Kornimate/medical-research-clean huggingface dataset:
carotid artery neovascularization in takayasu's and giant cell arteritis

Conditions: Takayasu's Arteritis; Giant Cell Arteritis; Arteritis; Vasculitis; Aortitis

Summary: the purpose of this study is to evaluate the ability of contrast enhanced carotid ultrasound to serve as an indicator of disease activity in patients with takayasu's arteritis or giant cell arteritis and to determine if patients with active arteritis have a thickening of their blood vessel walls compared to healthy people of the same age and gender.

takayasu's arteritis and giant cell arteritis are chronic, relapsing diseases of the large arteries which can lead to significant narrowing of the arteries through episodes of inflammation within the artery walls. the changes in the vessel walls will be determined by an ultrasound test looking at and measuring: carotid vessel wall changes called carotid intimal-media thickness (cimt) and the presence of new blood vessels (neovascularization) using a contrast agent. ultrasound findings will be correlated with markers of inflammation in the blood, findings from other radiology studies (such as mri) already ordered as part of routine clinical care, and physical exam findings and symptoms of consistent with disease activity. 15 arteritis patients and 5 healthy controls will be recruited.

Eligibility criteria:
inclusion criteria: * male and female patients \>18 years * diagnosis of takayasu's arteritis or giant cell arteritis * suspicion of common carotid involvement on the basis of physical examination (cervical bruit), carotidynia, documented cca involvement on an imaging study (mra, cta, or ultrasound), or documented upper extremity large vessel involvement on an imaging study (mra or cta or ultrasound). * ability to provide informed consent exclusion criteria: * prior stroke, carotid surgery or angioplasty * pregnant (or trying to become pregnant) * nursing * known or suspected cardiac shunt * documented hypersensitivity to the contrast agent * severe pulmonary hypertension or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias, or respiratory failure)

Keywords: takayasu's arteritis giant cell arteritis arteritis vasculitis aortitis disease activity carotidynia neovascularization carotid intima media thickness
glucose measurement using microneedle patches

Conditions: Diabetes

Summary: this study will compare three glucose measurement techniques among diabetic children and adolescents. the study seeks to determine if a microneedle patch (made from biocompatible polymers or metal), versus a lancet or intravenous catheter, would be a preferable option for monitoring glucose levels among the diabetic pediatric population.

fifteen children and adolescents with diabetes will be tested for their glucose measurements comparing interstitial fluid collected via a microneedle patch (made from biocompatible polymers or metal), versus the standard of care blood sample (lancet), and lab grade blood draw (intravenous catheter). samples will be taken hourly from all three devices for four hours. all four measurements will be compared against each other to see how close they are with measuring the glucose values. each participant will be asked to rate their apprehension prior to receiving each method for blood or interstitial fluid collection as well as the pain associated with each method immediately after collection.

Eligibility criteria:
inclusion criteria: * diabetes diagnosis exclusion criteria: * no exclusion criteria are specified

Keywords: pediatrics endocrinology adolescent microneedle
cohort study of efficacy and safety of interferon intermittent treatment of chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: this study was a retrospective clinical observational cohort study. all patients with chronic hepatitis b (chb) whose hbsag decreased by less than 10% were treated continuously with interferon in the department of hepatology, beijing ditan hospital, beijing medical university, beijing capital university, 2008.10-2017.4. the total interferon treatment time of the enrolled subjects was 48 weeks. the subjects were randomly divided into the following two observation cohorts: 1) patients with chronic hepatitis b treated with continuous interferon for 48 weeks; 2) intermittent interferon for 48 weeks of treatment for patients with chronic hepatitis b, the interferon treatment interval was 3 months. hbv dna content, hbsag/anti-hbs, hbeag/anti-hbe and biochemical markers, serum afp and liver imaging (liver ultrasound) were collected before treatment (baseline) and during treatment. the primary outcome measure was the rate at which hbsag disappeared at 48 weeks of treatment. the secondary evaluation index was the 48-week hbeag seroconversion rate. to investigate the efficacy, influencing factors and safety of interferon intermittent treatment of chronic hepatitis b.

