Kornimate/medical-research-clean huggingface dataset:
long-term surveillance of patients with venous thromboembolism: a nationwide prospective cohort study

Conditions: Venous Thromboembolism

Summary: this observational study aims to establish a prospective nationwide cohort of venous thromboembolism. the main questions it mains to answer are: * which patients with venous thromboembolism should accept long-term anticoagulation therapy? * mechanism and prognosis of venous thromboembolism. participants will receive yearly follow-ups through telephone, hospitalization, or outpatient care.

venous thromboembolism (vte), including deep venous thrombosis and pulmonary embolism, is a class of diseases with strong occultation, high mortality, and a high recurrence rate.long-term anticoagulant therapy can reduce the risk of recurrence. although long-term anticoagulation can reduce the risk of vte recurrence, it will also increase the risk of major bleeding and the economic burden of long-term anticoagulation. therefore, stratifying the risk of vte recurrence and preventing recurrence with accurate anticoagulant therapy is an urgent problem in vte management. investigators will establish a prospective nationwide cohort of vte, develop a unified follow-up plan, and conduct whole-life follow-up management for patients. demographic, clinical, imaging, laboratory indicators, gene, and other information of patients will be collected. a vte patient database with complete clinical phenotype data, genetic data, and biological samples will be established. investigators will construct a vte recurrence risk prediction model based on chinese data to provide clinical decision suggestions for clinicians to select appropriate individualized anticoagulant duration according to risk stratification. vte patients with low recurrence risk could avoid long-term anticoagulant therapy.

Eligibility criteria:
inclusion criteria: * age greater or equal to 18. * patients diagnosed with venous thromboembolism. exclusion criteria: * pregnant or lactating women * patients with active tumor
efficacy study of combined treatment with uric acid and rtpa in acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the purpose of this study is to determine whether the combined treatment with uric acid and rtpa is superior to rtpa alone in terms of clinical efficacy in acute ischemic stroke patients treated within the first 4.5 hours of symptoms onset.

oxidative stress is a major contributor to brain damage in patients with ischemic stroke. uric acid (ua) is an endogenous product derived from the metabolism of purins which in man is responsable of the 60% of the total antioxidant capacity of the organism. recent experimental evidences gathered by our and other research groups have shown that the exogenous administration of ua is neuroprotective both in cortical and subcortical brain areas as the result of its antioxidant properties. in these studies, animals treated with ua disclosed smaller brain infarction after transient focal ischemia, both using the intraluminal model or after the injection of autologous clots. moreover, our group first described greater neuroprotection in animals pretreated with rtpa (alteplase). likewise, we have recently shown that the administration of ua was free of serious adverse effects in stroke patients receiving rtpa within 3 hours of stroke onset. yet, preliminary data suggested that this intervention might translate into clinical benefits at 3 months follow-up. based on these data, we aim to conduct a phase 3, randomized, double-blind, controlled trial assessing the clinical efficacy of ua administration in acute ischemic stroke patients. currently, rtpa is the only approved therapy for stroke patients within the first hours of clinical onset, and oxidative stress is thought particularly relevant following ischemia/reperfusion. based on this ground, we aim to conduct this phase 3 clinical trial in ischemic stroke patients which are currently treated with rtpa within the 4'5 hour window.

Eligibility criteria:
inclusion criteria: * age older than 18 years old. * acute ischemic stroke treated with rtpa within the first 4.5 hours of clinical onset. baseline national institute of health stroke scale (nihss) \>6 and \<25, and modified rankin scale (mrs) of 2 prior to the stroke. * cranial ct disclosing the absence of blood in the cns. * informed consent. exclusion criteria: * presence of any of the valid exclusion criteria for the administration of rtpa in the current clinical practise. * history of gout with or without history of gouty nephropathy, or uric lithiasis. asymptomatic hiperuricemia under chronic treatment with allopurinol, or chronic treatment with lithium. * chronic renal insufficiency (baseline creatinine \> 1,5mg/dl).

Keywords: acute ischemic stroke thrombolysis alteplase uric acid neuroprotection oxidative stress
a study to evaluate the performance and safety of gp0045 for correction of moderate to severe nasolabial folds

Conditions: Nasolabial Fold; Safety

Summary: this is a study to assess the performance and safety of gp0045 when injected in the nasolabial folds. there is an 18 months follow up period.


