Kornimate/medical-research-clean huggingface dataset:
study of dmxaa (now known as asa404) in solid tumors

Conditions: Solid Tumors

Summary: this is a phase i study aimed at identifying safe doses of dmxaa in patients with solid tumors.

this is a dose escalation study conducted at a single center in new zealand. patients received dimethylxanthenone acetic acid (dmxaa) iv over 20 minutes once every three weeks, up to a maximum of 12 courses. cohorts of 3 patients received escalated doses of dmxaa until the maximum tolerated dose (mtd) was determined. the mtd is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicity. patients had solid tumors for which there was no standard therapy or were refractory to conventional therapy.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed solid tumor that is not amenable to any standard therapy or is refractory to conventional therapy 2. performance status who 0-2 3. life expectancy greater than 3 months 4. hemoglobin at least 90 g/l; wbc at least 3,000/mm3; platelet count at least 100,000/mm3 5. bilirubin within normal limits; alt less than 2 times upper limit of normal (uln); alkaline phosphatase less than 2 times uln 6. creatinine less than 130 umol/l 7. inr and aptt within normal limits 8. fertile patients must use effective contraception 9. at least 4 weeks since prior anticancer therapy and recovered from toxic effects exclusion criteria: 1. concurrent malignancy except cone biopsied carcinoma in situ of the cervix and adequately treated basal or squamous cell carcinoma of the skin 2. other serious medical condition 3. uncontrolled infection or serious infection within the past 28 days 4. pregnant or lactating 5. treatment with glucocorticosteroids within previous two weeks
role of double cuffed ptfe arteriovenous grafts in enhancing long-term patency in hemodialysis patients (extended poly tetra fluoro ethylene)

Conditions: End Stage Renal Disease

Summary: this randomized controlled trial will compare the double vein cuffed synthetic arteriovenous graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long-term patency of each modality

end-stage renal disease (esrd) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years.end-stage renal disease (esrd) arises from many heterogeneous disease pathways that alter the function and structure of the kidney irreversibly, over months or years. haemodialysis (hd) is a lifeline therapy for patients with esrd. a proportion of hemodialysis patients exhaust all options for permanent vascular access (fistula or graft) in both upper extremities.eptfe grafts are easily subjected to graft outflow tract intimal hyperplasia, which may lead to graft outlet stenosis and graft thrombosis after a certain period of usage. the commonest cause of ptfe graft failure is intimal hyperplasia (ih) at the venous anastomoses. our study aims to evaluate the influence of double cuffed eptfe grafts with autologous vein cuffs on the long-term patency of dialysis access, and compare the clinical patency and the complications occurring with the usage of the double cuffed graft to that with standard non cuffed grafts in chronic renal hemodialysis therapy. this randomized controlled trial will compare the double vein cuffed synthetic arteriovenous graft to the single vein cuffed synthetic and the non cuffed synthetic as regard to long term patency of each modality

Eligibility criteria:
inclusion criteria: 1. patients with end stage renal diseases and gfr less than 30 2. by clinical examination in ability to palpate distal or proximal upper limb veins 3. by duplex examination the diameter of cephalic or basilic veins are less than 3 mm or reported to be incompressible 4. patients with previous history of failed attempts of autogenous vein creation 5. patients with border line cephalic or basilica vein (3mm) and on intraoperative the vein diameter appears to be unsuitable (less than 3 mm). exclusion criteria: 1. all patients with palpable suitable forearm or arm veins 2. patients with baseline blood pressure less than 110/70 3. brachial artery of diameter less than 4 mm 4. patients with ligated brachial artery 5. patients with history of central vein stenosis 6. patients with immunodeficiency states

Keywords: esrd eptfe neointemal hyperplasia
effect of calcium + vitamin d supplementation on weight management in very-low calcium consumers

Conditions: Obesity; Overweight

Summary: the purpose of the study is to determine whether calcium plus vitamin d supplementation is conducive to weight and fat loss during energy restriction in very-low calcium consumers.

due to the contradicting findings in the hypothesis of calcium supplementation on weight and fat loss, which might be explained by the difference in initial calcium intake, the present study is aimed to evaluate the effect of calcium plus vitamin d supplementation on accelerating weight and fat loss in overweight or obese subjects with very-low calcium consumption(\<600mg/day). the hypotheses to be tested are: calcium plus vitamin d supplementation is conducive to body weight and fat loss in overweight or obese young adults during energy restriction 12 weeks after randomization.

