Kornimate/medical-research-clean huggingface dataset:
phase 1 study of awt020 in advanced cancer

Conditions: Advanced Cancer

Summary: the aims of this clinical trial are (1) to assess the safety of awt020 at different dose levels; (2) to determine the pharmacokinetics and pharmacodynamics of awt020 in subjects with locally advanced or metastatic cancer who have failed standard therapy.

this study will enroll subjects with locally advanced or metastatic cancer who have failed standard therapy. subjects enrolled into this study will be assigned a dose level and receive awt020 via intravenous infusion at a regular interval. the treatment will be continued until disease progression, withdrawal from study or death. the primary objective is to investigate the safety of this agent. the secondary objective is to investigate the pharmacokinetics, pharmacodynamic, potential anti-tumor activity and immunogenicity of this agent.

Eligibility criteria:
inclusion criteria: * subject has provided informed consent prior to initiation of any study specific activities or procedures. * subject must be ≥ 18 years of age or per local regulation. * subjects must have a histological diagnosis of solid tumors (carcinoma or sarcoma) or malignant lymphoma, either progressive locally advanced not amenable to local therapy or metastatic, which is refractory, ineligible (in the opinion of the investigator) or intolerant to standard therapy. subjects with hepatocellular carcinoma must be diagnosed with dynamic ct or mri if no tissue diagnosis is available. * subject must have performance status of 0, or 1 on the ecog performance scale. * subject with adequate organ function. * life expectancy is longer than three months. * subject must be able to receive effective contraceptive measures. exclusion criteria: * subject is allergic or intolerant to either anti-pd1 or interleukin-2 therapy. * subject has received prior immune-check point inhibitors and was discontinued due to greater than grade 3 toxicities. * subject is receiving other investigational agent or device. * subject has active infection, uncontrolled hypertension, unstable angina, uncontrolled diabetes mellitus, recent myocardial infarction, and congestive heart failure with ejection fraction less than 50%. * subject has prior allogeneic stem cell or bone marrow transplant or organ transplant. * subject has active central nervous system (cns) metastases or carcinomatous meningitis. * subject with hiv whose viral load is \> 400 copies/ml or cd4+ t cell counts are \< 350 cells/µl. * subject has baseline corrected qt interval (qtc) longer than 480 ms by fridericia formula. * subject is pregnant or breast-feeding. * subject has received live virus vaccine within 28 days prior to the first dose of study. * any other conditions that might compromise the safety of the subject or the integrity of the study.

Keywords: awt020 anti-pd1 interleukine-2 phase 1 first in human
cerebrovascular autoregulation during sepsis

Conditions: Sepsis; Delirium

Summary: the aim of the study is to correlate the dynamic cerebrovascular autoregulation by patients with sepsis with a sepsis-associated delirium.


Eligibility criteria:
inclusion criteria: * clinical symptoms of sepsis, severe sepsis and septic shock * possibility for measurement of transcranial doppler ultrasound * age over 18 years exclusion criteria: * preexisting cerebrovascular disease * preexisting immunological disease * traumatic brain injury * intracranial infectious disease * pregnancy

Keywords: brain, blood flow measurement techniques, flow velocity waveform analysis monitoring, intensive care sepsis transcranial doppler ultrasound (tcd) cerebrovascular autoregulation sepsis-associated delir
freestyle libre flash glucose monitoring system post approval study

Conditions: Diabetes Mellitus

Summary: this is a prospective, multi-center, non-randomized, single-arm, post-approval study of the freestyle libre flash glucose monitoring system intended to characterize the safety of the libre flash glucose monitoring system when used in people with diabetes.

up to 920 adult subjects, aged 18 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 736 subjects who complete the final visit. subjects will utilize capillary smbg for managing diabetes for 6 months (control phase) followed by diabetes management using freestyle libre for 6 months (intervention phase). subjects will maintain a diary/log book of adverse events during each phase. assessment of adverse events will occur via self reporting at each monthly visit and/or phone call.

Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age. * subject must have a diagnosis of type 1 or type 2 diabetes mellitus. * subject is currently using smbg for managing their diabetes. * subject must be able to read and understand english * in the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol. * subject must have access to an internet connected computer for uploading data from the blood glucose meter and freestyle libre system. * subject must be willing and able to provide written signed and dated informed consent. exclusion criteria: * subject is a member of the site staff. * subject is currently using or has previously used a continuous glucose monitoring system for managing their diabetes * subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. * subject is pregnant or is attempting to become pregnant at the time of enrollment. * subject is on dialysis at the time of enrollment. * subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. * subject currently is participating in another clinical trial. * subject is unsuitable for participation due to any other cause as determined by the investigator.
embryo aneuploidies and morphokinetics in ovarian stimulated and non stimulated ivf cycles

Conditions: Euploid Embryos

Summary: the purpose of this study is to compare the number of euploid embryos obtained per metaphase ii oocyte in unstimulated (modified natural cycles) and stimulated ivf cycles.

effects of ovarian stimulation on human embryo quality is still a subject of study. when natural and stimulated cycles have been compared, no differences have been observed in terms of embryo cleavage capacity, oocyte and embryo aneuploidy rate or incidence of aneuploidy in aborted foetuses. when mild and conventional doses of gonadotropins have been compared, a higher proportion of good morphological quality embryos are observed in the former. on the contrary, we showed that ovarian stimulation does not increase significantly the embryo aneuploidy rate in ivf derived human embryos when unstimulated and stimulated cycles were compared in oocyte donors. in this study, we want to compare the embryo aneuploidy rate between unstimulated and stimulated cycles in infertile patients, subjected to both ivf cycles with blastocyst biopsy and ngs-pgs. a comparison of the morphokinetics will also be performed.

Eligibility criteria:
inclusion criteria: * women * 30-38 years old (inclusive) * with regular menstrual cycles (25-35 days) * antimülleriana hormone \>5 pmol/l. * undergoing ivf treatment exclusion criteria: * bmi \>30 kg/m2 * repeated miscarriages * implantation failure * uterine or adnexal pathology * unable to be treated with gonadotrophins for the ovarian hyperstimulation * history of low response to ovarian hyperstimulation * participation in another study with pgs for monogenic pathology * cryptozoospermia in male partner
nutritional supplementation in the elderly with weight loss

Conditions: Sarcopenia

Summary: many elderly experience weight loss and weakness with normal aging. although there is extensive literature regarding nutritional advice for the elderly, there are few well- designed studies evaluating the effect of oral nutrition supplements in patients with weight loss and aging. the aim of this study is to examine the effect of dietary prescription with or without nutrition supplementation that includes soy protein, whey protein and fish oil in elderly patients who have suffered unintentional weight loss.

this is an 8-week, randomized, pilot study with elderly subjects (age 65 and older) with recent unintentional weight loss who will receive either two servings of supplement powder and fish oil or no dietary supplementation (n=10 for each group).

Eligibility criteria:
inclusion criteria: * male or female age 65 and older * non-smokers * weight loss \>3% body weight over 6-12 months * bmi ≤ 25 * living independently or in an assisted living facility exclusion criteria: * medical conditions that would lead to weight loss * active cancer undergoing treatment (chemotherapy, radiation therapy, or planned surgical intervention) * ckd stage iv-v (egfr \<30) based on medical records within the last 12 months * presence of dysphagia or odynophagia * actively taking blood thinner such as warfarin * known history of cirrhosis with presence of ascites * history of a surgical procedure for weight loss (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, lap-band) * any abnormal lab findings outside of normal limits as determined by the investigator * dietary conditions * diet restrictions including vegetarianism, veganism, soy-free diet, * fish and/or fish oil allergy or intolerance * milk allergy excluding lactose intolerance * follows a kosher diet * medications * use of appetite stimulants (including megestrol, dronabinol and cyproheptadine). * does not include medications used for depression (e.g. mirtazapine, paxil) if patient has been on a stable dose of this medication for at least 3 months prior to the start of this study * if participant is already taking a fish oil supplement, he/she must be willing to either stop the supplement or take the supplement the investigators are using in the study depending on the randomization assignment * additional * patient has implantable device such as a pacemaker or icd * unable to complete 6-minute walk test at baseline * hospitalization within the last 30 days * participation in a therapeutic research study within 30 days of baseline * living in a skilled nursing facility or long-term care facility * any other medical condition that principal investigator or co-investigators deem would preclude the patient from study participation

Keywords: elderly protein supplementation unintentional weight loss
e- ab sensor - based real-time diagnosis of influenza virus

