Kornimate/medical-research-clean huggingface dataset:
efficacy of arista-ah for restoring hemostasis following posterior long-segment spinal fusion.

Conditions: Hemostatics; Hemostasis; Spinal Deformity; Spinal Fusion

Summary: the aim of this study is to assess the efficacy of the arista ah for restoring hemostasis following a long segment posterior spinal fusion.

after being informed about the study and potential risks, all patients giving written inform consent will be included in the study during their preoperative visit. after eligibility criteria checking and based on their respective surgical indication, participants will be randomized in a single-blinded and stratified manner (participant only) in a 1:1 ratio to arista-ah or no arista-ah. the stratification process will consider the number of instrumented vertebra during each surgery (level 1: 5 to 8 vertebra; level 2: 9 or more instrumented vertebra).

Eligibility criteria:
inclusion criteria: 1. patient eligible to a posterior lumbar or thoraco-lumbar long-segment spinal fusion. 2. surgery targeting at least 5 adjacent vertebra combined with one of the following procedure: 1. intersomatic bone graft; 2. pedicle substraction osteotomy; 3. any other intervertebral osteotomy (e.g. smith-petersen osteotomy); 3. the use of a surgical drain inserted at the operative site is mandatory (suction drain and other drain are eligible); exclusion criteria: 1. subject under the age of 18 years old; 2. subject with a known haemostatic disorder; 3. subject with any infection or any immune system disorder; 4. subject not eligible to a posterior spinal surgery; 5. subject with a known allergy or any contraindication to the use of the study device; 6. currently pregnant or planning pregnancy; 7. prisoner or a ward of the state; 8. subject no willing to participate in the study; 9. subject not affiliated to a social security insurance.

Keywords: arista-tm posterior spinal fusion spinal surgery spinal deformity hemostasis
the differences of muscle activity between patients with copd and healthy adults

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study attempts to investigate the differences and relationships of respiratory parameters, muscle activity, and dyspnea during adl between patients with copd and age-matched healthy participants.


Eligibility criteria:
inclusion criteria: * 40 years or older * with the clinical diagnosis of copd exclusion criteria: * with the clinical diagnosis of asthma or cancer * with cardiovascular, musculoskeletal and neurological diseases limiting physical activities in daily life * in the unstable medical state * mmse under 25 * barthel index score under 61

Keywords: activities of daily living accessory inspiratory muscles oxygen consumption minute ventilation volume
pelvic floor muscle training with leva system for urge incontinence

Conditions: Overactive Bladder; Urge Urinary Incontinence; Mixed Urinary Incontinence

Summary: this is a pilot non-comparative study to assess the effectiveness of pelvic floor muscle training guided by the leva® system for improving change in subject-reported incontinence-related quality of life and urgency urinary incontinence (uui) episode frequency based on voiding diaries in women at 8 weeks.

our study aims to investigate a new alternative to formal pelvic floor physical therapy that may provide subjects with a more accessible, private method of undergoing pelvic floor muscle training (pfmt) with real-time biofeedback on performance. the leva® pelvic digital health system by renovia inc is a novel tool for subjects with urinary incontinence to train and strengthen pelvic floor muscles via directional mechano-transductive feedback on performance in the privacy of their own homes. we hypothesize that women using the leva® system will experience significant improvements in subjective urge-related incontinence symptoms. in addition, changes in incontinence-related quality of life and uui episode frequency will be determined.

Eligibility criteria:
inclusion criteria: * age 18-85 years old * urinary incontinence for ≥ 3 months * reporting at least "moderate bother" on item 2 on the udi-6, "do you experience urine leakage in related to the feeling of urgency" (on new patient paperwork) * if mixed urinary incontinence, medical epidemiologic social aspect of aging urinary incontinence questionnaire (mesa) score indicating urge-predominant mui (urge subscale % \> stress subscale %) * presence of ≥ 1 uui episode on 3-d bladder diary (see appendix 2) * is the baseline bladder diary consistent with the patient's typical habits? * not currently taking anti-muscarinic or beta3 agonist therapy (after at least 2 week wash-out period) * brink score \> 3 (see below) * access to smartphone technology, including ios or android™ exclusion criteria: * non-english speakers * severely impaired mobility or cognition * spinal cord injury or advanced/severe neurologic condition including multiple sclerosis, parkinson's disease * concomitant prolapse beyond the hymen or repair of prolapse in the previous 6 months * received intravesical botulinum injection within the previous 12 months * history of implanted nerve stimulator for incontinence * history of prior sling or vaginal mesh placement * previous diagnosis of interstitial cystitis * active pelvic organ malignancy * history of pelvic radiation * urethral obstruction * urinary retention or prolonged catheter use * less than 12 months post-partum are currently pregnant, or plan to become pregnant in the following 12 months * untreated symptomatic urinary tract infection * unevaluated hematuria * medical instability * not available for follow-up in 6 months * participation in other research trials that could influence results of this study

