Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics study on nevirapine resistance in tanzania

Conditions: HIV Infections

Summary: primary * pharmacokinetics of single dose nevirapine * the effect of single dose carbamazepine on the pk of single dose nevirapine * resistance against nevirapine before and after. * follow-up on hiv status newborns * relation between nevirapine levels in cord blood and plasma secondary \* safety of single dose nevirapine and nevirapine/carbamazepine hypothesis: single dose carbamazepine decreases development of resistance to nevirapine in hiv positive pregnant tanzanian women by decreasing nevirapine half-life.

without the use of preventative measures, the risk of mother-to-child transmission (mtct) of hiv-1 is estimated to vary between 25 and 48%. the regimen of single dose of nevirapine to the mother just before delivery and a single dose of nevirapine to the newborn within 24 - 72 hours after birth reduces the risk of mtct by 50%, is affordable in many situations and is therefore standard of care in many african countries, like tanzania. recent studies, however, have shown that this single dose to the mother can induce the occurrence of nevirapine resistance in a large number of mothers. the mechanism of occurrence of nevirapine resistance already after a single dose is most likely related to the long elimination half-life of the drug. the subtherapeutic plasma levels present the perfect environment for the occurrence of resistance as the concentrations are subinhibitory for several days.

Eligibility criteria:
inclusion criteria: * hiv infected * antiretroviral naive * not intending to relocate out of area during study * willing to adhere to follow up scheme * ability and willing to give written consent * pregnant between 18 and 40 years * willing and able to regularly attend the antenatal clinic exclusion criteria: * serious illness that requires systemic treatment or hospitalization * any condition that would compromise subject's ability to participate * previously treated for hiv with antiretroviral agents, including single dose nevirapine used for mtct * inability to understand the nature and extent of the trial and procedures

Keywords: hiv mother to child transmission; mtct nevirapine resistance pharmacokinetics treatment naive
ventricular arrhythmia after myocarditis in sportsman

Conditions: Myocarditis Acute; Ventricular Arrythmia

Summary: the study aims to assess the prevalence of ventricular rhythmic disorder after an acute myocarditis in sportsmen. 50 patients with acute myocarditis, confirmed by mri, will be assessed by ecg holter and treadmill stress test during a 1-year follow-up.


Eligibility criteria:
inclusion criteria: * acute myocarditis, diagnosed on the association of (a) recent viral infection (upper airway, gastro-intestinal) , (b) troponin increase, and (c) chest pain and myocarditis confirmed by cardiac magnetic resonance 2 out of 3 lake louise criteria, either t2 hypersignal, early enhancement or late gadolinium enhancement. * regular physical activity, recreational or competitive: \>=4 hours weekly * written informed consent exclusion criteria: * coronary artery disease * acute inflammatory cardiomyopathy (sarcoidosis, fulminant myocarditis, tako tsubo, eosinophilic myocarditis, lyme disease) * history of myocarditis * contra-indication to cardiac mri * patient unable to perform a treadmill stress test
phase ii study of clofarabine in adult patients with refractory or relapsed acute myelogenous leukemia

Conditions: Acute Myelogenous Leukemia

Summary: clofarabine (injection) is approved by the food and drug administration (fda) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (all) who have had at least 2 prior treatment regimens. this is a single arm, open-label, phase ii study of clofarabine in adult patients with refractory or relapsed acute myelogenous leukemia (aml). qualified patients must be refractory to one or two induction regimens, or have relapsed \< one year from the date of confirmation of the initial complete remission (cr). there will be two phases in this study - an induction phase and a consolidation phase.


Eligibility criteria:
inclusion criteria: * note: for inclusion and exclusion criteria, a regimen is defined as including induction, consolidation, and maintenance therapies. * diagnosis of aml according to fab classification * must not be eligible for therapy of higher curative potential, and must be in first or subsequent relapse and/or refractory * a karnofsky performance status (kps) of greater than or equal to 60. * if female of childbearing potential, patients must have a negative serum or urine pregnancy test within 7 days of study enrollment. men and women with reproductive potential must use as an effective contraceptive method while enrolled in the study. patients must have contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc. * signed, written informed consent. * ability to comply with study procedures and follow-up examinations. * adequate organ function as indicated by specific laboratory values (defined in the protocol), obtained within two weeks prior to registration. * classified as aml fab m3 (acute promyelocytic leukemia) and have been treated with at least 2 regimens (a retinoic acid containing regimen and an arsenic trioxide containing regimen) before being considered for this study. exclusion criteria: * note: for inclusion and exclusion criteria, a regimen is defined as including induction, consolidation, and maintenance therapies. * received previous treatment with clofarabine. * received more than two previous induction regimens or cycles for the treatment of aml. * relapsed \> 1 year. * have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment. * are pregnant or lactating. * have psychiatric disorders that would interfere with consent, study participation or follow-up. * are receiving any other chemotherapy or corticosteroids. patients must be off previous therapy for at least two weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment. * have any other severe concurrent disease. * have symptomatic cns involvement. * have chronic myelogenous leukemia (cml) in lymphoid blast crisis).

