Kornimate/medical-research-clean huggingface dataset:
6-year clinical evaluation of glass ionomer cements (gis) with resin coating on posterior teeth

Conditions: Dental Caries

Summary: the aim of this study was to evaluate the long-term clinical performance of two highly viscous encapsulated gics (equiafil and riva sc) covered with two different coatings (equia coat and fuji varnish) over 6-year using modified united state public health service (usphs) criteria. a total of 256 restorations were made with equiafil and riva sc. equia coat or fuji varnish was used randomly on the surface of the restorations. the restorations were evaluated at baseline, 6, 12, 18 months and 6 years after placement using modified usphs criteria. the results were evaluated with pearson chi-square and mann whitney u-test (p\< 0.05).

the aim of this study was to evaluate the long-term clinical performance of two highly viscous encapsulated gics (equiafil and riva sc) covered with two different coatings (equia coat and fuji varnish) over 6-year using modified united state public health service (usphs) criteria. fifty-four patients having class i and ii restorations/caries were included in the study. a total of 256 restorations were made with equiafil (gc corp, japan) and riva sc (sdi, australia). equia coat or fuji varnish was used randomly on the surface of the restorations. after cavity preparations, the teeth were randomly restored with one glass ionomer cement and coated with equia coat or fuji varnish. the restorations were evaluated at baseline, 6, 12, 18 months and 6 years after placement using modified usphs criteria. two evaluators checked color-match, marginal discoloration, marginal adaptation, caries formation, anatomical form, postoperative sensitivity and retention rate and photographs were taken at each recalls. the results were evaluated with pearson chi-square and mann whitney u-test (p\< 0.05). the 18-month results were presented at the ced iadr congress iheld in barcelona in 2010 (turkun ls, \& kanic o ,clinical evaluation of new glass ionomer coating combined systems for 18-months journal of dental research 89 (special issue b) abstract #402.) gurgan s et al. also mentioned our 18-month results in their published manuscript ( gurgan s,kutuk zb, ergin e, oztas zz \& cakir fy (2015) four-year randomized clinical trial to evaluate the clinical performance of a glass ionomer restorative system operative dentistry 40(2) 134-143).

Eligibility criteria:
inclusion criteria: 1. having good oral hygiene; 2. need for at least two or more posterior restorations in contact with neighbouring tooth and in occlusion with antagonist teeth; 3. teeth planned to be restore should be vital and symptomless; 4. the cavity isthmus size should be more than 1/3 of the intercuspal distance. exclusion criteria: 1. absence of adjacent and antagonist teeth; 2. teeth with periodontal problems; 3. teeth with preoperative pain or pulpal inflammations; 4. teeth formerly subjected to direct pulp capping; 5. patients having severe systemic diseases, allergies or adverse medical history.

Keywords: glass ionomers surface coating clinical trial
bioequivalence study of losartan potassium (100 mg tablet) [test formulation, torrent pharmaceuticals ltd., india] versus cozaar® (100 mg tablet) [reference formulation, merck & co. inc., usa] in healthy human volunteers under fed condition

Conditions: Healthy

Summary: objective: compare the single dose bioavailability of torrent's losartan potassium tablets 1 × 100 mg and cozaar® tablets 1 × 100 mg of merck \& co., inc. study design: randomized, two-way crossover, single-dose, open-label in 70 healthy human adult subjects


Eligibility criteria:
inclusion criteria: * the volunteers were included from the study based on the following criteria: * sex: male. * age: 18 - 45 years. . * volunteer with bmi of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. * healthy and willing to participate in the study. * volunteer willing to adhere to the protocol requirements and to provide written informed consent. * non-smokers or smoker who smokes less than 10 cigarettes per day exclusion criteria: * the volunteers were excluded from the study based on the following criteria: * clinically relevant abnormalities in the results of the laboratory screening evaluation. * clinically significant abnormal ecg or chest x-ray. * systolic blood pressure less than 100 mm hg or more than 140 mm hg and diastolic blood pressure less than 60 mm hg or more than 90 mm hg. * pulse rate less than 50/minute or more than 100/minute. * oral temperature less than 95°p or more than 98.6°p. * respiratory rate less than 12/minute or more than 20/minute * history of allergy to the test drug or any drug chemically similar to the drug under investigation. * history of alcohol or drug abuse * positive breath alcohol test * recent history of kidney or liver dysfunction. * history of consumption ofprescribed medication since last 14 days or otc medication since last 07 days before beginning of the study. * volunteers suffering from any chronic illness such as arthritis, asthma etc. * history of heart failure. * hiv, hcv, hbsag positive volunteers. * opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, * cocaine positive volunteers based on urine test. * volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. * administration of any study drug in the period 0 to 3 months before entry to the study. * history of significant blood loss due to any reason, including blood donation in the past 3 months. * history of pre-existing bleeding disorder. * existence of any surgical or medical condition, which, in the judgement of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. * inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
beta-glucans for hospitalised patients with covid-19

