Kornimate/medical-research-clean huggingface dataset:
antioxidation medication for noise-induced hearing loss

Conditions: Hearing Loss

Summary: this study will examine whether oral intake of 1200mg n-acetylcysteine/day will prevent temporary threshold shift in hearing among workers exposed to noise

both genetic and environmental factors contribute to noise-induced hearing loss (nihl). the cellular antioxidant system appears to protect cochlear hair cells from oxidative stress due to noise. previous animal studies showed protective effects of anti-oxidant medicines against nihl.the objective of this study is to test the hypothesis that preventive medication of antioxidation is related to susceptibility to nihl. the 53 noise-exposed workers from steel industries in taiwan will be recruited, and divided into n-acetylcysteine (nac)(acetine, 1200mg/day) group and placebo one. the duration of medication is 2 weeks initially. after washout for 2 weeks, the kinds of medications in these 2 groups will be crossover and used for 2 weeks. firstly, questionnaires interview about noise exposure, smoking, alcohol drinking, drug habit history and calculation of body mass index (bmi) will be done. the following methods would be performed individually after medication. with detailed local examination with otoscope, these subjects receive hearing tests by pure-tone audiometry (pta) and distortion product otoacoustic emissions (dpoae) before and after their daily works. the possible confounding factors including background noise, solvent, heavy metals, carbon monoxide and temperature in the workplaces will be assessed. the amount of noise exposure is evaluated by personal dosimeter. early morning, blood samples will be collected. deletion polymorphisms in the glutathione s-transferase (gst)t1 and gstm1 genes will be determined. statistical analysis will be performed to evaluate the relation between intake of anti-oxidant medicine and noise-induced temporal threshold shift (tts). the expected results of this study are to determine whether anti-oxidant supplements protect workers from noise-induced tts. we anticipate that these human studies might help elucidate the relative importance of anti-oxidant enzymes as risk factors for nihl.

Eligibility criteria:
inclusion criteria: * workers in steel industry * known exposure to noise at work exclusion criteria: * ever diagnosed as having diabetes mellitus * fasting glucose of 120 or greater

Keywords: noise hearing loss temporary threshold shift
radiofrequency technic's impact on perineal postpartum pain

Conditions: Delivery; Injury

Summary: a study in the postpartum period reveals that among women who delivered vaginally and having perineal lesions, between 95 and 100% of them suffer from perineal pain (episiotomy, tears from 1st to 4th degree) to 24 hours of vaginal delivery; and between 60 and 91% 7 days after delivery. severe pain that is not taken into account can become chronic pain. it has physical and psychological consequences. it is therefore essential to prevent these risks in young mothers. the main objective of this study is to assess the efficacy of radiofrequency treatment on perineal pain postpartum, after a vaginal delivery, instrumented or not, in patients with perineal lesions. a double-blind randomized prospective single-center study will be conducted on patients delivering at marseille's north hospital. women who gave birth to the north hospital site, with perineal lesions (tears, episiotomy) will be invited to enroll in the study. patients will be then randomized into two groups, one with radiofrequency treatment, the other without treatment with radiofrequency. the duration of inclusion is provided over 6 months. each topic will be followed over a period of 1 month. the total study duration is 7 months. the expected results are a significant reduction in pain scores during the first days postpartum in women with perineal alteration caused by a vaginal delivery instrumented or not. also an improvement in the quality of life of patients during the first days.


Eligibility criteria:
inclusion criteria: * patients who naturaly delivered with ou without instruments such as suction cup, spatulas, forceps * patients presenting perineal lesions exclusion criteria: * patients who delivered through cesarean section
study to evaluate safety & efficacy of flx-787-odt to treat fasciculations in tongue and appendicular muscle in adult subjects with als

Conditions: Amyotrophic Lateral Sclerosis; Fasciculation

Summary: the flx-787-107 study will determine how well flx-787-odt works to reduce fasciculations in patients with amyotrophic lateral sclerosis (als). the study will measure how often fasciculations occur, if tongue and muscle strength, speech, and swallowing are affected, and monitor any side effects that might develop while taking the investigational product. participants will be assessed before and after taking a single dose of flx-787-odt. approximately 15 people will take part in this study at one center in the united states. participants will be in the study for a single clinic visit and receive a telephone call 7 days later to monitor for side effects.


