Kornimate/medical-research-clean huggingface dataset:
the evaluation of the deepithelialized gingival graft healing

Conditions: Wound Heal

Summary: the aim of this study was to compare of the effects of different fixation methods on deepithelialized gingival graft wound healing. laser doppler flowmetry method was used to determine for blood perfusion changes. 40 patients were devided into two groups randomly and deepithelialized gingival graft procedure was performed and healings were evaluated by laser doppler flowmetry.

this study evaluates the effects of different fixation methods on the early healing period of deepithelialized gingival grafts placed for non-root coverage gingival augmentation by laser doppler flowmetry forty patients were assigned to study groups: 1)test : tissue adhesive or 2) control group: suture. forty patients completed the study. blood perfusion in the recipient site was measured by laser doppler flowmetry on the day of surgery and at 3 and 7 days after surgery. quality of life and pain at recipient sites were also investigated.

Eligibility criteria:
inclusion criteria: * 18 to 65 years of age * systemically healthy * inadequate amount or absence of keratinized gingiva on the labial side of the lower incisor region * no restorations on the lower incisor region * no mucogingival surgical history in the lower incisor region * no periodontal treatment within the previous year * no systemic antibiotics taken for 6 months before the study * not pregnant or lactating * no-smoking exclusion criteria: * lower 18 and upper than 65 years of age * systemical disease * adequate amount of keratinized gingiva on the labial side of the lower incisor region * restorations on the lower incisor region * mucogingival surgical history in the lower incisor region * periodontal treatment within the previous year * systemic antibiotics taken for ‡6months before the study * pregnancy or lactating * smoking history or current smokers
model-informed dose de-escalation of infliximab in patients with inflammatory bowel diseases

Conditions: Inflammatory Bowel Diseases

Summary: this is a monocentric, two-arm, non-randomised, non-blinded, historically controlled, interventional trial. the purpose of this trial is to investigate the effect of model-informed infliximab dose de-escalation on the infliximab exposure and therapeutic outcome as compared to standard dose de-escalation in patients with inflammatory bowel diseases.


Eligibility criteria:
inclusion criteria: * the subject or, when applicable, the subject's legally acceptable representative signs and dates a written informed consent form and any required privacy authorisation prior to the initiation of any study procedures. * the subject is aged 18 to 80 years inclusive. * the subject has a good understanding of the dutch language. * the subject is diagnosed with moderately to severely active ulcerative colitis or crohn's disease, confirmed by clinical, endoscopic, histological, and/or imaging criteria. * the subject was in maintenance therapy, later lost their response to treatment and subsequently gained steroid-free, clinical and biological remission following infliximab dose escalation (i.e., by increasing the dose and/or shortening the dosing interval) and had an infliximab trough concentration ≥5 mg/l. * adequate contraception in female subjects of reproductive age (oral contraception, intra-uterine device, sterilisation or barrier method). exclusion criteria: * the subject is aged \ 80 years. * the subject receives infliximab prophylactically (e.g. in the immediate postoperative setting). * the subject has an ostomy or an ileal anal pouch anastomosis. * if female subjects, when pregnant (based on a positive serum sample) or lactating or intending to become pregnant or nurse before, during or within 15 weeks after the last dose of study drug; or intending to donate ova during such time period. * the subject is participating in another interventional clinical trial.
immunogenicity and safety of adimflu-s, formulation 2010-2011, in infants aged between 6-12months old

Conditions: Influenza

Summary: the purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the seasonal flu vaccine(adimflu-s), as measured by hemagglutination inhibition (hai) at 4 weeks after two doses of study vaccine, 4 weeks apart, in infants between 6 and 12 months of age.


Eligibility criteria:
inclusion criteria: * boys or girls and aged \>= 6 months old to \<= 12 months old on the day of first vaccination; * subject's parent(s) or legal guardian(s) must be willing to comply with planned study procedures and be available for all study visits; * subject must be in good physical health on the basis of medical history, physical examination; * subject's parent(s) or legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure. exclusion criteria: * subjects had received influenza vaccine; * history of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication; * personal or family history of guillain- barre' syndrome; * an acute febrile illness within 1 week prior to vaccination; * current upper respiratory illness (uri), including the common cold or nasal congestion within 72 hours; * subjects with influenza-like illness as defined by the presence of fever (temperature \>= 38'c) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent; * immunodeficiency, immunosuppressive or significant chronic illness not suitable for inactivated influenza vaccination; * history of wheezing or bronchodilator use within 3 months prior to study vaccine; * receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt vaccination before the last blood sampling for immunogenicity evaluation; * receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt vaccination before the last blood sampling for immunogenicity evaluation; * receipt of any blood products, including immunoglobulin in the prior 3 months; * underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.

