Kornimate/medical-research-clean huggingface dataset:
artificial intelligence in subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Summary: the overall aim of this study is to, with the help of computer/data scientist and machine learning processes, analyse collected heart rate variability data in order to evaluate whether specific patterns could be found in patients developing delayed cerebral ischemia after subarachnoid hemorrhage.

patients with aneurysmal subarachnoid haemorrhage (asah), develop delayed cerebral ischemia (dci) in about 30% of the cases. dci is associated with increased mortality, persistent neurological deficit as well as impaired quality of life. it would benefit both patients and society to decrease these neurological injuries. one clinical problem is that the diagnosis of cerebral ischemia in sah patients often is delayed due to limitations in monitoring abilities. when detected, the neurological damage often turns out to be irreversible. several studies have used univariate and multivariate logistic regression analysis to identify risk factors for the development of delayed cerebral ischemia (dci) in patients with subarachnoid haemorrhage. however, these studies are based on data collected about the patients (e.g. age, gender), and the precision of these statistical models has generally been found to be low. recently, machine learning algorithms for the prediction of dci using a combination of clinical and image data have also been evaluated . however, prediction of dci does not prevent dci, to prevent dci a monitoring system needs to be developed that can warn physicians of imminent risk of cerebral ischemia, making it possible to intervene and prevent cerebral ischemia. variations in the autonomous nervous system, such as changes in the balance between the sympathetic and the parasympathetic nervous systems, can be detected by using heart rate variability (hrv) monitoring. hrv has been reported as a predictor of poor outcome after traumatic brain injury and stroke, including subarachnoid haemorrhage. however, hrv monitoring for detection of incipient cerebral ischemia has not been thoroughly evaluated. in a study of patients with asah, we collected hrv continuously in up to 10 days after admission, but just a small part of the hrv data was analysed off-line. fifteen of 55 patients developed dci during the acute phase, and the off-line analyse of hrv showed that the low/high-frequency ratio increased more in patients that developed dci (ref). this led us to try to analyse all of the collected hrv with the help of machine learning processes, and a collaboration with computer/data scientists was initiated. the overall aim of this study is to, with the help of computer/data scientist and machine learning processes, analyse collected hrv data in order to evaluate whether specific patterns could be found in patients developing dci during the acute phase after subarachnoid hemorrhage.

Eligibility criteria:
inclusion criteria: * adult patients * aneurysmal subarachnoid hemorrhage * admitted to neurointensive care unit at sahlgrenska university hospital, gothenburg, sweden exclusion criteria: * cardiac arrythmias * use of pacemaker
comprehensive management of diabetic patients with renal impairment : impact on blood pressure and glycemic control

Conditions: Diabetic Nephropathies

Summary: diabetes is the leading cause of end-stage renal disease in developed countries. hypertension and metabolic control are known to affect the progression of renal deficiency and patient's outcome. our project aims at implementing a multidisciplinary and systematic approach of diabetic patients with renal deficiency, and at evaluating the impact of metabolic and blood pressure targets as recommended by current guidelines.

complications of diabetes are influenced by the quality of blood pressure control and of metabolic control. several prospective studies have shown a positive effect of the implementation of such control, however metabolic and blood pressure targets are not achieved for about 30% of diabetic uremic patients. our project aims at evaluating a comprehensive management approach of diabetic patients affected by renal insufficiency, defined by glomerular filtration rate (grf) \<60 ml/min/1,73 m², through an alternate and complementary follow-up by the nephrologist and the diabetologist. during a first period (one year), patients are managed as "usually". after this period, the patients will start the multidisciplinary health care during at least two years. they will be followed-up by the diabetologist every 4 months. according to his gfr measured by renal clearance of cr-edta, the patient will be followed-up by the nephrologist every year if the gfr is between 60 and 40 ml/min, every 4 months if the gfr is between 40 and 20 ml/min, and every 1 or 2 months if the gfr is under 20 ml/min. gfr will be re-evaluated every year (cr-edta or cockcroft-gault formula) and so medical examination frequency. guidelines will be applied regarding blood pressure control (objective: \ 1g/24h, choice of drugs, implementation of the treatment...) and glycemic control (current guidelines according to the french health technology information agency, anaes). another important component of the management will be the implementation of nutritional balance and foot care. every two years, a detailed nutritional checkup will be planned by the diabetologist and a cardiologic check-up will be planned by the nephrologist during one day in the local nephrology department. a biobank will be built up after patient's consent. we will assess the impact of this intervention (guidelines application + multidisciplinary methodical and complementary follow-up) in terms of glycemic and blood pressure control. the percentage of patients who will obtain a good glycemic and blood pressure control will be analysed and compared between the two follow-up period (before/after the intervention). if validated this strategy may provide the basis of a care network focused on an optimum diabetic health care.

