Kornimate/medical-research-clean huggingface dataset:
azd6244 (arry-142886) solid oral dosage formulation in participants with advanced solid malignancies

Conditions: Tumor; Cancer

Summary: the primary purpose of the study is to assess the safety, tolerability and pharmacokinetics of a capsule of azd6244 in participants with advanced solid malignancies.


Eligibility criteria:
inclusion criteria: * cancer which is refractory to standard therapies * world health organization (who) performance status 0 to 2 * evidence of post-menopausal status or negative pregnancy test exclusion criteria: * radiotherapy/chemotherapy within 21 days prior to entry * brain metastases/spinal cord compression unless stable off steroids/anticonvulsants * evidence of severe/uncontrolled systemic disease * participated in an investigational drug study within 30 days

Keywords: advanced malignancy cancer eligibility malignancy
effect of febuxostat on endothelial dysfunction in hemodialysis patients.

Conditions: Endothelial Dysfunction; Endstage Renal Disease

Summary: the purpose of this study is to determine if the febuxostat has an effect on endothelial dysfunction on hemodialysis patients.

aim of the work: 1- evaluation of the effect of febuxostat on endothelial dysfunction in hemodialysis patients, through detection of: 1. primary endpoint: • reduction in asymmetrical dimethylarginine (adma) 2. secondary endpoints: * assessing the change in serum high sensitivity c-reactive protein (hscrp) * assessing the change in serum uric acid - the criteria for inclusion: 1. outpatients on maintenance hemodialysis. 2. age from 18-70 years old. 3. serum ua level 7.0 mg/dl or more. 4. stable clinical condition (no hospitalization in the previous 3 months) the exclusion criteria: 1. current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat) 2. history of hypersensitivity to febuxostat. 3. current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol. 4. participant in an another clinical trial within the past 4 weeks. 5. judged to be unsuitable as a subject by the attending physician. after two months , the patient will be reassessed regarding: a. adma serum level. b. change in serum hscrp. c. change in serum uric acid level.

Eligibility criteria:
inclusion criteria: * outpatients on maintenance hemodialysis. * age from 18-70 years old. * serum uric acid level 7.0 mg/dl or more. * stable clinical condition (no hospitalization in the previous 3 months) * informed consent in accordance with the declaration of helsinki. exclusion criteria: * current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat) * history of hypersensitivity to febuxostat. * current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol. * participant in an another clinical trial within the past 4 weeks. * judged to be unsuitable as a subject by the attending physician
adjuvant treatment for incomplete resection thymoma or thymic carcinoma

Conditions: Thymoma and Thymic Carcinoma

Summary: this study is designed to investigate whether adjuvant radiochemotherapy after incomplete resection has a better survival than adjuvant radiotherapy for thymoma or thymic carcinoma.

the previous trials have showed that radiotherapy was significantly associated with prolonged os and chemotherapy is playing an increasing role in treatment of patients with thymoma or thymic carcinoma.however,whether patients with thymoma or thymic carcinoma could benefit from adjuvant radiochemotherapy after incomplete resection remains controversial. the purpose of this study is to investigate whether adjuvant radiochemotherapy after incomplete resection can improve survival for thymoma or thymic carcinoma.

Eligibility criteria:
inclusion criteria: 18\~75 years old; eastern cooperative oncology group performance status of 0 to 2; pathologically confirmed ; incomplete resection (r1 or r2);have adequate bone marrow, hepatic, and renal function;patients receive incomplete resection within 3 months; written informed consent. exclusion criteria: patients with distant metastases; patients underwent radiotherapy or chemotherapy; patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; active clinical pulmonary infection; pregnant or nursing.

Keywords: thymoma thymic carcinoma adjuvant radiotherapy adjuvant radiochemotherapy incomplete resection
a metabolomics-based study to explore the mechanism of remission of metabolic syndrome after radical gastrectomy

Conditions: Metabolic Syndrome; Gastric Cancer

Summary: 1. analysis of preoperative and postoperative metabolite changes: through metabolomics technology, the changes of preoperative and postoperative metabolites in patients with gastric cancer complicated with metabolic syndrome were systematically analyzed, and the key metabolites related to the remission of hypertension, hyperlipidemia, and diabetes after surgery were found. 2. explore the influencing factors of postoperative remission of metabolic syndrome: combined with clinical data, the association between various metabolites and the degree of postoperative remission was evaluated, and the main factors affecting postoperative remission were determined. 3. reveal the mechanism of postoperative remission of metabolic syndrome: through multi-level metabolomics analysis, to clarify the metabolic pathways and mechanisms involved in the process of postoperative remission, and provide a new theoretical basis for the development of tumor metabolic surgery.

