Kornimate/medical-research-clean huggingface dataset:
clinical study of bivalirudin for percutaneous coronary intervention (pci)

Conditions: Coronary Heart Disease

Summary: bivalirudin is widely used as an anticoagulant to reduce the risk of bleeding in pci perioperative period. additionally, 15.7%-32.7% patients have diabetes mellitus who undergo percutaneous coronary interventions (pci), so bivalirudin was used to anticoagulate in these patients to evaluate its safety and efficacy.

bivalirudin is a specific reversible thrombin direct inhibitor and the function of thrombin activity site can be recovered through hydrolyzing bivalirudin by thrombin. therefore, bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (pci) for coronary heart disease, and 15.7%-32.7% patients have diabetes mellitus who undergo percutaneous coronary interventions (pci). at the same time, elderly patients have higher risk of bleeding whose age over 65, so bivalirudin can reduce the risk of bleeding and the incidence of net adverse clinical events for the elderly patients whose age over 65 with diabetes mellitus in pci perioperative period.

Eligibility criteria:
inclusion criteria: 1. ≥ 65 years, with diabetes mellitus. 2. patients who undergo selective pci therapy. 3. patients who agree to participate in this clinical trial and sign informed consent prior to surgery. exclusion criteria: 1. patients with acute coronary syndrome undergoing primary pci. 2. combined with other diseases, the life expectancy of patients don't exceed 1 year. 3. patients with active bleeding. 4. bleeding in the gastrointestinal or urogenital tract in the past 6 weeks. 5. combined with high risk of postoperative hemorrhage, such as active gastric ulcer, active ulcerative colitis, etc. 6. patients who have undergone major surgery in the last 1 month. 7. a history of intracranial bleeding or structural abnormalities, such as cerebral aneurysms. 8. patients with cardiogenic shock, or suspected myocarditis, infective endocarditis. 9. patients who received regular heparin therapy within 6 hours or low molecular weight heparin therapy within 8 hours, or other factors that the researchers believe may influence the outcome of the trial. 10. patients with severe uncontrolled hypertension. 11. patients with active hepatitis, hiv and other infectious diseases. 12. patients with contraindications of bivalirudin and heparin. 13. other researchers considered the patients are unfit to participate in this study.
functional neuroimage in assessment of post-stroke aphasia

Conditions: Stroke; Aphasia

Summary: the substantial efficacy and the possible mechanism of repetitive transcranial magnetic stimulation (rtms) improving language recovery remained unclear. it is hypothesized that the rtms was associated with increased synaptic connection and neural regeneration which can be evaluated via functional neuroimage and neurofiber imaging analysis. the effect of rtms intervention was monitored by clinical testing and neuroimaging study.

2-week rtms modulation has been proved to produce substantial clinical benefit with sham-controlled study. this trial aimed to investigate the possible mechanism and make clinical correlation.

Eligibility criteria:
inclusion criteria: * aphasic stroke in chronic stage (over 3 months) exclusion criteria: * no seizure history, no brain surgery history, no electronic device in brain or chest, no dementia

Keywords: stroke aphasia rtms functional mri speech training
evusheld assessment real world effectiveness in dod health system

Conditions: COVID-19; SARS-CoV-2; 2019 Novel Coronavirus Disease

Summary: an astrazeneca-sponsored observational, electronic healthcare record (ehr)-embedded retrospective cohort study to assess the real-world effectiveness of evusheld against sars-cov-2 infection, covid-19-related hospitalization, and other covid-19 related outcomes in the total eua-eligible patient population treated in dod health system.

this a phase iv observational, secondary data study to assess the effectiveness of evusheld in preventing covid-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system. the study is designed as an astrazeneca-sponsored observational, electronic healthcare record (ehr)-embedded retrospective cohort study to assess the real-world effectiveness of evusheld against sars-cov-2 infection, covid-19-related hospitalization, and other covid-19 related outcomes in the total eua-eligible patient population in the dod health system.

