Kornimate/medical-research-clean huggingface dataset:
virtual reality hypnosis and nurses' stress

Conditions: Hypnosis; Virtual Reality Therapy; Stress; Compassion Fatigue; Compassion Satisfaction; Emotions; Anxiety

Summary: the practice of nursing is based on helping relationships and empathy. the work is physically, mentally and emotionally demanding. this requires the mobilization of personal resources (lifestyle, coping strategies) and work resources (managerial, medical support, recognition) to cope with stress. when these resources are present, nurses can activate a resilience process through coping strategies. however, stress levels and emotional impact are such that they can lead to states of suffering and trauma such as compassion fatigue (cf). the prevalence of cf is high in the nursing profession and particularly among neonatal intensive care (nicu) nurses. several levels of intervention exist to prevent cf in services: organizational, inter-individual and individual. at the individual level, certain interventions such as meditation have been studied, showing positive effects with the highest levels of evidence. on the other hand, interventions such as hypnosis have not yet been studied in this context. there is, however, an interest in studying hypnosis as a non-pharmacological intervention to reduce stress and improve emotional regulation. indeed, the hypnotic process (promoting attentional and cognitive rest, redirecting attentional focus, reducing mental effort) is a resource activator. in order to combine individual and organizational support, the intervention must be offered in the workplace and during working hours, given the difficulty nurses have in extracting themselves from the service, the restricted break time and the acceptability of the virtual reality system. in a context where break time is short and precious, it is necessary to use a tool that adapts to these constraints. virtual reality with the hypnovr® tool meets these needs. this device acts as a restorative environment. it has already proven its effectiveness in the care of painful and stressed patients in critical situations. it has not yet been studied in the context of work-related stress in healthcare professionals, such as neonatal intensive care nurses. the protocol takes into account the results of studies reporting the effects associated with the use of virtual reality (vr).


Eligibility criteria:
inclusion criteria: * nurse * regularly work in a neonatal intensive care unit * be of legal age and not opposed to participating in research * fluency in french exclusion criteria: * age \< 18 * refusal to participate * current anticonvulsant or psychotropic treatment

Keywords: hypnosis virtual reality stress compassion fatigue neonatal intensive care nurses stress reduction program non pharmacological intervention
calcium electroporation for basal cell carcinomas - proof of concept study

Conditions: Basal Cell Carcinoma

Summary: 25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation

25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation, if partial or no response after 3 months the treatment was repeated. follow-up 3 and 12 months after last treatment.

Eligibility criteria:
inclusion criteria: primary low risk basal cell carcinoma less than 3 cm in diameter - exclusion criteria: immunosuppression or organ transplant recipients pregnancy or breastfeeding allergy to local anesthetics
clinical stabilization of hypercapnia: nippv v hvni

Conditions: Hypercapnic Respiratory Failure; Chronic Obstructive Pulmonary Disease; Dyspnea; Hypercapnic Acidosis

Summary: this study will evaluate the ability of high velocity nasal insufflation \[hvni\] to effect ventilation and related physiologic responses in hypercapnic patients when compared to noninvasive positive pressure ventilation \[nippv\].

the overall objective of this randomized study is to evaluate the efficacy of hvni, in comparison to nippv, to clinically stabilize and provide respiratory therapy to patients who have copd with moderate-to-severe hypercapnic respiratory distress upon presentation. it is hypothesized that hvni is comparable to nippv in the stabilization and relief of moderate-to-severe hypercapnic respiratory distress upon presentation, by relieving the patient's dyspnea (breathlessness) within 4 hours to a comparable degree to nippv.

