Kornimate/medical-research-clean huggingface dataset:
prospective cohort study of intravenous lipid emulsion for resuscitating critically-ill poisoned patients

Conditions: Overdose

Summary: the purpose of this project is to evaluate the case characteristics of patients who receive intravenous lipid emulsion therapy. previous literature to date has focused on animal studies or has been primarily limited to case reports or small case series. this prospectively collected data set will permit a much more detailed description of the use of lipid, its potential benefits, and potential harms.

the purpose of this project is to evaluate the case characteristics of patients who receive intravenous lipid emulsion therapy. a secondary objective is to determine the mortality in this critically ill population of individuals. previous literature to date has focused on animal studies or has been primarily limited to case reports or small case series. this prospectively collected data set will permit a much more detailed description of the use of lipid, its potential benefits, and potential harms.

Eligibility criteria:
inclusion criteria: * receiving intravenous lipid emulsion for treatment of a drug toxicity * evaluation of a medical toxicologist as part of the toxic registry consortium exclusion criteria: * not evaluated by a medical toxicologist participating in toxic

Keywords: ile lipid overdose resuscitation
development and validation of a quality of life instrument for actinic keratosis

Conditions: Actinic Keratosis

Summary: actinic keratoses (aks) are some of the most common lesions seen by dermatologists. flesh colored to erythematous, these lesions often present with scaling or crusting in sun damaged regions of the body. while they are physically visible and often palpable, these changes can also result in psychosocial changes in patients, including embarrassment about their skin or reduction in leisure activities to avoid further sun exposure. at the same time, aks are known to progress in a significant number of cases to squamous cell carcinoma (scc), a concern in terms of its metastatic potential. the primary purpose of developing this questionnaire is to examine how well it can potentially identify patients with actinic keratoses. however, since ak is associated with significant detriment to quality of life for validity/reliability assessment, the investigators propose to give a compilation of four self-assessment questionnaires (not specific to ak but validated for skin health in general) to subjects with at least one actinic keratosis and age- and sex- matched participants without aks, defined as the control population. these will include the skindex-16, the dlqi and the skin health calculator, as well as a questionnaire composed of items specific to predisposition to aks to be able to better assess the discriminatory power of the questionnaire.


Eligibility criteria:
inclusion criteria: * male or female, age 18 years or older being seen in a dermatology clinic * informed consent of participation must be given by subject exclusion criteria: * inability to complete all study questionnaires. * subjects who are unable to read and write english

Keywords: "sun spots" "pre-cancerous skin lesion"
diabetes medical nutrition therapy in southeastern african american women

Conditions: Type 2 Diabetes

Summary: a two-arm randomized controlled trial design will be used. participants will include 291 african american women with type 2 diabetes that are at risk for development and/or progression of diabetes complications. both arms, diabetes medical nutrition therapy (mnt) and diabetes mnt plus motivational interviewing (mi), will include: 1) a 3-month active intervention period of six biweekly (every other week), group-based, trained nutritionist-facilitated sessions; 2) a 3-month maintenance intervention period, which will include one group-based maintenance support session; and 3) a 6-month inactive period (no contact). the differences between arms is the integration of culturally-adapted mi exercises during the diabetes mnt plus mi active and maintenance intervention periods.


Eligibility criteria:
inclusion criteria: * african american * female * clinical diagnosis of type 2 diabetes for at least 6 months * at risk for development and/or progression of diabetes complications (hba1c ≥ 7.0% and either systolic blood pressure ≥130, ldl cholesterol ≥ 100, or bmi ≥ 30). exclusion criteria: --observed or diagnosed psychotic disorders
biomarkers for diagnosis and prognosis of endometrial carcinoma

Conditions: Endometrial Cancer

Summary: endometrial cancer (ec) is the most frequent gynecological malignancy but there is currently lack of both non-invasive diagnostic tools and novel markers to stratify patients based on their risk of future recurrence. patient care could be improved by advances in these two aspects. in the present study, the investigators aim to identify diagnostic serum metabolite and protein biomarker signatures for early detection of cancer in asymptomatic high-risk population and prognostic biomarkers for selection of patients with poor prognosis.

rationale: endometrial cancer (ec) is the most frequent gynaecological malignancy in the developed world. optimal treatment of ec depends on early diagnostics and pre-operative stratification to appropriately select the extent of surgery and to plan further therapeutic approach. currently, invasive endometrial histology is the gold standard for diagnosis, as there are no valid non-invasive methods available, and patient stratification is based on histopathology and surgical findings. there is a great need for efficient and reliable screening test for asymptomatic women with high risk of ec including lynch syndrome patients and tamoxifen treated patients. in addition, a prognostic test is needed to stratify pre-operatively ec patients with high risk of progression in need of radical surgery together with adjuvant chemo/ratio therapy from ec patients with good prognosis. in this project the investigators are addressing this lack of non-invasive diagnostic and prognostic biomarkers of ec. objective: the investigators aim to identify diagnostic serum metabolite and protein biomarker signatures for early detection of cancer in asymptomatic high-risk population and (secondary objective) prognostic biomarkers for selection of patients with poor prognosis.

