Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics (pk) of tki258 in cancer patients with normal and impaired hepatic function

Conditions: Solid Tumors; Hepatic Impairment

Summary: this is a multi-center, open label study to assess pharmacokinetics (pk) of tki258 at single-dose and steady state in adult cancer patients either with mild, moderate or severe hepatic impairment or with normal hepatic function. hepatic function in study patients will be categorized as normal, mild, moderate or severe based upon pre-dose (day 1) total bilirubin and ast/alt levels. starting dose of tki258 will depend on total bilirubin and alt/ast levels at baseline. patients will be treated until disease progression (assessed by recist 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.


Eligibility criteria:
inclusion criteria: 1. patients with histologically or cytologically confirmed solid tumor, excluding breast cancer, that is either refractory to the standard therapy or has no available therapies. 2. ecog performance status (ps) 0 or 1 3. patients must have measurable and/or non-measurable lesion(s) as assessed by computer tomography (ct) scan or magnetic resonance imaging (mri) per recist 1.1 exclusion criteria: 1. patients with known brain metastases. 2. patients who have undergone major surgery ≤ 4 weeks prior to starting study treatment other protocol-defined inclusion/exclusion criteria may apply

Keywords: solid tumors hepatic impairment child-pugh classification pharmacokinetics pk recist 1.1
evaluations of optimizing perioperative fluid management on postoperative pain outcomes

Conditions: Patients Major Laminectomy Surgery

Summary: patient characteristics, duration of surgery, and infusion volumes will be compared between the groups. oxygen transport and organ function will be compared length of hospital stay, morbidity, postoperative pain intensity were compared. continuous variables will be analyzed using the student t-test and discrete variables will be analyzed using chi-square test. p-value \<0.05 will be considered significant, where appropriate 95% confidence intervals will be calculated. statistical analysis will be carried out using standardize statistical programs spss 12.0 for windows.


Eligibility criteria:
inclusion criteria: * all patients are undergoing elective spine laminectomy exclusion criteria: * age \<20 yr * emergency surgery * coagulopathy * renal and hepatic dysfunction * hyperthyroidism, and cardiac rhythm other than sinus rhythm
study investigating the role of oxaliplatin duration in modified folfox-6 or capox regimen as adjuvant colon cancer therapy

Conditions: Colon Cancer

Summary: this study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified folfox-6 or capox treatment is not inferior to 6 months of oxaliplatin in modified folfox-6 or capox treatment in terms of disease free survival in patients with stage ii/iii colon cancer.

this study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified folfox-6 or capox treatment is not inferior to 6 months of oxaliplatin in modified folfox-6 or capox treatment in terms of disease free survival in patients with stage ii/iii colon cancer. in addition, we would like to characterize pharmacogenomic profile associated with toxicities and gene expression profiling to predict the recurrence of colon cancer as parallel study.

Eligibility criteria:
inclusion criteria: * curatively resected, histologically confirmed colon adenocarcinoma * ajcc/uicc high-risk stage ii, stage iii colon cancer * age over 18 years old * performance status (ecog scale): 0-1 * adequate major organ functions * patients should sign a written informed consent before study entry exclusion criteria: * colon cancer other than adenocarcinoma * rectal cancer * r1 or r2 resections * other malignancies within the last 5 years * symptomatic peripheral sensory neuropathy * presence of other serious disease * lactating or pregnant women * fertile women

Keywords: adjuvant folfox or capox therapy stage ii/iii colon cancer adjuvant therapy
investigation of the effects of discharge education strategies on quality of life and daily living activities in patients who have undergone intracranial surgery.

Conditions: Intracranial Surgery

Summary: it was planned to provide education using verbal education or verbal and picture-text brochure method as a discharge education strategy for patients who underwent intracranial surgery. in this context, it was aimed to compare the effects of two discharge education strategies used in the discharge education of patients who underwent intracranial surgery on the quality of life and daily living activities of the patients.

in this study, it was planned to provide education to patients who underwent intracranial surgery by using verbal education or verbal and pictorial brochure methods as a discharge education strategy. the evaluation of the effect of this education, which includes content on skin wound care, nutrition, drainage, exercise, medication management and seizures, on the quality of life and daily living activities of the patients in this context, it was aimed to compare the effects of two discharge education strategies used in the discharge education of patients who underwent intracranial surgery on the quality of life and daily living activities of the patients.

