Kornimate/medical-research-clean huggingface dataset:
study to evaluate the potential of air structuring protein to elicit allergic reactions in mold sensitized people

Conditions: Allergy to Mold

Summary: air structuring protein (asp) is a small protein derived from a fungus which is already widely used to produce enzymes that are added to foods. asp has the possibility of stabilising the air phase of ice-cream and therefore there is interest in asp as a potential ice-cream ingredient. toxicological tests have also been carried out to further confirm the safety of the material and no evidence of genotoxicity or acute toxicity has been observed in any of the tests. as part of the safety evaluation of a new protein for use in foods, the potential allergenicity is also investigated and unilever is sponsoring a study to evaluate this aspect of asp. this study will investigate: * whether asp has the potential to elicit a positive skin prick test (spt) in a population of participants with proven sensitivity to mould. * whether asp is responsible for any positive spt reactions, should they occur. * and if any positive spt reactions to asp occur, whether such reactions are clinically relevant with respect to food allergy. the study is divided in three stages. in stage 1 and stage 2, the spt is "open label," which means that both the participant and the study doctor will know which materials are being tested. in stage 3, the food challenge has a "crossover" design, meaning that participants will take one of the products (asp or placebo \[food containing no asp\]) during the first half of the study and the other treatment during the second half. the order of asp and placebo will be decided randomly, like tossing a coin. to make the comparison between asp and placebo as fair as possible, the food challenge is "double blinded." this means that neither the participant nor the study doctor will know which kind of products (asp or placebo) the participant is taking. this is a multi centre study which is taking place in the uk.


Eligibility criteria:
inclusion criteria: * males and females aged 18-60 years. * mould sensitised subjects diagnosed according to the eaaci/ga2len guidelines. * written informed consent from the subject. * normally active and otherwise judged to be in good health on the basis of medical history and screening assessment. * no allergic symptoms on the day of investigation. exclusion criteria: * pregnancy or lactation. * failure to comply with the protocol. * medication that may interfere with wheal formation in the skin or response to dbpcfc * participation in another clinical study involving a spt within 30 days prior to visit 1 or dbpcfc within 30 days prior to dbpcfc. * current skin disease of any type (eczema, acne, dermatitis, etc.) on the test site(s). * subjects with a condition the investigator believes would interfere with the evaluation of the subject, including proceeding to dbpcfc, or may put the subject at undue risk, e.g., a history of anaphylactic reactions and history of reactions to any component of the dbpcfc matrix other than asp.

Keywords: mold sensitized
association between sma flow and agi in critically ill patients

Conditions: Gastrointestinal Dysfunction; Critical Illness

Summary: acute gastrointestinal injury (agi) is related to poor outcomes of critically ill patients \[1\] through many underlying mechanisms \[2\]. it is also a part of the process of multiple organ dysfunction syndrome (mods). however, the morbidity of acute gastrointestinal dysfunction in critically ill patients is highly underestimated due to the scarcity of accurate measurement and thus the causes are still unclear. in this study, investigators are going to apply the technique of point-of-care ultrasound (pocus) evaluation on the bowel diameters, wall thickness and movement combined with intra-abdominal pressure to determine the occurrence of agi. the superior mesenteric artery (sma) blood flow is also evaluated by pocus to find out the association between sma blood flow and agi.

1. patients are recruited within 24 hours of our surgical icu admission. the patients are mostly admitted for post-surgery monitor in case of complications due to their baseline health conditions. in some cases, patients are admitted from the emergency room because of severe sickness. those who are with deep sedation and mechanical ventilation during the first ultrasound evaluation are eligible for the study. 2. written informed consent was obtained from all patients or next of kin before the recruitment. 3. information will be collected at enrollment, including demographic characteristics, diagnosis, and so on. 4. there will be two phases of ultrasound evaluation. in phase one, investigators perform ultrasound evaluation within 24 hours after icu admission to investigate the sma blood flow in supine position using pocus. in phase two, starting after the enteral feeding has been initiated, usually within 3 days after the enrollment, ultrasound evaluation on gi function will be performed according to gastrointestinal and urinary tract sonography ultrasound (guts) protocol using pocus. guts protocol includes the ultrasound measurement for bowel diameter, bowel wall thickness, peristalsis combined with intra-abdominal pressure(iap) measured through ureteral catheterization. all measurements would be used to calculate guts score to grade the agi \[4\].

Eligibility criteria:
inclusion criteria: 1. 18 \~ 80 years old; 2. under deep sedation (rass score ≤ -3) with mechanical ventilation at the time of enrollment; 3. acute physiology and chronic health evaluation ii (apache-ii) score ≥8. exclusion criteria: 1. pregnancy; 2. recent gastrointestinal surgery; 3. history of acute or chronic gastrointestinal dysfunction before icu admission; 4. primary or secondary vascular malformation of sma; 5. any contraindication to the use of ultrasound evaluation (e.g., abdominal incision).

