Kornimate/medical-research-clean huggingface dataset:
in situ simulation training in transferring critically ill covid-19 patients

Conditions: Simulation of Physical Illness; COVID-19 Respiratory Infection

Summary: this study aimed to determine the role of in situ simulation training during a pandemic by using standard and high-fidelity mannequins to improve interprofessional communication, skills, and teamwork in transferring critically ill covid-19 patients.

fourty subjects were randomly allocated into two large groups, the high fidelity simulator group and the low fidelity simulator group. each group was divided into small groups, consist of 2 doctors and 3 nurses. all subjects underwent the same interactive lectures, and two sessions of in-situ simulation according to their assign group. in-situ simulation and debriefing were performed by implementing appropriate personal protective equipment and social distancing. at the end of each simulation session, each group would underwent a debriefing session, which was performed by an experience instructor. the first simulation was aimed to teach participants skills and steps in transporting critically-ill covid-19 patients according to the hospital check-list. while the second simulation was aimed to assess skills, team work and communication that participants had learned from the previous simulation, by using assessment tools that had been developed before. in addition to comparing each point in the assessment tool between the two groups, the points that had been earned were also added up to get the overall points for total skills, cooperation and communication score. at the end of the session, learner immediate feedback were also collected using an online feedback form, which provided accountability for attendance, content learning, and course evaluation feedback.

Eligibility criteria:
inclusion criteria: * in good physical condition * had no history of involving in covid-19 patients care * willing to become study subject exclusion criteria: * doesn't want to become study subject

Keywords: in situ simulation intreprofessional training high fidelity mannequin
a human clinical trial evaluating the effect of mealshape™ on blood glucose level following consumption of standard meal

Conditions: Postprandial Glycemia; Postprandial Insulinemia

Summary: the purpose of the study is to evaluate the effect of mealshape, a ceylon cinnamon extract (cinnamomum zeylanicum) on blood glucose and insulin response after consumption of a standard meal composed of white bread, in healthy male and female volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and female volunteers, able to read and write, aged from 18 to 45 years inclusive at time of screening * good physical condition * body mass index (bmi) ≥ 18,5 and \< 25 kg/m² * written informed consent provided prior to screening, after receiving and understanding the subject information * stable body weight (\< 5% variation) within the last 3 months prior to screening. * subject accepting to keep the same lifestyle throughout the study regarding physical activity, no smoking etc. * registered with the french social security, in agreement with the french law on biomedical experimentation. exclusion criteria: * subject with type 1 or 2 diabetes * smoker. light smoker (less than 5 cigarettes per day) or former smoker (smoking more than 5 cigarettes per day) having stopped less than three months. smoking (or use of smoking substitute e.g. nicotine patch) is not permitted from screening throughout the study. * subject with fasting capillary blood glucose level \> 110 mg/dl. * subject with fasting capillary blood glucose level ≤ 110 mg/dl and 2 hours postprandial capillary blood glucose level \> 140 mg/dl during an oral glucose tolerance test. * subject with any sensitivity or allergy to any of the products used within this clinical trial. * intake of product (food and dietary supplement) having an effect on glycemia and insulinemia. * intake of all chronic medication excepted oestroprogestative or progestative contraception started at least three months preceding the screening visit.

Keywords: cinnamon extract postprandial glycemia glycemic index pre-diabetes metabolic syndrome
clinical evaluation of invigor toric 1-day contact lenses

Conditions: Astigmatism

Summary: an evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.

a non-dispensing, double-masked, randomized, contralateral study comparing the 1-day toric test contact lens against the 1-day toric control contact lens to evaluate the clinical performance over one hour of lens wear. each subject will be randomized to wear the test lens in one eye and the control lens in the other eye for each pair of lenses. each subject will be asked to wear four pairs of contact lenses in the study

Eligibility criteria:
inclusion criteria: * has had a self-reported oculo-visual examination in the last two years. * is at least 18 years of age and has full legal capacity to volunteer. * has read and understood the information consent letter. * is willing and able to follow instructions and maintain the appointment schedule. * is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. * currently wears soft contact lenses. * has clear corneas and no active ocular disease. * has not worn lenses for at least 12 hours before the examination exclusion criteria: * has never worn contact lenses before. * has any systemic disease affecting ocular health. * is using any systemic or topical medications that will affect ocular health. * has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * is aphakic. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study.
collecting and storing blood, bone marrow, and other samples from patients with acute leukemia, chronic leukemia, or myelodysplastic syndromes

