Kornimate/medical-research-clean huggingface dataset:
pharmacokinetic boosting of osimertinib

Conditions: Non Small Cell Lung Cancer

Summary: the main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. auc) is increased when osimertinib is co-administered with cobicistat in patients with relatively low plasma trough concentration while receiving the standard osimertinib dose.

osimertinib is a new targeted agent registered for the treatment of patients with egfr-mutated nsclc. however, the costs of those new treatments are extremely high. osimertinib is mainly metabolized by cyp3a4, and partially by cyp3a5. combination of osimertinib with a strong cyp3a4-inhibitor may result in a smaller first-pass effect and a decreased clearance of osimertinib, thereby increasing the exposure to osimertinib. cobicistat is a strong cyp3a4-inhibitor, this mechanism may be used to boost osimertinib, as is done for other drugs, mainly drugs used to treat hiv-infected patients. using this personalized treatment approach and combining the concepts of therapeutic drug monitoring (tdm) and pharmacokinetic boosting, osimertinib therapy could become much more cost-effective. by reducing the necessary dose of osimertinib, this strategy may ultimately result in a significant reduction in drug costs, as the additional expenditure for the cyp3a4 inhibitor and blood sample analysis are negligible compared to the price of osimertinib.

Eligibility criteria:
inclusion criteria: * patients with egfr-mutated nsclc receiving standard treatment with osimertinib for at least 2 months (steady state), without any signs of disease progression, or during treatment beyond progression, if treatment continuation is expected for multiple months. after anticipated ema approval of osimertinib adjuvant therapy, patients on adjuvant osimertinib treatment may also participate on the following conditions; if they are receiving standard treatment with osimertinib for at least 2 months (steady state), and if treatment will be continued for a longer period than necessary for participation in the osiboost trial. * age ≥ 18 years * who performance status ≤ 2. * able and willing to give written informed consent. * able and willing to undergo blood sampling for pharmacokinetic analysis. * patients with osimertinib plasma trough concentration below 195 ng/ml. plasma trough concentration of osimertinib will be determined in another study (metc mumc: 2018-0800). exclusion criteria: * any concurrent medication that is known to strongly inhibit or induce cyp3a4. * any concurrent medication that is primarily metabolized by cyp3a4 with a narrow therapeutic window. * impairment of gastrointestinal function that may alter the absorption of osimertinib or cobicistat (e.g. ulcerative disease, uncontrolled nausea or vomiting, malabsorption syndrome, small bowel resection). * refusing to refrain from consuming cyp3a4 influencing products, e.g. grapefruit(juice), st. john's wort. * pregnancy or breast feeding * child-pugh score class c, chronic liver disease.

Keywords: osimertinib cobicistat pharmacokinetic boosting
jeti lower extremity arterial thrombosis

Conditions: Arterial Thrombosis

Summary: the jeti registry is a prospective, single-arm, multi-center study to collect real-world data on the safety, performance, and clinical benefits of the jeti™ hydrodynamic thrombectomy system (jeti system) for the treatment of acute/subacute thrombosis in the peripheral vasculature. this post-market study will register approximately 280 subjects at approximately 30 centers globally. subjects participating in this registry will be followed through their 12-month follow up visit.


Eligibility criteria:
inclusion criteria: 1. subject was treated or is expected to be treated for acute/subacute thrombosis, as determined by the investigator, in the peripheral vasculature with the jeti hydrodynamic thrombectomy system. 2. subject or legally authorized representative must provide written informed consent. 3. subject must be ≥ 18 years of age exclusion criteria: 1. subject has previously been registered in the jeti registry in the last 12 months unless treated in the contralateral limb/different anatomy; patients treated in the contralateral limb/different anatomy within the last 12 months may re-enroll in the study. 2. subject is currently participating in another drug or device clinical investigation. 3. subject has active symptoms and/or a positive test result of covid-19 or other rapidly spreading novel infectious agent within the past 20 days.

Keywords: abt-cip-10433 arterial thrombosis lower extremity
the effectiveness of the letrozole-induced endometrial preparation protocol in frozen-thawed embryo transfer (fet)

Conditions: Letrozole; Infertility, Female

Summary: the goal of this single center, non-blinded, randomized controlled clinical trial to comparison of pregnancy outcomes and perinatal outcomes in patients undergoing ivf treatment (including icsi) with fet with letrozole-induce endothelial preparation protocol versus natural cycles, hormone replacement protocol. the main questions it aims to answer are: * to investigate whether letrozole-induce endothelial preparation is effective in improving the live birth rate and clinical pregnancy rate. * to explore its possible impact on clinically important indicators such as spontaneous abortion rate, implantation cycle cancellation rate, days of endothelial preparation, and number of visits to the clinic. the study subjects were randomized into groups starting at d1-d3 of the menstrual cycle. the study subjects were stratified according to whether their menstrual cycles were regular or not, and were divided into the following endothelial preparation regimens according to the pre-prepared stratified zoned randomized group numbers: (1) regular menstrual cycles (25-35 d): letrozole ovulation-promoting cycles, natural cycles, and hormone-replacement cycles; and (2) irregular menstrual cycles (\ 35 d): letrozole ovulation-promoting cycles, hormone-replacement cycle.