this project will last 2-3 years. all patients who meet the inclusion and exclusion criteria will be divided into three groups according to the type of metabolic syndrome, including hypertension, diabetes and hyperlipidemia, with 50 cases in each group. blood and feces of all patients were collected before surgery, 3 days after surgery, 6 months after surgery, and 1 year after surgery. the collected samples will be subjected to untargeted metabolomics analysis, using nmr-ivdr technology to detect the dynamic changes of all small molecular metabolites (mainly endogenous small molecular compounds with relative molecular weight within 1000 da) in blood and feces before and after stimulation or disturbance without bias. the differential metabolites of blood glucose, blood lipid, cholesterol, insulin, renin, aldosterone, and angiotensin were screened by bioinformatics analysis, and the pathway analysis of differential metabolites was performed to reveal the potential physiological mechanism of postoperative hypertension, diabetes, and hyperlipidemia

Eligibility criteria:
inclusion criteria: * 1. age \>18 years old. 2. patients with hypertension or diabetes for more than 1 year before surgery. 3. patients undergoing radical gastrectomy for gastric cancer. exclusion criteria: * 1. gastric stump cancer. 2. patients with distant metastasis. 3. patients who underwent combined resection of other important organs. 4. severe postoperative complications. 5. patients who are using drugs that may significantly affect metabolic status (such as hormonal drugs, potent immunosuppressants, etc.). 6. incomplete clinical data.

Keywords: gastric cancer metabolic syndrome
survival benefits of neoadjuvant systemic chemotherapy in muscle invasive bladder cancer

Conditions: Bladder Urothelial Carcinoma

Summary: muscle-invasive bladder cancer (mibc) is an aggressive disease with a high-risk of early metastasis and cancer specific mortality. the gold standard treatment of mibc is radical cystectomy (rc) in conjunction with concomitant bilateral pelvic lymphadenectomy . while radical cystectomy remains a primary management strategy for mibc, high rates of recurrence with surgery alone highlight the likelihood of occult micrometastatic disease at the time of diagnosis. due to the development and implementation of neoadjuvant chemotherapy prior to radical cystectomy, the prognosis for mibc patients undergoing radical cystectomy has improved .

the goals of neoadjuvant chemotherapy administration are to; eradicate the micro-metastases, avoid the release and implantation of malignant cells during cystectomy, and extend the survival of these patients. clinical trial data supports the use of neoadjuvant platinum-based chemotherapy for patients with non-metastatic mibc. based on level i evidence, use of preoperative platinum based chemotherapy is now included in the guideline recommendations from the american urologic association (aua), american society of clinical oncology (asco), national comprehensive cancer network (nccn), and european association of urology (eau) . in the southwest oncology group (swog) intergroup study, rc alone was compared with three cycles of neoadjuvant mvac (methotrexate, vinblastine, doxorubicin, and cisplatin), followed by radical cystectomy. this randomized trial showed that the median survival duration was 77 months in patients with combination treatment, and 46 months in patients with upfront rc alone.

Eligibility criteria:
inclusion criteria: * age \>18 * histological proven mibc patient treated with neoadjuvant systemic chemotherapy( platinum based ) exclusion criteria: * non muscle invasive bladder cancer (nmibc) * metastatic patients * patients treated with surgery firstly

Keywords: survival benefits neoadjuvant cth bladder cancer
comparison study between cefdinir & amoxicilline/clavulanate in acute sinusitis and assessment of quality of life

Conditions: Acute Bacterial Sinusitis

Summary: this study is a comparison between two commonly used antibiotics (cefdinir vs. amoxicillin/clavulanate) in patients with acute sinus infection, surveying quality of life. the hypothesis is that the two treatments would be at the least equivalent based on clinical outcome measures of improvement in quality of life.

the purpose if this investigation is to evaluate the rate of improvement ub quality of life (qol) in two different medications, a 10-day course of cefdinir 300 mg po bid versus a 10-day course of amoxicillin/clavulanate 1000 mg/62.5 mg xr bid, in the treatment of acute bacterial sinusitis.

Eligibility criteria:
inclusion criteria: * male and female outpatient adults greater than 18 years old fulfilling the case definition for acute bacterial sinusitis * case definition includes clinical signs and symptoms, radiographic findings and collection of purulent material from the sinus exclusion criteria: * symptoms less than 7 days and more than 3 weeks * history of sinus surgery within 3 months * history of frequent sinus infections (more than 2 episodes within the last 6 months) * history of kidney and liver disease * pregnant and nursing women * pre-existing disease that could predispose to sinus infections (cystic fibrosis or nasal polyps * immunosuppressed patients * history of allergy to either drug. patients with a documented history of allergies to either penicillin or cephalosporins will be excluded.

