Kornimate/medical-research-clean huggingface dataset:
home mechanical ventilation effectiveness and air leaks

Conditions: Pulmonary Disease; Chronic Respiratory Failure; COPD

Summary: non invasive ventilation (niv) usually presents air leaks that may determine the result of this treatment. the clinical usefulness of analyzing (and quantifying) these leaks during the adaptation period to niv has not been evaluated in prospective clinical studies as a predictive data of treatment effectiveness. our hypothesis is that air leaks are correlated to a successful adaptation to niv. and air leak magnitude may predict early failures of this treatment. and also, as we do not know if air leaks change during the adaptation period to niv, we do not know whether early detection of air leaks plays a role in the therapeutic outcome. our objective is to evaluate the clinical usefulness of quantifying air leaks during the adaptation period to niv as a predictor of effectiveness of this treatment. we also want to evaluate the correlation between air leaks and clinical-functional patients' profile, and the ventilatory parameters selected and to evaluate air leaks variability during the adaptation period to niv. method: we will determine the air leak magnitude in twenty patients during adaptation to niv. we will use vpap iii ventilators (resmed, australia), commercial nasal masks (mirage o ultra mirage) and vpap iii/reslinktm (resmed, north ryde, australia), a device that includes a monitoring system coupled with the vpap iii ventilator. this device allows to record air leaks and other ventilation parameters. we will perform four vpap iii/reslinktm recordings in each patient (the last night in hospital during the adaptation period, the first night at home, and one and two months later, after the initiation of niv treatment). we will also perform a complete pulmonary function test, quality-of-life questionnaire (sf36), and a tolerance to niv questionnaire in all patients at the onset of niv treatment and two months later. we will evaluate which patients will need to change treatment at the end of the adaptation period to niv. we also will analyze and compare air leaks magnitude in each of the four recordings stated above.


Eligibility criteria:
inclusion criteria: * patients with a restrictive pulmonary disease (slow evolution neuromuscular or thorax cage diseases, obesity or nocturnal hypoventilation) and hypercapnic chronic respiratory failure with standard criteria for niv. * copd patients who need niv because of another reason (obesity, nocturnal hyperventilation or nocturnal hypercapnic response to oxygen). * paco2 ≥ de 50 mmhg. * clinically stable (at least for one month). * possibility to fit a nasal mask for niv treatment (ultra mirage, mirage). exclusion criteria: * rapid evolution neuromuscular disease (amyotrophic lateral sclerosis). * serious comorbidity. * lack of patients comprehension or collaboration. * inability to fit a nasal mask for niv treatment (ultra mirage, mirage). * treatment compliance \< 4h/d.

Keywords: restrictive pulmonary disease with hypercapnic chronic respiratory failure. copd patients who need niv hypercapnic chronic respiratory failure.
effect of autogenic relaxation therapy on caregivers on perceived stress quality of life and caregiver burden

Conditions: Caregiver Burnout; Caregiver; Care Burden

Summary: caregivers are also faced with multiple stress factors. autogenic relaxation therapy will help caregivers relax and take time for themselves by getting away from the stressful life they have lived. although there are various studies on this subject (chegeni et al. 2018, seo and kim 2019, ramiraz-garcia et al. 2020, wang et al. 2021, bagheri et all 2021, ozhanlı and akyuz 2022), there is no study on caregivers as far as we could reach. as a result of this study, nurses will help caregivers, whom they work one-on-one in most areas, to relax, thus helping to increase the quality of patient care in home environments and contributing to the increase in the quality of life of the caregiver. thus, caregivers will be able to manage care more actively and effectively both at home and in clinics. based on this purpose, the aim of the study is to reduce the anxiety level of caregivers, increase the quality of life and reduce the burden of care after autogenic relaxation therapy to be applied to caregivers.


Eligibility criteria:
inclusion criteria: * being over 18 years old * being able to answer data collection forms * being able to speak turkish * being able to provide continuous or partial care to a patient for at least 3 months * being able to communicate exclusion criteria: * having epilepsy * not speaking or understanding turkish * having a neurological disability * having had an acute myocardial infarction * being diagnosed with schizophrenia and major depression * being addicted to alcohol or drugs * having a history of loss of consciousness
the effect of silver diamine fluoride (sdf) on bacteria involved in root or cervical carious lesions

Conditions: Caries

Summary: the study will compare bacteria levels in cavities before and after silver diamine fluoride (sdf) treatment.

to assess the effect of silver diamine fluoride (sdf) treatment on microorganisms present in root caries or cervical lesions by collecting microbial deposits before and 1 month after sdf application. bacterial samples will be collected from 20 adult subjects at the initial visit before application of sdf and one month after. at the 1 month recall, examination for caries arrest will be performed. all 40 bacterial samples will be sent to the forsyth institute to verify bacterial composition using homings technology.