Eligibility criteria:
inclusion criteria participants must meet all of the following criteria: * have undergone intracranial surgery * voluntarily agree to participate in the study * be between 18 and 75 years of age * be literate and speak turkish * be open to communication and cooperation * be mentally healthy * have no visual, hearing, or speech impairments exclusion criteria participants will be excluded from the study if they meet any of the following: * refuse to participate in the study * are not native turkish speakers * are illiterate * have visual, hearing, or speech impairments * have a diagnosed psychological disorder * have been diagnosed with dementia or alzheimer's disease

Keywords: patient discharge management
protein nutrition during weight loss

Conditions: Obesity

Summary: the purpose of this study is to minimize the loss of lean body mass that occurs during a weight-loss program in obese people by changing the nature of ingested protein and the pattern of protein feeding

in most physiological situations, the adequate amount of protein necessary to promote health is more and more well known. however, for an adequate protein intake, it was shown that the kinetic of amino acid delivery to the organism has an influence on the efficiency of protein utilization. in particular, caseins, slowly digested milk proteins, promote a better protein balance than rapidly digested milk soluble proteins in young subjects (boirie et al., 1997). in addition, changing protein feeding pattern (80% of daily protein consumed at noon vs 25%) significantly affect protein balance (arnal et al., 2000). in young healthy individuals, the best protein efficiency is obtained by spreading protein absorption over time (casein, and/or 4 isoproteic meal per day). on the contrary, in older individuals, due to alteration in the sensitivity of protein metabolism to feeding, it is better to use rapidly digested proteins (dangin et al., 2003), and / or to have a protein-rich meal once a day (arnal et al., 1999). another physiological situation that was not studied in this regard is obesity. obesity incidence is rapidly increasing around the world. when body mass index (weight / height2) becomes too high (\>30), it is often suggested to restrict energy intake. however, severe energy restriction leads to fat mass loss, but also to lean body mass loss, which should be prevented. our aim is to test whether for an adequate amount of total protein, it is possible to preserve lean body mass by using either casein, or milk soluble proteins, or by changing protein feeding pattern.

Eligibility criteria:
inclusion criteria: * bmi\>30 * sedentary * normal tsh exclusion criteria: * any serious health problem

Keywords: casein milk soluble proteins protein feeding pattern overweight obesity energy restriction protein metabolism lean body mass body composition nitrogen balance protein synthesis proteolysis spread pulse
colon capsule versus virtual colonoscopy for colorectal cancer screening

Conditions: Colorectal Cancer

Summary: france is among the countries with a high incidence of colorectal cancer. the prognosis associated with colorectal cancer is related to the development stage of the disease at diagnosis. thus, when the cancer is detected and treated at an early stage, the survival rate at 5 years was 90%. it is therefore a major issue of screening is widespread in france since the end of 2008. this screening is based on a two step strategy: 1) the occult blood in the stool (fobt) and if positive 2) the realization of an optical colonoscopy examination currently regarded as the evaluation procedure colon reference. but as part of this organized screening, 13% of those with a positive fobt ultimately refuse to have an optical colonoscopy. under the refusal, virtual colonoscopy may be proposed as an alternative according to the recommendations of the national health authority in 2010. but it has never been assessed as part of organized screening. similarly another alternative is recently developed colic capsule that benefits of development in recent years of the capsule for the small intestine which has become the gold standard for diagnosis of most diseases of the small intestine (bleeding occult, diagnosis of unknown colitis...). therefore the study proposes virtual colonoscopy or colon capsule for people with a positive fobt as part of organized screening and did not realize optical colonoscopy after the usual procedure and complete recovery. this study aims to answer the question of the place of colic capsule as part of organized screening. an economic component is integrated to assess, in terms of health insurance, the cost associated with these two exams, and compare them to the cost of optical colonoscopy. the proposed study is an observational study of impact of an alternative screening strategy for colorectal cancer whose primary objective is to compare the rate of acceptance of virtual colonoscopy and colon capsule in patients refusing optical colonoscopy.


Eligibility criteria:
inclusion criteria: * patients with a positive fobt at screening organized colorectal cancer, patients who have not achieved optical colonoscopy and who received the usual procedure and complete recovery exclusion criteria: * none

Keywords: screening colorectal cancer colon capsule virtual colonoscopy
probiotics: is it really that good? cost-effectiveness of treating the in-patient

Conditions: Diarrhea; Clostridium Difficile

Summary: medical literature has dealt with various perspectives of probiotic therapy - prevention of antibiotic associated diarrhoea, clostridium difficile, etc. however, there have been no published results which can provide a basis for a generalized recommendation or discouragement of probiotic use among various groups of hospitalized patients. the hypothesis is that the benefit in probiotic therapy in the admitted patient is by far larger than the actual cost of therapy. this assumption is probably true for all admitted patients and for patients on antibiotic therapy in particular.

probiotics are known as a food supplement available worldwide as an otc drug, with minimal side effects. probiotics have also been recommended as a food supplement to patients suffering of antibiotic side effects and to those suffering of ibd or ibs. all patients admitted to internal medicine and the medical intensive care unit will be randomly divided in a double blind fashion into two groups. group one will be provided with the probiotic mixture - one capsule, two times per day. group two will receive a placebo. group three will receive no therapy. objective parameters such as duration of hospital stay, mortality and diarrhea frequency will be recorded. in addition, the frequency of cdt as well as blood and urine cultures will be examined. furthermore, subjective measures will be examined by use of a questionnaire to be filled by the patient and/or his/her family members, or by the treating nurse. later the data will be processed and analyzed to compare between all the study participants and between the subgroups of the study (i.e. patients on specific antibiotic therapies). for each patient, the experiment will last throughout his/her entire hospital stay. the study is to last for one year and until 120 patients have participated.

