Kornimate/medical-research-clean huggingface dataset:
study to assess effects of age, weight, and body composition on the pharmacokinetics of iv diclofenac sodium

Conditions: Healthy

Summary: the purpose of this study is to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (dic075v) in adult volunteers.

this study is an open label, single center, single-dose study to assess the effects of age, weight, and body composition on the pharmacokinetic profile, safety, and tolerability of intravenous diclofenac sodium (dic075v) in adult volunteers. this study will be conducted in two cohorts. the first cohort of subjects will be selected based on body mass index (bmi) and weight criteria. the second cohort of subjects will be selected based on age.

Eligibility criteria:
inclusion criteria: * adult volunteers over age 18 exclusion criteria: * known allergy or hypersensitivity to diclofenac, aspirin, or other nsaids or to any of the excipients of the study preparation * history of previous and/or present cerebral hemorrhage, peptic ulceration, gi bleeding or any bleeding diathesis, positive for hepatitis b or hepatitis c or hiv antibodies

Keywords: adult volunteers
alcohol use during pregnancy in finland according to meconium samples

Conditions: Fetal Alcohol Spectrum Disorders

Summary: meconium samples are collected anonymously from newborns in helsinki university hospital maternity ward. the study tries to to find how many women continue to use alcohol during the second half of the pregnancy. meconium samples are tested for ethylglucuronide (etg), a metabolite of ethanol, that accumulates in the meconium. altogether 1000 samples are taken. the sample results are compared to anonymously answered questionnaire about alcohol use.


Eligibility criteria:
inclusion criteria: * newborn baby exclusion criteria: -
predictive modeling of necrotizing skin infections in snakebite patients

Conditions: Necrotizing Skin Infections; Snakebite Envenomation

Summary: this multicenter retrospective study aims to identify the risk factors associated with necrotizing skin infections following venomous snakebites and to develop a predictive model. clinical data from 99 patients treated between january 2020 and april 2024 at three hospitals in guangdong province, china, were analyzed.

venomous snakebites are a significant public health issue, particularly in tropical and subtropical regions like southern china. necrotizing skin infections are a severe but relatively rare complication of venomous snakebites, often resulting from delayed treatment and bacterial invasion. this study retrospectively analyzed clinical data from 99 patients with venomous snakebites treated at three hospitals in guangdong province between january 2020 and april 2024. the primary objective was to identify the major risk factors associated with the development of necrotizing skin infections and to build a predictive model to assist in clinical decision-making. the study included male and female patients aged 14 years and older. patients with incomplete medical records, long-term use of immunosuppressants, or underlying immunodeficiency diseases were excluded. multivariate logistic regression identified the snakebite severity score (sss), blood glucose levels, and d-dimer levels as significant independent predictors of necrotizing infections.

Eligibility criteria:
inclusion criteria: * diagnosis of venomous snake bites confirmed according to major international clinical guidelines and expert consensus. * availability of complete case data. * provision of written informed consent by the patients or their legal guardians. exclusion criteria: * age less than 14 years. * long-term use of immunosuppressants or corticosteroids. * presence of concurrent immunodeficiency diseases (e.g., hiv positive). * severe malnutrition. * incomplete medical records.

Keywords: snakebite necrotizing infection risk factors predictive modeling venomous snakes d-dimer snakebite severity score blood glucose levels
periprosthetic bone mineral density after total hip arthroplasty performed through a minimally invasive anterior approach (amis) with either an amistem or a quadra femoral component

Conditions: Osteoarthritis; Arthritis; Avascular Necrosis; Fracture of the Femoral Neck or Head; Congenital Hip Dysplasia

Summary: this is a monocentric, prospective, randomized clinical survey to verify if the periprosthetic remodelling brought about either the amistem or the quadra femoral component is equivalent.


Eligibility criteria:
inclusion criteria: * patients who are willing and able to provide written informed consent for participation in the study. written informed consent must be obtained prior to the patient's surgery. * patients presenting with disease that meets the indications for use for medacta implants defined by this study (on-label use (enclosure 2)). * patients must be willing to comply with the pre and post-operative evaluation schedule. * patients with only one lower limb arthroplasty exclusion criteria: * patient with metabolic bone diseases, use of steroids or other drugs affecting bone metabolism * patients with osteoporosis (pre-op t-score \< -2,5) * patients with significant comorbidities * patients with both hip and knee arthroplasty * patients with restricted mobility * patient with severe hip contracture * those with one or more medical conditions identified as a contraindication defined by the labeling on any medacta implants used in this study
safety and efficacy assessment of diagnostic microprobe (inprobe) in women at high risk of breast cancer (part i study)

Conditions: Breast Cancer

Summary: the purpose of this study is to preliminarily determine the correlation of her2 receptor levels detected with the inprobe diagnostic probe relative to receptor status as determined by standard methods (ihc/fish), in women with both her2-positive and her2-negative breast cancer.


