Kornimate/medical-research-clean huggingface dataset:
once daily aminoglycoside pharmacokinetics and optimal dosing in the burn population: a prospective study

Conditions: Burns; Infection

Summary: effective antimicrobial use in the burn population is important since this population is at an increased risk for infections during their stay in hospital as a result of their burn injury. tobramycin is an antibiotic that has activity against common burn wound associated pathogens, such as pseudomonas aeruginosa, and its use is becoming increasingly relevant due to the increased incidence of bacterial resistance to currently utilized antibiotics. once daily dosing of tobramycin has been safely and effectively used in the majority of infected patients for many years with the proposed benefits of optimized antibacterial activity and reduced nephrotoxicity compared to traditional dosing. but, the once daily dosing regimen has yet to be validated in the burn population. the purpose of this study is to validate the plausibility of once daily tobramycin dosing in the burn population with intent to determine a safe, effective, and efficient dosing regimen for this population.


Eligibility criteria:
inclusion criteria: * adult burn patient (≥ 18 years old) * total burn surface area less than 20% * at least 48 hours after the time of the initial burn injury event * has a suspected or confirmed infection * has been receiving antibiotic therapy for at least 24 hours exclusion criteria: * pediatric patients (\< 18 years old); * pregnant * documented history of cochlear or vestibular injury * creatinine clearance \< 50 ml/min * requiring any modality of dialysis * has been receiving antibiotic therapy for longer than 72 hours * known allergy or adverse reaction to aminoglycoside antibiotics * known allergy or adverse reaction to sulfites * diagnosis of parkinson's disease or myasthenia gravis

Keywords: aminoglycoside pharmacokinetics once daily dosing
risk evaluation of cancers in chinese diabetic individuals: a longitudinal study

Conditions: Cancer

Summary: phase 1: baseline investigation (nation-wide survey) aims: to investigate whether diabetes and prediabetes is a risk factor for cancers of all sites as well as for specific type of cancer, such as breast and colorectal cancer. subjects and methods: a nation-wide survey will be carried out in 200,000-250,000 individuals selected from 20-25 communities stratified according to geographic regions (northeast, north, east, south central, northwest, and southwest china), degrees of urbanization (large cities \[beijing, shanghai, and provincial capitals\], midsize cities, county seats, and rural townships), and economic development status (as assessed on the basis of the gross domestic product \[gdp\] for each province). a comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis will be performed in each study participant. diabetes and prediabetes should be diagnosed by ogtt according to the who 1999 criteria, while the diagnosis of cancer is established on the self-report questionnaire and cross checking with the tumor registry or a proof of doctor's diagnosis. phase 2: cohort follow-up aims : to examine factors that modify the risk of cancer in diabetes, prediabetes and normal glucose regulation (ngr). subjects and methods: to recruit and follow all type 2 diabetes, prediabetes, and sex,age-matched ngr (1:1) in each community for at least 3 years. for diabetes, treatment target is hba1c ≤ 7.0% with treatment paradigm recommended by local guideline.


Eligibility criteria:
phase 1 inclusion criteria: 1. age \>= 40 years old 2. gender: males and females 3. provide written informed consent 4. satisfactory compliance phase 2 inclusion criteria: 1. age \>= 40 and =\< 75 years old 2. gender: males and females 3. provide written informed consent 4. satisfactory compliance exclusion criteria: 1. history of cancer; 2. history of lada and other autoimmunity diseases; 3. acute diabetic complication, acidosis, etc; 4. moderate to severe liver, kidney dysfunction, i.e. alt/ast \> 2.5 times the upper limit of normal range or ccr \< 25ml/min; 5. any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.
post-stroke osteopathy

Conditions: Stroke (CVA) or TIA; Fracture; Fall

Summary: the sudden biomechanical inactivation, direct neuro-humoral effects and sustained systemic stress reaction, which commonly occur after stroke or tia, all may be of relevance in triggering alterations in bone metabolism and remodelling of bone microstructure. the objectives of this observational pilot study are to characterize falls and fractures and their circumstances (sex and age specific incidence, time course, risk conditions, localization) in ischemic stroke patients, study changes in the bone microstructure after ischemic stroke supported by high-resolution peripheral quantitative computer tomography, unravel a molecular mechanisms underlying the increased fracture risk (focus on wnt-signaling and ß-adrenergic projection), establish risk factors to estimate the risk of falls based on information from gait analysis as well as construct deep learning algorithms to identify bone microstructure parameters for predicting fractures.


