Kornimate/medical-research-clean huggingface dataset:
holmium-166 retrospective collection of real-world data

Conditions: Hepatocellular Carcinoma; Metastatic Cancer

Summary: the primary objective of the study is to further describe the general safety and clinical performance of quiremspherestm holmium-166 microspheres and quiremscouttm holmium-166 microspheres in a real-world post-market setting, with specific attention to outcomes per tumor origin.

this study, with an observational retrospective longitudinal design, is intended to collect data from the devices (quiremscouttm holmium-166 microspheres, quiremspherestm holmium-166 microspheres, and where available, q-suitetm) used in a post-market, real-world setting. it is non-comparative due to the retrospective nature of the study.

Eligibility criteria:
inclusion criteria: * patient with diagnosis of primary liver tumor or metastases in the liver. * patients treated with quiremscouttm holmium-166 microspheres and/or quiremspherestm holmium-166 microspheres from 15 july 2019 to 15 july 2021. * patient is ≥ 18 years. * if required by national regulation, patient has understood and signed written informed consent to retrospective data collection. exclusion criteria: * patients previously included in prospective interventional study with quiremscouttm holmium-166 microspheres and/or quiremspherestm holmium-166 microspheres.
mentorship program for individuals with autism spectrum disorder (asd)

Conditions: Autism Spectrum Disorder

Summary: the purpose of this pilot project is to evaluate the feasibility of a mentorship program for adolescents with autism spectrum disorder (asd). data will be collected from adolescents with asd and their parents/guardians. study findings will be used to inform further development of the mentoring program for individuals with asd.


Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder (asd) * age 14-18 * participants in the mentoring program. * participants must have fluent language and will speak and understand english. * participants must be able to commit to providing evaluation data. exclusion criteria: * have an intellectual disability (iq under 70)

Keywords: autism autism spectrum disorder
influence of physical training on mitochondrial function in type 2 diabetic patients

Conditions: Type 2 Diabetes

Summary: physical activity as treatment for patients with type 2 diabetes (t2d). treatment of t2d is often done by medication, changing the diet and increased physical activity. it is well established that physical training has a positive effect on the pathology of t2d such as increased insulin sensitivity and reduced fasting plasma glucose (7) and blood lipids (15). it is also well known that in healthy subjects endurance training increases mitochondrial density, lipid oxidation during submaximal exercise, and results in a number of qualitative changes in the control of oxphos (24). however, the effect of physical training on the mitochondrial function in skeletal muscle of patients with t2d has not been investigated. the purpose of this project is to investigate the effect of physical training on the mitochondrial respiratory function in muscles of patients with t2d. skeletal muscle biopsies will be taken before and after 10 weeks of physical training in patients with t2d and matched control subjects. mitochondria will be isolated from the muscle biopsies, and respiratory function, free radical production and ucp3 will be determined. furthermore, measures of maximal oxygen consumption (vo2max), heart rate and capillary lactate concentrations and carbohydrate and lipid oxidation will be determined partly to verify an increased aerobic capacity and partly to investigate the changes in these factors in t2d patients.


Eligibility criteria:
inclusion criteria: * male, * bmi above 26, * age between 40 and 65, * living a sedentary lifestyle exclusion criteria: * women * bmi under 26 * age under 40 and over 65 * trained subjects control subjects: relatives to type 2 diabetic patients, t2d trial subjects

Keywords: type 2 diabetes physical training mitochondrial function
epithelium-on cross-linking versus observation of fellow eyes of patients with unilateral clinically evident keratoconus

Conditions: Keratoconus

Summary: keratoconus (kc) is a bilateral asymmetric progressive corneal degenerative disease. the management of young patients, diagnosed with clinically evident kc in one eye and with no clinical signs of kc in the other eye, represents a real challenge for many ophthalmologists. the aim of the current study is to investigate the effectiveness and safety of epithelium-on accelerated cxl to stabilize the eye with no clinical signs of kc, in young patients with unilateral clinically evident kc, compared with standard care and follow-up only.

keratoconus (kc) is a bilateral asymmetric progressive corneal degenerative disease associated with corneal thinning and protrusion with resultant irregular astigmatism and visual loss. although several studies showed that epithelium-off corneal cross-linking (epi-off cxl) is more effective in preventing kc progression compared with epithelium-on corneal cross-linking (epi-on cxl), the removal of corneal epithelium in epi-off cxl might be associated with a number of serious complications such as persistent epithelial defects and sight-threatening infectious keratitis. additionally, recent systematic reviews and meta-analysis concluded that epi-on cxl is as effective as epi-off cxl in terms of visual and topographic stability of keratoconus, but has the advantage of being much safer avoiding the complications of epithelial removal. the management of the better eye, of young patients with unilateral clinically evident kc, is controversial. some ophthalmologists prefer to cross-link the better eye, while others prefer to conservatively follow it up, in order to avoid complications of epithelial removal in epi-off cxl.

