Kornimate/medical-research-clean huggingface dataset:
outcome after dental implant treatment

Conditions: PROMs; Peri-implantitis; Mucositis; Periodontitis

Summary: the general aim of this project is to investigate the long-term treatment outcome after implant therapy. the patients' satisfaction with implant treatment will be studied and correlated to biological and technical problems. the survival rates of implants at patient level and the degree of bone loss of remaining teeth and implants will be calculated. the levels of cytokines and bone loss markers in peri-implantitis sites and periodontal defects and at healthy sites will be analyzed in order to study the correlation between cytokine and bone loss marker levels, and clinical conditions. independent variables which could be regarded as significant risk factors or risk predictors on the incidence of peri-implantitis are aimed to be identified

* a questionnaire study will investigate patient satisfaction 8-14 years after dental implant therapy to study if complications influence the degree of satisfaction/quality of life. the questionnaire will be sent to 587 patients treated at the specialist clinic skanstull. * a clinical examination of a minimum 150 patients who answered the questionnaire will be performed: * to study the incidence of biological and technical complications on dental implants after a minimum of 10 year of function. * to study the survival rates of implants at patient level and the degree of bone loss of remaining teeth and implants. in addition, the correlation between bone loss of remaining teeth and bone loss of implants will be studied. * samples taken from the gingival crevicular fluid to investigate the profile of cytokines and bone resorption markers as well as to study the intra-individual correlation of cytokines and bone markers in gingival crevicular fluid from sites with peri-implantitis and periodontal defects in individuals with dental implants. * in addition, the salivary cytokine and bone resorption markers will be analyzed in order to identify disease-specific biomarkers as well as to study the correlation between the cytokine/bone resorption markers in saliva and in gingival/peri-implant crevicular fluid. * to identify significant risk factors or risk predictors on the incidence of peri-implantitis.

Eligibility criteria:
inclusion criteria: - treated at the specialist clinic skanstull, stockholm, sweden with dental implants between the years of 1999-2005 exclusion criteria: - deceased before or during the study period

Keywords: dental implant patient satisfaction treatment outcome cytokine profile risk factor risk predictor
evaluation of the safety, pharmacokinetics, and preliminary effect on scar formation by rxi-109

Conditions: Cicatrix; Scar Prevention

Summary: the primary purpose of this study is to evaluate the safety and tolerability of a single intradermal administration of rxi-109 at small surgical incisions in the abdominal skin that will later be removed during an elective abdominoplasty. the effect of rxi-109 versus placebo on scarring at these incision sites will be evaluated visually and histologically.


Eligibility criteria:
inclusion criteria: * subject must be a female in general good health with normal screening values * subject must be a good surgical candidate for an elective abdominoplasty * subjects must not be pregnant or lactating and utilize an effective method of contraception (if child-bearing potential exists) exclusion criteria: * currently pregnant or lactating * bmi greater than 35 at screening * use of tobacco or nicotine-containing products within the month prior to enrollment and while on study * any medical condition or current therapy which would make the subject unsuitable for this study in the opinion of the pi

Keywords: scar scar prevention fibrosis
multimodality biomarkers for noninvasive assessment of the fontan patient

Conditions: Single-ventricle; Myocardial Fibrosis

Summary: this is a single center prospective longitudinal exercise training study and will enroll approximately 50 fontan patients and 20 controls of a similar age, gender, bmi and physical activity level between the ages of 10-40 years. participants will undergo an mri of the fontan circulation. this will include imaging of the heart, lung and liver. this will include specific imaging for tissue characterization and assessment of myocardial fibrosis, liver fibrosis and disproportionate pulmonary blood flow. the investigators will then draw blood (approximately 10 ml) for assessment of serum biomarkers and circulating micrornas of interest. the participants will undergo exercise testing and will then start a 3-6 month long cardiac rehabilitation program. after the 3-6 month study period the participants will return back for a follow up and repeat all the testing completed at enrollement.

