Kornimate/medical-research-clean huggingface dataset:
dose escalation of desmoteplase in acute ischemic stroke (dedas)

Conditions: Stroke

Summary: the purpose of this study was to explore trends in safety and efficacy, and to find the optimal dose for the subsequent phase iii trial. the decision to initiate the phase iii trial will depend on both safety (incidence of symptomatic intracranial hemorrhage) and efficacy (reperfusion measured by mri and correlating with clinical outcome) profiles. the safety (incidence of symptomatic intracranial haemorrhage) and efficacy (reperfusion measured by mri and correlating with clinical outcome) profiles gained from this study were the basis of planning the phase iii.

acute stroke is the third leading cause of mortality in developed countries and the major medical cause of disability in adults. the outcome can be improved by early treatment with thrombolysis. alteplase (r-tpa) is the only approved thrombolytic drug in the indication of acute ischemic stroke. however, the use of alteplase is currently restricted by the need to administer it within 3 hours of symptom onset. as the risk of transforming a cerebral infarct into haemorrhage probably rises as the time elapsed increases, a thrombolytic drug that carries a lower risk of haemorrhage than alteplase may offer a wider time-to-treatment window and improve the safety profile. desmoteplase (dspa) with its high fibrin specificity, lack of neurotoxicity, potential neuroprotective effect, non-activation by ß-amyloid, and long terminal half-life may account for an improved safety and efficacy profile within the first 9 hours after onset of symptoms.

Eligibility criteria:
inclusion criteria: * scoring 4 to 20 on the national institute of health stroke scale (nihss) * showing a perfusion-diffusion mismatch on mri of 20 % * enrolment within a 3 h to 9 h time window after symptom onset. * 18-85 years of age exclusion criteria: * participation in any interventional trial in the previous 30 days. * women in the childbearing age. * any history of intracranial hemorrhage, subarachnoid hemorrhage, neoplasm, arteriovenous malformation or aneurysm. * conditions that, according to the judgment of the investigator, might impose an additional risk to any individual stroke patient when receiving study medication (this applied to patients on platelet-function inhibitors as well). * mri exclusion criteria: evidence of ich, evidence of sah, signs of extensive early infarction on dwi assessed by evidence of involvement of \>1/3 of the middle cerebral artery (mca) territory. no perfusion deficit, internal carotid artery (ica) occlusion ipsilateral to stroke lesion without additional ipsilateral mca, anterior cerebral artery (aca) or posterior cerebral artery (pca) occlusion. any intracranial pathology that would interfere with the mri assessment of acute ischemic stroke.

Keywords: acute ischemic stroke
a phase 2 study of mp-376 to prevent acute exacerbations in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: patients with chronic obstructive pulmonary disease (copd) suffer from frequent and recurrent acute exacerbations (aecb) which are associated with enormous healthcare expenditures and significant morbidity, specifically an increased risk of death, a decline in pulmonary function and a significant change in quality of life. bacteria appear to have an important role in acute exacerbations in chronic bronchitis and copd. studies of acute exacerbations in copd have shown a reduction in bacterial load with prolonged exacerbation-free interval. in addition, recent studies indicate that acquisition of a new strain of h. influenzae, m. catarrhalis, s. pneumoniae or p. aeruginosa are responsible for many of these exacerbations. chronic inflammation and bacterial infection predispose many patients to frequent and recurrent acute exacerbations. mpex believes that intermittent administration of inhaled mp-376 in high risk patients will decrease the incidence of acute exacerbations by both by lowering the organism burden, and resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial strains.

this study will be a phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of mp-376 inhalation solution given daily for 5 days in a 28 day treatment cycle to copd patients. study with completed results acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria (selected): * \> 40 years of age * history of copd * forced expiratory volume in 1 second (fev1) \</= 70% of predicted and fev1/forced vital capacity (fvc) \</= 0.7 value at screening * have at least two acute exacerbation episodes in the proceeding year * clinically stable with no changes in health status within the last 30 days * lifetime smoking history of at least 10 pack-years * willing and able to use a daily electronic diary exclusion criteria (selected): * use of any systemic or inhaled antibiotics within 30 days prior to baseline * history of hypersensitivity to fluoroquinolones or intolerance with aerosol medication * creatinine clearance \ /= 5 x upper limit of normal (uln) or total bilirubin \>/= 3 x uln at screening

