Kornimate/medical-research-clean huggingface dataset:
selection of farnesoid x receptor (fxr) ligands on the reactivation of latent hiv proviruses

Conditions: Human Immunodeficiency Virus I Infection

Summary: the fxreservoir#1 study (nct03618862) showed that certain fxr ligands reactivate latent viruses in the reservoir circulating in all hiv+ patients tested. these molecules appear as latency reversal agents (lra) of silent viruses of the hiv reservoir. they can be part of the strategy to eradicate this reservoir, responsible for recurrences of the infection when combined anti-retroviral treatments are stopped. two effective leads have been identified on in vitro tests and on ex vivo reactivation using fxreservoir#1. these molecules come from a chemical library of fxr ligands developed by the inserm team behind the discovery of a role for fxr in viral infections. a first series of optimized molecules derived from these leads has been synthesized; these molecules, after screening on viral and admet (absorption, distribution, metabolisme, excretion and toxicity) in vitro tests, must be tested ex vivo on cd4+ lymphocytes from the circulating peripheral reservoir of hiv+ patients in order to select the best molecules with lra activity. this step is essential before considering the clinical development of an lra.


Eligibility criteria:
inclusion criteria: * criteria relating to the population studied: patients aged 18 to 65 years old, men or women, regardless of ethnic origin. * nosological criteria: hiv-1 infection, documented by a complete western blot and/or a detectable viral load at the time of diagnosis, regardless of the viral subtype. * pathology severity and progression criteria: patients with a cd4+ count greater than 500 elements/mm3 at the last follow-up visit prior to inclusion in the study. undetectable viral load for at least six months on stable treatment. * criteria relating to treatments/strategies/procedures: current cart treatment mandatory, regardless of the combination of anti-retrovirals, effective with undetectable viral load. the number of processing lines is not limited. * criteria relating to regulation: absence of opposition exclusion criteria: * criteria relating to the population studied: pregnant or breastfeeding women * criteria relating to contraindications to the protocol explorations: acute or chronic anaemias acute infections, fever coagulation disorders, patients taking anticoagulants - criteria relating to regulation: subjects placed under judicial safeguard, guardianship or curatorship subjects participating in another research with an ongoing exclusion period.

Keywords: hiv lra fxr reactivation
consequences of at-risk alcohol consumption in icu patients

Conditions: Alcohol Abuse; Alcoholism

Summary: at-risk drinking is known to cause a high incidence of alcohol withdrawal syndrome which has a high impact on morbidity and mortality.

alcohol-use disorder has a significant impact on morbidity in surgical intensive care units and is known to cause alcohol withdrawal syndrome which mortality can reach 50% if left untreated. the aim of the study was to assess the impact of alcohol use disorder on one-year mortality and adverse icu outcomes such as agitation in a medical intensive care unit.

Eligibility criteria:
inclusion criteria: * all consecutive patients aged 18 years old or more admitted in icu exclusion criteria: * no exclusion criteria

Keywords: alcohol use disorders agitation intensive care unit restlessness alcohol withdrawal syndrome alcohol-dependence heavy drinking
the relation between movement patterns, balance performance, function of the inner ear and falls

Conditions: Accidental Fall; Postural Balance; Movement Disorders in Old Age

Summary: falls are one of the most common reasons for immobilisation and death in elderly population. this study aims at studying falls among a group of older people. the aim is to study the relation between movement patterns, balance performance, inner ear function and future falls. senior member will be recruited through the non-profit association "friskis\&svettis. measures of movement patterns, balance performance and innear ear function will be measured at baseline. falls will be monitored through falls diaries, collected every third month during a 12 month period.

falls are one of the most common reasons for immobilisation and death in elderly population. they will be even more essential to address when large birth cohorts grow older and life expectancy increases. number of elderly persons is constantly rising. when in 2010 there was 1730 000 over 65-year olds in sweden, the prognosis for year 2060 is 3221 000 persons. hence, it is important to find solutions for preventing falls. the aim of this project is to study the relation between movement patterns, balance performance, inner ear function and future falls. after measuring movement patterns, inner ear function and balance at baseline, falls will be monitored through falls diaries, collected every third month during a twelve month period in a group of older persons, recruited through the non-profit association "friskis\&svettis" in malmö, sweden. the study population will consist of senior members in the association, invited to workshops about balance.