Conditions: COVID-19

Summary: this randomised trial aims to assess the role of beta1-3 glucan supplementation in improving clinical symptoms and other outcomes amongst hospitalised patients with covid-19.

covid-19 can present as a life-threatening disease characterised by respiratory failure and high circulating levels of inflammatory cytokines. beta-glucans comprise a heterogeneous group of natural polysaccharides consisting of d-glucose monomers linked by a beta-glycosidic bond. they represent key structural elements of the cell wall and may serve as energy storage in bacteria, fungi including yeast, algae, and plants. in this triple-masked randomised trial, hospitalised patients requiring treatment with supplemental oxygen because of a laboratory-confirmed infection by sars-cov-2 will receive supplementation with 1-3 beta-glucans or placebo as part of their standard treatment. the primary endpoint of this trial is the intensity of clinical symptoms as detected by the wisconsin upper respiratory symptom survey (wurss). patients requiring mechanical ventilation at baseline will be excluded, as will those with cognitive impairment that precludes the use of clinical assessment scales, patients in which an order to limit therapeutic efforts has been issued, pregnant or breastfeeding women and those who decline to participate in this study. secondary outcomes will include clinical deterioration requiring admission to an intensive care unit, requirement of high-flow nasal cannula or invasive mechanical ventilation and overall survival. patients will be followed-up until hospital discharge or up to fifteen days after randomisation. statistical analyses will be undertaken by a statistician unaware of treatment allocation under the intention-to-treat principle.

Eligibility criteria:
inclusion criteria: * adult participants with an infection caused by sars-cov-2 confirmed with a reverse-transcription polymerase chain reaction (rt-pcr) obtained from a nasopharyngeal swab. exclusion criteria: * life expectancy \< 6 months * currently receiving invasive mechanical ventilation at baseline. * cognitive impairment that precludes the use of wurss or understanding the informed consent form. * refusal to participate.

Keywords: beta-glucans therapy signs and symptoms mechanical ventilation inflammation survival
documentation of the safety and effectiveness profile of the igg immunoadsorber globaffin® in clinical routine

Conditions: Autoimmune Diseases

Summary: documentation of the safety and effectiveness profile of the ce-labelled immunoadsorber globaffin® in clinical routine according to their intended use.

the objective of the study is the documentation of the safety and effectiveness profile of the ce-labeled immunoadsorber globaffin® in clinical routine according to their intended use. the primary objective for the igg adsorber globaffin® is the estimation of the mean relative reduction in total igg from pre- to post-treatment per treatment session.

Eligibility criteria:
inclusion criteria: * minimum age of 18 years * informed consent signed and dated by study patient and investigator/authorised physician * ability to understand the nature and requirements of the study * treatment with one of the immunoadsorber system globaffin® according to the intended use. exclusion criteria: general: * any condition which could interfere with the patient's ability to comply with the study * in case of female patients: pregnancy or lactation period (if patient is ≥ 55 years old or have been surgically sterilized, a negative pregnancy test is not required) * participation in an interventional clinical study during the preceding 30 days. * participation in an interventional clinical study with pharmacological active substances (e.g. therapeutic antibodies) during the preceding 60 days. * any deviation from the intended use study-specific: any contraindication listed in the valid instruction for use: * hypersensitivity or allergy against any materials used in either the immunoadsorber column or the extracorporeal circuit * inability to withstand the stress of an extracorporeal treatment procedure due to their age, their physical developments or their clinical constitution * previously demonstrated hypersensitivity associated with therapeutic apheresis * no suitable anticoagulation treatment, such as due to known hypersensitivity to heparin or acd-a * haemorrhagic diathesis in which extracorporeal apheresis procedures and anticoagulation performed have a high bleeding hazard * severe cardiovascular disease, so that extracorporeal treatment is not possible * acute, systemic infection

Keywords: therapeutic apheresis immune apheresis
intravenous interferon during liver transplant

Conditions: Hepatitis C; Cirrhosis

Summary: the main goal of this study is to prevent liver allograft infection with hepatitis c virus in hepatitis c positive patients undergoing liver transplantation. the hypothesis is that patients who receive ribavirin immediately before transplant and intravenous interferon alfa 2b during the anhepatic phase(while the liver is removed)will have sustained virologic response post liver transplant.

the study is evaluating intravenous interferon given during the anhepatic phase of lvier transplant. ribavirin was given as well. serial measurements for hcv rna were determined 12, 24 72, 96 hrs and 4 weeks after liver transplant.

