Kornimate/medical-research-clean huggingface dataset:
functional neuroimaging of pain using eeg and fmri

Conditions: Sickle Cell Disease

Summary: the purpose of this research is to use non-invasive imaging technologies to study how the human brain processes pain. the investigators will use contact heat to induce pain and record data scalp eeg and functional magnetic resonance imaging (fmri). what the investigators learn from this study will help us gain insights in pain management with broad socioeconomic impacts

functional imaging of brain networks associated with pain processing is of vital importance to aid developing new pain-relief therapy and to better understand the mechanisms of brain function. the pain response in the brain is a complex process, which involves multiple cortical brain regions, such as primary and secondary somatosensory cortices, anterior cingulate cortex, and insular cortex . recent advancement in neuroimaging techniques suggests the possibility to map the brain structure and networks that involve pain processing. electroencephalography (eeg) is a noninvasive monitoring technique, which is widely used to probe neurological disorders with high temporal resolution. few attempts have been made to use eeg to map the active brain regions in pain patients. functional mri (fmri) measures the hemodynamic brain response and could image the active brain regions with high spatial resolution. studies have shown that fmri is a useful tool to delineate the brain regions associated with pain processing. recent studies from simultaneous eeg and fmri recording have suggested that the eeg response to the pain may be correlated with the fmri response, and both eeg and fmri could be used to image the brain pain processing regions, such as the primary somatosensory cortex and anterior cingulate cortex. the aim of this research is to develop and evaluate a functional neuroimaging approach using eeg, fmri and eeg-fmri, in pain study. eeg, fmri, or simultaneous eeg-fmri will be collected in healthy subjects who receive external thermal stimulation inducing pain. the painful stimuli will be delivered at different intensity levels and the subject pain rating will be collected. the imaging technique combines the eeg signal with high temporal resolution and the fmri signal with high spatial resolution to obtain a spatiotemporal imaging of the brain electrophysiological and hemodynamic activity in response to different levels of pain. cross validation between this method and subject pain score will be used to quantitatively and qualitatively evaluate the technique. the successful completion of the current protocol will help establish an important imaging technology accessing pain level in an objective way.

Eligibility criteria:
inclusion criteria: * healthy subjects with no known neurological disorders * sickle cell patients with no metal implants exclusion criteria: * age over 65 in either group

Keywords: sickle cell
missed opportunities to pre-exposure prophylaxis for hiv infection on person newly diagnosed with hiv

Conditions: Virus-HIV

Summary: missed opportunity to pre-exposure prophylaxis is a survey study that will be addressed to newly infected with human immunodeficiency virus (hiv) persons. the purposes of this study is to understand why despite the fact that pre-exposure prophylaxis exist, these persons have been contaminated with hiv.

pre-exposure prophylaxis is a new strategy to prevent the occurrence of new cases of hiv. this prophylaxis strategy is based on taking antiretroviral drugs (arv) before and after exposition to a risk of hiv infection which can reduce drastically the contamination with hiv. a certain groups of population based on their sexual orientation, for instance man who have sex with man (msm), is among the groups that are highly exposed to this risk. to reduce this risk, french national regulatory authority (ansm), firstly through temporary usage recommendation followed by a marketing authorization extension, allowed the prescription of these antiretroviral molecules to persons presenting eligibility criteria as defined by regulatory authority. despite these preventive measures, the incidence of hiv such as the msm group still high. the missed opportunity studies has as objectives to try to disentangle real obstacles of prep use in france and to optimize prep criteria if needed.

Eligibility criteria:
inclusion criteria: * 18 years and older * understanding and speaking french * affiliated in or beneficiary of a social security (excluding state medical aid or ame that aren't considered as social security coverage) * men and women with a diagnosis of hiv infection known for less than three months and with recent hiv infection established on: a diagnostic confirmation test by western blot (wb) or immuno blot showing incomplete pattern. or previous hiv negative screening test performed within 6 months of diagnosis. exclusion criteria: * less than 18 years old * unable to understand french * not affiliated to a social security coverage * under guardianship or under curatorship

Keywords: vih prep risk factors prevention access to care
a study of newly formulated tylenol tablet (acetaminophen) and tylenol 8 hour (h) extended release (er) tablet (acetaminophen) in healthy participants

Conditions: Healthy

Summary: the purpose of this study is to evaluate the bioequivalence of the newly formulated tylenol tablet (acetaminophen 650 milligram \[mg\]) with respect to the tylenol 8 hour (h) extended-release (er) tablet (acetaminophen 650 mg) in healthy participants under fed conditions.


