Kornimate/medical-research-clean huggingface dataset:
phase 2b study of aslan004 in adults with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: phase 2b study designed to evaluate the efficacy and safety of aslan004 in adult patients with moderate-to-severe atopic dermatitis (ad) who are candidates for systemic therapy. this study will have 5 treatment arms (4 active and 1 placebo).


Eligibility criteria:
inclusion criteria: 1. male or female patients with a clinical diagnosis of ad for at least 1 year; 2. viga score of ≥3 at screening and baseline; 3. ≥10% bsa of ad involvement at screening and baseline; 4. easi score ≥16 at screening and baseline; 5. history of inadequate response to treatment with topical corticosteroids (tcs) or topical calcineurin inhibitors (tci); 6. twice daily application of a consistent amount of topical emollient for at least 7 days prior to randomization. exclusion criteria: 1. immunosuppressive/immunomodulating drugs, systemic therapies or phototherapy within 4 weeks prior to randomization; 2. treatment with leukotriene inhibitors within 4 weeks prior to randomization; 3. treatment with topical therapies (including tcs, tci, topical phosphodiesterase inhibitors, topical jak inhibitors) or prescription moisturizers, within 1 week prior to randomization; 4. previous treatment at any time prior to randomization with monoclonal antibody / biologic therapeutic agents as follows; 1. prior exposure to dupilumab (dupixent®) which was discontinued due to lack of efficacy, loss of response, or adverse event; 2. investigational or approved agents targeting interleukins il-4 or il-13 ligands or receptors of il-4 or il-13, including but not limited to lebrikizumab, tralokinumab or aslan004; 3. other investigational or approved biologic drug within 16 weeks or within 5 half-lives (if known), whichever is longer, prior to the baseline visit; 4. cell-depleting biologics, including, but not limited to, rituximab within 6 months prior to the baseline visit; 5. inadequate organ function, abnormal lab result, uncontrolled blood pressure or other health condition considered clinically significant by the investigator at the screening visit; 6. history of hiv, hepatitis b, hepatitis c or active/latent tuberculosis infection; 7. history of immunosuppression including history of invasive opportunistic infections; 8. treatment with live attenuated vaccine within 8 weeks prior to randomization; 9. parasitic infection within 4 weeks prior to baseline travel within 3 months prior to randomization to areas of high parasitic exposure; 10. have skin comorbidities that in the opinion of the investigator may interfere with study assessments; 11. pregnant or breastfeeding women; 12. patients unwilling to use adequate birth control. 13. active covid infection at baseline.

Keywords: atopic dermatitis il-13 aslan004 il-13rα1 eczema anti-il-13rα1 atopic eczema
risk of severe hepatic injury in patients with invasive candidiasis treated with echinocandins

Conditions: Invasive Candidiasis; Candidemia

Summary: the purpose of this study is to estimate the relative risk of severe hepatic injury in hospitalized patients with invasive candidiasis and candidemia who received anidulafungin, compared to patients who received caspofungin and/or micafungin.


Eligibility criteria:
inclusion criteria: * acute-care inpatients; * aged 18 years or older; * at least one dose of echinocandin therapy during the hospitalization; * primary or secondary icd-9 discharge diagnosis of invasive candidiasis / candidemia. exclusion criteria: * \< 18 years of age; * no recorded echinocandin therapy during hospitalization; * acetaminophen hepatotoxicity; * pre-existing autoimmune hepatitis; * autoimmune/metabolic liver disease; * primary biliary cirrhosis; * primary sclerosing cholangitis and orthotopic liver transplantation.

