Kornimate/medical-research-clean huggingface dataset:
assessment and prediction of cetuximab-induced hypersensitivity reactions using cetuximab specific ige detection

Conditions: Tumor Disease Including Colorectal Cancer; Head & Neck Squamous Cell Carcinoma

Summary: 1. background cetuximab (trade name erbitux) is a murine-human chimeric monoclonal antibody to human epidermal growth factor receptor (egfr). this drug has been used as a treatment for colorectal cancer and head and neck cancer. it is known that allergic reactions can occur in more than 5% of the patients, although the side effects are relatively low compared with other chemotherapeutic agents. it is known that cetuximab can induce hypersensitivity even at the first administration, unlike other anticancer drugs. in this study, we aimed to establish a model to predict patients with hypersensitivity reaction before administration of cetuximab and to provide safe chemotherapy. 2. recruitment method and consent procedure the study is designed for analysis patients scheduled for administration of cetuximab for the first time. patients matching the selection and exclusion criteria with voluntary agreement to the study will be enrolled. enrolled patients will be tested for skin prick test and serum sige before cetuximab administration.

* acquisition of agreement agreement, explanation, and consent form for study of human derived sample those that approved by the irb are obtained from patients who prospectively voluntarily participate in the study and provide human derived sample. * observation and evaluation values ① serum cetuximab-specific ige measurement (immunocap, conventional elisa) before administration of cetuximab ② cetuximab skin test using before cetuximab administration ③ clinical symptoms after cetuximab administration through chart review (vital signs, occurrence of adverse drug reaction) ④ check patient's underlying disease and allergy history * statistical analysis method chi-square test, fisher's exact test, student t-test, mann-whitney test, logistic regression test, cox's regression test, and roc curve will be used

Eligibility criteria:
inclusion criteria: * adult men and women over 18 years of age * patients scheduled for cetuximab administration according to standard treatment guidelines for the treatment of underlying tumor disease. exclusion criteria: * patients who did not consent to the study voluntarily after irb approval * persons who are vulnerable (including persons with disabilities, lack of physician capacity, pregnant status, persons who are accommodated in facilities, etc.) * those who can not read and understand the agreement
confocal micro-endoscopy in head and neck cancer/micro endoscopie confocale (mec)oto-rhino-laryngologie (orl)

Conditions: Malignant Pharyngo Laryngeal Tumors; Pre-malignant Pharyngo Laryngeal Tumors

Summary: the primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma.


Eligibility criteria:
inclusion criteria: * patients with malignant and pre-malignant pharyngo laryngeal tumors in whom direct laryngoscopy was performed under general anesthesia with biopsies for diagnostic or endoscopic removal * \> 18 years * signed icf exclusion criteria: * persons deprived of liberty * patients with history of allergy to patent blue * pregnant women or breastfeeding women

Keywords: patients with malignant and pre-malignant pharyngo laryngeal tumors
circulating tumor dna in patients summoned for colonoscopy; - a liquid biopsy for detection, characterization, individualized treatment and follow-up of colorectal cancer

Conditions: Colorectal Cancer; Colorectal Adenoma

Summary: coliq is a clinical study designed to evaluate the clinical usefulness of circulating tumor dna (ctdna) markers found in blood, as a liquid biopsy for diagnosis, prognosis and follow-up of colorectal cancer. the main questions it aims to answer are: 1) can a panel of ctdna markers identify crc patients among the other patients summoned for colonoscopy? and 2) does the type, number and level of ctdna markers vary with the subtype and clinical course of crc? participants will be asked to answer a questionnaire and give a blood sample at inclusion. in addition, patients with crc will be asked to give an extra test tube at their routine treatment and follow-up blood sampling.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years old summoned for colonoscopy * patient able to understand and sign written informed consent exclusion criteria: * patient \< 18 years old * patient unable to understand or give written informed consent * patient unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator as unlikely to complete the study

