Kornimate/medical-research-clean huggingface dataset:
the impact of endoscopic endonasal skull base surgery on olfaction

Conditions: Meningioma; Pituitary Disease; Pituitary Adenoma; Craniopharyngioma; Endoscopic Pituitary Surgery; Olfactory Dysfunction

Summary: in this study, the research team will investigate the incidence and etiology of olfactory dysfunction following endoscopic endonasal skull base surgery, by combining clinical assessments with histomolecular analysis.

the incidence of olfactory dysfunction following endoscopic endonasal skull base surgery remains unclear in current research, and the results vary widely. additionally, the pathophysiology of this postoperative olfactory dysfunction and the impact of this surgery on the trigeminal system has not been investigated to date. in this study, the investigators developed a state-of-the-art clinical pipeline with olfactory and trigeminal assessments, prior to and following endoscopic endonasal skull base surgery. furthermore, the investigators will collect surgical waste tissue from the posterior septal mucosa, which is removed during this procedure to gain access to the sphenoid sinus and the (para)sellar region. by performing histomolecular analysis, the research group aims to elucidate the pathophysiology of olfactory dysfunction following this surgery.

Eligibility criteria:
inclusion criteria: * adult patients scheduled for endoscopic endonasal skull base surgery exclusion criteria: * pre-existing anosmia * patients has a history of previous endoscopic endonasal skull base surgery

Keywords: olfactory dysfunction trigeminal dysfunction endoscopic endonasal skull base surgery pituitary surgery
efficiency of coupling targeted temperature management to brain temperature in severe brain injury

Conditions: Brain Injuries

Summary: in severe brain-injured patients, it is recommended to strictly control the fever in order to limit brain damage (objective of neuroprotection) via the targeted temperature management (ttm). in the guidelines, the target temperature is the systemic temperature, just for practical reasons (brain temperature not being monitored in most polyvalent icu). however, in nicu, the brain temperature is monitored routinely via the intra-cerebral pressure (icp) sensor. since in the febrile brain-injured patients the objective of the ttm is neuroprotection, it would be more appropriate to target temperature control over the cerebral temperature. the objective of this study is to evaluate the efficacy of ttm directly coupled to the brain temperature. adult patients with brain injury requiring icp monitoring (pressio 2, sophysa france) and fever requiring ttm (cerebral greater than or equal to 38.5 °c) will be enrolled. the ttm will be carried out according to the usual methods of the investigator's service: external cooling devices coupled with cerebral temperature (artic sun, bard france), including two phases: the cooling phase (h0 to h3) and the maintenance phase (from h3 to the end of the cooling). two groups will be formed. in the interventional group, coupling of the ttm will be carried out to the cerebral temperature. in the control group, coupling of the ttm will be carried out to the systemic temperature measured at the bladder site. the primary outcome will be the percentage of time during which the cerebral temperature will be measured within recommended target temperature range (i.e. 36 to 37 °c) during the maintenance phase (h3 to h12): comparison of averages. cerebral hemodynamic parameters (icp, transcranial doppler, and brain tissue oxygen partial pressure if available) will also be collected, in order to be correlated with the delta temperature (cerebral temperature minor systemic temperature). no medical device will be put in place specifically for the need of the study.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * hospitalized patient in neuro-resuscitation with peak monitoring with cerebral temperature measurement by an intra-parenchymal sensor (sophysa®) * patient in hyperthermia (tc ≥ 38.5 °c) and in a situation of brain pain exclusion criteria: * patient benefiting from a legal protection measure * pregnant or breastfeeding woman * previous participation in this study

Keywords: temperature targeted management (ttm) close loop brain temperature cerebral temperature systemic temperature neuroprotection fever control
study of fluid collection of the chest in children with pneumonia

Conditions: Community Acquired Bacterial Pneumonia; Paraneumonic Effusion

Summary: the purpose of this study is to determine the best treatment for children with a fluid collection in the chest associated with an underlying pneumonia. researchers generally agree that a child with a large fluid collection in the chest need to have the fluid drained in addition to anitbiotics. there have been many treatments studied in children that have been shown to be effective and safe, but the treatments have never been compared to each other in a randomized controlled study. the optimal treatment of pediatric parapneumonic effusions remains controversial. the objective of this study is to compare the use of conventional management (antibiotics with thoracostomy tube placement) with primary thorascopic drainage (see protocol). our hypothesis is that pediatric patients with parapneumonic effusion, regardless of pleural fluid composition and loculations, have decreased morbidity when treated with early thoroscopic adhesiolysis (vats) compared with conservative treatment.

the ultimate objective of this study is to rationalize treatment decisions. it is our hope that this pilot study will provide the basis for further randomized prospective studies. the expected benefit is that the current treatment and outcome of pediatric parapneumonic effusions will be determined. insights into the therapy that results in the least morbidity, hospital days, (and therefore cost) will be elucidated. if our hypothesis is valid, then a more aggressive surgical approach to the treatment of a parapneumonic effusion may be warranted. if the hypothesis is not valid, then the appropriate treatment for a parapneumonic effusion, irrespective of institution and personal opinion, should become more apparent.