Keywords: influenza vaccine immunogenicity
adjuvant colon cancer w/ eloxatin®/5 fu based regimen: accelox

Conditions: Colon Cancer

Summary: adjuvant colon cancer with eloxatin®/5 fu based regimen: accelox

it's a study of adjuvant colon carcinoma using eloxatin/5-fu based chemotherapeutic regimen called accelox as a definitive curative therapy.

Eligibility criteria:
inclusion criteria: * patients with adjuvant colon cancer exclusion criteria: * patients with diagnosis other than colon cancer.

Keywords: adjuvant colon cancer
water-soluble ubiquinol supplementation on blood glucose, lipids, oxidative stress, and inflammation in diabetes

Conditions: Diabetes

Summary: diabetes is considered an oxidative stress and a chronic inflammatory disease. coenzyme q10 (ubiquinone) is recognized as a lipid soluble antioxidant. ubiquinol is a reduced form of coenzyme q10 in our body after food or supplements intakes. studies have indicated that the water-soluble ubiquinol had better antioxidant activity and absorption than lipid-soluble. the purpose of this study was to investigate the effects of a water-soluble ubiquinol supplement (100 mg/d) on antioxidation and anti-inflammation in diabetes patients.

the patients with type 2 diabetes will recruit as subjects (n = 50) and randomly assign to the placebo (n = 25) or coenzyme q10 groups (n = 25). the intervention will administer for 12 weeks. the concentrations of coenzyme q10, oxidative stress marker (malondialdehyde), antioxidant enzymes activities (superoxide dismutase, catalase, and glutathione peroxidase), inflammatory markers \[c-reactive protein (crp), and interleukin-6 (il-6)\], and biochemical parameters (fasting glucose, a1c, insulin, c-peptide, and lipid profiles), and blood pressure will measure. hopefully, the results of this study could provide the information of water-soluble ubiquinol supplement for clinical doctors and dietitians recommend that diabetes patients deserve to know whether the use of coenzyme q10 supplement.

Eligibility criteria:
inclusion criteria: * the diagnostic criteria for type 2 diabetes were defined as a glycohemoglobin (a1c) ≧ 6.5%, a fasting glucose ≧ 7.0 mmol/l or a 2-h plasma glucose ≧ 200 mmol/l during an oral glucose tolerance test (ogtt), as well as the use of anti-hyperglycemic drugs. exclusion criteria: * pregnant or lactation women. * patients with liver or renal disease * antioxidant dietary supplements user. * patients under warfarin therapy. * patients with hypoglycemia (fasting glucose \< 60 mg/dl) or hyperlipidemia (fasting triglyceride ≧ 500 mg/dl)

Keywords: antioxidation anti-inflammation blood glucose blood lipids
comparison of two heparin formulations in patients with chronic renal failure.

Conditions: Thrombus

Summary: investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin sodium produced by laboratory hipolabor compared to heparin manufactured by app in patients on hemodialysis due to renal failure, through the control of hemostasis, verified by formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (ttpa and anti-xa) during the use of heparin


Eligibility criteria:
inclusion criteria: 1. research that patients agreed to participate and signed the written informed consent; 2. patients aged over 18 years, both sexes, regardless of color or social class; 3. patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system. exclusion criteria: 1. hypersensitivity to heparin sodium and / or benzyl alcohol; 2. history of bleeding or disease that the change of blood coagulation could aggravate or terminate the clinical manifestations, such as tables of active peptic or gastric ulcer; 3. severe liver disease; 4. cancer; 5. period of gestation; 6. genetic abnormality of the coagulation system; 7. multiple trauma; 8. use of aspirin in high doses (above 200mg per day); 9. use of glucocorticoids for at least 1 month; 10. use of other anticoagulants; 11. submission of a big surgery done less than 15 days; 12. history of persistent hypertension at the end of dialysis than 150/100 mmhg; 13. indicated doses of heparin 20% above or below 150ui/kg.

Keywords: preventing the thrombi formation
effects of the in situ simulation to competencies in cardiopulmonary resuscitation in the nursing team.

Conditions: Learning Disorders

Summary: introduction: in situ simulation is a methodology that meets the concept of permanent education, since it allows learning from the context of practice and in the work environment itself. objective: to compare the development of skills (knowledge and skills) for cpr between groups submitted to different in situ simulation periodicities, and to identify the level of confidence to participate in a cpr. method: a randomized controlled, non-blind study comparing 3 periodicities of educational intervention performed by in situ simulation. this study will include nursing professionals from the nephrology department of a university hospital. the sample will be composed of 24 randomized participants in the groups, using opaque envelopes for each periodicity of training and professional category, being subdivided into 3 groups of periodicities with intervals of 2, 4 and 8 months. the instruments will evaluate the knowledge and skills in cardiopulmonary resuscitation and the perception of preparation for performing the maneuvers.

the objective is to compare the development of skills (knowledge and skills) for cpr between groups submitted to different in situ simulation periodicities, and to identify the level of confidence to attend a cpr.