Keywords: female urinary incontinence urge urinary incontinence urgency frequency overactive bladder pelvic floor muscle training biofeedback
study examining prep-001 in healthy subjects

Conditions: Influenza A H3N2

Summary: phase 2 study, looking at the prophylactic efficacy, safety and tolerability to a repeated nasal dose of study drug after being infected with influenza a/perth/16/2009 (h3n2) virus.

screening took place up to 90 days before quarantine. volunteers completed an informed consent and underwent screening assessments to determine their eligibility. there were 2 study groups: cohort a: (sentinel): determined the challenge virus infection rate after inoculation with influenza virus on day 0. there was 12 subjects (open label, no randomisation) invited to attend quarantine on day -2 or -1. cohort b: examined the prophylactic efficacy, safety and tolerability of prep-001 compared to placebo (randomised 1:1). subjects attended on day -4/-3, dosed with prep-001 or placebo on day -2 and day-1 and then challenged with virus (volume confirmed from cohort a) on day 0. volunteers remained in quarantine unit for 8 days after inoculation. at day 28, end of study visit, volunteers seen and assessed by a study physician for well-being, on-going symptoms and adverse events.

Eligibility criteria:
inclusion criteria: * young healthy adults as determined by medical history, physical examination, serology (hiv and hepatitis b and c) and clinical laboratory tests. * female subjects were required to provide of a history of reliable contraceptive practice. exclusion criteria: * subjects who have a significant history of any tobacco use at any time. * any history or evidence of any clinically significant cardiovascular, dermatological gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal disease. * abnormal ecg
epicardial injection of hipsc-cms to treat severe chronic ischemic heart failure

Conditions: Heart Failure

Summary: the purpose of this clinical study is to evaluate the feasibility, safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes (hicm-188) during coronary artery bypass grafting (cabg) surgery in patients with severe chronic ischemic heart failure.

this is a single center, open-label, three-group dose-escalation (phase i) study followed by dose-extension (phase iia) study in up to 36 severe ischemic heart failure patients. it is estimated that up to 18 phase i patients will be received hicm-188 intramyocardial injection during cabg surgery. the maximum number of subjects after dose escalation and dose extension studies in each dose group is 12. all the subjects need take immunosuppressant after transplantation.

Eligibility criteria:
inclusion criteria: 1. 35-75 years of age (including 35 and 75 years) 2. willingness and ability to give written informed consent 3. patients with severe chronic ischemic heart failure 4. new york heart association (nyha) class iii or iv under optimal medical therapy 5. weakening or absence of segmental regional wall motion as determined by standard imaging. 6. lvef≤40% as assessed by mri 7. nuclide-myocardial metabolic perfusion imaging revealed infarcted myocardium in the left anterior descending branch (lad) coronary artery supply area 8. patients have indications for coronary artery bypass grafting exclusion criteria: 1. patient with pacemaker, implantable cardioverter defibrillator (icd), or cardiac resynchronization therapy (crt) treatment. 2. patients with severe valvular heart disease 3. patients had acute myocardial infarction or underwent percutaneous coronary intervention (pci) surgery within 1 month 4. patients with non-ischemic heart failure, acute viral myocarditis. 5. patients had acute cerebrovascular events within 1 month before screening. 6. diagnosed with malignancy within 5 years 7. autoimmune disease or long-term therapy with immunosuppressant 8. recipients of organ transplant. 9. patients undergoing other surgical operations (excluding resection of ventricular aneurysm). 10. severe ventricular arrhythmia 11. contraindication to cabg surgery 12. serum-positive for hiv, hepatitis bsag, hcv and tp. 13. contraindication to performance of mri or pet/ct scan. 14. contraindication to use immunosuppressant 15. be allergic to immunosuppressant 16. patients who had participated in other clinical trials within 3 months 17. women are pregnant, breastfeeding or blood pregnancy test positive 18. patients with other conditions are not eligible to participate in this clinical trial
comparative analysis of the effectiveness of the use of nimesulide and cbd oil in patients with pain in the preauricular region due to the pain-dysfunctional syndrome of the temporomandibular joint.

Conditions: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Temporomandibular Joint Pain

Summary: during the study, the effectiveness of analgesic therapy with nimmsulide and cannabidiol oil will be compared. two study groups will be formed. the study will be conducted on patients reporting to the dental prosthetics clinic of pum in szczecin. patients aged 18-65 years with pain located in the area of the temporomandibular joint and the preauricular area, resulting from a dysfunction of the temporomandibular joint, will be included in the study.


