Kornimate/medical-research-clean huggingface dataset:
combination vaccine immunotherapy (dribbles) for patients with definitively-treated stage iii non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this study will test an investigational vaccine, called dribbles, for the treatment of non-small cell lung cancer (nsclc). we hypothesize that vaccination with the dribble vaccine will cause an immune responses against proteins contained in the dribble vaccine and the protein antigens targeted by this strong immune response will include common antigens shared by both the vaccine and the patient's tumor.

this is an open-label, randomized study in which the first 33 patients will be assigned to receive the either: * dribbles vaccine and hpv vaccine * dribbles vaccine, hpv vaccine, and imiquimod * dribbles vaccine, hpv vaccine, and gm-csf after 11 patients have been assigned to each group, the study arm with the greatest number of vaccine-induced strong antibody responses will then continue with enrollment of 15 further patients. the primary objective is to determine the best strategy to induce strong (\>15 fold) tumor-specific or tumor-associated antibody responses in patients with stage iii a and b nsclc. the goal is to select one regimen to advance to additional clinical trials.

Eligibility criteria:
inclusion criteria: * stage iiia or iiib histologically proven non-small cell lung cancer * completion of definitive therapy * enrollment from 28 days to 12 weeks from completion of definitive therapy * toxicities from definitive therapy resolved to less than grade 1 * ecog performance status 0-1 * negative pregnancy test in women of childbearing potential * agree to avoid pregnancy or fathering a child while on study treatment * ability to give informed consent and comply with protocol * anticipated survival minimum of 6 months * prior therapy with investigational agents must be completed at least 3 weeks prior to study enrollment * normal organ and marrow function as defined by specific lab tests * archived tumor tissue available exclusion criteria: * active autoimmune disease except for vitilogo or hypothyroidism * active other malignancy * known hiv+ and/or hepatitis b or c positive * medical or psychiatric conditions that would preclude safe participation * ongoing chemotherapy

Keywords: lung cancer dribble vaccine imiquimod gm-csf hpv vaccine (ceravix) cyclophosphamide
performance of a tablet based workflow and decision support system with incorporated software algorithm used for glycaemic management

Conditions: Type 2 Diabetes

Summary: objective: to investigate the performance (safety) of the glucotab system for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward


Eligibility criteria:
inclusion criteria: * informed consent obtained after being advised of the nature of the study * male or female aged 18 - 90 years (both inclusive) * type 2 diabetes treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four exclusion criteria: * impaired renal function (serum creatinine ≥3.0mg/dl) * any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient * pregnancy * any mental condition rendering the patient incapable of giving his consent * terminally ill patients * participation in a trial within 3 months prior to this trial * known or suspected allergy to insulin
dose ranging study of ba 679 br inhalation powder in chronic obstructive pulmonary disease (copd) patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to investigate the dose response following single inhalation of ba 679 br inhalation powder in copd patients using pulmonary functions as indicators, and to compare data obtained with overseas study findings


Eligibility criteria:
inclusion criteria: 1. in a pulmonary function test of screening test ii, fev1.0 was less than 70% of predict normal and fev1.0 was less than 70% of fvc. 2. in the reversibility test of screening test ii, fev1.0 was improved by 10% or more at 1 hour after inhalation of 2 puffs of an anticholinergic agent (tersigan ® aerozol) 3. history of smoking (\ = 200 or more) 4. 40 years of age or older 5. regardless of sex and the length of disease period exclusion criteria: 1. a history of bronchial asthma 2. a history of atopic disease, such as allergic rhinitis 3. blood eosinophil of 440/µl or more 4. continuous use of steroid drugs (oral administration, inhalation or injection) at a dose equivalent to over 5 mg daily of prednisolone 5. a history of respiratory infection, including virus infection within 1 month before study initiation 6. tuberculosis, lung cancer or a history of pneumonectomy 7. glaucoma 8. under treatment of benign prostatic hypertrophy 9. hypersensitivity to anticholinergic agents or sympathomimetics 10. difficulty in expectoration of sputum 11. serious heart disease, renal disease, hepatic disease, endocrine disease or metabolic disease 12. use of any β blockers 13. a history of myocardial infarction within the past 1 year 14. a history of heart failure, cor pulmonale or arrhythmia requiring medication within the past 3 years 15. a history of drug abuse or alcoholism 16. treatment of psychotic disease 17. pregnancy, possible pregnancy or lactation 18. a history of participation in any other clinical studies within the past 6 months 19. judgment by the investigator that the patient is ineligible for inclusion in the present study
azd7687 multiple ascending dose study

