Kornimate/medical-research-clean huggingface dataset:
the gravity-vap (ventilator-associated pneumonia) trial

Conditions: Ventilator Associated Pneumonia

Summary: this study is planned to compare, in patients sedated, intubated and mechanically ventilated, the efficacy and safety of the lateral trendelenburg position in comparison to the semirecumbent position to prevent incidence of ventilator-associated pneumonia (vap).

this study is planned to compare, in patients sedated, intubated or tracheostomized and mechanically ventilated, the efficacy and safety of two body positions in reducing incidence of ventilator-associated pneumonia. the semi-recumbent position prevents gastro-oropharyngeal aspiration of bacteria laden gastric contents and the "gastro-pulmonary" route of colonization. the lateral-trendelenburg position aims to promote outward drainage of bacteria-laden oropharyngeal secretion, while avoiding bacterial translocation from the oropharynx into the lungs.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. patients expected to be oro-tracheally intubated for at least 48 hours or longer 3. enrollment time window within 12 hours following intubation exclusion criteria: 1. current and past participation in an other intervention trial conflicting with the present study 2. previous endotracheal intubation longer than 12 hours during the previous 30 days 3. patients with documented bronchiectasis 4. cystic fibrosis 5. witnessed pulmonary aspiration either prior or at intubation 6. patients with increased intracranial pressure, brain edema; or medical conditions that can worsen with increase in intracranial pressure 7. patients with significant heart failure and activity impairment (class iii-iv of the new york heart association (nyha) 8. spinal cord injury 9. bmi \> 35, or weight above 300 pound 10. grade iv intra-abdominal pressure: iap \> 25 mmhg or abdominal compartment syndrome , defined as a sustained iap \> 20 mmhg that is associated with new organ dysfunction / failure 11. pregnancy 12. orthopedic problems that will not allow the patient to be kept in one of the study positions

Keywords: vap
music for surgical intensive care (music)

Conditions: DELIRIUM

Summary: intensive care units (icus) are environments specialized in the care of critically ill patients. despite significant advances, icus are often seen as a dehumanized environment. among the various stressors in icus, anxiety, pain, psychomotor agitation and mental confusion, need for mechanical restraint, lack of privacy, noise, restricted visiting time with family members and excessive lighting stand out. the tripod composed of pain, anxiety and delirium (often associated with the presence of psychomotor agitation, mental confusion and altered level of consciousness) has a high incidence and morbidity. a set of prevention, intensity reduction and treatment measures has been proposed for these conditions, with a growing number of scientific evidence supporting their routine use. elderly patients tend to be particularly susceptible to the stressors described above. this aspect represents an additional source of concern for icus, since the elderly today represent the majority of patients admitted to icus. hospitalization in icus after surgical procedures is often an unknown moment for the individual and, consequently, associated with the development of numerous unpleasant sensations, directly interfering with the patient's recovery. music as a therapy tool in medical practice has been used since 1890. after a little more than two decades, in 1914 it was applied in a surgical procedure by physician evan kane as a way of "calming patients and diverting attention from fear". associated with combined therapy with local anesthesia. in this context, being a low-cost tool, with minimal adverse effects and high acceptability, the use of music has proven to be a great ally in the arsenal of non-pharmacological therapies for the prevention of delirium, anxiety and pain. we intend, through a randomized multicenter clinical trial, to investigate whether the use of music as therapy is capable of reducing the incidence of anxiety, pain and delirium in elderly patients undergoing surgical procedures and hospitalized during the postoperative period in intensive care units.


Eligibility criteria:
inclusion criteria: * elective surgery admitted to the icu in the immediate period after the surgical procedure; · age equal to or greater than 65 years exclusion criteria: * · moderate to severe dementia, defined by 2 to 3 points in the clinical dementia rating (cdr)66; * impossibility of verbal communication (eg: aphasia); * lack of understanding of the portuguese language; * inability to listen to music due to hearing impairment or intolerance to the use of headphones; * mechanical ventilation for more than 12 hours; * richmond agitation sedation scale (rass) less than or equal to 324; * neurosurgical and craniofacial procedures; * refusal or failure to sign the free and informed consent form (tcle).
a randomized, double-blind, comparative study of azithromycin versus clarithromycin in combination with ethambutol for the treatment of disseminated mycobacterium avium complex (mac) infection in aids patients

Conditions: Mycobacterium Avium-intracellulare Infection; HIV Infections

Summary: to evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with mycobacterium avium complex (mac) infection, and to determine whether an azithromycin-containing regimen is at least as safe and effective as the same regimen containing clarithromycin..

patients are randomized to receive azithromycin at one of two doses in combination with ethambutol or clarithromycin in combination with ethambutol for 24 weeks, after which they are evaluated for entry into a maintenance phase of treatment. clinical, microbiologic, and safety assessments are performed every 3 weeks for the first 12 weeks, then monthly for the remaining 12 weeks.

