Kornimate/medical-research-clean huggingface dataset:
predictive factors of good pulmonary penetration of antibiotics : antibiotics dosage in broncho-alveolar lavage

Conditions: Antibiotics; Pneumonia

Summary: respiratory infections are common and sometimes very severe. an insufficient dosage of the antibiotic could lead to a treatment failure a correct plasmatic antibiotic concentration is not a guarantee of a clinical success as it could not be a reflect of pulmonary concentration. the aim of this study is to determinate the predictive factors of pulmonary penetration of antibiotics in patients with a beta lactamines failure and who undergoes a flexible bronchoscopy.

to check if pulmonary concentrations of antibiotic are enough we will measure antibiotic concentration in the broncho-alveolar lavage (bal). this technique which is clinically relevant and reliable could determinate the pulmonary diffusion level for antibiotics by calculating the ratio between plasmatic and intra-alveolar antibiotic concentration. this ratio will be correlated with potential limitation factors of pulmonary diffusion as respiratory diseases (copd, cystic fibrosis, fibrosis...), sepsis, hypoalbuminemia. we have chosen to study the beta lactamin antibiotics because they are the most frequently used in pneumonia. moreover, the beta lactamins pulmonary diffusion is likely to be the lowest. finally, for patients with a known pathogen, we will divide this pulmonary concentration with minimal inhibitory concentration (mic). indeed, in severe pneumonia, to be sure of bactericidal activity, a pulmonary concentration of beta lactamines should be always higher than 4 to 5 times mic.

Eligibility criteria:
inclusion criteria: * patients who undergo a flexible bronchoscopic lavage and with a beta lactamines treatment as cephalosporin of 3rd generation (ceftriaxone / cefotaxime, ceftazidime), of 4th generation (cefepim), or amoxicillin-clavulanic acid, or piperacillin-tazobactam * patient major * informed and signed consent form exclusion criteria: * patient under chronic dialysis * patient placed under judicial protection

Keywords: antibiotics pneumonia broncho-alveolar lavage
experiences and needs of patients, their informal caregiver and healthcare professionals regarding lars

Conditions: Low Anterior Resection Syndrome; Rectal Cancer

Summary: exploration of the experiences and needs of patients with the low anterior resection syndrome, their informal caregiver and health care professionals. this is a qualitative study where semi-structured interviews will be conducted with patients and informal caregivers. next to that focus groups will be performed with healthcare professionals from different professions.


Eligibility criteria:
patients inclusion criteria: * adult patients (18+) * confronted with major low anterior resection syndrome after rectal cancer surgery exclusion criteria: * stoma at time interview * abdominal perineal resection informal caregivers inclusion criteria * adults (18+) * nominated by the participating patient as their principal caregiver exclusion criteria none healthcare professionals inclusion criteria * adults (18+) * caring for patients with lars exclusion criteria none

Keywords: low anterior resection syndrome
evaluation of safety, tolerability, and antiviral activity of ach-0143102 plus ribavirin in treatment-naive hepatitis c virus infection genotype 1b participants

Conditions: Chronic Hepatitis C Infection

Summary: the purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with ach-0143102 and ribavirin in genotype 1b (gt1b), treatment-naive, hepatitis c virus (hcv) participants.

a phase 1b, pilot study that evaluated the safety, tolerability, and antiviral activity of oral ach-0143102 administered in combination with ribavirin for 12 weeks in treatment-naive participants with chronic hcv gt1b.

Eligibility criteria:
inclusion criteria: * males and females aged 18 years and older. * clinical diagnosis of hepatitis c with gt1b. * chronic hepatitis c treatment-naive participants. * interleukin 28b genotype cc. * hcv ribonucleic acid \> 10,000 international units/milliliter at screening. * female participants must be willing to use 2 effective methods of contraception during the dosing period and for 6 months after the last dose of ribavirin. * male participants must be willing to use an effective barrier method of contraception throughout the dosing period and for 6 months after the last dose of ribavirin. male participants must agree not to donate sperm while enrolled in the study and for 6 months after the last dose of ribavirin. * willing to participate in all study activities and all study requirements. exclusion criteria: * body mass index \> 36 kilograms/meter squared. * pregnant or nursing females. * clinically significant laboratory abnormalities at screening. * previous participation in a clinical trial with protease inhibitor and/or non-structural protein 5a inhibitor. * human immunodeficiency virus infection or other liver diseases. * positive hepatitis b surface antigen. * liver cirrhosis. * uncontrolled psychiatric disease. * clinical evidence of chronic cardiac disease. * history of malignancy of any organ system within 5 years.
a study evaluating glycosphingolipid clearance in patients treated with agalsidase alfa who switch to agalsidase beta

Conditions: Fabry Disease

Summary: this is an exploratory study to evaluate changes in glycosphingolipid levels and other (exploratory) fabry disease parameters in male fabry disease participants who were previously treated with agalsidase alfa (replagal®) 0.2 milligram per kilogram (mg/kg) every two weeks (q2w) and who are being switched to agalsidase beta (fabrazyme®) 1.0 mg/kg q2w.


