Kornimate/medical-research-clean huggingface dataset:
success of zirconia and composite strip crowns for primary incisors

Conditions: Dental Caries in Children

Summary: the purpose of this study is to evaluate and compare the clinical and radiographic performance of zirconia and composite strip crowns bonded on primary incisors

zirconia and composite strip crowns will be placed on at least two primary incisor teeth, in a split mouth design. a caries-free primary incisor tooth will be used as control. 100 patients will be included in the study. the teeth will be randomized into two groups according to the crown type. group 1: zirconia crown 2: composite strip crown 3: control tooth. plaque index, gingival index, crown retention, presence of restoration failure, gingival margin extension, color match of the crowns and pulpal health of the teeth will be clinically evaluated at baseline and 1., 6., 12., 18., 24. months. the restorations will be evaluated radiographically at 6., 12. and 18. months. intra-oral photos will be taken directly after treatment and at control appointments. the data will be analysed statistically using fisher's exact test and pearson's chi-square test; and log-rank and the kaplan-meier will be used to estimate survival percentages.

Eligibility criteria:
inclusion criteria: * patients and parent of the patients who accept to participate and sign the informed consent * patients who have at least two primary maxillary incisor with caries that require crown restoration * teeth that have healthy lamina dura and periodontal ligament * teeth with no mobility and enough root length * patients that have good cooperation to the procedure exclusion criteria: * patients and parent of the patients who don't accept to participate and sign the informed consent * teeth that are previously restored * patients who are uncooperative * teeth that doesn't have opposing primary incisors * patients who have bruxism or deep-bite * teeth that are close to be erupted * teeth that have vital or non-vital pulp therapy

Keywords: zirconia crowns, composite strip crowns, dental caries
aqueous concentrations and pge2 inhibition of ketorolac 0.4% vs. bromfenac 0.09% in cataract patients

Conditions: Cataract

Summary: evaluation of the aqueous concentrations of 2 topical nsaids as well as the pge2 inhibition in human patients.


Eligibility criteria:
inclusion criteria: * healthy male/female 21 years of age of older. * patient understands and is willing to sign the written informed consent form * likely to complete the entire course of the study. * patient is scheduled to undergo cataract surgery * female patients of childbearing potential must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation). * patient is willing and able to administer eye drops and record the times the drops were instilled exclusion criteria: * patient has been using a topical nsaid within 1 week of study entry * patient has a known sensitivity to any of the ingredients in the study medications * patient has sight in only one eye * patient has a history of previous intraocular surgery * patient's doctor has determined they have a condition (i.e., uncontrolled systemic disease) or are in a situation that may put them at significant risk, confound the study results or may interfere significantly with their participation in the study * female patients who are pregnant, nursing an infant or planning a pregnancy * patients who are currently involved in another investigational study or have participated in one within the 30 days prior to entering this study
open-label safety and tolerability study of covaccine ht™ in healthy volunteers

Conditions: Vaccine

Summary: the study is being conducted to explore the safety and tolerability of covaccine ht in healthy male and female volunteers. in this study volunteers will receive intramuscular injections of covaccine ht.


Eligibility criteria:
inclusion criteria: * adult males or females of non child-bearing potential aged 25 to 65 years inclusive and between 19 and 35 kg/m2 body mass index (bmi) * generally healthy as determined by pre study medical history, physical examination, 12 lead ecg. * negative for hepatitis b surface antigen (hbsag), hepatitis c antibody and human immunodeficiency virus (hiv) i and ii tests at screening and rapid influenza diagnostic test at admission. exclusion criteria: * history of alcohol abuse in the last 5 years or drug abuse at any time, current significant alcohol consumption. * fever, active infections (such as influenza) and acute gastrointestinal symptoms following prior to first dosing * subjects with a previous serious reaction to a vaccine, such as angioedema or anaphylaxis

Keywords: vaccine, hypertension
safety and efficacy of lotus valve for tavi in patients with severe aortic stenosis in chinese population

Conditions: Aortic Valve Stenosis

Summary: to confirm the safety and efficacy of the lotus™ valve system in the chinese population for transcatheter aortic valve implantation (tavi) in symptomatic patients with severe aortic stenosis.


