Kornimate/medical-research-clean huggingface dataset:
a study of azithromycin in the prevention of mycobacterium avium complex disease (mac) in hiv-infected patients

Conditions: Mycobacterium Avium-Intracellulare Infection; HIV Infections

Summary: to evaluate the efficacy and safety of azithromycin administered once a week in the prevention of disseminated mycobacterium avium complex (mac) in severely immunocompromised hiv-infected patients with a cd4 count \< 100 cells/mm3.


Eligibility criteria:
inclusion criteria concurrent medication: required: * anti-pneumocystis prophylactic therapy (dihydropteroate synthetase inhibitors with or without dihydrofolate reductase inhibitors, pentamidine). allowed: * concomitant anti-hiv therapy (azt, ddi, ddc) or antifungal therapy (including azoles). patients must have: * hiv infection. * cd4 count \< 100 cells/mm3. * no mac positive blood cultures within 1 month prior to study entry. * no symptoms suggestive of disseminated mac infection (including unexplained diarrhea, fever, and night sweats) within 1 month of study entry. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * positive ppd within 3 months prior to study entry (negative ppd defined as \< 5 mm induration). * chest x-ray suggestive of any active disease, in particular tuberculosis. * known hypersensitivity to macrolide antibiotics. * any other acute clinical condition likely to interfere with completion of the protocol. * inability to care for self without considerable assistance and medical care. concurrent medication: excluded: * other investigational new drugs (except for foscarnet or ddc) unless prior agreement has been reached between the investigator and the pfizer project physician. * concomitant putative immunostimulants. patients with the following prior conditions are excluded: history of mac or mycobacterium tuberculosis (mtb) infection. prior medication: excluded within the past 4 weeks: * any putative anti-mac therapies including rifampin, rifabutin, clofazimine, ethambutol, cycloserine, ethionamide, amikacin, and ciprofloxacin or other quinolones thought to be active against mac.

Keywords: mycobacterium avium-intracellulare infection acquired immunodeficiency syndrome aids-related complex azithromycin
to validate an analytical method to measure concentration of tacrolimus in blood taken from finger pricks

Conditions: Validation; Dried Blood Spot; Transplant Patients

Summary: the principal aim of this study is to define the relationship between tacrolimus concentrations determined from the finger prick dbs (dry blood spot) method and those determined from blood samples collected by venepuncture in transplant recipients.

this will be a bioanalytical assay method cross-validation study using blood samples donated by up to 100 liver and 100 kidney transplant patients. subjects who will be attending a routine outpatient follow-up visit will be asked to provide 3 whole blood venepuncture samples (each sample = 3 ml blood) and 3 finger prick dbs blood samples at predose and at 1 and 3 hours postdose. all subjects will be discharged from the study and clinical site at 3 hours postdose. subjects will derive no benefit from the blood collection procedures and will be paid a predetermined stipend for participating in the study.

Eligibility criteria:
inclusion criteria: * stable adult transplant recipients aged ≥ 18 years maintained on a once daily advagraf® based immunosuppressive regimen for the prophylaxis of kidney or liver allograft rejection. exclusion criteria: * subjects who are still participating in another clinical study (e.g. attending follow up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months.

Keywords: dry blood spot (dbs) validation tacrolimus bioanalytical assay method cross-validation
the efficacy of a new crosslinked hyaluronan gel in prevention of intrauterine adhesion

Conditions: Intrauterine Adhesion

Summary: using american fertility society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in women without previous dilatation and curettage was examined.

study objectives: to evaluate the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesions formation after dilatation and curettage. design: randomized controlled trial. settings: six hospitals for maternal and child health care in china. patients: three hundred women undergoing dilatation and curettage for delayed miscarriage without previous dilatation and curettage. interventions: women were randomly assigned into either dilatation and curettage alone group or dilatation and curettage plus new crosslinked hyaluronan gel application group with 1:1 allocation. measurements and outcomes: all patients were evaluated using american fertility society classification of iuas during the follow-up diagnostic hysteroscopy, scheduled 3 months after dilatation and curettage procedure. the primary outcome was the number of women with iuas, and the secondary outcome was the adhesion scores and the severity of iuas.