Eligibility criteria:
inclusion criteria: * they must be nurses and nursing technicians. exclusion criteria: * not complete the evaluations * be under 18 years old
carboplatin, paclitaxel, bevacizumab and vorinostat for patients with advanced non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the primary objective of the study is to establish the phase ii recommended dose of vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and bevacizumab for patients with previously untreated advanced non-small cell lunc cancer.

since the regimen of bevacizumab, carboplatin and paclitaxel has become a standard regimen for the treatment of advanced non-squamous nsclc, new studies in this patient population will have to include this as a reference arm. addition of a fourth anti-cancer agent has now become the new strategy to improve the outcome for advanced non-squamous nsclc. since the regimen of vorinostat, carboplatin and paclitaxel is already in advanced stage of development it is important to study the safety and tolerability of vorinostat in combination with the three-drug regimen of bevacizumab, carboplatin and paclitaxel. therefore, we will evaluate vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and bevacizumab for patients with previously untreated advanced non-small cell lung cancer.

Eligibility criteria:
inclusion criteria: * advanced non-squamous nsclc * no prior chemotherapy for advanced disease * ecog performance status 0 or 1 * measurable disease * life expectancy \> 3 months * normal bone marrow, renal and hepatic function * ability to take oral medications * willingness to sign informed consent exclusion criteria: * history of brain metastasis * evidence of thromboembolic phenomenon and treatment with anticoagulants * pregnancy * uncontrolled inter-current illness * prior therapy with paclitaxel

Keywords: phase i advanced non-small cell lung cancer
gestational diabetes: induction versus expectant management of labour

Conditions: Gestational Diabetes; Gestational Diabetes Mellitus; Diabetes Mellitus, Gestational; Pregnancy-Induced Diabetes; Diabetes, Pregnancy Induced

Summary: the purpose of this study is to determine whether, in gestational diabetes mellitus (gdm) pregnancies, induction of labour at 38-39 weeks of pregnancy is superior to expectant management in terms of maternal and neonatal outcomes.

gestational diabetes mellitus (gdm) is one of the most common complications of pregnancy and its incidence is estimated as around 7%. babies born from women with gdm are significantly more exposed to perinatal risk. furthermore in gdm pregnancies an increased c-section rate has been observed, mostly unjustified. strong evidence, based on prospective studies and randomized controlled trials, in favour or against the effectiveness and safeness of induction in women with gdm, are missing. the aim of the present study is to identify the best management for these women at term and provide evidence that could change the current clinical practice. to reach this objective, 1760 eligible women will be recruited at 9 teaching hospitals (5 in italy, 4 all over the world). sample size has been estimated to demonstrate a difference between the two arms ≥ 6% (31% of c-section in the expectant group and 25% in the induction group; relative difference between the 2 groups equal to 20% in favor of induction; kjos et al, 1993), considering an α error equal to 5% and 80% power. patients will be randomized to induction of labour (n=880) or expectant management (n=880). data on maternal and neonatal outcomes will be collected at delivery and until maternal and neonatal discharge.

Eligibility criteria:
inclusion criteria: * maternal age \> 18; * singleton pregnancy in vertex presentation; * gestational age between 38-39 weeks verified by lmp and first trimester ultrasound when available; * women diagnosed with gdm in the current pregnancy \[diagnosis will be based upon abnormal 50 gr. gct (\>140) followed by \>2 abnormal indices in the ogtt (according to c\&c criteria). women with gct\>200 mg/dl will undergo 100 gr ogtt as well\]; * no other contraindications for vaginal delivery. exclusion criteria: * pre-gestational diabetes; * prior c-section; * suspected estimated fetal weight\> 4000 gr. at enrollment; * any known contraindications for vaginal delivery; * uncertain gestational age; * non-reassuring fetal status necessitating immediate obstetrical intervention (prompt delivery/prompt c-section); * maternal disease complicating pregnancy and necessitating delivery (e.g severe pet); * bishop score \>7 at enrollment; * major fetal malformation.

Keywords: induced labour expectant management c-section rate maternal outcomes neonatal outcomes
a study of disease progression in participants with geographic atrophy secondary to age-related macular degeneration

Conditions: Geographic Atrophy

Summary: this study seeks to better characterize relationships between visual function and the progression (worsening) of geographic atrophy (ga) due to age-related macular degeneration (amd). the study also will generate new information on the relationship between genetics and ga progression. this is a global, prospective, multicenter, epidemiologic study enrolling 200 participants with ga secondary to amd. the study visits are scheduled to occur every 6 months. the anticipated duration of the study is up to 60 months.


