Kornimate/medical-research-clean huggingface dataset:
evaluation of stargraft-2 for hemodialysis access

Conditions: End Stage Renal Disease

Summary: this study is a single site, prospective, single arm evaluation of the safety and effectiveness of the healionics stargraft-2 hemodialysis access graft. stargraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and infection. this study is an extension from a prior first in human (fih) study (nct03916731) with the stargraft av investigational device. that study also included control implants of commercially available standard eptfe grafts approved for the same use. the study is enrolling patients with end stage renal disease (esrd) requiring hemodialysis via a prosthetic vascular graft. the study proposes to: 1. evaluate the performance of the investigational stargraft-2 compared to the eptfe controls in the prior study and to published results, over a period of 6 months, with extended results to 1 year. 2. verify safety of the stargraft-2 multilayer construction in extended dialysis vascular access use. it is intended to enroll 25 subjects in this study.


Eligibility criteria:
inclusion criteria: 1. male or female, \> 18 years or age. 2. patient has given informed consent to participate in the trial. 3. stated willingness to comply with all study procedures and availability for the duration of the study. 4. able to effectively communicate with study personnel. 5. candidate for a new arterio-venous graft placed in the upper arm. 6. life expectancy judged to be at least 2 years. 7. axillary vein of greater than or equal to 7 mm in diameter. 8. brachial artery of greater than or equal to 4 mm in diameter. 9. acceptable cardiac risk level (cardiac output ≥ 3.5 l/min, pulmonary artery pressure ≤ 50 mmhg, ejection fraction ≥ 40%) 10. systolic blood pressure equal to or greater than 120 mmhg. 11. absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram. exclusion criteria: 1. unable or unlikely to comply with trial protocol and/or follow-up. 2. pregnancy. 3. clinically morbid obesity. 4. anatomical limitations. 5. immunodeficiency syndrome. 6. history of bacterial infection within 8 weeks prior to graft implantation. 7. history of hypercoagulation or bleeding disorders. 8. elevated platelet count \> 1 million per microliter of blood. 9. history of heparin-induced thrombocytopenia syndrome (hit). 10. medically confirmed stenosis of the veins downstream of the implant site. 11. inadequate arterial flow or pressure proximal to the implant site. 12. currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial. 13. fever greater than 38° c. 14. prior allergic reaction to silicone. 15. confirmed or suspected covid-19 infection within 8 weeks prior to graft implant, or ongoing covid-19 symptoms

Keywords: hemodialysis vascular access arterio-venous grafts (avg)
fast as a treatment for obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the objective of this study is to assess the feasibility and safety of tongue suspension using the siesta medical encore tongue suspension system for the treatment of obstructive sleep apnea (osa).

obstructive sleep apnea (osa) has become a major health problem in the united states. with prevalence in middle-aged adults of 2-4% of the population, untreated osa has been implicated in increased risk for cardiovascular disease, including hypertension and heart failure. the first and most common treatment for osa is continuous positive airway pressure (cpap) treatment, utilized by an estimated 3 million americans. cpap is effective in reducing apnea-hypopnea index (ahi) is used properly. however, the nasal mask required for cpap during sleep leads to poor acceptance and compliance rates. published studies on cpap have shown that only 58-8-% of patient accept cpap therapy and further 65-90% of these patients exhibit long-term compliance with cpap. it is widely accepted that the region behind the tongue is a major site of collapse during obstructive sleep apnea. in fact there are many surgical procedures performed currently to address tongue based collapse. these include rf ablation of the tongue base, genioglossus advancement, hyoid suspension, maxillomandibular advancement, and tongue base suspension. the current study is designed to evaluate the feasibility of tongue stabilization, and assess safety and treatment of the tongue stabilization.

Eligibility criteria:
inclusion criteria: * documented diagnosis of moderate obstructive sleep apnea (ahi 5-30/hour) measured within 12 months prior to the planned procedure * age \>/= 20 and \>/= 65 * body mass index ,/= 32 (kg/m\^2) * patient offered cpap and has refused of failed to continue cpap treatment or is not compliant with cpap * signed informed consent to participate in this study exclusion criteria: * prior osa surgery * active systemic infection * allergy to any medication used during implantation * previous history of neck or upper respiratory tract * significant dysphagia or speech disorder anatomical * identified obvious palatal stenosis * enlarged tonsils (3+) * anatomy unable to accommodate the implant other * other medical, social, or psychological problems that , in the opinion of the investigator, precludes the patient from receiving this treatment and the procedures and evaluations pre- and post-treatment * enrollment in another pharmacological or medical device study that may effect or bias the results of this clinical study * unable and/or not willing to comply with treatment follow-up requirements * pregnancy (female subjects of childbearing potential must have a negative pregnancy test prior to enrollment

