Kornimate/medical-research-clean huggingface dataset:
nb-uvb and puva vitiligo study

Conditions: Vitiligo

Summary: to evaluate if the combination of psoralen plus ultraviolet a and narrowband ultraviolet b is more effective than narrowband ultraviolet b alone in the treatment of vitiligo.


Eligibility criteria:
inclusion criteria: * vitiligo affecting more than 15% body surface area.

Keywords: vitiligo phototherapy photochemotherapy
post market registry for gore® tag® thoracic branch endoprosthesis

Conditions: Aneurysm; Dissection, Aortic; TAA Thoracoabdominal Aortic Aneurysm; Thoracic Aortic Aneurysm; Transection Aorta

Summary: the goal of this observational study is to collect mid-term post-market clinical follow-up data of gore® tag® thoracic branch endoprosthesis used according to the standard medical practice in patients presenting with vascular disease. this registry aims to answer questions related to the efficacy and safety of gore® tag® thoracic branch endoprosthesis.

the purpose of the gore® tag® thoracic branch endoprosthesis registry is to collect real-world data for this device. due to the nature of the registry, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. therefore, the sponsor will not be outlining requirements that would influence healthcare decisions. participants will be asked to return for regular scheduled visits as requested by their surgeon. patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.

Eligibility criteria:
inclusion criteria: patient or legally authorized representative (lar) provides written authorization and/or consent per institution and geographical requirements patient has been or is intended to be treated with an eligible registry device patient is age ≥ 18 years at time of informed consent signature. exclusion criteria: patient who is, at the time of consent, unlikely to be available for standard of care (soc) follow-up visits as defined by the site's guidelines and procedures. patient with exclusion criteria required by local law. patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of together registry enrollment. subjects cannot be enrolled in another together registry module protocol.

Keywords: tevar aneurysm dissection aorta endovascular stent graft thoracic branch endoprosthesis
nursing discharge teaching for multimorbid inpatients

Conditions: Chronic Disease

Summary: the objective of this study is to estimate the effect size of a nursing discharge teaching intervention on multimorbid inpatients activation level, health confidence, readiness for hospital discharge, experience with discharge care and rate and time to 7-days readmission.

seniors returning home from hospital have to manage several chronic conditions in addition to their daily tasks. the teaching provided by nurses during hospitalization is essential care to prepare them to manage their health at home. nevertheless, there is often a gap between professionals' belief that the teaching they have provided to patients has met their needs, and patients' perceptions of the relevance of the teaching content to their home situation. the time available to conduct this teaching is also short during the hospital stay and there is limited knowledge about how to adapt this teaching for patients who must manage multiple chronic conditions at the same time. thus, there is a real need to develop and test a new teaching nursing intervention to prepare for the return home that takes into account the unique and complex needs and characteristics of patients with multiple chronic conditions. tailoring teaching to seniors' life situation and level of activation (i.e., knowledge, skills and confidence in managing their health) would best meet the needs of these patients for managing their health at home. an intervention that takes these characteristics into account has been developed and will be tested in this study.

Eligibility criteria:
inclusion criteria: * 2 chronic diseases or more * being discharged home * able to speak, read and write in french exclusion criteria: * insufficient capacity to consent assessed with the university of california san diego brief assessment of capacity to consent (ubacc).

Keywords: discharge teaching nursing multimorbidity
effect on glycemic control of inhaled insulin alone or added to dual oral therapy after failure of dual oral therapy.

Conditions: Diabetes Mellitus, Type 2

Summary: to assess the impact on glucose control by inhaled insulin alone or added to two oral anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral anti-diabetic agents.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus as defined by american diabetes association (ada) at least 1 year earlier. * patients were required to have been treated with a stable oral agent regimen involving 2 antidiabetc medications: 1 insulin secretagogue (a sulfonylurea or replabinide) and 1 insulin sensitizer (a thiazolidinedione or metformin). exclusion criteria: * asthma, copd * smoking during the previous 6 months
intestinal stem cells characterization

Conditions: Inflammatory Bowel Diseases

Summary: a monocentric pilot studying intestinal organoids from endoscopic biopsies of ibd (crohn and ulcerative colitis), fap patients and healthy controls. investigate the morphological characteristics of organoids, the expression of genes and proteins of the wnt/apc/beta-catenin pathway within both isc.

