Kornimate/medical-research-clean huggingface dataset:
insulin start therapy application with resources and training

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the i-start study is to evaluate an educational phone application (app) designed to support patients with type 2 diabetes (t2dm) by reinforcing the necessary skills needed for insulin administration as part of diabetes self-management.

despite advances in technology and delivery systems, patients with t2dm continue to be reluctant to begin and adhere to insulin therapy for a variety of reasons. introducing insulin therapy is particularly problematic during a hospitalization or a brief routine outpatient visit given time and resource constraints. teaching people to administer an insulin injection requires time and ongoing support. therefore, this study aims to evaluate an educational phone application designed to support patients with t2dm by reinforcing skills and self-management behaviors needed for insulin administration. patients with t2dm who are starting insulin or need updated instruction on insulin will be invited to participate in this study to examine the effect of the phone app on psychological barriers to insulin as well as patient and provider satisfaction with and usability of the phone app in both outpatient and hospital settings.

Eligibility criteria:
inclusion criteria: * 18 years of age * able to read and follow study instructions in english (translations will not be provided) * t2dm requiring the use of prandial and/or long-acting insulin * ability to self-administer insulin therapy * willing to download the study app on their smartphone * able and willing to provide a signed consent * able and willing to follow all study procedures exclusion criteria: * pregnant (self-reported) * participants from the same household participating concurrently * use of a smartphone with ios version 10.0 or lower * use of a smartphone with android os 5.0 "lollipop" or lower * currently using a continuous subcutaneous insulin infusion device * participants with major depression * currently or planning to participate in a similar study that would affect the results of this study * currently or planning to participate in a clinical study that involves taking a drug, supplement, or use of an investigational drug * continued hospitalization or transfer to an assisted living facility * any condition the pi or designee deems to pose a risk to the participant in the study (includes anything that may prevent full participation in the study)

Keywords: psychological insulin resistance diabetes self-management mobile application
an investigation into beneficial effects of interferon beta 1a, compared to interferon beta 1b and the base therapeutic regiment in moderate to severe covid-19: a randomized clinical trial

Conditions: COVID-19

Summary: the present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming covid-19 in loghman hakim medical education center in tehran. patients will be randomly assigned to the three arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

according to previous studies, ifn-β has strong antiviral activity and also has an acceptable safety profile. based on possible therapeutic effects, we decided to lead an investigation into beneficial effects of interferon beta 1a, compared to interferon beta 1b and the base therapeutic regiment in moderate to severe covid-19. in a 2003 study, sars was treated with different human interferons and found that ifn-β was 5 to 10 times more effective than other types of interferons and the strongest antiviral drug possible against sars-cov. the present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming covid-19 in loghman hakim medical education center in tehran. patients will be allocated to three therapeutic arms (hydroxychloroquine + lopinavir / ritonavir + interferon-β 1a group and hydroxychloroquine + lopinavir / ritonavir + interferon-β 1b group and the base therapeutic regiment group, i.e., hydropinchloroquine + / ritonavir. for this purpose, we will use the method of balance block randomization for three groups. after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * covid-19 confirmed cases by means of rt-pcr * oxygen saturation (spo2) ≤ 93% or respiratory rate ≥ 24 * at least one of the following: calibrated contactless infrared forehead thermometry temperature of ≥37.8, cough, sputum production, nasal discharge, myalgia, headache or fatigue on admission. * time of onset of the symptoms should be acute ( days ≤ 14) exclusion criteria: * refusal to participate expressed by patient or legally authorized representative if they are present * patients with prolonged qt or pr intervals, second or third degree heart block, arrhythmias including torsade de pointes * patients using drugs with potential interaction with hydroxychloroquine + lopinavir/ritonavir, interferon-β 1a، interferon-β 1b. * pregnant or lactating women. * history of alcohol or drug addiction in the past 5 years. * blood alt/ast levels \> 5 times the upper limit of normal on laboratory results.

Keywords: covid-19 novel coronavirus interferon beta 1a interferon beta 1b
fenofibrate and metformin fixed combination vs rosiglitazone - fame rosi

Conditions: Dyslipidemia; Glucose Metabolism Disorder

Summary: under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed combination (fc) of fenofibrate and metformin on glycemic control is not inferior to that of rosiglitazone and the efficacy of fc of fenofibrate and metformin on triglyceride control is superior to that of rosiglitazone.


