Kornimate/medical-research-clean huggingface dataset:
local infiltration versus block against pains after high tibial osteotomy

Conditions: Osteoarthritis; Malalignment

Summary: the purpose of this study is to elucidate whether patients operated with high tibia open-wedge osteotomy for osteoarthritis of the knee can be treated more appropriately, so that both healing and rehabilitation are served optimally.

axis corrective surgery of the knee is an attractive alternative to the knee prosthesis in young active patients with unilateral osteoarthritis of the knee. the purpose of this study is to elucidate whether patients operated with high tibia open-wedge osteotomy for osteoarthritis of the knee pain can be treated more appropriately, so that both healing and rehabilitation are served optimally. proximal open-wedge tibia osteotomy is an accepted treatment option for younger patients with unilateral osteoarthritis of knee. 70 such operations are performed in the investigators orthopaedic divisions each year. the surgery involves cutting through the upper end of the tibia and opens the bone using specialized instruments. the tibia is lengthened on the medial side with the purpose of correcting the mechanical axis of the knee joint. the surgery is associated with many pains in the early postoperative phase. until now, pain treatment has been controlled with either epidural block, or regional block via femoral catheter. both treatments may involve risks such as loss of strength and sensibility disturbance, which often prolongs the early recovery and mobilization. moreover, pain treatment administered via femoral catheter is often not sufficient as a part of the area behind the knee joint is not covered. with the advent of new pain therapies, particularly intra operative administration of local anaesthetics directly in the operating field and catheter administration for postoperative pain management, there is hope that those disadvantages are eliminated. by ensuring an effective pain treatment and the possibility of early mobilization only hours after completion of surgery, this will allow for better patient care in terms of reduced pain, shorter hospitalization and quicker rehabilitation. new results show that the healing of bone opening is not compromised by rapid mobilization. the migration of bone parts around the opening is measured by roentgen stereometric analysis (rsa), with a precision of approximately 0.2 mm. this verifies stable healing of the bone opening.

Eligibility criteria:
inclusion criteria: * planned primary open-wedge high tibia osteotomy * patients (male/female) ≥ 18 år * patients giving written informed consent and authority. * patients receiving epidural anaesthesia exclusion criteria: * patients with intolerance to trial medications * rejection of or contraindicated epidural anaesthesia * patients with rheumatoid arthritis. * patients with body mass index (bmi) ≥ 35 * patients that do not read or write danish

Keywords: unicompartmental osteoarthritis varus malalignment opening wedge hto high tibia osteotomy
hypoglycemia associated autonomic failure in type 1 diabetes mellitus

Conditions: Type 1 Diabetes

Summary: elevations of plasma cortisol, a stress hormone, during prior episodes of low blood sugar (hypoglycemia) appear to be responsible for the deficient responses during subsequent hypoglycemia. our specific aim is to determine if dehydroepiandrosterone (dhea), a hormone with anti-corticosteroid actions, can prevent hypoglycemia associated autonomic failure in type 1 diabetic volunteers.

dhea is the acronym for dehydroepiandrosterone, a steroid hormone produced naturally from cholesterol in the adrenal glands of males and females. it is also sold as an over-the-counter dietary supplement, and seems to have anticorticosteroid effects. dhea antagonizes the effects of corticosterone on hippocampal function in rats and reduces responses to neural stress in mice. in our lab we have found that administration of the dhea to rats during antecedent hypoglycemia, preserves counter-regulatory responses to subsequent hypoglycemia. the purpose of this study is to determine if the same response occurs in humans.

