Kornimate/medical-research-clean huggingface dataset:
multicentre logic-insulin algorithm-guided versus nurse-directed blood glucose control during critical illness (logic-2)

Conditions: Critical Illness; Hyperglycemia; Hypoglycemia

Summary: most critically ill patients are confronted with hyperglycaemia, which is associated with an increased mortality and morbidity risk. normalising these elevated blood glucose levels by intensive insulin therapy may improve patient outcome, but is associated with an increased risk of hypoglycaemia. the logic-2 study hypothesises that the logic-insulin computerised software algorithm will allow better (less hyperglycaemia) and safer (less hypoglycaemia) blood glucose control in critically ill patients than nurse-directed blood glucose control.


Eligibility criteria:
inclusion criteria: * patients admitted to the icu with an expected stay of at least 48 hours and already receiving or potentially needing insulin infusion for blood glucose control. these patients should already have or need an arterial and central venous line * patients should be 18 years or older exclusion criteria: * not critically ill * age under 18 years * patients already enrolled in another intervention randomized controlled trial * patients expected to die within 12 hours (=moribund patients) * no arterial line or central venous line needed * pregnancy or lactating * patients suffering from ketoacidotic or hyperosmolar coma on admission * patients who have been previously been included in the logic-2 study * allergy to insulin

Keywords: software algorithm cardiac surgery
traumeel for pain after total knee/hip arthroplasty

Conditions: Total Knee and Total Hip Arthroplasty

Summary: we hypothesize that traumeel s is more effective than placebo in reducing 48-hour mean cumulative morphine consumption following total knee or hip arthroplasty. 224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the trial. patients will be randomized to receive either intraoperative injection and post operative oral traumeel s tablets or placebo injection (normal saline) and indistinguishable oral placebo tablets. baseline measurements of relevant outcome measures will taken preoperatively. in the recovery room, the patient will begin to receive iv dipyrone (optalgin) 1000mg, for a total of 4 doses during the first 24 hours postoperatively (1000 mg every 6 hours). once back in the ward, the patient will be connected to an iv patient-controlled analgesia (pca) device, enabling the self-administration of morphine at a set dose of 1mg every 8 minutes, should the patient require it. the pca memory registers the time and dose, and the data will be used later to evaluate post-operative pain.


Eligibility criteria:
inclusion criteria: * patients of either sex undergoing unilateral thap or tkap. * age over 18 years. * signature upon informed consent form exclusion criteria: * participation in another clinical trial within 4 weeks prior to enrollment. * refused to give verbal consent to the telephone interviews * impossibility to be reached during the 14-17 days post operative * inability to comply with the study protocol for any other reason * previous major surgical procedure on ipsilateral leg. * current use of analgesics for any other reason. * a history of chronic pain syndrome. * abused legal or illicit drug use. * hypersensitivity to botanicals of the compositae family * known sensitivity to paracetamol, codeine or tramadol.

Keywords: homeopathy pain traumeel s total knee arthroplasty total hip arthroplasty
dapagliflozin in stemi

Conditions: ST Elevation Myocardial Infarction; Myocardial Infarction

Summary: the goal of this clinical trial is to assess the safety and efficacy of sglt2i in limiting infarct size in patients with stemi referred for ppci. eligible stemi patients enrolled into the trial will be randomized to a sglt2i or placebo. cardiovascular magnetic resonance (cmr) imaging will be used to determine the infarct size.

dapa stemi is a single center, randomized, double-blind, parallel group study in which eligible participants with a stemi and undergoing ppci will be recruited and randomly assigned to dapagliflozin or placebo to take for 7 days. participants will be prescribed study treatment i.e. dapagliflozin (10 mg) or placebo daily for 7 days. a cmr will be obtained at day 3-5 to assess for infarct size. participants will have follow-up visits at 30, 90, and 180 days to assess for cardiovascular events.

