Kornimate/medical-research-clean huggingface dataset:
dental hygiene and peri-implant tissues homeostasis

Conditions: Peri-Implantitis

Summary: dental implants have revolutionized the field of dentistry, providing improvements in function and esthetics. they are not, however, without risks. bone loss around implants (i.e. periimplantitis) is an emerging public health concern. untreated, peri-implantitis leads to implant loss and jawbone defects. nonetheless, existing therapies have failed to show long-term efficacy. the pathogenesis of peri-implantitis is believed to be of bacterial etiology similar to periodontal disease. therefore, existing treatments duplicate strategies for the treatment of natural teeth. however, the titanium (ti) surface of implants is quite dissimilar to teeth. recent work from our lab has demonstrated that peri-implantitis is associated with increased release of ti particles around implants. these findings suggest that treatments targeting periimplantitis must be designed around ti material properties. a gap in knowledge exists regarding the potential triggers of increased ti dissolution from the implant surface and the mechanisms by which ti dissolution products amplify peri-implant inflammation. the aim of this study is to determine if the use of tooth-driven treatment approaches increase ti in the submucosal plaque.


Eligibility criteria:
inclusion criteria: * is the subject ≥ 25 years of age? * does the subject have an implant with a probing depth ≥ 5mm, bleeding on probing, and radiographic bone loss of \> 2mm? * is the subject committed to the study and the required follow-up visits? exclusion criteria: * is the subject immune compromised? * is the subject diabetic? * does the subject take steroid medication? * does the subject regularly use non-steroidal anti-inflammatories? * is the subject pregnant or intending to become pregnant during the duration of the study? * has the subject had previous implantoplasty? * did the subject take any antibiotics in the last 3 months?
covid-19 vaccine responsiveness in mm and waldenstrom

Conditions: Multiple Myeloma; Waldenstrom Macroglobulinemia; Immune System Disorder; Covid19

Summary: this research is being done to see if the immune (defense) system of people with multiple myeloma and waldenstrom's macroglobulinemia reacts to the covid-19 vaccine.

covid-19 vaccines are designed to help prevent infections, hospitalizations, and death from the covid-19 virus. normally, when the vaccine is administered, the immune system reacts by creating antibodies (proteins made by the body's immune system to fight infections such as covid-19) and helping the immune system's blood cells to fight it. in people with multiple myeloma and waldenstrom's macroglobulinemia, their immune system does not function normally, and an effective immune response may not occur. the research study procedures include screening for eligibility and the collection of data and biospecimens. it is expected that about 160 people will take part in this research study.

Eligibility criteria:
inclusion criteria: * age \>18 years. * lack of a contra-indication to a currently available covid-19 vaccine. * diagnosis of mm according to international myeloma working group (iwmg) criteria (cohort 1) or diagnosis of wm according to who criteria (cohort 2) * for treatment naïve wm patients (cohort 2a): * patient must have no prior history of anticancer treatment for wm. * the treating investigator must have no intention to initiate wm therapy within 2 months * for wm patients receiving btk inhibitor (cohort 2b): * patient must have no history of cytotoxic chemotherapy within 1 year, and no history of other anticancer therapy within 6 months. * for currently or previously treated wm patients (cohort 2c): * patient must not be currently taking a btk inhibitor or had recent exposure within 1 month of enrollment. current or prior history of any other wm-directed therapy is allowed. exclusion criteria: -

Keywords: multiple myeloma waldenstrom macroglobulinemia immune system disorder covid 19 vaccination
cholecalciferol to improve the outcomes of covid-19 patients