Eligibility criteria:
inclusion criteria: * inclusion in the stroke-card registry study * modified rankin scale (mrs) \< 5 * provision of signed and dated informed consent form * willingness to comply with all study procedures and ability to participate in the study over the complete study duration exclusion criteria: * persistent motor deficit before the onset event * not able to walk without walking aid or not able to put the full bodyweight on either leg before the onset event * medical history of stroke * premedication with corticosteroids for more than 6 weeks or pioglitazone or bisphosphonate within the last 12 months * limb amputation * bmi \ 35 kg/m2 * present or previous fracture in the distal radius or tibia interfering with hr-pqct * movement disorder interfering with hr-pqct imaging * women of childbearing potential

Keywords: high-resolution peripheral quantitative computer tomography bone microstructure
retrospective experience of cied implantation

Conditions: Cardiac Disease; Heart Failure; Coronary Artery Disease

Summary: the objective of this study is to retrospectively gather information on patients who underwent a cied procedure with either a cangaroo envelope, tyrx envelope, or no envelope.

a single center will retrospectively review up to 700 subjects who underwent implantation of a cied with a cangaroo envelope, tyrx envelope, or no envelope. all sets of subjects enrolled will also be examined for any follow-up visits and/or adverse events that occurred up to 12 months post-surgery.

Eligibility criteria:
inclusion criteria: * any patient that had a cied implanted with either a cangaroo envelope, a tyrx envelope, or no envelope on or after march 27, 2017 exclusion criteria: * any patient that had a cied implanted with any other type of envelope * any patient that had a cied implanted prior to march 27, 2017
physical activity intervention for older patients during chemotherapy for colorectal cancer

Conditions: Colorectal Cancer; Fatigue

Summary: this study will see if patient who undergo a physical activity intervention called walk with ease report experiencing less fatigue and a higher quality of life during chemotherapy for colorectal cancer than those who do not participate in this intervention.

the primary purpose of this multicenter, randomized controlled study is to evaluate the impact of a physical activity program on fatigue in older patients (≥60 years) undergoing adjuvant chemotherapy for colorectal cancer. the investigators also plan to evaluate physical function and quality of life as secondary objectives. the investigators' hypotheses are that people who undergo the physical activity intervention compared to those who do not, will: 1) report less fatigue, 2) report higher health related quality of life, and 3) have less decline in physical function. additionally, the investigators will characterize ≥grade 3 adjuvant chemotherapy associated toxicities in this older population, and describe the changes reported in fatigue, physical function, and hrqol over the course of chemotherapy.

Eligibility criteria:
inclusion criteria: * ≥ age 60 years (no upper age limit) * diagnosis of stage ii-iii colon or rectal cancer planned for treatment with adjuvant chemotherapy scheduled as part of standard treatment * able to read english (required for cga and other surveys administered) * approval from their treating physician to engage in moderate-intensity physical activity * patient-assessed ability to walk and engage in moderate physical activity * signed, irb-approved written informed consent exclusion criteria: * other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy * already walking or engaging in other physical activity \>120 minutes per week as documented via subject self-report * unable to walk or engage in moderate-intensity physical activity * one or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention

Keywords: chemotherapy adjuvant chemotherapy cancer therapy fatigue physical activity physical function tiredness colon cancer rectal cancer walk with ease colorectal cancer geriatric assessment geriatric elderly
visual outcomes and patient satisfactory after panoptix implantation in hyperopic cataract patients

Conditions: Cataract; Hyperopia

Summary: to evaluate visual outcomes and patient satisfactory after panoptix implantation in hyperopic cataract patients

patients with axial length ≤22.5mm will be recruited. the subjects will undergo bilateral uneventful phacoemulsification and implantation of panoptix. visual quality and patients satisfactory will be assessed three months after the surgery.

