Kornimate/medical-research-clean huggingface dataset:
endostar combined with ip second-line treatment of advanced esophageal squamous cell carcinomas

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the aim of this study is to explore whether endostar combined with ip as treatment could improve progression-free surial time (pfs) and to evaluate the safety of the chemotherapy regimens

this study is to explore whether endostar combined with ip as treatment could improve progression-free surial time (pfs) and to evaluate the safety of the chemotherapy regimens used as second-line treatment of advanced esophageal squamous cell carcinomas

Eligibility criteria:
inclusion criteria: histologically proven primary thoracic esophageal squamous cell carcinoma according to the esophageal ajcc2009 7th to determine new stage iv esophageal cancer the subject has pd after first-line chemotherapy or radiation within a year presence of at least one index lesion measurable by ct scan or mri according to recist 1.1 can eat more than liquid diet; no signs before esophageal perforation 18\~75 years ps:0-1 life expectancy of ≥ 3 months anc ≥ 2×109/l，plt ≥ 100×109/l，hb ≥ 90g/l tb ≤ unl； alt/ast ≤ 2.5×unl，akp ≤ 5×unl ccr≤ unl,scr≥60 ml/min normal electrocardiogram (ecg), the body had no unheal wounds radiotherapy before within the scope of the normal dose and not affect subsequent treatment prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions signed written informed consent exclusion criteria: breast-feeding or pregnant women, no effective contraception if risk of conception exists chronic diarrhea, enteritis, intestine obstruction which are not under control esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc. a second primary tumor (except skin basal cell carcinoma) the original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension with uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; primary brain tumors or cns metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms with bleeding tendency has inherited bleeding evidence of physical or blood coagulation disorder with clear chemotherapy drug allergy other researchers believe that patients should not participate in this testing -
study evaluating the helical ureteral stent

Conditions: Kidney Calculi

Summary: the boston scientific helical stent is a unique stent designed to improve flexibility and comfort. it is designed to conform more to the shape of the ureter (hollow tube connecting the kidney and the bladder) to ultimately improve patient comfort and decrease the need for painkillers.

ureteral stents have been used for many years for a variety of clinical indications. many surgeons routinely use ureteral stents after the endourologic removal of stones to facilitate in urine passage and facilitate excretion of any left over stones. there is a multitude of literature that reveals that most patients find ureteral stents to be uncomfortable. this discomfort often causes pain severe enough that patients anxiously anticipate stent removal, and often request early stent removal, and/or require use of pain medications that have many side effects and cause further discomfort to these patients.

Eligibility criteria:
inclusion criteria: 1. male or female; female patients must be sterile, post-menopausal or willing to use birth control during the course of the study 2. 19 years of age and older 3. having undergone shockwave lithotripsy-swl, or a diagnostic ureteroscopy or uncomplicated ureteroscopy for stone removal requiring retrograde placement of a ureteral stent for an anticipated duration of between 2 and 21 days 4. willing to sign the informed consent form 5. able to read, understand, and complete patient questionnaires exclusion criteria: 1. active, symptomatic urinary tract infection 2. non-stone related distal ureteral obstruction or stricture 3. clinically significant trauma or significant retained stone burden that could significantly contribute to patient discomfort 4. ureteral perforation or trauma 5. history of bladder reconstruction or interstitial cystitis 6. spinal cord injuries 6. pregnant or lactating females 7. non-stone related voiding dysfunction requiring supplemental bladder drainage tubes for more than 24 hours post operatively 8. patients with a solitary kidney 9. chronic use of pain or anti-spasmodic medication for symptoms other than stone related pain 10. if in the opinion of the investigator, the patient is not a suitable study candidate.

Keywords: kidney stones, ureteral stent, pain,
a study to assess the pharmacomri effects of aut00206 in healthy males

Conditions: Schizophrenia

Summary: a phase 1, single-centre, double-blind, placebo controlled crossover study to assess the pharmacomri effects of aut00206 in healthy male participants


Eligibility criteria:
inclusion criteria: * male aged 18 to 45 years, inclusive at visit 1. * healthy on the basis of medical history, psychiatric history, physical examination, vital signs, 12-lead electrocardiogram (ecg), haematology, blood chemistry and urinalysis within 6 weeks of visit 2. * right-handed. * not a regular smoker (maximum 5 cigarettes per week or equivalent). exclusion criteria: * history of, or current condition of, migraine headaches or has undergone operations to the head. * history of significant claustrophobia.
reach: study to determine the aetiology of chlormethine gel induced-skin drug reaction in early stage mycosis fungoides cutaneous t cell lymphoma (mf-ctcl)

Conditions: Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) (Stage IA-IB)