this is a single center prospective longitudinal study and will enroll approximately 50 fontan patients and 20 controls of a similar age, gender, bmi and physical activity level between the ages of 10-40 years. the investigators will enroll from pediatric cardiology and heart failure clinics and inpatient care units at children's health dallas, adult congenital heart disease clinics and inpatient care units at clements university hospital and the clinical heart center. this study will evaluate the multimodality biomarkers for assessment of fontan circulation including heart, liver and lung and change in these markers with exercise training. participants will receive an mri of the fontan circulation. this will include imaging of the heart, lung and liver. a blood draw (approximately 10 ml) for assessment of serum biomarkers and circulating micrornas of interest will be completed. the participants will also complete exercise testing and will then start a 3-6 month long cardiac rehabilitation program. frequent phone follow up (conducted by the research staff) and regular download of data from heart rate monitors will ensure adherence. after the 3-6 month study period the participants will return for a follow up and repeat all testing completed at enrollment.

Eligibility criteria:
inclusion criteria: * presence of a congenital heart defect that leads to single ventricle physiology * previously performed tcpa surgery * current age 10 years to 40 years * informed consent exclusion criteria: * history of exercise intolerance (peak vo2\<12ml/kg/min) * unstable arrhythmia at the time of screening * listed or being evaluated for heart transplantation * pregnancy or breast feeding * patient with pacemaker, av block other than 1st degree block, sick sinus syndrome or other arrhythmia that may influence ability to perform exercise test or magnetic resonance imaging

Keywords: myocardial fibrosis exercise training fontan
effectiveness of donor human milk supplementation for the treatment of hypoglycemia in the breastfed infant

Conditions: Neonatal Hypoglycemia

Summary: the purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula. hypothesis is that supplementation with commercially-sterilized donor human milk will improve hypoglycemia and limit formula use in exclusively breastfed infants.

enrolled infant participants will receive a maximum of two bottle feeding supplementations (of their designated treatment arm for either 20 calorie-per-ounce commercially-sterilized donor human milk or 20-calorie-per-ounce standard infant formula) as treatment if they meet hypoglycemia criteria. infant participants will complete the study if 1) they have received two bottle feeding supplementations for treatment of hypoglycemia, 2) they only received one bottle supplementation and hypoglycemia resolved, 3) if the medical teams deems the infants requires a higher level of care for their hypoglycemia (example: admission to the newborn intensive care unit for intravenous fluids with dextrose).

Eligibility criteria:
mother-infant pairs will be consented for participation via informed written consent. inclusion criteria: * mother/infant dyads deliverying at nebraska medicine hospital (omaha, ne, usa). * infant in the normal newborn nursery, born greater than or equal to 36 weeks gestational age. * infant with blood glucose after delivery of \< 40 milligrams/deciliter within the first four hours of life or blood glucose levels less than 45 milligrams/deciliter after four hours of life * deliverying mother plans to exclusively breastfeed. exclusion criteria: * infants born and directly admitted to the newborn intensive care unit * infants with known congenital abnormality or known inborn error of metabolism that influences growth and metabolic outcomes * infants deemed ward of state * mothers who do not plan to exclusively breastfeed at time of delivery * mothers less than 19 years of age

Keywords: neonatal newborn hypoglycemia human milk breastfed donor milk
observational study of somatropin treatment in children

Conditions: Growth Hormone (GH) Deficiency; Short Stature Homeobox Containing Gene (SHOX) Deficiency; SHOX Deficiency-related Disorder; Non-GH-deficient Growth Disorders

