Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of a bulk fill resin composite

Conditions: Dental Caries; Unsatisfactory or Defective Restoration of Tooth

Summary: the purpose of this clinical trial is to measure the clinical outcomes of tetric powerfill class i and ii restorations cured in 3 seconds with the bluephase powercure curing unit.


Eligibility criteria:
inclusion criteria: * each subject must need at least 1 restoration in a vital posterior tooth * must have given written consent to participate in the trial * replacement of defective restorations (i.e. fractured, stained, unaesthetic) with or with-out caries are acceptable * must be available for the required follow-up visits over 3 years * restored teeth must have occlusal contact with opposing teeth or restored teeth * restoration width should be equal to or greater than 1/3 the distance from buccal to lin-gual cusp tips * 75% of the restorations class ii (minimum) and 25% class i * each class ii will have at least one proximal contact * 75% in molars (minimum) and 25% in premolars * all restored teeth must have at least one occlusal contact in habitual closure * must have 20 or more teeth exclusion criteria: * if they have an allergy to ingredients of the materials under investigation (monomers) * do not meet all inclusion criteria above * have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or are immunocompromised) or disabilities meaning they may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene * have xerostomia either by taking medications known to produce xerostomia or those with radiation-induced xerostomia or sjogren's syndrome - as dry mouth increases tooth and restoration wear as well as the development of caries. * have teeth with advanced or severe periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored * present with any systemic or local disorders that contraindicate the dental procedures included in this study * have unstable occlusion * have severe grinding/bruxing or clenching or need tmj-related therapy * have tooth with exposed pulp during preparation or caries removal * teeth that are non-vital or that exhibit signs of pulpal pathology for restoration * teeth that require cuspal build-ups involving more than one cusp
effects of different forms of fatigue on double-task performance in the elderly

Conditions: Elderly

Summary: the dual task (walking and cognitive task at the same time) is increasingly used in geriatrics in protocols for detecting people who are falling and/or for highlighting cognitive disorders. however, frail elderly people tend to get tired quickly and a lack of awareness of the effects of fatigue on dual-task performance could alter the diagnosis. there are two types of fatigue: mental fatigue and peripheral muscle fatigue. each participant will do both types of fatigue over 2 appointments spaced by 7 days so that the subject can recover from induced fatigue. the sequence of fatigue tasks will be randomized. at the first appointment (day 0): 1. pre-fatigue assessment : * the subject must walk on 10m with round trip for 1min. * the subject must do the arithmetic count of 3 in 3 * then comes the evaluation in double task (walking and counting at once for 1min). the subject must walk on 10m with round trip for 1min by doing the arithmetic count of 3 in 3 at the same time. 2. mental fatigue task or muscle fatigue task (randomized) 3. post-fatigue assessment (the same as pre-fatigue assessment) 7 resting days second appointment (day 7) 1. pre-fatigue assessment : * the subject must walk on 10m with round trip for 1min. * the subject must do the arithmetic count of 3 in 3 * then comes the evaluation in double task (walking and counting at once for 1min). the subject must walk on 10m with round trip for 1min by doing the arithmetic count of 3 in 3 at the same time. 2. mental fatigue task or muscle fatigue task (randomized) 3. post-fatigue assessment (the same as pre-fatigue assessment)


Eligibility criteria:
young group inclusion criteria: * 20 to 40 years old exclusion criteria: * psychiatric disorders * severe hearing or vision loss * motor or sensory disability that may interfere with test completion old group inclusion criteria: * 65 to 90 years old * less than 3 fried's criteria of fragility * walking ability without technical assistance (at least 10m). exclusion criteria: * psychiatric disorders * severe hearing or vision loss * motor or sensory disability that may interfere with test completion old frail group inclusion criteria: * 65 to 90 years old * 3 or more fried's criteria of fragility * walking ability without technical assistance (at least 10m). exclusion criteria: * psychiatric disorders * severe hearing or vision loss * motor or sensory disability that may interfere with test completion
time effect of the pressure release technique application in the latent myofascial trigger points

Conditions: Myofascial Pain Syndrome

Summary: background: latent myofascial trigger points (mtrps) of the levator scapulae are high prevalent and may influence the neck and shoulder conditions. the pressure release is one of the most recommended manual therapy techniques. objective: to determine the time effect of the pressure release technique application in the latent mtrps of the levator scapulae muscle. design: a three-arm (1:1:1 ratio), double-blinded, parallel, randomized clinical trial. the manual technique than us apply, be sustained digital pressure with thumbs or with the 2nd-3rd fingers on the pgm below the pain threshold and gradually increases up to a ceiling of tissue resistance (barrier), as decreases, adds more pressure. different times of sustained pressure and the number of repetitions depending on time 30 (group 1, acts as a control), 60 (group 2) and 90 seconds (group 3) shall apply.