Keywords: clo221 clolar
a study to explore the safety and tolerability of doses of e2007 up to a maximum of 8 mg in patients with parkinson's disease who experience end-of-dose wearing off motor fluctuations

Conditions: Parkinson's Disease

Summary: this is a randomized, double-blind, two treatment, two group, parallel group study. subjects will be randomized to one of two treatment groups (e2007 or placebo) in a 3 to 1 ratio and receive treatment for a total of ten weeks (days 1 to 70).


Eligibility criteria:
inclusion criteria: * subjects of any race greater than or equal to 30 years of age * have a diagnosis of idiopathic parkinson's disease. subjects should fulfill the uk parkinson's disease society brain bank clinical diagnostic criteria (queen square criteria) and have a rating of 2 - 4 on the hoehn and yahr scale when in an 'off' state. * receiving an optimized regimen of anti-parkinsonian treatments that has been stable for at least four weeks before baseline. the regimen is not considered to be stable if "as required" or "on demand" dosing is routinely used or there is regular use of apomorphine or liquid forms of levodopa. * taking levodopa or levodopa-containing medications (e.g. co-beneldopa, cocareldopa) at least three times daily with a good response to each levodopa dose as evidenced from patient diaries or medical notes. * consistently experience end-of-dose "wearing-off" motor fluctuations. subjects should: * score greater than or equal to 1 on question 39 (what proportion of the waking day is the patient "off" on average?) of the full updrs at screening. * have at least 2.5 hours of "off" time on average per day recorded in the patient diary at baseline. * willing and able to provide written informed consent and adhere to the protocol requirements, including completion of a patient diary. exclusion criteria: * receiving treatment with medication known to induce cyp3a4 activity * previous stereotactic surgery (e.g. pallidotomy, subthalamic nucleus deep brain stimulation) for parkinson's disease * received an investigational product within four weeks prior to screening or having participated in a previous study with e2007. * clinically significant cognitive impairment \[mini-mental state examination (mmse) less than 24 or fulfilling dsm iv criteria for dementia due to parkinson's disease\]. * active hepatic disease, significantly reduced hepatic function or significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper limit of the normal range). * clinically significant ecg abnormality, including prolonged qtc (defined as qtc greater than or equal to 450 msec for males and greater than or equal to 470 msec for females using fridericia's correction). * clinically significant, cardiovascular, metabolic, respiratory, renal, endocrinological, gastrointestinal diseases, psychiatric disorders, and bacterial or viral infections within the previous 30 days. * history of drug or alcohol abuse. * women who are pregnant or lactating. * any condition that could, in the opinion of the investigator, place the subject at increased risk or is likely to prevent completion of the study
evaluation of micro-osteoperforation on rate of maxillary en-masse retraction

Conditions: Class II Division 1 Malocclusion

Summary: accelerated anterior teeth retraction with the help of microosteoperforation procedure and miniscrews.

the study contains 2 groups each contains 13 subjects, a control group (anterior segment retraction with the help of miniscrews) and an intervention group ( anterior segment retraction with the help of miniscrews and microosteoperforation)

Eligibility criteria:
inclusion criteria: * females with an age ranging between 16-30 years. * malocclusion that requires bilateral extraction of the maxillary first premolars and anterior segment retraction; angle class i mal-occlusion with bi-alveolar dental protrusions or class ii division 1. * healthy dental and periodontal condition with a good oral hygiene * absence of degenerative conditions. * full set of permanent dentition. exclusion criteria: * medically compromised patients. * previous orthodontic treatment * patients suffering from any congenital, hereditary or systemic diseases or asymmetries that might have an influence on tooth movement * chronic use of any medications affecting orthodontic tooth movement (eg: nsaids). * active periodontal affection or severe gingival inflammation.

