Kornimate/medical-research-clean huggingface dataset:
study of different doses of irinotecan and cisplatin for first-line extensive-stage small-cell lung cancer treatment

Conditions: Small Cell Lung Cancer

Summary: the purpose of this study is to identify the appropriate dose of irinotecan by dose escalation(dose climbing) test. the study would provide rationale for regimen decision in a future phase iii clinical trial, in which irinotecan combined with cisplatin(ip) will be selected as therapeutic drugs.

to determine the maximum tolerated dose (mtd) and limiting toxicity (dlts) of irinotecan in patients with extensive stage small cell lung cancer treated with irinotecan plus cisplatin

Eligibility criteria:
inclusion criteria: 1. age 18 to 65 years, male and female 2. histologically or cytologically confirmed extensive stage .small cell lung cancer(sclc )（except metastases only as pleural effusion） 3. no prior chemotherapy 4. metastatic lesion had been treated more than 14 days by palliative radiation therapy or surgery 5. with measurable tumor lesions (non-irradiated parts),(recist 1.1: without radiotherapy ,the longest diameter is more than 10mm by ct or mri ,except that lymph nodes need short diameter need more then 15mm, and the lesions can be accurately evaluated repeatedly measurable) 6. eastern cooperative oncology group(ecog) performance status 0-1 7. expected survival ≥ 3months 8. marrow,kidney, liver,heart and lung are well -functioning,and absolute count of * absolute neutrophil coun(anc) ≥ 2.0 × 109 / l * blood platelet(plt) ≥ 100 × 109 / l * hb≥ 90g / l * conjugative bilirubin(cb)≤ upper limit of normal(uln) × 1.5 * aspartate transaminase(ast )(glutamic oxalacetic transaminase,got): ≤ upper limit of normal(uln )× 2.5 * alanine aminotransferase(alt)(glutamate pyruvate transaminase,gpt): ≤ uln × 2.5 * serum creatinine: ≤ uln or calculated creatinine clearance≥ 60 ml / min * (pt inr) ≤ uln × 1.5 * ecg: no abnormalities in need of treatment 9. no pregnancy or no pregnancy demand at the end of the study within six months 10. must provide written informed consent. exclusion criteria: 1. patient have platinum compounds allergy history 2. patient with active ulcer disease or chronic enteritis patients 3. primary lesion(s) has (have) been treated by surgery or radiation 4. patient had received immune drugs treatment for anti-lung cancer indications or anti-cancer chinese traditional medicine treatment within two weeks 5. patients with interstitial pneumonia or pulmonary fibrosis 6. brain metastasis requiring treatment 7. patient with bronchus or bronchial stenosis or blockage and superior vena cava syndrome caused by serious invasion 8. patients with severe infections, severe abnormal secretion of (anti diuretic hormone,adh) syndrome, poorly controlled diabetes, severe complications requiring treatment vena cava syndrome 9. severe cardiovascular disease: hypertension that medical treatment can not be controlled , unstable angina, myocardial infarction within the last june a history of congestive heart failure\> 3 (nyha) and severe arrhythmia

Keywords: irinotecan small cell lung cancer
vascular endothelial growth factor (vegf) levels in retinal vein occlusion (rvo) during anti-vegf treatment

Conditions: Retinal Vein Occlusion

Summary: the purpose of this study is to treat patients with retinal vein occlusion with standard of care anti-vascular endothelial growth factor therapy and to correlate levels of vascular endothelial growth factor in the anterior chamber fluid of the eye. this study will evaluate if measuring the vascular endothelial growth factor will help predict the timing of when anti-vascular endothelial growth factor therapy will be needed.

ten patients, 5 with branch retinal vein occlusion and 5 with central retinal vein occlusion, will receive stand of care anti-vascular endothelial growth factor over the course of 52 weeks while undergoing a paracentesis prior to each treatment. during the paracentesis anterior chamber fluid will be removed to evaluate vascular endothelial growth factor levels along with other cytokines present in the anterior chamber fluid. ocular coherence tomography will also be collected at each visit to evaluate macular thickness which will be used to help determine treatment windows along with levels of vascular endothelial growth factor. patients with high levels of vascular endothelial growth factor and the presence of macular edema on ocular coherence tomography will be treated every four weeks. once vascular endothelial growth factor levels are reduced along with improvements of macula edema treatment windows will be extended to 8 weeks and then to 12 weeks once levels are normal and edema is no longer present.