Eligibility criteria:
inclusion criteria: * all patients hospitalized in the department of internal medicine for a minimum duration of 3 days. * age (all \>18) and gender are to have no impact on the usage of the drug. exclusion criteria: * patients who do not agree to participate in the study * patients on an npo (nothing per os) order, if npo includes medications * patients who suffer of celiac disease
a study to compare the effects of exenatide and sitagliptin on postprandial glucose in subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this purpose of this study is to compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * treatment with metformin for at least 2 months * has hba1c 7.0% to 11.0%, inclusive, at screening * body mass index (bmi)25 kg/m\^2 to 45 kg/m\^2, inclusive * list of medications that are not allowed or the patient has been on stable treatment for at least 2 months: * hormone replacement therapy (female subjects) * oral contraceptives (female subjects) * antihypertensive agents * lipid-lowering agents * thyroid replacement therapy exclusion criteria * has been treated with exenatide (byetta®) or any dpp-4 inhibitor prior to screening * received any study medication or participated in any type of clinical trial within 30 days prior to screening * has donated blood within 60 days of screening visit or is planning to donate blood during the study * treated with any of the following medications: * sulfonylurea or thiazolidinedione within 3 months of screening; * alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (symlin®)within 30 days of screening; * insulin within 2 weeks prior to screening or insulin for longer than 1 week within 6 months of screening; * drugs that directly affect gastrointestinal motility, including but not limited to, anticholinergics, macrolide antibiotics, dopamine antagonists, opioids, and reglan®(metoclopramide); * systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including advair®) steroids known to have a high rate of systemic absorption;

Keywords: diabetes exenatide sitagliptin amylin lilly
application and generalization of flutter mucus clearance device

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices.

respiratory diseases are still increasing in elder population. sputum detaining is a common contributing factor to acute exacerbation. the fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but need more clinical randomized control trial evidence.

Eligibility criteria:
inclusion criteria: * pulmonary department: available to perform the device, in-hospital patients * male and female * age: 45 - 85 years * chronic bronchitis, copd * thoracic surgery department and surgical department (upper abdomen): * patients with endotracheal intubation of general anesthesia * age: 40-75 years exclusion criteria: * not available to perform the procedure * untreated pneumothorax * diffusion interstitial lung disease * acute coronary syndrome * third stage hypertension * advanced cancer * severe heart, liver, renal , blood system and endocrine system dysfunction * noninvasive mechanical ventilation more than 6 hrs per day * patients with invasive ventilation and cannot weaning and extubation within 48 hours * active hemoptysis

Keywords: pulmonary disease, chronic obstructive flutter airway clearance sputum physical therapy techniques
study of cefepime-tazobactam (fep-taz) in complicated urinary tract infection (cuti) or acute pyelonephritis (ap)

Conditions: Complicated Urinary Tract Infection; Acute Pyelonephritis

Summary: this is a phase iii, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of fep-taz vs. meropenem in the treatment of hospitalized adults with cuti or ap.

approximately 1004 hospitalized adult subjects (≥18 years of age) diagnosed with cuti or ap will be enrolled in the study. the diagnosis of cuti or ap will be based on a combination of clinical symptoms and signs plus the presence of pyuria subjects will be randomized in a 1:1 ratio according to an interactive response technology (irt) electronic system to receive either fep-taz 4 g (2 g cefepime + 2 g tazobactam) iv every eight hours (q8h) or meropenem 1 g iv q8h. fep-taz will be administered as 2 consecutive infusions of 2 g (1 g cefepime + 1 g tazobactam)

Eligibility criteria:
inclusion criteria: meet the following clinical criteria for either cuti or ap: a. cuti: 1. have at least two of the following new-onset or worsening symptoms or signs: fever (oral, tympanic, or rectal temperature \>38°c \[\>100.4°f\]), which must be observed and documented by a health care provider nausea or vomiting dysuria, increased urinary frequency, or urinary urgency lower abdominal, suprapubic, or pelvic pain 2. have at least one complicating factor b. ap, defined as acute flank pain (onset within 7 days prior to randomization) or costovertebral angle tenderness on physical examination, plus at least one of the following new-onset or worsening symptoms or signs: 3. evidence of pyuria within 48 h prior to randomization, exclusion criteria: 1. known or suspected disease or condition that, in the opinion of the investigator, may confound the assessment of efficacy. 2. receipt of potentially-effective systemic antibacterial therapy within 72 h prior to randomization 3. rapidly progressive or terminal illness with a high risk of mortality due to any cause, including but not limited to acute hepatic failure, respiratory failure, or septic shock, such that the subject is unlikely to survive the study period
compassionate single subject use of fg-3019 (fibrogen) in locally advanced, unresectable pancreatic cancer