Eligibility criteria:
inclusion criteria: * diabetic patients affected by renal insufficiency defined by glomerular filtration rate \< 60 ml/min/1,73 m² by the cockcroft-gault formula * signed informed consent exclusion criteria: * pregnant woman * minors

Keywords: diabetes renal deficiency hypertension
emergency medicine pulmonary embolism testing multicentre study

Conditions: Pulmonary Embolism; D-dimer; Diagnosis

Summary: it is important to diagnose pulmonary embolism in a timely manner to prevent death and long-term disability. more than half a million people (4-5% of emergency department patients) are tested for pulmonary embolism, although the positive rate is low. imaging for pe testing exposes patients to radiation, is expensive, adds time to the emergency visit, and can lead to a false positive diagnoses. existing protocols aimed at reducing unnecessary pulmonary embolism imaging are complex and seldom used by emergency physicians. too many patients undergo unnecessary pulmonary embolism imaging. a new tool (called adjust-unlikely) could safely reduce pulmonary embolism imaging in canada. a research group composed of researchers, emergency physicians, and patients developed the adjust-unlikely clinical decision rule: a rule which has been customized for emergency physicians and emergency patients. adjust-unlikely is highly sensitive at the bedside, meaning there are very few false negative results. the study aim is to prospectively validate adjust-unlikely pulmonary embolism testing in emergency patients with suspected pulmonary embolism.


Eligibility criteria:
inclusion criteria: * emergency department patient who is tested by an emergency physician for pe exclusion criteria: * patient is \< 18 years of age * no documentation of whether pe is the most likely diagnosis * d-dimer is not tested or else not resulted during the emergency visit * the d-dimer level is known before documentation of whether pe is the most likely diagnosis * the d-dimer is ordered prior to the physician assessing the patient * the patient has previously registered that they opt out of all research at the participating site * the patient leaves against medical advice * the patient has had pe or deep vein thrombosis imaging (ct pulmonary angiogram, ventilation-perfusion scan or lower limb ultrasound) within prior 30 days * there is a new (non-pe) indication for anticoagulation * the patient was initiated on treatment for presumed pe prior to pe testing * the patient has previously been enrolled into the study * the patient has a prior history of lower extremity deep vein thrombosis without availability of a baseline ultrasound scan * the patient was transferred from another hospital organization * the patient does not reside in ontario * the patient has no valid ontario health insurance plan card

Keywords: d-dimer pulmonary embolism adjust-unlikely diagnostic emergency medicine
a study for tecfidera (dimethyl fumarate) capsules in korean participants with relapsing-remitting multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-remitting

Summary: the primary purpose of this study is to evaluate the overall safety and efficacy of tecfidera (dimethyl fumarate) as an oral treatment for korean participants with relapsing-remitting multiple sclerosis (ms) under routine clinical practice.


Eligibility criteria:
inclusion criteria: 1. the decision by the treating physician to prescribe tecfidera is made before participating in the post marketing surveillance (pms) 2. a participant data release consent form is signed and dated by the participant and/or legal representative 3. a korean participant is diagnosed as relapsing-remitting ms per approved korean label exclusion criteria: 1. participants with hypersensitivity to active ingredient or any of the excipients of tecfidera according to the approved korean label 2. participants with unresolved serious infection 3. participants who are participating in another study

Keywords: ms0008 dimethyl fumarate multiple sclerosis tecfidera korean participants
safety and biodistribution of technetium tc 99m ec20 in normal volunteers and ovarian cancer patients

Conditions: Ovarian Cancer; Healthy Volunteers

Summary: open-label, single-center, single-treatment group, baseline-controlled (for safety) study of the safety and biodistribution of technetium tc 99m ec20 in four normal subjects and four subjects with known or suspected ovarian cancer.

this was a single-center, open-label evaluation of a single injection of tc 99m ec20 containing 0.1 mg ec20 labeled with 15 - 20 mci of technetium-99m in normal volunteers and patients with known or suspected ovarian cancer. two normal volunteers and two patients also were to receive an injection of 0.25 - 2.0 mg folic acid 1 to 2 minutes prior to the injection of tc 99m ec20. serial blood samples and urine were collected during the 24-hour period following each injection for pharmacokinetic evaluation. serial whole body images were acquired during the 24-hour postdose period for dosimetry evaluations. safety was monitored through predose and postdose physical examinations, electrocardiograms (ecgs), vital signs and clinical laboratory evaluations. adverse events were monitored from the time of signing of informed consent to 24 hours postdose.

