Kornimate/medical-research-clean huggingface dataset:
antibiotic use & open fracture of the lower extremity

Conditions: Lower Extremity Fracture

Summary: it is important to recognize the potential for renal injury and be cognizant of this during the management of complex trauma patients. the primary aim of this study is to investigate the necessity of aminoglycoside usage for patients with open lower extremity fractures. hypothesis: adding aminoglycoside on top of cephalosporin in treating lower extremity fracture will make no significant difference in term of clinical outcomes when compared to cephalosporin alone.

the trauma patient is particularly susceptible to renal injury due to factors such as renal hypoperfusion in the acute setting, the concomitant administration of necessary intravenous contrast agents for diagnostic, and sometimes additionally therapeutic imaging (3). this is additionally complicated by the presentation of trauma patients with pre-existing renal disease. this study will assess whether prophylactic antibiotics \<72hrs have similar outcomes as ≥ 72 hrs of antibiotics, whether type of antibiotics impacts outcomes in patients in either group, help determine the incidence of infection in gustilo type iii lower extremity fracture when treated either with a single agent (cephalosporin) or dual agent (cephalosporin + aminoglycoside) and the complication profile of patients with gustilo type iii lower extremity fracture when treated either with a single agent (cephalosporin 1st generation) or dual agent (cephalosporin 1st generation + aminoglycoside).

Eligibility criteria:
inclusion criteria: * male and female patients ≥ 18 years of age * all patients with open grade ii or grade iii lower extremity open fractures according to the gustilo classification of open fracture. exclusion criteria: * any significant injuries in addition to the lower extremity fracture as determined by the pi that may confound the data. * inability to give informed consent or comply with data acquisition (part 3). * pregnant or breast feeding patients due to the potential risks to the mother and/or fetus. * prisoners * previous bone malignancy * bowel or enteric injury at index admission * tbi of ais ≥ 5

Keywords: gustilo
evaluation of pain and inflammation after injection of lucentis vs eylea for treatment of wet macular degeneration

Conditions: Neovascular Age-Related Macular Degeneration

Summary: this study is designed to compare the post injection inflammation and pain seen after intravitreal injections of ranibizumab vs aflibercept.

this is an open-label, phase i-ii study of post injection pain and inflammation after intravitreally administered ranibizumab and aflibercept in 100 subjects with neovascular age-related macular degeneration. we will enroll both treatment experienced ( patients who were treated with lucentis or eylea, but not avastin in the past) and treatment naive patients ( new onset neovascular amd with no history of intravitreal injections). the treatment experienced patients will be treated with the intravitreal medication other than what they were receiving in the past, for example, patients treated with lucentis will switch to eylea for study purposes and vice versa. consented, enrolled subjects will receive open-label intravitreal injection of either 0.5mg ranibizumab or 2mg aflibercept. a standard intravitreal injection protocol will be followed. patients will be reevaluated between 24-48 hours and 5-7 days post injections. a non-injecting physician will evaluate the patients for anterior chamber inflammation; this physician will be blinded about the specific treatment. anterior chamber inflammation is described as any cell or flare in the anterior chamber. these will be evaluated using standardization of uveitis nomenclature (sun) working group classifications. pain score will be evaluated using a numerical rating scale. each patient will have a standard script verbally read to them at their visit, and asked to rate their pain based on this scale.

Eligibility criteria:
inclusion criteria: 1. able to provide informed consent and comply with study assessments for the full duration of the study 2. age \>/= 65 years 3. new onset neovascular age-related macular degeneration or (see no.4) 4. previously treated neovascular age-related macular degeneration with lucentis or eylea intravitreal injections 5. visual acuity of 20/400 or better 6. no history of post injection pain or inflammation with prior treatments - exclusion criteria: 1. history of endophthalmitis in either eye 2. uncontrolled or symptomatic dry eye syndrome 3. history of anterior or posterior uveitis 4. history of post injection pain or inflammation with prior treatments 5. recent thromboembolic event(\<3 months) 6. pregnancy(positive pregnancy test) or lactation/premenopausal women not using adequate contraception -
can valacyclovir delay the need for initiation of human immunodeficiency virus (hiv) treatment in hiv-infected individuals?

Conditions: HIV Infection; Herpes Simplex Type II; HIV Infections

Summary: this study is a multicentre, randomized, placebo-controlled, fully blinded, clinical trial of twice daily oral valacyclovir 500mg versus placebo with the goal of delaying the need for initiating haart among hiv infected individuals who neither use nor require haart, and who have not used chronic suppressive anti-hsv therapy for at least the 6 months prior to study initiation.


