Kornimate/medical-research-clean huggingface dataset:
correct gastric tube placement in very low birth weight neonates

Conditions: Gastric Tube Placement

Summary: gastric tube (gt) placement is a recurrent procedure in vlbw infants due to feeding impairment correlated with low birth weight. correct gt depth is mandatory to ensure an appropriate and safe enteral feeding: x-ray is the gold standard in order to check gt position, but this cannot be routinely performed due to x-ray exposure risk. feeding a neonate through a misplaced gt is potentially harmful and may increase morbidity, mortality and hospitalization length. nurses estimate gt depth through external measurements. this study aims to identify the most appropriate insertion length predictor for orogastric tube placement in vlbw infants by comparing two different methods.

several methods have been suggested to estimate orogastric tube insertion length, but none of them has been validated in vlbw infants. the most commonly used methods are nex (nose-ear-xyphoid) and nemu (nose-ear-mid-umbilicus) as predictors of nasogastric tube insertion. for the purpose of the present study nex and nemu methods were adjusted for orogastric tube placement. hence, primary aim of this study is: to identify the most appropriate insertion length predictor for orogastric tube placement in vlbw infants by comparing nex and nemu methods. secondary aim is: - to develop a new mathematical formula, based on the neonate's weight or length, to predict the insertion length of orogastric tube in vlbw infants

Eligibility criteria:
inclusion criteria: * birth weight ≤1500 grams (very low birth weight infants) * need for both umbilical catheter and gastric tube positioning at birth exclusion criteria: * birth weight \>1500 grams * congenital respiratory or gastrointestinal tract malformations (from oral cavity to stomach included) * critically unstable preterm infants will be excluded according to nurse or physician evaluation

Keywords: vlbw - very low birth weight infant gastric tube enteral nutrition prematurity nursing
to study the efficacy & safety of oral na-921 (bionetide) in girls and women with rett syndrome

Conditions: Rett Syndrome

Summary: to study the efficacy \& safety of oral bionetide versus placebo in girls and women with rett syndrome

a randomized, double-blind, placebo-controlled, phase 2/3 study of na-921 (bionetide) for the treatment of girls and women with rett syndrome primary objective • to investigate the efficacy and safety of treatment with oral na-921 (bionetide) versus placebo in girls and women with rett syndrome key secondary objective • to investigate the efficacy of treatment with oral na-921 (bionetide) versus placebo on ability to communicate in girls and women with rett syndrome co-primary endpoints * rett syndrome behavior questionnaire (rsbq) total score - change from baseline to week 12 * clinical global impression-improvement (cgi-i) score at week 12 key secondary endpoint change from baseline to week 12 in: • communication and symbolic behavior scales developmental profile™ infant-toddler checklist- social composite score (csbs-dp-it social)

Eligibility criteria:
inclusion criteria: * female subjects 5 to 20 years of age, inclusive, at screening * body weight ≥12 kg at screening * can swallow the study medication provided as a liquid solution or can take it by gastrostomy tube * has classic/typical rett syndrome (rtt) * has a documented disease-causing mutation in the mecp2 gene * has a stable pattern of seizures, or has had no seizures, within 8 weeks of screening * subjects of childbearing potential must abstain from sexual activity for the duration of the study and for at least 30 days thereafter or must agree to use acceptable methods of contraception. subject must not be pregnant or breastfeeding. * the subject's caregiver is english-speaking and has sufficient language skills to complete the caregiver assessments * subject and caregiver(s) must reside at a location to which study drug can be delivered and have been at their present residence for at least 3 months prior to screening exclusion criteria : * has been treated with insulin within 12 weeks of baseline * has current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus), renal, hepatic, respiratory or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study * has a history of, or current, cerebrovascular disease or brain trauma * has significant, uncorrected visual or uncorrected hearing impairment * has a history of, or current, malignancy * has a known history or symptoms of long qt syndrome additional inclusion/exclusion criteria apply. patients will be evaluated at screening to ensure that all criteria for study participation are met. patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all pre-specified entry criteria).

