Kornimate/medical-research-clean huggingface dataset:
a new mutational and epigenetic signature to predict early opscc relapse

Conditions: Oropharyngeal Squamous Cell Carcinoma

Summary: inclusion of new biomarkers to improve the personalized treatment approach for hpv-positive and -negative oropharyngeal squamous cell carcinoma (opscc) patients is urgently needed. emerging evidences suggest that mutations in epigenetic regulators, as well as epigenetic changes, deeply influence the biology of opscc, thus representing attractive targets for the definition of novel molecular markers for this malignancy. based on these considerations, our project aims to retrospectively identify a new mutational and epigenetic signature to identify opscc patients at high risk of early relapse, and to set up a new multicenter prospective study in order to validate it


Eligibility criteria:
inclusion criteria: * newly diagnosed, previously untreated, histologically confirmed stage iii-iva opscc, according to ajcc 7th edition, * managed with definitive treatment modality (either radical surgery plus adjuvant radiotherapy ± chemotherapy or definitive chemo-radiotherapy) * minimum follow up of 2 years or who had disease recurrence within 2 years after the end of treatment. * neoplastic lesion contains ≥ 70% neoplastic cells exclusion criteria: patients: * with distant metastases at diagnosis, * who have been managed with palliative intent; * with previous history of head and neck cancer are not eligible

Keywords: oropharyngeal squamous cell carcinoma
efficacy and safety from a recombinant folding variant of bet v 1

Conditions: Allergy

Summary: efficacy and safety from a recombinant folding variant of bet v 1


Eligibility criteria:
inclusion criteria: * allergic rhinoconjunctivitis attributable to birch pollen * positive spt * positive east * positive specific provocation test exclusion criteria: * serious chronic diseases * other perennial allergies

Keywords: recombinant birch pollen allergy ige-mediated allergic disease attributed to birch pollen
power toothbrush use in nursing homes to eliminate mouth and body inflammation

Conditions: Periodontal Disease

Summary: the purpose of this study is to investigate whether brushing the teeth of nursing home residents with a power toothbrush as compared with standard care typically provided in nursing homes, will increase caregiver compliance with the provision of daily oral care as well as lower oral and systemic inflammation.

it is well recognized worldwide that residents of nursing homes have poor oral health primarily due to caregiver resistance in the provision of daily oral hygiene care. fear of being bitten or assaulted by the resident as well as lack of time and discomfort with working in the mouth, are reasons cited for this resistance. it is also now recognized that inflammation in the mouth can raise overall inflammation within the body potentially leading to serious health consequences. numerous studies involving periodic professional interventions as well as education and training of caregivers in oral care provision have not met with a great deal of success. caregivers in some studies have indicated preference to power toothbrushes as they are bulkier and longer eliminating the need for insertion of fingers into the mouth and subsequently alleviating fears of being bitten. this study hypothesizes that caregiver utilization of a power toothbrush may increase their compliance with daily oral care provision and could potentially result in elimination of oral and systemic inflammation.

Eligibility criteria:
inclusion criteria: * residents of nursing home * presence of any natural teeth * non-aggressive behavior * presence of periodontal inflammation exclusion criteria: * smoking * comatose * on a ventilator * aggressive behavior * presence of communicable disease * on antibiotics

Keywords: oral inflammation systemic inflammation compliance power toothbrushing nursing home residents
symptomatic ascites drainage with a patient-controlled vascular catheter.

Conditions: Malignant Ascites

Summary: the purpose of this study is to determine whether drainage with the usage of a fine, patient-controlled vascular catheter inserted into abdominal cavity is a feasible, safe and effective method in the management of symptomatic malignant ascites. complications' rate of the procedure and patients' quality of life, nutritional status and experience on the treatment are main endpoints.