Eligibility criteria:
inclusion criteria: patients aged 12 to 30 years presented with forme fruste (ffkc) or subclinical kc, based on the following criteria: 1. normal slit lamp examination 2. normal topography in ffkc and suspicious topography in subclinical kc with asymmetric bow-tie or inferior steeping (inferior-superior value less than 1.40 d in the anterior sagittal curvature map in pentacam) 3. clinical and topographic features of kc in the other eye. exclusion criteria: 1. corrected distance visual acuity (cdva) worse than 0.1 logmar 2. corneal thickness at the thinnest location less than 400 μm 3. severe ocular allergy (active catarrhal keratoconjunctivitis) 4. other corneal or ocular diseases 5. systemic diseases such as diabetes mellitus and autoimmune diseases

Keywords: keratoconus corneal cross-linking epithelium-on cxl
clinical validation of a blood biomarker test to detect early-stage pancreatic cancer (verifi)

Conditions: Cancer of the Pancreas; Pancreatic Cancer; Pancreas Neoplasms; Pancreatic Carcinoma Stage I; Pancreatic Carcinoma Stage II

Summary: this is a case-control study to clinically validate the performance of pancreasure, a protein biomarker test, to differentiate stage i and stage ii pancreatic ductal adenocarcinoma (pdac) patient samples from samples acquired from control patients not diagnosed with pdac but at increased risk of disease due to familial/genetic history or clinical symptoms.

this is the second case-control study to clinically validate the multi- analyte biomarker diagnostic model, pancreasure. serum samples will be collected for analysis from patients with pancreatic ductal adenocarcinoma (pdac) stages i and ii and non-pdac controls of similar demographics who were at increased risk of pdac because of their familial or genetic history. investigators and patients will not receive individual patient results, therefore patient care will not be impacted by test results. analysis of blood samples will be conducted in immunovia's laboratory in durham, nc by personnel who are blinded to subject data. biomarker results will be analyzed using a predefined (locked) algorithm with predefined (locked) cut-off resulting in a positive/negative test outcome.

Eligibility criteria:
inclusion criteria: * informed consent available * \> 45 years of age * pdac cases * treatment-naïve, pathologically confirmed pdac stage i or stage ii * sporadic or familial/genetic pdac * controls * individuals at high risk for pdac because of their familial and/or genetic history * individuals at high risk for pdac because of pancreatic cysts between 1.0cm and 3.0cm in diameter. * controls will be selected to have similar demographic features (age/gender) to pdac patients exclusion criteria: * prior treatment for pdac (i.e., prior resection, radiotherapy, or chemotherapy) * current immunosuppressive (e.g., systemic steroid therapy) or chemotherapy * major surgery or significant trauma within 12 weeks prior to blood sample collection * non-pdac malignancies within 3 years prior to sample collection squamous or basal cell skin carcinoma is not an exclusion criteria) * control patients who currently have * biliary obstruction secondary to gallstones * prior diagnosis or imaging evidence of chronic pancreatitis * cystic pancreatic lesions \>3.0 cm in diameter or showing worrisome features according to fukuoka consensus guidelines.

Keywords: early detection of cancer cancer diagnostic early detection of pancreatic cancer
evaluation of the impact of a digital tool mediascreen of preventive information for patients on the knowledge of the risk of pressure sores acquired during a hospitalization

Conditions: Pressure Sore

Summary: the study focuses on the impact of a digital mediascreen tool on the knowledge, technical know-how and behavioural skills in terms of pressure sores of patients. in addition, the cognitive impact of this type of tool will also be studied in our study population (self-esteem and feeling of personal effectiveness). the objective is to compare the impact of a digital mediascreen information tool with information tool compared to the usual paper-based prevention materials on knowledge of the risk of hospital-acquired pressure sores.


Eligibility criteria:
inclusion criteria: * patient in complete hospitalization in physical medicine and rehabilitation * patient affiliated to a social security system * patient presenting a low to high risk of pressure ulcer inferior or equal to or equal to 16 on the norton scale * patient having signed his consent exclusion criteria: * difficulty understanding and is unable to give free and informed consent * pregnant women * person deprived of liberty by a judicial or administrative administrative decision * major under legal protection by a judicial or administrative decision. * person in an emergency situation unable to give their informed consent
safety and efficacy of pegintron and rebetol combination therapy in patients with chronic hepatitis c in japan (study p04505)

