Kornimate/medical-research-clean huggingface dataset:
a phase 3 study to evaluate the efficacy of xw003 compared with dulaglutide in participants with t2dm

Conditions: T2DM; Type 2 Diabetes Mellitus

Summary: the aim of the study is to compare the efficacy and safety of two xw003 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (t2dm)

in this phase 3 study, eligible participants will be randomized in a 1:1:1 ratio to receive once-weekly subcutaneous xw003 (high or dose) or active comparator dulaglutide as add-on to metformin treatment for 52 weeks, including a dose-escalation period.

Eligibility criteria:
inclusion criteria: 1. ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures 2. sex: male or female; age: 18 to 75 years, inclusive 3. bmi: 20.0 kg/m\^2 to 35.0 kg/m\^2, inclusive 4. have been diagnosed with t2dm for at least 3 months and treated with a stable dose of metformin (≥1500 mg/day) in addition to diet and exercise during the 8 weeks prior to screening. 5. hba1c ranging from 7.5% to 11.0% at screening, inclusive 6. fpg ≤13.9 mmol/l at screening exclusion criteria: 1. history of type 1 or other types of diabetes mellitus 2. use of insulin during the 6 months preceding screening 3. history of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to screening. 4. history of acute or chronic pancreatitis or high-risk factors for pancreatitis 5. personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. 6. history of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months. 7. history of heart attack, stroke or congestive heart failure of grade 3 or 4 in the past 6 months.

Keywords: t2dm glucagon-like peptide-1 glp-1 ecnoglutide xw003
lifting effect on recovery after mastectomy

Conditions: Seroma Complicating A Procedure

Summary: breast cancer surgery has evolved towards ever more breast conserving direction. even thought the surgical regime has become easier for the patient, many instructions given to the patient after the operation base on instructions, which have been used when the performed operations have been more burdensome. previously the patients have been instructed to lift only light objects after the operation, but according to the current knowledge, this instruction might be unnecessary. the meaning of this study is to compare two patient groups to each other. the other group is instructed to avoid lifting, and the other group is given instructions to lift light weights several times daily. in the study we compare will this have an effect on 1. incidence of upper limb lymphedema 2. seroma formation after surgery 3. quality of patients life after the surgery inclusion criteria is patients underoing mastectomy but no axillary clearance on day-care basis. patietns will be randomized in two groups, the other as an intervention group and other as an control group. the patients are asked to fill a questionnaire considering recovery from the operation and possible wound healing problems. the amount of seroma is recorded. the volume of upper limbs is measured before and after the surgery. the study is started in january 2022 and finished in december 2024.


Eligibility criteria:
inclusion criteria: * patients with breast cancer diagnosis requiring mastectomy * patients being operated in day-care regime exclusion criteria: * patients not eligible for day-care mastectomy * patients undergoing axillary clearance operation
hydromorphone versus prochlorperazine + diphenhydramine for acute migraine

Conditions: Migraine

Summary: opioids are commonly used to treat migraine in north american emergency departments. we are comparing efficacy and adverse events of hydromorphone, an opioid, to that of prochlorperazine, a dopamine antagonist with known efficacy in migraine. prochlorperazine will be combined with diphenhydramine to prevent adverse events.


Eligibility criteria:
inclusion criteria: * migraine headache (international classification of headache disorders 3b criteria) exclusion criteria: * brain imaging ordered * fever * objective neurological findings * pregnancy/ breast feeding * allergy/ contraindication to investigational medication * history of addiction to opioids, use of methadone, any use of opioids previous 30 days
digital breast tomosynthesis versus digital mammography: a national multicenter trial

Conditions: Breast Neoplasms

Summary: the goal of this study is to determine the value of the new mammography technique called digital breast tomosynthesis (dbt) compared to the current standard technique digital mammography for the early detection of breast cancer. dbt is able to compute a three-dimensional image of a breast from several low-dose mammographies taken from different angles while the device is moving around the breast in a circular motion. this should overcome a significant limitation of digital mammography arising from the masking of breast cancer in a mammography image caused by overlying normal breast tissue. this is a study conducted in several austrian breast imaging centers.