Eligibility criteria:
inclusion criteria: * adults, 18 years or older with a known or suspected diagnosis of copd * presentation with acute hypercapnic respiratory failure * moderate to severe patient baseline hypercarbia/hypercapnia, defined as a baseline pco2 of 60 mmhg or higher * venous ph of 7.0 - 7.35 exclusion criteria: * severe metabolic derangements (e.g. suspected drug overdose, mixed acid/base disorder) * need for airway protection * primary condition of congestive heart failure * need for emergent intubation * pneumonia diagnosis with significant infiltrate on chest x-ray that is clinically correlated with pneumonia * inability to provide informed consent * pregnancy * known contraindication to perform procedures listed, or therapies described in the protocol * respiratory arrest or significant respiratory depression on presentation * significant nasal occlusion either unilateral or bilateral * absence of spontaneous respiration or known contraindication to hvni * extreme agitation or uncooperativeness that would hinder either arm of randomized therapy * determined by the clinician to be sufficiently unstable or unsuitable for this study
clinical evaluation of hybrid ceramic occlusal veneers bonded with two self adhesive resin cements

Conditions: Occlusal Wear of Teeth

Summary: this randomized clinical trial aims to evaluate the clinical performance of hybrid ceramic occlusal veneers cemented with two different bonding protocols: a self-adhesive bonding protocol with adhesive enhancement (beautilink sa cement with beautibond xtreme adhesive) versus another self-adhesive bonding protocol (relyx u200 self-adhesive resin cement with 3m universal bond).


Eligibility criteria:
inclusion criteria: * • age ≥ 21 years * vital teeth * sufficient tooth structure for veneer retention * willing and able to provide written informed consent * ability to attend all follow-up appointments * adequate oral hygiene as determined by the investigator exclusion criteria: * • patients with active periodontal disease (probing depth \> 4mm, bleeding on probing) * patients with severe parafunctional habits (e.g., bruxism confirmed by clinical examination) * poor oral hygiene (plaque index \> 30%) * pregnancy or nursing * systemic diseases affecting treatment outcomes (e.g., uncontrolled diabetes, immunosuppression) * known allergies to study materials (ceramic, or resin cement components) * inability to comply with study requirements * current participation in other dental clinical trials * active orthodontic treatment
a phase 2 study evaluating abt-751 in combination with taxotere in advanced non-small cell lung cancer

Conditions: Lung Cancer; Non-Small Cell Lung Cancer

Summary: to determine the efficacy of abt-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic nsclc.


Eligibility criteria:
inclusion criteria: * pathologically documented nsclc * locally advanced (stage iii) or metastatic (stage iv) nsclc * only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy) * only one prior anti-tumor treatment regimen in the curative setting * progressive disease following the previous anti-tumor treatment regimen * measurable disease by recist criteria * brain metastasis must be stable and well-controlled ecog performance score 0-2all anti-tumor therapy discontinued at least 3 weeks prior to study entryall adverse events from prior treatment are resolved or stableadequate hematologic, renal, and hepatic functionfemales must not be pregnantwilling to take adequate measures to prevent pregnancylife expectancy of at least 3 monthsable to complete the quality of life questionnairevoluntarily signed informed consent * only one prior anti-tumor treatment regimen in the curative setting * progressive disease following the previous anti-tumor treatment regimen * measurable disease by recist criteria * brain metastasis must be stable and well-controlled * ecog performance score 0-2 * all anti-tumor therapy discontinued at least 3 weeks prior to study entry * all adverse events from prior treatment are resolved or stable * adequate hematologic, renal, and hepatic function * females must not be pregnant * willing to take adequate measures to prevent pregnancy * life expectancy of at least 3 months * able to complete the quality of life questionnaire * voluntarily signed informed consent exclusion criteria: * greater that grade 1 neurological findings * allergy to sulfa medications * previous treatment with abt-751 or docetaxel * receipt of more than one investigational agent for nsclc * significant weight loss (\>10%) within 6 weeks of study entry * glucose-6-phosphate dehydrogenase deficiency or porphyria * significant systemic disease that would adversely affect participation * class 3-4 new york heart association classification status * other cancers except in situ carcinoma of the cervix, basal or squamous cell skin cancer, or any other cancer considered adequately treated and cured by the investigator

Keywords: lung cancer non-small cell lung cancer nsclc abt-751 docetaxel taxotere
effect of cobicistat versus ritonavir boosting on the brain permeation of darunavir in hiv-infected individuals