Eligibility criteria:
inclusion criteria: * patient with type 2 diabetes mellitus and dyslipidemia inadequately controlled with lifestyle modifications. exclusion criteria: * type 1 diabetes.

Keywords: treatment of dyslipidemia and of type 2 diabetes mellitus
biomarker testing and dna collection in subjects participating in protocol 22001

Conditions: Fragile X Syndrome

Summary: the subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001 will be offered participation in 22001a which will evaluate secreted protein before and after treatment with stx209 and placebo to determine if they correlate with effectiveness of treatment or susceptibility to treatment with stx209. these same subjects will also be asked to contribute a blood sample for dna (deoxyribonucleic acid) collection. the investigators will study the dna to determine if stx209 works better in people with specific gene variations, or to find new gene variations that predict how well stx209 works.


Eligibility criteria:
inclusion criteria: * subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001 exclusion criteria: * subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001

Keywords: fragile x syndrome biomarkers
hba1c and diagnosis of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: following the 6th tromso study subjects with hba1c \> 5.7 plus a subsample of subjects with lower hba1c values will be invited to an oral glucose tolerance test to see the predictive value of hba1c in the diagnosis of type 2 diabetes.


Eligibility criteria:
inclusion criteria: * participated in the 6 tromso study exclusion criteria: * type 2 diabetes

Keywords: type 2 diabetes hba1c vitamin d diagnosis
buttressed pancreatico-gastrostomy for soft pancreas with small diameter pancreatic duct in whipple procedure

Conditions: Pancreatic Fistula

Summary: post-operative pancreatic fistula after pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. more than 60 techniques were published in literature. soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. supporting duct to mucosa pancreatico-gastrostomy with trans-pancreatic transverse mattress u- shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.

post-operative pancreatic fistula after pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. more than 60 techniques were published in literature. soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. supporting duct to mucosa pancreatico-gastrostomy with trans-pancreatic transverse mattress u- shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients. the authors used this technique in pancreato-gastrostomy. data were collected, tabulated and analyzed to evaluate the new technique and its impact on the incidence of post-operative pancreatic fistula.

Eligibility criteria:
inclusion criteria: * patient diagnosed with resectable cancer head pancreas. * soft pancreas. * small pancreatic duct diameter. exclusion criteria: * unresectable cancer pancreas. * non soft pancreas. * dilated pancreatic duct.

Keywords: cancer pancreas pancreaticoduodenectomy pancreaticogastrostomy
multicenter benchmarking of functional and psychosocial outcomes of pediatric burn survivors

Conditions: Burn

Summary: the purpose of this study is to establish an expected recovery trajectory (recovery model) in terms of physical and psychological function of the pediatric burn patient.

the successful advancement of treatment for burns allows us now to save lives of children who sustain massive burn injuries. the purpose of this study is to establish an expected recovery trajectory (recovery model) in terms of the physical and psychological function for pediatric burn patients by assessing prospectively the outcomes of burn children who are treated at the four shriners hospitals for children (shc) burns hospitals. the study hopes to develop valid benchmarking of outcomes between the four hospitals and therefore, best practices will be utilized. this recovery trajectory will be used as a benchmark for functional and psychosocial outcomes following burn injury. * participants in the study complete a series of self reporting questionnaires over a forty-eight month period. there are a total of nine time points during the forty-eight month commitment when questionnaires are given to parent and/or guardian and patients if they are 11 years or older. * patients who undergo a reconstructive surgical procedure during their enrollment will fill a set of questionnaires related to the effects of the surgical procedure on their long-term recovery. the surgical procedure is not an intervention because of the study, it is part of their long-term follow-up care after their acute phase. there will be a pre-op and a six and twelve month post-op questionnaire. * the aim of this study is to develop an expected trajectory recovery model in terms of physical and psychological functioning. analysis of the data using validated burn specific questionnaires will allow benchmarking of outcomes between the four shriners burns hospitals. we aim to determine predictors of positive outcomes and focus on them as a standard of practice.