Keywords: regional blood flow gastrointestinal dysfunction critical care
study of oca in combination with bzf evaluating efficacy, safety, and tolerability in participants with pbc

Conditions: Primary Biliary Cholangitis

Summary: study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (oca) in combination with the investigational drug bezafibrate (bzf) in participants with primary biliary cholangitis (pbc).


Eligibility criteria:
inclusion criteria: * a definite or probable diagnosis of pbc * qualifying alp and/or bilirubin liver biochemistry values * taking ursodeoxycholic acid (udca) for at least 12 months or no udca for 3 months before day 1 exclusion criteria: * history or presence of other concomitant liver diseases * clinical complications of pbc * history or presence of hepatic decompensating events * current or history of gallbladder disease * if female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating * treatment with commercially available oca or other farnesoid x receptor (fxr) agonists, or participation in a previous study involving oca within 3 months before screening. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: primary biliary cholangitis primary biliary cirrhosis pbc hepatic impairment cirrhosis liver
proactive immune tolerance induction in chemotherapy for gynecologic cancer

Conditions: Ovarian Cancer; Endometrial Cancer; Cervical Cancer

Summary: the goal of this clinical trial is to evaluate the efficacy of proactive immune tolerance induction of chemotherapy (paclitaxel and carboplatin) for patients with gynecologic cancer. the main questions it aims to answer are: - does immune tolerance induction during the first three cycles of chemotherapy reduce the incidence of hypersensitivity reactions in the remaining cycles? participants will: * undergo immune tolerance induction or standard treatment during the first three cycles of chemotherapy as randomized, after which all participants will continue the remaining cycles with standard treatment. * receive a reduced dose of dexamethasone premedication if assigned to the experimental group, depending on the specific protocol of each clinical trial.

proactive immune tolerance induction is applied using an automated infusion pump with a pre-programmed protocol. it follows the same stepwise dosing scheme as conventional desensitization therapy used in patients who have experienced hypersensitivity reactions before. however, it is uniquely performed in patients without a prior history of hypersensitivity reactions, aiming to prevent sensitization itself.

Eligibility criteria:
inclusion criteria: * patients receiving paclitaxel and carboplatin chemotherapy for gynecologic malignancies. * patients with no prior history of hypersensitivity reactions to paclitaxel or carboplatin. * patients who are able to read and voluntarily provide written informed consent. * aged 19 years or older. exclusion criteria: * patients who do not wish to participate in this study voluntarily. * patients who, in the opinion of the investigator, are unsuitable for participation in this clinical trial.

Keywords: immune tolerance induction desensitization drug hypersensitivity chemotherapy
adult scoliosis correction by bipolar mini-invasive assembly without graft

Conditions: Scoliosis

Summary: the objective of the study will be to estimate the correction obtained with a metallic instrumentation, by mini-invasive technique with bipolar assembly and ilio-sacred euros ®) screw , without transplant at the adult as compared to that obtained with the surgery with complete exhibition of the rachis and bone graft.


Eligibility criteria:
inclusion criteria: * age \>18 * under guardianship * vertebral deformation \>20° * accept to participate exclusion criteria: * minor patient * surgery not including the pelvis
effectiveness of podiatry on plantar pain

Conditions: Heel Pain; Plantar Fasciitis; Plantar Pain

Summary: main objective: to value the effectiveness of the different quiropody interventions in the heel pain. secondary objectives: to evaluate the effectiveness of lasw different technologies in front of each one of the other experimental technologies. to analyze the state of general health and of quality of the patients' life in all the treatment groups. to analyze the study cost-effectiveness of each one of the experimental interventions. design: randomized controled trial, prospective. subject of study: patient that go to the assistance educational unit of podología of the e.u. sciences of the health with footpain like consultation reason. intervention: establishment of four experimental groups with intervention varied podológica. he/she will be carried out a complete pursuit with valuations at the 1,2, 6, 12 and 24 months, by means of pain scales and function of the foot (fhsq), the index postural of the foot (fpi), the study of pressures by means of biofoot/ibv and of the state of general health (sf-12) and quality of life (euroqol). variables: of intervention; treatment basic orthopodiatry, treatment advanced orthopodiatry, of treatment quiropody. of result: pain and function of the foot (fhsq), of the state of general health (sf12) and quality of life (euroqol). variables of characterization of the sample. analysis data: descriptive statistic, with measures of central tendency and dispersion of the study variables. they will be carried out statistical inferenciales between the main variables of intervention and result (square chi, t student, anova, mann-whitney, wilcoxon, according to types and normality of variables). likewise, measures of the size of the effect will settle down in the main variables of result, by means of the relative reduction of the risk, absolute risk and odds ratio, with their respective intervals of trust.