Keywords: obstructive sleep apnea tongue suspension
thoratec corporation heartmate php™ cardiogenic shock trial

Conditions: Cardiogenic Shock

Summary: the primary objective of this study is to assess reasonable safety and performance of the heartmate php to provide hemodynamic support for up to 72 hours in patients with cardiogenic shock requiring stabilization.

the heartmate php is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. this prospective, nonrandomized, controlled, single-arm, multi-center, open-label trial will evaluate the safety and performance of the device in patients with cardiogenic shock.

Eligibility criteria:
inclusion criteria: 1. patient is indicated for left ventricular support according to current medical guidelines ("current medical guidelines" applies only to patients enrolled in germany) 2. patient has a cardiac index of \ 5 mcg/kg/min, dobutamine \> 5 mcg/kg/min) and: * pcwp \> 18 mmhg, and * systolic blood pressure \< 100 mmhg, and * decreased organ perfusion as evidenced by urine output of 50 ml/hr or increased creatinine of 0.3 mg/dl from baseline obtained within 2 weeks, or cool extremities 3. written, signed, and dated informed consent exclusion criteria: 1. patient is \>85 years of age 2. right ventricular failure requiring mechanical circulatory support 3. st elevation myocardial infarction (stemi) within 30 days of procedure 4. cardiac arrest within 7 days of procedure requiring cpr 5. current treatment with mechanical circulatory device such as iabp, ecmo, centrifugal pump, etc. 6. documented acute myocarditis 7. active major cardiac rhythm disturbances (e.g., ventricular tachycardia, ventricular fibrillation). 8. hypertrophic disease or any left ventricular outflow tract obstruction 9. active sepsis defined as bacteremia, fever ≥ 101.5 degrees f 10. mural thrombus in the left ventricle 11. history of aortic valve replacement 12. end-stage renal disease requiring dialysis 13. documented presence of aortic stenosis (orifice area of 1.5 cm2 or less) 14. moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher) 15. platelet count \< 100,000 16. allergy or intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs 17. known coagulopathies 18. presence of risk factors for severe liver and/or renal dysfunction 19. stroke within 90 days of enrollment 20. significant peripheral vascular disease 21. history of heparin induced thrombocytopenia 22. patient is pregnant or planning to become pregnant during the study period 23. patient is breastfeeding. 24. any active disease (e.g., active cancer) which could affect the patient's participation in the study, or if life expectancy is less than 1 year. 25. any active disease in which the investigator determines would make the patient an inappropriate candidate for the study. 26. participation in another clinical study of an investigational drug or device that has not met its primary endpoint

Keywords: php cardiogenic shock percutaneous ventricular assist heart pump catheter thoratec corporation
automated detection and triage of large vessel occlusions using artificial intelligence for early and rapid treatment (alert)

Conditions: Stroke Workflow and Clinical Outcome Parameters

Summary: post market, prospective, randomized, controlled, multi center data collection study to evaluate the use of viz versus the standard of care in stroke workflow and clinical outcome parameters.

this study will be a multicenter, multi arm, prospective randomized study to evaluate the use of viz. the study will enroll all subjects that present at all participating centers that meet the study inclusion/exclusion during the period of study evaluation. all subject imaging (ct) data will be pushed to viz and evaluated by viz. randomization will occur at the time of image processing by viz that indicates the subject is positive for lvo per the software criteria (anterior location). subjects randomized to the standard of care arm of the study will not receive any information via an automated notification from viz. subjects that are randomized to the viz arm of the study will have an automated message sent to the enrolling center contacts. subjects will be followed for 90 days post treatment. data evaluation may occur at regular intervals throughout the study and at the completion of the study period.

Eligibility criteria:
inclusion criteria: a subject must meet all of the following inclusion criteria to be included in the study: 1. age of 18 years or greater. 2. signs and symptoms consistent with the diagnosis of a stroke. 3. stroke protocol imaging (cta) with a confirmed presence of anterior lvo via viz. exclusion criteria: a subject may not be included in the study if any of the following exclusion criteria are met: 1. poor or incomplete cta imaging data. 2. disagreement between neuroradiologist and stroke specialist or neurointerventionalist relative to presence of a stroke. 3. other serious, advanced, or terminal illness (investigator judgment) requiring treatment that significantly delays initiating transfer and/or treatment for stroke.