Eligibility criteria:
inclusion criteria: 1. consecutive pediatric patients with a bacterial pneumonia and parapneumonic effusion 2. community acquired disease 3. children age 0 to 18 years exclusion criteria: 1. hospital acquired pneumonia 2. thoracentesis or chest tube drainage outside hospital 3. patients with incorrected cardiac disease
an investigational scan (18f-dopa pet/ct) for improving the clinical management of brain tumors

Conditions: Malignant Brain Neoplasm

Summary: this phase ii trial studies how well the addition of 18f-dopa (amino acid) positron emission tomography (pet)/computed tomography (ct) to standard of care (soc) imaging can improve the clinical management of patients with brain tumors in over 50% of cases. pet is an imaging test that helps to measure the information about functions of tissues and organs within the body. a pet scan uses a radioactive drug (radiotracer) to show this activity. ct scan uses x-rays to create images of the bones and internal organs within the body. combining a pet scan with a ct scan can help make the images easier to interpret. pet/ct scans are hybrid scanners that combine both of the two modalities into a single scan. this allows images of both anatomy (ct) and function (pet) to be taken during the same scan. the 18f-dopa pet/ct scan is done with a very small amount of a radioactive tracer called fdopa. the pet/ct scan is then used to detect the location of tumors. using the 18fdopa-pet/ct scan in addition to the soc scan may improve the clinical management of patients with brain tumors.

primary objective: i. to determine whether the addition of amino acid pet to standard of care imaging impacts clinical management of brain tumor patients in over 50% of cases. secondary objectives: i. to assess the safety and tolerability of amino acid pet for brain tumor patients in response to food and drug administration (fda) guidance that such data is needed to support a potential new drug application (nda) for fluorodopa f 18 (18f-dopa). ii. to assess the rate of identification of tumor outside of standard magnetic resonance imaging (mri) imaging. outline: patients receive 18f-dopa intravenously (iv) and undergo pet/ct over 30 minutes on day 1. after completion of study intervention, patients are followed for 3 days.

Eligibility criteria:
inclusion criteria: * age 18 and older * diagnosis of a brain tumor * indication for amino acid pet imaging, including presurgical evaluation, radiation planning, mr imaging indeterminate for progression versus treatment effect, or clinical need for enhanced monitoring * ability to give appropriate consent or have an appropriate representative available to do so exclusion criteria: * patient is unable to undergo pet imaging * persons who are pregnant or nursing
bioequivalency study of letrozole 2.5 mg tablets under fed conditions

Conditions: Breast Cancer

Summary: the objective of this study was to prove the bioequivalence of letrozole tablet under fed conditions.


Eligibility criteria:
inclusion criteria: - no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to letrozole or any comparable or similar product.
computer-based dosage calculation for antibiotics

Conditions: Acute Kidney Insufficiency; Anti-Infective Agent Toxicity

Summary: adequate dosing of antiinfective therapy in critically ill patients with impaired or lost renal function or continuous renal replacement therapy is nearly impossible without measuring the drug concentration in blood samples. in many hospitals that is still not an option. the investigators aim to show, that computer based calculation can avoid over- or under-dosing.

adequate dosing of antiinfective therapy in critically ill patients is most important to improve outcome. patients with impaired or lost renal function or continuous renal replacement therapy are hard to calculate using drug information sheets or "lists" with recommendations. it is nearly impossible to avoid drug levels that are much to low or much to high without measuring the concentration in blood samples. since that possibility is still not available in every clinic we aim to show, how a computer based calculation can help to find the adequate dosing.

Eligibility criteria:
inclusion criteria: * patients requiring antiinfective therapy * patients with impaired renal function or requiring continuous renal replacement therapy exclusion criteria: * plasmapheresis or liver replacement therapy * renal replacement therapy with integrated cytosorb®-membrane * extracorporal live support

Keywords: renal replacement therapy
study to extend the maximum maintenance flushing interval for ports with distally valved catheters

Conditions: Cancer

Summary: this study is to compare the rate of adverse events in subjects with maintenance flushes greater than 28 days.

this study is a retrospective, multi-center data collection study to support extending the maximum recommended maintenance flushing intervals in subjects who have bard totally implanted ports with distally-valved catheters. this study is intended to provide clinical evidence in support of extending the maximum recommended maintenance flushing interval to a time point of potentially \>28 days for bard ports with distally-valved catheters. reduction in the number of maintenance flushes could help alleviate the inconvenience, reduce the time and expense, and minimize the invasive nature of the maintenance flushing procedure for patients and medical institutions. subjects will be eligible for analysis of the primary endpoint after the first successful maintenance flush of the port until (a) the first adverse event or (b) abandonment of the port. a financial analysis will be performed on an institutional basis to determine the approximate mean cost of flushing. these costs will be extrapolated into an approximate per-patient cost for the different flushing period durations. no financial information will be collected from subject medical records. all required information will be extrapolated from site staff.

