Kornimate/medical-research-clean huggingface dataset:
repeated bout effect i neuromuscular diseases

Conditions: Myopathy

Summary: the repeated bout effect (rbe) refers to the adaptation whereby a single bout of eccentric exercise protects against muscle damage from subsequent eccentric bouts. this effect has been shown in many muscle groups using both serum biomarkers, muscle soreness and imaging techniques. though the effect is well described in healthy, it has never been studied in patients with neuromuscular diseases (nmds). in healthy, the rbe is only described using eccentric exercise, but unlike healthy persons, patients with nmds can experience significant muscle damage with concentric exercise. this raises the question, if patients with nmds could also show rbe when performing concentric exercise.

the repeated bout effect (rbe) refers to the adaptation whereby a single bout of eccentric exercise protects against muscle damage from subsequent eccentric bouts. this effect has been shown in many muscle groups using both serum biomarkers, muscle soreness and imaging techniques. though the effect is well described in healthy, it has never been studied in patients with neuromuscular diseases (nmds). nmds are a common term for diseases that affect the muscles by disease processes in the motor neuron, peripheral nerve, neuromuscular junction or the muscles. the diseases can cause symptoms such as muscle weakness, muscle fatigue and sometimes muscle pain and varying degrees of physical disability. as the mechanisms for disease varies among nmds, it is likely that some patients will experience rbe in a similar fashion to healthy, while others may not. recent years have shown significant breakthrough in the treatment development for various nmds, and many of these treatments are currently or will soon be evaluated in clinical trials. as many trials will use exercise to evaluate treatment effect, it is vital to understand whether a single bout of exercise in itself provides a protective effect on the muscles of patients with nmds. in healthy, the rbe is only described using eccentric exercise, but unlike healthy persons, patients with nmds can experience significant muscle damage with concentric exercise. this raises the question, if patients with nmds could also show rbe when performing concentric exercise.

Eligibility criteria:
inclusion criteria: * age \> 18 years * the ability to complete the exercise challenge * no concurrent medical condition that could interfere with interpretation of the results * molecular diagnosis of the specific condition in specified patient groups or healthy control * no active muscle injury on the test day (caused by recent exercise, seizures, trauma, etc.) exclusion criteria: * cardiac or pulmonary disease contraindicating peak exercise testing or strenuous exercise defined as nyha-class iii-iv * veins that are too difficult to puncture for blood sampling, evaluated by the investigator * severe muscle weakness, that prevents the subject completing the exercise test, evaluated by the investigator
iv iron in association with tranexamic acid for hip fracture

Conditions: Hip Fracture; Anemia

Summary: it is a prospective randomized controlled study aiming to test if tranexamic acid combined to intravenous iron before and after surgery for hip fracture in elderly can decrease peri-operative red cell transfusion.

hip fracture is an increasing problem. anemia is a common finding in these patients with a prevalence ranging from 24% to 44% and is a strong negative prognostic marker. several studies have explored whether interventions to improve anemia result in better outcomes. thus, alternatives to allogenic red cell transfusion have been suggested in hip fracture, such as iv iron and tranexamic acid. the aim of the study is to test the effect of combination of iv iron with tranexamic acid before and after surgery for hip fracture on incidence of peri-operative red cell transfusion. it is a prospective randomized single-blinded monocentric study including 150 patients undergoing hip fracture surgery within 72 h after trauma aged ≥ 60 years divided in 3 groups: group a (iv fer+tranexamic acid), group b (tranexamic acid), group c (placebo). the main outcome was percentage of patients who receive red-cell transfusion during hospitalization. hemoglobin levels up to 60 days post-operatively and incidence of thrombotic events were secondary outcomes.