Keywords: biomarker liquid biopsy ctdna
a real-world clinical study on the treatment of menopausal syndrome with liuwei dihuang pills

Conditions: Menopausal Syndrome

Summary: to evaluate the clinical efficacy of the real-world liuwei dihuang pills for the treatment of female menopausal syndromes, and to provide a basis for effective, safe and rational clinical use of the drug.

in this study, the patients were divided into exposed and non-exposed groups based on whether or not they were taking liuwei dihuang pills. the patients in the non-exposed group were treated routinely, and the patients in the exposed group were treated routinely + liuwei dihuang pills. the patients in the exposed group were required to take the medication according to the dosage instructions for at least 4 consecutive weeks. combined use of drugs is allowed without interfering with the treatment plan, and the use of drugs and combined use of drugs should be recorded truthfully, including the dose, duration, frequency, and so on. the type of drugs used in combination and the corresponding daily dose, daily frequency and duration of treatment. during the course of treatment, patients in both groups were required to receive follow-up assessment once every 4 weeks. termination of the study included death, loss of patients, or achievement of study endpoints.

Eligibility criteria:
inclusion criteria: 1. age: 45-55 years old 2. patients with menopausal syndrome using liuwei dihuang pills 3. kidney yin deficiency syndrome exclusion criteria: 1. individuals allergic to any components of the drug or excipients; 2. individuals with other endocrine diseases; 3. individuals with organic lesions of the reproductive system; 4. individuals who have undergone bilateral oophorectomy, hysterectomy, or have ovarian dysfunction; 5. individuals with endometrial hyperplasia or unexplained vaginal bleeding; 6. individuals with malignant tumors, hematologic, or immune system diseases; 7. individuals with severe cardiovascular, cerebrovascular, liver, or kidney diseases (e.g., serum transaminase levels more than 1.5 times the upper limit of normal, serum creatinine above the upper limit of normal); 8. individuals with psychiatric disorders or dependence on alcohol or drugs; 9. individuals with mental illness or communication barriers; 10. individuals with other conditions that, in the investigator's judgment, may reduce the likelihood of enrollment or complicate the study process are not suitable for participation in this clinical research.

Keywords: liuwei dihuang pills the real world efficacy clinical study
study of artelon flexband® for patients undergoing soft tissue reconstruction of the anterior talofibular ligament (atfl) to treat lateral ankle instability

Conditions: Lateral Ankle Instability

Summary: the goal of this clinical trial is to analzye return to pre-injury activity level on study participants with lateral ankle instability undergoing a modified bröstrom reconstruction procedure for repair of the atfl. study participants undergoing atfl reconstructive procedure using the artelon flexband system as an augmentation device will be compared to study participants undergoing a standard modified bröstrom procedure alone. clinician reported safety and functional outcomes measures will be collected at baseline; and at 2-, 6-, 12-, 18 and 26-weeks and 1- and 2-years post-surgery.


Eligibility criteria:
inclusion criteria: 1. subjects between and including the age of 18-75 at the time of surgery. 2. subjects who were diagnosed with lateral ankle instability by physician clinical assessment. 3. subjects who will undergo a modified bröstrom procedure for an atfl repair with or without flexband augmentation device (does not require an isolated repair). 4. subjects that are able to understand, complete and sign the consent form. exclusion criteria: 1. significant secondary procedures done at the time of repair, including significant osteochondral lesions and/or significant microfracture of the talus or tibia that warrant modifying the typical lateral ligament repair post-op rehab protocol (minor microfractures and ocd lesions that do not warrant major bone debridement, synovectomies, and bone spur/osteophyte removals are allowed). 2. any concomitant orthopedic procedure that will extend the post-op rehabilitation (e.g., casting/immobilization) beyond the routinely prescribed rehab protocol following an atfl reconstructive procedure. 3. subjects undergoing a calcaneal osteotomy. 4. subjects requiring major additional tendon surgery (i.e., peroneal tendon repair or tenodesis). 5. neuropathy. 6. subjects with diabetes, who, in the opinion of the investigator, are not sufficiently controlled. 7. bmi greater than 40 kg/m2. 8. subjects with active worker's compensation cases 9. any subject with a history of infection of the ankle predating the ankle repair. 10. subjects with a systemic ligament laxity disorder (i.e., ehlers-danlos syndrome). 11. any orthopedic issue outside of the ankle that the investigator feels may impede functional endpoint outcome measures. 12. subjects who have a medical history that would likely make the subject an unreliable research participant. 13. subjects that are nursing or pregnant at the time of surgery. 14. subjects with physician assessed untreated alcohol or substance abuse at the time of screening. 15. subjects who are currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening.