Eligibility criteria:
inclusion criteria: * willingness and ability to provide written informed consent. * diagnosis of retinal vein occlusion with macular edema and central foveal thickness of greater than or equal to 300 microns confirmed by intravenous fluorescein angiography and optical coherence tomography * visual acuity between 20/25 and 5/200 exclusion criteria: * bilateral retinal vein occlusion * vision worse than 5/200 in study eye * history of myocardial infarction, ischemia, or cerebrovascular accident within 6 weeks of screening * concurrent proliferative diabetic retinopathy and/or maculopathy * concurrent exudative age-related macular degeneration * concurrent optic neuropathy with the presence of an afferent pupillary defect * previous vitrectomy in the study eye * currently pregnant or planning to become pregnant during the duration of the study. women currently breastfeeding are also excluded. * previous treatment for retinal vein occlusion in the study eye * any current medical condition which, in the opinion of the investigator is considered to be uncontrolled * history of allergy or hypersensitivity to study treatment, fluorescein, or any study procedure and treatment related ingredients (e.g. topical anesthetics, betadine, etc.)

Keywords: vision loss eye injections
wrist-worn sensors for tele-rehabilitation of the hemiparetic upper extremity

Conditions: Stroke; Hemiparesis

Summary: stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. using or attempting to use the affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor function recovery. the investigators are conducting a clinical study to test the efficacy of wrist-worn sensors that encourage affected limb use during activities of daily living.


Eligibility criteria:
inclusion criteria: * ischemic or hemorrhagic stroke at least 3 months prior to study enrollment * mild-to-moderate to severe upper-limb motor impairments (as measured by a score between 21 and 50 on the arm section of the fugl-meyer scale). exclusion criteria: * cognitive impairments that would significantly interfere with their ability to follow instructions (as measured by a score lower than 23 on the mini mental state examination scale) * severe attention deficits or hemispatial neglect (as measured by the mesulam cancellation test and the line bisection test); * severe range-of-motion limitations (as measured via physical examination) or severe spasticity (as measured using the modified ashworth scale) that would prevent safe performance of home-based exercises; * proprioceptive deficits that impair their ability to process feedback (as measured using the fugl-meyer assessment-upper extremity; sensory section). * implantable medical devices that are not compliant with the iso 14117:2012 and/or ansi/aami pc69 standards for bluetooth compatibility. we will ask subjects to provide us with their medical device record card and verify that the device complies with the above-mentioned standards. if not, they will be excluded from the study. * participation in upper-extremity rehabilitation program (i.e. outpatient occupational therapy, research study, ...). * recent (\< 3 months) botox injection in the upper-extremity or plan to undergo injections during the study timeline.
clinical usefulness of digital single-operator cholangioscopy(spyglass™) for post-liver transplant anastomotic stricture

Conditions: Liver Transplant; Complications; Biliary Duct Obstruction; Anastomosis, Obstructed

