Kornimate/medical-research-clean huggingface dataset:
variable pressure support trial

Conditions: Acute Lung Injury; Adult Respiratory Distress Syndrome; at Least 24 h of Controlled Mechanical Ventilation

Summary: in 2008 a new ventilation strategy termed variable pressure support ventilation (psv) was introduced, which is able to increase the variability of the respiratory pattern independent from the inspiratory effort. in experimental lung injury, variable psv was found to improve gas exchange and decrease the inspiratory effort, while reducing alveolar edema and inflammatory infiltration compared to conventional(non-variable) psv. importantly, variable psv reduced peak airway pressure and respiratory system elastance in a variability dependent manner.in addition, preliminary observations suggest that variable psv can reduce the work of breathing and improve patient comfort, but it is not known whether this new ventilatory strategy is able to speed the weaning from mechanical ventilation. since variable psv can reduce the mean pressure support, it may lead to a faster reduction of pressure support and, therefore, a shorter weaning period than conventional psv. the hypothesis of this study is that variable pressure support ventilation reduces the duration of mechanical ventilation to non-variable (conventional) pressure support ventilation.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * duration of controlled mechanical ventilation ≥ 24h * availability of a infinity v500 ventilator (ready to use) * informed consent according to local regulations * temperature ≤ 39 °c * hemoglobin ≥ 6 g/dl * pao2/fio2 ≥ 150 mmhg with positive end-expiratory pressure (peep) ≤16 cmh2o * ability to breath spontaneously exclusion criteria: * participation in another interventional trial within the last four weeks before enrollment in this trial * peripheral neurological disease associated with impairment of the respiratory pump * muscular disease associated with impairment of the respiratory pump * instable thorax with paradoxical chest wall movement * planned surgery under general anesthesia within 72 hours * difficult airway/intubation * existing tracheotomy at icu admission * expected survival \< 72 hours * home mechanical ventilation or on chronic oxygen therapy * suspected pregnancy

Keywords: acute lung injury adult respiratory distress syndrome interactive ventilatory support positive-pressure respiration ventilator-induced lung injury
negative pressure wound therapy-pico: cosmesis in repeat c-sections

Conditions: Hypertrophic Skin Condition of Anterior Abdomen

Summary: there are millions of births each year with 32% of women undergoing cesarean sections (c-sections), which results in skin scarring. repeat c-sections increased by 178% from 1979-2010. given the frequency of c-sections, it is important to achieve a desirable cosmetic outcome. the pico 7 dressing consists of a negative pressure wound therapy pump (npwt) connected to an absorbent gentle adhesive dressing that is applied to a wound. when the pump is activated, it acts by pulling excess fluid from the wound. the dressing absorbs this fluid and helps to prevent bacteria from entering the wound. it has been shown to prevent wound infections and promote healing. this study aims to compare the aesthetic appearance by using the patient and observer scar assessment scale (posas) scar assessment scale following closed incision negative pressure therapy with a pico 7 dressing to the standard abdominal dressing in women undergoing repeat cesarean sections

single, randomized controlled trial in women undergoing a repeat cesarean delivery. women will be randomized to placement of a pico 7 dressing or a standard abdominal dressing at the time of cesarean. the standard abdominal dressing will be removed approximately on postoperative day (pod) 1-2 and the pico 7 dressing will be removed approximately on pod 3-4 (prior to discharge). if the patient with a pico dressing remains inpatient for longer than 7 postoperative days, the pico dressing will be removed prior to pod 7, in accordance with device instructions. participants in both groups will be sent posas surveys at the two, four and six week visit window with primary outcome being aesthetic appearance (cosmesis) at six weeks. observers (healthcare providers) will complete a posas survey at the postpartum visit (\~4-6 weeks postoperative) to rate scar quality.

Eligibility criteria:
inclusion criteria: * scheduled or non-labor repeat cesarean delivery * one or more prior cesarean section(s) with prior pfannenstiel incision scar * gestational age \> 23 weeks * age 18 and older exclusion criteria: * patients with malignancy in the wound bed or margins of the wound * non-enteric and unexplored fistulas * necrotic tissue with eschar present * exposed arteries, veins, nerves or organs * exposed anastomotic sites * cellulitis or evidence of active infection * known allergy to adhesive tape * patient unwilling to follow-up * contraindication to npwt * bleeding disorder * therapeutic anticoagulation * allergy to any component of the dressing (perhaps list these as you will need to know to confirm eligibility of each patient) * prior irradiated skin
can exercise rewire the brain addiction circuitry?