this study was a retrospective clinical observational cohort study. all patients with chronic hepatitis b (chb) whose hbsag decreased by less than 10% were treated continuously with interferon in the department of hepatology, beijing ditan hospital, beijing medical university, beijing capital university, 2008.10-2017.4. the total interferon treatment time of the enrolled subjects was 48 weeks. the subjects were randomly divided into the following two observation cohorts: 1) patients with chronic hepatitis b treated with continuous interferon for 48 weeks; 2) intermittent interferon for 48 weeks of treatment for patients with chronic hepatitis b, the interferon treatment interval was 3 months. hbv dna content, hbsag/anti-hbs, hbeag/anti-hbe and biochemical markers, serum afp and liver imaging (liver ultrasound) were collected before treatment (baseline) and during treatment. the primary outcome measure was the rate at which hbsag disappeared at 48 weeks of treatment. the secondary evaluation index was the 48-week hbeag seroconversion rate. to investigate the efficacy, influencing factors and safety of interferon intermittent treatment of chronic hepatitis b.

Eligibility criteria:
inclusion criteria: * all patients with chronic hepatitis b meet the diagnostic criteria of china guidelines for the prevention and treatment of chronic hepatitis b (2015) exclusion criteria: * coinfection with other viruses including hcv, hdv, and hiv; * syphilis antibody positive; * co-exist other liver diseases including alcoholic liver disease, metabolic liver disease, fatty liver, drug induce liver injury, and autoimmune liver disease; * complication of cirrhosis or liver cancer.

Keywords: chronic hepatitis b interferon intermittent hbv hbsag hbv dna
effect of er,cr:ysgg sub-ablative laser irradiation on fissure caries prevention in permanent molars

Conditions: Caries,Dental

Summary: background: subjecting human dental enamel to sub-ablative laser has been suggested as a novel way of caries prevention. however, further studies are needed to establish its use as a routine clinical procedure for caries prevention. the aim of this study: this study aims to evaluate the effect of er,cr:ysgg subablative laser irradiation on caries resistance of occlusal fissures of permanent molars. materials and methods: in-vivo study, a split mouth randomized controlled trial with sixty patients having two fully erupted bilateral first permanent molars (icdas-ii score 0,1 or 2). the pits and fissures will be subjected to sub-ablative power of er,cr:ysgg laser (group 1, n=90) and will be compared with fluoride varnish application on the first permanent molars in the same arch(group 2,n=90). diagnodenttm readings and changes in icdas-ii score will be assessed at base line and at 3,6,9 and 12 months follow-up.


Eligibility criteria:
inclusion criteria: * participants of age 6-12 years old * patients ranking definitely positive or positive on frankl behavior rating scale * having at least two bilateral fully erupted first permanent molars with untreated non-cavitated occlusal surfaces with deep grooves, the included teeth will have international detection and assessment system (icdas-ii)/ severity scores 0, 1 or 2 * initial diagnodent score not exceeding value of 25 indicating only enamel involvement * patients whom their parents are willing to comply with all study procedures and protocols and will be given an informed consent to participate exclusion criteria: * patients with any known medical history of systemic diseases * patients having first permanent molar with hypoplastic or hypocalcified enamel * patients using medications that may affect the oral flora or salivary flow * patients treated with in-office fluoride treatment within the last 3 months prior to being enrolled in the study. * patients showing evidence of poor oral hygiene according to silness and löe plaque index

Keywords: er,cr:ysgg laser diagnodenttm acid resistance
antineoplaston therapy in treating patients with newly-diagnosed glioblastoma multiforme

Conditions: Glioblastoma Multiforme of Brain

Summary: rationale: current therapies for glioblastoma multiforme provide very limited benefit to the patient. the anti-cancer properties of antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors. purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on adults (≥ 18 years of age) with newly diagnosed glioblastoma multiforme.

