Kornimate/medical-research-clean huggingface dataset:
renal toxicity of iodixanol and iopromide in patients with renal dysfunction

Conditions: Kidney Failure, Chronic

Summary: the purpose of this study is to compare renal toxicity of iodixanol and iopromide in patients with renal dysfunction.

the study is designed to compare renal toxicity of iodixanol and iopromide after coronary angiography or percutaneous coronary intervention (pci) in patient with chronic kidney disease, considering original renal function and adequate hydration. the risk of varying degree of renal impairment, changes of serum cys c level will also be evaluated.

Eligibility criteria:
inclusion criteria: * provides written informed consent and is willing to comply with protocol requirements * is referred for cardiac angiography, with or without pci * has a documented predose serum creatinine level of 1.5～3.5 mg/dl for men and 1.3～3.0 mg/dl for women * serum creatinine levels of twice tests conform with the baseline criteria, and the difference of twice serum creatinine tests is not more than 30%(first test: within 3 month,prior to enrollment; second test: at enrollment) exclusion criteria: * has a history of hypersensitivity to iodine-containing compounds * has end-stage renal disease * has kidney transplantation * has creatinine clearance rates \>60 ml/min in last 3 months * has acute coronary syndrome with heart failure(above class ii in accordance with killip or class iii in accordance with the classification of the new york heart association (nyha)) and shock * patients with cancer * has diabetes with serious complications, other kidney organs * patients with serious blood system disease * heart failure \[class iii\~ⅳ in accordance with the classification of the new york heart association (nyha) and (or) pulmonary edema\] * patients with hepatic insufficiency\[3 times as alt and (or) ast normal reference value limit\] * has received an iodinated contrast agent within 14 days prior to the administration of the study agent * is scheduled to receive an iodinated contrast agent within 7 days after administration of the study agent * has acute renal failure or end-stage renal disease requiring dialysis in the past 3 months * use of 3 days continuously nonsteroidal anti-inflammatory drugs within 1 week of the procedure * patients with hypotension \[(sbp\<80 mmhg for over 1h and needing medication or intraaortic balloon counterpulsation(iabp) \] * uncontrolled condition of hyperthyroidism * pregnancy or lactation * is planned to receive the drugs without permission in this protocol * participating in another intervention research study in last 3 months * legally incapacitated or limitations * any other conditions not suitable to be enrollment

Keywords: chronic kidney disease coronary angiography contrast media percutaneous coronary intervention serum creatinine glomerular filtration rate iodixanol iopromide
safety study of second intraperitoneal (i.p.) infusion cycle of catumaxomab in patients with malignant ascites

Conditions: Malignant Ascites Due to Epithelial Carcinoma

Summary: this phase ii single arm, open-label study investigate the safety of a second cycle of catumaxomab in patients with malignant ascites due to carcinoma, requiring their first therapeutic puncture after treatment in the casimas study.

up to 30 evaluable patients from the casimas study will be enrolled. catumaxomab will be infused intraperitoneally with 3hour constant-rate infusions 4 times within 11 days with ascending dosages (10 - 20 - 50 - 150 µg).

Eligibility criteria:
inclusion criteria: * patients who have completed 4 infusions of catumaxomab in the casimas study * age \>= 18 years * karnofsky index \>= 60 % * patients with malignant ascites requiring their first therapeutic ascites paracentesis after at least 60days following last catumaxomab infusion in the casimas study * patients where standard therapy is either not available or no longer feasible exclusion criteria: * acute or chronic infection * concomitant treatment with investigational products other than catumaxomab, cancer, chemo- or radiotherapy * previous treatment with entirely murine monoclonal antibodies other than catumaxomab * liver metastases with volume \>70 % of liver metastasized tissue

Keywords: malignant ascites second cycle trifunctional
the effect of three methods used in reducing pain during dressing change

Conditions: Healthy

Summary: this randomized controlled study aims to determine the effect of listening to music (lm), ball squeezing (bs), and performing mathematical operations (mo) in reducing the pain experienced during the first dressing in children aged 8-18 with appendectomy.

the sample of the study consisted of 120 children (lm:30, bs:30, mo:30, control:30). a minute before dressing and during dressing, the children in the lm group listened to music, the children in the sb group squeezed the ball, the children in the mo group performed mathematical operations.according to the child, parent, and nurse assessment, it was determined that the mean pain score of the children in the lm and mo groups was lower than that of the bs group and control groups (p\< .05).

