Kornimate/medical-research-clean huggingface dataset:
platform switching vs regular platform implants. one year results from a rct

Conditions: Missing Teeth

Summary: the present study tested the hypothesis that platform switching (ps) and regular platform (rp) implants would have different outcomes in the bilateral single tooth replacements against the alternative hypothesis of no difference.

this study was designed as a randomised, controlled, split-mouth trial. eighteen patients, with bilaterally missing single bicuspid or molar had one of the sites to be restored randomly assigned to be treated according to the platform-switching concept with (ps group), or with matching implant-abutment diameters, (rp group). a total of 36 implants, (18 nobel replace tapered groovy ps, 18 nobel replace tapered groovy), were bilaterally installed. all the implants were inserted with an insertion torque between 35 and 45 ncm, in healed healthy bone and the healing abutment was connected at the same time. both implants were delayed loaded with screw retained temporary crowns 3 months after implant insertion and with screw retained definitive crowns 2 months later. outcome measures were implant survival, biological and prosthetic complications, radiographic marginal bone-level changes, soft tissue parameters (ppd and bop). clinical data were collected at baseline 6 and 12 months. statistical analyses were conducted using computational program sas (version 9.2), with 1-away anova and f-test. statistical significance was tested at the 0.05 probability level, and all values were presented as mean and standard deviation with 95% confidence intervals.

Eligibility criteria:
inclusion criteria: * need for single bilateral fixed implant-supported prosthesis in molar area * stable interocclusal contacts * ≥18 years of age * provided written informed consent * residual bone height ≥10 mm * residual bone thickness ≥6 mm with at least 5 mm of keratinised gingiva crestally exclusion criteria: * general contraindications to implant surgery * lack of occluding dentition in the area intended for immediate loading * periodontitis * bruxism * immunosuppression * previous history of irradiation of the head and neck area * uncontrolled diabetes * heavy smoker (\>10 cigarettes/day) * poor oral hygiene * current or past treatment with bisphosphonates * substance abuse * psychiatric disorder * inability to complete follow-up ≥1 year * lactation * implant insertion torque less than 35 ncm

Keywords: platform switching vs regular platform
evaluation of omegaven™ parenteral nutrition in patients with total parenteral nutrition (tpn)-induced cholestasis

Conditions: Parenteral Nutrition Associated Liver Disease PNALD; Cholestasis

Summary: the purpose of this study is to determine if established parenteral nutrition (pn) associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.

the primary objective of this study is to evaluate the need for and time to small bowel transplantation or liver transplantation. this will be calculated as both the age at time of primary transplant as well as the length of time from initial evaluation to transplant.secondary objectives are to determine if there are improvements in clinical measures associated with established parenteral nutrition- associated liver disease (pnald). these will be determined by measurement of total and direct bilirubin levels, platelet count, serum albumin, and changes in both length and weight growth curves.

Eligibility criteria:
inclusion criteria: * patients must be enrolled in the intestinal rehabilitation program at the university of nebraska medical center, and: * be unable to meet nutritional needs solely by enteral nutrition and be expected to require pn for at least another 30 days * have clinical evidence of parenteral nutrition associated liver disease (pnald) as defined as a direct bilirubin of 2 mg/dl or more. a liver biopsy is desirable but not necessary for treatment * signed patient informed consent exclusion criteria: * parent or guardian or child unwilling to provide consent or assent * inability or unwillingness on the part of parent/guardian or child to follow clinical recommendations of the intestinal rehabilitation program * allergies or clinical conditions precluding safe use of omegaven™

Keywords: pn parenteral nutrition fat emulsions omega-6 fatty acid liver disease fatty acid deficiency
developing anesthesia as post traumatic stress disorder (ptsd) therapy

Conditions: Healthy

Summary: this preclinical phase 1 development study in healthy volunteers seeks to identify if low doses of commonly used non-triggering anesthetic agents might have clinical utility for modulating emotional memory processing and to understand the nature of the brain mechanisms of drug action. optimally, a drug, dose and brain mechanism of action will be identified that will form the foundation for future use in clinical studies of patients with ptsd.


