothelial function will be measured non-invasively by flow-mediated changes in pulsatile blood volume in the finger-tips. vascular compliance (stiffness) will be assessed by tonometry of the radial pulse wave ("augmentation index") and diastolic puse wave analysis. plasma nitrate/nitrite levels mirror no production and will be measured spectrophotometrically by the griess reaction. plasma nitrotyrosine, an in vivo marker of no-dependent damage induced by reactive nitrogen intermediates derived from no, will be measured by elisa. exhaled no may provide an real-time measure of endothelial cell no production and can be measured by a hand-held device which contains an electrochemical detector sensitive to 5 ppb.

Eligibility criteria:
inclusion criteria: 1. type 2 diabetes mellitus, 2. stable antidiabetic regimen for 3 months 3. hemoglobin a1c \<8.6% 4. stable antihypertensive medication regimen for 3 months or more, including either an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker exclusion criteria: 1. any clinically significant abnormality on history, physical examination, or laboratory testing which could preclude safe completion of the study 2. significant cardiac conditions 3. lung disease 4. cigarette smoking 5. chronic kidney disease (stage 3 or greater) 6. type 1 diabetes 7. known contraindication to alpha- or beta-blocker therapy

Keywords: endothelial dysfunction blood vessel stiffness nitric oxide oxidative stress
study on treatment for patients with symptomatic oral lichen planus

Conditions: Lichen Planus, Oral

Summary: the primary objective of this study was to compare the therapeutic efficacy of tacrolimus gel versus an anti-inflammatory mouthwash in an oral solution for the management of patients suffering from symptomatic olp. the secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects.

thirty nine patients were assigned, through a randomized design, to receive tacrolimus ointment 0.1% or a mouthwash composed of calcium hydroxide 10%, hyaluronic acid 0,3%, umbelliferone and oligomeric proanthocyanidins, or an anti-inflammatory mouthwash (mouthwash which contains calcium hydroxide, hyaluronic acid, umbelliferone and oligomeric proanthocyanidins) for 3-months. at baseline (t0) and after 3 months (t1), patients were subjected to clinical and oral assessments and were evaluated for the symptoms (numerical pain scale, nrs score) and signs (thongprasom's score) of olp. data were calculated using t-test for the dependent variable, wilcoxon test and mann-witney u test.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * clinical diagnosis and histological diagnosis of olp on the basis of who criteria; * presence of symptoms related to olp. exclusion criteria: * presence of systemic conditions that may have affected the study results; * state of pregnancy or breastfeeding; * histological signs of dysplasia; * drugs inducing a lichen response (ace-inhibitors, β-blockers, etc.); * treatment of olp in the six months prior to the start of the programme; * presence of extraoral lesions (genital, skin and other) * history of previous immunodeficiency or hiv seropositivity; * previous allogeneic bone marrow transplantation; * presence of systemic lupus erythematosus or other autoimmune diseases.
transcranial electrical stimulation with visual comfort for treating chronic pain in inflammatory demyelinating diseases

Conditions: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System

Summary: non-invasive neurostimulation can effectively improve patients' symptoms and has shown good therapeutic efficacy in alleviating the symptoms of iidds (inflammatory immune-mediated demyelinating diseases). however, some patients have not achieved the desired results, which may be due to individual differences in neural responsiveness \[20\]. therefore, this study aims to assess the therapeutic effect of transcranial electrical stimulation combined with visual placebo on improving symptoms such as painful spasm in iidds patients, by considering both the overall characteristics of iidds disease symptoms and individual differences in patients. the study will explore the imaging characteristics, electrophysiological features of the disease symptoms, and their relationship with clinical manifestations, while analyzing the key factors that influence treatment efficacy.


