Kornimate/medical-research-clean huggingface dataset:
glomerular filtration rate-estimating equations during use of direct oral anticoagulants in elderly patients

Conditions: Atrial Fibrillation; Elderly Patients; Chronic Kidney Disease

Summary: atrial fibrillation in the elderly is a complex condition due to the high number of frequently associated comorbidities such kidney disease. direct oral anticoagulants (dabigatran, rivaroxaban and apixaban) are indicated for preventing thromboembolic events but renal function should be closely monitored for this age group when these drugs are used. dosing recommendations for prevention of stroke are based on renal clearance of creatinine (clcr) estimated using the cockcroft-gault formula. it is well known that clcr estimates predict a steeper decline with advancing age than glomerular filtration rate (gfr) estimates. this raises the possibility that substitution of commonly reported gfr for estimated crcl could result in different plasmatic concentrations of oral direct anticoagulants. the aim of this study was to compare estimates of clcr and gfr and determine the impact on the plasmatic concentration of these drugs in elderly patients with non-valvular atrial fibrillation.


Eligibility criteria:
inclusion criteria: patients with non-valvular atrial fibrillation -treated with dabigatran, rivaroxaban or apixaban - patients affiliated to national social health system -patients who agreed to ethical concerns of the study exclusion criteria: patients with consultation or hospitalization that made impossible a veinous punction at the steady state residual concentration time -patients under guardianship or trusteeship

Keywords: direct oral anticoagulants atrial fibrillation renal function ckd-epi plasmatic concentration
pediatric validation of conox monitor during surgery

Conditions: Anesthesia; Anesthesia Awareness; Nociceptive Pain; Pediatric ALL; Surgery; Pain

Summary: pediatric validation of conox monitoring device (qcon and qnox indices) for anesthesia depth during surgery


Eligibility criteria:
inclusion criteria: * general anesthesia using propofol, sevoflurane or desflurane * asa i - iv * surgical procedure longer than 60 minutes exclusion criteria: * neurological disorders * inability to correctly place bis and conox probes in forehead * pregnancy * active prescription for drugs involving chronic pain and / or central nervous system * hemodynamic instability
cardiovascular function in sub maximal exercise and performance in three daily activity tests after stroke

Conditions: Stroke; Hemiplegia

Summary: the purpose of this study is to explore the relationship between cardiovascular function of persons with post stroke conditions and their performance in three field tests. this is a validation study, aiming to determine during which of two activities vo2 measurements better express the functional restrictions caused by stroke, and to find out whether the total heart beat index can be used in the case of stroke survivors for the prediction of mechanical efficiency when measured during stair-climbing and of energy cost during treadmill walking. the hypothesis is that stair climbing (stc) is a more suitable form of exercise capacity testing compared to treadmill walk (tmw) since it potentially requires a greater amount of external work, and therefore will show stronger correlation with functional tests demonstrating the same ability, whereas tmw does not utilize the movement capability of participants to the fullest. another hypothesis is that cardiac response to the exertion can be used as a predictor of those measures during these exertions in the post stroke population.


Eligibility criteria:
inclusion criteria: * having acquired stroke at least 1 year before testing * chronic weakness and/or spasticity of the affected side * independent stair-climbers (with hand-rail) * received medical clearance from a physician * with cognitive level sufficient to comprehend instructions * participants' age will range between 40-69 * use of walking aid is permitted as long as the participant is able to walk on a treadmill with hand-rail. exclusion criteria: * unable to understand instructions * unable to ambulate * severe aphasia * heart failure or other medical conditions that preclude participation in the study.
hyperbaric oxygen therapy in calcaneal intraarticular fractures: can it decrease the soft-tissue complication rate?

