Kornimate/medical-research-clean huggingface dataset:
comparison of cpap modalities for osa treatment

Conditions: Obstructive Sleep Apnea

Summary: this is a crossover study comparing the effect of cpap fixed pressure, cpap flex -plus and sensawake on sleep quality, adherence to treatments, and psg parameters in patients with moderate to severe osa.

obstructive sleep apnea (osa) is associated with behavioral, cognitive, metabolic and cardiovascular conditions. continuous positive airway pressure (cpap) is the gold standard treatment for osa. despite being the most effective treatment for osa, 46 to 83% of patients do not adhere to cpap. new technologies for cpap treatment have been developed in order to improve patient's comfort, adherence and effectiveness in reducing apnea, hypopneas and flow limitation events. as an example, the flex- plus technology which increases inspiratory positive pressure and decreases expiratory positive pressure would soften the rhythm of breathing. sensawake is another technology which evaluates breathing pattern changes during cpap therapy. when the breathing pattern suggests that patient is awake, a prompt relief in pressure is activated, like ramp feature. however, it is not clear whether cpap flex- plus or sensawake are superior compared with fixed pressure cpap, in terms of polysomnographic parameters, especially flow limitation or adherence to treatment. objective: to compare the effect of fixed pressure cpap, cpap flex- plus and sensawake on sleep and compliance parameters in patients with moderate to severe osa. methods: fifty male patients with moderate to severe osa will be included in a crossover design study. all patients will use each cpap modality for 30 days in a randomized order, namely cpap with fixed pressure, flex- plus and sensawake. a week of washout period will be applied between treatments. all patients will wear the same nasal mask brand. at the end of each treatment (every 4 weeks), patients will undergo polysomnography and fill out epworth, fosq, pittsburgh questionnaires and a visual analogue scale assessing cpap side effects and patient´s comfort. finally, adherence to cpap modalities will be systematically checked.

Eligibility criteria:
inclusion criteria: * male gender * apnea-hypopnea index (ahi) score of ≥20 events/hour of sleep * 30-65 years-old * body mass index (bmi) ≤40 kg/m² exclusion criteria: * major neurological, psychiatric, cardiac or respiratory disease * use of psychoactive medication * other sleep disorders * patients referred to psg for bilevel, considered the need for pap ≥ 18 cm h2o * previous contact with any osa treatment.

Keywords: sleep apnea cpap
lung ultrasound in critically ill obstetrics and gynecological patients

Conditions: Obstetric Complication; Gynecologic Cancer; Lung Diseases; Ultrasound

Summary: pulmonary dysfunction aggravates the illness of critically ill obstetrics and gynecological patients. early identification with bedside technique and prompt management may improve the outcome of critical care in this vulnerable population

hormonal changes in a woman's menstrual cycle and changes during pregnancy affect the respiratory system. these changes especially during pregnancy and peripartum complicate the critical care management of the female patients. in addition to the effect of different pregnancy-related as sepsis, and preeclampsia which directly or indirectly predispose to pulmonary complications. the presence of difficulty in the transfer of critically ill patients mandates point of care modality. avoidance of fetal exposure to hazardous radiation demands safe technology. ultrasound arises as a screening method that can be performed rapidly and enables healthcare providers to make timely decisions with no radiation exposure. thus it facilitates the management of critically ill obstetric and gynecological patients. when compared to other imaging techniques; x-ray imaging is preferably restricted in parturient because of the ionizing risk on the fetus, and ct is not feasible in critically ill if there is a risk of transfer. thus ultrasound emerged as a bedside imaging technique. yet, the prevalence of the specific ultrasound signatures in that population is not clearly defined and its relation to poor outcome was not tested, this trial is the first trial to determine frequency, timing concerning admission, type of pulmonary abnormalities detectable by lus, and their associations with poor outcome in patients whether obstetrics or gynecology admitted to the icu specialized in women's intensive care