Eligibility criteria:
inclusion criteria: 1. patients (female and male) aged 18-65 years, able to swallow tablets 2. patients with pain located in the temporomandibular and preauricular regions resulting from temporomandibular joint dysfunction 3. patients with clinical diagnosis of temporomandibular joint dysfunction exclusion criteria: 1. patients with clinically diagnosed acute inflammation of the outer ear, middle ear, sinuses of the nose 2. patients allergic to nimesulide or cannabidiol oil 3. patients with contraindications to include therapy with nimesulide or cannabidiol oil such as: * gastric or duodenal ulcer disease, * severe blood clotting disorders, * severe liver dysfunction, * severe renal impairment, * severe heart failure, pregnancy, * breastfeeding, * concomitant intake of citrochrome blockers cyp3a4 or cypp2d6 (warfarin, macrolides, calcium channel blockers, benzodiazepines, cyclosporine, sildenafil, ssri, tricyclic antidepressants, opioids)

Keywords: temporomandibular joint cbd oil non steroid antyinflammatory drug nimesulide
pegasus crt study: atrial support study in cardiac resynchronization therapy

Conditions: Heart Failure

Summary: this study will look at different pacing modes (how a device is programmed to pace one's heart), and how these modes may assist in one's daily activities and how one is feeling.

pegasus crt is a multicenter trial that will assess the effect of a cardiac resynchronization therapy defibrillator (crt-d) device programmed to ddd-70 or dddr-40 compared to a crt device programmed to ddd-40 in heart failure patients. the effect of atrial support pacing in heart failure patients will be assessed using a clinical composite rating. a sub-study will evaluate the effect pacing mode has on exercise capacity in this heart failure population.

Eligibility criteria:
inclusion criteria: * patients who meet current indications for the contak renewal® family of cardiac resynchronization therapy defibrillator (crt-d) devices or future food and drug administration (fda) approved guidant crt-d devices * patients who sign and date a patient informed consent at, or prior to, the implant visit * patients who are in sinus rhythm at the time of implant * patients who remain in the clinical care of the enrolling physician in approved centers * patients who are on optimal pharmacologic therapy or who have developed a recent implantable cardioverter defibrillator (icd) indication that necessitates icd therapy concurrent with the optimization of pharmacologic therapy exclusion criteria: * patients whose medical condition is expected to preclude the use of the protocol-required pacing mode (dual chamber pacing \[ddd or dddr\]) and respective lower rate limits * patients with permanent atrial fibrillation or atrial flutter * patients who are in complete heart block * patients who have previously had a pacemaker, icd, or crt device * patients whose life expectancy is less than 12 months due to other medical conditions * patients who are expected to receive a heart transplant during the duration of the study * patients who have other cardiac surgeries or procedures planned but not yet performed * patients who currently have or who are likely to receive a tricuspid valve prosthesis * patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study. * patients who are younger than 18 years of age * patients who are mentally incompetent and cannot sign a patient informed consent form or comply with the study * patients who are or become pregnant
yoga for stress management in health care personnel

Conditions: Yoga; Stress, Psychological; Stress, Physiological

Summary: the purpose of this study is to investigate if yoga can be an effective stress management technique for health care personnel.

stress, both job related and personal, is an increasing problem in the health care sector. yoga is said to have a good stress-reducing effect. the participants will provide blood, urine, and saliva samples. they will take part in two different stress tests. they will also fill in various qualitative questionnaires, including the swedish questionnaire on health related quality of life (swedqual), antonovsky's sense of coherence scale (kasam), and the job stress survey (jss), both before the study starts and after 3 months of participation.

Eligibility criteria:
inclusion criteria: * bmi 18-30 * healthy * work in the health care sector exclusion criteria: * medication, including contraceptives and all medications or topical skin preparations with cortisone in any form (exception: hormone replacement therapy for hypothyroidism were included if their hormone levels were within the normal range)

Keywords: yoga stress stress management hypothalamus-pituitary-adrenal axis
evaluation of two levels of frequency of repositioning in the reduction of pressure ulcers

Conditions: Critical Illness

Summary: penfup fase 2, it is a multicenter study by parallel conglomerates, planned in order to evaluate the efficacy between two levels of frequency of postural change in intensive care units for adults of hospitals in various regions of colombia.

taking into account a design effect of 6.7, investigators planned to include 150 participants from each icu. investigators did calculate that a total of 22 icus are required, in which 11 will be assigned to the low frequency and 11 will be assigned to a high frequency group of postural change until obtaining a total of 1,650 patients in each arm of the study and a total of 3,300 participants in the study.