Eligibility criteria:
inclusion criteria: 1. provision of written informed consent to participate in the clinical investigation; 2. female patient aged ≥ 18 to ≤ 75 years; 3. the patient's overall health status as determined by eastern cooperative oncology group (ecog) from 0 to 1; 4. preserved full ability to communicate with the investigator and to understand and comply with the requirements of the clinical investigation plan; 5. high likelihood of attending follow-up appointments in accordance with the study design and completing this study in accordance with this clinical investigation plan. 6. the presence of a malignant neoplasm (breast cancer) confirmed by histopathologic examination of material from a gross needle biopsy of the tumor, with specific her2 receptor status. 7. patient referred for surgical treatment of breast cancer. exclusion criteria: 1. history of treatment with trastuzumab, or other her 2 receptor-binding antibody, as part of neoadjuvant (induction) therapy for currently diagnosed and treated breast cancer. 2. a skin disorder that prevents or contraindicates to perform a probe examination in the opinion of the investigator; 3. breast inflammation/infection on the day of the probe examination; 4. allergy to any component of the medical device that is the subject of this clinical investigation; 5. an implant in the breast where the inprobe study and surgery will be performed; 6. any physical or psychiatric condition, or laboratory test values outside the normal range, which in the opinion of the investigator constitute a contraindication to the patient's participation in this clinical investigation or pose a risk of exclusion from the study or premature termination of participation in the study; 7. any clinically significant abnormality in physical examination, vital signs, or laboratory tests that, in the opinion of the investigator, is a contraindication to participation in this clinical trial; 8. pregnancy or breastfeeding; 9. participation in another clinical trial within 30 days prior to signing informed consent to participate in this clinical investigation;
dispensing evaluation of a prototype contact lens and a marketed contact lens

Conditions: Myopia

Summary: the purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.


Eligibility criteria:
inclusion criteria: 1. the subject must be at least 18 years of age and no more than 39 years of age. 2. the subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of dw for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study. 3. the subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00d. 4. any cylinder power must be ≤ -0.75d. 5. the subject must have visual acuity best correctable to 20/25+3 or better for each eye. 6. the subject must read and sign the statement of informed consent. 7. the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. exclusion criteria: 1. ocular or systemic allergies or disease which might interfere with contact lens wear. 2. systemic disease or use of medication which might interfere with contact lens wear. 3. clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. 4. clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. 5. any ocular infection. 6. any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. pregnancy or lactation. 8. diabetes. 9. infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. hiv). 10. habitual contact lens type is toric, multifocal, or is worn as extended wear.
statin therapy in cardiac surgery

Conditions: Atrial Fibrillation; Myocardium; Injury

Summary: the purpose of stics trial (statin therapy in cardiac surgery) is to test whether perioperative treatment with rosuvastatin 20 mg once daily prevents post-operative atrial fibrillation and reduces perioperative irreversible myocardial damage in patients undergoing elective cardiac surgery.

evidence that pre- or perioperative statin treatment may reduce the occurrence of post-operative atrial fibrillation and improve clinical outcome in patients undergoing coronary artery bypass graft (cabg) or major vascular surgery has been largely generated by observational studies. in a recent meta-analysis of 6 randomized trials (of which only 2 had postoperative atrial fibrillation (af) as a predefined outcome) evaluating the use of perioperative statin treatment in patients undergoing cardiac surgery (n=651 patients in total - study size between 40 and 200 patients), statin use was found to reduce the patients' relative risk of developing postoperative af by 43% (rr 0.57, 95%ci 0.45,0.72) and their absolute risk by 14% (95% ci 8%,20%). although these findings would be consistent with a rapid and, possibly, lipid-independent antiarrhythmic effect of statins, they have important limitations (e.g., single-centre, small size, lack of continuous ecg monitoring, mostly "ancillary" findings") and less bearing on current clinical practice, as they mostly included statin-naïve patients. for these reasons, the recent guidelines for the management of af have not given a strong recommendation for the use of statins in the prevention of postoperative af. thus, whether intensive statin treatment in the perioperative period is associated with prevention of af, cardio protection, and improved clinical outcome remains to be demonstrated.

