Kornimate/medical-research-clean huggingface dataset:
clinical trial of autologous adipose tissue derived stromal cell therapy for ischemic heart failure

Conditions: Ischemic Heart Failure

Summary: mesenchymal stem cells have capability to differentiate into myocardium, vascular endothelial cell, vascular smooth muscle cell and will be useful for heart regeneration. adipose tissue is relatively enriched with mesenchymal stem cell compared to bone marrow tissue. in this trial, eligible ischemic heart failure patients will be proceeded intracoronary administration of autologous adipose tissue derived stromal cells by cardiac catheterization.

the population of the ischemic heart failure patients is enormous in japan and the only radical treatment for them is heart transplantation: however, the number of giving donor is extremely limited. mesenchymal stem cells have been capable to differentiate into mesodermal-lineage cells as well as endodermal-lineage cells such as myocardial cell. they reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. the latter tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. in this study, the ischemic heart failure patients will undergo intracoronary administration of autologous adipose tissue derived stromal cells through cardiac catheterization.

Eligibility criteria:
inclusion criteria: * heart failure patients occured by prior ischemic event whose ejection fraction must be less than 40%. exclusion criteria: * complicated severe other organ disease. * patient with malignancy. * history of chemotherapy or irradiation within 4 weeks. * patient with immunodeficiency * pregnancy or possibility of pregnancy * candidate who are judged to be not applicable to this study by doctors.

Keywords: ischemic heart failure myocardial regeneration adrc
the influence of cortical lateralization on selective motor control of the arm swing during independent walking after stroke.

Conditions: Stroke, Ischemic; Healthy

Summary: the upper limbs play an essential role for safe and efficient walking in healthy persons and persons post-stroke. nevertheless, in current post-stroke gait rehabilitation (research) the upper limbs are barely targeted. to address this gap, my project aims to investigate the selective motor control of the upper limbs during walking and the contribution of the cortical activity to the arm swing in independent walkers after stroke. to gain insight in the direct effects of stroke on the arm swing, the primary motor control of the arm swing will be evaluated by determining muscle synergies (i.e group of muscles working together as a task-specific functional unit). additionally, the cortical activity (eeg-analysis) during walking of persons post-stroke will be compared to healthy controls and the relationship between stroke-induced changes in cortical activity and arm swing deviations will be assessed. furthermore, i will evaluate whether improvements in cortical activity relate to improvements in primary motor control of the arm swing. this innovative project will be the first to investigate the direct coupling between the cortex and the muscle synergies in persons post-stroke during independent walking to investigate the arm swing. these fundamental insights in the primary motor control of the arm swing and the contribution of the cortical activity will allow to develop targeted interventions aiming to improve arm swing and as such optimize post-stroke gait rehabilitation. research questions: 1. how can muscle synergies explain arm swing alterations in independent walkers after stroke? 2. how do stroke-induced changes in cortical activity relate to arm swing deviations in persons after stroke? 3. are changes in primary motor control of the upper limb during walking related to normalization of brain activity in independent walkers after stroke?


Eligibility criteria:
stroke inclusion criteria: * first-ever, ischemic and cerebral stroke * maximum one-year post-stroke * able to walk at least 10 minutes (fac ≥ 3) * presence of upper limb paresis (nihss item 5a/b \> 0) exclusion criteria: * other neurological disorders healthy controls inclusion criteria: * older than 18 years * able to walk at least 10 minutes exlusion criteria: * pregnancy

Keywords: emg eeg gait arm swing kinematics
early rehabilitation in critically ill children - the picu liber8 study

Conditions: Delirium; Withdrawal Syndrome; Hospital Acquired Condition; Critical Illness Myopathy; Critical Illness