Eligibility criteria:
inclusion criteria: 1. patients with symptomatic severe aortic stenosis (echocardiographic criteria: av effective orifice area (eoa) of \ 40 mmhg, or av peak systolic velocity of \> 4.0 m/s; nyha-class ii or greater, angina pectoris, or syncope) 2. subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. 3. the subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed. 4. patients are technical and anatomical eligible for interventions exclusion criteria: 1. a known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin heparin (hit/hitts) and bivalirudin nitinol (titanium or nickel) ticlopidine and clopidogrel contrast media 2. subject refuses a blood transfusion. 3. other medical, social, or psychological conditions that in the opinion of an investigator precludes the subject from appropriate consent. 4. native aortic annulus size \ 29 mm per the baseline diagnostic imaging. 5. life expectancy is less than one year
psychobiological effects of meditation on offenders with psychopathy

Conditions: Mindfulness; Yoga

Summary: the investigators aim to explore the psychobiological effects of a 5-day meditation intervention on offenders within dangerous and severe personality disorders (dspd) unit at hmp whitemoor. dspd unit accommodates offenders with psychopathy or with two or more personality disorders. dpsd unit provides them with a 5-year rehabilitation programme that consists of group and individual therapy and aims to improve their self-regulation. this project includes a total of 60 participants and has two major methodological innovations. first, it will include yoga as an active control group that will be matched to the meditation intervention (which means it will have the same length and the same social components) and a passive control group that will be following their usual regimen. thus, the effects of meditation will be contrasted with another type of intervention and with not receiving any intervention. the second methodological innovation is the combination of psychological and biological measures. psychological measures include questionnaires (emotion regulation, mindfulness, stress) and cognitive measures (attention,empathy,behavioural control). biological measures include eeg to measure brain activity related to empathy; gene expression and protein interlukin-6 to measure changes in immune system; and stress related hormone cortisol. the investigators also aim to determine to whom does meditation benefit the most by exploring how initial expectations of meditation, personality, mood and previous life adversity predict outcomes of meditation or yoga. the data will be collected at three time points: at baseline, immediately after and 10 weeks after the 5-day intervention. the investigators expect that meditation and yoga will similarly improve mental and physical health. if this hypothesis are confirmed, these results will extend previous findings on the benefits of meditation and yoga to vulnerable populations, and would provide a cost-effective addition to prisoner rehabilitation.


Eligibility criteria:
inclusion criteria: * male offenders with dangerous and severe personality disorder aged 18-65 who will remain in the prison until at least february 2017. exclusion criteria: * major psychiatric or neurological disorders, previous meditation or yoga experience, unable to follow instructions in english,
efficacy and safety of inclisiran as monotherapy in chinese adults with low or moderate ascvd risk and elevated low-density lipoprotein cholesterol.

Conditions: Primary Hypercholesterolemia or Mixed Dyslipidemia

Summary: the purpose of this study was to evaluate the efficacy and safety of inclisiran as a monotherapy in chinese adults with low or moderate atherosclerotic cardiovascular disease (ascvd) risk and elevated low-density lipoprotein cholesterol (ldl-c) who were not on any lipid lowering therapy.

this study was designed as a randomized, double-blind, multi-center phase iii trial, with a placebo-controlled treatment period and an open label treatment period, to evaluate the efficacy and safety of inclisiran sodium 300 mg s.c. in participants aged 18 to 75 years with a low or moderate ascvd risk and fasting ldl-c value of ≥ 130 mg/dl but \< 190 mg/dl who were not on any lipid lowering therapy. the study consisted of 3 parts: * screening: the screening period was up to 14 days to allow adequate time for the eligibility evaluations. * core part: a double-blind, placebo-controlled treatment period of 180 days in which eligible participants were randomized 1:1 to receive either inclisiran sodium 300 mg s.c. (inclisiran group) or matching placebo s.c. (control group) on day 1 and day 90. the end of core part (eoc) visit was conducted on day 180. the database lock for the core part was planned to occur after all randomized participants have completed the eoc visit (or have discontinued from the study before eoc). the primary analysis was conducted after the database lock for the core part. • extension part: an extended treatment period of 180 days. in the extension part, participants originally randomized to inclisiran in the core part were to continue the inclisiran treatment while participants initially randomized to placebo were to transit to the inclisiran. the extension part was to start from the day 180 treatment dose (placebo in the inclisiran group and inclisiran for participants originally randomized to the control group).

Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any assessment is performed. * fasting ldl-c of ≥ 130 mg/dl but \< 190 mg/dl * triglycerides ≤ 400 mg/dl * categorized as low or moderate ascvd risk by the 2016 chinese guideline exclusion criteria: * use of any llt within 90 days prior to screening visit * history of ascvd * diabetes mellitus or fasting plasma glucose of ≥ 7.0 mmol/l or hba1c ≥ 6.5% * secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome other protocol-defined inclusion/exclusion criteria may apply.

