Kornimate/medical-research-clean huggingface dataset:
bryostatin 1 plus paclitaxel in treating patients with stage iiib, stage iv, or recurrent non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of bryostatin 1 plus paclitaxel in treating patients who have stage iiib, stage iv, or recurrent non-small cell lung cancer.

objectives: i. determine the overall, partial, and complete response rates in patients with stage iiib-iv or recurrent non-small cell lung cancer treated with bryostatin 1 and paclitaxel. ii. determine the overall survival and time to tumor progression in patients treated with this regimen. iii. determine the t cell subset analysis and serum levels of interleukin-6 and tumor necrosis factor alpha in these patients after receiving bryostatin 1 and correlate with clinical endpoints. outline: this is a multicenter study. patients receive paclitaxel iv over 1 hour on days 1, 8, and 15 and bryostatin 1 iv over 1 hour on days 2, 9, and 16. treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. patients are followed for at least 2 years for survival. projected accrual: a total of 15-40 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: histologically or cytologically proven stage iiib, iv or recurrent non-small cell lung cancer (nsclc) patients with stage iiib disease must have pleural effusion measurable disease patient characteristics: age: 18 and over performance status: ecog 0-2 karnofsky 50-100% life expectancy: not specified hematopoietic: wbc greater than 3,000/mm3 absolute neutrophil count at least 1,500/mm3 platelet count greater than 100,000/mm3 hepatic: bilirubin normal sgot less than 2 times normal renal: creatinine no greater than 1.5 mg/dl or creatinine clearance at least 50 ml/min blood urea nitrogen less than 1.5 times normal cardiovascular: no symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months no heart block worse than first degree, bundle branch block, or ventricular or supraventricular arrhythmia by 12 lead electrocardiogram other: not pregnant or nursing fertile patients must use effective contraception no uncontrolled concurrent illness including, but not limited to, ongoing or active infection prior concurrent therapy: biologic therapy: no concurrent colony-stimulating factors chemotherapy: no prior chemotherapy for nsclc endocrine therapy: not specified radiotherapy: greater than 4 weeks since prior radiotherapy surgery: not specified other: no other concurrent investigational agents no concurrent antiretroviral therapy (haart) in hiv positive patients

Keywords: recurrent non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
a trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of ba1301 in advanced solid tumors.

Conditions: Advanced Solid Tumours

Summary: this is an open label phase 1, first in human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of ba1301 in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. voluntarily signed informed consent and able to follow the trial treatment protocol and visit plan; 2. age ≥ 18 years old and ≤ 75 years old, male or female; 3. patients with locally advanced or metastatic malignant solid tumours that cannot be surgically resected as histologically or cytologically confirmed by standard therapy failure or refusal or inability to tolerate standard treatment regimens. 4. agree to provide archival or fresh tumour tissue for immunohistochemical evaluation for immunohistochemical detection of cldn18.2 expression. 5. eastern cooperative oncology group (ecog) strength status score of 0 or 1. 6. at least one evaluable lesion according to the efficacy evaluation criteria for solid tumours (recist1.1). 7. adequate organ function. 8. estimated survival ≥ 3 months; 9. negative blood pregnancy test result for females of childbearing potential at screening. exclusion criteria: 1. poorly controlled hypertension as judged by the investigator 2. received any chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, adc drug therapy, major surgery, or other anti-cancer therapy within 28 days prior to the first dose of trial drug. 3. known hypersensitivity to any ingredient of the therapeutic drug used in the study protocol; 4. positive hepatitis b virus surface antigen (hbsag) test; positive hepatitis c virus (hcv) antibody, treponema pallidum antibody, human immunodeficiency virus (hiv) antibody; 5. pregnant or lactating females, those who have recently planned to become pregnant; 6. those who have participated in and received any clinical trial drugs (excluding vitamins and minerals) or clinical trial device intervention within 28 days before signing informed consent; 7. other serious physical or psychiatric illness or laboratory test abnormalities at screening that may increase the risk of participating in the study, or interfere with the results of the study, and patients who, in the opinion of the investigator, are not suitable to participate in this study.
safety and efficacy study of a new chemotherapy agent to treat metastatic breast cancer

Conditions: Breast Neoplasms; Breast Cancer, Metastatic

Summary: the purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer schering pharma ag, germany.bayer schering pharma ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * metastatic breast cancer * no previous treatment with taxanes, and vinca alkaloids * use of highly effective birth control methods in females of child-bearing potential exclusion criteria: * more than 2 previous chemotherapies * previous participation in another trial within the last 4 weeks * breast feeding * active infections