Eligibility criteria:
inclusion criteria: * healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ecg) performed at screening. if there are abnormalities, they must be consistent with the underlying illness in the study population. this determination must be recorded in the participant's source documents * healthy on the basis of clinical laboratory tests performed at screening. if the results of the serum chemistry panel including liver enzymes, other specific tests, hematology, urinalysis or breathing alcohol test are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. this determination must be recorded in the participant's source documents and initialed by the investigator * blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 millimeters of mercury (mmhg) systolic, inclusive, and no higher than 90 mmhg diastolic * have no history of psychiatric disorder within the 5 years prior to the screening * have no history of gastrointestinal resection that may affect drug absorption exclusion criteria: * clinically significant abnormal physical examination, vital signs, or 12 lead ecg at screening as deemed appropriate by the investigator * known allergies, hypersensitivity, or intolerance to acetaminophen or its excipients * history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence) * taken any disallowed therapies as noted in local prescribing information, concomitant therapy before the planned first dose of study drug * use of any prescription or nonprescription medication (including oriental medicines) within 30 days before the first dose of the study drug is scheduled
continuation of the kronos early estrogen prevention study (keeps)

Conditions: Alzheimer Dementia

Summary: the purpose of this study is to investigate how blood flow to the brain affects cognition in women who are postmenopausal, and how the use of hormone therapy early in menopause might change brain function. the testing in this study will add to the knowledge about brain aging in women. researchers will determine if blood flow to the brain, brain structure, and cognition differences among women who took hormones in the past as part of kronos early estrogen prevention study (keeps; nct00154180), are currently taking hormones, or never took menopausal hormones.

this is a continuation of the kronos early estrogen prevention study (keeps) (keeps; nct00154180), a multicenter double blinded, placebo-controlled, randomized trial funded by the kronos longevity research institute, phoenix, az to test the hypothesis that hormone therapy started early in menopause (within the "window of opportunity") would slow progression of atherosclerosis as measured by changes in carotid artery intima-medial thickening and coronary arterial calcification. this study will involve a single follow-up evaluation of brain imaging and cognitive function of women who were randomized to menopausal hormone therapy (mht) or placebo, approximately 13 years post-randomization and nine years after the end of mht administration phase in keeps (nct00154180). no interventions are given as part of this study; any current hormonal treatments are by choice and prescribed by the participant's personal physician.

Eligibility criteria:
inclusion criteria: * participated in the original keeps trial. * able to understand study procedures. * willing to sign an authorization of consent in order to participate in this study. exclusion criteria: • women who have contraindications to mri or pet for safety reasons, such as an mri-incompatible implant or claustrophobia.
nhlbi type ii coronary intervention study

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Hypercholesterolemia, Familial; Myocardial Infarction; Myocardial Ischemia

Summary: to determine whether lowering of cholesterol with cholestyramine in a population with type ii hyperlipidemia led to a decreased rate of progression (a regression of coronary artery disease) as demonstrated by death, myocardial infarction, or progression of disease on angiography.

background: there is overwhelming evidence that increased cholesterol levels are associated with increased risk of cardiovascular disease. this study examined whether lowering of cholesterol through drug therapy in people who had coronary artery disease as determined by angiography led to regression of the disease, again as indicated by angiography and reduction in mortality or nonfatal myocardial infarction. the study should be contrasted with the coronary primary prevention trial (cppt), which determined whether lowering cholesterol through a combination of drug and diet therapy resulted in decreased cardiovascular mortality. it should be noted that patients in the cppt did not have known preexisting coronary heart disease. design narrative: a randomized, double-blind trial, with single experimental and control groups. the experimental group received drug therapy (cholestyramine); the control group received placebo. both groups received diet therapy. the endpoints were a significant difference in the progression of coronary disease as shown by angiography or a significant difference in new myocardial infarction or death. patients were followed under therapy for at least 5 years.

Eligibility criteria:
men and women with angiographically demonstrated coronary artery disease.
cellfx system for the treatment of cutaneous non-genital warts

Conditions: Warts; Warts Hand; Verruca

Summary: this prospective, non-randomized, multicenter pivotal study is designed to evaluate the safety and effectiveness of the cellfx system in patients with cutaneous non-genital warts on all areas of the body, excluding the face.

the study will enroll healthy adult subjects with a minimum of two cutaneous non-genital warts, excluding the face, with each wart lesion not exceeding 10 x 10mm. one of the warts for each subject will be untreated and will serve as the subject's internal control. macrophotography of all study warts will be captured along with investigator assessments using the wart measurement scale (wms) and lesion measurements for wart reduction. all subjects will be followed at 7, 30, 60, 90 and 120-days post-initial cellfx treatment. all wart lesions are eligible for re-treatment up to 3 times over the course of the study. adverse events will be documented.

