Kornimate/medical-research-clean huggingface dataset:
buprenorphine/naloxone treatment for opioid dependence-experiment ii-3 - 6

Conditions: Heroin Dependence; Opioid-Related Disorders

Summary: the purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in healthy, non-drug dependent volunteers.

not available at this time

Eligibility criteria:
inclusion criteria: individuals must be healthy, non-drug dependent volunteers, be at least 18 years of age, and have no prior history of drug or alcohol abuse or dependence. subjects must have had some minimal experience with opioids (e.g. at least two prior exposures) exclusion criteria: individuals with evidence of an active diagnostic and statistical manual of mental disorders (dsm-iv) axis i psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Keywords: heroin dependence
clinical outcomes after emr or esd of colorectal neoplasms - a multicenter registry

Conditions: Colorectal Cancer; Colorectal Neoplasms; Colorectal Adenoma

Summary: this study aims to establish a multicenter registry platform to capture clinical data from subjects undergoing colorectal emr and esd.

colorectal cancer (crc) is one of the most common causes of cancer-related death, however its morbidity and mortality can be reduced by colonoscopy screening and endoscopic removal of adenomas or early cancers.\[1\] endoscopic mucosal resection (emr) and endoscopic submucosal dissection (esd) are two main endoscopic treatment options for colorectal neoplasms. despite being a safe and convenient procedure, insufficient resection by emr can result in a high risk of local recurrence, particularly in lesions ≥ 20 mm. compared with emr, esd facilitates a higher rate of en bloc resection and a lower rate of local recurrence. a recent meta-analysis revealed that the local recurrence rate after colorectal esd was 1% during a 2-year follow-up period. in addition, esd can facilitate precise pathological diagnosis to assess the risk of lymph node metastasis of early crc to judge whether salvage surgery is needed. although the efficacy of colorectal esd has been demonstrated, its usage is largely limited by its technical difficulty and risk of complications. both short- and long-term data on clinical outcomes and safety profiles for colorectal emr and esd are needed. therefore, this study aims to establish a multicenter registry platform to capture clinical data from subjects undergoing colorectal emr and esd.

Eligibility criteria:
inclusion criteria: * subjects who undergo emr or esd for colorectal lesions. exclusion criteria: * not applicable.

Keywords: endoscopic mucosal resection endoscopic submucosal dissection
bleaching effect of strawberry extract versus hydrogen peroxide in patients with extrinsic staining

Conditions: Bleaching Effect and Postoperative Sensitivity of Strawberry Extract

Summary: with limited evidence based information in literature about using strawberry extract for teeth bleaching in patients with extrinsic staining , it is beneficial to evaluate this new material using a randomized controlled clinical trial to test the null hypothesis that this extract will have the same effect as hydrogen peroxide regarding the bleaching effect and hypersensitivity.

the whitening effect of strawberry is due to the presence of malic acid, which acts as a natural astringent to remove surface discoloration. the ellagic acid content in strawberry is ranging from 0.43 to 4.64 mg/g dry weight. the more amount of ellagic acid will produce more potential oh clusters as a powerful oxidizer thus make the more effective bleaching process. ellagic acid releases the oh and h radicals which will react with the tooth enamel organic molecules and disrupt the electron conjugation, as well as changing the energy absorption in the tooth enamel organic molecules to form smaller organic molecules with a lighter color. ellagic acid has an oh cluster, not cooh cluster like any other acids. the electronegativity of the oh group will be easier to break and react with the organic molecules of tooth enamel.

Eligibility criteria:
inclusion criteria: participant inclusion criteria: 1. at least 18 years old. 2. good general and oral health. 3. six present maxillary anterior teeth. tooth inclusion criteria: 1. yellowing of teeth due to age. 2. stains due to coffee or tea. 3. light tetracycline stain. * exclusion criteria: participant exclusion criteria: 1. patients undergoing radiotherapy or chemotherapy. 2. pregnant females or breast feeders. 3. bruxism and patients who reported tooth sensitivity. tooth exclusion criteria: 1. hypoplastic enamel. 2. carious lesion. 3. sensitive recession area or sensitive tooth. 4. amalgam staining. 5. non vital tooth. 6. discolration due to pulp trauma or necrosis. 7. presence of non carious cervical lesion.
clinical study of the solo tympanostomy tube device

Conditions: Ear Infection; Otitis Media

Summary: the objective of this study is post-approval evaluation of the safety and performance of the solo tympanostomy tube device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure

the study will be a multi-site, prospective, treatment-only study of the solo tympanostomy tube device. patients will already have a scheduled tympanostomy procedure.

