Kornimate/medical-research-clean huggingface dataset:
a phase ii combination of trastuzumab and ixabepilone versus trastuzumab and docetaxel in patients with advanced and/or metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of this randomized, phase 2 open-label study was to assess the response rate of participants with human epidermal growth factor receptor 2 (her2+) locally advanced and/or metastatic breast cancer (not previously treated with chemotherapy or trastuzumab) to treatment with ixabepilone plus trastuzumab and/or docetaxel plus trastuzumab.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic her2+ breast cancer not previously treated with chemotherapy or trastuzumab. * subjects who had received prior (neo)adjuvant chemotherapy or trastuzumab were eligible except if they relapsed within 12 months after the last dose of a taxane or trastuzumab given as (neo)adjuvant therapy. * measurable disease * left ventricular ejection fraction (lvef) ≥50% exclusion criteria: * prior chemotherapy or trastuzumab for metastatic breast cancer (mbc) * relapse within 1 year after (neo)adjuvant taxane or trastuzumab * neuropathy \> grade 1 * significant cardiovascular disease * any brain metastases

Keywords: locally advanced and/or metastatic breast cancer
efficacies of antimicrobial susceptibility-guided versus empirical therapy for rescue treatment of helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: the purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of helicobacter pylori infection, then comparing it with 14-day empirical therapy according to personal medication history.

helicobacter pylori(h.pylori), which infects about 50% of the global population, has been classified as the first risk factor of gastric cancer. strong evidence supports that h.pylori eradication is an effective approach to reduce the incidence of those pathological processes. antimicrobial susceptibility test can pick out sensitive drugs to kill h.pylori, and reduce secondary drug resistance. however, there is a lack of high quality rct to evaluate its efficacy in the rescue treatment of helicobacter infection. the investigator's study aims to assess the efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of helicobacter pylori infection. then, comparing this regimen with 14-day empirical therapy according to personal medication history to tell which one is better in clinic practice.

Eligibility criteria:
inclusion criteria: * patients aged 18-70 with persistent helicobacter pylori infection. * patients with previous helicobacter pylori eradication therapy for one or two times. exclusion criteria: * patients unable or unwilling to receive gastroscopy. * patients treated with histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks. * patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer. * patients with known or suspected allergy to study medications. * currently pregnant or lactating. * inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Keywords: antimicrobial susceptibility testing rescue therapy
evaluation of the correlation between the coronary stenosis degree with ffrct and the grade of stable angina pectoris

Conditions: Coronary Stenosis; Angina Pectoris

Summary: angina pectoris is the most common clinical manifestation of coronary heart disease（chd）, which is the main feature of chest pain caused by transient myocardial ischemia. chronic stable angina pectoris is the degree, frequency, nature and cause of angina pectoris in patients with no significant change in a few weeks. the disease incidence is complex, difficult to diagnosis and treatment, clinical should be combined with various inspection methods for diagnosis and differential diagnosis. fractional flow reserve of computerized tomographic scanning (ffrct ) allows computerized tomographic scanning（ct） to scan the determination of coronary blood flow and blood pressure in the heart at rest and hyperemia, but no need to additional check or drugs. this technique has been used for noninvasive fractional flow reserve (ffr) in the calculation, assuming normal artery, calculated by the ratio of the maximum blood flow and blood flow of coronary artery stenosis of an artery. along with the development and progress of computational fluid dynamics, in the resting state by computed tomographic angiography of coronary artery(ccta) image data based, simulation of coronary artery maximal hyperemia and according to the 3-dimensional model of the traditional method of reconstruction of coronary arterial tree and ventricular muscle structure, and in order to calculated coronary blood flow and pressure. ffrct is a novel non-invasive examination method, using computed tomographic angiography of coronary artery image data can be calculated ffr, and preliminary study proved that it has a high degree of correlation with traumatic ffr. therefore, this study aims to evaluate the correlation between the degree of coronary stenosis and the grading of angina pectoris by noninvasive means --ffrct, in order to provide a new idea for the diagnosis and differential diagnosis of coronary heart disease.


Eligibility criteria:
inclusion criteria: * after computed tomographic angiography of coronary artery (ccta) for the diagnosis of coronary heart disease patients exclusion criteria: * first, the patients with hematological diseases, infectious disease, end-stage renal disease and malignant tumor and other diseases. second, the patients with acute myocardial infarction. last, the percutaneous coronary intervention(pci) and coronary artery bypass grafting (gabg) after the operation.