Eligibility criteria:
inclusion criteria: * male or female, age ≥ 21 years * subject has an implanted bard port with a distally-valved catheter * subject has maintenance port flushes with heparin/heparinized saline or normal saline * subject is post infusional cancer therapy (solid tumor or hematologic) * subject has signed a hipaa authorization to use and disclose phi exclusion criteria: * subject is having port maintenance flushes/locks with citrate.

Keywords: ports catheters distal valved catheters maintenance flush subjects routine maintenance flushes
positron emission tomography (pet) imaging of cholesterol trafficking: clinical evaluation of [18f]fnp-59 in normal human subjects (groups 2, 3 & 4)

Conditions: Radiotracer; Hypertension; Cholesterol

Summary: this study will evaluate the feasibility of using a sub-therapeutic dose of a fluorine-18 analogue of np-59 (\[18f\]fnp-59) to image the adrenal gland. some participants are healthy normal subjects but have undergone interventions to manipulate hormones while other participants have known adrenal pathology.

groups 2 \& 3 used hormone manipulation using information gathered from group 1 which identified radiation dosimetry and optimal uptake time. group 4 (added to the study later) includes participants with known adrenal pathology. they will not have study associated hormone manipulation. all groups will be given a radio-tracer and pet/ct scans. the researchers believe that a fluorine-18 analogue of np-59, \[18f\]fnp-59, would greatly improve the imaging characteristics, by providing a pet imaging cholesterol analogue with significantly improved radiation dosimetry, and improved localization / sensitivity / specificity without concern of thyroid exposure.

Eligibility criteria:
inclusion criteria (groups 2 \& 3): * participants without any known adrenal pathology as normal controls for undergoing endocrine manipulation exclusion criteria (groups 2 \& 3): * pregnancy * unable to do imaging * body weight greater than 400 lbs (181 kg) * prisoners are not eligible * subjects unable to provide own consent are not eligible * current use of steroids, oral contraceptives (ocp), spironolactone, estrogen, androgen, progesterone, angiotensin-converting enzyme (ace inhibitors)/ angiotensin ii receptor blockers (arbs), or supplements that are hormone analogues. * known adrenal pathology inclusion criteria (group 4): * abnormal adrenal cortical hormone secretion exclusion criteria (group 4): * pregnant
soluble fibre enriched cho food study

Conditions: Diabetes; Healthy

Summary: the proposed study will examine the effects of incorporating a soluble fibre blend into commonly consumed refined carbohydrate foods on sensory parameters and postprandial blood glucose. a sensory evaluation will be conducted in phase i to asses for differences between the control and fibre enriched samples of white bread, mashed potatoes, muffin, hot breakfast cereal. phase ii will be investigating the postprandial blood glucose responses of the 8 test foods from phase i.

literature to date points to beneficial glycemic effects from consumption of soluble fibre; however, whole grain products consumption is below recommendations possibly due to the presence of unappealing characteristic organoleptic properties. white, refined products are still the choice of the general public. as such, we propose to investigate the feasibility of increasing health benefits of commonly consumed white, refined carbohydrate products by incorporating a soluble fibre blend. this research is important to determine the feasibility of developing fibre enriched carbohydrate foods that maintains the original organoleptic properties and is effective in reducing postprandial blood glucose response. 35 subjects will be recruited in phase i to complete a sensory evaluation on the test foods. following tasting of the control and fibre-enriched samples, data on each subjects' liking or disliking will be collected through a 9-point hedonic scale. an acute crossover rct will be conducted in phase ii by 10 healthy individuals. subjects will be randomized to consume one the treatments at each visit and blood glucose levels over 120min and satiety scores will be measured.