Eligibility criteria:
inclusion criteria: * age-related cataract patients * eye axis length ≤22.5mm and refraction ≥ +0.5d * predicted postoperative corneal astigmatism ≤0.75d * mesopic pupil size between 3.0mm to 5.5 mm * preoperative angle kappa ≤ 0.5 mm * preoperative corneal spherical aberration \<0.5μm, high order aberration \<0.5μm exclusion criteria: * in the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, marfan syndrome, etc.) * pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.) * history of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis * patients with history of ocular trauma or prior ocular surgery including refractive procedures * preoperative visual acuity of worse than 0.2 logmar in any eye.
n2 lung cancer project: neoadjuvant treatment followed surgery versus chemoradiation

Conditions: Non-small-Cell Lung Carcinoma; Surgery; Stage IIIA-N2; Chemoradiation; Survival

Summary: the objective of this multicenter retrospective study is to compare overall survival in patients with stage iiia-n2 nsclc treated with neoadjuvant treatment and surgery versus definitive chemoradiation. secondary objectives are to analyze disease-free survival, median survival, locoregional and distant relapses as well as mortality and toxicity related to treatment.

based on data published by the intergroup 0139 trial, induction therapy followed by surgery in patients with stage iiia-n2 nsclc can increase overall survival compared to exclusive radical chemoradiation treatment. the major handicap of all studies addressing the role of surgery in iiia-n2 nsclc is the difficulty of recruiting patients. therefore, multicenter studies are necessary to confirm the hypothesis generated by the int 0139.

Eligibility criteria:
inclusion criteria: * stage iiia (n2) disease * potentially resectable disease * stage lung cancer with ct scan or pet-ct. * n2 involvement: it is not necessary pathological proof. * no progression after induction treatment. exclusion criteria: * t4 or n3 stage. * bulky disease or not resectable.
combination of continuous low doses of vinorelbine, cyclophosphamide and interferon alpha 2b (" metronomic chemotherapy ") for antiangiogenic and antivascular effect. trial with pharmacodynamic study in adult advanced neoplasm

Conditions: Advanced Neoplasm

Summary: purpose: this phase i trial estimates the antiangiogenic and antivascular effect of 4 different levels of continuous low doses of the combination of vinorelbine, cyclophosphamide and interferon alpha 2b (" metronomic chemotherapy ")in adult advanced neoplasm. this study is non randomized, monocentric, and with a pharmacodynamic part. primary objective: estimation of the toxicity of the combination of continuous low doses of vinorelbine, cyclophosphamide and interferon alpha 2b. secondary objectives: estimation of the antiangiogenic and/or antivascular effect (vegf measurement) in radiography (dec-mri), biology and immunohistochemistry of the treatment.


Eligibility criteria:
inclusion criteria: * patients aged from 18 and older, * with metastatic or advanced solid tumor who received all standard treatments, * who ended their chemotherapy or radiotherapy treatment within 4 weeks (6 weeks for mitocyne)prior entry in the study. * all patients are included after being given written informed consent. exclusion criteria: * patients with stable disease, * history or presence of another cancer, * contraindication to administer the treatment, * contraindication to perform mri, * pregnancy or breast feeding.

Keywords: advanced neoplasm adult advanced neoplasm
the blood pressure analysis on critically ill patients

Conditions: Multiple Organ Failure; Intensive Care Unit Syndrome

Summary: the study is to explore the relationship between coefficient of variation of harmonic magnitude (hcv) and different organ failures among those critically ill patients. in the future, we can act as a warning system on patients with multiple organ failures or terminal illness, also as an indicator of treatment effect.


