Kornimate/medical-research-clean huggingface dataset:
a clinical trial assessing the safety and efficacy of biodegradable magnesium embolic microspheres for primary hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma Non-Resectable

Summary: the goal of this clinical trial is to determine if the addition of biodegradable magnesium metal microspheres to traditional tace (transarterial chemoembolization) is effective in treating hepatocellular carcinoma, and to assess the safety of these microspheres. the main questions it aims to answer are: * is the treatment more effective than traditional tace alone? * what additional medical issues arise when using the microspheres? researchers will compare tace with magnesium microspheres to traditional tace without microspheres to see if the addition of the microspheres improves treatment outcomes. participants will: * receive up to 3 treatments of tace with or without microspheres * undergo checkups and tests every 30 days * keep records of tumor size and other safety issues


Eligibility criteria:
inclusion criteria: 1. age range: 18 to 80 years inclusive, regardless of gender; 2. patients with primary hepatocellular carcinoma (hcc) at cnlc stage ib to iiia who require transarterial chemoembolization (tace) treatment and are unsuitable for or refuse surgical resection, liver transplantation, and ablation therapy; 3. ecog score ≤ 2, and child-pugh classification of a or b; 4. presence of at least one untreated, measurable tumor lesion with a diameter ≥ 3.0 cm according to mrecist criteria (the maximum diameter of the target lesion ≤ 10.0 cm); 5. patients with hepatitis b virus (hbv) or hepatitis c virus (hcv) infection who are willing to receive antiviral treatment throughout the study period; 6. voluntary participation in this clinical trial and signing of the informed consent form by the subject. exclusion criteria: 1. patients with prior embolization or other local treatments within 28 days before enrollment, or needing combined local treatment with tace; 2. received other antitumor systemic treatment within 28 days before enrollment; 3. unsuitable for tace due to lesion characteristics or vascular issues; 4. vp3/vp4 portal vein tumor thrombus; 5. tumor occupying ≥70% of liver volume; 6. decompensated cirrhosis or recent ascites drainage/tips; 7. severe allergies to contrast agents or embolization materials; 8. received blood products or certain corrective treatments within 7 days before enrollment; 9. abnormal blood counts (wbc, platelets, neutrophils, hemoglobin); 10. abnormal liver function tests (bilirubin, enzymes, albumin); 11. renal impairment (creatinine, creatinine clearance); 12. prolonged pt; 13. unsuitable feeding artery for tace or embolization risks; 14. expected survival \<6 months; 15. pregnant, lactating, or planning pregnancy; 16. factors affecting study results or necessitating study termination (alcoholism, drug abuse, severe diseases); 17. severe infections unsuitable for tace; 18. participation in other clinical trials within 28 days before enrollment; 19. other reasons deemed unsuitable by the investigator.
validation of readiband™ actigraph and associated sleep/wake classification algorithms

Conditions: Glioma; Glioblastoma

Summary: this pilot study will assess feasibility and to obtain initial estimates of efficacy of sleep activity and task effectiveness (safte) model, which can accurately estimate the impact of scheduling factors and sleep history on both safety and productivity. the safte model will be used to asses cancer-related fatigue and study potential associations of change in sleep patterns to tumor recurrence in patients with high grade glioma. data will be collected using the readiband™ sleep tracker (https://www.fatiguescience.com/sleep-science-technology/). the readiband device captures high-resolution sleep data, validated against the clinical gold standard of polysomnography with 92% accuracy. sleep data is transmitted to the cloud automatically for safte fatigue model analysis. we will correlate clinical progression data obtained from the patient's electronic medical record with safte data.


Eligibility criteria:
inclusion criteria i. patients aged between 22 and 70. ii. patients must have a histologic diagnosis of primary grade iv glioma. iii. patients must have received maximal debulking surgery and radiotherapy concomitant with temozolomide (≥ 75% of their recommended temozolomide dosage is required). iv. patients with kps ≥70. v. life expectancy at least 3 months. vi. patients must have signed informed consent for study participation. vii. patients should be english speakers. exclusion criteria i. patients enrolled in active clinical treatment trials for primary grade iv glioma. ii. patients with progressive disease after completion of radiotherapy concomitant with temozolomide as per rano criteria. suspected pseudoprogression should be confirmed by additional imaging studies ordered as part of standard care. iii. patients with known other active malignancy diagnosed in the past 3 years (except for in situ malignancies). iv. patients who are pregnant or trying to get pregnant. v. patients unable to wear the readiband device continuously during study duration. vi. patients with infra-tentorial tumors. vii. patients with known psychiatric concerns. viii. significant co-morbidities at baseline which would prevent maintenance temozolomide treatment: 1. thrombocytopenia (platelet count \< 100 x 103/μl) 2. neutropenia (absolute neutrophil count \< 1.5 x 103/μl) 3. ctc grade 4 non-hematological toxicity (except for alopecia, nausea, vomiting) 4. significant liver function impairment - ast or alt \> 3 times the upper limit of normal 5. total bilirubin \> upper limit of normal, if clinically significant 6. significant renal impairment (serum creatinine \> 1.7 mg/dl)
a clinical trial to evaluate the corneal endothelial health of ded subjects treated with cyclosporine

