Kornimate/medical-research-clean huggingface dataset:
the treatment of grade i sarcomas and benign, non-metastasizing highly invasive soft tissue tumors

Conditions: Sarcoma; Neoplasms

Summary: patients with grade i soft tissue sarcomas or benign, non-metastasizing invasive soft tissue tumors will receive wide local excision and be prospectively randomized as to either receive or not receive radiation therapy.

this is a randomized study. patients undergo surgical excision of all gross disease and then are randomized to arm i or arm ii. arm i: radiotherapy. involved-field irradiation. arm ii: no further treatment.

Eligibility criteria:
disease characteristics: biopsy-proven grade i soft tissue sarcoma or one of the following benign but highly invasive soft tissue tumors: abdominal and extra-abdominal fibromatosis (desmoid, aggressive fibromatosis), dermatofibrosarcoma protuberans, intramuscular lipoma (infiltrating lipoma), diffuse lipomatosis, leiomyoma of deep soft tissue, diffuse giant cell tumor of tendon sheath (proliferative synovitis). no clinical evidence of metastases in regional nodes or more distant sites. no primary intraperitoneal or retroperitoneal tumors. resection of all gross tumor at the time of surgical excision required (margins may be pathologically positive or negative). no von recklinghausen's disease. prior/concurrent therapy: biologic therapy: not specified. chemotherapy: no prior chemotherapy for sarcoma. endocrine therapy: not specified. radiotherapy: no prior radiotherapy for sarcoma. surgery: no more than 4 months since definitive surgery for primary lesion or recurrence. no prior amputation. patient characteristics: age: 18 and over. performance status: not specified. hematopoietic: not specified. hepatic: no cirrhosis. renal: no evidence of severe renal impairment. cardiovascular: no ischemic heart disease. other: no prior malignancy except basal cell carcinoma. no serious infection. no active bleeding disorder. no severe concomitant disease.

Keywords: adjuvant radiotherapy low-grade sarcoma radiotherapy randomized study sarcoma surgery
an open-label pilot study of coenzyme q10 in steroid-treated duchenne muscular dystrophy

Conditions: Muscular Dystrophy, Duchenne

Summary: this study will help to determine the safety and efficacy of the nutritional supplement coenzyme q10 when added to steroids as a treatment for duchenne muscular dystrophy (dmd). boys with dmd who are enrolled in this study will should be on a stable dose of steroids for at least six months, and will remain on their usual dose throughout the study. they will complete two screening visits within a one-week period, and if enrolled will then have their strength tested monthly for three months before beginning therapy with coenzyme q10. once coenzyme q10 therapy is started, participants will have their strength tested monthly for six months. following the six month treatment period, participants will be given the option to remain on coenzyme q10 until the study is completed.


Eligibility criteria:
subject inclusion criteria 1. age: 5 - 11 years old 2. ambulant 3. diagnosis of dmd confirmed by at least one the following: * positive x-linked family history for typical duchenne muscular dystrophy in older male relatives (onset by age 5 yr., wheelchair-bound by age 12 yr.) or * dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical duchenne dystrophy or * gene deletion test positive (missing one or more exons) in the central rod domain (exons 25-60) of dystrophin, where reading frame can be predicted as 'out-of-frame', and clinical picture consistent with typical duchenne dystrophy. 4. on glucocorticosteroids: children must be on a steady dose of prednisone or deflazacort, on any schedule (daily, alternate days, 10 days on, 10 days off or twice a week), for the last 6 months before starting the clinical trial. dose of steroid or schedule cannot be altered during the study. 5. evidence of muscle weakness by mrc score or clinical functional evaluation 6. ability to provide reproducible repeat qmt bicep score within 10% of first assessment score. 7. ability to swallow tablets subject exclusion criteria 1. failure to achieve one or more of the diagnostic inclusion criteria cited above. 2. symptomatic dmd carrier 3. previous (6 months or less) or current use of coenzyme q10 (for dmd or any other disease) 4. use of carnitine, other amino acids, creatine, glutamine, or any herbal medicines within the last 3 months. 5. history of significant concomitant illness or significant impairment of renal or hepatic function.

