Kornimate/medical-research-clean huggingface dataset:
the enriched environment as an integrated tool in the ward setting

Conditions: Stroke; Stroke, Acute

Summary: the goal of this longitudinal interventional study is to integrate the enriched environment (ee) in the context of the neurology clinic ward of the general hospital - university of padua, by verifying its effectiveness and impact on psychological well-being, functional recovery, activity level, and quality of life in people with stroke.

the ee will be integrated within the shared areas of the neurology ward and in inpatient rooms, providing materials and aids to encourage physical, cognitive and social activity. the study will recruit for 9 months plus 6 months of follow-up. it will recruited a total of 50 people with stroke (25 for experimental and control group). after providing informed consent, participants will be evaluated on admission, at discharge, at 4 weeks (follow-up phone interview) and at 6 months (telephone interview). participants will be psuedo randomized, as the ward will be environmentally enriched during consecutive alternating time frames. the instrument used to measure the multidimensional recovery will be the stroke impact scale. specific secondary outcomes will assessed the recovery in motor, cognitive and communication function, the impact on physical activity, mood, the type of activity of participants exposed to ee and the impact on the ward organization.

Eligibility criteria:
inclusion criteria: * ischaemic or haemorrhagic stroke, in any territory, occurring at least 24 hours before enrollment; * participant consent to participate in the study; * mecial stabilisation. exclusion criteria: * uncooperative participant, as assessed by themontreal cognitive assessment scale \< 15 * medically not stabtability and/or reduced level of consciousness and/or psychomotor agitation; * lack of trunk control (score \<12 in item 3 of the trunk control test: balance in sitting position) such that it is impossible to maintain a sitting position or a safe posture in a wheelchair; * speech evaluation confirming comprehension aphasia hampering understanding of informed consent.

Keywords: enriched environment in-patients setting
incidence and characteristics of postoperative cognitive dysfunction in elderly quebec francophone patients

Conditions: Delirium; Cognitive Impairment; Cognitive Decline; Cognitive Change; Postoperative Cognitive Dysfunction; Postoperative Delirium

Summary: the purpose of this study is to determine what percentage of patients have cognitive problems (for example, memory or concentration difficulties) after surgery and anesthesia, what the characteristics of these problems are, and whether they persist over time. in particular, the investigators want to study this in the french-speaking quebec population with cognitive evaluation tools adapted for this population.

multiple experimental and observational studies have established that a non-negligible percentage of individuals undergoing surgery and anesthesia will experience a postoperative decline in mental abilities. these cognitive changes can range from postoperative delirium to more subtle and longer lasting (weeks to months) impairments; these latter changes are often referred to in the literature as postoperative cognitive dysfunction (pocd). while the precise causes of pocd remain nebulous, a clear epidemiological risk factor is advanced age - a demographic group that accounts for an increasing percentage of elective surgeries in north america. several rcts have attempted to link specific aspects of anesthesia, such as depth of anesthesia, regional vs general anesthesia, hemodynamic parameters, specific anesthetic agents, etc., to the risk of developing pocd in both the elderly and general populations. results have often been conflicting and, based on current evidence, it is difficult to identify any specific anesthetic strategy that clearly reduces the risk of pocd. the present study aims to establish the incidence and neuropsychological characteristics of pocd in the investigator's local patient population as well as to establish the feasibility of pre- and postoperative cognitive testing with assessment tools adapted to and validated for quebec francophones in order to lay the groundwork for future studies by the research group of interventions targeting specific anesthetic techniques and monitoring modalities.

Eligibility criteria:
inclusion criteria: * 70 years of age or older * undergoing elective abdominal, gynecological, or urological surgery requiring post-operative hospitalization and with an expected anesthesia time of 60 minutes or more * seen in pre-operative clinic of maisonneuve-rosemont hospital exclusion criteria: * known dementia or other cognitive impairment * psychiatric disease * significant hearing or vision impairment * inability to communicate in french * allergy or other contraindication to medications in standardized anesthesia protocol

Keywords: anesthesia noncardiac surgery major surgery pocd
radiation therapy during and after lumpectomy in treating women with stage i or stage ii breast cancer

Conditions: Breast Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to kill tumor cells. giving radiation therapy during and after surgery may kill any tumor cells that remain after surgery. purpose: this phase ii trial is studying the side effects of giving radiation therapy during and after lumpectomy and to see how well it works in treating women with stage i or stage ii breast cancer.

objectives: * to determine the feasibility and acute tolerability of intraoperative electron radiotherapy (ioert) and external-beam radiotherapy (ebrt) after lumpectomy in women with stage i or ii breast cancer treated with breast conservation therapy. * to determine the local tumor control and distant tumor control rates in these patients. * to determine the long-term side effects and cosmetic outcome of ioert to the tumor bed and ebrt after lumpectomy in these patients. outline: patients undergo standard lumpectomy. patients with negative lymph nodes undergo intraoperative electron radiotherapy to the tumor bed. beginning 2-8 weeks after surgery, patients undergo whole breast external beam radiotherapy once daily for 24-27 fractions. after completion of study treatment, patients are followed periodically for up to 8 years.