Eligibility criteria:
inclusion criteria: * healthy adults. * between the ages of 18 and 35. exclusion criteria: * pregnancy. * left-handed. * unusual facial anatomy. * history of esophageal reflux. * respiratory problems. * central nervous system disorders. * cardiovascular problems. * kidney disease. * diabetes. * history of substance abuse. * history of adverse anesthetic reactions. * hepatitis. * failure to pass mri screening questionnaire. * fear of small-enclosed spaces. * mental illness. * non-native english speakers.
dabigatran etexilate for secondary stroke prevention in patients with embolic stroke of undetermined source (re-spect esus)

Conditions: Stroke; Secondary Prevention

Summary: this trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (esus). patients will be randomized to dabigatran or acetylsalicyclic acid (asa) (1:1 ratio) and have visits every three months. the study doctor may prescribe blinded concomitant asa for pts with coronary artery disease but this is not mandatory. all adverse events (aes), serious adverse events (saes), outcome events will be recorded. the trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).


Eligibility criteria:
inclusion criteria: * ischemic stroke with a brain lesion visualized by neuroimaging (either brain computed tomography (ct) or magnetic resonance image (mri)). the visualized stroke is a non-lacunar infarct , e.g. involving the cortex or \>1.5 cm (\>2.0 cm if measured on mri diffusion-weighted images) in largest diameter if exclusively subcortical.visualization by ct usually requires delayed imaging \>24-48 hours after stroke onset. * the index stroke must have occurred either up to 3 months before randomization (modified rankin scale(mrs) \ = 60 years plus at least one additional risk factor for recurrent stroke. * arterial imaging or cervical plus transcranial doppler (tcd) ultrasonography does not show extra-cranial or intracranial atherosclerosis with \>= 50% luminal stenosis in artery supplying the area of acute ischemia. * as evidenced by cardiac monitoring for \>= 20 hours with automated rhythm detection, there is absence of af \> 6 minutes in duration (within a 20 hour period, either as single episode or cumulative time of multiple episodes). further inclusion criteria apply. exclusion criteria: * modified rankin scale of \>=4 at time of randomization or inability to swallow medications. * major risk cardioembolic source of embolism such as: a) intracardiac thrombus as evidenced by transthoracic or transesophageal echocardiography, b) paroxysmal, persistent or permanent atrial fibrillation (af), c) atrial flutter, d) prosthetic cardiac valve (mitral or aortic, bioprosthetic or mechanical), e) atrial myxoma, f) other cardiac tumors, g) moderate or severe mitral stenosis, h) recent (\< 4weeks) myocardial infarction, i) valvular vegetations, or j) infective endocarditis. * any indication that requires treatment with an anticoagulant as per investigator's judgment. * history of atrial fibrillation (unless it was due to reversible causes such as hyperthyroidism or binge drinking, and has been permanently resolved). * other specific stroke etiology (i.e. cerebral arteritis or arterial dissection, migraine with aura/vasospasm, drug abuse). * renal impairment with estimated creatinine clearance (as calculated by cockcroft-gault equation) \<30ml/min at screening, or where investigator expects creatinine clearance is likely to drop below 30ml/min during the course of the study. further exclusion criteria apply.
evaluation of aesthetic impact in patients with systemic sclerosis

Conditions: Systemic Sclerosis

Summary: the primary objective is to assess the burden of aesthetic complication in systemic sclerosis. systemic sclerosis is associated with changes in skin aspect which can impact the appearance. aesthetic burden will be assessed through several scales and compared to a control group of health subjects.


