Kornimate/medical-research-clean huggingface dataset:
a study of ly3561774 in participants with mixed dyslipidemia

Conditions: Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Hyperlipoproteinemia

Summary: this a multicenter, phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of ly3561774 administered subcutaneously at various doses in participants with mixed dyslipidemia and on a stable dose of a statin.


Eligibility criteria:
inclusion criteria: * have fasting triglycerides (tgs) within the range of 150 (1.69 millimole/liter (mmol) to 499 milligram/deciliter (mg/dl) 2.26 to 5.64 millimole/liter (mmol/l) at screening. * have fasting ldl-c ≥70 mg/dl (1.81 mmol/l) at screening. * have non-hdl-c ≥ 130 mg/dl (3.36 mmol/l) at screening. * must be on a stable moderate or high-intensity dose of a statin for at least 2 months before screening and remain on the same medication and dose for the duration of the study. * have a body mass index within the range of 18.5 to 40.0 kilogram/square meter (kg/m²), inclusive exclusion criteria: * have in the 6 months prior to screening, uncontrolled type 1 or type 2 diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization, or have an hemoglobin a1c (hba1c) ≥8% at screening. * have a history of nephrotic syndrome. * have a history of acute or chronic pancreatitis. * have had within the past 3 months prior to screening * myocardial infarction * unstable angina * coronary artery bypass graft * percutaneous coronary intervention - diagnostic angiograms are permitted * peripheral artery disease * transient ischemic attack, or * cerebrovascular accident * have new york heart association class iii or iv heart failure or last known left ventricular ejection fraction \<30%. * have undergone ldl apheresis within 12 months prior to screening. * have clinically relevant anemia, as defined by the investigator. * have, within 1 year prior to screening or plan on having during the study, surgical treatment for obesity. * have within 3 years prior to screening a history of chronic alcohol abuse, iv drug abuse, or other illicit drug abuse. * have uncontrolled hypertension. * have used or are taking products for the purpose of lowering lipid levels (except for statins, pcsk9 inhibitors, bempedoic acid, and ezetimibe). this includes lipid-regulating medication, over-the-counter products, or herbal therapies.

Keywords: triglycerides ldl cholesterol mixed dyslipidemia
the engaging primary care in cancer survivorship (epics) study

Conditions: Breast Cancer; Colorectal Cancer

Summary: a quasi-experimental non-randomized pre/post with control group trial of two models of cancer survivorship care in early-stage colorectal and breast cancer survivors cared for in a community-based, integrated health care setting.

a quasi-experimental non-randomized pre/post with control group trial of two models of cancer survivorship care in early-stage colorectal and breast cancer survivors cared for in a community-based, integrated health care setting. the trial will test the efficacy of an embedded primary care provider (pcp) model (experimental condition) in which pcps are embedded within an oncology practice and will care for low-risk survivors who will be transitioned at 6-36 months post-treatment for comprehensive survivorship care. we hypothesize that a) patients in the pcp model will have superior receipt of recommended care compared to usual care; b) patients in the pcp model will perceive significantly better care coordination, self-efficacy, and confidence in their pcp compared to usual care; and c) use of unplanned and non-recommended care will be less in the pcp model compared to usual care.

Eligibility criteria:
inclusion criteria: * patients: adult (21+) kaiser permanente southern california members diagnosed and treated for pathologically confirmed first primary early-stage breast (stage 0, i, ii) or colorectal (stage i, ii) cancer within kaiser permanente southern california. completed active cancer treatment within the past 6-36 months; active treatment includes cancer-directed surgery, chemotherapy (includes herceptin (trastuzumab)), radiation therapy, and ovarian suppression therapy (e.g., goserelin (zoladex)). completed at least one office visit within kaiser permanente southern california medical oncology. at low-risk for cancer recurrence and treatment-related toxicities based on state of disease and treatment modalities. for our aim 2 survey: primary language of english or spanish (although we will assess our aim 1 participants for recorded preferred spoken language and adjust translations as needed). ability to complete surveys of patient-reported outcomes. * physicians: for centers assigned to the embedded primary care physician (pcp) model, pcps selected to participate must be board certified in a relevant primary care specialty; hold a valid and current md or advanced practitioner license; and be employed by the southern california permanente medical group. exclusion criteria: * patients less than 21 years of age * patients at high risk for recurrence and treatment-related toxicities based on stage of disease and treatment modalities