Eligibility criteria:
inclusion criteria patients must have: * hiv seropositivity. * disseminated mac. * no mac therapy between time of last positive blood culture draw and study entry (single-agent prophylaxis allowed). * life expectancy of at least 2 months. * consent of parent or guardian if below legal age of consent. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * known hypersensitivity to macrolide antibiotics (erythromycin, azithromycin, or clarithromycin) or ethambutol. * inability to take oral medications. * condition likely to interfere with drug absorption (e.g., gastrectomy, malabsorption syndromes). concurrent medication: excluded: * another investigational drug started in the week prior to study entry. prior medication: excluded: * mac therapy between time of last positive blood culture draw and study entry (although single-agent prophylaxis is allowed).

Keywords: mycobacterium avium-intracellulare infection drug therapy, combination ethambutol acquired immunodeficiency syndrome azithromycin clarithromycin
creation of an e-toileting log through classification of the physical properties of stool and urine using trueloo™

Conditions: Urinary Tract Infections; Infectious Diarrhea; Clostridium Difficile Infection; Gastrointestinal Disease; GastroIntestinal Bleeding

Summary: the purpose of this study is to assess the feasibility of trueloo™, an internet-connected smart toilet seat, in accurately monitoring and logging bowel movements and urinations of residents in senior living facilities across northern california.

the logging and monitoring of bowel movements and urinary events is an important aspect of preventative care for residents in senior living facilities, providing early warning signs for conditions that may otherwise cause complications if dealt with reactively. however, this information is sporadically collected - if at all - and subjectively interpreted by caregivers, leading to inconsistencies and unreliable data. toi labs, inc. has created trueloo™, an internet-connected toilet seat, as a solution to these issues. trueloo™ acquires time-lapse images of a bowel movement or urinary event automatically and under controlled conditions. residents enrolled in the current study will have a trueloo™ installed in their private bathroom, through which all bowel movements and urinary events will be tracked, anonymously, privately, and securely. as a result, an electronic bowel movement and urinary event log for each enrolled resident will be generated. given sufficient data, the trueloo™ system will complete such electronic logs automatically, identify points in time where particular enrolled residents may have experienced anomalous toileting patterns, and determine the relevance of such events through targeted health history and urine sampling.

Eligibility criteria:
inclusion criteria: * must be willing to participate and provide consent for the study; * must be a male or female, aged 55 or older; * must be a resident of a senior living facility; * must have regular access to a trueloo™. exclusion criteria: * candidates who are unwilling or unable to accept the requirements associated with installing trueloo™ in their residence, including power and wi-fi connectivity; * candidates who use certain types of toileting assistance devices that at this time are not compatible with trueloo™ (e.g., padded toilet seat risers).

Keywords: geriatric gastroenterology urinary
prediction of chronic lung allograft dysfunction

Conditions: Lung Transplant Rejection

Summary: chronic lung allograft dysfunction (clad) is the leading cause of long-term mortality after lung transplantation. several risk factors for clad have been identified, but the exact pathophysiology and triggering molecular factors remain largely unknown. moreover, in clinical practice, no integration of the different risk factors is achieved. clad is therefore diagnosed most often late with the persistent decline in respiratory function, revealing a profound and irreversible alteration of the pulmonary graft. several blood biomarkers that can predict the occurrence of clad more than 6 months before clinical diagnosis have been identified and validated. from these preliminary results, a composite score is being developed from independent samples from the colt (cohort in lung transplantation) cohort. the main objective of this project is to validate this robust and predictive composite score (biological and clinical) of clad.


Eligibility criteria:
inclusion criteria: * patients to receive lung transplants awaiting registration on the transplant waiting list * patients affiliated to a social security system * patients who have given their informed consent * patients weighing more than 26 kg * patients over 16 years of age exclusion criteria: * pregnant or breastfeeding women * patients unable to follow the protocol * patients with concomitant inflammatory diseases, regardless of acute, chronic or infectious rejection. * patients with a history of cancer in remission for less than 5 years, with the exception of localized skin cancers, excluding melanoma.

