Kornimate/medical-research-clean huggingface dataset:
a pilot study of 566c80 for the salvage treatment of toxoplasmic encephalitis in patients infected with the human immunodeficiency virus (hiv) who have failed or are intolerant of pyrimethamine-sulfadiazine

Conditions: Toxoplasmosis, Cerebral; HIV Infections

Summary: to evaluate the safety and tolerance of atovaquone (566c80) in aids patients with central nervous system (cns) toxoplasmosis. to evaluate the efficacy of 566c80 in the acute treatment and suppression of cns toxoplasmosis in aids patients who fail or who cannot tolerate conventional therapy.


Eligibility criteria:
inclusion criteria patients must have the following: * presumptive diagnosis of aids. * cerebral toxoplasmosis. * expected survival of at least four weeks without therapy. * willing and able to give informed consent. prior medication: allowed: * pyrimethamine-sulfonamide. * clindamycin-sulfonamide. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * significant emotional disorder or psychosis. * evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption. * other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. unwilling or unable to take 566c80 with a meal, enteral supplements (eg: * ensure plus) or pulverized form through a nasogastric tube. * active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen. concurrent medication: excluded: * drugs with potential anti-toxoplasmosis activity including sulfone, sulfonamide, trimethoprim, pyrimethamine and clindamycin during the acute therapy phase of the trial. * first three weeks of treatment: * retrovir (zidovudine) or any investigational agent including antiretroviral agents (eg: * ddi,ddc). patients with the following are excluded: * significant emotional disorder or psychosis. * evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption. * other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. unwilling or unable to take 566c80 with a meal, enteral supplements (eg: * ensure plus) or pulverized form through a nasogastric tube. * active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen. active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.

Keywords: toxoplasmosis aids-related opportunistic infections naphthoquinones encephalitis acquired immunodeficiency syndrome
oesophageal probe evaluation in rf ablation of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the trial will evaluate the influence of oesophageal probes in radio frequency (rf)-ablation of atrial fibrillation regarding oesophageal ulcers after ablation.

the trial will evaluate the influence of oesophageal probes in rf-ablation of atrial fibrillation regarding oesophageal complications after ablation. 200 patients will be prospectively randomised into 2 groups. the conventional group will undergo rf-ablation of atrial fibrillation using an oesophageal probe to measure the temperature during ablation. in the other group will receive ablation using fixed energy levels (25 watt) at the posterior left atrial (la) wall without an oesophageal probe , all patients will get a gastroscopy for evaluation of oesophageal complications the day after the procedure. all patients will have a 6 months follow up (fu) in our clinic to be reevaluated for complications (primary endpoint) and rhythm stability. (secondary endpoint)

Eligibility criteria:
inclusion criteria: * 12 lead ecg with documented atrial fibrillation * indication for rf ablation of atrial fibrillation according to the recent guidelines * signed informed consent * age 18-85 years exclusion criteria: * pregnancy or possible pregnancy without negative test within 48h prior to ablation * intracardiac thrombus * contraindication for oral anticoagulation * conditions, that may complicate the positioning of the oesophageal probe

Keywords: atrial fibrillation esophageal probe thermolesion
effects of dihydropyridine calcium channel inhibitors on respiratory gas exchanges in the intensive care unit: a pharmacovigilance study in vigibase® and a comparison with urapidil

Conditions: Hypoxia

Summary: due to their effects on hypoxic pulmonary vasoconstriction (hpv), dihydropyridine calcium channel inhibitors (cci) could lead to hypoxia in patients with a pulmonary shunt. to the present time only preclinical studies and case reports focused on this potential adverse drug reaction. we aimed to assess the reporting association between cci and hypoxia using the world health organization pharmacovigilance database (vigibase®).


Eligibility criteria:
inclusion criteria: * present in the database exclusion criteria: * chronology not compatible with the drug imputability
fetal parenchymatic evaluation (liver, spleen) using t2* sequences

Conditions: Iron Overload

Summary: the purpose of this study is to prospectively evaluated the t2\* values of normal feti.a standardized scale of t2\* values for fetal and neonatal iron organ overload have yet to be reported or devised.

the purpose of this study is to prospectively evaluate the t2\* values of normal feti. this study will be offered to mothers undergoing fetal mri for any indication. subjects will be required to sign an informed consent from. the addition of t2\* sequences will add 2-4 minutes to the whole scan, not exposing the mother or the fetus to ionizing radiation or the administration of contrast material. a standardized scale has been created and multi-center studies have been conducted using different vendor scanners in order to verify the consistency of these scale. t2 and t2\* sequences have been addressed anecdotally in the literature as non invasive options for the evaluation fetal iron deposition . however, a standardized scale of t2\* values for fetal and neonatal iron organ overload have yet to be reported or devised.