Conditions: AIDS-related Dementia Complex

Summary: the purpose of this study is to assess whether a boosting by cobicistat results in similar concentrations of darunavir in the brain compared to a boosting by ritonavir.

cobicistat is a new pharmacokinetic enhancer or booster of the hiv protease inhibitor darunavir. cobicistat is distinct from the conventional booster ritonavir in that cobicistat presents a more selective inhibition of the enzymes metabolizing drugs. in addition, cobicistat is a weaker inhibitor of the efflux drug transporters expressed at the level of the blood-brain barrier (i.e. p-glycoprotein (p-gp) and breast cancer resistance protein (bcrp)). a weaker inhibition of these efflux transporters could possibly result in less darunavir entering the brain when boosted by cobicistat as compared to a boosting by ritonavir. such a difference could potentially be critical in patients with hiv-associated neurocognitive disorders as sufficient drug levels are needed to efficiently inhibit hiv replication inside the brain. the aim of this study is to determine whether the boosting of darunavir by cobicistat results effectively in lower darunavir concentrations in the csf as compared to a boosting by ritonavir. the study will be performed in hiv infected patients presenting hiv associated neurocognitive disorders (hand) and requiring a lumbar puncture for clinical reasons. in addition, the patients will be only eligible if the are treated or if they qualify for a darunavir/ritonavir (800/100 mg once daily) containing regimen. darunavir concentrations will be measured simultaneously in the csf and plasma (csf/plasma ratio) first with the ritonavir boosting and subsequently with the cobicistat boosting.

Eligibility criteria:
inclusion criteria: * documented hiv infection * presence of hiv associated neurocognitive disorders requiring a lumbar puncture for clinical reasons * treatment or qualifying to be treated with a hiv therapy including darunavir/r (800/100 mg once daily) * ability to comply with the study requirements * informed consent exclusion criteria: * conditions which disrupt the blood-brain barrier and thereby impact the entry of drugs in the brain (meningitis, meningoencephalitis, multiple sclerosis, progressive multifocal leucoencephalopathy) * co-medications inhibiting/inducing p-glycoprotein and bcrp * co-medications inhibiting/inducing cytochrome p450 isoenzyme 3a4 (cyp3a4) * non adherence to treatment * pregnancy

Keywords: hiv darunavir ritonavir cobicistat csf pharmacokinetics
effect of pf-04360365 on abeta in patients with alzheimer's disease and healthy volunteers

Conditions: Alzheimer's Disease

Summary: the primary goal of this study is to evaluate the effect of pf-04360365 on the clearance of abeta from the csf (cerebrospinal fluid) in patients with mild alzheimer's disease and healthy volunteers. additionally, the study will assess the pharmacokinetics of pf-04360365, pharmacokinetic and pharmacodynamic relationships in plasma and csf and the safety and tolerability of single doses of pf-04360365 administered to patients with alzheimer's disease and healthy volunteers.


Eligibility criteria:
inclusion criteria: * males or females of non-childbearing potential (age 50 and over for alzheimer's disease patients; 21-45 for healthy volunteers) * for patients with alzheimer's disease: diagnosis of probable alzheimer's disease, consistent with criteria from both national institute of neurological and communicable disease and stroke and alzheimer's disease and related disorders association (nincds-adrda) and diagnostic and statistical manual of mental disorders (dsm iv) * mini-mental status exam score greater than or equal to 20 * rosen-modified hachinski ischemia score of \< or = 4 * on stable dose of background cholinesterase inhibitor or memantine at least 3 months prior to enrollment exclusion criteria: * diagnosis or history of other demential or neurodegenerative disorders * diagnosis or history of clinically significant cerebrovascular disease * specific findings on magnetic resonance imaging (mri); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities * history of autoimmune disorders * history of allergic or anaphylactic reactions

Keywords: alzheimer's disease antibody leucine abeta
is anxiety affect the anesthesia type performed in patients during caeserean section ?

