Kornimate/medical-research-clean huggingface dataset:
metformin therapy in type 1 diabetes mellitus.

Conditions: Loss of Control of Diabetes

Summary: the use of exogenous insulin and incorrect nutritional habits are conducive to obesity and excess weight. this leads to the development of insulin resistance, even in patients with type 1 diabetes mellitus. the purpose of this study is to assess the effects of metformin as adjunctive therapy on anthropometric parameters, insulin resistance and metabolic control in overweight and obese patients with type 1 diabetes mellitus. the study group consists of 200 caucasian type 1 diabetic patients with elevated adipose tissue content as measured by electrical bioimpedance, treated at the poznan university of medical sciences department of diabetology in 2009-2014. all patients have type 1 diabetes diagnosed by autoimmune antibodies, and are treated with intensive insulin therapy. this group is divided into metformin treated arm (group i+ m, 100 subjects), the remaining 100 patients are treated with insulin alone (control group, group i). metformin is administered at least 6 months at a mean dose of 1000 mg/day. the investigators would like to assess the impact of metformin treatment on metabolic control, insulin resistance and anthropometric parameters in overweight and obese patients with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * age \> 18 years \<60 years, * duration of diabetes \>3 years, * lack of metabolic control- hba1c\>7,5% (despite participation in 5-day who education program) * treated with intensive insulin therapy exclusion criteria: * metabolically decompensate diabetes with acetonuria, * suspected lack of compliance, * lack of glucose and ketones self-monitoring, * hypoglycaemic unawareness or recurrent severe hypoglycemia (defined as more than two episodes of hypoglycemia lowered than 60 mg/dl with loss of consciousness, required assistance to treat) in the past 3 months, * recurrent diabetic ketoacidosis (more than two episodes in the past year) * another serious medical illness, * pregnancy or sexually active woman unwilling to take birth control. * renal impairment (estimated on the value calculated glomerular filtration rate using the mdrd formula-estimated glomerular filtration rate, egfr\<45 ml / min * liver cell damage alanine aminotransferase (alt), aspartate aminotransferase (ast) greater than twice the upper normal limit), * history of drug or alcohol abuse or those who used this drug before * changes in the way of antihypertensive and antihyperlipemic treatment.

Keywords: type 1 diabetes mellitus, metformin, insulin resistance, obesity
intervention with riboflavin to improve vascular health and endothelial functioning in genetically at- risk adults

Conditions: Blood Pressure; Hypertension

Summary: high blood pressure is the leading risk factor for heart disease and stroke. approximately 12% of the population have a particular genetic factor (known as the tt genotype) which increases the risk of high blood pressure. previous studies conducted at this centre have shown that taking the b-vitamin riboflavin, for up to 3 months, decreases blood pressure in adults with the tt genotype. it is currently not known how riboflavin lowers blood pressure in those with the tt genotype but it could be as a result of altering blood levels of nitric oxide. nitric oxide causes blood vessels to expand, leading to improved blood vessel function, an important predictor of cardiovascular health. however, the effect of riboflavin supplementation on nitric oxide and blood vessel function has not been previously studied. furthermore, it is unclear whether taking riboflavin over a shorter period of time or at doses higher than 1.6 mg/d can also lower blood pressure and improve blood vessel function in this at risk group. therefore, the aim of this study is to assess the effects of riboflavin supplementation on blood pressure, biomarkers of nitric oxide bioavailability and blood vessel function. it is hypothesised that riboflavin supplementation will increase nitric oxide bioavailability, leading to reduced blood pressure and improved blood vessel function and, and that a higher riboflavin dose will lead to greater reductions in blood pressure.


Eligibility criteria:
inclusion criteria: * male * aged 60 years and below * pre-screened for mthfr 677tt genotype (tts and ccs individuals only invited) exclusion criteria: * consumer of b-vitamin supplements * consuming medication that interferes with b-vitamin metabolism

Keywords: blood pressure mthfr methylenetetrahydrofolate reductase riboflavin flow-mediated dilation nitric oxide
predictive model of axillary nodal status after neoadjuvant chemotherapy in breast cancer patients