Conditions: Overweight; Obese

Summary: the aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of azd7687 following multiple ascending dose administrations in in overweight to obese but otherwise healthy male subjects


Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study specific procedures * suitable veins for cannulation or repeated venepuncture. * have a body mass index (bmi) between 27 and 35 kg/m2 exclusion criteria: * fasting serum (s)-glucose ≥7.0 mmol/l or non-fasting s-glucose ≥11.1 mmol/l at screening. * any eating disorder or actively attempting to loose weight within 3 months prior to enrolment. * smoking more than 7 cigarettes per week from time of consent

Keywords: safety tolerability pk healthy overweight obese
a randomized, double-blind clinical trial on the efficacy of a dietary formulation containing medium-chain triglycerides (mct) and fiber in patients with psoriatic arthritis

Conditions: Psoriatic Arthritis (PsA)

Summary: the primary objective of this study is to evaluate the effects of a formulation containing medium-chain triglycerides (mcts) and vegetable fibers on the quality of life of patients with psoriatic arthritis, by monitoring the patients over a period of 3 months in a single-center interventional study. as secondary objectives, the study will assess the effects of the same formulation on disease activity and on certain blood parameters and dietary habits.

the diagnostic and therapeutic framework in the field of psoriatic arthritis (psa) is complex and not yet fully defined. despite significant advances in pharmacological therapy and although particularly satisfactory results can be achieved thanks to new-generation dmards (disease-modifying antirheumatic drugs), there is still a significant gap regarding factors that, in addition to pharmacological therapy, could help patients further improve their health status, primarily dietary habits. the aim of this study is to evaluate the effectiveness of a special medical food based on mcts and fiber in improving quantitative and qualitative parameters in patients with psa under stable pharmacological treatment and with low disease activity. specifically, this will be achieved through the analysis of health-related quality of life as perceived by patients, the impact of the disease on general life, body composition and sarcopenia, physical and mental health status of patients, dietary habits, and through an evaluation of metabolic and inflammatory blood parameters.

Eligibility criteria:
inclusion criteria: * adult patients: aged 18-80 years; * clinical diagnosis of psa meeting the caspar classification criteria; * low disease activity (4 \< dapsa ≤ 14) at the time of recruitment; * under stable pharmacological treatment with disease-modifying antirheumatic drugs (dmards) (conventional synthetic, targeted synthetic, or biological); * disease duration \> 6 months; * absence of metabolic diseases. exclusion criteria: * bmi ≥ 27 kg/m²; * current or desired pregnancies (confirmed by pregnancy test); * disease activity in remission (dapsa ≤ 4), moderate (14 \ 28) at the time of recruitment; * pediatric onset of the disease (\< 16 years); * patients on a vegan, ketogenic, or mct-rich diet (containing mct in supplement form or high amounts of palm or coconut oil); * presence of ketoacidosis/metabolic acidosis, decompensated liver cirrhosis, or medium-chain acyl-coa dehydrogenase (mcad) deficiency; * type 2 diabetes, cardiovascular diseases, hypertension, ischemic diseases, renal failure, malignant tumors, respiratory diseases, dyslipidemia, fibromyalgia, metabolic syndrome; * major depression; * gastritis, esophagitis, reflux syndrome, chronic inflammatory bowel diseases (ibd); * lactose intolerance.