Eligibility criteria:
inclusion criteria: * men and women, 65 years and older * the ability to ability to speak and understand swedish language. exclusion criteria: * age younger than 65 * not able to speak and understand swedish language

Keywords: accidental fall postural balance
predictors of clinical and neurological outcome in traumatic posterior fossa epidural hematoma

Conditions: Posterior Fossa Epidural Hematoma

Summary: the posterior fossa is a small space in the skull containing the brainstem and cerebellum. if a mass such as a hemorrhage grows in this region, particularly the brainstem and 4th ventricle, it can block the normal flow of cerebral spinal fluid leading to hydrocephalus, increased intracranial pressure.posterior fossa extradural hematoma (pfedh) is a rare neurosurgical entity, resulting in rapid clinical deterioration. the accumulation of blood in a potentially small space between the dura and occipital bone cause compression of the brain stem.these hematomas constitute almost 4% to 12.9% of all extradural hematoma cases. the extradural hematomas of the posterior fossa may be categorized as acute or delayed defined with respect to the brainstem compression appearing within or after 24 hours of injury, respectively. acute pfedh is characterized by medullar failure, occipital trauma associated with severe pain in the nuchal area, altered consciousness followed by rapid brainstem compression, respiratory depression, and subsequent death if not treated timely and appropriately.whereas, headache, neck pain, dysfunction of lower cranial nerve in response to pf lesions and cerebellar signs. the clinical features of pfedh are nonspecific; it may include occipital headache, vomiting due to raised intracranial pressure, and decreased consciousness level leading to death. the skull fractures must be considered as a predisposing factor for the development of delayed extradural hematomas. the aim of this study is : * to evaluate the outcome of patients with traumatic post fossa epidural hematoma * list the predictors of outcome for patients with post fossa epidural hematoma


Eligibility criteria:
inclusion criteria: * any age * traumatic posterior fossa epidural hematoma exclusion criteria: * spontaneous type of epidural heamatoma
use of melatonin for neuroprotection in asphyxiated newborns

Conditions: Hypoxic-Ischemic Encephalopathy; Cell Damage; Asphyxia Perinatal

Summary: protection of brain development is a major aim in the neonatal intensive care unit. hypoxic-ischemic encephalopathy (hie) occurs in 3-5 per 1000 births. only 47% of neonates have normal outcomes. the neurodevelopmental consequences of brain injury for asphyxiated term infants include cerebral palsy, severe intellectual disabilities and also a number of minor behavioural and cognitive deficits. however, there are very few therapeutic strategies for the prevention or treatment of brain damage. the gold standard is hypothermic treatment but, according to the literature, melatonin potentially acts in synergy with hypothermia for neuroprotection and to improve neurologic outcomes. melatonin appears to be a good candidate because of its different protective effects including reactive oxygen species scavenging, excitotoxic cascade blockade, modulation of neuroinflammatory pathways. the research study will evaluate the neuroprotective properties and the effects of melatonin in association with therapeutic hypothermia for hypoxic ischemic encephalopathy.

it is a randomized double blind, placebo controlled trial on 100 neonates with moderate to moderately to severe hypoxic ischemic encephalopathy (hie) . hie infants are randomized into two groups: whole body cooling group (n = 50 receive 72 hours of whole body hypothermia) and melatonin/ hypothermia group (n = 50; receive hypothermia and 5 daily enteral doses of melatonin 10 mg/kg). serum melatonin and autophagy levels are measured at enrollment, daily during the hypothermic treatment, at day 5 and 7 for the two hie groups. aeeg will be performed for 72 hrs during the hypothermic treatment and the re-warming. mri and spectroscopy analysis will be performed between day 5 and 7 of. after hospital discharge the infants will enter a follow-up program consisting in periodic clinical and developmental assessments until 2 years of age corrected for prematurity. an expert psychologist and a neonatologist will assess neurodevelopmental outcome using the bayley scales iii at 6-12-24 months of corrected age.

Eligibility criteria:
inclusion criteria: * gestational age \> 35 weeks and weight \> 1800 gr * apgar score \ 12 mmol/l or ph \< 7,0 at initial blood gas analyses * evidence of moderate or severa encephalopathy graded according to sarnat\&sarnat neurological evaluation * abnormal amplitude integrated electroencephalography exclusion criteria: * suspected inborn errors of metabolism * major chromosomal congenital defects

Keywords: autophagy neuroprotection melatonin hypoxic-ischemic encephalopathy hypothermia newborn neurological outcome perinatal asphyxia
a study to evaluate the safety and efficacy of mstt1041a (astegolimab) or uttr1147a in patients with severe covid-19 pneumonia

Conditions: COVID-19 Pneumonia

Summary: this is a phase ii, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of mstt1041a (astegolimab) compared with placebo and of uttr1147a compared with placebo, in combination with standard of care (soc), in patients hospitalized with severe coronavirus disease 2019 (covid-19) pneumonia.


