Kornimate/medical-research-clean huggingface dataset:
5-ala in recurrent glioma

Conditions: Glioma

Summary: the investigators propose a single-center, non-randomized, single-arm study at the barrow neurological institute/st. joseph's hospital for recurrent glioma. the 5-ala for recurrent glioma study will correlate presence of fluorescence in tumor tissue with pathological findings. this will be done using three cohorts in dose escalation. the investigators' hypothesis is that (for both low- and high-grade gliomas,) a lower dose of 5-ala will result in less false positive fluorescence.

the goal is to determine the dose of 5-ala which promotes the lowest volume of residual disease after resection of recurrent high grade glioma without compromising the demarcation between recurrent high grade glioma and postoperative bed normal tissue. sub-goals: 1. to determine the impact of the dose of 5-ala in improving volumetric extent of resection in patients with recurrent high grade gliomas 2. to determine the impact of the dose of 5-ala in improving overall survival of recurrent high grade glioma patients 3. to determine the impact of the dose of 5-ala in improving progression-free survival of recurrent high grade glioma patients 4. to determine the impact of the dose of 5-ala on the neurological morbidity of recurrent high grade glioma patients. patients with presumed recurrent glioma will be entered into the trial. those with recurrent disease will receive study drug (5-ala) in one of three dose-escalated cohorts (5 mg/kg; 10 mg/kg; 20 mg/kg). intraoperatively, patients will undergo resection with combined fluorescence microscopy and confocal microscopy. resected tissue specimens corresponding to the presence of fluorescence will be sent to pathology for examination. postoperatively, patients will have an mri with and without contrast within 48 hours of surgery. subsequent analysis of each patient will include assessment of the primary endpoint (volume of residual disease) by volumetrically quantifying the tumor before and after surgery using t1-weighted contrast-enhancement. similarly, volumetric extent of resection will also be measured.

Eligibility criteria:
inclusion criteria * presumed recurrent glioma * age \> 18 years * normal bone marrow function (wbc \> 3000, platelets \> 100,000) exclusion criteria * pregnancy * history of photosensitivity, porphyria, or exfoliative dermatitis * hepatic dysfunction in the last 12 months \[defined by aspartate aminotransferase(ast), alanine aminotransferase (alt) , alkaline phosphatase (alp) , bilirubin \> 2.5 x normal\] * serum creatinine \> 180 µmol/l * estimated glomerular filtration rate (egfr)\< 60 ml/min/1.73m2 * inability to undergo mri with contrast

Keywords: 5-ala 5-aminolevulinic acid fluorescence-guided surgery glioma astrocytoma glioblastoma oligodendroglioma recurrence of glioma
clinical study for comparative assessment of efficacy and safety of angal s, topical spray and anti-angin® formula, topical metered spray in treatment of patients with uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat

Conditions: Sore Throat

Summary: the purpose of this study was to evaluate no less therapeutic efficacy and safety of the angal s, topical spray \[menthol\], 0,5 mg + 2 mg (sandoz dd, slovenia) compared to anti-angin® formula, topical metered spray, 0,12 mg + 0,24 mg (llc "valeant", russia) in treatment of patients with uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat.


Eligibility criteria:
inclusion criteria: * voluntarily signed informed consent for participation in this clinical study; * 18 to 45 years old inclusive, male and female; * diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat; * onset of first symptoms of the uncomplicated acute infectious and inflammatory diseases of the pharynx (pharyngitis and/or tonsillitis) less than 48 hours prior to inclusion into the study; baseline tss score (tonsillopharyngitis severity score) ≥ 5 (total score); * body temperature 37,5 c (axillary). exclusion criteria: * use of analgesics within \<12 hours prior to the study start or/and inability to cancel them during the study; * use of antibiotics within \<48 hours prior to the study start or/and inability to cancel them during the study; * use of local therapy (sprays, rinses, lozenges) to pharynx within \<12 hours before study start or/and inability to cancel them, besides study medications; * use systemic or inhaled corticosteroids within ≤1 months prior to the study start and planned therapy of them during the study (besides skin means); * presence of symptoms of primary bacterial pharyngitis or secondary bacterial infection (including fever over 37,5 ° c, the presence of purulent raids in the throat, severe intoxication, leukocytosis, neutrophilia, shift leukocyte left (increasing the percentage of neutrophils sticks appearance younger forms of neutrophils), increased esr 30 mm/hr).

Keywords: angal s anti-angin formula sore throat no less therapeutic efficacy
facial skin health tracking feasibility in breast cancer patients

Conditions: Breast Cancer Female

Summary: this feasibility study will assess if tracking objective and subjective facial skin changes over time is acceptable to pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer. there is no intervention arm and no control group. skin health will be assessed through the instruments described below, and subjective data will be collected with self-administered questionnaires.

there are no studies objectively assessing changes to facial skin health in this population, but tools exist to objectively measure changes thus we have chosen to use those tools to measure skin health. before embarking on an intervention study showing improvement in skin health and patients' self-image and qol, we first need to see if 1) it is feasible to measure changes in skin health in this population and 2) if skin health does objectively change over the course of therapy.