Keywords: medium-chain triglycerides dietary fiber psoriatic arthritis calipso
gene expression profiles in predicting survival of patients with head and neck cancer

Conditions: Head and Neck Cancer

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict survival of patients with head and neck cancer. purpose: this laboratory study is assessing gene expression profiles in predicting survival of patients with head and neck cancer.

objectives: * identify gene expression profiles associated with survival by dna microarray assay analysis using rna from formalin-fixed paraffin-embedded tissue samples from patients with squamous cell carcinoma of the head and neck treated on clinical trial rtog-9501. outline: formalin-fixed paraffin-embedded tissue samples are analyzed by dna microarray analysis for gene expression profiling.

Eligibility criteria:
inclusion criteria: * diagnosis of squamous cell carcinoma of the head and neck, including 1 of the following sites: * hypopharynx * larynx * oral cavity * oropharynx * stage ii-iv disease * must have received treatment on clinical trial rtog-9501 * formalin-fixed paraffin-embedded tissue samples available exclusion criteria: * not specified prior concurrent therapy: * not specified

Keywords: stage ii squamous cell carcinoma of the lip and oral cavity stage iii squamous cell carcinoma of the lip and oral cavity stage iv squamous cell carcinoma of the lip and oral cavity stage ii squamous cell carcinoma of the oropharynx stage iii squamous cell carcinoma of the oropharynx stage iv squamous cell carcinoma of the oropharynx stage ii squamous cell carcinoma of the hypopharynx stage iii squamous cell carcinoma of the hypopharynx stage iv squamous cell carcinoma of the hypopharynx stage ii squamous cell carcinoma of the larynx stage iii squamous cell carcinoma of the larynx stage iv squamous cell carcinoma of the larynx
measuring urinary nano particles and metallic compounds in tcc patients

Conditions: Bladder Cancer

Summary: in many of urothelial carcinoma patients, one does not find common risk factors such as smoking. the medical center is located in an industrial city with known air and water pollution. the investigators decided to check the presence of nano particles and traces of metals in urinary samples of patients known and suspected for urothelial carcinoma and compare the results to both cystoscopic and cytological findings. the patients will fill a validated epidemiological respiratory disease survey and the results will be compared to a control group.


Eligibility criteria:
inclusion criteria: study group : 1. patients that need cystoscopy due to suspicion/known bladder malignancy. 2. patients that can read, understand and sign an informed consent form. control group: 1. patients that need cystoscopy due to others reasons than malignancy. 2. patients that present to the department of urology for surgery unrelated to malignancy of the urinary system ( prostatectomy, incontinence repair, circumcision, hydrocele/ varicocele repair, ureteroscopy etc). exclusion criteria: study group: 1. patients receiving bladder irrigations, pregnant women, children and those with impaired judgment 2. patients with a technically improper urine test. control group 1. patients receiving bladder irrigations, pregnant women, children and those with impaired judgment 2. patients with a technically improper urine test.

Keywords: bladder cancer
identification of minimum focal points in vision curve formation

Conditions: Presbyopia; Pseudophakia; Cataract; Refractive Errors

Summary: the primary objective of this study is to identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (aoc) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated pseudophakic presbyopia surgery.

this is a prospective, non-inferiority trial. 80 participants that underwent uncomplicated pseudophakic presbyopia surgery with bilateral premium intraocular lenses (iol) implantation will be recruited, and their postoperative visual curves (vac) will be evaluated for nine distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). then, using polynomial and spline interpolation methods on the measured data, the aim is to generate a unique polynomial of degree ninc -1 that satisfies all data points.

Eligibility criteria:
inclusion criteria: * age over 40, * previous bilateral premium cataract surgery, * best corrected visual acuity (bcva) \< 0,2 logmar exclusion criteria: * taking topical medication to reduce intraocular pressure (iop), * macular diseases, * corneal diseases, * inability to understand the procedure, * postoperative astigmatism \>1.50 diopters, * postoperative clouding of the posterior capsule

Keywords: pseudophakic presbyopic correction premium monovision trifocal diffractive intraocular lenses extended depth of field intraocular lenses
a 52 week study to evaluate the effects of losartan with or without hctz on plasma glucose, metabolic parameters, blood pressure in hypertensive patients with metabolic syndrome (0954a-331)

Conditions: Hypertension; Metabolic Disorder

Summary: to determine if a one year treatment losartan with or without hctz at different dosages have an effect on metabolic parameters in patients with hypertension and the metabolic syndrome.