Eligibility criteria:
inclusion criteria: patients diagnosed with neuromyelitis optica spectrum disorder, multiple sclerosis, or other central nervous system inflammatory demyelinating diseases that meet the diagnostic criteria; numeric rating scale (nrs) pain score ≥4; age between 18 and 65 years, regardless of gender; stable dose of immunosuppressive therapy for at least one month; edss score ≤6; right-handed; agree to participate and sign the informed consent form. exclusion criteria: a history of relapse within the past month; recent medication adjustments or treatment with modified electroconvulsive therapy, transcranial magnetic stimulation, or other neurostimulation techniques within the past month; participation in any other clinical trial within the past month or currently participating in another clinical trial; presence of cochlear implants, pacemakers, or implanted stimulators in the brain; skin integrity at the electrode placement site is compromised, or allergy to electrode gel or adhesive; a history of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections; pregnant or breastfeeding women, or those planning to become pregnant in the near future; a score of ≥3 on item 3 (suicide item) of the hdrs-17, or a history of severe psychiatric disorders; presence of severe or unstable organic diseases; poor patient compliance preventing cooperation with treatment, follow-up, or clinical, eeg, and imaging data collection; any other situation deemed unsuitable for participation in the study by the investigator.
detection of high-risk hpv in urine and cervical swab specimen using hpv diagnostic kit (bio farma)

Conditions: Human Papilloma Virus Infection

Summary: this study is a cross-sectional study to evaluate accuracy of high-risk dna-hpv testing using hpv diagnostic kit (bio farma) compared to standard kit (cobas® 6800 hpv from roche molecular systems) rt-pcr based in urine and cervical swab specimens.


Eligibility criteria:
inclusion criteria: * sexually active female aged 20-50 years * willing to participate in study and signed the informed consent form. exclusion criteria: * pregnant women * history of hiv infection * on menstruation period * history of complete hpv vaccination
biomarkers in tissue samples from patients with newly diagnosed breast cancer treated with zoledronic acid

Conditions: Estrogen Receptor-positive Breast Cancer; Invasive Ductal Breast Carcinoma; Progesterone Receptor-positive Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer

Summary: this pilot clinical trial studies biomarkers in tissue samples from patients with newly diagnosed breast cancer treated with zoledronic acid (za). studying samples of tumor tissue in the laboratory from patients receiving za may help doctors learn more about the effects of za on cells. it may also help doctors understand how well patients respond to treatment.

primary objectives: i. to evaluate 14 tumor biomarkers of growth and metastasis (10 by microarray and 4 by rt-pcr) for change in response to za. secondary objectives: i. to evaluate 30 measures of immunologic function (by luminex panel) for change in response to za a) after 48-72 hours and b) after 10-23 days. ii. to explore additional tumors biomarkers (approximately 20 by immunohistochemistry) for change in response to za. outline: patients receive zoledronic acid intravenously (iv) over 15 minutes on day 1. patients then undergo planned definitive surgery (lumpectomy or mastectomy) on day 10-23. tissue and blood samples from the initial biopsy and definitive surgery are collected to measure changes in biomarkers of tumor growth and metastasis, immunologic function, and the expression of genes important to breast cancer progression and metastasis. after completion of study treatment, patients are followed up at 40-44 days.

Eligibility criteria:
inclusion criteria: * postmenopausal women * diagnosis of early stage, invasive ductal carcinoma (for which a lumpectomy or mastectomy is planned prior to systemic therapy) * estrogen receptor (er)/progesterone receptor (pr) positive tumor (as confirmed by city of hope pathology department if done on the outside) or * biopsy proven er/pr positive tumor * ability to provide informed consent exclusion criteria: * tumor that lacks both estrogen and progesterone receptors * patients who will receive neoadjuvant therapy prior to definitive surgery * bisphosphonate therapy currently or within the past 12 months * regular use of anti-inflammatory agents, with the exception of a baby aspirin regimen per principal investigator's (pi's) discretion * renal impairment as determined by a creatinine clearance \< 60 ml/min as calculated by the cockcroft-gault formula using the patient's actual weight * current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures * recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
a study of human monoclonal antibodies, brii-196 and brii-198

Conditions: COVID-19

Summary: the aim of this phase 2 study is to evaluate the safety and efficacy of single dose iv infusion of brii-196 and brii-198 given as combination therapy in patients with severe covid-19, and mild to moderate covid-19 and asymptomatic carrier.


Eligibility criteria:
inclusion criteria: * subject ≥ 18 years, signing the informed consent. * sars-cov-2 infection by pcr ≤ 7 days * one or more of covid-19 related symptoms or measured fever present within 48 hours prior to study entry (subjects with mild-moderate covid-19) exclusion criteria: * recurring covid-19 patients * subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent * receipt of convalescent covid-19 plasma, sars-cov-2 mab treatment, sars-cov-2 vaccine, or other investigational treatments prior to study entry

Keywords: covid-19 phase 2 monoclonal antibody