Conditions: COVID

Summary: the recent inception of the coronavirus sars-cov-2, responsible for the coronavirus disease (covid-19), has caused thousands of deaths globally. the most frequently reported complications among covid-19 patients are from respiratory involvement. vitamin d has immunomodulatory effects that could protect against covid-19 infection. indeed, there is good evidence from randomized clinical trials suggesting that high doses of vitamin d administered during cold seasons prevent viral respiratory infections in at risk individual, and more recently, observational studies suggested that the mortality rate from covid-19 is inversely correlated with levels of serum 25(oh)vitamin d. the hypothesis of the study is that a high dose of vitamin d given orally to patients admitted to the hospital for covid-19 will prevent the occurrence of respiratory deragement and other adverse clinical events. to evaluate the aforementioned hypothesis, a randomized, controlled, double-blind, clinical trial comparing a 500.000 ui dose of vitamin d versus placebo among covid-19 patients at moderate risk, requiring hospitalization but without requirements of critical care at admission was designed. the intervention will be one dose of 500.000 ui given orally or matching placebo. the trial has a sequential design with two steps: * the first step, projected to include 200 patients, will assess the effects of the intervention on the respiratory sofa; and * if there is a detectable effects, the second step, projected to include 1264 patients, will assess the effects on a combined event that includes need of high dose of oxygen or mechanical ventilation. all study outcomes will be measured during the index hospitalization.

see above.

Eligibility criteria:
inclusion criteria: * sars-cov-2 confirmed infection; * admission to a hospital; * expected hospitalization in the center for at least for 24 hs; * oxygen saturation \>90% breathing without oxygen supplement; * age at least 45 years or the presence of one of the followings risk factors: * hypertension; * diabetes (type i o ii); * at least moderate copd or asthma; * cardiovascular disease (history of myocardial infarction, coronary angioplasty, coronary artery bypass grafting or valve replacement surgery); * body mass index \>=30; * signed written consent. exclusion criteria: * \<18 years old; * women in childbearing age; * \>= 72 hs since current admission; * requirement for high dose of oxygen (\>5 liters/minute) or mechanical ventilation (non-invasive or invasive); * history of chronic kidney disease requiring hemodialysis or chronic liver failure; * inability for oral intake; * previous treatment with pharmacological vitamin d; * history of: * previous treatment with anticonvulsants; * sarcoidosis; * malabsorption syndrome; * known hypercalcemia. * life expectancy less than 6 months; * known allergy to the study medication; * any condition impeding to bring informed consent.

Keywords: covid coronavirus sars-cov-2 vitamin d cholecalciferol respiratory insufficiency
early palliative care intervention in malignant glioma

Conditions: Malignant Glioma

Summary: the purpose of this research study is to determine the feasibility and acceptability of incorporating palliative care into the clinical care plans of patients newly diagnosed with malignant brain tumors. palliative care is a field of medicine that focuses on providing relief from symptoms and stress related to serious illnesses. this study will assess the feasibility of conducting a future study, and will gather data upon which to appropriately tailor the intervention and the future study design. the statistical analysis of this study will describe 8 components that encompass each of the 4 areas of focus or "domains": acceptability, demand, implementation, and integration.

patients who agree to participate at their initial consultation in our clinic will receive a referral to a palliative care (pc) provider who is also located in our clinic and an initial appointment will be scheduled with the pc provider. the frequency of follow-up visits with the pc provider will be at the discretion of the pc provider and the patient. visits with the pc and neuro-oncology providers will be scheduled on the same day whenever possible. as part of the study, participants will be asked to complete a number of questionnaires and assessment forms at different time intervals. these questionnaires and assessments are intended to track symptoms experienced during the course of treatment. total study duration is about nine months.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * patient must have histologically confirmed, newly diagnosed who grade iv malignant glioma (confirmation from biopsy, sub-total, or gross-total resection) * tumor must be de novo grade iv malignant glioma (i.e. not transformed from a lower grade) * patient should be planning to receive standard chemoradiation (3 or 6 week protocols are acceptable) * treating neuro-oncologist agrees to the patient's participation in this clinical trial * patient should be able to read and write english exclusion criteria: * patient who currently has a pc provider and/or is receiving hospice care or plans on initiating hospice at the time of enrollment