Eligibility criteria:
inclusion criteria: * patients undergoing hip fracture surgery within 72 h after trauma. exclusion criteria: * vascular events within the last 2 months such as cerebrovascular accident (cva), myocardial infarction (mi), venous thromboembolism (vte) and/or recurrent vte or arterial thrombosis. * patients receiving anticoagulation therapy with warfarin or clopidogrel. * history of seizures. * multiple fractures. * transfusion received during admission, prior to surgery (hb\< 8g/dl). * creatinine clearance less than 30 ml/min * known history of factor v leiden, protein c/s deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant * coronary stent placement within the previous 6 months * disseminated intravascular coagulation * subarachnoid hemorrhage * allergy for tranexamic acid * hypersensitivity to iron sucrose or any component of the formulation * clinical signs of acute thromboembolic event * malignancy * body weight \> 100kg * advanced dementia

Keywords: hip fracture anemia blood transfusion tranexamic acid intravenous iron
immediate effect of mobilization with movement on squat self-reported functional ability, pain intensity, and pain-free range of motion in people with knee osteoarthritis

Conditions: Knee Osteoarthritis (Knee OA)

Summary: mobilization with movement (mwm) appears to reduce pain, improve knee range of motion, and enhance physical functioning in individuals with knee osteoarthritis (koa). however, it remains unclear whether the severity grading of structural damage in koa affects its effects. this study aims to analyze the immediate effect of mwm on squat self-reported functional ability, pain intensity, and pain-free range of motion in people with koa, and to verify it its effect is influenced by the severity grading of structural damage.


Eligibility criteria:
inclusion criteria: * male or female; * aged over 45 years; * clinically diagnosed with symptomatic unilateral koa, classified as grade 1-3 according to the kellgren and lawrence system; * fulfilled the classification criteria of the american college of rheumatology for koa; * reported frequent episodes of pain in the knee joint during sit-to-stand movements for at least 3 months. exclusion criteria: * had koa secondary to rheumatoid arthritis and other inflammatory and autoimmune conditions; * reported lumbar pain radiating to the knee or lumbar pain as the primary complaint; * had a history of knee or lower limb surgery; * had a systemic or local infection; * had received an intra-articular corticosteroid or hyaluronic acid injection within the past 6 months; * reported current or past (within 4 weeks) oral corticosteroid use; * had any condition in the lower limbs that would prevent performing the deep squat test; * had clinical conditions in which manual therapy is generally contraindicated (such as fracture, osteoporosis, instability, infectious arthritis, tumors, joint ankylosis, acute inflammatory disorders, or lack of a diagnosed joint lesion).

Keywords: knee osteoarthritis manual therapy mobilization with movement functional status mulligan concept neurophysiological effect
impact of probiotics on antibiotic-associated diarrhea in community-acquired pneumonia

Conditions: Pneumonia; Probiotics; Diarrhea

Summary: the study goal is to determine whether oral administration of a probiotic mixture can reduce the incidence of antibiotic-associated diarrhea in patients with community-acquired pneumonia.


Eligibility criteria:
inclusion criteria: * adult patients aged 19 years or older admitted with a diagnosis of community-acquired pneumonia * patients eligible for oral medication administration (able to take oral or enteral feeding) exclusion criteria: * sepsis patients * patients admitted to the intensive care unit (icu) following endotracheal intubation * elderly patients aged 80 years or older * pregnant women * patients who have diarrhea at the time of admission * patients with a history of using probiotics within 3 months prior to admission * patients with a history of using laxatives within 1 week prior to admission * patients suspected of being in shock (mean arterial pressure \< 65 mmhg) at the time of admission
"lidocaine 4% cream (lmx4) vs placebo for pain due to lumbar puncture in infants 0-60 days of age."

Conditions: Pain

Summary: the study's hypothesis is lmx4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing lumbar puncture (spinal tap).

pain of infants will be measured using the neonatal facial coding system by videotaping the infant's face while they undergo the procedure. a comparison between the group that received active drug and the group that received placebo will allow a measurement of the difference, if any, of the pain experienced during the procedure of the infants.