Keywords: cancer survivorship models of care
a performance evaluation of the lumiradx point of care d-dimer assay

Conditions: Deep Vein Thrombosis; Pulmonary Embolism; Venous Thromboembolism

Summary: in patients with symptoms of venous thromboembolism (vte) (mainly deep vein thrombosis (dvt) or pulmonary embolism (pe)), the study will evaluate the agreement between the d-dimer measurements from the lumiradx poc d-dimer assay and a reference method, as an aid in diagnosis, assessment and exclusion of dvt and pe.

this is a performance evaluation study designed to assess the precision and accuracy of the lumiradx point of care (poc) d-dimer test when used in patients presenting with symptoms of venous thromboembolism (vte), which mainly comprises deep vein thrombosis (dvt) or pulmonary embolism (pe). the lumiradx poc d-dimer test is a quantitative immunoassay providing results in under 10 minutes. the accuracy of the lumiradx poc d-dimer test will be assessed using capillary whole blood, venous blood, and plasma samples, by comparison to the d-dimer results obtained from the same individuals as analysed by trained laboratory professionals using a reference device. the results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test in the european union (eu) and other relevant geographies. adult males and females presenting to the study sites with symptoms of vte will be included in the study. approximately 1000 subjects will be recruited in total. an initial analysis will be completed on the first 200 patients to determine accuracy of the lumiradx d-dimer test versus the reference method. the study will continue until 1000 patients are recruited and with a minimum of 120 confirmed vte events, in order to complete retrospective analysis using the lumiradx d-dimer cut-off for exclusion of vte. once consent is obtained, blood tube samples will be drawn and finger-stick samples of capillary blood will be taken from the subject, these will be applied directly to unique test strips for immediate measurement of d-dimer on the lumiradx poc d-dimer test. the d-dimer results obtained via the lumiradx d-dimer test will be used in a set of comparative analyses designed to determine the performance characteristics of the test. this study is an observational, cross-sectional design. as an observational study of an investigative device, results obtained during the course of the study will not inform or alter patient management or treatment decisions in any way.

Eligibility criteria:
inclusion criteria: subject is greater or equal to 18 years of age willing and able to provide written informed consent and comply with study procedures symptoms of thromboembolic event exclusion criteria: suspected sinus venous thromboembolism / cerebral venous sinus thromboembolism end-stage renal failure on haemodialysis current anticoagulant therapy (fragmin, lmwh) within the last 30 days patient has previously participated in this study life expectancy documented as \<30 days haemodynamically unstable (e.g. cardiogenic shock) patients taking anticoagulant therapy (doacs, warfarin, heparins etc) within the last 30 days patient deemed medically unfit to participate
independent predictors analysis and model construction of cavitary central lung cancer

Conditions: Central Lung Cancer

Summary: this study is a retrospective, multicenter clinical study. the main goal is to identify the risk factors for cavity formation in central-type lung cancer lesions, and to construct a prediction model for cavity formation in central-type lung cancer lesions based on the above risk factors.


Eligibility criteria:
inclusion criteria: 1. age：older than 18 years； 2. clinical or pathologically confirmed central lung cancer; 3. lesions without cavities at first diagnosis of central lung cancer; 4. performed complete laboratory and imaging research at the first diagnosis of the central lung cancer; 5. patients with cavities formation during follow up, and the cavities were independently confirmed by at least 3 imaging experts; 6. patients with complete medical records; exclusion criteria: 1. patients suffering other malignant tumors; 2. patients missing the imaging data; 3. patients missing the clinical data.