Eligibility criteria:
inclusion criteria cases: * endometrioid, serous, clear cell or mucinous endometrial cancer * dedifferentiated endometrial cancer * high grade or low grade endometrial cancer inclusion criteria controls: * benign uterine diseases, e.g. myoma uteri, prolapsed uterus * prophylactic hysterectomy for lynch syndrome exclusion criteria cases: * atypical hyperplasia * other types of cancer * sarcoma uteri * previous diagnosis of endometrial cancer exclusion criteria controls: * any cancer * benign ovarian diseases * previous ec * pregnancy at the time of enrollment

Keywords: metabolomics proteomics early diagnosis prognosis
the safety, tolerability, pharmacokinetics, and pharmacodynamics of uttr1147a in participants with neuropathic non-healing diabetic foot ulcers

Conditions: Neuropathic Diabetic Foot Ulcers

Summary: this trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of repeat dosing of uttr1147a in participants with neuropathic diabetic foot ulcers that do not respond adequately to standard wound care. participants across multiple sites will be assigned to one of five cohorts (cohort a, b, c, d, and e) based on the eligibility criteria and randomized to receive subcutaneous (sc) injections of either uttr1147a or placebo over 12 weeks in addition to standard wound care.


Eligibility criteria:
inclusion criteria: * have a diagnosis of type 1 or type 2 diabetes and confirmed peripheral neuropathy * have adequate circulation to the foot * have an ulcer area at screening up to 6 cm\^2 * up to date on all age-appropriate cancer screenings per local standards exclusion criteria: * have current evidence of osteomyelitis, cellulitis, or evidence of systemic infection * have gangrene present on any part of the affected foot * known peripheral arterial disease requiring revascularization * have a glycated hemoglobin a1c level of greater than (\>) 15% assessed at screening * are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents * have active malignancy or any history of a malignancy * use of oral antibiotics at the time of randomization for any reason in participants to be enrolled in cohorts a, b, e, and any additional uninfected patient cohorts
evaluation of the sphingolipid metabolite s1p as a novel biomarker in food allergy

Conditions: Food Allergy; Anaphylaxis

Summary: food allergies represent an increasing health concern in the industrialized countries and especially affect pediatric patients. in this population adverse reactions against food compounds can lead to anaphylactic reactions. despite substantial research efforts, clinical markers predicting disease severity and symptoms are missing to date. recent studies have revealed that sphingolipids, especially sphingosine-1-phosphate (s1p), play an essential role in allergy. it was reported that asthmatic patients have higher s1p levels in bronchiallavage fluids after allergen challenge. first experimental studies revealed a correlation of s1p and the outcome of anaphylaxis. furthermore, we have shown in our recent mouse study that s1p homeostasis is pivotal for food allergy induction and effector cell response. therefore, it is the aim of the presented pilot project to evaluate whether s1p serum titers are altered in food allergic children and if the s1p levels correlate with the outcome of anaphylaxis during double blind placebo controlled food challenges (dbpcfcs).


Eligibility criteria:
inclusion criteria: * patients between 1-17 years who have been reported to suffer from food allergic reactions and who are subjected to dbpcfc or open provocation * patients who are diagnosed by elevated allergen specific ige and/or positive skin prick testing * willingness to participate in the study exclusion criteria: * refusal to participate in the study * non-ige-mediated food allergy

Keywords: food allergy sphingosine-1-phosphate biomarker double-blind placebo-controlled food challenge anaphylaxis
ivonescimab in combination with docetaxel in advanced non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this is a phase 3 randomized, double-blind, multicenter study of ivonescimab combined with docetaxel versus placebo combined with docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) that has progressed on or after pd-(l)1 inhibitor-based therapy. the purpose of this study is to evaluate the efficacy and safety of ivonescimab versus placebo, combined with docetaxel in patients with advanced nsclc.