Conditions: Breast Cancer

Summary: the management of patients diagnosed with breast cancer (bc) with axillary nodal involvement is still a controversial topic. these patients' treatment usually involves the administration of a neoadjuvant chemotherapy (nac) in order to improve survival rates and increase local disease control. depending on the tumor subtype, an axillary pathologic complete response (pcr) is achieved in 40-70% of initially axillary node-positive patients (cn+). concerning patients with an axillary pcr, thus a clinically negative node status (cn0), axillary lymphadenectomy (alnd) might be replaced by less invasive surgical approaches and sentinel lymph node biopsy (slnb) is considered, in these cases, an effective alternative treatment. however, the relatively high false negative rates, reported in several validation trials, points out the complexity concerning these patients' treatment. moreover, histological findings' predictive and prognostic value, after slnb, of micrometastases and isolated tumor cells (itcs) is still unclear. currently, dual-tracer-guided lymph node biopsy and the surgical removal of ≥ 3 sentinel lymph nodes are known as effective strategies aimed to reduce the false negative rates. there are several ongoing clinical trials to understand and define the best approach for these patients. nowadays, there's great interest in potential prognostic role of systemic inflammation's biochemical markers such as neutrophil-to-lymphocyte ratio (nlr). systemic inflammation's markers may be nodal pcr's predictors after nac in node-positive breast cancer patients. the aim of the study is to develop and validate a pre-operative model, able to predict pcr after nac to select the patients suitable for a surgery de-escalation strategy.

this is a retrospective, observational, multicentric and no profit study. the study involves patients with diagnosis of cn+ breast cancer who underwent neoadjuvant treatment and then treated with lymph node biopsy or axillary lymphadenectomy, referring to the participating centers. for each patient the following clinical-anamnestic information will be collected: age, pre-nac blood cell count, tumor dimension, clinical staging (ct, cn), histological information (tumor subtype, grading, receptors' status, ki-67 value), neoadjuvant treatment regimen, clinical and radiological local response after nac, clinical and radiological nodal response after nac, type of surgery, number of examined lymph nodes, number of positive lymph nodes, pathological staging after surgery (ypt, ypn).

Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer confirmed by histological examination * patients who underwent neoadjuvant chemotherapy * axillary lymph nodes involvement at diagnosis (cn≥1), identified by clinical examination and/or imaging techniques and/or axillary lymph node cytology aspirate positive for breast cancer cells. exclusion criteria: * patients with m+ at diagnosis * contraindications for neoadjuvant chemotherapy
norepinephrine weaning in septic patients

Conditions: Septic Shock

Summary: the weaning rate of vasopressors drugs is usually chosen empirically by the clinician in critically patients. the investigators applied fuzzy logic principles to modify intravenous norepinephrine infusion rates during norepinephrine infusion in septic patients in order to reduce the duration of shock. the investigators goal was to reduce the duration of poorly controlled hemodynamic status.


Eligibility criteria:
inclusion criteria: * septic shock exclusion criteria: * less than 18 years * pregnancy * weight above 135 kg * requirement for continuous epinephrine infusion * severe head injury, stroke, a comatose state following cardiac arrest

Keywords: septic shock fuzzy logic norepinephrine weaning
characterization of adipose derived regenerative cells (adrcs) from patients with chronic heart disease

Conditions: Chronic Heart Failure

Summary: human adipose tissue is now recognized as an acceptable, highly abundant source of adipose-derived regenerative cells (adrcs). adrcs are a heterogeneous or mixed population of cells found in adipose tissue including adult stem cells, leukocytes, connective tissue and vessel-associated cells. autologous adult regenerative cells are thought to promote healing of scarred or injured tissue. while the investigators are learning more about the exact mechanisms every day, it is believed that this heterogeneous population of cells influences the local environment via cell-to-cell signaling, immune modulation, and differentiation into other cell types. the use of adrcs in the treatment of many different medical conditions (including cardiovascular disease, soft tissue defects, wound healing, and many more) is being evaluated in numerous clinical and preclinical studies around the world. while there is a considerable amount of information regarding the cellular composition of adrcs isolated from healthy donors, basically there is no much data regarding the adrc composition from cardiac patients. in this study, adipose tissue or cells from chronic heart ischemia patients, that would otherwise be thrown away in waste, will be provided to researchers who will study these cells with the objective to characterize adrcs derived from patients with a heart disease and to compare if a heart disease state does impact adrc cell composition.


Eligibility criteria:
inclusion criteria: * patients enrolled in the athena clinical trial that donated their leftover material to be studied. exclusion criteria: -

Keywords: adrcs, cell characterization
effect of olvanil supplementation on clinical, biochemical and anthropometric parameters in obese adults

Conditions: Obesity

Summary: capsaicinoids are defined as alkaloid compounds of the capsicum genus, they are characterised by the pungent flavor of chili. about the capsicum genus, there are more than 20 known compounds, including dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin and homocapsaicin. capsaicin is the most popular compound in the biotechnological food industries. recent studies has demonstrated the benefits of capsaicin in weight loss, however, the use of this molecule is limited given its high pungent capacity. pungency develops due to the high affinity of capsaicin for the transient vanilloid potential receptor type 1 (trpv1), which is primarily responsible for the transmission of pain. in order to eliminate pungency, capsaicin analogs have been developed, such as olvanil, this can become an alternative for its biotechnological and pharmaceutical purposes as an antiobesogenic treatment.