Eligibility criteria:
inclusion criteria: * generally healthy adult participants 18 years of age and older. * at least one tooth with active (soft) cavitated lesions of icdas score 5 or 6 near the gingival margin (coronal cervical caries at the cej or exposed root surfaces with soft active carious lesions exposing dentin). exclusion criteria: * adult participants who suffer from serious life-threatening medical diseases that interfere with basic daily self care activities. * patients taking antibiotics within the last two weeks. * patients using chlorhexidine or fluoride mouth washes within the last two weeks. * pregnant or breastfeeding women. * teeth with arrested (hard) cervical or root caries lesions. * teeth that have been diagnosed with an abscess or an irreversible pulpitis, or are mobile.

Keywords: caries cavity silver diamine fluoride (sdf) homings
diet and fat mass after traumatic spinal cord injury

Conditions: Obesity; Metabolic Disease; Spinal Cord Injuries

Summary: this is a randomized clinical controlled trial (rct) to investigate the impact of a personalized nutritional intervention on functional and clinical outcomes the first year after traumatic spinal cord injury. the long term goal is to prevent gain of body fat mass and obesity.

traumatic spinal cord injury (sci) is a devastating injury resulting from critical incidents like falls, sports- and traffic accidents, demanding lifelong specialist health care services. a major challenge is the prevalence of obesity following metabolic alterations after sci. obesity hampers independence and mobility and has a negative impact on quality of life. accumulation of adipose tissue is reported to be higher than in able-bodied, explaining the high risk of cardiometabolic disease in the sci population. food intake is the supreme variable in prevention of obesity after sci, however there is a paucity in studies investigating nutrition as a measure to prevent and reduce comorbidity. key questions that remains unanswered are how early adipose tissue accumulates, if nutritional manipulations can prevent obesity and how follow-up can help maintain a healthy lifestyle. in the present phd-study, we use mri techniques to quantify changes in body composition in a cohort study the first year after sci, and we employ a randomized controlled trial to test the efficacy of a nutrition intervention during rehabilitation aiming to prevent obesity. successful results will be implemented in care-programs at our hospital for those with sci and similar mobility impairments, with the aim of improving nutrition practice throughout the course of treatment

Eligibility criteria:
inclusion criteria: * traumatic spinal cord injury * levels c1-l2 * american spinal injury association (asia) impairments scale (ais) a-d exclusion criteria: * glasgow coma scale score (gcs) equal to or lower than 13 * below 18 years of age * medical issues like impaired cognitive function, progressive disorders and co-morbidities.
eosinophil markers and development of disease in allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: inflammatory proteins from eosinophil granulocytes in blood from patients with seasonal allergic hayfever have been shown to predict development of asthma at a six-year follow-up. this study is a 15-year follow-up of the same patients to verify earlier results and study disease development.

the study consists of a single visit at which patients fill in a questionnaire on actual hayfever and asthma symptoms as well as current treatment. blood samples and nasal lavages are drawn and analysed for eosinophils as well as eosinophil cationic protein and tryptase. spirometry is performed. if patients use drugs which can interfere with results, ie. corticosteroids or beta-agonists, biochemistry and/or spirometry are omitted.

Eligibility criteria:
inclusion criteria: * participant in earlier study (1995) exclusion criteria: * treatment with any kind of corticosteroid within two months will exclude from study of inflammatory parameters
use of dexmedetomidine in light to moderate sedation in the patient in the palliative situation of a sars-cov-2 / covid-19 infection

Conditions: COVID-19 Infection; Sars-cov-2; Respiratory Failure; Palliative Situation

Summary: the current sars-cov-2 epidemic is responsible for severe respiratory infections leading to end-of-life situations. dexmedetomidine may be indicated in mild to moderate sedation in palliative patients, due to its pharmacological characteristics. the hypothesis of this study is that dexmedetomidine would allow effective and safe light sedation in patients with respiratory failure in palliative situations suffering from covid-19 infection.