Eligibility criteria:
inclusion criteria: * consisted of the child and parent's consent to participate in the study, * the child and parent's speaking turkish at the level of native speaker, * the child's being 8-18 years old and undergoing appendectomy, * being the body temperature of the child in the normal level (36.5-37.2⁰c), * the child's not having intense nausea and vomiting, * the child's not having any physical, intellectual or neurological disability that would affect his/her participation. exclusion criteria: * having a mental or neurological disability * children with hearing and vision impairment

Keywords: pain appendectomy child distraction dressing
zonantax - zolendronic acid as neoadjuvant therapy plus anthracycline and taxane in locally advanced breast cancer

Conditions: Breast Cancer; Breast Disease; Neoplasms; Neoplasms by Site

Summary: the purpose of this study is to evaluate the association of zoledronic acid with standard treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast cancer her 2 positive.

this trial combines zolendronic acid with anthracycline followed taxane plus trastuzumab for neoadjuvant treatment of her 2 positive stage ii/iii breast cancer. zoledronic acid (zol) has activity of anti-bone resorption and shows diverse anti-tumor effects in vitro. some chemical and biological characteristics of zol indicate potential for inhibition of tumor growth in pre clinical studies the primary objective of the study is to evaluate the residual cancer burden (rcb) with the addition of zolendronic acid to standard neoadjuvant therapy. rcb is calculated as a continuous index combining pathologic measurements of primary tumor (size and cellularity) and nodal metastases (number and size). rcb index is a significant predictor of distant relapse-free survival, and can be used to define categories of near-complete response and chemotherapy resistance after neoadjuvant chemotherapy compared with currently used risk factors. additionally, the study will collect tissue biopsies and blood before and after treatment in order to correlate clinical outcomes with gene expression and radiologic data to predictive response.

Eligibility criteria:
inclusion criteria: 1. stage iia to iiib her-2 positive breast cancer 2. ecog performance ≤ 2 3. adequate hematologic function with: * absolute neutrophil count (anc)\> 1500/mm³ * platelets ≥ 100.000/mm³ * hemoglobin ≥ 9g/dl 4. adequate hepatic and renal function with: * serum bilirubin ≤ 1.5 x the institutional upper limit of normal (uln) * aspartate aminotransferase (ast) and alanine aminotransferase (alt)≤ 2.5 x the institutional upper limit of normal (uln) * alkaline phosphatase )≤ 2.5 x the institutional upper limit of normal (uln) * serum creatinine ≤ 1.5 x the institutional upper limit of normal (uln) or calculated creatinine clearance \> 50 ml/min 5. adequate cardiac function * left ventricular ejection fraction (lvef)with institutional normal range 6. knowledge of the investigational nature of the study and ability to provide consent for study participation exclusion criteria: 1. previous diagnostic of breast or other cancer 2. pregnancy 3. metastatic breast cancer 4. bilateral, synchronous breast cancer 5. any other disease(s), psychiatric condition, metabolic dysfunction, that contraindicates the use of study drugs or that woud make the patient inappropriate for this study 6. neuropathy grade \> 2 by the common terminology criteria for adverse events version 3.0 (ctcae v3.0)

Keywords: neoadjuvant therapy breast cancer her2 positive zolendronic acid
retention of metal reinforced polyamide denture base and heat cured acrylic resin denture base in complete mandibular denture

Conditions: Anodontia of Permanent Dentition

Summary: the trial is done in order to reinforce polyamide to improve its modulus of elasticity to be able to use it as a denture base material in all clinical cases