Eligibility criteria:
inclusion criteria: * all subjects were to be females 18 years of age or older who met the following criteria: 1. the four normal subjects were to be normal, as established by medical history, physical examination, and laboratory data, including cbc, serum chemistry, and urinalysis. 2. the two subjects with obvious advanced stage ovarian cancer were to have either histopathologically proven stage 3 or 4 disease or clinically obvious disease defined by 2 of the following 3 conditions: (1) pelvic mass (2) omental "caking", or (3) ascites. 3. subjects were to have newly diagnosed, treatment refractory, or recurrent disease. subjects were to be treatment naïve or at least 2 months since last non-surgical treatment. subjects were to have normal kidney and liver function. 4. the two subjects with suspected ovarian cancer were to have a known mass. subjects were to have normal kidney and liver function. 5. subjects were to provide informed consent prior to enrollment. exclusion criteria: * the following subjects were to be excluded: 1. subject was pregnant or breast-feeding. 2. subject was simultaneously participating in another investigative drug or device study, or had completed follow-up phase of any previous study within 30 days prior to enrollment in this study. 3. subject had a known history of chronic abuse of drugs or alcohol or had tested positive in the pre-study urine drug abuse screen. 4. subject was currently taking folic acid supplements and could not stop taking the supplements for a period of 3 days (2 days prior to the study and one day after last imaging procedure). 5. subject had physical condition that was unsuitable for radionuclide imaging. 6. subject had been administered another radiopharmaceutical that would interfere with the assessment of the biodistribution of technetium tc 99m ec20.

Keywords: ovarian cancer
reducing dexamethasone around docetaxel infusion

Conditions: Breast Cancer; Prostate Cancer

Summary: the manufacturer recommends two different regimens of prophylactic dexamethasone to prevent hypersensitivity and fluid retention reactions caused by docetaxel: a 3-day regime of dexamethasone 8mg twice a day starting the day before chemotherapy for breast cancer and for prostate cancer 3 times 8mg dexamethasone on the day of docetaxel infusion, given the concurrent use of prednisone 2dd5mg. there is little evidence that supports this high dose regimen used nowadays. there is need to re-evaluate this high dosage of dexamethasone for three main reasons. first, dexamethasone can give side effects such as manifestation of latent diabetes mellitus, immunosuppression, personality changes, irritability, euphoria, or mania and mood swings. second, dexamethasone is an immune suppressor, which might inhibit chemotherapy-induced apoptosis and compromise the efficacy of chemotherapeutic agents. third, dexamethasone is a cyp3a4 inducer, which might increase docetaxel clearance. this study aims to evaluate the feasibility of reducing prophylactic of dexamethasone around docetaxel infusion.


Eligibility criteria:
inclusion criteria: * patients with early breast cancer, or advanced breast cancer or prostate cancer patients receiving docetaxel (minimal 3 cycles monotherapy or in the regimen 4xac \> 4xdocetaxel or 3xfec\>3xdocetaxel or 6xtac) * age ≥18 years * who performance status 0-2 * adequate bone marrow function: white blood cells (wbcs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l * adequate liver function: bilirubin ≤1.5 x upper limit of normal (unl) range, alat and/or asat ≤2.5 x unl (\<5 x unl in case of liver metastases), alkaline phosphatase ≤5 x unl * adequate renal function: the calculated creatinine clearance should be ≥50 ml/min * survival expectation must be \> 3 months * written informed consent according to the local ethics committee requirements exclusion criteria: * known hypersensitivity for docetaxel, paclitaxel or other chemotherapeutic agent or products containing polysorbate 80 or an earlier experience of anaphylaxis for food, insect bites, medication or another foreign substance. * existence of edema of the limbs or trunk or elsewhere localized. * active second malignancy * diabetes mellitus * serious other diseases such as recent myocardial infarction (last 6 months), clinical signs of cardiac failure or clinically significant arrhythmias * female patients who are pregnant or breast-feeding * medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
early detection of disability and health promotion for community-dwelling elderly

Conditions: Elderly; Sarcopenia

Summary: this study evaluates the effects of exercise intervention on muscle strength and walking speed for the community-dwelling elderly. half of the participants will receive exercise training, while the other half will maintain their usual activities of daily living.

physical inactivity can result in physical frailty and sarcopenia. physical frailty and sarcopenia are two common and mostly overlapping geriatric conditions, which may cause negative consequences of aging, such as disability, hospitalization and mortality. regular physical activity has been suggested to maintain or improve functional capacity and body composition, as well as delay aging process. nevertheless, inactivity prevalence still significantly increases among older adults, especially those with a disability. one of the probable reasons is that the use of physical activities or exercise interventions is not tailored to the needs and capabilities of the elderly.