Eligibility criteria:
inclusion criteria: * full term (\>=37 weeks gestation) * age 0-60 days * undergoing lumbar puncture exclusion criteria: * unstable * premature (\<37 weeks gestation) * allergy to study medicine * parent refusal of consent

Keywords: pain lumbar puncture neonates infants emergency department topical anesthesia lmx4
3k3a-apc for treatment of amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: phase 2 open label trial to investigate the safety and potentially efficacy of 3k3a-apc in patients with amyotrophic lateral sclerosis (als).

this phase 2 open label trial seeks to investigate whether a novel therapy named 3k3a-apc is safe and potentially effective in patients with amyotrophic lateral sclerosis (als). a total of 16 patients with als will be enrolled into 2 dose cohorts with five doses of 15mg or 30mg doses given 12 hours apart in each cohort. the primary study outcomes are to ensure the safety and tolerability of 3k3aapc in als patients, and to determine whether 3k3a-apc is able to reduce the pathological changes that might possibly cause als.

Eligibility criteria:
inclusion criteria: 1. patients must have clinically definite als (awaji criteria) 2. male or female age 18 years and less than 75 years at time of als study 3. symptom onset less than 36 months before screening 4. diagnosis of als less than 24 months before screening 5. clinically definite upper motor neuron signs exclusion criteria: 1. current treatment with anticoagulants (e.g., warfarin, novel oral anticoagulants, heparin) that might preclude safe completion of the lumbar puncture 2. condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia 3. use of investigational drugs or devices within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme q10) 4. prolonged prothrombin time or activated partial thromboplastin time \>2xuln 5. severe hypertension or hypotension 6. glomerular filtration rate (gfr) \<35 ml/min 7. forced vital capacity (fvc) at screening of \<50% of predicted 8. prior exposure to any exogenous form of apc 9. inability to lie flat for procedures (mri, pet, lp) 10. pregnant or lactating during the study period

Keywords: als amyotrophic lateral sclerosis mnd motor neurone disease 3k3a-apc
efficacy of digital noise reduction strategies: a hearing aid trial

Conditions: Sensorineural Hearing Loss

Summary: the purpose of this study is to see if noise reduction programs in digital hearing aids help patients hear better than hearing aids without these programs. we also want to know if we can predict how successful patients will be with hearing aids.

the first goal of this project is to examine the efficacy of digital hearing aids incorporating three noise reduction strategies (i.e., directional microphones alone vs. directional microphones with dsp noise reduction algorithm 1 vs. directional microphones with dsp noise reduction algorithm 2) in terms of both speech understanding outcomes and functional outcomes. the second goal is to identify individual characteristics that are predictive of successful functional outcomes with hearing aids. this study employs a multi-site, randomized, blinded, 2x2 factorial parallel group design. three hundred subjects will be studied at three va medical centers (mountain home, tn; bay pines, fl; and los angeles, ca) over a period of three years. objective (word recognition ability and performance with degraded speech stimuli) subjective (self-assessment questionnaires, personality and depression assessments) and cost-effectiveness assessments will be measured for 4 randomized treatment groups receiving different digital hearing aid technology. subjects will be randomly assigned to wear hearing aids with directional microphones alone or directional microphones with noise reduction algorithm 1 or directional microphones with noise reduction algorithm 2 for a period of 8 weeks. subjects will complete post-testing after 8 weeks of hearing aid use.

Eligibility criteria:
inclusion criteria: 1. adult onset sensorineural hearing loss 2. english as the first language 3. bilateral symmetrical sensorineural hearing loss 4. patient is a candidate for directional microphone technology. 5. average audiometric thresholds for 500, 1000, 2000, 3000, and 4000 hz no better than 25-db hl in either ear. 6. no history of hearing aid use in the past 10 years 7. appropriate cognitive skills to participate in the study as determined by a passing score on the mini mental scale. 8. patient has a local telephone and address. exclusion criteria: 1. evidence of outer ear, middle ear, or retrocochlear pathology 2. any threshold from 500 to 2000 hz exceeds 70-db hl 3. known neurological or psychiatric disorders as determined by chart review 4. known comorbid diseases that would prevent completion of the study as determined by chart review 5. visual impairment that would interfere with reading the questionnaires