intestinal organoids are 3d mini-guts produced in vitro based on intestinal stem cell (isc) capabilities. these organoids contain all of the intestinal epithelial cells. the renewal of the two kinds of iscs, which are present at the bottom of intestinal crypts, is controlled by wnt/apc/beta-catenin pathway. mutations of genes involved in this pathway are found in intestinal polyposes like familial adenomatous polyposis (fap, apc gene). this model is of interest to study early pathophysiological events occurring within intestinal epithelium, in the context of fap and inflammatory bowel diseases (ibd). an excessive proliferation or an abnormal healing is found in fap and ibd respectively. investigators hypothesized that it could specifically involved one of the 2 iscs. columnar basal cells (cbc) and isc located at the +4 position from the bottom of the crypt (isc+4) can both differentiate into absorptive or secretory intestinal epithelial cells. however, cbc and isc+4 could have different metabolic, migratory functions, or stress survival. investigators designed a monocentric pilot study to develop intestinal organoids from endoscopic biopsies of ibd (crohn and ulcerative colitis), fap patients and healthy controls. investigators plan to investigate the morphological characteristics of organoids, the expression of genes and proteins of the wnt/apc/beta-catenin pathway within both isc. will also be studied the expression of key genes of tumor initiation (pten, bmpr1a, p53 and kras) and inflammatory parameters (cytokines and lipid mediators). the results of this study could improve the understanding of intestine renewal. later on, the development of new drugs could beneficiate to ibd and fap patients.

Eligibility criteria:
inclusion criteria: patient must have a coloscopy for intestinal pain - exclusion criteria: cancer -
personalized virtual reality naturalistic scenarios in cognitive impairment

Conditions: Cognitive Impairment; Cognitive Decline; Cognitive Deterioration; Anxiety State

Summary: the goal of this feasibility study is to investigate the feasibility of a personalized naturalistic virtual reality scenario by assessing motion-sickness effects, engagement, pleasantness, and emotions felt considering a sample of individuals with cognitive impairment resident at the azienda pubblica di servizi alla persona (apsp) "margherita grazioli", a long-term care home in trento (italy) in collaboration with the department of general psychology - university of padova (italy) and the centre for health and wellbeing-fondazione bruno kessler (italy). the current proof-of-concept and feasibility study is a one-session single-centre trial based on a mixed-methods approach inspired by the obesity-related behavioral intervention trials (orbit) framework for the design (phase ib) of digital interventions and their preliminary testing (phase iia).

the impact of customizing vr scenarios is growing, showing different kinds of positive effects, such as an increased sense of presence and engagement in the virtual environment. a relaxing and customizable vr environment could allow the management of any interfering environmental factors that might also be present in the natural context. additional investigations are still needed to obtain more consistent data on its feasibility and effectiveness. considering this evidence, the current proof-of-concept study is based on the following goals: * evaluate the impact of vr on self-reported and observational levels of motion-sickness, engagement, and pleasantness in older adults living with cognitive impairment and residing in long-term care. * investigate if personalized, relaxing virtual environments can positively impact feelings and state anxiety. * investigate the vr apparatus's usability from the health staff's perspective.

Eligibility criteria:
inclusion criteria: * italian mother tongue * clinical diagnosis of cognitive impairment (mild, moderate, or severe). exclusion criteria: * palliative care * clinical diagnosis of psychosis * severe neurological damage * a clinical diagnosis of epilepsy (or having first-degree relatives diagnosed with epilepsy) - - cardiac pacemaker or other metal devices * infectious or gastrointestinal disorders * open wounds at the level of the face * motor or visual dysfunctions and neuromuscular pain that prevent the use of oculus.

Keywords: virtual reality personalized virtual scenario user centered approach mixed-methods study user-experience feasibility study relaxation anxiety
high flow nasal cannula versus nasal continuous positive airway pressure

Conditions: Respiratory Insufficiency

Summary: the purpose of this study is to compare two common methods of providing respiratory support: nasal continuous airway pressure and high flow nasal cannula to see what effect it has on babies breathing. the investigators also will compare the effects of slightly changing the level of support these two different types of therapy on how easily your baby is breathing. changes in the level of support and between these two respiratory support modalities are frequently done and are part of the routine care in the neonatal intensive care unit.


Eligibility criteria:
inclusion criteria: * infants who are between 28 and 40 weeks of corrected gestational age at the time of study entry * currently on high flow nasal cannula receiving 3 to 5 lpm or on nasal continuous positive airway pressure at 5 to 6 cmh2p with and fio2 requirement \</= 40% by the clinical care team for clinical care purposes. * on current mode of support for \>/= 12 hours and have been extubated from a mechanical ventilator for \>/= 48 hours. exclusion criteria: * infants with skeletal or neuromuscular disorders that affect the accuracy of rip pft measurements.

