Kornimate/medical-research-clean huggingface dataset:
safety and effectiveness of vyc-12 hyaluronic acid injectable gel for treatment of superficial cutaneous depressions

Conditions: Skin Roughness

Summary: this study will evaluate the safety and effectiveness of vyc-12 hyaluronic acid (ha) injectable gel for filling fine lines, as measured by skin texture improvement, and for improvement of skin quality.


Eligibility criteria:
inclusion criteria: * participants in good general health * score of 2=moderate (coarse and uneven visual skin texture) or 3=severe (coarse visual skin texture, crosshatched fine lines) on both cheeks using the 5-point allergan skin roughness scale (asrs). exclusion criteria: * has undergone tissue augmentation with dermal fillers including ha, calcium hydroxylapatite, autologous fat, mesotherapy, or other cosmetic procedures (eg. face-lift, laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative procedures) in the face or neck within the past 12 months * has received any crosslinked ha filler in any anatomic area within the past 12 months * has undergone treatment with botulinum toxins in the face or neck within the past 6 months * has ever received semi-permanent fillers or permanent facial implants (eg. poly-l-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere in the face or neck * has facial hair that would interfere with the visualization of the face or neck * has undergone a dental procedure within the past 6 weeks * has a tendency to develop hypertrophic scarring * has a history of allergy to ha products and/or to gram-positive bacterial proteins as ha is produced by streptococcus-type bacteria * has a history of anaphylactic shock * has been previously diagnosed with streptococcal disease (eg. recurrent sore throat, acute rheumatic fever) * has current cutaneous inflammatory or infectious processes (eg. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the face or neck * is on an ongoing regimen of anticoagulation therapy (eg. warfarin) * is on an ongoing regimen of medications (eg. aspirin, ibuprofen) or other substances (eg, herbal supplements with garlic, gingko biloba, or ginseng) known to increase coagulation time within 10 days of undergoing study device injection * has begun using any over-the-counter or prescription, oral or topical, antiwrinkle products on the face or neck within the past 30 days.
prevention of venous thromboembolism in hemorrhagic stroke patients

Conditions: Hemorrhagic Stroke; Venous Thromboembolism; Deep Venous Thrombosis

Summary: patients with cerebral hemorrhage (ich) have a high risk of venous thromboembolism. intermittent pneumatic compression combined with elastic stockings have been shown to be superior to elastic stockings alone in reducing the rate of asymptomatic deep vein thrombosis after ich in a randomized trial (4.7% vs. 15.9%). graduated compression stockings alone are ineffective in preventing deep vein thrombosis in patients with ischemic or hemorrhagic stroke. less clear is the role of anticoagulation in the prevention of venous thromboembolism in patients with ich because the use of anticoagulants may cause an enlargement of the hematoma. in a multicenter, randomized trial, the investigators will assess the efficacy and safety of enoxaparin in the prevention of venous thromboembolism in patients with spontaneous intracerebral hemorrhage. enoxaparin (40 mg once daily) or standard therapy (graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization) will be given subcutaneously for not less than 10 days beginning after 72 hours from stroke onset.


Eligibility criteria:
inclusion criteria: * intracranial spontaneous hemorrhage on brain ct scan * intracranial hemorrhage during treatment with oral anticoagulants * bedridden patients (item 6 of nihss: motor leg points 3 or 4 or severe ataxia for cerebellar hemorrhage). exclusion criteria: * cerebral hemorrhage due to intracranial vascular malformation * rebleeding on ct scan after 72 hours from stroke (before randomization)

Keywords: hemorrhagic stroke venous thromboembolism prevention
achieving resilience in acute care nurses (arise).

