Kornimate/medical-research-clean huggingface dataset:
fgl2/fibroleukin and hepatitis c virus infection: a predictor of response to antiviral therapy

Conditions: Chronic Hepatitis C Virus Infection

Summary: the main objective of this study is to assess whether a recently-developed bioassay for the protein fgl2 can be used to predict the progression and/or response to treatment of hepatitis c virus disease in patients with chronic hcv infection. the hypothesis is that increased levels of fgl2 and increased numbers of t regulatory cells are associated with a failure to respond to treatment.

the current therapy for chronic hepatitis c virus infection leads to a sustained viral response in only 50% of treated patients. evidence suggests that a poor response to treatment may be the result of a dysfunction of immunoregulatory mediators including t regulatory cells (tregs) which secrete fgl2. the aim of this study is to test whether serum fgl2 levels can serve as a biomarker for clinical progress and treatment response in patients undergoing anti-viral therapy for chronic hcv infection. this study will measure the blood treg and fgl2 levels of patients with chronic hepatitis c as they undergo antiviral therapy and will compare those levels to their pre-treatment and post-treatment levels. treg and fgl2 expression levels will also be measured in patients' liver biopsy tissue when available. additionally, this study will examine the main form(s)of fc receptor expressed in these patients. the fc receptor is the hypothesized binding partner of fgl2, and the form expressed in a given patient may determine the downstream effects of fgl2's binding. these data along with clinical, biochemical and virological data will be used to determine whether there is a correlation between fgl2 levels and disease outcome and/or treatment response. the study will also recruit a group of normal healthy volunteers to give blood samples on two occasions so that the baseline range of fgl2 levels in healthy individuals can be established for comparison.

Eligibility criteria:
hcv patient population inclusion criteria: * able to give written consent * 18-70 yrs of age, both genders * willing to use adequate contraception * diagnosis of chronic hcv infection (of any genotype) based on 2 positive serology tests * availability of pre- and post-treatment viral load data * naive to antiviral treatment * availability of pre-treatment liver biopsy exclusion criteria: * less than 18 yrs, greater than 70 yrs of age * pregnancy * hbv, hdv, or hiv co-infection * any history of active alcohol or drug abuse volunteer population (control) inclusion criteria: * able and willing to provide written informed consent * willing to provide a brief review of medical history * 18-70 yrs of age, of either gender exclusion criteria: * less than 18, greater than 70 yrs of age * any history of liver, renal, lung, hematological or coronary artery disease * any history of active alcohol or drug abuse * any previous diagnosis of hbv, hcv, hdv or hiv

Keywords: antiviral therapy
comparison with open and totally laparoscopic gastrectomy for gastric cancer

Conditions: Gastric Cancer

Summary: in gastric cancer, laparoscopic gastrectomy is commonly performed in asian countries. in other regions where tumor incidence is relatively low and patient characteristics are different, developments in this issue have been limited. in this study, the investigators aimed to compare the early results for patients who underwent open or laparoscopic gastrectomy for gastric cancer in a center in turkey.

the patients who were operated in kocaeli derince training and research hospital between january 2014 and january 2019 consecutively due to gastric cancer were analyzed. the diagnosis was made by upper gastrointestinal endoscopy and endoscopic biopsy. clinical staging was done using contrast computed tomography (ct). positron emission tomography (pet) was used in patients with suspected metastasis.the patients were divided into two groups according to the technique applied (open, laparotomy). the first group (group 1; n: 30) consisted of patients who underwent open surgery, and the second group (group 2, n: 30) laparoscopic surgery.

Eligibility criteria:
inclusion criteria: * gastric cancer(adenocarcinoma) proven biopsy * operated by same surgical team * presence of distant metastasis exclusion criteria: * patients who underwent palliative resection * operated by a different surgical team * asa score: 4
eu pv for retapamulin-prescribing

Conditions: Impetigo

Summary: retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical antibiotics approved for human use. in the european union (eu), retapamulin is approved for the treatment of impetigo and secondarily-infected traumatic lesions in persons nine or more months of age. this study is designed to examine retapamulin use in the pediatric population less than nine months of age. we will conduct a five-year assessment of prescriptions for retapamulin using the general practice research database. for each year of reporting, the observed frequencies of prescriptions of retapamulin, with or without same-day co-prescriptions of topical mupirocin or fusidic acid, will be identified. the five-year reporting period will include five years of distinct, non-overlapping, non-cumulative prescription use of first exposure to retapamulin, with or without same-day co-prescription of topical mupirocin or fusidic acid.


