Kornimate/medical-research-clean huggingface dataset:
biomarker rule in/out in patients with acute diseases for validation of aki (brava) acute kidney injury

Conditions: Acute Kidney Injury

Summary: the presence or development of aki impacts on outcomes in patients presenting with acute conditions to the ed. as a result, treating physicians are often concerned with the risk of aki and take such risk in consideration when making subsequent therapeutic and diagnostic decisions which may result in delaying or withholding therapeutic measures in order to prevent further kidney damage (i.e. avoid imaging studies with contrast media). if clinicians could be informed early that a patient is at minimal risk for aki, they could deploy timely and optimal diagnostic and treatment procedures for the underlying disease of the patient without major concerns for causing or exacerbating kidney damage

in patients with acute diseases, it is mandatory for ed physicians to immediately detect the presence of aki or exclude; but unfortunately serum creatinine (scr) variations (based on kdigo or akin criteria), take 24 to 48 hours to manifest the presence of acute renal ongoing damage. aki is currently, infact, defined as an increase in scr of 1.5-fold from baseline within 24 to 48 hours, and decrease in diuresis from admission in hospitalization, using kdigo. as consequence, similarly to other biomarkers, such as troponins in acute coronary syndrome and d-dimer in pulmonary embolism, a laboratory test to rule in or rule out aki is needed in critical patients in ed and our primary objective would be to evaluate the role of urine timp-igfbp7 in this setting. primary objective of the brava study would be to evaluate the role of the urine biomarkers timp-igfbp7 in predicting the occurrence of aki in patients presenting to ed with different acute diseases and need for hospitalization.

Eligibility criteria:
patient inclusion criteria * age ≥ 21 years * \>30% risk of developing aki based on treating physicians' clinical evaluation and/or presence of one of the following conditions: * suspected or confirmed sepsis. * acute decompensated heart failure. * prolonged gastrointestinal losses from vomiting or diarrhea * major trauma * major bleeding (e.g. gastrointestinal, pulmonary, genitourinary) * severe burns * diabetic crisis (dka, hhs) * decompensated liver cirrhosis * acute coronary syndrome * emergent need for iodinated contrast studies * shock from any cause patient exclusion criteria * age \< 21 years. * unable to give informed consent * undergoing hemodialysis or peritoneal dialysis * pregnancy * terminal illness with \< 6 months prognosis * do-not-resuscitate status

Keywords: aki biomarkers urine timp-igfbp7 emergency department
evaluation of a socio-ecological cardiovascular disease prevention intervention for ultra-orthodox jewish hasidic women

Conditions: Cardiovascular Diseases; Health Behavior

Summary: the purpose of this research study is to design, implement, and evaluate a community level, socio-ecological based cvd prevention intervention using a participatory approach for women in a homogeneous ultra-orthodox jewish hasidic community in israel. a quasi-experimental, pre-post study design will be utilized, where all community participants will be exposed to intervention components. pre and post samples will be selected through randomized cluster sampling of pre-existing community groups. it is hypothesized that ultra-orthodox jewish hasidic women exposed to this community intervention will have improved healthy eating behaviors, reduced unhealthy eating behaviors, increased engagement in physical activity and sleep, and reduced risk for obesity (weight, bmi).

the purpose of this research study is to design, implement, and evaluate a community level, socio-ecological based cvd prevention intervention using a participatory approach for women in a homogeneous ultra-orthodox jewish hasidic community in israel. a quasi-experimental, pre-post study design will be utilized, where all community participants will be exposed to intervention components. pre and post samples will be selected through randomized cluster sampling of pre-existing community groups (n=239 ). intervention components will be designed through qualitative and quantitative data collection (focus groups, interviews, and questionnaires) from the target population and implementation will be conducted in partnership with community organizations. intervention components will include a health newsletter, health workshops, community evening/health project registration, lay leader training, neighborhood exercise groups, community walking programs with pedometers, healthy cooking contest, and school health promotion activities. it is hypothesized that ultra-orthodox jewish hasidic women exposed to this community intervention will have improved healthy eating behaviors, reduced unhealthy eating behaviors, increased engagement in physical activity and sleep, and reduced risk for obesity (weight, bmi).