Keywords: respiratory insufficiency infants high flow nasal cannula (hfnc) nasal continuous positive airway pressure (ncpap)
laparoscopic versus open repair of bilateral primary inguinal hernia

Conditions: Bilateral Inguinal Hernia; Postoperative Complications

Summary: currently, there is a controversy regarding the best approach for simultaneous repair of bilateral inguinal hernia. the aim of this study was to compare the outcome of laparoscopic versus open repair of bilateral inguinal hernia

this prospective randomized study included 120 consecutive patients with bilateral primary inguinal hernia treated at alexandria university hospital in the period between june 2014 and february 2017. patients were randomized by sealed envelopes into 3 groups, each includes 40 patients. group i treated by laparoscopic transabdominal preperitoneal repair using 2 separate meshes, group ii treated by open preperitoneal mesh repair, while group iii treated by bilateral lichtenstein repair. the 3 groups were compared regarding: operative time, postoperative complications, pain, hospital stay, return to normal activity and work, chronic groin pain, patient's satisfaction and 3 years recurrence rate. statistical analysis: numerical data in both groups was expressed as mean ± standard deviation (sd) and compared using one-way analysis of variance while categorical data was expressed as percentages and compared using chi-squared test. logistic regression test was used to determine predictors of postoperative complications. differences were considered significant at p \<0.05.

Eligibility criteria:
inclusion criteria: * patients with primary bilateral inguinal hernias in patients aged from 20 to 60 years exclusion criteria: 1. - immune compromised patients, 2. - morbid obesity (bmi \> 35 kg/m2) 3. - chronic liver or renal disease 4. - coagulopathy 5. - high-risk patients unfit for major surgery (asa iii or iv) 6. - recurrent hernias 7. - complicated hernias 8. - massive scrotal hernias 9. - previous infra-umbilical surgery 10. persistent groin pain due to other causes

Keywords: bilateral inguinal hernia laparoscopic versus open mesh repair operative outcomes recurrence
management of nausea and vomiting chemotherapy-induced in normandy

Conditions: Cancer; Nausea; Vomiting

Summary: the objective of this study was to evaluate the various parameters involved in the occurrence of nausea / vomiting during the first cycle of chemotherapy for solid tumors or hematologic among a group of chemotherapy-naive patients, despite anti standardized-emetics protocols.


Eligibility criteria:
inclusion criteria: * aged over 18 years * with solid tumors or hematologic in first line chemotherapy, administered intravenously, * able to understand the meaning of the questions * having given their written consent to participate in the survey. exclusion criteria: this does not concern patients who: * do not give their consent for participation * do not speak french * suffer from cognitive deficits * are under therapy * must receive a combination of radio-chemotherapy * present an occlusive syndrome * metastases (s) brain (s) clinically symptomatic (s) or radiologically proven (s) or a (of) tumor (s) brain (s) * have been previously treated with chemotherapy * present a cons-indication to corticosteroids, with anti-serotonin or nk1 receptor inhibitors * pregnant or breastfeeding.

Keywords: chemotherapy cancer nausea vomiting
effectiveness of steroid injection in treating patients with lateral epicondylitis

Conditions: Lateral Epicondylitis

Summary: the aim of this study is to evaluate the effectiveness of steroid injection and immobilization versus no immobilization in treating patients with lateral epicondylitis.


Eligibility criteria:
inclusion criteria: * age 18 to 65 years * confirmed lateral epicondylitis * had not received any treatment prior to enrolment exclusion criteria: * symptoms lasting less than 6 weeks * history of acute trauma, fracture, and/or surgery within 12 months * patients who had received corticosteroid injection, physiotherapy, splint or casting during the past 6 months * bilateral involvement and history of cervical disk herniation, radiculopathy or abnormal electrophysiologic study

Keywords: lateral epicondylitis treatment steroid immobilization
safety, efficacy, tolerability and pharmacokinetics of nnc 0070-0002-0182 in overweight or obese male and female volunteers

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: this trial will be conducted in the united states of america (usa). the aim of the trial is to investigate whether the drug is safe, well tolerated and to investigate the efficacy of nnc 0070-0002-0182 for the treatment of obesity. the subjects will be treated with drug and placebo. this registration covers the phase 2 part of a combined phase 1/phase 2 trial (phase 1 part of trial conducted between november 2007 and april 2008).


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 30.0-39.0 kg/m2 (obese) * females who consent to using double barrier method of contraception, are post-menopausal and older than 50 years, or have had total hysterectomy exclusion criteria: * clinically significant diseases * blood pressure greater than 140/90 mmhg * evidence of depression * recent diet attempts, treatment with diet drugs (within 3 months) * liposuction or other surgery for weight loss within the last year * evidence of eating disorders (bulimia, binge eating) * restricted diets (kosher, vegetarian) * smoker or history of drug or alcohol abuse * females of childbearing potential: positive pregnancy test
phase i study of the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple intravenously administered doses of pf-04236921 in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will evaluate the safety and tolerability of pf-04236921 administered monthly as three intravenous infusions. each group of patients will be assigned to a dose level; safety and tolerability of a low dose level will be required before proceeding to successively higher dose levels. blood tests will be performed to measure the amount of drug and changes in measures of inflammation.

safety and tolerability and pharmacokinetic/pharmacodynamic assessment of inflammation-related biomarkers.

