Kornimate/medical-research-clean huggingface dataset:
the effect of laser combined with pulp-capping agents on direct pulp capping

Conditions: Dental Pulp Exposure

Summary: the purpose of this randomized clinical study was to evaluate the efficiency of er,cr:ysgg laser irradiation combined with a resin based tricalcium silicate material and calcium hydroxide (ch) in direct pulp capping for 3 months follow-up period.sixty permanent vital teeth without symptoms and radiographic changes were randomly assigned to 4 groups (n=15): gr 1: the exposed area was sealed with ch paste, gr 2: the treated area was sealed with ch paste following er,cr:ysgg laser irradiation at an energy level of 0,5 w without water and 45% air, gr 3: resin based tricalcium silicate material (theracal lc) was applied directly to the exposed pulp, gr 4: theracal lc was applied following irradiation with er,cr:ysgg laser.

ch is used as gold standard in pulp capping procedures due to its beneficial properties such as induction of mineralization and inhibition of bacterial growth; however tunnel defects and cell inclusions in dentin bridges formed by ch may lead to leakage and bacteria penetration resulting in loss of vitality. theracal lc is a new light-cured, resin-modified, tricalcium silicate based material designed to use for direct and indirect pulp-capping aiming to achieve a bond to composite resins thus reducing micro-leakage.the formulation of theracal lc containing tricalcium silicate particles in a hydrophilic monomer provides significant calcium release that stimulates hydroxyapatite and secondary dentin bridge formation the use of laser for direct pulp capping has been suggested for the considerable advantages of lasers including decontamination effect, biostimulation effect, hemostatic and coagulant effect.the erbium, chromium-doped:yttrium, scandium, gallium and garnet (er,cr:ysgg) laser which is a relatively new device has been reported to ablate dental hard tissues thanks to its high absorption in water and also strong absorption by the hydroxyl radicals present in the hydroxyapatite structure

Eligibility criteria:
inclusion criteria: * permanent teeth with deep caries without symptoms * vital teeth * no periapical radiographic changes * the diameter of the exposed area is between 0,5 mm to 1,5 mm exclusion criteria: * spontaneous pain, * tenderness to percussion and palpation, * bleeding lasting over 3 minute after exposure, * periapical radiographic changes such as periradicular or furcal radiolucency, a widened periodontal ligament space and resorption.

Keywords: direct pulp capping er,cr:ysgg laser tricalcium silicate
a prospective, multi-site clinical study to collect user feedback using affirm® contrast biopsy

Conditions: Breast Cancer

Summary: currently, if a radiologist finds a suspicious lesion seen only on a diagnostic contrast enhanced digital mammography (cedm) exam requiring biopsy the biopsy procedure would likely be performed with mri guidance because there are currently limited solutions to biopsy with cedm guidance. affirm contrast biopsy will provide an additional solution to biopsy/localize lesions found by using a cedm imaging modality.


Eligibility criteria:
inclusion criteria: * females aged 40 years of age or older recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities * subject is able to read, understand, and sign the study specific informed consent form after the nature of the study has been fully explained to them exclusion criteria: * subjects who require a legally authorized representative (lar) for informed consent * subjects who, based on the physician's judgement, may be at increased risk for complications associated with renal function, anticoagulant therapy, or bleeding disorders * subjects who have had a previous allergic reaction to iv contrast agent

Keywords: breast biopsy, contrast biopsy
the immediate physiological and perceptual response to blood-flow restricted strength training with eccentric loading

Conditions: Healthy

Summary: decreasing workloads in strength training makes it more tolerable for a broad range of people. when designed as blood-flow restriction training, similar gains in strength and muscle mass are achieved compared to traditional training. adding high training loads to blood-flow restriction training only in the eccentric phase (bfr-ecc) might achieve superior gains in muscle strength while still maximizing tolerability of the training stimuli. this study aims to investigate the acute physiological and perceptual response of blood-flow restriction training with eccentric loading in comparison to traditional eccentric training. the study recruits healthy individuals ≥ 18 years.


Eligibility criteria:
inclusion criteria: * clinically healthy exclusion criteria: * physical or intellectual impairment precluding informed consent or protocol adherence * pain during exercise of any origin * history of thromboembolic event in the lower extremity * known pregnancy (no testing is carried out)

Keywords: blood-flow restriction training acute physiological response eccentric training
does routine assessment of gastric residuals in preterm neonates influence time taken to reach full enteral feeding?