Conditions: Influenza Caused by Unspecified Influenza Virus

Summary: the purpose of this study is to develop a real-time diagnostic technique with e- ab sensor for influenza virus detection, the investigators conduct a prospective clinical study. in comparison with results from direct sequencing of influenza virus, the investigators evaluate the performance of e- ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction. the potential factors which may interfere with the results would be investigated. with such technique, the investigators hope to make early diagnosis and give influenza virus patients early treatment to reduce the complications and case-fatality rate.

since april 15 and 17, 2009, when the first two cases of novel influenza a (h1n1) infection were identified in two southern california counties, as of 12 march 2010, the virus has spread to more than 213 countries and overseas territories or communities where it has caused the deaths of at least 16713 people. therefore, a rapid diagnosis is clinically necessary and can provide clinicians the rapid answers and make early treatment possible to reduce the complications and case-fatality rate. in addition, early diagnosis of the patients will alert parents and public health workers to prevent the contacts earlier and to limit the influenza spread. electrosensing antibody probing system (e- ab sensing), which was developed for the rapid and sensitive detection of hapten, proteins or viral antigen in medical samples, will be used for analyzing the interaction kinetics between q.anti-influenza-virus and its influenza virus antigen present in flu patients'and normal samples. the system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip (evchip) or lateral flow through (evsignal) formats. in electrosensing antibody probing, semiconductive antibodies are bound as a suitable electrosensing probe which specifically and selectively binds influenza-virus epitope target molecules in the test samples. the investigators evaluate the performance of e- ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction. the potential factors which may interfere with the results would be investigated. e- ab sensor threshold decisions must maximize its sensitivity. therefore, the threshold value in the test group is to find the decision could have 90% sensitivity and 90% specificity. with such technique, the investigators hope to make early diagnosis and give influenza patients early treatment to reduce the complications and case-fatality rate.

Eligibility criteria:
inclusion criteria: * a: the patients with confirmed or suspected infection. * b: the patients without disease. exclusion criteria: * patients will be excluded if they couldn't sign the consent.

Keywords: influenza virus
impact of diabetes continuing education on primary health care physicians' knowledge, attitudes and practice

Conditions: Diabete Mellitus

Summary: the main objective is to evaluate the effectiveness of a continuing education program on the knowledge, attitudes and practices of primary health care physicians towards a high quality of diabetes care in aseer region, saudi arabia.

background: diabetes is one of the rapidly growing chronic health conditions across the world. healthcare providers still continue to face difficulties in delivering optimal care and education worldwide. thus, continuing education is needed to improve knowledge, attitudes and practices of physicians. objective: to evaluate the effectiveness of a continuing education (ce) program on the knowledge, attitudes and practices of primary health care physicians (hcps) towards a high quality of diabetes care. design and methods: this is a quasi-experimental design composed of pre-test post-test uncontrolled experimental design. the study will include all phc physicians registered in health sectors of abha and khamis musheet cities, aseer region. the physicians will be invited to attend a ce program. all participants will fill out a questionnaire before and after the intervention. the change in knowledge and attitudes of the participants will be measured at the end of the program. after 4 months, the practice of physicians will be assessed through retrospective review of patient's files. impact: education programs could positively influence the knowledge, beliefs and attitudes of healthcare workers toward a high quality of diabetes care, which in turn plays a major role in improving clinical outcomes.

Eligibility criteria:
inclusion criteria: * all phc physicians registered in health sectors of abha and khamis musheet cities, aseer region * willing to provide informed consent to participate in the study exclusion criteria: * physicians worked at hospital * other health care professional (non-physicians)

Keywords: diabetes, continuing education, attitude, practice, health care physicians
use of the mask and current pandemic

Conditions: Face Mask Squeeze

Summary: due to the continued use of the mask in order to prevent the spread of covid-19, an impact on people is observed in different areas. the objective of our study was to collect impact aspects related to the continued use of the mask that may affect the quality of life of the population. for this, an observational study has been carried out that includes an interview with aspects related to headaches, problems in the temporomandibular joint, headache impact and quality of life.

introduction due to the continued use of the mask in order to prevent the spread of covid-19, an impact on people is observed in different areas. the objective of our study was to collect impact aspects related to the continued use of the mask that may affect the quality of life of the population. material and methods diseny. for this, an observational study has been carried out that includes an interview with aspects related to headaches, problems in the temporomandibular joint, headache impact and quality of life. participants. subjects of all ages from 18 years old will be recruited who use a mask daily for the avoidance of covid-19 and with the ability to answer the questions and complete the questionnaires. the study will be carried out at the faculty of physiotherapy of the university of valencia. the participants will sign an informed consent guaranteeing the confidentiality of the data. the study is approved by the ethics committee of our institution. outcomes. the sociodemographic characteristics and the use of the mask will be collected. subsequently, the evaluation instruments without the use of a mask and with the use of the same in: headache and the impact on headaches, pain related to temporomandibular joint and quality of life. all data will be coded in a database and analyzed later.