Eligibility criteria:
inclusion criteria: * be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). * age ≥ 18 years old and ≤ 75 years old at the time of randomization. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * expected life expectancy of at least 3 months. * histologically or cytologically confirmed diagnosis of nsclc. * locally advanced or metastatic nsclc (american joint committee on cancer \[ajcc\] 8th edition). * previously received systemic platinum-based chemotherapy and pd-1/l1 inhibitors. * at least one measurable lesion according to response evaluation criteria in solid tumors (recist) 1.1. * adequate organ function. exclusion criteria: * histologic or cytopathologic evidence of the presence of small cell lung carcinoma. * other malignancies within 3 years prior to randomization. * known actionable genomic alterations. * prior administration of any immunotherapy targeting immune mechanisms other than pd-1/pd-l1 inhibitors. * previous treatment with docetaxel. * history of severe bleeding tendency or coagulation dysfunction. * active autoimmune disease requiring systemic therapy within 2 years prior to randomization. * history of myocarditis, cardiomyopathy, and malignant arrhythmia.
advantage of using intraoperative visual evoked potentials to preserve visual function during surgical procedures near the optical pathways

Conditions: Surgery; Optic Nerve and Pathway Injury

Summary: visual morbidity (visual acuity and/or visual field deficit) must be taken into account during neurosurgical procedures for lesions near the optical pathways. part of this morbidity is due to surgical manipulation. there is no validated tool for intraoperative visual monitoring and few publications have studied this issue. in a preliminary work based on analysis of these publications, we defined technical, anaesthetic and analytical parameters in order to optimise intraoperative visual evoked potentials monitoring. these parameters are special devices used for transpalpebral stimulation, complete intravenous anaesthesia without halogen or nitrous oxide, and pertinent analysis criteria of visual evoked potential (vep). we suppose that these improvements will increase reliability of intraoperative vep.

this genuine optimised monitoring in france, set up in association with metrovision company, should help increasing intraoperative vep reliability as a monitoring tool for visual pathways function. in this study, we assess the predictive value of relevant intraoperative variations of vep (more than 50% variation of latency and amplitude) on the visual prognosis at six months after surgery the visual assessment consisting of a visual field, a visual acuity, and the performance of pattern transient vep, will be performed by an ophthalmologist before surgery, and at three and six months after surgery. an electroencephalogram with photostimulatory lighting will be used in pre-operative and will validate the absence of photo-induced epilepsy risk. during the intervention, veps associated to an electroretinogram will be performed by a neurosurgeon trained to the use of these tools by metrovision company: * under general anaesthesia, but before any surgery. * during the surgery, at predetermined surgical times (while performing the craniotomy or the sphenoid opening, at various times during the perioptic lesion dissection, after the lesion resection, when closing).

Eligibility criteria:
inclusion criteria: * patients with lesion compressing or near the optical pathways exclusion criteria: * patients with photic epilepsy

Keywords: surgery optic nerve and pathway injury visual event-related potential
safety and efficacy of ranibizumab in japanese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration

Conditions: Subfoveal Choroidal Neovascularization(CNV) Secondary to Age-related Macular Degeneration (AMD)

Summary: open-label multicenter, phase i/ii study comprising three phases (single dose, multiple dose and extension phase), assessing the safety and efficacy of ranibizumab (rfb002) in japanese patients with subfoveal choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd).

the safety and tolerability of single intravitreal injections of ranibizumab was evaluated in patients enrolled in the single dose phase (group a). patients who successfully completed the single dose phase (i.e. did not experience a grade-3 targeted adverse event) could enter the multiple dose phase and receive ranibizumab injections for an additional 11 months. simultaneously, the multiple dose phase was initiated in two parallel dose groups of additional patients (group b), who received ranibizumab injections for 12 months. after patients in group a and group b had completed the multiple dose phase, all patients who provided written consent and were considered eligible based on the inclusion and exclusion criteria of the extension phase had the opportunity to continue on study treatment with the individualized flexible treatment regimen guided by monthly acuity scores and other ophthalmic examinations until approval of ranibizumab in japan.

Eligibility criteria:
inclusion criteria 1. male or female patients 50 years of age or greater 2. patients with primary or recurrent subfoveal cnv secondary to amd 3. patients who have a bcva score between 73 and 24 letters in the study eye using etdrs-like grading charts (approximately 20/40 to 20/320) exclusion criteria 1. no prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy extension phase inclusion criteria: 1. personally provided written informed consent to participate in the extension phase. 2. patients with subfoveal cnv secondary to amd who had completed the multiple dose phase in either of the ranibizumab groups (group a or b). 3. patients could participate in the extension phase even if they failed to do so on the day of the exit visit in the multiple dose phase (group a and b), regardless of the time elapsed until the participation in the extension phase. exclusion criteria: 1. received anti-angiogenic drugs (bevacizumab, pegaptanib, ranibizumab, anecortave acetate, corticosteroids or protein kinase c inhibitors, etc.) or 2. participated in any clinical study of an investigational drug other than this one during the period between the exit visit of the multiple dose phase and the start in the extension phase, if they failed to be enrolled into the extension on the day of the exit visit. patients were to be excluded even when the fellow eye was treated with any of these drugs.