Eligibility criteria:
inclusion criteria: * well-demarcated area of ga secondary to amd * women of childbearing potential and men must agree to use adequate contraception for at least 30 days after fluorescein dye administration * the study is recruiting participants in two different cohorts: cohort 1: participants with unilateral ga or cohort 2: participants with ga in one eye and cnv (active or treated) with or without ga, in the contralateral eye exclusion criteria: * previous participation in any studies of investigational drugs for ga / dry amd (exception for studies of vitamins and minerals) * ga in either eye due to causes other than amd * history of vitrectomy surgery, submacular surgery, or any surgical intervention for amd * previous laser photocoagulation for cnv, diabetic macular edema, retinal vein occlusion, and/or proliferative diabetic retinopathy * any ocular/systemic medical conditions that, in the opinion of the investigator, could contribute to participant's inability to participate in the study or interfere with study assessments. * requirement for continuous use of therapy indicated in prohibited therapy
heated glass ionomer cement in primary molars

Conditions: Dental Caries; Glass-Ionomer Cement; Primary Teeth

Summary: objective: the aim of this study was to assess the influence of heated in the clinical success of proximal high viscosity glass ionomer cement (gic) restorations in primary molars. material \& method: this randomized, split mouth, multicenter study was performed in four different centers including 88 patients aged between 5-7 years old. selection criteria included clinically and/or radiographically detected proximal caries extending into the dentin tissue. a total of 250 primary molars were restored with a bulk fill gic (equia forte, gc, europe) and randomly allocated to one of the following groups: 1) non-heated (n = 125) and 2) heated (n = 125). led light (gc- d-light duo, tokyo japan) was used at standard mode 1200 mw/cm2, at 50-60 ºc, for 60 sec for heat application. all restorations were clinically evaluated using modified usphs criteria at the baseline, 6 months and 12 months. chi-square test, fisher's exact chi-square test, continuity (yates) correction, fisher freeman halton test and mc nemar test were used to compare qualitative data with descriptive statistical methods (frequency). kaplan meier and life tables were used for survival analysis. p value \< 0.05 was considered statistically significant.


Eligibility criteria:
inclusion criteria: * subject is mentally and systemically healthy * subject has at least two approximal carious lesions at both sides of jaws * subject has a normal occlusal relationship with natural dentition * subject has at least one adjacent tooth contact exclusion criteria: * subject has history of bruxism, * subject has allergies to ingredients of glass ionomer based restorative materials. * cavity/caries has highly mineralized pigmented lesions, hypoplasia, fracture or cracks, * subject has abrasion, erosion, abfraction, * subject has fistula, abscess or pathological mobility, * subject has pain, pulp exposure
telerehabilitation-based motor imagery in nonspecific low back pain

Conditions: Motor Imagery

Summary: low back pain is a common problem in society and causes loss of workforce. its lifetime prevalence reaches 80% and annual hospital admission rates in the adult population reach 15%.most studies on motor imagery suggested the effects of motor imagery are related to neuroplastic changes in the brain. studies have shown that similar brain regions are activated during motor imagery and real movement. however, the level of evidence about the effect of motor imagery on autonomic functions is limited. today, interest in telerehabilitation has increased due to the covid-19 pandemic. the aim of this study is to examine the effects of telerehabilitation-based motor imagery training in patients with non-specific low back pain.


Eligibility criteria:
inclusion criteria: * those who can read and write * patients who have not undergone surgery * those with a body mass index less than 30 m2/kg * to have sufficient computer knowledge to participate in the study or to have a relative who can help in this regard * having a computer and active internet connection at home exclusion criteria: * medically uncontrolled and uncooperative patients * patients who have undergone surgery to the lumbar region * history of falling in the last 6 months * those with serious orthopedic, vascular, neurological, psychiatric problems affecting balance * active malignancy * pregnancy * having severe vision and hearing problems

Keywords: non-specific low back pain telerehabilitation motor imagery
magnetic resonance elastography in infants

Conditions: Liver Disease

Summary: mri \& mre in infants

the purpose of the present pilot study is to determine the feasibility of using mri and mre to evaluate the liver in infants with suspected liver disease.

Eligibility criteria:
inclusion criteria: * infants \< 6 months of age * known liver disease based (liver enzymes, bilirubin, and/or ggt at least twice the upper limit of normal for age) * parental/lar permission obtained exclusion criteria: * standard mri exclusion criteria as set forth by the cchmc division of radiology * severe coagulopathy (inr \> 3 or platelets \<50,000)

Keywords: liver mre mri neonatal mr touch