Kornimate/medical-research-clean huggingface dataset:
family-centered obesity prevention: communities for healthy living (chl)

Conditions: Pediatric Obesity; Obesity

Summary: the communities for healthy living (chl) program is a family-focused intervention to promote healthy lifestyle behaviors including diet and physical activity among children (age 3-to 5-years) and their families, enrolled in head start.

this evaluation will test the effectiveness of a family-focused intervention, communities for healthy living (chl), implemented through head start. over 20% of preschool-aged children in the us experience overweight or obese. because obesity prevention depends heavily on the adoption of healthy lifestyle behaviors early in life, preventive efforts offer a higher promise for success if they are family-centered. effective family-centered interventions for obesity prevention in preschool-aged children, however, remain elusive. while a number of interventions have shown positive effects on child body mass index (bmi), results are inconsistent and short term effects are not maintained. what is more, because families at greatest risk of childhood obesity - including low-income, single-parent, and ethnic minority families - are the most difficult to recruit and retain, results are often limited in their applicability to high risk populations. in response, the researchers have partnered with head start to develop and test a new approach to family-centered childhood obesity prevention that addresses family engagement upfront. the chl program will be refined and rigorously tested for efficacy in collaboration with head start programs in the greater boston area, which collectively serve over 2000 low-income children each year. building on a previous pilot study, the investigators will broaden the parent-centered community based participatory research approach and include head start staff in the decision making and implementation process, refine intervention components, and expand technical assistance protocols to support head start ownership of chl while ensuring implementation fidelity. in addition, consistent with the overarching theoretical framework (family ecological model), neighborhood-level socioeconomic, food and physical activity environments around family homes and examine their impact on intervention outcomes will be measured to inform future scale up efforts.

Eligibility criteria:
primary outcome measures inclusion: * enrolled in a participating head start program * age 33 months to 5 years (i.e., meets head start age eligibility criteria) exclusion: * those not meeting inclusion criteria secondary outcome measures inclusion: * enrolled in a participating head start program * age 33 months to 5 years exclusion: * children not enrolled at a participating head start program * children less than 29 months or older than 59 months by sept 1

Keywords: childhood obesity preschool head start family interventions community based participatory research (cbpr) empowerment theory family ecological theory step wedge design low income
angiotensin ii in liver transplantation

Conditions: Liver Transplant; Complications; Vasoplegia

Summary: the purpose of this study is to determine the efficacy and safety of angiotensin ii as a second-line vasopressor (drug that raises the blood pressure) during liver transplantation.

this is a single center, randomized, double-blind, placebo-controlled trial. subjects will receive an infusion of either angiotensin ii (angii) or a saline control (placebo) in addition to usual care with traditional vasopressors (catecholamines and vasopressin) during liver transplantation (lt). angii is a vasopressor approved by the fda for the treatment of vasodilatory shock. it targets the renin-angiotensin system (ras) and has been shown to effectively raise the mean arterial blood pressure (map) in patients with septic shock. it also allows for lower doses of traditional vasopressors and may improve microcirculatory flow to the kidneys. the study drug will only be administered if the participants require \> 0.05 mcg/kg/min of norepinephrine while undergoing liver transplantation. the study drug will be titrated throughout the case and discontinued at the end of surgery. randomization will be stratified based on (a) the need for renal replacement therapy preoperatively and (b) the use of normothermic machine perfusion of the liver graft.

Eligibility criteria:
inclusion criteria: * age \> or = 18 years * liver transplantation from a deceased donor * model for end-stage liver disease sodium (meld-na) score \> or = 25 at the time of transplant (not counting meld exception points) * patient requiring \> 0.05 mcg/kg/min of norepinephrine (ne) during lt exclusion criteria: * living-donor liver transplantation (ldlt) * split liver transplantation (isolated right or left lobe) * donation after cardiac death (dcd) without normothermic machine perfusion (nmp) * acute liver failure (alf) * listed for or receiving simultaneous liver-kidney transplantation (slkt) * liver re-transplantation (patient who has previously received a liver transplant) * preoperative treatment with angiotensin ii receptor blocker or angiotensin converting enzyme inhibitor (within 48 h) * portopulmonary hypertension * left ventricular systolic dysfunction (defined as ejection fraction \< 45%) * active bronchospasm at time of lt * history of thrombotic or embolic disease, inherited hypercoagulable disorder, or therapeutic anticoagulation * portal vein thrombosis * celiac stenosis * end-stage renal disease (chronic egfr \< 15 ml/min/1.73 m2 or chronic rrt - not including aki requiring rrt) * history of raynaud's disease * known history of allergy to synthetic human angiotensin ii * subject intubated and/or mechanically ventilated prior to entering or for lt * presence of other condition or abnormality that would compromise the safety of the patient or quality of the data