Keywords: atfl reconstructive procedure flexband modified bröstrom reconstruction
advance- automated detection and volumetric assessment of ich

Conditions: Intracerebral Hemorrhage

Summary: to evaluate the performance of the viz ich volume algorithm.

to evaluate the performance of the viz ich volume algorithm to: 1. detect the presence of ich on brain imaging, 2. measure the volume of ich on brain imaging, 3. and to assess the algorithm processing time, 4. and the difference in time to notification, time to treatment, and clinical outcomes in comparison to standard of care.

Eligibility criteria:
inclusion criteria: * adult patients (18 and older) * presenting with symptoms suspicious for an acute stroke / intracranial hemorrhage * having a complete imaging data set including ncct +/- mri, cta and/or mra exclusion criteria: * subjects with poor or incomplete brain imaging.

Keywords: artificial intelligence ich
gut microbiome and icu delirium post cardiac surgeries

Conditions: Intensive Care Unit Delirium

Summary: icu delirium are assessed by clinical nurses twice every day. delirious patients are matched with patients according to their disease, gender and age range(±3 years). stool samples for gene sequencing are collected. gut barrier function are studied with several serum biomarkers (endotoxin, etc.). ecological analyses, regression models and mediation equation will be performed.

icu delirium are assessed by clinical nurses twice every day using confusion assessment method for the icu (cam-icu). delirious patients are matched with patients according to their disease, gender and age range(±3 years). stool samples for gene sequencing are collected within 24 hours after surgeries. gut barrier function are studied with several serum biomarkers (endotoxin, etc.). ecological analyses, regression models and mediation equation will be performed.

Eligibility criteria:
inclusion criteria: * to have had heart valve surgery or coronary artery bypass grafting (cabg) * to have no planned transfer to another ward or hospital within 24 hours after surgery * to have no preoperative cognitive impairment and can speak and read chinese * more than 18 years old exclusion criteria: * to have a hearing or visual impairment that could impact delirium assessment * to have a history of alcohol or drug abuse * to have a preoperative intestinal irritation syndrome or history of gastrointestinal disease * to have received antibiotics or probiotics within 28 days before admission * to have a life expectancy less than 24 hours * to have an experience of icu hospitalization, mechanical ventilation in the past 30 days * to have a cardiac surgery or hypoxic brain injury in the past 3 months.

Keywords: delirium
study to assess the efficacy and safety of rituximab in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will assess the efficacy and safety of different treatment regimens of rituximab (mabthera®/rituxan®), corticosteroids, and placebo, combined with methotrexate (mtx), in patients with active rheumatoid arthritis (ra).


Eligibility criteria:
eligibility criteria include, but are not limited to the following: * are between the ages of 18 and 80 years. * have been diagnosed with rheumatoid arthritis for at least 6 months. * have failed treatment (lack of efficacy) with at least 1 but no more than 5 disease-modifying anti-rheumatic drugs or biologics (other than methotrexate).