patients with symptomatic, refractory malignant ascites (ma) will be eligible for the study. in case a cancer treatment is not effective against ascites, or no target, systemic treatment is possible patients will be eligible for percutaneous placement of a vascular catheter into abdominal cavity followed be drainage performed in a regular basis when required, at home or ambulatory. adult patients with every malignant disease, female and male, and coexisting symptomatic ma can be recruited. clinical, quality of life (qol) and quality of the procedure data will be collected. the study is planned to be a multiinstitutional. a template is provided to collect essential clinical data concerned with a patient, malignant disease, procedure performance and complications. qol and patients' experience on the treatment is to be evaluated with formal questionnaires - eortc c15-pal and facit-ts-g - permission to use granted from eortc and facit respectively. additionally, a nutrition monitoring will be performed (if possible and feasible) in patients with ma and drainage. data will be saved in a computer, secured data base for calculations. a cohort of 150 patients is planned to be collected. duration of the study will depend on how many institutions will participate, and how fast patients will be recruited.

Eligibility criteria:
inclusion criteria: * patients with symptomatic, refractory malignant ascites, * supportive care (professional or family members) available at patients' home, * informed signed consent of the patient. exclusion criteria: * ascites not of malignant origin, * asymptomatic ascites, * suspected or clinically apparent infection especially at the site of planned drainage placement, * significant coagulopathy, * very poor performance status (ps4), * patient not able to read and sign informed consent, * mucinous ascites.

Keywords: ascites drainage catheter symptoms management quality of life malignant cancer
efficacy and safety of ranibizumab intravitreal injections versus dexamethasone intravitreal implant in patients with central retinal vein occlusion (crvo)

Conditions: Visual Impairment; Macular Edema; Central Retinal Vein Occlusion

Summary: this clinical trial is designed to compare ranibizumab in comparison with dexamethasone implant® after 6 months of treatment. in the study arm lucentis will be given monthly in a pro re nata scheme whereas the comparator dexamethasone implant is given once at month 0 with sham injections prn afterwards.


Eligibility criteria:
inclusion criteria: * patients diagnosed with visual impairment due to macular edema following crvo * diagnosis of crvo at maximum 6 months prior to screening * bcva using etdrs charts of 20/40 to 20/400 in the study eye exclusion criteria: * media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs * central retinal thickness (crt) \< 250 µm in the study eye * prior episode of rvo in the study eye * active formation of new vessels in the study eye * anti-vegf-treatment in the study or the fellow eye 3 months prior to baseline * iop ≥ 30mmhg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment * improvement of \> 10 letters on bcva between screening and baseline other protocol-defined inclusion/exclusion criteria may apply

Keywords: visual impairment macular edema central retinal vein occlusion dexamethasone implant ranibizumab
[68ga]ga-hbed-cc-exendin-4 and [68ga]ga-nota-exendin-4 pet/ct imaging in the same group of insulinoma patients

Conditions: Insulinoma

Summary: glucagon-like peptide-1 receptor (glp-1r)-targeted pet imaging with 68ga-labeled compounds is able to provide superior sensitivity and specificity to detect insulinoma, like the widely studied \[68ga\]ga-nota-exendin-4. this pilot study was prospectively designed to evaluate the early dynamic distribution of \[68ga\]ga-hbed-cc-exendin-4, a novel radiopharmaceutical targeting glp-1r, which was compared with \[68ga\]ga-nota-exendin-4 in the same group of insulinoma patients.

insulinoma is the most common cause of endogenous hyperinsulinemic hypoglycemia in adult patients without diabetes. the only curative treatment of an insulinoma is its surgical removal. therefore, exact preoperative localization of the insulinoma is critical to planning the surgical intervention. mr imaging, ct, or endoscopic ultrasound is normally used to localize insulinomas. however, the small size of the tumors (often,1 cm) limits the sensitivity of these methods. in recent years, a new receptor-targeted imaging technique, glucagon-like peptide-1 receptor (glp-1r) imaging, for detecting insulinoma has been established. glp-1r is expressed on benign insulinoma cell surfaces with very high incidence (\>90%) and density (8,133 dpm/mg of tissue). no other peptide receptor has been found to exhibit such high expression levels in insulinoma. \[68ga\]ga-hbed-cc-exendin-4, a novel radiopharmaceutical targeting glp-1r, with the urea fragment of a conjugate that employs the hbed-cc chelator for labeling with 68ga in order to in order to reduce the accumulation of radioactivity in the kidneys. this pilot study was prospectively designed to evaluate the early dynamic distribution of \[68ga\]ga-hbed-cc-exendin-4 compared with \[68ga\]ga-nota-exendin-4 in the same group of insulinoma patients.

