Kornimate/medical-research-clean huggingface dataset:
evaluation of nevelia® in terms of safety and efficacy for third-degree burns treatment or reconstructive surgery

Conditions: Third-degree Burns; Reconstructive Surgery

Summary: the dermal substitute nevelia® has received ce marking in july 9, 2013. its use in the neval protocol will be in accordance with its leaflet, i.e. for the treatment of burns or in case of reconstructive plastic surgery. the matric implantation will be followed by autologous skin grafting when the neodermis formation will be observed.

the neval protocol is a descriptive study conducted in order to confirm the clinical evidence of safety and performance of nevelia®, as described in the literature on equivalent products. this dermal substitute consists of an inner biodegradable dermal substitute made of bovine collagen (collagen of type i), covered with an outer silicone membrane. its porosity and the speed of degradation allow the act of recolonization by the fibroblasts and initiation of the vascularization process within 3 weeks. the application procedure requires removement of the silicone layer and wound covering with an ultra-thin epidermal graft, possibly meshed. this surgical procedure is well-known and permits an ultra-thin epidermal graft. all the patients will be treated with nevelia®, prior to autologous skin grafting within 3 weeks after its application. then, three follow-up visits will be planned: post operatively, at 6 and 12 months. the objectives are: * primary objective: to assess the type and frequency of complications * secondary objectives: * to assess the take rate of nevelia® * to assess the take rate of skin graft * to assess the satisfaction rate of physician and patient, * to assess the quality of the healed skin, * to assess the rate of re-operation at 12 months.

Eligibility criteria:
inclusion criteria: * patients aged 18 or older * patient geographically stable, * patient requiring dermal reconstruction after third-degree burns, reconstructive surgery or trauma surgery; * patient who signed the non-opposition form; * patient able to be followed up to 12 months. exclusion criteria: * patient with clinical signs of wound infection; * allergic patient or with known allergy to bovine collagen or silicone; * patient with life-threatening conditions; * patient receiving a treatment that may affect wound healing; * patient with an autoimmune or immunosuppressive disease; * patient with a suspected neurological disease as creutzfeldt-jakob disease; * patient simultaneously participating in another study; * pregnant or nursing woman.
effect of virtual reality distraction on procedural pain for children and adolescents in onco-hematology unit.

Conditions: Procedural Pain; Procedural Anxiety; Virtual Reality

Summary: * demonstrate the effectiveness of the virtual reality (vr) distraction on pain reduction in children and adolescents in onco-hematology unit compared to standard practice. * evaluate the impact of vr on the level of anxiety induced by invasive procedures * report traceability of assessment of pain and anxiety scores, and reproducibility of procedural analgesia techniques. * evaluate the impact of vr on the short-term consequences of procedural pain, especially in terms of phobia of care.

diagnosis and therapeutic management of onco-hematological pathologies in children and adolescents require multiple invasive procedures that cause pain and discomfort. these are paramedical procedures (blood sampling on the peripheral vein, placement of infusions, placement of hubert's needles on an implantable device, ...) and medical procedures (lumbar punctures, medullary punctures, ...). the short-term (phobia of care) and long-term consequences (memory of pain, behavioral disorders, nociceptive sensitization) are clearly reported in the medical literature, and the importance of thinking about pharmacological and non-pharmacological techniques well-established procedural pain prevention. the quality of the management of the pain and anxiety induced by these invasive oprocedures in pediatric onco-hematology conditions the adhesion to the care and the treatments, and thus constitutes a challenge in the care of the patients. the non-pharmacological methods are numerous and still insufficiently used by the care teams. virtual reality is on interesting option.

Eligibility criteria:
inclusion criteria: * children or adolescent supported in onco-hematologic unit. exclusion criteria: * serious behavioral disorders * serious neurosensory deficit

Keywords: children adolescent non pharmacological interventions onco-hematologic
the pattern of dry eye disease after cataract surgery

Conditions: Dry Eye Disease; Cataract; Ocular Surface Disease

Summary: this study is designed to explore dry eye disease (ded) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of ded and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during long-term follow-up.