Keywords: rett syndrome mental retardation, x-linked genetic diseases, x-linked
longitudinal investigation of cancer-related fatigue

Conditions: Cancer-related Fatigue

Summary: in the lift study 2000 cancer patients will be recruited at 6 months after diagnosis and extensively surveyed over five years on factors that are associated with fatigue.

the lift study aims to comprehensively investigate characteristics, determinants, and long-term course of fatigue. in addition, information shall be gained on the current state of fatigue treatment and care in germany and on the needs of affected patients. data will be collected by mailed or online questionnaires at 6, 9, and 12 months as well as 2, 3, 4 and 5 years post-diagnosis from 2000 cancer patients. besides questionnaires on socio-demographic, clinical and patient reported outcomes, saliva samples will be collected in order to gain new insights into biological mechanisms. moreover, detailed data on screening, diagnosis and counseling as well as therapies offered and administered to reduce fatigue will be surveyed, as well as the patients' state of knowledge, perception and prevailing needs regarding fatigue. tumor and cancer therapy data will be extracted from the epidemiological cancer registry. the results of the lift study aim to contribute to an improved, evidence-based and individualized treatment to avoid and ease cancer-related fatigue and will further promote patient-oriented offers and treatments.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * diagnosed with a primary tumor of breast, ovarian, or colon cancer * time since first diagnosis is 4 - 6 months * having received or currently receiving at least one of the following treatments: surgery, chemotherapy, radiotherapy, hormone therapy, or immune therapy. * able to understand and follow the study protocol. exclusion criteria: • any additional malignant or unclear neoplasm or carcinoma in situ at or since time of diagnosis of the considered primary tumor
evaluation of postpartum posttraumatic stress disorder at angers university hospital (espt-pp)

Conditions: Delivery; Post Partum

Summary: the purpose of this study is to estimate the prevalence of post-traumatic stress disorder (ptsd) at one month in women who have given birth at the university hospital of angers over a period of 1 year.

childbirth is a natural process expected, prepared and imagined by all future parents. a traumatic experience of childbirth and its consequences is a major problem that is often underestimated for women's health. some women may develop post traumatic stress disorder (ptsd) after delivery. the literature reports a prevalence of ptsd in relation to childbirth of 1.3 to 6%. symptoms of post-traumatic stress can be triggered by any event, perceived as threatening to the life or physical integrity of the person or a third party and causing intense fear, helplessness and horror. it may be thought that childbirth, by its psychological and physiological characteristics, can be described as an extreme experience and its experience depends on multiple factors. thus, an innocent childbirth for caregivers can be traumatically experienced by the woman. the symptoms described are symptoms of avoidance (inability to return to the scene of trauma, denial of trauma), symptoms of intrusion (nightmares, reviviscences) and symptoms of neuro-vegetative hyper activation (sleep disorders, anger, emotional indifference ). the development of ptsd following childbirth is a known phenomenon, but minimized and very little diagnosed by obstetric teams. therefore, it seems interesting to assess the prevalence of ptsd during childbirth in order to optimize our management, that is to identify patients at risk of ptsd and offer them adapted psychological follow-up. this study also aims to describe the kinetics of the development of post-traumatic postpartum symptoms and to study the risk factors for the development of ptsd.

Eligibility criteria:
inclusion criteria: * major and francophone patient, * giving birth (≥ 37 weeks of amenorrhea) to the maternity hospital of angers university hospital, * agree to participate in the study (signature of consent). exclusion criteria: * personal antecedent (s) of psychiatric pathology (s), * birth of a child born lifeless, * patient deprived of liberty by judicial or administrative decision, * patient subject to a legal protection measure, * patient unable to express her consent.

Keywords: posttraumatic stress disorder
the effects of cpap withdrawal on cerebral vascular reactivity and brain oxygenation in osa

Conditions: Sleep Apnea, Obstructive

Summary: obstructive sleep apnoea (osa) is a highly prevalent sleep-related breathing disorder associated with adverse cardiovascular outcome. underlying mechanisms are subject of debate. a causal relationship between osa and systemic hypertension as well as peripheral endothelial dysfunction was shown, and there is accumulating evidence from physiologic and observational studies that cerebral autoregulation is insufficient to protect the brain from the nocturnal consequences of osa. however, there are no data from randomised controlled trials proving a causal relationship between osa and impaired cerebral vascular reactivity (cvr). the aim of this randomised controlled trial is to study the effects of a short-term cpap withdrawal, and thus returning osa, on daytime cvr and brain oxygenation to establish whether there is a causal relationship between osa and cerebral vascular damage.