Summary: liver transplantation (lt) is an essential treatment for end-stage liver disease. although clinical outcomes of lt recipients have markedly improved, anastomotic biliary strictures (abs) are still occurred in 10-40% of post-lt patients. in the korea, living donor lt (ldlt) is the more common than deceased donor lt (ddlt). when ldlt is performed, the right lobe graft is usually used, and the right anterior and posterior segmental bile ducts (rasd/rpsd) of the graft are reconstructed by the duct-to-duct anastomosis method to the common hepatic duct of the recipient. when abs occurs in ldlt recipients, the stricture site is often very tight and twisted. so, conventional endoscopic procedure is challenging and success rate of ercp for abs is still unsatisfactory (about 60%). furthermore, approach to the rpsd is more intricate than that to rasd because the duct opening is located deeper in a posterior aspect. therefore, despite being able to benefit the patient, bilateral drainage (both rasd and rpsd) is considered to be more difficult and unilateral drainage of rasd is mainly performed. in 2015, high-resolution cholangioscopy (spyglass™) was introduced. the system enables direct visualization of the bile and pancreatic ducts strictures. the 3rd generation spyscope ds ii access \& delivery catheter introduced in 2018, features increased resolution and adjusted lighting to provide physicians with an even better view of the biliary and pancreatic ducts. to date, only several retrospective studies have evaluated the efficacy of spyglass for guidewire placement across the abs and to the best of our knowledge only one prospective study is ongoing (clinicaltrials.gov nct #03205072). in that study abs in both ldlt and ddlt patients are enrolled. private communications with the sponsor of this study, however, have reported that only approximately 10% of the cases are ldlt cases. in addition, there is no reported paper about the usefulness of spyglass for bilateral drainage and its clinical benefit in post lt abs. if successful bilateral drainage is performed by using spyglass, it may be more helpful for patients than unilateral drainage as it allows sufficient drainage of the transplanted liver. with this prospective study, we intends to investigate the efficacy of spyglass for bilateral drainage of abs in ldlt patients and improve drainage success rate. this results can be used as clinical basis for further studies such as randomized controlled trial.


Eligibility criteria:
inclusion criteria: * age 19 or older * patients who treated with ldlt (duct-to-duct anastomosis) * patients with confirmed anastomosis site biliary stricture using cross-sectional imaging study (ct, mri/mrcp). exclusion criteria: * patients with age 18 or under * pregnant woman * patients unable to endoscopic (transpapillary) approach due to prior surgical history * patients who did not provide informed consent to participation in the study
use of artificial intelligence (ai) to predict clinical outcomes in patients hospitalized for covid19 pneumonia during the 4 pandemic waves

Conditions: COVID-19 Pandemic

Summary: predictive models can be applied in different areas, during the emergency of the covid-19 pandemic, in fact, they have proven important in supporting health systems in planning strategic decisions and in formulating health policies for the containment of the disease. the covid-19 pandemic, in particular, has represented a real challenge for our healthcare system. in italy, it was divided into four main waves, each characterized by different types of patients and different therapeutic approaches progressively improved based on new scientific evidence. the objective is to carry out a study on the data of patients hospitalized for covid-19 at the asst of lecco during all four pandemic waves, with different degrees of severity of illness, collecting the data of interest and applying it to they use artificial intelligence to identify recurring patterns of clinical outcome in terms of survival and secondary infectious complications, so as to build new reliable predictive statistical models that can be used to predict the outcome of the patients themselves. the strong ambition of this project is that the application of artificial intelligence to data of such significant quantity can allow us to build valid statistical models which can then be hypothetically applied to any patient to predict, based on anamnestic characteristics, blood chemical parameters. at baseline and at the set treatment, the probability of survival and complications


Eligibility criteria:
inclusion criteria: * age \> 18 years; * hospitalization for covid-19 pneumonia at asst lecco. exclusion criteria: * hospitalization or finding of asymptomatic sars cov-2 infection.
instilled lidocaine vs placebo for pain management during vacuum assisted closure (vac) dressing changes

Conditions: Burn

Summary: patients will be randomized prospectively to one of two groups. one group will receive 5 mg/kg of 1% lidocaine, and the other will receive .9 normal saline, instilled into their vac sponge ½ hour prior to vac dressing change. all patients will complete a pain assessment tool prior to receiving the instilled lidocaine/placebo, immediately after the procedure and 1 hour after the procedure. pain scores will then be compared between the lidocaine and placebo groups. risks: lidocaine toxicity is a potential risk, but 5 mg/kg of 1 % lidocaine is below toxicity thresholds in an adult.

