Kornimate/medical-research-clean huggingface dataset:
assessment of clinical effects of coenzyme q10 levels in covid-19 patients in intensive care unit

Conditions: COVID-19

Summary: the study will be done in hacettepe university anesthesiology and reanimation intensive care unit. the investigators will accept covid-19 diagnosed or suspected patients to the icu. in the first day of hospitalization and after that once a week, the investigators will take blood samples from the patients to evaluate coenzyme q10 levels. our hypothesis is that there is a relationship between low coenzyme q10 levels and poor clinical outcome.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * being under the age of 18 * being pregnant * patient refusal
study of risk factors for the occurrence and severity of exertional heatstroke in the military environment

Conditions: Heat Stroke

Summary: although the circumstances of onset and management of exertional heatstroke have been identified for several years, its pathophysiology remains imperfectly understood. exertional heatstroke is the result of both extrinsic (i.e. environmental) and intrinsic (i.e. individual) contributing factors. extrinsic factors are well known (high ambient temperature and hygrometry, poorly "breathable" clothing, intense and prolonged physical effort) but some of them may be observed in milder conditions. in the french armed forces, 25% of the exertional heatstrokes that have been reported between 2005 and 2011 occurred below 17°c. intrinsic factors, on the other hand, are numerous and less consensual, partly because of the imperfect knowledge of exertional heatstroke physiopathology. potential factors include a thermoregulatory defect (inability to maintain a temperature plateau during an effort) and several genetic mutations may also contribute to explain a propensity to present an exertional heatstroke. while exertional heatstroke is clearly not a monogenic pathology, the association of several polymorphisms could contribute to this vulnerability. among the genes that have been explored, mutations in ryanodine receptor type 1 (ryr 1), calsequestrin-1 or angiotensin-1 converting enzyme (ace) appear to be potential candidates. however, it is very likely that other polymorphisms may be involved, such as: genes involved in sports performance and exercise rhabdomyolysis, in the inflammatory cascade, permeability of the digestive epithelial barrier, adenosine receptors and susceptibility to anxiety. finally, motivation is a mixed factor often claimed to be involved in exertional heatstroke but has never been quantified and needs to be objectified. to date, none of these hypotheses has been clearly assessed by comparing patients who experienced exertional heatstroke to healthy subjects.


Eligibility criteria:
inclusion criteria: * active military * between 18 and 45 years old * ability to the walk/run test exclusion criteria: * ongoing drug treatment (for the control group only), * bmi greater than or equal to 30, * contraindication to the ingestion of a core temperature capsule
the effect of topical brimonidine on the ocular hemodynamics in patients of poag using octa

Conditions: Glaucoma, Primary Open Angle; Ocular Blood Flow; Optical Coherence Tomography Angiography

Summary: topical brimonidine is a well-established topical antigalucoma, ocular hypotensive therapeutic that has been in use since 1996. brimonidine stands out among other topical ocular hypotensives in that it has a neuroprotective effect that is independent of iop reduction. this has been demonstrated in multiple animal and human controlled studies both in vivo and in vitro. the mechanisms proposed so far to account for this neuroprotection focus mainly on molecular level antiapoptotic effects and modulation of some excitatory stimuli like glutamate. in this study we try to test the hypothesis that a positive hemodynamic profile of brimonidine on ocular blood flow may be responsible at least in part for its unique neuroprotective effects.

