Kornimate/medical-research-clean huggingface dataset:
beatrice study: a study of bevacizumab (avastin) adjuvant therapy in triple negative breast cancer

Conditions: Breast Cancer

Summary: the main objective of the trial is to compare invasive disease-free survival (idfs) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab. the secondary objectives of this trial are to: * compare overall survival (os), breast cancer-free interval (bcfi), disease- free survival (dfs) and distant disease-free survival (ddfs) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab * evaluate the safety and tolerability of bevacizumab an exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * operable primary invasive breast cancer; * completed definitive loco-regional surgery; * primary tumor centrally confirmed as triple negative. exclusion criteria: * locally advanced breast cancers; * previous breast cancer history; * clinically significant cardiovascular disease.
a study of ro4917838 in participants with persistent, predominant negative symptoms of schizophrenia (nn25310)

Conditions: Schizophrenia

Summary: this multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of ro4917838 in participants with persistent, predominant negative symptoms of schizophrenia. participants, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of ro4917838 or matching placebo for 56 weeks (treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional treatment extension for up to 3 years. after 52 weeks, participants who were originally randomized to an active treatment will be randomly assigned to receive either placebo or continue on the originally assigned study treatment for 4 weeks washout period (week 52 to week 56) for the assessment of potential withdrawal effects in a blinded manner using participants staying on active treatment as a control. participants initially randomized to placebo will remain on placebo. after 56 weeks, participants who were switched to placebo in the washout period will return to their blinded, active treatment arm.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype * predominant negative symptoms * with the exception of clozapine, participants are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics) exclusion criteria: * evidence that participant has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder) * body mass index (bmi) of less than (\ ) 40 kilograms per meter square (kg/m\^2) * depressive symptoms, defined as a score of 9 or greater on the calgary depression rating scale for schizophrenia (cdss) * a severity score of 3 or greater on the parkinsonism item of the exrapyramidal symptoms rating scale-abbreviated (esrs-a) (clinical global impression, parkinsonism)
transcutaneous laryngeal ultrasound as an alternative to direct flexible laryngoscopy in assessment of vocal cords

Conditions: Ultrasound Therapy; Complications

Summary: to evaluate the diagnostic value of ultrasound in the assessment of the vocal cords compared with direct flexible laryngoscopy

thyroid and parathyroid surgery are the most common procedures in endocrine surgery worldwide. they are mainly associated with two major complications: recurrent laryngeal nerve (rln) palsy and hypoparathyroidism, the preservation of recurrent laryngeal nerve (rln) is an essential part of thyroid surgery {1}. the various methods to test the normal functionality of vocal cords (vcs) include direct visualisation under the fiber bronchoscope, indirect laryngoscopy, laryngeal muscles electromyography, computed tomography (ct), and magnetic resonance imaging (mri). we aimed to assess the usefulness of ultrasound (usg) in the examination of vc morphology and movement. recurrent laryngeal nerve injury ranges from 1.4 to 5.1% following surgery involving the thyroid gland. otolaryngology and head and neck surgery suggested that all patients undergoing thyroid and parathyroid procedures should undergo routinely preoperative and postoperative dfl \[6\]. laryngoscopy is considered the golden standard to evaluate vocal fold mobility preoperatively. as it can demonstrate a paralysis of the recurrent laryngeal nerve,. yet it is not common practice for many endocrine surgery teams because it is time consuming, imposes extra costs, and is in general, an unpleasant experience for some patients.{2} head and neck ultrasonography is a cost effective imaging tool that is currently used as an extension of patient physical examination. that is based on its safety (non invasive and non ionizing radiation dependent), repeatability, availability and good patient compliance (pain less and require no sedation). {3} recently portable ultrasound devices became widely available with dramatic improvement of the imaging quality rendering to increased diagnostic accuracy. availability, usability and mobility of the devices encourage bedside examination which is essential in non mobile patient and icu patient \[4\] . however, the experience is limited and the reliability of the tlus in thyroid and parathyroid surgery is still being debated

Eligibility criteria:
inclusion criteria: * patients scheduled for thyroid surgery * patients underwent thyroid surgery exclusion criteria: • patients with vocal cord paralysis because of any cause other than thyroid surgery complications

Keywords: ultrasound
changes of sleep on the sensoriomotor and cytokine in patients with osteoarthritis

