Kornimate/medical-research-clean huggingface dataset:
a phase 2 study with panzem in patients with relapsed or plateau phase multiple myeloma

Conditions: Relapsed Multiple Myeloma; Plateau Phase Multiple Myeloma

Summary: the purpose of the study is to determine the safety and effectiveness of providing 2-methoxyestradiol to patients with plateau phase or relapsed multiple myeloma. information regarding trough 2me2 levels will also be collected.


Eligibility criteria:
inclusion criteria: 1. have plateau phase (patients who have been previously treated with at least one conventional or high-dose chemotherapy who are currently off all therapy for at least 4 weeks and are considered to have stable disease) or relapsed mm. patients in plateau phase must have m-protein concentrations that are stable for at least 4 weeks prior to registration. 2. be at least 18 years of age. 3. have monoclonal plasma cells in the marrow. 4. have m-protein greater than or equal to 1g/dl in the serum or 200 mg of monoclonal light chain in a 24-hour urine protein electrophoresis. 5. have laboratory data as specified below: * ast and alt \< 2.5 x upper limit of normal (uln) * alk phos \< 5.0 x uln * direct bilirubin \< 2 x uln * creatinine \< 3.0 x uln * anc greater than or equal to 750 cells/mm3 * platelets \> 25,000/mm3 * hemoglobin greater than or equal to 7.0g/dl 6. have life expectancy of at least 3 months 7. have ecog performance status of 0, 1, or 2 8. women and men of child bearing potential must agree to use effective barrier contraceptive methods during study. 9. have the ability to understand the reuirements of the study, provide written informed consent, abide to study restrictions, and agree to return for the required assessments. exclusion criteria: 1. be pregnant or nursing. 2. have any condition that is likely to detrimentally affect regular follow up. 3. have a history of myocardial infarction within the last 3 months, angina pectoris/angina equivalent in the last 3 months, or uncontrolled congestive heart failure. 4. have an active infection 5. have had major surgery within 21 days of starting 2me2 administration 6. have additional uncontrolled serious medical or psychiatric illness 7. have had any active cancer in addition to the mm within the last 5 years (excluding superficial skin cancer) 8. have uncontrolled or untreated active bleeding or thrombotic disorder.
study on pharmacodynamic parameter and tolerability with subcutaneous immunotherapy in grass pollen allergic patients

Conditions: Rhinitis; Conjunctivitis; Asthma

Summary: the aim of this study is to test the pharmacodynamic equivalence with respect to ige-blocking factor and to compare the tolerability of two different updosing schedules with alk-flex sq


Eligibility criteria:
inclusion criteria: * a clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season * lack of adequate relief with symptomatic medication during the previous grass pollen season * positive skin prick test (spt) response to phleum pratense (wheal diameter \>= 3mm) currently performed or not older than 60 days before screening exclusion criteria: * fev1 \< 70% of predicted value at screening * bronchial asthma corresponding to gina step 3 or more, even if controlled * history of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months * previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years * exclusion criteria in accordance with contraindications in the spc of alk-flex sq

Keywords: allergen immunotherapy allergy to grass pollen
pre-surgical study: effect of metformin on breast cancer proliferation

Conditions: Breast Cancer

Summary: the purpose of this pilot study is to use a pre surgical intervention model to evaluate the biologic effects of metformin in women with newly diagnosed early invasive breast cancer. metformin is a drug commonly used to treat patients with diabetes. this model will be used to evaluate the effects of metformin.

breast cancer is the most common cancer and the second leading cause of cancer death among women in the united states. several epidemiologic studies have found an increased risk of breast cancer in women with type 2 diabetes. this association appears to be mediated by a state of hyperinsulinemia and insulin resistance. population based studies have also found a decreased risk of cancer in diabetic patients taking metformin, an oral biguanide derivative. proposed mechanisms include its effect on lowering serum insulin levels as well as modulation of cellular signaling pathways which inhibit tumor cellular proliferation.

Eligibility criteria:
inclusion criteria: * histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ (dcis) who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment * body mass index \> 25 * age ≥ 21 years * no prior chemotherapy, radiation therapy, or surgery within 6 months of study entry * signed informed consent exclusion criteria: * history of diabetes mellitus requiring medical therapy * treatment with other investigational drugs within 6 months of study entry * significant renal impairment with a creatinine \> 1.4 mg/dl * other serious intercurrent medical illness

Keywords: breast cancer metformin
long term immunity and safety following vaccination with the jev ic51 (ixiaro®, jespect®) in pediatric population in non endemic countries. uncontrolled, ph3 fu-study

Conditions: Japanese Encephalitis

Summary: the study investigates long-term immunity and safety of ic51 (ixiaro®, jespect®) in a pediatric population vaccinated in the parent study ic51-322.