Eligibility criteria:
inclusion criteria: * liver transplant for hepatitis c exclusion criteria: * allergy to interferon

Keywords: cirrhosis hepatitis c
study on tear proteins in diabetic retinopathy of type 2 diabetics

Conditions: Diabetes Mellitus

Summary: diabetes mellitus is becoming a global epidemic. there is a need to devise a non invasive method for detection of diabetes and its related complication. tear proteins are easy to collect causing no harm to a patient and different studies indicate that tear proteins of diabetic patients are significantly different from non diabetic population. this difference in the composition of tear proteins become more pronounced with advancement of diabetic retinopathy.

diabetes mellitus causes a significant alteration in tear proteins. if we analyze tear proteins by means of electrophoresis, hplc, and mass spectroscopy. we can find different type of tear proteins in different grades of diabetic retinopathy these biomarkers can help in mass screening , diagnosis and management of diabetic population.

Eligibility criteria:
inclusion criteria: * diabetic patients with type 2 diabetes * age above 30 * willing to participate exclusion criteria: * ocular surface disorders. * collagen vascular diseases * limbal hyperemia * previous ocular surgery * creatinine level above 1.0 * liver diseases

Keywords: tear proteins diabetic retinopathy hplc mass spectroscopy
strength training regimen for normal weight diabetics

Conditions: Diabetes Mellitus

Summary: the strength training regimen in normal weight diabetics (strong-d) study will examine the effectiveness of different exercise regimen types in controlling diabetes for the normal weight type 2 diabetes population.

in the strong-d study, participants are randomly assigned to strength training, aerobic training or a combined strength and aerobic training group. participants in the exercise group will attend exercise sessions over the course of 9 months at the ymca. participants will have opportunities to engage in other activities such as educational run-in visits that will allow for measurement of hemoglobin a1c and emphasize the importance of exercise in improving type 2 diabetes.

Eligibility criteria:
inclusion criteria: * recent hemoglobin a1c result between 6.5%-13% * diagnosis of type 2 diabetes mellitus * bmi between 18.5 -25 kg/m2 * blood pressure \< 160/100 * sedentary lifestyle * able and willing to enroll and meet requirements of the study exclusion criteria: * age less than 30 years or greater than 75 years * type 1 diabetes or use of insulin pump * triglycerides \>500 mg/dl * use of weight loss medication * bariatric surgery * consumes \>14 alcoholic drinks per week * pregnancy * plans to be away for more than four weeks * medical conditions which would prevent long-term participation or which would contraindicate physical activity
psychometric properties of a mobile application

Conditions: Spinal Cord Injuries

Summary: current methods to assess superficial size and area of pressure ulcers are either time-consuming (using transparency tracings techniques), costly (computers, softwares), or necessitating to touch the patient's skin (using commun rulers). a free smartphone application (for ios or android) has recently been developed to measures skin lesions. it is called imitomeasure. it does not require any contact with the patient. a photograph is taken with the smartphone, the limits of the lesion is then drawn with the health carers' finger on the phone's screen. the application computes the length, width and surface of the ulcer. this technique has not yet been validated, although it has been used to measure various types of skin lesions. the objective of this study is to validate this measurement technique on a sample of pressure ulcer in a population of patients with spinal cord injury (sci). reliability is assessed by comparison to the currently most frequently used techniques (transparency tracings and ruler-based), and fiability is assessed by intra-rater and inter-rater correlations. imitomeasure is a new smartphone application to measure wounds size. the present study assesses validity of the measure against common measures (ruler-based and transparency tracings), and the inter- and intra-rater reliability.


Eligibility criteria:
inclusion criteria: * complete or incomplete spinal cord injury, all delays or aetiologies * presence of one or more pressure ulcers stade ii to iv * adults exclusion criteria: * refusal to participate * local infection

Keywords: pressure ulcer validity of measures
adrenal artery ablation for primary aldosteronism with resistant hypertension

Conditions: Resistant Hypertension

Summary: primary aldosteronism(pa) is the most common endocrine cause of resistant hypertension. surgery and medicine are the main treatment for pa by the current guidelines. however,only a small part of patients with pa meet the surgical criteria, and most of them have to take spironolactone or other antihypertensive drugs for long time. on the other side, long-term inhibition of aldosterone receptor may cause hyperkalemia, male breast hyperplasia and other adverse reactions. moreover, hyperaldosterone is still not corrected by spironolactone, which cause extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized. with the development of adrenal vein sampling and adrenal ablation, the precise diagnosis and treatment of pa is possible. selective adrenal artery ablation (aaa) was observed with significant decrease of blood aldosterone and blood pressure in patients with pa, which made it promissing that primary aldosteronism with resistant hypertension could be relieved by adrenal artery ablation.