this prospective national multicenter multivendor trial aims at determining the impact of the novel technique digital breast tomosynthesis (dbt) in the assessment and screening for breast cancer. mammography is the primary imaging modality for the early detection of clinically occult breast cancer. despite advances in mammographic technique, mammography is still limited with regard to both sensitivity and specificity. in the majority of cases these limitations arise from the masking of subtle breast cancer lesions by overlapping breast tissue. dbt is a novel technique that tries to overcome these limitations by performing a 3d-reconstruction of breast tissue from multiple low-dose digital mammographic images acquired in several planes in a 15 to 50 degree angle. early studies indicate an advantage of dbt compared to the standard full field digital mammography (ffdm) in terms of an improvement of specificity without cutback in sensitivity. controversy continues over the use of dbt in combination with ffdm or as a standalone screening method without concomitant 2d imaging. unfortunately, the peer-reviewed publications evaluating dbt are limited and consist of single institution studies with a small number of participants. the purpose of this study is to evaluate the novel technique of dbt compared to routine ffdm in a clinical large sample study (600 participants) to provide the path to implementation of this new technique into clinical and screening routine.

Eligibility criteria:
inclusion criteria: * age \> 25 years (40 years or older for screening cohort) * no history of breast cancer * written informed consent * asymptomatic women in follow up for early detection of breast cancer or * patients with a recent positive mammography (bi-rads 3-5) exclusion criteria: * pregnant and breast feeding women * unable to tolerate breast compression * breast implants * unable to understand or execute written informed consent

Keywords: digital breast tomosynthesis digital mammography breast cancer detection
health economy register

Conditions: Breast Neoplasms

Summary: in breast oncology, the increasing number of oral and intravenous drug therapies pose great challenges for patient management. numerous studies demonstrate that well-informed patients develop higher confidence in their treatment and a greater sense of disease control, resulting in increased adherence and persistence as well as potentially better outcome. the electronic patient reported outcome (epro) tool cankado is designed to help oncologists to fill the gap between good, personalized care and a time and resource-saving treatment for cancer patients. cankado helps patients and their physicians regarding therapy management by a standardized documentation procedure and, if needed, direct feedback to patients by the integrated pro-react system. gera includes patients undergoing systemic therapy for breast cancer with access to cankado. the trial is based on questionnaires that are answered by patients via the cankado patient app. primary objective is to gain knowledge on the health economic impact of cankado resource utilization in breast cancer care including the evaluation of physicians' time and patient experience.


Eligibility criteria:
inclusion criteria: * men and women with breast cancer * ongoing medical drug treatment * 18 years or older * cankado account exclusion criteria: * lack of consent to study participation or lack of patient's ability to stuconsent
diagnostic impact of low-dose dobutamine echocardiography in low-flow low-gradient aortic stenosis

Conditions: Aortic Valve Stenosis; Valvular Stenosis; Valvular Heart Disease

Summary: when aortic valve-area is \ 40mmhg, the diagnosis of severe aortic stenosis (as) is straightforward. however, some patients present with an apparently reduced valve-area, despite transvalvular-gradient \<40mmhg; low-flow, low-gradient aortic stenosis (lflg as). when a patient with lflg as also presents with lvef \<50%, guidelines recommends performing a low-dose dobutamine-echocardiography (ldde) to confirm true-severe as. however, nearly 30% of patients with lflg as do not show an adequate respond to dobutamine. more commonly, patients present with the combination of lflg as, despite lvef≥50%. in this group of patients the use of ldde remains undisclosed. the purpose of this study is to examine the safety and diagnostic usefulness of ldde in patients with lflg as with lvef≥50%. furthermore we will examine factors associated with inadequate response to ldde. 150 symptomatic and/or asymptomatic patients with lflg and lvef≥50% and a control group with lvef\<50% will be enrolled at the department of cardiology, ouh. patients will undergo clinical evaluation including ldde, blood analyses, ct-scan and cardiac mri. only a limited number of studies examine the possible use of ldde in patients with lflg as and lvef≥50% and no study has been performed documenting the safety and feasibility.


