Kornimate/medical-research-clean huggingface dataset:
a first-in-human poc study with ben2293 in patients with mild to moderate atopic dermatitis

Conditions: Atopic Dermatitis

Summary: a randomised, adaptive design, double-blind, placebo-controlled, first-in-human, two-part study to investigate the safety, tolerability, pk and preliminary efficacy of multiple topical doses of ben2293 in patients with mild to moderate ad.

this protocol will be adaptive and designed to enable knowledge gained from the previous cohort to be applied to subsequent cohorts. changes made will be within the boundaries of the adaptive elements with clear control mechanisms and guidance for staying within these boundaries. part a is a randomised, double-blind, placebo-controlled, sequential group study to investigate ascending multiple topical doses of ben2293 in patients with mild to moderate ad. patients will participate in only one cohort. part b is a randomised, double-blind, placebo-controlled, parallel group study to investigate up to two dose regimens of topical doses of ben2293 administered for a maximum of 28 days in patients with mild to moderate ad.

Eligibility criteria:
inclusion criteria: * males and females with mild to moderate ad (based on viga) free from other clinically significant illness or disease that may adversely affect the safety of the patient or the integrity of the study as determined by medical history, physical examination, safety laboratory and other assessments. * history of ad for at least 6 months diagnosed by a dermatologist or gp. * previous or current successful treatment with topical corticosteroids. * a viga score of 2 (mild) to 3 (moderate) at both screening and day -1 (part a) and at screening, day-3 and day 1 (part b). exclusion criteria: * atopic dermatitis of such severity that the patient could not comply with the demands of the study and/or the patient is not a suitable candidate for a placebo controlled study, as per investigator's discretion. * any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive uv exposure, at the possible imp application sites. * patients who have ad lesions affecting \>3% untreatable areas (face, scalp, genitals, palms of hands or soles of feet). * have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the study area to be dosed that may interfere with study assessments. * patients who are excessively hirsute in areas of skin to be dosed with study ointment. * patients who are unwilling to stop hair removal by any means (including shaving, waxing or depilatory creams) to skin areas to be dosed with study ointment for 2 weeks prior to day -1 and throughout the duration of the study. * clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations as judged by the investigator (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, gastrointestinal, hepatic, or renal disorder). * the patient has participated in a clinical study and has received a medication or a new chemical entity within 3 months prior to day 1.
evaluation of patients with breast cancer using dce-mri, mrs, and proteomics

Conditions: Breast Cancer

Summary: rationale: diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance imaging(dce-mri), magnetic resonance spectroscopy (mrs), and tissue proteomics, may help doctors find and diagnose breast cancer and plan the best treatment. purpose: this clinical trial is studying mri and mrs with or without tissue proteomics analysis to see how well they work in evaluating healthy women and women who are undergoing surgery for breast cancer.

objectives: * to correlate data obtained by dce-mri and mrs in healthy women and in women who are undergoing surgery for breast cancer with data obtained by conventional x-ray mammography, tissue proteomics, and histopathology. * to evaluate the impact of mrsi data on treatment planning for radiotherapy and/or surgery. outline: healthy participants undergo dynamic contrast-enhanced (dce)-mri and magnetic resonance spectroscopic (mrs) for longitudinal studies of breast imaging and spectroscopy. patients with breast cancers undergo dce-mri and mrs prior to initiation of treatment (i.e., surgery, chemotherapy, or radiotherapy). after treatment has begun, patients then undergo repeat imaging (not more than 1 per month) for follow-up assessments and longitudinal studies. breast tissue samples are collected from patients undergoing surgery. samples are evaluated by histopathological and proteomic analysis for correlation with dce-mri and mrs findings. the study interventions are discontinued after definitive surgery is performed. projected accrual: a total of 10 healthy participants and 40 patients with breast cancer will be accrued for this study.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * women with breast tumors planning to undergo surgical resection * healthy volunteers, including any constitutionally healthy female with no history of breast cancer * hormone receptor status not specified patient characteristics: * female * menopausal status not specified * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * not acutely ill * no non-magnetic resonance-compatible ferromagnetic materials present in the body prior concurrent therapy: * prior chemotherapy and/or radiotherapy allowed

Keywords: recurrent breast cancer stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer
impact of microbiome-changing interventions on food decision-making

Conditions: Overweight and Obesity

Summary: the investigators aim to test the hypothesis that a microbiome-changing dietary intervention improves food decision-making and to determine the underlying microbiotal and metabolic mechanisms. to this end, 90 overweight/obese adults will be enrolled in a randomized controlled trial to test the effects of a pre-biotic dietary intervention (supplementary intake of soluble fibre) or a behavioural lifestyle intervention (weekly educational program) vs. control condititon (supplementary intake of isocaloric starch) over a period of 26 weeks. before and after the intervention/control period, participants will undergo task-based functional and structural mri and cognitive testing. the gut microbiota will be assessed using 16s rdna next-generation sequencing (v3/v4 region) in stool samples. diet, anthropometry and lifestyle will be monitored with questionnaires and metabolomics will be assayed in peripheral blood and stool (e.g. scfa). using a modulation of gut-brain communication through a prebiotic diet and lifestyle intervention, respectively, the investigators will be able to discover microbiota communities that play a key role for eating behaviour. related mechanistic insights could help to develop novel preventive and therapeutic options to combat unhealthy weight gain in our obesogenic society.


