Kornimate/medical-research-clean huggingface dataset:
5-year follow up study on the comparative performance of two-piece zirconia and titanium implants

Conditions: Dental Implants; Single Tooth Lost; Dental Implant Failed

Summary: a post-market, randomized-controlled, superiority clinical study to compare medium-term performance and safety of the straumann pure 2-piece ceramic implant with straumann bone level implant using a fully digital workflow.

dental implants are a key modality for tooth replacement. titanium dental implants have been the mainstay of dental implants as it osseointegrate well. titanium has a silver gray metallic color and therefore, to hide its presence and enhance the aesthetic appearance, the implant is usually placed deeper into the bone tissue and the gums. this has negative consequences since it becomes more difficult to keep the interface between the dental implant and the crown free from bacterial plaque and inflammation. the use of zirconia（a base form of metal with similar properties of titanium in terms of osseointegration) has attracted a lot of interest because of its color that is similar to the one of natural teeth.this study will hence compare the long term performance of standard 4th generation dental implants made of titanium with a second generation zirconia dental implant. the study will evaluate the occurence of biological and technical complications; patient satisfaction and with the aesthetics of the tooth replacement over time.

Eligibility criteria:
inclusion criteria: following criteria must be met for inclusion in the study: * patients must have voluntarily signed the informed consent form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data will be collected, analyzed, and published. * patients must be males or females who are a minimum of 18 years of age. * patients, who have received a single tooth replacement with a study implant as per-protocol in the premolar-to-premolar area (excluding lower incisors) in the mandible and maxilla and restored with a screw retained ceramic crown. exclusion criteria: * patients with conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability. * pregnancy or intention to become pregnant at any point during the study duration.
clinical validation of boneview for fda submission

Conditions: Fracture

Summary: the goal of this clinical validation is to assess comparative performances of physicians with and without the assistance of boneview for the diagnosis of fractures on radiographs. the performances are evaluated in terms of accuracy (primary endpoint with the pair specificity/sensitivity and the secondary endpoint ppv/npv) and in terms of time needed for diagnosis (secondary endpoint with the measurement of time on each case).


Eligibility criteria:
inclusion criteria: * anonymized standard x-ray exams of extremity/pelvis/rib cage/dorsolumbar spine not containing or containing fracture(s). * adult patient, with minimum age of 21 years old. exclusion criteria: * exams with one or more images including a body part not concerned by the intended use of boneview (skull and cervical spine) * cases with one or more images being used for model design and development. * exams with one or more images being of poor quality (lossy), which prevent a proper interpretation by the readers. * cases not containing a medically relevant number of views for correct diagnosis.

Keywords: fracture artificial intelligence x-rays radiographs
bioequivalence study

Conditions: Diabetes

Summary: the purpose of this study is to determine if tablets manufactured at different sites have the same bioavailability, that is yield similar blood levels/concentrations of the drugs and are handled by the body similarly

primary purpose: other: protocol designed to demonstrate the bioequivalence of the fixed dose combination of 5 mg saxagliptin and 1000 mg metformin extended release tablet manufactured in mt. vernon, indiana and humacao, puerto rico relative to the fixed dose combination tablet manufactured in mt. vernon, indiana and the bioequivalence of the fixed dose combination of 5 mg saxagliptin and 500 mg metformin extended release tablet manufactured in mt. vernon, indiana and humacao, puerto rico relative to the fixed dose combination tablet manufactured in mt. vernon, indiana in healthy human subjects under fed conditions

Eligibility criteria:
inclusion criteria: * healthy male and female subjects, 18-45 years of age * body mass index (bmi) of 18.0 to 30.0 kg/m2, inclusive * women must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product exclusion criteria: * any significant acute or chronic medical illness * estimated creatinine clearance of \<60 ml/min as calculated using the modification of diet in renal disease method current or recent (within 3 months of study drug administration) * gastrointestinal (gi) disease that could affect the absorption of study drug * inability to tolerate oral medication * history of allergies or adverse reactions to dpp4 inhibitors or metformin or related compounds * current smoker or recent (within 6 months of study drug administration) history of regular tobacco use (positive cotinine test)
resynchronisation therapy of right ventricle in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: pulmonary arterial hypertension is a disease characterised by pathological changes in the pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and pulmonary artery pressure. right ventricular failure is the main cause of death in patients with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the progressive increase in pulmonary vascular resistance associated with changes to the pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a patient's functional capacity and survival. right ventricular dyssynchrony was present in a substantial proportion of patients with pulmonary arterial hypertension and this dyssynchrony adversely affected right ventricular function.