Eligibility criteria:
inclusion criteria: * pediatric burn patients 18 years or less at time of injuries. * all high risk patients admitted for burn treatment with injuries \>/= 20% total body surface area (tbsa), \</= 20% tbsa to critical areas: hands, feet, face, and genitalia. * all low risk \</= 20% to non critical areas. * electrical, flame, scald, and chemical burns of at least a second degree nature. * english and spanish speaking patients admitted to shriners hospital within 30 days of injury exclusion criteria: * first degree burns * patients admitted \>30 days post acute injury. * patients that speak a language other than english or spanish. * patients who decline to be in the study. * patients with a non-burn injury

Keywords: burns functional psychosocial recovery long-term pediatric surgical outcomes benchmarking
expanded access for treatment with imetelstat

Conditions: Myelodysplastic Syndromes

Summary: the objective of this expanded access protocol (eap) is to provide access to treatment with imetelstat, the investigational product (ip), for eligible adult participants diagnosed with very low, low, intermediate risk (by revised international prognostic scoring system, ipss-r) myelodysplastic syndromes (mds) who are red blood cell (rbc) transfusion-dependent, have failed to respond or have lost response or are ineligible for esas, had not received prior treatment with either a hypomethylating agent or lenalidomide and were non-del(5q), until such time that imetelstat becomes commercially available.


Eligibility criteria:
key inclusion criteria: * documented diagnosis of mds according to world health organization (who) criteria confirmed by bone marrow aspirate and/or biopsy preferably within 24 but no more than 52 weeks prior to eap start. * very low, low, or intermediate risk mds (≤3.5) per ipss-r. * red blood cell (rbc) transfusion dependent, defined as requiring at least 4 rbc units over an 8-week period during the 16 weeks prior to eap entry; pre-transfusion hemoglobin (hb) should be less than or equal to 9.0 grams per deciliter (g/dl) to count towards the 4 units total. * has mds that has failed to respond or has lost response or are ineligible for esas. * to ensure participants have adequate iron stores they must have transferrin saturation greater than 20% and serum ferritin greater than 400 nanograms per milliliter (ng/ml). * eastern cooperative oncology group (ecog) performance status score of 0, 1 or 2. * hematology and biochemical laboratory test values within the protocol defined limits. * have no approved alternative treatment available. * inability to participate in a current imetelstat clinical study for the disease or conditions. * have a treating physician who has appropriately evaluated the benefit/risk profile for potential imetelstat treatment. key exclusion criteria: * have previously assessed as having ipss-r high or very high risk mds. * participant with del(5q) karyotype. * participant with mds/myeloproliferative neoplasm overlap syndromes. * participant has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients. * participant has received an experimental or investigational product or used an invasive investigational medical device within 30 days prior to eap entry or is currently enrolled in an investigational study. * prior treatment with imetelstat; or eligible for enrollment in an ongoing imetelstat clinical trial. * prior treatment with lenalidomide or a hypomethylating agent (example, azacitidine, decitabine, or decitabine/cedazuridine). * has received an esa or any anti-mds therapy, chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to eap entry. * prior history of hematopoietic stem cell transplant. note: other protocol specified inclusion/exclusion criteria may apply.
moca versus rfa in the treatment of primary great saphenous varicose veins

Conditions: Greater Saphenous Vein Injury

Summary: the newly developed mechanochemical endovenous ablation (moca) device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. previously we showed that endovenous moca, using polidocanol, is feasible and safe in the treatment of great spahenous vein (gsv) incompetence. however, larger studies with a prolonged follow-up to prove the efficacy of this technique in terms of obliteration rates are lacking. this randomized trial was designed to compare occlusion rate, post-operative pain and complications between radiofrequency ablation (rfa: the current treatment for gsv incompetence) en moca.