Eligibility criteria:
inclusion criteria: * 28 (14 males, 14 females) healthy volunteers aged 18-45 yr. * 28 (14 males, 14 females) type 1 diabetic patients aged 18-45 yr. * hba1c \< 11.0% * has been diagnosed type 1 dm * no major diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc) * body mass index \< 40kg/m-2 exclusion criteria: - pregnancy medical history- * hepatic failure/jaundice * renal failure * acute cerebrovascular/ neurological deficit physical exam- * pneumonia * fever greater than 38.0 c * blood labs according to protocol

Keywords: hypoglycemia dehydroepiandrosterone
comparison of mbr + suture tape, mbr, and anatomic reconstruction for clai in gjl cases: a prospective cohort study

Conditions: Ankle Sprains; Hypermobility Syndrome

Summary: gjl is a risk factor for postoperative recurrent instability following an mbr for clai. bpr with suture tape augmentation and anatomic reconstruction may provide more strength and stability. however, bpr with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. in addition, the outcomes between the bpr with suture tape augmentation and anatomic reconstruction were unknown.

generalized joint laxity (gjl) is a risk factor for postoperative recurrent instability following an open modified broström repair (mbr) for chronic lateral ankle instability (clai). mbr with suture tape augmentation and anatomic reconstruction may provide more strength and stability. however, bpr with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. in addition, the outcomes between the bpr with suture tape augmentation and anatomic reconstruction were unknown.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of lateral ankle pain and instability beighton score ≥4 age with 18 to 60 years exclusion criteria: * patients with an acute or subacute ankle injury (within 3 months) injury of the deltoid ligament alignment of lower extremity greater than 5 degrees fractures of the lower extremity stage iii or iv osteoarthritis patients who refused to participate in the study
the influence of covid-19 on the audio-vestibular system

Conditions: Covid19

Summary: the study's porpuse is to examine whether covid-19 causese a reduction in sensorineural hearing and vestibular function in recovered pateints - compared to healthy controls. both study groups will undergo audiometry, tympanometry, video head impulse testing, subjective visual vertigo testing and video-nystamography. previous audiometry results will also be aquired.


Eligibility criteria:
inclusion criteria: * ages 18-80 performed audiometry testing in the last two years exclusion criteria: * known inner ear dysfunction - sudden sensorineural hearing loss; autoimmune disease (cogan's syndrom, sle, ect.), familial/genetic sensorineural hearing loss, excessive noise exposure. knowm conductive hearing loss (air-bone gap\>10db) prior ear surgery chronic tympanic membrane perforation.
safety and efficacy of umbilical cord mesenchymal stem cell therapy for patients with progressive multiple sclerosis and neuromyelitis optica

Conditions: Progressive Multiple Sclerosis; Neuromyelitis Optica.

Summary: multiple sclerosis (ms) has been classically regarded as a chronic inflammatory autoimmune demyelinating disease of the central nervous system, along with a considerable pathological heterogeneity. neuromyelitis optica (nmo) is a severe inflammatory, demyelinating disease, and its clinical characteristics include recurrent optic neuritis and longitudinally extensive transverse myelitis. current therapies provide only modest control of progressive multiple sclerosis and neuromyelitis optica.stem cell therapy might open a light horizon in approaching to an efficient treatment in progressive ms and nmo. in this study, the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation will be evaluated in patients with progressive ms and nmo.


Eligibility criteria:
inclusion criteria: * mcdonald diagnosis of multiple sclerosis or 2006 diagnosis of neuromyelitis optica. * aged 16-65 years. * disease duration≥2years * poor response to steroid therapy. * written informed consent and follow the clinic trail procedure exclusion criteria: * cardiac insufficiency; renal insufficiency; hepatic insufficiency; total bilirubin higher than 1.5 times of upper limit of normal value; ast /alt higher than 2.5 times of upper limit of normal value. * combined pneumonia or other severe systemic bacteria infection. * severe drug allergic history or anaphylaxis to 2 or more food or medicine. * intracranial hypertension dues to other brain lesions (eg. brain cancer)/ * hiv+, tppa +， patients diagnosed as hbv or hcv. * tumor markers + * severe psychotic patients, cognitive dysfunction,or can not understand or sign the consent form. * coagulation disorders. * uncontrolled hypertension after treatment，blood pressure≥180mmhg/110 mmhg. * pregnancy. * enrollment in other trials in the last 3 months. * other criteria the investigator consider improper for inclusion.

