Kornimate/medical-research-clean huggingface dataset:
assessment of postoperative delirium with cam icu score in patients treated with serotoninergic reuptake (ssri) inhibitors and undergoing intervention of heart surgery on pump

Conditions: Delirium

Summary: the study aims to observe the presence of postoperative delirium in patients undergoing elective cardiac surgery, without changing the pharmacological prescriptions of the enrolled patients and the procedures carried out by normal clinical practice.


Eligibility criteria:
inhibitors of serotoninergic reuptake on inclusion criteria: * patients over 18 years old * patients undergoing elective cardiac surgery * patients diagnosed with depressive syndrome requiring treatment with inhibitors of serotoninergic reuptake excluding neurodegenerative diseases * patients on antidepressant therapy for more than 3 months at the time of enrollment exclusion criteria: * absence of written informed consent to the study * patients undergoing non-elective and emergency cardiac surgery * patients undergoing off pump surgery * patients with depression not on therapy * patients with existing malignancies * patients with acute infections in progress * patients with previous stroke, cerebral haemorrhage with relics * patients with acquired and congenital metabolic pathologies with cns alterations * patients with acute and / or chronic renal failure according to rifle score (exclude only f-l-e) * patients with acute and / or chronic hepatic insufficiency according to child - pugh score \<6 (but without encephalopathy); * patients with neurodegenerative diseases (dementias of all types both organic and vascular, parkinson's and ongoing delirium); * patients with previous or current drug and / or alcohol abuse * pregnant or postpartum period patients (6 months after delivery) inhibitors of serotoninergic reuptake off inclusion criteria: * patients over 18 years old * patients undergoing elective cardiac surgery * patients without a diagnosis of depressive and psychiatric illness requiring treatment with psychoactive drugs to the exclusion of neurodegenerative diseases exclusion criteria: * absence of written informed consent to the study * patients undergoing non-elective and emergency cardiac surgery * patients undergoing off pump surgery * patients with depression not on therapy * patients with existing malignancies * patients with acute infections in progress * patients with previous stroke, cerebral haemorrhage with relics * patients with acquired and congenital metabolic pathologies with cns alterations * patients with acute and / or chronic renal failure according to rifle score (exclude only f-l-e) * patients with acute and / or chronic hepatic insufficiency according to child - pugh score \<6 (but without encephalopathy); * patients with neurodegenerative diseases (dementias of all types both organic and vascular, parkinson's and ongoing delirium); * patients with previous or current drug and / or alcohol abuse * pregnant or postpartum period patients (6 months after delivery)

Keywords: delirium postoperative cam-icu score
characteristics and clinical implications of a clinical decision support system

Conditions: Chronic Illness; Opioid Use; Palliative Care

Summary: the investigators propose to study the feasibility, acceptability, usability and outcomes of a new clinical decision support system for clinicians of opioid therapy in the context of specialist palliative care for serious chronic illness. the system provides clinicians with patient-specific genetic information on opioid responsiveness and multi-drug interactions. this clinical decision support system should improve the clinician's ability to identify the optimal pain medication and dosage, and reduce risks associated with multi-drug treatment. investigators will conduct clinician survey's to collection information about the clinical decision support system. investigators will also conduct patient related questionnaires to determine any benefits or improvements in quality of life and symptom management from the clinical decision support system.


Eligibility criteria:
inclusion criteria: clinicians will be eligible if: 1. physicians or nurse practitioners who are practicing hospice and palliative care 2. responsible for making and implementing decisions about opioid therapy for pain patients will be identified by their treating clinicians. patients will be eligible if: 1. \> 18 years of age 2. palliative performance score ≥ 30% 3. reside in the community or at a nursing home 4. have \>1 serious chronic illness 5. have an assessed life-expectancy of at least 4 weeks 6. have a history of pain and have been taking prescribed opioid medication with a regimen that provides a minimum dose of 20 mg morphine or equivalent per day in scheduled doses for at least one week prior to recruitment 7. is expected to continue opioid therapy for the duration of study participation 8. is taking \> 4 non-opioid medications, each in a regimen providing continuous treatment of pain or another disorder 9. is expected to continue drug therapy for the duration of study participation 10. able to read, understand, and provide informed consent to participate exclusion criteria: there are no exclusion criteria for clinicians. patients will be excluded if: 1. pregnant women or women trying to become pregnant or nursing. women of childbearing potential must use an acceptable method of birth control for the duration of the study. (acceptable forms are oral birth control pills, condoms in combination with spermicide foam, iud, transdermal patches, birth control implants, vaginal ring) 2. palliative performance score \<30% 3. have taken an investigational product in the last 30 days 4. current use of illicit substances 5. immediate family members of site staff, or site staff may not be enrolled in the study without first obtaining irb authorization 6. any other medical or physical abnormality, disease, or disorder that would prohibit the patient from completing study procedures in the judgement of the investigator

Keywords: pharmacogenomics
evaluation of the noga system: detecting of respiratory related sleep disorders in cardiac patients

Conditions: Sleep Apnea

Summary: medical literature has shown that 1 out of 2 patients that are admitted to the hospital as a cardiac patient, will be found suffering from sleep breathing disorders. the medical literature also shows that there is an advantage of treating the sleep breathing disorders in addition to treating the cardiac disease or evaluating the heart failure condition to provide better clinical outcomes.this study is evaluating the ability to detect sleep and cardiac related breathing disordered.


