Kornimate/medical-research-clean huggingface dataset:
phase ii trial of combination therapy with irinotecan, s-1, and bevacizumab (iris/bev) in patients with unresectable or recurrent colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine whether irinotecan, s-1, and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer


Eligibility criteria:
inclusion criteria: 1. histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy 2. measurable disease or non-measurable but assessable disease according to the response evaluation criteria in solid tumors (recist) 3. patients with no previous treatment (radiotherapy or chemotherapy). patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment. 4. age ≥20 years 5. life expectancy of at least 3 months 6. ecog ps of 0 or 1 7. adequate function of major organs as defined below: 1. hemoglobin ≥9.0g/dl 2. white blood cell count ≥3,500/mm3 3. neutrophil count ≥1,500/mm3 4. platelet count ≥100,000/mm3 5. total bilirubin ≤1.5 mg/dl 6. ast and alt ≤100 u/l (\<200 u/l in patients with liver metastasis) 7. serum creatinine ≤1.2 mg/dl 8. creatinine clearance estimate by the cockcroft-gault method \>50 ml/min (reduce initial dosage by one step if ≥50 but \<80 ml/min) 8. able to take capsules orally. 9. no electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator. 10. voluntary written informed consent. exclusion criteria: 1. serious drug hypersensitivity or a history of drug allergy 2. active double cancer 3. active infections (e.g., patients with pyrexia of 38℃ or higher) 4. history of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year. 5. uncontrolled hypertension 6. serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes) 7. moderate or severe ascites or pleural effusion requiring treatment 8. watery diarrhea 9. treatment with flucytosine or atazanavir sulfate 10. metastasis to the cns 11. pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. men who are currently attempting to conceive children. 12. severe mental disorder 13. continuous treatment with steroids 14. urine dipstick for proteinuria should be \<2+ 15. patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism 16. major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks 17. long-term daily treatment with aspirin (\>325 mg/day) 18. history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding 19. judged ineligible for participation in the study by the investigator for safety reasons.

Keywords: s-1 irinotecan bevacizumab
nurse-led intervention to improve phosphate binder adherence

Conditions: End Stage Renal Failure on Dialysis

Summary: the study aim is to test the efficacy of one-year nurse-led interventions to improve the medication intake behaviour of chronic dialysis patients. the investigators hypothesis is the interventions leading to a 15% mean increase in intake, compared to standard care.

background phosphate binder nonadherence is ubiquitous. the results of adherence enhancing interventions are often disappointing. the aim is to test a nurse-led multifactorial intervention to enhance phosphate binder adherence. methods in a quasi-experimental clinical trial, phosphate binder adherence was measured electronically in 135 hemodialysis patients for one year and phosphatemia measured monthly. for all patients, months 1-2 were baseline (no interventions were performed). the intervention arm was given 1 "preparatory" intervention and then monthly 8 "maintenance" individualized management sessions. the control arm received standard of care.

Eligibility criteria:
inclusion criteria: * adult (≥18) * chronic hemodialysis ≥1 month * treated with phosphate binders * dutch-speaking exclusion criteria: * receiving professional medication care * cognitive impairment * nursing home residents

Keywords: adherence dialysis intervention nurse-led phosphate binders trial
the effect of microprocessor controlled prostheses on walking pattern and energy consumption

Conditions: Amputation, Traumatic; Gait

Summary: the aim of this study was to investigate mic and non-mic prostheses in terms of gait pattern and energy consumption in above-the-knee amputee patients.

background: the use of microprocessor controlled (mic) prostheses has increased in recent years, but the number of studies on gait pattern and energy consumption in above-the-knee amputee patients is very low. objective: the aim of this study was to investigate mic and non-mic prostheses in terms of gait pattern and energy consumption in above-the-knee amputee patients. methods: this observational clinical study included 34 unilateral above-the-knee amputees, separated into two groups as group 1 (n:17) using mic prosthesis, and group 2 (n:17) using non-mic prosthesis. the patients were compared in terms of gait pattern, gait capacity, energy consumption, mobility, quality of life, and prosthesis satisfaction levels according to the type of prosthesis. 3d gait analysis, exercise tolerance test, short form 36 (sf-36) health survey questionnaire, locomotor capabilities index-5 (lci-5), satisfaction with prosthesis questionnaire (sat-pro) and six-minute walk test (6mwt) were used as evaluation criteria.