Conditions: Hepatitis C, Chronic; Hepatitis C

Summary: this is a post-marketing surveillance of patients with chronic hepatitis c treated with pegintron and rebetol combination therapy in clinical practice in japan. the objective of the study is to evaluate the safety and efficacy of the combination therapy. the study will also compare the safety profile of the combination therapy among elderly patients and younger patients. post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. the results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria:
inclusion criteria: patients with chronic hepatitis c. * patients are serogroup 1(genotype i (1a) or ii (1b)). * the hcv-rna level in the blood is more than 10\^5 iu/ml by rt-pcr method, or 1meq./ml by b-dna method exclusion criteria: * patients with a history of hypersensitivity to test drugs or other interferon preparations * patients with a history of hypersensitivity to biological products, such as vaccines * patients being treated with shosaikoto * patients with autoimmune hepatitis * pregnant women, women who may be pregnant, and nursing mothers * patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.) * patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia) * patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia) * patients with chronic renal failure or renal function disorder with creatinine clearance of \<=50 ml/min * patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt * patients with serious hepatic dysfunction * patients with autoimmune hepatitis
artificial intelligence in breast cancer screening in region östergötland linkoping

Conditions: Breast Cancer

Summary: the purpose of this observational study is to assess whether the use of ai (transpara®) can lead to an improved quality of a double reading mammography screening program. this is investigated by performing ai as a third reader and as a decision support during the consensus meeting, compared with conventional mammography screening (double reading and consensus without ai).

the ai cancer detection system will act as a 3rd reader and will recall additional cases to the consensus conference: the exams that were not recalled by double reading but are classified as the 3% most suspicious exams, based on ai derived cancer-risk scores. secondly, ai is used as a decision support during consensus. ai risk scores and computer-aided detection (cad)-marks of suspicious calcifications and soft tissue lesions are provided to the reader(s). the hypothesis of this study is that the use of ai has the potential to improve the quality of the screening program by increasing the cancer detection rate without affecting the recall rate.

Eligibility criteria:
inclusion criteria: * women participating in the regular breast cancer screening program in region östergötland linkoping exclusion criteria: * women with breast implants or other foreign implants in the mammogram * women with symptoms or signs of suspected breast cancer

Keywords: artificial intelligence
predictors of skin temperature, plantar pressure and ulceration in diabetic foot patients.

Conditions: Diabetic Foot; Diabetes

Summary: diabetes is a chronic disease with increasing prevalence worldwide with a high burden to individuals and the society and it is expected to be the 7th leading cause of death in 2030. diabetes related complications manifest in many body parts, often in the foot, due to reduced blood flow and nerve damage, increasing the risk of ulcers and amputation. high plantar pressures during walking contribute to the development of foot ulcers and foot ulcer recurrence. emerging studies also point skin temperature as another predictor of foot ulceration. however, the number of studies including prediction models of plantar pressure and skin temperature are scarce, especially in patients with confirmed diagnosis of diabetic foot and a history of foot ulcer. factors like mobility, hardness of plantar soft tissue, foot deformities and other diabetes related characteristics have been related to plantar pressure measurements but not to foot skin temperature measurements, and the relation between skin temperature and plantar pressure has not been much explored in the literature. the role of these variables in the development of foot ulceration needs further attention, especially in patients with history of foot ulcers has they are at the highest risk to develop a foot ulcer. therefore, the goal of this research is to determine which variables can be used to predict plantar pressure and skin temperature and which factors are associated with the development of foot ulcers in patients with established diagnosis of diabetic foot. the associations between skin temperature and plantar pressure will also be addressed.


Eligibility criteria:
inclusion criteria: * adults (over 18 years) * diagnosed as diabetic foot patient * able to walk 10 meters without assistance exclusion criteria: * non-cooperating patients * patients with major amputations * patients with a draining ulcer and/or infection * patients with cognitive impairments

Keywords: skin temperature plantar pressure diabetic foot tissue hardness neuropathy peripheral artery disease
using intranasal midazolam (inm) and lidocaine for uncooperative children

Conditions: Burning Nose

Summary: aims: the objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to inm administration. design: this was a blinded, randomized placebo-controlled trial. sixty-three uncooperative children, aged 4 - 11.

background and aims: the use of intranasal midazolam (inm) has been commonly associated with a burning sensation of the nasal mucosa. however, despite its significance, this subject has received little adequate research focus. the objective of the current study was to evaluate the effectiveness of topical lidocaine in relieving pain related to inm administration. design: this was a blinded, randomized placebo-controlled trial. sixty-three uncooperative children, aged 4 - 11, were randomly assigned to one of three groups to receive the drug nasally via a pre-calibrated spray as per the following assignments: a: received 0.5 mg/kg midazolam, b: received lidocaine 2% prior to 0.5 mg/kg midazolam. c: received saline 9% (placebo), 0.5mg/kg. children were asked to record the degree of pain using wong-baker-faces- (wbfs) scale.