Eligibility criteria:
inclusion criteria: * subjects must be at least 21 and not older than 80 years of age * subjects must be able to read and speak english or spanish * subjects must sign a written informed consent to participate in the study, prior to any study related procedures * subject must have a minimum of two cutaneous non-genital warts, each not exceeding 10 x 10mm * subject is willing to undergo all study-mandated procedures * subject agrees to refrain from using all other wart removal products or treatments (topical medication including over-the-counter medications) during the study period exclusion criteria: * subject has an implantable electronic medical device. (pacemaker, implantable cardioverter defibrillator, etc.) * subject has cochlear implants * subject has an active systemic infection or history of an infection in the designated treatment area within 90 days of enrollment * subject has a history of and/or current tinnitus * subject is known to be immune-compromised * subject is taking a blood thinning medication (antiplatelet, anticoagulation, factor xa inhibitor, etc.) * subject has type 1 diabetes and is insulin dependent * subject has a known allergy to lidocaine or lidocaine-like products * subject is a member of a vulnerable population including individuals employed by the sponsor, clinic site, or entity associated with the conduct of the study * subject has a comorbidity or condition which may reduce compliance with this protocol, including follow-up visits * subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device)

Keywords: cellfx nano-pulse stimulation nps clearance
journey ii bcs eu observational trial

Conditions: Degenerative Joint Disease

Summary: post-market study to confirm the safety and efficacy of the journey ii bcs knee prosthesis.

multicenter, prospective, observational study to collect relevant clinical data from 167 subjects implanted with the journey ii bcs knee system. data from eligible subjects, who have provided written informed consent for the collection of their coded data will be recorded from the patient's medical file on specially designed case report forms (crf's). total study duration for participants will be 10 years with follow-up visits planned at 3 months, 1 year, 2 years, 5 years and 10 years post-surgery. an interim analysis describing the clinical outcome is planned after 5 years.

Eligibility criteria:
inclusion criteria * subject requires primary total knee arthroplasty with the journey ii bcs total knee system, including patella resurfacing * subject requires primary total knee arthroplasty due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis) * subject is of legal age to consent, agrees to consent to and to follow the study visit schedule, by signing the ec approved informed consent form exclusion criteria: * age \> 75 years * conditions that may interfere with the tka survival or outcome (i.e., paget's or charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease) * subject has inadequate bone stock to support the device

Keywords: total knee arthroplasty degenerative joint disease
contribution of l-tyrosine to recovery from operational strain on return from external operation

Conditions: Stress, Psychological

Summary: operational conditions amplify soldier's constraints and stress factors, upsetting individual and collective adaptive landmarks. the soldier's resistance is strained by the high intensity of stressors, by the long duration of exposure and by their cumulative effect. this may lead to a state of "operational strain" that refers to chronic stress and the allostatic load imposed by operational constraint. the investigators believe that operational strain could manifest itself by a kind of accelerated aging of the organism due to the increased allostatic load without sufficient resource restoration (neurotransmitter precursors, partial and repeated sleep deprivation, etc.). this aging mechanism would be reversible after a sufficient period of resource restoration (sleep, physical activity, adapted diet, etc.).


Eligibility criteria:
inclusion criteria: * from 18 to 65 years of age exclusion criteria: * tyrosine intake within the previous 15 days * history of neurological or psychiatric disorder * history of nephrological or endocrine disorder or liver failure * hereditary tyrosinemia

Keywords: l-tyrosine
effects of different vasodilators on coronary no-reflow during primary percutaneous coronary intervention in patients with acute myocardial infarction

Conditions: Acute Myocardial Infarction; Percutaneous Coronary Intervention

Summary: the purpose of this study is to evaluate the efficacy of three different vasodilators including diltiazem, verapamil and nitroglycerin for reversal of no-reflow/slow-flow during direct percutaneous coronary intervention for acute myocardial infarction.

no-reflow/slow-flow is a frequent observation during direct pci for ami and associated with a poor clinical outcome. the present pharmacological management involves the use of different vasodilators including nitrates, verapamil, adenosine and nicorandil. but no randomized trial has been conducted to assess any of these agents, or to determine the appropriate dosage. this prospective randomized study aimed to confirm favorable effects of diltiazem on no-reflow/slow-flow during direct pci for ami compared with verapamil and nitroglycerin.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute myocardial infarction * vessel timi flow \< grade ⅲ post-pci exclusion criteria: * heart failure of new york heart association (nyha) class ⅲ to class ⅳ * sick sinus syndrome * atrioventricular block (grade ⅱ and above) * sbp ≤ 90mmhg or cardiogenic shock * heart rate ≤60 bpm * pregnancy * renal or hepatic failure

Keywords: acute myocardial infarction percutaneous coronary intervention no-reflow phenomenon vasodilator agents
azacitidine combined with venetoclax and atra in newly diagnosed aml