Eligibility criteria:
inclusion criteria: * as voluntary participation in the study * age ≥18 years * having a unilateral above-the-knee amputation * the ability of independent ambulation in the community * at least 6 months since the amputation * use of the current prosthesis for at least 8 weeks exclusion criteria: * unwillingness to participate in the study * age \<18 years * limb length discrepancy of ≥2 cm * the presence of contracture or deformity * additional amputation * neuromuscular disease or comorbidity that may interfere with the study follow-up period of \< 6 months since the amputation * use of the current prosthesis for \< 8 weeks * being uncooperative
learning small bowel capsule endoscopy

Conditions: Endoscopy; Education; Simulation; Small Bowel Disease; Small Bowel Capsule Endoscopy

Summary: this project is a prospective study investigating the education of medical doctors in gastroenterology with no prior experience to evaluate small bowel capsule endoscopies with a diagnostic sensitivity \>90%


Eligibility criteria:
inclusion criteria: * medical doctors in medical gastroenterology or surgery exclusion criteria: * prior experience with evaluation of small bowel capsule endoscopy.
efficacy and necessity of time interval between instillation of two glaucoma eye drops

Conditions: Glaucoma; Glaucoma; Drugs

Summary: according to the american academy of ophthalmology's preferred practice pattern on primary open angle glaucoma, patients should wait five minutes between administering topical drops for intra-ocular pressure reduction. to date, no study has shown the efficacy of this waiting period. in this study, we aim to establish the clinical significance of keeping a time interval between glaucoma medications.

glaucoma is a chronic disease in which constant damage to retinal nerve fibers. in most cases the damage is caused by increased intra-ocular pressure (iop). without treatment, this disease can cause irreversible decrease in visual fields until the patient eventually becomes blind. the first line of treatment include topical eye-drops aimed at reducing iop. many patients require more than one drug type. according to the american academy of ophthalmology's preferred practice pattern on primary open angle glaucoma, patients who are using two or more drop types, should wait five minutes after the first drop, before administering the second type.. to date, no study has shown the efficacy of this waiting period. in this study, we aim to establish the clinical significance of keeping a time interval between glaucoma medications. the study composes of two separate parts: part 1 - the aim of this part will be to estimate the short term effect on iop reduction. healthy subjects willing to participate voluntarily, will be given two iop reduction drugs (tilopitc and alphagan) at different intervals in each eye. after which they will undergo repeated iop measurements over a course of 7 hours. part 2 - the aim of this part will be to estimate the short term effect on iop reduction. glaucoma patients treated in the glaucoma clinic at sheba-medical center who are taking two different types of iop reduction drugs in both eyes, will be recruited. the patients will be asked to keep a constant 5 minute interval between drops in one eye and to instill the drops in the other eye with no waiting time. after one month the patients will return for a revaluation of iop and then be asked to switch the eyes so that the eye in which the interval was not kept will now be the one in which the drop will be put after 5 minute interval.

