Kornimate/medical-research-clean huggingface dataset:
the effect of n-3 pufa plant oil intake on human metabolism

Conditions: Hyperlipidemias

Summary: the findings of previous experiments suggested that polyunsaturated fatty acids(pufas) has been linked to anti-hyperlipidemia, and reducing the risk of cardiovascular disease.this is a randomized double-blind trial, aims to study the effect of pufas on blood lipids and human metabolism. firstly, the investigators will investigate the efficacy of mixed plant oil(echium oil, camelina oil, safflower oil) and pure echium oil on improving the levels of blood lipids. secondly, next generation sequencing (ngs), ultra-high performance liquid chromatography-tandem mass spectrometric (uplc-ms/ms) and gas chromatography-mass spectrometry detection will be conducted to explore the role of pufas on gut microbiota as well as metabolites. thirdly, single nucleotide polymorphism will be genotyped by time-of-flight mass spectrometry to find the gene-environment interaction effect.


Eligibility criteria:
inclusion criteria: * aged between 30-60 years of age * marginal elevated blood lipids or hyperlipidemia\[total cholesterol≥5.2 mmol/l(200 mg/dl) or triglyceride≥1.70 mmol/l(150mg/dl) or low density lipoprotein cholesterol≥3.4 mmol/l(130 mg/dl)\] exclusion criteria: * pregnancy； * known cardiovascular disease, diabetes, hypertension and any other chronic disease； * known gastrointestinal disease, such as irritable bowel syndrome(ibs), functional bowel disease and so on； * acute or chronic inflammatory conditions; * liver or kidney dysfunction; * an unwillingness to discontinue nutritional supplements； * use of lipid-lowering, antiinflammatory, antidepressant, or blood pressure medication; * evidence of drug or alcohol abuse； * take antibiotics or probiotics in the last three months.

Keywords: polyunsaturated fatty acids echium oil hyperlipidemias metabolites gut microbiota
study of nmb drug ejecting balloon for arteriovenous fistulae

Conditions: Obstructive Lesions of Arteriovenous Dialysis Fistulae

Summary: the purpose of this study is to demonstrate the safety and effectiveness of the use of nmb's percutaneous transluminal angioplasty (pta) for the treatment of obstructive lesions of arteriovenous (av) dialysis fistulae/grafts.


Eligibility criteria:
inclusion criteria: 1. patient is 18 years old or older. 2. native arteriovenous fistula or synthetic arteriovenous access graft performed/implanted more than 45 days before enrollment and at least one successful hemodialysis session performed. 3. patient having obstructive lesion of native or synthetic arteriovenous dialysis fistulae/grafts, suitable for pta procedure. 4. patient who is willing and able to sign a written informed consent and that complies with procedures (including adherence to follow-up visits). exclusion criteria: 1. women who are pregnant or breast-feeding and women of childbearing potential who do not use adequate contraception. 2. previous participation in another study with any investigational drug or device within the past 30 days. 3. life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult. 4. known hypersensitivity to paclitaxel or structurally-related compounds. 5. severe reaction to contrast agents that cannot be adequately premedicated prior to procedure. 6. stenosis with corresponding thrombosis treated within 7 days before enrollment. 7. patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy. 8. infected grafts/fistulae.
postoperative pain of root canal therapy with three techniques

Conditions: Pain

Summary: the purpose of this prospective, randomized, double-blind study was to compare the prospective pain in asymptomatic mandibular molar teeth with necrotic pulp and periapical lesion using three different instrumentation files: hand, protaper universal, and wave-one files.

protaper universal system is one of the conventional multi-file rotary systems that prepared root canals with six files: three shaping files and three finishing files. a unique design element is varying tapers along the instruments' long axes. the three shaping files have tapers that increase coronally, and the reverse pattern is seen in the five finishing files. wave-one is reciprocation-based systems that instrumented root canals with only single file. some studies demonstrated that it has outperformed conventional continuous rotary nickel-titanium (niti) preparation in some aspects. the reciprocating motion of wave-one relieves the stress on the file by special counterclockwise (cutting action) and clockwise (release of the instrument) movements and, therefore, extends the durability of a niti instrument and increases its fatigue resistance in comparison with continuous rotation motion.