Conditions: Gastric Residuals Assessment; Prematurity; Sepsis Newborn; Necrotizing Enterocolitis of Newborn

Summary: the study aims to compare routine assessment of gastric residuals versus no assessment of residuals in preterm neonates with respect to time taken for achieving full enteral feeding and the incidence of possible complications, such as feeding intolerance, necrotizing enterocolitis, sepsis etc.

in general, regular assessment of gastric residuals and its´ evaluation prior to every feeding is considered standard practice for preterm neonates in neonatal intensive care units. it is believed useful to confirm correct placement of the orogastric or nasogastric tube and thought of as necessary to aid the decision of enteral feeding advancement by informing about possible remains of contents from previous feeding. furthermore, evaluation of gastric residuals is routinely performed in order to assess for feeding intolerance and used as a possible indicator of risk for development of necrotizing enterocolitis. however there is conflicting evidence to support the approach of routine gastric residuals assessment and it seems unclear whether it confers any clinical benefit. withholding of enteral feeding or cessation of advancement in the amounts given due to misinterpretation of routine gastric aspirates may have a negative impact on the preterm neonate. this can potentially involve prolonged indwelling of venous catheters, higher risk of infection and growth restriction with potentially worse developmental outcome in particular for very low birth weight infants. this randomized controlled clinical study aims to compare a control group with regular assessment and evaluation of gastric residuals and an intervention group with no routine assessment of residuals prior to feeding advancement, for the time taken to reach full enteral feeding and for occurrence of any observed complications including necrotizing enterocolitis.

Eligibility criteria:
inclusion criteria: * preterm neonate, born between 26+0 and 30+0 weeks of gestation * birth weight below 1500g * parental informed consent obtained exclusion criteria: * intrauterine growth retardation (birth weight below 5th centile for given gestational age and gender) * life-threatening events requiring full resuscitation at the delivery room (severe hypoxia, bleeding), and persistently raised lactate value of more than 5 mmol/l * circulatory instability requiring treatment with inotropes * highly suspected early onset sepsis with alteration of general clinical state, in particular with worsened peripheral perfusion and circulatory decompensation prior to study begin (during the first 6 hours after admission to nicu) * known malformations of gastrointestinal tract, known diagnosis of congenital diaphragmatic hernia, any other life-limiting serious congenital malformations

Keywords: gastric residuals assessment prematurity necrotizing enterocolitis of newborn sepsis newborn nutrition of newborn feeding tolerance of newborn
a new track ablation device for liver biopsy: a feasibility study

Conditions: Liver Neoplasms

Summary: the purpose of this study is to evaluate the effectiveness and safety of a new biopsy track ablation device for liver biopsy.

background: * percutaneous biopsy for hepatic masses has a potential risk of bleeding and peritoneal tumor seeding. * a new device for biopsy track ablation has been invented to reduce the risk of bleeding and peritoneal tumor seeding. method: * routine percutaneous biopsy for hepatic masses is performed. * immediate after obtaining tissue, biopsy needle track is ablated with a new biopsy tract ablator. * immediate (with ultrasound) and 24 hours (with ct scan) after procedure, occurrence of complications is evaluated.

Eligibility criteria:
inclusion criteria: * patients with a hepatic mass on ct scan or mri * patients who are referred for percutaneous biopsy of a hepatic mass * patients with normal range of platelet count and coagulation test exclusion criteria: * pregnant women * patients with ascites * uncooperative patients
comparison of adding emend to ponv/pdnv treatment regimen

Conditions: Postoperative Nausea and Vomiting

Summary: this study is looking at whether the addition of aprepitant (emend), an antiemetic, will provide added efficacy if added to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting.

this study is looking at whether the addition of a fairly new drug for the treatment of post-operative nausea and vomiting (ponv) and post-discharge nausea and vomiting (pdnv) will provide added efficacy if added to 2 drugs that are already used as a standard of care for ponv and pdnv. the patients that will be looked at will be deemed at higher risk for ponv and pdnv based on the procedure they are having done and/or on patient risk factors.

Eligibility criteria:
inclusion criteria: * patients with at least 2 of the common risk factors for ponv/pdnv; patients having a procedure deemed at high risk for ponv/pdnv exclusion criteria: * patients under 19 years of age; pregnant and breast-feeding patients

Keywords: nausea and vomiting
investigation to optimize hemodynamic management of left ventricular assist devices using the cardiomems™

Conditions: Heart Failure

Summary: this observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (lvad) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions

the study is an observational, single group study where all participants receive the same intervention. the study plans to enroll up to 100 patients at 25 us sites. all patients will have a heartmate left ventricular assist device (lvad) and a cardiomems device implanted as standard of care. after enrollment into the study, the patient will be followed until six month follow up completion. the objective of this clinical investigation is to understand the role of hemodynamic monitoring in lvad patients and: * characterize pa pressure measurements with the cardiomems hf system in lvad patients under different clinical and physiologic conditions * characterize the effects of pa pressure on functional status, quality of life, and hospital readmissions of lvad patients * evaluate target ranges for pa pressure and assess the impact of medication and pump speed changes on pa pressures

