Kornimate/medical-research-clean huggingface dataset:
study to evaluate darunavir/ritonavir + lamivudine versus continuing with darunavir/ritonavir + tenofovir/emtricitabine or abacavir/lamivudine in hiv infected subject

Conditions: HIV Infection

Summary: this is an open label randomized clinial trial to evaluate the treatment with darunavir/ritonavir (800mg/100mg) plus lamivudine (300 mg) once daily versus continuing with darunavir/ritonavir (800mg/100mg) once daily plus tenofovir/emtricitabine (300mg/200mg) or abacavir/lamivudine (600mg/300mg) in hiv infected subject with suppressed plasma viremia.


Eligibility criteria:
inclusion criteria: 1. acceptance to participate in the study, signing the informed consent document before conducting any study procedures. 2. patient with hiv infection older than 18 years. 3. treatment with darunavir/ritonavir once a day and tenofovir/emtricitabine or abacavir/lamivudine during at least 4 weeks at the moment of the screening 4. plasma hiv rna levels below 50 copies / ml for at least 6 months (two separate measurements at least 6 months with viremia \<50 copies / ml between both). 5. hbsag negative exclusion criteria: 1. pregnant or breastfeeding woman 2. evidence of lamivudine resistance (any previous genotype with mutation m184v/i or k65r) and/or to darunavir (population genotype show any of the following mutations: v11i, v32i, l33f, i47v, i50v, i54l/m, g73s, t74p, l76v, i84v, l89v). 3. history of virology failure (two consecutive viral loads above 200 copies/ml) while the patient was receiving a regimen with lamivudine or emtricitabine, with the following exceptions: * do not consider an exclusion criterion if the genotype performed at the time of failure does not demonstrate resistance to lamivudine and darunavir (see criteria 2). * do not consider an exclusion criteria in the absence of genotype if after the episode turns to maintain a viral load \<50 copies / ml with a treatment composed of lamivudine or emtricitabine + a nucleoside + a non-nucleoside. 4. history of abandonment of treatment including lamivudine or emtricitabine, with the following exception: - viral load prior to abandonment was \<50 copies / ml and subsequent reintroduction of the same treatment or another treatment consisting of lamivudine or emtricitabine + a nucleoside + a non-nucleoside returns to maintain viral load below 50 copies / ml . 5. previous treatment with bitherapy or monotherapy with lamivudine or emtricitabine 6. previous treatment with bitherapy or monotherapy with a regimen with a protease inhibitor that is terminated by viral rebound, when the absence of a genotypic resistance test available after viral rebound allow discard the resistance mutations either drug used. 7. the use of concomitant medication not permitted 8. presence of active acute infection, including opportunist infection that a judge of investigator that can difficult the participation in the trial 9. any laboratory results of the following: hemoglobin\<8,0 g/dl; neutrophils \<750 cells/µl; platelets \<50.000 cell/µl; creatinine ≥ 1,5 uln (upper limit of normal) 10. any clinical or analytic event that, in the investigator judgment, condition the patient safety
the effect of motivational interviewing on the level of self-efficacy and addiction in smoking cessation

Conditions: Quit Smoking

Summary: this study will be carried out to determine the effect of motivational interviewing on the level of self-efficacy and addiction in smoking cessation in nursing students.

this study will be carried out to determine the effect of motivational interviewing on the level of self-efficacy and addiction in smoking cessation in nursing students. the study was planned as a single-blind randomized controlled experimental study. the population of the research will be composed of students studying in the 1st, 2nd and 3rd years of ordu university and giresun university faculty of health sciences nursing department and who meet the research criteria, and the sample will be 90 students determined by power analysis. in the study, 30 students from ordu university faculty of health sciences nursing department will be in the experimental group and 30 students in the i. control group. 30 students from giresun university faculty of health sciences nursing department will be in the second control group. students in the experimental group will be given a motivational interview on quitting smoking for 40-50 minutes on average once a month for 6 months. no intervention will be applied to the students in the control groups during the research process, but a motivational interview will be applied once at the end of the research in terms of ethics. the data of the research will be collected with personal information form, fagerström nicotine addiction test, self-efficacy scale and stage of change evaluation form. in the study, repeated measurements will be made in the 1st month, 3rd month and 6th month. necessary institutional permission and ethics committee approval will be obtained for the research. the analysis of the data will be done by an expert statistician in a computer environment.