Conditions: Acute Myeloid Leukemia

Summary: this is a single arm study to evaluate the safety and efficiency of azacitidine (aza) combination with venetoclax and atra in patients with newly diagnosed acute myeloid leukemia. azacitidine, venetoclax and atra, may stop the growth of cancer cells, either by demethylation, by promoting cells differentiation or by killing the cells.

this study include newly diagnosed aml patients who will accept the therapy with aza combined with venetoclax and atra: (1)inductive therapy: aza 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 2 , 200mg orally for day 3, 300mg orally for day4-6, 400mg orally for day7-10,atra 45mg/m² for day 12-28, every 28 days for up to 2 cycles or progression; (2)consolidate therapy:atra 45mg/m2 per day for d1-21 ,aza 70mg/m² per day for days 1-7, every 28 days for up to 4 cycles or progression; (3) maintenance therapy:atra 45mg/m2 for d1-21 every 28 days,aza 70mg/m² per day for days 1-7, every 3 month till progression;

Eligibility criteria:
inclusion criteria: * newly diagnosed aml according to the who (2016) classification of acute myeloid leukemia. * age ≥ 18years. * ecog score: 0-3. * white blood cell count ≤ 25\*10\^9/l * total bilirubin ≤ 3x the institutional upper limit of normal if attributable to hepatic infiltration by neoplastic disease * ast (sgot) and alt (sgpt) ≤ 3x the institutional upper limit of normal * creatinine clearance ≥30ml/min exclusion criteria: * pregnancy or lactation. * acute promylocytic leukemia or chronic myeloid leukemia in blast crisis. * another malignant disease. * uncontrolled active infection. * left ventricular ejection fraction \< 0.3 by echocardiography or grade iii/iv cardiovascular dysfunction according to the new york heart association classification. * active hepatitis b or hepatitis c infection. * hiv infection. * other commodities that the investigators considered not suitable for the enrollment.

Keywords: aml azacitidine venetoclax atra
prospective open-label study of the emergence of drug resistance in patients infected with hiv-1 who are taking oral u-87201e

Conditions: HIV Infections

Summary: to determine the time course of development of resistance to atevirdine mesylate ( u-87201e ) in patients with hiv isolates showing in vitro resistance to zidovudine ( azt ). to determine the genotype changes in hiv reverse transcriptase associated with in vitro azt resistance to u-87201e. to determine the genotype and phenotype effects of treatment with a nondideoxynucleoside agent on the alterations of the hiv-1 population associated with in vitro azt resistance. to determine whether serial passage of patient pre-drug hiv isolates in the presence of u-87201e will generate the resistant mutants that may subsequently emerge in the patients.


Eligibility criteria:
inclusion criteria patients must have: * enrollment on protocol rv-43 (azt resistance study). * development of a primary rv-43 study endpoint-opportunistic infection. * hiv isolate with an azt ic50 \> 50 times that of the sensitive type strain. * able to swallow tablets without difficulty. * normal qtc interval on ekg. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * clinically significant hypersensitivity to piperazine type drugs (antepar, stelazine). * severe uncontrollable diarrhea or vomiting or known malabsorption. * symptomatic hyperlipidemia. concurrent medication: excluded: * other experimental drugs. * azt, ddi, ddc, foscarnet, immunomodulators or other agents with primary antiretroviral activity (exemptions by principal investigator permitted). patients with the following prior conditions are excluded: history of clinically significant cardiovascular disease or nervous system or muscle disease, including seizures, peripheral neuropathy, dementia, or motor dysfunction. prior medication: excluded: * experimental drugs within 4 weeks prior to study entry.

Keywords: virus replication acquired immunodeficiency syndrome antiviral agents
assessment of airway obstruction in infants with lower respiratory infections

Conditions: Bronchiolitis; Respiratory Syncytial Virus Infections

Summary: the purpose of this study is to evaluate how two different aerosol medications may improve airway function in infants with respiratory illness. we are using two different medications and comparing the difference in lung function after each medication. we will also be taking a nasal wash sample for vegf. we will be using this in comparing how infants respond to the aerosol medications as well. we hope to help standardize medications used for infants with bronchiolitis and rsv.

we hypothesize that vegf production is higher in children with rsv infection than in children with other viral infections and normal controls. in addition, the degree of vegf production is related to severity of airway obstruction. we also hypothesize that infants with higher vegf levels are more likely to improve lung function following racemic epinephrine than albuterol.

Eligibility criteria:
inclusion criteria: * group 1 infants between 2 and 24 months that are healthy * group 2 infants between 2 and 24 months that have rsv or bronchiolitis and defined as the first episode of wheezing exclusion criteria: * group 1 and 2 - no cardiac disease, no oxygen requirement, prematurity \< 37 weeks, and cannot be in the icu.

Keywords: infant respiratory syncytial virus bronchiolitis