Conditions: Stress, Psychological; Compassion Fatigue

Summary: nurses are exposed to myriad stressors, both in the workplace and in their everyday lives, which can lead to adverse personal and professional outcomes. while workplace stress cannot be eliminated, nurses can learn techniques to build resilience, mitigate stress, and decrease fatigue. organizational employee health, wellness, and assistance programs are all intentioned to provide this type of support; however, nurses often lack awareness of options and opportunities, and access can be a challenge. the purpose of the proposed study is to assess the outcomes of a multi-modal intervention and toolkit, arise, designed to enhance resilience and promote awareness of organizational resources for health, wellness, and employee assistance. we will evaluate the impact of participation in arise on resilience and other outcomes in nurses in critical care and trauma settings. as a best practice spotlight organization designated by the registered nurses association of ontario (rnao), this project will incorporate relevant recommendations from best practice guidelines (bpg) related to workplace health, safety, and well-being of the nurse; and preventing and mitigating nurse fatigue in health care.


Eligibility criteria:
inclusion criteria: * nurse in the medical-surgical and trauma-neurosurgical intensive care units (msicu and tnicu) and the medical/surgical floor (9ccn), * full-time or part-time employment status, * approval of clinical leader manager (clm), * receipt of written informed consent. exclusion crieria: * casual employment status * inability to attend intervention days

Keywords: resilience workplace stress occupational fatigue compassion fatigue peer support self-care employee assistance
effect of the consumption of a fermented milk enriched with plant sterols (france)

Conditions: Mildly Hypercholesterolemic Subjects

Summary: the purpose of this study is to investigate the effect on cholesterolemia profile of a low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in mildly hypercholesterolemic people treated or not by statins.


Eligibility criteria:
inclusion criteria: * male and female aged 18-75 years; bmi between 19 and 30 kg/m2 , ldl-cholesterol plasma level between 130 mg/dl to 190 mg/dl (bounds included) with or without statin monotherapy and without any other hypocholesterolemic treatment, accepting to follow the afssaps dietary recommendations for hypercholesterolemic patients, affiliated to a health coverage system, agreeing to a written informed consent exclusion criteria: * subject with plasma triglycerides (tg) levels\>250 mg/dl, with any cardiovascular event in the last 6 months, taking any hypocholesterolemic treatment) other than statin in monotherapy, diabetic (type i and type ii), receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, with any acute or chronic disease which could impact on results of the study

Keywords: plant sterol - cholesterol absorption - diet - dairy - ldl
pneumoperitoneum and trendelenburg position on fluid responsiveness

Conditions: Fluid Responsiveness

Summary: the increased intraabdominal pressure and intrathoracic pressure due to pneumoperitoneum negatively affect the cardiovascular system, relatively dynamic parameters may vary due to intraoperative fluid therapy.

after the general anaesthesia induction and intubation, dynamic parameters such as svv and ppv were monitored by pulse contour analysis.

Eligibility criteria:
inclusion criteria: * age\>18 years old patients * will undergo elective laparoscopic gynecological surgery * asa i-ii exclusion criteria: * obese patients (body mass index\> 30 kg.m2) * patients who had arrhythmia * patients who had cardiac insufficiency.
meta-analysis in post-marketing surveillances for sglt2 inhibitors in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to integrate the post-marketing surveillances data (specified use-results surveys on long-term treatment) of the 6 sglt2 inhibitors approved or applied in japan and to evaluate the safety and efficacy of long-term use of each under actual clinical practice conditions. in each post-marketing surveillance, 3000 patients who complete a 3 years treatment are enrolled. a total of 18000 patients are assessed in the meta-analysis.


Eligibility criteria:
patients with type 2 diabetes mellitus starting medication of sglt2 inhibitors
brush sign: radiolographic marker of cerebral infarctus prognosis

Conditions: Cerebral Infarction

Summary: today the treatment of ischemic stroke in acute phase is based on medicinal or endovascular revascularization. cerebral mri sequences help the diagnostic. this procedure uses deoxyhemoglobin as an endogenous tracer. this is also a scorer of cerebral ischemia and the increase lets visualized transcerebral veins in the suffering zone giving a brush aspect. several studies show the interest of this sign and conclude that deoxyhemoglobin presence is a predictive factor of cerebral ischemia. the aim of the study is to evaluate this brush-sign and correlate it with the prognosis retrospectively.