Eligibility criteria:
inclusion criteria: * being a 1st, 2nd, and 3rd year student of the nursing department, * continuing active education and training, * smoker at least one cigarette a day, * open to communication and cooperation, and * students who volunteer to participate in the study will be included in the study. exclusion criteria: * fourth grade, * having a serious psychiatric diagnosis (schizophrenia, bipolar disorder, psychotic disorder, etc.), * receiving professional support for smoking cessation, * changing schools during the research process and * students who do not want to continue the research will be excluded from the research.

Keywords: motivational interview smoking cessation self-efficacy level of addiction nursing students
incidence and impact of icu-acquired diaphragm weakness

Conditions: Diaphragm Dysfunction

Summary: icu survivors are at an increased risk of hospital and icu readmission. among the complications of icu stay, diaphragmatic dysfunction is common, with a prevalence of 60 to 80%, and is associated with increased mortality and prolonged hospital stays. furthermore, several studies have reported that the observation of impaired respiratory muscle function upon icu discharge is associated with a poor long-term prognosis. however, the incidence and prognostic impact of persistent diaphragmatic dysfunction at icu discharge have never been evaluated. the measurement of dyspnea, a composite evaluation of respiratory muscle function, has not been assessed for predicting prognosis upon icu discharge. the hypothesis of the project is that the presence of icu-acquired diaphragmatic dysfunction at icu discharge is associated with a poorer prognosis within 90 days.

diaphragmatic function of patients will be assessed by ultrasound within 24 hours following the weaning from ventilatory support and on the day the patient is deemed eligible for icu discharge. icu discharge will be defined a priori using a checklist. diaphragmatic activity will be assessed by bedside diaphragmatic ultrasound. patients will be positioned in a semi-sitting position (trunk inclination between 30 and 45°) to allow for better visualization of the right hemidiaphragm. the diaphragmatic assessment will include the measurement of inspiratory and expiratory thickness to calculate the diaphragmatic thickening fraction (intercostal approach) and the measurement of diaphragmatic excursion (subcostal approach) during the respiratory cycle. these measurements will be taken at rest. diaphragmatic dysfunction will be defined by a thickening fraction strictly less than 20% and/or a diaphragmatic excursion strictly less than 1 cm at rest. dyspnea will be assessed using a visual analog scale (vas) ranging from 0 (no dyspnea) to 10 (maximum dyspnea). it will be evaluated within 24 hours following the weaning from ventilatory support and on the day the patient is deemed eligible for icu discharge.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. invasive or non-invasive respiratory support (ventilation, high-flow oxygen therapy, whatever the reason) for at least 48 hours. 3. weaning from respiratory support (invasive or not) within the last 24 hours. 4. patient (or trusted person/relative) informed and not opposed to the study. exclusion criteria: 1. known pre-existing diaphragmatic dysfunction (phrenic lesion, neuromuscular disease, etc.) 2. patients with tracheostomy 3. non-communicating patients 4. patients deprived of liberty by court or administrative order, or under legal protection (guardianship, curators).

Keywords: icu diaphragmatic activity respiratory support
effects of weight loss on hepatic and muscle lipid content and on insulin sensitivity on obese adolescents with nafld

Conditions: Fatty Liver; Insulin Resistance

Summary: to assess whether reversal of fatty liver by moderate weight loss (8% of body weight) will lead to improvements in insulin sensitivity, which will be associated with changes in both glucose status and lipid profiles, in obese children and adolescents with fatty liver who have normal glucose or pre-diabetes.

this study will have two groups: one group that eats a moderate calorie, low-fat diet and is weighed regularly (every other week for 16 weeks) and the other who receives traditional diet therapy and returns in 16 weeks. both groups will undergo procedures that test glucose tolerance and measure liver and muscle fat content before and after study period.