Keywords: central lung cancer cavity predictor
perioperative propranolol in patients with post traumatic stress disorder (ptsd)

Conditions: Post-traumatic Stress Disorder

Summary: understanding what treatments may facilitate perioperative care of veterans with posttraumatic stress disorder (ptsd) is of great importance to the u.s. health care system. patients with ptsd are characterized by elevated central nervous system catecholamine concentrations and exaggerated and prolonged adrenergic responses to stress stimuli. at present, there are no data on the effects of perioperative beta blocker therapy in patients with ptsd, despite the rising significance of ptsd in veteran populations. this prospective, double-blind study proposes to randomize 150 veterans with ptsd scheduled for orthopedic, thoracic or vascular surgery at the san francisco va medical center to either a 14-day course of propranolol or placebo. this study will then follow these veterans for a one-year period to evaluate the effects of the intervention on veterans' surgical outcomes. the investigators hypothesize that patients with ptsd randomized to the propranolol group will demonstrate a reduced incidence of perioperative and postoperative morbidity and mortality.


Eligibility criteria:
inclusion criteria: 1. subjects scheduled for any surgical procedure under general anesthesia or combined general-regional anesthesia, with the exception of open-heart or intracranial surgery. regional anesthesia includes: 1) epidural anesthesia, 2) sub-arachnoid block (spinal), or 3)any regional nerve block 2. anticipated postoperative hospital admission (defined as at least one overnight hospital stay) exclusion criteria: veterans will be excluded if: 1. they are on beta blocker therapy at the time of the preoperative baseline assessment 2. they report sensitivity or allergies to propranolol, or a history of ptsd exacerbation with prior propranolol therapy 3. veterans who fulfill the aha/acc level i recommendation criteria for perioperative beta blocker therapy (e.g., metoprolol, atenolol) and should not be randomized to placebo group 4. medical exclusions criteria: high grade heart block without pacemaker (all patients with 2nd and 3rd degree heart block), marked resting bradycardia (heart rate ≤ 55 beats per minute), blood pressure \< 100 mmhg, uncompensated congested heart failure, severe hyperactive airway disease, and raynaud's disease 5. pregnancy 6. current use of medication that may involve potentially dangerous interaction with propranolol 7. circumstances that, in the opinion of the principal investigator, would preclude participation in a study of this type (e.g. medical concerns or difficulty in long-term followup). 8. open-heart surgery and intracranial surgery

Keywords: post-traumatic stress disorder propranolol surgery anesthesia
psycho-social consequences of systemic lupus erythematosus

Conditions: Lupus Erythematosus

Summary: this project will allow us to evaluate and understand the impact of sle on the couple's life and its relational and affective components. in addition, the psy-lup study will describe the representations that sick people and their relatives have of lupus disease. all the data collected will make it possible to target interventions with 1) patients and their relatives, in terms of therapeutic education, psychosocial support, support groups (associations); 2) caregivers caring for people with sle, so that they can integrate the issues of the patient's experience in their care practice and their reflection on therapeutic strategies.

systemic lupus erythematosus (sle) is a rare chronic autoimmune disease (1/2000 inhabitants) that evolves in periods of recurrent remissions. sufferers are most often young women of childbearing age. sle affects the life of a couple like family life (financial, emotional, relational or sexual conditions of the couple). in addition, the disease and its treatments can hinder the possibility of building a family project (pregnancy). the purpose of the psy-lup study is to study the impact of sle on the social participation of patients, that is to say on their ability to get involved in different areas of daily life. these repercussions could be all the more important as lupus disease is active and complicated by severe diseases such as kidney disease. we want to study how sick people and their loved ones (spouse in particular) think about lupus disease, how it fits into their life history, how people have adapted to this disease, and how it affects their lives. could have on their social participation, their social support, their life of couple. the psy-lup study will be carried out in different care services, and by telephone interviews at home, with two main axes: (1) a study by questionnaire with patients (n = 100); (2) a qualitative study through research interviews with patients (n = 40) and their spouses (n = 20). the realization of this project will allow us to evaluate and understand the impact of sle on the life of the couple and its relational and affective components. in addition, the psy-lup study will describe the representations that sick people and their relatives have of lupus disease. all the data collected will make it possible to target interventions with 1) patients and their relatives, in terms of therapeutic education, psychosocial support, support groups (associations); 2) caregivers caring for people with sle, so that they can integrate the issues of the patient's experience in their care practice and their reflection on therapeutic strategies.

