Kornimate/medical-research-clean huggingface dataset:
single-dose pharmacokinetics of bms-986177 in participants with hepatic impairment compared to healthy participants

Conditions: Thrombosis

Summary: a single oral dose of bms-986177 administered to subjects of mild hepatic impairment, moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics, safety, and tolerability in these subjects


Eligibility criteria:
inclusion criteria: * women not of childbearing potential (wnocbp) and males. women must have documented proof they are not of childbearing potential * bmi of 20.0 to 38.0 kg/m2, inclusive * hepatic subjects classified as child-pugh mild (class a) or child-pugh moderate (class b) who have had no significant change to disease status in past 6 months and are on stable treatment regimen * healthy subjects must not have clinically significant deviations from normal in medical history, physical exam, ecgs, vital signs or clinical lab values exclusion criteria: * evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation * use of corticosteroids, nonsteroidal anti-inflammatory compounds, aspirin or other antiplatelet agents or anticoagulants within 2 weeks of dosing * healthy subjects must not have used tobacco or have a history of drug or alcohol abuse within the last 6 months * subjects must not have a current or recent (within 3 months) gi disease that increases participant risk of gi bleeding or interferes with absorption of the study drug other protocol defined inclusion and exclusion criteria may apply
evaluation of the effect of suzetrigine (suz) on the pharmacokinetics of oral contraceptives in healthy female participants

Conditions: Pain

Summary: the purpose of this study is to evaluate the effect of suz on the pharmacokinetics of oral contraceptives.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index of 18.0 to 30.0 kilogram per meter square (kg/m\^2) * a total body weight greater than (\>) 50 kilogram (kg) * nonsmoker or ex-smoker for at least 12 months before screening key exclusion criteria: * history of febrile or acute illness that has not fully resolved by 14 days before the first dose of study drug * any condition possibly affecting drug absorption, distribution, metabolism, or excretion * relative contraindications to hormonal estrogen therapy that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant. this may include, but is not limited to, intolerance to hormonal contraceptives; hypertension; history of deep vein thrombosis; coronary artery disease; cardiovascular disease; systemic lupus erythematosus; migraine; history of breast or cervical cancer; cirrhosis; and history of liver cancer. other protocol defined inclusion/exclusion criteria will apply.
high flow nasal cannula rates in pediatric asthma

Conditions: Pediatric Asthma

Summary: this is a randomized, open-label, 3-armed feasibility trial will examine conventional oxygen therapy (cot) vs high flow nasal cannula at 4l/min flow vs hfnc at 2l/kg/min flow (max 60l/min) in moderate to severe pediatric asthma exacerbations.

the purpose of this feasibility trial is to examine the safety and efficacy of high flow nasal cannula in moderate to severe pediatric asthma exacerbations. eligible patients will be admitted to the pediatric intensive care unit (picu) after initial presentation to the emergency department (ed) or as a transfer from an outside hospital ed. patients will be admitted to the picu on standard asthma therapy (continuous albuterol and systemic corticosteroids) based on the discretion of the treating ed physician. upon picu admission, eligible patients will be consented, enrolled, and randomized into the study. all patients will be continued on standard asthma therapy of continuous albuterol at 20mg/hr and systemic intravenous corticosteroids. patient will be randomized into one of three groups: (1) conventional oxygen therapy at 2l/min via standard facemark (control group), (2) high flow nasal cannula at 4l/min, and (3) high flow nasal cannula at 2l/kg/min (max 60l/min). pediatric respiratory assessment measure (pram) scores and vital signs will be taken at baseline and hourly for two hours. after the two-hour long study is completed, patients will be placed on a respiratory support modality as per the treating physician's discretion. patients will be followed longitudinally after study completion.

Eligibility criteria:
inclusion criteria: * age 2-17 years old with prior clinical diagnosis of asthma * admitted to picu on standard asthma therapy defined as continuous albuterol and systemic corticosteroids * admitted to picu on either cot or hfnc * admitted to picu from either golisano children's hospital ed or as a transport from an outside hospital ed within 6 hours of initial presentation * pram score greater than or equal to 4 after completion of initial ed therapy exclusion criteria: * admitted to the picu on niv or invasive mechanical ventilation * admitted to the picu from general floors or \> 6 hours from initial presentation * presence of a tracheostomy or baseline niv requirement * pregnancy * immunocompromised state

Keywords: asthma high flow nasal cannula conventional oxygen therapy
use of blue light emitting diode in the treatment of women with bacterial vaginosis: a clinical trial