Summary: this is a pilot quality improvement implementation study that will measure the impact of a rehabilitation bundle implementation on the outcomes of interest. advancements in the care provided in pediatric intensive care units (picus) have led to fewer deaths in children. these improvements are unfortunately countered by the emergence of side effects of critical illness, known as picu-acquired complications (pacs). delirium, muscle weakness, drug dependency and withdrawal are increasingly common. pacs occur because children are often over-sedated and experience long periods of immobilization. pacs delay recovery, increase disability and worsen long-term function and quality-of-life. although they are preventable, pacs are very common and frequently overlooked by clinicians. this study aims to "liberate"children from critical illness and improve their recovery and functioning after discharge, through an innovative rehabilitation bundle of 8 complementary steps (picu liber8) to reduce sedation, allow children to awaken and breathe comfortably, encourage early mobilization, and engage families in their child's care.

this is a pilot quality improvement implementation study that will measure the impact of a rehabilitation bundle. the objectives are: 1. primary - implementation objectives: to determine the feasibility and resources required to implement picu liber8 in 2 picus, evaluate strategies for successful bundle adoption. co-primary - process objectives: to determine the impact of picu liber8 on the process of care. 2. secondary efficacy: impact on pacs and patient reported outcomes the methods consist of a picu liber8 bundle implementation plan (pronovost's 4 e's framework), and measurement of the impact of implementation through orchestrated testing (ot). for successful adoption of the picu liber8 bundle, the following are necessary: 1. a context appropriate implementation framework. 2. an implementation team leader. 3. inter-professional team engagement (i.e. rn, rt, md, pharmacy, allied health and family). 4. ability to customize picu liber8 to the needs of each site. we will use the pronovost's implementation framework, which has been shown to facilitate successful bundle adoption and improve the quality of patient care in adult and pediatric icus.17-19 this framework has 4 phases: engage, educate, execute and evaluate.

Eligibility criteria:
inclusion criteria: all children admitted to the pediatric intensive care unit with a minimum of 48h stay in the picu and more than one organ dysfunction. exclusion criteria: as this is an assessment of a quality improvement strategy there are no criteria for excluding participants.

Keywords: rehabilitation critical care child health quality improvement
clinical study of single incision laparoscopic cholecystectomy in the treatment of patients with acute cholecystitis

Conditions: Cholecystectomy, Laparoscopic

Summary: gallstone is a common disease in china.at present, the prevalence of gallstones in china is 15 %, and about 210 million people are sick. acute cholecystitis is acute gallbladder inflammation, is one of the main complications of cholelithiasis or gallstones. the removal of gallbladder and gallstones in patients with acute cholecystitis in the presence of biliary pain will prevent the recurrence of gallbladder and reduce the risk of cholecystitis progression. if gallbladder perforation is not treated in time, the mortality rate is 30 %. acute acalculous cholecystitis without treatment will be life-threatening, with a mortality rate of up to 50 %. at present, the vast majority of patients with acute cholecystitis are treated with 4-hole traditional laparoscopic cholecystectomy and open cholecystectomy. their postoperative quality of life, pain and scar-related complications, remain major factors for patients.in recent years, with the renewal of the concept of minimally invasive surgery and the continuous advancement of instruments and technology, single-incision laparoscopic cholecystectomy has also maximized the quality of life after surgery and reduced postoperative pain and scar-related complications. at present, there are few reports on randomized controlled clinical trials of silc in patients with acute cholecystitis, and there is a lack of large sample size studies.due to the difficulty of silc operation, the longer learning curve, the different equipment conditions and technical characteristics of each center, and the lack of standardized training, there is no effective consensus on the application indications and operation procedures of silc in acute cholecystitis surgery. based on the current status, the purpose of this study was to investigate the effect of silc on postoperative quality of life, postoperative pain, scar assessment and postoperative complications in patients with acute cholecystitis, so as to propose a standardized single incision laparoscopic operation procedure in the treatment of acute cholecystitis.