Eligibility criteria:
inclusion criteria: * hospitalized with covid-19 pneumonia confirmed per who criteria (including a positive pcr of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest x-ray or ct scan * peripheral capillary oxygen saturation (spo2) ≤93% (on room air or supplemental oxygen) or partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) ≤300 millimetres of mercury (mmhg) or requiring supplemental oxygen to maintain spo2 \>93% or requirement for supplemental oxygen to maintain spo2 at an acceptable level per local standard of care exclusion criteria: * pregnant or breastfeeding, or positive pregnancy test at screening * any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study * in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments * participating in another clinical drug trial * treatment with investigational therapy (other than for covid-19) within 5 half-lives or 30 days (whichever is longer) prior to initiation of study drug * use of janus kinase (jak) inhibitor within 30 days or 5 drug elimination half-lives (whichever is longer) prior to screening * have received high-dose systemic corticosteroids (≥1 mg/kg/day methylprednisolone or equivalent) within 72 hours prior to day 1 * known hiv infection with cd4 \<200 cells/microlitre (ul) or \<14% of all lymphocytes * alt or ast \>10 times the upper limit of normal (uln) detected at screening * history of anaplastic large-cell lymphoma or mantle-cell lymphoma * history of cancer within the previous 5 years unless it has been adequately treated and considered cured or remission-free in the investigator's judgment * clinical evidence of active or unstable cardiovascular disease (e.g., acute myocardial ischemia or decompensated heart failure), as determined by investigator assessment, ecg, laboratory assessment, or echocardiographic data * history of moderate or severe allergic, anaphylactic, or anaphylactoid reactions or hypersensitivity to any component of study treatment
a study to assess safety and efficacy of a novel patch infusor device and novel subcutaneous furosemide formulation combination in patients with heart failure

Conditions: Heart Failure

Summary: this is a single-centre, prospective, open-label, non-comparative clinical trial assessing the on-body performance of an investigational drug delivery device (sqin-infusor) in patients hospitalised due to hf.

the investigational product consists of a novel higher concentration (30mg/ml) furosemide formulation developed for subcutaneous administration and a novel patch pump placed on the abdominal skin. this trial will investigate the on body performance of novel patch pump delivering the novel formulation. study parameters include pharmacokinetic measurements and diuretic response following subcutaneous administration of 80mg of furosemide solution in 2.7ml in patients with heart failure (hf). recruitment will be restricted to 1 site with a recruitment target of 20 patients. all trial related activities will be conducted in an inpatient environment.

Eligibility criteria:
inclusion criteria: * • written informed consent * male or female ≥18 years of age * meet esc criteria for diagnosis of hf(4) * inpatient with a primary diagnosis of hf requiring treatment with intravenous furosemide at dose exclusion criteria: * • unable to consent to inclusion in study due to lack of capacity * requiring treatment with intravenous furosemide at dose \>200 mg per day as determined by the usual care team * current inotropes, vasopressors or intra-aortic balloon pump therapy * concomitant use of diuretics in 12 hours preceding administration of study drug with sqin-infusor * systolic blood pressure (sbp) \<90 mmhg * pregnancy or breastfeeding * left sided valve disease with planned surgery or percutaneous intervention * type 1 myocardial infarction during index hospitalisation (type 2 myocardial infarctions are allowed)(5) * any surgical or medical condition which prevents patient from ambulation during the infusion * renal impairment, defined as egfr \< 30 ml/min/1.73 m2 at screening. * patient on active cardiac transplant waiting list * potassium \<3.0 mmol/l * potassium \>6.0 mmol/l * sodium \<125 mmol/l * any contraindications for furosemide administration as per furosemide smpc * any surgical or medical conditions, which in the opinion of the investigator may pose an undue risk to the subject, interfere with participation in the study or which may affect the integrity of the data
vitamin e to prevent mucositis in children with cancer

Conditions: Cancer

Summary: the primary objective is to determine whether in children undergoing doxorubicin-containing chemotherapy, if topical vitamin e, when compared to placebo, decreases an objective measurement of oral mucositis.

oral mucositis is a common consequence of chemotherapy and is an important sequela of cancer therapy because it is painful and affects quality of life, may lead to hospitalization for hydration or pain control, and provides a portal of entry for oral microflora. in addition, oral mucositis has become a major dose-limiting toxicity and consequently, may limit delivery of anti-cancer therapy. despite the frequency of mucositis, there are no feasible therapies proven to be successful in preventing mucositis in children. vitamin e is a fat-soluble essential vitamin that may protect against doxorubicin-induced oral mucositis through its anti-oxidant properties. in this study, we will examine the efficacy of topical vitamin e as prophylaxis against chemotherapy-induced mucositis with a novel methodology appropriate for the study of rare conditions, namely combining n-of-1 trials using bayesian meta-analysis. the primary outcome is an objective mucositis score measured on days 7, 10, 14 and 17. secondary outcomes included daily pain and swallowing visual analogue scale scores, and world health organization mucositis scores collected on days 5 to 20. comparisons: objective and subjective mucositis scores will be compared in cycles associated with topical vitamin e versus cycles associated with placebo administration. we will use repeated measures analysis within a bayesian framework in order to conduct this comparison.