Eligibility criteria:
inclusion criteria: * any patient admitted to the obstetrics and gynecology intensive care unit exclusion criteria: * patient's refusal * inability to do a lung ultrasound examination during the first 24 hours of admission

Keywords: lung ultrasound critically ill peripartum critically ill gynecological cases
efficacy of oral versus intravenous acetaminophen for primary pediatric cleft palate repair

Conditions: Cleft Palate

Summary: the purpose of this investigator-initiated study is to determine whether acetaminophen is an effective pain reliever for primary cleft palate repair in children and possesses opioid sparing effects. additionally, the investigators will determine if patients who receive acetaminophen have less opioid related side-effects. the study will have three study groups based on whether the patient receives ofirmev® and opioids (fentanyl and morphine), oral acetaminophen elixir and opioids (fentanyl and morphine), or opioids (fentanyl and morphine) alone. total opioid (fentanyl and morphine) consumption will be tracked for the intraoperative period and 24 hours after surgery for all patients within the study and converted to morphine equivalents.


Eligibility criteria:
inclusion criteria: * children 5 months to five years of age * asa physical status i or ii * primary cleft palate repair alone or in some combination with bilateral myringotomy with tympanostomy (bmt), alveoplasty, vomer flap, rhinoplasty, and or cleft lip repair.? exclusion criteria: * repeat/revision cleft palate repair * contraindications to acetaminophen administration (liver or renal dysfunction, allergy) * chronic pain medications * diagnosis of chronic pain syndrome * contraindications to morphine (renal impairment, allergy) * seizure disorders and/or taking anti-seizure medications * contraindications to oral midazolam (liver dysfunction, allergy) * allergy to local anesthetics

Keywords: cleft palate surgery post-operative pain management acetaminophen
assessment of the safety and performance of elbow supports in the context of epicondylitis or a return to sport after sprain

Conditions: Epicondylitis; Elbow Sprain

Summary: decathlon has developed elbowmid500 and elbowstrap products which are medical devices that must be positioned around the elbow during sport practice, in order to limit symptoms related to epicondylitis or previous sprains (elbowmid500 only). the objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved decathlon elbowmid500 and elbowstrap products to demonstrate safety and performance of these devices in a real-world setting. outcome data collected from this study will provide the basis for post-market surveillance (pms) reporting, clinical study report (csr), clinical evaluation report (cer) on decathlon elbowmid500 and elbowstrap devices and support peer-reviewed publications on products performance and safety.


Eligibility criteria:
inclusion criteria: * subject is aged ≥ 18 years old * subject has an acute epicondylitis (stage 1 or 2) or a recent mild elbow sprain * subject performs regular physical activity (minimum of 2 sessions of 10 minutes per week) * the current condition of his/her elbow allows the subject to resume usual physical activity * subject has been informed and is willing to sign an informed consent form * subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks) * subject is affiliated to the french social security regime exclusion criteria: * subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent * subject has worn a support (elbow brace or articulated orthosis) in the last month during his/her sport practice * subject has resumed regular physical activity since his/her recent injury * subject has any medical condition that could impact the study at investigator's discretion * subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastane, polyester, elastodiene) • adult subject to legal protection measure
assessment of the endovascular aortic aneurysm repair's (evar) main body lateral movement impact on the rate of reintervention after aaa's treatment

Conditions: Abdominal Aortic Aneurysm

Summary: the strength of movement which are applied on the evar are not only cranio-caudal but also lateral. the movement of the evar's body within the aneurysm could be an instability's criteria of the evar. the investigators would like to show that this lateral movement is a risk factor of reintervention they should follow and suggest a reinforced medical follow-up to avoid complications.