overview: this is a single arm, open-label study in which adults (≥ 18 years of age) with newly diagnosed glioblastoma multiforme receive gradually escalating doses of intravenous antineoplaston therapy (atengenal + astugenal) until the maximum tolerated dose is reached. treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. objectives: * to determine the efficacy of antineoplaston therapy in adults (≥ 18 years of age) with newly diagnosed glioblastoma multiforme, as measured by an objective response to therapy (complete response, partial response or stable disease). * to determine the safety and tolerance of antineoplaston therapy in adults (≥ 18 years of age) with newly diagnosed glioblastoma multiforme. * to determine objective response, tumor size is measured utilizing mri scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. projected accrual: a total of 20-40 patients will be accrued to this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed glioblastoma multiforme * subtotal resection or biopsy only of tumor * measurable tumor by mri scan performed within two weeks prior to study entry * tumor must be at least 5 mm * no brain stem tumor patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * more than 4 months hematopoietic: * wbc at least 1,500/mm\^3 * platelet count at least 50,000/mm\^3 * hemoglobin at least 10 g/dl hepatic: * no hepatic failure * bilirubin no greater than 2.5 mg/dl * sgot and sgpt no greater than 5 times upper limit of normal renal: * creatinine no greater than 2.5 mg/dl * no history of renal conditions that would contraindicate high dosages of sodium cardiovascular: * no uncontrolled hypertension other: * not pregnant or nursing prior concurrent therapy: biologic therapy: * no prior immunotherapy * no concurrent immunomodulatory agents chemotherapy: * no prior chemotherapy * no concurrent antineoplastic agents endocrine therapy: * concurrent corticosteroids for cerebral edema allowed radiotherapy: * no prior radiotherapy surgery: * see disease characteristics * recovered from any prior surgery

Keywords: adult glioblastoma
expanded access to regn4461 for patients with lipodystrophy or monogenic obesity with complications of leptin deficiency or deficient leptin signaling


Summary: provide expanded access to regn4461 for patients with lipodystrophy or monogenic obesity with complications of leptin deficiency or deficient leptin signaling

expanded access requests are only being considered in response to individual patient investigational new drug (ind) applications. availability will depend on location.

Eligibility criteria:

Keywords: leptin (lep) leptin receptors (lepr)
a study of the cypher ses to treat restenotic native coronary artery lesions.

Conditions: Coronary Artery Disease

Summary: the main objective of this study is to assess the safety and effectiveness of the cypher™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion.

this is a multicenter (11 sites), non-randomized study. patients who meet the eligibility criteria will be treated with the cypher™ sirolimus-eluting stent. all patients will have a repeat angiography at six months post-procedure and will be additionally followed clinically at 1, 6 and 9 months and up to 3 years. the results of this study will be compared with the outcome of the gamma i / ii as the historical control.

Eligibility criteria:
inclusion criteria: 1. the patient has an in-stent restenosis of ≥ 60% and \< 100% (by qca online of the mld compared to the distal reference diameter) in a native coronary artery. 2. the study target lesion can not be located in a vessel containing another lesion requiring treatment. lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, but they must be successfully treated prior to the treatment of the study target lesion. exclusion criteria: 1. unprotected left main coronary disease with ≥ 50% stenosis; 2. patient previously treated with brachytherapy in any coronary vessel. 3. target lesion involves bifurcation including a side branch \>2.5mm in diameter. 4. the patient sustained a recent (\<72 hours) myocardial infarction defined as a serum ck 2x the upper limit of normal and elevated mb or abnormal lab values.
pharmacokinetic comparison of intradermal versus sub-cutaneous insulin and glucagon delivery in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the investigators are doing this research study to find out if the type of needle used to administer them affects the speed with which insulin and glucagon get into the blood. the investigators will compare a traditional insulin needle to an injection device, called the micronjet, that uses microneedles to deliver medication into the top layer of your skin.


