Aligner patients will be treated with Invisalign® aligners to correct malocclusion

Multibracket patients will be treated with self ligating orthodontic brackets

Orthodontic Appliances, Removable

Orthodontic Appliances, Fixed

Oral Microbiome

Cell Culture

Periodontal Index

Malocclusion will be treated with orthodontic appliances (fixed or removable)

orthodontic treatment

Medical University of Vienna

Microbiome and Immunogenity of Saliva During Orthodontic Therapy

Changes of Oral Microbiome and Immunogenity of Saliva During Orthodontic Therapy With Aligners and Multibracket Therapy - a Pilot Study

bacteria of the oral microbiome including cariogenic bacteria via dna sequencing

Michael Nemec

Staff member, dentist

One iron tablet once a day plus a 500 mg vitamin C tablet twice a day until delivery.

One iron tablet once a day plus a placebo tablet twice a day until delivery.

Anemia in Pregnancy

Vitamin C

Five Rivers Health Centers

Effect of Ascorbic Acid Supplementation in Pregnancy on Anemia (AAA)

Data will be used by the study team to test the study hypothesis

David S. McKenna

Principal Investigator

Fetal Medicine Foundation

Wright State University

Randomized Parallel Group, Placebo Controlled Trial

intervention administered to control group is a combination of drugs as follow: ciprofloxacin 500mg, cefixime 500 mg, metronidazole 500 mg, simvastain 40mg. all are mixed, placed in pulp chamber only one time and tooth is restored

intervention administered to experimental group is a ready made mixture of calcium hydroxide and iodoform, placed in pulp chamber only one time and tooth is restored

Necrotic Pulp

Postoperative Pain

mixture of calcium hydroxide and iodoform

Calcium Hydroxide, Iodoform, paste

3-mixtatin mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin

3-mixtatin

Pedodontic Department Cairo University

Evaluation of Postoperative Pain After Using 3MIX-TATIN Versus Calcium Hydroxide Iodoform Paste In Necrotic Primary Molars Treated by Lesion Sterilization and Tissue Repair Therapy

Evaluation of Postoperative Pain After Using 3MIX-TATIN Versus Calcium Hydroxide Iodoform Paste In Necrotic Primary Molars Treated by Lesion Sterilization and Tissue Repair Therapy: A Randomized Controlled Trial

measurment of post-operative pain by a questionnaire either present or absent

visual inspection either present or absent

Mahmoud M Saadoon

resident dr, department of pedodontics, cairo University

Step 1 - implantation of everolimus-eluting stent with imaging by MSCT, IVUS and OCT; Step 2 - injection of stem cells containing gold nanoparticles with silica-iron oxide shells.

Coronary Artery Disease

Atherosclerosis

Step 1 - IVUS, OCT-guided put in everolimus-eluting (drug-eluting-DES) stent + intravascular ultrasound (IVUS) mapping + harvesting stem cells with mesenchymal phenotype; Step 2 - culturing of stem cells in medium by gold nanoparticles with silica-iron oxide shells; Step 3 - micro-infusion of stem cells bearing NP into the lesion; Step 4 - detonation of nanoshells after migration of stem cells with NPs inside (until 7-10 days after transplantation). We expect 'melting' and 'burning' effects of PPTT, beneficial effects of bioactive products of stem cells lysis + benefits from further migration of stem cells from patch into the plaque

Stenting and micro-infusion of NP

Put stent in ischemia-related coronary artery by indications for PCI

Implantation of everolimus-eluting stent

Nanocenter of the Ural Federal University

De Haar Research Foundation

Ural Center of Modern Nanotechnologies, Institute of Natural Sciences, Ural Federal University

Ural Institute of Cardiology

Plasmonic Photothermal and Stem Cell Therapy of Atherosclerosis Versus Stenting

Plasmonic Photothermal and Stem Cell Therapy of Atherosclerosis With The Use of Gold Nanoparticles With Iron Oxide-Silica Shells Versus Stenting

Total plaque volume measured by intravascular ultrasound (IVUS), cubic mm.

Composite end-point of all-cause death, all MACE - major cardiovascular events, any revascularization

Analysis of IVUS(intravascular ultrasound)-related composition of plaque (calcified deposits, necrotic calcified core), fibro-lipid core and etc.

Clinical examination of major and minor bleeding under the antithrombotic therapy

Restenosis rate verified clinically + IVUS

Stent thrombosis rate verified clinically, angiography, IVUS

Ultrasound-related examination of coronary flow-mediated vasodilatation

Ultrasound-IVUS-related examination of coronary intima-media thickness

IVUS-related assessment of minimum diameter stenosis

IVUS-related assessment of minimum lumen diameter

Alexander Kharlamov

Research manager

Ural Medical University

Ural Federal University

60 patients in Nano group were treated with transplantation of nanoparticles (NP), particularly with a bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.