Keywords: vasoplegia angiotensin ii cirrhosis liver transplant liver transplantation hypotension acute kidney injury
neural mechanisms connecting deficient sleep and smoking relapse

Conditions: Tobacco Use; Tobacco Cessation; Insomnia

Summary: the study aims to investigate whether behavioral interventions promote cessation in adult smokers by ameliorating negative emotions and improving self-control and identify the neural markers of these effects.

the primary objectives of this study are to compare the effectiveness of two types of behavioral interventions, when combined with varenicline medication, in promoting tobacco cessation among treatment-seeking adults and to elucidate the underlying mechanisms. the secondary objective of this study is to examine sex differences. investigators will recruit from two primary sources: 1) community-based recruitment strategies including web and social media ads, lay community members to recruit, and local communication channels; 2) investigators will invite referred patients to the outpatient tobacco treatment service (tts) at yale-new haven hospital. all participants will be assigned to one of two behavioral interventions. both groups will receive treatment with varenicline and attend weekly individual counseling sessions (standard care or cognitive behavioral therapy for insomnia) and wear research-grade sleep actiwatches for passive sleep monitoring. participants will have a total of five expected research visits with a scheduled target quit date for week 4. participants will undergo mri at baseline and at week 4, and attend follow-ups at week 8, 12, and 26.

Eligibility criteria:
inclusion criteria: * english literate * report heavy tobacco use (including nicotine e-cigarettes) for \>6 months * meet biochemical cut off for recent cigarette smoking or e-cigarette use * optimal body mass index exclusion criteria: * currently enrolled in other treatments * neuropsychiatric exclusions that could interfere with study participation, increase risk of adverse events, and/or induce deficient sleep * medical contraindications for fmri, varenicline, and/or behavioral treatment * factors that cause deficient sleep and for which behavioral treatment has less benefit * women who are pregnant or nursing
using mri to identify areas to receive lower doses of radiation treatment in men with prostate cancerdose mapping to preserve quality of life

Conditions: Prostate Cancer

Summary: the purpose of this research is to gather information on the safety and effectiveness of using an imaging technique called magnetic resonance imaging (mri) to decrease radiation dose to the uninvolved prostate (areas of the prostate that do not clearly have cancer cells) while increasing radiation dose to the nodules (hardened areas of the prostate that have cancer cells).


Eligibility criteria:
inclusion criteria: * adult (≥ 18 years old) male patients with an ecog performance status 0-2 * histologically-confirmed, mri-visible prostate adenocarcinoma with nccn intermediate- or high-risk disease1 without extra-pelvic metastasis. exclusion criteria: * distant metastases * prior active treatment for prostate cancer including radical prostatectomy, high-intensity focused ultrasound (hifu), cryosurgery, adt, or cytotoxic chemotherapy for treatment of prostate cancer. patients with prostate cancer on active surveillance prior to the study are not excluded if they have not received active treatment. * prior pelvic radiotherapy including brachytherapy. * additional active concurrent malignancies (except localized cutaneous squamous or basal cell carcinomas). * comorbid conditions that, in the opinion of the treating radiation oncologist, preclude the patient from safely receiving the protocol-specified treatment including rt and/or adt. * patients with contraindications to mri including patients with ferromagnetic materials in their body (e.g. bioimplants, surgical hardware, shrapnel), patients who are unable to receive contrast due to history of allergy or impaired renal function (glomerular filtration rate \< 30 mil/min), and patients unable to tolerate mri for other reasons (e.g. significant claustrophobia). * patients for whom hydrogel or hyaluronic acid spacer will be placed. * patients incapable of giving informed consent. * patients who are unable to adhere to the experimental protocols for any reason.
a study to evaluate how the body processes 14c-vx-993 after a single oral dose

Conditions: Pain

Summary: the purpose of the study is to evaluate the routes and rate of elimination and recovery of total radioactivity (tra) and characterize the pharmacokinetic (pk) of vx-993 after a single oral dose of 14c-vx-993.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.)