Eligibility criteria:
inclusion criteria: * age\> 18 years * presenting an les according to acr or slicc criteria * being followed in marseille in nephrology or internal medicine as part of the competence center lupus paca * having agreed to participate in the study after information exclusion criteria: * minor person * person deprived of liberty * person not affiliated to a social security scheme
acceptance and commitment therapy in ssri-resistant obsessive compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the purpose of this study is to determine whether acceptance and commitment therapy is effective in the treatment of ssris-resistant obsessive- compulsive disorder.

the patients who were ssri-resistant will be randomized to act, aripiprazole, or smt. independent evaluators, blind to treatment,will evaluate patients during the study.the yale-brown obsessive compulsive scale (ybocs)will be used to measure ocd severity.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 65; 2. no less than 9 years in education; 3. a dsm-iv diagnosis of ocd 4. moderately symptomatic (yale-brown obsessive compulsive scale score≥16) 5. received at least two kinds of ssris at optimal dose for more than 12 weeks an optimal dose is described as following: clomipramine hydrochloride, at least 225 mg/d;fluoxetine, at least 60 mg/d; paroxetine hydrochloride, at least 60 mg/d; sertraline hydrochloride, at least 200 mg/d; fluvoxamine, at least 250 mg/d; citalopram hydrobromide,at least 60 mg/d; and escitalopram oxalate, at least 40 mg/d.patients who are unable to tolerate the supposed optimal doses were also eligible if at their maximally tolerated dose. exclusion criteria: 1. with comorbid axis i psychiatric disorders 2. drug abuse in the last 3 months 3. hamd\>25 4. too severe to receive act or evaluation 5. at high risk of suicide 6. pregnant or prepare for pregnancy 7. with somatic disorder 8. received aripiprazole(≥10mg for 8weeks) or act(8 times within 2 months) before 9. treated with no more than one kind of ssri before
effects of acarbose on endothelial function after a mixed meal in newly diagnosed type 2 diabetes

Conditions: Type 2 Diabetes

Summary: endothelial dysfunction (ed) has been suggested as a possible causal link between postprandial hyperglycemia and cardiovascular events in patients with type 2 diabetes. recent trials demonstrated a reduction of cardiovascular events by treatment with the alpha glucosidase inhibitor acarbose - a drug which mainly reduces postprandial glucose excursions. we were interested whether patients with newly diagnosed type 2 diabetes showed postprandial ed and if so whether acarbose was able to improve this condition.


Eligibility criteria:
inclusion criteria: * age 35-75 years * type 2 diabetes (newly diagnosed) * well glycemic control (hba1c \</= 8.1) * leucocyte count \> 6.2 or hs crp \> 1 exclusion criteria: * hs crp \> 10 * type 1 diabetes * previous treatment with antidiabetic drugs
addition of phytosterols to a low phytosterol diet

Conditions: Hypercholesterolemia; Coronary Heart Disease

Summary: studies have shown that phytosterols will lower ldl cholesterol. typical diets can contain between 250 to 500 mg of naturally-occurring phytosterols. long-term studies with phytosterol-containing products(such as margarines) have not taken into account the amounts of naturally occurring phytosterols in the diet. this means that the effects of small amounts of natural dietary phytosterols on ldl cholesterol are not known. in this study, we will examine the effects of phytosterols across a range of levels. the information will likely be used to further support and possibly extend the current dietary recommendations for phytosterol use.