Conditions: Microcirculation; Wound Healing

Summary: this study aims to test the hypothesis that postoperative daily hyperbaric oxygen therapy (hbot) decreases soft-tissue complication rate during the operative handling of intra-articular calcaneal fractures. minor motivations: 1. to evaluate microcirculatory criteria of cutaneous tissue predicting emerging wound healing defects, 2. to identify patients at risk for soft-tissue complication after calcaneal plate osteosynthesis and to determine the optimal time point for operative intervention using these microcirculatory criteria preoperatively, 3. to evaluate the effect of hbot on postoperative microcirculation, 4. to collect preliminary data to evaluate the economical impact of wound complications, with and without hbot, 5. to identify a correlation between hbot with expected limited soft-tissue complication rate and the clinical and radiographic outcome two years after surgery.

wound complication remains an important problem in calcaneal fractures, with some plate series quoting up to a 27% infection rate. the original hypothesis stimulating this study is that hbot after calcaneal plating can decrease such high rates of infection. validation of this hypothesis would not only alter guidelines for standard procedure (plate osteosynthesis), but would also help to avoid difficult follow-up operations and improve functional outcome after calcaneal fracture. to date, this therapeutic approach has not been systematically tested in the existing literature. as further motivation for this study, the assessment of the existent microcirculation as a potential screening parameter will be analysed. in order to do so, it is assumed that wound infection partially develops due to disruptions in the microcirculation. this leads to the hypotheses, that by measuring the microcirculation, patients at high risk for post operative infections could be identified before operation, planning a different less invasive approach or conservative treatment.

Eligibility criteria:
inclusion criteria: * acute displaced intraarticular calcaneal fracture exclusion criteria: * extraarticular or open fracture, re-fracture or past surgical procedures in calcaneal region, peripheral vascular disease, insulin dependent diabetes mellitus, macroangiopathy: study population is representative for all calcaneal fractures

Keywords: hyperbaric oxygen therapy calcaneal fracture calcaneal plating wound infection microcirculation
geko™ km40c hydrogel skin adhesion trial (xw-3)

Conditions: Leg Ulcer

Summary: hydrogel km40c is an electrically conductive skin adhesive incorporated in the self-adhesive, geko™ xw-3 neuromuscular electrical stimulation (nmes) device. km40c has been formulated to adhere to the skin giving good electrical contact for the electrodes, be easy to remove without damaging the skin and be non-irritant. km40c has been tested for safety in humans, however the skin adhesive performance of this improved hydrogel formulation has not been tested on patients receiving geko™ nmes treatment as an adjunct to standard care for wound management. the objective of this trial is to evaluate the skin adhesive performance of hydrogel km40c during clinical use of the geko™ xw-3 nmes device to determine whether skin adhesion is at least equivalent if not superior to the adhesive hydrogel km40a incorporated in the self-adhesive geko™ w3 device which is currently in use clinically. both devices are indicated for use to promote wound healing, the geko™ w3 nmes device is ukca and ce marked whereas the geko™ x-w3 is uk ca marked only.


Eligibility criteria:
inclusion criteria: 1. adult over 18. 2. patients who have a lower limb ulcer following evaluation by a tissue viability nurse specialist 3. intact healthy skin at the site of geko™ device application. 4. willing and able to give written informed consent 5. identified to receive geko™ treatment as an adjunct to standard care for wound management. exclusion criteria: 1. pregnancy or breast feeding 2. use of any other neuro-modulation device. 3. use of a cardiac pacemaker 4. current use of tens in the pelvic region, back or legs 5. contraindication to geko ™ nmes treatment 6. no response to geko ™ nmes i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting. 7. participation in any other clinical trial that may interfere with the outcome of either trial.

Keywords: geko nmes
ectoin® lozenges in the treatment of acute viral pharyngitis

Conditions: Acute Viral Pharyngitis

Summary: this a comparative, open label, parallel group, non interventional study which compares the tolerability and influence of ectoin containing lozenges to saline solution and lozenges containing hyaluronic acid for the treatment of acute viral pharyngitis. the observation takes place over a period of 7 days. response to treatment is recorded at day 1 and day 7 by the physician and by the patient in a dairy.