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive * a total body weight of more than (\>) 50 kg * participants must have at least 1 regular bowel movement per day key exclusion criteria: * history of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * any condition possibly affecting drug absorption, distribution, metabolism, or excretion * exposure to any non-environmental radiation within 12 months of dosing * participation in more than 1 radiolabeled study (if prior radiation exposure unknown) or participation in more than 3 radiolabeled studies (if radiation exposure known) in the 12 months before dosing or if the annual whole body radiation exposure from previous studies (including this dosing) exceeds fda-allowed maximum whole body radiation exposure of 5000 mrem other protocol defined inclusion/exclusion criteria may apply.
evaluating the predictive value of the nociception level index nol

Conditions: Pain; Anesthesia

Summary: opioids remain the cornerstone for perioperative analgesia, albeit frequently associated with side effects. most of these side-effects are dose-dependent. thus intra-operative monitors are necessary to measure the balance between nociception and anti-nociception (nan balance) by an adequate opioid administration. recently the nol monitor was released.the nol index ranges from 0 to 100 and is based on a nonlinear combination of nociception-related physiologic variables, specifically heart rate (hr), heart rate variability at the 0.15- to 0.4-hz band power, photoplethysmograph wave amplitude (ppga), skin conductance level, number of skin conductance fluctuations, and their time derivatives. the nol index estimates the nociceptive/antinociceptive state from these component measures using random forest regression. in our department, a combination of tci propofol (schnider model) and remifentanil (minto model) is used to for most of the anaesthetic procedures, including cardiac anaesthesia. remifentanil is titrated to prevent an increase in blood pressure and hearth rhythm at noxious stimuli, such as surgical incision, and adapted following hemodynamic trend during surgery. the hypothesis of this study is to develop a calibration test using the nol index variation to define the individual most appropriate nan balance using remifentanil tci before the start of surgery and before a very strong noxious surgical stimulus such as surgical incision in non-cardiac and cardiac surgery. before the start of surgery, the investigators want to titrate in each patient the remifentanil ce required to abolish the nol index response to a calibrated noxious tetanic stimulus (tetanus 60 mamp, 100 hz, 30 seconds). thus this individual remifentanil ce will be the remifentanil level programmed before surgical incision. nol and hemodynamic responses will be recorded during the entire duration of surgery. study protocol amendment: validation of the calibration study: data from the calibration phase will be used to derive a formula to predict individualised anti-nociception for incision.


Eligibility criteria:
inclusion criteria: * patients undergoing non-cardiac surgery * patients undergoing cardiac surgery (coronary artery bypass graft) * knowledge of french, english or dutch is required. exclusion criteria: * pregnancy * allergy or contraindications to one of the study drugs * bmi \>30 * history of drug and alcohol abuse, * preoperative analgesic drug use * heart rhythm disturbances (atrial fibrillation, atrial flutter). * the use of alpha-2 adrenergic agonists
bioequivalence of single dose extended release naproxen sodium (660 mg) tablet versus naproxen sodium (220 mg) tablet three times daily

Conditions: Pain

Summary: bioequivalence trial in healthy adult subjects to determine the bioavailability of 3 different sustained release formulations of naproxen 660 mg relative to the established commercial aleve 220 mg tablet.


Eligibility criteria:
inclusion criteria: * healthy ambulatory male and female subjects 18 to 55 years of age, inclusive * body mass index (bmi) of approximately 18.0 to 30.0 kg/m2, and a total body weight \>50 kg (110 lbs) * results of screening and clinical laboratory tests are within normal limits or considered not clinically significant by the principal investigator or sponsor * female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, intramuscular injection or double-barrier and have a negative pregnancy test at screening and on day 0 of each treatment period. female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy. * provide a personally signed and dated informed consent prior to inclusion in the trial indicating that the subject has been informed of all pertinent aspects of the trial. exclusion criteria: * history of hypersensitivity to aspirin (asa), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products * history of gastrointestinal bleeding or perforation, including bleeding related to previous nsaid therapy. active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding). * have taken asa, asa-containing products, acetaminophen (acetyl-para-amino-phenol or apap) or any other nsaid (otc or prescription) 7 days prior to dosing or during the treatment period, other than study treatment * loss of blood in excess of 500 ml within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis, or injury) * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) * positive alcohol or drug screen at screening or on day 0 of treatment periods 1 or 2 * females who are pregnant or lactating * smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (eg, nicotine patch, nicotine gum).
temporalis myofascial flap effectiveness

Conditions: Maxillary Sinus Neoplasms

Summary: this research is conducted as trial to improve lifestyle of patients with cranio-maxillofacial defects following major insults like trauma or tumor resection in form of speech problems or dysphagia by usage temporalis myofascial flap and assessment of it's effectiveness