Eligibility criteria:
inclusion criteria: * bmi \>= 25 kg/m2 or whr \>= 0.9/0.85 (m/d, f) * no mri contra-indication * written informed consent exclusion criteria: * athletes * occurrence of a clinically relevant psychiatric disease in the last 12 months, e.g. depression, substance abuse, eating disorders, schizophrenia * any chronic inflammatory or malignant disease * type 1 diabetes * previous bariatric/gastric surgery * pregnancy or breastfeeding woman
blood sample collection to evaluate biomarkers in subjects with untreated solid tumors

Conditions: Breast Cancer; Lung Cancer; Colorectal Cancer; Prostate Cancer; Bladder Cancer; Uterine Cancer; Kidney Cancer; Renal Pelvis Cancer; Pancreatic Cancer; Liver Cancer; Stomach Cancer; Ovarian Cancer; Esophageal Cancer

Summary: the primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

subjects who have been diagnosed, or who have a suspicion of diagnosis based on imaging, with any solid tumor. subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. there will be no further follow-up.

Eligibility criteria:
inclusion criteria: 1. subject is male or female \> 18 years of age. 2. subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer. or subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, or ovarian cancer based on imaging. 3. subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator. exclusion criteria: 1. prior or concurrent cancer diagnosis defined as: 1. any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); or 2. recurrence of the same primary cancer within any timeframe; or 3. concurrent diagnosis of multiple primary cancers 2. chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection. 3. any treatment for the primary malignancy or sites of metastases. subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection. 4. less than 3 days between fine needle aspiration (fna) of target pathology and blood collection. 5. less than 7 days between biopsy (other than fna) of target pathology and blood collection. 6. iv contrast (e.g. ct and mri) within 1 day \[or 24 hours\] of blood collection. 7. individual has a condition the investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Keywords: blood draw sample collection
delirium in elderly undergoing cardiac surgery and the significance of cholinesterase activity

Conditions: Postoperative Complications

Summary: the purpose of this study is to assess the association between the "point-of-care" (poc) measured che activity (acetylcholinesterase (che) + buturylcholinesterase (che)) and postoperative delirium in elderly patients undergoing cardiac surgery. furthermore the investigators aim to identify factors, which influence the baseline levels and the time course of che activity.

cardiac surgery in elderly patients is associated with serious complications, like increased morbidity, mortality and postoperative delirium with further hazardous consequences. the incidence of postoperative delirium in elderly is reported with a range from 36.6% - 54.9%. the pathophysiology of delirium is complex and the interaction of the cholinergic system and inflammation reaction is a relevant precipitant factor. it was suggested that there is a strong association between the perioperative plasma che activity and the inflammatory response in patients developing delirium. patients showed a significant reduction of the total che activity after orthopaedic surgery, with significant lower pre- and postoperative values of ache and buche and increased inflammatory response in patients developing postoperative delirium. it remains unclear if these results are applicable to other patient populations and which factors have influenced the low preoperative che levels. in patients suffering from a cardiac disease, a reduced total che respectively buche activity was significantly associated with mortality and long-term major adverse cardiovascular events. the investigators hypothesize that the che activity in peripheral blood can be used as a potential biomarker, to early detect patients at high risk for postoperative delirium.

Eligibility criteria:
inclusion criteria: * written informed consent * ≥ 65 years of age * scheduled to undergo elective cardiac surgery (coronary artery bypass graft (cabg), valve surgery, combined cabg-valve surgery) with the use of cpb * both genders exclusion criteria: * planned deep hypothermic arrest * acute / emergency procedures * surgery without extracorporeal circulation (ecc) * patients with a history of pseudocholinesterase deficiency * employees of the respective study centres * illiteracy * severe communication difficulties and severe vision or hearing problems * patients legally unable to give written informed consent * non-fluency in german language * severe psychiatric or neuropsychiatric disorders * mmse \< 24 points, short geriatric depression scale (gds) ≥ 10 points * recent (\<6 months) history of alcohol or drug abuse * the participation in a drug or device trial within the previous 30 days

Keywords: postoperative delirium cholinesterase activity buturylcholinesterase activity acetylcholinesterase activity elderly patients cardiac surgery
pro-adrenomedullin as a prognostic marker in neonatal sepsis

Conditions: Sepsis

Summary: the aim of this study was to clarify the prognostic value of serum pro-adrenomedullin level in neonatal sepsis. eighty term and preterm neonates with sepsis were enrolled in this study. eighty healthy matched neonates served as a control group.