Keywords: palliative care pro00091481 malignant glioma katherine peters david casarett
video-oculography and parkinson's disease

Conditions: Parkinson Disease, Idiopathic

Summary: this study aims to study, in patient with parkinson's disease, mild to moderate stage (according to movement disorder society clinical diagnostic criteria for parkinson's disease, postuma et al., 2015): * the evolution of oculomotricity markers over time. * the correlation between neurological evaluations (motor and non-motor scores), neuropsychological evaluations (cognitive disorders) and oculomotricity evaluation, over a follow-up period of 7 years. * the impact of antiparkinsonian drugs on the evolution of oculomotricity assessment by video-oculography. * the value of oculomotricity assessment by video-oculography as an evolutionary marker of the disease.


Eligibility criteria:
\*inclusion criteria: 1. male or female; 2. clinically defined idiopathic parkinson's disease (pd); 3. brain mri performed in routine care in the 12 months preceding inclusion; 4. cerebral datscan or cerebral pet with f-dopa, performed as routine care before inclusion (no time limit), confirming presynaptic dopaminergic denervation; 5. hoehn \& yahr score: 1 to 3; 6. normal clinical examination of oculomotricity (slight impairment of smooth pursuit accepted); 7. neuro-cognitive disorders: absent or minor (according to dsm5); 8. sufficient written and oral expression in french; 9. covered by a health insurance system; 10. written informed consent signed by the patient; 11. presence of a caregiver. \* exclusion criteria: 12. psychiatric comorbidity (except anxiety or mild to moderate depression); 13. neurological comorbidity, if significant; 14. brain mri showing: 1. significant cerebrovascular pathology (fazekas i admitted), 2. another brain disease, including stroke. 15. major cognitive impairment; 16. absolute exclusion criteria and "red flags" of the 2015 criteria orienting towards another degenerative pathology of the extrapyramidal system: * cerebellar syndrome * vertical oculomotricity disorders on clinical examination * motor symptoms restricted to the lower limbs * bilateral and perfectly symmetrical parkinsonism * early dystonia * clinical profile suggestive of behavioral variant frontotemporal dementia (bvftd) * progressive aphasia or apraxia * moderate or severe postural instability and / or early falls * early bulbar dysfunction (dysarthria, swallowing disorders) * ventilatory dysfunction (inspiration) * severe dysautonomia * dopa-resistance * neuroleptic treatment or related 17. normal mibg myocardial scintigraphy (if performed).

Keywords: parkinson's disease video-oculography oculomotor disorders oculomotricity neuropsychological evaluations movement disorder motor disorders non-motor fluctuations
esophageal atresia: a natural experiment of the effects of oral inoculation on the gut microbiome

Conditions: Esophageal Atresia

Summary: the purpose of this study is to understand changes of the gut microbiome due to esophageal atresia. the intervention will be to give a patient his or her own saliva through their gastrostomy tube (directly into the stomach) to observe if this can normalize microbial colonization of the gut.

after being informed about the study and its overall risks, parents will be given the option to enroll their infant. participants (infants) with esophageal atresia and a gastrostomy tube will be given their own saliva through their gastrostomy tube, directly into the stomach. samples of saliva and stool will be collected from these infants, and from a comparison group without esophageal atresia, as well as blood and urine to look for changes in immune responses and in metabolism.

Eligibility criteria:
inclusion criteria: * neonates with esophageal atresia (all, no exclusion criteria); maximum age at enrollment is 3 months. * neonates matched for gestational age without ea, also anticipated to require surgery (infants \>=32 weeks), or also premature (\<32 weeks) exclusion criteria (only for infants without ea): * sepsis * admission to study hospital after 7 days old * expected length of stay \<2 weeks
a study to assess the effects of dpp-4 inhibition on insulin sensitivity in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: type 2 diabetes results when the body does not produce enough insulin and/or is unable to properly use the insulin it makes (insulin resistance). this study was undertaken to assess the effects of vildagliptin on insulin sensitivity in people with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes at least 3 months prior to screening * blood glucose criteria must be met * on stable dose of metformin therapy * bmi less than or equal to 39 exclusion criteria: * type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes * treatment with thiazolidinediones or use of insulin within the previous 3 months * significant illness within 2 weeks prior to dosing * high fasting triglycerides as defined by the protocol other protocol-defined inclusion/exclusion criteria may apply