Keywords: accelerated tooth movement and anterior segment retraction and miniscrews and microosteoperforation
the role of resistant starch in covid-19 infection

Conditions: COVID-19

Summary: this study is a multicenter randomized trial to evaluate the efficacy of administering a dietary supplement containing resistant starch to non-hospitalized covid-19 positive subjects, the intervention will begin as soon as possible after subjects test positive for covid-19 and continue for 14 days. investigators hypothesize that short-term administration of a dietary supplement containing resistant starch has the potential to reduce rates of hospitalization and improve time to clinical recovery and symptoms in non-hospitalized covid-19 positive patients.

the covid-19 pandemic has caused a substantial strain on the healthcare system, with at least 14% of infected patients requiring hospitalization. identifying ways to ameliorate the progression and severity of the covid-19 infection and preventing hospitalization is critical. patients suffering from covid-19 have been shown to have a significant inflammatory response resembling that of cytokine release syndrome, and it is this inflammatory phase that is thought to drive fatality. to this end, a multi-center randomized clinical trial to determine the efficacy of resistant starch in reducing the need for hospitalization for covid-19 positive patients will be studied. this study will enroll 1500 non-hospitalized covid-19 positive individuals who are being monitored in the outpatient setting. patients will be randomized to either a dietary supplement containing resistant starch or a placebo for 14 days. our primary outcome is the rate of hospitalization for covid-19 related complications. secondary outcomes will look at time to recovery and symptom severity scores.

Eligibility criteria:
inclusion criteria: * greater than 18 years of age * covid-positive status * being monitored in an outpatient setting at one of our study sites: * yale new haven hospital (ynhh) * university of michigan * university of minnesota exclusion criteria: * inflammatory bowel disease * history of gastric bypass surgery * active clostridium difficile infection * active participation in another covid-19 interventional trial * any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with the protocol procedures. * reported allergy to starch * difficulty swallowing in order to prevent any aspiration risk * currently taking any il-6 inhibitors such as tocilizumab for any disease condition

Keywords: covid-19 resistant starch inflammation
interactions between cocaine and ethanol and disulfiram - 1

Conditions: Alcohol-Related Disorders; Cocaine-Related Disorders

Summary: the purpose of this study is to assess potential interactions between intravenous cocaine and ethanol and oral disulfiram.

this is a two-site, double blind, placebo-controlled inpatient study to determine the cardiovascular and psychiatric safety of alcohol use in cocaine-dependent subjects who had used cocaine after treatment with disulfiram.

Eligibility criteria:
inclusion criteria: * must meet dsm-4 criteria for cocaine abuse or dependence and are not seeking treatment. * ability to verbalize understanding of consent form and provide written informed consent and verbalize willingness to complete study procedures; be able to comply with protocol requirements. exclusion criteria: * please contact site for more information.
evaluation of objective perimetry using chromatic multifocal pupillometer

Conditions: Retinal Dystrophies; Retinitis Pigmentosa; Glaucoma

Summary: objective perimetry can better monitor visual field defects in retinal dystrophy and glaucoma patients than conventional subjective perimetry. the plr ( pupil light reflex to short and long wavelength stimuli should be significantly lower compared to healthy participants in areas of visual field defects in retinal dystrophy and glaucoma patients.

pupil light reflex (plr) will be measured by a chromatic multifocal pupillometer in response to short and long wavelength light with small spot stimulus in 76 points of the 30 degree visual field. a computerized infrared video pupillometer will be used to record changes in pupil diameter in response to short- and long-wavelength stimuli (peak 485 nm and 620 nm, respectively) presented by 76 leds, 1.8mm spot size, at light intensities of 10-3000 cd/m2 and duration of 1-3 sec at different points of the 30 degree visual field

Eligibility criteria:
inclusion criteria: * age 18-80 years old. * signing informed consent. * pupillary reflex to light. exclusion criteria: 1. cloudy corneas. 2. surgical intraocular ophthalmic procedure within the past 30 days. 3. no reactive pupils. 4. synechia of the iris to the lens after surgery or inflammation. 5. neovascularization. 6. axenfeld-rieger syndrome. 7. iris atrophy (ice syndrome). 8. iris coloboma. 9. sphincter damage due to ischemia. 10. sphincter damage due to trauma (tears of sphincter or diffuse damage to muscle). 11. sphincter damage due to herpes zoster uveitis. 12. sphincter damage due to high intraocular pressure. 13. iris tumor or cyst. 14. ectropion uvae. 15. adie's pupil. 16. third nerve aberrant regeneration of the iris sphincter. 17. rp patients with optic neuropathy with the potential of producing a positive rapd (relative afferent pupillary defect). 18. chronic use of myotics or mydriatics. 19. systemic medication that have affect on pupillary reflex . 20. any condition preventing accurate measurement or examination of the pupil.

Keywords: retinal dystrophies retinitis pigmentosa glaucoma visual field
the changes of cd4+t lymphocyte subsets in septic patients

Conditions: Sepsis; SIRS(Systemic Inflammatory Response Syndrome)

Summary: the purpose of this study is to explore the value of cd4+t lymphocyte subsets in cell immunity in the patients with sepsis.there are immunoparalysis in septic patients,the important player is the change of cd4+t lymphocyte,this immunoparalysis state contribute to the illness progress and outcome. comprehend the change regularity of septic patients' cell immunity can guide fiter and correcter treatment.