Eligibility criteria:
inclusion criteria: * cataract patients from 50 to 90 years old who underwent uncomplicated phacoemulsification performed by one (and same) experienced surgeon. * patients with no underlying ocular surface diseases (keratitis, keratoconjunctivitis and others). * patients who previously did not undergo any ophthalmic surgery. exclusion criteria: * patient expressed his wish to not participate in the study or discontinue it when already enrolled. * severe dry eye disease diagnosed with osdi/deq-5 and at least one of the following tests: tbut less than 10 seconds, tear osmolarity higher than 308 mosm/l or positive corneal staining. * glaucoma. * diabetes mellitus. * systemic connective tissue disease, autoimmune disease. * neurologic conditions including stroke, bell's palsy, parkinson's, trigeminal nerve dysfunction. * patients who underwent refractive surgery (lasik or prk). * contact lens users. * one or more of the following concomitant medications: psychiatric medicines, antihistamines and/or hormonal replacement. * patients who are already regularly using topical drops or ointments.
effect of low level laser therapy on the temporomandibular joint during treatment of skeletal class ii malocclusion

Conditions: Malocclusion Class II

Summary: to evaluate effect of low-level laser therapy (lllt) on mandibular condylar volume and position after treatment of class ii malocclusion with twin block (tb) functional therapy via cone beam computed tomography (cbct). materials and methods: twenty eight growing patients, 14 boys and 14 girls ranged in age 9-12 years, were randomly divided into control group (mean initial age 10.64±1.36 years) and laser group (mean initial age 10.55 1.45 years). all patients treated with tb appliance where gallium aluminum arsenide diode laser applied in one group weekly around tmj region for 12 sessions in three months with set parameters: continuous 635 nm, 50 mw, 4.5j/cm2, 45 seconds/ point, total dose per side 11.25j. cbct were obtained before and immediately after tb therapy, in addition to routine orthodontic records. changes in tmj and skeletal variables were analyzed and compared within and between both groups.

to evaluate the effect of low-level laser therapy (lllt) on mandibular condylar volume and position after treatment of class ii malocclusion with twin block (tb) functional therapy via cone-beam computed tomography (cbct). materials and methods: twenty-eight growing patients, 14 boys, and 14 girls ranged in age 9-12 years, were randomly divided into control group (mean initial age 10.64±1.36 years), and laser group (mean initial age 10.55 1.45 years). all patients treated with tb appliance where gallium aluminum arsenide diode laser applied in one group weekly around tmj region for 12 sessions in three months with set parameters: continuous 635 nm, 50 mw, 4.5j/cm2, 45 seconds/ point, total dose per side 11.25j. cbct were obtained before and immediately after tb therapy, in addition to routine orthodontic records. changes in tmj and skeletal variables were analyzed and compared within and between both groups.

Eligibility criteria:
inclusion criteria: * skeletal class ii (anb°\> 5°) with the normal maxilla (sna°=82°±4°) and retrognathic mandible (snb°\< 78°). * overjet greater than 5 mm. * minimal crowding in dental arches (≤ 3 mm). * the lower incisors should be on average inclination or slightly retroclined. * all the patients were in stages ii and iii based on the modified cervical vertebral maturation stages(cvms) according to bacetti et al. exclusion criteria: * previous history of orthodontic treatment. * congenitally missing or extracted permanent tooth (except third molars). * posterior crossbites or severe maxillary transverse deficiency. * severe facial asymmetry determined by clinical or radiographic examination. * poor oral hygiene. * systemic diseases that may affect orthodontic treatment results.
clinical trial evaluating gastrointestinal damage following administration pl3100 or naproxen in at-risk adults

Conditions: Gastroduodenal Ulcerations; Erosion

Summary: the purpose of this study is to determine the subchronic gastrointestinal (gi) safety of pl3100 versus naproxen in normal healthy volunteers.