Conditions: Osteoathritis and Sleep

Summary: osteoarthritis (oa) is one of the major health problems and their prevalence has increased in recent decades. it has been shown that oa causes negative effects on sleep and that these changes in sleep see to be correlated with the function and physical performance of patients with oa. however, no study to date has demonstrated the effects of sleep changes in sensorimotor control and systemic inflammatory response in patients with oa. the objective of this study is to assess the influence of sleep changes in sensorimotor control (postural and neuromuscular control) and inflammatory markers (cytokines) in patients with knee oa grade i or ii. participate in this study, 60 male volunteers, aged between 40 and 65. these volunteers will be divided into four groups: group 1 (n = 15): osteoarthritis and good quality sleep, group 2 (n = 15): osteoarthritis and poor quality sleep, group 3 (n = 15): without good and osteoarthritis quality of sleep, group 4 (n = 15): without osteoarthritis and poor quality of sleep. all volunteers will perform a polysomnography to detect the presence or not of changes in sleep. further testing on the isokinetic dynamometer to evaluate the acceleration time, maximum isometric torque and isokinetic concentric and eccentric maximum quadriceps muscle strength and a submaximal test to evaluate neuromuscular control. also there will be a test on the force platform to assess the uni-and bipedal postural control, as well as respond to the womac questionnaire that assesses the quality of life in patients with oa. blood will be collected for analysis of inflammatory cytokines (tnf-alpha, il-1alpha, il-1beta, il-6, il-8, il-12, il-10, tgf-beta). the significance level is 5% (p ≤ 0.05).

the experimental design of each volunteer (all groups) will be evaluated by a physician before beginning the study and posteriomente will perform a polysomnography. the day after polysomnography voluntary blood will be collected. a week after the volunteer will perform the balance test (force platform) and the test of strength (isokinetic).

Eligibility criteria:
inclusion criteria: * with and without osteoartrhitis * no other health problems * sedentary exclusion criteria: - other clinical and neurobiological conditions

Keywords: osteoarthritis sleep muscle strength balance
study on phenotypic characterization of combined pulmonary fibrosis and emphysema

Conditions: Pulmonary Fibrosis; Emphysema

Summary: this study is to evaluate the expression of biological markers in induced sputum and peripheral blood t lymphocytes of patients with combined pulmonary fibrosis and emphysema (cpfe). the features of cpfe would be observed, including pulmonary function tests and fractional exhaled nitric oxide （feno）.

a new disease including concomitant upper-lobe emphysema and lower-lobe fibrosis in radiology has been defined as (combined pulmonary fibrosis and emphysema, cpfe). cpfe has distinct clinical characteristics with the emphysema and the pulmonary fibrosis, including gender, age, clinical manifestation, pulmonary function tests and prognosis. normally th1/th2 is balanced. however, patients with emphysema had a significantly higher expression of th1. on the other hand, higher expression of th2 is involved in the development of pulmonary fibrosis. the expressions of th1 and th2 were proved to play a central role in pathogenesis of emphysema and pulmonary fibrosis, while are still unknown in patients of combined pulmonary fibrosis and emphysema. the study would observe the th1/th2 expression, pulmonary function tests , fractional exhaled nitric oxide （feno）and other features in cpfe patients.

Eligibility criteria:
inclusion criteria: 1. ipf-alone group: 10 patients meeting the ipf diagnosis criteria without emphysema. 2. cpfe group: 15 patients with ct presentation of concomitant upper-lobe emphysema and lower-lobe fibrosis. 3. emphysema-alone group: 15 patients with their ct diagnosis of emphysema without fibrosis. 4. control: 20 healthy sex- and age-matched volunteers including nonsmokers and smokers. none of the healthy volunteers with a history of respiratory diseases. exclusion criteria: 1. age \> 90 or \< 50 2. treated with corticosteroids or other immunomodulatory drugs 3. some known causes of interstitial lung disease such as collagen vascular disease, drug-induced lung disease, occupational disease. 4. an exacerbation in 4 weeks 5. subjects had a history of allergic diseases.

Keywords: emphysema; pulmonary fibrosis;chemokine;sputum
10-years nationwide alpine accidents in austria

Conditions: Alpine Accident; Frostbite; Cardiopulmonary Arrest With Successful Resuscitation; Lightning Injuries; Flight Accident

Summary: this observational study intends to analyze the characteristic of specific accidents happened in austrian's mountainous regions. the mechanisms of accidents which are evaluated are lightning accidents, cardiopulmonary resuscitation with or without automated external defibrillator, frostbite injuries, accidents with flying vehicle (e.g. paraglider, hang-glider...).

the data are collected retrospectively from the database of austrian alpine police force. these data are analyzed. the information from this database (scene of accident, weather, daytime...) is compared to secondary data collected from the university hospital of innsbruck. the comparison of both databases was approved by the austrian data protection agency. the goal of the study is to give detailed information of circumstances leading to accident and give medical information of the patient's condition and his outcome.