Summary: genesis is an open-label, multinational, multicenter, observational study to evaluate the safety and effectiveness of humatrope treatment. genesis is a modular program that includes: * core study: evaluating the safety and effectiveness of humatrope in the observational setting * genetic analysis sub-study: investigating the genetic defects underlying growth hormone (gh) deficiency and non-gh-deficient growth disorders * growth prediction sub-study: working to validate and refine specific models to accurately predict growth response to gh * short stature homeobox containing gene (shox) deficiency sub-study: elucidating the clinical, endocrine and radiological features of participants with shox deficiency due to loss of, or mutation in the shox gene (including participants with turner syndrome) * neoplasia sub-study: to characterize the natural history of neoplastic disease, especially in relation to recurrence/progression of primary neoplasia or development of secondary neoplasia in children with a history of neoplasia


Eligibility criteria:
inclusion criteria: all participants participating in genesis must be enrolled in the core study. participants for whom written consent to release information is provided may enter the core study if they meet any of the following inclusion guidelines: * treatment with humatrope for improvement of growth. * no treatment with somatropin in participants with a history of neoplasia or in those with any shox deficiency-related disorder. exclusion criteria: * participants with closed epiphyses are not eligible for genesis entry. however, participants may remain in the study if epiphyseal closure occurs during study participation.
biological specifications for denture designs

Conditions: Tooth Loss

Summary: the primary term goal of these research efforts has been to enhance the functional status, comfort and quality of life of edentulous patients by evaluating clinical procedures, denture designs and adjunctive therapies based upon a clear understanding of: (1) oral functional impairments caused by the loss of teeth and subsequent tissue changes; (2) neurophysiological mechanisms associated with oral functions; (3) metabolism of oral tissues; and (4) interactions between biological and psychological processes and denture characteristics. the primary purpose of the proposed clinical outcome study is to compare the relative efficacies of three different combinations of implant-supported maxillary and mandibular prostheses with traditional complete dentures for edentulous patients. completion of this study will determine the relative cost-effectiveness of the implant-supported denture treatments for use in the general population of edentulous patients.


Eligibility criteria:
inclusion criteria: * completely edentulous veterans with clinically acceptable conventional dentures. * both male and female applicants will be accepted and the prospective participants will be from 35 to 80 years of age. * patients who have been completely edentulous for at least two years and have clinically acceptable conventional dentures, which have been worn for at least 6 months. exclusion criteria: * verified history of medical conditions such as connective tissue disorders, blood dyscrasias, uncontrolled endocrine disorders, active tuberculosis, aids, leukemias, hodgkins, liver disfunction, osteoporosis, chronic nephritis, any chronic condition with life expectancy of less than five years as well as patients on long-term steroids, anticoagulants, and radiation therapy. * extremely poor oral hygiene. oral hygiene condition will be assessed from the amount of food debris, plaque and calculus in their present dentures. * insufficient mandibular or maxillary bone height to accommodate 10 mm long implants in potential implant sites. * presence of temporomandibular joint dysfunction and evidence of severe bruxism. * physician determines a contraindication for oral surgery. * candidate expresses reservations about participating for at least three years.

Keywords: dental implant
cilostazol and endothelial progenitor cell

Conditions: Myocardial Infarction, Acute

Summary: to assess impact of adjunctive cilostazol on endothelial progenitor cell (epc) mobilization in patients with acute myocardial infarction (to reveal the role of cilostazol in up-regulation of epc count)

primary endpoint: % change of epc count secondary endpoints: 1. changes of adp/aa/collagen-induced pft 2. changes of lipid profile and high sensitivity-c-reactive protein 3. change of teg measurements 4. change of pwv 5. predictors of epc count (baseline and 1-month) 6. ischemic (cv death, mi \& stroke) and bleeding events (barc)

Eligibility criteria:
inclusion criteria: * naïve ami * undergoing successful coronary stent implantation exclusion criteria: * high-risk patients for thrombotic event; * a history of active bleeding or bleeding diatheses; * contraindication to antiplatelet therapy; * hemodynamic or electrical instability; * oral anticoagulation therapy; * left ventricular ejection fraction \< 30%; * leukocyte count \< 3,000/mm3 and/or platelet count \< 100,000/mm3; * ast or alt \> 3 times the respective the upper limit; * serum creatinine level \> 3.5 mg/dl; * stroke within 3 months; * pregnancy; * non-cardiac disease with a life expectancy \< 1 year; * any patients not tolerable or suitable for coronary intervention; and * inability to follow the protocol