Eligibility criteria:
inclusion criteria: * subjects who have received two vaccinations in study ic51 322. (2) subjects who were enrolled as part of the immunogenicity subgroup of study ic51-322. * male or female healthy subjects aged ≥ 9 months to \< 21 years at the time of enrolment into this study. * written informed consent by the subject, the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable. exclusion criteria: * history of or clinical manifestation of any flavivirus disease during study ic51-322. * vaccination against je virus (jev) (except with ic51) at any time prior or planned during this study. * participation in another study with an investigational product during study ic51-322 or ic51-324. * history of or development of any immunodeficiency including post-organtransplantation after inclusion into study ic51-322. * history of or development of an autoimmune disease during study ic51-322. * administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying medications started during study ic51-322 up to first visit of study ic51-324. (for corticosteroids this means prednisone or equivalent at \>= 0.05 mg/kg/day. topical or inhaled steroids are allowed). * known infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv) or hepatitis c virus (hcv). * illicit drug use and/or a history of drug or alcohol addiction and/or current drug or alcohol addiction. * inability or unwillingness by the legal representative(s) and/or the subject (where applicable) to provide informed consent/assent and to abide by the requirements of the study. * persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).
performance of the acoustic based cadscor system in coronary artery disease

Conditions: Coronary Artery Disease; Angina (stable)

Summary: the purpose of this study is to determine if the cad score, collected from the cadscore system, performs as well as the coronary cta in determining coronary artery disease, in low to intermediate risk patients that are referred for coronary cta.


Eligibility criteria:
inclusion: * signed icf * male or female, aged 30 years or above * symptoms suggestive of stable coronary artery disease * no history of coronary artery disease(prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft). exclusion: * asymptomatic for angina or chest pain * implanted donor heart * previous coronary artery bypass graft(cabg) * previous coronary stenting or known cad * arrhythmia causing non-sinus rhythm * fragile or compromised skin, or abnormal anatomy or significant operation scars in the fourth left int3er costal 9ic4-l) recording area * implanted mechanical heart or mechanical heart pump * implanted pacemaker or cardioverter defibrillator(icd), other implanted active electronics or act5ive electronic support equipment closer than 50 cm to the cadscore system.

Keywords: cadscore
phase i pilot study of ad5-cb-cftr, an adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene, in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: objectives: i. assess the safety and efficacy of gene transfer into the nasal epithelium using ad5-cb-cftr, an e1-deleted adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene, in patients with cystic fibrosis (cf). ii. determine whether ion transport abnormalities in cf airway cells can be corrected.

protocol outline: groups of 3 patients receive 1 of 4 doses of ad5-cb-cftr, a recombinant e1-deleted adenovirus serotype 5 vector containing the cystic fibrosis transmembrane conductance regulator gene. ad5-cb-cftr is administered to 1 nasal cavity and the vehicle alone is administered to the opposite nasal cavity as the control.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- cystic fibrosis no mild genetic mutations, i.e., normal nasal chloride ion permeability at least 2 weeks since decrease in pulmonary function --prior/concurrent therapy-- at least 3 months since systemic cortisone at least 1 month since other therapeutic research study, e.g., dnase --patient characteristics-- other: adequate endocrine, liver, kidney, and cardiac function adenovirus antibody seropositive no pregnant or nursing women negative pregnancy test required of fertile women adequate contraception required of fertile patients

Keywords: cardiovascular and respiratory diseases cystic fibrosis genetic diseases and dysmorphic syndromes rare disease
the gilenya pregnancy registry

Conditions: Multiple Sclerosis

Summary: the purpose of the multi-national gilenya pregnancy exposure registry in multiple sclerosis (ms) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to fingolimod before (up to 8 weeks before last menstrual period (lmp)) and during pregnancy in routine clinical practice. the overall aim is to collect and evaluate data on maternal, fetal, and infant outcomes and compare it with reference populations.


Eligibility criteria:
inclusion criteria: * any woman with a diagnosis of ms * any woman currently pregnant * exposure to fingolimod during pregnancy or up to 8 weeks before lmp * signed informed consent exclusion criteria: * there are no specific exclusion criteria for this registry.