Eligibility criteria:
inclusion criteria: * documented diagnosis of als diagnosis of less than 5 years. * greater than 6 fasciculations per minute noted at least in the tongue by clinical, ultrasound, or emg evaluation. * normal oral cavity exam at screening. exclusion criteria: * presence of clinically significant or unstable condition that would result in an increased risk of study participation or difficulty in interpretation of the study results. * tremor or other movement disorder that would interfere with recording. * presence of major gastrointestinal disorders, such as inflammatory bowel disease, diverticulitis, active peptic ulcer disease, or significant gastroesophageal reflux disease (i.e., not well-controlled on antacids or proton pump inhibitors), or oral or esophageal lesions/ulcers. * presence of laryngospasm or significant swallowing problems. * inability to tolerate a spicy sensation in the mouth or stomach. * actively using illicit drugs or history of chronic substance abuse within the past year prior to screening, including abuse of alcohol. * participated in a clinical study (except natural history studies without administration of an investigational product) within 30 days prior to screening. * pregnant, breastfeeding, or planning to become pregnant. * blood pressure of ≥160 mmhg systolic and/or ≥100 mmhg diastolic. * clinically significant abnormalities in laboratory findings (including screening complete electrolyte panel, complete blood count, liver function tests).

Keywords: als amyotrophic lateral sclerosis fasciculation flx-787
to assess the level of adherence of subjects receiving saizen® via easypod™ in middle east

Conditions: Growth Disorders

Summary: this is a middle east, multicenter, observational study to evaluate adherence and long term outcomes of therapy in pediatric subjects using easypod™ electromechanical device for growth hormone treatment and to assess the level of adherence of subject receiving saizen® via easypod™.

subjects will be enrolled in a multicenter longitudinal observational study. parents/subjects will provide their informed consent/assent to upload their data for population-based analyses and, ultimately, clinical outcomes. adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. data will be collected both retrospectively and prospectively. this will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: • to assess the level of adherence of subjects receiving saizen® via easypod™ secondary objectives: * to describe the impact of adherence on clinical outcomes for subject receiving saizen® via easypod™ * to identify adherence subject profiling * to assess the impact of adherence on insulin-like growth factor 1 (igf1) (that is, above, below or within normal ranges)

Eligibility criteria:
inclusion criteria: * administered growth hormone via the easypod™ electromechanical device according to summary of product characteristic (smpc) * over the age of 2 years * under 18 years of age, or over 18 without fusion of growth plates * parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. if the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country exclusion criteria: * subjects taking growth hormone in whom growth plates have fused (that is, for taking growth hormone for it's metabolic effects) * contra-indications to saizen® as defined in the smpc * use of an investigational drug or participation in another interventional clinical study

Keywords: growth disorders saizen easypod growth hormone pediatric subject
suprachoroidal cls-ta with intravitreal aflibercept versus aflibercept alone in subject with diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: the purpose of this trial is to evaluate the safety and efficacy of suprachoroidal cls-ta used with intravitreal aflibercept in subjects with dme.

this is a phase 2, multicenter, randomized, double-masked, controlled, parallel-group study of 6 months duration in treatment-naïve subjects with dme. this study is projected to enroll approximately 60 subjects, randomly assigned 1:1 to one of two treatment groups. the study design includes up to 8 clinic visits over approximately 24 weeks. subjects will attend visits for screening (visit 1, days -30 to 0); randomization and baseline (visit 2, day 0 before dosing); dosing and evaluation (visit 2 after dosing to visit 5, day 0 through week 12); as-needed (prn) dosing and follow up (visit 6 through visit 7, week 16 through week 20), and end of study (visit 8, week 24).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 1 or type 2 dm * dme with central involvement (\> 300 µm in the central subfield on spectral-domain optical coherence tomography \[sd-oct\], in the study eye * etdrs bcva score of ≥ 20 letters read and ≤ 70 letters read in the study eye * naïve to local pharmacologic treatment for dme in the study eye exclusion criteria: * iop \> 21 mmhg in the study eye at visit 1 (day -30 to -1); subjects are not excluded if iop is \<22 mmhg in the study eye with no more than 1 iop lowering medication * any previous treatment in the study eye with an ocular corticosteroid implant * has significant media opacity precluding evaluation of retina and vitreous in the study eye. * history of glaucoma or optic nerve head change consistent with glaucoma damage * history of glaucoma surgery * history of clinically significant iop elevation in response to corticosteroid treatment ("steroid responder")

Keywords: diabetes mellitus diabetic retinopathy microneedle mircoinjection triamcinolone choroid choroid injection aflibercept suprachoroidal triamcinolone acetonide
malic acid in treatment of xerostomia