• all burn service patients (inpatients and outpatients in burn clinic) who are receiving vac therapy will be screened for study inclusion criteria. those with allergies to lidocaine will be excluded. participants will be enrolled until a sample size of 80 wound vac changes is achieved. up to 4 vac dressing changes can be included in this study per participant. subjects will be randomized prospectively for each dressing change. utilizing a randomized bracketed approach, patients will be assigned to one of two groups: lidocaine group or placebo group. the pharmacy research center (prc) will assign patient a study identification (id) number and record it along with their medical record number on the master study id list. they will then randomize the participants by drawing randomly shuffled green vs white index cards. (40 white card = 0.9 normal saline and 40 green card = 5 mg/kg of 1% lidocaine). they will draw up the appropriate amount of medication to be used, label it with the patients medical record (mr) #, date, and administration instructions and deliver it to the nurse who is doing the vac dressing change. they will keep the master randomization data collection tool in a locked drawer in her office.

Eligibility criteria:
inclusion criteria: * all burn service patients with a wound vac exclusion criteria: * allergy to lidocaine
effect of food on bioavailability of a modified release formulation of imatinib

Conditions: Healthy

Summary: this is a single center, four-treatment, four period, crossover study to evaluate the effect of food on the relative bioavailability of a single dose of imatinib (sti571) given as a 800 mg modified release tablet, mr2 compared to twice-daily doses of 400 mg film-coated imatinib tablets. there will be a 10 day wash out phase between treatments and a 1 week safety period at the end of the study. each participant will receive all four treatments


Eligibility criteria:
inclusion criteria * healthy male or female subjects (postmenopausal women) * able to communicate well with the investigator and comply with the requirements of the study. exclusion criteria * smokers * subjects using any prescription drug or over-the-counter (otc) medication (including herbal and alternative medication) within 2 weeks prior to dosing. * participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. * a past medical history or presence of clinically significant ecg abnormalities including: * history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated). * history of medications pre-disposing the subjects for gi bleedings/cerebral hemorrhage. * women taking any biphosphonates (fosomax like drugs) * history of being immunocompromised, including a positive hiv test result. * a positive hepatitis b surface antigen (hbsag) or hepatitis c test result. * females nursing infants. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: food effect bioavailability pharmacokinetic imatinib sti571 modified release formulation of sti571 cml chronic myeloid leukemia philadelphia chromosome
tenofovir in chronic hepatitis b with mild alt elevation

Conditions: Chronic Hepatitis B

Summary: this study aims to clarify whether patients with chronic hepatitis b with high viral load will benefit from oral antiviral therapy despite only mildly elevated serum liver enzyme.

chronic hepatitis b (chb) is a serious disease in taiwan, leading to substantial morbidity and mortality including hepatic failure, liver cirrhosis, and hepatocellular carcinoma (hcc). recently a large body of evidence supports that high level of serum hbv dna is an independent risk factor for late complications in chb patients. nucleos(t)ide analogues (nuc) are effective antiviral therapy that can potently inhibit replication of hepatitis b virus (hbv), and has been widely used in management of patients with chb. current practice guidelines recommend using serum alanine aminotransferase (alt) \> 2 times of the upper limit of normal (uln) as the prerequisite to initiate antiviral therapy in compensated chb patients without liver cirrhosis. however, serum alt level does not exactly correlate with serum hbv dna or liver tissue injury. whether antiviral therapy improves outcomes of patients with slightly elevated alt (i.e. 1-2 folds of uln) remains unknown.

Eligibility criteria:
inclusion criteria: * age between 25 to 70 years, * serum hbsag positivity for more than 6 months, * positive or negative serum hbeag, * serum hbv dna more than 2,000 iu/ml, * highest serum alt \> 1 fold of uln, but \< 2 x uln on at least two occasions (≧ 3 months apart) in the preceding one year, exclusion criteria: * co-infection with hiv, hcv, or hdv, * previous exposure to hbv antiviral therapy for more than 12 weeks, * presence of cirrhosis on histopathology, * hepatic decompensation defined as serum bilirubin \> 2mg/dl and prolonged prothrombin time \> 3 seconds, * concurrent malignant diseases including hepatocellular carcinoma, * severe co-morbidity with life expectancy \< 1year, * pregnant or lactating women, * organ transplantation except cornea or hair transplant, * suspected or confirmed chronic liver diseases from etiologies other than hbv (e.g. alcoholic hepatitis, wilson disease, hemochromatosis...etc), * serum creatinine \>1.5mg/dl