Conditions: Pancreatic Cancer

Summary: single compassionate use subject is an 83 year old woman with a history of lymph node positive breast cancer and recently diagnosed pancreatic cancer in may. with an eastern cooperative oncology group (ecog) of 2, it is felt that she cannot tolerate more aggressive chemotherapy. the investigators propose to administer fg-3019 on a compassionate pleas basis in combination with gemzar. the patient is currently being treated and is tolerating gemzar.

the fg-3019 treatment will be administered over a 28-day cycle: * dose: 35 mg/kg * route: iv over one hour following completion of gemcitabine infusion * schedule: * days 1, 8, and 15 * please note that day 8 infusion will on be completed during the first treatment cycle on drug evaluation the patient will be seen prior to every fg-3019 treatment by the treating physician. the following procedures will be conducted at each visit: * history and thorough symptom assessment * physical examination * laboratory assessments (these can be collected up to 3 days prior to treatment): * complete blood count (cbc) and differential * comprehensive metabolic panel (chemistry): bicarbonate, blood, urea, nitrogen (bun), calcium, creatinine, glucose, potassium, sodium * liver function tests: alkaline phosphatase (alp), alanine transaminase (alt), aspartate transaminase (ast), total bilirubin * carbohydrate antigen (ca) 19-9 ecgs will be conducted during the screening and end of treatment visits. ct scans of the chest and abdomen will be done every 12 to 16 weeks. all of these data will be recorded and stored with their source documents.

Eligibility criteria:
inclusion criteria: * signed consent form * have adequate liver function * have adequate bone marrow function exclusion criteria: * history of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies * any medical or surgical condition that may place the subject at increased risk while on treatment * uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with treatment requirements * current abuse of alcohol or drugs
the application of different sedation protocols in icu patients with severe pneumonia

Conditions: Severe Pneumonia

Summary: this study collected data from 600 patients with severe pneumonia to compare the duration of mechanical ventilation under different sedation regimens in real-world settings. it also evaluated and compared the sedation success rates, hemodynamic changes, and clinical outcomes of patients with severe pneumonia.

the study subjects were patients with severe pneumonia hospitalized in the department of respiratory and critical care medicine at xiangya hospital, central south university, from january 2024 to december 2024. patients meeting all the following criteria were enrolled: (1) diagnosed with severe pneumonia; (2) receiving mechanical ventilation and requiring sedation treatment; (3) age ≥ 18 years. patients were excluded if they met any of the following conditions: (1) allergic to routine sedative or analgesic medications; (2) had not undergone pain and sedation assessment; (3) transferred to another hospital during treatment; (4) abandoned treatment and were discharged within \<72 hours of treatment. data on patient demographics, laboratory tests, chest imaging, respiratory support methods, severity of illness assessments, sedative medication usage, and clinical outcomes were collected. the duration of mechanical ventilation under different sedation regimens in real-world settings was compared, and the correlation between sedation success rates, hemodynamic changes, and clinical outcomes in patients with severe pneumonia was evaluated and compared.

Eligibility criteria:
inclusion criteria: (1)from february 1, 2023, to march 30, 2024, diagnosed with severe pneumonia in the respiratory intensive care unit of xiangya hospital, central south university. the diagnosis of severe pneumonia is based on meeting at least one major criterion or three or more minor criteria: 1. major criteria: ①infectious shock requiring vasopressor therapy despite adequate fluid resuscitation;②respiratory failure requiring tracheal intubation or mechanical ventilation. 2. minor criteria: * respiratory rate ≥ 30 breaths/min; ②oxygenation index (pao2/fio2) ≤ 250; * involvement of multiple lobes; ④altered mental status and/or disorientation; ⑤blood urea nitrogen ≥ 20 mg/dl (7.14 mmol/l); ⑥systolic blood pressure \< 90 mmhg requiring aggressive fluid resuscitation. (2)patients receiving mechanical ventilation who require sedation treatment. (3)age ≥ 18 years. exclusion criteria: 1. allergic to routine sedative or analgesic medications. 2. patients who have not undergone pain and sedation assessment. 3. patients transferred to another hospital during treatment. 4. patients who abandon treatment and are discharged within less than 72 hours of treatment.

Keywords: severe pneumonia sedative