Conditions: Anxiety

Summary: in this study, investigators wanted to investigate the effect of preoperative anxiety level on anesthesia preference of patient. before surgery, patients will fill the forms of pain catastrophising scale (pcs), beck depression and beck anxiety scale. after surgery, these forms will be evaluated according to the choice of anesthesia.

anxiety is present due to many gait in the preoperative period. in studies that investigated anxiety levels in the preoperative period was found that 60-80% of the patients had significant anxiety. the present study is aimed to investigate the effect of preoperative anxiety level on anesthesia preference of cesarean patients. after approval, patients enrolled in the study is invited to complete the pain catastrophizing scale questionnaire, beck depression and beck anxiety scale. after surgery, the effect of anxiety on the choice of anesthesia will be evaluated (general or spinal anesthesia).

Eligibility criteria:
inclusion criteria: * between 18 and 40 years * planned to undergo ceserean * an american society of anesthesiologists score of 1 or 2 exclusion criteria: * psychiatric diseases * rejected to participation
covid-19 echo study

Conditions: Covid-19; Cardiac Disease

Summary: investigation of the cardiac manifestations of covid-19 in patients admitted to hospital

the covid-19 disease (caused by sars-cov-2) predominantly affects the lungs causing a pneumonia which can become severe and lead to death via a severe inflammatory response in the lungs for which patients require admission to intensive care units (icu) and artificial ventilation of their lungs. however, early reports from china have documented an element of injury to the heart present in up to 20% of patients. they have also documented patients who have died on icu from heart injury rather than lung injury in covid-19 positive patients. there are increasing numbers of reports of patients with covid-19 having significant inflammation of the heart. what is not known is the prevalence of significant inflammation of the heart secondary to the sars-cov-2 and also what the significance of the injury to the heart shown in 20% of patients through blood tests really represents. that is to say is the injury significant to the outcome of the patient? in order to investigate this, it is proposed to conduct a heart scan in covid-19 positive patients in hospital to determine what form of heart injury is caused by the disease as well as determining it's prevalence and whether a heart scan helps in risk stratifying the patient in terms of outcome. if it is found that there is a significant amount of heart injury done by the sars-cov-2 and it can be determined this at an early stage with a heart scan it may be possible to start a more aggressive strategy for the patient's management in hospital to reduce the chance of death. alternatively, if it is found that the incidence of heart injury is low and a heart scan makes no difference to the management of the patient, medical teams can be advised of this.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years old 2. positive swab or serology for covid-19 3. referred for echocardiographic evaluation for clinical reasons 4. willing and able to give assent exclusion criteria: 1. known hypersensitivity to perflutren or known excipients in luminity

Keywords: echocardiography
pregnancy eating attributes study

Conditions: Pregnancy

Summary: the primary purpose of this observational cohort study is to examine the role of "food reward" in maternal diet and weight change during pregnancy and postpartum. the study will further examine the importance of food reward in the context of behavioral control and other related aspects of eating behavior, as well as weight-related biomedical, psychosocial and behavioral factors including genetics, physical activity, stress, sleep and depression. four hundred and fifty women of varying baseline weight status will be enrolled early in pregnancy (before 12 weeks postpartum) and followed until 1 year postpartum. assessments will occur at baseline (\<12 weeks postpartum), during pregnancy at 13-18 weeks gestation, 16-22 weeks, and 28-32 weeks, and postpartum at 4-6 weeks, 6 months, 9 months and 12 months. measures will include assessments of food reward and related constructs, dietary intake, other health behaviors, and anthropometrics. clinical data and biological specimens will be obtained. infant anthropometrics and feeding practices will also be assessed. primary exposures include aspects of food reward and behavioral control, which will be assessed in multiple ways to maximize information and utility. primary outcomes include gestational weight gain, postpartum weight retention and dietary quality.