Eligibility criteria:
inclusion criteria: * adult (aged 18 years or older or as per local/provincial guidelines) * documented hiv-1 infection (determined by eia and western blot, sites' standard assays are acceptable if approved in advance by the pis for the study, dr. darrell tan and/or dr. sharon walmsley) * no use of chronic anti-hsv therapy for the past 6 months, and not anticipated to require chronic anti-hsv therapy during the study * antiretroviral naïve (no more than 14 days of total prior arv exposure) * cd4 count within the 400-900 cells/mm3 range (inclusive) on two consecutive occasions, with at least one measurement within 30 days of initiating trial (baseline visit) * does not meet recommendations for initiating arv therapy according to current guidelines exclusion criteria: * pregnancy or actively planning to become pregnant * receiving chemotherapy, chronic steroid therapy or other immunomodulatory medications (e.g. interferon, azathioprine, methotrexate, tnf-alpha antagonists, etc.) * estimated creatinine clearance \<30 ml/min * other medical condition likely to cause death within 24 months * enrolled in a therapeutic hiv vaccine or immunotherapy trial * enrolled in another trial investigating the impact of another intervention on hiv disease progression * hiv elite controller (ec), phenotypically defined here as documented duration of hiv infection of ≥5 years, a persistent cd4 cell count ≥500 cells/mm3, and a persistent plasma hiv viral load of \<1000 copies/ml in the absence of antiretroviral therapy

Keywords: hiv herpes simplex virus type ii genital herpes treatment naive
effect of olanzapine on sleep electroencephalogram (eeg) in schizophrenia patients

Conditions: Schizophrenia; Sleep

Summary: acute and sub-chronic administration of olanzapine has shown a favourable effect on the sleep disturbances in previously medicated schizophrenia patients with predominantly negative symptoms. the present study will be carried out to clarify the effect of olanzapine on polysomnographic profiles of schizophrenia patients in an acute phase of illness after controlling for the drug effects.

twenty schizophrenia patients (11 drug naïve and 9 drug free) will be studied over a period of six weeks of olanzapine treatment. patients will be assessed at the baseline on bprs, panss, cdss and uku side effect rating scales and a baseline 40 channels polysomnography will be done. after the initial assessment, patients will put on olanzapine treatment, in flexible dosages based on clinical response, for a period of six weeks when a final assessment on clinical rating scales and polysomnography will be done. the sleep data will be scored manually for staging based on rechtschaffen and kales criteria.

Eligibility criteria:
inclusion criteria: 1. male patients fulfilling international classification of diseases-10 diagnostic criteria for research for schizophrenia 2. aged 18-50 yrs 3. drug naïve or drug free (not receiving any psychotropic medication for the past 4 months) 4. consenting exclusion criteria: 1. any comorbid psychiatric illness 2. significant medical or neurological illness 3. history of significant head injury, epilepsy 4. substance use in the past 4 months excluding nicotine and caffeine 5. presence of a primary sleep disorder

Keywords: olanzapine schizophrenia polysomnography slow wave sleep
optimizing individual health care for young people with gender incongruence

Conditions: Gender Incongruence

Summary: this observational study focuses on evaluating the effect of the current health care program for danish children and adolescents with gender incongruence, which was established in january 2016. somatic outcome parameters include growth, bone health, body composition, metabolic parameters, hormone levels and concurrent diseases. psychosocial parameters include the trajectory of gender incongruence development, mental health, i.e. autism spectrum disorders, behavioural problems, self-harm, suicidal ideation and psychiatric diagnoses, and social context, i.e. family demographics, education, minority stress. this study aims to: 1. characterise the psychosocial profile of all children and adolescents referred for treatment, as well as the history of gender identity development and treatment trajectories. 2. systematically evaluate biological parameters before and during hormonal treatment with gonadotropin-releasing hormone (gnrh) analogues and cross-sex hormones, and to establish a biobank for those in hormone treatment. the investigators hypothesise that intervention with counselling and hormonal treatment is safe and has a positive impact on psychosocial well-being of transgender youngsters. the overall aim is to provide data for improving future family counselling, clinical care, patient satisfaction, patient safety and ultimately quality-of-life.


