Kornimate/medical-research-clean huggingface dataset:
autonomic recalibration

Conditions: Chronic Pain (Back / Neck); Autonomic Dysregulation

Summary: the goal of this clinical trial is to learn if autonomic recalibration works to reduce sympathetic dominance to alleviate dysfunctional myofascial pain. the main questions it aims to answer are: how is the autonomic nervous system (ans) affected during autonomic recalibration treatment (art)? how are myofascial tissue properties impacted from art? participants will: have 2 treatments of art on consecutive days. wear sensors to track hrv (heart rate variability) and gsr to verify autonomic recalibration. measure changes in range of motion by wearing a rokoko motion capture suit. measure changes in muscle stiffness through shear wave elastography.

myofascial pain contributes to opioid misuse and opioid use disorder. alternative non-drug therapies for myofascial pain, such as osteopathic manipulative treatment, are critical areas of research. an unexplored approach in osteopathic manipulative treatment is recruiting the regulatory assistance of the autonomic nervous system (ans) to alleviate myofascial pain. autonomic recalibration technique (art) is a manual and behavioral approach that employs osteopathic principles in addressing the neurobiological mechanisms that regulate myofascial pain. our central hypothesis is that art utilizes ans regulation to restore myofascial function and alleviate chronic myofascial pain. the scientific premise of this proposal is the need to document mechanistic evidence that the ans can be recruited to alleviate and eliminate pain by employing osteopathic principles. while elements of this approach have been employed by various practitioners, including manual and integrative clinicians including osteopaths, the innovation is to combine a manual bottom-up approach to shut down sympathetic tone, and a top-down approach to address trauma-based triggers that propagate pain. if successful, these preclinical data will be used in future grants to propose a clinical trial of art as an additional technique in osteopathic manipulative treatment to provide an alternative to surgical or drug treatment of chronic myofascial pain.

Eligibility criteria:
inclusion criteria: * dysfunctional myofascial pain, i.e., ongoing pain not relevant to an acute perturbation (e.g., recent injury) or known underlying condition (e.g., cancer). exclusion criteria: * known skin allergies to gel as found in common cosmetic or household products * can't make treatment appointments on two consecutive days * myofascial pain is deemed functional (normal response to acute injury or ongoing pathology) * lacking a covid-19 vaccination and a booster shot.

Keywords: chronic pain autonomic nervous system sympathetic dominance myofascial pain sympathetic tone dysfunctional pain primal reflex release technique shear wave elastography heart rate variability galvanic skin response rokoko motion capture range of motion posture
novel quadrilateral surface plate for acetabular fracture

Conditions: Fracture Dislocation

Summary: the novel plate could be used to manage acetabular fractures involving quadrilateral surface and posterior column, which may lower the intraoperative blood loss and reduce complication rate.

stoppa approach was more minimally invasive than ilioinguinal approach for pelvic and acetabular fractures. then, stoppa approach was widely used clinically. for the fragments involving quadrilateral surface, the kocher-langenbeck approach was added because the fixation of posterior fragments could not be obtained with reconstruction plate through single stoppa approach. novel quadrilateral surface plate was used in this study to examine its fixed role for posterior fragments. functional outcome and complication were recorded to compare with the results treated with reconstruction plate. if good results were obtained for the patients fixed with quadrilateral surface plate, it was meaningful to popularize the fixed method.

Eligibility criteria:
inclusion criteria: * over 18 years old * fracture involving quadrilateral surface * operation was conducted within 14 days * fixed with quadrilateral surface plate through stoppa approach exclusion criteria: * presented with a pathologic acetabular fracture * neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable * refused to participate * follow-up insufficient 12 months

Keywords: acetabular quadrilateral surface plate
study of efficacy of ranibizumab in different regimens in patients with diabetic macula edema

Conditions: Diabetic Retinopathy

Summary: the purpose of this study was to demonstrate that the change of best corrected visual acuity (bcva) was comparable in patients treated with ranibizumab at the discretion of the investigator vs. treatment according to a standard of care scheme (pro re nata, as needed).


Eligibility criteria:
inclusion criteria: * patients with type 1 or type 2 diabetes mellitus with glycosylated hemoglobin (hba1c) ≤ 12.0% * patients with visual impairment due to dme in at least one eye * bcva ≥ 24 and ≤ 78 letters in the study eye exclusion criteria: * active intraocular inflammation * any active infection in either eye at the * structural damage within 0.5 disc diameter of the center of the macula in the study eye * uncontrolled glaucoma in either eye at screening other protocol-defined inclusion/exclusion criteria may apply.

