Kornimate/medical-research-clean huggingface dataset:
the efficacy of acarbose and metformin on blood glucose fluctuation when combined with premix insulin

Conditions: Type 2 Diabetes

Summary: the study objective: to explore the efficacy of acarbose and metformin on glucose fluctuations as add on therapy in type 2 diabetes patients inadequately controlled with premix insulin.

study design:prospective, parallel group, active-control, randomized, open-label. study organization:single-center in china. endocrinology and metabolism department of 6th affiliated hospital of shanghai jiaotong university study population: type 2 diabetes inadequately controlled by premix-insulin therapy,40 patients per arm(acarbose add on/ metformin add on) both acarbose and metformin are widely used with premix-insulin in clinical practice, for the better glucose control and lower hypoglycemia incident. acarbose delay the absorption of digested carbohydrates from the small intestine and thus lower both postprandial glucose and insulin levels which sequently improve glucose fluctuation metformin improve the insulin resistance reduce the gluconeogenesis, glucose output and thus lower the fasting glucose

Eligibility criteria:
inclusion criteria: * diagnosed t2dm patients (who, 1999). * premix insulin therapy for more than 3 months, the daily dosage of insulin \>20iu and \<1iu/kg * 30 ≤age ≤ 70 years old, male or female * 7.0 ≤ hba1c ≤10.0% * 18.5≤ bmi ≤ 35 kg/m2 * written informed consent exclusion criteria: * subject with type 1 diabetes or gestational diabetes mellitus and other specific types dm * those who can not tolerate agi or who is suffering gi disease * metformin contradiction * concomitant 2 oral anti-diabetes medicine, or 1 oad with maximum dose * subject with repeated severe hypoglycemia and/or unawareness of hypoglycemia * known or suspected allergy to trial product(s) or related products * females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial * impaired liver function, * any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, cancer, tb, acute infection * uncontrolled hypertension * concomitant treatment which influences blood glucose * impaired renal function
tissue oxygenation measurements with modulated light (s-flare)

Conditions: Breast Cancer

Summary: to perform a pilot study of the s-flare imaging system, which uses low levels of safe, invisible, near-infrared light to measure tissue oxygenation during breast reconstructive surgery and to compare s-flare measurements to the gold standard, fda-approved, the vioptix optical probe.

this pilot study will enroll three patients who have chosen to proceed with deep inferior epigastric perforator (diep) flap breast reconstruction. this type of reconstruction uses skin and fat from the abdomen to reconstruct a new breast shape. the construct is vascularized through perforating arteries and veins that provide a blood supply to this tissue. current techniques to evaluate vessel selection rely on a handheld doppler used for confirmation of blood flow and perfusion; however, this modality is limited as it only assesses a specific point within the flap. the s-flare imaging system will be used to visualize vascularization in the diep flaps, and this study will compare measurements by the s-flare imaging system and the standard-of-care vioptix point probe.

Eligibility criteria:
inclusion criteria: * women or men above the age of 21 who are undergoing unilateral breast reconstruction after mastectomy. * women of childbearing age must have a negative pregnancy test as confirmed by anesthesiologist. exclusion criteria: * bmi \> 30.

Keywords: breast reconstruction breast cancer near infrared imaging
regional hypothermia in combination with endovascular thrombectomy in acute ischemic stroke

Conditions: Stroke; Neuroprotection; Hypothermia

Summary: the investigators have previous shown that regional hypothermia by the intra-arterial infusion of cold saline combined with mechanical thrombectomy in acute ischemic stroke is feasible and safe. the safety of selective brain cooling in patients undergoing mechanical thrombectomy, however, is not established in a randomized trial. the investigators therefore conducted this rct study to further explore the safety of regional hypothermia in patients with acute ischemic stroke who underwent mechanical thrombectomy.


Eligibility criteria:
inclusion criteria: * age ≥18 and ≤80 * clinical signs consistent with the diagnosis of an acute ischemic stroke * baseline nihss score obtained prior to randomization ≥8 * intracranial arterial occlusion of the distal intracranial carotid artery or * middle (m1/m2), demonstrated with cta, mra, dsa * the possibility to start treatment (artery puncture) within 6 hours from onset * regional hypothermia is expected to start within 15 minutes after recanalization * informed consent given exclusion criteria: * mtici\<2b after endovascular treatment * no significant pre-stroke disability (mrs ≤1) * previous nyha grade \> 1 * known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with inr \> 3.0 * baseline platelet count \< 50000/µl * baseline blood glucose of \ 400mg/dl * severe, sustained hypertension (sbp \> 220 mm hg or dbp \> 110 mm hg). note: if the blood pressure can be successfully reduced and maintained at the acceptable level using local treatment guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled. * seizures at stroke onset which would preclude obtaining a baseline nihss * subjects who have received iv t-pa treatment beyond 4,5 hours from the beginning of the symptoms * renal insufficiency with creatinine ≥ 3 mg/dl * woman of childbearing potential who is known to be pregnant or lactating * subject participating in a study involving an investigational drug or device that would impact this study * cerebral vasculitis * patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations * unlikely to be available for 3 months follow-up (e.g. no fixed home address, visitor from overseas). * ct or mr evidence of hemorrhage (the presence of microbleeds on mri is allowed) * aspect\<6 * subjects with occlusions in multiple vascular territories (anterior circulation and posterior circulation) * evidence of intracranial tumor (except small meningioma)
relating clinical outcomes in multiple myeloma to personal assessment of genetic profile