Keywords: acute bacterial sinusitis
imaging during surgery in diagnosing patients with prostate, bladder, or kidney cancer

Conditions: Bladder Cancer; Kidney Tumor; Prostate Cancer

Summary: this pilot clinical trial studies imaging during surgery in diagnosing patients with prostate, bladder, or kidney cancer. new diagnostic imaging procedures, may find prostate, bladder, or kidney cancer

primary objectives: i. the primary objective of this pilot study is to assess the ability of fluorescent imaging and photoacoustic imaging (pai) in a clinical setting to distinguish benign from malignant tissue. secondary objectives: i. to qualitatively determine the possible benefit of pai and fluorescent imaging over traditional white light imaging. outline: patients undergo fluorescence imaging and pai during robot assisted laparoscopic surgery.

Eligibility criteria:
inclusion criteria: * patients must have a pathologic confirmation of prostate cancer, bladder cancer, or kidney cancer based on previous biopsies or procedures or a strong concern for a kidney malignancy based on computed tomography (ct) or magnetic resonance imaging (mri) imaging * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * patients with a surgical history or anatomic variant that would preclude robot assisted laparoscopic approaches to their surgery (i.e. history of ventral hernia repair with mesh) * patients with medical co-morbidities who cannot tolerate laparoscopic surgery secondary to intra-abdominal carbon dioxide insufflation * patients with documented allergy or adverse drug reaction to indocyanine green or baseline serum creatinine greater than 1.5 mg/dl
trial of vaccine therapy with mrna- transfected dendritic cells in patients with androgen resistant metastatic prostate cancer

Conditions: Prostate Cancer

Summary: primary objectives: determination of safety and toxicity of vaccination with mrna transfected dc (based on blood samples, and adverse events). secondary objectives: determine immunological response to the vaccine (induction of specific t-cell response) and assessment of tumour response.


Eligibility criteria:
inclusion criteria: * must be at least 45 years of age. * must have histologically confirmed adenocarcinoma of the prostate. * must have evidence of disease progression while on lhrh agonist, or orchiectomy, with or without an antiandrogen for advanced prostate cancer. all patients will be maintained on the hormone regimen throughout this protocol that they were receiving at the time of entry or recent progression. increasing psa in three subsequent analysis. * must be ambulatory with a ecog performance score of \<2 * lab.values as following :anc ( 1.5 x 109/l; platelets ( 100 x 109/l, hb ( 9 g/dl (( 5.6 mmol/l). creatinine ( 140 µmol/l (1.6 mg/dl); if borderline, the creatinine clearance ( 40 ml/min, bilirubin \< 20% above the upper limit of normal, asat and alat ( 2.5 the upper limit of normal. albumin ( 2.5 g/l). * prior radiotherapy: a minimum of 4 weeks (8 weeks in case of extensive prior radiotherapy) must have elapsed between the end of the prior radiotherapy and entry into the protocol. * prior chemotherapy: a minimum of 4 weeks must have elapsed prior to entry in the study. * if the patient has received strontium-89 and alpha-radin, at least three months must have elapsed prior to entry in the study. * informed consent and expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to the ich-gcp guidelines. exclusion criteria: * history of prior malignancy other than prostate cancer, clinically evident within the 24 months preceding enrolment into the study, except curatively-treated basal cell or squamous cell carcinoma of the skin. * active infection requiring antibiotic therapy. * significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia. * autoimmune disease treated with steroid(s) * history of asthma, anaphylaxis or other serious adverse reactions to vaccines. * history of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis/dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome. * chemotherapy or other potentially immune-suppressive therapy that has been administered within 4 weeks prior to vaccination. * impending untreated spinal cord compression or urinary outlet obstruction. * any reason why, in the opinion of the investigator, the patient should not participate.
aspirin thromboprophylaxis after first-line total hip and knee replacement

Conditions: Hip and Knee Prosthesis Implantation

Summary: annually, more than 100,000 total hip prostheses (tha) and more than 100,000 total knee prostheses (tka) are implanted for osteoarthritis in france, and these figures are set to increase significantly in the future as in all industrialized countries. . venous thrombosis is a potentially serious complication after pth and ptg, justifying various prophylactic measures. in france, aggressive prophylaxis with low molecular weight heparin (lmwh) or direct oral anticoagulants (doa) was until recently recommended, because this drug is considered to be the most effective, at the cost of a bleeding risk implicitly assumed but often poorly. evaluated. a recent publication suggests that the risk of bleeding is currently greater than the risk of a thromboembolic event. more recently, foreign or international recommendations have broadened the range of these recommendations, notably by introducing aspirin as a possible prophylactic agent. while this molecule is potentially less effective than lmwhs or ados, it could decrease the risk of iatrogenic hemorrhage. the introduction of enhanced recovery procedures after surgery (raac) could decrease the risk of thrombosis without modifying the risk of bleeding, and thereby improve the cost-benefit ratio of aspirin, justifying its recent inclusion in the current french recommendations when the operated follows such a protocol.