Conditions: Vaginosis, Bacterial

Summary: bacterial vaginosis (bv) is a infectious process of the female genitourinary tract, an important health issue due to the high incidence and high rate of recurrence of the infection. therefore, new therapeutic modalities are sought with the capacity to minimize drug side effects and reduce cases of recurrence of the disease. the objective of this study is to evaluate the clinical and microbiological response of the 401+/- 5nm blue light emitting diode (led) in the treatment of women with bacterial vaginosis. the group of women with diagnosis of bacterial vaginosis will be submitted to the light therapy. these women will also be submitted to an evaluation and examination by a ginecologist before and after the therapy. there will also be an evaluation of the clinical condition and about the effects of the light through the questionnaire answered before and after participant's treatment. it's expected that the 41 +/- 5nm led will destroy the vb demonstrated by laboratory examination and also improves the signs and results analyzed by the gynecologist and participants.

a current treatment proposal is the use of blue led of 401 +/- 5 nm wich is a light that has antimicrobial effect when exposed to endogenous porphyrin of the pathogens. this exposition produces reactive oxygen and it causes cells death with no possibilities of resistance by the bacterium.

Eligibility criteria:
inclusion criteria: • women with 18 to 65 years old and with diagnosis of bacterial vaginosis exclusion criteria: • women with injury seen by pap smear, or in use of pacemaker, with diagnosis or suspicion of neoplasias, with heart diseases, pregnant or with diagnosis of epilepsy

Keywords: blue light emitting diode women
anticoagulation-free vv ecmo for acute respiratory failure

Conditions: Extracorporeal Membrane Oxygenation Complication

Summary: currently international experts recommend therapeutic anticoagulation for veno-venous extracorporeal membrane oxygenation (vv-ecmo). reports and case series suggest that the absence of therapeutic anticoagulation is safe for vv-ecmo. no randomized control trials have assessed this. the aim of this pilot study is to assess safety and feasibility of an "anticoagulation-free strategy" for veno-venous ecmo (vv-ecmo) in acute respiratory distress syndrome (ards).

although anticoagulation targets and monitoring strategies vary around the world, the current practice is still to anticoagulate patients on ecmo, mostly with ufh. however, the use of heparin coated circuits has changed their thrombogenicity. preliminary data suggest that a low-dose unfractionated heparin (ufh) strategy is non-inferior to a therapeutic dose ufh. indeed, in daily practice, when a patient on ecmo has severe bleeding complications, ufh is often stopped until the hemorrhagic issue is under control, sometimes for days. this has led some to hypothesize that anticoagulation might not be necessary for vv-ecmo, and a few case series report little to no increase in adverse events as a result. there are currently no randomized controlled trials comparing anticoagulation to no anticoagulation for patients supported with ecmo. anticoagulation is, for physiological reasons, less necessary during vv-ecmo than va-ecmo and this is the reason why our pilot study will focus on vv-ecmo only. whereas the whole ecmo device is identical for both configurations, the risk of systemic embolization (e.g., stroke) and its severe complications is much higher in va-ecmo where blood is reinjected directly into the systemic arterial system. moreover, in the presence of severely decreased left ventricular function requiring va-ecmo, the risk of left ventricular thrombus is very high and requires anticoagulation. during vv-ecmo, the risk of systemic embolization is low because the whole circuit is on the right side of the heart and relatively preserved biventricular function is needed to perform vv-ecmo the hypothesis is that vv-ecmo is safe and feasible without therapeutic anticoagulation for adults with ards. the objectives of this study is to assess, through a pilot study, the safety and feasibility of an "anticoagulation free strategy" for veno-venous ecmo (vv-ecmo) in acute respiratory failure

Eligibility criteria:
inclusion criteria: * adult patient with ards on vv-ecmo exclusion criteria: * contraindication to anticoagulation with ufh (known heparin-induced thrombocytopenia, active hemorrhage, any surgery precluding the use of anticoagulation), * indication for therapeutic anticoagulation (pulmonary embolism or deep vein thrombosis, chronic anticoagulation therapy before ecmo insertion) * low-flow (\<2 liters/min) vv-ecmo (ecco2r)

Keywords: extracorporeal membrane oxygenation anticoagulation thrombosis hemorrhage
study of the long-term safety of pramlintide in subjects with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: this is a multicenter, open-label extension study designed to examine the long-term safety of pramlintide treatment in subjects with type 1 diabetes who have successfully completed treatment in the parent study 137-150.


Eligibility criteria:
inclusion criteria: * the subject has completed the full dosing period in protocol 137-150.