Eligibility criteria:
inclusion criteria: * any mri study for fetus exclusion criteria: * known iron deposition problem in the mother of fetus

Keywords: liver, spleen , t2* , mri, fetus
pharmacokinetics/pharmacodynamics of nox-h94 in the human endotoxemia model

Conditions: Anemia of Chronic Disease

Summary: the purpose of this study is to assess the effect of the anti-hepcidin spiegelmer nox-h94 on iron homeostasis during systemic inflammation induced by endotoxin. in the human endotoxemia model, intravenously administered lipopolysaccharide elicits an inflammatory response with release of pro-inflammatory cytokines, such as il-6 and tnf-alfa, with subsequent induction of hepcidin. as a consequence of hepcidin induction, serum iron concentrations decrease. this study in healthy subjects investigates the capacity of nox-h94 to inactivate hepcidin and to prevent serum iron decrease in a pathophysiological model prior to studying the efficacy of nox-h94 in patients with anemia of chronic disease.


Eligibility criteria:
main inclusion criteria: * bmi between 18 and 30 kg/m², with a lower limit of body weight of 50 kg * healthy as determined by medical history, physical examination, vital signs, 12 lead electrocardiogram, and clinical laboratory parameters * serum iron and red blood parameters hb, mcv, ferritin, serum iron, and total iron binding capacity within reference range main exclusion criteria: * use of any medication, recreational drugs or anti-oxidant vitamin supplements within 7 days * use of caffeine, nicotine, or alcohol within 1 day * previous participation in a trial where lps was administered * surgery or trauma with significant blood loss or blood donation within 3 months * history, signs or symptoms of cardiovascular disease (vaso-vagal collapse or of orthostatic hypotension, resting pulse rate ≤45 or ≥100/min, hypertension, hypotension, ecg conduction abnormalities) * renal impairment: plasma creatinine \>120 µmol/l * liver function tests (alkaline phosphatase, ast, alt and γ-gt) outside of the reference range or total bilirubin \>20 µmol/l * hemoglobin or iron parameters (iron, transferring saturation, ferritin) outside of the reference ranges * history of asthma * immuno-deficiency * positive test of hiv type 1/2 antibodies, hbs antigen, hbc antibodies and hcv antibodies unless antibody titer is induced by vaccination * crp \> reference range or clinically significant acute illness, including infections, within 2 weeks * treatment with investigational drugs or participation in any other clinical trial within 30 days prior to study drug administration * known or suspected of not being able to comply with the trial protocol * inability to personally provide written informed consent and/or take part in the study
lumier² study : lupus molecular immunomonitoring to evaluate the risk of relapse

Conditions: Systemic Lupus Erythematosus (SLE)

Summary: we aim to determine the accuracy or blood transcriptomic signatures to predict the occurrence of flares in patients with sle that are clinically quiescent at inclusion systemic lupus erythematosus (sle) is a chronic auto-immune disease evolving by flares, with possible organ damage, and periods of remission. current biological markers of disease activity are not sufficient to predict the occurrence of flares, monitor response to treatment or adapt therapeutic strategies. a previous study on genome-wide whole blood transcriptomic signatures in sle (chiche et al, arthritis rheumatology 2014) has identified gene panels associated with sle disease activity

systemic lupus erythematosus (sle) is a chronic auto-immune disease evolving by flares, with possible organ damage, and periods of remission. current biological markers of disease activity are not sufficient to predict the occurrence of flares, monitor response to treatment or adapt therapeutic strategies. a previous study on genome-wide whole blood transcriptomic signatures in sle (chiche et al, arthritis rheumatology 2014) has identified gene panels associated with sle disease activity. we aim to determine the accuracy or blood transcriptomic signatures to predict the occurrence of flares in patients with sle that are clinically quiescent at inclusion. lumier² is a prospective multicentric observational study conducted in the departments of clinical nephrology, internal medicine and rheumatology in the south of france. adult patients with sle, clinically quiescent and with no change in treatment in the past 3 months, will be included and followed-up for 12 months. blood samples will be drawn every 3 months during 12 months in the absence of flare. patients presenting a flare will be sampled at the time of the flare and 1 month later. the inclusion of 300 patients is expected, with a test cohort (150 patients) and a validation cohort (150 patients).

