Kornimate/medical-research-clean huggingface dataset:
effectiveness of sugammadex on muscle relaxant reversal in preterm neonates

Conditions: Sugammadex

Summary: the primary aim of the work is to compare the efficacy of sugammadex and neostigmine in reversing rocuronium-induced muscle relaxation to reach complete recovery of neuromuscular block (tof ratio≥ 0.9) in preterm neonates. the secondary aim is to evaluate the safety of using sugammadex in preterm neonates and to detect any complications that may occur in this age group.


Eligibility criteria:
inclusion criteria: * preterm neonates * scheduled for elective inguinal hernia repair exclusion criteria: * drug hypersensitivity * patient is with any diseases affecting the neuromuscular junction * patients with family history of malignant hyperthermia

Keywords: sugammadex preterm neonates
long-term safety and efficacy evaluation of epi-743 in children with leigh syndrome

Conditions: Leigh Syndrome

Summary: epi-743 in leigh syndrome participants that participated in previous epi743-12-002 (nct01721733) study.

to monitor the long-term safety and neurodevelopmental effects of epi-743 on children who complete the epi743-12-002 placebo-controlled trial.

Eligibility criteria:
inclusion criteria: 1. diagnosis of leigh syndrome with genetic confirmation 2. completion of epi743-12-002 protocol and initiation of treatment within 14 days of month 12 visit in epi743-12-002 study 3. participant or participant's guardian able to consent and comply with protocol requirements 4. continued abstention from supplements excluded in epi743-12-002 study 5. botox® is allowed if approved by the sponsor exclusion criteria: 1. allergy to epi-743 or sesame oil 2. allergy to vitamin e 3. clinical history of bleeding or abnormal baseline prothrombin time (pt)/partial thromboplastin time (ptt) 4. hepatic insufficiency with liver function tests (lfts) greater than two times upper limit of normal 5. renal insufficiency requiring dialysis 6. end-stage cardiac failure 7. fat malabsorption syndromes precluding drug absorption 8. use of anticoagulant medications 9. participation in other clinical research studies/taking other experimental agents 10. participation in elective procedures that required sedation

Keywords: leigh syndrome mitochondrial disorders epi743 vincerinone
a follow-up study to assess resistance to abt-072 in hcv-infected subjects administered abt-072 in prior abt-072 studies

Conditions: Hepatitis C Virus Infection

Summary: this is a follow-up study with no treatment and only samples being collected.

the purpose of this study is to evaluate the development of specific viral mutations in response to treatment with abt-072.

Eligibility criteria:
inclusion criteria: - main selection criteria: a subject that has received either abt-072 or placebo in a prior study involving abt-072. exclusion criteria: - the investigator considers the subject unsuitable for the study for any reasons inclusive of, but not limited to, failure to comply with study procedures in a prior abt-072 clinical study.
quality and behavior of pelvic floor in runner women

Conditions: Pelvic Floor Disorders; Sport Injury; Stress Urinary Incontinence

Summary: the main objective is to analyze the relationship between the pf muscles and the other variables along the different tasks of daily life and during the race.

introduction: women are more likely to suffer injuries in the pelvic floor (pf) and urinary incontinence (ui) because of their anatomical characteristics. their participation in the sports field has been more active recently. there are studies that correlate the race with presenting weakness of the sp muscles and stress urinary incontinence (sui), so the race is considers as a risk factor for these affectations. however, there are few studies of real-time measurements during running. some runners may even present sui during daily activities (adl). the ui is not only a physical problem but also affects the social, emotional, psychological, sexual and professional level and may even lower their self-esteem or renounce the physical activity. objectives: the purpose of this study is to perform measurements of different variables in real time while running and in their adl. the main objective is to analyze the relationship between the pf muscles and the other variables along the different tasks of daily life and during the race. the secondary objectives are to differentiate these neuromuscular, physiological and biomechanical responses of pf and abdominal girdle (ag) according to the type of stroke, duration, intensity and distance. and compare results between both group (interventional group and no interventional group). material and method: randomized clinical trial will be performed with 59 female runners aged 25-44 years. the sample will be divided into two groups randomly. the study will be carried out health center called "tiro de pichón" in málaga.