Keywords: chronic lung allograft dysfunction lung transplantation biomarkers personalized medecine
the sex specific waist circumference cut off points to predict overweight or obesity

Conditions: The Focus of Study is to Determine the Waist Circumference Values to Predict Overweight or Obesity

Summary: the waist circumference (wc) cut off levels of the caucasian people may not represent the characteristics of different ethnic groups. the investigators aimed to determine sex specific wc cut off points to predict obesity, metabolic syndrome and increased cardiovascular risk in turkish adults.

waist circumference (wc) is an easy and reliable measure of visceral adipose tissue and a simple index of cardiovascular risk. the world health organization (who) reported sex specific wc cut off values for the caucasian people, named as action levels 1 and 2, to define the overweight or obese people. these cut off values, originally established in a dutch population, were later adopted by several medical organizations in order to define metabolic syndrome. however, these cut off levels may not necessarily represent the characteristics of the other populations. therefore it is recommended that the sex specific wc cut off points should be established for different ethnic groups. the investigators aimed to investigate whether the suggested sex specific wc cut off points for the caucasian adults are appropriate for the turkish adult population. the secondary aim of the study is to search for better wc cut off points to predict obesity, metabolic syndrome and increased cardiovascular risk in turkish adult men and women.

Eligibility criteria:
inclusion criteria: * adult male or nonpregnant female exclusion criteria: pregnant females, subjects younger than 20 or older than 83

Keywords: waist circumference, metabolic syndrome, cardiovascular risk
clinical gene therapy protocol for the treatment of retinal dystrophy caused by defects in rpe65

Conditions: Leber Congenital Amaurosis

Summary: the purpose of the study is to assess the safety and efficacy of the active substance raav-2/4.hrpe65 in patients with leber congenital amaurosis or congenital severe early-onset retinal degeneration associated with rpe65 mutation.


Eligibility criteria:
inclusion criteria: * mutations that code for abnormal rpe65 protein * presence of characteristic abnormalities in fundus * dramatic reduction of both rods ans cones erg responses * low visual acuity \<0.32 * inform consent signed exclusion criteria: * patients with chronic conditions such a haematological, cardiac, renal diseases * patients with, within the past 6 months, a clinically significant cardiac disease or known congestive heart failure, cardiac rhytm and conduction abnormalities * patients with pulmonaty dysfunction * patients with suspected rheumatoid arthritis * patients with current systemic infection........
hemodynamic effects of ketone esters in patients with sepsis induced cardiomyopathy

Conditions: Sepsis Induced Cardiomyopathy

Summary: sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection and is associated with a high mortality rate in the icu. sepsis induced cardiomyopathy (sicm) is a multi-factorial process that appears in approximately 50% of patients with sepsis/septic shock and is associated with increased mortality. it is suggested that ketone bodies are more efficient substrates of energy metabolism than glucose, with a lower oxygen consumption per atp-molecule produced and that the failing human heart increases the capacity to metabolize ketones. previous studies have found acute beneficial hemodynamic effects of ketone esters in patients with chronic heart failure and cardiogenic shock, respectively. improved hemodynamics and reduced systemic oxygen consumption as an effect of ketone esters might be of great benefit in patients admitted to the icu. thus, the investigators aim to investigate the hemodynamic effects of ketone esters in patients with sepsis induced cardiomyopathy in this randomized, placebo-controlled, double-blinded, cross-over, acute intervention study. .


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age admitted to the the intensive care unit (icu) * lvef \< 40% determined by a screening echocardiography (two projections: apical 4 chamber and 2 chamber) and analysed according to the simpson biplane method * ability for study personnel to perform transthoracic echocardiography * suspected or documented infection (suspected infection is defined as ongoing antibiotic treatment and/or body fluid culture sampling performed within 72 hours before screening) exclusion criteria: * diagnosis of heart failure with reduced ejection fraction prior to icu admission according to health records * surgical cause of icu admission * for patients in shock: other primary causes of shock than sepsis (i.e. hypovolemia, haemorrhage, cardiogenic etiology, pulmonary embolism, anaphylaxis) * blood ph \< 7.20 * severe gastroparesis * inability to position a nasogastric tube

Keywords: sepsis induced cardiomyopathy sepsis hemodynamics ketone ester ketones echocardiography randomized controlled trial cross-over trial cardiovascular
effectiveness of cognitive behavioral therapy of reduction of test anxiety

Conditions: Test Anxiety

Summary: this study will evaluate the role of group cognitive behavioral therapy in test anxiety. the study participants will be psychology undergraduates with social work and psychology majors. the students will be selected among those who score three or more in westside test anxiety scale will participate in the study. westside test anxiety will be used two weeks after completion of the group cognitive behavioral therapy protocol (flaxman, bond \& keogh. 2004). the result will be analyzed using the t-test and cohen's d.