Keywords: aging hearing aids hearing loss, sensorineural speech recognition
transepithelial corneal collagen crosslinking for keratoconus and corneal ectasia

Conditions: Keratoconus; Corneal Ectasia

Summary: corneal collagen crosslinking (cxl) has been proposed as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. during previous studies of the cxl procedure, the surface epithelial cells have been removed. transepithelial crosslinking in which the epithelium is not removed has been proposed to offer a number of advantages over traditional crosslinking including an increased safety profile by reducing the risk for infection as no epithelial barrier will be broken, faster visual recovery and improved patient comfort in the early postoperative healing period.

the objective of this study is to investigate the difference between two regimens of transepithelial crosslinking. the study will compare two riboflavin dosing regimens during the crosslinking procedure. the primary objective of this study is to evaluate the safety and efficacy of transepithelial corneal collagen crosslinking performed with riboflavin 0.1% for reducing corneal curvature. safety and efficacy outcomes will then be compared between the treatment groups. in particular, we will compare the two groups with regard to their efficacy in reducing corneal curvature. secondary outcomes will include visual acuity. safety assessments will include a tabulation of adverse events, patient symptoms, loss of visual acuity, changes in endothelial cell density, slit lamp examination of the cornea and lens, and contact lens tolerance for contact lens wearers

Eligibility criteria:
inclusion criteria: * 18 years of age or older * a diagnosis of keratoconus or a diagnosis of corneal ectasia after corneal refractive surgery * vision with contact lenses or glasses is worse than 20/20 * corneal thickness greater than 375 microns at the thinnest point exclusion criteria: * eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme. * corneal pachymetry ≤ 350 microns at the thinnest point measured by pentacam in the eye(s) to be treated. * previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications * clinically significant corneal scarring in the cxl treatment zone * pregnancy (including plan to become pregnant) or lactation during the course of the study * a known sensitivity to study medications * patients with nystagmus or any other condition that would prevent a steady gaze during the cxl treatment or other diagnostic tests. * patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.

Keywords: keratoconus corneal ectasia collagen crosslinking riboflavin
left ventricular free-wall ruptrue after acute myocardial infarction (lvfr-ami)

Conditions: Acute Myocardial Infarction

Summary: the left ventricular free-wall ruptrue (lvfr) is a serious complication caused high mortality.

the actual mortality of lvfr is close to 100%. despite the mortality rate for lvfr has been decreasing with the development of reperfusion therapy, the serious complication remains a difficult challenge. the coronary anatomy distribution associated with lvfr has an interesting phenomenon. from the perspective of different coronary distribution, we can better known the risk factors related to lvfr.

Eligibility criteria:
inclusion criteria: * patients be admitted for acute myocardial infarction (stemi or nstemi) exclusion criteria: * non-cardiovascular comorbidity for ami

Keywords: left ventricular free-wall ruptrue acute myocardial infarction coronary angiography
denosumab in current users of bisphosphonates for glucocorticoid-induced osteoporosis

Conditions: Osteoporosis

Summary: the purpose of this study is to study the efficacy of denosumab, a new drug, in the treatment of osteoporosis in patients using bisphosphonates.

there are no data on the use of denosumab in steroid induced osteoporosis. postmenopausal women with chronic use of glucocorticoid (gcs) are at high-risk of osteoporotic fractures. despite bisphosphonate treatment, a certain proportion of high-risk patients using chronic gcs either do not achieve a satisfactory gain in bone mineral density (bmd) or develop new fragility fractures. thus, more potent osteoporosis treatment is necessary for this subgroup of patients. this prompts the current study which aims to examine the efficacy of denosumab in current users of oral bisphosphonates for glucocorticoid-induced osteoporosis (giop).