Eligibility criteria:
inclusion criteria: * confirmed treated or untreated insulinoma patients; * \[68ga\]ga-hbed-cc-exendin-4 and \[68ga\]ga-nota-exendin-4 pet/ct within two consecutive days; * signed written consent. exclusion criteria: * pregnancy; * breastfeeding; * known allergy against exendin-4; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance
pirfenidone: a new drug to treat kidney disease in patients with diabetes

Conditions: Diabetes Mellitus; Diabetic Nephropathy

Summary: the purpose of this study is to determine whether a new investigational drug, pirfenidone, will be an effective therapy for diabetic patients with kidney dysfunction. our hypothesis is that administration of pirfenidone to type 1 and type 2 diabetic patients with advanced kidney disease will lead to preservation of kidney function.

diabetic kidney disease is the leading cause of new cases of kidney failure in the united states. in the kidneys of diabetic patients, there is accumulation of protein that leads to the formation of scar tissue and poor kidney function. because of this many patients eventually require dialysis or kidney transplantation. a new investigational drug, pirfenidone, has been shown to be beneficial in a number of diseases in which scar formation leads to disease progression. it is our goal to examine whether pirfenidone is effective at stabilizing or reducing progressive diabetic kidney dysfunction.

Eligibility criteria:
inclusion * type 1 or type 2 diabetes * males and females greater than or equal to 18 years. * abnormal kidney function determined by glomerular filtration rate * history of proteinuria * blood pressure controlled to \<140/90 on anti-hypertensive medication exclusion * cancer, liver disease, hepatitis, hiv+ * history of heart attack, unstable angina, stroke or peptic ulcer in the past 6 months * pregnant or planning to become pregnant during the study period * other known kidney disease besides diabetic nephropathy * expect to begin dialysis or receive a kidney transplant within 1 year of study enrollment

Keywords: kidney disease
the effect of early versus standard central line removal on growth of very low birth weight premature infants

Conditions: Growth Failure; CLABSI - Central Line Associated Bloodstream Infection

Summary: this study compares two different regimens of a central line removal in respect to weight at 36 weeks postmenstrual age in very low birth weight (vlbw) preterm infants. half of participants will have a central line removed at ≥100 ml/kg/d, while the other half will have a central line removed at ≥ 140 ml/kg/day.

eligible infants will be randomized in equal proportions between two groups. in the first group (group a - early central line removal) central line will be removed at the time the infant reaches 100 ml/kg/d of enteral intake. in the second group (group b - standard central line removal) central line will be removed at the time the infant reaches 140 ml/kg/d of enteral intake (full enteral intake). central lines will be removed after 3 well tolerated consecutive feedings (assessed by the physician) with no contraindications for central line removal present: * necessity of administration of drugs that must be given via central venous access, * necessity of administration of drugs that must be given intravenously along with difficulties to secure peripheral venous access, * necessity of prolonged (\> 7 days) administration of drugs that must be given intravenously, * necessity to continue parenteral nutrition along with difficulties to secure peripheral venous access. assessment of feedings tolerance will be at discretion of the physician taking care for the infant. after central line removal, infants in group a will continue to receive parenteral nutrition via peripheral venous access at the discretion of the physician taking care for the infant. the solution used to continue parenteral nutrition via peripheral venous access will contain at maximum 2,5% amino acids, 10% glucose and no calcium or phosphate preparations to ensure fluid's osmolality will not exceed 900 mosm/l and the solution will be well tolerated when administered via peripheral vein. parenteral nutrition will be prescribed according to the local protocol. enteral nutrition will be initiated during the first days of life and advanced gradually at the discretion of the neonatologist.