Eligibility criteria:
inclusion criteria: * hebrew, english, or yiddish speaker * ultra-orthodox jewish hasidic woman in the targeted community exclusion criteria: * none

Keywords: community-based intervention socio-ecological model participatory approach ultra-orthodox jewish women
the effect of taping in reducing the intensity of pain in primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: to determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea

primary dysmenorrhea is defined as cramping pain in the lower abdomen occurring just before or during menstruation, in the absence of other diseases. about 50-90% of the women experience menstrual pain, and approximately 15% of them suffer from a severe level of pain it is a common cause of absenteeism and reduced quality of life in women. from 21% to 96% of women with menstrual pain, reported to practice self-treatment either by pharmacological or nonpharmacological interventions. however, there are adverse events associated with the use of these drugs, including stomach ache, diarrhea, nausea, cutaneous reactions, liver or kidney damage or cardiovascular risk after discontinuing medication . therefore, many patients with menstrual pain usually seek complementary and alternative techniques. medical taping concept is an alternative treatment that use elastic adhesive tape, which is applied to the patient's skin under tension. it has the characteristic to cause elevation of the epidermis and thereby reduce the pressure on the mechanoreceptors below the dermis. this would have the effect of reducing nociceptive stimuli.

Eligibility criteria:
inclusion criteria: * women presenting menstrual pain, 4 or more in vas. * have attended gynecological examination in the past 18 months and had ever diagnosed as having a gynecological disorder different from primary dysmenorrhea * not have been diagnosed with secondary dysmenorrhea * regular menstrual cycles (cycle typical range of 21 to 35 days) * do not use an intrauterine contraceptive device (iud) or taking oral contraceptive pills * nulliparous * ability to complete questionnaires in spanish. exclusion criteria: * women with mild dysmenorrhea (pain lower 4 in a numeric pain scale range 0-10); * women with irregular or infrequent menstrual cycles (outside the typical range of cycle 21 to 35 days); * women using an intrauterine contraceptive device (iud) or taking oral contraceptive pills. * women who suffer from diseases diagnosed added * women to which it has undergone a surgical procedure for the treatment * provide skin lesions in the abdominal wall or in lumbar region * use or abuse of drugs or alcohol

Keywords: primary dysmenorrhea taping pain
tocilizumab real-life human factors (rlhfs) validation study

Conditions: Rheumatoid Arthritis

Summary: this study is designed to evaluate rlhfs concerning administration of the tocilizumab autoinjector ai-1000 g2 in adults with rheumatoid arthritis (ra) who have been receiving subcutaneous (sc) tocilizumab using the commercially available prefilled syringe and needle safety device (pfs-nsd). the study will enroll participants with ra, a subset of whom will be assigned to perform self-injection with the ai-1000 g2. enrolled caregivers (cgs) and healthcare professionals (hcps) will administer the ai-1000 g2 injection to the remaining study participants.


Eligibility criteria:
inclusion criteria: * participants with ra for greater than or equal to (\>/=6) months receiving 162 mg tocilizumab pfs-nsd for \>/=8 weeks and who are suitable for continued treatment at their currently prescribed dose * cgs and professionally qualified hcps who are able and willing to administer the injection exclusion criteria: * ra: functional status class iv * ra: neuropathies or other conditions that might interfere with pain evaluation * ra: pregnant or breastfeeding * ra: low neutrophil or platelet count at last laboratory assessment * ra: elevated liver enzymes at last laboratory assessment * current participation in another interventional clinical trial * criteria that might give the participant/cg/hcp an advantage in injection tasks such as employment in the pharmaceutical industry, etc.
crossover bioequivalence study of oxcarbazepine 600 mg suspension under fasted conditions

Conditions: Seizures

Summary: the objective of this study was to prove the bioequivalence of roxane laboratories' oxcarbazepine suspension 600 mg under fasted conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to oxcarbazepine or any comparable or similar product.
well being of obstetric patients on minimal blood transfusions

Conditions: Anemia

Summary: postpartum haemorrhage (pph) is one of the top five causes of maternal mortality in developed and developing countries. the most important treatment of pph is red blood cell (rbc) transfusion. the decision whether to prescribe rbc transfusion is mostly based on postpartum haemoglobin (hb) values. rbc transfusion should be aimed to reduce morbidity and especially to improve health related quality of life (hrqol). the goal of the womb study is to assess the effect of rbc transfusion on hrqol and to confirm the role of hrqol in deciding whether rbc transfusion is necessary.

the womb study is a multicenter trial in patients with pph, where a restrictive rbc transfusion policy will be compared with a more liberal rbc transfusion policy. primary outcome in this study is fatigue measured with the mfi questionnaire. inclusion criteria are: 1) 12-24 h after vd or cs; 2) 4.8 ≤hb≤ 7.9 g/dl; 3) blood loss ≥ 1000ml or hb decrease ≥ 1,9 g/dl; 4) age≥ 18 years; 5) no anaemic symptoms. patients will be randomised for a rbc transfusion or not. the total follow-up period is 6 weeks. hrqol will be measured at t=0 (12-24 hours postpartum) 3 days, 1, 3 and 6 weeks postpartum. at t=0 and 6 weeks postpartum hb value will be measured. for the patients who receive a rbc transfusion, the effect of the rbc transfusion will be measured with the hb value, hct, platelet and leukocyte count, and the temperature of the patient before and after the rbc transfusion. the sample size is 500 patients: 250 allocated to a rbc transfusion and 250 patients allocated to a restrictive policy.

