Kornimate/medical-research-clean huggingface dataset:
stress reduction using video googles on patients undergoing vascular surgery

Conditions: Carotid Artery Diseases; Regional Anesthesia; Distress, Procedural

Summary: one treatment option of internal carotid artery stenosis is open surgical endarterectomy. the operation is frequently carried out under regional plexus anesthesia, allowing the patient to remain awake during the procedure. this approach offers the advantage of monitoring for neurological changes during carotid artery clamping, allowing the surgical team to immediately respond by placing a shunt to ensure cerebral perfusion. as a result, performing surgery under regional anesthesia provides therefor a benefit. however, for patients, the procedure, which can last up to two hours or longer in some cases, may pose a significant burden. the fixed position, inability to move, sterile drapes over the face, manipulation by the surgical team, and anxiety about potential complications are just a few of the factors that may distress patients during the operation. increased sweating and reports of substantial subjective distress are not uncommon if the procedure is performed under local anesthesia. in many medical fields, devices and therapies are now being utilized to reduce patient stress in the perioperative setting. in procedures performed under local or regional anesthesia, such as in orthopedics or dentistry, efforts are being made to make operations more tolerable and less stressful for patients. for example, music and video goggles are employed to entertain and distract patients during the intervention. newer approaches using video googles appear in more and more fields to reduce distress. especially in vascular surgery and particularly in carotid surgery, the use of audiovisual distraction during the procedure has not been implemented to our knowledge, and its benefits remain undocumented. because of the special setting and burden for the patients it is highly necessary to test these devices in carotid surgery and explore potential benefits for these patients.


Eligibility criteria:
inclusion criteria: * planed carotid endarterectomy in local anesthesia exclusion criteria: * patients which are not able to communicate because of stroke or language barrier, * dementia or neurological damage which impairs answering questionnaires or the understanding of the situation during surgery * medication with steroids

Keywords: video googles carotid endarterectomy distress in patients vascular surgery
long term follow-up hybrid revascularization

Conditions: Coronary Artery Disease

Summary: objectives: the objectives of the year study are two-fold: 1. to determine the 5-7 year patency rate (rate of open bypass grafts) of the lita graft and stent of patients who have already had robotically-assisted hybrid cabg surgery using cta and mps-mibi. 2. to determine patient quality of life at 5-7 years after robotically-assisted hybrid cabg surgery

new techniques such as robotically-assisted hybrid cabg surgery need proper evaluation to ensure potential benefits gained are not harmful to that which we know to be of significant benefit to the patients, that being the left internal thoracic artery (lita) graft (one of the main coronary arteries supplying your heart with blood). we are therefore proposing a 5-7 year ct-angiography (cta) and myocardial perfusion scintigraphy (mps-mibi) to assess the patency rate of the lita graft and the stented graft in patients that have already undergone robotically assisted hybrid cabg.

Eligibility criteria:
inclusion criteria: - patients that have previously had hybrid robotic coronary artery revascularization performed approximately 5-7 years ago at the london health sciences centre, university hospital by dr. kiaii. exclusion criteria: - patients not described above

Keywords: cabg, hybrid, robotic surgery
comparison of postoperative delirium in elders anaesthetised with midazolam and without midazolam

Conditions: Postoperative Delirium

Summary: this research project is an observational cohort study by prospective chart review of patients that underwent surgery in multi-centers, china, in the years 2020-2022. the purpose of this study is to compare the occurrence of postoperative delirium with midazolam and without midazolam during non-cardiac surgery in elders.

post operative delirium will be diagnosed using the 3d- cam(confusion assessment method) which tests for four features with a series of questions. the features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present. the demographic data of the patients,type and site of surgery will be noted. preoperative hemoglobin, serum electrolytes and blood urea will be recorded. the intraoperative factors like duration of surgery and anaesthesia,use of intravenous fluids ,blood loss, number blood units transfused and opioid use will be studied at the time of surgery. the time to emergence and extubation following the completion of surgery will be noted. the postoperative factors like postoperative pain, nausea and vomiting, fever,hemoglobin,serum electrolytes and blood urea will be noted. preoperative and postoperative pain will be assessed using the numerical rating score on a scale of one to ten. the association of various preoperative,intraoperative and postoperative factors with pod will be determined.