Keywords: diabetes amylin pramlintide symlin
viusid in adults with acute fever of viral etiology

Conditions: Acute Fever of Viral Etiology

Summary: the purpose of the study is to assess the safety and effect of viusid (bags of 4 grams) administration in the treatment of acute fever of viral etiology as diagnosed by clinical, hematologic and serologic parameters. the duration of this open and randomized phase 2 clinical trial will be 6 days. the estimated number of persons with acute fever of viral etiology to be recruited and randomized for the study is 200. the primary outcome measure: platelet, leukocyte and granulocyte count will be assessed at the beginning and the end of the study.


Eligibility criteria:
inclusion criteria: * acute fever of viral etiology with less than 72 hours of progression * signed informed consent. exclusion criteria: * patients under treatment with other antioxidants. * inability to swallow the content of viusid bags

Keywords: viusid dietary supplements acute fever viral etiology
effect of probiotic on rhinovirus induced colds

Conditions: Common Cold

Summary: this is a randomized, double-blind placebo controlled trial to evaluate the effect of a probiotic (bl-04) on the occurrence of rhinovirus-associated common cold illness in the experimental rhinovirus challenge model. a previous study documented that bl-04 has significant effects on the innate immune response in the nose and this study will be powered to assess whether these effects translate into a demonstrable clinical benefit. volunteers will be given bl-04 or placebo for 28 days then challenged with rhinovirus. the primary analysis will be on the proportion of volunteers who develop a rhinovirus associated illness in the two treatment groups.


Eligibility criteria:
inclusion criteria: inclusion criteria at enrollment: * subject must be 18-60 years of age. * subject must read and sign a copy of the approved consent form * subject must have a serum neutralizing antibody titer of less than or equal to 1:4 to rhinovirus type 39 inclusion criteria at day -28 • female subjects must be using an effective birth control method. inclusion criteria at challenge: * female subjects must be using an effective birth control method. exclusion criteria: * antibiotic use within 3 months prior to day -28 * female subjects with a positive urine pregnancy screen * history of use of probiotics in the preceding two weeks * current cancer diagnosis or immunosuppressive therapy in the last 6 months * any clinically significant abnormalities of the upper respiratory tract * any clinically significant acute or chronic respiratory illness * any clinically significant bleeding tendency by history * hypertension that requires treatment with antihypertensive medications * history of angina or other clinically significant cardiac disease * any medical condition that in the opinion of the principal investigator is cause for exclusion from the study * history of regular use (more than 3 days in 7) of tobacco products within the preceding two weeks * history of drug or alcohol abuse in the 6 months preceding the study exclusion criteria at challenge: * any upper respiratory infection or allergic rhinitis in the two weeks prior to the challenge * female subjects with positive pregnancy screen prior to challenge * any medical condition that in the opinion of the principal investigator is cause for exclusion from the study * use of any anti-inflammatory (steroids or nsaids) or cough/cold or allergy preparation in the two weeks prior to the challenge
study of basivertebral nerve ablation treatment of chronic low back pain

Conditions: Chronic Low Back Pain

Summary: prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the intracept system.

this is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic low back pain for a minimum of 6 months with conservative care. participants will receive the intracept system procedure to ablate the basivertebral nerve within the vertebral body. treatment is performed on all vertebral bodies with modic type 1 or type 2 changes on mri from l3-s1.

Eligibility criteria:
inclusion criteria: * skeletally mature subjects at least 25 years of age * chronic low back pain for at least 6 months * failure to respond to at least 6 months of non-operative conservative management * oswestry disability index (odi) at least 30 points * modic changes type 1 or 2 exclusion criteria: * current or history of vertebral cancer or spinal metastasis * history of a fragility fracture * any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain * disc extrusion or protrusion

Keywords: vertebrogenic low back pain
intelligent intensive care unit

Conditions: Delirium; Confusion

Summary: delirium, as a common complication of hospitalization, poses significant health problems in hospitalized patients. though about a third of delirium cases can benefit from intervention, detecting and predicting delirium is still very limited in practice. a common characterization of delirium is change in activity level, causing patients to become hyperactive or hypoactive which is manifested in facial expressions and total body movements. this pilot study is designed to test the feasibility of a delirium detection system using movement data obtained from 3-axis wearable accelerometers and commercially available camera with facial recognition video system in conjunction with electronics medical record (emr) data to analyze the relation of whole-body movement and facial expressions with delirium.

the aim of the study is to assess the potential of using motion and facial expression data to detect delirium in icu patients by comparing motion and facial expression patterns in delirium and control groups. in this study, the investigators will use actigraph accelerometers to record each subject's movement patterns. also, a processed video using a commercially available camera interfaces with a specialized program to identify patient facial expressions and movement patterns. a total of 60 participants will be enrolled with delirium, and 30 patients without delirium will be used as control group. motion profiles will be compared in the motorically defined subgroups (hyperactive, hypoactive, normal) based on accelerometer and facial recognition data. then, differences in facial expression, number of changes in postures, and percentage of time spent moving will be compared between motorically defined subgroups and in delirium and control groups. emr data will also be used to assess the feasibility of detecting delirium by including additional information on related risk factors.