Conditions: Xerostomia

Summary: background: xerostomia is a subjective sensation of dry mouth resulting from quantitative and /or qualitative changes of saliva. patients receiving drugs like antihypertensives and antidepressants or patients receiving chemotherapy or radiotherapy for treatment of head and neck cancers may suffer from xerostomia. it also can be experienced in patients with systemic diseases like diabetes mellitus, systemic lupus erythematosus, sjogren's syndrome and rheumatoid arthritis. malic acid spray with concentration of 1% has grabbed the attention over the last few years as an effective treatment for xerostomia. study objective: to evaluate the effect of 1% malic acid spray in treatment of xerostomia in type 2 diabetic patients.

this randomized controlled clinical trial included 52 patients with type 2 diabetes mellitus suffering from xerostomia, divided equally into two groups. group-i was managed by topical spray containing 1% malic. group- ii was managed by a placebo spray. both groups received the treatment for 2 weeks. dry mouth questionnaire scores (dmq) and unstimulated salivary flow rate was collected before and after treatment.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus suffering from xerostomia. * patients aged between 35 and 50 years old. * glycated hemoglobin less than 7% (28) . * duration of diabetes mellitus not less than 4 years and not more than 8 years. exclusion criteria: * patients receiving any drugs that cause hyposalivation like anti-hypertensive drugs. * patients with any systemic disease reported to produce hyposalivation (sjogren's syndrome, hepatitis c, rheumatoid arthritis and lupus erythematosus) (8). * patients receiving chemo-therapy and radio-therapy. * mouth breathers.
effects of topical local anesthesia of pulmonary vein combined with vagus nerve block on the incidence of atrial fibrillation after thoracic surgery

Conditions: Atrial Fibrillation

Summary: this study intends to explore a new therapy to reduce the incidence of atrial fibrillation in thoracic patient who receive video-assisted thoracoscopic lobectomy .the results of the study are to assess the effects of this new intervention on the incidence，duration of atrial fibrillation and other complications including postoperative delirium after video-assisted thoracoscopic lobectomy .and reducing the burden of poaf on patients and their families, hospitals and public resources.


Eligibility criteria:
inclusion criteria: * thoracoscopic lobectomy and bilobectomy * asa class i-iii * age is greater than or equal to 50 years old * han nationality, mother tongue is chinese * the people signed informed consent exclusion criteria: * history of chronic atrial arrhythmia * sick sinus syndrome * history of second-degree atrioventricular block * taking class i or class iii antiarrhythmic drugs or β-receptor blocker * history of radiofrequency ablation * hyperthyroidism * contraindications of ropivacaine, lidocaine * pregnancy and lactation

Keywords: postoperative atrial fibrillation lobectomy thoracic surgery vagus nerve block pulmonary myocardial sleeve
safety and efficacy study of twhf in hiv patients with poor immune responses

Conditions: HIV

Summary: this study is a pilot study to evaluate impact of tripterygium wilfordii hook f (twhf) on t cell immune activation and immune activation in hiv-infected immunological non-responders. the investigators aim to evaluate the safety and efficacy profiles of twhf in hiv immunological non-responders.

the investigators recruited 23 patients from peking union medical college hospital outpatient clinic. they were all immunological non-responders. nineteen patients will receive triptolide wilfordii hook f extract (10mg tid po) plus current cart, while 4 patients will continue their current cart. this study will last for 12 months. patients will be followed up at month 0, 3, 6, 9, and 12. during each follow-up time point, adverse effects, t cell subsets, t cell activation markers and other routine tests will be ordered. the investigators hypothesis that twhf might boost cd4 cell recovery by reducing immune activation.

Eligibility criteria:
inclusion criteria: * continuous antiretroviral therapy \> 18 months, and consistent hiv-rna\< 40 copies/ml more than 12 months; * 18-65 years old; * male or female; * good adherence and promise to follow-up; * inform consent signed; * cd4 t cells less than 300/ul . exclusion criteria: * active opportunistic infection (not stable within 4 weeks 2 weeks ) or aids-related carcinoma; * hemoglobin (hgb) \ 1.5x uln, alt or ast or alkaline phosphatase (alp) \>3x upper limit of normal (uln), total bilirubin (tbil) \>2x uln, creatine kinase (ck) \> 2x uln; * pregnant or breastfeeding woman or woman with pregnancy plan; * active drug-user; * severe neurological defects; * active alcohol abuse; * severe gastrointestinal ulcer . * end-stage disease such as cirrhosis, chronic obstructive pulmonary disease, congestive heart failure, recent myocardial ischemia,tumor, etc those who are undertaking steroids, immunomodulator, anti-inflammatory agents

Keywords: hiv-infected immunological non-responders tripterygium wilfordii hook f immune activation
tranexamic acid in preventing postpartum hemorrhage in high risk pregnancies during elective cesarean section

Conditions: Postpartum Hemorrhage

Summary: postpartum hemorrhage (ppt) represents one of the major causes of maternal mortality . tranexamic acid is used in many studies in management of pph in combination with ecobolics. this study aims to evaluate the possible value of the use of tranexamic acid in prevention of postpartum hemorrhage .