Keywords: duchenne dystrophy dmd clinical trial cinrg
the efficacy and safety of low dose combination of ltg and vpa compared to cbz monotherapy

Conditions: Epilepsy

Summary: to evaluate the efficacy of usual monotherapy and low dose combination of lamotrigine and valproate. low dose combination may be more effective and tolerable because they are low dose and vpa reduce lamotrigine metabolism.

an open label, randomized, multicenter clinical trial to compare the efficacy and safety of lamotrigine / valproate coadministration and carbamazepine as initial pharmacotherapy in epilepsies

Eligibility criteria:
inclusion criteria: * age ≥16yr old * who are diagnosed as epilepsy definitely * who have minimum 2 unprovoked seizures and minimum 1 seizure in previous 3 months * who need aed therapy and no aed medication for previous 1 year (exclude emergency medication for less than 2weeks) * who is not pregnant * who can report seizure diary by him/herself or caregiver * who agree to this trial and provide informed consent. * type of seizures : of generalized tonic-clonic, complex partial, and/or simple partial motor seizures; exclusion criteria: * who has progressive cns disease. * has serious systemic or psychiatric disease * who is not suitable by investigator(uncooperative) * who can not fill up diary check card * is pregnant, breastfeeding, or planning to become pregnant * exclusion - absence s. juvenile myoclonic epilepsy, atonic seizure, alcohol or other substance abusers, mental retardation etc. * who cancels to agree to this trial and provide informed consent. * alt, ast, bilirubin and bun/cr levels are more than twice normal range of them * wbc value is 2000 and less, hb value is 9.0 and less, platelet count is 100,000 and less in cbc * who took investigation products before participating this study
multiparametric protocol for assessment of intraprocedural result of mitraclip procedure

Conditions: Residual Mitral Regurgitation

Summary: quantification of residual mitral regurgitation (mr) after mitraclip may be challenging. quantitative methods for severity assessment may be inaccurate and recent recommendations suggest an assessment of changes in both hemodynamic and echocardiographic parameters, but an established prospectively validated approach is still lacking.


Eligibility criteria:
inclusion criteria: * patients with either degenerative or functional, severe or moderate to severe mitral regurgitation (mr) undergoing percutaneous edge-to-edge repair at san raffaele hospital from april 2019. exclusion criteria: * none

Keywords: mitraclip residual mitral regurgitation mitral insufficiency
patellar tendinopathy - effect of training and enhancement of the collagen synthesis by insulin-like growth factor-i

Conditions: Tendinopathy

Summary: the purpose of the study is to test the hypothesis that stimulation of the synthesis of new structural tendon proteins combined with training improve the tendon structure in patients with chronic knee tendon pain.

randomized controlled intervention study: 12 weeks intervention period with training and injections of saline or insulin-like growth factor i. one year follow-up

Eligibility criteria:
inclusion criteria: * chronic patellar tendinopathy (\> 3 months) * anterior-posterior thickening of the tendon (1 mm compared to mid-tendon) * hypo-echoic area with enhanced vascularization exclusion criteria: injection * corticosteroid injection within the last 12 months * knee operation * knee osteoarthritis * diabetes * smoking * body mass index \>30
surgical stabilisation of rib fractures in non-ventilated patients

Conditions: Rib Fractures; Thorax; Fracture

Summary: the aim of the study is to investigate the effect of surgical stabilisation of rib fractures on clinical outcomes in patients that are not dependent on mechanical ventilation at the time of the treatment decision. to this end, data on all eligible patients will be extracted from the traumaregister® dgu. baseline demographics will be analysed using descriptive statistics. propensity matching will be conducted between the operative cohort (receiving ssrf by any technique) and the conservative cohort (not receiving ssrf). the effect of ssrf on the outcome variables will then be assessed using appropriate statistical tests.