Eligibility criteria:
inclusion criteria: 1. low-flow (svi\<35 ml/m2) low-gradient (mean gradient \<40 mmhg) as with estimated ava\<1.0 cm2 referred to the department of cardiology, odense university hospital. 2. age \> 18 years. 3. signed informed consent. exclusion criteria: 1. other moderate-severe valvular heart disease. 2. unwilling to participate in the study. 3. poor echocardiographic window. 4. inability to follow-up due to temporary citizenship registration number (cpr-number) or emigration within the study period. 5. pregnant women. 6. patients with severe chronic renal failure (egfr\<40 ml/min) will not undergo cardiac mri or ct angiography. 7. known contrast allergy.
low-intensity focused ultrasound and autonomic response

Conditions: Autonomic Dysfunction

Summary: studying the effects of low intensity focused ultrasound (lifu) to the dorsal posterior insula (dpi) and dorsal anterior cingulate cortex (dacc) on autonomic control using a test to probe the autonomic system. a cold pressor task will be performed pre and post lifu application. physiologic recordings will be recorded throughout.

characterize the effect of lifu to the bilateral dorsal posterior insula (dpi) and dorsal anterior cingulate cortex (dacc)) on autonomic control. the dpi is a critical brain area involved in autonomic function, being a core recipient of ascending pain and autonomic function. similarly, the dacc has been strongly implicated in autonomic control and works with the insula for autonomic processing. inconveniently, these brain regions lie deep to the cortex, prohibiting access using conventional noninvasive methods like transcranial magnetic stimulation (tms). lifu can be focused at depth to reach the insula and acc with high spatial precision. however, the effect of lifu to the human dpi and dacc on autonomic control is unknown. to address this, the investigators will target the right dpi and the dacc to assess how lifu to each of these areas affects autonomic responses and subjective report to the cold pressor task, a safe, reproducible autonomic challenge.

Eligibility criteria:
inclusion criteria: * does not meet exclusion criteria. exclusion criteria: the exclusion criteria below are regularly implemented in mri, ct, and eeg experiments for the safety of the subjects and for data quality assurance. * claustrophobia (scanning environment may be uncomfortable). * contraindications to mri: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants. * contraindications to ct: pregnancy * active medical disorder or treatment with potential central nervous system (cns) effects (e.g. alzheimer's) - * history of neurologic disorder. (e.g. parkinson's, epilepsy, or essential tremor) * history of head injury resulting in loss of consciousness for \>10 minutes. * history of alcohol or drug dependence (through self-report). * history of cardiac disease * a current or prior use of any cardiac medication (e.g. beta blockers or other anti-arrhythmics) * a history of diabetes mellitus or use of diabetic medications (e.g. metformin).
an open label study of bibw 2992/afatinib in advanced non-small cell lung cancer patients pre-treated with erlotinib or gefitinib

Conditions: NSCLC

Summary: advanced lung cancer (non-small cell lung cancer) with a mutation in the egfr (epidermal growth factor receptor) gene, which have disease progression after treatment with an egfr inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with chemotherapy will be recruited. the trial has only one arm, of afatinib daily treatment. blood and exhaled breath samples will be collected for investigations aiming to identify factors that predict response to afatinib.


Eligibility criteria:
inclusion criteria: * advanced nsclc * egfr mutation or six months or longer benefit from egfr tkis * disease progression on chemotherapy, or inability to receive chemotherapy for medical reasons. * disease progression on egfr tki, or the presence of an egfr mutation that does predicts for poor response to first generation egfr tkis. exclusion criteria: * inability to take oral drugs

Keywords: advanced nsclc egfr mutation tkis tyrosine kinase inhibitors
effect of cannula size on oxygen saturation during nasal high flow therapy in newborns