Eligibility criteria:
inclusion criteria: * pulmonary hypertension type i, iii, iv, v dana point classification * nyha classification equal or superior to stage ii * during right catetherization : cardiac index inferior or equal 2.5 l/mn/m2 and atrial pressure superior or equal 10 mmhg or cardiac index equal or inferior to 2.2 l/mn/m2 * optimal therapy considered by the referring specialist practioner of the patient exclusion criteria: * minor or incapacitated adult * pregnancy * unability to give free and informed consent * pulmonary hypertension type ii dana point classification * eisenmenger syndrome * patent foramen ovale * left bundle-brach block * pulmonary hypertension exacerbation * medical clinical situation considered inappropriate by the investigator * patient eligible for a heart-lung transplant * patient eligible for pulmonary endarterectomy * patient with poor echogenicity * filter in the inferior vena cava

Keywords: pulmonary arterial hypertension cardiac resynchronization therapy
a trial comparing efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial was conducted in africa, asia, europe, north and south america. the aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (diagnosed clinically) for at least 6 months * insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days) * current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase iv (dpp-iv) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to randomisation (visit 2) with the minimum doses stated: metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, dpp-iv inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose * hba1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory analysis * bmi (body mass index) below or equal to 40.0 kg/m\^2 exclusion criteria: * treatment with tzds (thiazoledinedione), or glp-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to visit 1 (screening) * anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mao (monoamine oxidase) inhibitors * cardiovascular disease within the last 6 months prior to visit 1 (screening) defined as stroke; decompensated heart failure nyha (new york heart association) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty * any clinically significant disease or disorder, except for conditions associated with type 2 diabetes mellitus, which in the investigator's opinion could interfere with the results of the trial * previous participation in this trial. participation is defined as randomised. re-screening of screening failures is allowed only once within the limits of the recruitment period * known or suspected hypersensitivity to trial product(s) or related products
a study to evaluate the effects of giving interleukin-2 (il-2) plus anti-hiv therapy to hiv-positive patients with cd4 cell counts of at least 350 cells/mm3

Conditions: HIV Infections

Summary: to demonstrate the safety and tolerability of subcutaneously administered interleukin-2 (il-2) plus antiretrovirals in patients with hiv infection and cd4 counts of 350 cells/mm3 or more. to demonstrate the immunological efficacy of subcutaneous il-2 therapy plus antiretroviral therapy relative to antiretroviral therapy alone. il-2, given through injection under the skin, in combination with anti-hiv therapy can increase cd4 cell counts. this study examines 3 doses of il-2 in order to determine the safest and most effective dose to use.

interleukin-2 administered subcutaneously, in combination with antiretrovirals, results in increases in cd4+ cell count that might impact upon hiv disease progression. a phase iii trial involving large numbers of hiv-positive patients is the next step in the development process. to develop appropriate clinical experience with the combination, this phase ii trial will allow administration of il-2 plus antiretroviral therapy to a small number of patients in sites being considered for the phase iii trial. patients are randomized to control therapy with antiretrovirals alone (36 patients) or antiretrovirals plus il-2 given subcutaneously every 12 hours for 5 days every 8 weeks. three doses of il-2 are studied, with 12 patients evaluated at each dose. if at least 9 of the first 12 patients complete the 5-day dosing period without dose-limiting toxicities, the next 12 patients randomized are treated with the next higher dose; if this dose is tolerated, the last 12 patients randomized receive the highest study dose. patients enrolled at the first two doses of il-2 who complete three courses have their dose escalated to a maximum of the highest dose.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive. * have a cd4 cell count greater than or equal to 300 cells/mm3. * are at least 18. * have been on antiretroviral therapy for at least 7 days prior to study entry. exclusion criteria you will not be eligible for this study if you: * abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect your safety or ability to complete the study. * have a history of cancer (other than kaposi's sarcoma), an aids-defining illness, a central nervous system (cns) abnormality, or an autoimmune/inflammatory disease. * are pregnant or breast-feeding. * have ever received il-2.