60 patients in Ferro group were managed with transplantation of iron-bearing nanoparticles (NP), particularly with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction. NP were detonated with NIR laser under the protection of anti-platelet therapy.

In case of control group (stenting control), XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.

60 patients in Nano group were treated with bioengineered patch that was grown with allogeneic stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.

Nano Group

60 patients in Ferro group were managed with intracoronary infusion of allogeneic stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.

Ferro Group

In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.

Stenting Control

Total

Sex: Female, Male

Region of Enrollment

Total atheroma volume (TAV, plaque-media volume, mm3) at 12 months. Quantitative coronary angiography (QCA) and Intravascular Ultrasound (IVUS) were performed pre-, post-procedure and at 12-month follow-up after a bolus infusion of i.c. nitrate. QCA was undergone with the CAAS II analysis system (Pie Medical B.V., Maastricht, The Netherlands) with analysis of different QCA parameters such as minimal lumen diameter, maximum lumen diameter, reference diameter, diameter stenosis, lesion length, percent atheroma volume (PAV), total atheroma volume (TAV), and lumen volume.

60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.

60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.

Total Atheroma Volume

MACE (major adverse cardiovascular events)-free survival reflects per cent of survived patients without MACE. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.

60 patients in Nano group were treated with transplantation of nanoparticles (NP), particularly with a bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation. Transplantation of nanoparticles: 60 patients into nanogroup with the use of 60/

60 patients in Ferro group were managed with transplantation of iron-bearing nanoparticles (NP), particularly with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP. NP were detonated with NIR laser under the protection of anti-platelet therapy. Transplantation of iron-bearing nanoparticles: 60 - int

In case of control group (stenting control), XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
Stenting: 60 - in sirolimus-eluting stenting control

MACE (Major Adverse Cardiovascular Events)-Free Survival

IVUS (intravascular ultrasound) and IVUS-VH (virtual histology) images were acquired simultaneously with a phased array 20 MHz intravascular ultrasound catheter EagleEye (Volcano Co., Rancho Cordova, CA, USA) with motorized pull-back at a constant speed of 0.5 mm/s. Four tissue components (necrotic core - red; dense calcium - white; fibrous - green; and fibro-fatty - light green or yellow) were identified with autoregressive classification systems. For each cross section stent struts were detected as areas of apparent dense calcium and necrotic core. All IVUS analysis was performed offline by a CoreLab of the Ural Institute of Cardiology.

Per Cent of Fibro-fatty Component

The Kaplan-Meier analysis of the cardiac event-free survival (failure-free survival). The end point in this study was cardiac event-free survival during follow-up, starting at randomization. Cardiac events included cardiac death, myocardial infarction and unintended revascularization. Cardiac death was defined as sudden death, death after the onset of symptoms suggestive of cardiac ischemia and death due to heart failure. Noncardiac death was defined as death due to all other causes. Myocardial infarction was defined as an increase in cardiac enzymes or new pathologic Q-waves on the ECG, or both. Unintended revascularization was defined as PTCA or CABG performed due to worsening of the patient's clinical condition, rather than the PTCA or CABG assigned by the revascularization team when patient management was determined.

Event Free Survival

Restenosis Rate

Late Definite Thrombosis

Coronary vasomotion was assessed with QCA. End-diastolic images of coronary arteries were evaluated at baseline, after intravascular infusion of acetylcholine (through a microcatheter at increasing doses up to 10-8, 10-7, 10-6 M with a washout period of at least five minutes between each dose), and after nitroglycerine application following acetylcholine (100 µg orally). In all patients, measurements were performed in two segments on site of intervention while 960 seconds. The artery diameter was calibrated against the contrast-filled tip of the catheter. Vasoconstriction to acetylcholine was defined as a 3% change of the mean lumen diameter after infusion of the maximal dose of acetylcholine. An investigator blinded to treatment group performed all measurements.

Coronary Vasomotion - Mean Lumen Diameter After Infusion of Acetylcholine 10-6 M

Per cent atheroma volume (PAV, plaque burden, %). Quantitative coronary angiography (QCA) and Intravascular Ultrasound (IVUS) were performed pre-, post-procedure and at 12-month follow-up after a bolus infusion of i.c. nitrate. QCA was undergone with the CAAS II analysis system (Pie Medical B.V., Maastricht, The Netherlands) with analysis of different QCA parameters such as minimal lumen diameter, maximum lumen diameter, reference diameter, diameter stenosis, lesion length, percent atheroma volume (PAV), total atheroma volume (TAV), and lumen volume.