Eligibility criteria:
inclusion criteria: * the study population will consist of all registered "research standard" patients on gprd, as evaluated annually for five years. for each year of observation, the denominator of persons will be patients registered for at least one month during the prior calendar year. hence, the five-year reporting period for distinct, non-overlapping, non-cumulative prescription use and will categorize persons by date of birth (mm/dd/year). exclusion criteria: * enrollment in gprd of less than one month duration.

Keywords: altargo bactroban fucidin fusidic acid mupirocin topical retapamulin united kingdom
information presentation formats

Conditions: Meningioma

Summary: prevention and early detection of medical problems can greatly reduce health care costs, yet time and again, people avoid or ignore services that could help detect medical problems early enough to prevent or reduce the severity of potential problems. the investigators seek to understand whether the elicitation of symptom admission by patients can predict people's perceived risk of the medical condition and voluntary pursuit of medical information.

we will present individuals with medically accurate information about a medical condition and measure people's perceptions of their own likelihood to having that medical condition. this will include an opportunity for people to pursue more information by directing them to a website that features more information about the condition. the initial information provision will vary slightly in presentation (method of eliciting symptoms will vary), and the rate at which individuals visit the subsequent medical website to receive more information will be recorded as a measure of information seeking behavior. rates will be compared across symptom elicitation conditions to determine which formats are most effective at encouraging information seeking about health issues. no personally identifying information will be collected, and all results will be reported in aggregate. critically, no deception will be used: participants will only be provided with information that is as accurate as possible (given existing knowledge in the health/medical fields).

Eligibility criteria:
inclusion criteria: * 18 or older * american exclusion criteria: * mechanical turk approval rate below 95%

Keywords: symptom assessment
glucocorticoid-induced osteopenia in children

Conditions: Crohn's Disease; Nephrotic Syndrome

Summary: the purpose of this study is to characterize the skeletal deficits and risk factors for impaired skeletal development in children requiring glucocorticoid therapy. we will compare the bone health of children treated with prednisone for nephrotic syndrome (ns with those treated with prednisone for crohn's disease (cd). childhood ns usually responds to prednisone and is not characterized by pathologies that can impact on bone. in contrast, cd is treated with prednisone, but is independently associated with poor growth and maturation, nutritional deficiencies and inflammation. due to the differences in the diseases, this comparison will allow us to distinguish between the prednisone-related and disease-related effects on bone in the two disease states.

prednisone, a glucocorticoid medication, is widely used for many pediatric disorders. studies have shown that this drug decreases bone formation, decreasing bone density and bone thickness in children. prednisone induced osteopenia, or low bone density, can be worsened by the effects of the underlying disease, such as delayed growth and maturation, malnutrition, and increased bone resorption (removal) by inflammatory compounds. the combined effects of decreased bone formation and increased resorption may be particularly detrimental to the growing skeleton. subjects will include 15 newly diagnosed ns patients, 60 patients with pre-existing ns, 90 patients with newly diagnosed cd, 45 patients diagnosed within the last two years and 200 healthy controls of similar age, gender and ethnicity. participants will visit the children's hospital of philadelphia (chop) three times over a 12-month period for assessment of bone mineralization and turnover, fracture history, dietary calcium intake, physical activity, growth, body composition, muscle strength and glucocorticoid exposure.

Eligibility criteria:
inclusion criteria: * ages 5-21 * clinical and pathological diagnosis of crohn's disease within the last 2 years * clinical diagnosis of nephrotic syndrome and taking corticosteroids within the last year * normal renal function gfr\>75 ml/min/1.73m2 * healthy controls exclusion criteria: * other major medical conditions affecting growth and/or bone health * significant cognitive or developmental disorders (if child is unable to cooperate sufficiently) * nonambulatory
registry of patients that have undergone ica or pci

Conditions: Coronary Artery Disease

Summary: in invasive coronary angiography there are multiple invasively obtained measurements to determine the funcitonal significance of cornary artery disease. in this registry, patients who have undergone invasive coronary angiography or percutaneous coronary intervention are included to investigate diagnostic and prognostic implications of the invasive measurements.


Eligibility criteria:
inclusion criteria: * 18 years * has undergone or will undergo a clinically indicated invasive coronary angiography. * has undergone or will undergo a clinically indicated percutaneous coronary intervention. exclusion criteria: * not willing / unable to provide informed consent.