Summary: adult patients with early stage mf-ctcl (stage ia-ib) will be eligible for this study. a total of 100 early stage mf-ctcl patients diagnosed in the past year will be enrolled. treatment with cl gel will be applied once daily to all skin areas affected by mf-ctcl and, for 8 weeks, one selected skin area unaffected by mf-ctcl (0.5% body surface area) until treatment response (complete response), study treatment duration completed (56 weeks), progression, or another withdrawal criterion is met. depending on the type of skin drug-related reaction (if any) occurring after application of cl gel, this study will categorize patients into three different groups corresponding to three different treatment patterns: * group a: patients with no skin drug reaction with cl gel application * group b: patients developing a skin drug reaction of any grade with cl gel application, not due to allergic reaction to cl gel, will continue treatment at reduced application frequency * group c: patients from group b unable to tolerate reduced cl gel application frequency will apply a potent topical steroid twice daily in addition to cl gel applied every other day


Eligibility criteria:
inclusion criteria: * diagnosis of mf-ctcl stage ia or ib at enrolment as per iscl/eortc revision to the mf and sézary syndrome classification and mf stage should have never met the criteria for stage iia or higher in the patient medical history * lesions cover less than 80% of bsa * age ≥ 18 * ecog/who performance status 0-2 exclusion criteria: * previous treatment with cl gel * concurrent or planned local or systemic anti-ctcl therapy * prior treatment with antihistamines or narrow band uv-b or puva therapy one week before enrolment, or systemic corticosteroids or radiotherapy in the last 4 weeks before enrolment * prior treatment with topical steroids in the patch test area (upper back) one week before enrolment

Keywords: mycosis fungoides (mf) cutaneous t cell lymphoma (ctcl)
lux-breast 2; afatinib in her2 (human epidermal growth factor receptor)-treatment failures

Conditions: Breast Neoplasms

Summary: the general aim of this study is to investigate the efficacy and safety of afatinib (bibw 2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with her2-overexpressing, metastatic breast cancer, who failed her2-targeted treatment in the neoadjuvant or adjuvant setting


Eligibility criteria:
inclusion criteria: 1. female patients \>=18 years with proven diagnosis of her2-overexpressing, histologically confirmed breast cancer 2. stage iv metastatic disease 3. at least one measurable lesion according to recist 1.1 (response evaluation criteria for solid tumours version 1.1). skin, bone and brain lesions are considered non-target lesions 4. must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and lapatinib treatment in the neoadjuvant and/or adjuvant setting exclusion criteria: 1. prior first line therapy for metastatic breast cancer 2. known pre-existing interstitial lung disease 3. active brain metastases 4. history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure nyha classification of 3, unstable angina or poorly controlled arrhythmia. myocardial infarction within 6 months prior to trial treatment. 5. cardiac left ventricular function with resting ejection fraction of less than 50%. 6. prior treatment with epidermal growth factor receptor (egfr)/her2-targeted small molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or adjuvant setting 7. prior treatment with paclitaxel in the past 12 months 8. must not have received prior vinorelbine treatment - further exclusion criteria apply
cardiac mri prior to invasive coronary angiography in patients with suspected non-st-elevation myocardial infarction

Conditions: Non-ST Elevation Myocardial Infarction; Acute Coronary Syndrome

Summary: patients with a suspected myocardial infarction are subdivided into st-elevation and non-st-elevation myocardial infarctions (stemi and nstemi, respectively) using an ecg. while patients with stemi are urgently referred to a cath lab, patients with nstemi usually undergo a planned invasive coronary angiography (ica) anywhere from 24-72 hours after arriving to the hospital. when an invasive coronary angiography can not explain the cause of a myocardial infarction, an mri of the heart (a cmr) is often done as a follow-up investigation. a growing body of evidence suggests that performing a cmr before the planned ica can provide an accurate diagnosis and defer the need for an ica in many of these patients with nstemi.

kapsica-cmr is an observational pilot study at the karolinska university hospital which aims to validate, in a swedish healthcare setting, the potentials of a cmr-first approach in patients with suspected nstemi. we plan on including 150 patients, both with (n=50) and without (n=100) previous myocardial infarction. in addition to a standard clinical cmr protocol, the study will test novel cmr techniques such as magnetic resonance angiography and magnetic resonance fingerprinting sequences in this cohort. patients will be recruited at both the solna- and huddinge sites of the hospital and include patients referred to ica from the visby- and södertälje hospitals. the findings on the cmr will be blinded to treating physicians, with exceptions for unexpected adverse findings. in the event that a cmr would be indicated in line with clinical practice, the cmr findings are unblinded.