Eligibility criteria:
inclusion criteria: * healthy patient exclusion criteria: * allergy to anesthetics, pregnancy, breastfeeding, vital teeth, unrestorable teeth, and teeth associated with pain or swelling

Keywords: pain root canal therapy endodontics file
safety and pharmacokinetics of rth258 in subjects with age-related macular degeneration

Conditions: Neovascular Age-Related Macular Degeneration

Summary: the purpose of this study is to assess the systemic pharmacokinetics (pk) and safety of 2 different doses of brolucizumab (3 milligrams (mg)/50 microliters (μl) and 6 mg/50 μl) when administered at 4-week intervals for a total of 3 intravitreal injections in subjects with neovascular age-related macular degeneration (amd).

this study has 2 arms with a 1:1 randomization. randomization will be stratified by japanese ethnicity. half of the subjects in each arm will be of japanese ethnicity. the other half of the subjects in each arm will be non-japanese. subjects in both arms will have visits at screening, day 0 (baseline), day 1 (24 hours post first injection), day 3, day 14, day 21, day 28, day 56, day 57 (24 hours post the injection on day 56) and day 84.

Eligibility criteria:
inclusion criteria: * provide written informed consent; * active choroidal neovascularization (cnv) lesions secondary to amd that affect the central subfield in the study eye; * best corrected visual acuity (bcva) \> 23 letters in the study eye at baseline; * 50 years of age or older at the time of screening. exclusion criteria: * any active ocular infection or inflammation; * treatment with aflibercept (eylea®), bevacizumab (avastin®), ranibizumab (lucentis®), brolucizumab, or an investigational drug for neovascular amd prior to enrollment in the study, as specified in protocol; * ocular surgery in the study eye, as specified in protocol; * uncontrolled glaucoma in the study eye, as specified in protocol; * use of steroids in the study eye, as specified in protocol; * medical conditions that may prevent study completion; * pregnant or nursing (lactating) women; * women of child-bearing potential unless using contraception; * uncontrolled blood pressure, as specified in protocol; * other protocol-specified exclusion criteria may apply.

Keywords: amd namd wetamd age-related macular degeneration
physician-pharmacist collaboration for osteoporotic patient follow-up

Conditions: Osteoporosis

Summary: the purpose of this study is to evaluate the follow-up of the osteoporotic patient by a physician-pharmacist collaboration.

treatments allow decreasing the personal fracture risk from 48% to 85% provided that the treatment period is continued at least 3 to 5 years and that hygienic and dietary measures are applied: optimization of the dietary calcium intakes (much more efficient and less dangerous than the medicinal intakes), preservation of a physical activity, fall prevention. the ability of bisphosphonate for decreasing significantly the number of fractures was proved, but the lack of lasting adhesion (persistence) and of flanking measures leads to believe their efficiency may be enhanced: the hip-fracture rate decreases from 2.1% for the non-adherents to 1,3% for the patients with observance, which represents a one-half reduction. the cost of surgery for a femoral neck fracture is estimated at 8500 euros. so the prevention of only one femoral neck fracture entails a huge economy. however, 50% of women stop their treatment before a year and the implementation of hygienic and dietary measures leads to a lifestyle change, and faces long time ingrained habits. only 42% of patients continue their treatment after two years, and only 16% after three years.

Eligibility criteria:
inclusion criteria: * older than 18 years old * having an osteoporosis treatment * following a therapeutical education for patient exclusion criteria: * opposition for anonymised data gathering
open label photo-documentation study of bpx-01 minocycline gel

Conditions: Acne Vulgaris

Summary: this is a multi center open label study intended to provide photo documentation and time to response data for bpx-01 1 and 2% minocycline topical gel for the treatment of moderate to severe non-nodular inflammatory acne vulgarism.

this was a 12-week, multi-center, open label, two-arm study. subjects will be assigned to treatment with 1% or 2% bpx-01 gel. subjects will apply 1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night for 12 weeks. lesion counts, iga, and patient-reported outcomes (pgi-s and pgi-i) will be performed to assess efficacy. photographs will be taken to document treatment effect. safety will be assessed with the vital signs, brief physical examination, clinical laboratory tests, cutaneous tolerance score, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, incidence of product related facial staining and collection of adverse events.