Keywords: invasive candidiasis candidemia severe hepatic injury echinocandins anidulafungin caspofungin micafungin
motor and premotor cortex stimulation for treatment of secondary focal dystonia with striato palliadal lesion : evaluation of safety and effectiveness

Conditions: Focal Dystonia

Summary: dystonia is a neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. this disease is very heterogeneous and can have many causes. current treatments (drugs, pallidal stimulation) improve primary generalized dystonias; however they are ineffective for focal dystonias following brain damage. cortex stimulation is a present and effective technique used in the treatment of chronic pain and could represent an interesting strategy to treat focal dystonias. this is the aim of the present study.

pilot study included 6 centres (clermont-ferrand, bordeaux, paris, créteil, lyon and grenoble) study progress : * 3 months to 1 month before chirurgical intervention : selection of patient that could be included in the protocol. * 15 days to 8 days before chirurgical intervention : inclusion visit. * operating phase : under anaesthesia, implantation of the neurostimulator and its components, and adjustment of stimulation parameters. * 1 month after chirurgical intervention : checking that all is fine (detection of undesirable events) * 2 months to 5 months after chirurgical intervention: randomization (double blind): the stimulator is put on position on or off * 5 months after chirurgical intervention : stimulators of all patients are stopped for one month whatever the group they belong. * 6 months to 9 months after chirurgical intervention: stimulatiors are put on position on or off (cross over with the first period). * 9 months to 13 months after chirurgical intervention: stimulators of all patients are started for four months whatever the group they belong. * 13 months after chirurgical intervention : study end

Eligibility criteria:
inclusion criteria: * age : \>18 years and \< 65 years * evolution time of dystonia \> 1 year * clinical stability of dystonia = 1 year * secondary dystonia due to a focal lesion (vascular or anoxic) of central grey nuclei * inefficiency of others treatments (anticholinergic, benzodiazepine, neuroleptique, botulinum toxin, etc.) * stability of treatment \>3 months * agreement of patients * affiliation to social security exclusion criteria: * significant heart vascular disease; significant respiratory, metabolic, renal or hepatic diseases * significant clinical and biological anomalies * disease or treatment in favour in bleeding * sever cognitive disorders * psychiatric evolutionary pathology * counter-indication during inclusion examination * chirurgical counter-indication * pregnant women ou women who nurse * person who participate to an other study

Keywords: cortex stimulation focal secondary dystonia effectiveness quality of life improvement focal dystonias secondary to central grey nuclei lesions
resection vs no resection of the primary in colorectal cancer with unresectable metastases

Conditions: Colonic Cancer; Unresectable Metastasis Originating in Colonic Cancer

Summary: main outcome: assess the impact of cancer-related survival at 2 years in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery followed by chemotherapy. to assess overall survival. to evaluate postoperative morbidity and mortality in patients treated with resection of the primary tumor. assess complications and meed for surgery in patients treated with systemic chemotherapy only during the course of the disease. identify and describe the complications related to chemotherapy and toxicity in the short and medium term systemic treatment. assessing the quality of life questionnaire qlq-c30 and qlq-cr29. to study prognostic survival factors. method: multicenter randomized clinical trail (22 hospitals). two parallel group in which to evaluate two therapeutic strategies for colorectal cancer metastasis unresectable stage iv: chemotherapy alone versus primary tumor resection plus chemotherapy. subjects: patients with unresectable nonmetastatic colorectal cancer. hypothesis:surgical resection of the primary tumor in stage iv colorectal patients with unresectable synchronous metastases increases by 14% overall survival compared to patients receiving systemic treatment with chemotherapy without resection of the primary tumor (survival of 34% vs 20%).

intervention: arm b (control): chemotherapy alone, regimen according to each center. arm a (experimental): surgery (complete tumoral resection; r0) followed by chemotherapy, regimen according to each center. statistical analysis: a power analysis showed that to assure a significance level of 0,05 and a beta error 0.20. 168 patients are necessary in each arm. it has been estimated a loss rate of up to 10%. differences between groups will be analyzed by t, u, x2, exact test and survival will be assessed according to kaplan and meier method. evaluation of safety of the trial will be made in the middle of the study statistically

