Kornimate/medical-research-clean huggingface dataset:
safety and tolerability of e5555 and its effects on markers of intravascular inflammation in subjects with acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: this is a multi-center, randomized, double-blind, placebo-controlled study to determine the safety and tolerability of e5555 in subjects with acute coronary syndrome (acs).


Eligibility criteria:
inclusion criteria: 1. males or females, 45 - 80 years of age 2. presenting with features of non-st segment elevation acs (unstable angina or myocardial infarction without persistent st elevation). and at least one of the following two criteria on admission: cardiac enzymes≥ uln for the local institution or ecg changes compatible with ischemia 3. randomisation possible within 24 hours of the onset of the most recent symptomatic episode. exclusion criteria: 1. history of acquired or congenital bleeding disorder, coagulopathy or platelet disorder, or history of pathological bleeding within the last 6 months 2. history of intracranial bleeding, history of hemorrhagic retinopathy, history of recent ischemic stroke or transient ischemic attack, or known structural cerebral vascular lesion 3. recent trauma, major surgery, percutaneous coronary intervention or coronary artery surgery 4. clinically significant haematological, hepatic or renal abnormalities 5. patients with some specific st-segment changes, severe congestive heart failure or uncontrolled cardiac arrhythmias at baseline 6. recent significant (as determined by the investigator) cardiovascular events

Keywords: acute coronary syndrome
effect of rotating magnetic therapy on blood glucose spectrum of type 2 diabetic patients with glargine therapy

Conditions: Type 2 Diabetes

Summary: the aim of the study is to assess the eﬀect of rotating magnetic therapy on blood glucose spectrum of type 2 diabetic patients with glargine therapy using flash glucose monitors


Eligibility criteria:
inclusion criteria: * volunteer to participate and sign informed consent prior to the study * patients with type 2 diabetes, who met who1999 diagnostic criteria, aged 18-70 years old, and were treated with insulin glargine alone and/or insulin glargine combined with oral hypoglycemic drugs, the treatment regimen was stable for more than 2 months * fasting blood glucose ranged from 6.1 to 13.9mmoll, and postprandial (or random) blood glucose was \<22.2mmol/l. * subjects can and are willing to conduct flash glucose monitoring and regular diet and exercise exclusion criteria: * patients with insulin allergy * patients treated with glp-1a or dpp-4 inhibitors or multipoint subcutaneous insulin injection in the last three months * impaired liver and kidney function with alt 2.5 times higher than the upper limit of normal value and serum creatinine 1.3 times higher than the upper limit of normal value * patients with metal foreign bodies or pacemakers * patients with a history of surgery in magnetic therapy site within one year * patients with obvious discomfort to magnetic therapy * patients with bleeding or bleeding tendency * patients with poor compliance and irregular diet and exercise * patients with acute complications of diabetes, such as infection, diabetic ketoacidosis, hypertonic coma and so on, and patients with stress status within four weeks * patients who are pregnant, breast-feeding, or intending to become pregnant * any other apparent conditions or associated diseases determined by the investigator: severe cardiopulmonary, endocrine, neurological, tumor, other pancreatic diseases, history of mental illness
a phase 2 study using aliya pef plus pembro for sarcoma

Conditions: Soft Tissue Sarcoma

Summary: the is a phase 2 that will evaluate the efficacy and safety of the aliya pef ablation system combined with pembrolizumab, an immune checkpoint inhibitor.in advanced soft tissue sarcoma. twenty subjects will be treated.