Keywords: interleukin-2 cd4 lymphocyte count anti-hiv agents
analysis of the stress induced by in situ simulation

Conditions: Psychologic Stress; Heart Arrest

Summary: vulnerability to psychologic distress induced by in situ simulation. objectives: psychological evaluation at short and long term on working satisfaction, mental health, and acute stress after in situ simulation. analysis of the stress vulnerability induced by simulation. design: non interventional study. primary outcome: psychologic distress analysis with validated psychologic distress inventory (job satisfaction survey (jss), general health quality (ghq), impact of event scale revisited (iesr), state-trait anxiety inventory-a (stai-a), state-trait anxiety inventory -b (stai-b)).


Eligibility criteria:
inclusion criteria: * team members: nurses, auxiliary nurse, residents, doctors, students exclusion criteria: * non volunteers

Keywords: in situ simulation in hospital cardiac arrest clinical audit education patient simulation
prevention of liver damage during liver surgery

Conditions: Liver Tumors

Summary: liver damage as a consequnce of ischemia (i) and reperfusion (r) is known to harm the liver and could hence be a critical factor of the postoperative outcome of patients undergoing liver surgery. in order to protect the liver from ischemic damage following interventions such as the pringle maneuver, preconditioning has been successfully applied in various animal models as well as in humans. since ischemia inevitably leads to cell hypoxia and subsequnet release of endogenuous metabolites, the investigators hypothesize that instead of brief periods of ischemia, the exogenuous infusion of purine analogues may also protect against subsequent prolonged periods of ischemia. moreover, after reperfusion, the antiinflamamtory action of purine ananlogue infusion can further attenuated liver damage.


Eligibility criteria:
inclusion criteria: * elective resection of liver tumors * age 18 to 80 years * informed consent exclusion criteria: * chronic obstructive pulmonary disease * heart insufficiency nyha iii-iv * atrio-ventricular conductance blockage ii. (mobitz) or iii. degree * atrial fibrillation * coronary heart disease (ccs iii. or iv. degree) * arterial hypertension * acute renal failure * increased intracranial pressure * gout * pregnancy

Keywords: liver surgery
role of eosinophil in fibrogenesis of systemic sclerosis

Conditions: Systemic Sclerosis; Systemic Scleroderma

Summary: eosinophils are involved in tissue remodeling and fibrosis in many inflammatory diseases. systemic sclerosis (ssc) is an autoimmune disease with fibrotic skin and lung complications. the profibrosing properties and data from the ssc literature suggest a possible role of the eosinophils in the process of fibrogenesis of ssc.

it will assess the activation state of blood eosinophils in ssc patients compared to healthy controls (ecp production in vitro, surface activation markers, whole transcriptome array, ..). it will also study skin eosinophils and their recruitment (extracellular eosinophil granules, eotaxins production in skin, ..)

Eligibility criteria:
inclusion criteria: * for ssc patients: * meeting the 2013 acr-eular criteria for diffuse ssc (n = 20) and limited ssc (n = 20) * having signed the informed consent * eosinophils ≥ 0.1 g / l on the last blood test (\<3 months) for healthy subjects: * without chronic pathology requiring long-term treatment * eosinophils between 0.1 and 0.4 g / l on recent blood test (\<3 months) exclusion criteria for patients and controls: * patient with an infection, state of emergency or progressive neoplastic pathology * pregnant or lactating women * history of atopy (allergic asthma, atopic eczema, allergic rhinitis, allergic conjunctivitis) * allergy to local anesthetics (for scleroderma patients only) * taking into account a minimum weight of 50 kg and in the absence of cardiorespiratory effects of scleroderma, only patients with at least 10 g of hemoglobin will be included

Keywords: eosinophil fibrosis systemic scleroderma
effect of quercetin on prophylaxis and treatment of covid-19

Conditions: COVID-19

Summary: novel coronavirus is defined to be the cause of covid-19, recently. it's known that covid-19 goes with excessive immune reaction of human body in severe cases. the investigators hypothesize that quercetin, as a strong scavenger and anti-inflammatory agent, can be effective on both prophylaxis and treatment of covid-19 cases. therefore, the aim of this study to evaluate the possible role of quercetin on prophylaxis and treatment of covid-19.

novel coronavirus is defined to be the cause of covid-19, recently. it's known that covid-19 goes with excessive immune reaction of human body in severe cases. quercetin is reported to be effective on treatment and prophylaxis of other sars like coronavirus infections, as a strong antioxidant and scavenger flavonoid without any adverse events. upon this data, the investigators hypothesize that quercetin can be effective on both prophylaxis and treatment of covid-19 cases. therefore, the aim of this study to evaluate the possible role of quercetin on prophylaxis and treatment of covid-19.