Eligibility criteria:
inclusion criteria: * adult patient (≥ 18 years old); * patient operated on for a first-line total hip or knee replacement by the principal investigator; * patient not having expressed his opposition, after information, to the reuse of his data for the purposes of this research. exclusion criteria: - subject having expressed opposition to participating in the study

Keywords: hip prosthesis implantation knee prosthesis implantation aspirin thromboprophylaxis heparin prophylaxis thromboembolic complications bleeding complications
levetiracetam xr in very heavy drinkers

Conditions: Alcoholism

Summary: the primary objectives of this study are to assess the efficacy of levetiracetam xr in increasing the percentage of subjects with no heavy drinking days and in reducing the weekly percentage of heavy drinking days in subjects with alcohol dependence confirmed by dsm-iv criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks per drinking day for women (designated as "very heavy" drinkers).


Eligibility criteria:
inclusion criteria: 1. the subject must be at least 18 years of age. 2. the subject must have a dsm-iv diagnosis of current alcohol dependence. 3. the subject must be seeking treatment for alcohol dependence and desires a reduction or cessation of drinking. 4. the subject must be able to verbalize understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in english and able to complete the questionnaires required by the protocol. 5. if the subject is female and of child bearing potential, she must agree to use at least one of the following methods of birth control, or she must be surgically sterile or postmenopausal: * oral contraceptives * contraceptive sponge * patch * barrier (diaphragm or condom) * intrauterine contraceptive system * levonorgestrel implant * medroxyprogesterone acetate contraceptive injection * complete abstinence from sexual intercourse, and/or * hormonal vaginal contraceptive ring. 6. the subject must be able to take oral medication, willing to adhere to the medication regimen, and willing to return for regular visits. 7. the subject must complete all psychological assessments required at screening and baseline. 8. the subject must provide evidence of stable residence in the last 2 months prior to randomization, have reasonable transportation arrangements to the study site, and have no plans to move within the next 3 months or unresolved legal problems. subjects must provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment. 9. the subject must have a breath alcohol concentration (bac) equal to 0.000 when s/he signed the informed consent document.

Keywords: alcoholism alcohol drinking alcoholic intoxication alcohol abuse
etelcalcetide to treat secondary hyperparathyroidism in hemodialysis patients with chronic kidney disease-mineral and bone disorder

Conditions: Secondary Hyperparathyroidism

Summary: the purpose of this study is to evaluate the effect of thrice weekly intravenous (iv) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (shpt) in hemodialysis patients with chronic kidney disease-mineral and bone disorder (ckd-mbd).


Eligibility criteria:
inclusion criteria: * subjects provides written informed consent * screening intact pth (ipth) ≥ 350 pg/ml and corrected calcium ≥ 8.5 mg/dl * hemoglobin ≥ 8.5 g/dl * serum transaminases (alanine transaminase \[alt\], aspartate transaminase \[ast\]) less than 2.5 times the upper limit of normal * adequate hemodialysis three times per week exclusion criteria: * history or symptomatic ventricular dysrhythmias * history of angina pectoris or congestive heart failure * history of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months * history of or treatment for seizure disorder within the last 12 months * postdialysis systolic blood pressure \> 180 mmhg or diastolic blood pressure \> 90 mmhg * serum magnesium below the lower limit of normal at screening

Keywords: clinical trial, phase 2 renal dialysis secondary hyperparathyroidism chronic kidney disease-mineral and bone disorder parathyroid hormone
vibration impact on parkinson's tremor

Conditions: Parkinson Disease

Summary: the primary purpose of this study is to test the safety, tolerability and efficacy of vibration (delivered by an experimental device called rmband that is worn on the subject's arm) on parkinsonian tremor. the rmband was developed by resonate forward, llc (rf). this rmband is designed to administer a vibration to the wearer to decrease or stop tremor in persons with parkinson's disease (pd).

participation will be completed in one visit at vcu parkinson's and movement disorders center. a baseline movement disorder society unified parkinson disease rating scale (mds-updrs) will be taken prior to vibration therapy. the rmband (experimental device) will be placed on the arm of the participant to provide the vibration therapy. the mds-updrs part iii will be repeated both during and after the therapy. participants will be asked to provide feedback about the device, the therapy session and how they are feeling.

Eligibility criteria:
inclusion criteria: * parkinson's disease (pd) as diagnosed by a movement disorder specialist * tremor caused by their parkinson's disease * ability to provide informed consent exclusion criteria: * known diagnosis of parkinson plus syndrome * dementia * other known non-pd cause of tremor * other known non-pd cause of limb dysfunction * presence of implantable cardiac device, severe neuropathy or sensory loss that would prevent perception of vibration stimulus * non-english speaker * prisoners * pregnant women