Eligibility criteria:
inclusion criteria: * an adult patient (at least 18 years of age) with a clinical identification of the metabolic syndrome using the idf definition: * abdominal (central) obesity as defined by the waist circumference in men of \> 102 cm and women of \> 88 cm or a bmi equal or greater than 30 kg/m2 and untreated hypertension with bp equal or greater than 140/90 mm hg but bp \< 180/110 mm hg or a patient receiving one or two antihypertensive agent(s) (diuretics, ace inhibitors, angiotensin ii receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) and whose blood pressure is not controlled: * bp equal or greater than 140/90 mm hg but equal or less than 160/100 mm hg or a patient whose hypertension is controlled (\< 140/90 mm hg) with a single anti-hypertensive agent (diuretics, ace inhibitors, and angiotensin ii receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) but who is unsatisfied or experiencing side effects warranting a discontinuation of the previous treatment and at one of the following: * fasting plasma glucose equal or greater than 5.6 mmol/l and \< 7.0 mmol/l * triglycerides \> 1.7 mmol/l or specific treatment for this lipid abnormality * hdl-c in men \< 0.9 mmol/l and in women \< 1.1 mmol/l or specific treatment for this lipid abnormality exclusion criteria: * a patient with a diagnosis of type ii diabetes defined as fasting blood glucose level equal or greater than 7.0 mmol/l or a 2hpg in a 75-g ogtt equal or greater than 11.1 mol/l or using any anti-hyperglycemic agents * known secondary hypertension of any aetiology (e.g., uncorrected renal artery stenosis, malignant hypertension, or hypertensive encephalopathy) * patient intolerant to any component of losartan 50 mg / losartan 100 mg / losartan 100 mg + hctz 12.5 mg / losartan 100 mg + hctz 25 mg or with a documented history of angioedema * patient with confirmed clinically significant renal or hepatic dysfunction and/or electrolyte imbalance on the basis of the case history or a recent laboratory test (serum creatinine \> 130 mmol/l or creatinine clearance \ 2 times above the normal range, alt \> 2 times above the normal range, serum potassium \ 5.5 meq/l) * patient with symptomatic heart failure (classes 3 and 4) * patient with a prior myocardial infarction or stroke within the last 6 months * patient who has undergone percutaneous coronary angioplasty or coronary artery bypass within the last 3 months * pregnant woman or a woman of childbearing potential
register to describe the treatment pattern of platinum-sensitive relapsed epithelial ovarian cancer patients in austria

Conditions: Recurrent Ovarian Carcinoma

Summary: various treatment options exist for patients with platinum-sensitive relapsed epithelial ovarian cancer (roc). the register will provide an overview of chosen treatments including the reasons, why these options were chosen.

patients at their first platinum-sensitive roc will be invited to participate in the register. these are all patients with recurrent disease 6 or more months after the last cycle of platinum containing chemotherapy. the observation period will begin by signing the informed consent form (icf) and will continue for up to a total of 24 months (+/- 4 weeks) after the diagnosis of the first relapse or until patient discontinuation for any reason, or patient's death. data on first study visit, subsequent recurrence during observation period and last observation will be collected in the electronic case report form (ecrf). the register will identify symptoms and factors that led to the diagnosis, chosen therapy and the reason for choosing the therapy. at inclusion, data on general patient information, primary diagnosis, previous therapy, and tumor characteristics are collected. during the course of observation data on systemic and maintenance treatments, radiotherapies, surgeries, and outcome are documented.

Eligibility criteria:
inclusion criteria: * women aged 18 years or older * presence of first platinum-sensitive roc (ovarian, peritoneal and/or fallopian tube cancer) * must have received at least 4 cycles of chemotherapy during primary therapy * at time of inclusion a treatment for roc must be planned * patients must not have more than 1 prior line of chemotherapy * signed informed consent exclusion criteria: * no knowledge of spoken and written german * signed informed consent is not given
sonographic assessment of fetal deglutition associated with hydramnion:its absence is indicative of central nervous system (cns) pathology

Conditions: Hydramnios

Summary: 310 singleton pregnancies (22-35 weeks) enrolled into the study. we assessed sonographically the fetal larynx in an axial plane through the mandible and observed the fetal deglutition movements .