Eligibility criteria:
inclusion criteria: * listed for bilateral tympanostomy tube insertion exclusion criteria: * anatomy that precludes sufficient visualisation of both the left and right eardrum * narrow ear canals * anatomy that precludes safe access to both the left and right eardrum * membrane \>25% sclerosis * congenital or craniofacial abnormalities * no available baseline audiometry and tympanometry
flash glucose measurement in patients on total parenteral nutrition

Conditions: Diabetes Mellitus

Summary: iv nutrition is a means of providing all the nutritional requirements of people who have severe bowel disease. at least 10% of people on longer term iv nutrition also have diabetes and iv nutrition includes delivering glucose directly to large veins. unsurprisingly this causes elevated blood glucose levels, particularly in people with diabetes. this can make treatment of hyperglycaemia more challenging. as a result this study aims to use a flash glucose monitoring device, the freestyle libre pro, to investigate what happens to glucose levels in patients receiving iv nutrition. we will look at this trend in 5 patients with diabetes and 5 patients without diabetes receiving iv nutrition.


Eligibility criteria:
inclusion criteria: * participants receiving tpn in leeds with or without diabetes exclusion criteria: * patients not receiving tpn * patients who do not speak english * patients who are unable to give consent

Keywords: total parenteral nutrition
exercise intolerance in elderly patients with diastolic heart failure

Conditions: Heart Failure, Diastolic; Obesity

Summary: the purpose of this study is to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with heart failure and a normal ejection fraction (hfnef) and body mass index greater than or equal to 30.

heart failure with a normal ejection fraction (hfnef, previously termed diastolic heart failure), accounts for the majority of heart failure cases in the population \> 65 years old and has been recognized as a true geriatric syndrome. exercise intolerance is the primary chronic symptom of hfnef and a major determinant of these patients' severely reduced quality of life; however little is known regarding its pathophysiology and treatment. therefore, our work has focused on understanding the pathophysiology of exercise intolerance in hfnef and developing and testing interventions that may improve this pivotal outcome in this highly prevalent disorder of older persons. the aims of the proposed study are to conduct a randomized, controlled, single-blinded, 2x2 design trial to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with hfnef and body mass index \>30 in order to test the following hypotheses: 1) both weight loss and exercise training will improve exercise intolerance and quality of life in older, obese patients with hfnef; 2) the combination of weight loss and exercise training will produce complementary effects on body and thigh muscle composition and additive improvements in exercise intolerance in hfnef; 3) improvements in exercise intolerance will correlate with improvements in lean body mass, reversal of adverse thigh muscle remodeling, and increased thigh muscle capillarity. the study has the potential to significantly advance our understanding of exercise intolerance and its treatment in the large population of older persons with hfnef.

Eligibility criteria:
inclusion criteria: * heart failure clinical score greater than or equal to 3 * age 60 and over * normal ejection fraction greater than or equal to 50% * bmi greater than or equal to 30 exclusion criteria: * valvular heart disease * significant change in cardiac medication \<4 weeks * uncontrolled hypertension * recent or debilitating stroke * cancer or other noncardiovascular conditions with life expectancy less than 2 years * significant anemia * renal insufficiency (creatinine \>2.5mg/dl) * psychiatric disease- uncontrolled major psychoses, depressions, dementia, or personality disorder * plans to leave area within 6 months * refuses informed consent * failure to pass screening test:pulmonary function, echocardiogram,or exercise

Keywords: diastolic heart failure heart failure elderly obesity
nourishing beginnings: addressing food insecurity during pregnancy

Conditions: Pregnancy Related; Food Insecurity; Premature Birth; Pregnancy Complications

Summary: this is a pilot project designed to test the feasibility of implementing a community health worker (chw)-led intervention to improve nutritious food access and consumption among pregnant people and to evaluate the effectiveness of this approach. the project will be conducted in partnership with the greater cleveland food bank and the better health partnership community health worker hub

the nourishing beginnings pilot study will enroll 160 pregnant individuals (\<22 weeks gestation) who are eligible to use the partnership community hub (i.e., medicaid eligible). participants will be randomly assigned into one of two intervention arms - either direct food delivery (n=80) or small financial resources and individualized navigation support for accessing local healthy foods (n=80). the pilot will (1) assess the feasibility and allow protocol refinement; (2) assess the preliminary impact of chw-led intervention; and (3) conduct a rigorous process evaluation of the implementation of the intervention using an effectiveness-implementation hybrid type 1 design. dietary behavior, psychosocial health, health care utilization, and health outcomes and birth outcomes will be tracked at baseline, mid-pregnancy, and at delivery, derived from both primary and secondary data sources (i.e., hub and claims data). critical implementation points (referral, chw touch points, and food delivery) will be assessed. intervention arms will be compared to a matched comparison group derived from local claims data for the same time period.