Eligibility criteria:
inclusion criteria: 1. patient is hospitalized in the cardiology department or in the sleep lab. 2. patients who is willing and able to tolerate a full night polysomnography 3. patient is not receiving oxygen treatment 4. patients is 18 years of age or above 5. patient is able and willing to sign the institution human subjects committee approved informed consent form. exclusion criteria: 1. patients can not tolerate a full night polysomnography. 2. patient is receiving oxygen. 3. participation in a clinical trial within the last 60 days and during the study. 4. life expectancy \< 1 month.
efficacy and safety of keepmed positive airway pressure device in patients with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: a prospective, multi-centre, single-arm, open-label, interventional study with a non-marketed medical device. the primary study objective is to assess the efficacy of the keepmed pap device on modification of respiratory characteristics in patients with osa at one therapy night in a sleep lab. secondarily, the safety of the use of the device in this setting is assessed.

the study includes a baseline visit, a habituation night, and a therapy night. both nights will be undertaken in the sleep lab under identical conditions and will include the keepmed pap therapy activated in parallel to polysomnography (psg). baseline diagnostic psg, performed within one month prior to enrollment to the study, will be used to assess the device efficacy. an interim analysis to re-estimate the sample size will be performed after availability of data of 50% enrolled and treated study patients. the sample size will be re-estimated based on the observed changes of ahi in the interim analysis.

Eligibility criteria:
inclusion criteria: age ≥18 years. newly diagnosed osa with ahi ≥ 15 events/hours. indication for osa pap therapy in routine clinical care according to applicable medical guidelines within one month prior to study enrolment. naïve to pap therapy, i.e. even no pap therapy during a psg night. weight \> 30kg. signed informed consent. exclusion criteria: body mass index (bmi) of ≤20 kg/m² or ≥ 35 kg/m². pathologically low blood pressure (systolic ≤90mm hg; diastolic ≤60 mm hg). current unstable or serious medical conditions (such as angina pectoris, myocardial infarction, cancer, stroke, dementia, congestive heart failure) which based on the physician's judgment might put the patient at high risk. mixed and central apnea index ≥ 5 events/hour in psg without pap therapy. bullous lung disease. tracheostomy. pneumothorax. pneumocephalus. cerebrospinal fluid leak. current sinus or middle ear infection. persistent blockage of one or both nostrils (including nasal septum deviation and nasal polyps) or any other reason that leads to difficulty of breathing through the nose while awake. any nasal, facial or head abnormalities that would not allow adequate placement of the device. previous diagnosis of insomnia, narcolepsy or periodic limb movement disorder that in the judgment of the clinician could affect sleep quality assessment. chronic respiratory disease (copd, pulmonary fibrosis or asthma) or fev/fvc ≤ 60% in history. history of respiratory failure. supplemental oxygen is required. uvulopalatopharyngoplasty or other surgical procedure to correct apnea. acute respiratory infection. subject recovered from covid-19 but suffers from on-going symptoms or when subject's covid-19 illness history can affect the study outcome based on the physician's judgment. pregnancy. medication that may alter sleep architecture.
levothyroxine supplementation for heart transplant recipients

Conditions: Heart Transplant Failure; Heart Transplant Infection

Summary: this will be a prospective, randomized study performed at a single tertiary referral academic medical center (university of california san francisco, ca), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. it will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.

studies have shown that thyroid hormone results in a higher number of organs available for transplant. increasingly, thyroid hormone supplementation is used amongst transplant donors. however, it is not the current standard of practice to supplement recipients without a prior medical history of hypothyroidism with levothyroxine. two large retrospective studies have demonstrated improved 30-days survival and lower risk of all-cause mortality for heart transplant recipients who receive levothyroxine in the post-operative context. no randomized trials have tested this hypothesis and so the investigators aim to trial the use of levothyroxine for heart transplant recipients at university of california san francisco using a double-blinded and placebo controlled randomized control trial study design. this will be a prospective, randomized study performed at a single tertiary referral academic medical center (university of california san francisco, ca), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. it will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.