Eligibility criteria:
inclusion criteria: 1. subject has cardiomems hf pa sensor and a commercially-approved heartmate lvad (group a) or subject has commercially-approved heartmate lvad, is experiencing nyha class iii symptoms, and has had a previous hf hospitalization and meets fda indications for cardiomems. the cardiomems pa sensor must be implanted within 72 hours of consent (group b) 2. signed an informed consent form and agreed to provide access to patient and device data (including cardiomems merlin.net data) 3. no connectivity or transmission problems with cardiomems 4. on heartmate lvad support for at least 3 months 5. age ≥ 18 years exclusion criteria: 1. current participation in an investigation that is likely to confound study results or affect study outcome 2. current participation in the momentum3 ide clinical trial and has not completed the two year follow-up for that trial 3. inability to perform 6mhw test due to conditions other than heart failure (e.g. severe arthritis, orthopedic issues, amputation etc.)

Keywords: cardiomems left ventricular assist device hemodynamic management
causes of comorbid infertility among women with rheumatoid arthritis

Conditions: Infertility; Rheumatoid Arthritis

Summary: the purpose of this study is to increase our understanding of infertility in women with rheumatoid arthritis (ra). in this study the study team will compare the differences in ovarian reserve (the ability to provide egg cells that are capable of fertilization), the frequency of ovulation and the number of pregnancies between women with and without ra. it is possible that ra activity and medications limit ovarian reserve and ovulation, which may increase infertility among women with ra. there are several suspected causes for infertility in ra, including age-related fertility decline, inflammatory changes that impact endometrial receptivity and discourage implantation, accelerated ovarian decline due to certain arthritis medications and increased frequency of anovulation (a menstrual cycle during which ovaries do not release an egg) due to ra activity. this study is the first step toward our long term goal of increasing the ability of all women with ra to build the family they desire.


Eligibility criteria:
inclusion criteria: 1. ra cohort: women diagnosed with ra (2010 acr/eular criteria) at least one year prior to enrollment 2. healthy cohort: women without autoimmune disease exclusion criteria: 1. unilateral or bilateral ovarian surgery 2. prior exposure to known or possible ovary-toxic medications (e.g., cyclophosphamide, other chemotherapeutic agents)

Keywords: infertility rheumatoid arthritis
the effect of two dietary interventions on the symptomatic control of people living with anxiety disorders.

Conditions: Anxiety Disorders

Summary: this randomised controlled trial will evaluate the effect of a ketogenic diet vs a conventional diet on the symptoms of patients living with anxiety disorders using a validate self-reported inventory.

it has been theorized that ketogenic diet could improve symptom control in patients living with anxiety disorders. animal models support this hypothesis but to this date, studies in humans are lacking. the investigators will randomise patients with a confirmed diagnosis of anxiety disorders to follow a ketogenic diet (\<50 grs of carbohydrate per day) or a conventional diet (50% carbohydrate, 30% lipids, 20% protein) for one month. symptom control will be assessed weekly using beck's inventory for anxiety. diet adherence will be measured using standardised food frequency logs and acetoacetate urine strips.

Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of anxiety disorder by psychiatrist. exclusion criteria: * patients with the diagnosis of drug abuse, cognitive impairment or dementia, porphyria, carnitine translocase deficiency and carnitine palmitoyl transferase deficiency.
transcranial direct current stimulation for chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the goal of this study is to investigate the role of central neural pathways in mediating chronic pain. the aim of the study is to test the effect of stimulating brain regions that are part of a network underlying central pain processing using a non-invasive brain stimulation technique, transcranial direct current stimulation (tdcs). prior studies have used tdcs to target both sensory related cortical areas and those important for higher-order representations of pain. this study will target brain regions important for the behavioral response to the chronic sensation of pain. the hypothesis is that stimulation of these brain regions can modulate not only the affective component of pain, but ultimately also improve functioning and quality of life. this hypothesis will be tested by treating study participants eighteen and older with chronic low back pain (clbp) of greater than six months using tdcs. to be part of this study, participants must meet all the inclusion and exclusion criteria.


