Kornimate/medical-research-clean huggingface dataset:
clinical survey of oticon medical healing cap

Conditions: Conductive Hearing Loss; Mixed Hearing Loss; Unilateral Partial Deafness

Summary: this study investigates the use of a new healing cap which, through altered design and choice of material, has been improved when it comes to minimizing the risk of it falling off as well as increasing patient comfort.

this study will primarily investigate the use of a new healing cap, healing cap ii. the new healing cap has the same function as previous healing caps, but it soft instead of hard. due to this, the healing cap is anticipated to not fall off as easily, but at the same time does not risk transferring larger forces than previously to the implant. secondly, the patients will start using the sound processor 1-2 weeks after surgery. the implant stability will be monitored before and after loading by the use of resonance frequency analysis, an established method to evaluate and monitor osseointegrated implants.

Eligibility criteria:
inclusion criteria: * patients eligible for treatment with a bone anchored hearing aid * 18 years or older exclusion criteria: * inability to participate in follow-up * diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
phosphorus 32 in treating patients with glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: radioactive drugs such as phosphorus 32 may be able to kill tumor cells. purpose: this phase i trial is studying the side effects and best dose of phosphorus 32 in treating patients with glioblastoma multiforme.

objectives: * determine the dosimetry toxicity of interstitial colloidal phosphorus p32 (c p32) in patients with recurrent or poor prognosis grade 4 astrocytoma. * determine the maximum tolerated dose of c p32 administered directly into the tumor of these patients. * determine the maximum tolerated fractionated dose of interstitial c p32 in these patients. * determine the therapeutic response rate to the acceptable single and fractionated doses of c p32 in these patients. outline: this is a dose-escalation study. patients receive interstitial colloidal phosphorus p32 (c p32) on day 0. courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 3 patients receive escalating doses of c p32 until the maximum tolerated dose (mtd) is determined. the mtd is defined the dose at which 2 of 3 patients experience dose-limiting toxicity. patients are followed at 1, 2, 4, 6, 9, 15, and 24 weeks. projected accrual: a minimum of 12 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically proven grade 4 astrocytoma (glioblastoma) * failed external beam radiotherapy and/or surgery or * poor prognosis disease * no clinical evidence of metastatic disease within the cns other than the primary tumor site * stereotactic biopsy or gross total excision with residual tumor * lesion 3 to 5 cm in size * no spinal cord tumor(s) patient characteristics: age: * 18 and over performance status: * karnofsky 70-100% life expectancy: * not specified hematopoietic: * wbc at least 3,000/mm3 * neutrophil count at least 1,900/mm3 * platelet count at least 100,000/mm3 * hemoglobin at least 9 g/dl (transfusion allowed) hepatic: * not specified renal: * creatinine no greater than 1.5 mg/dl * bun less than 25 mg/dl other: * not pregnant * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * see disease characteristics surgery: * see disease characteristics

Keywords: recurrent adult brain tumor adult glioblastoma adult giant cell glioblastoma adult gliosarcoma
efficacy of low-dose (10 mg) rosuvastatin in korean 4 statin benefit groups per 2013 acc/aha guideline

Conditions: Dyslipidemias

Summary: this study aimed to evaluate the efficacy of low-dose rosuvastatin (10 mg) in the 4 statin benefit groups requiring high- or moderate-intensity statin therapy according to the 2013 american college of cardiology/american heart association guideline in korean population.

the primary endpoint was percentage reduction in low-density lipoprotein (ldl) cholesterol. secondary endpoints were percentage reduction in other lipids and achievement of ≥50% reduction in ldl cholesterol. intention-to-treat analyses were performed.

Eligibility criteria:
inclusion criteria: 1. subjects with prior history of clinical ascvd 2. subjects with primary elevation of ldl cholesterol ≥190 mg/dl 3. subjects with diabetes, age 40 to 75 years, and ldl cholesterol 70 to 189 mg/dl 4. subjects without diabetes, age 40 to 75 years, ldl cholesterol 70 to 189 mg/dl, and with estimated 10-year ascvd risk ≥7.5%. exclusion criteria: 1. history of significant statin-induced rhabdomyolysis or myopathy 2. history of a significant hypersensitivity reaction to rosuvastatin 3. uncontrolled diabetes mellitus (hba1c \>9%) 4. uncontrolled hypertension (systolic blood pressure \>190 mmhg or diastolic blood pressure \>100 mmhg) 5. current active liver disease (alanine aminotransferase and/or aspartate aminotransferase \>2 times the upper limit of normal) 6. chronic kidney disease (serum creatinine clearance \<30 ml/min) 7. creatine kinase levels \>3 times the upper limit of normal 8. use of prohibited concomitant therapies 9. history of malignancy within the last 5 years 10. women who were pregnant, breast-feeding or of childbearing potential without contraception 11. subjects who would take any medication for purposes other than this trial within 30 days after taking this study's medication.