Eligibility criteria:
inclusion criteria: * icu patients in the 20-to-99 age range * subjects agree to sign the informed consent form and are willing to cooperate with arterial pulse measurement exclusion criteria: * subject has severe arrhythmia

Keywords: blood pressure arterial pulse coefficient of variation of harmonic magnitude
study of escitalopram in the treatment of specific phobia

Conditions: Phobic Disorders

Summary: this pilot study is designed to assess the efficacy of escitalopram in the treatment of specific phobia in adult outpatients.

this double-blind placebo-controlled pilot trial study is designed to assess the efficacy of 12 weeks of escitalopram vs. placebo in the treatment of specific phobia in adult outpatients. it is hypothesized that escitalopram is safe and effective in the treatment of specific phobia.

Eligibility criteria:
inclusion criteria: * adults 18-65 years of age * dsm-iv criteria for specific phobia according to the mini * for women of childbearing potential, a negative serum pregnancy test at screening * written informed consent exclusion criteria: * any current primary dsm-iv diagnosis other than specific phobia * history of dsm-iv substance abuse or dependence within the last months * lifetime history of bipolar i disorder, schizophrenia or other psychotic disorder, mental retardation, or other pervasive developmental disorder or cognitive disorder due to a general medical condition * suicide risk or serious suicide attempt within the last year * clinically significant laboratory or ekg abnormality or unstable medical condition * for women of childbearing potential, unwillingness to use an acceptable form of contraception during the study * subjects needing concurrent use of psychotropic medications

Keywords: specific phobia anxiety ssri clinical trial escitalopram
non-inferiority comparison of migrane® versus parcel ® for treatment of tensional cephaleia

Conditions: Tensional-type Headache

Summary: the purpose of this study is to evaluate the non-inferiority clinical efficacy of two different associations of drugs in the treatment of patients diagnosed with tensional-type headache in accordance with international headache society guidelines.

* open-label, non-inferiority, prospective, parallel group, intent to treat trial. * experiment duration: 56 days. * 04 visits (days -7, 0, 28 and 56). * efficacy will be evaluated for 10 episodes of tension-type headache. * adverse events evaluation.

Eligibility criteria:
inclusion criteria: 1. patients must be able to understand the study procedures agree to participate and give written consent. 2. tensional-type headache patients according to the international headache society criteria. 3. corporal body indices \< 40. exclusion criteria: 1. pregnancy or risk of pregnancy. 2. lactation 3. use of acetylsalicylic acid or corticosteroids or immunosuppressive therapy. 4. use of immunosuppressive drugs. 5. alterations of laboratory selective tests. 6. drugs or alcohol abuse

Keywords: headache migraine
effect of embryo migration in fresh oocyte donation cycles

Conditions: Infertility

Summary: the investigators aimed to evaluate the impact of embryo distance from fundal endometrium, measured 60 minutes after transabdominal ultrasound guided embryo transfer(et), on clinical pregnancy rates(cpr) and live birth rates(lbr) in fresh oocyte donation(od) cycles.

embryos were considered to be staying at the initial expulsion site for long years. however, in 1976 edwards and steptoe reported a tubal ectopic pregnancy after in vitro fertilization (ivf) with a day-3 embryo transfer, which may be accepted as the earliest evidence for migration of embryos from the cavity. the migration concept is very recently taken into consideration by few authors, with studies on fresh ivf and frozen et cycles. oocyte donation (od) is a method of art, in which by using young oocytes from donors the embryo quality is optimized. od cycles have high lbrs, and are the choice of treatment in advanced reproductive age, repeated ivf failure, premature ovarian insufficiency(poi) and particular heritable genetic diseases. donor oocytes can be used as fresh or cryoprotected-thawed, where fresh oocytes have higher lbrs. in the literature, there are no studies performed in fresh od cycles about air bubble and fundus distance after et, and there are no studies performed whether there is any embryo migration after 60 minutes of et and its effects on cpr and lbr. therefore, the investigators conducted this study to evaluate the impact of embryo distance from fundal endometrium, measured 60 minutes after transabdominal usg guided et, on cpr and lbr in fresh od cycles. in literature, this study is first to focus on embryo migration and lbr in fresh od cycles.