Eligibility criteria:
inclusion criteria: * heel and plantar pain exclusion criteria: * inflammatory infections and specific organic disease of foot

Keywords: chiropody podiatry insoles foot orthesis
impact of subthalamic nucleus deep brain stimulation on pain in parkinson disease

Conditions: Parkinson Disease

Summary: pain is a common symptom of parkinson's disease (pd) but the physiology remains poorly understood. recent work suggests that subthalamic nucleus deep brain stimulation (stn-dbs) could make a profit on the pain in pd. the investigator would drive a study with a follow up of pd patients before and after stn-dbs. the pain will be clinically explored by targeted questionnaires and electrophysiological through laser evoked potentials. the questionnaires are designed to quantify and characterize the pain in these patients. laser evoked potentials will, through repetitive stimulation, study both the functional status of the afferent nociceptive pathways, their habituation to repetitive nociceptive stimuli, and so better understand any abnormalities of the central processing of nociceptive information.


Eligibility criteria:
inclusion criteria: * a patient with idiopathic parkinson's disease * age between 30 and 70 inclusive. * no cognitive decline (mms greater than or equal to 24) * normal brain mri * informed consent signed * with or without pain sensation exclusion criteria: * presence of other neurological pathology that could explain the pain. * mms less than 24 * pregnant or breastfeeding women

Keywords: parkinson disease pain deep brain stimulation laser-evoked potentials
a new diagnostic method to assess paclitaxel-induced peripheral neuropathy

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: to assess the impact of paclitaxel treatment on the nerve excitability of the small and large nerve fibers

chemotherapy-induced peripheral neuropathy (cipn) is a common side effect of many chemotherapeutic agents, especially antineoplastic agents. to limit the nerve damages, early detection and management of cipn is crucial and leaves an urgent demand for new diagnostic tools. perception threshold tracking has enabled assessments of nerve excitability tests of both small and large sensory nerves and may be used to assess cipn at early stages. the purpose of this study is to examine whether a new nerve excitability test can detect changes in the membrane properties of the small and large nerve fibers during chemotherapy treatment. in this study nerve excitability tests will be performed with 2 different electrodes using a novel perception threshold tracking technique to assess the nerve excitability of small and large fibers. further quantitative sensory tests (qst) will be performed to estimate the vibration threshold, warm and cool perception thresholds, heat and cold pain thresholds, and perceived intensity to static mechanic stimulations will be assessed. symptoms of cipn will be assessed using the common terminology criteria for adverse events scale and a quality of life questionnaire cipn twenty-item scale.

Eligibility criteria:
inclusion criteria: 1. \> 18 years 2. histopathologically verified breast cancer 3. performance status according to who/ecog (ps) 0-2 4. candidate for adjuvant standard treatment with ec and paclitaxel 5. not previously treated with chemotherapeutic agents 6. neurological examination without pathological findings 7. willingness to voluntarily sign an informed consent exclusion criteria: 1. previously neoadjuvant treatment with chemotherapy 2. receives prophylactic bone marrow stimulants 3. hiv 4. diabetes mellitus 5. opioid requirement 6. symptomatic neurosensory disorders 7. neurological diseases, such as sclerosis and epilepsy 8. alcohol abuse 9. "palmar-plantar erythrodysesthesia syndrome" / ulceration of hands or feet 10. cannot understand written or oral information in danish 11. inability to cooperate

Keywords: assessment of nerve fiber excitability
the estimation of abdominal pressure by the bladder and gastric pressure

Conditions: Critically Ill Patients

Summary: the investigators aim to compare the bladder pressure to the gastric pressure in critically ill patients.

in critically ill patients, we will measure the gastric pressure by a gastric balloon and the bladder pressure by the intra-vesical pressure to find the optimal method to estimate the abdominal pressure.

Eligibility criteria:
inclusion criteria: * critically ill patients during invasive mechanical ventilation exclusion criteria: * contraindication to measure the bladder pressure
a clinical trial to evaluate drug-drug interactions and safety between "br1015-1" and "br1015-2" in healthy volunteers

Conditions: Hypertension

Summary: the purpose of this study is to evaluate pharmacokinetic interactions (drug-drug interaction) and safety between "br1015-1" and "br1015-2" in healthy volunteers.

