Kornimate/medical-research-clean huggingface dataset:
neuropsychiatric side effects of efavirenz in children living with hiv

Conditions: Efavirenz; Child Behavior; Cognitive Symptom; Medication Adherence; Drug-Related Side Effects and Adverse Reactions

Summary: efavirenz is among the preferred antiretroviral drugs for hiv-infected children. increasing evidence shows that central nervous system side-effects in adults are more common than previously thought. still, reliable data in children are lacking. as hiv-infected children nowadays have a prospect of reaching adulthood, there is an urgent need to identify potential long-term central nervous system side-effects, interfering with neurodevelopment and psychosocial maturation. using validated tools, we assessed (1) competence (social/activities/school) and psychopathology (internalizing/externalizing problems), (2) cognitive performance (intelligence and working memory), and (3) adherence in tanzanian children on an efavirenz or non-efavirenz based regimen in this cross-sectional observational study the investigators will examine neuropsychiatric and neurocognitive functioning in 126 children (aged 6-11 years) on long-term combination antiretroviral therapy (cart) with or without efavirenz.

in this cross-sectional observational study, we include hiv-infected children (6-12 years) on cart for ≥ 6 months, with viral loads ≤ 1000 copies/ml in kilimanjaro region, tanzania. psychopathology and competence will be assessed using the child behaviour checklist. cognitive performance will be assessed using the raven's coloured progressive matrices and the digit span test. non-adherence is defined as any reported missed doses over the previous 3 days or \<100% adherence since the last clinical visit. analysis of covariance and logistic regression models will be used to assess differences between groups. .

Eligibility criteria:
inclusion criteria: * aged 6 until 12 years * hiv seropositive * using cart, with or without efavirenz, for at least 6 months * registered patient at one of the participating centres * in the presence of at least one parent or caregiver who is part if the child's life/upbringing exclusion criteria: * switch of cart regimen in the last 6 months * history of brain injury, mental health and cognitive impairment before starting cart * hiv rna \>1000 copies/ml within the past year * any aids-defining illness or acute illness (e.g. fever, lowered consciousness, dehydration) at time of inclusion * children with parent(s) or caregiver(s) not wanting or not able to give informed consent

Keywords: efavirenz child behavior cognition medication adherence drug-related side effects
eeg@home (phase 2 of the project, measurements in healthy volunteers)

Conditions: Epilepsy

Summary: the goal of this project is the development of an eeg-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality eeg signals. the purpose is to use the eeg-cap to investigate clinical neurological disorders (e.g. epilepsy). the eeg-cap could also be used at home so that hospital admission in the emu can be avoided for some patients and an increasing number of patients can be examined. in phase 2 of the project will comprise of an eeg-registration with the different types of electrodes in healthy volunteers. for each volunteer the eeg-recording with dry electrodes will be compared to the eeg-recordings with conventionally used wet electrodes (bridge and cup electrodes). in addition each volunteer will undergo a somato-sensory evoked potential (ssep) measurement with different types of electrodes. analogously to the eeg-registrations, for each volunteer the ssep measurement with the dry electrodes will be compared to the ssep measurement with conventionally used wet electrodes (bridge and cup electrodes). each eeg-registration will take between 5 and 10 minutes. minimum 2 - maximum 10 healthy volunteers will be included. there will be an visual and clinical evaluation of the eeg-signals (blinded) and a technical evaluation of the eeg-signals. user experience will also be collected.


Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria:
a phase ⅲ randomized study of mitomycin/vindesine/cisplatin versus irinotecan/carboplatin versus paclitaxel/carboplatin with concurrent thoracic radiotherapy for unresectable stage ⅲ non-small-cell lung cancer

Conditions: Lung Cancer

Summary: to evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with cisplatin, vindesine, mitomycin for unresectable stage iii nsclc.