Keywords: copd patients
low-dose oral methotrexate versus colchicine for primary biliary cirrhosis

Conditions: Liver Cirrhosis, Biliary

Summary: objectives: i. compare the efficacy of low-dose oral pulse methotrexate (mtx) and ursodiol versus colchicine and ursodiol in patients with primary biliary cirrhosis (pbc). ii. determine the optimum dose and duration of mtx treatment. iii. investigate the role of fibrogenic cytokines (fc) in pbc pathogenesis and the effect of treatment on fc production.

protocol outline: this is a randomized, double-blind study. patients are stratified by prior/concurrent medical management. patients in the first group are treated with oral methotrexate 3 times a week and a daily oral placebo. patients in the second group are treated with daily oral colchicine and an oral placebo 3 times a week. therapy continues for 10 years. beginning year 2, daily oral ursodiol is administered to all patients. patients with disease progression are crossed to the alternate group or undergo liver transplantation if clinically indicated.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- biopsy proven primary biliary cirrhosis (pbc); disproportionate increase in alkaline phosphatase; positive antimitochondrial antibody test or symptoms consistent with pbc, e.g.: pruritus, fatigue, malaise, jaundice, elevated bilirubin no clinically advanced pbc, i.e.: bilirubin greater than 10 mg/dl or albumin less than 2.5 g/dl, determined by 2 analyses 10 weeks apart; bleeding esophageal varices or congestive gastropathy; chronic hepatic encephalopathy; chronic ascites --prior/concurrent therapy-- no concurrent drugs associated with chronic liver disease --patient characteristics-- hematopoietic: wbc at least 2500 platelets at least 100,000 (unless due to hypersplenism); hematocrit at least 30% renal: no renal disease that could cause liver dysfunction other: no history of alcohol abuse; no other medical illness that might cause liver dysfunction, e.g., severe cardiac failure; no pregnant women

Keywords: cirrhosis gastrointestinal disorders primary biliary cirrhosis rare disease
taper-shaped cuff endotracheal tube against respiratory infections

Conditions: Postoperative Pneumonia

Summary: the incidence of postoperative pneumonia after aortic surgery reaches 60%. in experimental lung model, endotracheal tube with taper-shaped cuff has been shown to decrease microaspiration. this effect has never been demonstrated in patients. the investigators hypothesize that use of endotracheal tube with taper-shaped cuff decreases the incidence of postoperative pneumonia in patients after aortic surgery.


Eligibility criteria:
inclusion criteria: * age ≥ 18 ans * elective aortic surgery * admission in icu after aortic surgery exclusion criteria: * tracheostomized patients

Keywords: after aortic surgery
study evaluating ekb-569 in advanced non-small cell lung cancer

Conditions: Non-Small-Cell Lung Carcinoma; Carcinoma, Non-Small Cell Lung; Lung Neoplasms

Summary: this non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered ekb-569 in subjects with advanced non-small cell lung cancer. patients must have been previously treated with a platinum- and docetaxel-based therapy either given concurrently or as separate regimens. the primary objective of the study is to assess the clinical activity of ekb-569 administered orally as a second-line or later stage treatment in subjects with advanced non-small cell lung cancer. secondary objectives include: * to further evaluate the safety of ekb-569 * to explore additional clinical activity parameters * to explore subject survival * to evaluate the pharmacokinetics of ekb-569 * to assess subject reported outcomes ekb-569 will be administered orally as a single-agent. eligible subjects will take ekb-569 daily as long as they do not have progressive disease and are tolerating treatment.