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis on a stable dose of methotrexate * rheumatoid arthritis disease activity as assessed by blood tests exclusion criteria: * serious or uncontrolled medical conditions * current or recent treatment with disease-modifying drugs other than methotrexate including but not limited to leflunomide, sulfasalazine, etanercept, infliximab, adalimumab, abatacept, rituximab * current oral glucocorticoid dose of more than 10 mg/d prednisone equivalent

Keywords: safety and tolerability pharmacokinetics pharmacodynamics pf-04236921
immunological characteristics of maternal-fetal transmission of cytomegalovirus in pregnancy

Conditions: Pregnancy; Cytomegalovirus Infections; Congenital Infection

Summary: analysis of several characteristics of blood from pregnant women with cmv infection according to maternal-fetal transmission. these include cmv viral load, cytokine profile in response to in-vitro stimulation with cmv peptides, meticulous analysis of anti cmv antibodies, maternal dna polymorphism and microarray of gene expression.

maternal cytomegalovirus infection in pregnancy may cause significant morbidity in the fetus. intrauterine cmv transmission occurs mainly during primary maternal infections, with a maternal-fetal transmission rate of about 40%. the mechanisms dictating cmv intrauterine transmission are unknown, and transmission is currently thought to be dependent on multiple factors, including the maternal and fetal immune system. to investigate the mechanism of transmission approaching laboratory prediction of transmission, the investigators collect blood from pregnant women with primary cmv infection, and analyze several characteristics. these include cmv viral load, cytokine profile in response to in-vitro stimulation with cmv peptides, meticulous analysis of anti cmv antibodies, maternal dna polymorphism and microarray of gene expression. these results will be analysed according to transmission as indicated by a positive culture / polymerase chain transcription of amniotic fluid or newborns urine / saliva.

Eligibility criteria:
inclusion criteria: * pregnant women * cmv infection: primary infection: (1) cmv-specific igg seroconversion or (2) demonstration of low avidity cmv-specific igg antibodies, (3) the primary appearance of cmv-specific igm with no previous igg, and (4) cmv dna or viral products in blood secondary infection: appearance of cmv-specific igm with positive igg exclusion criteria: * cmv status unclear * spontaneous or induced abortion * unknown fetal outcome

Keywords: cytomegalovirus cmv pregnancy transmission
exploratory study to determine tissue alterations of advanced hepatocellular carcinoma induced by electromagnetic waves of low energy amplitude modulated to specific frequencies during imaging study by mri

Conditions: Primary or Metastatic Tumor in the Liver Parenchyma

Summary: this is an exploratory, national, single-center, open-label study, being conducted at the institute of education and research of the syrian-lebanese hospital in collaboration with the radiology institute, the heart institute of the faculty of medicine of são paulo, hospital são paulo unifesp, and the departments of physics and mathematics at the university of são paulo in order to detect the presence of calcium flux change, tumor perfusion and electrical properties of tumor tissue when exposed to rf emf am by cancer-frequency specific in patients with advanced hcc and correlate these findings with hemodynamic changes assessed by non-invasive hemodynamic measurements. this study aims to demonstrate the presence of three mechanisms (hypothesis) that could be involved in the hemodynamic changes and the specific antitumor effect induced by exposure to rf emf am cancer-specific frequency. this study is not intended to study a therapeutic or diagnostic procedure. for this reason, will not be considered evolutionary clinical data during and after the intervention of the study.


Eligibility criteria:
inclusion criteria: all individuals selected for these studies should be in accordance with the following inclusion criteria: * patients must have a diagnosis of hcc. * presence of the primary or metastatic tumor at the time of the procedure, at least one (1) measurable lesion by recist criteria modified located in the hepatic parenchyma and size\> 2 cm. * patients with afp\> 400 ng / ml and image feature not need histopathological confirmation. but in patients with active b virus serology, the value of afp should be greater than 4000 ng / ml. the remaining patients should be histological confirmation of hcc. * patients may be in observation or presence of systemic or intra-hepatic treatment. * minimum age 18 years. * be subjected to mri study without need for sedation. exclusion criteria: * individuals selected for this study will be excluded if they are in accordance with the following exclusion criteria: * can not suspend anti-hypertensive drugs or beta blockers for at least 48 hours or be pacemaker carriers or other implantable device. * any restriction known to carry out study of magnetic resonance imaging. * menstrual delay, pregnant or breastfeeding. * presence of metal artifacts or implants that can alter the reading of the magnetic signal or heat or move during the mri procedure. * prior allergic event knowledge gadolinium or manganese chloride solution.