* study design: a prospective, longitudinal, interventional, uncontrolled study * participants: primary open angle glaucoma patients recruited during the period of study from the fayoum university hospital ophthalmic outpatient clinic. * methods: primary open angle glaucoma patients that are brimonidine naiive and at the same time either medication naiive or have been on a fixed antiglaucoma medication for at least a month prior will be commenced on brimonidine 0.2% bid with prior baseline imaging by oct angiography (optovue) of macula 6\*6 mm and onh 4.5\*4.5 mm. after commencing brimonidine patients will be followed up by oct angiography at three visits assigned for 1,2,3 months after commencing brimonidine. every time the patient is imaged by oct, imaging is done twice, once in a seated position at presentation and another- also in a seated position-, but after a protocol of right recumbency for 30 minutes in order to produce a postural position change as a vascular stress test to assess autoregulatory capacity of ocular and systemic circulation. at each visit, iop and arterial blood pressure are measured both in the seated position and after the 30-minute recumbency protocol in order to mathematically calculate the mean ocular perfusion pressure that will be correlated with oct angiography data including vascular density, as well as indirect parameters of blood flow. data will be statistically analysed using the spss software.

Eligibility criteria:
inclusion criteria: * primary open angle glaucoma patients. * brimonidine naiive. * medication naiive or on a fixed antiglaucoma medication for at least a month prior to commencing brimonidine. exclusion criteria: * glaucomas other than primary open angle glaucoma. * other comorbid diseses both ocular and systemic that might confound the density and flow measurements ( hypertension, diabetes, vasculitis, mactel, uveitis) * comorbid diseases that constitute relative or absolute contraindication to brimonidine ( pregnancy, lactation, bronchial asthma, cardiovascular diseases) * prior use of brimonidine. * a change in the glaucoma medication regimen within less than one month at time of presentation. * allergy to brimonidine or related compounds.
continuous alloreactive t cell depletion and regulatory t cell expansion for the treatment of steroid-refractory or dependent chronic gvhd

Conditions: Chronic GVHD After HCT for Cancer or Immune Disease

Summary: phase ii multicenter, canadian only study - open to 25 subjects. study open to subjects with steroid-refractory or dependent chronic graft vs host disease. series of 6 aphereses and 28 re-infusions over 24 weeks. primary endpoint is ffs at 24 weeks. primary objective is to measure the efficacy of care (continuous alloreactive t-cell depletion and regulatory t-cell expansion)


Eligibility criteria:
inclusion criteria: (main) * 1. newly diagnosed chronic gvhd as defined by the national institutes of health (nih) consensus with no more than 24 weeks of treatment with systemic steroids. and 2. chronic gvhd must be refractory or dependent to standard therapy, defined as (one of the following): * progression on prednisone 7 mg/kg/week for 2 weeks, or * stable disease on ≥ 3.5 mg/kg/week of prednisone for 4-8 weeks, or * inability to taper prednisone below 3.5 mg/kg/week. exclusion criteria: (main) * 1. persistent, recurrent or late-onset acute gvhd, without signs of chronic gvhd. or 2. overlap gvhd syndrome with uncontrolled features of previously diagnosed acute gvhd. or 3. treatment with more than two systemic non-steroidal immunosuppressants within 4 weeks prior to enrollment. or 4. time from allogeneic transplantation \> 2 years. or 5. lymphocyte count \< 0.2 x 109/l on two last consecutive cbcs before inclusion

Keywords: post stem cell transplantation steroid refractory dependent chronic
a trial of transplanting hepatitis c kidneys into hepatitis c-negative kidney recipients

Conditions: End Stage Renal Disease

Summary: the transplanting hepatitis c kidneys into negative kidney recipients \[thinker-next\] study will include adult kidney transplant candidates without hepatitis c virus (hcv) infection on the transplant waiting list who will consent to kidney transplantation from a deceased donor infected with hcv, followed by treatment with a direct acting antiviral. the one-year allograft function and one-year risk of cmv infection will be compared between thinker-next kidney transplant recipients and matched recipients who received hepatitis c uninfected kidney transplants (these patients are called transplant cohort). the survival rate of patients opting-in for offers of kidneys from hcv-viremic donors will be compared to the survival rate of matched comparators from the kidney transplant waitlist who did not consent to receive offers of a hcv-viremic kidney. lastly, renal pathologic findings will be compared among hcv-viremic donors and hcv-negative comparator donors.