Eligibility criteria:
inclusion criteria: * rib ais of ≥ 3 * initial hospital treatment exclusion criteria: * intubated preclinically or in the emergency department * glasgow coma scale (gcs) \< 9 at the time of the primary survey in the emergency department * no in-patient hospital management

Keywords: surgical stabilisation of rib fractures non-ventilator-dependent
study of low level laser therapy and word recognition in hearing impaired individuals

Conditions: Sensorineural Hearing Loss

Summary: the purpose of this clinical study is to determine the effectiveness of low level laser light therapy when applied around the head and ears in improving unaided word recognition in ears with sensorineural hearing loss.

sensorineural hearing loss accounts for about 90% of all hearing loss and is found in 23% of individuals older than 65 years. sensorineural hearing loss occurs when the hair cells of the inner ear and the neural pathways to the auditory cortex are damaged. in most cases, sensorineural hearing loss cannot be improved, reversed or 'cured.' current treatment options focus on methods that amplify external sounds and on teaching the patient various strategies to 'retrain' the brain to interpret external stimuli. low level laser therapy was first applied for the treatment of inner ear diseases by uwe witt, md of hamburg, germany in the 1980's. hearing impaired patients have inflammation and/or atrophy of the tissues and neural pathways connected to and supporting the cochlea's cilia hair structure, the hearing mechanism of the inner ear. low level laser therapy is believed to stimulate the mitochondria of the adipocyte cells, which subsequently increases the production of atp. the resultant surge in atp production works to repair damaged tissue and regenerate cells reversing some of the damage incurred to the cochlea and thus improving aspects of hearing function.

Eligibility criteria:
inclusion criteria: * sensorineural hearing loss. * mild or greater degree. * adult onset. * gradual onset. * hearing loss stable over past 12 months. * etiology of presbyacusis or noise-induced hearing loss. * unaided word recognition score between 28% and 86%. * english as primary spoken language. * willing and able to abstain from other treatments or medications to improve hearing ability. * willing and able to abstain from work or other activities that involve loud noise exposure. exclusion criteria: * central auditory processing disorder. * active/recurrent middle ear infection. * meniere's disease. * tympanic membrane perforation/tubes. * cochlear implant. * removal of acoustic neuroma. * hyperacusis/misphonia. * photosensitivity disorder. * active infection/wound in head/ear region. * pregnant/lactating. * serious mental health illness. * significant developmental disability/cognitive impairment. * history of drug/alcohol abuse. * involvement in litigation/worker's compensation/disability benefits for hearing loss. * other research participation in past 90 days. * use of ototoxic medications known to cause temporary or permanent hearing loss.

Keywords: sensorineural hearing loss tinnitus word recognition
congestive heart failure and atrial tachyarrhythmias in pmk patients

Conditions: Heart Failure，Congestive; Atrial Arrhythmia

Summary: the aim is to correlate relationship between congestive heart failure and onset of atrial tachyarrhythmias in pacemaker patients. both atrial events and state of congestive heart failure are collected automatically by implanted device.


Eligibility criteria:
inclusion criteria: * recent implant of dr pacemaker according to current guidelines * sinus rhythm at enrollment exclusion criteria: * pregnant women
open-label extension study of reslizumab in pediatric subjects with eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: this study is an open-label study where all subjects will receive active drug, reslizumab. subjects are able to enter this trial only through completion of study res-05-0002 (nct00538434). the goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic esophagitis.

subjects will enter this open-label extension study after completing the placebo-controlled, double-blind study res-5-0002 (nct00538434). the end of study visit for res-05-0002 will serve as the screening visit for this trial. all subjects will receive reslizumab and be followed by their principal investigators in an unblinded fashion. visits and administration of reslizumab will be monthly.

