Kornimate/medical-research-clean huggingface dataset:
3d printed custom applicators for hdr bt (disco)

Conditions: Gynecologic Cancer; Endometrial Cancer; Vaginal Cancer; Vulva Cancer

Summary: intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. this study is a phase iia non-randomised interventional pilot trial that will investigate the feasibility of successfully treating patients with 3d-printed custom applicators.

intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. current workflows for designing and constructing custom applicators with wax moulds are complex, time consuming and can result in a device that fails to meet original design specifications dictated by the planning system. in contrast, 3d-printed custom applicators provide the ability to design and print patient-specific devices that match optimal design specifications. the workflow for 3d-printed applicators is also more efficient with lower turn-around time and labour/equipment costs, and ensures a more robust product for treatment. despite these advantages there is currently no radiotherapy department offering 3d printed custom applicators at present. this study will investigate the feasibility of successfully treating gynaecological cancers with 3d-printed custom applicators.

Eligibility criteria:
inclusion criteria: * able to give informed consent * patients indicated for intracavitary brachytherapy * figo stage i-iva * ecog 0-2 * primary endometrial cancer, primary vaginal cancer, primary vulva cancer, recurrent gynaecological cancer exclusion criteria: * pregnancy * patients contraindicated for brachytherapy * inflammatory bowel disease/history of adhesions/bowel obstruction * renal transplant/horseshoe kidney * patients with significant lvsi or pelvic sidewall invasion * patients requiring interstitial brachytherapy implants

Keywords: 3d-printed applicator gynaecological cancer brachytherapy
a study in rheumatoid arthritis patients who have completed a preceding study with abbv-105 given alone or in combination with upadacitinib

Conditions: Rheumatoid Arthritis (RA)

Summary: this was a long-term extension (lte) study to assess the safety, tolerability, and efficacy of abbv-105 (elsubrutinib \[els\]) and abbv-599 (els 60 mg and upadacitinib \[upa\] 15 mg) in participants with rheumatoid arthritis (ra) who completed study m16-063 (nct03682705).

this was a phase 2, double-blind, multicenter, long-term extension (lte) study to assess the safety, tolerability, and efficacy of 3 doses of abbv-105 (elsubrutinib \[els\] 5 mg, 20 mg, and 60 mg) and abbv-599 (els 60 mg and upadacitinib \[upa\] 15 mg) in adults with active rheumatoid arthritis with inadequate response or intolerance to biologic disease-modifying antirheumatic drugs (bdmards). participants who successfully completed treatment in the feeder study m16-063, a phase 2 dose exploratory study, were eligible to participate in this study. those who met eligibility criteria and entered this study receiving els, abbv-599, or upa from study m16-063 continued on their previously assigned treatment through termination of this study. participants originally randomized to placebo in study m16-063 rolled over to abbv-599 in a blinded fashion in this study.

Eligibility criteria:
inclusion criteria: * participant has completed study m16-063 * participant has not developed any laboratory or clinical discontinuation criteria as defined in the study m16-063 protocol * participant is willing and/or able to comply with procedures required in the current study protocol exclusion criteria: * participant is currently enrolled or planning to enroll in another interventional clinical study while participating in this study (except the preceding study m16-063) * participant requires vaccination with any live vaccine during study participation, including at least 30 days after the last dose of study drug

Keywords: elsubrutinib abbv-105 upadacitinib abbv-599 rheumatoid arthritis (ra) long-term extension (lte)
interest of intravitreal corticotherapy as the first-line treatment for post-operative endophthalmitis

Conditions: Post-operative Endophthalmitis

Summary: one useful effect of early intravitreal corticotherapy is to diminish inflammatory complications after endophthalmitis, which may cause, at least in part, serious complications (retinal detachment, macular edema) which are, more than the infection, causes of the complications seen after acute endophthalmitis.