Eligibility criteria:
the inclusion criteria: * patients to be female, aged 18-45 years * without previous dilatation and curettage * undergoing dilatation and curettage for the current delayed miscarriage * all participants should be with normal liver/rental function and without systemic disease * agree to use adequate forms of contraception throughout the study * be in good compliance with the follow-up examination according to the study protocol. the exclusion criteria: * known/suspected intolerance or hypersensitivity to hyaluronan or its derivatives * genital tract malformation * inflammation of genital tract or pelvic cavity, clinical evidence of cancer in genital tract * suspected genital tuberculosis * abnormal blood coagulation * medical histories of peripheral vascular disease, alcohol/drug abuse, and mental illness * acute or severe infection * autoimmune diseases.

Keywords: intrauterine adhesion delayed miscarriage hyaluronan gel
adjunctive therapeutic treatment with human monoclonal antibody ar-105 (aerucin®) in p. aeruginosa pneumonia

Conditions: Pseudomonas Aeruginosa Pneumonia

Summary: prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic of aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia caused by p. aeruginosa.

this is a double-blind, randomized, placebo-controlled study of the human monoclonal antibody (mab) ar-105 for the adjunctive therapeutic treatment of p. aeruginosa pneumonia in mechanically ventilated subjects. subjects who are randomized will be treated with either standard of care (soc) antibiotics plus placebo or soc antibiotics plus ar-105. the study is being conducted at approximately 100 clinical sites across 17 countries. subjects who meet all of the inclusion criteria and none of the exclusion criteria are screened by the microbiological culture test and/or rapid diagnostic test of an endotracheal aspirate to confirm the presence of an active p. aeruginosa infection. following eligibility confirmation, the subject will be randomized in a 1:1 ratio to one of two treatment groups.

Eligibility criteria:
inclusion criteria: * informed consent * ≥18 years of age, ≥ 20 years of age (taiwan only),≥ 19 (s. korea only) * pneumonia due to p. aeruginosa * mechanically-ventilated * intubated * apache ii score between 10 and 35 exclusion criteria (main criteria): * being moribund * effective antibiotic therapy ≥48 hours * immunocompromised * underlying pulmonary disease that may preclude the assessment of a therapeutic response

Keywords: pseudomonas aeruginosa pneumonia
natives engaged in alzheimers research - 'ike kupuna

Conditions: Mild Cognitive Impairment; Subjective Cognitive Impairment

Summary: this study will conduct a group randomized trial to test the effects of a hula-based intervention in improving vascular risk factors for adrd and cognitive complaints and function over 12 months.

this study will conduct a pragmatic group-randomized trial (grt) with nhpis aged 50-75 years with at least 1 of 4 modifiable vascular risk factors for adrd (hypertension, hyperglycemia, obesity, or dyslipidemia) and either sci or mci using a wait-list control design to test the effects of the hula-based intervention. the primary outcomes will be vascular risk factors for adrd and subjective cognitive complaints. secondary outcomes will include measures of cognitive performance, physical function, and mental health.

Eligibility criteria:
inclusion criteria: 1. self-reported native hawaiian or other pacific islander ancestry; 2. ages 50+ but not older than 75 (optimal age range for preventing future dementia in people with cognitive impairment, above 75 is not likely to benefit from this study given their advance age); 3. has subjective cognitive impairment (sci) or mild cognitive impairment (mci); 4. have a diagnosis of hypertension, diabetes, dyslipidemia, or obesity (body-mass-index ≥ 30 kg/m2); 5. physically able and willing to engage in moderate physical activity necessary for hula; and 6. physician's approval to participate in moderate physical activity exclusion criteria: 1. currently pregnant; 2. already actively practicing hula at least once per week; or 3. clinical diagnosis of adrd (mild to severe); or 4. current diagnosed major depressive disorder at moderate or greater stage, or moderate or greater depression on the center for epidemiological studies depression scale (ces-d).