Keywords: vildagliptin type 2 diabetes insulin sensitivity insulin action
pharmacokinetic study of makena® (hydroxyprogesterone caproate injection, 250 mg/ml) and its metabolites in blood

Conditions: Pregnancy

Summary: this study will evaluate the levels of hydroxyprogesterone caproate and it's metabolites in blood throughout pregnancy there will be 3 cohorts of subjects cohort 1 (6 subjects) will have daily blood draws in the morning at approximately the same time each day for one week following their first dose of makena and will have blood drawn immediately prior to 2 successive makena doses during epoch 1 (24 - 28 weeks) and epoch 2 (32 - 36 weeks) cohort 2 (8 subjects) will have blood drawn to determine the trough concentration 7 days after their first dose of makena. subjects will have daily blood draws for one week following a dose of makena given in epoch 1 (24 - 28 weeks) and blood drawn immediately prior to 2 successive doses during epoch 2 (32 - 36 weeks) cohort 3 (16 subjects) will have blood drawn to determine the trough concentration 7 days after their first dose of makena. subjects will have blood drawn immediately prior to 2 successive doses in epoch 1 (24 - 28 weeks) and daily blood draws for one week following a dose of makena given during epoch 2 (32 - 36 weeks) a maximum of 10 subjects will be monitored on selected days following a completed course of makena therapy to determine the terminal elimination phase.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * singleton gestation. * gestational age 16 weeks 0 days to 20 weeks 6 days. * previous singleton spontaneous preterm delivery exclusion criteria: * multifetal gestation. * known major fetal anomaly or fetal demise. * progestin treatment in any form in the 4 weeks prior to study entry. * heparin therapy during current pregnancy or history of thromboembolic disease. * maternal medical/obstetrical complications including hypertension requiring medication or seizure disorder. * uterine anomaly other than fibroids * known hypersensitivity to hydroxyprogesterone caproate injection or its components. * any significant medical disorder that, in the opinion of the investigator, would be a contraindication to the use of the drug or would preclude accurate evaluation of the subject's condition or outcome or compromise the subject's safety in the study.

Keywords: makena pharmacokinetics prior preterm delivery hydroxyprogesterone caproate 17p
master study for the investigation of safety and efficacy of the siello pacemaker leads

Conditions: Cardiac Pacemaker Syndrome

Summary: the objective of this study is to prove the safety and efficacy of the siello pacemaker leads.

the assessment of the safety of siello pacemaker leads is based on the collection of complications which are related to the leads. the assessment of efficacy of the siello pacemaker leads is based on the collection of standard electrical lead data during the implant and follow-up procedures. subsequent to the implantation of the siello leads,five follow-up visits have been scheduled: at pre-discharge and after 1, 3, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * meet the indications for pacemaker therapy * understand the nature of the procedure * give informed consent * able to complete all testing required by the clinical protocol * available for follow-up visits on a regular basis at the investigational site exclusion criteria: * meet none of the pacemaker indications * meet one or more of the contraindications * have a life expectancy of less than six months * cardiac surgery in the next six months -enrolled in another cardiac clinical investigation- have other medical devices that may interact with the implanted pacemaker

Keywords: leads pacemaker efficacy safety
a novel congenital cataract category system