Eligibility criteria:
inclusion criteria: * informed consent * received at least two doses of study drug in study res-05-0002 (nct00538434) * did not withdraw from study res-05-0002 due to drug related adverse event * completed end of treatment visit for study res-05-0002 exclusion criteria: * pregnant or nursing females * concurrent immunodeficiency * current use of immunosuppressive drugs * did not tolerate study drug in study res-05-0002

Keywords: eosinophilic esophagitis cinquil
phase-i study of radiolabeled dfh-12 (pulmobind) for molecular imaging of the pulmonary circulation

Conditions: Pulmonary Disease; Pulmonary Hypertension

Summary: pulmonary hypertension (ph) can be the result of various clinical conditions. it may be idiopathic or associated with various cardiovascular and lung disorders. currently there is no test that can non-invasively detect abnormalities of the pulmonary circulation. there is a growing need for a non-invasive method to detect ph. there currently exists only ne agent approved in canada for clinical imaging of the pulmonary circulation, 99mtc-labeled macroaggregates. this agent is exclusively used for the diagnosis of physical defects of the circulation due to pulmonary embolus. this agent is larger than small pulmonary vessels, limiting its sensitivity to detect small vascular defects, as well as potential infectious risks since albumin macroaggregates are derived from human albumin. there is need then for new lung tracers that could provide a greater safety profile while enabling functional as well as anatomical imaging of the pulmonary circulation. dfh-12 (pulmobind) is a peptide derived from human adrenomedullin (hami-52). hence the development of this novel am derivative, pulmobind, for molecular imaging of the pulmonary circulation. pulmobind is labeled with 99mtc, the most commonly used imaging isotope in nuclear medicine.


Eligibility criteria:
inclusion criteria: * male or female greater than 18 years of age. female subjects must be post-menopausal (defined as two years after menstrual cycle) * within normal range for the following: bp systolic 100-140 mmhg and diastolic 50-90 mmhg; * hr 60-100 beats per minute; * oral temperature less than 37.6 degrees centigrade; * respiratory rate 12-20 breaths per minute; * normal lung function tests; * normal echocardiogram including estimation of pulmonary artery systolic pressure; * normal chest x-ray; normal electrocardiogram exclusion criteria: * any known chronic or acute medical condition with or without the need for chronic pharmacologic therapy or any condition that may interfere with normal biodistribution of dfh-12. includes but not limited to: * lung parenchymal or lung vascular diseases such as chronic obstructive pulmonary disease, * bronchitis, * lung cancer, * pleural effusion, * emphysema, * asthma, * pulmonary fibrosis, * occupational lung disease, * pulmonary hypertension (primary or secondary), * systemic hypertension, * diabetes, * cancer, * kidney disease, * liver disease, * heart failure or previous myocardial infarction, * coronary artery disease, * peripheral vascular disease or inflammatory disease; * subjects requiring chronic administration of any substance for a medical condition, active smoking or history of smoking for more than one year in the past 10 years, known self-reported alcoholism (active or abstinent); * unable to tolerate study procedures ex.(venipuncture, movement restrictions during imaging); * previous nuclear study since one week (to avoid cross-contamination)
diagnostic performance of a combination of leukocyte cell surface markers in predicting the risk of severe bacterial infection in febrile children under three months of age in the emergency department: a pilot study.

Conditions: Children Under 3 Months of Age With Fever

Summary: fever is a frequent reason for emergency department (ed) visits in infants under 3 months of age. although viral infections are the most common etiologies, the prevalence of severe bacterial infections (sbi) is high (10%). while in infants with sbi, establishing the diagnosis and initiating rapid intravenous antibiotic therapy is necessary, every effort should be made to avoid it in those at low risk of sbi. clinical examination and biomarkers are still sub-optimal for assessing the risk of sbi. as a result, the vast majority of these children receive inpatient intravenous antibiotic therapy. flow cytometry is a technique for measuring the expression of biomarkers on the cell surface of leukocytes in response to infection. a french team has identified a combination of some fifteen leukocyte cell surface markers that perform excellently in discriminating between bacterial and viral infections in a population of adults presenting to the emergency department with a suspected infection. however, there are no similar studies in children. the objective of the study is to assess the diagnostic performance of a combination of biomarkers on the cell surface of leukocytes in discriminating between bacterial and viral infection. infants less than 3 months of age, visiting the ed for fever will have an extra blood sample in order to measure those biomarkers. the performance of those biomarkers to identify sbi will be assessed.