Conditions: Multiple Myeloma

Summary: the primary objective of this observational study is to identify the molecular profiles and clinical characteristics that define subsets of myeloma patients during the course of the disease.

understanding the molecular basis of cancer is a critical step toward devising the most effective treatment of the patient as an individual. the promise of molecular targeted therapeutics and personalized cancer care has been demonstrated in breast and lung cancer and chronic myeloid leukemia. however, similar examples of success in multiple myeloma have not been achieved despite extensive basic research as well as clinical advances. what is well understood is that myeloma is a heterogeneous disease with great genetic and epigenetic complexity.22, 23 therefore, there remains a critical need to understand myeloma patient biology in the context of current patient care.24 the objective of this longitudinal study is to identify patient subgroups and phenotypes defined by molecular profiling and clinical features. these profiles will enable a better understanding of mechanisms of disease, drug response and patient relapse. ultimately the study is intended to drive successful drug development and patient care in multiple myeloma.

Eligibility criteria:
inclusion criteria: * patient is at least 18 years old. * patient has been diagnosed with symptomatic mm with measurable disease that includes at least one of the following: serum m protein ≥ 1g/dl urine m protein ≥ 200 mg/24 hrs involved free light chain level ≥ 10 mg/dl and an abnormal serum free light chain ratio (\ 1.65). * the patient is a candidate for systemic therapy that includes an imid® (e.g., lenalidomide, pomalidomide, thalidomide) and/or proteasome inhibitor (e.g., bortezomib, carfilzomib) as part of the initial regimen. * no more than 30 days from baseline bone marrow evaluation as per this protocol to initiation of first-line therapy. * patient has read, understood and signed informed consent. exclusion criteria: * patient is already receiving systemic therapy for mm (a single dose of bisphosphonates and up to 100 mg total dose of dexamethasone or equivalent corticosteroids are permitted prior to registration on study). * patient had another malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix). * patient is enrolled in a blinded clinical trial for the first-line treatment of multiple myeloma. patients may be enrolled in subsequent clinical trials as long as continued access to data and tissue, as per this protocol, is not prohibited.

Keywords: myeloma multiple myeloma observational longitudinal
genetic testing for men with metastatic prostate cancer

Conditions: Metastatic Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8

Summary: this research study provides genetic testing to men with prostate cancer that has spread to other parts of the body (metastatic prostate cancer) and will look for inherited genetic mutations in about 30 cancer-risk genes. the researchers seek to learn about the participant's opinions and concerns about genetic testing, to determine if this is an acceptable way to deliver testing and to potentially help guide the participant's treatment. neither treatment nor any decisions related to treatment will take place on this study, but researchers will share each participant's genetic testing results with that participant.

outline: participants receive web-based or hard-copy questionnaires and saliva collection kits via mail or in person. participants also provide saliva samples to be mailed back to color genomics for genetic testing once complete. participants then receive phone-based genetic counseling if they are identified to have an inherited mutation in a deoxyribonucleic acid (dna) repair gene. all participants have access to phone-based genetic counseling whether or not they are not found to have a mutation. after study completion, participants are followed up at 6 months.