Eligibility criteria:
inclusion criteria: short duration group * healthy individuals with negative past ocular history * able to give consent long duration group: * diagnosed with primary open angle glaucoma and being treated with two types of iop reduction drops. * no other medical ocular history. * no cognitive disfunction * able to give consent * no known arrhythmia exclusion criteria (both groups): * corneal disease preventing from visualization of the angle * closed angle * pregnant women * previous ocular surgery (including cataract or refractive surgery) * known allergy to ocular drops used in this study (e.g. brimonidine, timolol) * history of asthma or arrhythmia
fatty acid composition of subcutaneous adipose tissue in infants: a prospective and observational study

Conditions: Prematurity; Subcutaneous Adipose Tissue

Summary: the fatty acid composition in blood and subcutaneous adipose tissue of infants that have an clinical indicated operation is studied.

collection of: * subcutaneous adipose tissue of term infants and preterms after birth and at term during a clinically indicated operation. * blood before the operation. measurement of the fatty acid composition (especially arachidonic acid and docosahexaenoic acid) in subcutaneous adipose tissue and blood. aim is to compare the composition of the fatty acids in blood and adipose tissue of preterms at term and term infants. to calculate the fatty acid value in each infant the proportion of adipose tissue is determined with peapod before discharge from hospital.

Eligibility criteria:
inclusion criteria: * meeting criteria of the 3 cohorts exclusion criteria: * metabolic diseases of the infant * genetic diseases * missing agreement for the study

Keywords: preterm fatty acid docosahexaenoic acid arachidonic acid infant adipose tissue subcutaneous adipose tissue
which needle length for injecting insulin

Conditions: Diabetes Mellitus

Summary: background and aims: * in the netherlands most patients with diabetes mellitus that are treated with insulin, use an insulin pen for insulin administration. the injection technique can influence the absorption rate of insulin. * the aim of this study is to compare the effect of insulin injections using a 5 mm insulin needle with insulin injections using a longer needle, on hba1c, bloodglucose levels, hypoglycaemic events, bleeding, bruising, insulin leakage and pain perception. * study hypothesis: 'insulin injected with needles of 5 mm can be given without a skinfold. the length of the needle will not influence hba1c levels and bloodglucose levels'.

* in this randomised, clinical trial with cross-over design, 52 patients with diabetes type 1 and 2 using a 8 or 12 mm needle, are randomised into two groups. * group i starts using 5 mm needles for insulin administration, after 13 weeks group i returns to their previously used 8 or 12 mm needle * group ii continues using their own 8 or 12 mm needle, after 13 weeks group ii starts using 5 mm needles for insulin administration. * during each visit the hba1c level is measured and a copy is made of the logbook of the patient with the blood glucose measurements. * insulin doses and number of experienced hypoglycaemic events are registered at each visit. * the opinion and experiences of the patients regarding the different needles are obtained by using a questionnaire. * within-group analyses are computed, using the wilcoxon signed ranks test. between-group analyses are computed using the mann-whitney u test.

Eligibility criteria:
inclusion criteria: * males and females diagnosed with diabetes type 1 or 2 * using insulin for at least one year * using an insulin pen and a needle of 8-mm or longer * 18 years or older * capable of reading the written information * prepared to, and capable of signing an informed consent exclusion criteria: patients that * change their own insulin dosage and don't keep an administration of these changes * had an hba1c that varied more than 15 % in the past year * use a needle of 5 or 6-mm * have hypoglycaemia unawareness * are pregnant or wanted to become pregnant * have a bmi \< 18 * have a skinfold thickness of 10 mm or less at the injection sites (abdomen and thigh) * had hemoglobinopathies which could limit the ability of haemoglobin to be glycated * had skin problems like lipodystrofie

Keywords: injection devices injection technique insulin needles insulin administration
cataract surgery and inflammation - the role for preoperative nsaids (pre-cin)

Conditions: Cataract Surgery

Summary: the pre-cin trial is a randomized clinical three-arm trial comparing inflammation and cystoid macular edema for the medication regimens preoperative and postoperative topical nsaids to only postoperative topical nsaids to postoperative topical nsaids and steroids in patients undergoing cataract surgery.


