Kornimate/medical-research-clean huggingface dataset:
pulmonary diffusion of antibiotics in patients admitted for ards following sars-cov-2 pneumonia

Conditions: ARDS; SARS-CoV 2 Pneumonia

Summary: patients on mechanical ventilation (mv) following sars-cov-2 pneumonia frequently develop ventilator-associated pneumonia (vap). the incidence of mvap during sars-cov-2 infections ranges from 50 to nearly 90%. in addition, up to 80% of recurrences of vap (a new episode, most often attributable to the same bacteria) have been described, reflecting the failure of the initial antibiotic therapy. this incidence is much higher than that described for other etiologies of acute respiratory distress syndrome (ards). the investigators hypothesize that during vap, there is an alteration of the diffusion of intravenous antibiotics in the lung parenchyma in covid-19 patients in relation to several factors characteristic of sars-cov-2 infection. this altered diffusion may explain the high number of recurrences of mvap compared to non-covid-19 patients.


Eligibility criteria:
inclusion criteria: * 1. patient over 18 years of age 2. patient has given consent or consent obtained from the trusted person if the patient is not capable of consenting, after informed consent. 3. patient with ards 4. patient requiring mv for ards (as defined by berlin (15)), regardless of etiology (covid-19 or other cause of ards) 5. patient with suspected 1st episode of ards for which microbiological sampling is performed (bronchial aspiration, protected distal sampling (pds), bronchoalveolar lavage (bal)) 6. patients who have received probabilistic antibiotic therapy within 24 hours of the microbiological sample, including piperacillin-tazobactam (pip-taz) administered according to current recommendations. 7. patient who is a beneficiary of or affiliated to a social security system exclusion criteria: 1. patients for whom pip-taz is administered as a discontinuous infusion. 2. contraindication to the realization of a mini-lba: patient whose respiratory state is too precarious for the realization of a mini-lba for intra pulmonary antibiotics dosage (spo2\<94% under fio2 100% under vm), presence of a non drained pneumothorax, bronchial prosthesis, recent bronchial suture 3. patient with a second episode of pavm. 4. patients with kdigo stage ≥ 3 renal failure or extra-renal replacement therapy (creatinine measurement on the day of inclusion, performed as part of routine care). 5. patient on extracorporeal membrane oxygenation (ecmo) or extracorporeal co2 removal (ecco2r). 6. pregnant or breastfeeding women, patients under guardianship or trusteeship, deprived of liberty 7. patients who are moribund or for whom limitations of active therapies have been decided. 8. any condition, which in the opinion of the investigator, would not allow the implementation of the study procedures.

Keywords: mechanical ventilation antibiotics diffusion ards sars-cov 2
distribution of cyp2d6 multiplication, cyp2d6*5, and clinical implications in postoperative patients receiving tramadol analgesia in the minangkabau ethnic group, indonesia

Conditions: Post Operative Analgesia; Tramadol

Summary: cytochrome p450 2d6 (cyp2d6) is an important enzyme in metabolizing commonly used drugs such as tramadol hydrochloride (widely used opioid analgesic). genetic polymorphisms of the cyp2d6 gene have been shown to influence the pharmacodynamic properties of the administered drug. this study aimed to screen 63 postoperative patients (wild-type, cyp2d6\*5, and cyp2d6 multiplication) of minangkabau ethnicity in west sumatera, indonesia, who received tramadol using a modified long pcr method and to investigate the clinical impact of tramadol on the patients.

vas of 63 patients was determined by injecting tramadol at a dose of 100 mg 30 minutes before the operation was completed. it was observed in the recovery room at 30, 60, and 120 minutes. tramadol had an onset time of 15-60 minutes, with peak effectiveness at 2-6 hours postoperatively. pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).

Eligibility criteria:
inclusion criteria: * post operative patients who get analgesic tramadol exclusion criteria: * no exclusion criteria

Keywords: tramadol post operative minangkabau
covid-19 - multicenter study on nosocomial transmission of sars-cov-2 virus