Eligibility criteria:
inclusion criteria: * ≥18 years of age suspected nstemi (signs and symptoms suggest of acs with initial ecg showing no st-elevation) * planned ica where cmr can be performed without delaying ica * able to provide written informed consent exclusion criteria: * contraindications for cmr examination with gadolinium contrast (claustrophobia, egfr \<30ml/min/1.73m2, contrast allergy, and non-mri compatible implants) * arrythmias which hinder cmr examination * previous cabg * hemodynamic instability * myocardial infarction \<6 months prior to inclusion

Keywords: cmr mri cardiac mri cardiac magnetic resonance cardiac magnetic resonance imaging ami acs acute coronary syndrome nstemi non-stemi ica invasive coronary angiography coronary angiography t1 t2 magnetic resonance fingerprinting native t1 native t2 magnetic resonance angiography
mesenchymal stromal cells for degenerative meniscus injury

Conditions: Chronic Meniscal Injury

Summary: the present proposal has the objective to assess whether the addition of autologous ex vivo expanded mesenchymal stromal cells (xcel-m-alpha) to the conventional meniscal injury rehabilitation program is contributing in creating the proper healing environment for the meniscus repair. for this purpose, 20 patients will be randomized (10 per group) to one of the two treatment arms (rehabilitation + xcel-m-alpha or rehabilitation alone) . the conduction of this clinical trial will, in addition of having the aim of improving the patient's quality of life, contribute to consolidate an emerging new type of therapy which is still under development.

this is a prospective, unicentric, randomized, open-label, single-dose, two-arm, blinded assessor pilot study in which 20 patients with degenerative meniscus injury grade 3 (crues et al.) will enter the study with the primary objective of assessing the efficacy of the treatment by vas of pain at 12 month. secondary objectives are to evaluate the safety and efficacy through imaging procedures and clinical questionnaires (ikdc, koos, lysholm and sf-36. patients will be randomized to one of the two treatment arms (xcel-m-alpha and standard rehabilitation program or standard rehabilitation program alone). thereafter, patients will be followed for 12 months. imaging assessment will be performed by an independent blinded radiologist.

Eligibility criteria:
inclusion criteria: * patient between 40 and 60 years of age * degenerative meniscus injury grade 3 (crues et al.) * indication of conservative treatment * normal alignment of the knee (between 3º varus and 10 º valgus) * patient is able to follow a rehabilitation program * informed consent given by the patient in writing * patient is able to understand the trial. exclusion criteria: * traumatic meniscus injury * surgical intervention to the affected knee * local or systemic infection * intraarticular treatment of the affected knee with steroids or hyaluronic acid within the past 3 months * significant abnormal laboratory tests that contraindicates participation in the trial. * pregnant women or intend to become pregnant or breast-feeding * neoplastic process within the previous 5 years or without complete remission. * the patient is wearing a pacemaker, allergy to contrast, severe renal insufficiency or any other condition that contraindicates the magnetic resonance using contrast. * other pathologic conditions or circumstances that difficult participation in the study according to medical criteria * legally dependant patient. * the patient does not accept to be followed-up for a period that could exceed the clinical trial length

Keywords: chronic meniscal injury degenerative meniscus meniscus injury meniscal injury mesenchymal stromal cells mesenchymal stem cells advanced therapy bone marrow
prevalence of clinical strains of enterobacteria with reduced susceptibility to carbapenems in the north-west region of france

Conditions: Enterobacteriaceae

Summary: enterobacteria constitute a family of gram negative bacilli of the gastrointestinal flora. these micro-organisms are frequently responsible for nosocomial or community-acquired infections, for which treatment is essentially based on the use of beta-lactam antibiotics. this class of antibiotics comprises penicillins, cephalosporins, monobactams and carbapenems. carbapenems have the advantage of possessing a broad antibacterial spectrum and the capacity to resist the hydrolytic action of a large number of beta-lactamases, widespread inactivating enzymes. however, new enzymes, called carbapenemases, able to confer resistance to carbapenems either alone or in combination with additional resistance mechanisms such as loss of membrane permeability or overexpression of efflux systems, are currently emerging all over the world. carbapenemases represent a major public health problem because of the risk of therapeutic impasse and their high epidemic potential.


Eligibility criteria:
inclusion criteria: * patients in whom the results of bacteriological examinations reveal the presence of an enterobacteria strain with reduced susceptibility to carbapenems * control : patients ( infected or colonized ) a strain of enterobacter sensitive to carbapenems immediately isolated after a strain of enterobacter having decreased susceptibility to carbapenems from the same service and same hospital ( 2 strains susceptible strain with reduced sensitivity). exclusion criteria: * duplicate : same strain to a first strain of reduced sensitivity in isolated the same patient during the study period ( same bacterial species , even after characterization resistance mechanism).