Eligibility criteria:
inclusion criteria: 1. women or adult men (\>18 years of age) with various medical diseases requiring long-term prednisolone treatment. pre-menopausal women should have no plan for pregnancy within 2 years of study entry and agree to practice contraception during this 2-year period. 2. a daily dose of prednisolone (or equivalent) of more than 2.5mg within 3 months of study entry. 3. having received oral bisphosphonate treatment for at least 2 years. 4. suboptimal response to bisphosphonate treatment, defined as either one of the following: (1) failure of lumbar spine, femoral neck or total hip bmd values to increase; (2) values of lumbar spine, femoral neck or total hip bmd remain osteoporotic, ie. t scores \< -2.5 or z scores \< -2.0; or (3) development of new fragility vertebral or non-vertebral fractures despite at least 2 years' treatment with good compliance. 5. informed consent from patients. exclusion criteria: 1. patients with previous use of denosumab or teriparatide. 2. premenopausal women who plan for pregnancy within 2 years of study entry or who do not agree for contraception within this 2-year period. 3. patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism. 4. patients with unexplained hypocalcemia. 5. patients with serum creatinine level of \>=200umol/l.

Keywords: osteoporosis denosumab rankl glucocorticoids
analysis of all stillbirths in stockholm county 2017, a multidisciplinary audit

Conditions: Intra-Uterine Death

Summary: all stillbirths in stockholm during 2017 were analysed according to the primary outcomes which were preventable/non-preventable deaths and the level of delay. the secondary outcomes were: causes of death, standard of care pre and post stillbirth and if a summary of the possible causes of death was made as well as the planning of supervision of the next pregnancy.

this is a retrospective cohort study. a multidisciplinary team consisting of three obstetricians, one midwife and one neonatologist was assembled. the team represented the largest hospitals in the region-karolinska university hospital and stockholm soderl hospital. each team member in the audit group had access to all the medical patient charts from the hospitals and also the majority of the charts from the antenatal care clinics (anc). each team member independently assessed each case regarding causes of death, preventable/non-preventable deaths, the level of delay if there was any and the standard of healthcare provided to the patients with stillbirth, the postmortem examination of infant and mother and if there were any recommendations given for the next pregnancy. multiple meetings were organized for discussing the results of the individual assessment of each case. to enable an ethical discussion every member of the audit group signed a confidentiality form and all cases were assessed by comparison with local guidelines in praxis.

Eligibility criteria:
inclusion criteria: * all stillbirths in stockholm 2017 exclusion criteria: * missed abortion

Keywords: iufd
assessment of voriconazole penetration into the brain by fluorine-magnetic resonance spectroscopy

Conditions: Fungal Infection

Summary: the purpose of this study is to determine the amount of voriconazole in the brain by fluorine-magnetic resonance spectroscopy (mrs) and to compare brain levels to plasma levels.


Eligibility criteria:
inclusion criteria: * healthy male volunteers 18-55 years of age exclusion criteria: * subjects with any condition affecting drug absorption * subjects with a positive urine drug screen
sunphenon epigallocatechin-gallate (egcg) in relapsing-remitting multiple sclerosis (sunims study)

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: hypothesis: sunphenon, a green tea extract containing 95% egcg, given daily as oral medication over a period of 18 months has anti-inflammatory and neuroprotective properties in patients with relapsing-remitting multiple sclerosis as assessed by magnetic resonance imaging and clinical examination (edss and msfc).

this multicentric, national study investigates the efficacy and safety of egcg in patients with relapsing-remitting multiple sclerosis.

Eligibility criteria:
inclusion criteria: * male and female subjects age 18 to 60 * relapsing-remitting course of ms * stable treatment with glatiramer acetate at least 6 months prior to inclusion exclusion criteria: * primary or secondary progressive forms of ms * clinically relevant heart, lung, liver, kidney diseases * regular hepatotoxic co-medication * drug addiction * alcohol abuse

Keywords: multiple sclerosis inflammation neurodegeneration neuroprotection