Eligibility criteria:
inclusion criteria: * all patients male or female with no age limit * hospitalized for the diagnosis and treatment of acute endophthalmitis following cataract surgery * who had given their consent after being informed about intravitreal corticotherapy exclusion criteria: * patients who refused or were unable to give their consent * prior intravitreal corticotherapy
real time molecular characterization of diffuse large b cell lymphoma (dlbcl)

Conditions: Diffuse Large B Cell Lymphoma

Summary: the trial will enroll 194 previously untreated dlbcl patients over 20 months, with the objective to send to the local investigator an extensive molecular tumor characterization by d38 in at least 80% of enrolled patients. the feasibility and efficiency will be demonstrated by deploying and operating a nation-wide network of dedicated multidisciplinary platforms.


Eligibility criteria:
inclusion criteria: * dlbcl patients that will be eligible in front-line treatment for a combination of anthracycline-based chemotherapy plus anti-cd20 monoclonal antibody,rituximab: r-chop 14, r-chop 21, r mini-chop, r-acvbp, r-copadem. patients treated with r-chop associated with an experimental drug ((polatuzumab, tazemetostat, venetoclax, entospletinib, lenalidomide, ibrutinib, anti pd1/anti pdl1 ....) * a short corticotherapy (prednisone, maximum 7 days) given during pre-phase therapy is allowed. * eligible histological subtypes: in particular dlbcl nos, pmbl, high grade b-cell lymphoma (hgbcl) withmyc and bcl2 and/or bcl6 rearrangements, hgbcl nosfl grade 3b and untreated transformed low grade nhl. * ≥ 18 years old, ipi = 0-5 * with available tumor biopsy (ffpe) that can be sent to rt3 platform at the time of inclusion (or the say after inclusion at the latest). * patient that underwent needle core biopsy samples are not excluded if sufficient material is available for molecular and histopathological explorations exclusion criteria: * no available ffpe biopsy material or insufficient quality/quantity tumor samples according to prerequisite * no signed informed consent

Keywords: dlbcl real time molecular characterization
the effects of a polyethyleneimine-coated membrane (oxiris™) for hemofiltration versus polymyxin b- immobilized fibre column (toraymyxin™) for hemoperfusion on endotoxin activity and inflammatory conditions in septic shock- a randomized controlled pilot study (endox-study)

Conditions: Patients in Septic Shock

Summary: septic shock has a high mortality risk despite the availability of various treatments. endotoxin, that is present in the cell walls of gram-negative bacteria, is a potent trigger of innate immunity. endotoxin leads to an activation of a cascade with an overwhelming systemic overflow of pro- and anti- inflammatory mediators at the early phase of sepsis with generalized vascular endothelial damage, tissue injury and multi-organ failure. extracorporeal blood purification therapies aim to reduce the circulating level of endotoxin. different extracorporeal blood purification systems are available. the oxiris™ device comprises a surface treated an69 membrane capable to adsorb a large spectrum of plasma cytokines, such as il-6 and hmgb1 protein. the positively charged inner surface of the membrane allows absorbing negatively charged bacterial products such as endotoxin. from an historical perspective, filters containing an69-based membranes have been the most commonly used products for crrt in the management of critically ill patients and a substantial volume of published data exist. another extracorporeal endotoxin removal therapy is the hemoperfusion with toraymyxintm (pmx) filter, which is a cartridge selectively removing blood endotoxin. pmx is composed of polymyxin b covalently bonded to polystyrene-derivative fibres. it is well known that the polarity of the polymyxin b antibiotic binds endotoxin and has bactericidal activity. therefore, the rationale underlying extracorporeal therapy with pmx is to remove circulating endotoxin by adsorption. * trial with medical device


Eligibility criteria:
inclusion criteria: • patients with septic shock, defined as 30ml/kg of i.v. fluid administered within a period of 6 hours after initiation of vasopressor therapy with a vasopressor index =3, and at least one of the following criteria: metabolic acidosis, neurologic dysfunction, renal dysfunction, or acute hepatic dysfunction * male and female patients =18 years * endotoxin levels =0.6 iu eaa (measured at icu admission and repeated 24 hours later in case the initial value is =0.4 and \<0.6) exclusion criteria: • endotoxin levels \<0.6 iu eaa * pregnancy or breast feeding * neutropenia (circulating neutrophils \<500/µl) * pre-existing immune deficiencies or immune-suppressive therapy, especially corticosteroids * use of vasopressin (pitressin?) * organ transplantation within the last 12 months * terminally ill patients classified as "do not resuscitate" * history of sensitivity to polymyxin b or to anticoagulant (heparin) hit or allergy to heparin * need for extracorporeal membrane oxygenation (ecmo)
concordance of hypoglycemia measurement with simultaneous use of two devices for continuous glucose measurement.