Eligibility criteria:
inclusion criteria: * adult patients awaiting elective cardiac surgery who are willing and able to give informed consent for participation in the study and who are in sinus rhythm and not taking any antiarrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery. exclusion criteria: * history of obstructive hepato-biliary disease or other serious hepatic disease * untreated hypothyroidism * creatinine \> 200 umol/l * personal and family history of hereditary muscle disorders * known intolerance to statins or history of muscle toxicity with fibrates or statins. * on-going use of fibrates, niacin or of agents that are strong inhibitors of cytochrome p-450 or the p-glycoprotein within a month preceding randomization (cyclosporine, oral azole antifungals,macrolide antibiotics, protease inhibitors, nefazodone, amiodarone or ≥ 1l/day of grapefruit juice) * significant mitral valve disease (moderate or severe mitral regurgitation-eg. \> grade ii and/or mitral stenosis \& mitral annular calcification). * patients treated with any anti-arrhythmic agent (other than beta-adrenergic receptor blockers).

Keywords: surgical procedures, cardiac hydroxymethylglutaryl-coa reductase inhibitors rosuvastatin post operative atrial fibrillation
optical imaging of head and neck cancer

Conditions: Squamous Cell Carcinoma; Neoplasia; Head and Neck Cancer

Summary: this study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure.

the purpose of this study is to determine if optical imaging modalities used at the time of surgical resection for head and neck squamous cell carcinoma can help delineate normal from cancerous mucosa. the high resolution microendoscope, developed by our collaborators at rice university, can allow for real time visualization of tissue nuclei. the overall aim of this study is to determine if this device can be used to enhance the accuracy of intraoperative margin detection during tumor resection for head and neck cancer. at the time of tumor resection for head and neck squamous cell carcinoma, a wide field imaging device will be used to identify suspicious areas. the high resolution device will then image representative areas from the tumor, the tumor margin, and normal mucosa. a topical dye, proflavin, will be placed on the tissue to enhance the visualization of nuclei prior to imaging with the hrme device. following imaging, biopsies of the imaged areas will be taken and submitted for pathology diagnosis. the images of the biopsies will then be compared and the device will be evaluated for accuracy of margin detection at the time of tumor resection.

Eligibility criteria:
inclusion criteria: * biopsy proven squamous cell carcinoma of the oral cavity, oropharynx, larynx, hypopharynx * must be receiving surgical treatment for their cancer exclusion criteria: * presence of medical or psychiatric condition affecting the ability to give informed consent * known allergy to proflavin * pregnant or nursing females

Keywords: squamous cell carcinoma neoplasia optical imaging head and neck cancer oropharynx larynx oral cavity
a study of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line treatment in participants with recurrent/metastatic pd-l1 positive squamous cell carcinoma of the head and neck

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: the primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1l) treatment in recurrent/metastatic pd-l1-positive squamous cell carcinoma of the head and neck (scchn) on the basis of confirmed objective response rate. in addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.


Eligibility criteria:
key inclusion criteria: * histologically or cytologically confirmed recurrent/metastatic scchn involving the oropharynx, oral cavity, larynx, or hypopharynx, that is considered incurable by local therapies * known results from human papillomavirus (hpv) status test for oropharyngeal carcinoma * no prior systemic therapy for metastatic and/or recurrent scchn * measurable disease per response evaluation criteria in solid tumors (recist) v1.1 * tumor pd-l1 expression as determined by pd-l1 immunohistochemistry assay * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy \>=12 weeks key exclusion criteria: * disease suitable for local therapy with curative intent * progressive or recurrent disease within 6 months of the last dose of curative intent systemic treatment for locally advanced scchn * rapidly progressing disease in the opinion of the treating investigator * grade \>=2 unresolved toxicity related to surgery or other prior therapies * symptomatic, untreated, or actively progressing central nervous system (cns) metastases * history of leptomeningeal disease * active or history of autoimmune disease or immune deficiency * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (ct) scan * history of additional malignancy other than scchn within 5 years prior to randomization * prior treatment with cd137 agonists or immune checkpoint blockade therapies, including anti-ctla-4, anti-tigit, anti-pd-l1, and anti-pd-1 therapeutic antibodies * treatment with systemic immunostimulatory agents or systemic immunosuppressive medication * pregnancy or breastfeeding
food addiction clinical treatment program

Conditions: Food Addiction

Summary: the purpose of this current study is to establish the feasibility of, and preliminary support for, a clinical treatment program utilizing interventions from various empirically supported treatments for obesity-related eating disorders and substance use disorders

to establish the feasibility of recruiting, enrolling, and treating individuals who meet criteria for fa in a group behavioral intervention for 16 weeks. data from the current study will be used for the purposes of further exploration of the fact program in a larger randomized controlled trial. we hypothesize the study will demonstrate the feasibility of evaluating this treatment in future studies