Conditions: Infection Viral

Summary: infection with the sars-cov-2 coronavirus strain is associated with severe morbidity and mortality estimated today from 2% to 4%. elderly patients or patients with serious chronic conditions justifying hospitalization are particularly at risk. the risk of infection with sars-cov-2 during hospitalization is also substantial and increased in fragile patients. several cases of infection among healthcare professionals had been reported. the hypothesis is that similar to the corona virus agent responsible for sras and the influenza virus, nosocomial outbreaks of sars-cov-2 to be feared. health care professionals and caregivers are populations-at-risk as they are exposed in the community and can transmit sars-cov-2 to hospitalized patients, and are also exposed to hospitalized patients infected with sars-cov-2. describing hospital-acquired cases and sars-cov-2 infection transmission chains in healthcare settings is vitally essential to achieve control of this epidemic. to improve the quality of care and patient safety, this data must be accompanied by an analysis of the impact of infection control measures. in addition, an effective infection control program is urgently required to control the spread of the virus and protect both uninfected patients who require care for other medical or surgical conditions as well as health care professionals. the main objective of this prospective, non-interventional - observational, hospital based study in adults and children is to describe and document suspected or confirmed cases of nosocomial sars-cov-2 infection, the clinical spectrum and the determinants (risk factors/protective factors) at participating hospitals. characterization of the clinical features of the sars-cov-2 infection will help to identify potential sources of virus transmission as rapidly as possible and enable implementation of appropriate hygiene practices in hospitals.


Eligibility criteria:
inclusion criteria: 1 ) any adult or child or member of the nursing staff from the study participant hospital who presents an infectious syndrome including the following definition : 2) suspect case: fever above 37.8 ° c if no antipyretics are taken; and or cough or pharyngeal pain or other symptom suggestive of respiratory infection. and at least 1 of the following characteristics: * return from a trip to china, or to a country in which the increase in the incidence of infections in sars-cov-2 has been proven; * close contact (sharing the same place of family, professional life, same plane, etc.) with a person defined as a suspected or confirmed case; * occurring in an establishment having received at least one case of suspected or confirmed infection at sars-cov-2. or 3) confirmed case: the same clinical definitions, in addition to a positive rt-pcr-type virological diagnostic result specific to sars-cov-2 exclusion criteria: * anyone who does not meet the above definition.
3m study - maria malmö mobile telephone study

Conditions: Substance Use Disorders

Summary: the present study, in an out-patient setting for substance use treatment in adolescents, examines the effect on treatment retention of a mobile telephone follow-up technique (interactive voice response), with or without personal feedback. subjects in treatment for substance use disorders will be followed by automated mobile telephone contact with questions about psychiatric symptoms and substance use, and the investigators hypothesize that this technique, including a personal feedback reporting back to the client whether his or her status is changing in one way or another, may increase the treatment retention, possibly by means of an intensified treatment contact.


Eligibility criteria:
inclusion criteria: * patient applying for substance use disorder treatment at out-patient facility maria malmö, malmö, sweden, who are less than 25 years old and who provide written informed consent to participate in the study. exclusion criteria: * patients who do not provide written informed consent to the study, or whose psychiatric condition or language difficulties make it impossible for them to understand patient information and give informed consent to the study.

Keywords: substance use disorders adolescents retention mobile telephone follow-up interactive voice response
postmarketing surveillance study for quadrivalent influenza vaccine (vaxigriptetra inj.) in subjects aged 3 years old and above

Conditions: Influenza

Summary: the objective is to describe the safety profile after 1 dose of vaxigriptetra inj. administered in subjects aged 3 years old and above under routine clinical practice. the planned duration of each subject's participation in the study will be 21 to 28 days.


Eligibility criteria:
inclusion criteria: * aged 3 years and above on the day of enrollment * for subjects aged 3 to 18 years: informed consent form has been signed and dated by the parent or other legally acceptable representative. * for subjects 19 years and above: informed consent form has been signed and dated by the subject. * receipt of one dose of vaxigriptetra inj. (on the day of inclusion) as part of routine clinical practice according to the approved local product insert exclusion criteria: - participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure
a phase 1b/2 study of serabelisib in combination with canagliflozin in patients with advanced solid tumors

Conditions: Breast Cancer; Endometrial Cancer; Lung Cancer; Colo-rectal Cancer; Head and Neck Cancer

Summary: this study aims to test the hypothesis that combining serabelisib, a pi3k alpha isoform inhibitor, with an sglt2 inhibitor, canagliflozin will improve efficacy in the treatment of patients with advanced solid tumors.

this study aims to test the hypothesis that controlling the glucose/insulin feedback will enhance the efficacy of pi3k inhibition in treating solid tumors. the treatment consists of serabelisib, a pi3k alpha isoform (pi3kα) inhibitor, combined with the sodium-glucose cotransporter-2 (sglt2) inhibitor canagliflozin. the study will assess the safety and efficacy of the combination in adult patients with advanced solid tumors harboring mutations that may be dependent on pi3kα activity: pik3ca mutations and kras mutations.

