Kornimate/medical-research-clean huggingface dataset:
effect of self-assembling peptides on the progression of non-cavitated proximal caries

Conditions: Proximal Caries

Summary: the aim of this randomized controlled, double-blinded, split-mouth clinical trial was to evaluate the efficacy of self-assembling peptide p11-4 solution (curodont™ repair) with fluoride varnish on the progression of non-cavitated proximal caries compared to casein phosphopeptide-amorphous calcium phosphate (cpp-acp) with fluoride varnish (mi varnish™) sodium fluoride (naf) varnish (profluorid® varnish). the study included 300 permanent molars belonging to 150 children, aged between 7 to 13 years old, who had two non-cavitated proximal carious lesions.

first, the subjects were randomly allocated to three main groups with 50 individuals in each. then the carious lesions belonging to each subject were randomly assigned to two subgroups based on different treatment agents used: group 1; p11-4+naf/naf, group 2; p11-4+naf/cpp-acp+naf, group 3; cpp-acp+naf/naf. accordingly, test 1 lesions received p11-4+naf combination, test 2 lesions received cpp-acp+naf varnish, and control lesions received naf varnish alone. at the 6th and 12th months after the clinical applications, profluorid® varnish application was repeated for test 1 and control lesions, and mi varnish™ application was repeated for test 2 lesions. at the end of the 12 months, carious lesion progression status was evaluated radiographically, by using independent visual reading, pair-wise visual reading, and digital subtraction radiography (dsr) methods.

Eligibility criteria:
inclusion criteria: * children who had two permanent molars with non-cavitated proximal carious lesions that included one in the right jaw and the other one in the left jaw, and in contact with neighboring teeth, * non-cavitated proximal carious lesions which is radiographically extending into either the outer half of the enamel (e1), the inner half of the enamel (e2) or the outer third of the dentin (d1), * children who had not any systemic disease that prevents the application, * cooperative children who allowed to radiographic examinations and clinical applications. exclusion criteria: * there is caries/restoration on the different surface of the tooth to be treated, * there is caries/restoration on the contact surface of the tooth adjacent to the tooth to be treated, * non-cavitated proximal carious lesions which is radiographically extending into the middle third of the dentin (d2) or the inner third of the dentin (d3), * there is cavitation on the proximal surface of the tooth to be treated, * non-cooperative children who had not allow to radiographic examinations and clinical applications, * children and parents who denied the participation in the follow-up appointments.

Keywords: proximal caries, p11-4, cpp-acfp, fluoride varnish
safety study of single administration intravenous treatment for influenza

Conditions: Influenza

Summary: the purpose of this study is to characterize the safety and pharmacology of single administrations of avi-7100, a candidate treatment for influenza.

influenza a, a member of the orthomyxoviridae family, is composed of a negative-sense,single-stranded and segmented ribonucleic acid (rna) genome. an urgent need exists for new forms of treatment for influenza a based on (a) the known propensity of this virus to undergo both continuous low-level antigenic drift and less frequent but unpredictable major antigenic shift leading to pandemic disease, (b) the clear failure of vaccination, even when strains are reasonably matched, to prevent influenza-related illness in a significant proportion of vaccine recipients, and (c) the increased frequency of resistance to approved forms of therapy for influenza (eg, the adamantane derivatives and, more recently, the na inhibitor, oseltamivir). avi-7100 is an experimental phosphorodiamidate morpholino antisense oligomers with positive charges on selected subunits (pmoplus™). avi-7100 specifically targets viral messenger rna sequences. the present study is designed to characterize the safety, tolerability and pharmacokinetics of escalating single-administration doses of avi-7100 in healthy human subjects.