Eligibility criteria:
inclusion criteria: geriatric surgical patients ≥65 years old underwent elective non-cardiac surgery exclusion criteria: history of neuropsychiatric diseases including delirium, mental disorders, parkinson, dementia, etc.; the operation was cancelled due to various reasons after the patient was enrolled; severe liver disease; severe renal dysfunction defined as either having creatinine clearance \< 30 ml/min or being dialysis-dependent; patients who undergo second operation in a short period; refused to participate in the study.
comparison between celution preparation and manual preparation of adipocyte derived regenerative cells, using stromal vascular fraction cell counts (compare)

Conditions: Obesity

Summary: this scientific study is meant to establish correlation in stromal vascular fraction (svf) cell counts between our manual method of harvesting and cytori's celution automated system. future scientific studies involving adipocyte derived regenerative cells (adrcs) will be based on svf cell counts from the more economical manual method of harvesting if this study shows good correlation.

this study requires lipoaspirate obtained from liposuction. lipoaspirate is typically discarded in the biohazard waste disposal system. we will be using the lipoaspirate (which would otherwise be discarded) in this study. lipoaspirate contains adipose tissues. with a suitable enzymatic separation method, stromal vascular fraction (svf) can be separated from the adipose cells (adipocyte). adipocyte derived regenerative cells has been isolated from the stromal vascular fraction (svf) of adipose tissues. there are two methods of obtaining the svf from the adipose tissue in this study. one is called the manual preparation and the other the celution preparation. the celution preparation is an automated system, providing a constant standard by which to compare the manual preparation of svf. this study aims to establish correlation between the manual preparation and celution preparation. the purpose of establishing correlation is to allow the manual preparation of svf to be used in future scientific studies. the manual preparation has the advantage of being more economical than the celution automated system. in future scientific studies, we hope to establish correlation between survival rates of fat graft and svf cell counts. currently fat grafting is an accepted list a aesthetic procedure in singapore to enhance facial features and in breast augmentation. however results vary widely among patients, and seems unpredictable. a possible hypothesis is that the survivability of the fat graft is dependent on the number of naturally occurring adrcs found in the fat graft. in the future we hope to conduct a scientific study on this hypothesis using the manual preparation. the secondary purpose for this study is to correlate svf cell counts with the age, sex, weight, bmi and anatomical area of liposuction.

Eligibility criteria:
inclusion criteria: * patients who already opted for liposuction * patients who consents to donate the lipoaspirate after liposuction * patients more than 21 years of age exclusion criteria: * patients with history of organ failure * patients with history of carcinoma * patients who are pregnant

Keywords: adrc adipocyte derived regenerative cells stem cells liposuction cytori celution lipoaspirate is obtained from patients who have opted for liposuction and consent to donate the lipoasirate for this study, which would otherwise be discarded.
bicarbonate for in-hospital cardiac arrest

Conditions: Cardiac Arrest

Summary: this is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of sodium bicarbonate during adult in-hospital cardiac arrest. there will be 22 enrolling sites in denmark. 778 adult patients with in-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. the primary outcome is return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.


Eligibility criteria:
inclusion criteria: 1. in-hospital cardiac arrest 2. age ≥ 18 years 3. received at least one dose of adrenaline during cardiopulmonary resuscitation (cpr) exclusion criteria: 1. clearly documented "do-not-resuscitate" order prior to the cardiac arrest 2. prior enrollment in the trial 3. invasive mechanical circulatory support at the time of the cardiac arrest 4. known or suspected pregnancy at the time of the cardiac arrest 5. known objection by the patient to participate in the trial 6. clinical indication for bicarbonate administration
safety and tolerability of bvs857 in subjects with insulin resistance

Conditions: Insulin Resistance

Summary: the study will assess the safety, tolerability, drug label and effect in subjects with and without insulin resistance.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects with insulin resistance * subjects with controlled hypertension and hyperlipidemia exclusion criteria: * smokers * history of drug or alcohol use * autonomic dysfunction * significant illness or cardiovascular disease * immunodeficiency disease other protocol-defined inclusion/exclusion criteria may apply

Keywords: safety bvs857 insulin resistance
clotfoam as an adjunct to hemostasis in abdominal surgery - liver bleeding is encountered

Conditions: Bleeding

Summary: phase 1 single-arm study evaluating clotfoam as an adjunct to hemostasis in abdominal surgery in which liver bleeding is encountered.