Keywords: subfoveal cnv, amd, ranibizumab
remineralization effect of βtricalcium phosphate nanoparticles versus functionalizedβtricalcium phosphate nanoparticles

Conditions: White Spot Lesions[Initial Caries]on Smooth Surface of Tooth

Summary: the study collects sixty non carious sound human permanent premolars from tanta university's maxillofacial surgery department. the teeth are cleaned and prepared, and randomly assigned into four groups. the specimens are analyzed using an edx analysis scanning electron microscope, and surface micro-hardness is determined using a digital display vickers micro-hardness tester.

the study involves collecting sixty non carious sound human permanent premolars from an outpatient clinic at tanta university's maxillofacial surgery department. the teeth are selected for their absence of caries, hypocalcification restoration, fracture fluorosis, and cracks. the teeth are cleaned and prepared for the study, including demineralization and artificial incipient enamel carious lesion preparation. the teeth are randomly assigned into four groups: functionalized nano ᵦ tricalcium phosphate particles, nano ᵦ tricalcium phosphate particles, sodium fluoride mouth wash, and artificial saliva. the ph of all groups is adjusted at 7. the specimens are treated in a daily ph cycling regime, with daily solution replacements. the specimens are then dried and analyzed using an energy dispersive x-ray (edx) analysis scanning electron microscope. the element content distribution of calcium and phosphorus elements is measured, and the specimens are evaluated at base line, after demineralization, and after 2, 4, and 6 weeks. surface micro-hardness is determined using a digital display vickers micro-hardness tester. data will be collected, presented, and statistically analyzed using spss software package system using anova at a significance level of 0.05.

Eligibility criteria:
inclusion criteria: * the selected teeth were free from caries, hypocalcification restoration, fracture fluorosis and cracks exclusion criteria: -
a test of the effectiveness of a device and distraction for pediatric immunization pain

Conditions: Procedural Pain

Summary: the hypothesis of this study is that distraction cards used by the caretaker along with a vibrating cold pack placed proximal to the site of immunization will decrease the pain of routine pediatric immunizations when compared to a placebo device or standard care.

needle pain is the most common and the most feared source of childhood pain, resulting in needle phobia for 10$ of adults. current standard of care for immunizations in the us is no pain relief. an inexpensive, immediately effective form of needle pain control could reduce needle phobia or vaccine refusal in the long term if demonstrated to be effective for immunization pain. distraction can decrease procedural distress in children by 50%. the effect of using a multi-modal pain and distraction relieving approach has not been rigorously studied.

Eligibility criteria:
inclusion criteria: * children receiving routine immunizations exclusion criteria: * no caregiver present * chronic illness requiring frequent injections * clear cognitive impairments affecting communication

Keywords: pain
a study comparing oxymetazoline 1% cream to rhofade

Conditions: Bioequivalence

Summary: randomized, double-blind, placebo controlled

subjects in this randomized, double-blind, placebo controlled study will be randomly assigned to treatment sequences with the test product, reference product or placebo control.

Eligibility criteria:
inclusion criteria: 1. healthy male or non-pregnant female aged ≥18 years with a clinical diagnosis of facial rosacea; 2. provided irb approved written informed consent; 3. a cea score of ≥3 prior to study drug application 4. a psa score of ≥3 prior to study drug application exclusion criteria: 1. female subjects who were pregnant, nursing, or had planned to become pregnant during study participation; 2. history of hypersensitivity to the study product; 3. presence of ≥3 facial inflammatory lesions of rosacea; 4. particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, and isolated pustulosis of the chin); 5. raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, sjögren's syndrome, or depression; 6. excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that could interfere with diagnosis or study assessments; 7. presence of significant hypertension or circulatory disease
adjunctive yu-tone music therapy for systemic lupus erythematosus: a prospective cohort study

Conditions: Systemic Lupus Erythematosus; Music Therapy

Summary: the goal of this observational study is to investigate the long-term adjunctive effects of traditional chinese five-tone therapy (yu tone) in patients with systemic lupus erythematosus (sle). the main question it aims to answer is: does yu-tone music therapy improve psychological well-being and quality of life in sle patients when used as a complementary intervention alongside standard pharmacotherapy? participants already receiving yu-tone music therapy as part of their integrative care for sle will complete validated online questionnaires assessing psychological distress (e.g., anxiety, depression), disease-related quality of life, and medication adherence monthly for 2 years.


Eligibility criteria:
inclusion criteria: * meet the 2019 acr/eular classification criteria for sle; ② adults aged 18 years or older; ③ provide informed consent to participate in the study. exclusion criteria: * presence of severe organ dysfunction (e.g., renal failure, cardiac insufficiency) or psychiatric disorders; ② diagnosed with hearing impairment or auditory disorders; ③ inability to comprehend or complete study questionnaires (e.g., due to cognitive impairment or language barriers).