Eligibility criteria:
inclusion criteria: women \<40 years of age undergoing ivf or icsi at our reproductive center with a total of ≤3 superovulation cycles , and with ≥2 cleavage embryos or ≥1 blastocyst were cryopreserved. previous cycles of embryo transfer ≤ 2 and only one transfer cycle with 1-2 embryos per study subject was enrolled. exclusion criteria: 1. patients with chromosomal abnormalities in either spouse, hydrosalpinx, severe endometriosis, adenomyosis, and uterine and uterine cavity organic diseases such as uterine malformations, endometrial polyps, and uterine adhesions; 2. patients who underwent pre-implantation genetic diagnosis (pgt); 3. patients who underwent icsi using surgically obtained epididymal or testicular spermatozoa; 4. patients with a body mass index (bmi, = weight/height2 ) \> 30 kg/m2; 5. patients with recurrent spontaneous abortions; 6. patients with sequential embryo transfer.

Keywords: frozen-thawed embryo transfer letroziole endothelial preparation protocol
identification of a responsive subpopulation to hydroxychloroquine in covid-19 patients using machine learning

Conditions: COVID-19; Coronavirus; Mortality

Summary: the purpose of this study was to assess the performance of a machine learning algorithm which identifies patients for whom hydroxychloroquine treatment is associated with predicted survival.

in a multi-center pragmatic clinical trial, covid-19 positive patients admitted to 6 united states medical centers were enrolled between march 10 and june 4, 2020. a machine learning algorithm was used to determine which patients were suitable for treatment with hydroxychloroquine.

Eligibility criteria:
inclusion criteria: * patient admitted to covered ward and tested positive for covid-19 * patient had coviage applied to electronic health record data within four hours of covid-19 test exclusion criteria: * patient not admitted to covered ward or tested negative for covid-19 * patient had coviage applied to electronic health record data greater than four hours after covid-19 test
epidural analgesia during labour

Conditions: Anesthesia, Obstetrical; Analgesia, Epidural

Summary: randomized single blind trial based on comparing the way the local anesthetic is dosificated during labour. the pain control is evaluated and compared with both dosage techniques (pcea vs pieb)using levobupivacaine and fentanyl. the primary objective is to see no differences in pain control(vas, visual analog scale). the secondary goals are the differences in motor block(bromage scale), satisfaction (likert scale), the outcome (eutocic, instrumental o cesarean section), second stage of labour time, newborn´s apgar and ph and total dosis and secondary effects of local anesthetic.

there is a protocol where every healthy primiparous women have the chance to join the study after the explanation and the informed consent is signed. there are blind envelopes with the two kinds of treatment and the investigator only has to follow the protocol.

Eligibility criteria:
inclusion criteria: * 20- 40 years-old women * primiparous women * dilatation 3- 7 cm * no risk illnesses for epidural block * no risk pregnancy * signed informed consent exclusion criteria: * illnesses which are a risk for pregnancy * multiparous women * contraindicated diseases for epidural block * women who can not understand the procedure * women who do not want to sign the informed consent * patients with drug´s allergy

Keywords: pieb pcea levobupivacaine
safety and efficacy comparison of tg-873870(nemonoxacin) to levofloxacin in community-acquired pneumonia

Conditions: Community-Acquired Pneumonia

Summary: this study will test the safety and efficacy of tg-873870(nemonoxacin) compared with levofloxacin in adult patients with community-aquired pneumonia(cap)

community-acquired pneumonia(cap) remains a leading cause of death in both developing and developed countries. in the choice of antibacterial agents used to treat cap, fluoroquinolones have received considerable attention because of their wide spectrum of bactericidal activity. tg-873870(nemonoxacin), a non-fluorinated quinolone (nfq), is a selective bacterial topoisomerase inhibitor. this study will test the safety and efficacy of tg-873870(nemonoxacin) compared with levofloxacin in adult patients with community-aquired pneumonia (cap) .