Eligibility criteria:
inclusion criteria: * male or female and between the ages of 18 and 50 years in good general health * volunteers must be willing to use barrier methods of contraception or be of non-childbearing potential * volunteers must be willing to undergo a urine screen for drugs of abuse exclusion criteria: * pregnancy or breastfeeding. * any clinically relevant abnormalities in physical examinations, vital signs, ecg, clinical chemistry, hematology or urinalysis * positive test for human immunodeficiency virus, hepatitis b or hepatitis c or known history of hiv infection
study to evaluate the effects of bms-813160 on protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease

Conditions: Diabetic Kidney Disease

Summary: the purpose of this study is to determine whether bms-813160 will reduce the amount of protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * clinical diagnosis of type 2 diabetes mellitus with macroalbuminuria (uacr between 200 and 3500 mg/g) * background angiotensin converting enzyme inhibitor (acei) or angiotensin-receptor blocker (arb) therapy exclusion criteria: * clinical diagnosis of type 1 diabetes * unstable cardiovascular, metabolic, or other chronic disease status * estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m2 * high risk of infection or immune compromise * clinically significant ecg conduction abnormalities * drugs with significant potential to affect bms-813160 exposure
maintenance or withdrawal of urate lowering therapy according to ultrasound features in gout patients: a randomised controlled trial stop treatment in gout

Conditions: Gout Chronic

Summary: according to international recommendations, urate lowering therapy (ult), mainly the xanthine oxidase inhibitors (xois) allopurinol and febuxostat, should be prescribed lifelong in gout patients. however, this recommendation comes up against very poor adherence to ult, since around half of patients stop their treatment at 5 years. moreover, there is uncertainty about the cardiovascular tolerance of febuxostat taken over the long term. finally, although xois are generally well tolerated, they can cause side effects and require regular biological monitoring. the hypothesis is that the risk of flares following withdrawal of ult is very low in gout patients when urate store is depleted and repeated ultrasounds (us) do not demonstrate the reappearance of urate deposits.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * gout, defined according to the 2015 acr/eular classification criteria * no flares for at least 2 years * no tophi * currently receiving allopurinol or febuxostat taken for at least 2 years and sua levels ≤ 60 mg/l * no urate deposit on ultrasound at inclusion visit at both mtps 1 and knees * ability to provide informed consent * women of childbearing potential (wocbp) are required to have a negative pregnancy test before treatment and must agree to maintain during treatment highly effective contraception (ie,abstinence, combined estrogen- and progestogen-containing hormonal contraception, ovulation inhibitors (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (iud); intrauterine hormone-releasing system (ius); bilateral tubal occlusion; vasectomised partner). * health insurance exclusion criteria: * unstable systemic medical condition (e.g., new york heart association stage iv heart failure, recent myocardial infarction, advanced cancer) * history of allergy to allopurinol or febuxostat or one of the excipients * association with azathioprine, mercaptopurine (cytostatics-antimetabolites) * contraindications to experimental medicinal products or auxiliary medicinal products * ckd stage 4 (egfr less than 30 ml/mn/1.73 m2) * ongoing treatment with uricosurics (benzbromarone and probenecid) or uricase * patient on sma (state medical aid-ame) * participation in other clinical trial on medicinal product for human use * lack of contraception for women of childbearing potential.
the effects of rotator interval hydro-dissection in primary adhesive capsulitis.

Conditions: Adhesive Capsulitis of Shoulder

Summary: adhesive capsulitis (ac) is a significant cause of chronic shoulder pain and disability. non-surgical option consisting of intraarticular corticosteroid (ia cs) injection with structured physiotherapy (pt) is the current standard of care. more recent randomized controlled trials have found that rotator interval (ri) hydro-dissection approach leads to better improvement in pain as compared to ia approach. despite being non-inferior to surgical management, long-term outcome studies of patients treated with ia cs injection and pt have shown that patients only achieve satisfactory outcomes in 72.3% of patients after a mean symptom duration of 41.8 months. furthermore, cs injections are associated with significant systemic and local adverse effects such as cushing syndrome, osteopenia/ osteoporosis, infection, and hyperglycemia. in recent years, dextrose injection has emerged as an effective alternative to cs-based injections to treat chronic painful musculoskeletal conditions such as chronic low back pain, peripheral nerve entrapment and lateral epicondylitis. the investigators aim to study the effects of ri hydro-dissection with dextrose 5% (d5%) on pain relief, shoulder rom and shoulder function in patients with primary ac.