Eligibility criteria:
inclusion criteria: * age 18 years or older with clinical type 1 diabetes for at least one year * diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (novolog), insulin lispro (humalog), and insulin glulisine (apidra). * ability to consume a sufficient amount of carbohydrates over 2-3 hours to cover 5 units of rapid acting insulin * stimulated c-peptide \<0.1 nmol/l at 90 minutes after liquid mixed meal tolerance test. exclusion criteria: * unable to provide informed consent * unable to comply with study procedures * current participation in another diabetes-related clinical trial other than one that is primarily observational in nature. potential subjects enrolled in trails of passive monitoring equipment, such as continuous glucose monitors (cgms), are not excluded * inadequate venous access as determined by study nurse or physician at time of screening * pregnancy * hemoglobin less than 13.5 for men and less than 12 for women * history of pheochromocytoma (fractionated metanephrines will be tested in patients with history increasing the risk for a catecholamine secreting tumor to include episodic or treatment refractory hypertension defined as requiring 4 or more medications to achieve normotension, paroxysms of tachycardia, pallor, or headache, or personal or family history of men 2a, men 2b, neurofibromatosis, or von hippel-lindau disease) * history of adverse reaction to glucagon (including allergy) besides nausea and vomiting * history of adrenal disease or tumor * hypertension (blood pressure \> 160/100 mm/hg at screening or day of study visit * history of allergy to aspirin or any history of aspirin intolerance, including reye's syndrome, or gastric ulcer or bleeding associated with salicylates. * blood dyscrasia or bleeding diathesis, such as hemophilia, von willebrand's disorder, and idiopathic thrombocytopenic purpura (itp) * peptic ulcer

Keywords: intradermal pharmacokinetics microneedle insulin glucagon
different methods of tranexamic acid application in controlling peri operative bleeding in gynecomastia surgery

Conditions: Pharmacological-Aggravated Urticaria

Summary: different methods of tranexamic acid application in controlling peri-operative bleeding in gynecomastia surgery

the term "gynecomastia" is derived from the greek words "gyne" = woman and "mastos" = breast and is a benign enlargement of the male breast. it is the most common condition affecting the male breast due to enlargement of both ductal and stromal tissue\[1\]. plastic surgeons frequently perform gynecomastia operations as cosmetic procedures. since these operations result in relatively little blood loss, there is little information in the literature about how to minimise blood loss during these cosmetic procedures some preventive measure against bleeding and hematomas include perioperative blood pressure control, use compressive dressing, different types of suction drains, size of incision, careful hemostasis, and infusion of adrenalin during local anesthesia, infusion of tranexamic acid in tumescent or intravenous directly

Eligibility criteria:
inclusion criteria: * age (16 - 45 years) * any grade of gynecomastia well be included exclusion criteria: * age (\ 40 years) * history of previous gynecomastia surgery * patients with known allergy to tranexamic acid * patients with abnormal coagulation profile (according to american society of anesthesiologists guidelines for preoperative preparation of surgical patients) * patients who are receiving treatment for known hyper-coagulable state. 6. patients with history of cardiac disease or thromboembolic events.
mesenchymal stem cells in patients diagnosed with covid-19

Conditions: Covid19

Summary: the propose of this study is implement adjuvant therapy with adipose tissue derived-mesenchymal stem cells (mscs) for critical covid-19 patients admitted to the intensive care unit of the regional hospital lic. adolfo lópez mateos of the institute for social security and services for state workers to reduce cytokine storm and contribute to the favorable resolution of respiratory insufficiency and multiple organic failure.

within the epidemic context of phase 3 that currently exists in mexico, implementation of new treatments that have shown to be beneficial for patients in a critical state in other countries is an urgent need. adipose tissue derived-mesenchymal stem cells for could favor the regulation of patient immune system to reduce the proinflammatory state and promoting the regeneration of damaged tissues. patients diagnosed covid-19 and confirmed positive with the virus by pcr, will be treated with two intravenous infusions mscs on the day 1 (d1) and the day 3 (d3) of the treatment consisting of 1x106/kg each. we will assess the pulmonary lesion area by chest x-ray or computed axial tomography at baseline and days 2, 3, 5, 10, 15, 20, and 25. days to clinical improvement (to be evaluated on days 2, 3, 5, 10, 15, 20, 25), considering temperature and other vital signs measurement, arterial oxygen saturation, blood chemistry (including liver function tests), creatine phosphokinase, c reactive protein, immune cells (cd3+, cd4+, cd8+, cd16+, cd19+, and cd56+ lymphocytes), pro-inflammatory cytokines (il-1β, il- 2, tnf-α, itn-γ, il-4, il-6, il-10), immunoglobulins (iga, igg, igm, and ige), hla profile expression, and weaning from mechanical ventilation.