Eligibility criteria:
inclusion criteria: * healthy woman between 25 and 44 years old. * women not pregnant. * women who run at least 10 km / week. * in case of having children, it has to be 12 months after childbirth, having had the first postpartum menstruation and having left breastfeeding. exclusion criteria: * women pregnant or suspected of it. * postpartum less than one year. * having the period during the exploration for the classification in groups or during the day of the measurements. * present operation in the urogenital region as well as any visceral or spinal operation. * urinary tract and/or vaginal infections. * vaginal lesions; anorectal lesions or bleeding. * women with gynecological bleeding; urethral obstruction; fistulas; malformations (ectopic ureter, etc); genital prolapse. * women with pain in pelvic floor or lower limbs or back. * pain during the race. * allergy to silver, nickel and/or latex.

Keywords: pelvic floor athletes
effects of micronized fenofibrate on fasting and postprandial lipoproteins, inflammatory mediators and thrombosis

Conditions: Hypertriglyceridemia With the Metabolic Syndrome

Summary: this is a randomized placebo controlled clinical trial designed to investigate the effects of micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic individuals with two or more other characteristics of the metabolic syndrome.

the aim of this study was to determine the effects of micronized fenofibrate (160 mg/daily) on: 1. fasting and postprandial lipids and lipoproteins after a standarized test meal. 2. fasting and postprandial oxidized fatty acids and oxidized low density lipoprotein after a standarized test meal. 3. fasting and postprandial inflammatory mediators after a standarized test meal. 4. fasting and postprandial lipopolysaccharide-stimulated cytokine production after a standarized test meal. 5. fasting and postprandial markers of hemostasis, fibrinolysis and blood viscosity after a standarized test meal.

Eligibility criteria:
inclusion criteria: 1. males and postmenopausal females 18 years of age with fasting triglycerides greater than or equal to 1.7 mmol/l and \<6.9 mmol/l 2. two or more of the following adult treatment panel iii (1) criteria of the metabolic syndrome: abdominal obesity (waist circumference \>89 cm in females and \>102 cm in males); low high-density lipoprotein cholesterol (hdl-c) (\ 130 or diastolic blood pressure \>85 mm hg) or current drug therapy for hypertension; and impaired fasting glucose (between 6.1 mmol/l and 7.0 mmol/l). exclusion criteria: 1. included types 1 or 2 diabetes 2. body mass index \>40 kg/m2 3. use of lipid-lowering therapies 4. oral hypoglycemic therapies 5. insulin 6. aspirin \>81 mg daily 7. regular use of non-steroidal anti-inflammatory agents or cyclooxygenase-2 inhibitors, corticosteroids (oral and inhaled), anti-oxidants (including multivitamins), herbal or fiber supplements recent changes in type or formulation of hormone replacement therapy (in the last 6 months) 8. alcohol intake \>3 drinks per day 9. untreated hypothyroidism or recent change (within 2 months) of thyroid replacement therapy 10. cigarette smoking (current or within the last 6 months)

Keywords: hypertrigliceridemia metabolic syndrome obesity fenofibrate lipoproteins cytokines
leveraging mhealth messaging to promote adherence in teens with ckd

Conditions: Chronic Kidney Diseases; Adherence, Medication; Communication

Summary: the overall goal of this study is to develop and test effectively framed mobile health (mhealth) messages to promote medication adherence in teens with chronic kidney disease (ckd).