a total of 56 subjects will be invited to be enrolled in a study approaching the properties of a capsaicin analog: olvanil, along with nutritional guidance. this double blind, randomized, parallel clinical trial will consist in a 8-week intervention with recurrent visits every 4 weeks. in every visit, all subjects will undergo a body composition analysis as well as blood tests. this study proposes three objectives for reaching a further understanding of the effects of olvanil: 1. compare the anthropometric parameters at baseline versus final time between the groups. 2. compare the clinical parameters at baseline versus final time between groups. 3. compare the concentrations of the biochemical parameters at baseline versus final time between the groups. once the project is finished, the research strategies for new studies will be improved. in the same way, the application of the knowledge generated in it will be encouraged towards the health care of patients with obesity who could attend our service on future occasions. finally, we would disseminate the knowledge generated in our institutional community, which would increase the impact of the project.

Eligibility criteria:
inclusion criteria: * 25-59 years of age * both sexes * subjects who agree to participate in the study and all signed informed consent * bmi 30 kg/m2 - 39.9 kg/m2 exclusion criteria: * currently consuming any of the following drugs: nsaids, anticoagulants, hypoglycemic, or hypolipemic drugs * diagnosed autoimmune diseases * diagnosed cancer * pregnancy and breastfeeding * suffering from gastritis and hemorrhoids * subjects who wish to abandon the study

Keywords: capsaicin analogs olvanil anthropometry
torpedo study: a study on rapid effect of tocilizumab in patients with rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs (dmards) or anti-tnf

Conditions: Rheumatoid Arthritis

Summary: this study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to dmards or anti-tnf. for the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. after 4 weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every 4 weeks. methotrexate or dmard therapy will be continued throughout study treatment. target sample size is \>100.


Eligibility criteria:
inclusion criteria: * adult patients \>/= 18 years of age * active moderate or severe rheumatoid arthritis of \<10 years duration with inadequate response to methotrexate or anti-tnf * on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose * patients receiving oral corticosteroids and/or nsaids should be at stable dose for 4 weeks exclusion criteria: * rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra * functional class iv by acr classification * history of inflammatory joint disease other than ra * previous treatment with cell-depleting therapies, abatacept or rituximab * active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics \<4 weeks or oral antibiotics \<2 weeks prior to screening
a study of rizatriptan for the treatment of acute migraine in patients on topiramate for migraine prophylaxis

Conditions: Migraine

Summary: this study will provide additional efficacy data for rizatriptan when used for an acute migraine attack in patients already taking topiramate for migraine prophylaxis.


Eligibility criteria:
inclusion criteria: * patient has a history of migraine with or without aura for more than one year, with between 2 and 8 moderate to severe attacks per month * patient is currently taking at least 50 mg topiramate daily for migraine prophylaxis * patient can distinguish between migraine and other types of headache * patient agrees to remain abstinent or use effective birth control during the study exclusion criteria: * patient is pregnant or breast-feeding * patient has a history of mostly mild migraines or migraines that resolve within 2 hours * patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in the 3 months prior to screening. * patient was \> 50 years old at age of migraine onset * patient has history of heart disease * patient has uncontrolled hypertension * patient has had cancer within 5 years of screening (excepting certain skin and cervical cancers) * patient has started taking selective serotonin reuptake inhibitors (ssris) or serotonin-norepinephrine reuptake inhibitors (snris) or has changed doses within 3 months of screening * patient is taking more than one other migraine prophylactic medication * patient has repeatedly failed to respond to or tolerate rizatriptan
tissue expander/implant reconstruction: a single-blinded, randomized, controlled trial

Conditions: Breast Cancer

Summary: following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. at the same operation as your mastectomy, a tissue expander is put under the skin and muscles of your chest. following your surgery, the tissue expander is gradually filled with salt water over a period of months. once the expander is filled to the size of your new breast, a second operation is performed. at this time, the tissue expander is removed and a permanent breast implant is placed. this is a standard procedure. we are interested in learning about the use of alloderm in breast reconstruction. alloderm can be used instead of some of your own chest muscles, in order to cover and protect a tissue expander. we want to know if the use of alloderm can decrease your pain or discomfort after surgery and after the filling of your tissue expander. alloderm is made from human tissue. when alloderm is made all the cells that could cause your body to reject it are removed. when it is placed in your chest, your own cells will then grow into the alloderm, causing it to act like the muscle it is replacing. in this study, you will either have reconstruction with alloderm or without alloderm.