Keywords: fingolimod fty720 gilenya multiple sclerosis ms safety pregnancy pregnancy outcomes
evaluation of frail elderly in ambulatory primary care

Conditions: Frailty

Summary: evaluate the sensitivity of the gerontopole scale, used by general practitioners in primary care outpatients for the diagnosis of frailty in non-dependent people more than 65 years old, using as reference the "évaluation gériatrique standardisée clinique" (egs)


Eligibility criteria:
inclusion criteria: * independent patients exclusion criteria: * dependent outpatient, assessed with a "activity of daily living" (adl) score \< 6/6 * outpatient with occuring severe health episode less than a month before inclusion
a multi-center cardiac pyp scan registry in taiwan

Conditions: Heart Failure; Cardiac Amyloidosis

Summary: amyloid deposition in the heart is called cardiac amyloidosis (ca); 95% is immunoglobulin light chain amyloidosis (al) and transthyretin amyloidosis (attr). hereditary (attrm) or wild-type (attrwt) depends on whether the attrm gene is mutated or not. the most common mutation in taiwan is a97s, 80% have left ventricular hypertrophy. the good prognosis depends on early diagnosis and correct treatment strategy. bone-avid tracers such as 99mtc-pyp/dpd/hmdp could detect ca. the mechanism is not clear yet, which may be related to the microcalcification. al amyloidosis is mostly between visual score grade 0-2, and attr-cm is usually grade≥2 on pyp scan, or heart to contralateral (h/cl) ratio, and it might replace invasive myocardial biopsy. however, there are no large-scale clinical studies, lack of standardization data, and limited information in comparison between clinical and imaging parameters. the project will enroll patients with suspected or diagnosed with ca according to ca diagnostic algorithm. clinical data and image parameters are collected and compared. the project aims to set up prediction models based on the multi-parameters of pyp scan using artificial intelligence technology, including imaging registration and alignment technology, and standardization. the investigators further use the key cardiovascular data elements and imaging-derived database using model training network to extract image features to develop the diagnostic and prognostic prediction models, which are expected to validate the clinical significance and improve patient-centric performance and efficient clinical decision making.

the investigators will retrospectively and prospectively collect total pyp scans that had been performed on suspected or diagnosed attr-cm patients in medical centers in taiwan and follow-up at least 1 year. you are enrolled based on clinical suspicions such as "red-flag" signs using ultrasound, nt-pro bnp and clinical data according to the diagnostic algorithms. if you are with grade 2 and 3 pyp myocardial uptake, genetic testing is arranged, serum and urine al tests results will be confirmed. before reading, the imaging quality will be evaluated (good quality, fair but interpretable, poor but interpretable, poor and insufficient for interpretation). all the images will be visually graded by experienced nuclear medicine physicians with consensus. it helps understand the real-world data.

Eligibility criteria:
inclusion criteria: 1. ≥ 20 years of age 2. documented diagnosis or r/o of attr amyloidosis exclusion criteria: 1. pregnant or nursing (lactating) women. 2. important systemic diseases (except heart disease or neurological diseases) such as liver cirrhosis, active malignant tumors, etc., with a life expectancy of less than 6 months. 3. patient who refused clinical follow up.
the effect of simulation-based training on postpartum haemorrhage management skills

Conditions: Simulation Training; Nursing; Postpartum Hemorrhage

Summary: this study was planned to determine the effect of simulation-based training using two different reality levels-visually enhanced mental simulation (vems) and hybrid simulation-on postpartum haemorrhage (pph) management skills in nursing students.

this study will be conducted to determine the effect of simulation-based training using two different reality levels-visually enhanced mental simulation (vems) and hybrid simulation-on postpartum haemorrhage (pph) management skills in nursing students. pph is one of the leading causes of postpartum maternal mortality and its effective management requires the knowledge, skills and coordination of the healthcare team. however, it is difficult for nursing students to acquire these skills directly in the clinical environment due to rare observation and structural limitations in education. simulation-based education stands out as an important method to develop such critical clinical skills. in this randomised comparative study, 4th year students studying at bandırma onyedi eylül university, department of nursing who have completed the course of women's health and diseases nursing in the spring semester of the 2024-2025 academic year will be included in the study. the sample size was calculated by g\*power analysis and a total of 64 students were randomly assigned to two groups. one of the intervention groups will receive pph management training with vems method and the other will receive pph management training with hybrid simulation. the training programme will be conducted within the scope of a structured curriculum including theoretical training, skills training and simulation applications. 'participant information form', "postpartum haemorrhage management observation form" and "student satisfaction and confidence in learning scale" will be used to collect data. the skill levels of the students will be evaluated by two independent observers, and learning satisfaction and self-confidence levels will be measured through the scales. the findings of the study are expected to provide important contributions in evaluating the effect of simulation-based training on pph management skills. in particular, it is investigated whether the low-cost and highly applicable vems method is effective in terms of student satisfaction, confidence in learning and skill development as an alternative to traditional simulation approaches. the results obtained from the study may provide evidence-based recommendations to increase the efficiency of simulation applications in nursing education.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the research * to have a grade point average of 2.00 and above exclusion criteria: * not participating in all stages of the training programme * incomplete completion of data collection tools * wanting to leave the research.