Conditions: RDS - Infants; TTN

Summary: treatment with nasal high flow therapy (nhf) is an increasingly popular method of respiratory support in newborns. safe and effective use of nhf requires selection of an appropriate nasal prong-to-nares ratio because leak can influence the delivered pressure. to the best of our knowledge, this is the first study to investigate the effect of using different nhf cannula size on peripheral oxygen saturation in newborns with respiratory distress.

nhf will be applied at 8 l/min using the airvo 2 through smaller and larger optiflow nasal cannula. the study will have a randomized crossover design. the larger or smaller cannula size will be applied as the first intervention during each experiment. during each experiment, if the larger cannula is applied first, then the smaller cannula will be applied second and if the smaller cannula is applied first, then the larger cannula will be applied second. each experiment will last for 1.5 hour. * during baseline, supplemental oxygen will be added during nhf therapy to keep spo2 in normal ranges (90%-94%). when the spo2 has stabilized then the level of supplemental oxygen will be set for the entire experiment unless there is a significant change in spo2 as determined by the attending consultant. * there will be three consecutive 30-min periods of recording during each experiment and each experiment will last approximately 1.5 hour. * ventilation will be assessed by respiratory inductance plethysmography (respitrace) and transcutaneous carbon dioxide and oxygen. * recordings will be made using adinstruments powerlab and labchart software with video recording of the patient. * routine measurement of heart rate, respiratory rate and oxygen saturations will be performed as per standard neonatal practice. the researcher is an experienced neonatal consultant who will be directly observing the baby throughout the study.

Eligibility criteria:
inclusion criteria: 1. term and near term newborns with respiratory distress receiving treatment with nhf 2. ≤ 48 hours old 3. fio2 ≥ 0,4 4. written parental informed consent exclusion criteria: 1. infants who are clinically unstable and unsuitable for non-invasive respiratory support as judged by consultant clinician (meet nhf failure criteria). 2. known major upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly 3. a parent has not given written informed consent to their baby's participation. 4. prior intubation and/or surfactant administration 5. known or suspected hypoxic ischemic encephalopathy

Keywords: rds ttn nasal high flow therapy newborn
dietary supplementation of lactogyn in women with bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: the objective of the study is to determine clinical efficacy of lactogyn (lactobacillus crispatus, l. brevis, l.acidophilus) in prevention of recurrent bv

according to classification, this is a phase 2 randomized parallel group prospective controlled dietary study to evaluate efficacy of a dietary supplement, a combination of l. crispatus lmg s-29995, l. brevis, and l. acidophilus in women aged from 18 through 45 years suffering from rbv. the 2 phase of the study has been ascribed as there is no evidence that oral capsules with l. crispatus lmg s-29995, l. brevis, and l. acidophilus have a potential efficacy in rbv. qualifying women received a combination of the three probiotic strains with a half daily recommended dose of vitamin c or just vitamin c without probiotics, a control supplementation, via oral route of administration for up to 120 days. during the intake of active or control formulations, participants kept a structured 120-dsd, where they recorded test capsules intake, screen for symptoms of bacterial vaginosis, and food intolerance events. based on repeat physical examination with application of amsel and nugent criteria the main conclusions over the efficacy of probiotic strains were made.

Eligibility criteria:
inclusion criteria 1. informed consent form signed; 2. age: 18-45 years; 3. able to swallow capsules; 4. recent symptomatic bv successfully treated with metronidazole tablets in a dose of 500 mg 2 times daily for 7 days; 5. less than 48 hours after treatment of acute bv defined as three out of four amsel criteria; 6. willing to communicate intimate history for the study purposes; 7. consent not to use spermicides for 4 months after starting tdc; 8. stated availability throughout the study period and a mobile phone. exclusion criteria 1. post-menopausal; 2. pregnancy or high risk of; 3. breast feeding; 4. currently active std as determined by history, physical examination, and laboratory tests; 5. diabetes mellitus; 6. inflammatory bowel disease; 7. alcohol or drug addiction as guessed by investigator; 8. absence of refrigerator; 9. known moderate to severe disease of any systems; 10. difficulty to comprehend study requirements as judged by physician; 11. any erosions, herpes like lesions, cervicitis during vaginal examination; 12. treatment of bv with other than metronidazole antibiotic; 13. use of any investigational drug within the previous 30 days; 14. use of drugs that suppress the immune system.
cerebral near infrared spectroscopy in out-of-hospital cardiac arrest and neurological prognosis