\*study objective: after repeated administration of br1015-1 and br1015-2 for healthy volunteers, the pharmacokinetic interactions and safety are evaluated. \*investigational product (and regimen) 1. br1015-1: administration of br1015-1 60 mg once a day for 5 days 2. br1015-2: administration of br1015-2 1.5 mg once a day for 5 days 3. br1015-1+br1015-2: co-administration of br1015-1 60 mg and br1015-2 1.5 mg once a day for 5 days

Eligibility criteria:
inclusion criteria: * subjects are given sufficient explanations about the trial objectives and contents as well as properties of investigational drugs before participating in the trial, and will voluntarily express their consent by signing an irb-approved written consent to participate in the trial. * healthy adults aged 19 to 55 years at screening. * the subject's weight is 50 kg or more for males, 45 kg or more for females, and body mass index (bmi) is 18.0 or more but 30.0 kg/m2 or less. exclusion criteria: * those who have history of clinically significant diseases including hypersensitivity reaction, intolerability and anaphylaxis to major ingredients and other ingredients of investigational products. * those who have history of clinically significant diseases including allergy reaction to yellow no. 5 (sunset yellow fcf). * those who have a history of clinically significant diseases related to liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncology system, cardiovascular system (including orthostatic hypotension), etc. * those who have medical history of gastrointestinal system diseases (for example: crohn's disease, peptic ulcer disease, etc.) and operations that may influence the absorption of investigational drugs. (however, appendectomy, hernia operation, endoscopic polypectomy and hemorrhoids/anal fissure/anal fistula surgeries are excluded.) * those with abnormal findings from the screening tests (medical interview, vital signs, electrocardiography, physical checkup, blood test, urinalysis, etc.) are judged to have clinical significance. * those who are positive to hbsag, hcv ab, hiv ab, vdrl tests at screening. * those with any of the following results at screening: * ast or alt \> twice the upper limit of normal range * t. bilirubin \> twice the upper limit of normal range * estimated glomerular filtration rate (e-gfr) \< 60 ml/min/1.73m2 (ckd-epi method used) * na \> 150 meq/l or \<130 meq/l * k \> 5.5 meq/l or \<3.0 meq/l * those with systolic blood pressure \> 160 mmhg or \ 100 mmhg or \< 70 mmhg from vital signs at screening. * others who are judged to be ineligible to participate in the trial by the investigator.
a deep learning radiomics model for predicting occult peritoneal metastases of pancreatic adenocarcinoma

Conditions: Pancreatic Neoplasms

Summary: occult peritoneal metastases (opm) in patients with pancreatic ductal adenocarcinoma (pdac) are frequently overlooked during imaging. we aimed to develop and validate a ct-based deep learning-based radiomics (dlr) model with clinical-radiological characteristics to identify opm in patients with pdac before treatment.

this retrospective, bicentric study included 302 patients with pdac (training: n = 167, opm-positive, n=22; internal test: n = 72, opm-positive, n=9: external test, n=63, opm-positive, n=9) who had undergone baseline ct examinations between january 2012 and october 2022. handcrafted radiomics (hcr) and dlr features of the tumor and hcr features of peritoneum were extracted from ct images. mutual information and least absolute shrinkage and selection operator algorithms were used for feature selection. a combined model, which incorporated the selected clinical-radiological, hcr, and dlr features, was developed using a logistic regression classifier using data from the training cohort and validated in the test cohorts.

Eligibility criteria:
inclusion criteria: patients with suspected pancreatic tumors who underwent contrast enhanced ct and pathological examinations at center 1 and center 2 were eligible for inclusion in this study. exclusion criteria: * (a) pathologically diagnosed pdac by pathology, (b) time intervals between contrast-enhanced ct and pathology less than 2 weeks; (c) history of pancreatic surgery, (d) history of pancreatic malignancy, and (e) poor ct image quality that undermined peritoneal lesion assessment
an epidemiological survey of cancer-related fatigue among taiwanese cancer patients

Conditions: Cancer

Summary: the aim of this study is to examine the prevalence, severity, impacts and managements of crf among taiwanese cancer patients.

the cross-sectional survey is conducted at oncology inpatients unit and outpatients clinics of hospitals in taiwan. furthermore, the results will elucidate not only the epidemiology of crf in taiwan, but will supply physicians with more understanding about crf, and help them to enhance the quality on cancer care to being perfected in the future.

Eligibility criteria:
inclusion criteria: * (1) patients who signed the informed consent form * (2) the age of eligible patients should be \> 20 years old. * (3) inpatients or outpatients who have been given a diagnosis of cancer * (4) able to communicate verbally and completely fill out the questionnaires exclusion criteria: * patients who have been given a diagnosis of cognitive impairment are unable to complete the questionnaires
bacteriological link between upper and lower airways in cystic fibrosis and primary ciliary dyskinesia

Conditions: Cystic Fibrosis; Primary Ciliary Dyskinesia

Summary: cytobacteriological examination of sputum and bacteriological sampling in the middle meatus.


Eligibility criteria:
inclusion criteria: * patients over 6 years old * patients with cystic fibrosis or primary ciliary dyskinesia. * patients capable of performing an expectorations * patients having been informed of the research, having received the information note and not having opposed the research exclusion criteria: - refusal to participate in the study