hypertension is a risk factor for chronic kidney disease (ckd) progression. only 77% of adolescents with ckd are adherent to antihypertensive medications despite evidence that adherence slows disease progression. mobile health (mhealth) applications show promise for improving adherence but most are not designed within health-promotion frameworks, only send medication reminders, use unreliable outcome measures, and/or have small effects on adherence. nonadherence is a public health problem that may benefit from using health communication strategies to advance beyond reminders and improve mhealth efficacy. highly effective health messages modify perceptions, attitudes, and skills to facilitate behavioral change; inappropriately framed messages (e.g., use of fear appeals) may have unintended, negative effects on health behaviors (i.e., reduce adherence). for adolescents with ckd, framing mhealth messages to motivate adherence may be a key factor in preventing disease progression; however, there has been little research to guide the use of this approach. hence, the current study aims to develop and test effectively framed mobile health (mhealth) messages to promote medication adherence in teens with ckd. prior to study recruitment, the intervention messages will be developed by the research team and key stakeholders before testing in this pilot randomized controlled trial (rct). adolescents/young adults with ckd will be invited to participate in the pilot rct to evaluate the intervention messages versus an active control condition; the primary outcome is antihypertensive medication adherence and secondary outcomes are participants' responses to surveys.

Eligibility criteria:
inclusion criteria: * adolescents/young adults aged 11-21 years * physician diagnosis of ckd stage 1-4 * currently prescribed an antihypertensive medication and anticipate staying on an antihypertensive through the study duration (switching medication classes is permitted) * must have daily access to a wi-fi-enabled electronic device (e.g. ios, android 4.2 or higher, phone, tablet, computer) to receive private health information. exclusion criteria: * adolescents/young adults who are on dialysis or had a kidney transplant * sibling participating in the study, unable to comprehend spoken english * cognitive delay precluding completion of study procedures * and prescribed a liquid form of an antihypertensive medication (cannot be monitored).

Keywords: adherence adolescence mhealth
acute effects of beet juice intake on the vascular function of hypertensive patients

Conditions: Hypertension

Summary: to assess the acute effects of only one dose of beet juice on hypertensive subjects treated with vascular endothelial function parameters, using the microvascular reactivity method.

systemic arterial hypertension is an established risk factor for cardiovascular disease (cvd). among the main modifiable environmental factors of hypertension, the investigators highlight inadequate eating habits, such as low vegetable consumption. clinical studies have shown that inorganic nitrate from beet juice intake has a protective effect against cvd due to reduced blood pressure, inhibition of platelet aggregation and prevention of endothelial dysfunction. however, there is still no consensus on its benefits of inorganic nitrate in vascular health. associated with this, there are no previous studies in the literature that correlate the acute effects of inorganic nitrate intake on endothelial function assessed by microvascular reactivity through laser. the objective of the present study is to evaluate the acute effects (single dose) of inorganic nitrate, through the ingestion of beet juice, in the vascular parameters and endothelial function of treated hypertensive patients of both sexes.

Eligibility criteria:
inclusion criteria: * patients of both sexes * age between 40 and 70 years * previous diagnosis of primary systemic arterial hypertension * signed the informed consent term. exclusion criteria: * secondary hypertension * systolic blood pressure greater than or equal to 180 mmhg or diastolic bp greater than or equal to 110 mmhg * in use of beta-blockers * diabetes mellitus * history of cancer * use of any dietary supplement * any serious life-threatening illness * cardiovascular diseases
mesenchymal stem cell conditioned medium-derived pleiotropic factor in treating residual burn wound

Conditions: Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Residual Burn Wound

Summary: treatment of extensive deep burn residual wounds is a common problem in burn plastic surgery. due to bacterial invasion, excessive maturation of granulation tissue, poor abrasion resistance of new epithelium, and coexistence of wound healing and dissolution can lead to delayed wound healing. residual wounds rarely heal spontaneously and are prone to recurrence. mesenchymal stem cells (msc) boost tissue repair through paracrine. many biological effectors, including igf-1, vascular endothelial growth factor (vegf), tgf-β1 have been found in msc conditioned media (msc-cm), and play a role in promoting tissue repair and regeneration.our previous animal experiments have confirmed the role of msc-cm in regulating wound inflammation, repairing damaged repair cells and promoting wound regeneration. in here, we will evaluate the safety and effectiveness of mesenchymal stem cell conditioned medium-derived pleiotropic factor in treating residual burn wound.