Conditions: Out-of-hospital Cardiac Arrest (OHCA)

Summary: out-of-hospital cardiac arrest (ohca) prognosis remains poor : 7% of patients surviving without neurological impairment. 65% of patients dying after hospital admission were neurologically impaired. when treating a patient with ca, neurological outcome remains extremely difficult to predict, especially in the pre-hospital setting. practitioners have very little objective information to help them with neuropronostication. although an etco2 level of \< 10 mmhg is associated with a poor neurological prognosis, european recommendations point out that this data alone is not currently sufficient to predict a patient's prognosis or to make a decision to stop resuscitation. current recommendations do not suggest any other objective parameter during resuscitation for neuropronostication of patients with out-of-hospital cardiac arrest. cerebral tissue oxygen saturation (rso2) is measured using the near infrared spectrometry (nirs) technique. cerebral nirs (cnirs) enables non-invasive measurement of changes in cerebral oximetry during the management of a cardiac arrest (ca). various clinical studies conducted over the last ten years have demonstrated that there is a probable link between cnirs levels during resuscitation and return of spontaneous circulation (rosc), but a clear threshold value has not been defined. the aim of the nisohca study is to confirm that a 40% threshold of cnirs in the pre-hospital setting for ohca can specifically predict survival with good neurological outcome at d90 .


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * non-traumatic out-of-hospital cardiac arrest witnessed and managed by the mobile emergency unit (smur). exclusion criteria: * scalp/cranial or facial injury preventing the placement of electrodes for nirs measurement. * spontaneous cardiac activity upon the arrival of the smur. * decision by the smur physician not to initiate specialized resuscitation.

Keywords: out-of-hospital cardiac arrest cerebral near infrared spectroscopy (nirsc)
abatacept s.c. for agvhd prevention in haplo-hct

Conditions: Abatacept; Acute-graft-versus-host Disease; Haplo-identical HCT; Prevention

Summary: acute graft-versus-host disease (agvhd) is a potentially fatal complication after allogeneic hematopoietic cell transplantation (hct), particularly for that with a hla-mismatched donor. abatacept has been demonstrated as a potent drug to reduce the risk of agvhd, but the efficacy of subcutaneous form has yet been investigated. this trial is designed to preliminarily determin the efficacy and saftey of subcutaneous abatacept in the prevention of agvhd after haplo-identical hct.


Eligibility criteria:
inclusion criteria: 1. age≧18 years 2. ecog score 0-2 / karnofsky score≧80 3. haplo-hct is proposed 4. conditioning with motified bu/cy+atg regimen 5. having the following hematologic malignancies with transplant indications: 1. acute leukemia 2. myelodysplastic syndrome 3. aggressive lymphoma 6. expected survival ≥ 3 months 7. written informed consent can be acquired 8. agree to use effective contraception exclusion criteria: 1. with a history of allo-hct previously 2. allergic/intolerant to abatacept 3. contraindications to the use of abatacept 4. hiv infection, or active hbv infection or hcv infection 5. uncontrolled active infection 6. vital organ function intolerated to transplantation 7. other malignancies except for the following diseases: malignant tumors that have been cured for at least 3 years without active lesions; adequete treated non-melanoma skin cancer, malignant amygdala, and carcinoma in situ without active lesions 8. evidence of complications or medical conditions that may interfere with research or put the subjects at serious risk, including but not limited to severe cardiovascular disease (e.g. new york heart association grade iii or iv heart disease, myocardial infarction in the past 6 months, unstable arrhythmia or unstable angina) and/or severe lung disease (e.g. history of severe obstructive lung disease and symptomatic bronchospasm) 9. pregnant and lactational women 10. any life-threatening disease, medical condition, or organ dysfunction unfit for participants, or may interfere with the absorption or metabolism of abatacept