Keywords: diabetic macular edema visual impairment
large-scale expansion and characterization of mesenchymal stem cells for clinical application

Conditions: Knee Injuries

Summary: according to many recent research, mesenchymal stem cells (msc) isolated from synovial membrane and infrapatellar fat pad have higher ex vivo proliferation capacity, multipotency and ability to undergo chondrogenesis. based on this concept, the investigators plan to get two removed tissues (synovial membrane and infrapatellar fat pad) from patients who have an operation of total knee replacement. the investigators are going to isolate and expand msc from these two tissues respectively, and then compare the chondrogenesis ability for clinical application. in the other hand, the investigators plan to build techniques and procedures which comply with "good tissue practices (gtp)"


Eligibility criteria:
inclusion criteria: patient who have an total knee replacement surgery exclusion criteria: patient who don't sign the agreement

Keywords: mesenchymal stem cells
prevention of pre-eclampsia and sga by low-dose aspirin in nulliparous women with abnormal first-trimester uterine artery dopplers

Conditions: Pre-eclampsia; Intra-uterine Growth Restriction

Summary: the objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous pregnant women selected as "high-risk" by the presence of a bilateral uterine artery notch and/or bilateral uterine artery pi ≥ 1.7 during the first trimester ultrasound scan (11-13+6 weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * nulliparous (no previous pregnancy ≥ 22 sa) * singleton pregnancy * gestational age ≤ 15 +6 weeks * bilateral uterine artery notch (grade ≥ 2) and/or bilateral uterine artery pi ≥ 1.7 during first trimester ultrasound (crl between 45 and 84 mm) * maternal informed consent obtained * affiliated to social security system exclusion criteria: * women considering voluntary pregnancy termination (≤ 14 weeks) * pre-existing (maternal) indication for premature delivery before 37 weeks * fetal condition detected during the first trimester scan (fetal malformation or nuchal translucency ≥ 95th percentile) * women under anticoagulation * allergy or hypersensitivity to kardegic® or one of its constituents * secondary hemostasis disorder responsible for bleeding or risk of bleeding * peptic ulcer under evolution * lupus or antiphospholipid syndrome

Keywords: low dose acetylsalicylic acid prevention pre-eclampsia intra-uterine growth restriction primiparous women bilateral uterine artery notches first quarter
long term complications in head and neck cancer patients

Conditions: Head-and-neck Cancer

Summary: problem: with increasing numbers of cancer survivors, strategies to prevent long-term complications in cancer patients become more important. adolescent and young adult (aya) head and neck cancer survivors treated with radiotheray (rt) are prone to long-term complications, especially vascular and psychosocial complications. although several studies point to the importance of these long-term complications, structured survivorship care for aya hnc survivors is still lacking. primary objective: to investigate in aya hnc survivors treated with unilateral rt at least 5 years before, the long-term vascular complications in terms of carotid wall changes (ultrasonography, mri), cerebral vascular complications ((silent)brain infarctions, white matter lesions) and cardiovascular risk management profile. secondary objective: to investigate in aya hnc survivors treated with unilateral rt at least 5 years before, the long-term psychosocial complications (subjective memory complaints, depression, anxiety, fatigue, speach handicap, anxiety for recurrence, quality of life, objective cognitive failure) study design prospective cohort study. patient population aya hnc survivors ≥ 5 years after unilateral rt, either alone or in combination with surgery and/or chemotherapy. controls the ultrasonography (intima media thickness, elastography) and mri measurements of the irradiated carotid wall will be compared to the non-irradiated carotid wall. cognitive performance will be compared to normative data. the cognitive performances of the right hemisphere tests will be compared to the cognitive performances of the left hemisphere tests. the frequency of silent brain infarcts and vascular white matter lesions of the irradiated vascular territory will be compared with the non-irradiated territory. intervention structured survivorship care ≥ 5 years after rt conform the personalized cancer survivorship care model of the radboudumc expertisecenter of late effects after cancer, complemented with carotid ultrasonography (imt and elastography), mri of the carotid arteries and brain), neuropsychological assessment battery and self-reported questionnaires concerning depression, fatigue, qol, positive health and employment status.


Eligibility criteria:
inclusion criteria: * hnc patient treated with unilateral rt at age 18-40 years 5-10 years before * informed consent exclusion criteria: * contra indication mri * able to communicate in dutch language

Keywords: head and neck cancer radiotherapy complications vascular
human sperm epigenetics in embryonic development.