Eligibility criteria:
inclusion criteria: * person suffering the injury searched for; exclusion criteria: -
tivozanib in combination with paclitaxel in patients with locally recurrent or metastatic triple negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: this is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer.

this is a phase 2 multicenter, double-blind, randomized, placebo-controlled, two-arm study for subjects with locally recurrent or metastatic triple negative breast cancer. patients will be randomized 2:1 to either tivozanib hydrochloride and weekly paclitaxel or placebo and weekly paclitaxel. subjects will be stratified based on eastern cooperative oncology group (ecog) performance score (0 vs 1) and line of treatment (first vs second). all subjects will be evaluated for progression free survival and overall survival as well as safety and tolerability. biomarker and pharmacokinetic (pk) analysis are also included in study. this study will determine whether tivozanib hydrocholoride combined with weekly paclitaxel improves clinical outcomes in patients with triple negative breast cancer.

Eligibility criteria:
inclusion criteria: * locally recurrent or metastatic tnbc, defined as er/pr \<1%, her2 0-1+, or 2+ with negative fish * measurable disease per recist version 1.1 * ecog performance status of 0 or 1 * confirmed available archival tumor tissue. exclusion criteria: * more than 1 prior systemic chemotherapy for treatment of locally recurrent or metastatic breast cancer (neoadjuvant and adjuvant therapy is allowed provided the subject did not progress within 12 months of taxane based therapy * prior treatment with vegf pathway targeted agent * major surgery within 4 weeks or minor surgery or radiotherapy within 2 weeks of first dose of study drug * known history of central nervous system metastasis (subjects with previously treated (radiotherapy or surgery) brain metastasis that have been stable off steroids or enzyme-inducing antiepileptic drugs for at least 3 months following prior treatment may be enrolled) * significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders * significant serum chemistry or urinalysis abnormalities * significant cardiovascular disease, including: uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to administration of first dose of study drug; and symptomatic left ventricular dysfunction or baseline left ventricular ejection fraction (lvef) by multigated acquisition scan (muga) or echo. * severe peripheral neuropathy ≥ grade 2 * currently active second primary malignancy

Keywords: tivozanib hydrochloride triple negative breast cancer paclitaxel pharmacokinetics biomarkers metastatic breast cancer mbc tnbc
efficacy of gabapentin in alcohol dependency treatment

Conditions: Alcohol Drinking; Heavy Drinking

Summary: the study aims to study the effect of gabapentin on the number of alcohol drinking days and heavy drinking days in the thai clinical alcohol-dependent population by using the double-blinded randomized controlled approach. one-hundred and twelve individuals with alcohol dependence were randomly assigned equally into two groups including treatment with gabapentin and placebo. thirty-four patients (30.3%) completed the study protocol, i.e. treatment with gabapentin at least 300 mg per day or placebo orally once a day for twelve weeks. pattern of alcohol drinking were obtained from the timelime followback. drinking behaviors were compared between the two groups by poisson repeated measures model.


Eligibility criteria:
inclusion criteria: * current diagnosis of alcohol dependence exclusion criteria: * having major psychiatric disorders including schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, or suicide risk based on a clinical interview by attending psychiatrist * receiving other medications not in the protocol of the study for any reasons or having history of using other substances including methamphetamine, heroin, cannabis, inhalants, mitragyna speciosa (or kratom in thai), except tobacco based on self-report * having a medical disease, e.g. essential hypertension, diabetes, renal (e.g., normal renal test) or liver disease (e.g., liver function test was not higher than two times of normal range and gamma-glutamyl transferase (ggt) is less than 800 u/l), epilepsy, stroke * having history of alcohol withdrawal seizure or delirium based on clinical interview by attending psychiatrist * having moderate to severe alcohol withdrawal symptoms based on score \>13 of the clinical interview for withdrawal alcohol arlington (ciwa - ar) at the time of recruitment * having cognitive impairment based on score \< 24 from the mini mental state exam (mmse) * having history of allergy to gabapentin * pregnancy or breast feeding.
use of palliative performance and symptom distress scales in older patients with advanced ovarian cancer

Conditions: Ovarian Cancer

Summary: rationale: measuring changes in performance status and symptoms distress in patients with cancer may help doctors predict how patients will respond to treatment, and may help the study of cancer in the future. purpose: this clinical trial is studying changes in performance status and symptoms distress in older patients with advanced ovarian epithelial cancer undergoing surgery and/or chemotherapy.

objectives: primary * to evaluate the changes in performance status and symptom distress in older patients with presumed or advanced ovarian cancer undergoing surgery and/or chemotherapy. secondary * to explore the association between these changes with chemotherapy drug change, dose reduction, or dose delay due to toxicity in these patients. * to explore the association between these changes with the development of surgical complications in these patients. * to observe the response in the geriatric assessment (ga) and report the individual item scores. outline: patients complete the palliative performance scale and the mccorkle symptom distress scale questionnaires at baseline, at 10-20 days after surgery\*, at 14-21 days after courses 3 and 6 of chemotherapy ( if applicable), and at approximately 2-3 months at the patient's first follow-up visit. the research team completes the professional geriatric assessments. patients' medical records are also reviewed for any surgical complications, chemotherapy toxicities, dose reductions or delays, or change in medications secondary to chemotherapy toxicities. note: \*patients who complete the assessments and questionnaires at baseline but who are found not to have ovarian cancer during surgery will remain eligible for assessment of surgical complications.