Keywords: breast cancer breast neoplasms
effect of probiotics on infant's fecal microbiota composition

Conditions: Microbial Colonization

Summary: randomized clinical trial to evaluate the effect of two probiotic strains which belong to bifidobacterium longum and pediococcus pentosaceus species on fecal microbiota composition in healthy infants. secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.

double-blind, randomized, placebo-controlled clinical trial to determine the effect of the probiotic strains bifidobacterium longum and pediococcus pentosaceus on fecal microbiota composition in infants. healthy babies with ages comprised between 60 and 90 days who meet inclusion and exclusion criteria will be randomized 1:1:1 to one of the following study groups: one group will receive bifidobacterium longum, another group will receive pediococcus pentosaceus and the other one will receive placebo for 3 months. other study outcomes comprise anthropometric growth, frequency and consistency of the stools, digestive tolerance, wellbeing, number, type and duration of infections and functional gastrointestinal disorders, and adverse events.

Eligibility criteria:
inclusion criteria: * healthy infants * age between 1 and 90 days * gestational age between 37 and 42 weeks * appropiate birth weight for gestational age (between p10 and p90) * apgar test score for birth normal at 1' and 5' of 7-10 * whose parents accept the follow-up of the study procedures and sign the informed consent exclusion criteria: * infants participating in other clinical study * fed with infant formula containing probiotics or other aliments or food supplement based in probiotics 4 weeks prior the start of the study * infants who have taken antibiotics 4 weeks prior the start study * infants with cow's milk protein allergy, lactose intolerance or other digestive diseases * mother's pathological background and during gestation: neurologic disorders, matabolopaties, diabetes mellitus type 1, chronic disease (hypothyroidism), maternal malnutrition * acute congenital or acquired diseases which can interfere with the growth and the normal feeding of the infant * torch complex infections * every other diseases related with the immune system * parents who can not accomplish the follow-up of the study (medical criterium)

Keywords: probiotics infants microbiota
short or long schemes of antibiotic prophylaxis for prostate biopsy

Conditions: Men Who Must Undergo a Prostate Biopsy Related to Prostate Cancer Suspicion.

Summary: the purpose of this study is to determine whether long antibiotic prophylactic is more effective than a short traitement in infective complications for prostate biopsy

prophylactic antibiotic is used to minimize the infective complications risk following transrectal biopsy of the prostate. the majority of works points to the need of antibiotic prophylaxis previously to transrectal prostate biopsy. however, there is a lot of controversy and diversity of therapeutic schemes in the literature concerning the ideal drug to be used and the time employed for infectious prophylaxis. the objective of this randomised study was to assess 2 different schemes of antimicrobial prophylaxis, aiming to determine the difference in infective complications with a single dose of ciprofloxacin 2 hours before the procedure vs. ciprofloxacin for 3 days

Eligibility criteria:
inclusion criteria: * abnormal digital rectal examination * abnormal psa values to be excluded those patients with: * ciprofloxacine contraindication * indwelling urethral catheter, * positive urine culture, * presence of cardiac valve prosthesis, * uncontrolled diabetes mellitus, * use of antimicrobials in the 7 days prior to biopsy. * urinary endoscopic procedure in the 7 days prior to biopsy * coagulation defect * renal insufficiency * hepatic insufficiency

Keywords: prostate, infection, biopsy, antibiotic, prophylaxis
skills training to enhance vocational outcomes in veterans with serious mental illness