Eligibility criteria:
disease characteristics: * histologically confirmed primary invasive breast carcinoma, meeting the following criteria: * stage i or ii disease (t1-t2, n0, m0) * tumor pathologically determined to be ≤ 5 cm in diameter * single, discrete, well-defined primary tumor * no multicentric disease and/or diffuse malignant appearing microcalcifications * any microcalcifications must be focal * specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications * no axillary lymph node involvement * axillary lymph node status can be determined by level i and ii lymph node dissection or sentinel lymph node sampling * must have pathologically negative surgical margins * no evidence of metastatic breast cancer * hormone receptor status not specified patient characteristics: * ecog performance status 0-2 * menopausal status not specified * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy prior concurrent therapy: * no prior irradiation to the area of planned radiation field * concurrent hormone therapy allowed

Keywords: stage i breast cancer stage ii breast cancer
orbital artery doppler ultrasound in brain death

Conditions: Brain Death

Summary: brain death is the irreversible loss of all activity in the brain, brainstem, and cerebellum, the part of the central nervous system that remains inside the skull. the clinical diagnosis of brain death should be supported by ancillary tests that provide information about cerebral blood flow or electrical activity in the brain. some of the ancillary tests that evaluate cerebral blood flow include transcranial doppler ultrasonography (tdus), computed tomography (ct) angiography (cta), and catheter-based cerebral angiography. this study hypothesized that orbital doppler ultrasonography (odus) alone is more effective than tdus in detecting intracranial blood flow in diagnosing brain death. to this end, the investigators examined the results of odus in patients diagnosed as brain dead who underwent ct angiography.


Eligibility criteria:
inclusion criteria: * suspected brain death exclusion criteria: * eye surgery, * uncontrolled diabetes mellitus, * facial trauma, * hypothermia, * hypotension (systolic pressure \< 100 mm hg) * endocrine-metabolic coma
the effects of amino acid supplement during acute inflammation.

Conditions: Febrile Illness Acute; Inflammation; Metabolic Diseases

Summary: the purpose of the study is to investigate the metabolic effects during acute inflammation with and without the nutritional supplement of amino acids. e. coli endotoxin (lps, lipopolysaccharide) is used to initiate an inflammatory response. the study is an interventional randomized placebo study including 8 healthy male subjects. each subject participates 3 times (different days) and are given one of following interventions: * placebo (nacl) * endotoxin, us standard reference e.coli + placebo (nacl) * endotoxin, us standard reference e.coli + amino acids (intravenously) it is our hypothesis that the nutritional intervention during acute inflammation plays an important role in lipid and protein metabolism.


Eligibility criteria:
inclusion criteria: * male gender * 20\<bmi\<30 * age \> 25 years old * written consent before starting the study exclusion criteria: * allergy for soya products ore egg * diabetes * epilepsy * infection * immune defects * heart disease * dysregulated hypertension * participating in other trials using radioactive tracers or x-rays the last year.
impact of peripheral vascular stiffness assessment on risk prediction in patients with myocardial infarction

Conditions: Myocardial Infarction; Vascular Stiffness; Heart Failure

Summary: risk assessment after myocardial infarction is critical in daily practice and evolution toward heart failure especially diastolic heart failure remains a key issue. all consecutive patients with myocardial infarction (either stemi or nstemi but excluding type 2 mi) presenting at university hospital of lille within 48 hours after symptom onset will be recruited in the rigid-mi registry. the rigid-mi study proposes to deeply evaluate at 1 month after mi: peripheral vascular disease, vascular stiffness, ventriculo-arterial coupling and other usual risk factors. the main objective is to identify clinical, biological and imaging parameters associated with poor prognosis, especially evolution toward diastolic heart failure, recurrence of mi, and bleeding.