Eligibility criteria:
inclusion criteria: * able to provide informed consent * active waiting list status for isolated kidney transplant * 18 years of age or older * no living kidney donor * panel reactive antibody (pra) ≤97% (most recent cpra at time of screening). patients with a pra of 98-100% at screening can be included unless patient has a most recent cytotoxic pra of \>25% or calculated pra \>50% where multiple moderate level hla antibodies exist and in the opinion of the local site investigator represents substantial hla sensitization. if patient has a pra of 98-100%, the donor-recipient pair must meet additional eligibility criteria. exclusion criteria: * hepatocellular carcinoma * hepatitis b surface antigen and/or dna positive * active hepatitis c infection * hiv rna-positive or hiv antibody positive * other chronic liver disease (excluding non-alcoholic fatty liver disease \[nafld\] with normal liver enzymes) * persistently elevated liver transaminases (defined as the upper limit of normal at the reference laboratory) * advanced hepatic fibrosis or cirrhosis * primary focal segmental glomerulosclerosis (fsgs), fsgs recurring in initial transplant, or other disease process at high risk of early graft failure per the treating transplant nephrologist * current use of amiodarone or dronedarone (due to interaction with sofosbuvir) * transplant candidate requires antibody desensitization protocol for transplantation * female who is pregnant, planning to become pregnant during the study, or breast-feeding * participation in another interventional study, from a period starting 6 months prior to screening to last study visit, that the study pis judge would interfere with either the aims or the safety of the thinker-next study.
regular home use of dual-light photodynamic therapy in the management of chronic periodontitis

Conditions: Periodontitis

Summary: the study is a single site, randomized clinical trial designed to determine the efficacy of the lumoral treatment in periodontitis patients.

lumoral treatment is a ce-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. the device mechanism of action is antibacterial photodynamic therapy. the device is used by swishing a mouth rinse, strongly adhering to dental plaque. the plaque-adhered photoactive mouth rinse can be activated by a simple use light applicator. the antibacterial efficacy far exceeds chlorhexidine, without side effects in long-term use. preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction. this early-stage study is designed to determine the efficacy of the lumoral method in periodontitis patients. improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. in addition, the device might have a photobiomodulation effect on periodontal tissues.

Eligibility criteria:
inclusion criteria: * periodontal disease stage i-iii, according to criteria the american academy of periodontology (aap) with at least 2 mm interdental cal in the site of greatest loss * age of 18-85 years * presence of \> 20 teeth * agreement to participate in the study and to sign a written consent form exclusion criteria: * untreated/uncontrollable diabetes mellitus (dm) with hba1c \>7%, and hba1c \> 8 if insulin treated dm * any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease * use of medicine that would affect the periodontal tissue within the last 6 months (antibiotics, anti-inflammatories, anticonvulsants, immunosuppressants, or calcium channel blockers, including doxycycline, bisphosphonates and chlorhexidine) * periodontal treatment during the previous 3 months * allergic to the photosensitizer * presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol * removable major prosthesis or major orthodontic appliance * active smoking, or habitual use of smokeless tobacco products * pregnancy or lactation * a need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment

Keywords: lumoral lumorinse periodontitis anti-bacterial photodynamic therapy apdt plaque ammp-8
postmarketing surveillance study of berotec® n 100 µg metered-dose inhaler in chronic obstructive respiratory tract disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: study to obtain data about changing from the chlorofluorocarbon (cfc) - containing berotec® 200 µg metered - dose inhaler to the cfc - free berotec® n 100 µg metered - dose inhaler


Eligibility criteria:
inclusion criteria: * patients were included in the study only if they had been treated with berotec® 200 µg metered - dose inhaler before switching to the cfc-free berotec® n 100 µg metered - dose inhaler exclusion criteria: • contraindications listed in the instructions for use/summary of product characteristics for berotec® n 100 µg metered - dose inhaler
opposite: outcome prediction of systemic treatment in esophagogastric carcinoma