Eligibility criteria:
inclusion criteria: 1. male or female patient with age range from fifty five to sixty five completely edentulous and in good medical condition 2. patients have skeletal angle's class i maxillo-mandibular relationship and sufficient inter arch distance. 3. free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles. 4. free from any tempro-mandibular disease. 5. good oral hygiene. exclusion criteria: 1. neuromuscular disorder and orofacial disease. 2. tempromandibular joint and muscle pain 3. xerostomia or excessive salivation. 4. limited mouth opening
real versus sham manual therapy for rcrsp

Conditions: Shoulder Pain

Summary: a convenience sample of subjects with rcrsp recruited through announcements at the benemerita universidad autonoma de puebla will be treated with an exercise program with sham or real manual therapy for 5 weeks. the hypothesis of the present study is that the addition of manual therapy to a therapeutic exercise program produces better benefits in comparison to the same exercise program with sham manual therapy procedures in the management of patients with rcrsp.

the objective of this study is to demonstrate that the combination of manual therapy and therapeutic exercise achieves better results in the management of the patient with shoulder pain. for this, manual therapy techniques in the thoracic region and in the shoulder together with a therapeutic exercise program will be applied. the investigators will compare this intervention protocol with placebo manual therapy techniques and the same therapeutic exercise protocol.

Eligibility criteria:
inclusion criteria: * unilateral shoulder pain of non-traumatic origing lasting more than three months. * pain evoked with active shoulder movements. * pain and weakness evoked with manual muscle strength tests for abduction and/or external rotation. * minimal or no rest pain (less than 3 points in a numeric pain rating scale). exclusion criteria: * other shoulder pathologies than rcrsp. * systemic diseases. * neural symptoms. * neck pain. * radiculopathy. * to have been treated for shoulder pain in the last three months.
oct angiography in the glaucoma diagnosis

Conditions: Glaucoma

Summary: glaucoma is a chronic degenerative disease of the optic nerve. it is the second cause of blindness worldwide and a frequent cause of irreversible blindness. in 2020, epidemic health authorities have predicted about 80 million glaucoma patients. glaucoma can be treated by topical treatment (eye drops), laser or surgery. a premature diagnosis of glaucoma is very important to prevent irreversible blindness. pachymetry, optical coherence tomography (oct) and visual fields exams are fundamental for the development of the glaucoma diagnosis. the severity of glaucoma is defined with hodapp-parrish-andersen visual field criteria. according to these criteria, glaucoma can be classified as early (with average visual field deviation, md, of 0 to -6 db), moderate (md of -6 to -12 db) and severe (md worse than -12 db). the progression of glaucoma is being identified by the visual fields tests, and also by the progression of alterations in the optic nerve head. the visual fields tests are long and difficult (30 minutes). it is therefore important to create additional tests and anticipate the diagnosis, in order to avoid the irreversibility of glaucoma.

the oct angiography (octa) is a non-invasive technology, marketed since 2014, that uses oct with infrared light, with no radiation nor side effects, to evaluate within seconds the vascularization of the fundus, retina and optic nerve head, which may be useful for the glaucoma diagnosis. a recent meta-analysis has shown a decrease of the vascular density (dv) in glaucoma, so that octa may be useful in the advanced diagnosis of glaucoma. however, the vd values obtained were different depending on the device. in addition, no studies with the oct triton (topcon®) device were considered in the analysis. the authors suggested the development of dedicated software, which would allow the evaluation of vd with different devices for a more independent and valid assessment. on the other hand, recent studies show that the diagnostic capacity of octa may be superior to that of oct, and that octa may be more useful in determining the severity of glaucoma than oct. it is therefore necessary to evaluate the additional diagnostic tests whether they are non-invasive and whether it allow us to give a faster diagnosis. this study is aimed at comparing the diagnostic utility of octa with standard complementary glaucoma examinations (oct and cv).

