Kornimate/medical-research-clean huggingface dataset:
mri in finding hypoxia in patients undergoing chemo and radiation for head and neck cancer

Conditions: Head and Neck Cancer

Summary: rationale: diagnostic procedures, such as functional mri, may help measure oxygen levels in tumor cells and may help in planning cancer treatment. purpose: this phase i trial is studying functional mri to see how well it works in finding hypoxia in patients undergoing chemotherapy and radiation therapy for stage iii or stage iv head and neck cancer.

objectives: * determine the undertaken oxygen sensitive mri for the detection of hypoxia in patients with stage iii-iv head and neck cancer. * correlate mri parameters with histology, gene expression, and plasma osteopontin. * correlate tumor hypoxia measurements with patient prognosis and treatment response. outline: * pre-therapy mri: patients undergo blood oxygen level dependant (bold) contrast mri on room air breathing over 2 minutes and with oxygen gas over 15 minutes. patients also undergo mr-spectroscopy over 15 minutes to measure choline and lactate markers, and dynamic contrast mri with gadolinium contrast over 8 minutes. * chemoradiotherapy: patients receive platinum based chemotherapy every two weeks. patients also undergo radiation therapy for 6 weeks. * post-radiation mri: patients undergo mri as before chemoradiotherapy. blood and tumor samples are collected at baseline for biomarker analysis associated with tumor progression or response. after completion of study, patients are followed every 3 months for up to 1 year.

Eligibility criteria:
disease characteristics: * histologically confirmed squamous cell carcinoma of the head and neck * stage iii or iv disease * measurable disease * scheduled to undergo standard treatment including radiation therapy and chemotherapy * participation on study # 092004-010 for tissue procurement patient characteristics: * ecog performance status 0-2 * serum creatinine ≤ 1.5 or creatinine clearance ≥ 40 * body mass index ≤ 34 kg/m\^2 * not claustrophobic * no other contraindications to mri (i.e., implanted pacemaker device) * not pregnant or nursing * negative pregnancy test * no allergy to gadolinium prior concurrent therapy: * see disease characteristics
combined laser-surgical technology of rrd treatment

Conditions: Rhegmatogenous Retinal Detachment

Summary: purpose: to assess the efficacy and safety of combined laser-surgical technology of rrd treatment

the study takes place in the s.n. fyodorov "eye microsurgery" federal state institution located in moscow, russian federation. the study will include 50 patients with rhegmatogenous retinal detachment due to a horseshoe-tear. in addition to the standard ophthalmological examination, all patients will undergo wide-field optical coherence tomography to determine the extension and localization of the vitreoretinal traction zone. the obtained data will be used to planning the 1st step of laser-surgical treatment. all patients will undergo a combined laser-surgical technology, which includes 3 steps: 1) nd-yag laser excision of the vitreoretinal traction zone 2) pneumatic retinopexy (10% c3f8) 3) barrier laser photocoagulation around retinal break after retinal attachment. the patients are going to be followed up for at least 1 year, the main outcome measures are postoperative primary and final anatomic outcome, bcva and complications.

Eligibility criteria:
inclusion criteria: 1. rhegmatogenous retinal detachment extending from the 9-o'clock to the 3-o'clock meridians. 2. superior retinal break from 9 o'clock to 3 o'clock 3. single retinal break not greater than 1 clock hours in size 4. physically and mentally co-operated in post-operative head positioning 5. no (or minimal) proliferative vitreoretinopathy 6. none or mild vitreous hemorrhage. exclusion criteria: 1. severe concomitant eye pathologies (glaucoma, diabetic retinopathy, macular hole, traumas); or 2. ocular media opacities 3. previous ocular surgeries 4. age \<18 years 5. previous retinal detachment (index eye)
tele-support for emergency medical technicians

Conditions: Cardiac Arrest

Summary: in this manikin-based simulation study the impact of tele-support during a simulated pediatric out-of-hospital cardiac arrest scenario on emergency medical technicians' guideline adherence, on gaze behavior as well as on performance of resuscitation management and cognitive load will be analyzed.

80 emergency medical technicians (emt) will take part in this simulation study. the participants will be confronted with a scenario of an 8-year old boy, while wearing eye tracking glasses. in a parallel group design, the teams will be randomly assigned to a group performing advanced life support (als) without further support (group 1) or with additional tele-support (group 2). in case of support, an emergency physician assists the team performing the cardiopulmonary resuscitation management via a real-time remote connection.

