Kornimate/medical-research-clean huggingface dataset:
closing -tb gaps - for people living with hiv: tb guidance for adaptable patient-centered service

Conditions: Tuberculosis; HIV Coinfection; Tuberculosis Infection

Summary: tuberculosis (tb) is the world's leading infectious cause of mortality and responsible for 1/3 of deaths in people living with human immunodeficiency virus (plhiv). children and adolescents living with hiv (calhiv) are disproportionately affected due to inadequate preventive services, large case detection gaps, treatment and adherence challenges, and knowledge gaps. this project will generate evidence to inform interventions targeting several of these weaknesses in the tb/hiv cascade of care. early detection and treatment of tb improve outcomes in people living with hiv (plhiv). a key challenge in the detection of hiv-associated tb has been the implementation of screening that identifies the correct population for diagnostic testing. increasing evidence demonstrates the poor performance of recommended symptom screens and diagnostic approaches. hence, the investigators aim to define a more accurate tb screening and testing strategy among plhiv (objective 1 and objective 2). tb preventive treatment (tpt) averts hiv-associated tb. nevertheless, among plhiv, tpt initiation and completion rates are sub-optimal and effective delivery strategies are not defined. as such, the investigators aim to identify the most effective tpt delivery strategy through shared decision making and by integrating approaches proven to be effective at improving hiv treatment adherence (objective 3). although evidence demonstrates that isoniazid preventive therapy (ipt) is cost-effective in young children living in tb/hiv high burden settings, the cost-effectiveness of newer short-course tpt has primarily been studied in the context of a tb low-burden, high-income setting. the investigators aim to generate evidence to fill this knowledge gap and inform policy for plhiv living in tb/hiv high burden settings (objective 4). this study is supported by the centers for disease control and prevention of the u.s. department of health and human services (hhs) as part of a financial assistance award totaling an anticipated $5,000,000 over five years with 100 percent funded by cdc/hhs.


Eligibility criteria:
objectives 1 and 2: inclusion criteria: * hiv positive or hiv exposed and presumptively positive while awaiting confirmatory testing in infants exclusion criteria: * do not provide informed consent or assent as appropriate or are currently being treated for tb objective 3: inclusion criteria: * negative tb symptom screen or for whom tb disease has been ruled out in accordance with who guidelines in adults and according to consensus definitions for child tb exclusion criteria: * do not provide informed consent or assent as appropriate or are currently being treated for tb

Keywords: tb/hiv co-infection pediatric tuberculosis tuberculosis preventive therapy
circulating tumor dna (ctdna) for early treatment response assessment of solid tumors

Conditions: Healthy Volunteer; Prostate Cancer; Head and Neck Cancer; Esophageal Cancer; Genitourinary Cancer; Sarcoma; Breast Cancer; Colon Cancer; Gastrointestinal Cancer; Solid Tumor Cancer; Lung Cancer; Skin Cancer; Melanoma

Summary: earlier detection of disease recurrence will enable greater treatment options and has strong potential to improve patient outcomes. this project is translational and has the potential to lead to future translational research opportunities, including interventional trials in which therapeutic escalation is offered at the early circulating tumor dna (ctdna) molecular residual disease (mrd) detection timepoint. ultimately, the integration of ctdna into the clinical workflow has the potential to enhance cancer diagnosis, treatment, surveillance, and prognosis, and guide clinical decision-making in this era of personalized precision medicine.