Conditions: Cataract

Summary: congenital cataracts (cc) are the leading cause of childhood visual disabilities and treatable childhood blindness worldwide1. cc patients have a wide range of presentations of lens opacities and are generally categorized into several groups based on the etiologies, anatomical positions, or shapes of lens opacities. cataractous eyes of cc patients are also frequently complicated with other anterior segment abnormalities due to their close anatomical relationships and similar developmental origins. lens opacities in different positions may be related to specific anterior segment abnormalities; for example, anterior polar cataracts are associated with greater corneal astigmatism (ca). however, no studies have systematically related the position of lens opacities to specific anterior segment abnormities, mainly due to the small number of cc patients, a lack of proper equipment, and a lack of awareness of these important relationships.

congenital cataracts (cc) are the leading cause of childhood visual disabilities and treatable childhood blindness worldwide1. cc patients have a wide range of presentations of lens opacities and are generally categorized into several groups based on the etiologies, anatomical positions, or shapes of lens opacities. cataractous eyes of cc patients are also frequently complicated with other anterior segment abnormalities due to their close anatomical relationships and similar developmental origins. lens opacities in different positions may be related to specific anterior segment abnormalities; for example, anterior polar cataracts are associated with greater corneal astigmatism (ca). however, no studies have systematically related the position of lens opacities to specific anterior segment abnormities, mainly due to the small number of cc patients, a lack of proper equipment, and a lack of awareness of these important relationships. using the largest cc database in the zhongshan ophthalmic center (zoc), the current study compared the anterior segment characteristics of cc patients with lens opacities in different positions and further proposed a modified cc category system based on the specific relationships between the position of lens opacities and anterior segment characteristics. knowledge of these relationships is beneficial for further understanding of cc occurrence and development and has clinical significance for cc diagnosis and treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of congenital cataract * less than 18 years old exclusion criteria: * with other ocular abnormalities including severe corneal diseases, lens luxation, glaucoma, retinal diseases, nystagmus, nanophthalmos, and strabismus.

Keywords: congenital cataract;anterior segment characteristics
targeted dose finding of canakinumab (acz885) for management of acute flare in refractory or contraindicated gout patients

Conditions: Acute Gout

Summary: this 8-week study is designed to determine the target dose of canakinumab (acz885) for the management of acute flare in gout patients who are contraindicated to non-steroidal anti-inflammatory drugs and/or colchicine. the efficacy of acz885 will be compared to the corticosteroid triamcinolone acetonide.


Eligibility criteria:
inclusion criteria: * history of at least 1 gout flare prior to the screening visit * meeting the american college of rheumatology (acr) 1977 preliminary criteria for the classification of acute arthritis of primary gout. * presence of acute gout flare for no longer than 5 days. * baseline pain intensity \> or = to 50 mm on the 0-100 mm vas. * contraindicated for, intolerant or unresponsive to nsaids, colchicine or both. exclusion criteria: * rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis. * presence of severe renal function impairment * contraindication to intramuscular injection * known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment * evidence of active pulmonary disease * live vaccinations within 3 months prior to the start of the study * use of forbidden therapy other protocol-defined inclusion/exclusion criteria applied

Keywords: acute flares gout anti-interleukin-1β monoclonal antibody colchicine triamcinolone acetonide
amg 162 (denosumab) phase 3 study (desirable study) in participants with rheumatoid arthritis on disease-modifying antirheumatic drugs (dmards) treatment

Conditions: Rheumatoid Arthritis

Summary: to evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by amg 162 administered subcutaneously to rheumatoid arthritis participants.

to evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by amg 162 administered subcutaneously at a dose of 60 mg every 6 months or every 3 months for 12 months to rheumatoid arthritis participants.

Eligibility criteria:
inclusion criteria: * diagnosed with rheumatoid arthritis according to the american college of rheumatology (acr) criteria for rheumatoid arthritis classification (1987 revision) or the 2010 acr-eular (the european league against rheumatism) classification criteria for rheumatoid arthritis exclusion criteria: * functional class iv according by the acr revised classification (1991)

Keywords: rheumatoid arthritis denosumab rankl rank amg 162 joint damage developmental phase iii