Eligibility criteria:
inclusion criteria: * age\>18 years old * hospitalized for cerebral infarction * mca territory * mri within 24hours * sequence of magnetic susceptibility (swan) exclusion criteria: * incomplete cerebral infarct * mri not possible
c11-sodium acetate pet/ct imaging for metastatic disease in intermediate-to-high risk prostate adenocarcinoma

Conditions: Prostate Cancer; Prostate Adenocarcinoma

Summary: positron emission tomography using carbon-11 acetate (ac-pet) may help find local or distant metastases from prostate cancer. this clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments.

objectives: * determine the role of positron emission tomography using carbon-11 acetate (ac-pet) in the initial and subsequent management of patients with prostate cancer at intermediate or high risk for recurrence after initial curative therapy. * compare the value of ac-pet in predicting recurrence of prostate cancer with that of conventional approaches (e.g., pre-operative clinical staging, prostate-specific antigen, gleason score, prostate and lymph node histology) in these patients.

Eligibility criteria:
inclusion criteria: male patients will be studied who have prostate cancer: * diagnosed with prostate adenocarcinoma * has completed conventional staging examinations, including histologic evaluation with gleason score, ct scan of the abdomen and pelvis, and whole-body bone scintigraphy candidate for curative prostatectomy or curative radiotherapy or staging lymphadenectomy prior to surgery * deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following: * gleason score \>= 7 or psa \>= 10 * gleason score \< 7 or psa \<10 ng/ml with positive surgical margins, biopsy proven or suspected regional nodal involvement or conventional imaging showing limited metastatic disease that may be amenable to directed radiotherapy * rising or non-responding psa exclusion criteria: * \< 18 years old * claustrophobic patients

Keywords: intermediate high risk radiation therapy planning surgical immunotherapy chemotherapy hormone
china diabetes cognitive dysfunction early diagnosis and intervention study (china-decode study)

Conditions: Type 2 Diabetes; Subjective Cognitive Decline; Mild Cognitive Impairment; Dementia; Cognitive Dysfunction

Summary: type 2 diabetes (t2d) and dementia are both diseases with increasing incidence and prevalence globally, leading to substantial economic burdens for families and society. notably, diabetes significantly increases the risk of cognitive dysfunction, which is classified into preclinical stage, mild cognitive impairment and dementia based on the disease severity. cognitive dysfunction is a critical contributor to disability and mortality in elderly diabetes patients. early diagnosis and intervention are crucial for delaying disease progression, enhancing treatment efficacy, and mitigating the impact of dementia. currently, research and clinical management of cognitive dysfunction in individuals with diabetes are in their infancy, characterized by limitations such as single-center studies, limited sample sizes, inconsistent diagnostic criteria, and insufficient data sharing. consequently, clinical diagnosis and treatment strategies are underdeveloped, medical staff's related knowledge is lacking, and potential therapeutic targets remain unexplored. in view of these problems and shortcomings, the population cohort study is supposed to be carried out based on accurate diagnosis and constructed the high standard information and sample bank. the study will establish the standard and quality system of t2d with cognitive dysfunction cohort study (unified standards and norms). the study will integrate the standard biological samples stratified acquisition function module (homogeneity and precision) of cognitive dysfunction in t2d, and complete the construction of biological samples bank and clinical diagnosis and treatment information database. the study will apply and develop brain structural and functional imaging technology to support precision diagnosis of cognitive dysfunction in t2d.

the neuropsychological test battery are used to access the cognitive function of subjects in the study. the laboratory examinations, brain mri and olfactory function measurements will be done in the screening period. the samples such as plasma, serum, urine and faeces et al. of the subjects will be collected in the study.