Eligibility criteria:
inclusion criteria: 1. participants must be listed for heart transplantation 2. age ≥18 years 3. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. patients with pre-existing thyroid related condition including hypothyroidism, hyperthyroidism and malignancy 2. patients with a known allergy or intolerance to levothyroxine 3. patients participating in another study evaluating an investigational drug within the past 30 days.
educational intervention related to pelvic floor care in females in sport: actitud

Conditions: Pelvic Floor Disorders

Summary: pelvic floor dysfunctions (pfd) are especially prevalent among females who practice and compete in sport. one of the main reason is the great physical effort required to achieve the maximal sports performance. as conservational management, increasing the females' information is an important research line. however, gender stereotypes, embarrassment and normalization among females make it difficult to seek professional care. in this situation, prevention or management of pfd is limited. new technologies could facilitate engaging virtual educational approaches. this study will evaluate the effects of an educational intervention compounded by three sessions (60 min of duration) with one week apart, about pfd, habits related with it, and existing gender stereotypes. to this end, all female who practice and compete in any sport in spain will be invited to attend an educational online intervention with theoretical-practical content about pfd. as eligibility criteria, participants should train and compete in any sport, and have federative license from regional or national sports federation at the moment of the start of the study. participants should have at least 16 years old. the investigators expect 400 athletes to fulfill the questionnaires, of which the investigators expect 200 to attend the educational intervention. before the educational intervention, all females will reply an anonymous questionnaire to inform about their knowledge of pfd, daily practices related to pfd, influencing gender stereotypes and pfd self-reported diagnosis. one month later, this questionnaire will be sent to females (both athletes who attended the educational intervention or not) to describe changes after attending the online educational intervention and compared to those females who did not attend it. the main outcomes will be the level of knowledge about pf, the number of habits potentially related to pfd, and score of gender stereotyped beliefs. as an additional outcome, it will be considered the pfd self-reported symptomatology.

the educational intervention consisted on three 60-minutes online sessions, organized as follows: session 1: anatomical information about pelvic floor and exercises about pelvic floor consciousness; session 2: function and dysfunction of pelvic floor and exercises related; session 3: risk factor for pelvic floor dysfunctions and exercises to strengthen the pelvic floor musculature.

Eligibility criteria:
inclusion criteria: * to train and compete in any of the sport modality. * to have federative license from a regional or national sport federation in the season when study starts. exclusion criteria: * non applicable

Keywords: female sport education
turning night into day: transcontinental provision of telehealth by and for the emory community

Conditions: Mental Fatigue

Summary: the purpose of the study is to determine if temporarily relocating clinicians who deliver remote care using the eicu telehealth system to sydney, australia will lead to greater job satisfaction, reduced physiologic stress, and improve performance. four nurses and six physicians will be sent to a site in sydney australia on a rotating basis to determine whether providing care during the australian daytime is more efficient and precise than providing care during the night in the united states.

the purpose of the study is to determine if temporarily relocating clinicians who deliver remote care using the eicu telehealth system to sydney australia will lead to greater job satisfaction, reduced physiologic stress, and improve performance. four nurses and six physicians will be sent to a site in sydney australia on a rotating basis to determine whether providing care during the australian daytime is more efficient and precise than providing care during the night in the united states. as part of this pilot, each participant will undergo a series of evaluations before leaving, while in australia, and after returning. the evaluations will include questionnaires related to well-being, task assessment (such as completing a paper maze or performing arithmetic), physiology assessment (such as continuous measure of heart rate by a wristwatch type device), and stress assessment (by sampling saliva and measuring cortisol and interleukin-1 beta). the researchers would like to determine whether normalization of the provider's (physician or nurse who are the research subjects) sleep-wake cycle improves subjective and objective well-being. additionally, investigators seek to determine whether normalization of the provider's (physician or nurse who are the research subjects) sleep-wake cycle improves alertness and focus, and determine whether normalization of the provider's (physician or nurse who are the research subjects) sleep-wake cycle improves job performance.

Eligibility criteria:
inclusion criteria: * clinicians working in the clinical operations room at emory university hospital who volunteer participation in the study exclusion criteria: * declining to participate after the first phase of data collection

Keywords: mental fatigue critical care
immune regulation in chronic aspergillus infection after covid-19 infection

Conditions: Aspergillosis

Summary: this study aims to collect clinical cases and follow-up data from patients with chronic pulmonary aspergillosis, post-covid-19 aspergillosis, and post-covid-19 patients without aspergillosis. using in vitro assays, we will measure the phagocytic function of neutrophils when stimulated by fungal hyphae, their ability to produce neutrophil extracellular traps (nets), the expression of cell surface molecules at the time of enrollment, changes in cell surface molecule expression after stimulation with fungal hyphae, and the quantification of autoantibodies in the blood. this research will focus on the short-term (within 3 months), medium-term (6-12 months), and long-term (more than 12 months) changes in cell surface molecules and functions following infection.