Eligibility criteria:
inclusion criteria: 1. birth weight ≤ 1500 g (very low birth weight). 2. birth weight ≥ 3rd percentile at a given gestational age. 3. central line inserted (picc or uvc). 4. oral intake not exceeding 100 ml/kg/d at randomization. 5. lack of congenital illness or malformation that may affect growth. 6. signed parental consent. exclusion criteria: 1. birth weight \> 1500 g. 2. birth weight \< 3rd percentile at a given gestational age. 3. the absence of a central line. 4. oral intake ≥100 ml/kg/d at randomization. 5. congenital illness or malformation that may affect growth. 6. lack of informed consent. 7. participation in other intervention (investigational) trials, that may affect the primary outcome.
cryospray to reduce pain during venous cannulation

Conditions: Catheterization; Anesthetics, Intravenous; Elective Surgical Procedures

Summary: this trial aims to evaluate if cryospray can reduce pain during intravenous cannulation in elective surgery compared to a placebo spray.

venous cannulation is a common practice in the health care system. before any procedure, intravenous access is always placed before induction of any anaesthesia. for many patients placement of a venous catheter is associated with pain and discomfort. any quick and easy reduction in pain during the procedure is important for patients. cryospray has been described as an easy-to-use supplement of analgesia to alleviate pain during intravenous access. cryospray has been shown to reduce pain in venous cannulation in the emergency setting but not in the elective setting. a search in the literature reveals 2 recent metanalyses reporting 8 included trials and 11 included trials, respectively. both metanalyses call for further research in relation to patients' satisfaction. by randomizing patients to either cryospray or placebo before venous cannulation, we hypothesize that cryospray reduces pain during venous cannulation compared to placebo.

Eligibility criteria:
inclusion criteria: * 18 years or older and able to give consent exclusion criteria: * unable to give consent * infection * coloring or bruises at the puncture site (use of corticosteroid etc). * no vein signs visible after application of vein stasis. * allergy to coolant spray. * contraindication for vein stasis or vein cannulation (ex raynauds disease etc). * has participated earlier in the trial.

Keywords: cryospray
c-reactive protein/albumin ratio and acne vulgaris

Conditions: Acne Vulgaris

Summary: objective: acne vulgaris, an inflammatory disease, was investigated in this study with the claim that c-reactive protein (crp) / albumin ratio and some hematological parameter ratios have the potential to be used as inflammatory markers to monitor disease severity and prognosis. methods: a descriptive cross-sectional study was conducted with two groups of patients aged 18-65 years, 61 patients diagnosed with acne vulgaris and 35 healthy control patients, and routine hemogram and biochemical parameters were compared. the global acne severity index was used to determine the severity of acne vulgaris.


Eligibility criteria:
inclusion criteria: * acne vulgaris patients diagnosed by a dermatologist * healthy participants without acne * 18-40 years of age * voluntary participation exclusion criteria: * aged below18 or above 40 years * not voluntarily participated patents * pregnants, breast milked mothers, emergency situations

Keywords: acne vulgaris crp albumin ratio
development of a method for converting visual analogue scale (vas) scores for pain and mobility to eq-5d answers

Conditions: Cardiovascular Diseases

Summary: the objective of this study is to investigate how mobility and pain scores, measured on a visual analogue scale (vas), correspond to patients' euroqol-5dimensions-3levels (eq-5d-3l) answers on pain and mobility. in addition, the investigators want to evaluate patients' undergoing coronary artery bypass grafting (cabg) quality of life postoperatively, depending on the vein harvesting method used.

many health economic researchers prefer that a treatments effect is measured in the quantity and quality of life (qol) the treatment provides. this enables them to calculate effect in the generic quality adjusted life-years (qalys). patients' qol can be estimates by having patients' answer the eq-5d-3l questionnaire. however, when performing a post hoc health economic evaluation, data is often incomplete. often there is no information available regarding the patients' qol and some health economic researchers therefore resort to various conversions of other measurements of effect to qol. such conversions thereby enable them to calculate effect in qalys even though they had incomplete information. however, no method has been developed for converting eg. vas pain scores to qol and the methods currently used are arbitrary. with this study the investigators wish to develop such a method and in the process evaluate our own arbitrary qol conversion from a prior study by asking the same type of patients. the study is an observational study with no intervention.