Eligibility criteria:
inclusion criteria: * age ≥45 years; * type 2 diabetes diagnosed according to the american diabetes association criteria; * willingness and ability to complete systematic neuropsychological tests; * understanding of the research procedures and methods, potential benefits and risks of the trial, and sign written informed consent. exclusion criteria: * fewer than 6 years of education; * left-handedness; * dementia; * acute metabolic complications such as diabetic ketoacidosis, hyperglycaemic hyperosmolar state and hypoglycaemic coma within the previous 3 months; * history or presence of neurological or psychiatric disorders; * presence of hypothyroidism; * history of malignancy, or severe kidney or liver dysfunction.
mediastinal microdialysis in patients with oesophageal or cardia cancer treated by resection

Conditions: Anastomotic Leakage; Esophageal Cancer

Summary: postoperative anastomotic leakage is a serious complication in patients with oesophageal or cardia cancer. early diagnosis and treatment are mandatory. the primary aim of the present study is to investigate the clinical use of mediastinal microdialysis and whether is able to detect anastomotic leakage prior to the development of clinical symptoms.

patients undergoing oesophageal or cardia resection for cancer are monitored by mediastinal microdialysis during the postoperative period. subcutaneous microdialysis serves as a control. samples are collected every 4-hour. samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient. a total of 30 patients will be included in this pilot study. the results of the mediastinal microdialyses will be compared with the clinical course in each patient. the results form the uncomplicated courses will be used to define the normal variations in mediastinal microdialysis. this will be compared to results from patients with various complications.

Eligibility criteria:
inclusion criteria: * histological verified oesophageal or cardia cancer exclusion criteria: * lack of consent, otherwise none
a feasibility study to evaluate the turris facet fusion system in lumbar spinal surgery

Conditions: Spinal Disease

Summary: this is a prospective, exploratory study to verify intra-operative handling and safety and to collect preliminary short-term safety and efficacy data of the turris® facet fuser, a small bioresorbable device for the immediate immobilization of the facet joint. patients eligible for study enrollment will present with degenerative lumbar spinal diseases involving the l4/l5 segment and requiring spinal fusion.

the turris® facet fuser is an investigational resorbable device intended to support spinal segment fusion in individuals suffering from degenerative lumbar spinal diseases. the device is directly inserted in the facet joint of the affected segment using the bonewelding® technology, a soft tissue sparing, ultrasound based insertion method which confers immediate stability to the implant. aim of this prospective, exploratory study is to verify intra-operative handling and safety of the turris® facet fusion system and to collect preliminary short-term safety and efficacy data on this innovative implant by observing the healing process over a period of one year.

Eligibility criteria:
inclusion criteria: * one-level fusion at l4/l5 with dorsal instrumentation and, if required, with monolateral decompression and/or intervertebral disc removal and implantation of an intervertebral implant exclusion criteria: patient * had previous surgical stabilizations at the involved or adjacent levels * has lytic spondylolisthesis * has degenerative spondylolisthesis grade ii or higher * has radiographic signs of significant instability and/or hypermobility of the segment (\>3mm translation, \>11° rotation difference from adjacent level) * has scoliosis \> 10° at the involved segment * has osteoporosis to a degree that spinal instrumentation would be contraindicated. * has presence of active malignancy. * has overt or active infection, either local or systemic * is less than 18 years old * is pregnant or plan a pregnancy during the study duration * has a bmi \> 35 * has a progressive neuromuscular disease * has a condition which requires postoperative medications that may interfere with bone metabolism * has a history of autoimmune disease * has a history of endocrine or metabolic disorders known to affect osteogenesis * is mentally ill or incompetent * is an alcohol and/or drug abuser * is not available for follow up visits
safety and efficacy of ledipasvir/sofosbuvir fixed dose combination administered in patients infected with chronic genotype 1 or 4 hcv for use in the peri-operative liver transplantation setting

Conditions: Hepatitis C Virus Infection

Summary: the primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (ldv/sof) fixed-dose combination (fdc) therapy at the time of liver transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis c virus (hcv) infection who are undergoing primary liver transplantation.