Eligibility criteria:
inclusion criteria: * clinical sepsis and/or proven sepsis. exclusion criteria: * acute kidney injury * intracranial hemorrhage (grade iii and iv)

Keywords: pro-adrenomedullin neonatal sepsis prognosis sepsis marker clinical sepsis proven sepsis
randomized double-blind clinical trial of rebamipide vs esomeprazole in the treatment of nsaid-induced gastropathy

Conditions: NSAID Induced Gastropathy

Summary: primary objective: to determine the levels of malondialdehyde (mda) and immunohistochemistry surrogate of inflammation in patients with nsaid-induced gastric mucosal injury treated with rebamipide 3x a day vs esomeprazole 40mg once a day. secondary objective: for patients who become symptomatic during nsaid treatment, to compare the proportion of patients with positive treatment effects using the likert scale. third objective: to compare the proportion of patients with positive treatment effects as determined by modified lanza scoring between the two groups.


Eligibility criteria:
inclusion criteria: patients with rheumatoid arthritis and osteoarthritis who developed dyspeptic symptoms while on nsaid for at leat 4 weeks who fulfill any of the following criteria: 1) have not been on nsaids (nsaid-naïve) as they are newly diagnosed patients or satisfies all of the following criteria: a) have not received nsaids for more than 2 years continuously, b) have not received nsaid for at least 3 months, c) does not take more than the therapeutic dose required for any of the following nsaids: aspirin (at max. 4000mg.day), naproxen (at max. 1375mg/day), ibupropen (at max. 2400mg/day), diclofenac (at max. 200mg/day), piroxicam (at max. 40mg/day). 2) gastric mucosal lesions on upper endoscopy (lanza score ≥ 1) 3) more than 18 and less than 65 years old 4) medically cleared and consents to undergo upper endoscopy 5) willing to participate in the trial and sign an informed consent form exclusion criteria: 1. patients with known malignancy 2) women who are pregnant and breastfeeding 3) psychiatric illness 4) severe co-morbid illness like renal failure, cirrhosis, etc. 5) history of intake of any anti-secretory agent for the past 2 weeks 6) patients with coagulation disorders and hematologic problems 7) complicated ulcers, i.e. bleeding, perforating, etc. 8) patients with evidence of portal hypertension i.e. varices, portal gastropathy, etc. 9) history of gastric surgery 10) patients on cox-2 inhibitors 11) modified lanza score of 0 12) herbal medications or complementary alternative medicines (e.g. glucosamine chondroitisulfate, etc. 13) (+)h.pylori test by rut (rapid urease test) and biopsy.
comparison of acular ls versus nevanac for pain control in eyes undergoing prk

Conditions: Myopia; Hyperopia

Summary: to determine the ability of two topical nonsteroidal anti-inflammatory drops (acular ls \& nevanac) to help control pain following photorefractive keratectomy (prk).

laser vision correction is the most commonly performed elective surgical procedure in the united states. although laser-assisted in-situ keratomileusis (lasik) is the more popular technique, a growing number of surgeons have switched to surface ablation techniques, including prk, lasek and epi-lasik.1 with surface laser procedures, the corneal epithelium is removed by a variety of techniques (laser, manual debridement, diluted alcohol2,3, epi-keatome) prior to laser reshaping of the corneal stroma. following the procedure, a contact lens is placed on the eye to promote epithelial regeneration. due to the size of the epithelial defect, it can take between 3 to 6 days for the epithelium to regenerate. during this healing process, patients often complain of moderate to severe ocular pain, and delayed healing may result in an increased risk of infection or corneal haze4. over the past decade, a variety of methods have been used to assist with reducing pain following surface laser procedures. topical nonsteroidals have been shown in a number of studies to help reduce the degree of pain following prk. topical dilute tetracaine has also been shown to assist with the reduction of pain following prk. oral pain medications, such as vioxx, celebrex, and even prednisone have been recommended as additional treatment options for pain control. in october 2005, a new topical nonsteroidal anti-inflammatory drop, nevanac, was approved by the fda. nevanac was approved with a a tid dosing schedule. acular ls is the current market leader for topical nsaid eye drops. acular ls is typically used on a qid dosing schedule.