Eligibility criteria:
inclusion criteria: * male or female 18 to 25 years of age, generally healthy * habitual calcium intake below 600mg/d * overweight or obese (bmi between 24 and 35kg/m2, refer to the chinese standard) * stable body weight (body weight change less than 1kg two months before screening) * less than 3 times of 20min of physical exercise per week * signed written informed consent exclusion criteria: * coronary heart disease, hypertension, diabetes; hepatic insufficiency or renal insufficiency, hyper- or hypothyroidism, mal-absorption, cholesterol concentrations requiring pharmaceutical treatment * pregnant or lactating woman * use of calcium supplements, oral antidiabetic agents, antihyperlipidemics or any other medications affecting metabolism 30 days before randomization * participating in another weight loss programs (i.e. taking oral pharmacotherapeutic agents and/or herbal preparations intended for the management of obesity; excessive physical activity; be on a diet) * on special diets (i.e. vegetarian) * presently taking or have recently taken a prescription drug such as fluoroquinolone antibiotics, tetracycline, or levothyroxine (thyroid medication) * participating in another clinical trial 6 months before randomization * unlikely to be compliant (i.e. alcohol, drug abuse) * refusal or inability to give informed consent to participate in the study

Keywords: calcium carbonate vitamin d body weight body fat metabolic parameters energy restriction very-low calcium consumers obesity overweight
a study to evaluate the efficacy and safety of bimekizumab in chinese adult study participants with moderate to severe plaque psoriasis

Conditions: Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis

Summary: the primary purpose of this study is to compare the efficacy of bimekizumab administered subcutaneously (sc) for 16 weeks versus placebo in the treatment of study participants with moderate to severe plaque psoriasis (pso).


Eligibility criteria:
inclusion criteria: * study participant is chinese male or female ≥18 years of age * study participant has plaque psoriasis (pso) for ≥6 months prior to the screening visit * study participant has psoriasis area and severity index (pasi) ≥12 and body surface area (bsa) affected by pso ≥10% and investigator's global assessment (iga) score ≥3 on a 5-point scale. * study participant is a candidate for systemic pso therapy and/or phototherapy * female study participants must be postmenopausal or permanently sterilized or if childbearing potential must be willing to use protocol defined highly effective method of contraception throughout the duration of the study until 17 weeks after last administration of investigational medicinal product (imp) and have a negative pregnancy test at screening and prior to first dose exclusion criteria: * female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 17 weeks following the final dose of imp * study participant has a form of pso other than chronic plaque-type (eg, pustular, erythrodermic, guttate, or drug-induced pso) * study participant has an active infection or history of infection(s) as defined in the protocol * study participant has known tuberculosis (tb) infection, is at high risk of acquiring tb infection, or has current or history of nontuberculous mycobacterium (ntmb) infection.study participant has a past history of active tb involving any organ system unless adequately treated and is proven to be fully recovered upon consult with a tb specialist * study participant has a diagnosis of inflammatory conditions other than pso vulgaris or psoriatic arthritis (psa) * study participant has presence of significant uncontrolled neuropsychiatric disorder. study participants with history of suicide attempt within the 5 years prior to the screening visit must be excluded. study participants with history of suicide attempt more than 5 years prior to the screening visit must be evaluated by a mental health care practitioner before enrollment.

Keywords: psoriasis pso bimekizumab chinese adults study participants
comparing prognostic performance of sepsis 2 and sepsis 3 strategies at the emergency service

Conditions: Sepsis

Summary: in 2016, the third international consensus proposed a new strategy to screen aggravating risk in patients with septic shock. this strategy is based on quick-sofa and the sofa score. the main objective is to compare the prognostic performance of sepsis 3 against the previous strategy sepsis 2 to predict the admission in intensive care unit or the intra-hospital death.

this study compare the prognostic performance of two strategies. it's a monocentric, retrospective study in patients admitted to the emergency department.

Eligibility criteria:
inclusion criteria: * aged of 18 years or more * initiation of one or more antibiotics in the accident and emergency department in the metz-thionville hospital (chr) site mercy, for curative purpose, regardless of the infectious aetiology * hospitalized in the chr metz-thionville thereafter exclusion criteria: * minors patients * absence of antibiotic treatment initiated in the emergency department * prescription of antibiotic treatment in the emergency department for preventive purpose * transferred by hospitalisation service of chr metz-thionville in the emergency department * absence of hospitalisation following their passage through the emergency department * transferred to hospitalisation in an other establishment * presence, at the admission, of an antibiotic treatment * patients deceased in the emergency department
various type of genetic events in patients with intellectual disability