Keywords: progressive multiple sclerosis neuromyelitis optica umbilical cord mesenchymal stem cell
plasma injections plus exercise for patellar tendinopathy

Conditions: Patellar Tendinopathy

Summary: this is a randomized controlled clinical trial to investigate the effectiveness, safety and tolerability of platelet-rich plasma (prp) injections for treatment of patellar tendinopathy in adults 18-50 years of age. subjects will be randomly assigned to three parallel treatment groups: 1. leukocyte-rich prp injection + exercise 2. leukocyte-poor prp injection + exercise 3. saline injection + exercise (control) primary endpoints are (1) the number (rate) and severity of adverse events as reported by both patients and study physicians during the first 12 weeks after initiation of treatment, (2) patient-rated tolerability of treatment; (3) the change in function (visa score) and treatment success (global improvement scale) over six months of a post-injection exercise protocol.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 and ≤ 50 years of age at enrollment visit * documentation of a clinical diagnosis of patellar tendinopathy, grade-iiib blazina stage, confirmed on ultrasound * previously tried an exercise program of at least six weeks duration * fluent in official language of study site * written informed consent obtained from subject * normal values on screening laboratory panels (cbc, pt, ptt, inr, serum creatine, alt, alp, ast, bilirubin, albumin) exclusion criteria: * for women of child-bearing potential, positive pregnancy test at enrollment visit * major surgery in the past three months * surgery on the symptomatic knee * bleeding disorder * systemic inflammatory disease * arthritis or degenerative knee condition * recent fluoroquinolone use * subjects who have any requirement for the use of systemic steroids or immunosuppressants * subjects who are known to be hiv positive * uncooperative patient, or patients who are incapable of following directions or who are predictably unwilling to return for follow-up examinations * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
the effect of lavender inhalation on sleep quality in individuals with coronary heart disease

Conditions: Nursing Caries

Summary: the study is planned to be conducted as a two-group randomized controlled trial to determine the effect of lavender inhalation on individuals with coronary heart disease. research data will be collected at çukurova university medical faculty balcalı hospital cardiology clinic between january-june 2023. in the study, at least 56 samples were found to be sufficient for the sample size. the data of the study will be collected using the personal information form and the pittsburg sleep quality index.


Eligibility criteria:
inclusion criteria: * able to understand and speak turkish, * who agreed to participate in the research exclusion criteria: * people with communication difficulties and mental retardation * people with coagulation disorders * people with migraines and chronic headaches * people with an allergy to lavender (lavandula angustifolia mill) * it is the desire to leave the research.
fibromyalgia and psychiatric symptoms among pms and pmdd patients

Conditions: Premenstrual Syndrome

Summary: assessing fm and psychiatric disorder in patients suffering from pms or pmdd


Eligibility criteria:
inclusion criteria: * pmdd * pms * referral to gynecologist clinic without symptoms of pms or pmdd
focal vibrations and neuropathic pain in diabetic peripheral neuropathy

Conditions: Peripheral Neuropathy; Diabetic Neuropathies

Summary: most of the literature found on whole body vibrations(wbv) instead of focal muscle vibrations (fmv) in diabetic peripheral neuropathy patients. the studies found on the effects of focal vibrations could not be generalised on the huge population of diabetes mellitus (dm) induced neuropathic pain because of small sample size and due to subordinate studies i.e, pilot studies done on the focal vibrations in which 3 different modes of vibrations is used without comparing with the control group. these studies are not much valuable in literature as well as for clinical purposes due to lack of control group. as mentioned in previous studies that better results achieved with the wbv on pain in diabetic peripheral neuropathyso that the hypothesis can be made that when fmv directly applies on the focal region that may influence the pain and/or peripheral neuropathy status.