Keywords: ffrct angina pectoris grade fractional flow reserve ccta
adult patients undergoing open colectomy ma402s23b303

Conditions: Bowel Obstruction

Summary: this study is designed to compare the standard of care against exparel(r) to determine if total opioid consumption is reduced when using exparel, therefore possibly reducing total hospitalization costs.

this is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with exparel compared with postsurgical administration of standardized intravenous (iv) morphine sulfate or sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.

Eligibility criteria:
inclusion criteria: * male or female, 18 years of age and older. * patients scheduled to undergo open segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy. * ability to provide informed consent, adhere to study visit schedule, and complete all assessments. exclusion criteria: * patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol. * patients who abuse alcohol or other drug substance. * patients with severe hepatic impairment. * patients currently pregnant or who may become pregnant during the course of the study. * patients with any psychiatric, psychological, or other condition that the investigator feels may make the patient an inappropriate candidate for this clinical study. * patients who have participated in an exparel study within the last 30 days. * patients who have received an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study. * patients who undergo any concurrent surgical procedure during the ileostomy reversal surgery in addition, the patient will be ineligible if he/she meets the following criteria during surgery: * patients who have any concurrent surgical procedure. * patients with unplanned multiple segmental resections or large intestine. * patients who have unplanned, temporary or permanent colostomies, ileostomies, or the like placed. * patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or an other analgesic, local anesthetics, or anti-inflammatory agents. * patients who receive entereg(r).

Keywords: open colectomy
safety and efficacy of mipomersen (isis 301012) as add-on therapy in high risk hypercholesterolemic patients

Conditions: Hypercholesterolemia; Coronary Heart Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of statin and who have a diagnosis that puts them at least at high risk of coronary heart disease (chd).

hypercholesterolemia is characterized by markedly elevated low density lipoproteins (ldl). elevated ldl is a major risk factor for chd. mipomersen is an antisense drug that reduces a protein in the liver cells called apolipoprotein b (apo-b). apo-b plays a role in producing low density lipoprotein cholesterol (ldl-c) (the "bad" cholesterol) and moving it from the liver to one's bloodstream. high ldl-c is an independent risk factor for the development of chd or other diseases of blood vessels. it has been shown that lowering ldl-c reduces the risk of heart attacks and other major adverse cardiovascular events. the purpose of this study is to determine whether mipomersen safely and effectively lowers ldl-c in patients with high cholesterol who are at high risk for chd and who are already on the maximally tolerated dose of statin. this study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period. participants who finished treatment or who discontinued prematurely from the study for any reason were assessed for safety for 24 weeks after the last study drug dose.

Eligibility criteria:
inclusion criteria: * diagnosis of hypercholesterolemia (ldl-c ≥ 100 mg/dl) * at high risk of chd * on stable, maximally tolerated statin therapy for 8 weeks * on stable, low fat diet for 12 weeks * stable weight for 6 weeks exclusion criteria: * significant health problems in the recent past including heart attack, stroke, coronary syndrome, unstable angina, heart failure, significant arrhythmia, hypertension, liver disease, cancer, type i diabetes.
high flow therapy in icus across ibero america

Conditions: Nasal High Flow Therapy; Intensive Care Unit; Ventilatory Failure; Hypoxia; Hypercapnic Respiratory Failure

Summary: the study aims to describe the use of nasal high flow (nhf) in the intensive care units of participating centers in iberoamerica. it will describe the indications for the use, the clinical outcome of patients , and the therapeutic failure of nhf therapy in patients staying in an intensive care unit in the participant centers in iberoamerica.


Eligibility criteria:
inclusion criteria: * over 18 years old * admitted to medical or surgical icu * requirement of high nasal flow therapy exclusion criteria: * post-extubation failure * patient unable to protect airway * diagnosed shock * glasgow equal or under 8
novel vascular manifestations of chronic obstructive pulmonary disease

Conditions: COPD

Summary: cognitive impairment is a known consequence of cerebral small-vessel disease. moderate to severe cognitive impairment has been shown in up to 60% of certain individuals with copd and is likely to profoundly influence an individual's ability to manage their disease. in addition to cerebral small vessel damage and cognitive dysfunction, other organs such as the heart, kidneys, and retina are likely to be susceptible to small-vessel damage in copd. several large population studies have shown that copd is a significant independent risk factor for myocardial infarction, with the effect most marked in early, mild disease. we propose to compare non-invasive mr brain imaging of white matter microstructure (diffusion tensor), cerebral perfusion (arterial spin labelling) and accumulated cerebral small vessel disease (cerebral microbleeds), in copd patients to smokers without copd. in addition we plan to explore mechanisms of cerebral small vessel disease in copd by looking for associations between arterial stiffness, end organ vascular damage and cognitive function.