Eligibility criteria:
inclusion criteria: * male or female \> 18 years old * all patients treated in the vascular surgery department of besançon for an abdominal aortic aneurysm with an endoprothesis (symptomatic or asymptomatic) exclusion criteria: * patient in emergency situation (ruptured abdominal aortic aneurysm) * life expectancy supposed to be inferior to 1 year * legal incapacity or limited capacity * pregnant female * patient unlikely to cooperate with the study * patient without health insurance

Keywords: aortic endovascular aneurysm
the differential effects of diabetes therapy on inflammation

Conditions: Diabetic Nephropathy; Type 2 Diabetes

Summary: this study aims to determine if different diabetes treatments have different effects on inflammation; in particular, kidney inflammation. this type of inflammation is common in people with diabetes, and can lead to kidney failure. this study will investigate the effect of different types of diabetes treatment on kidney inflammation. this will help us to decide if certain types of medicine should be preferred in people with evidence of inflammation in their kidneys, as this may help prevent major complications including kidney failure.

in this prospective cohort study, patients who are clinically determined to require escalation of their glycaemic therapy, and prescribed a dpp4 inhibitor, glp-1 receptor agonist, or insulin, will be invited to participate. blood and urine samples will be taken before, 4 to 8 weeks after, and 26 weeks after starting the new therapy. markers of inflammation, renal function and glycemic control will be measured at each timepoint.

Eligibility criteria:
inclusion criteria: * age over 30 years * diagnosis of type 2 diabetes for one year or more * diagnosis of dkd as defined by two distinct albumin:creatinine ratio measurements above the gender specific range in the local reference laboratory with an interval of no less than eight week between measurements * stable dose of an inhibitor of the renin angiotensin system for a period of 8 weeks exclusion criteria: * any cognitive impediment that preclude the participant from giving free and informed consent * substance abuse including alcohol excess * use of a glp-1 analogue in the last 6 months * pregnancy * hypersensitivity to the prescribed treatment
treatment of an acute deep vein thrombosis (dvt) with either rivaroxaban or current standard of care therapy

Conditions: Deep Vein Thrombosis; Venous Thrombosis

Summary: following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (dvt). the main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute dvt in routine clinical practice.


Eligibility criteria:
inclusion criteria: * female and male patients * patients \>= 18 years * patiebts with diagnosis of acute dvt and who have an indication for anticoagulation therapy for at least 12 weeks, who are willing to participate in this study and are available for follow-up exclusion criteria: * exclusion criteria must be read in conjunction with the local product information.

Keywords: treatment of venous thromboembolism thromboembolism venous thromboembolism embolism and thrombosis vascular diseases cardiovascular diseases thrombosis
data-driven sdm to reduce symptom burden in af

Conditions: Atrial Fibrillation; Patient Engagement

Summary: this study is a single-group feasibility study evaluating decision aid visualizations which display common post-ablation symptom patterns as a tool for shared decision-making. the specific aim of the clinical trial is to evaluate the feasibility of putting the visualizations into clinical practice (n=75). the hypothesis is that patients will report low decisional conflict and decision regret and high satisfaction with their decision about whether to undergo an ablation or not.

atrial fibrillation (af) is the most common heart rhythm disorder, and nearly 90% of patients experience symptoms such as shortness of breath that directly impair their health-related quality of life (hrqol). catheter ablation is a minimally invasive, surgical procedure that is routinely performed to treat af and associated symptoms with the goal of improving hrqol, but also carries potentially serious risks. shared decision-making (sdm), in which treatment decisions are aligned based on high quality evidence and patient values and goals of care, is a widely encouraged practice for navigating complex healthcare decisions such as these. however, sdm around rhythm and symptom management does not routinely occur due to a lack of detailed evidence about symptom improvement post-ablation, and a lack of decision aids to communicate evidence to patients. the overarching goal of this award is to create an interactive patient decision aid composed of established evidence from clinical trials together with novel "real world" evidence about symptom improvement post ablation mined from electronic health records (ehrs). the investigators propose to use "real-world evidence" drawn from electronic health records (ehrs) to characterize post-ablation symptom patterns, and display them in decision-aid visualizations to support shared decision-making (sdm). in this project, the investigators will first use natural language processing (nlp) and machine learning (ml) to extract and analyze symptom data from narrative notes in ehrs. the investigators will also employ a rigorous, user-centered design protocol created during the principal investigator's post-doctoral work to develop decision-aid visualizations. in the clinical trial, the investigators will evaluate the feasibility of implementing these interactive decision-aid visualizations in clinical practice.