Conditions: Dry Eye Disease

Summary: the objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with dry eye disease (ded)

the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell density (cells/mm²) will be evaluated in comparison to a hypotonic saline solution in subjects with ded after 12 months of treatment.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent; * have a subject reported history of dry eye disease (ded) in both eyes * be able and willing to follow instructions, including participation in all trial assessments and visits. exclusion criteria: * be a woman who is pregnant, nursing, or planning a pregnancy; * unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control * clinically significant slit-lamp findings or abnormal lid anatomy at screening * ocular/periocular malignancy * history of herpetic keratitis * have any primary or secondary corneal endothelial disorder such as fuchs dystrophy or other endothelial dystrophy, significant guttata * ongoing ocular or systemic infection at screening or baseline * presence of uncontrolled systemic diseases * presence of known allergy and/or sensitivity to the study drug or its components * intraocular surgery or ocular laser surgery or significant trauma within 365 days before visit 1, or have any planned ocular surgeries during the trial period; * have a known allergy or sensitivity to the imp or its components * have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the trial results, or may interfere with the subject's participation in the trial significantly. * randomized in a previous cyclasol trial
clinical evaluation of the long-term effects of contact lens care systems

Conditions: Myopia

Summary: the purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.


Eligibility criteria:
inclusion criteria: * be at least 18 years old. * signed informed consent and investigator to record this on case report form (crf) in appropriate space. * require a visual correction in both eyes (monovision allowed but not monofit). * have a contact lens spherical distance requirement between +6.00d and -9.00d in both eyes. * astigmatism of 1.00d or less in the better eye and 1.50d or less in the other eye. * be correctable to a visual acuity of 20/30 (6/9) or better in each eye. * have normal eyes with no evidence of abnormality or disease. exclusion criteria: * requires concurrent ocular medication. * any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. * clinically significant corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear. * worn lenses on an extended wear basis in the last 3 months. * diabetic. * infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., hiv). * polymethyl methacrylate (pmma) or rigid gas-permeable (rgp) lens wear in the previous 8 weeks. * has had refractive surgery. has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study. * abnormal lacrimal secretions.
rqc for the prevention of alzheimer's disease and retinal amyloid-β

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Cognitive Decline

Summary: the goal of this clinical trial is to evaluate whether oral resveratrol, quercetin, and curcumin (rqc) can prevent the accumulation of retinal amyloid-β and/or cognitive decline over 24 months in adults aged 50-90 with stage 1 or 2 alzheimer's disease as described in fda-2013-d-0077. the trial will also evaluate the safety and tolerability of rqc. curcumin, which binds to amyloid-β, will act as a fluorescent label to identify retinal amyloid-β in vivo using optical coherence tomography (oct)-autofluorescence imaging. the investigators will longitudinally evaluate the effect of rqc on retinal amyloid-β load cognitive outcomes including the clinical dementia rating scale sum of boxes (cdr-sb) and the mini mental state examination (mmse), and potential microvascular biomarkers. the investigators will also evaluate associations between retinal amyloid-β and progression to early alzheimer's disease (mild cognitive impairment). the investigators will compare rqc, taken daily for 24 months, with curcumin alone, taken only during the 7 days preceding each of the six study visits to see if rqc can prevent (or reduce) amyloid-β and prevent the onset of mild cognitive impairment.


Eligibility criteria:
inclusion criteria: * 50-90 years of age at screening. * male or female * any race or ethnicity. * provide written informed consent. * availability for the duration of the study. * ability to speak, read, and understand english. * ability to take oral medication and be willing to adhere to the rqc regimen. * have adequate literacy, vision, and hearing for neuropsychological testing at screening exclusion criteria: * mmse score 0-25, indicating more than subtle cognitive abnormalities * cdr-sb score \> 0, indicating functional impairment * clinical diagnosis of any non-alzheimer's disease (ad) type of mild cognitive impairment (mci) or dementia * taking pharmaceutical anti-aβ monoclonal antibodies (i.e., leqembi, aduhelm). * participation in another clinical study with an investigational product during the last 90 days. * presence of hepatic disease or kidney disease * clinically significant or unstable hematologic, cardiovascular, pulmonary, gastrointestinal, endocrine metabolic, or other systemic disease. * diagnosis of gastrointestinal or stomach condition including but not limited to irritable bowel syndrome (ibs), ulcerative colitis, peptic ulcers, crohn's disease, gastroesophageal reflux disease, gastritis, severe dyspepsia, and intestinal malabsorption. * clinically significant abnormal values in hematology, coagulation and platelet function, clinical chemistry, or urinalysis at screening (such as those with prolonged prothrombin time (pt), anemia, low neutrophil or platelet count, elevated liver function tests, low glomerular filtration rate).