Eligibility criteria:
inclusion criteria: patients with thermal burns are all residual wounds that have not healed after 1 month; the distance between adjacent residual wounds of the same patient is greater than 10cm; patients signing informed consent - exclusion criteria: patients with severe heart, lung, liver, kidney, blood and mental system diseases; combined with diabetes, hypertension and malnutrition; patients with shock, severe systemic infections, and pregnant or lactating women. -
impact of four patient information leaflets (pil) on patient behaviour

Conditions: Gastroenteritis; Pharyngitis

Summary: to assess the impact of four patient information leaflets (pil) on patient behaviour in primary care.

a patient who visited, for a gastroenteritis or a pharyngitis, one gp of the intervention group, received a patient information leaflets (pil) related to his disease and his age: either the gastroenteritis leaflet for adult or the one for child, either the pharyngitis leaflet for adult or the one for child.

Eligibility criteria:
inclusion criteria: * adult patient. * minor child accompanied by a responsible adult. * the patient or the caregiver must be reachable by telephone within ten to fifteen days following the consultation. exclusion criteria: * illiterate patient * patient refusing follow-up call. * patient with visual or hearing impairment. * patient non-francophone. * private patient of liberty by judicial or administrative. * person being a measure of legal protection.

Keywords: patient information leaflets primary care patient behaviour pharyngitis gastroenteritis
study evaluating the safety and efficacy of islatravir in combination with lenacapavir in virologically suppressed people with hiv

Conditions: HIV-1 Infection

Summary: the primary objective of this study is to evaluate the efficacy of oral weekly islatravir (isl) in combination with lenacapavir (len) in virologically suppressed people with hiv (pwh) at week 24.


Eligibility criteria:
key inclusion criteria: * received bictegravir/emtricitabine/tenofovir alafenamide (b/f/taf) for ≥ 24 weeks at screening. * documented plasma human immunodeficiency virus type 1 (hiv-1) ribonucleic acid (rna) \< 50 copies/ml (or undetectable hiv-1 rna level according to the local assay being used if the limit of detection is ≥ 50 copies/ml) for ≥ 24 weeks before and at screening. * plasma hiv-1 rna \< 50 copies/ml at screening. key exclusion criteria: * history of prior virologic failure while receiving treatment for hiv-1. * prior use of, or exposure to, islatravir (isl) or lenacapavir (len). * active, serious infections requiring parenteral therapy \< 30 days before randomization. * active or occult hepatitis b virus (hbv) coinfection, defined as hepatitis b core antibody (hbcab) positive, hepatitis b surface antigen (hbsag) positive, or hbv deoxyribonucleic acid (dna) positive as determined by the central laboratory. * active hepatitis c virus (hcv) coinfection, defined as detectable hcv rna. * any of the following laboratory values at screening: * creatinine clearance (clcr) ≤ 30 ml/min according to the cockcroft-gault formula * cd4+ t-cells \< 200 cells/mm\^3 (cohort 1); cd4+ t-cells \< 350 cells/mm\^3 (cohort 2). * absolute lymphocyte count \< 900 cells/mm\^3 (cohort 2). * individuals of childbearing potential (as defined in protocol) who have a positive serum pregnancy test at screening or positive urine and serum pregnancy tests at day 1 prior to study drug administration. * individuals who plan to continue breastfeeding during the study. * documented historical or screening resistance reports showing nucleoside/nucleotide reverse transcriptase inhibitors (nrtis) or non-nucleoside/nucleotide reverse transcriptase inhibitors (nnrtis) resistance mutations in reverse transcriptase, including m184v/i (cohort 2). note: other protocol defined inclusion/exclusion criteria may apply.
clinical and functional variables in oncology

Conditions: Cancer, Metastatic; Cancer; Survivorship

Summary: the aim is to analyse the effect of a therapeutic exercise and education programme in several clinical and functional outcomes in cancer patient and survivors

in the oncology field, both patients and survivors have to face several symptoms, like cancer-related fatigue or pain. cancer patients also have affected quality of life, lower levels of function and they are at higher risk of weight gain following diagnosis. given the risk of obesity, both exercise and diet play a key role in recovery from cancer. hence, the aim of this study is to show the effect of a therapeutic exercise and education programme (teep) in clinical and functional, including practical nutritional education in other clinical and functional secondary outcomes in cancer patients and survivors. variables included are: body composition, mediterranean-diet adherence, quality of life (qol) and functional outcomes (limb functionality, physical activity, physical function and handgrip strength). furthermore, laboratory variables like muscle thickness (ecography) and muscle activity (electromyography) were included.