Eligibility criteria:
inclusion criteria: * patients with: * tmj ankylosis * osteomyelitis following mucormycosis * following tumor resection like maxillectomy or temporal bone resection * following orbital exentration due to tumors or infections * following massive trauma * facial reanimation exclusion criteria: * • history of head \& neck embolization as it may compromise blood supply of the flap * extensive tumors involving maxillary artery * history of head \& neck radiation or chemotherapy * temporalis muscle wasting due to any reason * bad general condition

Keywords: temporalis flap maxillofacial defects reconstruction
effects of hypnosis therapy on outcomes in total knee replacement

Conditions: Anxiety; Opioid Use

Summary: the purpose of this study is to collect information to evaluate the role of the psychogenic component of pain induced by anxiety on postoperative outcomes in major orthopaedic surgery and to determine whether hypnosis therapy provided during the perioperative period will lead to decreased use of opioid therapy. patients are randomly assigned to one of two treatment groups: (i) usual care, or; (ii) hypnotherapy treatment. patients have an equal chance of being assigned to one of the two groups.


Eligibility criteria:
inclusion criteria: * diagnosis of primary knee arthritis, in need of a total knee arthroplasty. * the ability to read, speak, and understand english * the ability and willingness to use a web-based application (oberd) on a smartphone, pad/tablet, or computer * 18 years of age or older exclusion criteria: * revision total knee arthroplasty * any knee procedure except a primary knee arthroplasty, since these procedures have shown to result on increased postoperative pain compared to primary surgery * patients with active cancer or receiving palliative care

Keywords: hypnosis total knee arthroplasty total knee
exploration of standard surgical indication in gallbladder benign disease

Conditions: Gallbladder Stone; Cholecystitis; Gallbladder Polyps

Summary: this study evaluates life quality of patients who were diagnosed with gallbladder benign disease through gastrointestinal quality of life index (giqli) scale. researchers will establish a database including 20,000 patients. through observational followup and statistic analysis，identifing a model or scale to standardized surgical indication, help surgeons and patients determine the best treatment decision.

the incidence of gallbladder benign diseases are increasing today. most patients are accepting cholecystectomy. is it better postoperation for this sort of patients? in other words, there is no specific indication for cholecystectomy in gallbladder benign diseases. investigators want to explore the specific surgical indication for these patients so that surgeons could help patients make the best decision according to our evaluation model. this model may be a scale that summarizes and quantizes correlative factors of individual, which will be discussed by statisticians and experts of biliary surgery.

Eligibility criteria:
inclusion criteria: * patients diagnosed with gallbladder benign disease, including gallbladder stone、cholecystitis and polypoid lesions of gallbladder from december 2016 to september 2018. * have been clearly informed the purpose of this study, methods and other information, voluntarily participate in this study and sign informed consent. exclusion criteria: * complicated with bile duct stones and other biliary tract disease or suspected with gallbladder carcinoma、biliary tract cancer. * complicated with severe diseases such as organ dysfunction that cannot accept surgery * abdominal operation history. * pregnant or lactation. * coagulopathy.
feasibility and efficiency of screening for neurodevelopmental disorders by an advanced practice nurse in children with congenital heart disease

Conditions: Congenital Heart Disease in Children; Neurodevelopmental Disorders

Summary: feasibility and efficiency of screening for neurodevelopmental disorders by an advanced practice nurse in children aged 1 to 5 with congenital heart disease

congenital heart disease (chd) is the leading cause of birth defects. over 90% of children born with chd reach adulthood. 50% of them will develop a neurodevelopmental disorder (ndd) that could affect life and long-term prognosis, including scholar and social integration and health related quality of life. in france, there is a lack of medical resources to screen ndd in this population and to refer patients for appropriate and early treatment. investigators plan to propose a systematic early screening of ndd by an advanced practice nurse (apn) during the usual cardiac follow-up. children with chd aged 1 to 5 will be included. if ndd is suspected, the patient will be referred to a neuropsychologist for ndd diagnosis confirmation and management planning. patients with higher ndd risks (neonatal cardiac surgery) will benefit from a systematic neuropsychologist evaluation. this study will investigate the feasibility and performance of an apn screening in this ndd-high risk population.

Eligibility criteria:
inclusion criteria: * congenital heart disease with stable status defined by last operation \>3 months, no cardiac decompensation in the last 3 months, no planned surgery within 6 months after the inclusion * cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life, * patient aged 1 to 5 years. * no previous medical diagnosis of ndd * parental or legal guardian's consent. * social security affiliation (for france only) exclusion criteria: * genetic or poly-malformative syndrome with usual neurodevelopmental care (camps-type care network) * neurodevelopmental status evaluation within the last 6 months.

Keywords: congenital heart disease neurodevelopmental screening advanced practice nurse organization of care neuropsychological assessment