this is a phase 2 study that will evaluate the efficacy and safety of the aliya pef ablation system plus pembrolizumab, an immune checkpoint inhibitor in advanced soft tissue sarcoma. the aliyatm system (galvanize therapeuticstm) is a biphasic monopolar pulsed electric field (pef) system that induces cell death in a manner independent of thermal processes, enabling focal ablation without denaturing stromal proteins or inducing significant muscle contraction. pembrolizumab is a programmed death receptor-1 (pd-1)-blocking indicated for various malignancies including melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, etc.both aliya and pembrolizumab are fda approved products. objectives:primary: o evaluate progression free survival at 6 months; secondary: to evaluate the objective response rate by recist v1.1 via ct scan or mri at week 6 and every 6 weeks thereafter until end of treatment (eot); to determine progression-free survival (pfs) at 6 months and overall survival, and to evaluate the incidence and grade of treatment related adverse events. exploratory: to evaluate pef-treated dose-response- pre-pef and follow-up as per standard of care after pef energy delivery by recist v1.1 and irecist criteria, and to conduct biomarker analyses performed on tumor homogenate prep (thp) and lab blood draws collected at follow-up visits as per standard of care, which may include flow cytometry analyses of cell populations, cytokines, tumor-specific t-cell and b-cell populations, and tumor-specific igg antibody quantities.the population to be studied include male and female subjects 18 years of age or older, of any ethnicity, with advanced soft tissue sarcoma.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age * pathologically confirmed diagnosis of pleomorphic sarcoma, myxofibrosarcoma, leiomyosarcoma, liposarcoma, synovial sarcoma * previously treated or untreated patients * measurable disease with at least one target lesion amenable to pef * life expectancy at least 3 months * adequate hematologic, liver and kidney function * ecog performance status of 0-1 * willingness to sign informed consent * negative pregnancy test if female exclusion criteria: * patients with untreated cns disease * anticancer therapy within 2 weeks * concurrent immunotherapy * pregnant women * autoimmune disorder * severe or uncontrolled systemic disease.
enhancing treatment adherence in pediatric asthma with a problem solving intervention

Conditions: Asthma

Summary: the purpose of this study is to determine the effectiveness of a tailored problem solving intervention in increasing adherence to asthma management behaviors in african american adolescents with asthma.

background: children and adolescents who are unable to adhere to their medical regimen for the management of chronic illness present considerable challenges to health care providers and researchers. pediatric asthma is a chronic illness where the consequences of non-adherence are particularly detrimental and widespread, especially among economically disadvantaged minority children and their families. studies of intervention of asthma management are needed for this population. design narrative: the aim of the proposed study is to test the efficacy of a problem solving intervention that is tailored to the observed adherence behaviors and identified barriers to increasing adherence in african american children and adolescents with asthma, and their families. patients are randomized to either a tailored problem solving intervention, or a control group who will receive family education intervention. duration of the intervention is four months.

Eligibility criteria:
inclusion criteria: * african american * family income to be below the poverty line * physician-based diagnosis of asthma of at least 12 months * moderate to severe asthma (moderate asthma includes daily symptoms, daily use of inhaled short acting beta-agonist, exacerbations greater than 2 times per week that affect activity, and nighttime symptoms greater than once a week, fev1 or peak flow pef between 60 and 80 percent predicted and pef variability greater than 30 percent; severe asthma includes continual symptoms, limited physical activity, frequent exacerbations together with frequent nighttime symptoms, fev1 or pef less than 60 percent predicted, and pef variability greater than 30 percent) * likely to be on a stable and daily medication (inhaled steroid) that can be modified electronically for the time period required to participate in the study exclusion criteria: * presence of a serious comorbid chronic condition
efficacy and safety of hmr1766 in patients with fontaine stage ii peripheral arterial disease

Conditions: Intermittent Claudication

Summary: the primary objective is to investigate in patients suffering from intermittent claudication due to fontaine stage ii peripheral arterial disease (pad) whether a 26-week treatment by hmr1766 on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of hmr1766 to placebo, and calibrating such effect versus cilostazol.