Eligibility criteria:
inclusion criteria: * elective cabg patients * use of a vein segment for conduit during cabg

Keywords: qol quality of life vas visual analogue scale cabg coronary artery bypass graft qol conversion post hoc hta
physical activity, meal composition, and rmr among children adolescent and adults

Conditions: Obesity

Summary: resting metabolic rate (rmr) is the amount of energy the body uses at rest, and accounts for 60%-70% of daily energy expenditure. although measured at rest, rmr is strongly influenced by physical activity because the increased metabolic rate during exercise is partially carried over even when exercise stops. therefore, persons who are physically active maintain higher rmr and less body fat than do sedentary controls. it is well known that high energy intake stimulates whereas caloric restriction reduces rmr. food thermogenesis corresponds to approximately 10% of daily energy expenditure. diet-induced thermogenesis is greater on a high protein and carbohydrate diet than on a fat diet. other factors the affect rmr are age (rmr tends to decline progressively over the life span) and body composition (lean body mass is regarded as the main determinant of rmr). however, the research regarding the effect of a specific combination of macronutrients and exercise on rmr is scarce. therefore, the aim of the current study is to assess the combined effect of a meal composition and physical activity on rmr in normal weight and overweight children, adolescents and adults.

one hundred (100) healthy volunteers, 50 normal weight (nw) and 50 overweight (ow), age 6-30 will be recruited for the current study. all participants and/or their parents will sign informed consent prior to their participation. participants will visit the clinic 4 times, with a week's difference between them. participants will arrive at the clinic after 12 hours of fasting and avoiding physical activity for 14 hours. during the first visit, their rmr will be measured, and 15min later they will perform 60 min of aerobic training, and 15 minutes later they will be asked to drink 300ml of water, followed by a second rmr test. in the consecutive visits they will follow the same routine without the first rmr test, and drink either carbohydrate enriched shake, protein enriched shake or fat enriched shake; in a random order.

Eligibility criteria:
inclusion criteria: * ages 6-30 years. * normal weight and over weight participants exclusion criteria: * elite athletes * participants with physical limitations concerning strenuous physical activity.

Keywords: rmr macro nutrients exercise
muscle dysfunction in patients with hematological diseases referred to stem cell transplant

Conditions: Hematologic Diseases; Chronic Myeloid Leukemia; Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Myelodysplastic Syndromes; Non Hodgkin Lymphoma; Stem Cell Transplant Complications; Chronic Lymphocytic Leukemia

Summary: purpose: to investigate the effect of the disease and hsct on muscle dysfunction and to investigate the prognostic role of muscle dysfunction at critical decision points in patients with hematological diseases referred to hematopoietic stem cell transplant (hsct). hsct: patients diagnosed with malignant hematological diseases who are referred to myeloablative hsct, to a myeloablative "reduced toxicity conditioning" regime with fludarabine and treosulfane (flutreo) or to non-myeloablative hsct.

rational: patients diagnosed with malignant hematological diseases undergoing hsct are faced with poor prognosis. the treatment is demanding and associated with severe deconditioning potentially leading to worse prognostic outcomes. to what extend patients body composition at the point of referral to hsct, as well as changes in body composition throughout the cancer continuum is associated with cancer outcomes is currently not well described, specifically if this should be part of standard clinical evaluation in order to optimize therapy-efficacy. recent findings suggest that pathophysiological alterations in skeletal muscle mass and function can have significant implications for the risk of disease progression and long term prognosis.

Eligibility criteria:
inclusion criteria: * patients diagnosed with acute myelogenous leukaemia (aml), acute lymphatic leukaemia (all), chronic myelomonocytic leukaemia (cmml), myelodysplastic syndrome (mds), chronic lymphatic leukaemia (cll), malignant lymphomas or multiple myeloma (mm) referred to myeloablative hsct, myeloablative rtc-hsct or non-myeloablative hsct at the department of haematology, rigshospitalet, blegdamsvej. exclusion criteria: * age \<18; pregnancy; physical or mental disabilities precluding test of muscle function; inability to read and understand danish

Keywords: muscle mass muscle strength complications patient reported outcomes pro physical function hematopoietic stem cell transplant