Keywords: alzheimer's disease mild cognitive impairment retinal amyloid-β microvascular biomarkers early alzheimer's disease
gastrointestinal transit times and motility in severe ulcerative colitis obtained by motilis-3d-transit

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to describe gastrointestinal (gi) motility in patients suffering from severe ulcerative colitis (uc) and to compare these results with similar results from a study on healthy subjects. both studies are done with the use of motilis 3d-transit system which consists of a small electronic capsule ingested and detected by a receiver carried by the patient. position and orientation of the capsule are interpreted by dedicated computer software and transit times, progression velocity and contraction frequencies can be revealed. the study is mainly descriptive and is designed to test and evaluate the usefulness of the motilis 3d transit system in uc patients and to tell us more about gi motility during severe inflammation. motilis 3d-transit system gives us a unique chance to study the gastrointestinal canal as a whole during severe illness. we expect to include 20 patients suffering from severe uc admitted to hospital with the purpose of getting medical treatment. we do not expect any drop out, but in case of drop out a new patient will be included.


Eligibility criteria:
inclusion criteria: * severe ulcerative colitis (modified truelove and witt score) * signed informed consent obtained * fasted since midnight exclusion criteria: * known gi related symptoms complaints or gi diseases * swallowing disorders * cancer or other life threatening diseases or conditions * pregnancy or breast-feeding * previous abdominal surgery * abdominal diameter \>140cm? * drug abuse or alcoholism * irregular bowel movements * known cardiovascular or pulmonary diseases * participation in any clinical study within the last 30 days * cardiac pacemaker or infusion pump or any other implanted or portable electro-mechanical medical device. * medication affecting gi motility * mri within the next four weeks

Keywords: gastrointestinal motility inflammatory bowel disease transit time
dietary factors associated to colorectal premalignant lesions (colomar-1)

Conditions: Nutrition Related Neoplasm/Cancer

Summary: this study aims to find a correlation between fish protein intake and other dietary habits and colorectal premalignant lesions in healthy volunteers. it also aims to describe gut microbial profiles for each dietary pattern, in order to elucidate the role of fish intake in cancer prevention.

colorectal cancer incidence is increasing in developed countries specially among young adults due to risk factors as modern dietary, smoking, low physical exercise and obesity. some foods (fruits, vegetables, nuts, other seeds and legumes) are assumed to prevent occurrence of colorectal cancer, while red and processed meat intake are strongly associated with increased risk of colorectal tumors. however, evidence on fish intake is still scarce, and the mechanisms and drivers of their potential health benefits are also only partially known. on the other hand, colonoscopy remains the gold standard for colon cancer screening. our study aims to explore the relationship among fish intake, microbiota and molecular alterations during a colonoscopy screening program of healthy volunteers. this is a preliminary proof-of-concept study (colomar-1) to evaluate the feasibility of the entire research program (colomar-2). the main objectives of this pilot are: 1. to determinate the feasibility of the entire research project obtaining data for all the study participants (colonoscopy, blood sample, feces sample and dietary questionnaire). 2. to evaluate the presence of precancerous lesions (colonic polyps) and colorectal malignant tumors in all the participants. 3. to find molecular alterations (alkylating signature) in normal mucosa of right and left-sided colon samples. 4. to describe microbiota composition in all the participants. 5. to determinate correlation between dietary habits and clinical and molecular findings of the study. 6. to calculate the overall sample size of the entire research program (colomar-2) in base to dietary patterns and alkylating signature prevalence of the participants)

Eligibility criteria:
inclusion criteria: * 45 years old or more. * be willing to participate in the study. exclusion criteria: * pregnancy * previous colorectal cancer. * familial colorectal cancer syndrome. * previous colonoscopy and colon polypectomy (last five years ). * inflammatory bowel disease. * medical contraindication for colonoscopy at investigator´s criteria.