Eligibility criteria:
inclusion criteria: * subjects with aged between 18 and 60 years. * subjects with presence of latent pgm levator scapulae muscle. exclusion criteria: * pregnant. * subjects with spontaneous pain. * subjects with neck or shoulder pain. * subjects with musculoskeletal injuries. * subjects with neurological problems. * fibromyalgia

Keywords: myofascial trigger points liberation for pression therapy soft tissue
the influence of non-caloric artificial sweeteners on youth with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the investigators aim to further the understanding of environmental factors that may underlie variations in body composition seen in youth with type 1 diabetes (t1d). non-caloric artificial sweeteners, broadly consumed in many individuals with t1d, are a modifiable dietary factor that may be associated with negative health outcomes, particularly those relevant to the future risk of diabetes-related complications. investigators will measure body composition (the amount of fat and muscle in the body and where the fat is stored) using a bioelectrical impedance analysis machine and dexa scanner. blood will be drawn for the following labs: hba1c, lipid panel, comprehensive metabolic panel and leptin. participants will also answer questions about their diets and consumption of artificial sweeteners.


Eligibility criteria:
inclusion criteria: 1. males and females aged 5-17 years with a clinical diagnosis of t1d of ≥ 6 months in duration 2. bmi between the 5th and 95th percentile exclusion criteria: 1. presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism or celiac disease that is well-controlled on a gluten free diet. 2. diabetes other than t1d 3. chronic illness known to affect glucose metabolism 4. psychiatric impairment, with the exception of well-controlled depression or anxiety, that will affect the ability to participate in the study 5. female participants of child-bearing age with reproductive potential must not be knowingly pregnant 6. any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
accuracy of automatic contusion volume scanning for predicting the incidence of pneumonia in patients with thoracic trauma

Conditions: Pneumonia; Thoracic Trauma

Summary: the goal of this retrospective observational study is to evaluate the diagnostic accuracy of pulmonary contusion volume in predicting early pneumonia in patients with thoracic trauma. the primary question we aim to answer is: what is the diagnostic accuracy of pulmonary contusion volume in predicting pneumonia within 7 days post-trauma? moreover, we aim to explore which is the overlap between the contused segments and those developing pneumonia. finally, we aim to explore relevant differences in radiomic features between contused segments that developed pneumonia.


Eligibility criteria:
inclusion criteria: * admission to the ed for trauma as primary diagnosis * whole-body contrast ct scan performed within 6 hours from admission exclusion criteria: * age \<18 years

Keywords: aast aisthorax pneumonia trauma
antisense therapy to block the kallikrein-kinin pathway in covid-19

Conditions: Covid19

Summary: up to 1/3 of all patients infected with covid-19 can develop complications that require hospitalization. severe pneumonia associated with acute respiratory distress syndrome (ards) is the most threatening and feared complication of covid-19 infection, with mortality rates close to 50% in some groups. autopsies between these severe cases reveal severe capillary involvement, with signs of intense inflammatory changes, microvascular thrombosis, endothelial injury and abnormal tissue repair. the available evidence suggests that abnormal activation or imbalance in the counter-regulation of the kallikrein-kinin system may play a central role in a positive feedback cycle, leading to consequent diffuse microangiopathy. blockade of the kallikrein-kinin system can therefore prevent deterioration of lung function by reducing inflammation, edema and microthrombosis. the objective of this phase iib study is to assess the preliminary effects on the oxygenation parameters of an antisense oligonucleotide that inhibits pre-kallikrein synthesis in patients with moderate to severe covid-19.

the objective of this phase iib study is to assess the preliminary effects on the oxygenation parameters of an antisense oligonucleotide that inhibits pre-kallikrein synthesis in patients with moderate to severe covid-19. this is a blind randomized pilot clinical study which aims to include 110 patients (55 per arm).

Eligibility criteria:
inclusion criteria: 1. patients with covid-19 who need supplemental oxygen 2. women must not be pregnant or breastfeeding, and must be surgically sterile or in the postmenopausal stage (without risk of becoming pregnant). 3. men must be surgically sterile or abstinent or, if they are having sex with risk of pregnancy, the subject must use an effective method of contraception from the moment they sign the informed consent form until at least 24 weeks after the dose of the study drug (isis 721744 or placebo). exclusion criteria: 1. patients on invasive mechanical ventilation or who may need mechanical ventilation for the next 24 hours. the use of non-invasive ventilation and/or a high-flow nasal catheter is permitted. 2. patients with \> 10 days since symptom onset or more than 48h of oxygen use 3. pregnancy, breast-feeding or risk of becoming pregnant 4. hemodynamically unstable (use of vasoconstrictors, such as norepinephrine, at any dose) 5. previous diagnosis of heart failure at functional class iii or iv 6. previous uncontrolled hypertension (more than 3 drug classes use at home) 7. severe lung disease (use of home oxygen) 8. age \ 80 years 9. physician and family not committed to full life support and/or with severe existing illness with a life expectancy of less than 12 months 10. refusal to accept informed consent and/or unwillingness to comply with all requirements of the study procedure and security monitoring