Keywords: mci alzheimer's disease alzheimer's disease and related dementias vascular dementia adrd sci native hawaiian and pacific islander nhpi hula cultural based intervention behavioral intervention
non-alcoholic fatty liver disease and its treatment

Conditions: NAFLD

Summary: dipeptidyl peptidase-4 inhibitors (dpp-4i), key regulators of the actions of incretin hormones, exert anti-hyperglycemic effects in type 2 diabetes mellitus (t2dm) patients. a major unanswered question concerns the potential ability of dpp-4i to improve intrahepatic lipid (ihl) content in nonalcoholic fatty liver disease (nafld) patients. the aim of this study was to evaluate the effects of sitagliptin on ihl in nafld patients.

a prospective, 24-week, single-center, open-label, comparative study enrolled 68 chinese nafld patients with t2dm. subjects were randomly divided into 4 groups: control group who did not take medicine (14 patients); sitagliptin group who received sitagliptin treatment (100mg per day) (17 patients); metformin group who received metformin (500mg three times per day) (17 patients); and sitagliptin plus metformin group who received sitagliptin (100mg per day) and metformin (500 mg three times per day) (20 patients). ihl, physical examination (waist circumstances, wc; body mass index, bmi), glucose-lipid metabolism (fasting plasma glucose, fpg; hemoglobin a1c, hb1a1c; triglycerides; cholesterol; alanine aminotransferase, alt; aspartate aminotransferase, ast) were measured at baseline and at 24 weeks.

Eligibility criteria:
inclusion criteria: * age 30-70 years old * fulfillment of the diagnostic criteria for t2dm by who in 1999 (hba1c ranged from 7% to 10%, fpg \< 11 mol/l, 2-hour blood glucose postprandial \< 20mmol/l) * fulfillment of the diagnostic criteria for nafld according to the guidelines of the chinese medical association in 2010. the ihl content was measured by using 1h-magnetic resonance spectroscopy (1h-mrs) quantitative detection, and the liver fat content of the enrolled subjects was more than 5.5%. the subjects included in this study had either no history of alcohol consumption or their alcohol intake was less than 70 g/week in males and less than 140 g/week in females. liver transaminase and serum creatinine were less than two times the upper limit of normal exclusion criteria: * t2dm complicated with ketoacidosis, hyperosmolarity, acute and chronic infection ● serious heart, liver, kidney, lung disease, and liver damage * alcoholic fatty liver * drug use that influences glucose metabolism such as thiazide diuretics and hormones within three months * hypertension ≥ 180/110 mmhg * gastrointestinal disease or absorption dysfunction * recent trauma, surgery, or other conditions resulting in an increased stress response within the past three months.
effects of ginger supplementation on nf-kb in peripheral blood mononuclear cells in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this study evaluates the effect of ginger on nf-kb level in peripheral blood mononuclear cells in type 2 diabetic patients. half of patients will receive ginger, while the other half will receive placebo.

ginger is a plant with lots of phytochemicals which have antioxidant effects. it reduces the nf-kb levels in the cells because of its antioxidant effects. it can reduces insulin resistance as a result of nf-kb reduction in diabetes.

Eligibility criteria:
inclusion criteria: * type 2 of diabetes diagnosed for 1 to 10 years * age 30-60 years * bmi = 18.5-35 kg/m\*m * treatment with metformin or glibenclamide exclusion criteria: * treatment with insulin * weight loss more than 10% in 6 months * treatment with tzds (thiazolidinediones) * pregnancy and breast feeding * smoking and alcohol consumption * multivitamin-mineral and polyphenols and omega-3 and 6 supplementation in the last 3 months and during study * ginger supplementation and herbal medicines * anticoagulation consumption such as heparin and warfarin * nsaids such as diclofenac and salicylate drugs such as aspirin, corticosteroids such as prednisone consumption during 1 month ago and during the study * infectious and inflammatory diseases such as rheumatoid arthritis * impaired hepatic, renal and gastrointestinal function * cancer * currently suffering from acute illness that needs medical treatment