Keywords: endothelial progenitor cell myocardial infarction, acute platelets cilostazol
vorinostat in treating women with ductal carcinoma in situ of the breast

Conditions: Breast Cancer

Summary: rationale: vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. purpose: this clinical trial is studying how well vorinostat works in treating women with ductal carcinoma in situ of the breast.

objectives: * to evaluate the in vivo molecular and biological effects of vorinostat by analyzing changes in proliferation and apoptosis, histone acetylation, and hdac protein expression in women with ductal carcinoma in situ of the breast. outline: patients receive oral vorinostat twice a day for 3 days in the absence of unacceptable toxicity. patients then undergo lumpectomy or mastectomy 2 hours after the last dose of vorinostat. blood and tissue samples are collected at baseline and during surgery for biomarker laboratory studies. samples are analyzed by immunohistochemistry for ki-67, hdac1 and hdac6 protein expression, and histone h4 and α-tubulin acetylation. after completion of study therapy, patients are followed for 1 month and then every 6 months for 5 years.

Eligibility criteria:
disease characteristics: * histologically confirmed (by core biopsy) ductal carcinoma in situ * stage 0 disease * hormone receptor status not specified patient characteristics: * menopausal status not specified * ecog performance status 0-2 * anc ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * hemoglobin ≥ 9 g/dl * potassium and magnesium levels normal * prothrombin time or inr ≤ 1.5 times upper limit of normal (uln) (unless the patient is receiving therapeutic anticoagulation) * partial thromboplastin time ≤ 1.2 times uln (unless the patient is receiving therapeutic anticoagulation) * serum creatinine ≤ 1.5 times uln or creatinine clearance ≥ 60 ml/min * not pregnant or nursing * negative pregnancy test * fertile patients must use 2 effective barrier methods of contraception * no known psychiatric or substance abuse disorder that would preclude cooperation with the study requirements * no active hepatitis a, b, or c infection * no active hiv infection * no other active infection * no other malignancy within the past 5 years * no condition that would interfere with the absorption or intake of vorinostat * no history or current evidence of any condition or laboratory abnormality that would confound study results, interfere with the patient's participation in the full duration of the study, or that would not be in the best interest of the patient to participate prior concurrent therapy: * more than 2 weeks since prior iv antibiotics, antivirals, or antifungals * no prior gastrointestinal surgery or other procedure that would interfere with the absorption or intake of vorinostat * no prior or concurrent therapy with any other hdac inhibitor, including valproic acid * no prior treatment with any other investigational agent * no concurrent systemic steroids * no concurrent anticancer chemotherapy, radiotherapy, biological therapy, or other investigational therapy

Keywords: ductal breast carcinoma in situ
treatment of class ii malocclusion combined with low-level laser

Conditions: Malocclusion, Angle Class II

Summary: this experimental study will evaluate the effect of combined treatment with low-level laser and functional appliances (twin-block) on the correction of class ii malocclusion, compared with the control group treated with functional appliances (twin-block) only. the study sample will consist of 40 patients with class ii malocclusion. the sample will be allocated randomly into two groups: a control group and an experimental group. functional appliance (twin-block) will be applied for all patients. low-level laser will be applied for the experimental group only. the skeleto-dental changes occurring after functional treatment will be assessed using cephalometric radiographs; pre- and post- treatment changes for each group will be evaluated individually.

class ii malocclusion is considered as the most common malocclusion between patients. recently low-level laser enters the world of dentistry, some studies assessed the effect of low-level laser on the growth of mandibles and condyles in animals and showed that there is a good effect of laser on the mandible growth. this study will evaluate the effect of low-level laser on the growth of the mandible and the duration of functional treatment. twin-block will be applied in two groups: the control group will receive the twin-block only, and the experimental group will receive the twin-block combined with low-level laser therapy on the tmg region. cephalometric radiographs will be gotten before and after functional treatment to evaluate the dento-skeletal changes.