Conditions: Acute Leukemia; Chronic Leukemia; Myelodysplasia

Summary: as one of the nation's largest cooperative cancer treatment groups, the alliance for clinical trials in oncology (alliance) is in a unique position to organize a leukemia tissue bank. the member institutions diagnose hundreds of patients with leukemia or myelodysplastic syndrome each year, and uniformly treat these patients with chemotherapy regimens. the alliance offers centralized data management for the clinical history, the classification of the leukemia and myelodysplastic syndrome, cytogenetics, flow cytometric analysis, treatment and follow-up. the highly skilled health care providers at each member institution are familiar with obtaining informed consent, completing data questionnaires and shipping specimens. there currently exists a central processing facility where samples are prepared for a variety of cellular and molecular studies. hence, the patient resources, the health care providers, and a processing facility for a leukemia tissue bank are all in place. what is needed, however, and is addressed in the current protocol, is a formal mechanism to procure bone marrow, blood and normal tissue from patients with hematologic malignancies who are to be enrolled on alliance (cancer and leukemia group b \[calgb\]) treatment studies.

the objective of the study is to collect and store specimens from every newly diagnosed patient with acute or chronic leukemia or myelodysplastic syndrome (mds) who are entered on a calgb protocol for previously untreated patients. bone marrow aspirate and blood specimens are obtained from patients at diagnosis, remission, or relapse and stored. buccal smears are obtained at diagnosis, and dna is extracted and preserved. it was anticipated that the specimens collected under this protocol would be used by a large number of investigators. this protocol does not describe the details of each approved project (eg, eligibility age range).

Eligibility criteria:
* previously untreated patients on a calgb treatment protocol for leukemia (acute or chronic) or myelodysplasia are eligible. patients must be registered to calgb 9665 prior to receiving any therapy for their disease. * signed informed consent
safety and pharmacokinetics of odm-209

Conditions: Prostate Cancer Metastatic; Advanced Breast Cancer; Castration-resistant Prostate Cancer; Metastatic Breast Cancer

Summary: the purpose of this first-in-human study is to evaluate safety and tolerability of odm-209 and find the dose of odm-209.

part 1: to evaluate the safety and tolerability of odm-209, to define the maximum tolerated dose (mtd) and dose limiting toxicities (dlts) of odm-209, if feasible, to define the recommended dose of odm-209 and replacement therapy for part 2 of the study. part 2: to further evaluate the safety and tolerability of odm-209, to evaluate the preliminary anticancer activity of odm-209.

Eligibility criteria:
main inclusion criteria: * written informed consent (ic) obtained. * age ≥ 18 years. * ecog performance status 0-1. * adequate marrow, liver and kidney function. * able to swallow study treatment. main prostate cancer specific inclusion criteria: * histologically confirmed adenocarcinoma of the prostate. * castration resistant prostate cancer with serum testosterone \< 50 ng/dl. * metastatic disease. * ongoing androgen deprivation therapy with gnrh analogue, or have had bilateral orchiectomy. * have had treatment with at least one line of second generation androgen receptor targeting therapy and one line of chemotherapy. main breast cancer specific inclusion criteria: * histologically confirmed breast carcinoma * er positive, her2-negative advanced breast cancer * postmenopausal or pre/perimenopausal if amendable to be treated with gnrh agonist or antagonist. * documented disease progression after treatment with at least 2 lines of systemic treatment for advanced breast cancer. of these, at least one line must have been endocrine treatment in combination with a cdk4/6 inhibitor. main exclusion criteria * history of pituitary dysfunction. * known brain metastases or active leptomeningeal disease. * active infection or other medical condition that would make corticosteroids contraindicated. * hypotension or uncontrolled hypertension. * clinically significant cardiovascular disease, e.g. myocardial infarction, arterial thrombotic events, or pulmonary embolism in the past six months, unstable angina, or congestive heart failure (new york heart association \[nyha\] class ii-iv). * prolonged qtcf interval. * use of any investigational drug 4 weeks prior to the start of the study treatment.