Eligibility criteria:
inclusion criteria: * moderate-high risk for covid-19 * obtained informed consent exclusion criteria: * declined to participate * genetic/chromosomal abnormalities * any kind of sensitivity or allergy for quercetin * history of previous hypersensitivity with quercetin
effects of lifestyle modification on metabolic parameters in type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: the study is a randomized controlled study comparing the metabolic effect of a 3 month intensive lifestyle modification intervention in korean type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * age 25 or older, * type 2 diabetes mellitus, * hba1c 6.5-10% bmi 23 or higher. exclusion criteria: * type 1 diabetes, * recent (within 3 months) cardiovascular event, * severe hepatic or renal dysfunction, * insulin use, * glucocorticoid use.

Keywords: type 2 diabetes mellitus lifestyle modification
catheter dislocation and the influence of different catheter fixation in pediatric patients

Conditions: Catheter Complications

Summary: insertion of intravenous or intra-arterial catheter is one of the most common procedures in anesthesiology and intensive care medicine. after successful insertion, proper catheter fixation is required to maintain the catheter correct position with the aim to preserve catheter patency, prevent excessive movements of catheter or even iatrogenic catheter extraction/dislocation. beside the historically preferred surgical fixation to the skin of the patient (invasive method, repeated percutaneous punction), atraumatic fixation by special dressing is currently available in clinical practice. in pediatric patients, due to limited cooperation, higher risk of dislocation exists.

pediatric patients with intravenous and/or intraarterial catheters with estimated length of insertion over 72 hours will be included into the trial.type of catheter fixation (surgical versus atraumatic) will be evaluated. demographic data, local and systemic complication between the group of surgical fixation and atraumatic fixation will be evaluated.

Eligibility criteria:
inclusion criteria: * pediatric patients with intravenous/intraarterial catheter secured at departement of pediatric anesthesiology and intensive care medicine * estimated length of catheter left in place longer than 72 hours exclusion criteria: * estimated length of catheter left in place shorter than 72 hours * impossible patient´s evaluation after catheter insertion

Keywords: intravenous intraarterial catheter fixation withdrawal dislocation
the effects of exercise in anxiety in children with asd

Conditions: Autism Spectrum Disorder; Anxiety; Behavior

Summary: this study will examine the effects of a school based exercise programme on anxiety and behaviour levels in children with autism.

this study will examine the effects of a school based exercise programme on anxiety and behaviour levels in children with autism. local special autism schools and primary and secondary schools with specialised classes for children with autism will be approached to participate in the project. the age profile of the children will be 4-18 yrs of age and they will have mild-severe levels of autism. the exercise programme will delivered 3 times per week in the schools over periods of 8-16 weeks dependent on the severity of autism within the children. questionnaires will be given to the parents and teachers of the children at the beginning and at the end of the programme to assess changes in anxiety levels and behaviour as a result of the exercise programme.

Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder exclusion criteria: * any medical condition which excludes the child from partaking in exercise

Keywords: autism anxiety exercise behaviour
recovery profiles after c spine surgery: with or without dexmedetomidine as an anesthetic adjuvant

Conditions: Cervical Spondylosis

Summary: the purpose of this study is to determine the recovery profiles after general anesthesia in patient undergoing anterior cervical spine surgery. this study will compare the riker sedation agitation scores between two groups, with or without dexmedetomidine as an anesthetic adjuvant.


Eligibility criteria:
inclusion criteria: * asa 1-3 * elective case for acdf surgery * plan for extubation after surgery exclusion criteria: * sbp\>140 mmhg * cad * hr\<50 bpm, heart block * motor weakness \> grade 4 * bmi \>30 * allergic to dexmedetomidine, fentanyl

Keywords: anterior cervical spine surgery acdf dexmedetomidine anesthesia agitation riker sedation agitation scores