Eligibility criteria:
inclusion criteria: * patients with primary adhesive capsulitis * aged 35 to 65 years of age * duration of symptoms in between 3 to 18 months * limitation in flexion, abduction, and external rotation greater than 30 degrees compared to normal * limitation in internal rotation with hand to back shoulder test below l4 exclusion criteria: * diagnosis of connective tissue disease or inflammatory arthritis * history of surgery to the affected shoulder * history of shoulder dislocation/ fracture * neurological weakness of the affected upper limb * ultrasound findings of rotator cuff or lhbt tendinopathy * plain radiographs showing significant glenohumeral joint osteoarthritis (kallgren-lawrence grade 3 or 4) * other sources of chronic pain * bilateral adhesive capsulitis * history of pain intervention to the shoulder joint in the past 3 months * allergic reaction to local anesthetic agent
visuprime® eye drops

Conditions: Macular Degeneration, Age Related; Myopic Choroidal Neovascularisation; Proliferative Diabetic Retinopathy; Diabetic Macular Edema; Macular Edema of Right Retina (Diagnosis)

Summary: the study purpose is to assess the efficacy of visuprime® eye drops in preventing the conjunctival bacterial load in patients undergoing to anti-vegf injection.

multicentre, double-masked, placebo-controlled randomized 1:1 of the visuprime® treatment in patients undergoing intravitreal anti-vegf injection.

Eligibility criteria:
inclusion criteria: * adult patients (age ≥ 18) * naïve and pre-treated patients scheduled for ivi * diagnosis of one of the following: * armd * mcnv * proliferative diabetic retinopathy * diabetic macular oedema * macular oedema secondary to retinal vein occlusion * the subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the local ethics committee (ec). exclusion criteria: * use of systemic antibiotics, corticosteroids within 3 months * use of topical antibiotics and or corticosteroids within 15 days from study enrolment * use of topical artificial tears within 15 days from the enrolment * use of topical antiseptic agents within 1 month from study enrolments * presence of topical ocular therapies that cannot be suspended for the entire duration of the study * ongoing ocular or systemic inflammatory or infectious processes * known hypersensitivity to the constituents of the study product * diagnosis of open-angle glaucoma * uveitis * acute and chronic conjunctival disease * any intraocular surgery within 6 months from study enrolment, excluded ivi * severe and moderate dry eye * pregnancy or breast-feeding * participation in other clinical studies * patients with cognitive impairment and unable to manage home-assigned treatment.
study of berberine hydrochloride in prevention of colorectal adenomas recurrence

Conditions: Colorectal Adenoma

Summary: berberine hydrochloride is a conventional component in chinese medicine. in recent years, anticancer activity of berberine hydrochloride have been explored. the aim of this study is to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas.

colorectal adenomas are well-known to be precancerous lesions that develop into colorectal cancers on the basis of the adenoma-carcinoma sequence. the effects of screening for colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer have been established. because of the high recurrence rates of colorectal adenomas in patients who have undergone polypectomy, the potential chemopreventive agents that may reduce the risk of colorectal adenoma recurrence need to be investigated. berberine hydrochloride is a conventional component in chinese medicine. in recent years, anticancer activity of berberine hydrochloride have been explored. the aim of this study is to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas by conducting a randomized, placebo-controlled, prospective clinical.