Eligibility criteria:
inclusion criteria: * the participant and/or his parent/legal guardian is willing and able to provide signed informed consent, and the participant, if less than (\<) 18 years of age, is willing to provide assent if deemed able to do so * participant is male and has been treated with agalsidase alfa at 0.2 mg/kg q2w for the 12 months prior to switching to agalsidase beta * the participant has a confirmed diagnosis of fabry disease by alfa-galactosidase a (alfa-gal) activity and/or genotyping per local standards * the participant when switched to agalsidase beta receives the labeled dose, that is, 0.9 to 1.1 mg/kg (1 mg/kg) q2w, and must be willing to maintain the labeled dose for the duration of the study exclusion criteria: * the participant is on dialysis or is post renal transplantation * the participant is in end-stage cardiac failure * the participant and/or his parent or legal guardian, in the opinion of the investigator, is unable to adhere to the requirements of the study * the participant has been switched from agalsidase alfa to agalsidase beta and does not have historical blood and urine samples

Keywords: alpha-galactosidase a a-gal fabry gl-3 fabrazyme
stemi and incretins treatment

Conditions: STEMI; Coronary Artery Disease; Coronary Syndrome; Coronary Arteriosclerosis; Diabetes

Summary: st elevation myocardial infarction (stemi) patients affected by multivessels coronary artery stenosis, represent a clinical relevant problem. the management and prognosis of these patents are supported by few literature data. therefore, in this study authors enrolled real world diabetic vs. non diabetic patients admitted for stemi and associated to multi vessels coronary disease. then these diabetics were divided in incretin users (6 months of incretin treatment before study enrollment) vs. never incretin users. in these patients authors studied all cause mortality, cardiac mortality, and major adverse cardiac events at 12 months follow up.

st elevation myocardial infarction (stemi) patients affected by multivessels coronary artery stenosis represent a class of patients really challenging to treat. in fact, treatment, clinical management, and prognosis are supported by few literature data. therefore, in this study authors enrolled real world patients admitted for stemi and associated to multi vessels coronary disease. multivessels (mv) coronary stenosis were characterized by non obstructive coronary stenosis (nocs) as coronary lesions \ 0.8. therefore, stemi was treated by percutaneous coronary intervention by primary angioplasty and direct stenting (des stenting) of culprit vessel lesion. then these stemi-mv-nocs patients were divided in diabetics vs. non diabetics, and received conventional full medical therapy for stemi. then these diabetics were divided in incretin users (6 months of incretin treatment before study enrollment) vs. never incretin users. study outcomes were all cause mortality, cardiac mortality, and major adverse cardiac events at 12 months follow up. authors studied these study outcomes comparing diabetics vs. non diabetics at 12 moths follow up, and diabetics incretin-users vs. never-incretin-users.

Eligibility criteria:
inclusion criteria: aged \>18, first stemi, stemi with multi vessels coronary stenosis. exclusion criteria: aged \< 18, renal impairment, mono vessel stemi, severe depression of left ventricle ejection fraction (lvef \<35%).
nasal bridge pressure injury prevention

Conditions: Pressure Ulcer of Skin; Pressure Injury

Summary: the primary goal of this study is to explore whether applying the mepilex foam on the nasal bridge directly between the skin and the n95 mask will prevent nasal bridge pressure injury among nursing staff, secondary to long-term ( \>8+ hours) wear time. the secondary goal is to evaluate if using the mepilex maintains the seal of the mask.

nurses use the n95 mask as part of the personal protective equipment (ppe) when caring for patients with covid-19. the n95 mask covers their nose and mouth with a tight seal. nurses wear the mask for more than 8 hours per day, as a result they are at increased risk for skin injury on the nasal bridge. mepliex is foam dressing which has been used to prevent pressure injuries to the skin. this study will evaluate if using mepilex or band-aid on the nasal bridge of the nurses who wear the n95 for more than 8 hours decreases the potential for skin injury. in addition, the investigators will test if the mepilex or band-aid also maintains the seal of the mask. maintaining the seal is important to ensure that the nurse is not exposed to the virus. the investigators will be working with nurses who do not directly take care of covid-19 patients to ensure the safety of all participants.