Eligibility criteria:
inclusion criteria: * systemic sclerosis according to acr-eular 2013 exclusion criteria: * non french native * aesthetic sequel from other conditions
sample size definition in cochrane hepato-biliary trials

Conditions: Definition of Sample Size in Randomized Clinical Trial Assessing Liver Disease

Summary: sample size definition provides important information, allowing the groundwork for transparent reporting. the sample predefinition allows the trial to be large enough to be able to address the question that is being asked. the aim of the present study is to assess, in all the randomized controlled trials (rct) included in the cochrane hepato-biliary group (chbg) systematic reviews, the quality of reporting sample size the accuracy of the calculations, the accuracy of the a priori assumptions and the effect on the agreement with pooled results in meta-analyses.

the investigators aim to answers to these questions questions * how large a proportion of recent hepato-biliary rcts does report an adequate sample size estimation? * primary outcome is clearly defined ? and clinical meaningful ? * is the sample size calculation based on the primary outcome ? * does the predicted control event rate coincide with the actual one? * what is the predicted intervention effect? * are confidence intervals of primary outcome results reported? is there evidence of difference between the two arms? * is the effect size so large (\> 50%) to suggest post hoc definition ? * what is the accepted error alpha and beta? * how many study do not comply with the usual rule of alpha = 5% beta = 20%? * do trials with planned sample size do better than those without ? is the overlap between ci results less frequent ? are their results more frequently "statistical" significant ? * do trials with planned sample more frequently agree with pooled results in meta-analysis ? * has the protocol been published in a public register before inclusion of participant? * how often is intention-to-treat analyses employed as primary analysis? * how often is the trial results resting upon subgroup analysis? methods: all the randomized clinical trials included in a systematic review of the cochrane hepato-biliary group (according to my search 272) were detected and retrieved. only two arm, parallel group superiority randomised controlled trials with a single primary outcome. the investigators excluded reports for which the study design was factorial, cluster, or crossover for all selected articles, the investigators systematically retrieved and assessed the full published report of the trial, any extra material or appendices available online, the study design article, if cited, and the details of online registration of the trial, if mentioned. a standardised data collection form was generated on the basis of a review of the literature and a priori discussion and tested by the research team.

Eligibility criteria:
inclusion criteria: * two arms, parallel group superiority randomised controlled trials with a single primary outcome, exclusion criteria: * reports for which the study design was factorial, cluster, or crossover

Keywords: sample size liver disease
pain management in pediatric adenotonsillectomy

Conditions: Pain Management

Summary: tonsillectomy is considered one of the most frequent minor surgeries conducted on a day-case basis on children, and usually associated with pain and sore throat. this study aimed to include 80 children, asa physical status i\&ii aged 4-15 years, and undergoing tonsillectomy. the purpose of this study is to determine the analgesic efficacy of topically applied lidocaine and tramadol in relieving post-operative pain in children following tonsillectomy.

pain and sore throat following tonsillectomy are typical. as a result, the issue of adequate post-tonsillectomy pain management remains a significant therapeutic obstacle. several medications, including nonsteroidal anti-inflammatory drugs, corticosteroids and narcotics have been utilised to alleviate pain following tonsillectomy. nevertheless, they have numerous undesirable negative consequences. nsaids may impede hemostasis and increase the propensity for bleeding. opioid may result in respiratory depression, nausea, and vomiting. consequently, the major purpose of this study is pain alleviation with minimal adverse effects. this prospective, randomized, double-blind controlled clinical study will include 80 children, undergoing tonsillectomy, to receive either topical tramadol 5% or lidocaine 2%. modified visual analogue scale (m-vas), bleeding, nausea, vomiting, sore throat, otalgia, fever, halitosis, and constipation will be recorded.