Eligibility criteria:
inclusion criteria: 1. have histologically or cytologically confirmed locally advanced or metastatic solid tumors. 2. have a tumor harboring a mutation in pik3ca or kras genes. 3. have received prior therapy and have recurrent or persistent disease without standard therapies available, or are ineligible to receive standard therapies. 4. have measurable disease as defined by response evaluation criteria in solid tumors (recist) version 1.1 5. have eastern cooperative oncology group performance status (ecog ps) of ≤2 6. have adequate organ function. 7. have adequate birth control during the course of the study. 12. are able to receive canagliflozin exclusion criteria: 1. diagnosis of primary brain tumor 2. untreated brain metastasis or history of leptomeningeal disease 3. have received prior chemotherapy within 28 days or other anticancer agents within 28 days of 5 half lives (whichever is the shorter duration) before the first administration of study drug. the exception is patients in cohort 4 (pik3ca-mutated breast cancer) are allowed to receive ongoing endocrine therapy. 4. have diabetes mellitus requiring insulin therapy 5. have diabetes mellitus requiring insulin secretagogue therapy 6. have poorly controlled diabetes mellitus defined as glycosylated hemoglobin a1c (hba1c) \>7.5% 7. have a secondary malignancy requiring therapy or are unstable without therapy. 8. known impaired cardiac function or clinically significant cardiac disease. 9. myocardial infarction or unstable angina within 6 months before the first administration of study drug. 10. pregnant (positive serum pregnancy test) or breastfeeding
addressing health disparities in chronic low back pain with patient-clinician relatedness

Conditions: Chronic Low-Back Pain

Summary: the primary objective of the current research is to assess the effect of an enhanced patient-clinician relationship when compared to a limited patient-clinician relationship on measures of chronic low back pain and objective functional measures. the second objective is to examine racialized disparities in chronic low back pain among individuals who identify as non-hispanic black and non-hispanic white using a qualitative approach. lastly, the study team will explore relationships between psychosocial components of low back pain, pain and functional outcomes, and patient-clinician relationship measures.


Eligibility criteria:
inclusion criteria: 1. self-reported low back pain located between the 12th rib and the gluteal fold. 2. low back pain lasting at least 3-months. 3. low back pain for more than half of the days in the past 6-months. 4. age 18-45 years old. 5. reports at least 3 out of 10 average pain over the past week on the numerical pain rating scale. 6. reports having more back pain when compared to leg pain. exclusion criteria: 1. does not meet any of the above inclusion criteria. 2. if there is a reported low back procedure scheduled within the upcoming 8-weeks including an epidural injection or spinal surgery. 3. if low back pain care (i.e. physicians visits, physical therapy) is being received through worker's compensation or no fault insurance. 4. dizziness, vestibular, or visual difficulties that cause balance problems over the past 2-weeks. 5. any lower or upper extremity surgery within the past year or any prior history of spine surgery, spinal fracture, or malignancy in the spine will not be included in the study. 6. individuals who are pregnant or breastfeeding.

Keywords: patient-clinician relationship back pain chronic pain biopsychosocial health disparities
bioequivalence study of bosutinib pediatric capsule relative to commercial tablet under fed condition

Conditions: Healthy Participants

Summary: this study is intended to establish bioequivalence of the bosutinib age-appropriate capsule formulation to the commercial tablet formulation in healthy participants under fed condition. the comparison will be performed using the pharmacokinetic parameters that define the rate and extent of absorption, those are cmax and auc. a statistical analysis will be performed comparing these parameters calculated after administration of a single 100 mg dose with the tablet formulation (100 mg x 1) as the reference treatment and the capsule formulation (100 mg x 1) as the test treatment.


Eligibility criteria:
inclusion criteria: 1. female participants of non childbearing potential and/or male participants must be 18 to 54 years of age, inclusive, at the time of signing the icd. 2. capable of giving signed informed consent as described in appendix 1, which includes compliance with the requirements and restrictions listed in the icd and in this protocol. exclusion criteria: 1. evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease. 2. any condition possibly affecting drug absorption.

Keywords: bosutinib, bioequivalence, cmax, auc
association between prolactin levels in pregnant women in covid-19. gether with rates of breastfeeding and the covid-19 virus

Conditions: Breastfeeding; COVID-19 Infection

Summary: background: currently in the world, 41% of children under 6 months are exclusively breastfed. the covid-19 pandemic has had a major impact on breastfeeding.; methods: a statistical analysis of linear regression, prolactin analysis in the 3rd trimester of pregnancy and 15 days 15 after delivery was performed in women with covid- 19 infection and healthy, finally the rates of 16 breastfeeding were evaluated. the sample was made up of 680 pregnant women from the valladolid 17 health area, central region of spain.


Eligibility criteria:
inclusion criteria: * pregnant women under the coding of the clinical process of normal pregnancy or diagnosis of covid-19 infection exclusion criteria: * no informed consent. * no pregnant women. * older than 50 years old. * younger than 16 years old.