Eligibility criteria:
inclusion criteria: * the sample will consist of nursing staff working on non-covid units, including: medical surgical units, operating rooms or ambulatory care- labor and delivery unit, maternity unit and medical oncology unit, at newyork-presbyterian (nyp) lawrence hospital. exclusion criteria: * exclusion criteria: a score on \> 5 the covid anxiety scale. the scale has 4 questions with 5 possible options (rated 1 - 5), to evaluate the effect of covid19 on the individual. the lowest possible score is 0, the highest possible score is 20. a score of 5 states that the individual experiences covid19 related anxiety for 'rarely' or 'not at all". excluding participants with a score of \> 5 will prevent unnecessary harm to study participants or exacerbate symptoms of anxiety. * nurses working in the emergency department, intensive care unit or a unit with a focus on the exposed covid-19 population * non-clinical nurses, volunteer or agency registered nurses * known history of skin breakdown or damage to the nasal bridge * history of skin-related conditions including (acne vulgaris, psoriasis, herpetic lesions to mouth, nasal areas) * history of surgery to nasal bridge * pregnant nurses in their third trimester * history of respiratory extended respirator use in addition to the hours collected in this study.

Keywords: pressure injury prevention personal protective equipment nursing nasal bridge n-95 mask
3d imaging: prognostic role in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: pulmonary hypertension is a rare and severe disease, affecting a young population. survival is very poor and has been closely related to right ventricular dysfunction. current prognostic equations rely mostly on right heart catheterization data. the identification of simple echocardiographic prognostic factor is urgently needed. it could help identifying with a non invasive method, high risk patients who could benefit from an intensive specific therapy. 3d right ventricular imaging is a new echocardiographic tool which provides rv volumic analysis, rv ejection fraction, overcoming the classical limits of 2d ultrasound. the aim of this study is to validate a new software for 3d analysis of the right ventricle and assess its prognostic role in pulmonary hypertension. to do so, the investigators will realize a prospective monocentric longitudinal cohort study, including 100 pulmonary hypertension patients. echocardiographic data will be collected at baseline and after 6 months.


Eligibility criteria:
inclusion criteria: * patients \> 18 years old * pulmonary hypertension diagnosed by right heart catheterization * informed consent obtained * affiliation to the french national health insurance exclusion criteria: * associated significant left heart disease * sub-optimal acoustic windows * patient unable to attend follow-up visits
ppi for prevention of post-sphincterotomy bleeding

Conditions: Bleeding; ERCP

Summary: endoscopic biliary sphincterotomy is a common and important procedure for biliary access and therapy during endoscopic retrograde cholangiopancreatography (ercp). bleeding is one of the important complications related to sphincterotomy. this study determines the role of proton pump inhibitor (ppi) in preventing post-sphincterotomy bleeding in patients undergoing ercp and sphincterotomy.

eligible patients will be randomized to receive either high dose ppi or standard care. ppi will be given before ercp and continue for one week after the sphincterotomy. both overt and occult bleeding will be documented up to 10 days after the sphincterotomy. bleeding rates of the two groups will be compared.

Eligibility criteria:
inclusion criteria: * consecutive patients undergoing ercp who will require sphincterotomy exclusion criteria: * previous sphincterotomy/papillotomy * previous polya gastrectomy * patients on maintenance ppi * pregnant and lactating women * age \<18 years * previous liver transplant * unable to consent for study

Keywords: ercp sphincterotomy proton pump inhibitor
epidural-inhalational versus epidural-intravenous anaesthesia on anti-tumor immunity in patients with cancer colon

Conditions: Immunity Factors in Cancer Colon Patients

Summary: surgery is the primary treatment for colon cancer. however, the rate of recurrence or metastasis in colon cancer can be as high as 30%, even in stages 1 and 2 . most colon cancer-related deaths are caused by metastatic disease . many patients with colon cancer harbour micrometastases and disseminated tumour cells at the time of surgery . whether the micrometastases develop into clinically significant metastases depends on the immune system's ability to eradicate them.the aim of the study is to declare the effect of epidural-intravenous based anesthetic technique on anti-tumor immunity and in comparison to epidural inhalational based anesthetic technique in patients undergoing open surgical resection of colon cancer.