Keywords: nf-κb ginger
comparison between standard and ultrasound integrated approach for risk stratification of syncope in the emergency department

Conditions: Syncope

Summary: this is a observational prospective study. for patients presenting to the emergency department with loss of consciousness, emergency physicians will be asked to screen the real syncope without an evident and immediate cause for the loss of consciousness (e.g. vasovagal) and/or at least one high risk condition as listed by the european society of cardiology in the 2009 guidelines for the diagnosis and management of syncope (i.e. severe structural or coronary artery disease, clinical or ecg features suggesting arrhythmic syncope, and important co-morbidities). in case of a real syncope not clearly physiopathologically explained and no high risk conditions, the emergency physician in charge will check risk factors for high risk syncope and categorize again every cases. a high risk syncope is characterized by at least one high-risk characteristic (based on 2015 "syncope clinical management in the emergency department consensus"): syncope during exertion, in supine position, with new onset of chest discomfort, palpitations before the loss of consciousness, family history of sudden death, congestive heart failure, aortic stenosis, left ventricular outflow tract disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, left ventricular ejection fraction \ 450 ms). low and intermediate risk syncopes will be enrolled and evaluated using an integrated point-of-care sonographic approach (based on history, physical exam, electrocardiogram, and lung, focus cardiac and venous compression ultrasonography). after discharge, the risk of patient's syncope will be determined by reviewing the entire medical records.


Eligibility criteria:
inclusion criteria: * patients evaluated in the emergency department for loss of consciousness exclusion criteria: * identification of cause of loss of consciousness after initial evaluation; * loss of consciousness classified as high risk syncope.

Keywords: syncope point-of-care ultrasound
pivotal study of the fred stent system in the treatment of intracranial aneurysms

Conditions: Intracranial Aneurysms

Summary: the purpose of this study is to evaluate the safety and effectiveness of the microvention flow redirection intraluminal device (fred) system when used in the treatment of wide-necked intracranial aneurysms.


Eligibility criteria:
inclusion criteria: * participant whose age ≥ 22 and ≤75 years * participant has single target aneurysm located in the internal carotid artery * participant sign and date an irb/ec approved informed consent prior initiation of any study procedures exclusion criteria: * participant who suffers from an intracranial hemorrhage in the last 30 days * participant who suffers from a subarachnoid hemorrhage in the last 60 days * participant with symptomatic extracranial mass or currently undergoing radiation therapy for tumor of the head and neck region * participant who is pregnant or breastfeeding * participant has an arteriovenous malformation (avm) in the area of the target aneurysm
outcomes of the nanoscopic partial meniscectomy versus standard arthroscopic partial meniscectomy

Conditions: Meniscus Tear

Summary: standard arthroscopy has been the gold standard for treatment of meniscus tears since the 1980's. the purpose of this study is to analyze the clinical outcomes of using the smaller diameter nanoscope for partial menisectomy. the authors hypothesize that the nanoscopic partial menisectomy patients will have less pain and return function faster than standard arthroscopy.


Eligibility criteria:
inclusion criteria: * mri positive for meniscus tear * more than 3mm of joint space on pa flexion weightbearing x rays * primary arthroscopy exclusion criteria: * workers compensation * older than 60 years of age * revision surgeries

Keywords: arthroscopy meniscus meniscectomy nanoscopic
efficacy and safety of topical bromfenac ophthalmic solution vs. placebo in subjects with allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: the primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment in subjects with a history of allergic conjunctivitis


Eligibility criteria:
inclusion criteria: * history of clinically active allergic conjunctivitis * agree to return for all required visits * agree to avoid disallowed meds exclusion criteria: * known hypersensitivity to bromfenac and salicylates
oncologist-initiated cancer genetic testing for pancreatic cancer patients