Keywords: cholesterol, ldl asian rosuvastatin low-dose
correlation between targeted hba1c values and prevention of recurrent cardiovascular events in type 2 diabetes after pci

Conditions: Diabetes Mellitus; Percutaneous Coronary Intervention

Summary: diabetes is a leading social and economic burden in the world. it is the main reason of macrovascular disease incidence and mortality. prospective studies have demonstrated that high glycosylated hemoglobin (hba1c) levels are associated with an increased risk of cardiovascular events in a population of diabetic patients without a history of coronary artery disease. further, the predictive value of high preprocedural glycemia levels has been reported in diabetic patients undergoing percutaneous coronary intervention (pci). the aim of the present study was to assess the predictive value of preprocedural hba1c levels for cardiovascular complications in a large population of diabetic patients undergoing pci with stent implantation. glycosylated hemoglobin (hba1c) reflects the average blood sugar level in the past 2-3 months. as glycosylated hemoglobin has been clinically tested and standardized internationally, increasing evidence is recommended for routine monitoring in diabetes care. the american diabetes association (ada) suggested that in the treatment of diabetes, blood sugar control should control hba1c level below 6.5%. although，there is evidence that controlling blood glucose can reduce the incidence of microvascular complications, in the past three trials, intensive glycemic control did not significantly reduce adverse cv events in patients with onger duration of diabetes.therefore, most primary and secondary prevention guidelines recommend hba1c below 6.5% or 7% to prevent adverse cardiovascular outcomes in patients with diabetes mellitus. the optimal target level of glycosylated hemoglobin is still hotly debated. in addition, there is still lack of evidence for the level of hba1c in patients with major vascular disease history in secondary prevention of recurrence cardiovascular events. therefore, to explore and determine the optimal level of blood glucose control is the focus of controversy in preventing recurrence cardiovascular events in diabetic patients. investigator will combine epidemiology and metabolomics to study the effect of glycosylated hemoglobin on secondary cardiovascular events, and further determine whether to strengthen hypoglycemic treatment after pci.

this is a longitudinal cohort study including retrospective study, prospective study and nested case-control study.the first cross-sectional survey was conducted in 2021.

Eligibility criteria:
inclusion criteria: - 1. age ≥ 18, male or female; 2. all patients with diabetes combined with pci operation; exclusion criteria: * 1. less than 18 years old 2. pregnancy 3. patients with preoperative glycosylated hemoglobin index deficiency 4. chronic maintenance hemodialysis patients

Keywords: glycated hemoglobin percutaneous coronary intervention metabolomics diabetes mellitus cardiovascular risk
non-invasive transcranial focused low-intensity ultrasound stimulation in patients with mild lewy body dementia

Conditions: Lewy Body Dementia

Summary: a randomized controlled clinical study was conducted in the xuanwu hospital single center of capital medical university to preliminarily explore the efficacy and safety of transcranial focused low-intensity ultrasound stimulation in the treatment of dementia with lewy bodies in the early stage, to clarify the effective mechanism and form an effective clinical treatment plan.

this project plans to recruit 20 patients with mild lewy body dementia.they were randomly divided into transcranial focused low-intensity ultrasound active stimulation group and sham stimulation group. patients receive treatment three days a week, and the daily treatment time is 20-30 minutes.the duration of treatment is 4-12 weeks. before treatment, cognitive assessment, resting eeg, head mri and pet examination of glucose metabolism were completed.complete the overall cognitive assessment, resting eeg and mri examination within one week after the treatment, and complete the overall cognitive assessment and pet examination of glucose metabolism at the follow-up 6 months after the treatment.fill in the treatment side effect scale and adverse event form.keep the original oral drug dosage unchanged during the treatment process.

Eligibility criteria:
inclusion criteria: * male or female dlb patients between the ages of 50-85; * the psychological evaluation was in accordance with mmse score of 18-24 (including 18 and 24) and cdr score of 0.5. * can cooperate to complete clinical research. exclusion criteria: * there is a definite history of cerebrovascular stroke, and there are definite symptoms or signs of neurological deficit at the time of onset, and there are corresponding responsible lesions left by neuroimaging。 * those who have a history of alcoholism, or drug addiction, or neurological diseases such as brain trauma, epilepsy, encephalitis, normal intracranial pressure hydrocephalus, etc. that can cause cognitive impairment. * suffering from systemic diseases that may lead to cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiency). * have a history of using antipsychotics for more than five years before diagnosis. * there are contraindications for head mri examination.
prospective study of intensity-modulated proton therapy (impt) for small cell lung cancer

Conditions: Small-cell Lung Cancer

Summary: to assess the safety and efficacy of intensity-modulated proton therapy (impt) for small cell lung cancer (sclc)

to determine the optimal schedule for three-dimensional verification imaging and necessary re-planning of patients undergoing impt for a rapidly changing tumor (small cell lung cancer). * to determine the rate of cardiac toxicities from impt in patients with small cell lung cancer compared with historical controls receiving photon-based treatment. * to determine the rate of pneumonitis and esophagitis from impt and compare with historical controls receiving photon based treatment.