Eligibility criteria:
inclusion criteria: * 10 to 21 yrs of age * non-smoking * bmi \>95th percentile for age and gender, but bmi \<40 * suspicion of fatty liver, with a high alt (\>35) * normal glucose tolerance or prediabetes (impaired glucose tolerance or impaired fasting glucose) exclusion criteria: * females of child-bearing potential who are not using birth control * pregnant or lactating females * current medications except oral anti-diabetic medications and hormonal birth control * lipid-lowering medication that increases liver enzymes * significant kidney dysfunction (creatinine \>1.5 mg/dl) * current heavy ethanol use or recent history of binge drinking * history or evidence of hepatitis a, b, or c, wilson's disease, or alpha-1-antitrypsin deficiency * known to be hiv positive * symptomatic angina pectoris or cardiac insufficiency as defined by the nyha classification as functional class iii or iv * major vascular event within 6 months of screening (e.g. mi, stroke) * active cancer within 5 years prior to screening * current systemic disease, including type 1 or 2 diabetes * enrolled in another research study within 1 month prior to screening * implanted paramagnetic material (all subjects will need to fill out the yale magnetic resonance center safety checklist) * anemia (hct \<35%)

Keywords: steatosis fatty liver insulin sensitivity fatty liver (steatosis)
clinical trial of avl-3288 in schizophrenia patients

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: single-center, outpatient, randomized, double-blind, placebo-controlled, 3-treatment-phase, cross-over study to evaluate the safety, tolerability and efficacy of two oral doses of avl-3288 each compared to placebo, in patients with schizophrenia.

this study will be in 24 non-smoking outpatients with schizophrenia or schizoaffective disorder. subjects will complete three treatment phases, each involving 5 straight days of taking avl-3288 (10 mg or 30 mg study drug or placebo) followed by a 16 day washout period in which subjects do not take the study drug to ensure that the drug is completed eliminated from the body before the next phase.

Eligibility criteria:
inclusion criteria: * dsm-v diagnosis of schizophrenia or schizoaffective disorder * rbans total scale score \>62 * willing to provide informed consent * medically stable for study participation * taking an antipsychotic medication other than clozapine at a stable dose for at least 4 weeks * judged clinically not to be at significant suicide or violence risk exclusion criteria: * substance abuse (excluding nicotine) within last 90 days * ecg abnormality that is clinically significant * current clozapine use * participation in a study of investigational medication/device within 4 weeks * pregnancy, lactation, or lack of use of effective birth control * active tobacco use * presence or positive history of significant medical or neurological illness, including cardiac illness, wbc \ 1.5 times upper limit of normal. hemoglobin less than 130 g/l (13 g/dl) in males or 120 g/l (12 g/dl) in females or known hiv + * contraindication to mri scanning, including metal implants or claustrophobia * medicinal patch, unless removed
rosacea and ivermectin

Conditions: Rosacea

Summary: the primary hypothesis is that weekly digital interactions and routine measurement of tewl rates and sc hydration levels will promote patient adherence to maintenance ivermectin therapy and prevent disease relapse. the project will consist of a trial in which thirty subjects with rosacea receive ivermectin therapy and are randomized to receive either no intervention, a weekly digital survey to assess patient's attitudes towards ivermectin therapy, or a portal hydration measurement device that measures tewl rates and sc hydration levels. the study team will measure adherence objectively in all groups with electronic monitors attached to the containers of the ivermectin, which all subjects will be told to use daily for maintenance therapy. additionally, the hydration measurement device can transmit data to an internet server via a smartphone using bluetooth technology, thereby allowing providers to monitor a patient's tewl rate and sc levels.