Eligibility criteria:
inclusion criteria: * ability to adequately understand the verbal explanations and the written subject information provided in local language and ability to give consent to participate in the study * signed and dated informed consent to participate in the study, including photo consent * subjects with intent to undergo correction of both nasolabial folds exclusion criteria: * known/previous allergy or hypersensitivity to any injectable hyaluronic acid (ha) gel * known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics * any condition (medical or other) that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study) * participation in any other clinical study with an investigational product within 30 days before treatment

Keywords: hyaluronic acid, lidocaine
a trial to evaluate two antibiotics for the treatment of acute exacerbation of chronic bronchitis (aecb)

Conditions: Chronic Bronchitis

Summary: this trial is a research drug study to compare the effects of two antibiotics for the treatment of acute exacerbation of chronic bronchitis


Eligibility criteria:
inclusion criteria: * diagnosis of chronic bronchitis (chronic cough and sputum production on most days for three consecutive months for more than two consecutive years) and clinical evidence of aecb as demonstrated by both the following symptoms: * production of purulent sputum as defined by gram stained sputum specimen * presence of all of the following: * increased sputum production * increased dyspnea * increased cough * at least two exacerbations of aecb in the past 12 months * documented fev1 less than 80% of predicted exclusion criteria: * a chest radiograph consistent with pneumonia * treatment with any systemic antibiotic within the twenty-one days prior to study entry or those with a chance of receiving other systemic antibiotics during study participation

Keywords: azithromycin sr; moxifloxacin; acute exacerbation of chronic bronchitis (aecb)
healthy volunteer visibility study of micromachined tags for the detection of surgical sponges

Conditions: Injury Due to Foreign Object Accidentally Left in Body During Surgical Operation

Summary: surgical sponges can be accidentally left inside patient's bodies. we are working on special tags (called microfabricated tags) that surgeons can put on their sponges. then, if the surgeons forget to remove a sponge from a patient, they'll be able to detect these special tags in an x-ray.

surgical sponges can be accidentally left inside patient's bodies. we are working on special tags (called microfabricated tags) that surgeons can put on their sponges. then, if the surgeons forget to remove a sponge from a patient, they'll be able to detect these special tags in an x-ray. we wish to take x-rays of healthy people's abdomens with microfabricated tags lying on them. the x-rays will help us improve our system for detecting sponges left inside people's bodies.

Eligibility criteria:
inclusion criteria: 1. healthy men and women 2. ages 18 or older - exclusion criteria: 1. under 18 years of age 2. pregnant female or if female has not had a negative pregnancy test prior to the research scans. -
evaluation of physical capacities within the company and effect of a personalized versus traditional training program on the quality of life of sedentary employees

Conditions: Healthy Volunteers; Health

Summary: the practice of a physical activity, even moderate, plays an important role in the prevention and the management of the main chronic non-communicable diseases (cardiovascular diseases, certain cancers, diabetes, obesity, osteoporosis ...) as well as by improving psychological health. several studies have shown that physical activity has a positive impact on the economy of companies via the reduction of absenteeism and the improvement of productivity. however, it seems important to individualize these recommendations in order to prescribe the best possible dose of physical activity for each individual. in this project, the investigators want to test the physical qualities of employees in order to prescribe the best possible dose of physical activity with the ultimate goal of improving quality of life. the originality of this project is to evaluate physical capacities directly within the company of the participants instead of hospital unit.

physical activity (pa) is one of the major determinants of health. indeed, the practice of a physical activity, even moderate, plays an important role in the prevention and the management of the main chronic non-communicable diseases (cardiovascular diseases, certain cancers, diabetes, obesity, osteoporosis ...) as well as by improving psychological health. the effects are beneficial regardless of age, gender and state of health. moreover, in addition to the well-being of employees, several studies have shown that physical activity has a positive impact on the economy of companies via the reduction of absenteeism and the improvement of productivity. today, the world health organization (who) prescribes 150 min of physical activity per week regardless of the person's profile (active employee, employee working in his office, construction worker, etc.).. in this project,the investigators therefore want to test the physical qualities of employees in order to prescribe the best possible dose of physical activity with the ultimate goal of improving quality of life.

Eligibility criteria:
inclusion criteria * sedentary people * affiliate to health care organism * subject who gave their consent * employee of a company having accepted the terms of the study, as well as the agreement of the occupational physician exclusion criteria: * people with degenerative disease * cardiovascular trouble * subject who are not able to understand the proceeding of the study or to give their consent

Keywords: sport parallel physiopathology physical activity prescription quality of life exercise company
study of vx-770 on midazolam and rosiglitazone and the effect of fluconazole on vx-770

Conditions: Cystic Fibrosis

Summary: the objectives of this study are to evaluate the effects of vx-770 on midazolam and rosiglitazone, and the effect of fluconazole on vx-770.