Eligibility criteria:
inclusion criteria: * medicaid eligible * enrolls in the chw hub * able to read and understand english exclusion criteria: -

Keywords: food insecurity community health workers food delivery prenatal nutrition social determinants of health
evaluation of effectiveness and safety of nobori stent

Conditions: Coronary Artery Disease

Summary: the objective of this study is to evaluate effectiveness and safety of nobori stent in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus- or paclitaxel-eluting stents).

this study is a non-randomized, prospective, open-label registry to compare the efficacy and safety of nobori stents versus first-generation des in patients with coronary artery disease.

Eligibility criteria:
inclusion criteria: * patients receiving nobori stents. * the patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethics committee of the respective clinical site. exclusion criteria: * patients with a mixture of other dess. * terminal illness with life expectancy \<1 year. * patients with cardiogenic shock.
reach out and read (ror) in the neonatal intensive care unit (nicu) study

Conditions: Anxiety; Parent-Child Relations; Literacy

Summary: the goal of this clinical trial is to learn about the effects of the reach out and read program on infants and their families in the neonatal icu. the main goals of this study are: * to complete a needs assessment for literacy interventions in the nicu population through evaluating baseline home literacy scores. * to evaluate the effects of the ror intervention on parental stress levels as assessed by the 6-question state-trait anxiety index (stai-6) * to evaluate the effects of the ror intervention on parent-infant bonding by comparing scores on the 25-item postpartum bonding questionnaire (pbq) * to evaluate the effects of the ror intervention on the home literacy environment by comparing home literacy scores participants will complete three questionnaires that include demographic information, home literacy scores, the postpartum bonding questionnaire and the state-trait anxiety index; once at study enrollment, once at 36 weeks corrected gestational age, and once at 3 months corrected gestational age. researchers will compare the control group (standard care) and a group that receives reach out and read education to see whether exposure to reach out and read affects literacy behaviors, parental anxiety, and parent-infant bonding.


Eligibility criteria:
inclusion criteria: * families of subjects born between 24w0d and 33w6d gestation * primary language is english or spanish exclusion criteria: * severe clinical instability such that the principal investigators do not think the infant will survive to 36 weeks gestation
lp(a) lowering study of pelacarsen (tqj230) in us black/african american and hispanic participants with elevated lp(a) and established ascvd

Conditions: Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease

Summary: study ctqj230a12303 is a randomized, double-blind placebo-controlled, phase iiib study to evaluate the efficacy, safety and tolerability of pelacarsen (tqj230) 80 mg s.c. qm compared with placebo s.c. qm in us black/african american and hispanic participants with established ascvd and elevated levels of lp(a) who are treated for cardiovascular (cv) risk factors according to local practice/guidelines for the reduction of cardiovascular risk.

ctqj230a12303 is a randomized, double-blind, placebo-controlled, multi-center, phase iiib study to evaluate the efficacy ( measured by reduction of the lp(a) levels) and safety of pelacarsen (tqj230) 80mg s.c. qm compared to placebo in us black/african american and us hispanic participants, with established atherosclerotic cardiovascular disease (ascvd) as evidenced by history of coronary heart disease, cerebrovascular disease or symptomatic peripheral artery disease (pad) and elevated levels of lp(a).

Eligibility criteria:
inclusion criteria: * male and female us black/african american and us hispanic participants 18 to ≤ 80 years of age * lp(a) ≥ 125 nmol/l at the screening visit, measured at the central laboratory * on standard of care (soc) therapy for risk factors other than lp(a), including ldl-c (ldl-c lowering therapy dose stable for at least 30 days), elevated blood pressure and diabetes, at the randomization visit according to local practice/guidelines. * established ascvd disease defined as documented: * coronary heart disease (chd) and/or * cerebrovascular disease (cvd) and/or * peripheral arterial disease (pad): exclusion criteria: * uncontrolled hypertension * heart failure new york heart association (nyha) class iv * history of malignancy of any organ system * history of hemorrhagic stroke or other major bleeding * platelet count \<140,000 per mm3 * active liver disease or hepatic dysfunction * significant kidney disease * pregnant or nursing women

Keywords: elevated lp(a) cardiovascular disease pelacarsen (tqj230)
assessing moral cognitive skills in adults with autism spectrum disorders

Conditions: Autism Spectrum Disorder

Summary: in the international literature, it is currently accepted that, relative to neurotypicals, people with autism spectrum disorder (asd) present patterns of moral judgments marked by a minimization of intentionality and a strong condemnation of agents responsible for accidents. however, until now, all studies are based on declarative paradigms, and no one has proposed to examine the relationship of people with asd to moral transgressions (i.e. to a bad action done deliberately or to a good deed deliberately omitted) in an implicit paradigm, that is, when the answer is made on the assignment of an expressive face to these moral offenses. furthermore, no study has investigated whether diminished sensitivity to intention and intransigence of incidental judgment occur in both automatic (implicit) and deliberative (explicit) settings. investigators planned to study how people with asd without intellectual disability process emotions expressed by others in response to different forms of moral offense and to examine whether patterns potentially contrast in degree and/or kind with those of neurotypicals.