Eligibility criteria:
inclusion criteria: * pathologically confirmed small cell lung cancer, limited or extensive stage. * patients who are offered thoracic radiotherapy with intensity-modulated proton therapy (impt) techniques delivering 30-66 gy in 15-33 fractions at 2 gy per fraction, at the recommendation of the treating radiation oncologist. * age 18 or greater exclusion criteria: * prior radiation therapy which would provide significant dose overlap with the planned target volume(s) * pregnancy
melanoma: genomic profiles, molecular markers and therapeutic implications

Conditions: Melanoma

Summary: the goal of this study is to evaluate the genomic profiles and investigate the prevalence of germ line and pathogenic mutations in greek population with early and metastatic melanoma and their correlation with the treatment and prognosis of the disease.

in this context, it is aimed to utilize tissue biopsy tests that will focus on specific areas of clinical applications, namely, diagnosis, prognosis and identification of mutations for targeted therapy and assessment of acquiring treatment resistance. thus, the tissue biopsy next generation sequencing (ngs) panels in development by nipd genetics will be used in clinical practice as complementary diagnostics. for tumor genotyping of the 200 patients with melanoma skin cancer in the present study it will be used the comprehensive tissue biopsy melanoma cancer panel from nipd genetics these panels are designed to target clinically actionable and clinically significant mutations that will provide physicians with genetic information regarding a) prediction of the patient's response to targeted therapy, b) prognosis, that is, prediction of clinical outcome, c) diagnosis and molecular classification of melanoma cancer. the panel allows for the detection of single nucleotide (snvs) and copy number variants (cnvs), as well as gene fusions and indels; it necessitates at least 400ng of appropriate quality dna template that is achievable from ffpe samples and is validated with molecular standards and controls for the exclusion of artefacts. thorough histological evaluation of the formalin-fixed-paraffin-embedded (ffpe) tumor tissue blocks will be done by an experienced pathologist to evaluate h\&e sections for confirmation of diagnosis, histologic type, grade and tumor cell content (tcc%). dna isolation will be performed from 10 μm whole sections following manual macro-dissection to enrich samples for tumor dna, whereby tcc will be assessed as an approximate metric for tumor dna in the extracted samples, corresponding to tumor nuclei vs. all nuclei in the areas marked for macro-dissection. a total of 200 patients with melanoma skin cancer are expected to be included in the analysis based on the number of patients registered in the hellenic cooperative oncology group's (hecog's) database along with the ability to achieve precision around the primary and secondary endpoints. primary endpoint will be the evaluation of the prevalence of mutations, while the secondary endpoint will be the assessment of prognostic significance of mutations with respect to overall survival (os).

Eligibility criteria:
inclusion criteria: * melanoma skin cancer patients * the ability to achieve ffpe exclusion criteria: -
post-prandial liver glucose metabolism in pcos

Conditions: Polycystic Ovarian Syndrome; Obesity; Hepatic Steatosis

Summary: the investigators will measure if hepatic metabolism is upregulated in obese girls with pcos and hepatic steatosis (hs), compared to pcos without hs and obese controls without hs.

this will be a cross-sectional study with 4 groups of youth. a 6 hour ostt (oral sugar tolerance test) with an oral u-c13 glycerol tracer will be paired with nuclear magnetic resonance spectroscopy (nmr) isotopomer analysis of serum samples to describe flux through the hepatic pentose phosphate pathway, tca cycle and fas pathways in girls with pcos receiving lifestyle only, metformin or oral contraceptive treatment, and obese girls with regular menses receiving lifestyle therapy. hepatic steatosis will be measured with mri. please note that 3 study groups: pcos on metformin, pcos on oral contraceptive treatment, and obese girls with regular menses were not funded in the study, so no participants were enrolled in these 3 arms of the study.