Eligibility criteria:
inclusion criteria: * age 18-65 years * active work as an emergency medical technician exclusion criteria: * pregnancy * prior knowledge of study setting or simulation scenario

Keywords: simulation pediatric out-of-hospital cardiac arrest advanced life support eye tracking cognitive load emergency medicine patient safety telemedicine anaesthesiology
laparoscopy versus clinical follow up to detect diaphragm injury

Conditions: Diaphragm Injury

Summary: title: a randomized prospective study comparing non operative management with laparoscopic treatment in patients with a diaphragm injury following left thoracoabdominal stab wounds. aim of the study: the aim of this study is to access the clinical outcome of potential occult diaphragm injuries in a group of patients presenting at the groote schuur trauma centre with left sided thoracoabdominal stab wounds, if an expectant non operative management course is taken. objects of the study: to obtain the above mentioned aim the study will undertake; * to do laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury. * to assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.


Eligibility criteria:
inclusion criteria: * hemodynamically stable patients * patients with penetrating stab wounds bounded by * superiorly the 4th intercostal space * lateral the tip of the left scapula * inferior by the left costal margin * medially by the sternum * signed informed consent exclusion criteria: * hemodynamically unstable patients * previous penetrating injury to the area mentioned under inclusion criteria * patients requiring early surgical exploration for injuries other than diaphragm injuries * if a diaphragm injury is detected on imaging * a positive pregnancy test

Keywords: diaphragm injury herniation
clinical therapeutic potential of novel microbiome lp-51 on xerosis individual based on xerosis-microbiome index

Conditions: Xerosis

Summary: the purpose of this clinical trial is to assess the skin hydration and transepidermal water loss improvement, pruritus relief, and microbiome alteration effects of a lactobacillus sp. product (lactobarriome 5% cream) compared to a placebo cream to prove the skin improvement effects of lactobarriome 5%, which is a nature-friendly material derived from intravaginal microflora that can replace chemical components commonly used as ingredients for existing cosmetics. the impact of lactobarriome 5% cream, formulated with lp51 culture filtrate, on dry skin was assessed through a 4-week double-blind clinical trial. participants were selected based on predefined inclusion and exclusion criteria. using a simple randomization method, participants were assigned to either the experimental group (receiving the test formulation) or the control group (receiving a placebo). the products were applied twice daily-morning and evening-to a 3 cm area on both the proximal and distal sides of the designated arm's crook. clinical evaluations were conducted at baseline, as well as after 2 weeks and 4 weeks of product use. these assessments included visual inspections, subjective pruritus evaluations, skin hydration levels, and transepidermal water loss (tewl) measurements, all performed by a skincare professional. furthermore, magnified images were captured using a folliscope, and skin samples were collected to analyze microbial changes post-treatment. before application, the designated arm was washed with water and allowed to rest for 30 minutes under controlled conditions (22±2°c, 50±10% relative humidity).


Eligibility criteria:
inclusion criteria: * healthy participants, including men and women, aged 19-70 * without acute or chronic diseases (excluding atopic dermatitis) * individuals suffering from dry skin and itchiness in the test area (crook of the arm) * those with objectively proven skin barrier damage demonstrated by a transepidermal water loss (tewl) value of ≥12 g/h/m² and a skin hydration value below 35 (corneometer measurement) * individuals who provided voluntary informed consent * those who agreed to comply with study visits and observations exclusion criteria: * individuals with active skin diseases requiring treatment * those with an esif score \>6 * individuals with a history of antibiotic, steroid, immunosuppressant, antihistamine, or retinoid use, or phototherapy within the last 4 weeks * individuals who used skin disease-related supplements or moisturizers within 2 weeks * those participating in other clinical trials within the last 4 weeks * individuals with frequent exposure to uv light * pregnant or lactating women * those planning pregnancy during the trial period * any other factors deemed unsuitable by the investigator

Keywords: xerosis-microbiome index microbiome therapeutic
participatory organizational intervention for improved use of assistive devices for patient handling

Conditions: Musculoskeletal Disorders; Occupational Injuries

Summary: epidemiological studies have shown that patient transfer is a risk factor for back pain, back injuries and long term sickness absence, whereas consistent use of assistive devices during patient transfer is associated with reduced risk of back injury. in consequence, danish hospitals have made great efforts to increase knowledge, availability and use of assistive devices to reduce work-related physical strain due to patient transfer. yet, a recent survey among more than 300 nurses and nurses' aides showed that two thirds rarely uses assistive devices during patient transfer. thus it seems relevant to investigate barriers, opportunities and practical solutions for increasing use of assistive devices among healthcare workers. the purpose of this study is to evaluate a participatory organizational intervention for improved use of assistive devices during patient transfer.