Eligibility criteria:
inclusion criteria: 1. receipt of evusheld under the fda eua for evusheld 2. eligibility for evusheld use under the eua. - exclusion criteria: * none

Keywords: evusheld tixagevimab and cilgavimab pre-exposure prophylaxis covid-19 sars-cov-2 effectiveness
evaluation of the program si! for preschool education: a school-based randomized controlled trial

Conditions: Healthy Lifestyle; Cardiovascular Disease

Summary: cardiovascular disease continues to be the principal cause of death in the world. at present, the risk factors for cardiovascular disease continue to appear at an earlier age permitting prevention activities and the promotion of healthy habits to focus on children. numerous studies have shown that these factors can be controlled in children through school-based interventions. at the same time, data shows that there is a persistence of unhealthy lifestyles (ie sedentary lifestyles, the use of tobacco, etc...) that begin in childhood and are perpetuated until adulthood. therefore, the acquisition of healthy lifestyles should begin as early as possible. the si program for preschool education is an intervention that is both school and home based designed to improve the habits, knowledge and attitudes in four key areas: food (diet), physical activity, knowledge of the body and managing emotions. this intervention will be implemented in children from three to five years of age, in their parents and in their teachers. to evaluate the efficacy of this intervention, the principal aim of the phase of evaluations is to quantify the behavior changes in the three groups/populations mentioned. the evaluation has been designed according to the controlled intervention model, in which twenty-four schools from the community of madrid will be randomized to implement the program si! for preschool education or to function as control schools.


Eligibility criteria:
inclusion criteria: * the schools must be located within the municipality of madrid * the schools must be public * the schools must have, at the least, two classes for preschool education, for children 3, 4 and 5 years of age * the schools must make available the use of the cafeteria. exclusion criteria: * na

Keywords: diet physical activity knowledge attitudes habits lifestyle school-based
phase 1b study of ccx872-b in patients with pancreatic adenocarcinoma

Conditions: Pancreatic Cancer

Summary: this is an open-label phase 1-b study to evaluate the safety and efficacy of ccx872-b in patients with pancreatic adenocarcinoma also receiving folfirinox chemotherapy.

study acquired by amgen and all disclosures were done by previous sponsor chemocentryx.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non-resectable pancreatic adenocarcinoma with or without metastases * eastern cooperative oncology group (ecog) performance status score ≤ 2 * anticipated life expectancy ≥ 12 weeks * radiographically measurable disease acc. to recist 1.1 * use of adequate contraception (as described in protocol) * ability to provide written informed consent and comply with study requirements exclusion criteria: * received other cancer treatment or investigational drug within 4 weeks prior to screening * women who are pregnant or breastfeeding * had major surgery within 4 weeks of first dose of study drug * inadequate liver, renal or bone marrow function within 2 weeks of first dose * serious concurrent illness, altered medical status or any uncontrolled medical condition * any infection requiring antibiotic or anti-viral treatment within 4 weeks of screening * known active hiv, hbv or hcv infection * inability to swallow tablets * history or presence of any medical condition or disease which, in the opinion of the investigator, may place the subject at unacceptable risk for study participation
concor® bioequivalence study in chinese participants (darmstadt-nantong)

Conditions: Healthy

Summary: the purpose of this study is to assess is the bioequivalence (be) of concor 5 milligram (mg) tablets manufactured by merck/china nantong (test product) and concor 5 mg tablets manufactured by merck/germany darmstadt (reference product) in chinese healthy participants under fed or fasted condition.


Eligibility criteria:
inclusion criteria: * participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests and cardiac monitoring * participant must have a body weight within 50-90 kilogram (kg) and body mass index (bmi) within the range 19-26 kilogram per meter square (kg/m2) (inclusive) * participant must have negative screen for alcohol and drugs of abuse at screening and on admission * both male and female participants. the investigator confirms that each participant agrees to use appropriate contraception and barriers, if applicable * participant must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the icf * other protocol defined inclusion criteria could apply exclusion criteria: * participant must not have any condition, including any uncontrolled disease state, that in the investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation * participant should not have positive screen for hepatitis b surface antigen (hbsag), hepatitis c virus (hcv) antibodies, human immunodeficiency virus (hiv) antibodies, and treponema pallidum antibodies * participant must not have received any prescription or non-prescription medication within 28 days before the first study intervention administration, including multivitamins and herbal products (example, st john's wort, or traditional chinese medicines) * participant must not have participation in a study trial within 90 days prior to first drug administration; blood donation (equal or more than 400 milliliter \[ml\]) or significant blood loss within 90 days prior to first drug administration * other protocol defined exclusion criteria could apply

Keywords: bisoprolol clinical equivalence pharmacokinetic
effectiveness of intracoronary injection of eptifibatide in primary coronary intervention in stemi patients