Conditions: Schizophrenia; Bipolar Disorder; Psychotic Disorders

Summary: maintenance of employment is dependent upon being able to successfully integrate into one's work setting. this can present a significant challenge to individuals with serious mental illness, as they typically exhibit impairment in their ability to accurately perceive and understand social exchanges. presently the most established intervention is social cognition and interaction training (scit), a 12-week group intervention in which participants learn strategies to enhance emotion recognition and to assess the accuracy of their interpretation of social interactions. to enhance transfer of training gains to functional outcomes, participants will be paired with a social mentor to facilitate completion of homework and to ensure that skills are practiced outside of treatment (supported scit). the study will examine the impact of supported scit on social and work role functioning. the specific aims are: 1. to assess the feasibility of providing supported scit to individuals with serious mental illness who are engaged in compensated work activity. 2. to assess the impact of supported scit on social cognitive skills as well as work and social performance. 3. to assess durability of intervention-induced change 3 months after the end of intervention. a single blind study will be conducted in which participants between 18-70 with serious mental illness (schizophrenia, schizoaffective disorder, and bipolar disorder) are assigned to 12 weeks of supported scit. intervention will consist of one 2-hour small group training sessions and 30 minutes of individualized supported practice of skills with a treatment facilitator weekly. feasibility will be assessed with attendance at group and individual sessions. baseline, post-intervention (3-month), and follow-up (6-month) assessments will measure social cognitive abilities and functional outcomes. potentially confounding variables such as symptom severity and outside treatment hours will also be assessed. it is hypothesized that supported scit will be completed by at least 75% of veterans. the intervention is predicted to improve social cognitive skills and social and work performance. training gains are expected to be sustained 3 months after intervention.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder * veteran * engaged in compensated work activity, volunteer work, school * age 18 to 70 exclusion criteria: * currently meet criteria for substance abuse or have met criteria for substance dependence in that previous 6 months * have an estimated premorbid iq below 70, * have a history of a clinically significant head injury or neurological disease * do not speak english well enough to comprehend testing procedures * do not demonstrate adequate understanding of study procedures to give informed consent
effect of fasting on the non-invasive measurement of the body's water compartments

Conditions: Dehydration; Perioperative Complication

Summary: preoperative fasting is defined as refraining from food for at least 6 hours and clear fluids for at least 2 hours prior to anaesthesia. on the one hand, it is a procedure that reduces the risk of aspiration of food content and the occurrence of mendelson's syndrome, and on the other hand, it was considered to be the cause of disturbances in water management in patients undergoing general anaesthesia. however, reports from recent years have found that moderate preoperative fasting does not influence the risk of hypovolemia in anesthetized patients. it is also known that in fasting people the total body water is reduced. thus, it can be assumed that there are mechanisms causing the movement of extravascular water into the lumen of blood vessels. for several years, the body composition monitor (bcm) device for non-invasive measurement of the volume of individual water compartments of the human body has been available on the market. it allows to determine the volume of total body water, intracellular body water and extracellular body water. it is mainly used during dialysis, but it can also be used in other circumstances that require the determination of the body's hydration status. the principle of this method is based on non-invasive bioimpedance measurement with the use of 4 electrodes placed on two extremities. the aim of the study is to determine whether there is a fluid shift between the intracellular and extracellular compartments in people undergoing preoperative fasting. examination of this issue would allow for the development of hypothesis regarding the optimal perioperative fluid therapy. if there was a shift of fluid from the intracellular space, it seems more rational to supplement fluid deficiencies resulting from starvation with a 5% glucose solution. if, on the other hand, no fluid shift from the intracellular space was detected, which would suggest shifts within the extracellular space, it would be advisable to hydrate the patient with crystalloid solutions.


Eligibility criteria:
inclusion criteria: * american society of anesthesiology (asa) general condition assessment 1 or 2 exclusion criteria: * chronic kidney disease * circulatory failure * phenylketonuria * history of hypoglycaemic episodes or any carbohydrate metabolism disorders.
atrial fibrillation duration and cortical lens opacity

Conditions: Atrial Fibrillation (AF); Cataract Cortical

Summary: the prevalence of atrial fibrillation (af) and the risk of stroke increase with a higher cha2ds2-vasc score. osmotic stress, which also contributes to cortical cataract formation, increases in the presence of diseases that raise the cha2ds2-vasc score. knowledge of af duration is crucial because it heightens the risk of af-related complications. this study investigated whether the presence of cortical cataracts, classified using the lens opacity classification system (locs)stage, can predict the presence and duration of af.

atrial fibrillation (af) is the most common type of heart rhythm disorder encountered in clinical settings and is associated with increased morbidity and mortality. the prevalence of af and the risk of stroke increase with higher cha2ds2-vasc scores . cortical cataracts develop at the periphery of the lens and progress toward the center in a spoke-like pattern. the incidences of af and cortical cataracts significantly increase with age . similar to subclinical af, the initial onset of af may go undetected, and the time required for af to become permanent varies. longer episodes of af and higher cha2ds2-vasc scores are strongly associated with an increased annual risk of stroke or systemic embolism , making it essential to estimate the duration of af. cortical cataract stages can be easily identified and monitored through simple biomicroscopic examination. to our knowledge, no reliable method currently exists to predict the duration of af of unknown onset. this study investigated the relationship between cortical cataract stages and the presence and duration of af by analyzing p.osmolarity data and comparing it with the lavi.