diabetic neuropathy is the most common complication associated with diabetes mellitus, affecting approximately 50-70% of patients with diabetes. the prevalence of pain and of paraesthesia were 20% and 33% 10 years after diagnosis of diabetes mellitus (dm). dpn is the leading cause for disability due to foot ulceration and amputation and significantly lowers quality of life (qol). neuropathic pain is caused by a lesion or disease of the somatosensory system, including peripheral fibres (aβ, aδ and c fibres) and central neurons. thus the prevalence of dpn and limitations of current studies make evident the need for future research.the study going to be taken with a large sample size, further testing the efficacy of fmv as a treatment for dpn and also check the detraining effects after discontinuation of therapy for 1 month so that the gaps in the literature can be full filled

Eligibility criteria:
inclusion criteria: * diabetic type ii patients. * score \>12 at leeds assessment of neuropathic symptoms \& signs (lanss) * diagnosis of diabetic peripheral neuropathy, using previous history, physical examination and vibration perception test of the patients * post diabetic duration of 10 years * patient with lower limb pain ranges from 3 to 5 on short form mcgill pain exclusion criteria: * lower extremity amputation * neuropathy other than diabetes

Keywords: pain neuropathy diabetes
the gut brain axis, effect of dietary changes and probiotics supplement on depression symptoms .

Conditions: Gut-brain Axis; Dietary Changes; Probiotics Supplement; Depression Symptoms

Summary: to investigate the effects of a high-fiber diet and probiotic supplementation on depression symptoms in adult individuals.

depression is prevalent mental health disorder that significantly impacts individuals' quality of life. despite the availability of effective treatments such as pharmacotherapy and psychotherapy, there are still significant limitations to these approaches. medications can have unwanted side effects and may not be effective for all patients, while psychotherapy can be time-consuming and expensive. furthermore, many individuals may not have access to these treatments due to financial, geographical, or cultural barriers. a more recent study published in the journal of pediatric gastroenterology and nutrition in 2020 investigated the effects of a probiotic supplement on gastrointestinal symptoms and quality of life in children with functional abdominal pain. the study found that the probiotic supplement improved gastrointestinal symptoms and quality of life in the children. overall, while there is limited research on probiotics in egypt, the available studies suggest that probiotics may have potential health benefits for various populations. however, further research is needed to better understand the optimal types, doses and duration of probiotic supplementation for specific health outcomes in egyptian populations.

Eligibility criteria:
inclusion criteria: * healthy individuals aged 18 to 65 years. * both sexes. exclusion criteria: * pregnancy or lactation * recent use of antibiotics or corticosteroids (within the past 3 months) * chronic medical conditions that may interfere with study participation or interpretation of results (e.g., hypo or hyperthyroidism , cancer, diabetes, cardiovascular disease) * current or past diagnosis of major depressive disorder or anxiety disorder * current use of antidepressant or anxiolytic medications * history of gastrointestinal disorders or diseases (e.g., inflammatory bowel disease, celiac disease , malabsorbtion ) * history of substance abuse or dependence
neural, behavioural, and clinical effects of tdcs in pdoc; feasibility study

Conditions: Consciousness Disorder; Brain Injuries; Vegetative State; Minimally Conscious State

Summary: this study evaluates the feasibility of an experimental protocol that combines advanced multi-modal imaging of the brain with clinical and behavioural scales to characterise the neural, behavioural, and clinical effects of transcranial direct current stimulation (tdcs) for rehabilitation in pdoc