Eligibility criteria:
inclusion criteria: 1. major patient 2. relating to palliative care 3. with sars-cov-2 infection 4. requiring light to moderate sedation corresponding to a rass score of -1 to -3 exclusion criteria: 1. pregnant, lactating woman. 2. hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the summary of product characteristics 3. advanced heart block (level 2 or 3) unless a pacemaker. 4. uncontrolled hypotension. 5. acute cerebrovascular pathologies. 6. use of other sedative drugs

Keywords: covid-19 sars-cov-2 infection respiratory failure palliative situation
magnetismm-2: study of elranatamab (pf-06863135) in japanese participants with multiple myeloma

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: the purpose of this study is to confirm the safety and tolerability of elranatamab (pf-06863135) in japanese participants with relapsed or refractory mm.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma (imwg criteria) * measurable disease, as defined by at least 1 of the following 1. serum myeloma (m) protein ≥0.5 g/dl (5 g/l) 2. urine m protein ≥200 mg/24 h 3. serum free light chain (flc) \>100 mg/l (10 mg/dl) with abnormal kappa:lambda ratio * participants must have progressed on or been intolerant of at least 3 prior therapies including proteasome inhibitor, imid drug and anti-cd38 antibody, either in combination or as a single agent * ecog ps 0, 1 or 2. ps 3 is permitted if ps is due solely to bone pain * adequate bone marrow, hematological, kidney and liver function * resolved acute effects of any prior therapy to baseline severity or ctcae grade 1 * not pregnant and willing to use contraception exclusion criteria: * poems syndrome * any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ * history of active autoimmune disorders * any form of primary immunodeficiency * history of severe immune-mediated adverse event with prior immunomodulatory treatment * stem cell transplant within 12 weeks prior to enrollment * active graft versus host disease other than grade 1 skin involvement, or that requiring immunosuppressive treatment * requirement for systemic immune suppressive medication * active, uncontrolled bacterial, fungal, or viral infection, including hbv, hcv, known hiv or aids related illness and sars-cov2 * previous administration with an investigational drug within 4 weeks or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer) * known or suspected hypersensitivity to component of elranatamab (pf-06863135), murine and bovine products * live attenuated vaccine within 4 weeks
6% hydroxyethyl starch (130/0.4) coload for postspinal anesthesia hypotension

Conditions: Adverse Effect

Summary: the purpose of this study is to investigate the ed50 and ed90 for an effective 6% hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. the incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. colloid fluid coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. however, the ed50 and ed90 for an effective 6% hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension are still unknown. the purpose of this study is to investigate the ed50 and ed90 for an effective 6% hydroxyethyl starch (130/0.4) coload infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

Eligibility criteria:
inclusion criteria: * 18-40 years * primipara or multipara * singleton pregnancy ≥ 37 weeks * american society of anesthesiologists physical status classification i to ii * scheduled for elective cesarean section under spinal anesthesia exclusion criteria: * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmhg * hemoglobin \< 7g/dl * coagulation or renal function disorders * known allergy to hydroxyethyl starch * fetal distress, or known fetal developmental anomaly

Keywords: hydroxyethyl starch 130/0.4 coload hypotension cesarean section
8-week randomized, open-label study to evaluate food effect on efficacy and safety of oral aliskiren 300 mg in patients with hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.


Eligibility criteria:
inclusion criteria: * patients with essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy). * patients with an office bp ≥ 140/90 mmhg and \< 180/110mmhg at the randomization visit and the preceding visit * patients must have an absolute difference of ≤ 10 mmhg in both their mssbp and their msdbp between the randomization visit and the preceding visit exclusion criteria: * malignant hypertension or severe hypertension (grade 3 of who classification; mssbp ≥180 mmhg or msdbp ≥110 mmhg) * history or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease (pkd). * type 1 or type 2 diabetes mellitus with a fasting glycosylated hemoglobin (hba1c) \> 8% * evidence of renal impairment as determined by one of the following: serum creatinine \>1.5 x uln or egfr \< 30 ml/min/1.73m2 at visit 1, a history of dialysis, or a history of nephrotic syndrome other protocol-defined inclusion/exclusion criteria may apply. -

Keywords: food effect, hypertension, aliskiren
physiological intermolecular modification spectroscopy (pims) in ulcerative colitis with golimumab

Conditions: Ulcerative Colitis

Summary: aim of this study is to determine wether the macromolecular spectral characteristic of ulcerative colitis patients - measured by physiological intermolecular modification spectroscopy (pims) - is a predictive factor for response to simponi treatment