subjects will be offered an opportunity to participate in the study. subjects will either have a diagnosis of rosacea. a total of 30 subjects will be enrolled. after consent and basic demographics, a study team member will use the gpskin barrier® to measure the baseline moisture level of the face of all subjects. subjects will also fill out questionnaires pertaining to quality of life, accountability, and severity of rosacea. subjects will be randomized into one of three arms: the control group (n= 10), the digital interaction group (n=10), or the gpskin group (n=10). all subjects will receive ivermectin equipped with an electronic monitor to measure adherence for daily treatment of rosacea. the digital interaction group will receive a survey by email each week asking about their use ivermectin generated by causa research. the subjects in the gpskin group will receive the gpskin barrier® to measure their moisture level of their face daily. subjects will be instructed to use the ivermectin once daily. subjects will return at 3 months. at this visit, the data from the electronic adherence monitoring will be downloaded, the ivermectin will be weighed, and the subject will fill out the same questionnaires (quality of life, accountability, and severity of rosacea). the intervention subjects will be evaluated on their use of the gpskin barrier® to measure their stratum corneum hydration. subjects not randomized to the email intervention group will receive an accountability questionnaire at the beginning and end of the study.

Eligibility criteria:
inclusion criteria: * subject is 18 years of age or older. * subject has a working knowledge of english. * subject with a diagnosis of rosacea * subjects without a known allergy to ivermectin * subjects with access to a smart phone exclusion criteria: * subjects under 18 years of age. * subject does not have a working knowledge of english. * subject with a diagnosed skin condition other than rosacea * subjects with a known allergy to ivermectin * subjects without access to a smart phone
a pk-pd study of psn821 in type 2 diabetes patients (t2dm)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of psn821 in patients with type 2 diabetes. subjects will be assessed for beta-cell function using a hyperglycaemic clamp before the start of treatment and at the end of a 12 week treatment period as the primary endpoint. hba1c, fasting plasma glucose and body weight are secondary endpoints.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes according to the american diabetes association criteria, diagnosed at least 12 months prior to screening. * male or female, between 18 and 75 years of age, inclusive. * body mass index of 25 - 45 kg/m2, inclusive. * diabetes managed on a stable regimen of diet, exercise and metformin monotherapy (without dosage adjustments within 4 weeks prior to screening). * haemoglobin a1c (hba1c) of 7.5 10% at screening. * fasting plasma glucose (fpg) of between 7 - 13.3 mmol/l at screening and day -1. * males who are, and whose partners are able to comply with contraceptive advice. * females of non child-bearing potential. * willing to sign the written informed consent form (icf) to participate in the study and to abide by the study restrictions. exclusion criteria: * patients with type 1 diabetes or maturity onset diabetes of the young or secondary forms of diabetes, such as due to pancreatitis. * marked diabetic complications. * illness or medication that impacts on the scientific integrity of the study.
oral immunotherapy for desensitization in children, adolescents, and young adults with hen egg allergy

Conditions: Hen Egg Allergy

Summary: to determine the efficacy and safety of ar201 in a characterized oral desensitization immunotherapy (codit™) regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive.

this is a phase 2, randomized, double-blind, placebo-controlled study of the efficacy and safety of ar201 in a codit regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive. the study was conducted at 8 sites in the united states.

Eligibility criteria:
key inclusion criteria: * age 4 to 26 years, inclusive * written informed consent from subjects, as appropriate per local requirements, and parent/guardian * written assent from subjects who are minors, as appropriate per local requirements * history of physician-diagnosed hen egg allergy * elevated egg specific ige and/or mean wheal diameter on spt to egg * experience dose-limiting symptoms at or before the 300 mg challenge dose of dried egg white protein on screening dbpcfc * use of effective birth control by sexually active female subjects of childbearing potential key exclusion criteria: * history of severe or life-threatening anaphylaxis within 60 days before screening * history of non-ige mediated hen egg allergy such as food protein-induced enterocolitis syndrome (fpies) * history of eosinophilic esophagitis (eoe), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (gerd), symptoms of dysphagia or recurrent gastrointestinal symptoms of unknown etiology * history of a mast cell disorder including systemic mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema * history of chronic disease (except asthma, atopic dermatitis, or allergic rhinitis) which may require a change in immunosuppressive medication regimen or chronic corticosteroid use * history of cardiovascular disease, including uncontrolled or inadequately controlled hypertension * developing dose-limiting symptoms to placebo challenge during the screening dbpcfc * having the same place of residence as another subject in the study * any other condition that, in the opinion of the investigator, precludes participation for reasons of safety