Keywords: large vessel occlusion
neuromuscular and cognitive fatigue during a 24 hour treadmill running exercise

Conditions: Healthy

Summary: the main purpose of the present study is to determine the relative contributions of central and peripheral fatigue during an ultra-endurance exercise.

for that purpose, 14 subjects running 24 hours on a treadmill will be compared with a control group being awake during the same period. subjects who running will have electrically evoked forces on the muscles associated emg activity, blood samples and muscle biopsy.

Eligibility criteria:
inclusion criteria: * the subjects of the experimental group will be recruited among experienced ultra-runners . they all have run at least a 12 hour race or longer. * the control group will be recruited among experienced ultra-runners . age of control group will be age experimental group more or less 2 years. exclusion criteria: * the subjects will not be selected if: * they were injured in the 3 months before the experiment * they had a tendon or joint pathology that could impair strength measurements. * they participate to an other experiment at the same time

Keywords: running during 24 hours voluntary evoked force on the muscles electrically evoked force on the muscles emg activity muscle biopsy subjects will be recruited among experienced ultra-runners
hyaluronic acid in patients with gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux

Summary: gastroesophageal reflux disease (gerd) remains one of the most common pathologies seen among gastroenterologists, surgeons, and primary care physicians. the high prevalence of this condition lead to further investigations in its prevention, diagnosis, and management. for the treatment of this chronic condition, improvement in quality of life and long-term durability should be considered. nowadays, proton pump inhibitors (ppis) are considered the mainstay in the treatment of the patients with gerd; however, due to the increasing concern related to its safety in its long-term use and the over prescription of these drugs, new surgical and endoscopic interventions have emerged. a local treatment based on injections of hyaluronic acid, a natural nonimmunogenic mucosal defense, in the lower esophageal mucosa is a tentative treatment option for these patients. based on this, the investigators pursue to assess the effects of hyaluronic acid in gastroesophageal reflux control.

gerd is one of the most common digestive pathologies, with a prevalence between 20% and 40% of adults. for the treatment of the disease, proton pump inhibitors (ppis) have undoubtedly shown effective results; however, in around 30% of patients the complete resolution of symptoms fails. for the latter, new therapeutic options should be considered. as a modern well-tolerated approach, and for local treatment, hyaluronic acid (ha) appeared to be an option for symptoms relief. ha is a glycosaminoglycan that acts as a natural defense for esophageal mucosa, able to organize the reticular structure as a filter to prevent the diffusion of high molecular substances. in addition, one of its remarkable features is the induction and control of epithelial cells turnover improving the re-epithelization process and the ulcer healing. in addition, hyaluronic acid compounds have shown no migration from the injection site in up to a three-year period. based on the above, the investigators aim to assess the effectiveness of hyaluronic acid in gastroesophageal reflux control, to considered it as an alternative effective treatment.

Eligibility criteria:
inclusion criteria: * adults \>18 years old * patients with diagnosis of gerd (distal esophageal acid exposure time \> 6% on 24hour ambulatory ph-impedance monitoring) * patients with abnormal distal esophageal acid exposure time (4%-6%) on 24-hour ambulatory ph-impedance monitoring * patients who authorized for endoscopic approach. exclusion criteria: * pregnancy * any clinical condition which makes endoscopy inviable. * patients with severe anatomic conditions such as esophageal strictures, barret´s esophagus, hiatal hernias. * previous esophageal surgery. * patients with a history of upper gastrointestinal neoplasia. * inability to provide informed consent

Keywords: gastroesophageal reflux hyaluronic acid esophageal sphincter
urinary incontinence: reproductive/hormonal risk factors

Conditions: Urinary Incontinence

Summary: this study is a continuation or follow-up of two previous studies (rrisk and rrisk2) conducted at the kaiser division of research. this study will invite previous study participants, as well as a randomly selected group of northern california kaiser permanente members, to participate in an interview, mailed survey and lab visit. the purpose of this study is to examine the risk factors for bladder and pelvic problems.

using a cohort established during two previous studies (rrisk, cn-97svand-01-h and rrisk2 cn-02svand-07-h), this study will follow a well characterized cohort of middle-aged and older women who have been members of kaiser permanente medical care plan (kpmcp) of northern california continuously since age 18. the cohort is composed of over 2000 women for whom we have data from abstracted medical records, in-person interview, voiding diaries, physical assessments, laboratory data, and banked sera. our cohort is unique in including a substantial number of women from the 4 major ethnic/race groups (white non-hispanic, black, asian and hispanic.) for this study, we will re-interview as many study participants from rrisk and rrisk2 as are willing. this study will also expand to further increase its diversity by adding a total of 450 black, asian and hispanic women to the cohort. the overall goal of the study is to advance our understanding of mechanisms of urinary incontinence and facilitate the translational development of novel approaches to treatment and prevention.