Conditions: Male Infertility; Epigenetic Disorder

Summary: a total of 60 men (40 with a history of infertility and treatment with assisted reproduction and 20 infertile controls achieving conception naturally) will be asked to provide at least one semen sample each for conventional semen analysis including measurement of dna-fragmentation and semen preparation with swim-up. the prepared semen sample will then analyzed by comprehensive microscopy analyses aiming at identifying distinct subpopulations of spermatozoa based on chromatin density and composition, mitochondrial and acrosome function and epigenetic markers. in addition, spermatozoa samples of selected individuals will be subjected to comprehensive analyses of the chromatin and rna expression status using epigenomic approaches.

hitherto male infertility has been defined by conventional semen analysis only, which mainly consists of determining concentration, progressive mobility and morphology of spermatozoa. however, the diagnostic accuracy of conventional semen analysis is poor and has very limited relationship with the outcome of assisted reproductive medicine. preliminary data suggest that differences in chromatin density and epigenetic status of sperm may be more relevant, in particular with respect to the growth and differentiation of early embryos. chromatin density, morphology, mitochondrial status and epigenetic state in sperm of infertile men with disturbances of early embryo development in vitro will be compared with those of infertile men with normal embryo development and with fertile controls. primary outcome: features of chromatin density will be determined through staining of large numbers of spermatozoa. differences in the staining results will be compared with known fertility outcome. secondary outcome: development of significant staining parameters towards the selection against sperm with reduced embryonic competence and/or in favor of sperm supporting embryonic development after assisted reproduction, thereby using flow cytometry and sorting (facs) .

Eligibility criteria:
inclusion criteria: * men with a history of infertility. sperm concentration must be \>15 millions per ml. exclusion criteria: * no vulnerable persons will be invited to participate.

Keywords: assisted reproductive technology dna fragmentation histone protamine blastocyst
ro60 expression in macrophages in sjogren's disease

Conditions: Sjogren's Syndrome

Summary: context: the ro60 protein associates with yrnas (or rnys) to form the rornp complex, which regulates rna surveillance and maturation. it is hypothesized that its impairment by nuclear penetration of the anti-ro60 autoantibodies, would deregulate the anti-inflammatory response in monocytes/macrophages (mo/mp) in patients with sjögren's disease (sd).


Eligibility criteria:
inclusion criteria: * patients with ssp subjects aged between 18 and 75, without chronic disease; subject meeting the classification criteria for ssp; subject with positive anti-ssa serology; french-speaking subject able to give written consent; subject affiliated to the sécurité sociale or an equivalent scheme; subject willing to have blood samples taken; * control subjects subjects aged between 18 and 75, without chronic disease and not meeting ssp classification criteria; subject who understands and speaks french and is able to give written consent; subject affiliated to the french social security system or an equivalent scheme; subject willing to have blood taken; exclusion criteria: * subject receiving current anti-inflammatory treatment (e.g. corticosteroid therapy, non-steroidal anti-inflammatory drugs) or a regimen of more than 1 month within the last 3 months; * subject undergoing biotherapy or cytoreductive treatment; * subjects with positive serologies for human immunodeficiency virus (hiv), viral hepatitis b virus (hbv) and viral hepatitis c virus (hcv) in the 3 months preceding the inclusion visit; * protected persons as defined in articles of the french public health code.

Keywords: sjogren's syndrome cardiovascular risk ro60 protein connective tissue disorder
immune effects of low-dose naltrexone in me/cfs

Conditions: Fatigue Syndrome, Chronic

Summary: the main objective of this study is to test if naltrexone, when taken in low doses, has an anti-inflammatory effect that may be associated with positive clinical outcomes in people with chronic fatigue syndrome (cfs). in part, the present study, is a continuation of prior work in which we showed that chronic fatigue symptoms are associated with immune activity, and that low-dose naltrexone might exert anti-inflammatory effects in fibromyalgia, which is thought to share some pathophysiological and clinical characteristics with cfs.


Eligibility criteria:
inclusion criteria: 1. meet the 1994 case definition criteria for cfs (assessed through semi-structured interview and the depaul university fatigue questionnaire): * criteria: * severe chronic fatigue ≥6 consecutive months not due to ongoing exertion or other medical condition associated with fatigue; * fatigue interferes with daily activities and work; * reports ≥4 symptoms that started with or after the fatigue, from: * post-exertion malaise \>24 hours * unrefreshing sleep * short-term memory or concentration impairment * muscle pain * joint pain without swelling or redness * headaches of a new type/pattern/severity * lymph node tenderness * frequent or recurring sore throat 3. cfs symptoms for ≥12 months 4. participant completes daily self-report during the 4-week baseline period; 5. able to attend uab on all scheduled appointments exclusion criteria: 1. blood draw contraindicated or otherwise not able to be performed 2. high-sensitivity c-reactive protein (hs-crp) ≥3 mg/l 3. erythrocyte sedimentation rate (esr) \>60 mm/hr 4. positive rheumatoid factor 5. positive anti-nuclear antibody (ana) 6. levels of thyroid stimulating hormone or free thyroxine outside uab lab reference values 7. diagnosed rheumatological or auto-immune condition 8. clotting disorder 9. use of blood thinning medication 10. oral temperature \>100˚f at baseline 11. febrile illness or use of antibiotics in the 4 weeks before study commencement; 12. planned surgery or procedures during the study period, or operated on in the 4 weeks before study commencement 13. pregnant or planning on becoming pregnant within 6 months 14. regular use of any anti-inflammatory medication (such as aspirin, ibuprofen, naproxen) 15. known allergy or adverse effects following naltrexone or naloxone administration 16. opioid use (self-reported or positive on urine test) 17. significant psychological comorbidity that in the discretion of the investigator compromises study integrity and/or a baseline hads depression subscale score of ≥16 18. current litigation or worker's compensation claim 19. current participation in another treatment trial 20. vaccinated in the 4 weeks before study commencement (vaccination during the study period is allowed as long as the drug is administered at least 4 weeks prior to a study blood draw).
lysyl oxidase, semaphorin 7a and semaphorin 3a in patients with systemic sclerosis