it is widely appreciated that almost all proteins and other biological macromolecular in vivo exist, at least transiently, as components of structural and functional complexes. this transient interaction in simple component solutions have been studied using well established daylight light scattering (ls) method which reflects molecular oscillation (7-12). protein association, protein unfolding, protein aggregation and cellular crowding are known to affect the normal function of cellular system (13-19). in many cases, the resulting small changes in normal protein-protein intra- and intermolecular interactions are thought to lead to a variety of human diseases (20, 21). based on these and the acquired knowledge on ls, the cutting edge technology, pims has been developed. pims is a label free technology that is able to study protein-protein and protein-solvent interactions in multi-component solutions. it provides individual real time dynamic fingerprint of total physiological macromolecular assemblies in a tissue in presence and absence of exogenous molecules (drug or drug candidate, peptide or protein). this technology is based on dynamic molecular resonance of proteins and macromolecules. cellular extracts in physiological conditions are frozen at -37°c. macromolecular spectra are registered as the temperature within the sample raises from -37 to 37°c. this provides, within the organ of interest, dynamic fingerprint of an individual entire macromolecular assemblies. the present technology can therefore rapidly and specifically determine the response of a tissue or cell when an exogenous molecule is administrated. it reflects patient molecular capacity to respond to the drugs effect and allows to identifying different subpopulations within a group in response to a specific treatment. it highlights the responders from non-responders to a given treatment.

Eligibility criteria:
inclusion criteria: * moderate to severe active ulcerative colitis * qualified for initiating golimumab therapy, i.e.inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine or intolerance of medical contraindications to such therapies * must be able and willing to provide written informed consent * must have a negative tuberculosis screening or if inactive (latent) tuberculosis diagnosed anti-tuberculosis therapy to be started before initiation of golimumab therapy in accordance with local recommendations exclusion criteria: * cancer * type one diabetes * current infection and/or inflammation other than related to ulcerative colitis * autoimmune diseases * any contraindications stated by golimumab product label

Keywords: ulcerative colitis golimumab physiological intermolecular modification spectroscopy pims
study of the increase in icu beds capacity during covid-19 pandemic in france

Conditions: Coronavirus Infections; COVID19 Outbreak in France

Summary: for preventing the overwhelming of icu beds capacity during covid-19 pandemic in france, national and regional health-care institutions decided to optimize the intensive care unit beds availability by opening new icu beds in institutions with and without prior icu. the present study was design to retrospectively describe the origin of the icu beds and human resources created during the covid-19 outbreak in france.

since december 2019, the sars-cov-2 coronavirus disease has caused a worldwide outbreak of respiratory illness that rapidly invaded leading the world (who). its most severe form is dominated by an acute respiratory distress syndrome (ards) with other organ failures requiring mechanical ventilation and admission in intensive care unit (icu). with a wide pandemic effect and a long length of mechanical ventilation, the intensive care units were quickly full. for preventing the overwhelming of icu beds capacity, national and regional health-care institutions (then french health minister, every regional health) decided to optimize the intensive care unit beds availability by opening new icu beds in institutions with and without prior icu. daily icu beds availability was assessed in each institution, and at the regional level to organize potential patient transfers across regional and national hospital. moreover, an extraordinary mobilization and joint efforts of medical, paramedical and administrative staff allowed getting the caregivers for managing the most severe patients in each icu. all physicians who could manage icu patients were involved in this crisis. in this context, anesthesiologists (who have gotten an icu education during their studies) were involved, as the surgical activity has been reduced to the vital procedures. this overall organization permitted the admission of more patients than the initial maximum national capacity of icu beds.

Eligibility criteria:
inclusion criteria: * hospital having icu during covid-19 outbreak in france exclusion criteria: * hospital refuse to participate

Keywords: covid-19 critical care intensive care
the effect of music and environmental noise isolation on bronchiolitis severity in hospitalized children: a randomized control trial

Conditions: Bronchiolitis

Summary: bronchiolitis is an infectious disease, with no effective treatment. music and mozart's works specifically, has been shown to have a positive effect on physiological parameters, while environmental noise is considered to be harmful. we aimed to evaluate the short-time effect of listening to music and detachment from environmental noise on the severity of bronchiolitis in hospitalized children.

mp3 player devices were uploaded with 3 different pieces: 1) sonata for 2 pianos in d major, k.488 by mozart (2) instrumental music ("to the point", by dean evenson \& tom barabas) and (3) silence. all music or silence pieces were identical in length (24 minutes in accordance to the duration of the sonata). music fragments were played using headphones suitable and approved for use in children - gsi (grason-standler) insert earphone tip-50 (50 ohm) (grason standler inc. madison, wi, usa). sound frequency and volume were adjusted to the age appropriate values33 children were randomly divided into 3 groups according to the type of intervention. randomization, numbering of the mp3 players and coding of the content were done by a research coordinator not involved in evaluation of the patients nor in analysis of the results.

Eligibility criteria:
inclusion criteria: * patients aged 0-24 months, with the clinical diagnosis of bronchiolitis. exclusion criteria: * children who failed neonatal hearing screening or in whom the results of the screening were not available were excluded from the study. * children who were not able to maintain listening for at least 10 minutes were excluded from data analysis

Keywords: double blind randomized controlled study prospective