Conditions: Gastric Neoplasm; Gastroesophageal Junction Adenocarcinoma; Esophageal Adenocarcinoma; Gastric Adenocarcinoma; Esophageal Neoplasms

Summary: patients with locally advanced, resectable gastric or esophagogastric junction adenocarcinoma will receive a biopsy of the primary tumor, followed by standard-of care neoadjuvant systemic treatment; after neoadjuvant therapy tumor biopsies will be taken from different sites of the resection specimen. * aim 1: organoid cultures of pre-treatment tumor biopsies will be established and exposed to the same chemotherapy as the corresponding patient; in vitro response to treatment will be correlated with the in vivo response of patients. * aim 2: whole genome, methylome and rna sequencing of tumors biopsies and organoids will be performed prior to as well as after systemic treatment. histological and clinical outcome will be correlated with molecular subtypes.


Eligibility criteria:
inclusion criteria: histologically confirmed, resectable adenocarcinoma of the gej (type i-iii) or the stomach (ct2, ct3,ct4, any cn category, m0), or any ct cn+ m0 with the following specifications: * ecog-score ≤ 2 * patient is fit to undergo surgery (either subtotal or total gastrectomy, transhiatal or abdominothoracic esophagectomy) * no preceding cytotoxic or targeted therapy * no prior partial or complete tumor resection * exclusion of distant metastasis by ct or mri of thorax and abdomen, and optionally bone scan (if osseous lesions are suspected due to clinical signs) exclusion criteria: * patients with distant metastasis * known hypersensitivity against components of the neoadjuvant systemic treatment * documented history of congestive heart failure nyha ≥iii, myocardial infarction within the past 3 months before the start of neoadjuvant treatment * uncontrollable high-risk cardiac arrhythmia, e.g. significant ventricular arrhythmia * past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated early stage cancers such as basal cell carcinoma of the skin and in situ carcinoma of the cervix or the bladder.
enteral feeding and early gut colonization of preterm infants

Conditions: Premature Birth of Newborn

Summary: the aim of this study is to evaluate the potential role of the enteral feeding systems on the bacterial colonization of premature infants during their nicu admittance and its evolution after 2 years, which is the age when the infant's gut starts to contain an adult-like microbiota.

first spontaneously evacuated meconium and fecal samples were collected by the medical staff of the hospital weekly from the diapers of the infants during their stay at the neonatal intensive care unit. to evaluate the potential role of the enteral feeding systems as a site for colonization by nosocomial bacteria, and, its impact on early gut colonization of preterm neonates, mother's own milk, donor milk and preterm formula samples were obtained after passing through the external part of the enteral feeding tubes and cultured. later, when the infants reached 2 years of age, parents were contacted by phone to provide an additional fecal sample if their infants had not taken antibiotics within the previous 2 months.

Eligibility criteria:
inclusion criteria: * gestational age of less than 32 weeks or with birth weight of less than 1,200 g exclusion criteria: * any malformation or suffering from any genetic metabolic disorder
evaluating the influence of showing patients their predicted teeth alignment on their expectations and satisfaction

Conditions: Crowding, Tooth

Summary: patients who have moderate crowding will be treated in this study. the efficacy of showing the predicted alignment of patient's teeth at the end of orthodontic treatment previously to treatment on their expectations from orthodontic treatment and their satisfaction with their teeth alignment will be assessed.

it is known that most patients expect that orthodontic treatment will improve their appearance which increases their confidence and self-esteem level. the ability to approach patient's expectations to reality is crucial to making them reasonable and to improve patient's satisfaction with treatment outcomes.

Eligibility criteria:
inclusion criteria: * class i malocclusion with moderate crowding (between 4-6 mm of tooth-size-arch-length-discrepancy). * good oral hygiene and periodontal health. * no severe skeletal discrepancy. * normal proclination for the upper and lower incisors. exclusion criteria: * bimaxillary dentoalveolar severe protrusion. * need for extraction. * previous orthodontic treatment. * subject with psychological abnormalities. * congenitally missing or extracted teeth (except for the third molars). * history of previous trauma to the maxillofacial region or surgical interventions.