Eligibility criteria:
inclusion criteria: * patients must be 18 years and older at the time of the signing of the informed consent. there is no upper age limit. * scheduled for standard phacoemulsification cataract surgery (group 1 - 3) * scheduled for combined phacoemulsification cataract surgery and migs stent (group 4) * ability to cooperate fairly well during the examinations * willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (icf) and in this protocol. exclusion criteria: * contraindications for use of any medication (as listed in the approved spc, e.g. allergy, pregnancy, breastfeeding) * pregnancy * diabetes * mature cataract * active or chronic uveitis with recommendation for steroid treatment * previous trabeculectomy * other ophthalmological conditions and/or complicating factors requiring steroid treatment (group 1 - 3) * cornea pathology requiring specific medication regimens (e.g. herpes pathology, previous corneal transplantation) patients with complications or other complicating factors during surgery that causes the surgeon to demand both nsaids and steroid treatment will be excluded from the main analysis. these patients will be followed postoperatively as part of the study and included in additional analyses (for example as part of an intention to treat analysis). for patients scheduled for cataract surgery in both eyes, only the first operated eye will be included, however, both eyes will be examined.
rheumatoid arthritis synovial tissue biopsy study

Conditions: Rheumatoid Arthritis

Summary: in this proof-of-concept study, the investigators intend to collect synovial biopsies from mtx-resistant ra patients prior to and 12 weeks after initiation of tnf-blocking therapy (period 1). in addition to conventional histological and immunohistochemistry characterization of the samples, single cell rnaseq studies will be performed, with a particular focus on synovial t cells and fibroblasts. clinical response to tnf blocking therapies will be assessed using validated measurements, which will result in the identification of novel mechanisms and markers of resistance to tnf inhibition in mtx-resistant ra patients.

all patients (n=50) included in this trial will be diagnosed with ra according to the acr/eular 2010 classification criteria. they will be eligible for standard-of-care therapy using tnf blockers, because they have active disease despite previous administration of two conventional dmards (including methotrexate) for a period of at least 3 months each. disease activity at study entry (before initiation of tnf blockade) and at 12 weeks will be assessed using das28-crp (composite score that integrates numbers of tender and swollen joints, serum crp concentrations, and patient's evaluation of disease activity on a visual analogic scale) and eular response criteria. all treatments other than tnf blockade will be stable for at least 4 weeks before study entry, and for the whole duration of the study (4 months after initiation of tnf blockade). all clinical assessments will be performed by the investigators. efficacy will be assessed according to the acr/eular core set of response (das28-crp, cdai, sdai, haq) of tnfi and jaki in period 2 for non-responders to tnfi.

Eligibility criteria:
inclusion criteria: 1. males or females (not nursing and not pregnant) at least 18 years of age. women of child-bearing potential are eligible if they are practicing effective contraceptive measures. 2. subjects must meet the criteria of the 2010 eular/acr criteria for the diagnosis of rheumatoid arthritis 3. subjects must have a disease activity as defined by a tender joint count \> 4, swollen joint count \> 4 from 68 joints and a das28-crp \>3.7. (this value is the cut off level to obtain a reimbursement for bdmards in belgium). 4. subjects were treated with mtx 15 mg a week (or 7.5 mg in case of poor tolerance) for at least 3 months. 5. subjects must be naive to tnf inhibitors (adalimumab, etanercept, infliximab, certolizumab, golimumab) and other b- or tsdmards (abatacept, tocilizumab, rituximab and jak inhibitors) exclusion criteria: 1. women of child-bearing age who are unwilling or unable to use an acceptable method to avoid pregnancy 2. women who are pregnant or breastfeeding 3. subjects with a history of cancer within the last five years (other than nonmelanoma skin cell cancers cured by local resection). existing non-melanoma skin cell cancers must be removed prior to dosing. 4. subjects with any serious bacterial infection and at risk for tuberculosis (tb). 5. subjects who are unable to accept and perform the synovial biopsy procedure.
a pilot study to evaluate the impact of dexmedetomidine on breast cancer recurrence after surgery