in any open surgery bleeding usually occurs. surgeons try to stop the bleeding by using his/her usual surgical practice. these include, but are not limited to: suturing (stitches), ligation (tying up) or cautery (to burn in order to stop or prevent bleeding). it is often necessary for surgeons to use an additional treatment to stop the bleeding. this may include the use of a hemostatic product (used to stop bleeding). this phase i study consists of a single arm evaluating the safety of clotfoam as an adjunct to hemostasis. clotfoam® is an investigational product-a gelatin-based hydrogel carrying a fibrin monomer-that has been designed for supportive treatment in general surgery for the improvement of hemostasis, where standard techniques are insufficient. the evaluation will be conducted in 24 patients who are scheduled to undergo elective open surgery in which liver bleeding is encountered requiring control of mild-to- moderate bleeding where standard surgical techniques are expected to be ineffective and/or impractical. all subjects who meet eligibility criteria and who provide informed consent to participate will be assigned to clotfoam topical treatment. subjects who will be screened for eligibility to participate in this study will be those who are scheduled to with undergo an elective (non-emergency) hepatic wedge resection or anatomic resection (of 1 to 5 contiguous hepatic segments or a surgical procedure in which liver bleeding is encountered such as removal of the gall bladder (open), bile duct excision wherein an appropriate target bleeding site is identified. subjects undergoing living-related liver donation are also eligible. participants will have post-operative follow ups at day 1,2,5, and 10 post-procedure, 2 weeks post procedure, and 12 weeks post-procedure. the follow up visits will consist of safety evaluations (physical exam, adverse event assessment, laboratory evaluations).

Eligibility criteria:
inclusion criteria: * subject is expected to survive 6 months from the date of screening, if female and of child-bearing potential, subject has a negative serum pregnancy test prior to surgery and agrees to not breast feed her child (if applicable) for duration of study treatment and completion of study follow-up visits, if subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits exclusion criteria: * pregnant females
cardiovascular-protective effects of herbal medicine danshen-gegen

Conditions: Hypertension

Summary: atherosclerosis (in particular stroke and heart attack) is the most important health issue in modernized society and high blood pressure is an important predisposing factor. hypertensive subjects with other chronic disease such as diabetes mellitus or impaired renal function are particularly vulnerable to these atherosclerotic complications in spite of standard antihypertensive therapies. danshen and gegen are commonly used in chinese materia medica as treatment for cardiac symptoms and atherosclerosis-related disorders. the objective of this study is to test danshen and gegen as an cardiovascular-protective adjunctive regimen to prevent high-risk hypertensive cohort from primary atherosclerosis.

danshen and gegen (d\&g) are two traditional herbal medicines used for cardiac symptoms in ancient chinese medicinal literature. recent studies suggest their therapeutic effects in blood pressure and lipid-lowering, anti-oxidation, microcirculation-promoting, foam cells-modulation and have beneficial effects on atherogenic process in coronary patients. to evaluate the potential of d\&g in primary atherosclerosis prevention in high risk hypertension. patients with high risk hypertension associated with left ventricular hypertrophy, diabetes mellitus and renal insufficiency were randomized to receive d\&g herbal capsules (2gm/day), or (1gm/day) or identical placebo capsules in double-blind and parallel fashion for 12 months on top of their anti-hypertensive treatments. flow-mediated dilation (endothelium-dependent dilation, fmd) and nitroglycerin-induced dilation (endothelium-independent dilation, ntg) of brachial artery, and carotid intima-media thickness (surrogate atherosclerosis marker, imt) were measured by high resolution b-mode ultrasound.

Eligibility criteria:
inclusion criteria: * high-risk hypertension: asymptomatic hypertensive (pretreatment bp\>160/95mmhg) subjects, currently blood pressure under control (bp\<140/90mmhg), * aged 35-70 years * with either (i)left ventricular hypertrophy on ecg or echocardiographic criteria, (ii) diabetes mellitus, or (iii) mild renal impairment (plasma creatinine 120-250µmol/l) exclusion criteria: * known intolerance to d\&g due to adverse effect, patients with bleeding, disorders or on long-term anticoagulation.
functionality and neurocognition in patients with bipolar disorder after a physical-exercise program (finext-bd study)

Conditions: Bipolar Disorder

Summary: this is a study that aimed to deep in the physiopathology of bd and see how, through potential modifiable areas of the patients' lifestyle, the prognosis and evolution of the pathology can be improved.

randomized interventionist study (ratio 1:1) with two parallel branches, blinded by evaluators (the evaluator does not know the branch of treatment to which the patient belongs )to evaluate if an individualized moderate-to-vigorous physical exercise intensity program as adjuvant therapy to standard drug therapy will improve the functional and neuropsychological status of patients with bipolar disorder. the effectiveness of the intervention will be assessed by an extensive battery of clinical tests, physical parameters (e.g. brain structure changes measured by optical coherence tomography) and biological parameters (inflammation, oxidative stress and neurotrophic factors). the total sample of the study will be 80 patients and a sample of 40 controls (individuals without psychiatric pathology). the sample of patients will be divided into 40 patients in each group at random. in the intervention group, a supervised physical exercise treatment by high-intensity interval training (hit) will be performed during 16 weeks with 2 sessions per week (32 sessions in total).three visits will be made in both groups: baseline visit at the beginning of the study, at 4 months (at the end of the intervention) and at 10 months (6 months after the end of the intervention)