Eligibility criteria:
inclusion criteria: 1. provision to sign and date the consent form 2. stated willingness to comply with all study procedures and be available for the duration of the study 3. be a pre or perimenopausal woman age 18 or over 4. be a patient with a new diagnosis of breast cancer who plans to undergo systemic chemotherapy or endocrine therapy, but who has not yet started treatment exclusion criteria: 1. postmenopausal status (one year without a menstrual period) 2. pregnant women (pregnancy test not required) 3. prior cancer diagnosis of any type other than breast cancer 4. history of prior treatment with chemotherapy or radiation therapy 5. chronic skin disease including scleroderma, discoid lupus, atopic dermatitis, rosacea, eczema, or psoriasis 6. use of a retinoid-based prescription facial skin product within the past 11 month
saliva composition and oral hygiene in children with celiac disease before and after the change in diet

Conditions: Celiac Disease

Summary: the celiac disease (cd) is a disease with an immune and genetic component that is activated by the presence of gluten, and damages the intestine mucosa and causes malabsorption of food. in the oral environment the investigators see enamel defects and recurrent ulcers. celiac patients have to keep a restrict gluten-free diet, in order to prevent the clinical symptoms of the disease (such as diarrhea, stomach ache and weight loss). it has been assumed that the patients have less cariogenic diet, and that caries prevalence is not as high as in normal population. in celiac patients the investigators find enamel defects that are characterized with pits and deep fissures and sometimes the complete loss of enamel. these defects are classified by the grading of the cd related ded's (dental enamel defects) according to aine. these defects are symmetrical defects in the permanent dentition, in teeth that develops at the same time. the cause is thought to be hypocalcaemia or genetic. these defects were found in 42.2% of celiac patients in appose to only 5.4% in healthy population. recurrent ulcers were found in 41% in the oral cavity of celiac patients, compare to 27% in healthy population. after changing the diet to a gluten-free diet, an improvement is seen in the presence of these ulcers.


Eligibility criteria:
inclusion criteria: * celiac disease exclusion criteria: * no other systemic condition * age 3-18 * children on medication

Keywords: oral health in children with celiac disease
intrawound vancomycin powder in spinal fusion surgery

Conditions: Spinal Fusion Acquired

Summary: vancomycin powder (for solution for infusion) will be investigated (off-label usage) in spinal fusion surgery. the powder will be locally administered into to the wound cavity before wound closure. hypothesis: locally applied vancomycin powder leads to a reduction in postoperative surgical site infections

vancomycin is being widely used as an antibiotic agent for intravenous and topical use. the surgical application of vancomycin powder in austria is limited as there is no powder with marketing authorization for intraoperative, intrawound usage. previous reports widely document the application of vancomycin powder for solution for infusion. the powder is not soluted, but instead directly spread throughout the wound surface. limited data is available for spinal fusion surgery, mostly retrospective studies. results were promising, but the low evidence level does not allow for a conclusion regarding routine usage. additional randomized, controlled trials are necessary to further investigate this matter. this trial aims to investigate vancomycin powder "xellia" 1000mg, which has a marketing authorization, in an off-label usage (intrawound, intraoperatively) in spinal fusion surgery. the investigational medicinal product will be used unmodified.

Eligibility criteria:
inclusion criteria: * planned tlif (transforaminal lumbar interbody fusion) or plif (posterolateral lumbar interbody fusion) surgery * tlif/plif fusion length of one or two motion-segments or * one motion-segment tlif/plif in conjunction with one motion-segment decompression surgery or microscopic disc surgery (microdiscectomy) * fusions within l1 (first lumbar vertebra) through s1 (sacrum) * age of 18-years or older * signed informed consent exclusion criteria: * preoperative inflammatory or infectious state (c-reactive protein levels above 10mg/l) * allergic to vancomycin, teicoplanin or penicillin * preexisting auto-immune disease with an impaired immune system * current post-traumatic vertebral injury (e.g. vertebral split fracture) * preexisting renal impairment * preexisting cochlea damage * pregnancy

Keywords: spinal fusion topical antibiotics vancomycin surgical site infection
efficacy of oral probiotic and antibiotic administration in patients with chronic periodontitis

Conditions: Chronic Periodontitis

Summary: the aim of this randomized placebo- controlled clinical trial is to evaluate the effects of lactobacillus rhamnosus sp1- containing probiotic tablets and azithromycin tablets as an adjunct to scaling and root planning (srp). material and methods: fifty-four chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3, 6, 9 and 12 months after therapy. all patients will receive scaling and root planning and randomly will be assigned over an probiotic experimental (srp + probiotic, n=18), antibiotic experimental (srp + azithromycin, n=18) or control (srp + placebo, n=18) group. probiotic will be used once per day during 3 months. antibiotic will be used once per day during 5 days.