Eligibility criteria:
inclusion criteria: * patients who undergo immediate, postmastectomy, tissue expander/implant reconstruction * patients ≥ 21 and ≤ 75 years of age exclusion criteria: * patient refusal * patients who will undergo any of the following: * single-stage implant reconstruction * combined autogenous tissue expander/implant reconstruction * patients with a history of prior irradiation * patients with a history of prior surgery with breast implants * patients with a history of prior axillary lymph node dissection * patients who are pregnant the following eligibility will be confirmed at the time of surgery. * patients who are deemed intraoperatively by the attending surgeon to have significant mastectomy flap ischemia. * patients who have an axillary lymph node dissection at the time of mastectomy (patients undergoing sentinel lymph biopsy are eligible)

Keywords: breast expander breast reconstruction implants 08-024
evaluation of prophylactic use of a preoperative iabp in high-risk coronary artery bypass graft surgery

Conditions: Ischemic Cardiomyopathy; Heart Failure

Summary: background: the intra-aortic balloon balloon pump (iabp) has been used as a method of percutaneous circulatory assistance high surgical risk patients undergoing coronary artery bypass graft surgery (cabg); although its applicability has been questioned by clinical trials showing poor impact to reduce the mortality due to cardiogenic shock associated with postoperative acute myocardial infarction (ami), the real benefit reducing mortality in the postoperative context (po) has not been determined examined through a prospective study with an adequate design. objective: to compare po complications such as mortality, perioperative infarction and other complications in patients with high surgical risk undergoing cabg in comparison with controls.

methods: quasi-experimental, prospective, comparative, non-randomized study. the decision to place the biac is not part of the study and depends on the multidisciplinary decision of a heart team, based on the individualized risk / benefit. the study population consists on high surgical risk patients with atherosclerotic coronary disease undergoing cabg in our centre between 2014-2018. patients are excluded if any condition is present: cardiogenic shock, with ami 48 hours prior and / or severe aortic insufficiency. in one group biac will be inserted 1-6 hours before surgery (biac group) and a second group is control (non-biac group). a minimum 30-day postoperative follow-up of will be performed, with primary end points (mortality and ami type v) and secondary end points (additional po complications). analysis: an evaluation of normality distribution k-s will be performed, the means of quantitative (t-test) and categorical variables (fisher or χ² pearson) will be compared. a multivariate analysis will be performed with linear logistic regression to evaluate the influence of age, sex, peripheral arterial disease (pad) and euroscore-ii on the primary goal. statistical significance will be considered when p \<0.05. softwares: graphpad-prism-5.0 and spss-15.0

Eligibility criteria:
inclusion criteria: * all patients greater than 18 years * scheduled for coronary artery bypass graft (cabg) surgery were eligible * multiple vessel disease with or without left main coronary artery (lmca) significant stenosis (\>50%) * written informed consent provided exclusion criteria: * prior cardiogenic shock, * acute myocardial infarction (ami) less than 48 hours prior to enrollment * previous iabp use * ami mechanical complications * aortic regurgitation greater than grade ii in severity (on a scale of i to iv, with higher grades indicating more severe regurgitation) * tachyarrhythmia * other aortic procedures * other non-cabg surgical procedures * massive pulmonary embolism * older than 90 years of age * any coagulopathy * severe concomitant disease associated with a life expectancy of less than 6 months.

Keywords: intra-aortic balloon pump coronary artery bypass graft preoperative
efficacy of bioceramic materials for bone defects repair

Conditions: Bone Lesion; Cartilage Degeneration; Osteo Arthritis Knee; Bone Fracture; Bone Injury; Bone Loss

Summary: the purpose of this study is to demonstrate the effect of bioceramic implants on the repair of human bone defects, and to explore the application of bioceramic materials in bone defects, bone implantation, and bone fusion. the surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.

the surface microstructure of β-tricalcium phosphate bioceramic implants can be effectively controlled to guide the regeneration of bones, promote the restoration of bones, accelerate the speed of recovery, and improve bone quality, which is of great clinical and social significance.

Eligibility criteria:
inclusion criteria: 1. patients who voluntarily take the test and sign the informed consent form; 2. patients aged 18-65 years old with no history of allergies; 3. patients able to communicate well with the investigator and follow the requirements of the entire trial. exclusion criteria: 1. patients who refuse to sign the informed consent form to participate in the trial; 2. patients who are not in the age range of 18 to 65 years; 3. patients with diseases unsuitbale for the trial: history of allergies, severe cardiopulmonary disease, coagulation dysfunction, alzheimer's disease, cerebral atrophy, acute phase or sequelae of cerebrovascular disease, cognitive impairment; 4. patients in the acute phase of local or systemic bacterial infections; 5. patients who cannot cooperate with the operation and evaluate the effect; 6. other conditions that are considered inappropriate by the investigator to participate in the study.