Eligibility criteria:
inclusion criteria: 1. subjects must give their signed and dated written informed consent 2. subjects must be aged \>40 and ≤ 85 3. subjects with a smoking history \> 10 pack years. 4. copd group: subjects with a fev/fvc \<70% exclusion criteria: 1. resting oxygen saturations \<92% on room air. 2. long term oxygen therapy 3. recent exacerbation of copd (4 weeks) 4. ischaemic heart disease 5. cerebrovascular disease 6. uncontrolled hypertension 7. diabetes mellitus 8. hepatic failure 9. neurological disease 10. non-cured tumours 11. obstructive sleep apnoea 12. current of past alcohol/drug abuse 13. known history of dementia 14. visual or hearing impairment that precludes neuropsychological assessment 15. neuropsychological tests undertaken outside the study 16. pregnant women or women who are lactating 17. known alpha 1 anti-trypsin deficiency as a cause of their copd 18. history of psychiatric disorders, or other conditions that will impact on the validity of their consent or interfere with compliance to perform study procedures. 19. contra indication to mri scanning -

Keywords: copd cognitive function mri brain aortic stiffness cerebrovascular disease
chronic endometritis and benefits of antibiotics in women with recurrent miscarriage

Conditions: Recurrent Miscarriage

Summary: the aim of the study is to estimate the incidence of ce, evaluate the endometrial microorganism of ce, and investigate the therapeutic benefits of antibiotics for women with unexplained recurrent miscarriage and ce.

eligible women, based on the inclusion and exclusion criteria, will be recruited from the miscarriage clinic in the prince of wales hospital. endometrial sampling (es) will alternatively be conducted during mid-luteal phase. in natural cycles, all the subjects will have a daily urine test from day 9 of the menstrual cycle to identify the luteinizing hormone (lh) surge. the es will be obtained precisely 7 days after lh surge. endometrial samples will be obtained using a pipelle sampler as an outpatient procedure. the endometrium will be divided into three aliquots. one will be fixed in 4% formalin for 24 hours, routinely processed and embedded in paraffin wax. one will be investigated by microbial culture for infectious agents and one will be sequenced to reveal the endometrial microbiota. ce will be diagnosed either by the presence of plasma cells and changes in endometrial stromal cells identified using he and ihc, or by the finding of infectious agents using microbial culture. the selection of antibiotics will be based on the type of infectious agents or empirical, doxycycline 100mg bd po. for 14 days, for women with negative microbial culture. endometrial biopsy will be repeated at the same time point after antibiotic treatment for women with ce. for persistent subjects with negative culturing, ciprofloxacin 500mg, bd po., and metronidazole 400mg tds po. for 14 days will be used. the treatment will be repeated for three courses at maximum for women with persistent ce according to their willingness.

Eligibility criteria:
inclusion criteria: * women with a history of 2 or more consecutive miscarriages before 24 weeks of gestation * women aged 20-45 years old exclusion criteria: * uncorrected uterine anomalies, such as the septate or bicornuate uterus, fibroids (submucous/intramural) * untreated hydrosalpinx * antiphospholipid syndrome * known clinical autoimmune disease * undergoing immunotherapy * abnormal thyroid function * abnormal karyotyping of couples * known immunodeficiency pathologies such as diabetes or hiv * currently taking other antibiotics or other trial medications or tcm; * currently or previously involved in other clinical trials with medication intake; * those with active pelvic inflammatory disease or suspicion of infection etc.

Keywords: chronic endometritis antibiotics unexplained recurrent miscarriage women
utilizing novel dipole density capabilities to objectively visualize the etiology of rhythms in atrial fibrillation

Conditions: Persistent Atrial Fibrillation

Summary: a prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the acqmap™ system in the ablation of persistent atrial fibrillation. (cl-af-002 - eu) a prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the acqmap™ system in the ablation of persistent atrial fibrillation. (cl-af-001 - canadian)

a prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the acqmap™ system in the ablation of persistent atrial fibrillation. (cl-af-002 - eu) a prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the acqmap™ system in the ablation of persistent atrial fibrillation. (cl-af-001 - canadian) the research study was conducted in the eu and canada. the protocol and the corresponding nct number is as follows: nct02462980 (protocol cl-af-001, site ontario, canada dr. verma = pi) the above record was combined into one as both protocols are essentially identical (one is post market \[eu\] and the other pre-market \[canada\] and one study report will be written that encompasses the data/results for both protocols.