Eligibility criteria:
inclusion criteria: * patients with acute pharyngitis according to instruction for use * female or male individuals ≥ 18 years * agreement to abide by the routinely provided doctor's appointment for follow- up (reflected in the planned visits of observation plan resist) exclusion criteria: * contraindications according to instructions for use * male or female person under 18 years * sore throat for more than 5 days * any disease that can, in the opinion of the treating physician to affect the outcome of the study. * patients with known intolerance to one of the substances used * surgical procedures to the mouth and throat in the last 6 weeks before inclusion in the nis * bacterial pharyngitis * pregnancy

Keywords: non interventional study ectoin lozenges pharyngitis
swiss_clearance - compartment compressibility monitoring using cpm#1

Conditions: Compartment Syndromes

Summary: compartment syndrome is a very serious musculoskeletal disorder, which can lead to potentially devastating consequences, such as limb amputation and life- threatening conditions. it is a well described medical condition considered to be an orthopaedic emergency affecting all ages. even though compartment syndrome is a well described medical condition, the appropriate treatment (i.e., fasciotomy to release tissue pressure) is invasive and involves its own risks. furthermore, and of most critical importance is the timing for the intervention of a fasciotomy. the concerned limb may already have had severe, sometimes even irreversible, tissue damage due to high intra- compartmental pressure within 6 to 10 hours. the standard diagnostic method for compartment syndrome is an invasive intra-compartmental pressure measurement via insertion of a pressure monitoring device into the muscle compartment. commercially available intra compartmental pressure monitors have a highly variable intra-observer reproducibility and user errors are common. compared to the invasive modalities, the compremium compartmental compressibility monitoring system (cpm#1) shows promising advantages for the clinical application. not only is the technology used for the cpm#1 device safe and non-invasive for the patient with only initial training required for the healthcare professionals, but it has also demonstrated high intra- and inter- observer reproducibility (as per bench tests and clinical settings with prototypes, to be confirmed in clinical studies like this one). the use of the cpm#1 device therefore facilitates the measurements, as it is based on pre-existing ultrasound methods and avoids any further risks to the patients compared to invasive compartmental pressure diagnosis methods.


Eligibility criteria:
inclusion criteria: * healthy volunteer * male or female * age 18 to 84 years exclusion criteria: * previous surgery to or fracture of the leg and/or forearm * peripheral arterial or venous disease * history of compartment syndrome * limb anomalies * general muscle disorder
bolus calculator and wireless communication with blood glucose meter in management of type 1 diabetes mellitus (t1dm).

Conditions: Type 1 Diabetes Mellitus

Summary: bolus calculator (bc) is one of the advanced functions in modern insulin pumps (csii)models. together with wireless communication with blood glucose meter potentially facilitates achieving the target post prandial glucose levels. in this rct authors assessed whether use of wireless communication between compatible devices: minimed insulin pump and blood glucose meter contour link (cl), bayer results in more frequently bolus calculator using and what is the impact of exerting this tool on metabolic control in type 1 diabetic patients.

in this rct 156 patients were randomly assigned to one of the 3 arms: group a- subjects using insulin pump bolus calculator wirelessly connected with blood glucose meter, group b- subjects using insulin pump bolus calculator without wireless communication with blood glucose meter or group c- insulin pump, without bolus calculator function. we compared the glycated hemoglobin levels and post- prandial hypoglycaemia after 3 months of observation between the groups. we also assessed secondary endpoints (mentioned above). patients were estimated at three time points: at the beginning, after 6 weeks and after 3 months of intervention. investigators performed computer reports at each visit, with medtronic carelink pro software.

Eligibility criteria:
inclusion criteria: * 7- 18 years old * type 1 diabetes mellitus for over 1 year * treatment with insulin pump with bolus calculator function * hba1c \< 10% * expressed written informed consent exclusion criteria: * recall the consent

Keywords: diabetes insulin pump bolus calculator contour link
tre in type 2 diabetes (see food study 3)

Conditions: Type2Diabetes

Summary: hyperglycemia in patients with type 2 diabetes mellitus is initially treated with metformin coupled with intentional caloric restriction, which is difficult to sustain due to multiple barriers, including acquiring the necessary knowledge, teaching the intervention, cost of delivery and potential burden on quality of life. in contrast to intentionally restricting calories, time restricted eating (tre), presents a simplified view of eating focused on restricting the eating window, which allows ad libitum intake per a person's dietary preferences during a daily fixed eating window. this study proposes a 24 week feasibility study to test if tre is a viable alternative to caloric restriction in improving glycemic measures while accounting for weight loss in overweight/obese patients \[bmi:25-45 kg/m2\] with metformin-only treated type 2 diabetes.