Keywords: rituxan ra
development of a deep learning system for identification of neuro-ophthalmological conditions on color fundus photographs in emergency department

Conditions: Eye Diseases

Summary: in recent years, artificial intelligence (ai) has been widely integrated into the medical field, contributing in particular to improved patient diagnosis. the bonsai study, brain and optic nerve study with ai, in which our team is participating, has successfully demonstrated the ability of ai to identify individual neuro-ophthalmological or neurological pathologies affecting the optic nerves and/or brain, from a simple fundus image. while this is a promising advance, it remains limited in current clinical practice. our major challenge is to be able to identify a wider range of optic nerve and/or brain pathologies simultaneously in the same analysis, so as to improve patient management, especially for those referred to emergency departments. indeed, in the absence of a precise diagnosis, complications can be irreversible and life-threatening. among the most alarming clinical signs in the emergency department is papilledema of stasis, which, accompanied by acute headaches, may indicate the presence of intracranial hypertension, inflammatory or ischemic pathology. the latter may be a manifestation of horton's disease. our team has developed an ai algorithm to diagnose retinal and optic nerve abnormalities based on retinophotographs taken under ideal conditions during scheduled consultations, and not on images of patients presenting to the emergency department. in hospitals without ophthalmology emergency departments, it is essential that emergency physicians (emergency physicians, general practitioners, neurologists) are able to assess the fundus in the absence of an ophthalmology specialist. this assessment, although part of the general examination, often presents challenges for non-ophthalmologists. the aim of our study is to improve the performance of our ai algorithm so that it can discriminate between different retinal and optic nerve pathologies in the emergency department. we therefore plan to build a database of fundus images by prospectively including patients presenting to the ophthalmology and neurology emergency departments of the fondation adolphe de rothschild hospital. the performance of the algorithm developed will be evaluated according to standard criteria of sensitivity, specificity, area under the curve (auc) and accuracy.


Eligibility criteria:
inclusion criteria: * patient aged 18 and over * presenting to the emergency department of the fondation adolphe de rothschild hospital * express consent to participate in the study * member or beneficiary of a social security scheme exclusion criteria: * patient under legal protection * pregnant or breast-feeding women
lung dose in patients treated with yttrium-90 for hepatocellular carcinoma

Conditions: Liver Neoplasms

Summary: to calculate the amount radiation the lung receives in patients receiving yttrium-90 for liver cancer.

to calculate the delivered lung dose using quantitative volumetric analysis in a cohort of patients with unresectable hepatocellular carcinoma who undergo selective internal radiation therapy (sirt) with yttrium-90 glass microspheres (therasphere®)-and compare this analysis to the lung dose estimated by established criteria. in addition, this study, will summarize the pre and post-treatment clinical data to describe the urmc y-90 experience.

Eligibility criteria:
inclusion criteria: * adults ≥ 18 years with no upper limit.-receiving y-90 therasphere liver directed therapy * pathology proven diagnosis of hepatocellular carcinoma, metastatic colon cancer or other metastatic diseases to be treated with sirt (y-90) * surgical resection not feasible at time of initiation of pre-treatment workup -\> 6 months projected life span * ecog 0-2 exclusion criteria: * previous radioembolization of one or more liver lobes or segments without available treatment planning and procedural documentation ie. at another facility prior to urmc y-90 radioembolization.

Keywords: liver neoplasma lung radiation dose
a study of semagacestat for alzheimer's patients

Conditions: Alzheimer's Disease

Summary: the primary objective of the original study was to assess the safety of semagacestat in alzheimer's disease (ad) patients during 24 months of open-label treatment. baseline for the efficacy measures is defined as the baseline for feeder studies lfan (nct00594568) and lfbc (nct00762411). for all safety analyses (adverse events), baseline for patients will be week 0 of this study (lfbf). preliminary results from lfan and lfbc showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. study drug was stopped in all studies. studies lfan, lfbc and lfbf have been amended to continue collecting safety data, including cognitive scores, for at least seven months. the ct-registry will reflect results of analyses from the original protocol in addition to those from the amended protocol. very few participants from lfbc rolled over into lfbf (n = 9). due to insufficient sample size, the data for lfbc participants who rolled into lfbf were not analyzed.