Keywords: quantiative flow ratio qfr fractional flow reserve ffr instantaneous wave-free ratio ifr invasive coronary angiography percutaneous coronary intervention
the effects of mastication on energy release from walnuts

Conditions: Obesity

Summary: with an emphasis on oral processing, this study seeks to characterize the mechanisms that account for the high satiation properties of walnuts and low energy yield during digestion.

recent evidence indicates up to 20% of the energy from walnuts is not absorbed. this low bio accessibility is comparable to almonds with markedly different physical properties and much higher than for pistachios with similar physical characteristics. these counter-intuitive findings require mechanistic explanations so they may be accepted and used to formulate policy and clinical recommendations. it is proposed that the differences in the structure of nuts accounts for the energy yield results. in addition, the whole nut yields superior effects on fullness and this leads to focus on oral processing. it may be that the mechanical act of chewing generates satiety sensations or it may be that the mechanical disruption of the parenchymal call walls releases lipid and protein and their higher concentrations activate the release of gut peptides associated with satiety. visit 1: participants will report the laboratory of sensory and ingestive studies following and overnight fast, and having refrained from using oral care products for at least two hours prior to the visit. participants who meet the bmi requirements, will have electrodes placed on their wrist, upper, and lower jaw and will be asked to chew the following stimuli: walnuts, almonds and pistachios for 15 seconds and expectorate the bolus into a beaker. however, when presented with 5 g walnuts participants will be asked to chew until the point where they would normally swallow and then spit the bolus into a beaker. the chewing conditions are randomized and include: 1) 5 g nuts alone, 2) 5 g nuts with 5 ml water, 3) 5 g nuts with 5 ml apple juice, 4) 5 g nuts with 5 g plain yogurt, 5) 5 g nuts with 5 g sweet yogurt. following each chewing condition, participants will rate hedonic preference on a 9-point scale. visit 2 and 3: following an overnight fast, the participant will be placed in a semi-supine position and a catheter will be placed in a vein in the antecubital space of one arm. a 9 ml baseline blood sample will be collected. participants will complete a validated appetite questionnaire on a palm pilot right after the baseline blood draw. the participants will then consume 28 g of walnuts or 28 g walnut butter given in random order. additional blood samples and appetite questionnaire will be taken at 15, 30, 45, 60,120, and 180 minutes. the blood will be stored in a minus 80 freezer to be analyzed at a later date for insulin, glucose, glp-1, ghrelin, and pyy.

Eligibility criteria:
inclusion criteria: * natural dentition and no oral pathology * rate hedonic value of all study foods between 3 and 7 on a 9-point category scale. exclusion criteria: * bmi between 18-35 kg/m2

Keywords: energy availability walnuts
novatears® eye drops observational study nt-003

Conditions: Dry Eye Syndromes

Summary: this observational study is intended to collect outcome data from a cohort of 30 patients suffering from dry eye disease due to chronic ocular graft-versus-host disease (gvhd) who are treated with the medical device novatears® eye drops for a duration of 11 to 13 weeks.


Eligibility criteria:
inclusion criteria: * according to novatears® instruction for use * ≥ 18 years * patients after an allogeneic hematopoietic stem cell transplantation with dry eye disease due to chronic ocular graft-versus-host disease * ability and willingness to provide written informed consent * ability and willingness to participate in all examinations * willingness and ability to return for follow up visit exclusion criteria: * patients with known hypersensitivity to any of the components of novatears® * patients with contact lenses, pregnancies, or who are breast feeding * patients with dry eye disease caused by any other known underlying systemic disease * patients planning an ophthalmologic surgical procedure during the course of this pmcf study * patients using lipid-containing or tear-film stabilizing eye drops/sprays except cyclosporin formulations
observational study at the influence of malnutrition on infections

Conditions: Malnutrition

Summary: the purpose of this trial is to determine whether nutritional status has an impact on nosocomial infections. study population are patients undergoing early neurological rehabilitation.


Eligibility criteria:
inclusion criteria: * patients in early neurological rehabilitation * informed consent given exclusion criteria: * none

Keywords: malnutrition infection neurological
adjunctive clindamycin for cellulitis: c4c trial.

Conditions: Cellulitis

Summary: the aim of this study is to see whether the addition of clindamycin, a protein inhibiting antibiotic, to the standard antibiotic treatment of limb cellulitis, with flucloxacillin, results in less tissue damage and a more rapid resolution of both systemic and local features, in a cost-effective manner. this study is a randomised controlled trial comparing clindamycin with placebo.

criteria to be used to assess tissue damage and clinical response: 1. fever, tachycardia, neutrophil count, urea and other laboratory parameters at five and ten days post first dose of clindamycin 2. limb swelling (by the measurement of limb circumference), skin surface temperature and tissue damage (by the proportion of the limb affected) 3. document the duration between initial systemic features and the development of local signs 4. examine the effect of the duration between systemic and local features and first dose of flucloxacillin on the subsequent duration and severity of cellulitis 5. examine the effect of duration between the first dose of flucloxacillin and the first dose of clindamycin on the subsequent duration and severity of cellulitis 6. identify and quantify possible side effects of clindamycin

Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 or over who have a diagnosis of cellulitis of a single, upper or lower, limb * who are able to understand the study and give consent * who are able to take oral medication exclusion criteria: * patients with a confirmed history of penicillin, flucloxacillin or clindamycin allergy * patients known to be colonised with methicillin-resistant staphylococcus aureus or methicillin-resistant staphylococcus aureus isolated from wound within the last year * patients unable to take oral medication * previous history of clostridium difficile colitis * clindamycin taken within the last 30 days * clinically unstable * unable to understand the study or give consent * any doubt over the certainty of the diagnosis of cellulitis * patients taking any drug that is incompatible with either flucloxacillin or clindamycin * pre-existing diarrhoea

Keywords: clindamycin cellulitis flucloxacillin group a streptococcus staphylococcus aureus
surgical trial to evaluate the impact of a lymphoscintigraphy prior to sentinel node biopsy in early breast cancer

Conditions: Early-Stage Breast Carcinoma

Summary: sentinel node biopsy is a well established tool for axillary staging in early breast cancer. so far the impact of a preoperative lymph node scintigraphy is unclear. this study aims to clarify whether a preoperative lymphoscintigraphy is of additional benefit in a prospective randomized multicenter study design.

sentinel node biopsy is a well established tool for axillary staging in early breast cancer. so far the impact of a preoperative lymph node scintigraphy is unclear. several studies indicate sentinel node biopsy to be a reliable method irrespective of prior lymph node scintigraphy, but data from prospective randomized trials are not available. although a preoperative lymph node scintigraphy is not explicitly demanded in current s3 guidelines in germany its performance is a common practice. if a preoperative lymphoscintigraphy could be safely omitted, possible benefits are a facilitation of the preoperative workflow as well as cost reduction for health care systems. this study aims to clarify whether a preoperative lymphoscintigraphy is of additional benefit in a prospective randomized study design. in the two study arms sentinel node biopsy is performed either with or without knowledge of the preoperative lymphoscintigraphy findings. primary end point is the average number of histologically detected sentinel lymph nodes per patient in both treatment arms.

Eligibility criteria:
inclusion criteria: * invasive mamma carcinoma as verified by core cut biopsy * extensive ductal carcinoma in situ as verified by core cut biopsy (at least 5 cm or at least 2,5 cm and g3 grading) * clinical stage tumor t1-t3 * no signs of axillary lymph node metastasis on clinical examination including ultrasound examination * no signs of distant metastatic disease * male/ female patient in the age not less than 18 years * karnofsky performance status at least 70% or eastern cooperative oncology group (ecog) score not higher than 1 * written patient informed consent exclusion criteria: * suspect axillary lymph nodes on clinical/ultrasound examination * positive fine-needle biopsy of axillary lymph nodes * sentinel lymph node biopsy to be performed after neoadjuvant chemotherapy * recurrence of a mamma carcinoma * prior extensive surgery of breast or axilla * inflammatory or extramammary breast cancer * pregnancy * contraindication to the radionuclide * inability to understand the studies purpose * inability to receive surgery * no written patient informed consent

Keywords: lymphoscintigraphy sentinel lymph node biopsy
adipose cell derived regenerative endothelial angiogenic medicine

Conditions: Peripheral Vascular Diseases; Cardiovascular Diseases

Summary: the main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in patients with critical leg ischemia.


Eligibility criteria:
inclusion criteria: * severe peripheral vascular disease not amenable to bypass or angioplasty * age \>40 years old * normal renal function (creatinine \< 1.6) * non pregnant female * lifespan \> 6 months exclusion criteria: * age \<40 years old * refusal to give informed consent and/orcognitively disabled * congestive heart failure or stroke in the last 3 months * history of cancer or myeloproliferative disorders * proliferative retinopathy * pregnancy * positive screening test for hiv, hepatitis b or hepatitis c * buerger patient * cachexia or predicted impossibility for a biopsy of at least 30 grams of fat tissue * pregnancy or lactation * having been non controlled severe pathology

Keywords: critical leg ischemia adipose derived stroma/stem cells autologous angiogenesis
conjunctival autologous transplantation using fibrin glue in primary pterygia

Conditions: Pterygium; Primary

Summary: to evaluate the recurrence and postoperative complications rates after conjunctival autograft surgery using fibrin adhesive for primary pterygium


Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary pterygium * symptomatic pterygium * limbal invasion exclusion criteria: * secondary pterygium

Keywords: pterygium autologous transplantation conjunctiva fibrin tissue adhesive recurrence