Eligibility criteria:
at the department level: hospital departments with frequent patient handling will be eligible for participation in the cluster-randomized study. at the individual level (questionnaire replies): inclusion criteria: * healthcare workers with daily patient handling (based on questionnaire reply at baseline) exclusion criteria: * none
mesenchymal stem cells derived exosomes in osteoarthritis patients

Conditions: Osteoarthritis, Knee

Summary: present research focuses on the potential of exosomes, which are small vesicles secreted by mesenchymal stem cells (mscs), as a therapeutic approach for osteoarthritis (oa). oa is a degenerative joint disorder characterized by the destruction of cartilage and loss of extracellular matrix. it's associated with pro-inflammatory cytokines and increased expression of matrix metalloproteinase (mmp) and "a disintegrin and metalloproteinase with thrombospondin motifs" (adamts). mscs have been explored as a new treatment for oa over the last decade1. it's suggested that the paracrine secretion of trophic factors, in which exosomes play a crucial role, contributes to the mechanism of msc-based treatment of oa. exosomes derived from mscs may suppress oa development. they carry bioactive molecules of the parental cells, including non-coding rnas (ncrnas) and proteins and anti-inflammatory factors. these exosomes have shown a significant impact on the modulation of various physiological behaviors of cells in the joint cavity. this research provides hope for developing more effective and predictable methods of using msc-derived exosomes for oa treatment.


Eligibility criteria:
inclusion criteria: * chronic history (for at least 3 months) of knee joint pain * body mass index (bmi) between 21.5 and 29.5 * radiographically documented knee osteoarthritis of grades 1 to 3 (kellgren-lawrence (k-l) radiographic classification scale) exclusion criteria: * rheumatoid arthritis and other rheumatic diseases * varus or valgus more than 10 degrees; lateral subluxation of the patella * deformity at the joint levels or adjacent to the knee due to fracture or any other injury * complete rupture of the ligament and meniscus leading to laxity or locking * serious systemic, oncohematological, autoimmune diseases; history of severe allergy; serious failure of vital organs, inability to walk * hyaluronic acid infiltration within the previous six months * hemoglobin levels \<10 g/dl;
the development and evaluation of sleep intervention for perinatal family

Conditions: Sleep; Psychological Distress; Perinatal Problems

Summary: background: sleep disruptions and disturbances are highly prevalent among new mothers and fathers and negatively affect their mental health and infant development outcomes. effective sleep interventions are vital for family health. objectives: to develop a sleep intervention for mother-father-infant triads, and to evaluate the effects on sleep improvement, emotional distress, and infant health outcomes. methods: in this proposal, we plan to conduct a parallel-group two-arm randomized controlled trial on pregnant women and their partners. mother-father-infant triads will be recruited and randomly allocated to the intervention group (receiving a sleep intervention) or the control group. data will be collected with repeated measures, and the relationship between studied variables will be analyzed with descriptive and inferential statistics. anticipatory results: the development and evaluation of an evidence-based sleep intervention will provide a scientific insight into sleep care for pregnant women and their families.

the primary outcome is the severity of insomnia symptoms. the secondary outcomes of parents' sleep quality, objective sleep indicators, symptoms of depression and anxiety, and heart rate variability will be collected. infant sleep quality, infant feeding, and infant health outcomes will also be assessed. data will be analyzed using descriptive and inferential statistics.

Eligibility criteria:
inclusion criteria: 1. first-time mothers and their partners aged 20 and older; 2. currently 30 weeks gestation or more, singleton; 3. insomnia severity index score greater than 10; 4. living with a husband or partner; 5. both women and their partners are willing to participate in and adhere to the research protocol; 6. be able to read and speak the mandarin language exclusion criteria: 1. sleep disorders, depression or anxiety disorders; 2. medical diseases with abnormal heart rate variability, or arrhythmia; 3. taking medicines that may affect the autonomic nervous system or 4. night shift workers; 5. obstetric complications, including gestational hypertension, preterm labor, labor complications, or postpartum complications; 6. infants with fetal deformity, or neonatal complications; 7. no access to internet resources

Keywords: sleep quality perinatal depression anxiety infant sleep infant health
effectiveness of a cbt based mobile application

Conditions: Depressive Symptoms

Summary: this research aims to explore the effect of a mobile application designed on the basis of cognitive behavioral therapy on college students suffering from depression in terms of their symptoms, suicidal thoughts, and other relevant variables.