Keywords: fish colon cancer rectal cancer
human immunodeficiency virus (hiv) food insecurities

Conditions: Food Insecurities; Cardiometabolic Comorbidities; HIV; PreDiabetes; Type 2 Diabetes Mellitus (T2DM)

Summary: the objectives of this study are to better understand how fi (food insecurities) contributes to the development of cardiometabolic comorbidities among pwh (people with hiv) and to test a novel bilingual fi intervention designed to reduce these comorbidities among food insecure pwh. the pi and staff will conduct this study in partnership with the wake forest infectious diseases specialty clinic, one of the largest ryan white-funded clinics in north carolina, which serves more than 2,000 pwh annually from a predominantly rural catchment area that includes south central appalachia. this area has high rates of both fi and hiv.

the proposed study the team has created a conceptually integrated, mixed methods study that includes * longitudinal data collection to explore the difference in the prevalence and incidence of cardiometabolic comorbidities between food secure and insecure pwh * implementation and evaluation of the wecare/secure intervention designed to improve insulin sensitivity among food insecure pwh with prediabetes or type 2 diabetes (t2dm) * semi-structured individual in-depth interviews to understand the effect of the intervention on fi and insulin sensitivity among participants in an randomized controlled trial (rct) trial * broad dissemination of study findings to inform both research and clinical practice

Eligibility criteria:
inclusion criteria: * participant must be a patient of the wake forest infectious diseases specialty clinic * be living with hiv * ≥18 years of age * provide informed consent exclusion criteria: * unable to speak english or spanish * have cognitive impairment that would prevent participation

Keywords: food insecurity
optimizing the diagnosis of acute appendicitis

Conditions: Acute Appendicitis

Summary: aim of the study: to identify the signs of acute appendicitis delta signs - clinical, laboratory or ultrasound signs, whose change (delta) would allow to identify or deny the diagnosis of acute appendicitis without a computed tomography examination and thus to lower computed tomography rates.

this study consists of two parts: * in the first part investigators enroll all patients (except pregnant) that are refered to vilnius university hospital santaros clinics with suspected acute appendicitis in order to get cohort data. all patient get primary clinical evaluation, laboratory tests (wbc, crp) an ultrasound examination. * after primary evaluation if final diagnosis could not be made, and investigator still suspect acute appendicitis, participant is included in to randomised study part. * randomised sudy part has two arms: control and observation groups. * control group get the traditional diagnostic path - is refered to ct scan examination. * observation group get repeated evaluation after 8-12 hours and only than is diagnosis stays unclear, patient gets a ct scan. * all patient are contacted after 30 days after visit to our hospital, to get information about their health status and possible additional visits to other hospitals or operations.

Eligibility criteria:
inclusion criteria: * patient with the symptoms of acute appendicitis: pain in the right lower quadrant, pain migration from epigastrium to right lower quadrant, nausea, rebound pain, elevated temperature. exclusion criteria for randomized part: * pregnant patient. inclusion criteria for randomized part: * after primary clinical, laboratory and ultrasound examination diagnosis of acute appendicitis could not be confirmed or excluded. * no other gynecological, urological ir gastroenterological pathology is confirmed. exclusion criteria for randomized part: * clinical symptoms lasts for longer than 48 hours * signs of peritonitis
effects of silybum marianum on treatment of patients with chronic hepatitis c

Conditions: Hepatitis C

Summary: the purpose of this study is to determine the effects of silymarin on outcomes of patients with hepatitis c.

silymarin has been claimed to have a beneficial effect in various types of liver injury, including alcoholic liver disease, drug and toxin induced hepatotoxicity, and acute and chronic viral hepatitis.

Eligibility criteria:
inclusion criteria: confirmed chronic hepatitis c (hcv ab (+), hcv rna (with pcr) (+)) normal or increased liver enzymes (alt and ast) not using interferon or ribavirin due to patient sensitivity or not consenting. exclusion criteria: the pregnant patients patients with side effect which confirmed with rechallenge test

Keywords: hepatitis c silymarin quality of life
posterior macular adhesion: a potential risk factor for non-exudative age related macular degeneration (amd) to develop exudative amd

Conditions: Dry Age-related Macular Degeneration; Detachment of the Posterior Hyaloid

Summary: choroidal neovascularisation in age related macular degeneration is one of the major causes of legal blindness in the western world existing in two major occurences, the dry and the wet form.the etiology of age related macular degeneration is yet unknown. genetic factors, oxidative stress, ischaemia, and aging of the retinal pigment epithelium are discussed as etiologic factors. the risk of rapid vision loss is much higher in wet amd, a dry form may transform to a wet form. from a prior study the investigators know that the posterior hyaloid is significantly more frequent attached in wet amd. this study is conducted to examine whether the attached posterior hyaloid is a risk factor to develop wet amd in dry amd cases.


Eligibility criteria:
inclusion criteria: * dry md * age over 50 years exclusion criteria: * macular pathologies other than age related macular degeneration (like diabetic maculopathy, macular pucker, macular hole) * prior vitrectomy or buckle surgery * uveitis posterior, multifocal chorioiditis * pathologic myopia * diabetic retinopathy * visualization of the macula not possible (dens cataract, vitreous haemorrhage)

Keywords: age-related macular degeneration detachment of the posterior hyaloid amd