Eligibility criteria:
inclusion criteria: * chronic low back pain ≥ 6 months duration in the lumbar region, present more than half the days of the month, and on average be at a moderate level of severity in the last month * at least one trial of physician recommended medication (e.g. acetaminophen, nsaids, skeletal muscle relaxants) * pre-existing opioid and non-opioid pain medication must be non-existent or stable (medications have not changed for one month) * be able to understand, read and write english * if female and of childbearing age, agree to use acceptable birth control during the study treatment period (oral contraceptives, history of tubal ligation, history of a hysterectomy, or a reliable barrier method) exclusion criteria: * lifetime diagnostic and statistical manual (dsm) iv diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition * current dsm-iv diagnosis of substance dependence for alcohol, sedative/hypnotic drugs, stimulants, cocaine * current cancer, infection, or inflammatory arthritis * broken skin or other lesions in the area of the electrodes * uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation * presence of metal in the cranial cavity * holes in the skull made by trauma or surgery * pacemakers, medication pumps, and other implanted electronic hardware * pregnancy
effect of nicorandil in type 2 diabetic obese patients

Conditions: Diabetes Mellitus, Type 2

Summary: 1. evaluating the effect of nicorandil on glycemic control of diabetic obese patients treated with sulfonylureas. 2. investigating the effect of nicorandil on body weight of diabetic obese patients treated with sulfonylureas.


Eligibility criteria:
inclusion criteria: * diabetes duration ranged from 1 to 10 years. * body mass index (bmi) \>30 kg/m2. * the selected patients are treated with sulfonylureas alone. * the age of selected patient ranged from 18 and 60 years. exclusion criteria: * pregnant and lactating females. * patients with hypersensitivity to nicorandil. * uncontrolled hypertension and its antihypertensive medications * severe renal or hepatic disease.

Keywords: type 2 dm, nicorandil, obesity
self-management of chronic low back pain: targeting patient activation

Conditions: Chronic Low-back Pain; Patient Activation

Summary: patients with chronic low back (clbp) pain report reduced physical function and ability to participate in social roles and are more likely to use opioid pain medications. while self-management interventions have been shown to support these patients, effectiveness has been limited due to poor patient engagement. "patient activation" encompasses the skills, knowledge, and motivation that a person has to manage the person's health. supporting patient activation may improve the effectiveness of self-management for clbp. in this single-masked pilot study of adults with clbp, patients were randomized to receive either no intervention (control) or 6 weekly sessions of an evidence-based web-based self-management program (smp) with or without health behavior change counseling (hbcc) using motivational interviewing. participants were assessed at baseline and at 12 and 26 weeks using the patient activation measure, oswestry disability index and patient-reported outcomes measurement information system (promis) physical function, social role participation, and pain interference. the investigators assessed acceptability and feasibility based on recruitment, session attendance, and follow-up.


Eligibility criteria:
inclusion criteria: * adults (18+ years of age) * seen in primary or specialty care practice for non-specific low back pain * chronic low back pain per the nih task force on research standards for clbp * worst back pain of at least 4/10 points * oswestry disability index of at least 24% * english speaking exclusion criteria: * history of lumbar spine decompression/laminectomy or fusion surgery in the past 6 months * possible non-musculoskeletal cause for lbp symptoms diagnosis at baseline * "red flag" lbp diagnosis in the previous 6 months (e.g., cauda equina syndrome, osteomyelitis, or spinal neoplasm) * neurological disorder resulting in moderate to severe movement dysfunction * presence of any psychotic disorder

Keywords: self-management nurse-led web-based
effect of nutritional efforts on discharged elderly patients

Conditions: Malnutrition

Summary: the study is a randomized controlled study, ongoing over 16 weeks. at discharge, the intervention group receives guidance from a clinical dietician, where an individual nutrition plan is made. the dietitian will perform a telephone follow-up after 4 and 30 days. it will also be possible for the participant, relatives or municipality to contact the dietician if nutritional questions arise. at the time of discharge the intervention group will receive a package containing foods and drinks that will cover their nutritional needs the first day after discharge. they will also get a goodiebag containing samples on protein-rich milk-based drinks. data is collected on quality of life, appetite, physical function, dietary intake, weight, height, energy and protein needs, as well as experience of discharge and cooperation with the municipality. if there is a need, information about nutrition status will be sent to the municipality so the municipality can take over nutritional treatment. the control group receives standard treatment.


Eligibility criteria:
inclusion criteria: * patients admitted to oncology, gastro-medical / surgical, and medical department, hgh, herlev. * age: 50+ * at admission, found in nutritional risk score ≥3 according to nrs-2002. * on special food concept, herlev's glories during hospitalization * discharged to own home in a municipality in planområde midt (ballerup, herlev, lyngby-tårbæk, gentofte, gladsaxe, rødovre, egedal, rudersdal, furesø). * can read, hear and understand danish * cognitive able to participate in the study, based on whether they are informed in time, place and own data. exclusion criteria: * food allergy or intolerance * planned weight loss or following a special diet * receives enteral or parenteral nutrition * patients with moderate to severe dysphagia, defined with a need for gratin or a creamy diet * patients who does not want a food package or goodiebag * patients who are permanently bedridden * patients who are discharged to nursing homes or rehabilitation * patients in isolation * late palliative patients * terminal patients

Keywords: hospital readmissions seniors