Eligibility criteria:
inclusion criteria: all patients had histologically or cytologically confirmed locally advanced nsclc. all patients must not have undergone any previous therapy for nsclc. patients had to have measurable disease, an eastern cooperative oncology group (ecog) performance status 0 or 1, and to be less than 75 years old. adequate organ (bone marrow, renal, liver, heart, and lung) function was required. all patients gave written informed consent. exclusion criteria: the exclusion criteria consisted of pulmonary fibrosis, pleural effusion, pregnancy, lactation, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, uncontrollable diabetes mellitus, and infection. -
study evaluating the effect of desvenlafaxine on the pharmacokinetics of midazolam

Conditions: Major Depressive Disorder

Summary: the main purpose of this study is to evaluate the effect of desvenlafaxine administered as dvs sr on the pharmacokinetics of midazolam in healthy male and female subjects. the amount of drug in the body and the effect of the drug will also be evaluated.


Eligibility criteria:
inclusion criteria: * men or non-pregnant, non-lactating women, 18 to 55 years of age inclusive at screening. * healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ecg). * nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 ilbs). exclusion criteria: * presence or history of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * presence or history of glaucoma or intraocular pressure. * any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product. * allergy to midazolam, other benzodiazepine, desvenlafaxine, or venlafaxine. * acute disease state (eg, nausea, vomiting, fever, or diarrhea) with 7 days before study day 1. * admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements. history of drug abuse within 1 year before study day 1.

Keywords: depression
trial to evaluate safety and tolerability of aln-ttr01 in transthyretin (ttr) amyloidosis

Conditions: Transthyretin Mediated Amyloidosis (ATTR)

Summary: the purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of aln-ttr01 in patients with transthyretin (ttr) mediated amyloidosis (attr).


Eligibility criteria:
inclusion criteria: * diagnosis of ttr amyloidosis * adequate blood counts, liver and renal function * women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must use an adequate method of birth control * males agree to use appropriate contraception * willing and able to comply with protocol-required visit schedule and visit requirements and provide written informed consent. exclusion criteria: * known human immunodeficiency virus (hiv) positive status * receiving antibiotics for bacterial infection within 7 days of screening * known or suspected systemic viral, parasitic or fungal infection * receiving an investigational agent within 30 days prior to study drug administration * poor cardiac function * considered unfit for the study by the principal investigator * known sensitivity to oligonucleotides * employee or family member of the sponsor or the clinical study site personnel.
preemptive strike with bortezomib in multiple myeloma patients

Conditions: Multiple Myeloma

Summary: to evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.

although advances in the treatment of multiple myeloma have led to improved remission rates, the risk for serious relapse is very high. the drug bortezomib has been highly effective for treatment of the disease in an advanced stage such as post-transplant relapse. due to the need of maintenance therapies, it is necessary to look to certain drugs that may prolong remission and increase the quality of life. bortezomib, when taken at the beginning of remission, may prove to be a beneficial maintenance drug for the management of multiple myeloma.

Eligibility criteria:
inclusion criteria: * diagnosed with multiple myeloma currently or previously enrolled on uark 98-026 and currently event-free at the time of the evaluation. * performance status of 0-2 based of southwest oncology group (swog) criteria * previously documented platelet count \> 75,000/ul within a 35 days prior to enrollment * previously documented peripheral absolute neutrophil count \>1,000/ul within 35 days prior to enrollment. * adequate renal function * signed informed consent * female subject is post-menopausal or willing to use acceptable birth control * male subjects agree to use acceptable method of contraceptive exclusion criteria: * hypersensitivity to bortezomib, boron, or mannitol * female subject is pregnant or breastfeeding * experienced myocardial infraction within 6 months prior to enrollment * received other investigational new drugs within 14 days before enrollment * received any anti-myeloma therapy within 14 days * serious medical or psychiatric illness likely to interfere with participation in this clinical study * diagnosed or treated for another malignancy within 3 years of enrollment
evaluation of immune cell markers in diagnosis of tuberculosis