Eligibility criteria:
inclusion criteria: * signed and dated, institutional review board (irb) or independent ethics committee (iec)-approved informed consent form before any protocol-specific screening procedures * histologic and/or cytologic diagnosis of locally-advanced or metastatic non-small cell lung cancer in subjects who are not curable by conventional therapy exclusion criteria: * chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas) * prior radiotherapy to \>25% of bone marrow * prior epidermal growth factor receptor-targeting therapy

Keywords: advanced non-small cell lung cancer
early prediction of postpartum glucose metabolism abnormalities in gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus

Summary: this project is expected to screen reliable serum markers in pregnant women with gestational diabetes mellitus (gdm) by using metabolic profiling and lipid profiling clinical high-throughput mass spectrometry technology. we intend to build an early pregnancy prediction model for postpartum glucose metabolism abnormalities of gdm. at the same time, this project plans to develop a predictive management system based on this model, so that it can be widely used in clinical detection process, realize the advance of the early warning window period of abnormal glucose metabolism, and provide theoretical guidance for the early postpartum blocking of gdm to the outcome of abnormal glucose metabolism.


Eligibility criteria:
inclusion criteria: * plan to have routine prenatal examinations and give birth in the research center * gdm was diagnosed at 24-28 gestational weeks * singleton pregnancy * without other pregnancy complications * willing to cooperate with the hospital to follow up exclusion criteria: * have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, aids, etc. * fetus has a known deformity or genetic defects * incomplete clinical data
ask questions (asq):implementation of a communication intervention

Conditions: Stage II Breast Cancer; Stage III Breast Cancer; Stage IV Breast Cancer; Stage II Colorectal Cancer; Stage III Colorectal Cancer; Stage IV Colorectal Cancer; Stage II Lung Cancer; Stage III Lung Cancer; Stage IV Lung Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer; Stage II Ovarian Cancer; Stage III Ovarian Cancer; Stage IV Ovarian Cancer; Stage II Cervical Cancer; Stage III Cervical Cancer; Stage II Bladder Cancer; Stage III Bladder Cancer; Stage IV Bladder Cancer; Stage II Kidney Cancer; Stage III Kidney Cancer; Stage IV Kidney Cancer

Summary: this clinical trial implements a communication intervention to improve patient-oncologist communication in the outpatient medical oncology setting. a communication brochure called the asq brochure may help patients prepare for the doctor visit by thinking through the questions that patients and patients' family want to ask the doctor.

patient-centered communication is critical to providing high-quality care. in patient-provider clinical interactions, providers are responsible for several aspects of patient-centered communication. however, to reach the goal of providing the best possible treatments, patients should also actively participate by asking questions and expressing their concerns. question prompt lists, simple lists of questions provided to patients before clinic visits to help them prepare for the appointment, have been tested in several medical contexts and patient populations, including among an underserved, minority population in detroit, and have been shown to contribute to improved outcomes related to better communication quality. using a re-aim framework, this descriptive, mixed methods, single-arm intervention study assesses the implementation of an evidence-based communication intervention (question prompt list), the "asq brochure". the asq brochure is designed to improve patient-oncologist communication and other outcomes by improving patient self-efficacy for managing patient-physician interactions. investigators will recruit 225 patients and implement the asq brochure at seven karmanos cancer center network sites. participants are newly diagnosed patients with (stages i-iv) cancer for which systemic therapy is likely a recommended treatment.

Eligibility criteria:
inclusion criteria: * adults 18 years of age or older * have a first appointment to see a medical oncologist at a karmanos cancer institute (kcc) site for medical/systemic treatment for a new, confirmed diagnosis of stages i-iv cancer * speak and read english well enough to be able to understand consent documents * given the diverse population seen at kci, we will make attempts to recruit a representative sample. our strategy will be simply to ask recruiters to make special attempts to recruit a representative sample. if that strategy fails after the first 10 patients we will build in requirements that at least 25% of the patients self-identify as non-white exclusion criteria: * not specified
efficacy of acupuncture and low-level laser in temporomandibular disorders