Eligibility criteria:
inclusion criteria: * age ≥18 years * sle defined by acr criteria * clinically quiescent disease (sledai =\< 4 without clinical flare) and absence of treatment increase in the past 3 months * written informed consent exclusion criteria: * pregnancy, lactation
effects of physical therapy on improving disc height, postural stability, pain and function in persons with discogenic low back pain

Conditions: Low Back Pain; Disk Prolapse

Summary: lumbar degenerative disc disease and discogenic low back pain is comparatively common and disabling musculoskeletal condition, however there is no conclusive evidence regarding the positive effects of conservative physical therapy management in terms of radiological changes and improvement in disc height. for this reason, the current study will not only look into the positive effects of conservative physical therapy on postural stability, pain and function, but also in terms of disc height in persons with discogenic low back pain.


Eligibility criteria:
inclusion criteria: * both male and female participants * aged 18-50 years old * low back pain intensity less than 80/100mm on visual analogue scale * positive centralization phenomenon * low signal intensity of iv disc on t2 - weighted mri * high intensity zone towards the posterior aspect of the disc on mri exclusion criteria: * individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study.
evaluation of hemostasis in bleeding and thrombotic disorders

Conditions: Blood Coagulation Disorders, Inherited; Thrombotic Disorder

Summary: the objective of this study will be to assess the coagulation system in-vitro in a variety of bleeding and clotting disorders using the roteg analyzer and the thrombin generation assay.

this is an exploratory study involving blood coagulation assays in a select group of individuals receiving treatment for their congenital or acquired bleeding or clotting disorder at uthealth houston. the roteg is a newly developed coagulation analyzer which allows the continuous assessment of whole blood coagulation from the formation of the first fibrin fibers and activated platelets, to the formation of a three-dimensional whole blood clot until the eventual dissolution of the clot. this device will not be used as a diagnostic or procedure tool. no recommendations regarding interpretation of the results or implications for future treatment will be provided.

Eligibility criteria:
inclusion criteria: patients with congenital or acquired bleeding or clotting disorders who have provided informed consent and/or assent exclusion criteria: poor venous access

Keywords: hereditary bleeding disorder thrombotic disorder
a comparison of patch vs. pill estrogen therapy on testosterone levels and thyroid tests in menopausal women

Conditions: Menopause

Summary: this study compares the effects of 12 weeks of treatment with transdermal versus oral estrogen therapy on testsoterone levels and thyroid tests in healthy, naturally menopausal women.


Eligibility criteria:
inclusion criteria: * healthy * naturally menopausal women * aged 42-70 years * currently using combination estrogen-progestin replacement therapy exclusion criteria: * women with contraindications to hrt use, including:unexplained vaginal bleeding, liver disease, breast or endometrial cancer, venous thromboembolic events * thyroid disease * adrenal disease

Keywords: menopause testosterone androgens sex hormone binding globulin thyroid function cortisol
effect of storage condition on cd47 expression level in platelet concentrate

Conditions: Platelet Storage Pool Deficiency

Summary: effect of storage condition on cd47 expression level in platelet concentrate

cd47 is a cell surface glycoprotein expressed on all cell types .it is an attractive target for therapy because it is involved in regulation of cell survival and cell death by acting as a ligand for signal-regulatory protein alpha expressed on macrophages

Eligibility criteria:
inclusion criteria: * donors met aabb criteria exclusion criteria: * donors not met aabb criteria
prevention and treatment of frostbite infection with antimicrobial pharmacokinetic analysis

Conditions: Frostbite

Summary: this study will compare the effectiveness of two different treatments for preventing infection from frostbite injuries. these two treatments are a) aloe vera and b) long-acting silver wound dressings. the investigators will also study the safety and effectiveness of dalbavancin, an fda approved antibiotic used for treating people who develop frostbite wound infections, as well as evaluate how frostbite damage to individuals' bodies may affect how fast their kidney clear drugs from their systems.


Eligibility criteria:
inclusion criteria: * all aims, aged ≥18 - \< 99 years old admitted to uch burn center with frostbite injury * aim 1: admitted to uch burn center with acute (within 4 days of cold exposure) frostbite injury * aim 2: admitted to uch burn center with a clinically confirmed or suspected infected frostbite wound exclusion criteria: * pregnant patients * prisoners * anticipated death within 48 hours of admission * inability to obtain consent from patient, legally authorized representative, or proxy * aim 1:patients admitted five days and later from frostbite injury. patients who have a clinical infection at baseline. any patients that have a contra-indication for the use of either aloe (allergy), or silver (allergy). * aim 2: any patients that have a contraindication for use of dalbavancin, including known history of hypersensitivity to dalbavancin, vancomycin, or other glycopeptide antibiotics. patients with infections known to be caused by vancomycin-resistant enterococcus; or those with stage iv or v chronic kidney disease, or with cirrhosis (childs-pugh c); or those with anticipated death within 48 hours of infection. * aim 3: anuria due to chronic kidney disease (ckd)
random trial for elderly patients with nsclc

Conditions: Non-Small Cell Lung Cancer

Summary: 1. recently a radomized trial of vinorelbine versus best supportive care in patients at 70 years of age or older demonstrated a definite improvement in overall survival rate and quality of life with chemotherapy. 2. the role of combination therapy containing the platinum compound, which is the standard therapy for the young patients is still vague. 3. gemcitabine and carboplatin have favorable toxicity profile.