Eligibility criteria:
inclusion criteria: * uncooperative children scored 1 or 2 on frankle scale. * had no medical history of neurological or cognitive alterations. * no facial deformities. * asa classification i. * requiring dental treatment under local anesthesia. exclusion criteria: * known allergy to midazolam or any other benzodiazepines. * upper respiratory tract infection with nasal discharge.

Keywords: midazolam lidocaine intranasal burning children
apatinib and etoposide capsule versus weekly paclitaxel in patients with platinum resistant ovarian cancer

Conditions: Ovarian Cancer

Summary: the study is conducted to evaluate the efficacy, safety and tolerability of apatinib (375 mg qd) and etoposide capsule (50 mg/d, d1-14, q3w) in subjects with platinum resistant or refractory ovarian cancer compared with weekly paclitaxel (80 mg/m2, d1, d8, d15, q3w).


Eligibility criteria:
inclusion criteria: 1. 18 years and older 2. epithelial ovarian, fallopian tube or primary peritoneal cancer 3. platinum refractory and resistant disease (disease progression during platinum therapy or within 6 months of platinum therapy) 4. eocg performance status of 0-1 exclusion criteria: 1. uncontrolled hypertension ( systolic ≥140 mmhg or diastolic ≥90 mmhg despite antihypertensive therapy) 2. known hypersensitivity to any of the study drugs or excipients. 3. known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); 4. congenital or acquired immune deficiency (e.g. hiv infected)
validation of diagnostics to identify glucose-6-phosphate dehydrogenase activity in the us

Conditions: G6PD Deficiency

Summary: the primary objective of this study is to assess the accuracy of the sd biosensor standard g6pd analyzer in measuring g6pd activity when used by trained health care workers.

this is a cross-sectional diagnostic accuracy study with up to 250 participants with a goal of obtaining 20 deficient and 20 intermediate samples. the clinic will recruit and consent study participants. clinic staff will draw 3 whole blood samples and obtain finger stick capillary blood. g6pd activity is reported in terms of grams of hemoglobin (hb), hence the hemoglobin concentration must be measured. clinic staff will perform the investigational standard diagnostics (sd) biosensor point-of-care (poc) test for glucose-6-phosphate dehydrogenase (g6pd) deficiency and a hemocue® hemoglobin test on finger stick capillary blood and on the venous blood samples. another venous blood sample will be sent to a clinical laboratory improvement amendments (clia)-certified laboratory for reference testing by the gold standard assays: * g6pd measurement by spectrophotometry using the pointe scientific g6pd reference assay * hemoglobin measurement by a hematology analyzer individuals identified as g6pd deficient with the reference test will be notified of their results by the clinic and referred to their physician for follow-up.

Eligibility criteria:
inclusion criteria: -willingness to provide consent exclusion criteria: -blood transfusion in the past 90 days by self-report

Keywords: g6pd deficiency
development of a decision support system to prevent and treat disease-related malnutrition

Conditions: Malnutrition

Summary: the prevalence of disease-related malnutrition among hospitalized patients is 30-50%. there is a lack of tools to follow up the nutritional treatment of these patients. the investigators develop the decision support system "myfood" which can be used to assess patients' dietary intake, evaluate intake against individual needs, and propose nutrition related measures and an individual nutrition plan for each patient. the investigators will study the clinical effects of using myfood among hospitalized patients. in addition the implementation of the tool among healthcare workers will be studied.

the prevalence of disease-related malnutrition among hospitalized patients is 30-50%. disease-related malnutrition increase the morbidity and mortality among patients and leads to longer length of stay. there is a lack of tools to follow up the nutritional treatment of patients at nutritional risk. the decision support system "myfood" is developed in the project with the purpose to prevent and treat disease-related malnutrition. myfood includes 4 modules: 1) a function to register patient needs and symptoms, 2) dietary assessment function, 3) automatic evaluation of dietary intake compared to individual needs, 4) feedback, including a report on intake of energy, protein, and liquids compared to individual needs, and recommendations for nutritional measures and an individual nutrition plan. clinical effects of using myfood among hospitalized patients will be studied in a randomized controlled trial. in addition, the implementation of the tool among nurses and other healthcare workers will be explored.

Eligibility criteria:
exclusion criteria: * \<72 hours expected hospital stay * terminal patients * pregnant * psychiatric patients * patients who cannot read the norwegian language * patients diagnosed with: sickle cell anemia, haemophilia, or deep vein thrombosis

Keywords: disease-related malnutrition ehealth decision support system clinical nutrition