Eligibility criteria:
inclusion criteria: * age greater than 50 years * able to follow simple instructions * willing to participate and sign consent form exclusion criteria: * unstable angina or epilepsy * severe visual deficits * cognitive dysfunction * other musculoskeletal conditions that will limit mobility

Keywords: early detection health promotion community-dwelling elderly
the effect of local anesthetic injection depth on procedural pain and discomfort during fluoroscopically guided lumbar transforaminal epidural injections

Conditions: Lumbar Radiculopathy Due to Spinal Nerve Compression

Summary: lumbar transforaminal epidural injection is helpful for the treatment of lumbosacral radicular pain. but needle handling during the procedure may cause pain and discomfort to the patient. at the local skin anesthesia step, local anesthetics injection to the muscle layer along the needle pathway as well as the subcutaneous layer may reduce the procedural pain. in addition, it can reduce the injection site pain that may occur after the procedure.

1. a planned fluoroscopically guided lumbar transforaminal epidural injection should be performed after receiving the informed consent of the patient. 2. this study is single-blind because it is not possible to blind the practitioner performing the injection. 3. subjects were randomly assigned to the subcutaneous anesthesia group (group a) and the muscle anesthesia group (group b) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers. 4. after the procedure, a resident who does not know of this study records the patient's pain and discomfort. and on follow-up visits, post injection site pain is checked. 5. because of the large difference between the skilled and unskilled patients, the procedure in this study is performed by only one skilled practitioner

Eligibility criteria:
inclusion criteria: 1. magnetic resonance imaging (mri) and clinical manifestations of adult men and women over 20 years of age are eligible for radiculopathy due to back nerve root compression and subject to fluoroscopically guided lumbar transforaminal epidural injection at the suspected spinal nerveroots level. exclusion criteria: 1. blood clotting disorder 2. infection around the site 3. contrast agent allergy 4. uncontrolled cardiovascular, cerebrovascular, kidney disease 5. past history of spinal surgery (ex, spinal fusion) 6. if can not block due to non-cooperation with subjects (ex, if you can not take the stomach) 7. patients taking narcotic analgesics

Keywords: epidural steroid injection procedural pain local anesthetic injection
clinical investigation of the modified rayner monofocal aspheric 600c (with axis marks) intraocular lens

Conditions: Cataract

Summary: this will be a prospective, open-label, 125 subject (maximum), two-year multicentre investigation to assess the safety, effectiveness and rotational stability of the modified 600c (axis marks) intraocular lens (iol) in subjects undergoing cataract extraction.


Eligibility criteria:
inclusion criteria: * male or female aged ≥21 years of age. * cataract for which phacoemulsification extraction and posterior iol implantation has been planned for the operative eye. * best corrected distance visual acuity (bcdva) projected to be better than 20/30 (+0.18 logmar) in the operative eye after cataract removal and iol implantation. * calculated iol power requirement within the range +8.0 to +34.0d * if present, subject must have corneal astigmatism of \<1.50 d in the operative eye. * expected dilated pupil size ≥ 5.0 mm in diameter to visualise the axis markings * subject must provide written informed consent. * subject must be able to return for scheduled follow-up examinations for 24 months after surgery. exclusion criteria: * history of ocular trauma or prior ocular surgery in the operative eye. * microphthalmia * corneal decompensation or endothelial insufficiency * pseudo exfoliation * pars planitis * subjects with diagnosed degenerative visual disorders in the operative eye (e.g.,macular degeneration or other retinal disorders) that are predicted to cause future visual acuity losses to a level of 20/30 (+0.18 logmar) or worse. * inability to achieve secure placement in the designated location e.g. absence of a secure peripheral anterior capsule, zonule laxity or dehiscence; posterior synechiae to the capsular bag * active ocular disease in the operative eye, e.g., clinically significant dystrophy, chronic severe uveitis, proliferative diabetic retinopathy, or chronic glaucoma. * concurrent participation in another drug or device investigation. * patients who are expected to require retinal laser treatment. * females who are pregnant, nursing or plan to become pregnant during the study.