Conditions: Temporomandibular Joint Disorders

Summary: temporomandibular joint disorders (tmd) , a musculoskeletal condition , includes a series of clinical problems involving the temporomandibular joint (tmj), the masticatory muscles, and related structures.this study evaluates the efficacy of integrated traditional chinese and western medicine in the treatment of tmd.

in this study, 84 patients ranging in age from 18 to 65 years with diagnoses of tmd will be randomly divided into two groups: an experimental group (eg) who will receive the integrated traditional chinese and western medicine treatment group(with low-level laser therapy+acupuncture) and a control group who will receive the only western medicine treatment(with low-level laser therapy).both approaches will be applied 3times a week for 3 weeks.

Eligibility criteria:
inclusion criteria: 1. diagnosis of tmd according to the diagnostic criteria for tmd research diagnostic criteria (dc/tmd）which are manifested as joint pain during mouth opening and chewing, mouth opening limitation (\<40mm), joint clanging, masticatory creatine distension and weakness, which affects normal eating. 2. aged 18-65; 3. unilaterally; 4. no any other treatment on tmd in the last 3 months; exclusion criteria: 1. there are tumors, joint degeneration and other serious lesions ; 2. patients with a history of tmj trauma or surgery,joint anatomical variation; 3. women pregnant and suckling period; 4. serious systemic diseases of bone and joint, such as rheumatoid arthritis

Keywords: low-level laser therapy acupuncture
vitamin d supplementation in cutaneous malignant melanoma outcome

Conditions: Cutaneous Malignant Melanoma

Summary: to assess whether vitamin d supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.

to assess whether vitamin d supplementation, in the follow up period after diagnosis and surgery of a first cutaneous malignant melanoma, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin d levels in serum and vitamin d receptor (vdr) immunoreactivity in the primary tumor.

Eligibility criteria:
inclusion criteria: 1. older than 18 years and younger than 80 years of age. 2. histologically proven malignant melanoma, stage one b (ib) to three (iii) not participating in other clinical trial. 3. the only treatment for melanoma is surgical treatment. 4. complete resection of melanoma. 5. single primary invasive cutaneous melanoma 6. signed ethical committee approved informed consent 7. serum phosphate, serum calcium at the entry of the study within normal limits of laboratory reference exclusion criteria 1. pregnant/lactating women or planning on becoming pregnant during the study 2. known hypersensitivity to vitamin d or its components. 3. pre-existing renal stone disease, chronic renal disease with glomerular filtration rate (egfr) \< 30 ml/min/1.73 m2 or renal dialysis. 4. liver failure or chronic liver disease with liver enzymes \> 2 fold upper limit of normal (uln). 5. history of parathyroid disease or granulomatous disease (tbc and sarcoidosis) 6. history of malabsorption syndrome or any medical condition that might interfere with vitamin d absorption. 7. history of small intestine resection. 8. history of other malignancy within the last 5 years except for carcinoma in situ of the cervix or basal cell carcinoma or squamous cell carcinoma of the skin or in situ malignant melanoma. 9. chronic alcohol abuse. 10. medical or logistic problems likely to preclude completion of the study. 11. taking medication that predisposes to hypercalcemia (digoxin, lithium, thiazide diuretics) or taking medication that would affect metabolism of vitamin d (anticonvulsants, corticosteroids, h2-receptor antagonists) 12. intake of vitamin d supplements within 6 months prior to entry of the study.