Eligibility criteria:
inclusion criteria: * objectively confirmed osa (at the time of original diagnosis) with an oxygen desaturation index (odi) and apnoea-hypopnoea-index (ahi) of ≥20/h. * currently an oxygen desaturation index (≥4% dips) of ≥15/h during an ambulatory nocturnal pulse oximetry performed on the last night of a four-night period off cpap. * treated with cpap for more than 12 months * device usage \>4h per night, \>80% of the last 365 days, and ahi\<10 with treatment (according to cpap machine download data). * age between 20 and 75 years. * written informed consent as documented by signature. exclusion criteria: * previous ischemic or haemorrhagic stroke; known cerebral aneurysm or arterio-venous malformation. * carotid artery stenosis \> 70% * use of alpha- and beta-adrenergic blocking medication, antianginal medications, triptans, selective cox-inhibitors * unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (\>180/110 or \<90/60mmhg) * implanted pacemaker or internal cardiac defibrillator * changes in medication during the trial * previous ventilatory failure (awake spo2 \ 6kpa). * obesity hypoventilation syndrome, copd * previously diagnosed with cheyne-stokes breathing. * current professional driver or any previous sleep related driving accidents. * caffeine or nicotine abuse 12 hours before measurements

Keywords: continuous positive airway pressure stroke cerebrovascular reactivity brain oxygenation
study of a model-based approach to blood glucose control in very-low-birthweight neonates

Conditions: Hyperglycaemia

Summary: very low birthweight neonates commonly develop high blood sugar levels. there is an association between high blood sugar levels and poorer short term outcomes but it is not known whether the high sugar level itself actually causes the problems. there are a range of ways to manage high sugar levels but there are no consensus guidelines to follow. one option is to manage the high sugar levels with an infusion of insulin. studies looking at insulin infusions have often used fixed protocols to guide the amount of insulin to be given and are often complicated by hypoglycaemia. this study investigated whether using a model-based approach to individualise insulin administration to neonates with high sugar levels would provide a safe and effective management option for controlling blood sugar levels and avoid the complication of low blood sugar levels.


Eligibility criteria:
inclusion criteria: * birthweight \<1500g * blood sugar \>/= 10mmol/l * clinician decision to start an insulin infusion exclusion criteria: * infants who were moribund and not expected to survive

Keywords: hyperglycaemia very low birthweight infants insulin
enhancing heart failure self-care

Conditions: Heart Failure

Summary: to test the effectiveness of a motivational intervention compared with standard patient education in improving economic and clinical outcomes in patients enrolled in an existing heart failure (hf) disease management program.


Eligibility criteria:
inclusion criteria: * chronic heart failure, hospitalized for heart failure or hospitalized for heart failure within the past 30 days, speak and read english exclusion criteria: * severe renal failure requiring dialysis, hiv-aids, psychosis, uncorrected hearing loss

Keywords: motivational therapy
the influences of single chamber vs. multi-chamber blood flow restriction cuffs

Conditions: Blood Vessel Disease; Muscle Edema

Summary: the purpose of this study is to investigate the use of single (sc) and multi-chamber (mc) blood flow restriction (bfr) cuff exercise on indices of arterial stiffness, muscle morphology, and participant perception.

thirty adults aged 18-40 years old will undergo three treatment sessions (control (no bfr), sc bfr, and mc bfr) in a randomized order separated by one week. a familiarization session will also occur one week before starting the treatment period. each subject will undergo a series of tests including anthropometry, ultrasonography of the carotid artery, applanation tonometry, ultrasonography of the vastus lateralis, blood pressure acquisition, body composition, and maximal strength assessments (1rm). the exercise trial will consist of sets of dumbbell wall squats performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1rm using 60% of the supine limb occlusion pressure (lop) with 1-minute rest intervals. assessments will be performed immediately before and after the exercise bout during each treatment session. two-way anovas will be used to examine the main effects of treatment and treatment-order interaction on pulse wave velocity, muscle cross-sectional area, and perceptual response.

Eligibility criteria:
inclusion criteria: 1. physically active (\> 1,000 met/min/wk) for at least six months. 2. weight stable for previous 6 months (+/-2.5 kg) 3. female subjects only- reported regular menstrual cycles for the last 2 years exclusion criteria: 1. bp\>140/90 mmhg 2. bmi\>40 kg/m2 3. diabetes 4. familial hypercholesterolemia 5. past or current history of chd, stroke or major cvd events. respiratory diseases (not including asthma), endocrine or metabolic, neurological, or hematological disorders that would compromise the study or the health of the subject. 6. women must not be pregnant, plan to become pregnant during the study, or be nursing 7. active renal or liver disease 8. all medications and supplements that influence dependent variables\* 9. recent surgery \< 2 months 10. alcohol abuse 11. sleep apnea 12. claustrophobia
coping strategies-psychological flexibility in patients hospitalized for ischemic cardiovascular disease (picture)