Eligibility criteria:
inclusion criteria: * skeletal class ii malocclusion because of mandibular retrognathia * anb \> 4 * overjet \> 5 * snb \< 78 exclusion criteria: * poor oral hygiene * previous orthodontic treatment. * patients with syndromes, clefts, or craniofacial abnormalities. * reason of contraindication of functional treatment

Keywords: low-level laser functional treatment twin-block rct
gbe deficiency (gsd iv and apbd) natural history study

Conditions: Glycogen Storage Disease Type IV; Adult Polyglucosan Body Disease; GSD4; GSD IV; APBD

Summary: collection and review of clinical information related to glycogen branching enzyme (gbe) deficiency, diagnosed as glycogen storage disease type iv (gsd iv) or adult polyglucosan body disease (apbd generated during clinic visits.

this natural history study will serve as a repository of clinical, laboratory, and biochemical information on individuals with gbe deficiency, diagnosed as either gsd iv or apbd. this information will allow a more definitive description of gbe deficiency to be developed, which will permit development of treatment strategies for this disease. duke will be the only site where this study takes place. however, since this is a rare disorder, participants who receive care for gbe deficiency at other institutions will be included. we will collect retrospective data from patient charts on diagnosed individuals, as far back as necessary to capture the clinical course of the disorder. prospective data collected from patient charts after enrollment will be captured as well. participant's medical records will be continually reviewed for the duration of the study. data will be collected from medical records and will only pertain to clinically relevant information, including, but not limited to: demographic and diagnostic information, tissue biopsy results, medical and family history, review of systems, imaging studies, results of liver, muscle, and nerve function testing, and urine and blood laboratory results.

Eligibility criteria:
* diagnosis of gsd iv or apbd via: * two variants in the gbe1 gene * deficient gbe activity in liver, muscle, skin fibroblast or other tissue * one variant in gbe1 gene with evidence of disease that is pathogenic, per the clinician * able to provide informed consent for self (adults) or affected individual (minor or adults with a legally authorized representative) * able to provide consent for release of medical records * pregnant women with a diagnosis of gsd iv or apbd will be included * histology as confirmed by clinician
intensive molecular and electropathological characterization of patients undergoing atrial fibrillation ablation

Conditions: Atrial Fibrillation; Atrial Fibrillation Paroxysmal; Atrial Fibrillation, Persistent

Summary: rationale: although there are several individual factors which are known to influence the chances of successful atrial fibrillation (af) ablation, it remains a challenge to identify patients at risk for ablation failure with satisfactory certainty. objectives: to identify predictors of success of af ablation including clinical factors, af recurrence patterns, anatomical and electrophysiological characteristics, circulating biomarkers and individual genetic background. study design: prospective registry of patients undergoing af ablation. clinical characteristics and results of routine tests are collected. in addition, the following (non-standard) tests are performed: extended surface electrocardiogram (extecg), extended rhythm monitoring, biomarker testing, genetic analysis, questionnaires. in subgroups of patients transesophageal electrocardiogram (te-ecg), epicardial electroanatomical mapping and/or left atrial appendage (laa) biopsy is performed. study population: patients aged 18 years and older with documented af, scheduled for af ablation. main study endpoints: ablation success after 12 and 24 months, defined as freedom from any episode of documented atrial arrhythmia after the blanking period.


Eligibility criteria:
inclusion criteria: * 18 years of age or older; * documented atrial fibrillation; * scheduled for af ablation or redo af ablation; * able and willing to provide written informed consent. exclusion criteria * serious patient condition before ablation; * physically or mentally unable to provide written informed consent.

Keywords: pulmonary vein isolation cryoballoon ablation radiofrequency ablation atrial fibrillation