Keywords: codit™ (characterized oral desensitization immunotherapy™) hen egg allergic children desensitization ar201 allergy hen egg allergy characterized hen egg allergen oral immunotherapy chea (characterized hen egg allergen) food allergy
medico-economic evaluation comparing the impact of the new fixed-dose nivolumab regimen with the old mg/kg regimen in the management of patients with metastatic cancer

Conditions: Metastatic Cancer

Summary: nivolumab is a selective monoclonal antibody that binds to the programmed cell death 1 (pd-1) receptor and causes reduced tumor growth. it is currently approved in france in many indications. the firsts therapeutics indications validated by the french health authorities from 2015 - metastatic melanoma2, squamous and non-squamous nsclc, kidney cells carcinoma - were based on clinical trials demonstrating a clinical advantage over standard nivolumab treatment at a dose of 3mg/kg every two weeks. by comparing the results predicted by simulation based on a pharmacokinetic model with those obtained in clinical trials, the manufacturer of nivolumab concluded that a fixed dose of 240 mg was equivalent to that calculated based on the weight of the patients, and the european and then french health authorities have validated this change in clinical practice the objective of the imepoca study is to assess in real life the economic and clinical impact of the dose modification of nivolumab that occurred in december 2018 in france. in order to assess the economic efficiency of the change in dose strategy at the national level, 2 cohorts of patients from the national health data system (snds), treated for metastatic cancer and followed up over 1 year will be compared: one having benefited from the weight-dependent dosage and the other having benefited from the fixed dosage


Eligibility criteria:
inclusion criteria: * patients with metastatic melanoma, non-small cell lung cancer (nsclc) and renal cell carcinoma treated with nivolumab monotherapy * patients whose nivolumab treatment was initiated between 2015 and 2020 * patients with health insurance exclusion criteria: * patients whose nivolumab treatment initiated in 2017 in mg/kg has progressed to a fixed dose in the 1st year of treatment * patients treated with nivolumab in the adjuvant setting for melanoma with lymph node involvement or metastatic disease and who have undergone complete resection (approval in 2018 for this indication) * patients whose nivolumab treatment has been initiated in 2018

Keywords: nivolumab lung kidney cancer melanoma cost-effectiveness
incidence of retained surgical devices and treatment

Conditions: Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical Tools

Summary: it has been estimated that in the united states alone 48 million operations are performed annually and most involve the use of multiple surgical items, including needles and other sharp objects, surgical sponges, and surgical instruments1. textile material and instruments forgotten in a patient undergoing an invasive procedure is a negligence of an entire team responsible for maintaining patient safety. a retained surgical foreign body (rsfb) usually requires at least a second surgery for retrieval of the object, and also carries a risk for major complications including morbidity and death2. retained foreign bodies are underreported to minimize exposure to possible litigation3. therefore, the real occurrence of rsfb is underestimated, recently there has reported an incidence of 0.356 / 1,000 patients whereas others reported a rate of 1/5000 with an associated mortality ranging from 11 to 35% 4-5. therefore, there is a need for improved systems and methods for identifying and tracking surgical items, including needles and other sharp objects, surgical sponges, and surgical instruments during a surgical procedure.

all cases investigated due to retained material during hospital surgical treatment will be included. incidence, type of procedure performed, the prevalence and guilty of the personal actuating will be considered.

Eligibility criteria:
inclusion criteria: * any patient who during internment for surgery had an accident of forgetfulness in the material used for their treatment. exclusion criteria: * no exclusion criteria