Conditions: Breast Cancer

Summary: dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery. previous studies in cells and animals show that dexmedetomidine may promote cancer growth. the purpose of present study is to examine whether utilization of dexmedetomidine in patients undergoing surgery for primary breast cancer increases breast cancer recurrence and metastasis, and to investigate its effects on the patients' immune system.

women diagnosed with breast cancer undergoing elective surgery under general anesthesia will be randomly allocated to dexmedetomidine group or control group. patients from both groups will receive midazolam, propofol, fentanyl, remifentanil and cis atracurium for total intravenous anesthesia. bis value will be controlled between 40-60 during surgery. patients of dexmedetomidine group will receive a loading does of 1ug/kg dexmedetomidine since 15 mins before induction, and receive another 1ug/kg of dexmedetomidine at a rate of 0.5ug/kg/h for 2 continuous hours during surgery. patients of control group will receive same amount of normal saline. patients will be followed up for 36 months to measure the incidence of cancer recurrence and metastasis. serum form patients of both groups will be collected at 24 h after surgery. the number of cd3+ , cd4+, cd8+ cells and nk cells in the serum will be compared between the two groups. serum levels of ifn-γ, il-12，il-4 and vegf will also be measured and compared.

Eligibility criteria:
inclusion criteria: * asa grade i-iii * age range of 18 to75 * patients diagnosed primary breast cancer * patients will have elective mastectomy exclusion criteria: * with history of breast operation * patients diagnosed with inflammatory breast * severe mental or physical illnesses(like liver, renal, brain or lung disease) * with history of opioid addiction * patients diagnosed metastatic breast cancer * contradictions or an allergy to dexmedetomidine
stellate ganglion block in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the goal of this clinical trial is to test the efficacy of stellate ganglion block in obstructive sleep apnea. the main question it aims to answer are: • can stellate ganglion block improve obstructive sleep apnea? patients were randomly divided into two groups, all provided with routine therapy. based on this, the experimental group was given stellate ganglion block. the video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

obstructive sleep apnea is of increasingly high prevalence. the goal of this clinical trial is to test the efficacy of stellate ganglion block in obstructive sleep apnea. the main question it aims to answer are: • can stellate ganglion block improve obstructive sleep apnea? patients were randomly divided into two groups, all provided with routine therapy. based on this, the experimental group was given stellate ganglion block. the video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Eligibility criteria:
inclusion criteria: * patients aged over 18 years diagnosed with obstructive sleep apnea by polysomnography * patients with moderate to severe obstructive sleep apnea * patients who have undergone continuous positive airway pressure treatment for at least 3 months but have not achieved satisfactory therapeutic effects * patients who voluntarily agree to receive stellate ganglion block treatment and sign the informed consent form exclusion criteria: * patients with a history of allergy or contraindications to local anesthetics or corticosteroids * patients with severe cardiovascular, cerebrovascular, respiratory, hepatic, or renal diseases * patients with a history of neck surgery or cervical spine disease * patients with psychiatric disorders or other medical conditions that may affect the safety or effectiveness of stellate ganglion block treatment * pregnant or lactating women * patients who have participated in other clinical trials within the past 3 months
passive leg raise induced stroke volume changes in elderly prior to elective surgery measured by lidcoplustm

Conditions: Stroke Volume; Cardiovascular System; Fluid Therapy

Summary: this is a pilot study to investigate whether patients at advanced age are fluid responders via a reversible fluid challenge, the passive leg raise test. this will be measured with a non-invasive cardiac output monitor, the lidco (lidco hemodynamic monitoring) .

the intervention is as simple as a passive leg raise with measurement of effect on stroke volume.

Eligibility criteria:
inclusion criteria: * patients ≥80 years of age, undergoing elective urologic surgical procedure exclusion criteria: * age \<80 years, severe aortic insufficiency, first case of the day on the operation program, unavailability of research personnel and contraindication to lithium.