Eligibility criteria:
inclusion criteria: * recurrent acute tonsillitis * chronic tonsillitis * tonsillar hypertrophy with or without obstructive sleep apnea exclusion criteria: * parent refusal * hypersensitivity * history of bronchial asthma * renal impairment * impaired liver function * bleeding disorders

Keywords: topical analgesia lidocaine tramadol modified visual analogue scale
effect of ischemic preconditioning on atrial fibrillation after electrocardioversion

Conditions: Atrial Fibrillation

Summary: remote ischemic preconditioning is one way to influence the success of therapy in cardiovascular patients. by means of remote ischemic preconditioning the incidence of atrial fibrillation after cardiac surgery was reduced by 54%. the investigators aim to investigate the effect of ischemic preconditioning in an easy-to-perform protocol with regard to the recurrence of atrial fibrillation after electrical cardioversion.


Eligibility criteria:
inclusion criteria: * patients with paroxysmal or persistent atrial fibrillation who give written informed consent to participate in the study * age \> 18 years * consent capacity exclusion criteria: * age under 18 years * pregnancy * lack of consent capacity
safety study to evaluate bms-830216 in healthy subjects

Conditions: Obesity

Summary: the purpose of this study is to evaluate the safety profile, tolerability, and pharmacokinetics of single oral doses from 10 mg up to 1200 mg of bms-830216 (pro-drug of bms-819881) in healthy subjects


Eligibility criteria:
inclusion criteria: * healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ecg), and clinical laboratory evaluations will be eligible to participate in the study * women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men between ages of 18 to 45 exclusion criteria: * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations
everest-hn 1: evolution of a patient-reported symptom-based risk stratification system

Conditions: Head and Neck Cancer

Summary: can a patient-reported symptom-based risk stratification system improve the suspected head and neck cancer (hnc) pathway? our methodology includes six interlinked work packages to deliver our aim, with everest-hn 1 encompassing the first of these and seeking to optimise a patient-reported symptom inventory for hnc and outline requirement specification for the symptom input clinical (sync) system.

the everest-hn pathway should be based on a comprehensive understanding of existing hnc diagnostic pathways and what patients and clinicians value in these. the language used within the everest pathway needs to be accessible and optimal to elicit appropriate information.

Eligibility criteria:
inclusion criteria: patients: * adults ≥ 18 years referred via suspected hnc pathway without previous history of hnc * participants willing and able to give informed consent for participation in the study. clinicians: * staff at participating sites involved in the diagnostic pathway for people with suspected hnc. exclusion criteria: * individuals who do not meet the inclusion criteria.
folfoxiri compared with folfiri for metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of the study is to evaluate if the exposure to all the three active cytotoxic agents (folfoxiri regimen) is superior in terms of response rate to conventional chemotherapy with the folfiri regimen as first-line treatment of metastatic colorectal cancer patients.

survival of patients with metastatic colorectal cancer is correlated with the proportion of patients who receive all the three active drugs in the course of the disease, but not with the proportion of patients who receive any second-line therapy. in a sequential strategy, not all patients who progress after first-line chemotherapy are able to receive second-line treatment. moreover, there is a correlation between the response rate to chemotherapy and the postchemotherapy radical resection rate of metastases. therefore, a way to improve the outcome of metastatic colorectal cancer patients could be to administer a first-line regimen containing the three active agents.

Eligibility criteria:
inclusion criteria: * adenocarcinoma of the colon or rectum * unresectable metastatic disease * age 18 to 75 years * eastern cooperative oncology group (ecog) performance status of 2 or lower if age 70 years or younger or ecog performance status of 0 if age 71 to 75 years measurable disease according to whocriteria * leukocyte count of at least 3,500/mm3, neutrophils count of at least 1,500/mm3, platelet count of at least 100,000/mm3 * serum creatinine of 1.3 mg/dl or less * serum bilirubin less than 1.5 mg/dl and ast, alt, and alkaline phosphatase 2.5 x normal values or less (\</= 5 if liver metastases) * previous fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before random assignment exclusion criteria: * previous palliative chemotherapy for metastatic disease * previous chemotherapy including irinotecan or oxaliplatin * symptomatic cardiac disease, myocardial infarction in the last 24 months or uncontrolled arrhythmia * active infections * inflammatory bowel disease * total colectomy