Eligibility criteria:
inclusion criteria: - moderate to severe inflammatory non-nodular acne vulgaris exclusion criteria: * female subject who is breastfeeding, pregnant or planning a pregnancy during the study * have other skin condition or disease that would interfere with the study * have had any prior treatment with minocycline * have a known or suspected allergy to tetracycline class products * have used otc medications for the treatment of facial acne within the last 14 days * have used any prescription topical or oral medications for the treatment of facial acne in the last 28 days * have had a facial procedure (chemical peel, dermabrasion, laser, etc) within the last 8 weeks
efficacy of 595 nm pulsed-dye laser in treatment of discoid lupus erythematosus

Conditions: Lupus Erythematosus, Discoid

Summary: forty dle lesions from patients will be recruited in the study. the lesions on one side of the body were block-randomized into the treatment group and the other side served as a control. the patients can continue their systemic treatments and the pdl is designed to be used as an adjunctive treatment. treatments with the pdl will be delivered in the treatment group every 4 weeks for 4 consecutive months while the lesions in the control group received a sham. the patients will be evaluated at baseline (week 0), week 4, 8, 12, and at follow-up period of 4, 12 weeks after the final treatment (week 16, 24). erythema index (ei), texture index (ti) will be obtained and digital photographs will be taken and modified cutaneous lupus erythematosus disease area and severity index (mclasi) will be assessed in every visit. the digital photographs will later be evaluated by 3-blinded dermatologists. moreover, side effects and patients' satisfaction score will also be recorded.


Eligibility criteria:
inclusion criteria: * age \> 18 years * has at least two dle lesions, located in the same anatomical location of the body, which the different of mclasi are not more than 1 point * dose not undergo any procedure or laser treatment within 4 weeks before entered the study * dose not received any localised therapy of dle eg. topical corticosteriod/immunomodulator within 4 weeks before entered the study * dose not receive the topical chemical peeling within 4 weeks before entered the study * has already received at least 1 systemic standard treatment for dle and continue until the rest of the study * can follow the study's protocol exclusion criteria: * pregnancy or lactation * history of skin cancer * history of photo allergy * history of bleeding tendency * history of abnormal wound healing

Keywords: lupus erythematosus, discoid pulsed-dye laser
genetic analysis of chronic central serous chorioretinopathy masquerading as neovascular amd

Conditions: Age Related Macular Degeneration; Choroidal Neovascularization; Central Serous Chorioretinopathy

Summary: the study will be designed as a case control evaluation to compare the genetic profiles of three groups of patients categorized according to diagnosis. group 1 - cnv secondary to csc group 2 - csc without cnv group 3 - cnv secondary to advanced amd.

to determine if patients presenting with type 1 neovascularization believed to be secondary to csc are genetically distinct from typical csc patients without neovascularization or patients presenting with choroidal neovascularization (cnv) secondary to advanced amd. disease associated markers detecting variants in arms 2, complement factor h (cfh) complement component 3 (c3), complement component 2 (c2) , factor b (fb), vegfa or other genetic polymorphisms associated with cnv will be evaluated to determine if the csc neovascular group is genetically distinct from the csc group without neovascularization or the advanced amd group.