Eligibility criteria:
inclusion criteria * individuals aged 18-75 years * individuals who had at least one and no more than 6 histologically confirmed cras removed within 6 months before recruitment * individuals who are able to swallow pills * individuals who voluntarily sign the consent form after being fully informed and understanding the purpose and procedure of this study, characters of the disease, effect of medication, methods of related examinations, and potential risk/benefits of the study 4.2 exclusion criteria * individuals whose adenoma was not completely removed during previous colonoscopy * individuals with a history of familial adenomatous polyposis (fap) or hereditary non-polyposis colorectal cancer (hnpcc, lynch syndrome) * individuals who are taking regularly aspirin, nonsteroidal anti-inflammatory drugs (nsaids), cyclo-oxygenase 2 (cox2) inhibitors, calcium or vitamin d * individuals with a history of subtotal/total gastrectomy or partial bowel resection * individuals who are intolerant to another colonoscopy examination * individuals who are hypersensitive or intolerant to the drugs * individuals with severe heart, liver or kidney disease, or any cancer history * individuals presenting severe constipation * pregnant women, women during breast-feeding period, or women with expect pregnancy * individuals with mental diseases who are not able to cooperate * individuals who are involved in designing, planning or performing this trial
sleep ergonomics in low back pain

Conditions: Low Back Pain

Summary: the aim of this study is to investigate the effect of sleep ergonomics guidance given by physiotherapist on pain and disability in patients with low back pain. in this randomized controlled trial participants are assigned either into the intervention or the control group. the intervention group will receive detailed instruction on sleeping ergonomics whereas the control group will only be instructed to avoid painful sleeping posture. the initial hypothesis is that in the intervention group pain and disability will decrease more compared to the control group.


Eligibility criteria:
inclusion criteria: * low back pain * pain during sleep or exclusion criteria: * fibromyalgia * inflammatory rheumatic disease * severe depression or other psychiatric diagnosis * previously received specific guidance in sleep ergonomics

Keywords: low back pain sleep ergonomics
screening of hepatocellular carcinoma in patients with compensated cirrhosis

Conditions: Compensated Cirrhosis

Summary: liver carcinoma is becoming the main complication of cirrhosis. treatment of symptomatic or large tumors is disappointing. regular ultrasonographic screening of small (curable) tumors is currently recommended, but the best periodicity is unknown.this randomized trial is aimed to compare 6-month (current recommendation) and 3-month ultrasonographic screenings.

patients: all consecutive patients with compensated hbv, hcv, alcohol or hemochromatosis-related cirrhosis (without any previous clinical complication including liver cancer). randomization: factorial: ultrasonography (3-month versus 6-month); serum alfa-fetoprotein assay (none versus 6-month). end points: rate of small tumors (first main criteria); survival (second main criteria).

Eligibility criteria:
inclusion criteria: * compensated cirrhosis exclusion criteria: * antecedent of osmic acid synoviorthesis or of isotopic synoviorthesis of the studied knee * intra-articular injection of triamcinolone hexacetonide in three months preceding the inclusion or by a different corticoid in the month preceding the inclusion * evolutionary infectious or neoplastic pathology

Keywords: cirrhosis hepatocellular carcinoma screening randomized hbv hcv alcohol hemochromatosis
post discharge trial to enhance immunity in severely malnourished children

Conditions: Child Malnutrition

Summary: the goal of this study is to evaluate the efficacy of microbiota-directed food in comparison to zinc with micronutrient powder and khichuri on changes in circulating immune cells (monocytes, t cells, b cells, and nk cells) in malnourished children after recovery from acute infection. the study aims to answer the research question: does microbiota-directed food (mdf) compared to zinc with micronutrient powder (mnp) and khichuri therapy enhance immunity in children with severe acute malnutrition? the researcher will compare the effectiveness of microbiota-directed food (mdf) versus zinc with micronutrient powder (mnp) and khichuri therapy to see if mdf enhances immunity in severely malnourished children. severely malnourished children will: * receive microbiota-directed food (mdf) or zinc with micronutrient powder (mnp) and khichuri every day for 12 weeks. * phenotyping of circulating immune cells (nk cells, t cells, b cells) will be conducted using flow cytometry and fluorescence-activated cell sorting techniques.