Conditions: Tuberculosis Infection

Summary: diagnosis of active and latent pulmonary tuberculosis, as well as extrapulmonary tuberculosis, is still a major challenge of tb control in china. this observational study aims to evaluate tb-antigen responsive t cell markers in the diagnosis of tuberculosis and extrapulmonary tuberculosis and try to find new prompt and cost-effective laboratory tests for active tb screening.

the enrolled patients will be grouped into active or latent tuberculosis according to the bacteriological evidence of tb. the tb-antigen responsive t cell markers will be examined. the performance of each t cell marker for the diagnosis of active tb will be systematically evaluated.

Eligibility criteria:
inclusion criteria: * any patients suspicious of tb infection * tb culture and xpert test required * chest x-ray required exclusion criteria: * anti-tb therapy before the sample collection.
oct technology development to assess ocular integrity and characterize ocular integrity and intraocular scatterers

Conditions: Uveitis

Summary: the purpose of this study is to develop and demonstrate new technologies that will enable a non-contact, compact eye imaging system based on oct to assist an early responder in acute care settings (like an emergency room) to help assess eye trauma and inflammation (swelling inside the eye).


Eligibility criteria:
inclusion criteria: - pre-clinical: employees or students (over the age of 18) of the duke eye center or biomedical engineering willing to be imaged with oct system - pilot (er): patients (over the age of 18) presenting emergently to the duke emergency room with traumatic eye injuries and/or suspected open globe - pilot (uveitis): patients presenting to the duke eye center with active uveitis and microhyphema or hyphema; patients who have independently consented to undergo vitreous tap or biopsy for their uveitis care at the duke eye center exclusion criteria: - pre-clinical: subject cannot be a direct report to any of the pis or other key personnel of this study - pilot (er): hemodynamically unstable, unable to consent - pilot (uveitis): unable to consent; cornea or lens opacity/scar which would block the imaging modality
effects of vitamin d supplement before and during pregnancy on birth weight

Conditions: Birth Weight; Vitamin D Deficiency; Pregnancy

Summary: the purpose of this study is to determine whether a daily supplement of vitamin d, taking before and during pregnancy, effects child birth weight, pre- and postpartum complication and bone mineral density during lactation.


Eligibility criteria:
inclusion criteria: * p-oh25-vitamin d \< 50 nmol/l * woman age 30-35 years * in good general health exclusion criteria: * infertility * intake of 400 iu or more vitamin d/day * cancer * alcohol or drug abuse * calciummetabolic disturbances * spontaneous abortion within last 6 month
early parkinson's disease (pd) cross-sectional

Conditions: Parkinson's Disease

Summary: purpose: 1. to see if cytokine levels and oligomeric alpha-synuclein levels in blood and cerebrospinal fluid could be used as biological markers for parkinson's disease (pd) onset and progression. 2. to characterize and define patterns in the clinical features of sleep, olfactory function and motor function in the early stages of idiopathic (sporadic) parkinson's disease (pd)and atypical or late parkinsonian syndromes. procedures: all subjects, control,early pd diagnosis and atypical or late parkinsonian syndromes, will have 1) a medical and neuro history and physical including videotaping of movements, 2) neuropsychological testing, 3) a sleep study, 4) olfactory (sense of smell) testing, 5)blood draw and lp for serum and csf testing, \& 6) functional mri. all of these procedures are often done in the diagnosis of pd. any test performed prior to enrollment as part of the clinical evaluation may be used in place of repeating the procedure. subjects will have 1 set of study visits (up to 3 visits) in order to accomplish a complete set of data.