background: college students encounter the transition from adolescence to adulthood, thereby possibly facing various factors causing depression. however, instead of consulting a professional, most college students seek help online or through contacts, or internalize their emotions. the current situation could be due to the low efficiency of depression prevention and the limited consultation provided at campus. while many studies have examined adopting mobile applications in dealing with depression, they have not shown consistent results. the cross-sectional research has been the most common; few randomized controlled trials have been conducted. hence, much empirical evidence is needed to identify the effect of a mobile application. aim: this research aims to explore the effect of a mobile application designed on the basis of cognitive behavioral therapy on college students suffering from depression in terms of their symptoms, suicidal ideation, and other relevant variables. methodology: this is a randomized controlled trials study. the participants, aged 20 and above, were recruited from three universities of science and technology of similar nature. all of them suffer from depression symptoms and have used wi-fi smartphones. they were randomly assigned to the control group and the treatment group. the treatment group received an intervention involving the participants' use of the mobile application for 12 weeks, at least once a week, 20 minutes per session. the generalized estimating equation was adopted to analyze the results regarding the depression symptoms, suicidal ideation, help-seeking attitudes, emotional self-awareness, and mobile health (mhealth) literacy. expected outcomes: the results obtained by tracking the symptoms of depression from the empirical research design conducted on campus will provide a reference to understanding to what extent mobile applications could be an appropriate intervention for college students. clinical application: the research findings could provide insights for policymaking in respect of helping a person with depression on campus to better meet college students' needs.

Eligibility criteria:
inclusion criteria: * suffer from depression symptoms. * aged 20 and above. * being able to communicate in chinese or taiwanese. * used wi-fi smartphones. * agree and obtain written consent. * in the school term during research. exclusion criteria: * have a full-time job. * who has been diagnosed with bipolar disorder, asperger syndrome, and schizophrenia. * who have the health conditions associated with visual impairments, auditory impairments, and mobility impairments, that are limited to the use of accessibility mobile applications.

Keywords: mobile application cognitive behavioral therapy depression symptoms
randomized, double-blind, placebo-controlled study to evaluate the effect of roflumilast on endothelial function in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: revasc is a randomized, double-blind, placebo-controlled study which will involve 150 patients with chronic bronchitis and copd diagnosed cardiovascular disease. the recruitment period beginimg in the coming weeks, will last nine months. patients included in the study will receive treatment for three months with roflumilast 500 mg (75 patients) or placebo (75 patients) in a randomized manner. the ciberes, as promoter of this study is expected to release final results for the third quarter of 2013. eight centers in madrid will be involved in this clinical trial: fundación jiménez díaz, hospital la princesa, hospital gregorio maranon hospital clinico san carlos, hospital la paz, hospital ramón y cajal hospital doce de octubre and hospital puerta del hierro. roflumilast is a potent phosphodiesterase-4 inhibitor (pde4). its clinical efficacy has been studied in an extensive clinical program involving over 12,000 patients with copd. in these studies, roflumilast (in combination with long-acting bronchodilators) reduced the number of exacerbations and improved lung function, especially in those patients with associated chronic bronchitis.


Eligibility criteria:
inclusion criteria: * signed informed consent * 55-75 years of age * current and former smokers \>20 cigarettes pack-yr (if former smokers withdrawn \>1 year) * diagnosis copd (gold criteria1 for more than a year before v0) * presence of chronic bronchitis (cough and/or expectoration for more that 3 months/yr for more than 2 consecutive yrs. in the absence of other potential cause) * post-bronchodilator fev1\<70% reference * presence of established cvd, cvd equivalent or diabetes mellitus * presence of chronic systemic inflammation, determined on: 1. serum crp ≥ 2 and \< 10 mg/l or 2. serum fibrinogen \> 518 mg/dl and leucocytes \> 8,6\*106 /mm3 exclusion criteria: * episode of copd exacerbation and/or copd treatment change during the last 2 months before v0 * history of asthma, significant residual lung lesions or bronchiectasis on chest x-ray * apnea-hypopnea syndrome * poorly controlled cvd risk factors (table 2) and/or change in their treatment during the last 3 months before v0 * clinically significant cardiac arrhythmias or valve disease * severe concomitant immunological, inflammatory, infectious or neoplastic diseases * moderate or severe hepatic insufficiency (b or c class, following child-pugh scale) * severe neurologic and/or psychiatric disorder, including depression with suicidal ideas * alcohol and/or drug abuse during the last 12 months before v0 * hypersensitivity to roflumilast or to any of its excipients * pregnancy or potential pregnancy * participation in other clinical trial during the last 30 days before v0 * language difficulties to follow the instructions of the study

Keywords: post-bronchodilator fev1<70% reference chronic bronchitis presence of estavlished cvd, cvd equivalent or diabetes mellitus