Conditions: Pancreatic Cancer

Summary: pancreatic cancer (pc) has a dismal prognosis. approximately 10% of pc patients carry a germline pathogenic variant in a cancer susceptibility gene, whose identification can lead to better treatments for the patient and participation in cancer prevention programs for their family members. conventional genetic testing for pc patients is based on the family history of cancer, and may take up to six months from the point of meeting with the treating physician to receiving the results from a genetic counsellor. the median overall survival for these patients is 6 - 12 months, which may prevent them from having the genetic testing in the first place, or from receiving further targeted treatments. patients with pc need a more comprehensive knowledge of their disease for better treatment planning. this includes genetic testing in absence of family history of cancer. the investigators designed a one year study to assess the feasibility of medical oncologist initiated cancer genetic testing for all newly diagnosed pc patients unselected by family history. for patients with negative genetic testing, no further testing will be ordered after the disclosure of results. patients with positive genetic testing results will be informed and referred to cancer genetics clinic. the investigators expect to enroll 100 patients in 1 year. patients will be asked to complete satisfaction questionnaires according to the satisfaction with genetic counseling scale in multiple time points (pre-testing, post-testing, at 6 months and at 12 months). designated oncologists will be asked to evaluate the process using the oncologist satisfaction survey after every five counseled patients. three primary objectives will include 1) assessment of the turnaround time for genetic testing results; 2) assessment of patient satisfaction; 3) assessment of oncologist's satisfaction. secondary objectives will include assessment of association between genetic testing results and types of treatment and overall survival.


Eligibility criteria:
inclusion criteria: * • newly diagnosed exocrine pancreatic cancer * patient consents to blood draw and genetic testing * treating oncologist at odette cancer centre * no conditions that would prevent patients from completing the study-related questionnaires or understanding the consent process * valid phone number * email address to send link to online family history questionnaire * treating physician agrees to complete the referrals exclusion criteria: * patient declines genetic testing * blood transfusion within the past month * allogenic bone marrow transplantation * history of comprehensive panel genetic testing
detection of bladder tumors after 30 min instillation of hexvix

Conditions: Bladder Cancer

Summary: the objective of the study is to compare hexvix® flexible cystoscopy and white light flexible cystoscopy in the detection of histological confirmed bladder tumor lesions defined as dysplasia; cis; ta; t1; and ≥ t2 after 30 minutes intravesical instillation of hexvix®.

this study is an open, prospective, within patient, controlled, multi-center, phase iia study in patients with bladder cancer. the bladder of all patients will be instilled with 50 ml hexvix® 8 mm solution and evacuated after 30 minutes. after bladder evacuation, the bladder will be examined under white light cystoscopy using the karl storz flexible videocystoscope. tumors visible under white light will be mapped. then the bladder is evaluated with blue light and lesions seen by blue light will be mapped. biopsies of all visible tumors will be taken using both white and blue light prior to resection of all lesions.

Eligibility criteria:
inclusion criteria: the patients should be indicated for a transurethral resection of the bladder (turb) based on an outpatient cystoscopy and fulfil the following inclusion criteria: * patients with multiple bladder tumors, defined as ≥2 lesions, based on an outpatient cystoscopy. * patients with known urinary urge symptoms or patients who have problems or pain holding back the urine for a time longer than 30 minutes. * age 18 years or above exclusion criteria: * patients with known tumors in the prostatic urethra or distal urethra * gross haematuria. (note: gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy). * patient with porphyria. * hypersensitivity to the active substance or to any of the excipients of the solvent * participation in other clinical studies with investigational drugs either concurrently or within the last 30 days. * women of child-bearing potential meaning that only post-menopausal women, women who had their ovaries removed, and women who are otherwise physically unable to bear children can be included. * patients who have received bcg or chemotherapy within three months prior to study inclusion. * conditions associated with a risk of poor protocol compliance. * patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol * mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the clinical study. * patients unlikely to comply with protocol

Keywords: hexvix bladder cancer cystoscopy patients with known or suspicion of bladder cancer