Eligibility criteria:
inclusion criteria: 1. 35-80 year old men \& women 2. patients with ipd or parkinsonian syndromes, or controls consisting of healthy subjects, or subjects who have a non-neurodegenerative diagnosis but are otherwise healthy. 3. gives written informed consent 4. pregnant women are not excluded, but will be identified by hcg. exclusion criteria: 1. parkinsonian symptoms not due to idiopathic (sporadic) pd, such as those that are medication induced, toxic substance induced or representative of an atypical parkinsonian syndrome will be categorized separately. 2. any unstable or uncontrolled medical or psychiatric condition. 3. renal (creatinine over 1.6) or hepatic insufficiency (lft three-fold higher than normal range), or a history of significant cardiac disease. 4. if there is a history or evidence of coagulopathy, on medications such as plavix, aggrenox, heparin, coumadin, or large doses of aspirin, must be able to remain off these medications for at least 3 days, and have stable blood coagulation values prior to any lumbar puncture (lp). 5. significant dementia (mmse\<25/30 or moca\<25/30) that would interfere with study procedures or the giving of informed consent for the study . 6. active infections including skin, respiratory or gi infections, and hiv+ (if undergoing an lp). 7. any evidence of a different neurodegenerative disorder, for example, alzheimer's disease or huntington's disease. 8. fmri will not be performed is screening questionnaire identifies a reason.

Keywords: parkinson's disease
eszopiclone for the treatment of posttraumatic stress disorder

Conditions: Posttraumatic Stress Disorders

Summary: the purpose of this study is to determine if eszopiclone relative to placebo (sugar pill) is effective and tolerable for people with posttraumatic stress disorder (ptsd)-related sleep disturbance. the investigators will also examine the impact of treatment on sleep patterns, memory recall bias, and level of inflammatory markers (cytokines). the investigators predict eszopiclone will lead to greater improvement than placebo in measures of ptsd symptoms, memory recall bias, and level of inflammatory markers.


Eligibility criteria:
inclusion criteria: * male or female outpatients age 18-65 with a primary diagnosis of ptsd and associated sleep disturbance * good physical health * willingness and ability to comply with the requirements of the study protocol exclusion criteria: * women pregnant, lactating, or of childbearing potential not using medically accepted contraception * concurrent use of other psychotropic medications at least two weeks prior to baseline * concurrent use of other anti-inflammatory medications or anti-cytokine medications. if used on an as-needed (prn) basis, subjects may enter the study, but will be excluded from cytokine analyses * concurrent use of beta-blockers less than one month prior to baseline * serious medical illness or instability for which hospitalization may be likely within the next year * seizure disorders with the exception of a history of febrile seizures if they occurred during childhood * sleep apnea or restless leg syndrome * concurrent psychotherapy initiated within 3 months of randomization or ongoing psychotherapy of any duration directed specifically toward treatment of ptsd and/or sleep disturbance * patients with significant suicidal ideation * current legal actions related to trauma or an ongoing relationship with assailant

Keywords: post-traumatic stress disorder sleep disturbance insomnia cytokines anxiety traumatic event memory
cerebral bleeding in covid-19 ards patients on veno-venous ecmo

Conditions: Acute Respiratory Distress Syndrome; Extracorporeal Membrane Oxygenation Complication; Corona Virus Infection

Summary: critically ill patients with severe acute respiratory distress syndrome (ards) sometimes require treatment with veno-venous extracorporeal membrane oxygenation (ecmo) to support gas exchange. to prevent clotting of the ecmo circuit, these patients need to be anticoagulated. this protective anticoagulation also leeds to an increased bleeding risk. most critically ill covid-19 patients suffer from an ards and some require ecmo support. however, the optimal strategy and targets for the anticoagulation of these patients remain uncertain. studies have shown that covid-19 is associated with endotheliopathy probably leading to procoagulatory effects. on the other hand, the incidence of bleeding complications associated with this endotheliopathy is not clear and remains to be elucidated. anticoagulation of covid-19 patients on ecmo thus poses a challenge for clinicians. the hypothesis of the current project is that covid-19 patients with ards on ecmo exhibit a higher number of bleeding complications compared to historical control patients with non-covid-19 ards requiring ecmo support.