Eligibility criteria:
inclusion criteria: * diagnosis of paroxysmal af according to international classification of diseases, tenth revision (icd-10) * scheduled consultation at newyork-presbyterian hospital (nyp) to discuss catheter ablation * symptomatic af at baseline * age 18 years and older * able to read and speak english * willing/able to provide informed consent exclusion criteria: * asymptomatic af * severe cognitive impairment * major psychiatric illness * concomitant terminal illness that would preclude participation

Keywords: shared decision-making (sdm) symptom burden decisional conflict decision regret decision satisfaction
functional lung imaging with dect and 4dct

Conditions: Non Small Cell Lung Cancer

Summary: the basic premise of this pilot study is to enroll 40 patients over 3 years who have stage ii, iii, or iv non-small cell lung cancer and are planned for definitive treatment with concurrent chemoradiation where a contrast enhanced 4dct is planned.


Eligibility criteria:
inclusion criteria: * patients have histologic diagnosis of non-small cell lung cancer * patients have ajcc stage ii, iii or iv disease were the plan is to receive definitive concurrent chemoradiation to 60 gy or higher * age \> 18 years of age * patients are able to provide informed consent * no additional lung radiation is planned until after the 2nd ct on this study (i.e. patient does not have a solitary pulmonary nodule or second primary that the plan is to undergo sbrt) * patient must have adequate kidney function to receive iv contrast (following institutional policy supplied by radiology). the cutoff level for serum creatinine is 1.6 mg/dl * negative urine pregnancy test before every ct scan exclusion criteria: * allergy to iv iodine contrast * severe claustrophobia * further thoracic radiation therapy is planned.
live music therapy to reduce anxiety, pain and improve sleep in post-operative lung transplant patients: a pilot study

Conditions: Lung Transplant; Complications

Summary: the purpose of this prospective pilot study is to determine if live music therapy reduces patients' perception of pain and anxiety, reduces benzodiazepine use and pain medication use, length of stay in the icu, and length of stay in hospital, and improves sleep in post-lung transplant patients. the purpose and objectives of the study are the following: * to determine if music therapist delivered patient preferred live music and therapeutic intervention will reduce participant's perceived anxiety in post-lung transplant patients. * to determine if music therapist delivered patient preferred live music and therapeutic intervention will reduce participant's perceived pain in post-lung transplant patients. * to determine if music therapist delivered patient preferred live music and therapeutic intervention in post-lung transplant patients will reduce participant's use of benzodiazepine medication for anxiety. * to determine if music therapist delivered patient preferred live music and therapeutic intervention three times in post-lung transplant patients will reduce participant's use of pain medication. * to determine if music therapist delivered patient preferred live music and therapeutic intervention in post-lung transplant patients will reduce participant's total time of intubation, length of stay in icu, and length of stay in the hospital. * to determine if music therapist delivered patient preferred live music and therapeutic intervention will improve the quality and length of sleep in post-lung transplant patients.