Eligibility criteria:
inclusion criteria (selected) * male and female healthy adult subjects exclusion criteria (selected) * subject has protocol specified significant medical history. * subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study. * subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other nsaid.

Keywords: nsaid-induced gastroduodenal ulcerations or erosion
the effect of the covid-19 on patient preferences and decision making for obstructive urinary stone interventions

Conditions: Urinary Stone; Urinary Calculi; Covid19

Summary: in this study, the investigators aim to evaluate the intervention preferences of patients with obstructive urinary stones who are suitable for operation during the covid-19 pandemic. the secondary aim is to compare and evaluate the preferences compared to the pre-pandemic period and to gain a perspective on how the decision-making process has changed from the patient's point of view. thus, by trying to understand how the covid-19 epidemic affects the treatment choice decisions of patients, the investigators aim to determine how the state of anxiety changes these preferences.

the transformative impact of the covid-19 pandemic on healthcare use remains an open question. at the onset of the pandemic, policies to limit transmission were adopted, including stay-at-home decisions, social distancing, and postponing elective surgery. such policies have contributed to reduced emergency room admissions, increased concern about covid-19, and hospital systems have had to prioritize emergency intervention. obstructive urolithiasis is a clinical condition that usually causes severe flank pain and causes emergency admission. it is still unclear how the epidemic impairs the treatment pathways of the obstructive urolithiasis that contributes to the emergency room visit. treatment options range from observation and medical expulsive therapy to operative interventions such as extracorporeal shock wave lithotripsy, ureteroscopy and percutaneous nephrolithotomy. patient preference, stone characteristics and comorbidities are of great importance in decision making. however, since obstructive ureteral stones that cannot be resolved spontaneously can cause irreversible renal parenchymal damage and obstructive pyelonephritis in a short time, the option of operation is always prioritized. patient perspectives on how covid-19 is changing healthcare use and decision-making still remain unclear. in our study, the investigators plan to record patient treatment preferences by explaining in detail how and where treatment options will be applied, success and complication rates for patients diagnosed with obstructive urolithiasis and suitable for intervention in the outpatient clinic. in addition, when evaluating patient preferences, the investigators foresee to determine how the covid-19 pandemic process has changed compared to before. it is planned that our study will have a patient-centered approach with detailed oral and written information in outpatient clinic conditions.

Eligibility criteria:
inclusion criteria: * obstructive urinary stone exclusion criteria: * previous operation for urinary stone * presence of bladder stone * presence of stent in the ureter * previous radiotherapy to the pelvic and abdominal region * pregnancy * neurological disease

Keywords: urinary stone obstructive stone covid19 stone surgery
relationship between primary percutaneous coronary intervention, door-to-balloon times, and mortality for heart attack patients across england

Conditions: Myocardial Infarction

Summary: the degree to which elevated mortality associated with weekend or night-time hospital admissions reflects poorer quality of care ('off-hours effect') is a contentious issue. we examined if off-hours admissions for primary percutaneous coronary intervention (ppci) were associated with higher adjusted mortality and estimated the extent to which potential differences in door-to-balloon (dtb) times-a key indicator of care quality for st elevation myocardial infarction (stemi) patients-could explain this association. nationwide registry-based prospective observational study using myocardial ischemia national audit project data in england. we examined how off-hours admissions and dtb times were associated with our primary outcome measure, 30-day mortality, using hierarchical logistic regression models that adjusted for stemi patient risk factors. in-hospital mortality was assessed as a secondary outcome. our study found that higher adjusted mortality associated with off-hours admissions for ppci could be partly explained by differences in dtb times.