Eligibility criteria:
inclusion criteria: * fresh oocyte donation cycles * anatomically anteverted-anteflexed recipient uterus * partners with normal sperm parameters exclusion criteria: * data of women who did not give approval * ivf cycles * frozen-thawed embryo transfer cycles * cryopreserved-thawed od cycles * abnormal sperm parameters or need of any testicular interventions * anatomically retroverted-retroflexed recipient uterus * teneculum required embryo transfers * difficult transfers

Keywords: embryo migration embryo transfer fresh oocyte donation cycle live birth rate
exercise and venous compression on upper airway resistance in obese teenagers with osa

Conditions: Pediatric Obesity; Sleep Apnea, Obstructive

Summary: the purpose of this study is to assess the effects of physical exercise, associated or not with venous compression of the leg, on obstructive sleep apnea (osa) severity and upper airway resistance in obese teenagers. half of the participants will undergo physical exercise and compression socks program, and the other half of subjects will undergo physical exercise program without compression socks.

obesity is an important factor of osa development in children and teenagers, and physical activity is a relevant alternative to promote osa decrease with ou without weight loss. physical activity, beyond the improvement of body composition and exercise cardiorespiratory capacity, restricts fluid retaining in the lower limb of the leg by the activation of musculovenous pump. fluid retaining is involved in osa severity because of nocturnal fluid shift from legs to rostral zone which promotes pharyngeal oedema development and upper airway collapsibility. it has been previously shown that venous compression leads to beneficial fluid regulation in osa subjects and appears as an efficient tool in osa management. to the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with osa.

Eligibility criteria:
inclusion criteria: * obese adolescents (bmi \> 97th percentile), * patients aged from 12 to 17 years old, (born between 07/01/2003 and 09/01/1197), * enrolled in a pediatric obesity center with diet and physical activity programs and psychological management, * without observed tonsils hypertrophy (mallampati and friedman scores), * without contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography, * with physical activity certificate issued by a cardiologist * covered by the national insurance scheme of his/her legal representative, * having signed, as well as his(her) legal representative, the informed consent of participation. exclusion criteria: * non obese adolescents (bmi \< 97th percentile) * patients aged under 12 or over 17 years old, * not enrolled in a pediatric obesity center with diet and physical activity programs and psychological management, * with observed tonsils hypertrophy (mallampati and friedman scores), * with contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography, * without physical activity certificate issued by a cardiologist * uncovered by the national insurance scheme of his/her legal representative, * not having signed, as well as his(her) legal representative, the informed consent of participation.

Keywords: pediatric obesity obstructive sleep apnea physical exercise compression socks rostral fluid shift
long-term results of tonsillectomy in the treatment of obstructive sleep apnea in adults

Conditions: Obstructive Sleep Apnea; Tonsillar Hypertrophy; Sleep Apnea Syndromes

Summary: long-term results of tonsillectomy in the treatment of obstructive sleep apnea in adults

the investigators are studying long-term efficiency of tonsillectomy in adults with obstructive sleep apnea caused by tonsillar hypertrophy. these patients have undergone tonsillectomy in 2004-2018 and now 3-17 years later investigators will perform new polysomnographies and compare these results with preoperative values. especially the reduction in apnea-hypopnea index (ahi) will be evaluated. the quality of life and possible symptoms will be measured with questionnaires.

Eligibility criteria:
inclusion criteria: * age at least 16 during tonsillectomy * preoperative obstructive sleep apnea and ahi (apnea-hypopnea index) \> 14 * tonsillectomy has been done because of the symptoms caused by tonsillar hypertrophy (icd-10 diagnostic codes g47.3, r06.5 or j35.1) * in addition to tonsillectomy, patients may have undergone shortening of uvula and/or radio frequency ablation of soft palate exclusion criteria: * ahi \< 14 * in addition to tonsillectomy patient has undergone uvulectomy, uvulopalatoplasty, uvulopalatopharyngoplasty or mandibular advancement * other, evaluated by investigator

Keywords: tonsillectomy obstructive sleep apnea tonsil surgery