Conditions: Physical Exercise

Summary: the aim of the present study is to apply neuroimaging techniques to investigate how physical exercise may influence the addiction circuitry, ultimately reducing alcohol consumption and craving in youth binge drinkers. this proposal will advance knowledge on how exercise may modulate the neurocircuitry of addiction. uncovering the neurobiological mechanisms underlying the interactive neural effects of exercise and alcohol intake may provide additional scientific insights for the development of preventive and intervention programs for youth bd and aud.

the proposed research plan focuses on the identification of changes in the structural and functional brain parameters (e.g. volume, brain activity), in response to a physical exercise (pe) protocol, on the neurocircuitry of addiction, after a 4 month-intervention program in college binge drinkers (bds). the main objectives of this proposal are: o1) to evaluate the potential benefits of pe on the brain structure and function, particularly in the neurocircuitry of addiction, in a sample of portuguese college students with a binge drinking pattern of alcohol use; and o2) to determine whether the pe intervention reduces craving and alcohol consumption levels in bds. the present project will involve: i) a pre-intervention comprehensive evaluation of behavioral (alcohol consumption), psychological (craving levels), physiological (vo2, hrv), and neurological (neuroimaging) variables; ii) a training phase consisting of 48 sessions (3 weekly sessions\*16 weeks) of aerobic (exp group 1), agility-cognitive (exp group 2) exercise and stretching (control group; iii) a post-intervention evaluation of behavioral, physiological, and neurological (neuroimaging) variables; iv) and a 6 months' follow- up evaluation of behavioral, physiologicaln and cognitive variables. a randomized controlled trial will be implemented at the university of minho. it will include a total of 60 college students with a binge drinking pattern of alcohol intake, 20 participants per condition.

Eligibility criteria:
inclusion criteria: * binge drinking \> or = 5 ; \> or =4 for women alcoholic drinks * in the same time window (±2h) * at least once per month * \<150 minutes of physical activity per week exclusion criteria: * major and/or unstable medical conditions * physical limitations that may constraint the practice of exercise * cardiovascular and respiratory insufficiency * history of traumatic brain injury or neurological disorder * non-corrected sensory deficits * personal history of psychopathological disorders * family history of alcoholism or substance abuse in first degree relatives * consumption of medical drugs with psychoactive effects (e.g., sedatives or anxiolytics) during the month previous to the assessment * use of illegal drugs and audit scores \>20 * mri contraindications * current or previous (past year) participation in a physical exercise program

Keywords: addiction circuitry binge drinking neuroimaging
genetic epidemiology of primary biliary cirrhosis (pbc)

Conditions: Primary Biliary Cirrhosis

Summary: primary biliary cirrhosis (pbc) is a progressive liver disorder of unknown cause. current evidence suggests that genes, the genetic material we inherit from our parents, in combination with environmental factors, likely play an important role in the development of pbc. this study is being done to investigate whether genes make people more likely to develop pbc. discovery of these proposed genes will help us better understand how pbc developes, and subsequently, to apply new approaches for its prevention, diagnosis and treatment.


Eligibility criteria:
inclusion criteria: * men and women between the ages of 18-90 who have a history of pbc. * pbc patients who have undergone a liver transplant are eligible. * family members (1st degree relatives) of enrolled pbc patients are eligible. exclusion criteria: * individuals with no history of pbc or those unable to provide consent.

Keywords: primary biliary cirrhosis pbc cholestatic liver disease
evaluation of the efficacy and safety of risperidone injections given once a month to adults with schizophrenia or schizoaffective disorder

Conditions: Schizophrenia; Psychotic Disorders

Summary: the purpose of this study is to assess the effectiveness and safety of long-acting risperidone given as a once monthly injection to adult patients with schizophrenia or schizoaffective disorder.

risperidone, taken by mouth on a daily basis, has been an effective treatment for schizophrenia and schizoaffective disorder. risperidone is also available in a long-acting injectable form so that patients can take their medicine by bi-weekly injections. this study will assess the effectiveness and safety of long-acting risperidone injection given once a month instead of every two weeks (based on previous studies with dosing every 2 weeks). during the four-week lead-in phase, patients will receive one 50-milligram injection every two weeks for two doses. patients continue to take their prescribed dose of risperidone tablets (from 2 to 6 milligrams per day) for the first 14 days. after the first month, patients will receive one 50-milligram injection once a month for 48 weeks. this dose can be increased to 75 milligrams if patient meets relapse criteria, and is willing to stay in the trial. patients will be asked questions to help determine how well the monthly injections are working. laboratory tests (including drug levels), physical examinations and adverse event reporting will be performed to determine the safety of the monthly injections. risperidone oral tablets, 2 to 6 milligrams per day, for first 2 weeks; long-acting risperidone intramuscular injections, 50 mg in 2 milliliters of liquid, every 2 weeks for 1 month, then injections once a month for 48 weeks. monthly injection dose may be increased to 75 mg in 2-ml if needed.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder * stable with respect to disease symptoms and other medical conditions * stable on antipsychotic therapy with oral risperidone 2 to 6 milligrams per day for 8 weeks before study * if female, using birth control. exclusion criteria: * hospitalized within 8 weeks of beginning the study * at risk to self or others * presence of liver or kidney damage * use of oral antipsychotic drugs other than risperidone within the past 8 weeks, of injected antipsychotics within the past 6 months, of long-acting risperidone in an earlier study, of investigational drugs within the past 30 days, or of electroconvulsive therapy within the past 12 months * pregnant or breast-feeding * if female, not using birth control * abusing drugs or alcohol.