Conditions: Type 1 Diabetes; Hypoglycemia

Summary: the aim of this study is to compare two frequently used sensors for continuous glucose monitoring (cgm); freestyle libre and dexcom g 7. more precisely, the investigators want to investigate if there is any difference in the hypoglycemic range for these two devices.

the investigators are including adults with type 1 diabetes who already are using a dexcom g 7, in their diabetes treatment. simultaneously with their dexcom g7, the participants will get the libre 2 sensor attached, and are to wear this for a period of 14 days. the libre sensor is a freetsyle libre 2. glucose data are compared for paired values within a time interval of 5 min or less. in this way the investigators have access to nearly simultaneous glucose values from two different cgm's. in addition, the participants are given a contour next one, and are asked to measure their blood glukose with fingerprick if their dexcom registers a glucose value \< 5 mmol/l. by this project, we hope to gain more precise information about the two most widely distributed cgms, and their function in the hypoglycemic area. this, can have impact on healthcare professionals' future therapeutic instructions, regarding the use of insulin adjustment and carbohydrate compensation.

Eligibility criteria:
inclusion criteria: type 1 diabetes using dexcom g 7 - exclusion criteria: do not want to participate -

Keywords: hypoglycemia continuous glucose monitoring dexcom libre blood glucose
maintenance treatment with capecitabine metronomic chemotherapy and chinese traditional medicine in metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the optimum regimen of maintenance treatment after first-line chemotherapy in patients with metastatic colorectal cancer （mcrc） is unknown. this study was designed to determine the efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy plus chinese traditional medicine. in this prospective, open-label, randomised controlled trial, the investigators will recruit 159 mcrc patients who have finished 18 to 24 weeks first-line chemotherapy and disease evaluation is sd, pr or cr. the patients will then accept chinese traditional diagnosis and be randomised into two group, capecitabine metronomic chemotherapy only as control group and the metronomic chemotherapy plus chinese traditional medicine as experimental group. this treatment regimen will be continued until progression, death, or an unacceptable adverse event. the primary endpoint is progression-free survival (pfs). secondary endpoints are overall survival (os), quality of life (qol) and toxic effects.


Eligibility criteria:
inclusion criteria: 1. unresectable metastatic colorectal cancer with pathological confirmation. 2. patients have accepted 18-24 weeks first-line chemotherapy and disease evaluation is sd, pr or cr. exclusion criteria: -

Keywords: metastatic colorectal cancer maintenance treatment chinese traditional medicine clinical trial efficacy safety
effects of sodium intake on (pk/pd) relationship of a single dose of a renin angiotensin system-blocker

Conditions: Healthy

Summary: the impact of sodium intake on plasma drug concentrations has previously been reported in the literature for verapamil and quinidine but, to the investigators' knowledge, never with renin-angiotensin system blockers such as at1r antagonists and angiotensin converting enzyme inhibitors.

the impact of sodium intake on plasma drug concentrations concentrations obtained after a single oral dose of ras blocking drugs (ramipril 10 mg, valsartan 160 mg, candesartan 8 mg) or a blocker as control (atenolol 50 mg) will be compared in healthy normotensive men randomly assigned to a 6-day replated-sodium diet or a sodium depletion.

Eligibility criteria:
inclusion criteria: * 64 (16 per treatment goup) non-smoking healthy male volunteers * aged between 18 and 35 years after a complete clinical examination * safety laboratory measurements * having given written informed consent. exclusion criteria: * hypertension * known disease * diabetes mellitus * known hypersensitivity * contraindication to ace inhibitors * history of cardiac or pulmonary disease or asthma conditions which do not permit medical follow-up and compliance with the study protocol.