Keywords: carbapenems
oral health and risk factors for oral disease

Conditions: Periodontal Diseases; Dental Caries; Quality of Life

Summary: oral health has improved considerably in recent decades in sweden, as well as in other countries. however, despite great improvements with regard to periodontal disease and dental caries in recent decades, global problems still persist, and as a consequence of retaining natural teeth high up in age, the risk for oral disease increases.

traditionally, the number of teeth has been a measure of good oral health, and the world health organization (who) stipulated goals of a minimum of 20 functional teeth at the age of 80 years have been reached in some industrialized countries. oral health means more than good teeth and is integral to general health. the relationship between oral and general health has been recognized. for example, periodontal disease is associated with diabetes and rheumatoid arthritis. the severity of periodontal disease and number of teeth have been associated with an increased burden of cardiovascular disease. there is a lack of longitudinal studies of oral health and risk factors for oral disease.

Eligibility criteria:
inclusion criteria: * none exclusion criteria: * none
communication book in pragmatic communication in vascular aphasics

Conditions: Aphasia; Communication

Summary: this study aims to evaluate, in communication tasks, the pragmatic effectiveness of the communication book in the general conditions of use and its maintenance in the implementation of the compensatory strategies of communication in severe aphasias.

data from the literature have demonstrated the effectiveness of speech therapy in aphasic vascular. in the face of sequelae, particularly in the most serious aphasia, a palliative approach aims to increase the functional effectiveness of communication in everyday life. the communication book has been developed in this perspective, addressing aphasics whose language communication skills are greatly reduced. early use in this trial is warranted by implantation prior to the onset of potentially deleterious compensatory mechanisms seen in the late-stage aphasic sequelae. this study aims to evaluate, in communication tasks, the pragmatic effectiveness of the communication book in the general conditions of use and its maintenance in the implementation of the compensatory strategies of communication in severe aphasias.

Eligibility criteria:
inclusion criteria: * informed consent after information. information is also given to the person of trust when it exists. * aphasic subjects admitted to hospital or seen in consultation following a 1st ischemic or hemorrhagic symptomatic vascular accident constituted * during the first year of onset of aphasia * adults over 18 years old * french * phasic disorder of severe severity expression (overall severity score between 0 and 2 at the diagnostic battery for the assessment of aphasia scale) * residual ability to understand clinical assessments and informed consent; information about the objectives and the procedure of the research will also be given to the patient's designated confidant * motor capacity for comfortable sitting and transfers with help * affiliation to health insurance * no deficits in visual perceptual tests (researched using the visual decision of objects and montreal protocol for the evaluation of visual gnosis), which allows the use of the communication book, exclusion criteria: * refusal or impossibility of consent * disturbance of vigilance * insane state * psychiatric history requiring hospitalization in a specialized environment * perceptual disturbance, visual agnosia not allowing the use of the image support * pregnancy or breastfeeding * administration after the occurrence of stroke of a product for which an effect on the recovery of aphasia has been reported: piracetam, bromocriptine, donepezil, dextroamphetamine (if treatment with these products has been performed, inclusion is possible after a weaning period of 15 days) * simultaneous inclusion in another therapeutic protocol of language disorders
evaluation of peripheral neutrophils in antisynthetase syndrome

Conditions: Antisynthetase Syndrome

Summary: antisynthetase syndrome (as) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-trna synthetases. a pathogenic role of neutrophils was described during inflammatory myopathies, with increased netosis correlated with disease activity and muscle damage. higher number of alveolar neutrophils was observed in patients with rapidly progressive forms of interstitial lung disease. peripheral neutrophils could represent a simple biomarker of severity and activity in patients with antisynthetase syndrome. the main objective is to compare circulating neutrophils between severe and non severe patients with antisynthetase syndrome. secondary objectives are: 1) to evaluate correlation between circulating neutrophils and organ-specific severity, 2) to compare circulating neutrophils at time of diagnosis and circulating neutrophils after 6 months of treatment in patients with antisynthetase syndrome.


Eligibility criteria:
inclusion criteria: * patients with antisyntheatse syndrome according to solomon criteria
a multiple-dose study of gantenerumab in japanese alzheimer&apos;s disease patients

Conditions: Alzheimer's Disease

Summary: objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamic effects of multiple doses of gantenerumab in subject with mild to moderate ad.


Eligibility criteria:
inclusion criteria: * have a diagnosis of probable ad dementia, based on nincds/adrda criteria * meet dsm-iv criteria for dementia of the alzheimer type * mmse score : 16 to 26 etc. exclusion criteria: * meet the exclusion criteria of mri at screening. * a history of significant neurodegenerative diseases or dementia other than alzheimer's disease. etc.