Eligibility criteria:
inclusion criteria: * meets national institute of neurological and communicative disorders and stroke/alzheimer's disease and related disorders association (nincds/adrda) criteria for probable alzheimer's disease * completed semagacestat study lfan or study lfbc through 88 weeks * must continue to have a reliable caregiver * capable of swallowing whole oral medication * agrees not to participate in other investigational compounds for the duration of study exclusion criteria: * meets lfan or lfbc study discontinuation criteria at the last visit of the lfan or lfbc study
sarecycline truncal acne safety and efficacy response

Conditions: Acne Vulgaris

Summary: the purpose of this study is to determine the efficacy and safety of oral sarecycline 1.5 mg/kg/day in truncal acne. patients with moderate to severe acne vulgaris will be observed over a period of 12 weeks. lesion counts, investigator's global assessments, photography, and safety measures will be assessed for the trunk and face.


Eligibility criteria:
inclusion criteria: * male or female age 9 or above. * clinical diagnosis of moderate to severe truncal acne based on iga exclusion criteria: * known or suspected allergies or sensitivities to any components of the study drug. * any disorders that would preclude the use of tetracycline-class antibiotics or sarecycline. * any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the investigator's judgment) if the subject takes part in the trial. other protocol defined inclusion/exclusion criteria may apply.

Keywords: acne vulgaris sarecycline tetracycline truncal acne
an investigation of nnc 0151-0000-0000 in subjects with systemic lupus erythematosus (sle)

Conditions: Inflammation; Systemic Lupus Erythematosus

Summary: this trial is conducted in the united states of america (usa). the aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and signs of bioactivity of increasing repeated doses of nnc 151-0000-0000 in subjects with systemic lupus erythematosus (sle).

the trial was terminated before any patients were exposed to the trial drug based on new findings indicating that dose escalation with multiple doses should be performed in a different trial population.

Eligibility criteria:
inclusion criteria: * diagnosis of systemic lupus erythematosus (sle) * disease duration: 6 months or longer * stable, mild to moderately active systemic lupus erythematosus (sle) * receiving stable maintenance therapy exclusion criteria: * significant lupus nephritis * active central nervous system (cns) disease * significant arterial or venous thrombosis (blood clots) within 12 months prior to trial start * body weight of 260 lbs/120 kg or more * history of alcohol or substance abuse * history of cancer * infections * viral infections: hiv, hepatitis b or c, epstein-barr virus (ebv), cytomegalovirus (cmv), varicella-zoster virus (vzv), or herpes simplex virus (hsv-1 or hsv-2) * tuberculosis * severe systemic bacterial, viral or fungal infections within the past 12 months prior to trial start * immunosuppressive and immune modulating therapy
dentine hypersensitivity management kap study

Conditions: Dentin Sensitivity

Summary: the study aims to assess and compare the knowledge, attitudes, and practices of egyptian and nigerian dentists on etiology, diagnosis, and management of dh. also to identify if level of education, culture and environment have influence in the diagnosis and management of dh.

diagnosis of dentin hypersensitivity is a challenge faced by dentists with different educational levels and the condition might be overlooked and not properly managed leading to persistent pain and poor quality of life for patients. till the now, literature lacks rigorous guidelines for systematic diagnosis, prevention, categorization of severity and management of dentin hypersensitivity. this study intends to spot the light on the current approaches adopted by dentists in egypt and nigeria towards diagnosis and management of dentine hypersensitivity. it also intends to compare the findings and identify the influence of geographic location, different educational levels, and degree of dental education in the management of dentine hypersensitivity

Eligibility criteria:
inclusion criteria: * must be a dentist * must be in clinical practice * must be practicing in egypt or nigeria * willingly choose to participate in the study exclusion criteria: * dentists that choose not to participate in the study