Keywords: high sodium diet low sodium diet renin-angiotensin system blockers at1 receptor (at1r) antagonist ace inhibition
association of hb f level with clinical severity of beta thalassemia

Conditions: Beta Thalassemia

Summary: the production of hb f after birth is an important factor in modifying the clinical severity of beta thalassemia because an increased gamma-globin level will bind the additional a-globin and form hb f. the objective of this project is to evaluate the association of hb f level with phenotypic diversity of patients with beta thalassemia.


Eligibility criteria:
inclusion criteria: * diagnosed with beta-thalassemia exclusion criteria: * iron deficiency anemia
the effect of low-concentration atropine combined with auricular acupoint stimulation in myopia control

Conditions: Myopia

Summary: to compare the effect of myopia control between patients treated with low-concentration atropine eye drops combined with auricular acupoint stimulation and those treated with atropine alone.

myopia has been an increasing problem among school children, especially in asian countries. high myopia is not only a refractive problem, but also a disease that can result in a number of sight-threatening complications such as macular degeneration, retinal detachment, glaucoma, and cataract. atropine is a long-acting non-selective muscarinic antagonist that blocks accommodation by paralyzing ciliary muscles; it may affect remodeling of the sclera and suppress the elongation of axial length. acupuncture and acupressure have been widely used in traditional chinese medicine for thousands of years. auricular acupoint stimulation by acupuncture or acupressure has been reported to improve visual acuity in myopic patients. therefore, we want to compare the effect of myopia control between patients treated with low-concentration atropine eye drops combined with auricular acupoint stimulation and those who treated with atropine alone.

Eligibility criteria:
inclusion criteria: * children aged from 6 to 12 years with myopia, defined as spherical equivalent (se) of -0.5 diopter (d) or less, were recruited from the outpatient clinics from january 2011 to june 2012. exclusion criteria: * (1) abnormal iop (\>21 mmhg) at presentation, (2) astigmatism or anisometropia of more than 1.5 d, (3) amblyopia or strabismus, (4) the presence of any related eyelid diseases, ocular diseases, or auricular diseases, (5) the presence of hemostatic disorders or other related major systemic diseases, (6) history of allergy to atropine, (7) previous or current use of contact lenses, bifocals, progressive lenses, or other forms of treatment for myopia.

Keywords: myopia atropine anterior chamber depth auricular acupoint axial length
radiomics based on multimodal imaging in predicting staging and prognosis of pancreatic cancer

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: retrospectively analyzed radiomics features of pancreatic ductal adenocarcinoma to predict staging and prognosis

pancreatic cancer is the most malignant tumor of the digestive system and the seventh leading cause of cancer-related death worldwide.the rate of lymph node metastasis in pancreatic cancer is as high as 59%.lymph node metastasis is an important prognostic factor, which is closely associated with poor prognosis of pancreatic cancer patients.preoperative accurate prediction of lymph node status has important clinical value.at present, the preoperative ln status of pancreatic cancer patients is mainly evaluated by conventional imaging methods such as ct and mri.the accuracy of evaluating ln state only from the perspective of morphology is poor.ductal adenocarcinoma of the pancreas is highly malignant, has a median disease-free survival of only about 1 year, and most pancreatic cancer patients eventually relapse.at present, tnm staging system is mainly used for prognosis evaluation.however, even among patients with the same tnm stage, the prognosis is still significantly different, which reflects the lack of prognostic information provided by the tnm stage.imaging omics extracts a large number of quantitative features from medical images in a high-throughput manner to enable non-invasive analysis of intra-tumor heterogeneity.in this study, we planned to construct a prediction study of preoperative lymph node metastasis and prognosis of pancreatic cancer based on multimodal imaging, so as to provide a basis for clinical treatment decision and prognosis.