Keywords: cutaneous malignant melanoma vitamin d cholecalciferol
changes in biomarkers of cancer in women with breast cancer and without evidence of disease who were given phytomed™

Conditions: Breast Cancer

Summary: the purpose of this study is to determine whether the administration of the phytomed™ complement reduces crp in women with histologically confirmed ajcc stage 0-iiia breast cancer which has been completely surgically resected and without evidence of disease as determined by their physician


Eligibility criteria:
inclusion criteria: * women with histologically confirmed ajcc stage 0-iiia breast cancer which has been completely surgically resected. * no evidence of disease as determined by their physician. * er+ and/or pr+ tumour. * receiving an aromatase inhibitor (letrozole, anastrazole, exemestane) or tamoxifen at a stable dose for at least 3 months at trial entry. * post-menopausal women, defined as: (1) above 50 years of age who have not menstruated during the preceding 12 months or who have follicle-stimulating hormone levels (fsh) \> 40 iu/l, (2) those under 50 years of age who have fsh hormone levels \>40 iu/l, or (3) those who have undergone a bilateral oophorectomy. * crp ≥3.9 mg/l measured as the mean of two consecutive weekly tests. * aged 18 years or older * ecog performance status 0-1 * between 2 and 5 years from their initial surgery for breast cancer. * life expectancy of at least 6 months * at least 6 months since last chemotherapy * laboratory tests performed within 14 days of trial starting: 1. granulocytes ≥ 1,500/µl; 2. platelets ≥ 100,000/µl; 3. haemoglobin ≥ 12.0 g/dl; 4. total bilirubin equal to or below upper limit of normal (uln); 5. ast and alt equal to or below uln; 6. alkaline phosphatase equal to or below uln; 7. serum creatinine equal to or below uln; * able to provide informed consent to receive the trial treatment, to provide biological specimens, self-administer oral medica-tion unsupervised for a prolonged period of time, and to complete a medication diary. exclusion criteria: * pregnancy or breastfeeding * who have had a malignancy (other than breast cancer) which required radiotherapy or systemic treatment within the past 5 years. * known cardiac disease (arrhythmias, myocardial infarction, bundle branch block, ischemic heart disease, uncontrolled hypertension) * known autoimmune disease or inflammatory disorder * any condition requiring the use of systemic corticosteroids or any other immunosuppressive agents (e.g. cyclosporin, tacrolimus, azathioprine). * women with known immunodeficiency (such as hiv). * patients with infection by septicaemia, infection, acute hepatitis, or other uncontrolled severe medical condition * routine use of aspirin \>81 mg/d or nsaids (\> 400 mg po 4 times/day of ibuprofen or naproxen \> 500 mg/d) or any use of celecoxib or similar cox-2 inhibitors; * subjects are asked not to take dietary supplements, olives or olive oil for 1 month prior to trial enrolment and during the trial. * who are taking bisphosphonates

Keywords: breast cancer stage 0-iiia no evidence of disease
the effect of isosorbide mononitrate in reducing pain during cooper intrauterine device insertion

Conditions: IUD Insertion Pain

Summary: the aim of the study is to evaluate the efficacy of isosorbide mononitrate vaginal administration in reducing pain during copper iud insertion in nulliparous women


Eligibility criteria:
inclusion criteria: * nulliparous women requesting copper iud device insertion exclusion criteria: * parous women, contraindications to iud insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly
hepatitis c testing in va community-based outpatient clinics

Conditions: Hepatitis C

Summary: the visn1 va hepatitis c testing and linkage to care quality improvement project aims to increase the proportion of veterans tested for hcv in those born between 1945-1965 and in vulnerable, high-risk groups.

the visn1 va hepatitis c testing and linkage to care quality improvement project aims to: (1) increase the proportion of veterans tested for hcv in those born between 1945-1965 and in vulnerable, high-risk groups, (2) increase linkage to specialized hcv care among visn 1 va veterans diagnosed with hcv infection, and (3) evaluate whether race, ethnicity, gender, or other markers of social disparity influence completion of hcv testing and linkage to specialty care, and whether disparities are reduced by the planned visn 1 va hcv quality improvement (qi) program. the central focus is to reduce delays in diagnosis and linkage to treatment evaluation, management of comorbidities and contraindications, and subsequent initiation.

Eligibility criteria:
inclusion criteria: * veterans * born in the period of 1945-1965 ("birth cohort") * with an outpatient visit in primary care at a visn1 facility in fy 2016 exclusion criteria: * n/a

Keywords: hepatitis c