Eligibility criteria:
inclusion criteria: * overweight/obese adults with metformin-only treated type 2 diabetes * 18-65 years old * bmi:25-45 kg/m2 * hba1c: 6.5-8.5% * self-reported weight must be stable \[±5 pounds\] for at least 3 months prior to the study * owns a smartphone. exclusion criteria: * active or anticipated pregnancy during the study * type 2 diabetes treated with medications other than metformin * presence of eating disorders as noted by screening survey.

Keywords: type 2 diabetes diet intervention intermittent fasting caloric restriction time restricted eating
senolytics to slow progression of sepsis (stop-sepsis) trial

Conditions: Sepsis; Acute Infection; Organ Failure

Summary: the long-term goal is to test the clinical efficacy of senolytic therapies to reduce progression to and severity of sepsis in older patients. the central hypothesis is that a threshold burden of sncs predisposes to a sasp mediated dysfunctional response to pamps, contributing to a disproportionate burden of sepsis in older patients. the study hypothesizes timely treatment with fisetin will interrupt this pathway. a multicenter, randomized, adaptive allocation clinical trial to identify the most efficacious dose of the senolytic fisetin to reduce the composite cardiovascular, respiratory, and renal sequential organ failure assessment score at 1 week, and predict the probability of success of a definitive phase iii clinical trial.


Eligibility criteria:
inclusion criteria: * age \>=65 years * primary diagnosis of acute infection (per investigator judgment) * sofa \>1 * admission order to the hospital * expected length of stay \>=48 hours (per investigator judgment) exclusion criteria: * admission to the icu * vasopressors, mechanical ventilation, or dialysis * comfort care only * total bilirubin \>3x or ast/alt \>4x upper limit of normal * egfr \< 25 ml/ min/ 1.73 m2 * hemoglobin \<7 g/dl; white blood cell count ≤ 2,000/mm3; absolute neutrophil count ≤1 x 10\^9/;, or platelet count ≤ 40,000/μl * known hiv, hepatitis b, or hepatitis c * invasive fungal infection (per investigator judgment) * uncontrolled effusions or ascites (per investigator judgment) * new/active invasive cancer except non-melanoma skin cancers * known hypersensitivity or allergy to fisetin. * active treatment with potential drug-drug interactions * enrolled in another sepsis clinical trial
177lu-dtpa-omburtamab radioimmunotherapy for leptomeningeal metastasis from solid tumors (breast, nsclc, malignant melanoma)

Conditions: Leptomeningeal Metastasis; Solid Tumor, Adult

Summary: adults with leptomeningeal metastasis from solid tumors will be treated with 177lu-dtpa-omburtamab, which is a radioactive labelling of a murine monoclonal antibody targeting b7-h3.

part 1 is a dose-escalation phase with a 3+3 sequential-group design in which patients will receive a dosimetry dose followed by maximum of five 5-week cycles of treatment doses of intracerebroventricular 177lu-dtpa-omburtamab. part 2 is a cohort-expansion phase in which patients will receive a treatment at the recommended dose determined in part 1, until confirmed lm progression, unacceptable toxicity, or for maximum of 5 cycles, whichever comes first; however, the total number of cycles will be determined based upon data from part 1 (e.g., the dosimetry data) to minimize the risk of radiation necrosis and decreased neurological function end of treatment will take place within 5 weeks after the last cycle and thereafter the patients will be enter the follow-up period. the patients will be followed for up until one year after first dose (part 1) and 2 years after first dose (part 2).