Eligibility criteria:
inclusion criteria: * accepted referral to the gender identity service. exclusion criteria: * none.
a study to evaluate the safety and pharmacokinetics abbv-399 in japanese participants with solid tumors

Conditions: Advanced Solid Tumors Cancer

Summary: an open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of abbv-399 in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * participant with histologically confirmed advanced solid tumor. * participant must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit. * participant has an eastern cooperative oncology group (ecog) performance status of 0 to 2. * participant must have measurable disease per response evaluation criteria in solid tumors (recist) version 1.1. * participant has archived diagnostic formalin-fixed paraffin embedded (ffpe) tumor tissue available for analysis. * participant has adequate bone marrow, renal, and hepatic function. exclusion criteria: * participant has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days, or herbal therapy within 7 days prior to the first dose of abbv-399. * participant has known uncontrolled metastases to the central nervous system. participants with brain metastases are eligible after definitive therapy provided they are asymptomatic off systemic steroids and anticonvulsants for at least 2 weeks prior to first dose of abbv-399. * participant has unresolved clinically significant adverse events \>= grade 2 from prior anticancer therapy except for alopecia or anemia. * participant has had major surgery within 21 days prior to the first dose of abbv-399.

Keywords: abbv-399 maximum tolerated dose (mtd) maximally administered dose (mad) dose escalation pharmacokinetics advanced solid tumors cancer solid tumors
extending urine analysis by direct mass spectrometry

Conditions: Urinary Tract Infection (Diagnosis)

Summary: the aim of this study is to evaluate the effect of an extension of conventional urine diagnostics with mass spectrometry in patients with a suspected uti. mass spectrometry is done directly from the urine sample (without an intermediate bacterial culture).the primary outcome is the time from the entry of a urine sample in the microbiological laboratory to the adequate/optimal/definitive treatment. secondary outcomes are the time to diagnosis of a therapy relevant uti, the quantity of antibiotics prescribed per patient and ward and a comparison of the length of hospital stay.

urinary tract infections (uti) have a high incidence rate and are one of the main reasons for initiating an antibiotic therapy, both, in the ambulatory and hospital setting. mass spectrometry and improved sample preparation allows same-day identification of the causing agent of an uti. this could shorten the time of suboptimal and potentially harmful empirical therapy. additionally adverse effects from and the development of resistance against the applied antibiotic agent could be diminished. matrix assisted laser desorption ionization (maldi)- time of flight (tof) mass spectrometry (ms) (maldi-tof ms) is already the preferred identification method in an increasing number of laboratories since it outperforms biochemical identification by speed and precision. this study tries to evaluate this new method to identify the causing agent of an uti and evaluates its clinical implications. this research project is a clinical trial that intends to analyse urine of patients with suspected urinary tract infections by mass spectrometry. this patient material is conventionally processed and not retrieved particularly for study purposes. health-related personal data is collected from patients on the wards of the clinic for internal medicine at the university hospital basel that have a urine sample analysed during the study period. no health-related personal data is particularly collected for this study.

Eligibility criteria:
inclusion criteria: * patients of the clinic for internal medicine at the university hospital basel with a suspected uti and a minimum of one urine sample sent to the clinical microbiology laboratory. additionally at least one of the following: * patients consented to the general (i.e. "hospital-wide") use of their data and samples for research purposes. * patients consented to be enrolled in this study (by being informed about this study and signing the study specific consent form). * patients who are exempted from the need for a consent by way of an exception in agreement to the decisions of the competent ethics committee. exclusion criteria: * minors or persons who declined the general use of their data and samples for research purposes (hospital wide consent) and declined or did not decide on the study specific consent form are not included.
effects of tolperisone on measures of drowsiness and cognitive function

Conditions: Healthy

Summary: a randomized, 4-period, crossover study to characterize the effects of tolperisone 200 mg and 400 mg (supratherapeutic dose) three times a day (tid) over 3 days of dosing on measures of simulated driving performance, cognitive function and drowsiness and compared to placebo and cyclobenzaprine (single-day, residual effect, multiple-day).