Eligibility criteria:
inclusion criteria: * previously participated in the rrisk or rrisk2 studies at the kaiser division of research. exclusion criteria: * not a part of the previous rrisk or rrisk2 cohorts.

Keywords: urinary incontinence incontinence bladder problems bladder dysfunction
development of a multipurpose dashboard to monitor the situation of emergency departments

Conditions: Emergency Medicine

Summary: an emergency department (ed) is a healthcare service that provides the first clinical assessment and treatment to patients with various acute conditions. these departments, however, are often overwhelmed by the large volume of patients. as a consequence, ed crowding has become a global concern and has been correlated to reduced timeliness and effectiveness of care and increased patient mortality. concerning input, 20% to 30% of patients are brought to the ed by ambulance; the remaining are self-presenting for the vast majority. notably, non-urgent conditions characterize a high proportion of all ed visits worldwide, and almost all of these visits involve self-presenting patients. increasing the awareness of these patients about the mandate of eds and the real-time situation of the neighboring emergency departments has the potential to reduce the self-presentation of patients with minor, non-urgent conditions. such patient empowerment can be achieved through a dashboard. concerning throughput, working in the ed requires emergency physicians and nurses to treat many patients at once while maintaining situational awareness of the surroundings. this is especially true for the head of the department, but it also holds for all physicians. it can be crucial, for example, for physicians to know if there is a bottleneck in the flow of the entire patient care process, such as a particularly high average waiting time for radiology reporting or cardiologic consultation. the availability of this information allows countermeasures to be put in place to regain efficiency. all this can be achieved through dedicated dashboards automatically fed from various information system. in addition, appropriate dashboards also enable health policymakers to monitor specific epidemiological phenomena, such as the emergence of certain infectious diseases, in a timely manner.


Eligibility criteria:
inclusion criteria: * adult * arrived at emergency department between 1 january 2025 and 31 december 2025 exclusion criteria: - none
ultrasound-guided adductor canal block for total knee replacement

Conditions: Complications; Arthroplasty; Knee Injuries

Summary: total knee arthroplasty is associated with intense early postoperative pain. fast track recovery programs including early therapy protocols and early hospital discharge are being implemented at various hospitals. the postoperative analgesic pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. adductor canal blockade is commonly used to provide postoperative analgesia for total knee arthroplasty (tka) surgery. the investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive tka surgery.

the investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive tka surgery.

Eligibility criteria:
inclusion criteria: * participants 40 to 75 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia exclusion criteria: * patient refusal * american society of anesthesiologists physical status classification of 4 or higher * pre-existing neuropathy in the femoral or sciatic distribution * coagulopathy * infection at the site * chronic opioid use (greater than 3 months) * pregnancy * medical conditions limiting physical therapy participation * any other contra-indication to regional anesthesia
a short and long intravenous infusion study to evaluate the safety, pharmacokinetics, and pharmacodynamics of bms-962212 in healthy subjects

Conditions: Thrombosis

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics following increasing doses of 2 h (part a) and 5 day (part b) continuous iv infusions of bms-962212 in healthy subjects across the expected pharmacodynamic dose range.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecg, and clinical laboratory determinations * body mass index (bmi) of 18 to 32 kg/m2 inclusive \[as calculated by bmi = weight (kg)/ \[height (m)\]2 * this study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, subject has not been randomized / has not been treated). if re-enrolled, the subject must be re-consented * men, ages 18 to 45 years, inclusive; women, ages 18-45, who are not of child-bearing potential * women must not be breastfeeding exclusion criteria: * any significant acute or chronic medical illness * women of child-bearing potential * current or recent (within 3 months of study drug administration) gastrointestinal disease which by the judgment of the investigator may increase a subject's risk of gastrointestinal bleeding (e.g., peptic or gastric ulcer disease, severe gastritis, history of gastrectomy) * any major surgery within 12 weeks of study drug administration * history of blood transfusion, clinically significant bleeding event(s), or documented genetic bleeding diathesis or thrombophilia * for aspirin containing arm participants only: known allergy to non-steroidal anti-inflammatory drugs or history of intolerance or abnormal sensitivity to aspirin (e.g gastrointestinal intolerance, bruising or bleeding, aspirin induced breathing difficulties or nasal polyps) other protocol defined inclusion/exclusion criteria could apply