Conditions: Ischemic Cardiovascular Disease

Summary: the aim of this trial is to investigate the coping strategies/physiological flexibility construct in patients hospitalized for ischemic cardiovascular disease and the possible association with recurrence of clinical events (any hospitalization and type thereof, myocardial infarction, stroke and death) during the follow up, the patient's decision to participate to clinical trials approved in the center and the adherence to cardiovascular medications.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * able to provide informed consent * able to speak and read in the local language spoken in hospital * admission to the hospital for ischemic cardiovascular disease exclusion criteria: * cannot provide written informed consent * under judicial protection, tutorship or curatorship * unable to understand and follow study-related instructions or unable to comply with study protocol * cognitive impairment * severe psychiatric disorders according to dsm-5-tr criteria diagnosed in the last 6 months

Keywords: ischemic cardiovascular disease mental stress coping strategies patient's decision to partecipate to clinical trial adherence to the medications psychological flexibility acceptance and commitment therapy hexaflex brief cope test mpfi test cfq test maas-8 test cvd-aaq test
effects of music combined with cbt on chronic subjective tinnitus

Conditions: Subjective Tinnitus; Sleep Disorder

Summary: this study retrospectively analyzed the first and second visit data of chronic subjective tinnitus patients who received music combined with cognitive behavioral therapy in our hospital in recent years. behavioral tests and tinnitus questionnaires, as well as sleep and depression scores, were used to analyze the therapeutic effects of this approach. eeg results were analyzed as a potential neurobiological marker to explore the neural mechanism of tinnitus symptom improvement.

the subjects of this study were chronic subjective tinnitus patients and normal controls who were treated with music therapy combined with cognitive behavioral therapy (music-cbt) in the department of otolaryngology of sun yat-sen memorial hospital from december 2016 to march 2024 and who had completed re-examination. the pre- and post-music-cbt data of past patients who met our study conditions were collected for retrospective statistics. the complete sample data included medical history, pure tone audiometry, tinnitus matching, tinnitus questionnaires (tinnitus handicap inventory, visual analog scales, tinnitus functional index), sleep quality questionnaire (pittsburgh sleep quality index), and depression questionnaire (hamilton depression scale -24 items). the resting state electroencephalogram (rs-eeg). retrospective statistical analysis was conducted to determine the clinical efficacy and influencing factors of music-cbt for chronic subjective tinnitus at 3 months and long term. finally, the neural mechanism of music-cbt for tinnitus treatment was analyzed based on rs-eeg results.

Eligibility criteria:
inclusion criteria: * adults aged between 18 and 60 * a total score of 18 or higher on thi * a constant tinnitus that can be matched * right-handed * no significant medical or psychiatric conditions exclusion criteria: * intermittent, pulsating or objective tinnitus * central nervous system disease * cognitive impairment * other contraindications for eeg testing

Keywords: chronic subjective tinnitus music therapy cognitive behavioral therapy neural mechanism
mri of the chest under high frequency ventilation

Conditions: Non-invasive Ventilation; High-frequency Ventilation; Healthy Volunteer

Summary: the purpose of the study is to evaluate the benefit on image quality of mri of the chest performed under high frequency non-invasive ventilation. this technique indeed allows to generate an apnea duration of several minutes with acquisitions performed at full inspiration. this study will be applied on healthy subjects.

high frequency ventilation (hf-v) has been applied by using a non-invasive interface allowing to obtain a prolonged apnea in awaken subjects. such an application should be of interest for mri taking into account its susceptibility to motion of the chest and the imperfect techniques of respiratory gating that are usually performed at end expiration. the purpose of this study is to assess the benefit on image quality of different sequences performed with and without the device in healthy subjects.

Eligibility criteria:
inclusion criteria: * healthy subjets : normal respiratory function and no known lung disease * age \>=18y exclusion criteria: • pregnancy

Keywords: mri chest apnea
evaluation of effectiveness and safety of synergy xd and synergy megatron™ stent

Conditions: Coronary Artery Disease; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Coronary Disease

Summary: the objective of this study is to evaluate the effectiveness and safety of synergy xd stent and synergy megatron™ stent in the "real world" daily practice as compared with the other drug-eluting stents.

this study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of synergy xd stent and synergy megatron™ stents versus other drug-eluting stents (des) in patients with coronary artery disease.

Eligibility criteria:
inclusion criteria: * patients ≥ 19 years old * patients receiving synergy xd stent(s) or synergy megatron™ stent(s). * the patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate institutional review board/ethics committee of the respective clinical site. exclusion criteria: * patients with a mixture of other drug-eluting stents (dess) * terminal illness with life-expectancy ≤1 year. * patients with cardiogenic shock

Keywords: drug eluting stent percutaneous coronary intervention real world