Keywords: schizophrenia schizoaffective disorder long-acting risperidone intramuscular injection
study of boosted atazanavir (atv) versus non-boosted atv in naive patients

Conditions: HIV Infections

Summary: the purpose of this study is to find out if 300 mg of atv plus 100 mg of ritonavir (rtv) works as well as 400 mg of atv alone as part of a regimen with stavudine xr and lamivudine to slow or stop the progression of hiv infection in patients who have never used anti-hiv drugs.


Eligibility criteria:
inclusion criteria: * signed informed consent * hiv rna greater than or equal 200 copies/ml at screening * 18 years old or older * must use barrier contraception * women of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours before beginning to take the study medications exclusion criteria: * unable or unwilling to use acceptable method of birth control for the entire study period including 8 weeks after the study * women using oral contraceptives, pregnant or breastfeeding women * women who have a positive pregnancy test on enrollment or before beginning to take the study medications * people who have a life expectancy of greater than 12 months * newly diagnosed hiv-related oi or any medical condition requiring acute therapy at the time of enrollment * any antiretroviral therapy within 30 days prior to screening * any prior antiretroviral therapy (greater than 30 days of nrti and/or greater than 7 days of non-nucleoside reverse-transcriptase inhibitor (nnrti) or protease inhibitor therapies) * any of the following conditions: cushings syndrome, gilbert's syndrome, untreated hypothyroidism or hyperthyroidism, suspected primary (acute) hiv infection, obstructive liver disease, proven or suspected acute hepatitis in the 30 days prior to study entry, intractable diarrhea (at greater than 6 loose stools per day for at least 78 consecutive days) within 30 days prior to study entry, history of hemophilia, history of acute or chronic pancreatitis, presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease * active alcohol or substance abuse * history or signs and symptoms of bilateral peripheral neuropathy greater than grade 2 at the time of screening * previous therapy with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study start or the expected need for such therapy or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect cyp3a4 * inability to swallow capsules

Keywords: hiv treatment naive
nutritional and metabolic management of toxidermia patients requiring intensive care (ten metabolism)

Conditions: Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum

Summary: retrospective observational cohort study including all patients admitted for toxidermia (lyell syndrome, stevens-johnson syndrome (sjs), or other extensive skin destruction) to the burn unit of the adult icu of the lausanne burn center between 2006 and 2020. inclusion criteria: age \>18 years and admission to the burn-icu for toxidermia whatever body surface affected. exclusion criteria: to have declined access to the medical record, a stay shorter than 24 hours, and major burns. the observation period will be limited to the first 31 days of the icu stay. all variables related to nutritional and metabolic management will be recorded

there are yet no description of the metabolic characteristics of patients admitted for toxic epidermal necrolysis (ten) or stevens-johnson syndrome (sjs) which are a rare condition, often assimilated to major burns in terms of metabolic requirements. we will conduct a retrospective observational cohort study including all patients admitted for toxidermia (general term including ten or lyell syndrome, sjs, and other extensive skin destruction) to the burn unit of the adult icu of the lausanne burn center between 2006 and 2020. the primary outcome will be compliance with the icu's feeding protocol (feeding route, early start of enteral feeding, ), and secondary outcomes will include the adequacy of energy and protein delivery, and use of indirect calorimetry, and the comparison with both general and burn critically ill patients from prior studies in the icu. inclusion criteria: age \>18 years and admission to the burn-icu for toxidermia whatever body surface affected. exclusion criteria: to have declined access to the medical record, and a stay shorter than 24hours, and major burns. the observation period will be limited to the first 31 days of the icu stay. the recorded variables will include demographic characteristics, severity scores (sapsii, score of toxic epidermal necrosis (scorten for sjs/ten), nutrition risk screening (nrs) score), body surface area (bsa) affected by the disease, fluid intakes and balance (exudate volume estimation not included) of the first 10 days, body weight during the stay, renal function, length of mechanical ventilation and of icu stay. nutritional variables include the route of feeding, the 24hr energy prescription and delivery, protein, glucose, and lipid intakes, propofol, insulin, indirect calorimetry (ic) studies. laboratory blood results include glucose, prealbumin, albumin, c-reactive protein (crp), triglycerides, creatinine, and trace elements (cu, se, zn). descriptive statistics: wilcoxon rank test, while chi2 test, changes over time with one-way anova .