Eligibility criteria:
inclusion criteria: * all post-lung transplant patients at utsw clements university hospital starting june 1, 2021 exclusion criteria: * post-lung transplant patients with chests left open directly after or (before being taken back to the or and having their chests closed)
brain glucose metabolism during transcranial direct current stimulation

Conditions: Depression

Summary: with this study we will be able to dose-dependently measure real-time glucose metabolism changes after non-invasively stimulating superficial parts of the dlpfc, a commonly used target in therapeutic tdcs applications. this will provide further insight if and how tdcs is capable to change one of most reliable parameters of brain metabolism.

with this study, we will be able to substantiate if regional and whole brain glucose metabolism is affected by tdcs, assess the amount of signal change in relation to different currents and measure differences in glucose metabolism under stimulation reactivity between healthy subjects and depressive patients. the objective is to investigate the changes of regional cerebral metabolic rate of glucose (rcmrglu) in the brain after transcranial direct current stimulation in healthy subjects and depressive patients. the design is a cross-sectional proof of principle study in 20 healthy subjects and 20 depressed patients. during the pet scan tdcs will be applied with varying stimulus intensity. furthermore, subjects will undergo a second pet scan with single-blind sham stimulation in order to validate the effects of tdcs. rcmrglu will be quantified using voxel-wise and roi-based approaches. changes in rcmrglu associated with tdcs-application will be calculated with a general linear model in a ramp function of the task-specific glucose uptake, according to previous work in our group. exploratory statistical testing will be done using a paired samples t-test between task and rest conditions.

Eligibility criteria:
inclusion criteria: healthy controls: - aged 18 to 55 years somatic and psychiatric health based on medical history, physical examination, ecg, laboratory screening, scid-i and ii willingness and competence to complete the informed consent process depressed patients: current major depressive episode during unipolar major depression (md) according to scid-i (with hamd\>17) no other concomitant axis-i disease apart from anxiety disorder, which must be secondary to md standard antidepressant medication stable during the last 4 weeks exclusion criteria: * concomitant major medical or neurological illness, including history of seizures any current substance abuse disorder according to dsm-v (urinary test and history) including current sedative usage in mdd patients ect, tms or nmda-antagonists (ketamine) during the past 6 months. current augmentation with anti-epileptics, or other drugs affecting seizure threshold failure to comply with the study protocol or follow the instructions of the investigators pregnancy participants with previous total radiation exposure dose of 30msv over the last 10 years (according to legislation on radiation protection). left-handedness

Keywords: transcranial direct current stimulation positron emission tomography
the effect of music therapy applied to pregnant women on anxiety and stress

Conditions: Music Therapy

Summary: anxiety and stress increase in primiparous pregnant women and especially in the third trimester of pregnancy. this study was conducted to investigate the effect of music therapy applied to pregnant women who will give birth for the first time and are in the last trimester of their pregnancy on anxiety and stress. the study is a randomized controlled trial. pregnant women in the application group were regularly listened to music for 20 minutes a day for 10 days. in the study, pregnant women in the application and control group were trained by the researcher on preparing for normal delivery. the pregnant women who participated in the study completed the personal information form, the state and trait anxiety inventory and the pregnancy stress rating scale at the beginning. 10, the last day of study. on the day, the scales are repeated.

aims and objectives: this study aimed to evaluate the effect of music therapy on the anxiety and stress levels of primiparous pregnants in the third trimester. background: anxiety and stress during pregnancy, when not well-managed, can lead to negative birth outcomes. design: this study is a randomized controlled trial. methods: this study was conducted in turkey with 120 pregnant, 60 of whom were in the music group and 60 in the control group. research data were collected with personal information form, state-trait anxiety inventory and pregnancy stress rating scale-36. pregnants were made to listen to music for 20 minutes every day for ten days. the anxiety and stress levels of pregnant were measured before and after the intervention.

Eligibility criteria:
inclusion criteria: * pregnant women aged 18 and over, * primiparous pregnants, * in the third trimester (28 and above gestational week), * speaking and writing in turkish, * having no vision-hearing problems, * having and using internet-supported online web 2.0 tools, * volunteering to participate in the study were included in the study within the scope of inclusion criteria. exclusion criteria: * pregnant women who did not meet the inclusion criteria and pregnant women who did not listen to music regularly were excluded from the study.

Keywords: midwifery pregnancy music anxiety stress