Keywords: metastatic castration-resistant prostate cancer advanced hormone receptor positive breast cancer
autologous multipotent mesenchymal stromal cells in the treatment of amyotrophic lateral sclerosis

Conditions: Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is a progressive neurodegenerative disease that targets motor neurons. prognosis is invariably fatal within 3-5 years since manifestation of the disease. despite improved understanding of the mechanisms underlying als, the treatment remains essentially only supportive and focused on symptoms relief. over the past few years, stem cell research has expanded greatly as a tool for developing new therapies to treat incurable diseases. stem cell therapy has been shown as promising in several animal als models and human clinical trials.

subjects will be assigned to autologous mesenchymal stromal cell (amsc) treatment according to inclusion and exclusion criteria (see below) screened four times prior to administration. then the subjects will be observed for three consecutive yearsafter a half year of screening period, the autologous multipotent mesenchymal stromal cells from bone marrow will be isolated. the cells will be cultivated for 3 passages (3 - 4 weeks) in order to get sufficient amount for therapy, cell suspension for intrathecal application will be prepared and introduced intrathecally through lumbar puncture. subsequently, all the subjects will be observed at the range of standard medical care used at these types of interventions.

Eligibility criteria:
inclusion criteria: 1. established diagnosis of definite als according to el escorial criteria 2. riluzole naive or stable dose for at least 2 months, 3. life expectancy more than 2 years 4. patients able to provide written informed consent. exclusion criteria: 1. fvc less than 70% 2. in case of primary bulbar paralysis less than 15 points on norris bulbar scale, 3. less than 15 points on norris spinal scale, 4. pregnancy, breastfeeding 5. coagulopathy, 6. skin infection at the site of bone marrow aspiration or application of the cell product, 7. gastrostomy, 8. any significant medical condition that would compromise the safety of the patient (e.g. recent myocardial infarction, congestive heart failure, renal failure, liver failure, cancer, systemic infection, recurrent thromboembolic disease .....), 9. alcohol or drug abuse 10. cancer. 11. women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners 12. fertile men not using proven contraceptive measures including effective contraception of their partner (established oral contraception, intrauterine device, ligation of the uterine tube)
safety study of imexon treatment of patients with metastatic or disseminated malignancy

Conditions: Neoplasm Metastasis

Summary: amp-011 is a phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. the objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.


Eligibility criteria:
inclusion criteria: * previously treated malignant disease of any type. * prior treatment; at least one prior regimen required. * able to perform the activities of daily living. * off prior cancer therapy for at least 4 weeks. * if female, neither pregnant nor nursing. * willing to use contraceptives to prevent pregnancy. * no other serious illnesses. * no other active malignancy. * no serious infections. * no other current drug therapy for the cancer. * blood counts and blood chemistries in or near normal range. * prior radiation is permitted. exclusion criteria: * no active brain metastases.

Keywords: metastatic cancer disseminated malignant disease
efficacy, immunogenicity, and safety study of the 9vhpv vaccine in japanese males (v503-064)

Conditions: Warts, Genital; Neoplasms, Anal

Summary: the purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of v503 (9-valent human papillomavirus \[9vhpv\] vaccine) in preventing human papillomavirus (hpv)-related anogenital persistent infection, and to evaluate the safety/tolerability of v503, in japanese males who are 16 to 26 years of age. it is hypothesized that administration of a 3-dose regimen of v503 reduces the combined incidence of hpv 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of hpv 31/33/45/52/58-related anogenital persistent infection, compared with placebo. the study includes a base study to assess efficacy and safety of v503, and an extension study. participants who received placebo in the base study will be eligible to receive v503 vaccine on day 1, month 2, and month 6 of the extension study. participants who received less than 3 doses of v503 in the base study will be offered the opportunity to complete the 3-dose regimen in the extension study.