Eligibility criteria:
inclusion criteria: * male and female aged 18 years old and over; * fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °c or lower than 36 °c (b)respiratory rate above 20/min, or pco2 below 32 mmhg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands. * clinically suspected infection; exclusion criteria: * were under 18 years of age; * were refused by the patients or his/her familiality; * were suffering from acquired immunodeficiency syndrome,virlhepatitis,autoimmune diseases and hematology; * use medicine which can affect immune system,such as glucocorticoid and immunosuppressant * died within 24h after being taken into the icu, or refused to get involved in the study, or gave up treatment during the period of observation

Keywords: cd4+t lymphocyte subsets sepsis immunoparalysis
exploration of microcirculatory alteration and endothelial dysfunction by adaptive optics in multiple sclerosis

Conditions: Sclerosis, Multiple

Summary: it's a pilot, interventional prospective monocentric study. it aims to compare the wall / lumen ratio (wlr) of retinal arterioles (common marker of microangiopathies) between patients with multiple sclerosis and controls using the technique of adaptive optics.


Eligibility criteria:
patient inclusion criteria * major patient between 18 and 50 years * patient with relapsing or remitting multiple sclerosis defined according to revised mc donald criteria 2010 * written, free and informed consent dated and signed * patient affiliated to a social security scheme control inclusion criteria: * person between the ages of 18 and 50 * written, free and informed consent dated and signed * person affiliated to a social security scheme * person with multiple sclerosis exclusion criteria: * contraindication to the use oxygen (o2): acute or chronic respiratory insufficiency * pregnant or lactating woman * inability to see fundus (cataract), retinopathy, glaucoma * use of vasoactive substances (eg nasal decongestants, triptans, alkaloids) in the last 48 hours * use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, ..) and steroids (corticosteroids) in the last 48 hours * known diabetes or taking antidiabetics in the last 48 hours * use of statins in the last 48 hours * known hypertension or antihypertensive treatment in the last 48 hours * any cardiac pathology (valvulopathy, angina, ventricular arrhythmia or atrial fibrillation), vascular (arteritis obliterating the lower limbs, stenosis of the arteries with encephalic destiny, coronary artery disease) or significant respiratory (asthma, chronic obstructive pulmonary disease, interstitial pathology) * alcohol consumption within 8 hours * ophthalmoparesis or incapacitating nystagmus (impossibility of correctly evaluating the fundus)
matrix therapy and bacterial keratitis

Conditions: Bacterial Keratitis

Summary: the purpose of this study is to evaluate efficiency of cacicol20 for bacterial keratitis. it is a double blinded comparison of epithelial defect in two groups of patients randomized between cacicol20 and physiological salt solution.

extracellular matrix, composed of glycosaminoglycans (gag) and matricial proteins, has a key role in tissular homeostasis. the matrix therapy is a new class of medical substance, called rgtas, regenerating agents, consist of chemically engineered polymers adapted to interact with and protect against proteolytic degradation of cytokines. otr4120 (cacicol20) is an heparan sulphate (hs) mimetic that can replace the degraded hs and protect and improve the bioavailability of cytokines. it aims to facilitate and potentiate the wound healing by restorating the natural microenvironment. cacicol20 was used in treating corneal dystrophies and chronic corneal ulcers. it significantly favored corneal healing. it was well tolerated with no side effects. bacterial keratitis is a serious ocular condition that may result in significant sight-threatening corneal sequelae. the common risk factors for infectious keratitis include ocular trauma, contact lens wear, recent ocular surgery, preexisting ocular surface disease, dry eyes, lid deformity, corneal sensational impairment, chronic use of topical steroids, and systemic immunosuppression. serious cases of keratitis are hospitalized to administrate an intensive hospital-made local antibiotic. the purpose of this study is to evaluate efficiency of cacicol20 for bacterial keratitis. it is a double blinded comparison of epithelial defect in two groups of patients randomized between cacicol20 and physiological salt solution.

Eligibility criteria:
inclusion criteria: * - hospitalized patients for bacterial keratitis in ophthalmology department, clermont-ferrand university hospital .with a controlled local infection after 48 hours local antibiotics. * with a corneal ulcer diameter \> 2 millimeters exclusion criteria: * - ulcers deeper than the superficial stroma, perforated ulcers or pre-perforated, requiring a surgical intervention \< 15 days. * clinical suspicion and/or microbiological evidence of fungal or parasitic infection * non controlled infection in spite of 48 hours intensive local antibiotics * allergy * silver or copper salts treatment * ocular surgery within the last 1 month * unable to follow up medical examinations for geographical, social, physical or psychological reasons * patient already included in another clinical trial * pregnant patients or breastfeeding * person under a legal protection measure, under guardianship * not cover by social insurance.

Keywords: bacterial keratitis otr4120 matrix therapy