Eligibility criteria:
inclusion criteria: * age \>18 years * admission to the burn-icu exclusion criteria: * declined access to the medical record * stay shorter than 24hours

Keywords: critical care metabolism nutrition protein
remote support for cochlear implant recipients: evaluation of the hearcare med-el app

Conditions: Hearing Loss, Sensorineural; Cochlear Implant

Summary: this clinical investigation intends to assess safety and performance of the hearcare med-el app, a remote care option for recipients of med-el cochlear implants

remote care solutions can provide cochlear implant users a greater convenience, accessibility, and personalized care. these advantages stem from the ability to fine-tune and adjust their devices from the comfort of their own environments, without the need for frequent and time-consuming in-person clinic visits. remote care allows clinicians to remotely assess data, provide guidance, and make necessary adjustments, all while minimizing the need for physical presence. this streamlined approach translates to increased capacity for serving a larger number of patients, ultimately leading to improved patient outcomes. the hearcare med-el app is a mobile smartphone application designed for recipients of at least one compatible med-el cochlear implant and respective audio processor. the app manages technical checks on compatible cochlear implants and audio processors, creates and utilizes backups of audio processor configurations, and performs updates of audio processor configurations by acting as an executive organ of the maestro system software. the app reduces face-to-face follow-up appointments of users/caregivers with hearing professionals while maintaining safe and ongoing care for all individuals. this clinical investigation aims to evaluate the hearcare med-el app regarding safety and performance.

Eligibility criteria:
inclusion criteria: * age \> 18 years * implanted with at least one med-el cochlea implant (ci) for at least 3 months * fitted with at least one audio processor compatible with the hearcare med-el app (i.e. sonnet 2, sonnet 2 eas, rondo 3 or newer) * signed and dated informed consent form (icf) before the start of any study-specific procedure exclusion criteria: * lack of compliance with any inclusion criteria * implanted with c40x and c40c * implanted with an auditory brainstem implant (abi) or split electrode array * anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study (e.g. psychological disorders, neurologic or motoric comorbidity that could restrict subjects from using the app)
questionnaire to assess gastrointestinal symptoms of oral iron.

Conditions: Anemia; Constipation; Diarrhea; Abdominal Pain; Heartburn; Side Effect

Summary: oral iron supplementation is often associated with rapid onset of gastrointestinal side-effects. the aim of this study was to develop and trial a short, simple questionnaire to capture these early side-effects and to determine which symptoms are more discriminating. the study was a double-blind placebo-controlled randomized parallel trial with one week treatment followed by one week wash-out. subjects were randomized into two treatment groups (n=10/group) to receive either ferrous sulphate (200 mg capsules containing 65 mg of iron) or placebo, both to be taken at mealtimes twice daily during the treatment period. subjects completed the questionnaires daily for 14 days. the questionnaire included gastrointestinal symptoms commonly reported to be associated with the oral intake of ferrous iron salts (i.e. nausea, vomiting, heartburn, abdominal pain, diarrhoea, and constipation).


Eligibility criteria:
inclusion criteria: * generally healthy subjects. exclusion criteria: * the presence of any chronic disease, pregnancy or lactation were considered as exclusion criteria.

Keywords: healthy participants gastrointestinal side-effects associated with oral iron
effects of binaural beat music on elderly sleep

Conditions: Sleep Quality

Summary: background: older people in long-term care institutions often have poor sleep quality and depression, which may negatively affect their health and welfare. binaural beat music (bbm) has been proposed as a possible intervention. however, its effects on older people with poor sleep quality in long-term care institutions is still unclear. objective: this study aimed to examine the effects of binaural beat music on sleep quality, heart rate variability, and depression in older people with poor sleep quality in a long-term care institution methods: a single-blind randomized controlled trial design was employed and 64 older participants with poor sleep quality were recruited from a long-term care institution in taiwan. participants were randomized into the bbm group or control (sham) group (32 per group) and received 14 days of intervention. during the intervention period, participants in the experimental group listened to 20 minutes of taiwanese hokkien oldies embedded with bbm once in the morning and afternoon thrice a week. participants in the control group only listened to taiwanese hokkien oldies. questionnaires and heart rate variability analysis were used to assess participants' sleep quality, heart rate variability, and depressive symptoms.


Eligibility criteria:
inclusion criteria: * inclusion criteria were participants who: were aged 65 years and older, had a psqi score\> 7, were able to understand questionnaire contents and communicate in mandarin or taiwanese hokkien, stayed in institution for 1 month and more, and did not receive antidepressant within 3 months prior to and during the intervention. exclusion criteria: * exclusion criteria were those with hearing loss, history of bipolar disorder or schizophrenia diagnosed by a physician, and had an acute physiological disease, such as cold, fracture, or trauma.