Eligibility criteria:
inclusion criteria: * patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis etiology (symptoms present for 6 months or longer and not significantly changed within the past 3 months) * initial claudication distance of 30 to 250 meters at screening constant workload treadmill test * confirmation of underlying peripheral arterial disease (pad) at screening * confirmation of symptom stability at randomization based on constant workload treadmill test performance * the patient must have optimal cardiovascular risk prevention and appropriate management of pad, including clopidogrel at the dose of 75mg per day, during the study period exclusion criteria: * patient participated in investigational clinical trials in the last month prior to screening * pregnant or breast-feeding woman or woman without documented double birth control measures for at least 3 months prior to randomization * symptoms of pad before the age of 40 years * recent initiations or discontinuation of treatment by vasoactive agents (e.g., pentoxifylline, berprost sodium, papverine, isoxsuprine, nylidrin, cyclandelate, and niacin derivatives). patients treated by cilostazol within 3 months prior to screening will also be excluded * recent lower-extremity surgical or endovascular arterial reconstructions or sympathectomy, or recent deep venous thrombosis * recent occurrence of at least one of the following: acute myocardial infarction, unstable angina, coronary artery bypass graft, percutaenous coronary intervention, transient ischemic attack or stroke the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: peripheral artery disease
visual performance of dailies total1 multifocal and acuvue oasys max 1-day multifocal in presbyopic lens wearers

Conditions: Presbyopia

Summary: the purpose of this study is to measure the logmar visual acuity when presbyopic soft lens wearers are fit with dailies total1 multifocal and acuvue oasys max 1-day multifocal.


Eligibility criteria:
inclusion criteria: 1. are at least 42 years of age and has full legal capacity to volunteer; 2. have signed an information consent letter; 3. are willing and able to follow instructions and maintain the appointment schedule; 4. habitually wears soft contact lenses for the past 3 months (minimum); 5. are presbyopic and require a reading addition of at least +0.75d and no more than +1.75d; 6. can be refracted and achieve monocular spectacle distance vision of at least 20/25 snellen (or +0.10logmar) visual acuity; 7. have contact lens power requirements that fall within the available study lens parameters (distance sphere: +6d to -9d; near addition as per each lens design); 8. can be fit with the initial fitting guidelines provided by the lens manufacturer and use either low or medium add (same add in both eyes). exclusion criteria: 1. are a current habitual wearer of dailies total1 multifocal or acuvue oasys max 1-day multifocal; 2. has refractive astigmatism higher than -0.75dc in either eye; 3. are participating in any concurrent clinical or research study involving intervention or invasive ocular tests; 4. have any known active ocular disease and/or infection; 5. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 6. are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 7. have known sensitivity to the diagnostic pharmaceuticals to be used in the study; 8. have undergone refractive error surgery; 9. are a member of the centre for ocular research \& education (core) directly involved in the study.
erythropoietin for anemia due to zidovudine in human immunodeficiency virus infection

Conditions: Acquired Immunodeficiency Syndrome; Anemia; Hematologic Diseases; HIV Infections; Blood Disease

Summary: to determine whether administration of human recombinant erythropoietin (repo) improved or eliminated the anemia seen in human immunodeficiency virus (hiv) infected patients after therapy with zidovudine (zdv).

background: reports had shown that between 24 and 78 percent of patients with acquired immune deficiency syndrome treated with zidovudine for four to six months developed significant bone marrow toxicity, requiring zidovudine dosage alterations, blood transfusions, or cessation of therapy. while zidovudine efficacy had been demonstrated in patients with aids or arc, it was also evaluated in patients with aids-related illness, as well as in asymptomatic hiv-infected individuals. the clinically significant zidovudine-induced anemia developing in a substantial number of these patient groups and requiring blood transfusions could cause a significant drain on the blood supply in the united states. the project was part of an institute-initiated study on the pathobiology of bone marrow suppression in aids or aids-related complex. the concept was approved at the may 1987 national heart, lung, and blood advisory council. the request for applications was released in december 1987. design narrative: double-blind, placebo-controlled. patients received intravenous repo (1000 iu/kg) or placebo twice per week. the five patients in group a had no transfusion history. the five patients in group b had a history of transfusions. prior to the study, the authors determined that treatment would continue for twelve weeks or until the hemoglobin reached 12.5 g/dl. after the twelve week study period, patients were eligible to receive open label erythropoietin (500 iu/kg, twice a week). for numerous reasons, recruitment of patients was a major problem in this trial. the study originally estimated a total of 64 patients.