Eligibility criteria:
inclusion criteria: patients referred for ppci meeting the following criteria are eligible for the study: * ischemic chest discomfort of ≥30 minutes duration, and * onset of chest pain ≤12 hours prior to entry into the study, and * one of the following high-risk criteria on a standard 12 lead ecg: a. anterior stemi with st-segment elevation ≥2mm (0.2 mv) in each of at least 2 contiguous precordial leads (v1-v6) b. extensive non-anterior stemi defined as st-segment elevation of \>1mm in two or more contiguous non-anterior leads accompanied by i. 8 or more leads with \> 1 mm st elevation or depression, or both; or ii. sum of st- segment elevation \>20mm exclusion criteria: * age \< 18 years * any contraindication to undergo cmr imaging * killip 4 (cardiogenic shock on presentation) * therapy with sglt2i within last 8 weeks * type 1 diabetes mellitus * pregnancy * nursing mother * unwilling to use appropriate forms of contraception, as applicable * chronic symptomatic hf with prior hospitalization for hf within the last year * hospitalization * known history of prior mi * any non-cv condition with a life expectancy of less than one year * previous randomization in the present study * participation in a study with another investigational device or drug \< four weeks * inability to provide informed consent * confirmed ketoacidosis at time of admission * known severe hepatic impairment (cirrhosis) * severe renal impairment (egfr \< 30 ml/min1.73m2 (based on prior or baseline blood work) * known severe valvular heart disease * need for cabg within 90 days based on the results of the initial coronary angiogram * false positive stemi (based on the results of the coronary angiogram)
study of mab 216 with chemotherapy for treatment of pediatric relapsed or refractory b-progenitor acute lymphoblastic leukemia

Conditions: Leukemia, Lymphocytic, Acute; Leukemia; Acute Lymphoid Leukemia (ALL)

Summary: this is a phase i trial in patients with relapsed or refractory leukemia of a human monoclonal antibody that kills b cell acute lymphoblastic leukemia. the trial will study the safety, pharmacokinetics, and anti-tumor activity of the antibody given as a single agent and with vincristine.


Eligibility criteria:
inclusion criteria:- patients must be \> than 12 months at the time of study entry. * patients must have had histologic verification of b-lineage all with bone marrow relapse or refractory disease that is unresponsive to traditional chemotherapy. * for patients without prior allogeneic bone marrow transplant (bmt): * second or subsequent bone marrow relapse * primary refractory marrow disease * m3 marrow (\> 25% blasts) * for patients with prior allogeneic bmt: * first or subsequent bone marrow relapse post-bmt * m3 marrow or m2 (\> 5% and \< 25% blasts) if cytogenetic or variable number tandem repeat (vntr) confirmation * confirmation of antibody reactivity * patient's leukemic blasts (peripheral blood or marrow) must be documented to bind mab 216 in vitro (teng lab). * patient's red blood cell (rbc) documented to not express fetal "i" antigen and rbc shown to not bind mab 216 in vitro (teng lab) * patient must not be eligible for therapies of higher priority * performance level karnofsky 50% for patients \> 10 years of age and lansky \>= 50 for patients \<= 10 years of age. * life expectancy must be at least 8 weeks. * patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study: * myelosuppressive chemotherapy: must not have been received within 2 weeks of entry onto this study. * biologic: at least 7 days since the completion of therapy with a biologic agent. * no hematologic criteria for white blood cell (wbc), hemoglobin (hgb), or platelets * patients with thrombocytopenia should be responsive to platelet transfusions and must not have uncontrolled bleeding. * adequate renal function defined as: a serum creatinine that is less than or equal to 1.5 x normal for age * adequate liver function defined as: total bilirubin \<= 1.5 x upper limit of normal (uln) for age, and sgpt (alt) \<= 5 x upper limit of normal (uln) for age * adequate cardiac function defined as: shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 50% by gated radionuclide study. * all patients and/or their parents or legal guardians must sign a written informed consent/assent. * all institutional review board (irb) and food and drug administration (fda) requirements for human studies must be met. exclusion criteria:- central nervous system (cns) 3 or refractory cns leukemia * isolated extramedullary relapse * uncontrolled infection * lack of mab 216 binding to patient's leukemic blasts in vitro * binding of mab 216 to the"i" antigen on patient's erythrocytes * prior treatment with rituximab
the therapeutic effect of co-administration of pentoxifylline and zinc in men with idiopathic asthenozoospermia

Conditions: Men Infertility

Summary: the aim of this study was to investigate the therapeutic effect of co-administration of pentoxifylline and zinc on sperm apoptosis in men with idiopathic infertility

this study is being performed as a double-blind randomized clinical trial on idiopathic infertile men referred to the infertility clinic of shafa clinic. patient satisfaction, non-use of contraceptives, men aged 25 to 43 years, and idiopathic infertility according to who criteria (world health, 2010) are our study criteria. any medication that may affect the course of spermatogenesis should be discontinued during the study. semen samples are taken from patients (before and after interventions) and apoptosis tests are performed on semen samples.