Eligibility criteria:
inclusion criteria: * eligible healthy donors will be at least 18 years of age. exclusion criteria: * healthy donors younger than 18 years of age
cefiderocol pharmacokinetics in adult patients with cystic fibrosis

Conditions: Cystic Fibrosis; Pneumonia, Bacterial

Summary: there is established evidence that adult patients with cystic fibrosis (cf) may have altered antibiotic pharmacokinetics compared with non-cf patients. cefiderocol is a newly approved broad spectrum intravenous siderophore cephalosporin antibiotic, which has potent in vitro activity against multidrug resistant pseudomonas aeruginosa, burkholderia cepacia complex, achromobacter species, and stenotrophomonas maltophilia, all pathogens implicated in cf pulmonary exacerbations. this study will determine the pharmacokinetics and tolerability of cefiderocol in 12 adult cf patients admitted for a pulmonary exacerbation at one of 4 participating hospitals in the us. patients will remain on standard of care iv antibiotics and receive 4-6 doses of cefiderocol 2 grams infused over 3 hours every 6-8 hours, depending on kidney function. blood will be sampled after the final dose to determine concentrations and pharmacokinetics of cefiderocol. safety and tolerability will be assessed throughout the 2 day study.

participants will receive 4-6 doses of cefiderocol 2 grams every 6-8 hours, in addition to standard intravenous antibiotic therapy selected by the site. just prior and then after the final dose, a total of nine blood samples will be collected to measure cefiderocol concentrations. data will be fit to a population pharmacokinetic model. the final model will be utilized in a monte carlo simulation to determine the probability of several different dosing regimens retaining concentrations above the minimum inhibitory concentration (mic) for at least 75% of the dosing interval. these data will be utilized to determine an optimized dosing regimen for adults with cf.

Eligibility criteria:
inclusion criteria: * documented diagnosis of cf * acute pulmonary exacerbation as the primary reason for admission to the hospital with requirement to receive systemic antibiotic treatment exclusion criteria: * females that are pregnant and/or breastfeeding * history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication) * history of a lung transplant at any time in the past or any other organ transplantation (e.g., liver) within the last 6 months * moderate to severe renal dysfunction defined as a creatinine clearance \< 60 ml/min (as calculated by the cockcroft-gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis * a hemoglobin less than 8 gm/dl at baseline * any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
study evaluating the excretion of moxidectin into the breast milk of lactating, non-breastfeeding women

Conditions: Infection

Summary: the purpose of this study is to evaluate the extent of moxidectin transfer into the breast milk of lactating women and to provide the initial pharmacokinetic and safety profile of moxidectin in lactating women.


Eligibility criteria:
inclusion criteria: healthy lactating women aged 21 to 45 years inclusive at screening. women should: * be at least 12-weeks postpartum after uncomplicated delivery with a full milk supply established. * be willing to discontinue breastfeeding permanently and should be in the process of weaning their infant. care should be taken to ensure that subjects have not discontinued breastfeeding an infant in order to participate in the study. * not plan to breastfeed within 9 months of study drug administration. * be willing to fully express breast milk from both breasts during the duration of the milk collection portion of the study. subjects must be able to express milk from each breast at each pumping session using a breast pump. * body mass index in the range of 18 to 35 kg/m2. exclusion criteria: * presence or history of any disorder that may prevent the successful completion of the study. * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
the effect and safety of combined anti-platelet treatment in acute ischemic stroke due to large artery atherosclerosis

Conditions: Cerebral Infarction; Stenosis Artery

Summary: currently, aspirin plus clopidogrel is considered as a standard acute treatment of ischemic stroke, based on results of chance and point trial. however, still a considerable portion of patients showed early stroke recurrence, especially in those with stroke due to large artery atherosclerosis. cilostazol may have benefit in reducing early stroke recurrence of neurologic deterioriation. the post-hoc analysis of csps.com showed that use of cilostazol after 15 days of stroke was effective for preventing subsequent stroke. the effect of adding cilostazol was more effective in those with large artery atherosclerosis and those receiving clopidogrel than aspirin.