Eligibility criteria:
inclusion criteria: * colorectal cancer above to 12 cm from the anal verge * unresectable synchronous metastases * no contraindications for chemotherapy * absence of peritoneal carcinomatosis, central nervous system o bone metastasis. * performance status ecog ≤ 2 (eastern cooperative oncology group) * uncontrolled concomitant medical conditions that may compromise to chemotherapy * significant symptomatic cardiac disease * not pregnancy or breastfeeding exclusion criteria: * cases of rectal tumours below 12cm from anal verge, or locally advanced tumours invading blood vessels, nerves or bone. * multiple bone metastasis or central nervous system metastasis * other neoplastic disease in the 5 previous years, except squamous or basal cell skin carcinoma or cervical "in situ" carcinoma * significant heart disease (chronic congestive heart failure, symptomatic coronary disease) or myocardial infarction in the previous 6 months * peripheral neuropathy * patients who do not give informed consent

Keywords: colonic cancer metastasis
liver mri with primovist/eovist in pediatric subjects who are suspected or have focal liver lesions.

Conditions: Liver Neoplasms; Adenoma; Carcinoma; Liver Abscess

Summary: medical records are reviewed to obtain information about the use of a mri diagnostic imaging agent (contrast agent) called primovist/eovist in children older than 2 months and less than 18 years. data that has been recorded in the child's medical records relating to the injection of primovist/eovist will be collected. information will be collected from up to 2 weeks before the child received primovist/eovist until 12 months after the child received primovist/eovist. copy of the child's mr images that were taken right before and after the child received primovist/eovist and all other reports (laboratory reports, other imaging reports, etc) that are part of the child's medical records during that time period will be collected.


Eligibility criteria:
inclusion criteria: * age \>2 months and \<18 years of age at the time of the primovist/eovist enhanced mri * mri with primovist/eovist due to suspected or known focal liver lesions * evaluable safety data * evaluable efficacy data: precontrast and postcontrast magnetic resonance (mr) images must be available for review * if the above criteria are met, the principal investigator (pi) and/or designee will obtain a signed consent for medical records release including access to anonymized electronic copies of the pre- and post-primovist/eovist mri scans, in accordance with local regulatory requirements in order for subjects to be enrolled in the study. exclusion criteria: * a subject will be excluded from this observational / retrospective study if the subject has previously been enrolled into this study. subjects may only be entered once into this study, even if they have been imaged multiple times and for different indications.

Keywords: liver neoplasms adenoma liver cell carcinoma hepatocellular liver abscess
iv plerixafor with mitoxantrone etoposide and cytarabine for acute myeloid leukemia (aml)

Conditions: Leukemia, Myeloid, Acute

Summary: in this phase i extension study, the investigators seek to test the safety of both higher doses of plerixafor as well as intravenous dosing to maximize inhibition of the target, cxcr4.

in this study, we are seeking to target the leukemia microenvironment to overcome disease resistance. we hypothesize that by disrupting the interaction of leukemic blasts with the bone marrow microenvironment, we may sensitize leukemic blasts to the effects of cytotoxic chemotherapy. in current formulations, the volume of plerixafor required to administer doses higher than 240 mcg/kg may result in significant discomfort with repeated daily injections. in this phase i extension study, we seek to test the safety of both higher doses of plerixafor as well as intravenous dosing to maximize inhibition of the target, cxcr4.

Eligibility criteria:
inclusion criteria: * acute myeloid leukemia diagnosed according to who criteria with one of the following: * primary refractory disease following ≥ 1 round of induction chemotherapy * first relapse or higher * age between 18 and 70 years * ecog performance status ≤ 2 * adequate organ function defined as: * creatinine ≤ 1.5 x institutional uln * ast ≤ 2 x uln except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia) * alt ≤ 2 x uln except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia) * total bilirubin ≤ 2 x uln except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia) * left ventricular ejection fraction of ≥ 40% by muga scan or echocardiogram * women of childbearing potential and sexually active males must be willing and able to use effective contraception while on study * able to provide signed informed consent prior to registration on study exclusion criteria: * acute promyelocytic leukemia (aml with t(15;17)(q22;q11) and variants) * peripheral blood blast count ≥ 50 x 103 /mm3 * active cns involvement with leukemia * previous treatment with mec or other regimen containing both mitoxantrone and etoposide * pregnant or nursing * concurrently receiving any other investigational agent * received colony stimulating factors filgrastim or sargramostim within 48 hours or pegfilgrastim within 14 days of study * less than 2 weeks from the completion of any previous cytotoxic chemotherapy (excluding hydroxyurea) * severe concurrent illness that would limit compliance with study requirements
evaluation of frailty and functional capacity in end-stage liver disease