Keywords: inclisiran ldl-c monotherapy atherosclerotic cardiovascular disease atheroma atherosclerosis lipid lipid lowering therapy (llt) cholesterol hypercholesteremia mixed dyslipidemia tc (total cholesterol) apo b non hdl-c lp(a) pcsk9 pcsk9 inhibitor sirna low ascvd risk moderate ascvd risk
tmc125-c227: a phase ii randomized, active-controlled, open label trial to investigate the efficacy and tolerability of tmc125 in hiv-1 infected subjects, who are pi-naive and with documented genotypic evidence of nnrti resistance from previous nnrti use

Conditions: HIV Infection

Summary: the purpose of this study is to determinate the effectiveness, safety and tolerability (how well the body accepts the drug) of an investigational non-nucleoside reverse transcriptase inhibitor (nnrti) called tmc125.

patients who have previously received a first hiv nnrti containing regimen or who have received an nnrti containing treatment for prevention of mother to child transmission (mtct), and who have never used a protease inhibitor (pi) may be eligible to participate. tmc125 (at 800 mg b.i.d. of the old formulation and after the formulation switch, 200 mg b.i.d. of the new formulation) will be studied versus an active control (investigator selected pi). all patients will receive an underlying therapy containing 2 investigator selected nrtis. 300 patients will be enrolled in argentina, brazil, mexico, peru, chile, costa rica, russia, south-africa, spain, thailand, uk, usa, thailand, india and malaysia. the duration of the study is 48 weeks with an optional extension for patients in the tmc125 treatment group until virologic failure or commercial availability of the drug. tmc125 at 800mg twice daily of the old formulation; after the formulation switch, tmc125 at 200mg twice daily of the new formulation. the initial duration is 48 weeks with an optional extension for patients in the tmc125 treatment group until virologic failure or commercially availability.

Eligibility criteria:
inclusion criteria: * male or female, age 18 years or older * documented hiv-1 infection * stable nnrti-containing art (minimum 12 weeks) at screening or treatment interruption (minimum 4 weeks) at screening or having received an nnrti alone or in combination with other arvs for prevention of mtct * plasma viral load at screening above 1000 hiv-1 rna copies/ml * prior nnrti-experience with documented genotypic evidence of resistance to currently available nnrtis (defined as at least one nnrti-associated mutation per ias-usa drug resistance mutation guidelines) * sensitive to the 2 nrtis to be used as underlaying art * subject has given informed consent exclusion criteria: * previous treatment with protease inhibitors * presence of any currently active aids defining illness except stable cutaneous kaposi's sarcoma and wasting syndrome due to hiv infection * current or past history of alcohol and/or drug use which, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures * acute hepatitis a, b or c or chronic hepatitis b or c with elevated lfts of \> 3 times uln

Keywords: hiv infection tmc125 non-nucleoside reverse transcriptase inhibitor protease inhibitor tmc125-c227
electronic archive of patients with diagnosis and suspected prenatal diagnosis of aortic coarctation

Conditions: Aortic Coarctation

Summary: the purpose of this prosective and retrospective observational study is to analyze the clinical and echocardiographic characteristics of infants with prenatal diagnosis of suspected aortic coarctation (coao) in order to identify clinical and instrumental elements that can predict the risk of developing aortic coarctation in the neonatal period so that we can identify patients who are at high risk and would therefore require intensive care and observation; compared with low-risk patients, for whom early discharge would be evaluable.

our study has the intention of analysing the clinical and echocardiographic characteristics of infants with prenatal and neonatal diagnosis of suspected coao, transferred at birth to the o.u. of cardiology and paediatric cardiac surgery at the policlinico di sant' orsola in order to identify reliable predictors of coao, in particular reliable in presence of the ductus arteriosus of botallo. it is an observational study: patients participating in the study will not undergo to any procedures outside the normal clinical practice; likewise, the clinical variables that will be collected for study are those that are commonly collected by the physician in daily clinical practice. this study therefore involves the observation of current clinical practice without the application of any kind of 'intervention'.the primary objective of the study is: to identify the clinical and/or echocardiographic features predictive of the development of aortic coarctation through the creation of a data collection with which to census all patients with a diagnosis of suspected or overt aortic coarctation, admitted from 01/01/2007 to 31/12/2026 at the paediatric cardiology and cardiac surgery centre of the policlinico di sant'orsola, bologna.

Eligibility criteria:
inclusion criteria: * patients with pre-natal or post-natal diagnosis of aortic coarctation from 01 january 2000 until approval (retrospective phase) and from approval until 31 december 2026 (prospective phase) exclusion criteria: * patients whose diagnosis of aortic coarctation is postnatal, considered to be \>1 month after birth * prenatal diagnosis of genetic disease (e.g., turner's sdr) * coarctation in the setting of complex congenital heart disease
microglial activation role in als (maria)