310 singleton pregnancies (22-35 weeks) enrolled into the study. we assessed sonographically the fetal larynx in an axial plane through the mandible and observed the fetal deglutition movements .we encountered two cases of hydramnios were no deglutition movements could be noted. in all other cases the deglutition was normal. the motivation to conduct the current observational prospective study was to assess whether there is a link between absence of fetal deglutition and cns pathology of the fetus. in the first case the fetus deceased at 35 weeks of gestation; obduction was declined by the parents. in the second case caesarian section at 33 weeks was carried out recently due to fetal distress. the infant is still in uncapable of swallowing and there for is under investigation at the neonatal center of our hospital.

Eligibility criteria:
inclusion criteria: * singleton pregnancy(22-35 weeks) exclusion criteria: * positive toxoplasmosis screening,drug and/or antidepressants addiction.

Keywords: fetal deglutition larynx fetal cns pathology sonography hydramnios
study to assess the activity of nexrutine® in prostate cancer patients

Conditions: Prostate Cancer

Summary: the purpose of the study is to (1) to determine the rate of psa decline (the number declining). tissue will be obtained for ancillary studies and (2) to determine the number of patients with a psa decline to \<1.0 ng/ml at 3 months in patients receiving nexrutine® with standard radiation therapy. the secondary objective is to confirm the tolerability of this regimen. the third objective (ancillary studies) is to evaluate the molecular response of nexrutine®. molecular response is defined as changes in the molecular pathways.


Eligibility criteria:
inclusion criteria: 1. have a histologic diagnosis of prostate cancer (in more than 1 core) with one of the following: * gleason \> 6, * unilateral gleason 6 in ≥ 3 cores, * bilateral gleason 6, * psa \> 10.0 ng/ml. 2. age ≥18 years. 3. has an ecog performance status 0-2 or karnofsky 60-100. 4. has the following laboratory values at study entry: absolute neutrophil count (anc) ≥ 1,500 cells/μl; platelet count ≥ 100,000 cells/μl; hemoglobin ≥ 9 g/dl; total serum bilirubin ≤ 1.5 x institutional upper limit of normal (uln); alt and ast ≤ 1.5 x institutional uln if alkaline phosphatase is ≤uln creatinine and bun ≤ 1.5 x institutional upper limit of normal (uln) 5. signed informed consent 6. no new, undiagnosed bone pain or has a negative bone scan. (within 2 months of consent) if there is no bone pain, then a bone scan is not required. exclusion criteria: 1. has documented metastatic disease. 2. has received a prior chemotherapy or androgen ablation. 3. has received prior immunotherapy. 4. has been previously treated with strontium, samarium, other systemic radioisotopes or radiation therapy. 5. has diagnosis of congestive heart failure 6. currently taking anticoagulation medications, i.e., coumadin or heparin. over the counter aspirin and ibuprofen are allowed. 7. is receiving any other investigational agents for cancer. 8. has a history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of prostate cancer. 9. has a serious intercurrent illness with a life expectancy of less than 5 years. 10. has a concomitant medical, psychological, or social circumstance, which would interfere with compliance with the protocol treatment and follow-up. 11. use of any herbal or alternative regimens, which may have antineoplastic or hormonal activity (including but not limited to finasteride, dutasteride, saw palmetto, pc-spes, shark cartilage, etc), is prohibited while receiving study treatment. 12. clinical stage t3 or t4 and psa \>10 ng/ml and gleason \> 8. 13. patient is to receive adjuvant androgen ablation with the radiation. 14. ekg which shows a baseline qtc \> 450 msec or ischemic changes. for ischemic changes, patient will be eligible if evaluated and cleared by internal medicine. 15. previous history of drug-induced qtc prolongation and/or concurrent treatment with medications that are known to produce or are suspected of qt prolongation.

Keywords: nexrutine prostate cancer