Eligibility criteria:
inclusion criteria: men and women are eligible who: * are of any race or ethnicity between 18 to 80 years of age; * are in generally good health; * have moderately elevated blood cholesterol(ldl cholesterol between 100 and 189 mg/dl) * will eat only the foods that are provided by the center during the diet periods; * will drink no more than 5 cups of caffeine-containing beverages a day; * will consume no more than 1 alcoholic drink a day; * will abstain from the consumption of alcohol for 48-hours prior to blood draw days exclusion criteria: * are younger than 18 or older than 80 years; * have very high cholesterol(ldl cholesterol equal to or above 190 mg/dl or triglycerides equal to or above 250 mg/dl); * have very high blood pressure(equal to or above 160 mm hg systolic or 95 mm hg diastolic); * are overweight( bmi greater than 35 kg/m2) * are taking lipid-lowering, or any other medication known to affect blood cholesterol; * have diabetes mellitus, cancer, heart, liver and/or kidney disease, or chronic disease that might interfere with participation;

Keywords: phytosterols cholesterol excretion cholesterol absorption diet mass spectrometry deuterium
safety and efficacy study of ustrap™ in male urinary incontinence

Conditions: Urinary Incontinence

Summary: few surgical methods to treat male stress urinary incontinence have been assessed in comparative, randomised interventional studies. ustrap is a new adjustable-pressure 4-arm device. the artificial sphincter is currently considered the gold standard device in this field. the aim of this randomised prospective international study is to assess the efficacy and safety of the ustrap® device comparatively with an artificial sphincter (ams800) in the treatment of stress urinary incontinence following prostate removal in cancer patients.


Eligibility criteria:
inclusion criteria: disease-related criteria: * persistent urinary incontinence \>= 12 months following radical prostatectomy for prostate adenocarcinoma * presenting an indication for surgical insertion of a medical device * 24h pad test \> 100 g per day * controlled prostate adenocarcinoma, with psa ≤ 1 ng/ml population-related criteria: * male subjects aged 18 years and over * having provided free, informed written consent to take part in the study * patients independent and able to use the collar without difficulty and able to manage an artificial sphincter * patient able to understand and sign the consent form and to complete questionnaires * patient without mental impairment * patients belonging to or covered by social security. exclusion criteria: disease-related criteria: * documented neurological bladder or history of neurological disease liable to interfere with urinary symptoms. * presence of urethral anastomotic stenosis preventing passage of the fiberscope at the initial endoscopy * severe symptomatic hyperactive or hypoactive bladder not controlled by drug therapy * severe constitutional haemorrhagic disease or haemophilia * patients presenting urinary infection not controlled * patients presenting severe renal failure and obstructive pathologies of the upper urinary tract with severe renal failure. * patients presenting deep immune deficiency * patient presenting recto-urethral fistula * patient with tumor of bladder * patient having bladder stones with failure of bladder stone treatment criteria related to incontinence treatment: * allergy to any of the components of the medical devices * history of surgery to insert a medical device for treatment of incontinence (e.g. artificial sphincter, suburethral strap, continence balloons, etc.) * history of periurethral injection of filling agents * inability to use either of the study devices * drug treatment: duloxetine or any treatment likely to modify continence results * not receiving and not likely to receive radiotherapy at any time throughout the 12-month follow-up period population-related criteria * foreseeable unavailability during the study . patient deprived of liberty by administrative or judicial decision or under legal guardianship * participation in another clinical trial in the 3 months preceding the initial visit

Keywords: radical prostatectomy , device,
consciousness-specific brain network connection of propofol sedation and prolonged disorders of consciousness

Conditions: Consciousness Disorder

Summary: consciousness-specific brain network connection of propofol sedation and prolonged disorders of consciousness based on electroencephalography and auditory event-related potentials


Eligibility criteria:
inclusion criteria: * age 18 - 65 years old, native chinese speaker, dextromanuality; * chronic disorder of consciousness; * spinal cord electrical stimulator implantation under general anesthesia; * signed informed consent. exclusion criteria: * continuous sedation was administered within 72 hours prior to the study; * open head injury, parenchymatectomy and other damage of brain structural integrity; * the intracranial compliance decreased due to hydrocephalus and swelling; * known hearing impairment; * airway stenosis and various causes of severe ventilation or ventilation dysfunction; * known or suspected cardiac dysfunction; * allergic to intravenous general anesthetics; * associated with other mental or neurological diseases; * other reasons are not suitable to participate in this study.

Keywords: prolonged disorders of consciousness propofol brain functional connectivity electroencephalography