Conditions: Amyotrophic Lateral Sclerosis

Summary: neuroinflammation, characterized in particular by microglia activation, is an essential component of amyotrophic lateral sclerosis (als) pathogenesis. translocator protein (tspo) is recognized as a specific and sensitive biomarker of neuroinflammation, reflecting disease activity. an experimental radiopharmaceutical specific of tspo expression, namely \[18f\]dpa714, allow to quantify this microglial activation using positon emission tomography (pet) imaging. the purpose of this study is to longitudinally correlate the spatial distribution of neuroinflammation with the pro- or anti-inflammatory state of activated microglia cells in als, in order to evaluate neurotoxic or neuroprotective microglia activity, by complementary approaches in 20 als patients: * in vitro: measuring concentrations of several pro- and anti-inflammatory cytokines secreted by microglial cells in the cerebrospinal fluid (csf). * in vivo: \[18f\]dpa714 pet imaging. these assays will be performed in the framework of the clinical follow-up of als patients, at the diagnosis of als disease and 6 months latter.


Eligibility criteria:
inclusion criteria: * signed informed consent * age ≥ 18 years old * patient with probable or definite sporadic amyotrophic lateral sclerosis (als) form according to the modified criteria of el escorial * treated with riluzole 2 weeks * evolution less than 18 months * mini-mental state examination (mms) score ≥ 26 and frontal assessment battery (fab) (normal) * affiliated to a social security system exclusion criteria: * another unbalanced progressive pathology * vascular diseases (hypertension, diabetes, smoking, dyslipidemia) unbalanced * forced vital capacity \<75% * weight loss\> 10% of the weight before disease * status "low affinity binder" or "mixed affinity binder", the tspo respect to the \[18 f\] dpa-714, which can interfere with the process of neuroinflammation: drugs with anti-inflammatory drugs (nsaids, corticosteroids, azathioprine, anti-tumor necrosis factor (tnf), antibiotics) * benzodiazepine in the week before the pet scan \[18f\] dpa-714 given the potential consequences for tspo receivers * contraindications to mri in patients with: 1. metallic foreign body eye. 2. any implanted electronic medical irremovably (pacemaker, neurostimulator, cochlear implants ...) 3. metal heart valve, 4. vascular clips formerly located on cranial aneurysm. * treatment in the month before the pet scan \[18f\] dpa-714 antagonist n-methyl-d-aspartate (nmda) (memantine) * pregnant women, lactating women, and women in age for procreation and without reliable contraception or without history of hysterectomy * ◦person under guardianship

Keywords: amyotrophic lateral sclerosis disease pet microglial activation
measuring the glycemic index and tracking metabolites of new and emerging lentil varieties

Conditions: Hyperglycemia; Dietary Modification

Summary: it is not known whether different lentil varieties have the same efficacy in lowering blood glucose. similarly, the carbohydrate component of lentils responsible for lowering blood glucose is not known, nor is the bioavailability of lentil metabolites and polyphenol bioactive.

the overall aim of this work is to produce credible evidence for substantiating a food health claim for post prandial blood glucose lowering by lentil. although several studies have shown that lentil consumption results in a lowering of post prandial blood glucose, it is not known whether different lentil varieties have the same efficacy. similarly, the carbohydrate component of lentils responsible for lowering blood glucose is not known, nor is the bioavailability of lentil metabolites and polyphenol bioactive. the investigators hypothesize that the slowly digestible starch content of lentil is inversely related to in vivo glycemic response. the specific aims of this study are: (i) to identify the putative component(s) in lentil that might account for its blood glucose lowering effect, and (ii) to identify differences in blood glucose reduction among lentil varieties. these aims will be achieved in a three-step process. firstly, in vitro studies will be pursued to determine the carbohydrate fractions of 20 new and emerging canadian lentil varieties. secondly, these results will be used to choose 8 lentil varieties with different slowly digestible starch content for a human glycemic index study. thirdly, identification of lentil metabolites will be achieved by collecting extra capillary blood (200ul)and urine samples at fasting and 120min for measurement of polyphenols and metabolites using established hplc and metabolomics techniques.

Eligibility criteria:
inclusion criteria: * male or non-pregnant females, 18-75 years of age, inclusive * body mass index (bmi) \< 40 kg/m² * willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit. * normal fasting serum glucose (\<7.0mmol/l capillary corresponding to whole blood glucose \<6.3mmol/l). * understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator. exclusion criteria: * failure to meet any one of the inclusion criteria * known history of aids, hepatitis, diabetes or a heart condition * subjects using medications or with any condition which might, in the opinion of dr. wolever, the medical director of gi labs, either: 1) make participation dangerous to the subject or to others, or 2) affect the results. * major trauma or surgical event within 3 months of screening. * unwillingness or inability to comply with the experimental procedures and to follow gi labs safety guidelines. * known intolerance, sensitivity or allergy to any ingredients in the study products.

Keywords: glucose glycemic index lentil polyphenols metabolites bioavailability