Eligibility criteria:
inclusion criteria: * if female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control) * must be a suitable candidate for oral antibiotic therapy and must be able to swallow capsules intact * must have a clinical diagnosis of cap based on clinical evidence * must have a chest radiograph demonstrating new or persistent/progressive infiltrates * must be able to produce sputum exclusion criteria: * clinically significant conduction or other abnormality on 12-lead ecg, or qtc interval * patients with cap that, in the investigator's judgment, is severe enough to require hospitalization for intravenous antibiotic therapy and/or supplemental oxygen therapy with icu support * known or suspected severe bronchiectasis, cystic fibrosis, active pulmonary tuberculosis or infection with other mycobacteria or fungi, known bronchial obstruction, a history of post-obstructive pneumonia, other confounding respiratory diseases, such as lung cancer, malignancy metastatic to the lungs, lung abscess, empyema, suspected aspiration pneumonia due to vomiting, or non-bacterial respiratory infection (chronic obstructive pulmonary disease \[copd\] is not exclusionary) * infection acquired in a hospital, nursing home, or other long-term care facility, or hospitalization for any reason within the previous 14 days * treatment with any antibiotics within the past 7 days prior to randomization, unless documents to be a treatment failure(72 hours treatment and not responding) * anticipation of the requirement for additional treatment with non-study antibacterials for any reason during the patient's participation in the study * treatment with chemotherapeutic agents or oncolytics during the 6 months prior to randomization or anticipated requirement for such agents during the course of the study * known or suspected cns disorder that may predispose the patient to seizures or lower the seizure threshold

Keywords: community-acquired pneumonia fluoroquinolone tg-873870 nemonoxacin
gene therapy for diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: ft-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (ci-dme). diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. in the latest guidelines, anti-vegf therapy is preferred for ci-dme. administration of ft-003 has the potential to treat ci-dme by providing intraocular protein which is durable expressed in therapeutic level. ft-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with ci-dme receiving anti-vegf therapy in clinical practice.


Eligibility criteria:
inclusion criteria: * subjects that are willing and able to follow study procedures; * female or male patients ≥18 years old at the time of signing the icf; * clinically diagnosed with ci-dme * hba1c≤10% * the best corrected visual acuity (bcva) of the studied eye is ≤ 73 letters exclusion criteria: * presence of any other intraocular diseases other than ci-dme in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator
study for characterisation of predictive parameters of clonal evolution in subjects with gata2 germline mutation

Conditions: GATA2 Gene Mutation

Summary: this trial is a translational, open-label, multi-site, retrospective and prospective cohort study of 250 patients aiming to characterize predictive parameters of clonal evolution in a population of subjects carrying the germline gata2 mutation. this study will be conducted on a population of subjects either with previous germline gata2 mutation identified or newly identified for germline gata2 mutation in the context of routine care. prospective cohort: 150 subjects will be included in this interventional prospective cohort study: * alive subjects previously identified with a germline gata2 mutation through the already existing "neutropenia database"; * subject identified in the investigating centers in the context of a newly identified germline gata2 mutation. for each included patient, biological samples (blood and bone marrow samples) will be collected at baseline visit and then during 5 years, according to the samples taken in the standard practice. no additional sampling will be performed for the study. retrospective cohort: subjects (100 cases in total) previously identified with germline gata2 mutation through the already existing "neutropenia database" and with the following features may enter the retrospective cohort: * deceased patients, * lost to follow-up patients. clinical follow-up data will be obtained from this database and/or patient's medical report. for each retrospective case, archived blood and bone marrow samples (collected in a sanitary setting) will be sent to sponsor's centralized unit for analysis.


Eligibility criteria:
inclusion criteria: 1. all subject, at any age, with a germline gata2 mutation. 2. patient followed in the center within a standard of care procedure or clinical trial. 3. signed written informed consent. for minor patients: patient assent and legal guardian(s) written informed consent obtained before inclusion in the study and prior performance of any study-related procedure. 4. for french patients: patient affiliated to a social health insurance. exclusion criteria: 1. gata2 somatic mutation. 2. any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure. 3. person who has forfeited his/her freedom by administrative or legal award or who is under legal protection, with the exception of persons under curatorship who may be included in the study.

Keywords: gata2 gene mutation myelodysplastic syndromes acute myeloid leukemia spectrum 2
comparison of diagnostic accuracy for predicting histology of colorectal lesions

Conditions: Colorectal Neoplasms

Summary: chromoendoscopy (indigo carmine or acetic acid) and narrow band imaging (nbi) could make accurate evaluation in predicting of invasive depth of colorectal neoplasia. nbi could be the first choice.

to compare the diagnostic accuracy of chromoendoscopy indigo carmine or acetic acid and nbi for differentiating neoplastic from non-neoplastic colorectal lesions, differentiating adenomas from carcinomas, and differentiating early carcinomas from invasive ones. included colorectal lesions consecutively distribute in a 1:1 ratio to 2 groups.

Eligibility criteria:
inclusion criteria: * consecutive patients with more than one lesion ≧ 6mm . exclusion criteria: * patients with chronic inflammatory bowel disease, advanced cancer, insufficient bowel preparation, familial adenomatous polyposis (fap) * lesions ≦ 5mm and submucosal tumor (smt).