Conditions: Systemic Sclerosis

Summary: the aim of our study is to find a biomarker for fibrosis or vasculopathy in systemic sclerosis. we will evaluate a possible correlation between semaphorin 7a, semaphorin 3a and lysyl oxidase and fibrosis (lung and skin) or vasculopathy in patients with systemic sclerosis. the results obtained may help us diagnose these complications of systemic sclerosis and hopefully even monitor patient treatment.


Eligibility criteria:
inclusion criteria: * systemic sclerosis patients * written consent to participation in study exclusion criteria: * serious active medical condition * other autoimmune rheumatic disease * current or past allergic/inflammatory reaction * liver disease * pregnant or breastfeeding * illegal drug or alcohol abuse
perampanel single ascending dose transcranial magnetic stimulation biomarker study in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: to evaluate if transcranial magnetic stimulation can be used as a biomarker in amyotrophic lateral sclerosis (als).

to measure the effect on motor threshold (mt) by transcranial magnetic stimulation (tms) after a single dose of perampanel at two dose levels.

Eligibility criteria:
inclusion criteria: 1. a probable laboratory supported, probable or definitive als diagnosis by revised el escorial criteria. 2. sporadic or familial als. 3. ages of 18-70. 4. agree to use reliable contraception 5. randomization will occur after a baseline mt has been established; any subject in whom a mt cannot be established will be excluded. 6. caregiver willing to report adverse behavioral events. - exclusion criteria: 1. history of epilepsy. 2. significant laboratory abnormality (ast or alanine aminotransferase \>3x upper limit of normal, or glomerular filtration rate \<60) 3. history of aggressive behavior. 4. subject unwilling to abstain from alcohol for 2 weeks after each dosing. 5. history of drug abuse in the last 5 years 6. other severe medical conditions, including psychiatric conditions, which would cause an increased risk in the opinion of the investigator, including but not limited to renal failure and liver failure. 7. skull defect or other physical contraindication for tms 8. pacemaker or implanted defibrillator 9. inability to take study capsule by mouth females only: subject is pregnant \[as confirmed by a positive serum human chorionic gonadotropin (hcg) test for females of reproductive potential (frp) only\], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow use of reliable contraception. -
a prospective, multicenter all comers study of phasix mesh for ventral or incisional hernia repair

Conditions: Ventral Hernia; Incisional Hernia

Summary: collect data on safety, performance, and effectiveness of phasix mesh in subject requiring primary ventral and incisional hernias.

pilot study of patients across all wound classes for recurrence

Eligibility criteria:
inclusion criteria: * subject or subject's legally authorized representative must be willing to give written informed consent * subject must be diagnosed with ventral or incisional hernia * subject must be willing to undergo open ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol. exclusion criteria: * subject is an active smoker (if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery). * subject's hernia has recurred four or more times. * subject's body mass index (bmi) \>40 kg/m2. * subject has peritonitis. * subject is on or suspected to be placed on chemotherapy medications during any part of the study. * chronic steroid use or immunosuppression drugs (\> 6 months). * subject has cirrhosis, and/or ascites. * subject is american society of anesthesiology class 4 or 5. * subject is pregnant or planning to become pregnant during the course of the study. * subject is known to be infected with human immunodeficiency virus (hiv). * subject has a life expectancy of less than 2 years at the time of enrollment. * subject has been treated with an investigational product in the past 30 days. * subject is part of the site personnel directly involved with this study * subject has a known allergy to tetracycline hydrochloride or kanamycin sulfate, the test device or its component materials. * subject has any condition that in the opinion of the investigator would preclude the use of the study device, or preclude the subject from completing the follow-up requirements