Eligibility criteria:
inclusion criteria: * stemi patients admitted from 1 january 2007 to 31 december 2012 * stemi patients aged over 18 years * stemi patients admitted directly to '24/7' ppci-capable hospitals for ppci * discharge diagnosis of stemi * provision of ppci based on initial reperfusion strategy exclusion criteria: * hospitals performing less than 20 procedures per year * hospitals performing ppcis only during regular hours * interhospital transfers * ppcis conducted within 6 hours on hospital arrival
free walking exercise in obstructive sleep apnea patients with non-alcoholic fatty liver

Conditions: Obstructive Sleep Apnea; Non-alcoholic Fatty Liver

Summary: research evaluating the impact of continuous positive airway pressure (cpap) \& walking exercise on fatigue severity, liver enzymes and sleeping quality in patients with non-alcoholic fatty liver disease who also have obstructive sleep apnea. forty patients are divided into two groups: twenty patients cpap and other twenty patients for cpap and walking program .

research evaluating the impact of continuous positive airway pressure (cpap) \& walking exercise on fatigue severity, liver enzymes and sleeping quality in patients with non-alcoholic fatty liver disease who also have obstructive sleep apnea. forty patients are divided into two groups: twenty patients cpap and other twenty patients for cpap and walking program .

Eligibility criteria:
inclusion criteria: * the body mass index (bmi) \< 35 kg/m2. * obstructive sleep apnea patients with fatty liver exclusion criteria: * liver transplantation , alcoholic fatty liver, antipsychotic medications, bariatric surgery; cardiac , renal problem , liver cancer ; pregnancy,orthopedic problems, systemic diseases, respiratory dysfunctions, neurological dysfunctions.
the heidelberg engineering anterion anterior segment cornea and iol precision and agreement study

Conditions: Cataract; Healthy Eye; Cornea Abnormality; Post-Keratorefractive Surgery; IOL

Summary: this is a prospective clinical study that will be conducted at one clinical site located in the united states to assess anterior segment parameters with the anterion


Eligibility criteria:
inclusion criteria: 1. age 22 years or older 2. able and willing to undergo the test procedures, sign informed consent, and follow instructions 3. able to fixate 4. with the following eye pathology status for the individual eye population: * a. eye with normal anterior segment and crystalline lens * b. eye with a cataract of grade 1.5 or higher * c. eye with abnormal corneal shape * d. eye with status post-keratorefractive surgery * e. eye without a crystalline lens exclusion criteria: 1. subjects which were enrolled in the b-2018-1 clinical study 2. active infection or inflammation in the study eye 3. insufficient tear film or corneal reflex 4. physical inability to be properly positioned at the study devices or eye exam equipment 5. rigid contact lens wear 2 weeks prior to imaging 6. soft lenses worn within one hour prior to imaging 7. with the following eye pathology status for the individual eye population: * a. eye meets eligibility criteria for eye populations b, c, d or e * b. eye meets eligibility criteria for eye populations c,d or e * c. eye meets eligibility criteria for eye populations d or e * e. eye with abnormal corneal shape (except status post-keratorefractive surgery)
saline flush to reduce the amount of residual air inside a stentgraft delivery system

Conditions: Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aortic Diseases; Aortic Arch Aneurysm; Stroke

Summary: non-randomized studies have shown that de-airing of the delivery system with an increased volume of saline may be associated to a decrease in periprocedural stroke during thoracic endovascular aortic repair. this study is designed to provide evidence that 4xifu-dose volume of saline flush vs. standard ifu-dose saline flush is associated to a decrease in the amount of intra-sac air detected on the first follow-up imaging after evar.


Eligibility criteria:
inclusion criteria: * endovascular aortic repair of an abdominal aortic aneurysm using either of these devices: terumo/bolton treo, terumo anaconda, cook zenith alpha abdominal exclusion criteria: * concomitant use of an iliac bifurcation device due to insufficient common iliac landing zone on either side

Keywords: endovascular evar tevar stentgraft de-airing
influence of in-line microfilters on systemic inflammation in adult critically ill patients

Conditions: Systemic Inflammation

Summary: studies showed that infusion or injection of drugs and fluids results in introduction of microparticles into the bloodstream. these microparticles may cause organ damage and stimulate the immune system thus aggravating the underlying disease. given that critically ill patients are characteristically suffering from a high disease severity and receive large amounts of fluids and drugs, they may be at particular risk of harm by these microparticles. in-line microfilters have been shown to clear microparticles from intravenous drugs and solutions. the investigators hypothesize that use of in-line microfilters reduce the days with the systemic inflammatory response syndrome in adult critically ill patients.