Eligibility criteria:
inclusion criteria: * female confirmed pregnant \<12 weeks at screening * uncomplicated singleton pregnancy anticipated * age \>=18 and \<45 at screening * willingness to undergo study procedures and provide informed consent for her participation and assent for the baby's participation * bmi \>=18.5 (to qualify as normal: 18.5-24.9; overweight 25-29.9; or obese : \>=30) * able to complete self-reported assessments in english * access to internet with email to complete self-reported assessments * plan to deliver at unc hospital * plan to remain in the area for 1 year following delivery exclusion criteria: * pre-existing diabetes (type 1 or type 2) * multiple pregnancy * participant-reported eating disorder * any fetal anomaly requiring surgery with hospital admission following delivery (e.g. ntds, gastroschisis, cardiac defects, trisomy 21) * any medical condition contraindicating participation in the study such as chronic illnesses or use of medication that could affect diet or weight e.g. cancer, hiv, active renal disease, mi in the last 6 months, chronic steroid use, thyroid disease requiring medication, or autoimmune disease (rheumatoid arthritis, lupus, antiphospholipid antibody syndrome, scleroderma) * psychosocial condition contraindicating participation in the study such as bipolar, schizophrenia, major affective disorder, substance abuse.

Keywords: pregnancy gestational weight gain dietary intake food reward
ds titanium ligation clip in urology (prostatectomy and nephrectomy)

Conditions: Prostate Cancer; Kidney Cancer; Congenital Abnormality of Kidney; Nephrolithiasis; Kidney Tuberculosis; Nephritis; Kidney Injury; Hydronephrosis

Summary: prospective, monocentric, single arm, observational pmcf - study on the performance and safety of double-shank titanium ligation clip in urology (prostatectomy and nephrectomy)

the objective of this observational study is to collect systematically and proactively data regarding the aesculap® ds titanium ligation clip under daily clinical practice when used in urology in different indications. the hypothesis of this study is that this event, slippage / movement of the clip, is extremely rare through the design if used in accordance with the instructions for use (ifu). the observed rate through the total number of clips might be a valuable parameter and could influence future research. furthermore, this study is one of the pmcf measures which enable the manufacturer to monitor the safety and performance of the aesculap® ds titanium ligation clips. the products bear the ce-marking and are routinely used within this institution for the above-mentioned procedures.

Eligibility criteria:
inclusion: inclusion criteria: * planned da vinci radical prostatectomy using ds titanium ligation clips (according to the ifu) - or * planned laparoscopic nephrectomy using titanium ligation clip (according to the ifu) - or * planned da vinci partial nephrectomy using titanium ligation clip (according to the ifu) * patient's written informed consent * age ≥ 18 years * intraoperative usage of ds titanium ligation clips (according to the ifu) exclusion: exclusion criteria: • none

Keywords: ligature of vessels and hollow organs marking of anatomic structures for radiological detection ligation prostatectomy nephrectomy minimally invasive surgical procedures laparoscopy
combination of lanreotide autogel 120mg and temozolomide in progressive gep-net

Conditions: Gastroenteropancreatic Neuroendocrine Tumors

Summary: the purpose of the study is to evaluate the efficacy and tolerability of the combination of lanreotide autogel 120 mg and temozolomide in patients with progressive gastro-entero-pancreatic neuroendocrine tumours (gep-net) graded as g1 or g2 (g1/g2). all progressive tumours classified according to response evaluation criteria in solid tumours (recist, 1.1).


Eligibility criteria:
inclusion criteria: * provision of written informed consent prior to any study related procedures * inoperable, gastro-entero-pancreatic-neuroendocrine tumour g1 or g2 (proliferation index, ki67-index: 0 to ≤20%) confirmed by pathological/histological assessment * progressive disease within 12 months before inclusion (recist 1.1: increase of \>20% tumour load; by computer tomography (ct) or magnetic resonance imaging (mri) * measurable disease according to recist 1.1. * metastatic disease confirmed by ct/mri. * functioning or non-functioning net (g1, g2). * positive octreo-scan (≥ grade 2 krenning scale) or positive dota (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid)-tate (tyr3-thre8-octreotide or dota-tyr3-octreotate)/toc (tyr3-octreotide) -pet (positron-emission-tomography) -ct within 12 months prior to screening exclusion criteria: * has the diagnosis of insulinoma * has a diagnosis of a multiple endocrine neoplasia (men)