Kornimate/medical-research-clean huggingface dataset:
effectiveness of focused tele-education in reducing diabetes complications during ramadan

Conditions: Diabetes Mellitus; Fasting; Diabetes Complications

Summary: introduction diabetes is a global emergency with detrimental clinical and financial consequences. poorly managed diabetes leads to a myriad of serious complications, especially cardiovascular and infectious complications, with consequent increased cost and mortality rate. for muslims in particular, the annual fasting month of ramadan is one such period when diabetes control is essential. adequate adjustments in diabetes management need to be made in line with the allowed mealtimes to avoid the risk of diabetes complications during ramadan. objective investigators aim to investigate the effectiveness of ramadan-focused structured diabetes tele-education to reduce diabetes complications during ramadan fasting for muslims with diabetes in south east asia. methodology in a parallel group randomized controlled trial, investigators aim to recruit 300 adults with diabetes who are able to fast at least 15 days in ramadan. you will be randomized to the intervention group comprising of a ramadan-focused structured diabetes tele-education and control group receiving standard care. you will be reviewed again after ramadan. the primary outcome is the incidence of hypoglycemia in ramadan. the secondary outcomes are incidence of other diabetes complications in ramadan episodes including hyperglycemia, episodes of acute infections, attendances in clinic and emergency department, hospital admissions, and compliance to recommendations for diabetes management during ramadan. clinical significance the study enables investigators to evaluate ramadan-focused structured diabetes tele-education to reduce the risk of diabetes complications for a large population during the fasting month.


Eligibility criteria:
inclusion criteria: * adults with diabetes planning to fast in ramadan, 1. adults with type 2 diabetes aged at least 21 years old, 2. able to fast at least 15 days in ramadan based on experience of fasting in previous year's ramadan, 3. underlying type 2 diabetes treated with basal insulin and one or more doses of prandial insulin, or at least twice-daily premixed insulin 4. performed laboratory tests as per standard care - glycated haemoglobin (hba1c), serum low density lipoprotein- cholesterol, serum triglycerides, serum high density lipoprotein- cholesterol, serum total cholesterol and serum creatinine 5. ability to give informed consent, 6. ability to perform self-monitoring blood glucose 7. have had diabetes-related clinic visits or hospitalization in the past 10 months. 8. have the capacity for video conferencing (internet connection with mobile phone or computer) exclusion criteria: 1. severe diabetes complications including end-stage renal failure 2. severe hypoglycemia and hyperglycemic crises within the last 3 months 3. advanced comorbidities negating the ability to fast 4. pregnancy 5. patients on oral medications alone or oral medications plus basal insulin alone 6. patients on sulfonylureas
gapco2 and respiratory rate in patients under volume mechanical ventilation

Conditions: Shock

Summary: as an approximate of the difference between venous-to-arterial co2 tension (∆pco2), ∆pco2 is proportional to co2 production and inversely related to cardiac output (fick equation). anaerobic co2 production is thought to occur when tissue hypoxia is present, mostly because of buffering of bicarbonate ions by the protons produced in excess secondary to the hydrolysis of adenosine triphosphate. therefore ∆pco2 has been proposed as a marker of tissue hypoxia.

an increased ∆pco2 (\> 6 mmhg) could be used to identify patients who still remain inadequately resuscitated, when deciding when to continue resuscitation despite a central venous oxygen saturation (scvo2) \> 70% associated with elevated blood lactate levels. under steady states of both vo2 and vco2, p (v-a) co2 was observed to increase in parallel with the reduction in cardiac output. however, spontaneous breathing and hyperventilation may reduce paco2 and prevent the co2 stagnation-induced rise in pvco2. to date,these studies of ∆pco2 and respiratory rate in septic shock patients under volume mechanical ventilation are rarely.

Eligibility criteria:
inclusion criteria: patients were included in the study, if the attending physician find the persistence of signs of hypoperfusion (oliguria, mottled skin, central venous oxygen saturation (scvo2) \ 8 g/dl),despite achieving adequate intravascular volume and adequate mean arterial pressure (map) \> 65 mmhg as recommended by the surviving sepsis campaign. exclusion criteria: exclusion criteria were pregnancy, copd，age less than 18 years old, unstable hemodynamic condition (change of vasoactive drug dosage or fluid administration within 1 h preceding the protocol) and uncontrolled tachyarrhythmias (heart rate\>140 beats/min).