Eligibility criteria:
inclusion criteria: * 14 natural teeth, excluding third molars * 10 posterior teeth * 35 years old * 5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm bleeding on probing ≥20% of sites extensive bone loss determined radiographically exclusion criteria: * periodontal treatment before the time of examination * systemic illness * pregnancy anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study

Keywords: periodontitis azithromycin probiotic
the effect of brizo on lower urinary tract symptoms (luts) related to benign prostatic hypertrophy (bph)

Conditions: BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS)

Summary: a randomized, placebo controlled double-blind, 12-week treatment trial in men with moderate to severe symptoms of benign prostatic hyperplasia. the trail is about to examine the effect of brizo® on reduction of bph related symptoms.

1. males in good general health 50 years of age and older, with symptoms of moderate to severe benign prostatic hyperplasia. 2. 120 patients: study arm- min. 80 patients placebo arm- min. 40 patients final aim for stat. sig.: 75% of recruitment group (90 patients) 3. duration - 12 weeks with 3 visits: 0,6,12 weeks 4. the following procedures are utilized: * physical exams - visit 1,3. * drugs/food supplement usage questionnaire - visit 1. * product supply control - visit 1,2.3 * clinical laboratory tests : psa, cbc, bun - visit 1,3. * uroflowmetry test visit - visit 1,3. * ipss- international prostate symptom score - questionnaire - visit 1, 3. * iief questionnaire - visit 1, 3. 5. dosage: 1 capsule twice daily (morning \& evening) can be taken with or without food

Eligibility criteria:
inclusion criteria: males in good general health at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia exclusion criteria: * inability to complete the questionnaire. * patients with or suspected of having prostate cancer. * patients who have undergone a surgical procedure in the past year and / or who have taken medications or supplements in the past six months to treat bph. * patients treated with drugs for kidney / urinary tract problems. * allergy to soy.
does the covid-19 vaccination rate change according to the education, income, culture level, prosociality ?

Conditions: Vaccination Refusal

Summary: "does the covid-19 vaccination rate change according to the education, income, culture level, social mindfulness and prosociality ?"

in this study the investigators will examine the correlation of the covid-19 vaccination rates of the cities with income, cultural level and various education levels. furthermore, vaccination rate change with respect to social mindfulness and prosociality will be investigated also? the investigators hypothesize that a) income \& culture level is positively correlated with vaccination rate, b) if "time spent in education" increases (from illiterate, primary/mid/high school to bsc, msc \& phd) vaccination level increases, c) if social mindfullness or prosociality increases, vaccination rate increase also? the results of this study make it easier for us to understand why anti-vaccine people are against vaccination. the results may lead to more different variables and questions being included in questionnaires to understand resistance against vaccination. our basic variables are vaccination rates of cities, education level distribution (illiterate, primary school, middle school, high school, bachelor's degree, master degree, doctoral degree percentages) of cities, per capita income in the city, number of movie theaters per capita in the city and internet book sales of cities in turkey. the investigators will do this work for other countries also as new data become available. for social mindfulness and prosociality vs. vaccination rate investigation, the investigators will use primarily doesum et al.'s 2021 research variables: svo (social value orientation) and somi (social mindfulness) with who vaccination rate tables.

Eligibility criteria:
inclusion criteria: * over 15 years old exclusion criteria: * under 15 years old

Keywords: covid-19 vaccination education level social mindfulness prosociality
effects of a health workforce capacity building and quality improvement intervention in kinshasa

Conditions: Maternal Death; Infant Death; Stillbirth

Summary: the aim of the study is to evaluate a health workforce capacity building and quality improvement intervention focused on integrated day-of-birth and post-pregnancy care at 16 hospitals in kinshasa, democratic republic of congo. the intervention package consists of a low-dose, high-frequency (ldhf) training of health workers, support for quality improvement teams, and provision of critical equipment, supplies and drugs within a quality improvement (qi) framework.

the health workforce capacity building and quality improvement intervention will be implemented in two phases: eight facilities will receive the intervention in phase 1 and the remaining eight facilities will receive the intervention in phase 2. objective 1: for objective 2 on facility-based health outcomes, the study design is a cluster-randomized evaluation in phase 1. the intervention's effects will be assessed by comparing an intervention group and a control group of facilities. these will be selected from 16 kinshasa health facilities. intervention and control facilities' monthly reported health outcomes will be compared in a 12-month baseline period and 12-month period during and after the intervention implementation (phase 1) in a difference-in-difference analysis. in phase 2, all facilities will have their monthly service statistics and health outcomes reviewed for trends in improvement. overall, in phase 1, eight intervention sites will be matched to eight sites serving as controls. in phase 2, the eight phase 1 control sites will then receive the same package as the intervention sites in phase 1. sites will be stratified by case load, low and high (over 90 births per month), and funding (public or private funding). within each stratum, prior to start of the intervention, there will be random selection to intervention and control groups to allow for baseline comparability between groups.