Eligibility criteria:
inclusion criteria: * women older than 18 years * 12-24 hours after delivery (vaginal or caesarean section) * patients are in a clinical obstetric setting * blood loss of more than 1000 ml or hb decrease ≥ 1,9 g/dl * hb value between 4.8 g/dl and 7.9 g/dl * working knowledge of the national language * written consent for participating this study (informed consent) exclusion criteria: * patients with severe preeclampsia/ hellp syndrome * rbc transfusion during or after delivery but before t=0 * patients with malignancy * patients with severe congenital haemolytic disease, like thalassemia or sickle cell disease * patients with compromised immunological status, congenital or acquired by medical treatment or infectious disease (eg. hiv) * severe active infectious disease at the time of proposed inclusion * severe cardiac, pulmonary, neurological, metabolic or psychiatric co- morbidity (asa ii/iii) at the time of proposed inclusion * severe physical complaints (tachycardia of more than 100 bpm, dyspnoea, syncope, heart problems) at the time of intended inclusion * peripartum death of the newborn, or the newborn being in critical condition on neonatal intensive care

Keywords: postpartum hemorrhage red blood cell transfusion health related quality of life
a study to evaluate the efficacy and safety of povorcitinib (incb054707) in participants with moderate to severe hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa (HS)

Summary: the purpose of this study is to evaluate the efficacy and safety of povorcitinib (incb054707) in participants with moderate to severe hidradenitis suppurativa (hs) over a 12-week placebo controlled period, followed by a 42-week extension period.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe hs for at least 3 months prior to the screening visit. * total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits * hs lesions in at least 2 distinct anatomical areas (examples include but are not limited to left and right axilla or left and right inguinocrural fold), 1 of which must be at least hurley stage ii or hurley stage iii, at both the screening and baseline visits * documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for hs (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their hs). * agreement to not use topical and systemic antibiotics for treatment of hs during the placebo-controlled period. * agreement to not use a diluted bleach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by hs lesions during the placebo-controlled period. note: over-the-counter soap and water is allowed. * agreement to use contraception * willing and able to comply with the study protocol and procedures. * further inclusion criteria apply. exclusion criteria: * presence of \> 20 draining tunnels (fistulas) at either the screening or baseline visit. * women who are pregnant (or who are considering pregnancy) or breastfeeding. * medical history including thrombocytopenia, coagulopathy or platelet dysfunction, q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator. * laboratory values outside of the protocol-defined ranges. * further exclusion criteria apply.

Keywords: hidradenitis suppurativa hidradenitis acne inversa hs incb054707 povorcitinib
simulation training as a tool to decrease occupational stress in icu personnel

Conditions: Education, Health

Summary: the purpose of the study is to check wether training mixed teams of physicians and nurses from intensive care units on patient simulators reduces stress in team members.

patient safety and the prevention of medical error are primary goals of healthcare organizations. stress reduction may reduce or ameliorate such errors. simulation training, using advanced patient simulators, has been shown to improve diagnostic, resuscitation and technical skills amongst physicians and nurses.we intend to check wether stress during icu shifts may be reduced by using specifically designed scenarios based on real life experience,in integrative multidisciplinary icu teams.

Eligibility criteria:
inclusion criteria: * intensive care physicians and nurses working in respiratory icu willing to participate in the study exclusion criteria: * unwilling to participate

Keywords: intensive care stress education simulation
immunogenicity and safety of v503 in chinese males 9 through 19 years old (v503-053)

Conditions: Genital Warts

Summary: this study is designed to demonstrate non-inferior immunogenicity of 3 doses of the 9-valent human papillomavirus (9vhpv) vaccine (gardasil™9, v503) in chinese males 9 through 19 years of age, and 2 doses of the 9vhpv vaccine in chinese males 9 through 14 years of age, compared to the 3 dose regimen in chinese males 20 through 26 years of age (from merck protocol v503-052). the primary hypothesis is that each of the 3-dose regimen in chinese males aged 9 through 19 years and 2-dose regimens in chinese males aged 9 through 14 years induces non-inferior competitive luminex immunoassay (clia) geometric mean titers (gmts) at one month post last dose compared to the 3-dose regimen in chinese adult males aged 20 through 26 years. a noninferiority margin of 0.67 in the gmt ratio (9 through 19 years of age or 9 through 14 years of age vs 20 through 26 years of age) is used for each hpv type.