the primary aim of the project is to retrospectively analyze the incidence of bleeding complications (especially cerebral bleedings) in critically ill covid-19 patients with ards requiring ecmo support. the incidences of bleeding will be compared with a historical control cohort of non-covid-19 patients on ecmo support. the data analysis will be set up within a multicentric, retrospective study involving the university hospital zurich (switzerland), the medical school hannover (germany) and the university hospital bonn (germany). the aim of the multicentric approach is to increase the case load and to improve the validity of the data, which could possibly have therapeutic implications in the future. aside from demographic and baseline date, mortality and causes of death, comorbidities, the anticoagulation strategy (substance, targets of anticoagulation) and laboratory parameters of the anticoagulation during the bleeding events will be collected. furthermore, the intensity of the ecmo treatment (blood flow, sweep gas flow, oxygen requirement) during the bleeding events and the catecholamine use during ecmo implantation will be analyzed. to enhance comparability, intensive care specific treatments (proning, sedation and analgesia, covid-19 targeted therapy) will be collected and analyzed.

Eligibility criteria:
inclusion criteria: * critically ill patients with ards requiring ecmo support from all three study sites * age \> 18 years exclusion criteria: - presence of an objective, declared denial to participate
effect of alirocumab(proprotein convertase subtilisin/kexin type9 inhibitor) and rosuvastatin or rosuvastatin alone on lipid core plaques in coronary artery disease evaluated by near-infrared spectroscopy intravascular ultrasound

Conditions: Coronary Artery Disease; Angina Pectoris

Summary: the purpose of this study is to verify whether additional administration of alirocumab exerts a stronger stabilizing effect on the vulnerable plaque in cad, compared with statin alone administration in patients receiving pci. therefore, the change in maxlcbi (4 mm) of the coronary artery 9 months after administration by addition administration of alirocumab is evaluated as the main evaluation item as compared with statin administration alone for patients who have cad and received pci. also, change of plaque properties is compared with baseline and evaluated. this study is a single-center, randomized, open-label study, using alirocumab, rosuvastatin as test drugs. based on the findings obtained in this study, it is possible to clarify the mechanism of stabilization of the plaque in a patient with coronary artery disease, which in turn suppresses the progress of plaque in coronary artery disease, resulting in primary or secondary there is a possibility that it can contribute to prevention.

the investigators investigate the change in the maxlcbi (4 mm) value calculated by nirs-ivus at the time of pci and at the treatment evaluation after 9 months compared with the group of alirocumab(alirocumab75mg/2week+losuvastatin10mg/daily) and standard treatment (losuvastatin10mg/daily alone). and also the investigators evaluate lcbi(lesion), angle of a lipid core, eem csa, lumen csa, minimum lumen diameter, plaque burden, lesion length by nirs-ivus.

Eligibility criteria:
inclusion criteria: * patients who underwent pci for acs or stable coronary heart disease * patients with ldl-c ≥70 mg/dl under daily 10mg rosuvastatin * patients who remained 25-75% stenosis with coronary angiography * patients who obtained analyzable images and calculated maxlcbi (4 mm) with nirs-ivus * patients aged ≥20 years old at pci * patients who agree to be enrolled in the trial give signed written informed consent exclusion criteria: * patients who have been treated previously with at least one dose of any anti-pcsk9 monoclonal antibody * patients had uncontrolled hypertension (systolic blood pressure \>180 mmhg or diastolic blood pressure \>110 mmhg) between the time of pci and randomization visit * known hypersensitivity to alirocumab or rosuvastatin * all contraindications to alirocumab and/or rosuvastatin as displayed in the respective national product labeling for these treatments * known history of hemorrhagic stroke * currently under treatment for cancer * patients on lipoprotein apheresis * patients with severe liver or renal dysfunction * pregnant or breastfeeding women * patients recognized as inadequate by attending physician

Keywords: alirocumab nirs-ivus lcbi