Conditions: End Stage Liver Disease

Summary: development of fibrosis plays a main role in the pathophysiology of liver diseases. the rate of progression in fibrogenesis varies according to the type of underlying liver disease and varies with the environment and host-related factors. end-stage liver diseases are characterized by systemic vascular resistance and decreased arterial blood pressure, increased heart rate and cardiac output . disruption of regulation of neurogenic, humoral and vascular functions is effective in these cardiovascular changes. in end-stage liver diseases, glycogen storage and corruption of glyconeogenesis cause muscle protein and fat to be used for energy, resulting in weight loss and muscle weakness. according to the latest data of the republic of turkey ministry of health in turkey in 2223 patients are waiting for liver transplantation. acute and chronic liver disease and infectious complications lead to an increase in the number of hospitalizations and prolonged hospital stay and severely affect the functional status and mortality. in recent years, more attention has been paid to complications from chronic diseases, including malnutrition, sarcopenia, poor functional capacity, and frailty. there are few studies in the literature examining functional capacity and physical frailty in end-stage liver disease. the aim of this study was to investigate the relationship between functional capacity and frailty in end-stage liver disease.

the decrease in functional capacity is a finding that affects quality of life in chronic liver diseases. in a study, 6 minute walk test was associated with mortality in patients with cirrhosis and survival was lower in patients walking less than 250 meters. malnutrition is a common complication of end-stage liver disease. it is a complex condition that causes loss of muscle and fat mass, loss of body weight, increased pro-inflammatory cytokines, anorexia and fatigue, resulting in sarcopenia. sarcopenia is generally defined as a loss of muscle mass and muscle strength and is directly related to adverse outcomes in these patients. in the evaluation of malnutrition in end-stage liver disease, evaluation of skeletal muscle (mass, strength, functionality) provides an objective way to determine malnutrition, since most intrinsic markers originate from existing liver disease (eg albumin, prealbumin, lymphopenia levels).

Eligibility criteria:
inclusion criteria: * follow-up with end-stage liver disease in hacettepe university faculty of medicine, department of gastroenterology * volunteering for research exclusion criteria: * presence of hepatopulmonary syndrome * presence of portopulmonary hypertension * uncontrolled severe hepatic encephalopathy * previous history of liver transplantation * presence of orthopedic problems that will affect the research * presence of neurological deficits * severe chronic obstructive pulmonary disease or heart failure

Keywords: end stage liver disease frailty exercise test muscle weakness exercise tolerance hand strength muscle strength
the effect of l-citrulline malate on ankle brachial index among patients with coronary heart disease

Conditions: Coronary Heart Disease

Summary: in this randomized clinical trial before and after study we will assess the effect of l-citrulline malate on brachial index in patients with coronary heart disease based on their smoking history. twenty patients with coronary heart disease with no history of diabetes or other chronic diseases and with no history of myocardial infarction in the last 6 months will participate in our trial.a written well-versed permission was attained from all patients. we will measure the brachial index tow times once before giving l-citrulline malate and the other time after 2 weeks giving it.patients receiving l-citrulline malate as a 1 gram dry powder agent twice a day, that should in use with 250 mg dilute water .the patients will followed after 2 weeks by measuring brachial index which is our primary outcome measurement in this trial.we assumed that the brachial index in both smoker and non-smoker group of patients with coronary heart disease would change to normal or close to normal after giving 1 gram l-citrulline malate twice a day for 2 weeks.