Eligibility criteria:
inclusion criteria: * in the case of survivors: patient who had been surgically treated for their primary tumour with no evidence of recurrence at the time of recruitment. the inclusion of patients undergoing hormonal treatment radiotherapy or antiher therapy will be allowed. * in the case of cancer patients: patient who had been dignosed by cancer. in both cases, all participants have to maintain the minimum physical function to perform exercise in group. exclusion criteria: * patients were excluded if they had suffered any cardiovascular event defined as stable or unstable angor, acute pulmonary edema, cardiac rhythm disorders, or syncope of cause not affiliated in the year prior to inclusion

Keywords: cancer oncology metastasis survivors exercise therapy therapeutics complementary therapies fatigue assesment
a study of baricitinib (ly3009104) in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sjia)

Conditions: Systemic Juvenile Idiopathic Arthritis

Summary: the reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sjia). participants are assigned to 1 of 2 cohorts. in cohort 1, participants will receive baricitinib or tocilizumab reference. in cohort 2, participants will receive baricitinib.


Eligibility criteria:
inclusion criteria: * participants must have a diagnosis of systemic juvenile idiopathic arthritis (sjia) as defined by international league of associations for rheumatology (ilar) criteria with onset before the age of 16 years * participants must have at least 2 active joints at screening and baseline * cohort 1 (il-6 inhibitor therapy naive): participants who are at least 1 year and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age * cohort 2 (open-label baricitinib): participants who are at least 1 year and less than 18 years of age exclusion criteria: * participants must not have polyarticular jia (positive or negative for rheumatoid factor), extended oligoarticular jia, enthesitis-related jia, or juvenile psoriatic arthritis * participants must not have persistent oligoarticular arthritis as defined by the ilar criteria * participants must not have a history or presence of any autoimmune inflammatory condition other than jia * participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis * participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study * participants must not have biologic features of macrophage activation syndrome (mas) over the past 12 weeks * participants must not have a current or recent (\<4 weeks prior to baseline) clinically serious infection * participants must not have a positive test for hepatitis b virus * participants must not have evidence of active tuberculosis (tb) or untreated latent tb

Keywords: systemic fever flare sjia jia
hearing aids, counseling and the significant other

Conditions: Hearing Loss

Summary: the purpose of this study is to examine the effect of enhanced patient-centered counseling (pcc) and the influence of spousal involvement in pre-fitting counseling on hearing-aid outcomes.


Eligibility criteria:
inclusion criteria: both men and women with hearing loss and their live-in partners will serve as subjects in this study. the subjects with hearing loss will have a mild to moderately-severe hearing loss in both of the ears, will have word recognition scores of 40% or better bilaterally, and will be about to get new hearing aids. live-in partners may also have up to a moderately-severe degree of hearing loss but cannot have prior experience with hearing aids nor have plans to get hearing aids during the course of their participation in this study. their word recognition scores should also be 40% or better bilaterally. all subjects also will meet the following additional inclusion criteria: 1. age 20-85 years; 2. intact mental status as assessed by the mini-mental state examination (mmse; folstein, folstein \& mchugh, 1975); 3. no evidence of any major medical illness requiring long-term assistive care, as determined by the katz index of independence in activities of daily living (katz, down, cash \&grotz, 1970); 4. able to read and respond to english; and 5. willing and able to give written informed consent to participate in this investigation. exclusion criteria: failure to satisfy any of the requirements listed above or if their live-in partner fails to meet the criteria.

Keywords: hearing loss hearing aids spouses rehabilitation