Eligibility criteria:
inclusion criteria: * those studying social work and psychology as major subjects, those who have scored 3 and above in westside test anxiety scale exclusion criteria: * those scoring below 3 in westside test anxiety scale
study to evaluate the safety and efficacy of teropavimab and zinlirvimab in combination with lenacapavir in virologically suppressed adults with hiv-1 infection

Conditions: HIV-1 Infection

Summary: the primary objective of this study is to evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bnabs) teropavimab (formerly gs-5423) and zinlirvimab (formerly gs-2872) in combination with the hiv capsid inhibitor lenacapavir (len).


Eligibility criteria:
key inclusion criteria: * on first-line antiretroviral therapy (art) for ≥ 2 years prior to screening. a change in art regimen ≥ 28 days prior to screening for reasons other than virologic failure (vf) (eg, tolerability, simplification, drug-drug interaction profile) is allowed * no documented historical resistance to the current art regimen * plasma hiv-1 rna \< 50 copies/ml at screening * documented plasma hiv-1 rna \< 50 copies/ml for ≥ 18 months preceding the screening visit (or undetectable hiv-1 rna level according to the local assay being used if the limit of detection is ≥ 50 copies/ml). unconfirmed virologic elevations of ≥ 50 copies/ml (transient detectable viremia, or "blip") prior to screening are acceptable. * proviral phenotypic sensitivity to both teropavimab and zinlirvimab at screening by the phenosense mab assay (monogram biosciences) for inclusion in the primary cohort; sensitivity at screening by the phenosense mab assay (monogram biosciences) to 1 mab, either teropavimab or zinlirvimab, within 18 months prior to enrollment for inclusion in the optional pilot cohort -- in both cohorts, teropavimab sensitivity is defined as 90% inhibitory concentration (ic90) ≤ 2 μg/ml; zinlirvimab sensitivity is defined as ic90 ≤ 2 μg/ml; * cluster determinant 4+ (cd4+) count nadir ≥ 350 cells/μl * screening cd4+ count ≥ 500 cells/μl * availability of a fully active alternative art regimen, in the opinion of the investigator, in the event of discontinuation of the current art regimen with development of resistance key exclusion criteria: * comorbid condition requiring ongoing immunosuppression * evidence of current hepatitis b virus (hbv) infection * evidence of current hepatitis c virus (hcv) infection (prior infection cleared spontaneously or with treatment is acceptable) * history of opportunistic infection or illness indicative of stage 3 hiv disease note: other protocol defined inclusion/exclusion criteria may apply.
a randomised controlled trial of self-help mindfulness-based cognitive therapy for health workers

Conditions: Psychological Stress

Summary: this study examines whether a mindfulness-based self-help book is effective at reducing healthcare workers' levels of stress and improving their wellbeing.

this study is a randomised controlled trial (rct) examining the efficacy of a mindfulness-based cognitive therapy self-help book ('mindfulness: a practice guide to finding peace in a frantic world') relative to a wait-list control, in healthcare staff. it builds on a previous pilot rct (http://www.isrctn.com/isrctn16486066). a battery of measures will be administered at baseline (week 0), post-intervention (week 9) and follow-up (week 21). this trial is designed to test the following hypotheses. primary hypothesis -mindfulness-based cognitive therapy self-help (mbct-sh) participants, in comparison to waitlist control participants, will show a reduction in symptoms of stress by the end of mbct-sh (week 9). secondary hypotheses * the improvement detailed in the primary hypothesis will be maintained at a follow-up 12 weeks after the end of the mbct-sh (week 21). * mbct-sh participants, in comparison to waitlist control participants, will show improvements in mindfulness, other-compassion, self-compassion, anxiety, depression, burnout and mental well-being by the end of mbct-sh (week 9), and these improvements will be maintained at a follow-up 12 weeks after the end of the mbct-sh (week 21). * mbct-sh participants, in comparison to waitlist control participants, will show a reduction in the number of sickness absence days from the three months preceding the intervention to the three months following the intervention. * increases in self-compassion and mindfulness from week 0 to week 9, will mediate the effects of mbct-sh (relative to waitlist control) on levels of stress, depression, anxiety, wellbeing and burnout.

Eligibility criteria:
inclusion criteria: 1. being currently employed by sussex partnership nhs foundation trust (in the uk) in a role or roles that involve direct delivery of healthcare. 2. having at least one day per week of direct contact with uk national health service service users. 3. agreeing to refrain from engaging in another form of psychological therapy during the course of the study. 4. having self-reported sufficient english language reading ability to read and understand the self-help book exclusion criteria: 1. being currently on leave of absence from work. 2. having previously received a minimum dose (defined as 50% of a course or more) of a mindfulness-based intervention.

Keywords: mindfulness-based cognitive therapy self-help healthcare staff