Eligibility criteria:
inclusion criteria: * children aged between 7 and 90 days * visiting the emergency department with fever (temperature greater than or equal to 38° measured rectally in the emergency department or reported by parents) or whose fever is detected during the emergency department visit (temperature greater than or equal to 38° measured rectally in the emergency department) * consent signed by one of the two parents/guardians exclusion criteria: * weight less than 2,500 grams * chronic illness (heart failure...) * known immune deficiency * congenital anomaly significantly modifying the probability of bacterial infection (pulmonary malformation, esophageal atresia...) * antibiotic therapy in the previous 48 hours * clinically evident source of fever: skin infection, joint infection, etc. * parents or guardians unable to understand french * non-affiliation with a social security scheme (including ame)

Keywords: fever diagnostic severe bacterial infections
understanding experimentally induced hot flushes

Conditions: Hot Flashes

Summary: the purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. the investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (lupron), which is a manufactured (artificial) hormone that makes the body think that it has reached menopause temporarily. most women begin to have hot flushes within 4 weeks after taking leuprolide and resume menses 3 months later. the investigators will administer questionnaires to evaluate changes in sleep and mood over the course of the study.


Eligibility criteria:
inclusion criteria: * women 18-45 years old * premenopausal * willingness to use barrier methods of contraception during study and after completion of study until menses resume * good general health exclusion criteria: * pregnancy * breastfeeding * hot flushes * hemoglobin at the screening visit less than 10 gm/dl * abnormal liver function tests * abnormal renal function tests * bmi \> 35 kg/m2 * previously diagnosed osteoporosis or osteopenia * psychiatric disorder involving mood, anxiety, psychotic disorder, current anorexia nervosa, or current alcohol or substance-use disorder * previous severe depression * evidence of suicidal or homicidal ideation * sleep apnea, narcolepsy, or other diagnosed sleep disorder * contraindication, hypersensitivity, or previous allergic reaction to gnrh agonists * regular use of centrally active medications * use of hormonal medications for at least 2 months * use of ketoconazole, clomiphene citrate, or anabolic/androgenic steroids in the preceding 3 months * renal insufficiency * abnormal vaginal bleeding * history of thrombo-embolism or cardiovascular disease * history of congestive heart failure or other conditions requiring sodium restriction * history of spinal cord compression * metastatic vertebral lesions * memory disorders * urinary tract obstruction * history of liver, kidney, pulmonary, or metabolic disease

Keywords: lupron premenopausal hot flashes
a comparative study of robotic thyroidectomy using transaxillary approach versus conventional open thyroidectomy

Conditions: Papillary Thyroid Carcinoma

Summary: most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. robotic thyroidectomy which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction.

most patients with thyroid tumors are effectively treated surgically by practitioners experienced in the techniques of thyroidectomy. many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. robotic thyroidectomy which can hide the operative scar was associated with a higher degree of patient cosmetic satisfaction. in this study, we designed a prospective study comparing the cosmetic satisfaction and the postoperative body image change which associated with patient self-esteem between robotic thyroidectomy and conventional open thyroidectomy group.

Eligibility criteria:
inclusion criteria: * patients with papillary thyroid carcinoma who underwent thyroidectomy * age was over 20 years old exclusion criteria: * keloid * previous neck or anterior chest operation history * the patients who underwent combined radical neck dissection * the patient with postoperative wound problem * the patient with underlying systemic disease which can make influences on the wound healing process * the patient who can not read and understand the questionnaire