Eligibility criteria:
inclusion criteria: * radical resection was performed, and histopathologically confirmed pancreatic ductal adenocarcinoma and lymph node status;2) ct and/or mri enhancement examinations were performed 2 weeks before surgery;3) patients with complete clinical data exclusion criteria: * (1)patients who received radiotherapy or chemotherapy before preoperative imaging examination;2) poor image quality.
a study estimating the time course of pf-04764793 in the blood following dosing by oral inhalation from dry powder inhalers

Conditions: Healthy

Summary: the purpose of this study is to investigate the time course of pf-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 21 and 55 years. * body mass index (bmi) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * a positive urine drug screen. * history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males. * pregnant or nursing females.
study of cm326 in participants with chronic rhinosinusitis with nasal polyposis

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: this is a multi-center, randomized, double blind, placebo-controlled phase ii study to evaluate the efficacy and safety of cm326, and to observe the pharmacokinetics, pharmacodynamics and immumogenicity of cm326 in patients with chronic rhinosinusitis with nasal polyposis (crswnp).

chronic rhinosinusitis (crs) is a chronic inflammatory disease of the sinus mucosa. chronic rhinosinusitis can be clinically divided into chronic rhinosinusitis without nasal polyps (crssnp) and chronic sinusitis with nasal polyps (crswnp), with an incidence ratio between the two of about 4:1. patients with crswnp usually show more severe clinical symptoms and are more likely to relapse after surgery. the overall prevalence of chronic rhinosinusitis in our country is 8%, of which 11.2% are accompanied by asthma. the prevalence of chronic rhinosinusitis with nasal polyps (crswnp) is 1.1%. with changes in the living environment and acceleration of urbanization in china, the overall morbidity is estimated to keep rising.

Eligibility criteria:
inclusion criteria: * male or female subjects, aged between 18 and 75 years old (inclusive). * subjects who are capable of understanding the nature of the study and voluntarily signing the informed consent form (icf). * prior treatment with systemic corticosteroids (scs) within two years before screening, and/or contraindicate to or intolerance to systemic corticosteroids, and/or with prior surgery to nasal polyps 6 months before the screening. exclusion criteria: * allergic or intolerant to mometasone furoate spray or cm326. * have received allergen-specific immunotherapy that initiated within 3 months prior to randomization or planned to be initiated during the study period. * participated study of cm326. * systemic immunosuppressive therapy for inflammatory or autoimmune diseases within 8 weeks or 5 half-lives prior to baseline (whichever is longer). * starting leukotriene receptor antagonist therapy within 4 weeks prior to baseline. * with antrochoanal polyps. * with severe deviation of the nasal septum occludes at least one nostril. * with persistent rhinitis medicamentosas. * with acute sinusitis, nasal infection, or upper respiratory tract infection at screening. * have symptoms or whose ct scan suggests allergic fungal sinusitis. * with malignant or benign neoplasm of nasal cavities. * with other uncontrolled serious diseases or recurrent chronic diseases. * have severe hepatic and renal impairment.
clinical characteristics of patients with sleep apnea in korea

Conditions: Sleep Apnea Syndromes

Summary: sleep-disordered breathing including obstructive sleep apnea (osa) is an extremely common medical disorder associated with important morbidity. the purpose of this study is to understand the clinical features and course of patients with sleep apnea in korea. participants who are suspected of sleep apnea due to symptoms such as snoring, witnessed apneas, waking up with a choking sensation, excessive sleepiness, non-restorative sleep, difficulty initiating or maintaining sleep, fatigue or tiredness, and morning headache will be prospectively recruited at the outpatient clinic of seoul national university hospital. after polysomnography (psg) or respiratory polygraphy, patients with sleep apnea including osa and central sleep apnea (csa) will be followed regularly. participants not having sleep apnea (apnea-hypopnea index \< 5/hour) will only have a baseline visit. for only participants with the informed consent of donating blood, their blood samples will be collected and stored in the seoul national university hospital-human biobank (snuh-hub).


Eligibility criteria:
inclusion criteria: * participants who are suspected of sleep apnea due to symptoms such as snoring, witnessed apneas, waking up with a choking sensation, excessive sleepiness, non-restorative sleep, difficulty initiating or maintaining sleep, fatigue or tiredness, and morning headache exclusion criteria: * none