Eligibility criteria:
inclusion criteria: * age \> 25 * bmi \>25 * yfas \> 6/11 (severe range) * willing to commit to a 16 week group therapy program from 4 - 5:30 pm on thursdays in winston-salem, nc * english speaking exclusion criteria: * current participation in professional weight loss program and unwillingness to suspend it for 16 weeks during treatment * obesity medications with exception of diabetes medication with weight loss benefit (ie metformin), * current nicotine use or substance use disorder (based on meeting the clinical cutoff for the alcohol use disorders identification test and/or cannabis use disorder identification test * history of weight loss surgery, * current/history of severe mental illness (\> 3 psychiatric hospitalizations since age 18, * schizoaffective disorder, bipolar disorder, psychotic disorder, or personality disorder), * current/history of lithium, abilify, saphris, vraylor, clozaril, latuda, zyprexa, seroquel, risperdal, or geodon, * current pregnancy or breastfeeding, * prior diagnosis of anorexia nervosa, diagnosis of bulimia nervosa in the last 5 years, * high currents rates of restrictive eating disorder symptoms based on the eating disorder diagnosis scale (edds; (i.e., any endorsement of vomiting or laxative/diuretic use to manage weight and endorsement of fasting or excessive exercise more than 2 or 3 times a week)

Keywords: obesity associated disorder binge eating weight, body
a study on the verification of kidney ct non-inferiority using low concentration contrast agent

Conditions: Renal Disease

Summary: this prospective study aims to evaluate clinical usefulness of low-voltage renal ct using low-concentration contrast agent and to compare with existing imaging techniques.


Eligibility criteria:
inclusion criteria: * subjects with no abnormalities in renal function (serum creatinine \ 45ml/min/1.73 m2) in blood tests performed within one month * those who understand the contents of the research subject explanation and voluntarily sign the consent form exclusion criteria: * body mass index \> 30 * subjects whose renal function abnormality was confirmed in a blood test (serum creatinine \> 1.4 mg/dl , gfr \< 45ml/min/1.73 m2) conducted within one month * diabetic patients taking metformin * those with a history of urinary tract obstruction * those with a history of bladder, urinary tract, or kidney surgery that may affect the evaluation of the contrast agent in the renal parenchyma * those whose anatomical deformities have been identified in previous images that may interfere with image analysis * those who know or have been reported to have a history of contrast agent side effects in previous ct scans * those with a history of hypersensitivity or adverse reactions to iobrix (intravascular ct contrast) or iodine based agent * those with severe thyroid disease * pregnancy * those who are judged unsuitable for clinical trials by the researcher for reasons such as having other severe diseases or being judged to have a high risk of adverse reactions to intravascular contrast agents
a study on the peripheral blood in patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the goal of this study is to conduct analyses on the changes of cell growth factors, inflammatory factors, metabolites, plasma proteome, etc. in the blood of patients with acs (acute coronary syndrome), as well as their correlations with the disease prognosis, based on multi-omics or other related research methods. the main questions it aims to answer are: the growth factors that have significant changes in the peripheral blood of the acs population, especially fibroblast growth factors? inflammatory factors and chemokines related to the onset of acs? the metabolites and proteins that are significantly altered in the peripheral blood after the onset of acs? researchers will compare acs population to control group (patients without coronary artery disease, valvular heart disease, structural heart disease, or any other kind of cardiomyopathy). the peripheral venous blood from the participants will be collected within 24 hours after their admission to the hospital.


Eligibility criteria:
inclusion criteria: for acute coronary syndrome (acs) group st-segment elevation myocardial infarction (stemi) * cardiac troponin (ctn)\>99th upper limit of normal (uln) or creatine kinase-myocardial band (ck-mb)\>99th uln * st-segment elevation with a convex upward morphology * in conjunction with one or more of the following conditions: persistent ischemic chest pain; echocardiographic evidence of abnormal segmental ventricular wall motion; or abnormal coronary angiography findings. non-st-segment elevation myocardial infarction (nstemi) * ctn\>99th uln or ck-mb\>99th uln * accompanied by one or more of the following situations: persistent ischemic chest pain; new st-segment depression or low and inverted t waves; echocardiography showing segmental ventricular wall motion abnormalities; abnormal coronary angiography. unstable angina (ua) * ctn normal * ischemic chest pain with an electrocardiogram showing transient st-segment depression or flattened and inverted t waves * evidence of coronary artery stenosis for control gourp * patients without coronary artery disease, valvular heart disease, structural heart disease, or any other kind of cardiomyopathy exclusion criteria: * lactating or pregnant women * patients with malignant neoplasms * severe hepatic/renal dysfunction * severe hematological disorders * autoimmune diseases