Conditions: Intellectual Disability

Summary: currently, for a patient with intellectual disability without a recognizable syndrome (most cases), the way to diagnosis is often long, tedious and expensive because different approaches are used one after the other to identify structural variants (duplications, deletions and other) and point mutations (sequencing of one or more candidate genes). the development of high-throughput sequencing techniques (next generation sequencing: ngs) has drastically increased the detection of point mutations offering the possibility to test a large number of genes simultaneously. ngs also shows a huge potential in detecting structural variants. the objective of this research is to assess the sensitivity of a simultaneous detection of point mutations and structural variants by ngs approaches. this would bring together in a single step the equivalent of performing an array-comparative genomic hybridization (cgh) analysis plus performing a targeted sequencing of candidate genes. investigators will compare two approaches for this simultaneous detection: a targeted enrichment of candidate genes coding regions using probes covering these regions associated with a backbone of genomic probes, an approach that could be implemented immediately in diagnostic at the hospital, and a whole genome sequencing (wgs), that is currently a too expensive tool for routine diagnosis but that should be the approach used in the future. investigators will compare these two approaches to the traditional one: cgh array + wgs. the implementation of a "one step" strategy to detect both types of mutations (punctual and structural) would accelerate and improve the access of patients to a molecular diagnosis.


Eligibility criteria:
inclusion criteria: * patients with developmental disabilities * no etiologic diagnosis but suspected genetic cause * fragile x syndrome research negative exclusion criteria: * children born to consanguineous couples * diagnosis already established or suspected * identification of an independent etiology
the validation of a cad screening algorithm based on facial photos in community population

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate the effectiveness of a coronary heart disease screening algorithm based on facial photos in community population.


Eligibility criteria:
inclusion criteria: * community population with a pre-test probability greater than 5% for coronary artery disease exclusion criteria: * prior percutaneous coronary intervention (pci) * prior coronary artery bypass graft (cabg) * the history of heart failure * with artificially facial alteration (i.e. cosmetic surgery, facial trauma or make-up) * other situations which make patients fail to be photographed

Keywords: artificial intelligence
a long-term follow-up study of patients who received vor33

Conditions: Leukemia, Myeloid, Acute

Summary: vor33 long-term follow-up (ltfu) study

vbp201 study is the vor33 long-term follow-up (ltfu) study focusing on assessing long term safety and efficacy of vor33. this study may last up to 15 years (counted from the date of vor33 infusion completion). all patients who have participated in a study involving the drug product vor33 and have completed the applicable study or prematurely discontinued, but have at least received the vor33 infusion, will be asked to participate in the ltfu study.

Eligibility criteria:
inclusion criteria: * a patient is included in this study if he/she: 1. has received any part of or all of a vor33 infusion exclusion criteria: * there are no exclusion criteria.

Keywords: aml acute myeloid leukemia cd33 allogeneic hct hematopoietic stem cell transplant leukemia
probiotics and gbs colonization in pregnancy

Conditions: GBS Rectovaginal Colonization; Neonatal Sepsis

Summary: multicentric, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of gbs in women at low obstetric risk.

multicenter, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of gbs in women at low obstetric risk. the study includes low obstetric risk pregnant women within the 33rd week of gestation, with vaginal delivery expected. it excludes women who during pregnancy had a positive urine culture for gbs, women with a previous newborn suffering from early sepsis, use of antibiotics in the month prior to enrollment, women unable to understand the study and sign informed consent. intervention daily oral administration of two capsules of the giellepi spa class iia medical device "respecta" or placebo, to be taken with a glass of water preferably between meals, starting from the 30th week of pregnancy until the 37th week after having vagino-rectal swab screening performed.

Eligibility criteria:
inclusion criteria: * low obstetric risk pregnant women by the 33rd week of gestation, * vaginal delivery expected. exclusion criteria: * positive urine culture for gbs, * previous newborn suffering from early sepsis, * use of antibiotics in the month prior to enrollment, * women unable to understand the study and sign informed consent.

Keywords: probiotics pregnancy gbs colonization
the effects of environmental factors on the macro-genome and metabolism of obese patients.