Eligibility criteria:
inclusion criteria (icu patients): * intensive care unit patient * 18 years of age or older exclusion criteria (icu patients): * anticipated intensive care unit stay less than one day * less than 18 years of age * inability to wear a motion sensor watch (actigraph) inclusion criteria (healthy controls): * 18 years of age or older. * sleeps in home environment exclusion criteria (healthy controls): * does not sleep in home environment * less than 18 years of age * inability to wear a motion sensor watch (actigraph)

Keywords: consciousness alertness cognition activity level delirium hyperactive delirium hypoactive delirium facial expression posture intensive care unit
23 gauge and 20 gauge vitrectomy for rhegmatogenous retinal detachments

Conditions: Retinal Detachment

Summary: this study is a comparison (23 gauge vs 20 gauge instrumentation) of surgical instrumentation for retinal detachment repair.

the majority of studies on ppv for prd up to this time have used 20-gauge instrumentation. currently, both 23-gauge and 20-gauge instrumentation are commercially available for ppv. no studies have reported the efficacy of 23-gauge ppv compared to 20-gauge ppv for primary pseudophakic rrd. as a result, many retinal surgeons choose the modality based on personal preference.

Eligibility criteria:
inclusion criteria: * ability to provide written consent and comply with study assessments for the full duration of the study. * presence of retinal detachment with history of cataract surgery. * vision of hand motion or better. exclusion criteria: * presence of a very large tear or type of retinal detachment usually a result of trauma. * prior eye surgery except for cataract surgery. * presence of significant scar tissue. * presence of retinal detachment due to hole in the macula.

Keywords: rrd rhegmatogenous retinal detachment ppv pars plana vitrectomy gauge
supplementation with omega-3: mechanism of action

Conditions: Hypertriglyceridemia

Summary: this is a trial of two marketed fish oil supplements, one with a high epa:dha ratio and the other with a high dha:epa ratio, to examine differential effects on platelet function, blood pressure, and fasting triglyceride levels.

observational studies have shown that fish consumption is associated with a lower risk of cardiovascular disease, and clinical trials have demonstrated that fish oil nutritional supplementation is associated with improvement in cardiometabolic risk factor profiles including fasting triglycerides and blood pressure. however, the mechanisms of action of fish oils are not well understood. specifically, the effects of different compositions in terms of the ratio of the fatty acids epa and dha are not known. we are proposing a pilot and feasibility study of fish oil nutritional supplementation in 40 healthy adult participants with two different commercially available fish oil (high epa/dha ratio, high dha/epa ratio, sample of 20 per group) with the hypothesis that 4 weeks of supplementation with fish oil results in differential changes in platelet function, blood pressure and fasting triglyceride levels . we will also bank blood and urine for future mechanistic studies. this pilot study will allow us to collect preliminary data for definitive mechanistic studies of the effects of fish oil supplementation and to demonstrate the feasibility of this protocol.

Eligibility criteria:
inclusion criteria: * healthy adults 20-75 years of age. * participant of the principal investigator's prior studies studies who have agreed to be contacted for future studies. exclusion criteria: * current user of fish oil supplements * current user of statins * allergy to fish or seafood products * diagnosed/treated diabetes mellitus * using aspirin or nsaids or other "blood-thinning medication"

Keywords: fish oils triglycerides blood pressure
artificial intelligence in molecular imaging: predicting parkinson's risk in rem sleep behavior disorder

Conditions: Parkinson Disease; REM Sleep Behavior Disorder; Dementia, Lewy Body

Summary: the study aims to systematically document the course of rem sleep behavior disorder (rbd) and investigate possible clinical and imaging biomarkers for disease progression and conversion risk to parkinson's disease (pd), dementia with lewy bodies (dlb), and multiple system atrophy (msa). the study will use artificial intelligence to analyze imaging and develop a reliable method to predict and stratify patients approaching conversion to overt a-synucleinopathy. participants will be clinically evaluated and 2 imaging procedures will be done.


Eligibility criteria:
inclusion criteria: 1. confirmed clinical irbd diagnosis by movement disorder specialists according to the international classification of sleep disorders 2. written informed consent exclusion criteria: 1. known diagnosis of pd or other neurodegenerative disorder 2. unequivocal signs of parkinsonism on examination 3. narcolepsy or other known causes of rbd 4. moderate to severe obstructive sleep apnea 5. abnormal neurological or mri examination

Keywords: parkinson disease artificial intelligence rem sleep behavior disorder