Keywords: antisense kallikrein-kinin
the evaluation of thrombogenicity in patients undergoing watchman left atrial appendage closure trial

Conditions: Left Atrial Appendage Closure; WATCHMAN Device Implantation

Summary: this study will evaluate thrombogenicity in patients undergoing left atrial appendage closure using the watchman device. parameters of thrombosis and platelet function, as well as other bio-markers, will be measure before, during, and after watchman implantation at several follow up visits.


Eligibility criteria:
inclusion criteria: * subject indicated and scheduled for watchman device implantation at ihvi (inova heart and vascular institute) * subject may be of either sex and of any race, and must be \>18 years of age. * subject must be willing and able to give appropriate informed consent. * the subject is able to read and has signed and dated the informed consent document including authorization permitting release of personal health information approved by the investigator's institutional review board (irb). exclusion criteria: * subjects with contraindications for watchman device implantation intracardiac thrombus is visualized by echocardiographic imaging, an atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present, the laa (left atrial appendage) anatomy will not accommodate a device, any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate tee - transesophageal echocardiography probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present, there are contraindications to the use of warfarin, aspirin, or clopidogrel, the patient has a known hypersensitivity to any portion of the device material or the individual components such that the use of the watchman device is contraindicated * ligated or oversewn left atrium * concurrent participation in any investigational study. * subject likely to not be available to complete all protocol-required study visits or procedures, to the best of the subject's and investigator's knowledge * history or evidence of any other clinically significant disorder, condition, or disease other than those outlined above that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Keywords: watchman left atrial appendage closure thrombosis platelet function
fresolimumab in systemic sclerosis

Conditions: Diffuse Systemic Sclerosis

Summary: the purpose of this study is to determine if fresolimumab is safe in treating people with systemic sclerosis (scleroderma) and to investigate the effect of fresolimumab in the skin of these individuals.


Eligibility criteria:
inclusion criteria: * meet acr criteria for diffuse systemic sclerosis * \< 24 months since onset of first ssc manifestation other than raynaud's phenomenon * modified rodnan skin score ≥ 15 * male or female adult ( ≥ 18 years of age) * able and willing to give written informed consent and comply with study protocol exclusion criteria: * moderate or severe pulmonary disease w/ fvc \ 20% of lung fields by hrct * treatment with investigational drug within 4 weeks of screening * ongoing use of high dose steroids (\> 10mg/day) or unstable steroid dose in past 4 weeks * treatment with immunosuppressive, cytotoxic, or antifibrotic drug within 4 weeks of screening * positive for hiv, hbv, and/or hcv * known active infection (bacterial, viral, fungal, mycobacterial, or other); not including fungal infection of nail beds or any major infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening * patients w/ history of malignancy or premalignant lesion * history of keratoacanthoma or squamous cell carcinoma * moderate to severe hepatic impairment * ssc renal crisis within 6 months or creatinine \> 2.0 * lack of iv access for medication administration * moderate or severe cardiac disease with significant arrhythmia, heart failure, or unstable angina * anemia (hb \< 8.5 gm/dl) * thrombocytopenia or blood clotting disorder * patients with organ transplant (including allogeneic bone marrow transplant)
effects of low intensity therapeutic ultrasound on endothelial function

Conditions: Diabetes Mellitus, Type 2

Summary: endothelium is a cell layer that interposes blood and smooth muscle of vessels. this biological sensor reacts to physical and chemical stimuli by synthesis and/or liberation of regulatory substances like nitric oxide (no), which acts on vascular tone, growth of muscle cells and platelet aggregation and leukocyte. clinically, endothelial function measured by technique flow-mediated dilation (fmd) is a strong predictor of cardiovascular events and all-cause mortality. previo study demonstrated that continuous and pulsed therapeutic 1-mhz ultrasound waveforms improved endothelial function in health volunteers and this vasodilation persisted for 20 min, which provided them with anti-inflammatory vascular effects. in subjects with type 2 diabetes (dm2) the chronical hyperglycemia and dyslipidemia reduce no bioavailability causing endothelial dysfunction. low intensity therapeutic ultrasound is an electrotherapeutic instrument employed in musculoskeletal injuries that promotes endothelium-dependent vasodilation, and its mechanism of action has not been studied on dm2. the aim of our study is evaluate endothelial function of patients with dm2 after different waveforms (placebo, continuous and pulsed) of therapeutic ultrasound. therapeutic ultrasound is a electrotherapeutic instrument that can changes arterial endothelial function of subjects with dm2 because of no bioavailability increasing, which implies anti-inflammatory and vasodilatory beneficial alterations for diabetic patients.

evaluation of endothelial function will be made by flow-mediated dilation (fmd). the therapeutic ultrasound will applied over brachial artery using continuous (cut: 0,4w/cm2), pulsed (put: 20% duty cycle, 0,08w/cm2sata) and placebo (equipment off) waveforms during 5min in 3 intercalated days.