Eligibility criteria:
inclusion criteria: * age 20-70 yrs. * asa class i and ii * elective open surgery for non-metastatic cancer colon stage i,ii exclusion criteria: * patient refusal * known allergy to the study medications * patients with compromised immune function ( associated blood diseases, immunosuppressive drugs, chemotherapeutic agents, corticosteroids) * contraindications to epidural insertion e.g. infection at insertion site and coagulopathy
studying lipids as potential biomarkers in patients with fabry disease

Conditions: Fabry Disease

Summary: compare levels of lipids between well characterised enzymatically-genetically-phenotypically patients with fabry disease and healthy controls (with no fabry disease). correlate levels of lipids in patients with fabry disease to clinical outcomes/manifestations of the disease.

the hypothesis is that sphingosine-1 phosphate (s1p) or any other related sphingoid bases and/or other lipid class could be a marker of the severity of cardiovascular remodelling in fabry disease. the overall approach is, by minimising possible pre-analytical and analytical biases, to study by lipidomics in well characterised enzymatically, genetically and phenotypically patients with fabry disease, if s1p or any other lipid (including other glycosphingolipids) is shown to be a biomarker for the diagnosis, monitoring of disease activity and prognosis (including cardiovascular outcomes).

Eligibility criteria:
inclusion criteria for cases: * adult men and women * well characterized fabry disease in terms of i. alpha-gal a enzyme activity, ii. mutation in alpha-gal a (gla) gene, and iii. disease manifestations * followed at one of the 3 centers for patients with fabry disease in sweden (karolinska in stockholm, sahlgrenska in gothenburg, akademiska in uppsala) signed informed consent prior to sample collection is mandatory for inclusion to the study. inclusion criteria for controls: * adult men and women * followed/treated at the endocrinology or nephrology in- or out-patient clinic at sahlgrenska university hospital in gothenburg * matched for age, sex, estimated glomerular filtration rate (egfr) with the cases with fabry disease exclusion criteria for controls: * fabry disease * liver disease with elevated transaminases * ongoing infection

Keywords: biomarkers fabry disease lipidomics
study on surgical treatment strategies for moderate ischemic mitral regurgitation

Conditions: Mitral Valve Insufficiency; Mitral Valve Annuloplasty; Coronary Artery Bypass

Summary: this study aimed to compare the efficacy of isolated coronary artery bypass grafting and coronary artery bypass grafting + mitral valve repair in moderate ischemic mitral regurgitation patients through a cohort and explore the potential risk factors of the clinical outcomes.


Eligibility criteria:
inclusion criteria: 1. adult coronary artery disease patients complicated with moderate ischemic mitral regurgitation. 2. undergoing coronary artery bypass grafting with or without mitral valve repair. exclusion criteria: 1. patients under the age of 18 years, 2. patients complicated with more than moderate ischemic mitral regurgitation or undergoing mitral valve replacement, 3. patients complicated with primary mitral valve disease other than ischemic mitral regurgitation, such as rheumatic mitral regurgitation or mitral valve leaflet prolapse, 4. patients undergoing concomitant aortic valve procedure.
bioequivalence study of zonisamide capsules 100 mg of dr.reddy's laboratories limited under fed conditions

Conditions: Healthy

Summary: the objective of this study was to compare the rate and extent of absorption of dr. reddy's zonisamide 100 mg capsule to that of zonegran® 100 mg capsule after a single, one-capsule dose in subjects fed a high standard fat meal.

this was an open label, randomized, balanced, single dose, two-period, two-treatment, two-sequence crossover study, performed under fed conditions. subjects were confined to the sfbc clinical research facility from at least 10 hours prior to drug administration, until after the 24-hour post-dose blood draw, in each period. the treatment phases were separated by a washout period of 28 days.

Eligibility criteria:
inclusion criteria: * is the individual a healthy, normal adult man or non-child bearing potential woman who volunteers to participate? * is s/he at least 18 years of age? * is his/her bmi between 19 and 30, inclusive? * is s/he considered reliable and capable of understanding his/her responsibility and role in the study? * has s/he provided written informed consent? exclusion criteria: * does the individual have a history of allergy or hypersensitivity to zonisamide or sulfonamides? * does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? * does s/he have serious psychological illness? * does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? * does s/he have a positive urine drug screen, or a positive hiv-1, or hepatitis b or c screen, or a positive pregnancy test? * has s/he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation? * is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken? * has s/he used any prescription drug during the 14-day period prior to study initiation, or any otc drug during the 72-hour period preceding study initiation? * is s/he unable to refrain from the use of all concomitant medications during the study? * has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 ml or more), during the six week period preceding study initiation? * has s/he donated plasma during the two week period preceding study initiation? * has s/he received an investigational drug during the 30 day period preceding study initiation?