Eligibility criteria:
inclusion criteria: * the icu manage adult patients, over 18 years of age, with any type of emphasis (surgical, medical, neurological, or mixed); * patients are admitted in critical condition (with life support); * the director accepts the commitment of the care assigned in the randomization (for a period of 3 months). exclusion criteria: * intermediate care units in which patients mobilize themselves. * covid patients or other patients exposed to different mobilization patterns (e.g., 12 hours prone vs 12 supine)
cognitive impairment related to atrial fibrillation prevention trial

Conditions: Atrial Fibrillation

Summary: cognitive and functional decline observed in atrial fibrillation (af) patients are related to thrombotic and/or cardioembolic events. use of warfarin for the prevention of stroke in af patients, despite effective, remains beyond desired levels because of interactions with food and fluctuations in blood levels. because of a more stable anticoagulation state, dabigatran may offer better protection against thrombotic phenomenon and, consequently, mitigate the process of cognitive and functional compromise.

this will be a prospective parallel study including two hundred atrial fibrillation patients \> 65 years old and scoring chads2vasc \> 1. patients will be randomized to receive warfarin (inr between 2 and 3) or dabigatran (150 mg twice daily) for two years. after one year and at the end of the study, individuals will be evaluated regarding cognitive endpoints following the national institute of neurological disorders and stroke-canadian stroke network vascular cognitive impairment harmonization standards (hachinski et al. stroke 2006;37:2220-2241). the investigators will use the 60 minutes evaluation protocol complemented by the montreal cognitive assessment (moca).

Eligibility criteria:
inclusion criteria: * atrial fibrillation * cha2ds2-vasc score for atrial fibrillation stroke risk (chads2vasc) greater than 1 exclusion criteria: * heart valve disease * previous stroke or transient ischemic attack * cognitive impairment or any severe neurological disorder * major surgery in the last 30 days * planned elective surgery in the next three months * intracranial, ocular, spinal, retroperitoneal, or articular bleeding without trauma. * gastrointestinal bleeding in the last 12 months * symptomatic gastric ulcer * hemorrhagic disease * use of thrombolytics * uncontrolled hypertension * active cancer * contraindication for warfarin use * reversible causes of atrial fibrillation * creatinine clearance \< 30 ml/min * active endocarditis * active hepatitis * severe anemia * left ventricle ejection fraction \< 35%

Keywords: atrial fibrillation cognition cognitive impairment anticoagulation dabigatran warfarin efficacy
aldesleukin in participants with metastatic renal cell carcinoma or metastatic melanoma

Conditions: Metastatic Renal Cell Carcinoma; Metastatic Melanoma

Summary: this study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.


Eligibility criteria:
inclusion criteria: * performance status eastern cooperative oncology group: 0 or 1. * adequate organ function. exclusion criteria: * pregnancy or lactation. * prior treatment with any form of il-2. * organ transplant. other protocol-defined inclusion/exclusion criteria may apply

Keywords: metastatic renal cell carcinoma metastatic melanoma aldesleukin il-2
prospective validation and application of an artificial intelligence-based model for evaluating the efficacy of breast cancer patients after neoadjuvant therapy

Conditions: Breast Cancer

Summary: breast cancer has become the world's number one cancer. while its therapeutic efficacy is increasing, how to achieve non-invasive evaluation of the efficacy of neoadjuvant therapy (nat) for breast cancer patients and thus avoid surgery has become a bottleneck problem that needs to be broken through in clinical diagnosis and treatment. existing non-invasive evaluation strategies are limited to single-center, single-modality modeling, and have problems such as low performance and poor versatility. therefore, in the early stage of this study, multi-modality breast cancer patient data from multiple centers across the country were collected and the establishment of an artificial intelligence (ai) efficacy prediction model was preliminarily completed. on this basis, this project intends to further improve the multi-center prospective validation study of the prediction model. the research results will help solve the scientific problem of non-invasive judgment of nat efficacy in breast cancer patients and provide a new paradigm for the research of high-performance ai diagnosis and treatment auxiliary systems applicable to multiple centers.

(1) prospectively collect breast mri original images (dce and adc sequences) and corresponding clinical and surgical pathological data of multi-center breast cancer patients before and after neoadjuvant treatment, store and transport them via mobile hard disks, and input the processed data into the established efficacy determination model stored in a dedicated cloud server; (2) use artificial intelligence to automatically delineate the roi area and extract the imaging genomics and deep learning features therein, and combine the clinical pathological characteristics of the patients to further prospectively verify the effectiveness of the established pcr efficacy determination model.

Eligibility criteria:
inclusion criteria: * patients who were treated in the above research centers between january 1, 2024 and october 31, 2025; * ≥18 years old, female, ecog score ≤2; * pathological biopsy confirmed invasive breast cancer; * ajcc (8th edition) stage i-iii; * mri imaging data before and after neoadjuvant therapy; * planned mastectomy or breast-conserving surgery after neoadjuvant therapy, and postoperative pathological information obtained. exclusion criteria: * bilateral breast cancer, multiple lesions, or occult breast cancer; * poor mri data quality; * patients who had received other anti-tumor treatments before enrollment; * patients with other malignant tumors