Eligibility criteria:
inclusion criteria: 1. age of 20 years or older 2. acute ischemic stroke due to large artery atherosclerosis (both including intra and extracranial atherosclerosis) which may be defined by a ischemic lesion confirmed at diffusion-weighted image and a corresponding significant stenosis (more than 50% of diameter reduction) proximal to the ischemic lesion confirmed by mr or ct angiography. 3. able to start imp within 72h from stroke onset 4. acquisition of written informed consent prior to study entry exclusion criteria: 1. large infarction unable to start antiplatelet treatment 2. combined with acute intracranial haemorrhage 3. with initial haemorrhagic transformation 4. previous mrs higher than 2 5. indicated for anticoagulation 6. contraindication for aspirin, clopidogrel or cilostazol 7. requirement of long term nsaid 8. pre-planned for surgery 9. unable to withdraw consent 10. unavailable to participate based on judgement of the investigator 11. participants of reproductive potential (porp)/ participants of childbearing potential (pocbp) who do not agree to practice methods of birth control or remain fully abstinent from sexual activity with the potential for conception.
oxidative stress biomarkers to monitor and early detect health impairment in workers exposed to silica (caesar stone)

Conditions: Silicosis

Summary: silicosis is well-known occupational disease caused by free crystalline silica (silicon dioxide) and is marked by inflammation and pulmonary fibrosis. there are cumulative evidences that exposure to caesar stone (quartz surface products that manufactured from up to 93% quartz, polymer resins and pigments) is particularly dangerous to exposed workers. goals: to examine marble workers exposed to caesar stone in order to propose a working plan of surveillance and prevention by biological monitoring.

study participants would be recruited during two years of the study. they will be asked to come to a single visit at pulmonary laboratory of tel aviv medical center. during the meeting, participants will be given a precise explanation about the tests they will perform and after signing the informed consent will perform following tests: 1. induced sputum (is) - will be done after pretreatment with short acting beta-2 agonist and 3% saline will be administrated by an ultrasonic nebulizer for up to 20 min. differential cell count, particle size distribution test of the particulate matter (with a eyetech analyzer (ankersmid, yokneam, israel)will be done from is samples and evaluation the activity of heme oxygenase 1 (ho-1) protein from is supernatants. 2. ebc-exhaled breath condensate-will be done by condensation expiratory air and particulate matter and markers of oxidation will be measured. 3. participants will be asked to complete occupational questionnaire. 4. pulmonary function tests (pfts): the measurement will be performed using standard protocols according to american thoracic society/european respiratory society (ats/ers) guidelines. including lung diffusion testing. laboratory tests of induced sputum and ebc will be done within a week of a participant visit. analysis of data will be done after the completion of data collection and laboratory tests.

Eligibility criteria:
inclusion criteria: 1. male 2. 18-70 years old 3. at least six months of professional exposure to caesar stone exclusion criteria: 1. other occupational exposure (welding of any kind) 2. chronic obstructive pulmonary disease (copd), tuberculosis, asthma, autoimmune disease in healthy exposed workers 3. interstitial lung disease in exposed workers with clinically approved silicosis

Keywords: silicosis
assessment of high flow nasal cannula oxygenation in ebus bronchoscopy

Conditions: Lung Cancer; Lymphadenopathy

Summary: this study is a prospective randomised trial where a computer will randomly allocate patients to one of two possible methods of delivering oxygen during the procedure of bronchoscopy. this trial compares high flow nasal cannula (hfnc) with nasal prongs in delivering oxygen to patients undergoing endo-bronchial ultrasound guided trans- bronchial nodal aspiration (ebus-tbna) a specialised form of bronchoscopy procedure. hfnc uses humidified higher gas flow rates than conventional low flow systems such as nasal prongs which are limited by the respiratory rate and effort.