Eligibility criteria:
inclusion criteria: * patients diagnosed with bipolar disorder type i according to the criteria of the dsm-5 manual, diagnosis made by structured interview scid-p. * the study includes patients with first episode and multiple episodes. at the beginning of the study they must be in euthymia, that is, there will be no current diagnosis of manic, hypomanic or depressive episode. relapses during follow-up and the presence of subindromial symptoms at any time will not result in exclusion from the study. * patients may be treated with any treatment according to clinical guidelines. * age: 18-65 years * speak spanish correctly * informed consent for the study of the patient exclusion criteria: * presence of organic diseases of the central nervous system (cns) or history of head trauma with loss of consciousness * intellectual disability. * acute inflammatory disease * treatment with anti-inflammatory drugs during the week prior to sample taking * pervasive developmental disorders. * pregnancy and lactation
laplace-timi 57: low-density lipoprotein cholesterol (ldl-c) assessment with pcsk9 monoclonal antibody inhibition combined with statin therapy

Conditions: Hyperlipidemia

Summary: to evaluate the effect of 12 weeks of subcutaneous (sc) evolocumab (amg 145) administered every 2 weeks (q2w) or every 4 weeks (q4w), compared with placebo, on percent change from baseline in ldl-c when used in addition to a statin in adults with hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 to ≤ 80 years of age * on an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks * fasting ldl-c ≥ 85 mg/dl * fasting triglycerides ≤ 400 mg/dl exclusion criteria: * myocardial infarction, unstable angina, percutaneous coronary intervention (pci), coronary artery bypass graft (cabg) or stroke within 3 months prior to randomization * type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (glycosyated hemoglobin (hba1c) \> 8.5%) * uncontrolled hypertension * new york heart association (nyha) iii or iv heart failure, or known left ventricular ejection fraction \< 30% * uncontrolled cardiac arrhythmia

Keywords: hypercholesterolemia proprotein convertase subtilisin/kexin type 9 (pcsk9)
providing healthy food access and physical activity opportunities at boy scouts of america summer camp

Conditions: Childhood Obesity

Summary: to measure impact of improved healthy food access and physical activity opportunities at summer boy scout camp, a four-week intervention to address nutrition and physical activity with youth (n=911) and adults (n=247) was conducted at bashore scout reservation in jonestown, pennsylvania between june and july of 2016. intervention components included dining hall menu modifications, healthy messaging, introduction of nutritious snacks available for purchase, and a physical activity challenge. menu modifications resulted in improved satisfaction scores related to portion sizes (+28%) and variety (+14%), decreased plate waste, and consistent food costs. introduction of nutritious snacks at trading post resulted in increased satisfaction (+13%) and increased sales per person (+20%). physical activity increased (+22%) as a result of a step competition between troops. small changes towards a healthier camp were widely accepted and successful, indicating potential for translation to other camps within the organization.


Eligibility criteria:
inclusion criteria: 1. age: ≥18 years 2. sex: male or female 3. fluent in written and spoken english 4. boy scout staff, troop leader or parent of boy scout camper exclusion criteria: 1. not fluent in written and spoken english 2. non boy scout stafftroop leader or not a parent of a boy scout camper 3. decisional impairment

Keywords: adolescent nutrition physical activity
effects of carvedilol on health outcomes in heart failure

Conditions: Heart Failure, Congestive

Summary: the purpose of our study was to determine if a strategy of starting a heart medication (beta-blocker) before patients leave the hospital and then being seen by a nurse manager would reduce subsequent hospitalizations compared to usual care. hypothesis: a nurse-directed heart failure management program with inpatient initiation of beta blockers will improve health outcomes in a vulnerable, predominantly hispanic and african american population.

heart failure is a leading cause of death and hospitalization in the us. designing practical approaches to improving heart failure care is therefore a national health priority. one retrospective study suggested that patients taking beta-blockers while hospitalized for heart failure had a lower risk of rehospitalization at 6-months. one prospective study suggested that starting beta blockers among hospitalized heart failure patients is safe and improves compliance. however, improved outcomes of this approach have not been prospectively demonstrated. comparison: inpatient initiation of the beta-blocker carvedilol coupled with outpatient follow-up with a nurse manager was compared to usual care by internists and cardiologists.

Eligibility criteria:
inclusion criteria: * primary hospitalization with heart failure and lvef \< 40% * patient informed consent has been obtained * absence of pulmonary congestion * age \> 18 years exclusion criteria: * end-stage renal or hepatic disease * acute myocardial infarction as primary diagnosis during index hospitalization * life-expectancy \< 6-months * contraindication to beta blocker use * current beta-blocker therapy * planned bypass or valve surgery during index hospitalization

Keywords: beta-adrenergic blockers disease management