Eligibility criteria:
inclusion criteria: * caucasian * 30 years and older (csc) * 50 years and older (advanced amd) * genders eligible for study: both * completed consent form * diagnosis of choroidal neovascularization in at least one eye exclusion criteria: * patient age less than 30 years (csc). * patient age less than 50 years (amd). * presence of retinal disease involving the photoreceptors and/or outer retinal layers other than amd and csc such as high myopia, retinal dystrophies, retinal vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases which have been present prior to the age of 30. * opacities of the ocular media, limitations of pupillary dilation or other problems sufficient to preclude adequate fundus photography. * missing informed consent * previous sample donation under this protocol

Keywords: age related macular degeneration choroidal neovascularization central serous chorioretinopathy
digital auscultation test - ipf data collection

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the aim of this study is the data collection for patients with ipf and symptom matched controls to create a database of lung auscultation sounds and basic patient characteristics.


Eligibility criteria:
inclusion criteria: * male or female patients * age ≥ 45 years at the day of the study visit * diagnosis: * for patients with confirmed idiopathic pulmonary fibrosis (ipf) diagnosis - a clinical diagnosis of ipf within the last 24 months from the day of the study visit, according to the american thoracic society (ats)/ european respiratory society (ers) 2011 guideline \[p11-07084\] or * for the symptom matched control - patients without a ipf diagnosis but with one of the confirmed current conditions as: * asthma diagnosed according to gina guidelines, * copd diagnosed according to gold guidelines, * pneumonia, * upper respiratory tract infection, or * acute bronchitis. * signed and dated written informed consent in accordance with good clinical practice (gcp) and local legislation prior to admission to the study exclusion criteria: * any other current respiratory condition other than the pulmonary disease which qualified the patient eligibility based on inclusion criterion 3 * any condition, according to investigator's assessment, which will not allow the patient to comply with protocol assessments or need a legal representative * patients with a history of lobectomy, pneumonectomy or lung transplant * patients with a body mass index (bmi) \>30,0 kg/m² * previous enrolment in this study * women who are pregnant
effect of remazolam besylate combined with remifentanil analgesic sedation on the prognosis of patients with sepsis

Conditions: Sepsis

Summary: in this study, midazolam was used as a control to investigate the effect of remazolam besylate combined with remifentanil on analgesia and sedation in patients with mechanical ventilation of sepsis on the prognosis of patients, and to provide evidence for the safe application of remazolam besylate in patients with sepsis.


Eligibility criteria:
inclusion criteria: 1. mechanical ventilation patients with sepsis who are expected to stay in icu for ≥48h; 2. the condition was allowed to remain in shallow sedation (rass-2 \~0); 3. obtain informed consent from patients or family members exclusion criteria: 1. pregnancy or breastfeeding; 2. general anesthesia surgery within 48 hours; 3. severe, pre-existing parenchymatous liver disease with clinically significant portal hypertension, child-pugh grade c cirrhosis or acute liver failure; 4. patients with acute and chronic renal insufficiency requiring dialysis treatment; 5. severe craniocerebral injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, epileptic status, etc. 6 medical ethics committee of the first affiliated hospital of ningbo university; 6. patients with a history of alcohol or drug abuse; 7. any condition that prevents the correct assessment of cognitive function, such as speech and sensory disorders or mental disorders (language difficulties or organic mental dysfunction); 8. failure to obtain informed consent or authorization; 9. participate in other exploratory clinical trials within 6 months prior to screening; 10. known or suspected allergy to the study drug.
automated diabetes prevention program

Conditions: Pre-Diabetes

Summary: the objective for this pilot project is to determine the feasibility and effectiveness of the interactive voice response protocol (ivr) on physical activity and eating behaviors in a group men and women who have been identified by their physician as being pre-diabetic. we hypothesize that participants receiving the ivr follow-up will have greater positive changes in their physical activity and eating behaviors when compared to those who receive only the standard-care pre-diabetes class.

patients diagnosed with pre-diabetes present a unique opportunity for health care providers to implement preventive practices. behavioral intervention strategies that target weight reduction or maintenance and increased fitness not only provide exceptional cardiovascular benefits, but also play an important role in delayed development or prevention of type 2 diabetes mellitus (dm). this study was designed to determine the feasibility and effectiveness of automated telephone support calls targeting physical activity and healthful eating as strategies for weight loss for patients with pre-diabetes. participants with pre-diabetes who participated in a 90-minute diabetes prevention class were consented to participate in this behavioral study and were then randomly assigned to receive automated telephone support targeting physical activity and nutrition weight loss strategies or to a no-contact control group. objective physical activity (accelerometer), self-reported dietary intake, and body weight were assessed at baseline and at 3-months follow-up.