Keywords: chronic hepatitis b hepatitis b viral dna antiviral therapy tenofovir
exercise training and knee joint proprioception in rheumatoid arthritis

Conditions: Rheumatic Arthritis

Summary: rheumatoid arthritis (ra) is a chronic disorder that affects 0.5% to 1% of adults and is the result of an autoimmune attack against joint tissues. in recent years, advances in anti-rheumatoid drugs and treatment strategies have improved the health status of patients with ra. however, many patients do not achieve disease remission and experience progressive functional impairment. according to 2003 data from the national health interview survey in the united states, by 2030, approximately 25% of adults aged 18 years and older are expected to have doctor-diagnosed arthritis, and 9.3% of adults are expected to have arthritis-related activity limitations. in order for patients with ra to perform activities of daily living, it is very important for them to maintain their balance, i.e., their sense of proprioception. it is known that knee proprioception is decreased in ra. in addition, the presence of pain, decreased muscle strength, and functionality in patients with ra lead many of them to adopt a sedentary lifestyle. the main aim of this study was to evaluate the effects of exercise training on knee joint proprioception in individuals with ra. in addition, it also aims to examine how exercise training improves pain, functionality, performance, fear of falling, biopsychosocial status, and quality of life. the importance of this research is that it provides more scientific data for improving knee joint proprioception in individuals with ra and guides clinical practice. it is also expected to contribute to the development of a comprehensive approach to improving the quality of life of patients by demonstrating not only the physical but also the psychological and functional effects of exercise training.


Eligibility criteria:
inclusion criteria: * being diagnosed with ra * being able to walk * being between the ages of 40-65. * accepting to participate in the study and approving the informed consent form. * being literate and able to use technological devices. exclusion criteria: * having acute inflammatory pathology in the knee joint. * knee arthroplasty surgery. * intra-articular or systemic corticosteroid use in the last 3 months. * having participated in an ftr program in the last 3 months. * advanced musculoskeletal, cardiac or peripheral vascular disease. * significant system or organ failure. * having a disease that will affect cognitive functions such as alzheimer's disease or dementia

Keywords: exercise proprioception biopsychosocial model knee muscle strength
platelet gel in systemic sclerosis

Conditions: Scleroderma, Systemic

Summary: * systemic sclerosis (scleroderma; ssc) is a connective tissue disease characterized by a progressive fibrosis of the skin and visceral organs. * a diffuse cutaneous microvascular damage occurs in 30-50% of patients, often leading to digital ulcers development, responsible for pain, functional disability, disfiguring scars, digital bony reabsorption, infection and osteomyelitis. * although the availability of drugs as i.v. prostacyclin analogs, oral vasodilating agents, oral phosphodiesterase-5 inhibitors, oral endothelin receptor blockers has improved the prognosis, digital ulcers are frequently refractory to the medical treatment. * preliminary data seems to demonstrate a pivotal role played by some growth factors (pdgf, tgf beta 1-2, igf) in the process of ulcers healing: tissue regeneration and re-epithelization. alpha-granules in the platelets store these factors in significant amount. * recently, the application of a gel rich in platelets, prepared from donors' plasma taken by apheresis, seems to be beneficial to enhance pressure and vascular ulcers healing. * on the basis of these considerations we expect that application of a platelet gel, combined with advanced dressing and conventional medical therapy, makes a more rapid healing of digital ulcers in patients with systemic sclerosis. we decided to conduct a double blind rct to test this hypothesis


Eligibility criteria:
inclusion criteria: * digital ulcers (npuap stage≥2) in patients with ssc (acr criteria) * current medical treatment with intravenous prostanoids * availability to come to our centre for weekly ulcer assessment and medication * capacity to give informed consent exclusion criteria: * clinical evidence of skin infection * current treatment with bosentan or sildenafil * presence of necrotic material occluding the wound bed.

Keywords: scleroderma, systemic therapeutic platelet gel