Eligibility criteria:
inclusion criteria: * is a healthy chinese male. * has not had sexual debut at the time of enrollment, and does not plan on becoming sexually active during the vaccination period (day 1 through one month post last dose). exclusion criteria: * has a history of known prior vaccination with an hpv vaccine. * has a history of hpv-related external genital lesions, hpv-related intra-anal lesions, or hpv-related head and neck cancer. * has a history of severe allergic reaction that required medical intervention. * has received immune globulin or blood-derived products in the past 6 months or plans to receive any before one month post last dose. * 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 im injections.
future optimal research and care evaluation - aortic stenosis

Conditions: Severe Aortic Valve Stenosis; Moderate Aortic Valve Stenosis

Summary: in the past decade the treatment of aortic valve stenosis has rapidly changed. at first, transcatheter aortic valve implantation (tavi) was a last resort option for inoperable patients. nowadays, it more and more becomes an alternative to surgical aortic valve replacement (savr) - also in younger and lower risk patients. this poses important questions to clinical practise regarding the optimal life-time management of each individual patient. which involves (durability of) treatment modality (surgical vs. transcatheter vs. conservative treatment) as well as the duration and type of the required antithrombotic treatment. objective: to evaluate the effect of treatment modality (surgical vs. transcatheter vs. conservative treatment) and its complications on quality of life and survival in aos patients.


Eligibility criteria:
inclusion criteria: * older than 18 years of age * severe or moderate aortic stenosis no exclusion criteria are applicable to this registry
does thiamine help vomiting and nausea in pregnancy?

Conditions: Hyperemesis Gravidarum

Summary: there are different treatments for nausea and vomiting in pregnancy. according to the acog recommendations, promethazine is the first line of parenteral treatment after oral treatment had failed. thiamine is given to prevent wernicke encephalopathy. this research try to find out whether thiamine helps the vomiting and nausea as well, by comparing the response to thiamine and promethazine in women who suffer from nausea and vomiting in pregnancy.

* research groups: pregnant women eho visit the emergency room for nausea and vomiting in pregnancy, pregnancy age 12 weeks or less * after basic examinations and hydration, the women will randomized to thiamine or promethazine treatment. * if no improvement is shown, the patient will be treated with the other drug * the patients will be interviewed on their current visit and every two weeks until 14th week of gestation * the interview includes medical history and details about their illness, other treatments, hospitalization etc.

Eligibility criteria:
inclusion criteria: * pregnant women until 12th week of gestation * the women visit the er because of nausea and vomiting * the women didn't received thiamine yet exclusion criteria: * pregnant women over 12th week of gestation * women that received thiamine before * women that allergic to the studied drugs

Keywords: nausea vomiting pregnancy thiamine promethazine nausea and vomiting in pregnancy
dna methylation and arsenic-associated urothelial carcinoma

Conditions: Urothelial Carcinoma

Summary: the investigators previously pointed out the significant association between urinary arsenic profiles and urothelial carcinoma (uc) risk through a 12-year follow-up study. further, the investigators observed the increased uc risk in people with lower plasma folate and higher homocysteine than those with higher plasma folate and lower homocysteine in 2010. s-adenosylmethionine (sam) is one factor included in one-carbon metabolism pathway and is the main donor of methyl group in cells. the ratio of sam and its metabolite s-adenosylhomocysteine (sah) not only reflected the intake level of dietary folate but also demonstrated the extent of global dna methylation. these factors might play important roles in uc carcinogenesis. the investigators would expect to take three years to explore the interactions among global dna methylation, one-carbon metabolic pathway factors, urinary arsenic profiles, the polymorphisms and haplotype of glycine n-methyltransferase (gnmt) and uc. in the first year, the investigators would measure the levels of plasma folate, homocysteine, sam and sah and evaluate the associations between these factors and uc risk. in the second year, the investigators would set up the method of immunohistochemistry stain and compare the differences between the global dna methylation from bladder tissues and blood. in the last year, this investigators would analyze the gnmt gene polymorphism and haplotype variation. at the same time, the investigators would explore the impact of gnmt genetic variation and global dna methylation on uc risk. based on the results from our research, the investigators might propose that the decreased ratio of sam/sah resulted in uc risk increased. this mechanism might be through the changed levels of urinary arsenic profiles and global dna methylation.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of urothelial carcinoma * the voluntary of participating the study exclusion criteria: * age smaller than 20 years * pregnant women * not willing to participate the study because of their personal reasons