Eligibility criteria:
inclusion criteria: * health providers: * currently on the roster of maternity ward providers working at one of the 16 selected facilities at the time of the training module. * willing to attend a jhpiego clinical training workshop and offer consent as study participant. * age 18 or older. exclusion criteria: * there are no exclusion criteria
18f-fdg pet/ct imaging for breast cancer

Conditions: Breast Cancer Female; Breast Cancer Recurrent

Summary: purpose to investigate the ability of 18f-fdg pet/ct imaging to detect metastases not detected by conventional imaging (ct and bone scintigraphy) in patients diagnosed with stage ii/iii and locoregional recurrent breast cancer (bc) which can affect the choice of treatment. hypothesis the hypothesis is that 18f-fdg pet/ct can provide information about disease stage beyond the currently used conventional imaging (ct and bone scintigraphy) in patients diagnosed with stage ii/iii or locoregional recurrent bc. objectives primary: to evaluate if a 18f-fdg pet/ct scan in the initial work up of patients diagnosed with stage ii/iii or locoregional recurrent bc will lead to change in staging and/or treatment. secondary: * overall survival (os) and progression-free survival (pfs) in the patients with upstaging based on findings on 18f-fdg pet/ct scan compared with the patients with unchanged stage of disease following 18f-fdg pet/ct. * obtain size of the primary bc from ct/mri scan and evaluate if these metrics are correlated to outcome. * obtain pet parameters from the primary bc: maximum, mean, and peak standardized uptake value (suvmax, suvmean, suvpeak), metabolic tumour volume (mtv), total lesion glycolysis (tlg), total mtv and total tlg and evaluate if these metrics are correlated with outcome. * obtain ct and pet texture parameters from the primary bc and evaluate if these metrics are correlated with outcome. * blood and tumor samples for molecular characterisation:


Eligibility criteria:
inclusion criteria: * patients with high risk primary or recurrent breast cancer * non pregnant women \> 18 years * not receiving active treatment of other cancer types. * eastern cooperative oncology group (ecog) status 0-2. exclusion criteria: * pregnant woman * males * age under 18 * patients receiving active treatment for other cancers * poor general conditipon (ecog 3 or higher)
magnesium isoglycyrrhizinate followed by diammonium glycyrrhizinate and combined with entecavir in chronic hepatitis b

Conditions: Chronic Hepatitis b; Liver Inflammation

Summary: this study evaluates the addition of glycyrrhizin to entecavir in the treatment of patients with chronic hepatitis b in china. half of participants will receive magnesium isoglycyrrhizinate followed by oral diammonium glycyrrhizinate and entecavir in combination, while the other half will receive a placebo and entecavir.

chronic hepatitis b(hbv) has a high prevalence (\>8%) in china. entecavir, aguanosine analog, is a potent and selective inhibitor of hbv dna polymerase. glycyrrhizin has been used for more than 30 years in the treatment of liver diseases in asian countries, who can relieve necro-inflammatory and liver fibrosis or cirrhosis recent study has shown that inflammation plays the important role in chronic hbv and fibrosis or cirrhosis disease progression, but antiviral therapy only may not reduce inflammation ideally. the addition of glycyrrhizin to entecavir in the treatment may slow disease progression in patients with chronic hbv and advanced fibrosis or cirrhosis.

Eligibility criteria:
inclusion criteria: * hepatitis b surface antigen \[hbsag\]-positive, * either hepatitis b e antigen (hbeag)-positive or hbeagnegative/hepatitis b e antibody (hbeab)-positive disease were eligible, * serum alanine aminotransferase (alt) levels 3-10×the upper limit of normal (uln),serum total bilirubin(tbil)levels\<2×uln exclusion criteria: * co-infection with hepatitis c virus, hepatitis d virus, or human immunodeficiency virus; * other forms of liver disease; * more than 24 weeks of therapy with a nucleoside or nucleotide analog with activity against hbv, and therapy with any anti-hbv drug within 24 weeks prior to randomization; * more than 12 weeks of therapy with liver protectants, and therapy with glycyrrhizin; * has decompensated liver function or has a hint of hepatocellular carcinoma (hcc); * during the study patients were not allowed to use other medicines.

Keywords: necro-inflammatory glycyrrhizin entecavir hepatic biological parameters liver fibrosis