Eligibility criteria:
inclusion criteria: * male and female kaiser-permanente of colorado members age 18 and above who have been diagnosed with pre-diabetes and who have enrolled in a clinically indicated pre-diabetes class. * subjects must be english speaking and have a telephone exclusion criteria: pregnant females * enrollment in another research study involving diabetes or weight management during the time of the study.

Keywords: diabetes mellitus weight control healthy eating physical activity
this study will describe the burden of dengue fever virus (denv) illness among household members aged 6 months to 50 years of selected communities in latin america and southeast asia

Conditions: Dengue; Dengue Vaccines

Summary: the purpose of this study is to describe the burden of denv illness among household members aged 6 months to 50 years of selected communities in latin america and southeast asia.


Eligibility criteria:
inclusion criteria: * written and signed informed consent (and assent if the subject is below the legal age of consent) obtained from the subject/from subject's parent(s)/lar(s). for a subject below the legal age of consent is, his/her signature will be obtained on the informed assent form, if applicable. * a male or female between, and including 6 months and 50 years of age at the time of enrolment (subjects become ineligible on their 51st birthday). * subject and/or the subject's parent(s)/lar(s) who the investigator believes can comply with the requirements of the protocol (e.g., willingness to go to the hospital/healthcare centre for visit(s) in case of acute febrile illness, able to observe the signs of dengue and to understand how to take and report body temperature, etc). * subject who plans, at the time of enrolment, to remain at same residence/study area during the one or two year study period (as applicable). * household should be reachable by phone (residence phone or mobile phone). note: pregnant or lactating female or female planning to become pregnant can be recruited into the study. exclusion criteria: * child in care. * participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator's judgement. * terminal illness or severe mental incapacity.

Keywords: dengue household southeast asia latin america surveillance
diabetes registry graz for biomarker research

Conditions: Type1diabetes; Type 2 Diabetes; Adiposity

Summary: the diabetes registry for biomarker research graz is a prospective cohort-study including subjects with type 1 and type 2 diabetes, rare types of diabetes, obesity and dyslipidemia, aiming to collect data, blood and urine samples of all subjects on an annual basis.

obesity and diabetes represent probably the most challenging threat to public health in the 21st century. despite well-controlled established cardiovascular risk factors, the residual risk in subjects with diabetes mellitus is significantly higher than the risk in those without the condition and it is well established that current risk prediction models for cardiovascular disease using established risk factors do not fully explain the future cardiovascular risk. therefore, biomarker for better risk stratification are needed, in particular in subjects with diabetes mellitus. prospective cohorts, meticulously clinically phenotyping subjects, regularly following them and collecting biomarker samples is one key approach for finding new biomarker panels, that are predictive of treatment response and future micro- and macrovascular complications. the diabetes registry for biomarker research graz was initiated in november 2015. subjects with type 1 and type 2 diabetes, rare types of diabetes, obesity or dyslipidemia are recruited in the outpatient clinic for diabetes, lipid and metabolic disorders at the university clinic graz or in the rehabilitation center st. radegund. as of september 2021, 1250 subjects are recruited. blood and urine samples samples are collected at baseline and at annual follow up visits as well as data on medical history, diagnoses and medication.

Eligibility criteria:
inclusion criteria: * 18 - 99 years * informed consent has to be given in written form * at least one of the following diseases: * type 1 diabetes * type 2 diabetes * type 3 diabetes * maturity onset diabetes of young (mody) * late onset diabetes of the adult (lada) * adipositas (bmi \> 30kg/m2) * lipid metabolism disorder exclusion criteria: * no written informed consent * no willingness to participate in this registry

Keywords: cohort study