Conditions: Acute Myocardial Infarction

Summary: the achievement of high local concentration of eptifibatide, a gp 2b3a inhibitor,via direct intracoronary injection, promotes (in vitro) clot disaggregation. it remains unclear if it is of superior benefit than the routine intravenous administration of these agents. in patients presenting with acute myocardial infarction, and undergoing primary coronary intervention, intracoronary administration of eptifibatide may increase local drug concentration by several orders of magnitude and promote clot disaggregation with a minimal increase in systemic drug concentration, and in that way enhancing myocardial perfusion and survival.

patients will be randomized, prospectively, single blinded into one of two arms:1)intravenous administration of eptifibatide and 2) intracoronary administration. the primary end-point will be the angiographic achievement of timi 3 flow at the infarct related artery and timi myocardial perfusion grade (blush) and the electrocardiographic surrogate of myocardial perfusion the st segment resolution. the secondary end-points will be the occurrence of bleeding or hemorrhagic complication according to timi classification and the lvef at one month compared with baseline

Eligibility criteria:
inclusion criteria: * acute myocardial infarction candidate for primary coronary angioplasty, presenting within 12 hours of onset of pain and ability to clearly identified only one infarct related artery. exclusion criteria: * contraindications for antiplatelet therapy such as bleeding disorders, * thrombocytopenia, * severe uncontrolled hypertension, * recent stroke (\<6 months), * intracranial hemorrhage at any time * patients after recent major surgery (\<30 days), * previous myocardial infarction * previous revascularization either by cabg or pci and 9)patients presented with cardiogenic shock.

Keywords: primary pci acute myocardial infarction myocardial blush primary coronary intervention in acute myocardial infarction focusing on the effect of the study drug on the immediate timi flow at the infarct related artery and on the myocardial perfusion evaluated by the timi myocardial perfusion grade or blush
progressive resistance training for fibromyalgia

Conditions: Fibromyalgia

Summary: patients in the experimental group underwent a progressive resistance training program, performed twice a week for 12 weeks. the charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. the following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. in addition to strength training, the experimental group also conducted a structured education program in one hour class once a week for five weeks. patients in the control group performed the same education program.


Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia according to the criteria of the american college of rheumatology; * feminine gender; * age between 18 and 65 years; * pain between 3 and 8 cm in the numerical pain scale (end); * have not changed treatment for fibromyalgia in the past three months; * agree to participate in the study and sign the informed consent form. exclusion criteria: * cognitive deficit that does not allow the understanding of the evaluation instruments; * other diseases that make it impossible to perform the exercises; * physical activity started or changed in the last three months; * physical therapy in the last six months; * in litigation.

Keywords: fibromyalgia pain function quality of life
safety and efficacy of agn-210669 ophthalmic solution compared with bimatoprost ophthalmic solution in patients with open-angle glaucoma or ocular hypertension

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this study will evaluate the safety and efficacy of agn-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * diagnosis of primary open-angle glaucoma or ocular hypertension in each eye * requires bilateral treatment with an iop-lowering medication * best corrected visual acuity of 20/100 or better in each eye exclusion criteria: * use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months * inability to fast for up to 10 hours * prior refractive laser surgery (eg, lasik, radial keratectomy, photorefractive keratectomy) * intraocular surgery or iop-lowering laser surgery (eg, laser trabeculoplasty) within 6 months * current or anticipated use of artificial tears or any ocular medications aside from study medications during study * anticipated wearing of contact lenses during study
effect of adding renin-angiotensin system inhibitors to standard antidiabetic therapy on glycemic control in patients with type 2 diabetes ellitus

Conditions: Diabetes Mellitus, Type 2

Summary: type 2 diabetes mellitus (t2dm) is a progressive metabolic disorder in which a substantial number of patients cannot attain treatment target despite antidiabetic drugs. the renin-angiotensin system (ras) has recently been implicated in the development of insulin resistance and impaired glucose metabolism. this study investigates the effect of adding ras inhibitors to standard antidiabetic therapy in patients with t2dm. the primary outcome measure is the change in serum glycosylated hemoglobin a1c after 24 weeks of treatment. secondary outcomes measures include changes in plasma lipid profile and blood pressure after treatment.


Eligibility criteria:
inclusion criteria: * adults over 21 years of age * clinically diagnosed type 2 diabetes mellitus * recipients of metformin monotherapy * compliance with prescriptions and dietary intervention exclusion criteria: * recipients of any second-line antidiabetic drug in addition to metformin * recipients of any antihypertensive medication before study enrollment * hemoglobin disorders * chronic kidney disease * thyroid dysfunction
bone stimulator for spondylolysis

Conditions: Spondylolysis; Symptomatic Spondylolysis; Athletes

Summary: this prospective study aims to investigate the effectiveness of bone stimulator therapy as adjunct treatment of spondylolysis in athletic populations. by evaluating its impact on pain reduction, functional improvement, osseous bony union and return-to-sport time, the investigators seek to provide valuable insights into the role of bone stimulation therapy as a potential treatment modality for this challenging condition.