Eligibility criteria:
inclusion criteria: * acute cholecystitis（gradeⅰ，ii） exclusion criteria: * combined with liver cirrhosis (child grade b and above) * upper abdominal surgical history; * changes in surgical plan (conversion to laparotomy,cholangiography, bile duct exploration, bile duct injury repair, abscess clearance, multivisceral resection.) * patients and their families do not agree with the treatment lost follow-up

Keywords: single-incision laparoscopic cholecystectomy conventional laparoscopic cholecystectomy
salivary linc00657 as a diagnostic biomarker for oral squamous cell carcinoma

Conditions: Oral Squamous Cell Carcinoma

Summary: this study was designed to verify the role of salivary linc00657 as a diagnostic marker in oral squamous cell carcinoma (oscc) patients as compared to oral lichen planus (olp) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to mir-106a. a total of 36 participants were included.

this study was designed to verify the role of salivary linc00657 as a diagnostic marker in oral squamous cell carcinoma (oscc) patients as compared to oral lichen planus (olp) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to mir-106a. a total of 36 participants were included, subdivided into 3 groups: group i: 12 patients diagnosed with oscc. group ii: 12 patients diagnosed with olp. group iii: 12 systemically free individuals with no oral mucosal lesions. statistical analysis and roc analysis were performed

Eligibility criteria:
inclusion criteria: * group i : oral squamous cell carcinoma lesions (oscc) * group ii: oral lichen planus lesions (olp) * group iii: systemically healthy volunteers exclusion criteria: * oral lesions other than oscc / olp in group i and ii * any oral lesion in group iii * pregnant females

Keywords: oral squamous cell carcinoma, oral potentially malignant disorders, saliva, linc00657, mir-106a.
skydiving as a model of psychological stress and its effect on intestinal barrier function

Conditions: Psychological Stress Due to Skydiving

Summary: in this study, it will be investigated how psychological stress evoked by skydiving affects the intestinal permeability in 20 healthy subjects. participants attend two visits: 1) skydiving visit, 2) negative control visit. at all visits, saliva samples, blood samples, and faecal samples are collected, and the multi-sugar permeability test is performed. in this test, participants drink a sugar solution and then collect urine for 5 and 24 h. the ratio of the sugars detected in the urine is a reflection of the intestinal permeability. saliva samples are collected for assessment of cortisol, a stress marker. blood and faecal samples are collected for assessment of markers of intestinal barrier function and inflammation.


Eligibility criteria:
inclusion criteria: 1. written informed consent prior to any study related procedures 2. age \> 18 till \<50 3. novice skydivers (first or second tandem jump) 4. signed up for tandem skydive 5. willing to abstain from probiotic products or medications known to alter gastrointestinal function throughout the study exclusion criteria: 1. abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy. 2. current diagnosis of hypertension. 3. current diagnosis of psychiatric disease. 4. over 100kg or with a body mass index over 35. 5. systemic use of steroids in the last 6 weeks. 6. use of antibiotics or antimicrobial medication in the last month. 7. daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening. 8. usage of medications that could affect the barrier function, except oral contraceptives, during the 14 days prior to screening. 9. diagnosed inflammatory gastrointestinal disease. 10. regular use of probiotics in the last 6 weeks. 11. smoking and/or chewable tobacco. 12. planned changes to current diet or exercise regime. 13. use of laxatives, anti-diarrhetics, anti-cholinergics within last 4 weeks prior to screening. 14. use of immunosuppressant drugs within last 4 weeks prior to screening. 15. women: pregnancy, lactation. 16. abuse of alcohol or drugs. 17. any disease/condition which in the investigator's opinion could interfere with the intestinal barrier function. 18. any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial.
prevention of sars-cov-2 in hospital workers s exposed to the virus

Conditions: SARS-CoV-2 Infection

Summary: the investigators propose to set up a preventive trial of infection in hospital workers at risk of coronavirus infection by comparing the rate of sars-cov-2 infection in a population of negative sars-cov-2 hospital workers receiving preventively azithromycin, hydroxychloroquine or a placebo

randomized clinical trial with 3 arms : hydroxychloroquine group, 300 subjects/azithromycin group, 300 subjects/ placebo of hydroxychloroquine group, 300 subjects. hospital workers workers will be invited to participate in the study in each hospital and they will be included after giving their consent, assessment of their eligibility criteria, endonasal pcr and serolology at baseline. they will be randomized in one of the 3 arms, receive their treatment and will be followed by physical visit (at day 2, day 5, day 15, day 28) and by phone (at day) 40 days with clinical data collection (tolerance and clinical signs of infection). at the end of treatment, another serology will be collected.