patients with prolonged disorders of consciousness (pdoc) have very limited therapeutic options, and they often show little to no progress over time. here, the investigators will assess whether transcranial direct current stimulation can improve patients' responsiveness. the investigators will use a protocol designed to target specific brain networks that have been shown to play a key role in explaining the lack of voluntary responses in pdoc. the study will focus on characterising the mechanisms of action of tdcs and the bases for potential individual differences in responsiveness to the stimulation across participants. this feasibility study is the first step towards developing personalised tdcs interventions to restore external responsiveness in pdoc patients. its results will inform the design of a future trial fully powered for characterising neural, behavioural, and clinical effects of tdcs in pdoc as well as the mechanisms underlying individual differences in responsiveness.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * receiving care at a recruitment site, with a consensus clinical diagnosis of pdoc from any aetiology (i.e. traumatic or non-traumatic injury). * stable and with no need of mechanical support (i.e. respirator, etc.) exclusion criteria: * scalp skin sores or any skin damage at the electrode sites * metallic implants in the face or skull * craniectomy or cranioplasty * no evidence of auditory startle in clinical observations, or absent brainstem auditory evoked potentials in recent clinical history (if data available) * mri incompatible: metal plates incompatible with mri scanners, pacemaker, inability to lay flat for prolonged periods of time, aneurysm clips, neurostimulators, brain/subdural electrodes, etc. (mri stream only)
comparison of the verifynow® aspirin test and prutest® platelet reactivity tests with investigational reagent to reagents registered in japan

Conditions: Platelet Aggregation; Coronary Artery Disease

Summary: this is a multi-center convenience sample prospective study comparing the results of the verify now® aspirin test and prutest® platelet reactivity tests with the japan investigational reagents to reagents registered in japan in the expected population receiving aspirin (asa) and the p2y12 inhibitor clopidogrel.

* the primary objectives of this study are to compare the results of: * the verifynow aspirin test with aa, an investigational reagent as defined in japan, against lta with aa investigational reagent as defined in japan (study reference reagent), in subjects receiving dapt (asa and clopidogrel or subjects taking no platelet inhibitors including asa; * the verifynow aspirin test with aa, an investigational reagent as defined in japan, against lta with collagen (study reference reagent), o in subjects receiving dapt (asa and clopidogrel) or in subjects taking no platelet inhibitors including asa * the verifynow prutest with adp, an investigational reagent as defined in japan, and pge1, against lta with adp, an approved reagent in japan (study reference reagent) and pge1, and * the verifynow prutest with adp (an investigational reagent as defined in japan) and pge1 against lta with adp reagent approved in japan (study reference reagent) with no pge1, o in up to 75 subjects receiving dapt (asa and clopidogrel) and in up to 55 subjects taking no platelet inhibitors (total up to 130 subjects).

Eligibility criteria:
inclusion criteria: * males and females 18 years of age or older. * subjects regularly taking asa and clopidogrel, for a minimum of 4 days prior to enrollment, or subjects taking no platelet inhibitors including asa. * willing to participate and able to understand the study, including their rights and any risks associated with their participation, and sign an informed consent. * able and willing to donate a blood sample of 15ml. • exclusion criteria * enrolled in any other study that involves an investigational drug and/or device. * smoked within one hour before blood draw. * had caffeine within 2 hours before blood draw. * had meals with high fat content within 8 hours before blood draw. * a platelet count below 92,000/µl, or above 502,000/µl for verifynow aspirin test.\* * a platelet count below 119,000/µl, or above 502,00/µl for verifynow prutest.\* * a hematocrit level below 29%, or above 56% for verifynow aspirin test.\* * a hematocrit level below 33%, or above 52% for verifynow prutest.\* * within the past 48 hours, exposure to any of the following drugs: * antiplatelet/glycoprotein inhibitors \[eptifibatide, tirofiban\] * any antiplatelet drug except clopidogrel and asa \[e.g. ticagrelor, prasugrel\]

Keywords: platelet aggregation p2y12 inhibitor
effects of repeated doses of lu af35700 on drug metabolizing enzymes

Conditions: Drug Reactions

Summary: this study will help determine which types of drugs that may interact with lu af35700


Eligibility criteria:
inclusion criteria: * body weight at least 50 kg and body mass index 19 - 30 kg/m2 * good general health ascertained by a detailed medical history, laboratory tests and physical examination exclusion criteria: -pregnant or lactating women other protocol defined inclusion and exclusion criteria may apply