Eligibility criteria:
no eligibility criteria
the effect of music intervention on anxiety, fear, and pain in pediatric patients receiving intrathecal chemotherapy

Conditions: Nurse's Role

Summary: intrathecal chemotherapy is often used to prevent the spread of cancer to the central nervous system in pediatric patients and is one of the most invasive procedures. it is believed that the way it is administered and the complications experienced after treatment negatively affect the comfort of the pediatric patient, leading them to refuse the treatment.

receiving sedation is one of the pharmacological procedures for intrathecal chemotherapy which creates a particularly difficult situation for the child. however, since pharmacological methods increase the cost and cause toxicity in children, in recent years, the symptoms that occur in cancer treatment have been tried to be controlled with non-pharmacological methods. music intervention facilitates a sense of control in patients and provides mental distraction, emotional smoothness, and relaxation, which have been found to have pain relief effects.

Eligibility criteria:
inclusion criteria: * to be between 6-12 years old, * being treated in the hematology and oncology clinic, * about to receive intrathecal chemotherapy treatment, * the child not having pain before intrathecal chemotherapy treatment exclusion criteria were, * refusing to participate in the study, * being under 6 years of age and over 10 years of age, * the child having pain prior to intrathecal chemotherapy treatment, * having any physical or mental disability, * not being able to speak turkish.

Keywords: anxiety hematology-oncology nursing pain intervention randomized controlled trial fear
the role of cvp and ef in patients with cardio-renal syndromes

Conditions: Heart Failure

Summary: the aim of the study is to explore association between increased central venous pressure, ejection fraction and renal dysfunction (egfr) in patients with cardio-renal syndromes type 1 and 2. the pilot study was set to provide the expected correlation coefficient for a sample size determination of the subsequent study.

objectives the aim of the study is to explore association between increased central venous pressure (cvp), ejection fraction (ef) and renal dysfunction (egfr) in patients with cardio-renal syndromes type 1 and 2. background the pathophysiology of impaired renal function in cardiovascular disease is multifactorial. recent investigations suggest that management of patients based on low-flow theory does not lead to improved outcomes. relative importance of right heart dysfunction (manifested as increased cvp) has not been evaluated . precise understanding of bidirectional pathways by which the heart and kidneys influence each other is necessary to define optimal treatment strategies specific to the subtypes, as therapies directed towards one organ system may have beneficial or unfavorable effects on the other. methods the study is of non-experimental (observational) type, based on retrospective chart review. the patients' personal identifiers are concealed and an anonymized datasets used (unique code given to each patient, which is kept secure under the control of hospital staff).

Eligibility criteria:
inclusion criteria: * hf (nyha class i - iv, with preserved and reduced ef) and reduced gfr (cardio-renal syndromes 1 and 2) exclusion criteria: * independent risk factors for renal impairment (e.g. diabetes, sepsis) * primary nephropathy or secondary nephropathy due to diseases other than hf

Keywords: cardio-renal syndrome right heart dysfunction central venous pressure egfr low-flow theory
observational study of oxygen delivery during a fractional fluid expansion

Conditions: Hypovolemia; Impaired Oxygen Delivery; Cardiac Output, Low

Summary: fluid expansion during cardiocirculatory insufficiency was helped by cardiac output monitoring. however, the goal of fluid expansion was to increase the oxygen delivery, which consider cardiac output, but also haemoglobin which decrease during a fluid challenge. the maximalization of cardiac output could decrease the oxygen delivery if the haemodilution was too wide. the aim of this study was to describe the oxygen delivery during a fluid expansion conducted for cardiac output maximalization, following actual guidelines.