Eligibility criteria:
inclusion criteria: * from 18 years old will be recruited who use a mask daily for the avoidance of covid-19. * that they use the face mask at least 2 hours a day * with the ability to answer the questions and complete the questionnaires. exclusion criteria: * i do not use the mask * institutionalized subjects

Keywords: protection sars-cov-2 cephalalgia mastication well-being
treatment of low-risk submassive pulmonary embolism with flowtriever

Conditions: Pulmonary Embolism

Summary: this study is focused on investigating the efficacy and safety of the flowtriever device to treat low-risk submassive pulmonary embolism.

in this study, patients that present with low-risk submassive pulmonary embolism with hemodynamic stability and with either positivity of cardiac biomarkers, or radiographic or echocardiographic evidence of right ventricular strain will be assigned to be treated with mechanical thrombectomy, which includes conscious sedation, via flowtriever.

Eligibility criteria:
inclusion criteria i1. ≥ 18 years of age i2. clinical signs and symptoms of low-risk intermediate pulmonary embolism defined per 2019 esc guidelines: only one of the following: * presence of either rv strain or rv dilation on ct scan or echo tte * 4th generation troponin t \> 0.01 ng/ml or 5th generation troponin t \>14 ng/l troponin i \> 51.4 ng/l (northwell reference laboratory) i3. spesi score 0 or \>1\* \*signs of rv dysfunction on echo tte or ctpa or elevated cardiac biomarker levels may be present, despite a calculation of spesi 0. i4. echocardiogram, computed tomography pulmonary angiogram, or pulmonary angiographic evidence of proximal filing defect in at least one main, lobar, or segmental pulmonary artery with or without pulmonary infarction i5. hemodynamically stable exclusion criteria e1. patients with active and severe covid-19 infection (e.g. using ventilator, requiring hemodynamic support) e2. unable to anti-coagulate with heparin or alternative e3. known sensitivity to radiographic contrast agents that cannot be pre-treated e4. life expectancy \< 6 months e5. current participation in another study that may interfere with the patient's participation in this study. e6. inability to consent e7. patient is pregnant or plans to become pregnant within the next 6 months and/or currently breastfeeding. e8. subsegmental pulmonary embolism only
ultra-high frequency - electrocardiogram (uhf-ecg) for the diagnosis of ventricular electrical dyssynchrony (ved)

Conditions: Bradycardia; Heart Failure; Ventricular Dysfunction

Summary: the purpose of this study is to demonstrate the safety and effectiveness of the vdi uhf-ecg system in the diagnosis of ventricular dyssynchrony when compared to the 12-lead ecg in patients with bradycardia and heart failure indicated for pacemaker implantation.


Eligibility criteria:
inclusion criteria: * adults with bradycardia scheduled for pacemaker implant or heart failure patients indicated for cardiac resynchronization therapy (crt) with one of the following: * bradycardia with ventricular synchrony and qrs duration \< 110 ms in men or \< 100 ms in women or; * bradycardia with left bundle branch block and qrs duration \> 140 ms in men or \> 130 ms in women or; * bradycardia with right bundle branch block and qrs duration \> 130 ms in men or \> 120 ms in women or; * heart failure with left bundle branch block and qrs duration \> 140 ms in men or \>130 ms in women. * understands the nature of the study and is willing to comply with all study requirements. * provides written informed consent. * a negative pregnancy test prior to the procedure for participants of child-bearing potential. exclusion criteria: * complete av block (3rd-degree av block) without a stable escape rhythm or other circumstances where there is no measurable qrs. * subjects with a previous or current pacemaker or defibrillator implant. * anatomical or other conditions that may make a 12-lead ecg difficult to obtain, such as an allergy to components of the ecg pads, burns, open wounds, etc. * currently enrolled in another investigational device or drug trial that has not completed the active treatment phase and/or would conflict with this study. * other co-morbid condition(s) that could limit the participant's ability to participate in the study or to comply with study requirements or impact the scientific integrity of the study.