Eligibility criteria:
inclusion criteria: * signed informed consent * affiliated to national health insurance (french social security number) * presenting with mi within 48 hours of symptom onset exclusion criteria: * patient under curatorship * type 2 mi * presenting with mi after 48 hours of symptom onset * pregnancy or lactating * refuse to participate * no national health insurance (no french social security number)

Keywords: prognosis vascular stiffness heart failure myocardial infarction
dietary fat and endothelial function in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to evaluate the effects of the add-on of extra vergin olive oil or butter to a high glycemic index meal on endothelial function in subjects with type 1 diabetes and healthy subjects.

impaired endothelial function is an early manifestation of atherosclerosis and predictor of incident cardiovascular events. diabetes affects arterial vasodilation by reducing the bioavailability of no and more in general affecting the balance between the atheroprotective and atherothrombotic properties of the endothelium. a consistent number of studies has so far documented that mediterranean-style diet associates with reduced risk of cardiovascular diseases and diabetes. intake of extra virgin olive oil (evoo), that is a common but not necessary ingredient of the mediterranean diet, seems to further enhance the beneficial cardiovascular effect and reduce the incidence of diabetes. we have designed the present study to test whether evoo supplementation acutely influences endothelial function in t1dm. evoo supplementation wil be compared to butter supplementation in the context of a high glycemic index (gi) meal that is known to increase pp glycemic burden.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, * diagnosis of type 1 diabetes since at least 1 year, * hba1c \<8.5% (69 mmol/mol), * stable insulin therapy for at least 3 months before the enrolment into the study exclusion criteria: * pregnancy, celiac disease, history of cardiovascular diseases, hypertension, hyperlipidemia, retinopathy, nephropathy, neuropathy, and ongoing treatment with vasoactive drugs.

Keywords: endothelial function fmd gastric emptying post prandial glycemia dietary fat evoo butter
t138067 versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients

Conditions: Hepatocellular Carcinoma

Summary: this is an international, multicenter, randomized study of intravenous t138067 versus intravenous doxorubicin in hepatocellular carcinoma (liver cancer). patients can not have been treated before with chemotherapy and surgery is not recommended for their cancer. a total of 750 subjects will be enrolled in this study.


Eligibility criteria:
key inclusion criteria include: * pathologic diagnosis of unresectable hcc * chemotherapy-naïve for hcc * child-pugh class a or b liver disease * measurable disease (i.e., at least one lesion that is at least 20 mm in one dimension) on computerized tomography (ct) scan or magnetic resonance imaging (mri) or at least one lesion that is at least 10 mm on spiral ct scan * karnofsky performance status of ≥ 70% * life expectancy of ≥ 12 weeks * adequate hematologic function (i.e., absolute neutrophil count \[anc\] of ≥ 1500 cells/mm3, platelet count of ≥ 80,000 cells/mm3, hemoglobin of ≥ 8.5 g/dl) * total bilirubin of ≤ 1.5 upper limit of normal (uln) * aspartate transaminase (ast) and alanine transaminase (alt) ≤ 5 uln * serum creatinine of ≤ 2 x uln key exclusion criteria include: * severe, concurrent disease that would make the subject inappropriate for enrollment * subjects who have received prior intravenous or intra-arterial chemotherapy, chemoembolization, intratumoral ethanol injection, cryosurgery, radiofrequency ablation, or embolization for their hcc. (note: prior surgical resection, immunotherapy, hormonal therapy, radiotherapy, and/or orthotopic liver transplantation are allowed) * history of other cancer within the past 5 years other than adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix * new york heart association (nyha) class iii or iv heart disease or a left ventricular ejection fraction of \<50% or acute anginal symptoms * females who are pregnant or breast-feeding * received any investigational agent within 4 weeks of enrollment * history of central nervous system metastases or carcinomatous meningitis * clinically apparent ascites * major surgery within 4 weeks of study enrollment

Keywords: liver cancer
surgery for traumatic optic neuropathy

Conditions: Traumatic Optic Neuropathy

Summary: the pathophysiology of traumatic optic neuropathy (ton) include a primary and secondary mechanism of injury. at present, no studies validate a particular approach to the management of ton. there are three management lines for these patients that include 1)observation only;2)medical treatment with high or megadoses of methylprednisolone; and 3)surgical intervention. studies have shown that forces applied to the frontal bone and malar eminences are transferred and concentrated in the area near the optic canal. the tight adherence of the optic nerve's dural sheath to the periosteum within the optic canal is also thought to contribute to this segment of the nerve being extremely susceptible to the deformative stresses of the skull bones. in this study, investigators aim to make a randomized controlled trial to certify the efficiency of optic nerve canal decompression for ton patients.

surgical intervention's efficiency and outcome for ton patients will be clearly present after this randomized controlled trial study.

Eligibility criteria:
inclusion criteria: * patients with the history of traumatic brain injury or craniofacial trauma * optic nerve compression（intraneural edema, nerve sheath hematoma or canal fracture with impingement) * amplitude and latency abnormal or ratio of amplitude of abnormal to normal side. exclusion criteria: * glasgow coma scale，score\<8 * patients with good visual acuity and visual evoked potential amplitude ratio more than 50% * other contraindications for surgery
to evaluate the safety, tolerability and analgesic efficacy of saf312 in postoperative dental pain patients

Conditions: Postoperative Pain

Summary: the study will assess the analgesic efficacy and safety and tolerability of a single oral dose of saf312 in postoperative dental pain patients after 3rd molar extraction.