Eligibility criteria:
inclusion criteria: * the subjects that joined the study will be alphabetized volunteers * age between 25 and 65 years old, * absence of morbid obesity, * non-smokers, * with no symptoms of skeletal muscle disorders, * no previous performing cardiovascular surgery, * no previous diagnose of rheumatic, neurological, oncological, immune or hematologic diseases, * without evidence of psychiatric diseases and/or cognitive deficit. exclusion criteria: * insulin dependent diabetes * leukocytosis, impaired fasting glycemia (\ 300 mg/dl) and * brachial artery diameter less than 2.5mm and larger than 5.0mm. * on the day of the assessments have consumed of the alcoholic drink, caffeine and citrus juice

Keywords: endothelial function ultrasonic therapy vascular endothelium nitric oxide ultrasound
cd38-targeted chimeric antigen receptor t cell (cart) in relapesd or refractory acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: this is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted cd38 chimeric antigen receptor engineered t cell immunotherapy (cart) in the treatment of cd38 positive relapsed or refractory acute myeloid leukemia.

the patients will receive infusion of car t-cells targeting cd38 to confirm the safety and efficacy of cd38 car t-cells in relapsed or refractory acute myeloid leukemia.

Eligibility criteria:
inclusion criteria: * cd38 positive relapsed/refractory acute myeloid leukemia * age 6-65 years. * left ventricular ejection fractions ≥ 0.5 by echocardiography * creatinine \< 1.6 mg/dl * aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal * total bilirubin \<2.0 mg/dl * karnofsky performance status ≥ 60 * expected survival time ≥ 3 months (according to investigator's judgement) exclusion criteria: * patients are pregnant or lactating * uncontrolled active infection * class iii/iv cardiovascular disability according to the new york heart association classification * active hepatitis b or hepatitis c infection * patients with hiv infection * patients with history of seizure * active central nervous system leukemia

Keywords: cd38, cart, aml
postpartum smoking relapse prevention by breastfeeding promotion

Conditions: Smoking, Cigarette; Breastfeeding

Summary: this is a randomized controlled trial to prevent postpartum smoking relapse by breastfeeding promotion. the intervention group (n=30) will receive multicomponent breastfeeding intervention from late pregnancy to 6 months postpartum, while the attention placebo control group (n=30) will receive general infant care counseling and support. the key outcome is the rate of postpartum smoking relapse.

the investigators propose the first randomized controlled trial to reduce postpartum smoking relapse by breastfeeding promotion from late pregnancy to 6 months postpartum. the investigators will enroll 60 pregnant women who successfully quit smoking within 3 months before or during this pregnancy (\<28 weeks). all participants will receive breastfeeding education during late pregnancy. right after delivery, participants who are still smoking abstinent will be randomized into either the breastfeeding intervention group (n=30) or the attention placebo control group (n=30). the intervention group will receive multicomponent interventions consisting of postnatal lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants). the control group will receive counseling and support focusing on general infant care with attention and compensation similar to the intervention group. the primary outcomes are rates of postpartum smoking relapse verified by urine cotinine test. specific aim 1 is to examine the efficacy of breastfeeding promotion intervention on postpartum smoking relapse. specific aim 2 is to collect preliminary data regarding potential mediating mechanisms: increases in lactation hormones (plasma oxytocin and prolactin), reductions in stress and negative affect, and enhancing mother-infant bonding and maternal motivation to protect the infant from secondhand smoke exposure. this innovative and feasible pilot study can yield promising preliminary data to strongly support our future application of a nih r01 grant proposal that has the potential to reduce smoking-related harms to both the mother and the infant, and maximize the protective effects of breastfeeding on infant health and development.

Eligibility criteria:
inclusion criteria: * be pregnant or in the first 1 month postpartum * be 18 years or older * have quit smoking cigarettes during or before this pregnancy * be willing to receive infant care and breastfeeding education * be able to read, listen, and talk in english exclusion criteria: * medical conditions contraindicating breastfeeding such as hiv infection, active tuberculosis, and breast removal * current heavy drinking (more than 2 drinks a day) * current use of illicit substances * being strongly against breastfeeding

Keywords: postpartum relapse