Eligibility criteria:
inclusion criteria: * scheduled for an ablation of persistent atrial fibrillation exclusion criteria: * any duration of continuous af lasting longer than 12 months * previous af ablation * significant structural heart disease * previous cerebral infarct * major bleeding disorders * pregnant or lactating
sensation of dyspnea and experience of patients with heart failure

Conditions: Decompensated Heart Failure

Summary: this randomized clinical trial aims to evaluate patients with decompensated heart failure undergoing an early mobilization protocol with the use of immersive virtual reality glasses compared with patients undergoing the same protocol but without immersive virtual reality. the primary outcome will be the sensation of difficulty breathing, and the secondary outcome will be whether this technology provided a positive experience for patients in the intervention group that was superior to that of patients in the control group.

this randomized clinical trial aims to assess the sensation of dyspnea in patients undergoing an early mobilization protocol with immersive virtual reality and their experience using this technology. the study population consists of patients with acute decompensated heart failure in an intensive care unit at a teaching hospital. the 3-day protocol will include active exercises with an in-bed cycle ergometer, orthostasis, and ambulation. the intervention group will perform all exercises using virtual reality glasses. the variables will be collected before and after each intervention.

Eligibility criteria:
inclusion criteria - patients with 18 years or older * being hospitalized for 24 hours or more * diagnosis of acute heart failure decompensated * being lucid and colaborative exclusion criteria: * mechanical ventilation or circulatory support * neurodegenerative diseases * pregnant patients * hemodynamic instability at baseline * score on the borg rating of perceived exertion scale borg ≥ 4 at rest * high risk of falls * difficulty communicating * not adapt with the immersive virtual reality glasses

Keywords: early mobilization cardiac rehabilitation virtual reality exercise tolerance patient experience
esba1008 microvolume study

Conditions: Exudative Age-Related Macular Degeneration

Summary: the purpose of this study is to demonstrate a treatment effect of esba1008 applied as a microvolume injection or infusion on retinal function and morphology in subjects with exudative age-related macular degeneration (amd).

this 4-cohort study was conducted in 2 stages. stage 1 consisted out of 2 cohorts. in each cohort subjects were randomized 10:3 to either receive esba1008 (cohort 1 : 2 injections, cohort 2 : 1 infusion and 1 injection) or 2 lucentis injections. stage 2 was conducted similarly with a different dosing level for esba1008 (cohort 3 and 4). subjects had follow-up visits at day 7 and day 14. all cohorts receiving esba1008 on day 0 also received esba1008 6mg/50 μl via injection on day 28. after the day 28 visit (all cohorts), subjects returned for follow up visits at day 42 and day 56.

Eligibility criteria:
inclusion criteria: * sign informed consent document; * able to make the required study visits and follow instructions; * age-related macular degeneration in the study eye; * visual acuity within protocol-specified range; * 340 μm minimal central subfield thickness (csft; spectralis equivalent) * other protocol-defined inclusion criteria may apply. exclusion criteria: * both eyes: any active infection or inflammation; * study eye: any treatment for exudative age-related macular degeneration (amd) other than vitamin supplements; * study eye: any current or history of macular or retinal disease; * study eye: any concurrent intraocular condition such as cataract or diabetic retinopathy that, in the opinion of the investigator, could either require medical or surgical intervention during the course of the study to prevent or treat visual loss; * study eye: other ocular conditions or diseases that, in the opinion of the investigator, could compromise visual acuity; * study eye: uncontrolled glaucoma; * history of a medical condition that, in the opinion of the investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product; * women of childbearing potential who are lactating, pregnant, planning to become pregnant, or not using adequate birth control methods for the duration of the study; * intraocular surgery within 3 months of baseline; * study eye: any history or current evidence of retinal angiomatous proliferation (rap) lesions based on clinical exam; * other protocol-defined exclusion criteria may apply.

Keywords: exudative age-related macular degeneration wet amd choroidal neovascularization (cnv) vascular endothelial growth factor (vegf)
safety and efficacy of an2728 topical ointment, 2% in children, adolescents, and adults (aged 2 years and older) with atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the purpose of this study is to investigate the safety and efficacy of an2728 topical ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis.


Eligibility criteria:
inclusion criteria: * males or females 2 years and older * has a clinical diagnosis of atopic dermatitis (ad) according to the criteria of hanifin and rajka * has ad involvement ≥ 5% treatable %bsa (excluding the scalp) * has an isga score of mild (2) or moderate (3) at baseline/day 1 * all female subjects of childbearing potential must use acceptable methods of contraception from the screening visit continuously until 30 days after stopping study drug exclusion criteria: * as determined by the study doctor, a medical history that may interfere with study objectives * unstable ad or any consistent requirement for high potency topical corticosteroids * history of use of biologic therapy (including intravenous immunoglobulin) * recent or anticipated concomitant use of systemic or topical therapies that might alter the course of ad * recent or current participation in another research study * females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study * participation in a previous an2728 clinical trial

Keywords: atopic dermatitis