Eligibility criteria:
inclusion criteria: atrial fibrillation patients exclusion criteria: advanced hf (new york heart association class 4), decompensated hf prior cataract surgery diabetic ketoacidosis alcohol use severe hyponatremia \[sodium level of \&lt; 125 meq/l\], nephrotic syndrome cirrhosis hypothyroidism
study to evaluate the effect of multiple doses of biil 284 bs on the pharmacokinetics of prednisone in healthy male subjects

Conditions: Healthy

Summary: study to evaluate the effect of multiple doses of biil 284 bs on the pharmacokinetics of a single dose of prednisone


Eligibility criteria:
inclusion criteria: * written informed consent signed and dated prior to participation into the study * all participants in the study should be healthy males, aged 18-50 years old inclusive * all participants should be within (+- 20%) of their ideal body weight (broca-index) * non-smokers (subject who have never smoked) or ex-smoker for at least one year with a smoking history, no greater than five pack-years (1 pack year = 20 cigarettes per day for 1 year) * ability to comply with the concomitant therapy restrictions as detailed in clinical trial protocol (ctp) * subjects will be off all prescription drugs. o.t.c. drugs must be discontinued for at least two weeks prior to participation in the study. if throughout the study, subjects need any o.t.c. medication, the investigator will call the clinical monitor and this will be reviewed on a case-by-case basis. restrictions for different medications are described in ctp * subjects will have no evidence of clinically relevant concomitant disease based upon complete medical history, full physical examination, chest-x-ray (if not done in previous 6 months), ecg and clinical laboratory tests exclusion criteria: * viral respiratory tract infection or a respiratory tract infection within the six weeks preceding dosing with study medication * small or difficult to locate arm or hand veins that would impair the clinicians ability to draw blood samples or to place a venous catheter * subjects with a known drug or alcohol dependence (absence of dependency for 10 years) or who drink more than 60 g of alcohol per day, history of significant allergic reactions to drugs or sensitivity to aspirin or positive drug screen * use of investigational new drug in the preceding month or six half-lives (whichever is greater) prior to the first screen at visit 1 * donation of blood during the month preceding visit 1 * subjects receiving hyposensitization therapy who are not on a stable dose for the last three months before visit 1 * subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders * subjects with known history of orthostatic hypotension, fainting spells or blackouts * subjects with chronic or relevant acute infections * subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * subjects with eosinophilia \> 7 % * subjects who received any other drugs, which might influence the results of the trial during the weeks prior to dosing with study medication * subjects who participated in excessive physical activities (e.g. competitive sports) within the last week before dosing with study medication
delayed release (dr) risedronate compared to immediate release (ir) in postmenopausal women

Conditions: Postmenopausal Osteoporosis

Summary: randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study in approximately 201 postmenopausal women. a subset of subjects (approximately 102) will also participate in a pharmacokinetic (pk) component of the study. each subject will be randomized to 1 of 3 treatment regimens for 3 months.


Eligibility criteria:
inclusion criteria: * female, 45 to 80 years of age, in good general health * postmenopausal ≥2 years, surgically or naturally * body mass index less than or equal to 32 kg/m\^2 at screening exclusion criteria: * no use within 3 months prior, nor use for more than 1 month at any time within 6 months of: glucocorticoids, anabolic steroids, estrogens, selective estrogen-receptor modulators (serms), or estrogen-related drugs, progestins, calcitonin, vitamin d supplements (\>1200 iu per day), calcitriol, calcidiol, or alfacalcidol at any dose, any bisphosphonate. fluoride (≥10 mg/day), strontium (≥50 mg/day), parathyroid hormone, investigational bone active agents. * allergic or abnormal reactions to bisphosphonates * history of cancer within 5 years, excluding squamous and basal cell carcinoma with 6 month remission * positive pregnancy test * no depot injection \>10,000 iu vitamin d in previous 9 months. * no history of gi disease that requires medication, or history of crohn's disease, ulcerative colitis, diverticular disease, polyps, or surgery that could have changed gi structure or motility. * no history of frequent diarrhea or constipation that requires regular laxative use. * no history of alcohol or durg abuse, hyperparathyroidism, cancer previous 5 years, major surgery within 1 month prior to screening, diabetes, uncontrolled hypertension, cardiovascular, hepatic, renal or gi disease. * no active hyperthyroidism, osteomalacia, use of anticonvulsant medication, or allergic reaction to bisphosphonates