Eligibility criteria:
inclusion criteria: * normotensive (sbp\<140mmhg, dbp \<90mmhg) * bmi 18.5 - 25 kg/m2 * post-menopausal or not pregnant women exclusion criteria: * allergy or sensitivity to test meals * swallowing difficulties * chronic use of medications or fibre * gi conditions affecting stomach ph * must not be enrolled in another study * history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, celiac /gastrointestinal disease, hiv positive or aids

Keywords: pgx fibre postprandial glycemia
chinese colorectal cancer database

Conditions: Colonic Cancer; Rectal Cancer; Prospective Studies

Summary: 1. to establish the chinese people's own clinical data database of colorectal cancer, reflecting the law and characteristics of colorectal cancer patients in china. 2. based on colorectal cancer surgery, collect clinical data, especially data on clinical manifestations, complications, laboratory tests, auxiliary examinations, postoperative clinical effects, surgical complications, and colorectal cancer recurrence, so as to lead the direction of clinical practice and academic research of colorectal cancer surgery in china. it provides a certain basis for future research on colorectal cancer. 3. provide academic consultation and data support to national health authorities.


Eligibility criteria:
inclusion criteria: * adenocarcinoma of the colon by biopsy * tolerable to surgery * be able to understand and willing to participate in this trial with signature exclusion criteria: * can not tolerate the surgery * history of serious mental illness * the researchers believe the patients should not enrolled in
feasibility evaluation of magnetic resonance imaging and positron emission tomography for bladder cancer diagnosis and staging

Conditions: Bladder Cancer; Transitional Cell Carcinoma

Summary: the purpose of this study is to to find out if the mri and pet scans can truly stage patients with bladder cancer. both scans use newer ways to find out if your disease has grown beyond the bladder. the radioactive tracer used for the pet scan is called c-11 acetate. we want to see if pet scan will be able to take a picture of the inside of your body that is better than other scans such as the ct scan and mri. therefore, the findings of the pet scan will be compared with other imaging studies as well as the surgical findings.


Eligibility criteria:
inclusion criteria: * thirty (30) patients will be enrolled in this pilot study. * all patients will have a clinical or histologic diagnosis of bladder cancer with active disease identified within the bladder at the time of consent and imaging. * patients with primary resectable lesions, and localized or regionally extensive disease will be eligible with residual disease in the bladder at the time of imaging. * all patients will have consented to treatment at mskcc exclusion criteria: * prior pelvic radiation for bladder cancer * non-transitional cell histologies * patients deemed not appropriate surgical candidates * patients that are pregnant or lactating * patients that cannot tolerate being in the pet or mri scanner for the duration of the study. patients deemed unable to receive a contrast enhance ct will remain eligible. * vulnerable patients (minors, mentally retarded, prisoners, etc.)
seroprevalence of infection-induced sars-cov-2 antibodies (covid-19) in children

Conditions: COVID-19

Summary: it is unknown what proportion of children have been exposed to sars-cov-2 and how many have antibodies among children seeking medical care for non-covid-19 related conditions. the aim of this study is to identify children with igg antibodies to sars-cov-2 who have not been previously diagnosed and are presumed/confirmed covid-19 negative, then determine the level of immunity in this population which could inform further decisions about covid-19 vaccine strategies for children

enrolled participants will have a survey about demographic information, history of previous suspected/confirmed covid-19 infection or exposed to sars-cov-2, covid-19 vaccination status. for participants aged less than 12 months, participants' mothers' status of covid-19 vaccination and/or previous infection will be recorded. participants will then complete serologic testing for sars-cov-2 igg antibodies using residual plasma specimens collected/stored for routine laboratory tests on the date of enrollment. the study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between demographic characteristics and antibodies levels.

Eligibility criteria:
inclusion criteria: * age ≤ 18 years old. * seeking medical care at vietnam national children's hospital for any condition not related to acute covid-19 * have not been previously diagnosed and are presumed/confirmed covid-19 negative * have blood specimens collected for any routine biochemistry test on the date enrollment exclusion criteria: * refusal to participate in this study.

Keywords: sars-cov-2 seroprevalence igg antibodies children vietnam covid-19
the proposed study aims to investigate the impact of adjunctive vitamin d gel application on gingival crevicular fluid levels of alkaline phosphatase and interleukin-8 in periodontitis patients undergoing phase 1 periodontal therapy. by elucidating the molecular mechanisms underlying the therapeutic

Conditions: Periodontal Pocket

Summary: the proposed study aims to investigate the impact of adjunctive vitamin d gel application on gingival crevicular fluid levels of alkaline phosphatase and interleukin-8 in periodontitis patients undergoing phase 1 periodontal therapy. by elucidating the molecular mechanisms underlying the therapeutic effects of vitamin d, this research seeks to contribute to the development of more effective treatment strategies for periodontitis.


Eligibility criteria:
inclusion criteria: * patients with attachment loss 3-4 mm * periodontal pocket ≤ 5 mm exclusion criteria: * - patients with sensitivity to the medication used in the study. * patients with a history of antibiotic use or anti-inflammatory drugs during the previous 3 months prior to the study. * patients with systemic diseases. * pregnant and lactating females. * smokers and tobacco chewers. * patients not compliant with oral hygiene procedures.