in the comora project, participants will participate to two independent tasks: an explicit one of deciding whether or not an emotion expressed on the face of a third person would be an appropriate emotional reaction to the offense, and an implicit one in which the subjects will have to determine the fastest sex to which the face expressing such or such an emotion belongs. this procedure initiates an implicit processing of the facial expression. the theoretical hypotheses of the comora project are the following: * in the explicit response condition, people with asd will show different emotional assignment patterns than controls do, depending on the nature of the offense (accidental transgression, attempted harm, and intentional harm). * in the implicit response condition, people with asd will exhibit emotion processing patterns identical to those of controls. * the differences in responses of controls and people with asd in the explicit condition will be underpinned by executive functions and social cognitive performances.

Eligibility criteria:
inclusion criteria: asd group: * diagnosis of asd according to dsm-5 criteria * age between 18 and 40 years old * francophone * affiliated to social security * having given their consent to participate in the study * patient under guardianship and curatorship neurotypical group: * age between 18 and 40 years old * francophone * affiliated to a social security scheme * having given their consent to participate in the study exclusion criteria: asd group: * diagnosis of intellectual development disorder established according to dsm-5 criteria * language, sensory or motor impairments hindering participation in the study control group: * neurodevelopmental pathology (declarative) * neurological pathology * language, sensory or motor impairments hindering participation in the study

Keywords: moral cognition autism spectrum disorders
eye shields for infants after dilated exam

Conditions: Infant, Newborn, Disease; Pain; Retinopathy of Prematurity; Eye Diseases

Summary: the eyes of hospitalized infants are often assessed by dilated exam, and there is evidence that infants experience post-exam stress. investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.

neonatal eye examinations are the standard of best practice in pediatrics. in the acute clinical setting, infants' eyes are inspected for eye development, defect, and disease. there is anecdotal and clinical evidence that infants experience stress after eye dilation. investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.

Eligibility criteria:
inclusion criteria: * chronological age 0-12 months * infants who require dilated eye exams * parent or legal guardian consent/permission granted exclusion criteria: * more than a two-week interval between dilated eye exams * prior or ongoing medical treatment or therapy for the eye(s) * functional blindness diagnosed by eye exam

Keywords: eye shield eye protector eye patch eye mask phototherapy
multicenter infection surveillance study following colorectal procedures

Conditions: Surgical Wound Infection

Summary: this study is a multicenter, open label, observational, postmarketing surveillance study of the on-q® silver soakertm in the united states and canada. this study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal surgical procedures.

this study is a multicenter, open label, observational, postmarketing surveillance study of the on-q® silver soakertm in the united states and canada. this study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal procedures.

Eligibility criteria:
inclusion criteria: * men and women, \>18 years of age; * scheduled for elective colon procedure; * ability to complete patient survey questionnaires; * provision of informed consent exclusion criteria: * patients with a prior allergic reaction to morphine, demerol, dilaudid, fentanyl, marcaine (bupivacaine), lidocaine or naropin (ropivacaine); * procedures for hemorrhoids; * inability to perform follow up assessments

Keywords: colorectal surgery
catheter ablation of all inducible at post af ablation

Conditions: Atrial Tachycardia; Atrial Fibrillation

Summary: in the treatment of symptomatic drug resistant persistent atrial fibrillation (ps af), catheter ablation has a class iia indication. during the follow-up, a significant amount of patients (\~50%) will experience atrial tachycardias (at) recurrence. the endpoint of at ablation during the second procedure has not been validated. at present, several strategies are considered as good clinical practice. main objective: to evaluate if ablation of all inducible at post af ablation (atpafa) offers as substantial benefit in comparison with ablation of the clinical atpaf only during a redo procedure post initial persistent af ablation. secondary objectives: to evaluate the prognosis of non-inducibility during a redo procedure for atpafa


Eligibility criteria:
inclusion criteria: * male or female adults (≥18 years old) * patients with stable atpaf at least two months after the first af ablation procedure. * consent signed by the patient after reading the information leaflet exclusion criteria: * mental or physical inability to take part in the study * spontaneous af in the ep lab * presence of any pulmonary vein stents * presence of any pre-existing pulmonary vein stenosis * presence of any cardiac valve prosthesis * clinically significant mitral valve regurgitation or stenosis * myocardial infarction, pci / ptca or coronary artery stenting within the last 3 months * unstable angina * any cardiac surgery within the last 3 months * nyha class iii or iv congestive heart failure * uncontrolled hyperthyroidism