Eligibility criteria:
inclusion criteria: 1- patients with coronary heart disease without history of diabetes or any chronic disease 2- no myocardial infarction in last 6 months 3-ejection fraction more than 50% 4- please to recruit in the trial 5-no uncontrolled blood pressure 6- with stable condition when come to the clinic exclusion criteria: 1- those who refuse to being in the trial 2- those which their total condition become worse 3- ccu admission as a result of being unstable 4- patients with chronic heart failure(chf)

Keywords: l-citrulline malate,coronary heart disease, brachial index
rapid diagnosis of myocardial damage and coronary stenosis with magnetic resonance imaging (mri)

Conditions: Myocardial Infarction

Summary: the hypothesis is that single-shot imaging of myocardial infarction is possible in atrial fibrillation using mri late enhancement technique

50 outpatients in jonkoping county with a diagnosis of in-hospital myocardial infarction, are asked to participate in this study comparing segmented true fisp late enhancement with single-shot truefisp late enhancement for the diagnosis of myocardial damage. the study does not intervene regarding treatment but is a comparison of the diagnostic power of the two mri techniques.

Eligibility criteria:
inclusion criteria: in-hospital diagnosis of myocardial infarction exclusion criteria: pacemaker, not willing to participate, metallic objects in brain or eyes,

Keywords: myocardial infarction mri late enhancement atrial fibrillation
genistein stimulates insulin sensitivity through gut microbiota

Conditions: Metabolic Syndrome; Obesity

Summary: there is evidence that genistein present in soy can improve insulin resistance in rodents and humans with metabolic syndrome (mets). however, it is not known if this improvement is associated with changes in the gut microbiota. in the present study, the investigators show that the consumption of genistein for 2 months could have an effect on insulin resistance in subjects with mets. this effect will be accompanied by a modification of the gut microbiota taxonomy. as a consequence, there will be a reduction in metabolic endotoxemia accompanied by an increase in amp-activated protein kinase (ampk) phosphorylation and the expression of genes of fatty acid oxidation in skeletal muscle.

the investigators included 45 participants who met the following inclusion criteria: adults between 20 and 60 years of age with a diagnosis of mets, homa index greater than 2.5, bmi ≥30 and ≤ 40 kg / m2 and who signed the consent letter. patients who had any added pathology, pregnancy, smoking or consumed medications were excluded. once the letter of informed consent was accepted, the patients were assigned to the respective treatment group. these individuals were advised to consume the recommended diet for subjects with mets according to the guidelines of the atpiii. participants were randomly distributed to consume a) placebo treatment or b) genistein capsules (50 mg/day). the participants were followed for 2 months. in the previsit, informed consent letters were given, and blood samples were taken to evaluate glucose concentration, lipid profile, lipopolysaccharide and serum insulin. also determined blood pressure, body weight, height, body composition and gut microbiota. the presence of insulin resistance was determined by means of the homa-ir index and by an oral glucose tolerance test. after 2 months, the same variables were assessed, and an expert surgeon in the operating room performed a vastus lateralis muscle biopsy, then rna extraction and gene expression microarray assay was performed

Eligibility criteria:
inclusion criteria: * adults (men and women) between the ages of 18 and 50. * patients with obesity (bmi ≥ 30 and ≤ 40 kg / m2) and with insulin resistance (homa - ir index ≥ 2.5). * mexican mestizos (parents and grandparents born in mexico). * patients who can read and write. exclusion criteria: * • patients with any type of diabetes. * patients with kidney disease diagnosed by a medical or with creatinine\> 1.3 mg / dl for men and \> 1.1 mg / dl for women and / or bun\> 20 mg / dl. * patients with acquired diseases that produce obesity and diabetes secondarily. * patients who have suffered a cardiovascular event. * patients with weight loss \> 3 kg in the last 3 months. * patients with any catabolic diseases. * gravidity status * positive smoking * treatment with any medication

Keywords: genistein gut microbiota ampk fatty acid oxidation