Eligibility criteria:
inclusion criteria: * patient whose age ≥ 18 years * patient consultant in the ophthalmology department of the marie-thérèse health center or the polyclinique de la baie * french speaking patient * patient affiliated to a health insurance plan * patient having given free, informed and express consent exclusion criteria: * patient with another ophthalmological pathology or a history of ophthalmological pathology * patient with a history of ophthalmic surgery except for uncomplicated cataract surgery * patient under guardianship or curatorship * patient deprived of liberty * pregnant or lactating woman

Keywords: glaucoma oct octa
comparison study of coaguchek xs pt and laboratory innovin pt by ntuh lab medicine

Conditions: Deep Vein Thrombosis

Summary: comparison study of coaguchek xs pt and laboratory innovin pt by ntuh lab medicine

this trial is going to proceed in two phases: familiarization phase and evaluation phase. the preliminary comparison study consists of ten (10) patients being tested with the coaguchek system and the laboratory reference method. this preliminary study is intended to help familiarize the operator with the dosing of the coaguchek xs pt strips and to serve as an indicator as to whether some of the variables. evaluation phase consists of testing seventy (70) patient samples with the coaguchek xs system and with the laboratory method.

Eligibility criteria:
inclusion criteria: * warfarin continuously treated patients exclusion criteria: * warfarin recently discontinuous treatment

Keywords: pt dvt
novel drug delivery technique via retroject device

Conditions: Glaucoma

Summary: the purpose of this study is to identify whether or not injection of a study drug (ethacrynic acid) using the investigational retroject device is able to lower eye pressures in patients with advanced glaucoma. 20 patients with advanced glaucoma with visual acuity less than 20/200 and intraocular pressures (iop) \>20mmhg on maximum medical therapy will be asked to participate in the study. the first five patients will have the retroject device placed over their eye for 30 seconds and then removed. assuming no issues, then it will be placed on the eye for one minute. the second group of patients (3 total) will have the retroject device placed on the eye and then an injection of ethacrynic acid into the episcleral vein. the third group of patients (12 total) will have the retroject device placed on the eye and then will be randomized in a 2:1 ratio to receive either an ethacrynic acid injection or a balanced salt solution injection. all 20 patients will then return for intraocular pressure measurements on days 1, 2, 3, and 7 as well as 6 weeks after injection. in addition, the patients will undergo pre and post intervention corneal endothelial assessments (endothelial cell count, shape analysis, and pachymetry). potential safety issues are unlikely and include bleeding, infection, pain, ototoxicity, or temporary or permanent loss of vision.


Eligibility criteria:
inclusion criteria: * age 55 years or older of both sexes * iop \>20 mmhg on maximal treatment * \<20/200 visual acuity * willing to sign informed consent forms exclusion criteria: * monocular patients with bleeding disorders * patients on anticoagulant or antiplatelet medications * patients who had prior laser surgeries (slt or alt)

Keywords: novel drug delivery technique for glaucoma patients
photobiomodulation therapy for idiopathic facial paralysis

Conditions: Bell's Palsy

Summary: objective: bell's palsy is characterized by acute, unilateral onset that compromises function and esthetics, exerting a considerable impact on the social, professional, and psychological aspects of the lives of affected individuals. without treatment, 30% of patients with complete paralysis will not completely recover. therefore, shortening the recovery time will accelerate the recovery process leading to better results. the objective of this study was to determine whether photobiomodulation therapy with laser acupuncture therapy could relieve symptoms in patients with bell's palsy. methods: this study was an open-label, randomized controlled trial including 96 patients that undergoing bell's palsy. all the patients received oral vitamin b1. patients were assigned to the laser acupuncture (la) group and control group, with 102 patients in each group. la group were received 4 weeks of laser treatment (3 times per week), while control group were received sham laser treatment. clinical outcome measure comprised the house-brackmann grading system, facial clinimetric evaluation scale (face), sunnybrook facial grading scale (sbfg), and electrophysiological testing, including electroneuronography (enog), electromyography (emg) and blink reflex. all the measurements were collected at the first day and at the end of study. all reported p values were two-sided and were declared statistically significant when less than 0.05.


Eligibility criteria:
inclusion criteria: * (1) clinical diagnosis of bell's palsy. (2) adults over 18 years of age and under 60 years of age. exclusion criteria: - (1) systemic disease, such as severe diabetes, malignant tumors and other serious consumptive diseases. (2) serious mental illness or social problems, and neurological disorders. (3) planning for pregnancy, in pregnancy or lactation.