Conditions: Obesity and Overweight

Summary: the present study was designed to include obese patients diagnosed with obesity in the first affiliated hospital of chongqing medical university and a healthy control population. by analysing the relationship between metabolic parameters and macrogenomes in obesity, identifying key metabolic and macrogenomic differences between obese patients and healthy populations, and establishing the association between environmental factors and obesity-related metabolic disorders, the investigators will be able to provide new biomarkers and intervention targets for obesity prevention and treatment.

obese patients who attended the first hospital of chongqing medical university and intended to undergo bariatric surgery were screened according to the inclusion and exclusion criteria. patients' basic personal information and biological specimens including blood, faeces and urine were collected for metabolic and macro-genomic analyses. air pollution exposure of the study subjects was collected by telephone follow-up. metabolite profiles in blood and urine were analysed using liquid chromatography-mass spectrometry (lc-ms). microbial community composition in faecal samples was analysed using 16s rrna gene sequencing. metabolic and macrogenomic differences between obese and control groups were compared using t-test or mann-whitney u-test. logistic regression analyses were used to assess the independent effects of different environmental factors on metabolism and macrogenome. identify key metabolites and microorganisms associated with obesity using random forest and principal component analysis.

Eligibility criteria:
inclusion criteria: * age ≥18 years; * obese patients with bmi ≥30kg/m2; * patients did not undergo surgical treatment before enrolment; * willing to participate in this study and sign the informed consent form; * complete clinical data. exclusion criteria: * patients with systemic diseases such as severe cardiorespiratory insufficiency that affect the choice of treatment regimen; * pregnant or lactating women; * patients who are not suitable for enrolment as assessed by the investigator; * patients with incomplete clinical data.

Keywords: obesity environment air pollution macrogenomics metabolism
an extended-release form of clonidine as an anti-manic agent: an add-on, open-label study

Conditions: Bipolar Disorder, Mania

Summary: the investigators plan to to study an extended-release form of clonidine, which the investigators hope will be even better tolerated than the immediate-release form, as an antimanic agent. subjects will receive an extended-release form of clonidine in addition to their usual medication regimen on the second day of this three-day study. rating scales, a record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3 days. any medication changes made by the attending psychiatrist and prns administered will be recorded throughout the study.

clonidine has been reported to be effective in a variety of hyperadrenergic states, including mania. it is generally well-tolerated and does not result in the severe adverse effects that are associated with many antipsychotics and mood stabilizers used in the treatment of mania, such as weight gain and akathisia. there is some suggestion that clonidine may be particularly effective in a subset of refractory cases and in patients who cannot tolerate antipsychotic medications or lithium. the investigators plan to to study an extended-release form of clonidine, which the investigators hope will be even better tolerated than the immediate-release form, as an antimanic agent. subjects will receive an extended-release form of clonidine in addition to their usual medication regimen on the second day of this three-day study. rating scales, a record of sleep, and a questionnaire of adverse effects will be recorded on each of the 3 days. any medication changes made by the attending psychiatrist and prns administered will be recorded throughout the study. the investigators believe that studying as few as 10 subjects will give the investigators a sense as to whether the addition of clonidine is helpful in reducing manic symptoms and if the rate of adverse effects is unacceptable.

Eligibility criteria:
inclusion criteria: * meet scid criteria for bipolar disorder, type i, mania with ymrs \> 15 * no significant improvement in symptoms after three or more days of hospitalization * documented medical evaluation without identified acute or serious medical illness * negative pregnancy test in women of child-bearing age exclusion criteria: * involuntary commitment or lack of capacity to provide informed consent * low blood pressure

Keywords: mania clonidine bipolar disorder
evaluation of a patient portal intervention for diabetes: a pilot randomized controlled trial

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to conduct a two-arm, parallel-design, pragmatic randomized controlled trial of a patient portal intervention for diabetes, my diabetes care, to evaluate its effect on patient activation and secondary cognitive, behavioral, and clinical outcomes.

300 adult patients with type 2 diabetes mellitus will be randomized to one of two arms. 150 will be assigned to receive access to the intervention (my diabetes care) embedded within an existing patient web portal (my health at vanderbilt) at vanderbilt university medical center. 150 will be assigned to a usual care comparison arm with access currently available version of my health at vanderbilt without the my diabetes care. patients will be invited by mail (or email) to be screened for enrollment in the study. eligible and interested patients will be emailed a link to a secure study website where they will complete a web consent form. at enrollment, participants will complete a baseline questionnaire and diabetes health data will be abstracted from the patients' electronic health record (ehr) before being randomized to the intervention or control arm. participants will receive additional follow-up questionnaires and diabetes health data will be abstracted from the ehr at 3-month and 6-month follow-ups to assess outcomes. in addition, system usage will be collected.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * currently being treated with at least one antihyperglycemic medication * able to speak and read in english * reliable access to a computer (desktop or laptop) with internet capabilities * active vumc patient web portal (known as my health at vanderbilt) account exclusion criteria: * residing in a long term care facility * medical condition that affects my memory or ability to think. * severe visual impairment * currently participating in another diabetes-related research study

Keywords: diabetes patient activation patient web portals health information technology