Eligibility criteria:
inclusion criteria: * signed informed consent form (icf) providing agreement for germline genetic testing, use and release of health and research trial information * documented evidence of metastatic prostate cancer; * oncologist note within 4 months * all computed tomography (ct), bone, positron emission tomography (pet) scan reports within 12 months * all prostate-specific antigen (psa) values within 12 months * all available pathology reports from diagnosis, prostatectomy, and/or metastatic biopsy * willingness to provide basic demographic information, family cancer history, and treatment history * willingness and ability to complete patient reported outcomes questionnaire (on-line or hard copy) at enrollment, and at 6-month follow-up * willingness and ability to provide saliva sample exclusion criteria: * unable or unwilling to provide all of the necessary information for eligibility, e.g. decisionally impaired * incomplete inclusion criteria * study team members

Keywords: prostate cancer metastatic genetic testing cancer risk brca1 brca2
a prospective observational study to describe clinical outcomes, treatment patterns, patients characteristics among patients with hr+/her2- advanced bc initiating treatment with risarg®, piqray®, endocrine therapy or chemotherapy in routine clinical practice in russia

Conditions: Breast Cancer

Summary: this study is planned as a prospective multicenter nis. this study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule. patients with hr+/ her2- advanced or metastatic bc that initiated treatment with ribociclib, alpelisib, mono endocrine therapy or chemotherapy will be included into the study across seven russian districts.

patients will attend the sites in accordance with routine clinical practice. it is assumed that visits will be conducted every 3-4 months. patients will undergo standard procedures and tests according to clinical guidelines and physician's judgement. available data from routine clinical management of the patients will be collected at patients' visits to the clinical site. patients enrolled in the study will be followed up until death or study close whichever occurs first. the recruitment period is planned for 24 months, observation period for maximum of 24 months, with total duration of study 4 years. patients may discontinue from this nis at any time.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years at the moment of ribociclib, alpelisib, monoet or ct treatment initiation. 2. female gender. 3. confirmed diagnosis of locally advanced/metastatic not amenable to surgery hr+/her2- bc (progressed following prior therapy or de novo) for whom the treating physicial took the decision to initiate treatment with ribociclib, alpelisib, monoet or ct before entering the study. 4. patient who initiated treatment with ribociclib, alpelisib, monoet or ct no longer than 4 weeks (28 days) prior to written informed consent for this study. 5. patients with ecog performance status ≤ 2. 6. provision of written informed consent. exclusion criteria: 1. patients with a life expectancy of less than 3 months at the time of abc diagnosis per the investigator's judgment. 2. patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (patients participating in other investigator initiated trial or nis can be included as long as their standard of care is not altered by the study). 3. patients receiving active treatment for malignancies other than bc at the time of enrollment. 4. patients who are unable to understand the nature of the study.

Keywords: breast cancer cdk4/6 inhibitors advanced hr+/her2- breast cancer ribociclib risarg alpelisib piqray russia
retrospective trial on the efficacy and safety of intravitreal ozurdex in patients with diabetic macular edema.

Conditions: Diabetic Macular Edema

Summary: to review the safety and efficacy of injections with ozurdex (700 μg dexamethasone) in clinical practice management of patients with dme.


Eligibility criteria:
inclusion criteria: * adults (≥18 years) with diabetes * dme in the study eye (if both eyes have dme both eyes will be included in analysis) * bcva minimum of 20/200 (35 letters) * central macular thickness (cmt) ≥300 µm * patients with dme who were treated with ozurdex at least twice (baseline is before the first ozurdex injection). * follow up of at least 6 months after the last ozurdex injection given * complete records including bcva (oct and fluorescein angiography (fa) if available) throughout the follow up exclusion criteria: * patients with me not secondary to diabetes mellitus (dm). * presence of other retinopathies (amd, rvo) or visually significant ocular morbidity (e.g. advanced glaucoma, corneal opacity) * previous ocular trauma or surgery other than cataract extraction * intravitreal triamcinolone ≤6 months before baseline * intravitreal bevacizumab, ranibizumab, or pegaptanib \<1 months before baseline * marked intraocular pressure (iop) elevation in response to any previous steroid treatment * ocular hypertension (oht) in the study eye(s) * iop \>23 mm hg without antiglaucoma medication * iop \>21 mm hg with one antiglaucoma medication * use of 2 or more antiglaucoma medications * glaucoma - visual fields (vf) defect \> 4 db

Keywords: macular diabetic edema ozurdex retrospective european intra-vitreal injections
hla-g immuno-inhibitor checkpoint study in patients with covid-19 infection: molecular and cellular assessment

Conditions: Covid19

Summary: the aim of the research is to study the immune checkpoint linked to the hla-g molecule in the dysregulation of the control of covid-19 infection.

single-center, prospective, open-ended, interventional study with minimal risks and constraints. patients will be divided into 3 groups: patients not infected with covid-19, patients infected with covid-19 not hospitalized, patients infected with covid-19 hospitalized.

Eligibility criteria:
inclusion criteria: * patient with possible or confirmed infection by covid-19 exclusion criteria: * patient without liberty or guardianship

Keywords: hla-g
study of retinal vascular changes after ocular blunt trauma

Conditions: Ocular Injury

Summary: this study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received ocular blunt trauma.

to investigate, using optical coherence tomography angiography, early retinal vascular features 48 hours after ocular trauma and to detect their changes during 6 months' follow up. the optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed analysis of retinal vascular features.