Keywords: idiopathic facial paralysis bell's palsy photobiomodulation rct
a study to compare insulin pump with conventional treatment in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: insulin deficiency resulted from progressive beta cell failure and insulin resistance in type 2 diabetes requires exogenous insulin therapy, escaping from oral antihyperglycemic agents. previous data have been suggested that continuous subcutaneous insulin infusion (csii) does not only have efficacy in glucose control but also restore beta cell failure. the investigators plan to compare the efficacy/safety and beta cell function between insulin pump treatment and the intensification of conventional treatment in patients with uncontrolled type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * age: 18 \~ 85 yrs * hba1c: \> 7.5% * no change of anti-diabetic medication within 3 months exclusion criteria: * systemic corticosteroid administered within previous 6 months * pregnancy * severe liver or renal disease, heart failure * history of cancer within 5 years * thyroid disease * anti-obesity drugs or slimming products within previous 3 months
effect of powerbreath versus transcutaneous electrical diaphragmatic stimulation on the severity of copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a common and treatable disease characterized by progressive airflow limitation and tissue destruction. it is associated with structural lung changes due to chronic inflammation from prolonged exposure to noxious particles or gases most commonly cigarette smoke. powerbreathe device (power-breathe international ltd., southam, warwickshire, uk) is an inspiratory muscle training and this device has recently shown benefits on pulmonary function. also, the power-breathe® device's effects on the strength of the diaphragm muscle and minimize muscle weakness and wasting in copd patients. neuromuscular electrical stimulation (nmes) is commonly used in physical therapy to increase muscle strength and promote muscle hypertrophy. nmes applied to respiratory rehabilitation is called transcutaneous electrical diaphragmatic stimulation (teds).

sixty patients will be assigned randomly into two equal groups with pre and post treatment protocol application. group a: thirty patients will be treated by power breathe along with their prescribed medication. group b: thirty patients will be treated by transcutaneous electrical diaphragmatic stimulation (teds) along with their prescribed medication.

Eligibility criteria:
inclusion criteria: * the patient selection will be according to the following criteria: 1. male patients diagnosed with stage 2\&3 copd. 2. all patients are under full medical control. 3. their ages will range from forty-five to sixty-five years. 4. patients with bmi from 25-29.9 kg/m2 exclusion criteria: * patients with the following criteria will be excluded from the study: 1. lack of language or cognitive abilities to fill out questionnaire. 2. patients with cardiac pacemaker. 3. contraindications for inspiratory muscle training (e.g. a history of recent lung surgery, recent pulmonary embolism, history of recurrent spontaneous pneumothorax, other serious lung disease). 4. existing arterial aneurysm. 5. clinical signs of unstable cardiac event (eg. congestive heart failure). 6. patients with malignant disease. 7. acute copd exacerbation within the last 4 weeks. 8. any need for supplemental oxygen. 9. patients with gastro-esophageal reflux disease. 10. patients with active hemoptysis.
assessing the effect of computer-based auditory training on adult cochlear implant speech and quality-of-life outcomes

Conditions: Cochlear Implants; Bilateral Sensorineural Hearing Loss

Summary: the purpose of this study is to compare the effectiveness of a free computer-based auditory training program, sound success (advanced bionics, valencia, ca), with the current standard of care of patient-directed auditory training in improving common measures of speech recognition and cochlear implant (ci) specific quality-of-life in new adult ci recipients in their first year post-activation.


Eligibility criteria:
inclusion criteria: * adult patients with a diagnosis of bilateral moderate-to-profound sensorineural hearing loss who are undergoing unilateral or simultaneous bilateral cochlear implantation at the mayo clinic in rochester mn. exclusion criteria: * patients undergoing revision implantation, completion bilateral cochlear implantation, or implantation for unilateral deafness will be excluded from enrollment * patients unable or unwilling to use a computer or similar device will be excluded from enrollment. * patients will be excluded if they speak a language not supported by the sound success platform. sound success is available in english, spanish, french, italian, dutch, polish, and danish.