Eligibility criteria:
inclusion criteria: * children aged 6 months to 36 months, and * severe acute malnutrition as evident by weight-for-length z-score (wlz) \< -3 and or mid-upper arm circumference (muac) \< 11.5 cm, and or edema of both feet, and * completed the acute phase management for sam and stayed at nru for 7±4 days, with no medical complications, e.g. lethargic/unconscious, convulsions, unable to drink, persistent vomiting, respiratory distress. * residing within the dhaka district. * parents/guardians provided written informed consent. exclusion criteria: * wlz ≥ -3 or muac ≥11.5 cm. * presence of lethargy/unconsciousness, convulsions, unable to drink, persistent vomiting, respiratory distress. * participants who receive multiple courses of antibiotic (\>2 courses during acute phase) treatment for a prolonged period (\>14 days). * persistent diarrhea (≥14 days). * chronic illness or disability affecting food intake, e.g. tb, hiv, congenital defects, cerebral palsy * treated for sam in the previous 3 months. * known case of soy, peanut, or milk protein allergy. * any sibling of the enrolled child.

Keywords: immunity malnutrition microbiota-directed food (mdf) zinc nk cells gut microbiota
a study of ly3015014 in healthy participants with high cholesterol

Conditions: Healthy Volunteers; Hypercholesterolemia

Summary: this is a study in healthy participants with high levels of "bad" cholesterol who are already taking a popular type of cholesterol-lowering medication called statins. following multiple doses of ly3015014, investigators will study the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body. participants will remain in the study for about 3 months, not including screening. screening is required within 28 days before the study starts.


Eligibility criteria:
inclusion criteria: * participants must be healthy males or females without childbearing potential as determined by medical history and physical examination * have body mass indexes of 18 to 35 kilograms per square meter (kg/m\^2), inclusive, at screening * have screening low density lipoprotein-c (ldl-c) of between 100 and 180 milligrams per deciliter (mg/dl), inclusive, while having taken a stable dose of statin exclusion criteria: * have known allergies to compounds related to ly3015014 or any components of the formulation or known clinically significant hypersensitivity to biologic agents * have a history of atopy, significant allergies to humanized monoclonal antibodies, clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions \[including but not limited to erythema multiforme major, linear immunoglobulin a (iga) dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis\] * have significant history of or current cardiovascular (excluding controlled hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication, or of interfering with the interpretation of data * have received any vaccine(s) within 1 month of ly3015014 dosing or intend to do so during the study * have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing
effect kinesio taping on acute-onset muscle soreness and calf muscle extensibility among endurance athletes

Conditions: Muscle Soreness

Summary: in recent years, athletes have frequently utilized kinesio tape (kt) to enhance their performance. despite widespread use, data regarding its efficacy and mechanism of action is lacking among healthy endurance athletes. this study aims to determine the effect of kt application on acute-onset muscle soreness and the extensibility of the calf muscles in endurance athletes.

the study followed a single-blinded one-arm crossover repeated-measures randomized controlled design and included fifty-five endurance athletes (mean age, 16.40±2.69) from different stadia in delhi, india. outcome measures, including the ankle dorsiflexion range of motion (adfrom), were measured using a universal goniometer before, immediately after application of either kt or sham tape, and after treadmill running. however, the pain due to acute-onset muscle soreness was measured using a numeric pain rating scale (nprs) immediately, 10 min, and 30 min after treadmill running.

Eligibility criteria:
inclusion criteria: * endurance athletes, including cyclists, badminton players, long-distance runners * both males and females aged between 10-20 years * having bmi within the normal range (19-25) * cooperation in the study exclusion criteria: * other than endurance athletes * aged less than ten and more than 20 years * bmi fall beyond the normal range, either underweight or overweight * musculoskeletal injuries, skin problems * non-cooperation in the study

Keywords: kinesio tape sham tape ankle dorsiflexion range of motion pain muscle soreness