Eligibility criteria:
inclusion criteria: * aged between 18 and 65. * rt-pcr positive for sars-cov-2 (berlin protocol). * moderate to severe acute respiratory insufficiency (100 mmhg \<pao2/fio2 ≤ 200 mmhg). * confirmatory diagnosis of pulmonary injury by chest teleradiography or computed axial t tomography. * being under standard therapy for covid-19. * informed consent signed by the patient or a legally acceptable representative (in the case of the legal representative, informed consent could be obtained by a phone call or email with the subsequent written confirmation). exclusion criteria: * reserved prognosis (survival expected by the physician of fewer than three days). * being under immunosuppressive drug treatment. * severe kidney failure (estimated glomerular filtration rate \< 30 ml/min) or under continuous kidney replacement therapy, hemodialysis, or peritoneal dialysis. * immunosuppressed patients (except when the cause is corticosteroid treatment). * pregnant or lactating women. * patients who plan to become pregnant during the study period or within six months after the end of the study period. * participation in another clinical trial with an experimental drug during the last 30 days. * pathologies that in medical judgment constitute a contraindication to participate in the study.

Keywords: covid-19 adjuvant therapy mesenchymal stem cells mexico
the effectiveness of a counselling intervention on the uptake of hiv care services among hiv infected patients in uganda

Conditions: HIV

Summary: the purpose of this study is to evaluate the impact of follow-up counselling after hiv diagnosis through home-based hiv counselling and testing (hbhct), on linkage to pre-antiretroviral therapy (pre-art) care in uganda.

data on linkage to pre-antiretroviral therapy (pre-art) care after hiv diagnosis through home-based hiv counselling and testing (hbhct) in sub-saharan africa (ssa) are scarce. the few existing data suggest that only 13% to 54% of hiv-infected persons identified through hbhct enter pre-art care. no studies have rigorously evaluated interventions aimed at improving linkage to pre-art care following hbhct in ssa. this study will evaluate the effect of follow-up counselling after hiv diagnosis through hbhct on linkage to pre-art care in masaka, south-western uganda. the study is a cluster randomised trial of the effectiveness of referral to pre-art care and follow-up counselling (intervention) compared to referral to pre-art care only (control), for individuals diagnosed with hiv through hbhct. the intervention will be administered at months 1 and 2, and linkage to care assessed at month 6 post-hbhct. data will be collected on socio-demographic characteristics, sexual risk profile, hiv testing history, hiv status disclosure, linkage to care, cd4 count testing and results, cotrimoxazole prophylaxis, and art initiation. at least 224 hiv-infected participants will be enrolled from 28 clusters (14/study arm). approximately 84 hiv-uninfected individuals will also be recruited into the study to reduce the possibility of revealing the sero-status of the hiv-infected participants.

Eligibility criteria:
hiv-infected participants inclusion criteria: 1. hiv-infected adult (≥18 years) 2. willing to provide informed consent 3. willing to receive follow-up counselling at home exclusion criteria: 1. previous or current receipt of hiv care from an art provider 2. on-going participation in other health-related research 3. intending to change residence in the next 6 months 4. conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness hiv-uninfected participants inclusion criteria: 1. hiv negative adult (≥18 years) 2. willing to provide informed consent 3. willing to receive follow-up counselling at home exclusion criteria: 1. intending to change residence in the next 6 months 2. conditions that may make it difficult to provide informed consent e.g. reported (by the individual, relatives or other community members) on-going psychiatric illness

Keywords: hiv counselling care antiretroviral therapy linkage uganda africa