Per Cent Atheroma Volume

Target lesion revascularization, per cent

Target Lesion Revascularization

Per Cent of Fibrous Component

Per Cent of Necrotic Core

Per Cent of Calcium

Minimal Lumen Diameter

MACE includes per cent of patients with cardiac death. STEMI (ST-elevation myocardial infarction), non-STEMI, and TLR (target lesion revascularization). An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.

60 patients in Nano group were treated with transplantation of nanoparticles (NP), particularly with a bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. NP were activated with NIR laser at 7 days after the intervention. Transplantation of nanoparticles: 60 patients into nanogroup with the use of 60/15-70/40 nm silica-gold nanoparticles (NPs) transplanted by endoscopic cardiac surgery in the composition of bioengineered on-artery patch grown on the basis of biopolymeric scaffold and host circulating CD45-CD34-CD73+CD105+ progenitor cells

60 patients in Ferro group were managed with transplantation of iron-bearing nanoparticles (NP), particularly with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction. NP were detonated with NIR laser under the protection of anti-platelet therapy.
Transplantation of iron-bearing nanoparticles: 60 - into ferro-magnetic group with 60/15-70/40 nm silica-gold iron-bearing NPs with delivery in hand of magnetic navigation system

MACE

Cardiac death includes per cent of patients passed away due to any cardiac death. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.

Cardiac Death

TLR (target lesion revascularization) reflects per cent of patients with TLR. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.

TLR (Target Lesion Revascularization)

TVR (target vessel revascularization) reflects per cent of patients with TVR. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.

TVR (Target Vessel Revascularization)

Mean number of membrane defects on membrane of red blood cells calculated with atomic force microscopy (AFM) in random patients. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively.

Blood for ex-vivo cytotoxic analysis (20.0 ml from a random patient) was collected for analysis at the Center for Modern Nanotechnologies of the Ural Federal University from the random naive patients to the BD Vacutainer (NJ, USA) plastic heparin tubes (spray-coated) with 150 USP units of sodium heparin per 10.0 ml, and then diluted by 0.1 g/l silica-gold NPs.

Exposure of Nanoparticles

Blood for ex-vivo cytotoxic analysis (20.0 ml from a random patient) was collected for analysis at the Center for Modern Nanotechnologies of the Ural Federal University from the random naive patients to the BD Vacutainer (NJ, USA) plastic heparin tubes (spray-coated) with 150 USP units of sodium heparin per 10.0 ml, and then diluted by saline.

Sham

Mean Number of Membrane Defects on Membrane of Red Blood Cells

Overall Study

Dr. Alexander Kharlamov

Stable Angina

Heart Failure

Multivessel Coronary Artery Disease

60 patients into nanogroup with the use of 60/15-70/40 nm silica-gold nanoparticles (NPs) transplanted by endoscopic cardiac surgery in the composition of bioengineered on-artery patch grown on the basis of biopolymeric scaffold and host circulating CD45-CD34-CD73+CD105+ progenitor cells

Transplantation of nanoparticles

60 - into ferro-magnetic group with 60/15-70/40 nm silica-gold iron-bearing NPs with delivery in hand of magnetic navigation system

Transplantation of iron-bearing nanoparticles

60 - in sirolimus-eluting stenting control

Stenting

De Haar Research Task Force

Transfiguration Clinic

Plasmonic Nanophotothermal Therapy of Atherosclerosis

Plasmonic Photothermal Therapy of Flow-Limiting Atherosclerotic Lesions With Silica-Gold Nanoparticles: a First-in-Man Study

The raw data will be partially shared (a Protocol for NANOM-FIM trial and related DREAM project; raw data with atomic force microscopy and scanning electron microscopy) in Mendeley Datasets and ResearchGate without any additional dissemination.

silica/hemorrhage

Microbiome and Immunogenity of Saliva During Orthodontic Therapy

Effect of Ascorbic Acid Supplementation in Pregnancy on Anemia (AAA)

Evaluation of Postoperative Pain After Using 3MIX-TATIN Versus Calcium Hydroxide Iodoform Paste In Necrotic Primary Molars Treated by Lesion Sterilization and Tissue Repair Therapy

Plasmonic Photothermal and Stem Cell Therapy of Atherosclerosis Versus Stenting

Plasmonic Nanophotothermal Therapy of Atherosclerosis

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