Eligibility criteria:
inclusion criteria: * subjects with a peripheral arterial pulse oximetry ≥ 90% breathing room air * age ≥ 18 years * able to breathe spontaneously throughout the procedure exclusion criteria: * respiratory or cardiac failure * recent myocardial infarction \< 6 weeks ago * on long term oxygen therapy, those with tracheostomy and/ or non-invasive or invasive mechanical ventilation * nasal and/ or nasopharyngeal disease * inability to give informed consent * dementia * hepatic or end stage renal disease * pregnancy

Keywords: endobronchial ultrasound high flow nasal oxygen
study of ngm313 in obese participants

Conditions: Obese

Summary: the purpose of the study is to evaulate the safety, tolerability, and efficacy of ngm313 in obese participants


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 30-43 kg/m2 * waist circumference \> 40 inches in males or \> 30 inches in females * normal ecg readings exclusion criteria: * significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder * history of any known congestive heart failure (chf) * history of macrovascular disease
pupillometer as a pain index during general anesthesia

Conditions: Anesthesia, General; Pupil; Pain

Summary: this study evaluates the validity of pupil diameter as an indicator of pain during surgery under general anesthesia.

pupil diameter is known to be strongly correlated with sympathetic tone. during surgery under general anesthesia, there is no standardized means of pain assessment. as pain activates sympathetic nervous system, we hypothesized that pupil diameter can be a marker for pain during surgery.

Eligibility criteria:
inclusion criteria: * children undergoing surgery under general anesthesia with total time of less than two hours exclusion criteria: * children whose parent or legal guardian declined to enroll * any use of opioids during surgery * history of hypersensitivity to any anesthetic agents * any medication that can affect sympathetic nervous activity * presence of underlying ophthalmologic disease
evaluate f901318 (olorofim) treatment of invasive fungal infections in participants lacking treatment options

Conditions: Invasive Fungal Infections

Summary: a study to evaluate olorofim (f901318) for the treatment of invasive fungal infections in participants lacking suitable alternative treatment options.

an open label, single arm phase iib study of olorofim (f901318) in participants with invasive fungal infections with limited treatment options. participants received study treatment for up to 12 weeks in the main phase of the study. at the investigator's request and after discussion with the medical monitor, open-label treatment with f901318 could be continued in patients judged by the investigator to need therapy beyond 84 days and considered likely to continue to benefit from extended treatment.

Eligibility criteria:
inclusion criteria: * male and female aged at least 18 years, or male and female aged 16 years or 17 years and who weigh at least 40 kg whom have given informed consent * ability and willingness to comply with the protocol. * able to take oral medication * females must be non-lactating and at no risk of pregnancy * male with female partners of childbearing potential must either abstain from sexual intercourse or use a highly effective means of contraception * participants with invasive fungal disease * participants who have limited alternative treatment options exclusion criteria: * women who are pregnant or breastfeeding. * known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug. * participants with chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis. * human immunodeficiency virus (hiv) infection but not currently receiving antiretroviral therapy. * participants with a medical condition that may jeopardize adherence to the protocol or may cause unacceptable additional risk to the participant * previously enrolled participants or participants enrolled in any clinical trial within the last 30 days * participants receiving treatment limited to supportive care due to predicted short survival time. * prohibited concomitant medications. * any exclusion criteria required by local regulatory authorities.

Keywords: anti fungal invasive aspergillosis rare moulds coccidioidomycosis
a non-inferiority study with two treatment arms eszopiclone 3 mg versus zopiclone 7.5 mg - for the treatment of insomnia

Conditions: INSOMNIA

Summary: the primary objective of the study is to determine whether eszopiclone (eurofarma) is non-inferior to the reference drug zopiclone (imovane®, sanofi-aventis) in the treatment of insomnia.

the primary objective of the study is to determine whether eszopiclone (eurofarma) is non-inferior to the reference drug zopiclone (imovane®, sanofi-aventis) in the treatment of insomnia. to that end, the latency to persistent sleep (lps) will be used as a primary endpoint at the end of the treatment, measured by polysomnography. the secondary objectives and endpoints of this study are as follows: * to evaluate the efficiency of eszopiclone compared to zopiclone by means of the patient's clinical history, using as secondary endpoints: * variables of the sleep diary of the associação fundo de incentivo à psicofarmacologia (see appendix a), namely: * latency time to the beginning of the sleep; * frequency of night wake-ups; * time awake during bedtime; * early morning awakening; * total time in bed; * sleep efficiency; * sleep variables measured by actigraph; * insomnia severity index (see appendix b);45 * pittsburgh sleep quality index (see appendix c);46 * to evaluate the safety of eszopiclone compared to zopiclone by means of adverse events in each study arm.