Eligibility criteria:
inclusion criteria: * infertile men * have had at least one year of unprotected intercourse infertility * asthenozoospermia exclusion criteria: * men with varicocele * hypersensitivity to pentoxifylline \& zinc, * pelvic organic pathologies * congenital adrenal hyperplasia * thyroid dysfunction * cushing's syndrome * hyper prolactinemia * androgen secreting neoplasia * severe hepatic * pancreatitis * kidney diseases * gallbladder diseases * patients with alcohol consumption * patients who use cigarettes and drugs
metastatic colorectal cancer treated with regorafenib and folfiri

Conditions: Colorectal Cancer

Summary: the survey is a retrospective study to evaluate the prognotic value of egfr expression, kras mutations and tumor sideness in patients with metastatic colorectal cancer treated with regorafenib and folfiri as a third- or fourth-line setting.

primary objective: progression-free survival secondary objecive: overall survival, best objective response, disease control rate and adverse events number of subjects: 41 patients with metastatic colorectal cancer treated with regorafenib and folfiri as a third- or fourth-line setting. plan of the study: 1. this is a retrospective study. 2. study schedule study date: the time getting approval letter issued by both regulatory authority and institutional review board (irb). duration of the study: 5 years. 3. duration of treatment: treatment was administered until disease progressed.

Eligibility criteria:
inclusion criteria: * age between 20-85 years old * histologically proven metastatic colorectal cancer (mcrc). * patients with progressing mcrc who were previously treated with folfox, folfiri, anti-vgfr monoclonal antibody (moab), and anti-egfr moab if kras-wild-type tumors were identified. * patient was able to understand the requirements of the study and written informed consent was obtained from each subject. exclusion criteria: * patients who do not meet the including criteria or unwilling to participate

Keywords: egfr kras tumor sideness folfiri regorafenib metastatic colorectal cancer
dietary influences on caries index among sudanese and egyptian adult population

Conditions: Dental Caries

Summary: the objective of this study is to compare the caries index between sudanese and egyptian adult population in patients with different diet habits and different oral hygiene state in range of (18-40) years old

a main factor for planning any preventive program is to accurately assess a person's risk of developing a caries. there is a relative lack of data pertaining to adults in the developing world in general and in sudan in particular. most of the studies focused on school children. many people in sudan do not receive regular dental care and have acute problems when seen by a dentist. in sudan the dentist-to-patient ratio is 1:33,000 compared with approximately 1:2,000 in most industrialized countries. relative to the size of the sudanese population, there are very few dentists and this restricts access to regular dental care. other factors which influence dental. attendance in sudan include the lack of public funding for oral healthcare and dental insurance schemes to ameliorate the cost of care. for this reason, insufficient awareness of the culture of selecting suitable foods to preserve the health of the mouth and teeth, as prevention is better than treatment . the study will help the clinician to compare the incidence of caries between different nationality they have different diet habits ,food traditions , and they have different education and cultural levels as these factors can reflect the health care system , and to determine the effect of these factors clearly on dental caries it also allow the clinician to develop the most suitable preventive treatment plan for each patient by evaluating the main causative factor to patient and to eliminate that factor so that we can arrest an ongoing active lesion and prevent developing a new lesion at lowest therapeutic cost. the patient will be informed in the same visit about the causative factor of the carious lesion in general, the role of diet in particular and instructed about the suggested treatment plan ,to change the lifestyle to the better and strengthen the concept of "prevention is better than treatment"

Eligibility criteria:
inclusion criteria: * patients should be in range of 18-40 years old. * patient should have good periodontal health. * sudanese and egyptian population exclusion criteria: * patient below 18 years and above 40 years old * nationality other than egyptian and sudanese

Keywords: dental decay
cardio-protective effect of metformin in patients undergoing pci

Conditions: Elective Percutaneous Coronary Intervention; Ischemic Reperfusion Injury

Summary: this is a two-arm randomized parallel study. patients who will be meeting the above-mentioned criteria and agree to take part in the study, were asked to sign an informed consent prior conducting the study. the whole study protocol were presented to the local institutional review board (irb).


Eligibility criteria:
inclusion criteria: * adult patients (age above 18) * undergoing elective pci exclusion criteria: 1. hypersensitivity to metformin or any component of the formulation 2. patients with current or any history taking metformin either for diabetes mellitus or any other reason such as polycystic ovarian syndrome. 3. patients diagnosed with type 1 or 2 diabetes mellitus. 4. any oral or injectable hypoglycemic therapy (e.g. insulin, sulfonylureas) 5. severe renal dysfunction (egfr less than 30 ml/minute/1.73 m2 ) from any cause, including shock or septicemia; acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis). 6. treatment with systemic glucocorticoids within 3 months of randomization (due to its potential effect on plasma glucose and hba1c levels). 7. metabolic acidosis (total co 2 below the laboratory lower limit of normal on most recent blood chemistry panel). 8. need for coronary artery bypass grafting. 9. participation in other clinical trial in the 30 days before enrollment. 10. the existence of a life-threatening disease with a life-expectancy of less than 6 months.
16-week efficacy and 2-year safety, tolerability and efficacy of secukinumab in participants with active ankylosing spondylitis

Conditions: Spondylitis, Ankylosing

Summary: the purpose of this study is to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (pfs) and to assess efficacy, safety and tolerability up to 2 years in subjects with active as despite current or previous nsaid, non-biologic dmard, or biologic anti-tnfα therapy.