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent or for those individuals where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative (lar) willing and able to provide consent on behalf of the individual. * hcv rna infection with quantifiable virus at screening * must have chronic genotype 1 or 4 hcv infection for ≥ 6 months by medical history or liver biopsy * currently on the liver transplantation wait list * screening electrocardiogram (ecg) without clinically significant abnormalities. * a negative serum pregnancy test result is required for females key exclusion criteria: * any previous solid organ transplant * any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with participant's treatment, assessment, or compliance * hiv infection or a positive hepatitis b virus surface antigen result * history of malignancy (with exception of hepatocellular carcinoma within milan criteria, certain resolved skin cancers or other early cancer for which surgical resection is considered to be completely curative) * treatment with any approved or experimental medication with known anti-hcv activity within 1 month prior to screening date * prior exposure to an hcv non-structural protein (ns)5a inhibitor * patients on hemodialysis prior to or at the time of transplantation will be excluded * creatinine clearance (clcr) \< 40 ml/min at screening or \< 40 ml/min on day of transplant * participation in a clinical study with an investigational drug or biologic within 28 days prior to screening visit * receipt or planned receipt of an organ from an hcv positive donor note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: liver transplant hepatitis c gilead communicable diseases infection liver diseases rna virus infections
effects of sevoflurane and propofol on light flashed evoked pupillometry

Conditions: Blindness

Summary: this is a study to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.

the degree of a relative afferent pupillary defect (rapd) has been correlated with the severity of an eye injury and has been shown to have prognostic significance as an indicator of retinal ischemia. therefore light flashed evoked pupillometry (lfep) may serve as a useful indicator of visual function. lfep's are not known to be sensitive to anesthetics. we will measure lfep's using different anesthetic techniques to see if there are measurable differences in the latency, amplitude and constriction velocity of the pupillary reflex. prior to induction of anesthesia, pupillometer readings will be taken in the supine position in both eyes. the patient will be anesthetised using a standard induction technique. for maintenance of anesthesia a remifentanil infusion will be administered and supplemented by either propofol infusion (at 120 and 160 mcg/kg/min)or sevoflurane (at 1.5 and 2.5% end-tidal in random sequence. the patients will receive muscle relaxants as needed. pupillometry readings will be taken in both eyes after induction, after steady maintenance has been achieved and every 10 minutes for 30 minutes at each drug dose.

Eligibility criteria:
inclusion criteria: * planned orthopedic surgery on the lower extremities and positioned on the back exclusion criteria: * recent bout of conjunctivitis or pink eye * condition which inhibits the normal pupillary function of my eye

Keywords: blindness ischemic optic neuropathy
internet-delivered cbt for anxiety related to asthma

Conditions: Asthma; Anxiety

Summary: this is a randomized controlled trial to investigate efficacy of a internet-delivered cbt for anxiety related to asthma.

asthma is one of the most common chronic diseases and is often associated with anxiety. in a two prior studies (clinicaltrials.gov id: nct03158194; nct03486756) a protocol for exposure-based cognitive behaviour therapy (cbt) for anxiety related to asthma was developed, and standardised to an internet-delivered format and tested for feasibility and acceptability as an internet-cbt. the aim of the current study is to evaluate the efficacy of exposure-based internet-cbt for anxiety related to asthma compared to treatment as usual (tau). the plan is to include 90 participants consecutively during 2020.

Eligibility criteria:
inclusion criteria: * asthma diagnosed by a physician * worry about asthma or limitations in daily life due to asthma at exclusion criteria: * a serious psychiatric condition; e.g., suicidality, psychosis or severe substance addiction * chronic obstructive pulmonary disease (copd) or other chronic airway disorders other than asthma