Eligibility criteria:
inclusion criteria: * male or female, age between 30-65 years old. * primary aldosteronism with resistant hypertension. * informed consent signed and agreed to participate in this trial. exclusion criteria: * secodary hyertension due to other causes. * history of depression,schizophrenia or vascular dementia . * history of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months. * hypohepatia (ast or ast is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy. * renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome. * acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction. * fertile woman without contraceptives. * any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the anti-hypertensive drugs. * allergic to or have contraindication to the contrast agents and alcohol.

Keywords: resistant hypertension; aldosteronism
management of pes planovalgus with talocalcaneal coalition ,osteotomy vs arthroereisis

Conditions: Talocalcaneal Bar; Pes Planus

Summary: the investigators compare the corrective osteotomies vs arthroereisis in management of talcalcaneal coalition in adolescents as regard the outcome to provide the best intervention for the patient

in talocalcaneal coalition management is controversial so in this study the invstigators try to compare techniques other than coalition excision only or fusion only by using two types of intervention including first coalition excision and multiple corrective osteotomies according to deformity as evans ,medial displacement calcaneal osteotomy and cotton osteotomy vs coalition excision and arthroereisis the investigators compare functional and radiological outcomes and complication to provide the best management for these patients .

Eligibility criteria:
inclusion criteria: * flat foot due to talocalcaneal coalition symptomatic patient resectable coalition age between 10 and 20 exclusion criteria: * flat foot of other etiology age more than 20 concurrent knee deformity unless corrected before surgery extensive coalition more than 50 %of posterior facet
study of sqz-eapc-hpv in patients with hpv16+ recurrent, locally advanced or metastatic solid tumors

Conditions: Adult Solid Tumor

Summary: this is a phase 1/2, first-in-human, open label, multicenter study to assess safety and tolerability, antitumor activity, and immunogenic and pharmacodynamic effects of sqz-eapc-hpv as monotherapy and in combination with pembrolizumab in patients with recurrent, locally advanced, or metastatic hpv16+ solid tumors. the study includes patients with head and neck, cervical, anal, vulvar, or penile cancer.


Eligibility criteria:
inclusion criteria - all patients: * male or female patients ≥18 years of age * histologically confirmed incurable or metastatic solid tumors that are hpv16+ (performed during screening locally or centrally, or based on documented historic test results) * eastern cooperative oncology group (ecog) performance status (ps) of 0 to 1 * at least 1 measurable lesion according to recist 1.1 * must have a lesion that can be biopsied with acceptable clinical risk and agree to have a fresh biopsy at screening and on cycle 2 day 8 (+/- 2 days) * patients must agree to venous access for leukapheresis and be willing to have a central line inserted if venous access is an issue * adequate organ function and bone marrow reserve performed within 14 days prior to leukapheresis inclusion criteria - part 2: • patients must not have been treated with immune check-point inhibitors exclusion criteria - all patients: * treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to leukapheresis. * systemic treatment with either corticosteroids (\>10 mg of prednisone or the equivalent per day) or other immunosuppressive medications within 14 days prior to leukapheresis * patients treated with non-corticosteroid based immunosuppressive agents within the last 6 months prior to leukapheresis * patients with active, known, or suspected autoimmune disease may not be eligible and should be discussed with the sponsor * patients with \>grade 1 aes related to previous treatment with anticancer or investigational therapy that do not resolve at least 2 weeks prior to leukapheresis, except grade 2 neuropathy, ototoxicity, mucositis, fatigue, alopecia, or endocrine disorders managed with hormone replacement * known hiv infection, active hepatitis b or hepatitis c, or active mycobacterium tuberculosis infection * has known active central nervous system metastases * have active interstitial lung disease and any history of myocarditis * major surgery within 2 weeks of leukapheresis exclusion criteria - part 1b: * known hypersensitivity to pembrolizumab * history of any grade 3 immune-related ae (irae) from prior immunotherapy exclusion criteria - part 2: • prior treatment with an immune check-point inhibitor

Keywords: recurrent cancer metastatic locally advanced cancer head and neck cancer cervical anal vulvar penile sqz-eapc-hpv hpv16 human papillomavirus 16 eapc enhanced antigen presenting cells cell therapy pembrolizumab checkpoint inhibitors immunotherapy solid tumor therapeutic vaccine advanced solid tumor throat cancer