Keywords: covid-19 infection pregnant women prolactin levels breastfeeeding
facilitating improvements in kidney health using a smartphone app counseling program in patients with diabetes

Conditions: Chronic Kidney Disease; Diabetes Mellitus; Albuminuria

Summary: this pilot study tests the feasibility of dietary app-supported tele-counseling in the treatment of patients with stage 1-3a chronic kidney disease (ckd) and diabetes.

patients with diabetes and stage 1-3a ckd receive instructions on downloading and using myfitnesspal on their smartphone or computer to log meal data daily, weekly website educational materials, and weekly telephone visits with a dietician for 8 weeks. patients receive a follow-up phone call from the dietitian and 5 and 11 months for further support and counseling, and are also invited to attend a local dietitian-led grocery tour. this pilot study examines the feasibility of dietary app-supported tele-counseling in the treatment of patients with stage 1-3a chronic kidney disease (ckd) and diabetes. main outcomes include sodium intake assessed by 24 hour urine collection as well as other dietary measures related to kidney disease (sodium/potassium ratio, healthy eating index score, 24-hour urine phosphorus, estimated net endogenous acid production) and health measures (24-hour ambulatory blood pressure, weight, albumin/creatinine ratio)

Eligibility criteria:
inclusion criteria: * age \> 21 years * diabetes diagnosis (type i or type ii) * last urine albumin/creatinine ratio (acr) within the past two years \> 30 mg/g * last outpatient estimated glomerular filtration rate (egfr) within the past year \> 45 ml/min/1.73m2 * last outpatient systolic blood pressure (sbp) within the past year \< 160 mmhg * last outpatient diastolic blood pressure (dbp) within the past year \<100 mmhg * preceding egfr decline rate less than -2 ml/min/1.73m2/y * at least 2 outpatient egfr measurements in electronic health record, separated by at least 2 years * agreeable to change diet (decrease sodium and red/processed meat intake, increase fruit and vegetable intake) * access to smartphone or computer exclusion criteria: * inability to understand english * myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure within 6 months. * current treatment for malignancy * planned bariatric surgery * pregnancy or planning to become pregnant within next 2 years * self-reported average consumption of \> 14 alcoholic beverages per week * psychiatric hospitalization in past year * unstable angina * urine acr \> 2500 mg/g * last potassium \> 5.0 mg/dl * hypoglycemia episode in past 1 month (glucose \< 70 mg/dl) * principal investigator discretion (i.e. concerns about safety, compliance)

Keywords: mobile application chronic kidney disease diabetes mellitus albuminuria diet
intestinal phosphate transporter expression in ckd patients

Conditions: Chronic Kidney Diseases

Summary: the aim of the present study is to study the expression of the various phosphate transporters in patients with normal or moderately impaired renal function or in patients on dialysis. in particular, the investigators want to clarify whether napi-iib expression level decreases in ckd patients, which would render it a potentially inadequate pharmaceutical target in these patients.

elevated serum phosphate is a potent predictor of death and cardiovascular events in patients with renal disease. control of serum-phosphate to desired target ranges is insufficient in many patients with advanced chronic kidney disease (ckd), in particular dialysis patients despite dietary restrictions, optimized dialysis regimens and the use of phosphate binders. one reason why for example, phosphate binders are insufficient to control phosphate uptake in the intestine or why they even loose efficacy, is a compensatory upregulation of phosphate transporters in the gut wall. thus, several companies attempt to specifically interfere with intestinal phosphate transporters, in particular the napi-iib transporter. however, recent chugai data obtained in experimental ckd challenge the assumption that napi-iib is the major therapeutic target in this situation. in addition to napi-iib, pit-1 and -2 also might contribute to phosphate transport. in normal human intestinal mucosa the most prominent expression of all 3 transporters is observed in the duodenum, i.e. an area, which can easily be assessed by endoscopy. during endoscopy a biopsy for research purposes will be obtained. chugai will evaluate the expression level of napi-iib, pit-1, pit-2, and villin1 at the mrna and, if possible, the protein level.

Eligibility criteria:
inclusion criteria: * upper endoscopy for suspected or known esophageal or gastric pathology * upper endoscopy for screening purposes * written consent to take part in the study exclusion criteria: * food intake within 8 hours prior to the endoscopy * major duodenal pathology, in particular duodenitis or duodenal ulcers or tumor * contraindication to duodenal biopsy such as bleeding disorder * treatment with medication known to regulate the expression or activity of intestinal phosphate transporters (e.g. nicotinamide) * kidney transplant patients * alcohol or drug abuse * mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study * participation in a parallel clinical trial * subjects who are in any state of dependency to the sponsor or the investigators * employees of the sponsor or the investigators * subjects who have been committed to an institution by legal or regulatory order

Keywords: phosphate transporter ckd duodenal biopsies