Keywords: metastatic colorectal cancer phase iii folfoxiri folfiri
venous to arterial carbon dioxide difference (p₍ᵥ-ₐ₎co₂): predictor of septic patient prognosis depending on the scvo₂

Conditions: Septic Shock

Summary: the investigators will include 120 patients with a diagnosis of septic shock in accordance with the definition given by the 2001 expert consensus. two groups of patients are likely to participate in this study: patient hospitalized in intensive care for a septic shock = primary patient + patient who develops, the waning of his hospitalization in intensive care for another reason, a septic shock = secondary patient. haemodynamic monitoring by transpulmonary thermodilution allow a patient's close monitoring during the initial phase supported. the clinical and biological data, demographic and the severity scores are collected for each patient during the first three days of stay. to predict the unfavorable evolution of the patients, a measure of the sofa score at the input (j0) and third day (j2) is performed. the investigators analyzed mortality at day 28 in patients with increased p₍ᵥ-ₐ₎co₂ and those with increasing of organ failure. this research will be conducted according to good clinical practice. an information will be distributed to patients.


Eligibility criteria:
inclusion criteria: * patient with a diagnosis of septic shock * initial lactate in patients should be≥ 2 mmol / l. * the presence of circulatory insufficiency defined by a systolic blood pressure ≤ 90 mmhg (or a drop in blood pressure≥ 50 mmhg in hypertensive patients) * one or more of the following: oliguria defined as diuresis≤ 0,5 ml/ kg / h for at least two hours; the presence of signs of cerebral hypoperfusion; the highlighting of mottling * the presence of a femoral arterial catheter and a central venous line in the superior vena cava position * hemodynamic monitoring with semi-invasive monitoring of cardiac output with thermodilution exclusion criteria: * patient no longer in the initial phase of septic shock * absence of semi-invasive cardiac monitoring with thermodilution * vulnerable people * absence of informed consent
association of periodontal inflammation on immune response in wound healing

Conditions: Inflammation of Mouth

Summary: subjects who are in need of extraction of a posterior tooth will be recruited for this study. prior to extraction, periodontal clinical markers of inflammation, body-mass index and dental radiographs will be measured/taken. the posterior tooth will be atraumatically extracted and a small soft tissue biopsy of the extraction site will be taken. at the two week follow-up, sutures will be removed and another small biopsy of soft tissue will be taken. subjects will be seen again at 3 months for a final collection of clinical data and radiographs.

twenty-five healthy adult subjects (aged 21-70) requiring extraction of a posterior tooth will be recruited for this study. prior to extraction, a limited-view cone beam computed tomography radiograph will be taken as well as clinical measures of periodontal inflammation (probing depths, recession, bleeding on probing, gingival crevicular fluid sampling). the extraction will be completed atraumatically and with local anesthesia. following extraction, a small biopsy of the soft tissue of the extraction site will be taken and the site then sutured. at the two-week postoperative visit, sutures will be removed and another soft tissue biopsy of the healing site will be collected (along with clinical data from the adjacent teeth). the soft tissue biopsies will be fixed and processed for inflammatory endocytes present during wound healing. at the three-month postoperative visit, all clinical parameters of wound healing will be evaluated; including inflammatory measures (probing depths, recession, bleeding on probing, gingival crevicular fluid sampling) from the adjacent teeth; as well as a limited-view cone beam computed tomography radiograph. the biopsies will be processed to obtain single cell counts with half of the preparation stained and analyzed via multiparameter flow cytometry. the other half of single cells obtained from the tissue biopsies will be cryopreserved for cellular indexing of transcriptomes and epitopes-sequencing.

Eligibility criteria:
inclusion criteria: * non-restorable posterior tooth (molar/premolar) in need of extraction exclusion criteria: * systemic disease that effects inflammation

Keywords: periodontitis wound healing extraction