Eligibility criteria:
inclusion criteria: * patients with pathologically confirmed, advanced(clinical stage iiib or iv) nsclc * no previous chemotherapy history * age ≥ 65 years * ecog performance status ≤ 2 * adequate marrow function (anc ≥ 2,000/mm3, platelet ≥ 100,000/mm3), renal and liver function (total bilirubin \< 2.0 mg/dl, ast/alt levels \< 3 × the upper limit of normal, serum creatinine \< 2.0 mg/dl) * patients with informed written consent exclusion criteria: * patients with other major illness(active infection, severe heart disease, concomitant malignancy, etc)
blind elderly melatonin treatment study

Conditions: Blindness

Summary: the primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of elderly blind individuals to the 24-hour day.

the investigators intend to study as many as 26 subjects through up to four melatonin treatment regimens, all of which involve a dose step-down in which the melatonin dose will be reduced gradually to find the lowest effective dose. the 4 treatment plans differ only in the start dose and the time of administration. successfully treated subjects will enter a one-year intensive assessment of the safety and efficacy of melatonin treatment in which the subject will take the same dose for one year and complete biweekly assessments of efficacy and side-effects. the final phase of the study involves a placebo discontinuation, in which the subject's circadian rhythm will be returned to the baseline rhythm (this may take up to 6 months for some subjects).

Eligibility criteria:
inclusion criteria: * adults 55-100 years old * blindness for at least one year, verified by an ophthalmologic exam * ability to comply with the requirements of the experimental protocol * no clinically significant abnormalities (other than blindness) on a general physical examination * subjects must be competent to sign informed consent exclusion criteria: * abnormal heart, liver or kidney function; a current axis i psychiatric or substance abuse disorder according to the dsm-iv manual * a diagnosis of obstructive sleep apnea (apnea index \> 10) or nocturnal myoclonus (\> 10 associated arousals/hour) * external demands that limit the ability to maintain a regular schedule, e.g., night shift work

Keywords: melatonin circadian rhythms sleep
correlation between ultrasound-assessed quadriceps muscle mass and baseline whole-body densitometry muscle index in the post-cancer population (jump research ii)

Conditions: Cancer; Post-cancer; Hematology

Summary: therapeutic advances in oncology have transformed the prognosis of cancer patients, placing a significant number of them either in a context of recovery or in prolonged remission close to a chronic disease. thus, the reconquest of a life after cancer becomes possible but raises many challenges for the patient, his entourage, the medical profession and our society. one of the major challenges is the detection and management of treatment side effects for all patients. in addition to the standard organic assessment (glycaemia, creatinine, liver test, blood count), we are mainly interested in muscle deconditioning and cognitive impairment, which are particularly disturbed in these populations. after the evaluation day, patients are referred to the most appropriate structures (adapted physical activity, sports for health, and rehabilitation at henry gabriel hospital). jump research is part of axis 2 of the 2021-2030 cancer plan: "limiting sequelae and improving quality of life", through sheets 1 (research) / 6 (access and quality) / 7 (prevention). this leads to the concrete implementation on the territory of adapted care channels in the city: medical structure, physiotherapy, adapted physical activity (apa) structures, associative structures; which makes it possible to develop and strengthen the city-hospital link. finally, it allows the patient to take ownership and get involved in the project, allowing in the future to make them truly active in they care and to advise and motivate their peers. this non-interventional research is classified as "research involving human subjects", class 3 . the objective of this research is to evaluate the impact of cancer on the musculoskeletal system and to test ultrasound as a clinical examination for the detection of sarcopenia in this population.


Eligibility criteria:
inclusion criteria: * age : 18 to 74 years * localization of the primitive: breast, lung, melanoma, testicle, bladder, kidney, ovary, colon and pancreas, hemopathy * patient who benefited from the post-cancer assessment day exclusion criteria: * active cancer (relapse or new cancer) * pregnant or breastfeeding women * major cognitive impairment making comprehension and exercise difficult * amputation of both lower limbs (for ultrasound) * difficulty understanding oral and written french * adults under legal protection (guardianship, curatorship or safeguard of justice)

Keywords: post-cancer sarcopenia medical evaluation muscle