Keywords: narrow band imaging（nbi） indigo carmine acetic acid colorectal lesions predicting histology
effects on nurses' quality of working life of an educational intervention to strengthen their humanistic practice

Conditions: Patient-Centered Care

Summary: haemodialysis (hd) patients constitute a vulnerable population with considerable health needs. they are often older persons with comorbid chronic conditions. despite the substantial technical care they receive, these patients indicate that the quality of the human relationship that develops with nurses-the pivotal element in the care this population receives-can become therapeutic. this feature of the human relationship constitutes the cornerstone of the humanistic practice (caring practice) that all nurses should adhere to. however, according to some authors, such practice tends to fade over time. in 2012, a pilot study allowed to test an educational intervention based on watson's theory of human caring, the aim of which was to optimise nurses' humanistic practices. the intervention, first developed in quebec and adapted in switzerland by a committee of experts, was delivered to a group of nine hd nurses (canton of vaud, switzerland) and evaluated. preliminary results (qualitative and quantitative) showed the intervention to be highly feasible and acceptable. moreover, in terms of preliminary outcomes, participating nurses appeared to strengthen their caring attitudes/behaviours toward hd patients post-intervention. quantitative analyses of patients' questionnaires showed that hd patients perceived significant changes in nurses' caring attitudes/behaviours and maintained their level of quality of life (qol) over time, which is a definite gain for this population. in light of these positive results, it is important to pursue this line of investigation in order to examine more accurately the intervention's effects on both nurses and patients. to this end, the investigators propose conducting a mixed-methods cluster randomised controlled trial (rct) to assess the effects of an educational intervention to strengthen humanistic practice among nurses working in hd units in french switzerland, on perceived quality of the nurse-patient relationship (npr), nurses' team cohesion, nurses' quality of working life (qowl), and hd patients' qol. knowledge acquired in the course of the study will contribute to strengthen nurses' humanistic practice, a key factor in hd patients' qol.


Eligibility criteria:
inclusion criteria: * nurses: 1. have at least 6 months' work experience in the department; 2. consent to take part in the study. in addition, nurses who intend to leave the hd unit in the 3 months to come will be excluded * patients 1. be at least 18 years of age and under active treatment for at least 6 months; 2. understand and read french; 3. able to provide informed consent. exclusion criteria: * nurses: 1. intention to leave the hd unit in the 3 months after the beginning of the project * patients 1. being diagnosed with dementia 2. being a new hd patient

Keywords: educational intervention watson's theory of human caring quality of working life of haemodialysis nurses quality of life of haemodialysis patients
pilot study on the submental area

Conditions: Body Fat Disorder

Summary: the purpose of this study is to evaluate the safety and feasibility of cryolipolysis for non-invasive reduction of submental fat.


Eligibility criteria:
inclusion criteria 1. male or female subjects \> 18 years of age and \< 65 years of age. 2. presence of submental fat, which in the investigator's opinion, may benefit from the treatment. 3. no weight change exceeding 10 pounds in the preceding month. 4. agreement to maintain his/her weight (i.e., within 10 pounds) by not making any major changes in their diet or lifestyle during the course of the study. 5. subject has signed a written informed consent form. exclusion criteria 1. skin laxity in the neck or chin area for which reduction in submental fat may. 2. evidence of any cause of enlargement in the submental area other than localized subcutaneous fat. 3. enlargement on the anterior neck that may prevent the proper placement of the applicator. 4. treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area. 5. botulinum toxin injections within the neck or chin area. 6. history of a fat reduction procedure in the area of intended treatment. 7. history of prior surgery in the area of intended treatment. 8. current dental infection. 9. known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. 10. known history of raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. 11. impaired skin sensation or thermal sensitivity in the intended treatment area. 12. open or infected wounds in the intended treatment area. 13. currently taking or has taken diet pills or weight control supplements within the past month. 14. any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation. 15. active implanted device such as a pacemaker, defibrillator, or drug delivery system. 16. pregnant or intending to become pregnant in the next 5 months. 17. lactating or has been lactating in the past 6 months. 18. unable or unwilling to comply with the study requirements. 19. currently enrolled in a clinical study of any other unapproved investigational drug or device. 20. any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Keywords: lipolysis cryolipolysis fat reduction
safety and efficacy of a drug delivery system in glaucoma

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * man or woman 21 years of age or greater * open angle glaucoma or ocular hypertension * corrected visual acuity in each eye of 20/200 or better exclusion criteria: * previous glaucoma intraocular surgery or refractive surgery * planned contact lens use during the study * clinically significant ocular or systemic disease that might interfere with the study * use of chronic corticosteroids by any route