Eligibility criteria:
inclusion criteria: * ambulatory male or female, between 21 and 65 years of age, inclusive, for the entire duration of the study (from screening through day 3 of last treatment period). * body mass index (bmi) range between 18.5 and 30.0 kg/m2, inclusive. * subject must possess a valid driver's license and be an active driver and have driven a minimum of 10,000 miles (about 16,000 km) per year for the previous 3 years. * subject must demonstrate simulator sickness questionnaire scores that are not indicative of simulator sickness as defined in the driving simulation operations manual. * subject must have a regular sleep pattern, not be engaged in shift-work, and in general, have at least 7 hours of sleep each night. exclusion criteria: * history of sleep disorders, including insomnia, sleep apnea, restless legs syndrome (rls), or narcolepsy, night-shift workers, routine daytime napping or oversleeping on weekends days (off work) or a score higher than 10 on the epworth sleepiness scale (ess) at screening. * a history of difficulty in falling asleep or staying asleep in the previous 3 months that is considered clinically significant by the investigator. * subject has traveled across 2 or more time zones (trans meridian travel) in the last 2 weeks prior to randomization or is expected to travel across 2 or more time zones during the study. * subject has any physical condition (e.g., severe vision issues, hand use limitations) that would prevent the subject from performing the cognitive or drowsiness assessments. * subject has a presence or history of any medically diagnosed, clinically significant psychiatric disorder, including depression, anxiety, insomnia, schizophrenia, or bipolar disorder. * consumes more than 3 cups of coffee per day. * female subjects who are pregnant or lactating. * any clinically significant medical abnormality, any clinically significant chronic disease, or any clinically significant finding on physical examination. * subject with a genotype status of poor-, ultrarapid-, or indeterminate- metabolizers of cytochrome cyp2d6. * subject is unable to remain in the research unit for each of the treatment periods. * subject has visual or auditory impairment which in the opinion of the investigator would interfere with study related procedures or study conduct.
an exploratory investigation of dietary supplementation and its effect

Conditions: Quality of Life

Summary: the primary objective of this study is to understand if the test product (hum supplement) improve symptoms experienced.

this will be a 2-arm randomized, double-blinded, placebo-controlled study.

Eligibility criteria:
inclusion criteria: * female * willing to maintain the current dietary pattern, activity level, and stable body weight for the duration of the study * must be in good health (don't report any medical conditions asked in the screening questionnaire) * willing and able to provide written informed consent exclusion criteria: * allergies to any test product ingredients * any other severe chronic disease * pregnant, want to become pregnant for the duration of the study, or who are breastfeeding * participating in an investigational health product research study
molecular characteristics of phlegm-heat syndrome in ischemic stroke

Conditions: Ischemic Stroke, Acute

Summary: the molecular characteristics of ischemic stroke with phlegm-heat syndrome and candidate biomarkers were identified based on multi-omics data. the main purpose of this study is to validate the molecular characteristics and biomarkers of phlegm-heat syndrome in ischemic stroke, and to demonstrate the association of biomarkers with clinical outcomes.

this is a cohort study in patients with acute ischemic stroke. the demographic characteristics, traditional chinese medicine (tcm) syndromes, and other baseline information will be recorded. at the same time, baseline peripheral blood will be collected. these participants will be followed up to 90 days of onset, and 90-day modified rankin scale (mrs) scores will be assessed. the collected blood samples will be tested by multi-factor detection technology for candidate biomarkers.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke. * symptom onset within 72 hours. * diagnosis of phlegm-heat syndrome or non-phlegm-heat syndrome. * male or female ≥18 years and ≤ 80 years. * with written informed consent. exclusion criteria: * acute infectious diseases or acute exacerbations of chronic diseases within one month before enrollment. * patients has previous stroke. * other conditions that lead to motor dysfunction (e.g., severe osteoarthritis, rheumatoid arthritis). * renal or hepatic insufficiency, tumors, immune diseases, severe underlying diseases. * other conditions that affect the collection and evaluation of clinical information (e.g., severe aphasia, mental illness).
comparative study of scalp cooling system and chemical cold cap (cohair study)

Conditions: Primary Breast Cancer

Summary: this is a phase iii, single-center, prospective, open-label, randomized,controlled study

to conduct a prospective randomized controlled study comparing the effect of scalp cooling system (dignicap) and chemical cold cap on preventing chemotherapy-induced alopecia in a group of breast cancer patients receiving standard anthracycline followed paclitaxel regimens. to obtain the exact data on the role of different methods of preventing alopecia in chinese women with breast cancer. pass 11 software was used to calculate the sample size. according to the results of previous studies, the hair retention rate of the cold cap group was 67.7%, the hair retention rate of the scalp cooling system group was 50.5%, α=0.05，power=0.8. the sample size was calculated to be at least 128 cases in each group, 256 cases in total.

Eligibility criteria:
inclusion criteria: * female patients, 18≦age ≦66 years * invasive breast cancer diagnosed with core needle needle biopsy * staging i-ii * without chemotherapy contraindications, and planned to receive neoadjuvant chemotherapy with a standard regimen (containing 4-cycle dose-dense anthracycline followed 4-cycle paclitaxel) * attend the study voluntarily, sign the informed consent exclusion criteria: * history of malignant tumors * with chemotherapy contraindications * with severe dermatosis and severe sparsity * history of chronic diseases such as cerebrovascular disease, migraine and hyperthyroidism * uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection * refuse to join the study

Keywords: alopecia scalp cooling system cold cap