Eligibility criteria:
inclusion criteria: * patients between the ages of 16 to 40 years of age diagnosed with symptomatic spondylolysis by one of the investigators * patients who plan to attend prescribed physical therapy * patients who participate in a regular sport whether that be professional, collegiate or recreational exclusion criteria: * any condition which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions * patients with contraindications to bone stimulator therapy * patients with pacemaker and implantable cardioverter defibrillator * patients with previous spine surgery * patients with metabolic bone conditions * patients who use nicotine products * vulnerable populations * non-english speaking services
peg-asp, etoposide and gemcitabine for natural killer/t lymphoma

Conditions: Treatment Refusal

Summary: extranodal natural killer/t-cell lymphoma (enktl) is an aggressive form of non-hodgkin's lymphoma and shows extremely poor survival. this prospective pilot study to evaluate the efficacy and safety of pegylated aspargase(peg-asp)combined with etoposide and gemcitabine (peg) treatment in this population.

treatment peg dosages were as follows: days 1 and 8,30min intravenous infusion of 1000mg/m2 gemcitabine;day1,4h intravenous infusion of 100mg/m2 etoposide,day1-3,deep intramuscular injection of 2500unit/m2 peg-asp at three different sites.the regimen was repeated every 3 weeks.stage ie/iie patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got complete remission ,partial regression or stable disease.three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (gy) per daily fraction with 5-6 weeks. the involved-field radiation (ifrt) dose was 50-56 gy.stage iiie/ive patients were given for a maximum of six cycles.refractory/relapsed patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. autologous haematopoietic stem cell transplantation (ahsct) was recommended after achieving cr for advanced stage and refractory/relapsed patients

Eligibility criteria:
inclusion criteria: 1. pathologically confirmed, previously untreated or refractory/relapsed enktl as defined by the world health organization classification; 2. age≥18 years; 3. eastern cooperative oncology group (ecog) performance status of 0-2; 4. at least one measurable lesion; 5. adequate haematologic function (haemoglobin \> 9.0 g/l, absolute neutrophil count \> 1500/ml, platelets \> 75,000/l), 6. adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal), 7. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); 8. normal coagulation function and electrocardiogram results. 9. prior chemotherapy and radiotherapy should have been completed \>4 weeks 10.earlier,willingness to provide written informed consent. exclusion criteria: -

Keywords: extranodal natural killer/t-cell lymphoma nasal type chemotherapy radiotherapy
analysis of the use of the fetal movement counting for prolonged pregnancy.

Conditions: Prolonged Pregnancy

Summary: prospective mono-centric randomized open-label study (randomization 1: 1, 2 groups) comparing a group of patients who received conventional information to a group of patients who had been sensitized to a fetal active movement count technique. the study will take place at the university hospital center of saint-etienne in the gynecology-obstetrics department. an information brochure on the study will be handed over at the end of the term consultation to 41+0 weeks of gestation. after collecting the consent of the patient, the distribution between the two groups will be done by randomization. thus, for the fetal active movement count group, fetal active movement count education will be proposed during the term consultation with the submission of an information brochure. the "control" group will also receive a simple information pamphlet with, in writing, what patients currently receive orally: definition of active fetal movements, and the need to consult if the patient perceives less movements of her fetus .the principal objective is to compare perinatal morbidity in relation with the sensation of decrease active fetal movements in case of late pregnancy, according to the fact if the patients use or not the afm's count.


Eligibility criteria:
inclusion criteria: * any pregnant woman presenting herself in the gynecology-obstetrics department of the hospital of saint-etienne during the term consultation at 41 weeks of amenorrhea + 0 day. * non pathological singleton pregnancy except for balanced gestational diabetes * patient affiliated with or entitled to a social security plan * patients who have given their participation agreement and signing the consent exclusion criteria: * woman refusing to participate in the study (lack of consent) * non-francophone woman (and / or enable + read french) * woman making a maternity change for childbirth (risk of follow-up bias) * pathological pregnancy * participation to another interventional study. * patient subject to legal protection or unable to express consent * patient who has already benefited from an awareness of the afm's account

Keywords: perinatal morbidity prolonged pregnancy fetal active movement count