Eligibility criteria:
inclusion criteria: * subjects must be male or female and between 18 and 55 years of age. * subjects must be judged to be in good health. * subjects must have a body mass index (bmi) from 18 to 30 kg/m2. exclusion criteria: * history of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject. * subjects who have human immunodeficiency virus (hiv), hepatitis c, or active hepatitis b. * female subjects and female partner(s) of male subjects who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug. * history of cardiovascular disease, hypoglycemia, or edema.
effects rtms combined with fluoxetine on motor recovery in stroke patients

Conditions: Stroke; Motor Function

Summary: in this study investigator's aim to assess the effect of a type of non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rtms) in conjunction with fluoxetine on motor recovery after stroke.


Eligibility criteria:
inclusion criteria: * ischemic infarction within the past 2 years post event that has caused hemiparesis or hemiplegia, as self-reported and/or confirmed by medical record. * older than 18 years old. * upper extremity weakness defined as a score of \>11 and ≤56 on the arm motor fugl-mayer motor scale. * minimal pre-stroke disability defined as a score of \<3 in the modified rankin scale. * subjects need to be able to follow directions and participate in 2 hours of testing with short breaks. * subjects need to be able to provide informed consent. exclusion criteria: * any substantial decrease in alertness, language reception, or attention that might interfere with understanding instruction for motor testing * excessive pain in any joint of the paretic extremity (not applicable to severe stroke subjects), as self reported * contraindications to single pulse tms (will be used to measure cortical excitability) such as: history of seizures, unexplained loss of consciousness, any metal implants in the head, frequent or severe headaches or neck pain, any other electronic implanted medical devices such as pacemakers, defibrillators, or implant medication pump. * patients who have taken fluoxetine in the past 5 weeks. * patients taking any other ssri at the time of enrollment or in the previous month. * patients taking any other medication likely to have adverse interaction with ssris (all the medications the patient is taking will be carefully reviewed, as noted below in "monitoring of important drug interactions"). * active depression on admission to srh defined by a score of 24 or higher in the hamilton depression rating scale (ham-d) * concurrent medical condition likely to worsen patient's functional status in the next 6 months such as: cancer, terminal heart, kidney or liver disease, as self-reported and/or confirmed by medical record. * pregnancy.

Keywords: repetitive transcranial magnetic stimulation rtms tms fluoxetine
study looking at combination therapy (sitaxsentan+sildenafil) vs. monotherapy (sitaxsentan alone) sr-paas -sitaxsentan efficacy and safety trial with a randomized prospective assessment of adding sildenafil

Conditions: Pulmonary Arterial Hypertension; Pulmonary Hypertension

Summary: as monotherapy for pulmonary arterial hypertension (pah) begins to fail additional therapies are introduced. although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited.


Eligibility criteria:
inclusion criteria: * previously enrolled in b1321001 (nct00795639) and completed the 12-week study as planned. exclusion criteria: * treated with an investigational drug, other than sitaxsentan sodium in b1321001 (nct00795639), or device that has not received regulatory approval within the 30 days prior to baseline/day 1 or during the study.

Keywords: endothelin receptor antagonist (etra) sitaxsentan
biomarker-based prognostic assessment

Conditions: Acute Coronary Syndrome; Stable Angina

Summary: coronary artery disease (including stable angina and acute coronary disease) remains the leading mortality and morbidity worldwide. improvement in biomarker, imaging research have led to new predictors for the prognosis, which may have great clinical value in the current era of personalized medicine. however, there is no available biomarker-based prediction rule for risk assessment of adverse events in patients with stable angina and acute coronary disease. therefore, we aim to develop and validate a new biomarker-based risk model to improve the prognostication of adverse events (e.g. ischemic and bleeding events ) in the patient population.

patients enrolled in qilu hospital of shandong university (jinan, china), chinese pla general hospital hospital (beijing, china) and peking university first hospital (beijing, china) are designed as the development cohort to derive the risk prediction models of ischemic and bleeding events. patients enrolled in peking university third hospital ( beijing, china) zibo central hospital (zibo, china) are designed as the independent validation cohort.