Keywords: simulation training nursing postpartum hemorrhage
treatment of acute rhino-sinusitis with essential oils of aromatic plants

Conditions: Rhino-Sinusitis

Summary: this randomized, double blind, parallel group study, compared the efficacy of spray containing aromatic essential oils of some herbal plants, against placebo in the treatment of patients with acute rhino-sinusitis. study objectives: primary to demonstrate a relief in the nasal obstruction within 20 minutes after first administration of treatment with the spray. secondary to demonstrate a reduction of a defined symptoms sum score based on symptoms and signs comparing baseline therapy from the beginning to the end of 3 days treatment

this study compared the efficacy of spray containing aromatic essential oils of eucalyptus citriodora, eucalyptus globulus, mentha piperita, origanum syriacum, and rosmarinus officinalis, against placebo in the treatment of patients with acute rhino-sinusitis. in- vitro and clinical studies suggest therapeutic potential of aromatic herbs and trees oils in the treatment of rhino-sinusitis. the pharmacological and clinical activity of eucalyptus citriodora, eucalyptus globulus, mentha piperita, origanum syriacum, and rosmarinus officinalis, include anti-inflammatory, anti-bacterial and anti-viral activities. some of these herbs and trees oils have direct activity on the respiratory tract, the coughing reflex and the airflow in the nasal tract.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute rhino-sinusitis. * active disease less than 96 hours * patients agree to sign informed consent according to gcp and israel national regulations. exclusion criteria: * acute sinusitis that need to get an antibiotically treatment . * nasal polyposis. * under any antibiotically treatment. * asthma disease. * under coumadine therapy. * hyper sensitivity to aromatic essential oils. * any immuno-suppressive disease

Keywords: rhino-sinusitis; herbal medicine; traditional medicine; aromatic essential oils;
whole body 111in-exendin-4 imaging study in insulinoma patients

Conditions: Hyperinsulinism; Hypoglycemia; Insulinoma

Summary: the purpose of this study is to determine whether the investigators' new imaging modality (111in-exendin-4) has advantages in detecting insulinomas in comparison to conventional imaging.

insulinomas arise from pancreatic cells and are the most frequent hormone-active tumours of the pancreas. insulinomas produce insulin and can become life threatening if they cannot be localised and removed surgically. complete tumour resection cures most patients, hence surgery is the treatment of choice for begin and malignant insulinomas. the potential for surgical cure necessitates accurate tumour localisation before surgery because preoperative imaging facilitates the detection of small localised, multiple and metastatic insulinomas. however, the successful localisation of insulinomas is an challenging problem since approximately 30% of insulinomas cannot be visualised radiographically. a novel nuclear medicine scanning method using radioactive exendin-4 (111in-exendin-4) has recently been developed for imaging of insulinomas. 111in-exendin-4 accumulates specifically in insulinoma cells via the glucagon-like peptide-1 (glp-1) receptor. the accumulation of 111in-exendin-4 can be visualised by the use of a special camera (single photon emission computed tomography (spect) camera) that detects radioactivity and lights up tumours as hot spots. the decision to perform surgery is independent of this study. if surgery is performed a small sample of the tumor will be used for identifying the sites where 111in-exendin-4 binds to the tumor.

Eligibility criteria:
inclusion criteria: * biochemically proven endogenous hyperinsulinism confirmed by hypoglycaemia with neuroglycopenic symptoms, inadequately high serum insulin and c-peptide concentrations and negative sulfonylurea screening as well as low serum beta-hydroxybutyrate concentrations * able and willing to provide written informed consent exclusion criteria: * renal insufficiency (creatinine \> 140 micromol/l) * pregnancy or positive pregnancy test which will be performed in all patients without contraception and aged \< 50 years * allergy to exendin-4 (byetta®)

Keywords: glucagon-like peptide-1 receptor targeting insulinoma imaging exendin-4 molecular imaging