Eligibility criteria:
inclusion criteria: * diagnosis of cancer and treated at the hospital for sick children, toronto, canada * planned chemotherapy includes at least two identical courses of doxorubicin-containing chemotherapy in which the dose of doxorubicin was at least 60 mg/m2 per course * at least 6 years of age and less than 18 years * lives in the greater toronto area exclusion criteria: * allergy to vitamin e or placebo ingredients * child is unable to comply with topical vitamin e application * cild is receiving head or neck irradiation

Keywords: vitamin e cancer pediatrics supportive care oral mucositis bayesian analysis n-of-1 trial prophylaxis
rural veterans with post-traumatic stress disorder (ptsd) and comorbid mild traumatic brain injury (tbi): a feasibility study

Conditions: Post-Traumatic Stress Disorders; Traumatic Brain Injury

Summary: this study is being conducted to understand whether training in tasks that require perceiving and thinking about things, or cognition, can improve memory in veterans who have been exposed to a blast explosion and have tbi and ptsd. a primary goal of the study is to determine whether it is feasible for veterans who don't live close to a va to perform this cognitive training at home.

many military personnel have experienced traumatic brain injury (tbi) and posttraumatic stress disorder (ptsd) as a result of the current afghanistan and iraq wars. tbi occurs when a sudden force causes the brain to move, causing damage to brain cells. ptsd is an anxiety disorder associated with serious traumatic events. blast explosions can lead to tbi. people who experience tbi as a result of a blast injury are more likely to experience ptsd than people who have tbi not due to blast. tbi and ptsd may be associated with memory problems in some patients. because therapy for ptsd sometimes requires learning new ways to think about things and making new responses, being able to remember the new information being learned is important. it is possible that improving memory may also improve ptsd treatment. this is a prospective study of operation enduring freedom and operation iraqi freedom (afghanistan and iraq wars; oef/oif) veterans who will undergo two neuropsychological and psychiatric assessments prior and subsequent to a cognitive training intervention. this is a feasibility study to ascertain whether oef/oif veterans diagnosed with mild tbi and comorbid ptsd and who live in rural locations will adhere to the schedule demands required of a computer-based cognitive training protocol.

Eligibility criteria:
inclusion criteria: * rural residence * willingness to commit to the time requirements of the study * undergoing treatment for posttraumatic stress disorder (ptsd) as assessed by a clinician, diagnosed with mild traumatic brain injury (tbi) * native english speaker * 20-40 years * normal or corrected to normal vision and hearing. exclusion criteria: * substance dependence * major depression with suicidal ideation * psychotic disorder * history of neurological disorder other than mild traumatic brain injury (tbi) due to blast from operation enduring freedom (oef) and operation iraqi freedom (oif) (i.e., afghanistan and iraq wars) deployment * history of known or suspected learning disorder.

Keywords: ptsd tbi cognition cognitive training
intravenous immune globulin (ivig) treatment protocol in kidney transplant patients

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to test the clinical and laboratory observations of ivig therapy in the highly sensitized patient. we will study the effects of patients treated with ivig or cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. the goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.

the purpose of this study is to test the clinical and laboratory observations of ivig therapy in the highly sensitized patient. we will study the effects of patients treated with ivig or cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. there are two arms in the study, one in which ivig is administered to patients who have living donors with positive crossmatch results, and another in which intravenous immune globulin is administered to patients with no living donor and have a pra greater than 30% for 3 consecutive months and a crossmatch with a cadaveric donor while on kidney transplant waiting list. the goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.

Eligibility criteria:
inclusion criteria: * 12 years of age or older * diagnosed with end stage renal disease * currently receiving either hemodialysis or peritoneal dialysis * active on the kidney or kidney/pancreas transplant list * medical clearance of the kidney donor if live related transplant * elevated panel reactive antibody (pra) greater that 30% for 3 consecutive monthly tests and one positive crossmatch with a cadaveric donor while on the transplant waiting list exclusion criteria: * received ivig within 6 months prior to enrollment * hiv positive * positive hepatitis be-antigen and/or hepatitis b viral dna * selective iga deficiency or known antibodies to iga * allergy to human immune globulin * pregnant or breast feeding