Eligibility criteria:
inclusion criteria: hospital workers working at ap-hp hospitals over the age of 18 * hospital workers who have signed consent * no signs of covid-19 infection * women who are likely to procreate should have a negative pregnancy test on inclusion day. in addition, they should use at least one effective contraceptive method before starting treatment, during treatment and up to 8 months after the last drug tested during the trial. sexually active men should also have effective contraception during treatment and for at least 8 months after the last drug tested during the trial. * affiliated or beneficiary of social security exclusion criteria: * history of sars-cov-2 infection confirmed by pcr or serology is available at inclusion * a history of clinical episode suspecting a pcr-confirmed or unconfirmed covid-19 infection. * pregnancy and breastfeeding * allergy or contraindications to one of the 2 drugs in the study * known retinopathy * long congenital qt syndrome (or known in the family) * qtc or 450 ms in men, or 460 ms in women, if fc 55/mn (except in case of intense sport practice), if esv on baseline ecg, if qrs - or 120 ms, if ac/fa, if the pr or bav lengthening * history of severe ischemic heart disease or unbalanced heart failure. * clinically significant bradycardia known * known kidney or liver failure * known g6pd deficit * subject who received antiviral treatment in the 14 days prior to inclusion * subject who had treatment with azithromycin or hydroxychloroquine, in the 14 days prior to inclusion * hypokaliemia (\ =120 micromol/ll, increase in transaminases at baseline (\>=2n)

Keywords: covid-19 sars-cov-2 hydroxychloroquine azithromycin caregivers
study evaluating techniques for measuring tear production

Conditions: Dry Eye Disease

Summary: this will be a vehicle-controlled, masked, randomized study conducted at a single site in the united states. all participants enrolled will have dry eye disease (ded). the study will consist of 2 visits. at visit 1, eligibility will be assessed at screening. all eligible subjects will then be enrolled and randomized to one of two treatment groups (1:1): active (0.003% ar-15512) or control (ar-15512 vehicle). subjects in each treatment group will then be randomized 1:1 to which visit (visit 1 or 2) anesthetic will be used with the schirmer test.


Eligibility criteria:
inclusion criteria: * have used, and/or desired to use artificial tears for ded symptoms within 6 months prior to visit 1 * within the last year from visit 1, have a documented schirmer test with or without topical anesthesia score ≥ 2 and ≤ 10 mm/5 min * within the last year from visit 1, have documented symptoms of ded * corrected visual acuity (snellen) 20/200 or better in both exclusion criteria: * use of artificial tears within 2 hours prior to visit 1 * use of ocular cyclosporine or other prescription ophthalmic solution for ded (e.g., restasis®, cequa®, xiidra®) within 30 days of visit 1 or anticipated use during the study period. * regular use of any topical ocular non-ded medication or use of a topical ocular non-ded medication within 2 hours of visit 1 * use of contact lenses in either eye within 7 days prior to the screening visit or planned use during the study * punctal or intracanalicular plug present in either eyelid or anticipated plug insertion or occlusion at any time during the study.
validation of a questionnaire to identify signs and symptoms of nephrogenic systemic fibrosis

Conditions: Nephrogenic Systemic Fibrosis

Summary: the primary aim of this study is to validate a questionnaire as a screening tool to identify subjects with symptoms suggestive of nephrogenic systemic fibrosis (nsf). the investigators believe that there will be difference between subjects with nsf and other skin conditions and normal skin.


Eligibility criteria:
inclusion criteria: 1. male or female subjects 18 years of age or older. 2. willing and able to understand and provide oral informed consent. 3. able to complete study and comply with study procedures. exclusion criteria: 1. subject is unable to provide oral consent. 2. psychiatric or other conditions which might, in the opinion of the principal investigator, interfere with study evaluations or pose a risk to subject safety during the study.