Eligibility criteria:
inclusion criteria: * extraction of two or more impacted (partial or full) third molars. at least one of the impaction should be lower jaw. * each patient will evaluate her/his post-surgical pain intensity prior to taking trial medication. * to be eligible for this trial, post surgical pain must be moderate to severe -- subjects should be in good health otherwise as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening. * female subjects should be either postmenopausal or should have had surgical sterilization. exclusion criteria: * patients with known hypersensitivity to diclofenac, aspirin, acetaminophen or to antipyretics or with allergies manifested by attacks of asthma, urticaria or acute rhinitis following treatment with aspirin or other agents with cyclooxygenase-inhibiting activity such as nsaids. * use of antipyretic/analgesic drugs from 48 hrs pre-dose to 24 hrs postdose * presence of bleeding disorder (history of excessive bleeding after dental procedures or minor injuries) * patients with diabetes mellitus. * presence, history of, or family history of malignant hyperthermia or anesthesia-related events that may be suggestive of malignant hyperthermia. * an abnormal ecg at screening, including pr\>200 ms, qrs\>110 ms, qtcf\ 450 ms, lead ii t wave abnormalities. non-specific t wave abnormalities in leads other than lead ii are permissible if not accompanied by any other morphological abnormalities. * patients with infection e.g. dental abscess other protocol-defined inclusion/exclusion criteria may apply

Keywords: postoperative pain
application of lars ligament in bone prosthesis replacement

Conditions: Malignant Tumor

Summary: this is a single-center, prospective, real-world observational study designed to enroll all patients eligible for enrollment. basic data, treatment methods, postoperative complications and limb function were collected. the differences in postoperative complications, postoperative limb function and so on between patients who underwent lars ligament implantation and bone prosthesis replacement (ligament group) and patients who underwent bone prosthesis replacement (control group) were compared.

this is a single-center prospective real-world observational study of 100 eligible patients with bone tumors who are scheduled to undergo lars ligament implantation and/or bone prosthesis replacement in henan cancer hospital in the next 10 years. basic data, treatment methods, postoperative complications and limb function were collected. the differences in postoperative complications, postoperative limb function and so on between patients who underwent lars ligament implantation and bone prosthesis replacement (ligament group) and patients who underwent bone prosthesis replacement (control group) were compared.

Eligibility criteria:
inclusion criteria: men and women of all ages are welcome. pathologically confirmed in our hospital as a subtype of malignant tumor. he received lars ligament and bone prosthesis replacement at our hospital. exclusion criteria: not applicable.
interventions to decrease heat stress among latinx farmworkers in idaho

Conditions: Environmental Exposure

Summary: the goal of this study is to collaborate with farmworker, community organizations, and labor contractors/employers to develop workplace- and individual-level interventions, and evaluate the efficacy of those interventions in decreasing physiological and perceived heat stress among latinx farmworkers in idaho.

occupational heat exposure presents one of the clearest acute and long-term health threats to farmworkers and will continue to worsen under climate change. exposure to extreme heat can lead to heat-related illnesses (hri), a continuum of diseases that can range from mild symptoms (e.g., dizziness, fatigue, vomiting) to severe and life-threatening conditions including convulsions, coma, and even death. it is becoming increasingly urgent to identify effective strategies to prevent the health impacts of heat exposure among farmworkers as climate change increases the frequency, intensity, and duration of heat waves. the few studies that have examined this topic have identified some beneficial impacts of increasing access to cold water and shade at the workplace, however studies to date have been limited by their investigation of individual- and workplace- interventions in isolation and research teams that do not engage farmworkers and community-based organizations. further, the studies that have been conducted have taken place primarily in states with regulations that prohibit work over a specific heat index, and it is important to examine the impacts of interventions to decrease heat stress in states without these regulations, such as idaho. the aims of this study are to collaborate with farmworkers, farmworker employers, and community organizations to develop and evaluate the efficacy of multi-level interventions in mitigating physiological and perceived heat strain among latinx farmworkers in idaho. the investigators further aim to examine the efficacy of educational programs (e.g., training in identifying and preventing personal and occupational risk factors for heat stress) on knowledge, behaviors, and perceptions. leveraging our existing and well-established relationships with multiple community partners, the investigators will disseminate the research findings and promote the implementation of health-protective heat interventions to farmworkers, farmworker employers, and stakeholders across idaho and the mountain west. this study was motivated by concerns voiced by participants in a previous study of latinx farmworkers led by the current team of researchers and community organizations. here, the investigators aim to respond directly to their stated concerns regarding occupational heat exposure.

Eligibility criteria:
inclusion criteria: * identify as hispanic/latinx, currently working in an agricultural field in idaho exclusion criteria: * under age 18 years

Keywords: farmworker heat exposure