Eligibility criteria:
inclusion criteria: * insufficiency of the gsv * signed informed consent * patient willing to participate in follow-up scheme * age \> 18 years * ultrasound criteria for endovenous treatment have been met: * diameter gsv between 3-12 mm * no thrombus in the to be treated segment of the gsv exclusion criteria: * patient not able to give informed consent * patient unable to present at follow-up visits * other treatment is more suitable * pregnancy and breast feeding * known allergy/ contra-indication for sclerotherapy * previous ipsilateral surgical treatment of varicose veins * deep venous thrombosis or lung emboli in medical history * anticoagulant therapy * c5-c6 varices * immobilization * fontaine ii or iv peripheral arterial disease * severe kidney function decline (gfs \< 30 ml/min) * coagulation disorder or increased risk for thrombo-embolic complications(hemofilie a or b, v. willebrand disease, glanzmann disease, factor vii-deficiency, idiopatic thrombocytopenic purpura, factor v leiden) * liver diseases accompanied by changes in blood coagulation, livver cirrhosis

Keywords: gsv primary varicose veins great saphenous vein treatment
optimal stimulation parameters to disrupt epileptiform activity

Conditions: Refractory Epilepsy

Summary: open-loop electrical stimulation has been found to reduce spike activity and seizures, but determining the optimal parameters to achieve these effects requires a brute force trial-and-error approach that relies on subjective physician discretion. we will compare the performance of stimulation parameters identified in rodent models to the recommended parameters for neuromodulation used in clinical practice.


Eligibility criteria:
inclusion criteria: - undergoing intracranial eeg investigation at massachusetts general hospital during presurgical epilepsy evaluation exclusion criteria: - baseline spike ripple rate \< 0.5/min.
fatal cerebral infarction after nasal augmentation with hyaluronic acid

Conditions: Magnetic Resonance Angiography

Summary: this study discussed the pathogenesis, treatment, and prognosis of severe cerebral infarction and ophthalmic artery occlusion for aisan induced by hyalruonic acid filler injection.

intra-arterial thrombolysis and retrobulbar injection of hyaluronidase have been used for ha-induced ophthalmic artery obstruction.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cerebral infarction exclusion criteria: * fat embolism

Keywords: cerebral infarction hyaluronic acid embolism
the influence of chinese medicine on metabolomics in menopausal or postpartum women

Conditions: Menopausal Women

Summary: traditional chinese herbal medicine, no matter mono-therapy or poly-pharmacy, is composed of complicated chemical constituents. many confounding factors influence activity of chinese herbs, including the origin of the herbs, safety of the products and consistency between batches. study of the effectiveness and mechanism of chinese herbs in vivo is much more challengeable due to unresolved problems of product quality control, screen of effective principles, monitor of the marker constituents and the targets for site of action. in this project, we will introduce the concept of metabolomics to detect total metabolites spectra as the biomarkers of chinese herbs intervention. correlation will be analyzed between changes in total metabolites and clinical improvements when menopausal women receive suan tsao jen tang or jia wey shiau yau san, and postpartum women receive生化湯.


Eligibility criteria:
inclusion criteria: * insomnia according to psqi\>6 * informed consent * female * age 40-65 years exclusion criteria: * in 3 months before participating in and studying, happen great accident or heavy night shift or have time difference problems (such as the long-range flight) . * spiritual disease (melancholia,etc.) ,obstructive sleep apnea, heart disease history (the acute heart attack, cardiac arrhythmia) , hypertension , diabetes mellitus, cancer. * take melatonin or melatonin agonist, such medicines as acetylcholine, glutamate, serotonin, norepinephrine, gaba, histamine, adenosine, prostaglandins,etc..

Keywords: suan-tsao-jen-tang ,jia-wey-shiau-yau-san,metabolomics,menopause
effect of allopurinol treatment on insulin resistance

Conditions: Hyperuricemia; Prediabetes; Insulin Resistance

Summary: several studies showed that hyperuricemia is an independent risk factor for development of diabetes mellitus. however none of the previous studies have investigated the effect of lowering serum uric acid levels on insulin resistance of which is also named as prediabetes. with this background in mind, we aimed to test the effect of lowering serum uric acid level with allopurinol on insulin resistance.


Eligibility criteria:
inclusion criteria: * age ≥ 30 * serum uric acid level ≥7mg/dl * glomerular filtration rate ≥60 ml/min exclusion criteria: * presence of diabetes mellitus * history of gout * history of allopurinol use * body mass index ≥35 kg/m2 * proteinuria ≥ 1gr/ day * presence of autoimmune disease * rheumatology associated disease * presence of hypothyroidism or hyperthyroidism * presence of diseases which may cause chronic inflammation or microalbuminuria (e.g. malignancy, chronic liver disease, hypertension, chronic lung disease)