Eligibility criteria:
inclusion criteria: * primary ductal or lobular breast cancer, non-small cell lung cancer, or malignant melanoma * type i or type ii lm with a "confirmed" or "probable" diagnosis according to eano-esmo guidelines 2017 * life expectancy more than 2 months, as judged by the investigator * ecog performance status 0, 1, or 2 * acceptable hematological status and liver and kidney function * written informed consent obtained in accordance with local regulations * presence of an intracerebroventricular access device before first dosing exclusion criteria: * obstructive or symptomatic communicating hydrocephalus * progressive systemic (extra-leptomeningeal) disease * uncontrolled life-threatening infection * ventriculo-peritoneal shunts without programmable valves. ventriculo-atrial or ventriculo-pleural shunts * received craniospinal irradiation (for intraparenchymal or dural metastases) or intrathecal cytotoxic anti-cancer therapy less than 3 weeks prior to first dose of 177lu-dtpa-omburtamab * severe non-hematologic organ toxicity; specifically, any renal, cardiac, hepatic, pulmonary, or gastrointestinal system toxicity grade 3 or above prior to enrolment * grade 4 nervous system disorder. hearing loss or stable neurological deficits due to brain tumor are allowed * unacceptable coagulation function prior to first dosing defined as inr grade 2 or above * female of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods or male who is not using highly effective contraceptive method * other significant disease or condition that in the investigator's opinion would exclude the patient from the trial. * smallest diameter of treated or untreated nodular or linear leptomeningeal metastasis \>0.5 cm on mri (part 2 only)
development of physical activity features for ear-worn devices

Conditions: Hearing Loss; Well Aging

Summary: this study incorporates data collection to aid in development of software features related to physical activity for users of ear-worn devices.

this exploratory study involves data collection of adults performing physical activities and activities of daily living for the purpose of comparing data collected by the ear-worn device under test and established gold standard/reference devices and consumer electronic devices. data collected will be used in the development of software features related to physical activities to benefit the experience of ear-worn device users.

Eligibility criteria:
inclusion criteria: * age 40 - 85 * minimum height 5'3" * fully vaccinated against covid -19 * willing and able perform various exercise activities at a light and moderate relative intensity, such as riding a stationary bike, walking and jogging on a treadmill, and performing squatting movements. * non-smoker for the past 6 months. * willing to abstain from caffeine and alcohol 6 hours before participation. * willing to fast from eating 4 hours before participation. exclusion criteria: * history of chronic heart disease or significant cardiac events (e.g. cardiac arrythmia). * diagnosed with diabetes mellitus or other metabolic disorder. * history of cerebral vascular accident. * history of pulmonary disorder. * experiencing orthopedic injury or disorders that restrict movement or cause painful physical activity. * history of neurodegenerative or neuromuscular pathology. * advised by a healthcare professional to not participate in physical activity.
evaluating fluid strategies in thoracic surgery patients utilizing a goal directed approach

Conditions: Hypotension; Kidney Injury

Summary: the purpose of this study is to conduct a prospective, randomized, controlled trial comparing a restrictive vs. conservative fluid strategy in thoracic surgery patients. excessive perioperative fluid has been retrospectively implicated in the development postoperative acute lung injury (pali) and pulmonary edema following lung resection. however, fluid restriction in these patients is not without risk and may compromise end organ perfusion (i.e. acute kidney injury). the hypothesis is that a conservative fluid approach in thoracic surgery patients will result in better end organ perfusion with fewer occasions of acute kidney injury (aki) without causing an increase in postoperative acute lung injury or pulmonary edema.


Eligibility criteria:
inclusion criteria: * between 18-89 years of age * undergoing pulmonary lobectomy with open or video assisted thoracotomy exclusion criteria: * patient refusal * pregnancy * cardiac arrhythmia * pacemaker dependency * severe aortic insufficiency * idiopathic hypertrophic subaortic stenosis * prisoners * decisionally challenged * patients that refuse to receive intravenous fluid products made from human plasma (albumin 5%) * patients with skin infection or breakdown on their fingers * severe peripheral vascular disease * evidence of compromised finger perfusion will be excluded

Keywords: hypotension kidney injury