Eligibility criteria:
inclusion criteria: * confirmed cases include patients diagnosed with pulmonary aspergillosis, acute or subacute aspergillus infections, and aspergillosis in other anatomical sites (such as sinuses, middle ear, liver). additionally, this study will enroll patients with chronic obstructive pulmonary disease (copd), asthma, or those undergoing treatment for pulmonary tuberculosis who continue to exhibit worsening pulmonary radiological findings without a clear etiology, necessitating hospitalization or outpatient care for unexplained community-acquired pneumonia. patients with bronchiectasis, emphysema, pulmonary fibrosis, or other chronic pulmonary conditions who are under continuous follow-up and treatment at our institution will also be included if clinically diagnosed with aspergillosis. the control group will consist of patients who, based on clinical evidence, have no history of prior exposure to aspergillus or aspergillosis infection after contracting covid-19. exclusion criteria: * individuals aged below 20, pregnant women, patients with advanced-stage (stage ii and above) lung cancer, individuals diagnosed with malignancies, patients with mental health disorders requiring consent from a legal guardian for participation, and those in critical end-stage conditions.
evaluating long term safety of lacosamide (lcm) to carbamazepine controlled-release (cbz-cr); initial monotherapy in epilepsy subjects 16 years and older

Conditions: Epilepsy; Monotherapy

Summary: compare safety of lacosamide (lcm) to carbamazepine controlled-release (cbz-cr) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of adverse events (aes), withdrawal of subjects due to aes, reporting of serious aes (saes).


Eligibility criteria:
inclusion criteria: * subject/legal representative is considered reliable and capable of adhering to the protocol * subject has remained seizure free and completed the maintenance phase of the sp0993; or subject has experienced 1 or more seizures on the first or second target dose during the sp0993 maintenance phase * subject is expected to benefit from participation in sp0994 in the opinion of the investigator exclusion criteria: * subject is receiving any investigational drugs or using any experimental devices in addition to lcm or cbz-cr * subject experienced a seizure at the third target dose during the evaluation phase or maintenance phase of the sp0993 study * subject is taking benzodiazepines for a non-epilepsy indication * subject meets a withdrawal criterion from the previous study sp0993 * subject is experiencing an ongoing sae from the previous study sp0993 * subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (yes) to either question 4 or question 5 of the columbia suicide severity rating scale (c-ssrs) at screening. or subject has a positive response (yes) to either question 4 or question 5 of the c-ssrs at screening in the "since last visit" version

Keywords: lacosamide
effect of strength-resistance exercise in the reduction of gestational diabetes in pregnant women with overweight or obesity

Conditions: Diabetes, Gestational

Summary: the aim of this trial is to test the efficacy of regular resistance exercise in early pregnancy to prevent gestational diabetes mellitus in overweight/ obese pregnant women.

the growing rate of obesity is a major public health problem in the west, where 28% of pregnant women are overweight and 11% are obese. worldwide, 50% of pregnant women are obese or overweight. one of the problems directly related to obesity is gestational diabetes. in fact, its prevalence is increasing as the prevalence of obesity increases, as well as other complications of pregnancy. the prevalence of gestational diabetes in our environment is 6-12%. compared with pregnant women with bmi \<25 kg/m2, pregnancies among women with obesity are at increased risk of several adverse outcomes, including early pregnancy loss, congenital anomalies, stillbirth, pregnancy-associated hypertension, preterm birth and postterm, gestational diabetes mellitus, multiple gestation, cesarean delivery, and birth of a macrosome. the consequences of obesity in pregnant women can be decreased through physical activity. this hypothesis is due to several mechanisms: reduction of blood pressure, improvement of the lipid profile, reduction of oxidative stress and the proinflammatory state. in recent years, scientific societies have published new recommendations on physical exercise in pregnant women with clear guidelines. even this, less than 15% of patients do the recommended exercise. usually the recommended exercise is aerobic and in the group of obese and overweight patients this type of exercise requires more effort and time, with the consequent worse adherence. in non-pregnant patients, exercise has been shown to be related to a decrease in cardiovascular risk and dm2. however, in pregnant patients, a meta-review of systematic reviews has shown that although lifestyle interventions decrease weight gain, they do not have a clear benefit in terms of maternal-fetal outcomes.

Eligibility criteria:
inclusion criteria: * bmi≥25 kg/m2 * singleton pregnancies exclusion criteria: * chronic hypertension * pre-pregnancy dm (type i or 2 diabetes mellitus) * cardiovascular disease * history of preterm delivery

Keywords: exercise weight gain pregnant obese overweight