Eligibility criteria:
inclusion criteria: * patients undergoing prk for myopia or hyperopia exclusion criteria: -

Keywords: prk laser vision correction surface ablation pain wound healing corneal haze
use lenalidomide (revlimid®) in combination with dexamethasone in clinical practice for the treatment of newly diagnosed multiple myeloma (mm) transplant ineligible patients

Conditions: Multiple Myeloma

Summary: the aim of this non-interventional study is to collect primarily the percentage of patients who receive the full dose of dexamethasone (20 or 40 mg orally once daily on days 1, 8, 15 and 22 of the repetitive 28-day cycles, 20 mg in \>75 year old patients) in the registered indication under practice conditions.

multiple myeloma is still a persistent and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system. it is a rare but incurable disease. on average, multiple myeloma is diagnosed in people 65-74 years of age, and the majority of newly diagnosed patients may not be eligible for more aggressive treatment options such as high-dose chemotherapy with stem cell transplant. in february 2015 revlimid® (lenalidomide) was approved in combination with dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. furthermore, in may 2019 revlimid® was approved in combination with bortezomib and dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. looking in more detail at the combination of lenalidomide and dexamethasone, the role and especially the most adequate and effective dosage of dexamethasone in long term use with lenalidomide is not clearly defined or well characterised it is therefore of great relevance to gain insights into the clinical practice and the routine of dexamethasone management and dosing in long term use with revlimid.

Eligibility criteria:
inclusion criteria: * signed informed consent * age ≥ 18 years * newly diagnosed multiple myeloma * not suitable for stem cell transplantation * appropriate methods of contraception according to the risk minimization program (rmp) * adequate thrombosis prophylaxis exclusion criteria: * pregnant and lactating females * no other formal exclusion criteria according to most recent european summary of product characteristics (smpc)

Keywords: multiple myeloma revlimid lenalidomide non-transplantable
the association between albumin administration and short-term rebleeding risk in cirrhosis patients with acute variceal hemorrhage and stable hemodynamics

Conditions: Cirrhosis; Acute Variceal Haemorrhage

Summary: the impact of albumin administration in cirrhotics with acute variceal hemorrhage (avh) is controversial. we aim to investigate the short-term rebleeding risk associated with albumin administration in a retrospective study of hospitalized cirrhotics with avh with stable hemodynamics. this retrospective analysis includes clinical data of cirrhosis patients with acute variceal bleeding admitted to our hospital from january 2021 to october 2023. propensity score matching will be performed to account for potential confounders associated with albumin use for outcome analysis. according to the outcome, patients will be divided into rebleeding group and non-rebleeding group. to investigate the impact of albumin infusion on the rebleeding risk in the propensity-matched cohort, patients will be divided into albumin user group and albumin non-user group. the primary outcome is the rebleeding risk within 30 days after discharge.


Eligibility criteria:
inclusion criteria (1) patients were diagnosed with liver cirrhosis with esophageal and gastric varices; (2) patients were presented with any evidence or signs of acute upper gastrointestinal bleeding within 3 days before admission, including hematemesis, melena, and positive fecal occult blood. (3) endoscopy or imaging data suggested the presence of avb. exclusion criteria (1) patients with unstable hemodynamics (patients whose sbp\ 120 bpm at admission). (2) patients who were initially treated at other facilities but later transferred to our hospital without comprehensive medication records. (3) ages \ 85 years old. (4) patients with incomplete data.
study of molecular markers in cutaneous inflammation between psoriatic lesional skin and healthy non-lesional skin

Conditions: Psoriasis

Summary: the project topic consists on re-conciliating the fine tuners of the gene expression "micrornas" and the immunopathogenic occasions responsible for skin disorders in context of skin infection and inflammation such as psoriasis. the skin is a network of effector cells and molecular mediators that constitute a highly sophisticated "skin immune system (sis) described by jan d bos in 1986. the cutaneous homeostasis maintenance is dependent on the cross talk between several immune sentinels present in the different compartments of the skin as well as the interplay between innate and adaptive immune responses. the whole is under the control of gene regulation. however, cutaneous homeostasis disruption occurs when the sis safe framework erroneously sends aggravation signals due to gene regulation disbalance via inflammatory cellular and molecular mediators into the site of infection causing chronic inflammation characterized by thick red irritated skin lesions. the latter was showed to have a characteristic microrna (regulators of gene expression) signature.


Eligibility criteria:
inclusion criteria: * men or women between 18 and 75 * clinical diagnosis of chronic active psoriasis in non-pustular plaque * treated locally with topical corticosteroids exclusion criteria: * patient who did not give express consent to participate * no affiliation to a social security scheme * patient treated systemically * thrombocytopenic patient * patient known to be hiv-positive * septic patient * patient with only facial lesions * patient with psoriasis with joint involvement * patient participating in another study * patient protected under the law (under guardianship or trusteeship) * pregnant or lactating woman

Keywords: psoriasis il-22 mir-21