Eligibility criteria:
inclusion criteria: 1. female 2. ages 12-21 3. sedentary- less than 2.5 hours of moderate (jogging, swimming etc) exercise a week. 4. bmi equal or greater than the 90th percentile for age and gender 5. for pcos groups: * (nih definition) irregular menstrual cycles at least 1.5 years after menarche, and * either clinical evidence of hyperandogenism, or * elevated testosterone (above the norms for age/tanner stage) at time of screening, or documented prior to initiation of therapy for ocp and metformin groups. 6. for pcos groups: * patients un-treated or currently treated with either metformin 1500-2000 mg a day, or * oral contraception (30-35 mcg ethynyl estradiol a day) for at least 6 months, with \> 80% adherence confirmed via refill frequency from pharmacy. 7. for non-pcos groups: * regular menstrual cycles at least 1.5 years after menarche, and * no clinical evidence of hyperandrogenism. exclusion criteria: 1. use of medications known to affect insulin sensitivity: * oral glucocorticoids within 10 days, * atypical antipsychotics, * immunosuppressant agents, * hiv medications. * nexplanon, depo-provera or mirena progesterone only contraceptives. * dermal patch or vaginal ring contraception methods. * for controls only: metformin or oral contraception. 2. currently pregnant or breastfeeding women. development of pregnancy during the study period will necessitate withdrawal from the study. 3. severe illness requiring hospitalization within 60 days 4. diabetes, defined as hemoglobin a1c \> 6.4% 5. bmi percentile less than the 90th percentile for age and sex. 6. weight \>325 lbs or \<84 lbs. 7. anemia, defined as hemoglobin \< 10 mg/dl 8. diagnosed major psychiatric or developmental disorder limiting informed consent 9. implanted metal devices that are not compatible with mri 10. use of blood pressure medications 11. known liver disease other than nafld or ast or alt \>150 mg/ml -

Keywords: hepatic de novo lipogenesis
technical evaluation of brahms pct direct

Conditions: Infection

Summary: validation of the technical performance of the brahms ptc direct point-of-care assay under routine conditions with native patient samples. the clinical validation is planned as a method comparison to a reference method (brahms pct sensitive kryptor, elecsys brahms pct). the study hypothesis is to show a highest correlation between the new product and the reference methods.

procalcitonin (pct) is a highly sensitive and specific marker which can be detected in the blood stream in response to a bacterial infection. in contrast to conventional infection disease markers pct permits the differential diagnosis between bacterial and viral infections. the marker is implemented on intensive care units (icu) and emergency departments (ed) worldwide since 1996. until now various technologies all basing on the use of serum or plasma samples are available in the market. brahms gmbh (clinical diagnostics division of thermo fisher scientific) as manufacturer of the procalcitonin assays has developed a new quantitative immunochromatographic whole blood point-of-care assay, the brahms pct direct. the test follows the principle of a sandwich assay with two anti-pct antibodies, one immobilized on a nitrocellulose membrane and the tracer antibodies labeled with gold. validation of the technical performance of the product under routine conditions with native patient samples. the clinical validation is planned as a method comparison to a reference method (brahms pct sensitive kryptor, elecsys brahms pct). the internal pre-studies were performed with blood samples spiked with recombinant pct and with native patient samples. the primary objective of this study is to show a highest correlation between brahms pct direct with the pct reference method for pct- positive and negative samples. the secondary object of this study is to show the advantage of brahms pct direct in time to result in comparison to the reference method.

Eligibility criteria:
inclusion criteria: * age \> 18 years * possible infection at initial presentation * informed consent exclusion criteria: * none

Keywords: procalcitonin infection point-of-care
a single-center study on the effect of systemic/selective lymph node dissection on the prognosis of ground glass nodules smaller than 3cm and with components with consolidation/tumor ratio between 0.5-1

Conditions: Progression; Postoperative Recovery

Summary: a single-center study on the effect of systemic/selective lymph node dissection on the prognosis of ground glass nodules smaller than 3cm and with components with consolidation/tumor ratio between 0.5-1

a single-center study on the effect of systemic/selective lymph node dissection on the prognosis of ground glass nodules smaller than 3cm and with components with consolidation/tumor ratio between 0.5-1

Eligibility criteria:
inclusion criteria: patients enrolled in the study must meet all of the following conditions: * 1.aged between 25 and 75 years; * 2. ggo is diagnosed by thin-section lung ct (thickness \<1.5mm) within one month before surgery; * 3. the maximum diameter of the ggo is smaller than 3cm; * 4. the solid component in ggo between 50%-100%; * 5. preoperative examination showed that the patient could tolerate lobectomy; * 6. the patient is able to understand and comply with the study and has provided written informed consent. exclusion criteria: patients meeting any of the following criteria are not eligible for this trial: * 1. patients with a history of lung surgery; * 2. postoperative pathology showed non-primary lung cancer; * 3. the scope of surgical resection is larger than one lung lobe; * 4. patients with a history of other tumors; * 5. patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis); * 6. unable to cooperate with the researchers because of dementia or cognitive decline * 7. other situations that are not in conformity with the standards and requirements of this trial.