Eligibility criteria:
inclusion criteria: * gestational age of 28 weeks or more. * chronic hypertension. * preeclapmsia -eclampsia. * multiple pregnancy. * uterine liomyomas. * polyhydraminos. * fetal macrosomia. * associated thrombocytopenia * history of postpartum hemorrhage. exclusion criteria: * patients with rheumatic heart disease. * patients with history cardiac valve replacement. * current or past history of dvt. * women on any anticoagulant therapy. * sensitivity to tranexamic acid * pregnancies with any abnormally implanted or located placenta.

Keywords: tranexamic acid
prospective assessment of the rockall risk scoringsystem in patients with upper gastrointestinal hemorrhage

Conditions: Gastrointestinal Bleeding

Summary: this study aimed to assess the validity of the rockall score for the prediction of rebleeding and death in patients with upper gastrointestinal bleeding.

this present study aimed to evaluate: assess the validity of the rockall score for the prediction of rebleeding and death in patients with upper gastrointestinal bleeding. 1- technical design: the technical design included research design, setting, subject and tools for data collection. research design: a descriptive exploratory design was followed to achieve the aim of the study. study setting: this study was conducted between tropical department in ainshams university and gastroenterology and hepatology department in theodorbilharz research institute. sample size: epi - info program version 6 was used for sample size calculation guided by power of the test = 80% - confidence level =95% and accepted margin of error = 5% and risk ratio = 5.5 - total sample minimum accepted = 50 this study included 50 recipients and done tropical department in ain shams university and gastroenterology and hepatology department in . theodore bilharz research institute

Eligibility criteria:
inclusion criteria: * adult egyptian patients. * patients with acute upper g.i hemorrhage. * informed consent. exclusion criteria: * refuse to participate in this study.
diagnostic value of dect scan compared to diagnostic needle aspiration

Conditions: Gout

Summary: rationale: gout is a disease with growing incidence and complexity due to increased life expectancy, co-morbidity and medication. the disease can be diagnosed by microscopy, demonstrating monosodium uric acid (msu) in synovial fluid of the affected joint or in tophi (subcutaneous or peritendinous msu depositions). in daily practice, however, the diagnosis is difficult to ascertain due to sampling error (no synovial fluid acquired because the needle was not exactly placed in the affected joint, or the location of the gout might have been extra-articular e.g. around tendons) or to a different cause of acute arthritis (e.g. infection, reactive arthritis). recently, dual energy ct scan has become available. this technique allows the visualization and quantification of msu. although imaging modalities such as dect show promise in the classification of gout, the studies to date have been small and have primarily involved people with established disease. a study with cross-sectional design in which patients for whom the clinical questions "does this patient have gout?" are referred for participation may contribute to assess the value of dect scan in diagnosing acute arthritis caused by gout. objective: assessment of value of dect scan in diagnosing acute arthritis, caused by gout. study design: prospective study population: patients with acute mono or oligo arthritis without prior diagnosis, the rheumatologist has an indication for diagnostic needle aspiration. nature and extent of the burden and risks associated with participation, benefit and group relatedness: in current daily practice, patients with acute mono- or oligo-arthritis without prior diagnosis undergo a diagnostic aspiration of the affected joint. this can be done by blind aspiration or ultra sound guided aspiration depending on the judgement of the rheumatologist. the aspirated synovial fluid is then assessed by polarized microscopy to detect msu crystals. the diagnostic value of dect in acute gout attacks had not yet been established and is therefore not used in daily practice. in this study all patients undergo dect scan to assess the value of dect scan in diagnosing acute arthritis caused by gout. if the dect scan demonstrates msu depositions and the diagnosis of gout was not ascertained prior to dect scanning by msu crystals in the synovial fluid, then additional ultrasound guided aspiration will take place, with knowledge of dect results, followed by repeat microscopy


Eligibility criteria:
inclusion criteria: * age \> 18 years * mono or oligo arthritis (2-3 swollen joints) * indication for diagnostic aspiration of an inflamed joint in which gout is one of the possibilities exclusion criteria: * polyarthritis ( up to 4 swollen joint); * chrystal proven gout in history * patient is on uric acid lowering therapy (allopurinol, benzbromaron, febuxostat) * hip arthritis\* * metal or prosthesis of the inflamed joint * highly suspicion of infectious arthritis * pregnancy * contra indication of joint aspiration (skin infection, hemophilia) * no informed consent