Keywords: nephrogenic systemic fibrosis screening
long-term outcomes in sle at peking university people's hospital

Conditions: Systemic Lupus Erythematosus

Summary: this study aims to prospectively follow patients diagnosed with systemic lupus erythematosus (sle) at peking university people's hospital, assessing long-term outcomes such as disease activity, organ involvement, survival, and quality of life. findings will support individualized patient management and contribute to understanding disease progression in the chinese population.

this single-center, prospective observational cohort study aims to evaluate the long-term clinical outcomes of patients diagnosed with sle at peking university people's hospital. sle is a chronic, heterogeneous autoimmune disease that can lead to cumulative organ damage, impaired quality of life, and premature mortality. although disease control has improved with the advent of immunosuppressive therapies, predicting long-term outcomes remains a challenge. the study will enroll adult sle patients and follow them for a period of up to 10 years. data will be collected at regular intervals, including clinical assessments, laboratory findings, treatment history, and patient-reported outcomes. a particular focus will be placed on measuring disease activity using validated indices such as the sle disease activity index (sledai) and on evaluating the achievement and maintenance of lupus low disease activity state (lldas). lldas is a validated treat-to-target goal associated with reduced damage accrual and improved prognosis. it will be assessed at each follow-up visit based on established criteria, including low disease activity (sledai-2k ≤4 with no major organ activity), no new disease activity, low-dose glucocorticoid use (prednisone ≤7.5 mg/day or equivalent), and stable standard immunosuppressants. the frequency, duration, and determinants of achieving and sustaining lldas over time will be analyzed as a key outcome, alongside major organ involvement, flare rates, survival, and quality of life. this study will provide real-world data on long-term disease trajectories in a chinese tertiary hospital population and offer insights into predictors of favorable outcomes, guiding personalized disease management strategies and supporting the implementation of treat-to-target approaches in clinical practice.

Eligibility criteria:
inclusion criteria: * all patients must meet at least one of the following classification criteria for systemic lupus erythematosus (sle): the 1997 american college of rheumatology (acr) revised classification criteria; the 2012 systemic lupus international collaborating clinics (slicc) classification criteria; the 2019 eular/acr classification criteria for sle. all patients must be over the age of 18 and competent to provide written consent. exclusion criteria: * patients less than 18 years of age and patients who are unable to consent are excluded from the study.

Keywords: sle lldas survival
a study to assess efficacy and safety of efgartigimod ph20 sc in adults with ocular myasthenia gravis

Conditions: Myasthenia Gravis, Ocular

Summary: the purpose of this study is to evaluate the efficacy and safety of efgartigimod ph20 sc given by a pre-filled syringe in adult patients with ocular myasthenia gravis. the study consists of a part a (approximately 7 weeks) and a part b (up to 2 years). in part a, half of the participants will receive efgartigimod ph20 sc and the other half will receive placebo. in part b, all participants will receive efgartigimod ph20 sc. the participants will be in the study for about up to 2 years and 12 weeks.


Eligibility criteria:
inclusion criteria: * is at least 18 years of age and the local legal age of consent for clinical studies * has been diagnosed with myasthenia gravis and supported by seropositivity for achr-ab; or abnormal neuromuscular transmission demonstrated by abnormal neurophysiology testing and history on positive edrophonium chloride testing or demonstrated improvement on mg therapy" * is mgfa class i (any ocular muscle weakness) * has a screening and baseline mgii (pro) ocular score of at least 6 with at least 2 ocular items with a score of at least 2 exclusion criteria: * other diseases that lead to eyelid drooping, peripheral muscle weakness, or diplopia * known autoimmune disease or any medical condition other than indication under study that would interfere with an accurate assessment of clinical symptoms of ocular myasthenia gravis or puts the participant at undue risk

Keywords: myasthenia gravis ocular myasthenia