Eligibility criteria:
inclusion criteria: * critical illness * expected length of stay in the intensive care unit \> 24 hours * central venous catheter in place or placed within the first 24 hours exclusion criteria: * age \< 18 years * pregnancy * neutropenia or known immunesuppresion * limited intensive care * inclusion into another clinical trial * refusal of written informed consent

Keywords: microparticles in-line microfilters systemic inflammation organ failure critical illness adult
national danish protocol. surgery+ sbrt for m1 prostate cancer patients

Conditions: Prostate Cancer Metastatic

Summary: a prospective, open label phase 2 clinical trial assessing safety, complications and feasibility of radical prostatectomy (rarp) plus local stereotactic body radiotherapy (sbrt) to bone metastases in combination with short-term medical castration to a select population of prostate cancer patients with oligometastatic disease.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older and willing and able to provide informed consent; 2. stage ct1 ≤ ct3b, clinical resectable 3. gleason score ≥ 6 4. m1 1. ≤ 3 bone metastases localized to the spine, pelvis or humeral/femoral bones as evaluated by 68ga-psma pet/ct and magnetic resonance imaging (mri) 2. absence of psma uptake in retroperitoneal lymph nodes, (outside the anatomical region of extended pelvic lymph node dissection as described in the european association of urology (eau) guidelines. 3. no visceral metastasis 4. metastases suitable for stereotactic body radiotherapy 5. non symptomatic bone lesions 5. eligible for surgery exclusion criteria: 1. prior curative intended treatment for prostate cancer 2. prior androgen deprivation therapy (adt) 3. history of another invasive cancer within 3 years of screening, with the exception of fully treated cancers with a remote probability of recurrence. the medical monitor and investigator must agree that the possibility of recurrence is remote for exceptions. 4. eastern cooperative oncology group (ecog) performance status \> 1 5. evaluated not able to fulfil the study protocol. 6. contraindications against mri

Keywords: radiotherapy prostatectomy androgen deprivation therapy
outlook quality of life intervention study

Conditions: Cancer; Congestive Heart Failure (CHF); Chronic Obstructive Pulmonary Disease (COPD); End Stage Renal Disease (ESRD)

Summary: the purpose of this study is to determine whether discussions of life story, forgiveness, and future goals improve quality of life for patients with serious illness.

this is a randomized control trial to evaluate the feasibility of the outlook intervention. 221 veterans with advanced cancer, congestive heart failure (chf), chronic obstructive pulmonary disease (copd) or end stage renal disease (esrd) were randomly assigned to one of three intervention groups and completed a brief battery of pre-test measures. subjects in the first group ("outlook intervention") were randomized to meet with a facilitator three times for a period of 45 min-1 hour. participants were asked in the first session to discuss issues related to life review. they were asked in the second session to speak in more depth about issues of regret, forgiveness and things left undone. the subject of the final session was heritage and legacy. participants in the attention control group were randomized to meet with a facilitator three times for a period of 45 min- 1 hour and listen to a non-guided relaxation audio disc (cd). participants in the third group ("treatment as usual") were exposed to no interventional sessions. participants were assessed with post-test measures administered by a blinded interviewer one week and 3 weeks after the intervention window.

Eligibility criteria:
inclusion criteria: * patients with * advanced cancer * congestive heart failure * copd * end stage renal disease exclusion criteria: * cognitive impairment * inability to speak * non-english speaking

Keywords: quality of life end of life self-disclosure palliative care