Eligibility criteria:
inclusion criteria: * sign the informed consent form for the study; * be ≥ 20 to ≥ 64 years old; * have diagnosis of symptomatic primary insomnia for at least 3 months; * have polysomnography conducted at least 90 days before the inclusion in the study with sleep time less than 6.5 hours and sleep latency ≥ 20 minutes; * be able not to take any insomnia medication for 14 days before randomization to the study (washout period). exclusion criteria: * diagnosis of other sleep disorder by polysomnography conducted 90 days before the inclusion in the study; * use of any medication affecting the sleep, such as psychotropic, hypnotic or antihistamine agents for at least 15 days before the inclusion in the study; * use of any herbal supplement for insomnia or melatonin during the 14 days before entering the study; * current use of liver metabolized medication, especially those metabolized through the cytochrome p450 enzyme complex, especially through the cyp3a4 and/or cyp2e1 routes; * history of daily use of alcohol beverages in quantities equivalent - from the ethanol standpoint - to two cans of beer a day (35 g of alcohol/day); * history of substance abuse or dependence; * patients with severe co-morbidities (at the investigator's opinion); * presence of liver disorders, cirrhosis or liver failure; * presence of psychiatric disorders diagnosed at the adult life or currently under treatment; * pregnant and breastfeeding women and women who want to become pregnant during the study period and who refuse to use a proper contraceptive methods during the study.

Keywords: insomnia for the treatment of insomnia
efficacy and safety of tacrolimus sustained-release capsules in induction phase treatment in lupus nephritis

Conditions: Lupus Nephritis

Summary: this is a pilot study to evaluate the efficacy and safety of tacrolimus sustained-release capsules (advagraf) for the induction therapy of lupus nephritis (ln) (v, iii +v, iv+v).


Eligibility criteria:
inclusion criteria: 1. subjects of either sex, 14-65 years of age; 2. diagnosis of systemic lupus erythematosus (sle) according to the albumin-creatinine ratio (acr) criteria (1997); 3. kidney biopsy within the 6 months prior to study with a histologic diagnosis (isn/rps 2003 classification of ln) class v, iii +v, iv+v; 4. ln (class iv+v): proteinuria \> 1g/24hr or scr \> 1.3 mg/dl or active urinary sediment (erythrocyte cast, \> 5 white blood cell count (wbc) /high power field (hpf)(excluding infection ), \> 5 red blood cell count (rbc)/hpf; 5. ln (class v or iii +v ): proteinuria \> 2g/24hr or scr \> 1.3 mg/dl; 6. provision of written informed consent by subject or guardian exclusion criteria: 1. inability or unwillingness to provide written informed consent 2. usage of immunosuppression therapy (mmf, cyclophosphamide (ctx), cyclosporine a (cysa), methotrexate (mtx) ect) for more than 1 week within 1 month or pulse intravenous mp treatment prior to recruitment 3. scr \> 4mg/dl (354umol/l) 4. needing pulse intravenous methylprednisolone (mp) or intravenous immunoglobulin 5. lupus encephalopathy 6. diagnosed diabetes mellitus (dm); malignant tumors (except fully cured basal cell carcinoma) 7. history of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study 8. any active systemic infection or history of serious infection within one month of entry 9. known infection with hiv, hepatitis b, or hepatitis c 10. known hypersensitivity or contraindication to tacrolimus, corticosteroids 11. participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening 12. pregnancy, nursing or use of a non-reliable method of contraception.

Keywords: lupus nephritis tacrolimus induction phase