Eligibility criteria:
inclusion criteria: * age older than 40 years * diagnosis of previous ocular blunt trauma * absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases. * absence of significant lens opacities, low-quality oct and oct-a images. exclusion criteria: * age younger than 40 years * absence of previous ocular blunt trauma * presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases. * presence of significant lens opacities, low-quality oct and oct-a images.
influence of renal function on the circadian variation of cardiac troponin

Conditions: Chronic Kidney Diseases

Summary: cardiac troponin is the preferred biomarker for the diagnosis of acute myocardial infarction. whereas the diagnosis is based on an increase and/or decrease in the concentrations of cardiac troponins with at least one value above the 99th percentile value of the reference population together with the evidence of ischemia, serial sampling is needed. knowledge of the variation in cardiac troponin levels over time in individuals in a normal rest state (not during an acute myocardial infarction), also called the biological variation, is important regarding the interpretation of the serial cardiac troponin levels. a recent study by our group showed a circadian rhythm in cardiac troponin levels. this circadian rhythm is important regarding the interpretation of the serial cardiac troponin levels. increased ctni and ctnt concentrations are common in subjects with renal impairment. the mechanism of the elevated concentration of ctn in these subjects is still unclear. it is hypothesized that impaired renal clearance contributes to elevated levels of ctn. however, it is not clear whether renal function affects the biological variation and circadian rhythm of ctn. the monitoring of the biological variation and circadian rhythm of ctn in subjects with impaired renal function creates the opportunity to assess the effect of renal clearance on the circadian rhythm of cardiac troponins.


Eligibility criteria:
inclusion criteria: * ckd stage 3 or 4 * no dialysis * no evidence of active, acute cardiovascular disease exclusion criteria: * history of acute myocardial infarction in the last year * history of pulmonary embolism in the last six months * anemia (hb \< 6.5 mmol/l)
baricitinib, methotrexate as monotherapy or combination in the treatment of rheumatoid arthritis - an open label randomized clinical trial

Conditions: Rheumatoid Arthritis

Summary: the goal of this open-label randomized clinical trial is to assess the efficacy of baricitinib 2 mg in comparison to methotrexate 25 mg as monotherapy followed by baricitinib 4 mg in comparison to methotrexate 10 mg and baricitinib 2 mg combination in patients with rheumatoid arthritis with moderate to severe disease activity. the main question it aims to answer: • is there any difference in the efficacy of baricitinib as monotherapy in comparison to methotrexate monotherapy or methotrexate-baricitinib combination in the treatment of rheumatoid arthritis

this open-label randomized clinical trial will be conducted in the department of rheumatology, bsmmu. the rheumatoid arthritis patients with moderate to high disease activity at baseline, disease activity score (das28esr\>3.2) will be considered as primary entry criteria for this study. consecutive sampling method will be applied. the study will be done in 2 phases, duration of each phase 24 weeks. considering inclusion and exclusion criteria, total 132 patients are randomized into group a and group b following block randomization. each group will be consisting of 66 patients. in phase 1 group a will be put on baricitinib 2 mg once daily and group b will be put on methotrexate 25 mg weekly. the patients who fail to achieve remission or low disease activity by 24 weeks eligible for entry into phase 2 where group a will be put on baricitinib 4 mg and group b will be put on baricitinib 2 mg in combination with methotrexate 10 mg. follow-up will be done at the 4th, 12th and 24th week in phase 1 and 28th, 36th and 48th week in phase 2. response to treatment will be evaluated by das 28 esr. at the end of 24th week endpoint for efficacy will be assessed at by das 28esr. adverse effects will be assessed by history, physical examinations and investigations. results will be compared among two groups with a 95% confidence interval and a p-value of \< 0.05. the degrees of statistical significance between groups will be analyzed by unpaired t-test and/or mann-whitney u test. qualitative data in between groups will be analyzed by the chi-square test. probabilities of associations will be assessed by calculating spearman´s rank correlation coefficient

Eligibility criteria:
inclusion criteria: * 1. patients more than 18 years of age 2. patients fulfill the acr/eular 2010 classification criteria for rheumatoid arthritis 3. patients with das 28 esr\> 3.2 exclusion criteria: * 1. recent or concurrent infection including active tuberculosis 2. haemoglobin (hb) \ three times the upper limit of normal 7. estimated glomerular filtration rate \< 60 ml/minute/1.73 m2 8. co-morbid illness- e.g., malignancy 9 . pregnant or breast feeding woman

Keywords: baricitinib, rheumatoid arthritis