Eligibility criteria:
inclusion criteria: moderate to severe as, prior radiographic evidence according to the modified ny criteria (1984), inadequate response to nsaids. exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a chest x-ray or mri, previous exposure to il-17 or il-17r targeting therapies, previous exposure to any biological immunomodulating agent excluding tnf antagonists, previous cell depleting therapy. other protocol-defined inclusion/exclusion criteria do apply.

Keywords: ain457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, secukinumab, self-injection
a study of the safety, pharmacokinetic drug interaction and efficacy of etc-1002 and atorvastatin in subjects with hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: this study will assess the safety, atorvastatin pharmacokinetics, and ldl-c lowering efficacy of etc-1002 versus placebo in hypercholesterolemic subjects on background therapy of atorvastatin 10 mg.


Eligibility criteria:
inclusion criteria: * for subjects on current daily statin therapy - ldl-c 100-220 mg/dl and triglycerides \<350 mg/dl (prior to switching to sponsor -provided atorvastatin 10 mg/day and stopping all other lipid-regulating drugs and supplements) at the s1 visit, * for subjects not on current daily statin therapy - ldl-c ≥ 110 mg/dl and ≤ 220 mg/dl exclusion criteria: * acute significant cardiovascular disease * uncontrolled hypertension

Keywords: atorvastatin drug-drug interaction combination therapy
negative pressure therapy, minimally invasive and accessible technique in the treatment of massive subcutaneous emphysema in covid-19 or non infected critical patients

Conditions: Subcutaneous Emphysema; Covid19

Summary: background numerous surgicals treatments have been described for the massive subcutaneous emphysema; however, some of these techniques cannot be carried out in a critical care unit and they are related with high morbidity and exposure in positive sars cov-2 patients. more effective, less invasive and isolated procedures should be implemented. technique negative pressure therapy (npt) that can allow effective solving of massive subcutaneous emphysema in a short period (5 days) with a minimally invasive approach at the bedside in covid-19 or non infected critical patients. conclusion npt is an effective and low invasive strategy for the management of ees in critical patients with high risk of mortality.


Eligibility criteria:
inclusion criteria: * subcutaneous emphysema that compromises ventilation exclusion criteria: * declined therapy
clarksdale diabetes and metabolism clinic chec study

Conditions: Diabetes

Summary: this study will involve established clinic patients. the rapid estimate of adult literacy in medicine will be administered during patients' regular clinic visits. patients will then be referred to the consumer health education center (chec)by healthcare providers who will fill out a referral form. the form will be given the the chec health educator who will assist patients in finding literacy-appropriate health information. bmi and hgb a1c values will be compared after 3 months and 6 months to baseline values. it is hypothesized that objective assessment of patient use of literacy-appropriate, health information from the clarksdale diabetes and metabolism clinic chec will improve hgb a1c and bmi values among patients.


Eligibility criteria:
inclusion criteria: * established patients of the clarksdale diabetes and metabolism clinic between the ages of 18 and 64. exclusion criteria: * individuals who are not established patients of the clinic and are not between the ages of 18 and 64.

Keywords: diabetic patients at the clarksdale diabetes and metabolism clinic and must be between the ages of 18 and 64 years of age.
the effect of repeated lifestyle intervention on weight loss maintenance

Conditions: Obesity; Overweight

Summary: in denmark and the western world, there is an increasing prevalence of obesity probably due to a combination of inadequate daily physical activity and a high energy intake. one approach to achieve weight loss and change life style is to participate in an intensive supervised prolonged life style modification course. the immediate effect is often positive, but over time the overall effect is limited as the majority will not maintain weight loss and a changed life style. in this study we will analyse the results of the intensive lifestyle intervention as it has been practised at ubberup folk high school over the last 13 years. as some people have several stays at ubberup folk high school we want to we have a special interest in the effect of repeated lifestyle intervention. research question: what is the effect of several lifestyle interventions on weight loss maintenance? the study design is retrospective and descriptive and will be based on a lifestyle intervention, as it has practiced in a real life setting at ubberup folk high school.


Eligibility criteria:
inclusion criteria: * former participants of the intensive lifestyle intervention at ubberup folk high school. exclusion criteria: * gastric bypass surgery or banding

Keywords: lifestyle intervention change of body composition physical activity weight loss maintenance