Eligibility criteria:
inclusion criteria: 1. hospitalized patients with the diagnosis of any type of coronary artery disease (stable angina, unstable angina, non st-segment elevation myocardial infarction or st-segment elevation myocardial infarction) 2. age ≥18 years of age and \<85 years of age 3. patient or guardian provided informed written consent exclusion criteria: 1. prior surgery (cardiac or non-cardiac), trauma or clinically evident coagulopathic bleeding (e.g. gastrointestinal, genitourinary, et al) 2. patient with non-cardiac co-morbidities with life expectancy less than 12 months 3. patients unwilling or unable to comply with all clinical follow-up schedules at 30 days, 6 months and 12 months after discharge
effects of a supervised progressive resistance training with breast cancer patients during adjuvant radiotherapy

Conditions: Breast Cancer; Cancer-related Fatigue

Summary: the purpose of this randomized intervention study is to investigate the effects and biological mechanisms of a supervised 12-week progressive resistance training on fatigue and immunological and inflammatory biomarkers in breast cancer patients during adjuvant radiotherapy. to determine the effect of the exercise itself beyond potential psychosocial effects due to attention by trainers or the group support, patients in the control group have a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation training (jacobsen method).


Eligibility criteria:
inclusion criteria: * histologically confirmed primary breast cancer, stage i-iii, after lumpectomy or mastectomy, indication for adjuvant radiotherapy * bmi: 18-40 * ability to understand and follow the study protocol exclusion criteria: * contraindication for exercise * participation in the beate trial or another systematic resistance or relaxation training
melatonin and coronary artery calcification

Conditions: Coronary Artery Calcification

Summary: the investigators planned to research the association between plasma melatonin and coronary artery calcification in a chinese population.

coronary artery calcification (cac) is prevalent in coronary artery disease (chd), and the extent of cac predicts cardiovascular risk. the causes of cac include dysregulated matrix metabolism, epitaxial mineral deposition, inflammation, oxidative stress, and apoptosis. melatonin is the main indoleamine produced by the pineal gland; it is known recently to have anti-inflammatory, anti-cancer and antioxidant activities. several studies have shown that melatonin protects against inflammation and apoptosis in vascular calcification. melatonin also inhibits oxidative stress-induced apoptosis and calcification in endplate chondrocytes. however, no study has evaluated whether melatonin is associated with cac in patients with coronary atherosclerosis. the investigators planned to research the association between plasma melatonin and coronary artery calcification.

Eligibility criteria:
inclusion criteria: patients with angina-like chest pain, were included in this study. all subjects had blood samples collected and all underwent a coronary cta scan. exclusion criteria: 1. melatonin treatment 2. coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery) 3. heart failure or cardiomyopathies 4. hepatic failure 5. renal dysfunction 6. haemolytic disorders 7. thyroid disease 8. neoplastic diseases 9. acute infectious or inflammatory conditions.

Keywords: melatonin coronary artery calcification relation
low-dose acetylsalicylic acid before non-cardiac surgery

Conditions: Surgery; Platelet Dysfunction

Summary: this study aims to assess independent factors associated with the clinical decision to discontinue asa preoperatively in patients undergoing elective non-cardiac surgery.

acetylsalicylic acid (asa) is widely used for primary and secondary prevention of cardiovascular diseases. a prothrombotic rebound phenomenon after aspirin cessation has been reported. asa withdrawal is associated with an increased incidence of adverse cardiac events. in individuals with previous percutaneous coronary intervention (pci), cessation of asa may cause stent thrombosis or myocardial infarction. however, many patients undergo non-cardiac surgery within the first two years after pci. perioperatively, two counteracting risks have to be taken into account, first, the risk of thromboembolic complications, if asa medication is discontinued and second, the risk of surgical bleeding, if asa therapy is continued. however, factors contributing to preoperative decision-making for asa-withdrawal are still unclear. this study aims to assess independent factors associated with the clinical decision to discontinue asa preoperatively in patients undergoing elective non-cardiac surgery. in particular this study aims to determine if the presence of coronary stents is independently associated with asa discontinuation. furthermore this study assesses, if benefit-risk-estimates (numerical rating scales) of the patients and the supervising physicians are associated with the decision to withdraw asa. study design patients on long-term asa undergoing non-cardiac surgery as well as their supervising anesthesiologist participate in a preoperative survey. detailed information about asa medication, perioperative asa use, comorbidities, factors that might be associated with the decision to discontinue asa preoperatively and benefit-risk-estimates (numerical rating scales) are sampled by questionnaires.

Eligibility criteria:
inclusion criteria: * 18 years and older * scheduled for elective non-cardiac surgery * regular long-term asa use, defined as daily low-dose (≤100mg) asa therapy, even if asa-medication was interrupted within the last 30 days before study inclusion exclusion criteria: * \< 18 years * no consent given

Keywords: bleeding adverse cardiac events adherence, medication aspirin acetylsalicylic acid