Eligibility criteria:
inclusion criteria: * clinical findings highly suggestive of advanced ovarian epithelial cancer undergoing surgery for definitive diagnosis and staging * ≥ 65 years of age exclusion criteria: * prior diagnosis of ovarian cancer * inability to read and speak english * inability to comply with study requirements

Keywords: psychosocial effects of cancer and its treatment perioperative/postoperative complications stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer
dysport® adult lower limb spasticity follow-on study

Conditions: Post-stroke Spasticity; Spasticity Post-Traumatic Brain Injury

Summary: the purpose of this research study is to assess the long term safety of dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.


Eligibility criteria:
inclusion criteria: * completion of dysport® adult lower limb spasticity double blind study y-55-52120-140 (nct01249404) exclusion criteria: * fixed contractures in lower limb
the relationship between vitamin d and hepatitis b virus replication

Conditions: Vitamin D and Hepatitis B Virus

Summary: 149 hbv carriers with inadequate serum vitamin d levels were randomized to two groups: one is supplied with vitamin d and another without as controls. the markers of hbv replication were compared before and after treatment.

this is a randomized case-control trial. a total of 149 hbv carriers with inadequate vitamin d (\< 30 ng/ml) level were enrolled. they were randomly divided to two groups: one group receiving vitamin d supplement (1600 iu/day) for 2 months and another group as controls. the serum vitamin d, hbv dna and qhbsag levels were measured at baseline and after vitamin d supplement. whether hbv dna and qhbsag have significant change after vitamin d supplement can be determined.

Eligibility criteria:
inclusion criteria: * \>20 y/o, hbv carrier * serum vitamin d \< 30ng/ml exclusion criteria: * other known causes of hepatitis

Keywords: hbv dna, qhbsag
implementation of physical exercise at the workplace (irma06) - slaughterhouse workers

Conditions: Musculoskeletal Disorders

Summary: the prevalence of pain in the shoulder, arm and hand is high among slaughterhouse workers, allegedly due to the substantial load of these body regions during work. work disability is a common consequence of these pains. lowering the physical exposure through ergonomic intervention may be a strategy to reduce the workload. an alternative strategy could be to increase the physical capacity through strength training of the shoulder-, arm- and hand-muscles. this study investigates the effect of two contrasting interventions, i.e. load reduction (ergonomic intervention) versus training of physical capacity (strength training) on pain and work disability in slaughterhouse workers. the main hypothesis is that strength training intervention for 10 weeks compared with ergonomic intervention results in reduced pain of the shoulder, arm and hand.


Eligibility criteria:
inclusion criteria: * slaughterhouse worker * the pain should have lasted at least 3 months * pain intensity during the last three months of \>= 3 (scale 0-10) in the shoulder, elbow or hand * the pain should be frequent (at least 3 days per week) exclusion criteria: * life threatening disease * pregnancy
dose effect of limicol on (ldl)-cholesterol levels

Conditions: Hypercholesterolaemia

Summary: the principal objective of this study is to investigate the dose-effect of the limicol food supplement on ldl-cholesterol level in moderate hypercholesterolaemia subjects.


Eligibility criteria:
inclusion criteria: * about 18 to 65 years (inclusive). * subject has a stable weight for at least three months before the start of the study. * subject able and willing to comply with the protocol and agreeing to give their consent in writing. * subject affiliated with a social security scheme. * subject willing to be included in the national register of volunteers who lend themselves to biomedical research.

Keywords: cholesterol ldl-cholesterol coronary artery disease red yeast rice plants extract cholesterol excess delivery of health care
transcatheter heart valve (thv) sizing and leakage after transcatheter aortic valve implantation (tavi) before and after establishing routine preprocedure multi slice computerized tomography (msct) aortic assessment. a retrospective registry study

Conditions: Aortic Stenosis

Summary: the objective of this study is to evaluate the effect of annular sizing strategy (mdct versus tee) in transcatheter aortic valve implantation on the prevalence and severity of paravalvular regurgitation.


Eligibility criteria:
inclusion criteria: * patients implanted with a thv at aarhus university hospital exclusion criteria: * learning curve patients (the first 40 patients implanted with a thv device at aarhus university hospital, skejby).