Keywords: crowding simulation prediction expectation satisfaction three-dimensional set up
using virtual reality to control the audio-visual inputs during ketamine/esketamine treatment

Conditions: Depression

Summary: investigators aim to examine the role of audiovisual inputs during treatment with ketamine/esketamine in affecting tolerability and effectiveness of treatment of depressive episodes, by providing patients with a relaxing environment using virtual reality goggles and noise cancelling headphones, and assessing whether these tools can improve the tolerability and effectiveness of treatment with ketamine/esketamine


Eligibility criteria:
inclusion criteria: * participants must be at least 18 years old * patients must have completed the acute series of treatment and weekly optimization phases of ketamine/esketamine treatment, and currently receiving continuation/maintenance treatment written consent for the study procedures * ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements. exclusion criteria: * hearing or visual impairment to the degree that would interfere with ability to see or hear vr content. * difficulty in understanding spoken or written english * unable to provide informed consent * dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the study procedure (per investigator judgment) * any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study. * was previously enrolled/randomized into the study

Keywords: ketamine esketamine virtual reality
decrease obstructive sleep apnea (osa) sympathetic tone : impact of apap vs cpap

Conditions: Sleep Apnea Syndromes

Summary: the present study aims to compare muscle sympathetic neural activity by microneurography after one month treatment of fixed versus auto-adjusting cpap treatment and its impact on arterial blood pressure

background: sleep apnea syndrome (sas) currently affects 10% of general population. it is characterized by the occurrence during the sleep of the upper airways closure which cause repeated asphyxia. it is a public health problem due to its cardiometabolic complications. indeed, the absence of sas treatment increases cardiovascular mortality by 12% at 10 years. the main physiopathological mechanism is the activation of cardiovascular sympathetic control (the short-term regulation of blood pressure which bring in the sympathetic nervous system) an exposure to intermittent chronic hypoxia (caused by sas) bring an increased of muscle sympathetic nerve activity (msna) contributing to elevated blood pressure continuous positive airway pressure (cpap) can partly reduce this risk by decreasing elevation of blood pressure caused by the sas. it has recently been demonstrated that all cpap devices are not equivalent. indeed, the auto-adjusted cpap treatment induces a reduction in blood pressure lower than the reference treatment fixed cpap. to this extent it is interesting to conduct a new randomized trial comparing these two treatments with vascular sympathetic tone. this will be assessed by peroneal microneurography recording. objective: compare muscle sympathetic neural activity (msna) by microneurography after one month of fixed versus auto-adjusted cpap treatment in osa patients naive from pressure therapy methods: prospective study, single-site, randomized, double-blind, parallel, one month controlled trial. after the diagnosis of sleep apnea, patients will be randomized for one month treatment with fixed ou auto-adjusting cpap. measurements of msna, heart rate variability and catecholamines will be held before and after treatment. an interim analysis will be performed after the inclusion of 24 patients based on group sequential design. assuming an α error of 5%, a statistical power of 80%, and a unilateral situation : 34 patients per arm will be needed to be enrolled in the study. the enrollment target for the study will be reviewed and may be refined following the study interim analysis and taking account 20% of study drop-out.

Eligibility criteria:
inclusion criteria: * patient with osa (ahi ≥20 / h) * patient with daytime sleepiness * naive of any pressure treatment of osa * patient able to provide written informed consent * not a vulnerable person or legally protected adult. exclusion criteria: * pregnancy * person deprived of liberty or subject to a legal protection measure. * patient with serious heart failure (according to investigator judgment) * patient with central sleep apnea index above 20% of ahi * patient with a significant intercurrent pathology that can influence the results. (according to investigator judgment).