one group of 20 anticipated patients

Eligibility criteria:
inclusion criteria: * adults over 18 years * patients in intensive care after cardiac surgery under mechanically ventilation and with oesophageal doppler exclusion criteria: * arrythmia * pregnancy or childrens * patients without cardiac output monitoring with oesophageal doppler * patients without medical indication for fluid expansion * urgency surgery

Keywords: hypovolemia fluid challenge fluid expansion oxygene delivery cardiac output
the effect of stellate ganglion block on postoperative sleep disturbance and cognitive function in elderly surgical patients

Conditions: Stellate Ganglion Block

Summary: postoperative delirium is an acute state of confusion, which is characterized by changes in attention and cognitive functions and fluctuations in consciousness; postoperative cognitive dysfunction is a common central nervous system complication in elderly patients after surgery, often manifested as memory, obstacles in abstract thinking and orientation are accompanied by a decline in social activity ability. postoperative delirium and cognitive dysfunction can prolong hospital stay, increase medical expenses, affect postoperative functional recovery, and even increase postoperative mortality. sleep disorders are a group of diseases that affect the ability to sleep well regularly and cause severe impairment of social and occupational functions. stellate ganglion block is a selective sympathetic ganglion block, in which a local anesthetic is injected into the loose connective tissue of the neck including the stellate ganglion. there are complex connections between stellate ganglia and multiple brain regions in the brain, which can improve postoperative delirium, cognitive function and sleep disturbance to a certain extent, and have certain guiding significance for postoperative rehabilitation of elderly patients.


Eligibility criteria:
inclusion criteria: 1. age ≥ 60 years; 2. asa grade i-iii; 3. operative time ≥ 2 h for laparoscopic radical resection of a suspected; gastrointestinal malignancy. exclusion criteria : 1. patient's lack of consent to participate; 2. known allergy to anesthetic drugs; 3. history of psychiatric or neurological disease(s); 4. long-term use of opioids or sedative-hypnotic drugs; 5. previous or planned neurosurgical procedures; 6. contraindications to epidural anesthesia; 7. hearing or visual impairment that precludes scale assessment.

Keywords: delirium cognitive dysfunction sleep disorders
protocol for patients above 75 years undergoing emergency laparotomy

Conditions: Frailty; Surgery--Complications; Outcome, Fatal; Frail Elderly Syndrome; Post-Op Complication; Gastro-Intestinal Disorder

Summary: in the propel study the effect of a protocol designed for elderly patients about to undergo emergency abdominal surgery will be investigated. the protocol addresses issues of both frailty and ceiling-of -care decisions.

in the "propel" study, investigators will test the effect of a care bundle designed for patients aged ≥75 years undergoing emergency laparotomy/laparoscopy. an interdisciplinary team of anesthetists, intensivists, surgeons, and geriatricians developed the care bundle, and the essential elements are frailty scoring, surveillance and optimization of patients, surgical treatment within predefined criteria, and postoperative delirium monitoring. preoperatively, patients with abdominal pathology requiring emergency surgery will be evaluated for frailty by the surgical team, using standardized frailty scores. palliative care could be an alternative to surgery in very frail patients. the decision to not perform surgery is a clinical decision made with the patient and/or relatives in a shared decision-making process. frailty scoring can assist in this procedure. the effect of the care-bundle will be compared to a historical cohort, using 30-day mortality as the primary outcome.

Eligibility criteria:
inclusion criteria: - patients above 75 years with clinical suspicion of abdominal condition requiring surgery exclusion criteria: * former inclusion in "propel" * surgery for incarcerated hernia without laparotomy * appendectomy without laparotomy * palliative surgery for already known inoperable gastrointestinal tumor * palliation without surgical treatment * vascular surgery