Eligibility criteria:
inclusion criteria: * is a japanese male 16 to 26 years of age * has no more than 5 lifetime sexual partners exclusion criteria: * has a history of known prior vaccination with an hpv vaccine or plans to receive one outside the study * has a history of external genital warts * has a history of severe allergic reaction that required medical intervention * has received immune globulin or blood-derived products in the past 3 months or plan to receive any before month 7 of the study * has a history of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, human immunodeficiency virus (hiv), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition * has received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids * has a known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections * has ongoing alcohol or drug abuse within the past 12 months
a study of mtps9579a in participants with refractory chronic spontaneous urticaria

Conditions: Chronic Spontaneous Urticaria

Summary: this pilot and dose-ranging study will evaluate the efficacy, safety, and pharmacokinetics of mtps9579a compared with placebo in participants with chronic spontaneous urticaria (csu) refractory to antihistamines. this study comprises two parts. in part 1, participants will be randomized to receive mtps9579a or placebo. on the basis of positive results from part 1, a dose-ranging part 2 may be opened, where participants will be randomized to receive one of four mtps9579a doses or placebo.


Eligibility criteria:
inclusion criteria: * diagnosis of csu refractory to sgh1-ahs at the time of randomization * demonstrated ability to comply with the required use of the ediary for the duration of the study * for patients on h2 antihistamines or ltras for non-csu indications, treatment at a stable dose for \>=2 weeks prior to screening, with no anticipated changes throughout duration of study, including the screening period * for women of childbearing potential: agreement to remain abstinent or use contraception * for men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm exclusion criteria: * previous participation in a clinical trial of mtps9579a * chronic urticaria with known cause or other disease with symptoms of urticaria or angioedema * other skin disease associated with chronic itching * uncontrolled disease where flares are commonly treated with systemic corticosteroids * history or evidence of any clinically significant medical condition/disease or abnormalities in laboratory tests that, in the investigator's judgment, preclude the patient's safe participation and completion of the study, or interferes with the conduct and interpretation of the study * history of anaphylaxis without clearly identifiable avoidable antigen * history of anaphylaxis to any biologic therapy for any indication
safety study of antria cell preparation process to enhance facial fat grafting with adipose derived stem cells

Conditions: Lipoatrophy; Aging; Wrinkles

Summary: the primary purpose of this study is to demonstrate the safety of injecting the stromal vascular fraction (svf) \[containing adipose derived stem cells (adscs)\] enriched fat grafts into regions of the face that require enhancement. the safety of svf will be evaluated throughout the course of the study phase through the assessment of laboratory values, physical examinations, adverse events, safety phone calls etc.


Eligibility criteria:
inclusion criteria: 1. female or male, age 18 years or older 2. subjects that are scheduled for liposuction and facial fat grafting procedures for cosmetic purposes 3. facial volume defects which could be treated with a total graft volume of between 1ml and 50ml 4. bmi between and including 23 and 28 5. able to understand and provide written and verbal informed consent exclusion criteria: 1. currently taking or have taken nsaids within last two weeks or corticosteroids within the last six weeks prior to screening 2. diagnosis of any of the following medical conditions: * active malignancy (diagnosed within 5 years), except for treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm * active infection * type i or type ii diabetes 3. subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits, dementia, and/or otherwise considered by the investigator to be unlikely to complete the study) 4. subjects with a known drug or alcohol dependence within the past 12 months as judged by the investigator 5. subjects with major illnesses involving the renal, hepatic, cardiovascular, and/or nervous systems 6. subjects with elevated kidney and/or liver functions 7. any other disease condition or laboratory results that in the opinion of the investigator may be clinically significant and render the subject inappropriate for the study procedure(s), may alter the accuracy of study results, or increase risk for subjects. 8. subjects with life-expectancies less than 9 months 9. subjects with known collagenase allergies 10. subjects with idiopathic or drug-induced coagulopathy 11. pregnant females 12. on radiotherapy or chemotherapy agents 13. taking strong cyp450 inhibitors such as protease inhibitors (ritonavir, indinavir, nelfinavir, saquinavir), macrolide antibiotics (clarithromycin, telithromycin), chloramphenicol, azole antibiotics (ketoconazole, itraconazole) and nefazodone. 14. subjects with a history of keloids or hypertrophic scar formations

Keywords: autologous adult stem cell adipose derived stem cell stromal vascular fraction svf antria shah rahimian leonard maliver david bizousky rahul gore lee quist dudley mcnitt