Keywords: sepsis, shock,lactate,volume controlled ventilation
pilot study of etoposide-based therapy and hematopoietic cell transplantation for hemophagocytic lymphohistiocytosis

Conditions: Hemophagocytic Lymphohistiocytosis

Summary: the investigators would like to propose a pilot study evaluating the efficacy of etoposide combined with immunosuppressive agents for adult secondary hemophagocytic lymphohistiocytosis (hlh), in order to prove out whether the modification of previous hlh-94 or hlh-2004 protocol for childhood patients can improve the outcome and decrease the toxicities. the results of this pilot study will be a base of a more-improved phase-2 protocol.

the treatment of hlh in adult patients has not been determined yet. actually, we adopted the treatment protocol hlh2004, which was developed for pediatric hlh patients. the hlh2004 protocol, which is a potent and successful treatment for hlh, has shown some limitations in the treatment of adult hlh. first, the dose of etoposide is somewhat high for adult patients to tolerate. second, the high incidence of opportunistic infection such as fungal, bacterial, and viral has threatened the patients. third, more aggressive and intensive approach to adopt allogeneic hematopoietic cell transplantation will be needed earlier in adult patients. based on these rationales, we developed a modified protocol based on hlh2004 to pit the treatment of adult hlh patients.

Eligibility criteria:
inclusion criteria: * patients whose clinical findings satisfy 5 or more criteria out of the following 8 ones 1. fever ≥ 38.5 ℃ for ≥ 7 days 2. splenomegaly ≥ 3 fb below left subcostal margin 3. cytopenias affecting ≥ 2 of 3 lineages in pb hb \< 9 g/l platelet \< 100 x 109 /l anc \< 1.0 x 109 /l 4. hypertriglyceridemia and/or hypofibrinogenemia (fasting triglycerides ≥ 265 mg/dl, fibrinogen ≤ 1.5 g/l) 5. hemophagocytosis in bm or spleen or ln 6. low or absent nk-cell activity ( according to local laboratory reference) 7. serum-ferritin ≥ 500 mcg/l 8. soluble cd25(sil-2 receptor) ≥ 2,400 u/ml * 18 years of age and over. * all patients (or his/her family when the patient cannot sign the consent form because of his/her general conditions) give written informed consent according to guidelines at institution's committee on human research. exclusion criteria: * hlh from malignancy (such as lymphoma, myeloma, leukemia, and other solid tumor) * hlh from rheumatic disorder (such as sle, aosd, antiphospholipid antibody syndrome) * patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible * nursing women, pregnant women, women of childbearing potential who do not want adequate contraception * male patient who reject the methods of avoiding pregnancy via methods such as abstinence, barrier method (condom etc). * patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)

Keywords: secondary hemophagocytic lymphohistiocytosis of adults
the dermisgraft epithelialization and late scar healing

Conditions: Burns

Summary: study synopsis title; the dermis graft: epithelialization and late scar evaluation a clinical prospective multicenter trial objectives; the objective of this study is to compare a dermal graft with a conventional split thickness skin graft regarding healing quality and scarring. design; the study is a prospective, controlled clinical multicenter trial. study population; atleast 20 burn patients (18-80 years) with a full thickness burn that requires permanent skin cover. time plan; enrollment will continue until atleast 20 patients have been included and completed the study.

background: donor site morbidity is a major concern such as wound healing disturbances, hypertrophic scarring and hypo-/hyperpigmentation. the dermal graft technique is an alternative to the standard split-thickness skin graft (stsg) technique to minimize donor site morbidity. immediate cover of the donor site after harvest leaving a non-exposed wound is a big advantage. the aim of the study was to compare the functional and aesthetic outcome between two treatment methods (dermal graft with stsg). methods: from february 2017 to december 2020, 21 patients received a dermis graft and a regular split-thickness skin graft in a prospective randomized study design. the recipient and the donor site were compared separately regarding healing time, scarring and patient subjective satisfaction. all sites (both donor and recipient) were analyzed histologically regarding remodeling and scar formation.

Eligibility criteria:
inclusion criteria: * thermal \& chemical burns \< 30 % tbsa * males \& females between 18-80 years old * at least one coherent full thickness wound measuring 15 x 7.5 cm * a minimal of 15 x 7.5 cm coherent undamaged skin located at frontal or lateral side of one of the thighs for graft harvest. exclusion criteria: * patients with severe cutaneous trauma at the same site as the burn injury * previous burns at the treatment site * severe cognitive dysfunction or psychiatric disorder * chronic skin disorder * chronic use of systemic or local corticosteroid * chronic use of anticoagulants or platelets * autoimmune disease * active hepatitis * full thickness burns of head, genitalia, axilla or upper third of medial upper arm
modified bfm-95 regimen as first-line chemotherapy in adults with t- lymphoblastic lymphoma

Conditions: Lymphoma, Lymphoblastic

Summary: this study evaluates the efficacy and tolerability of treatment for t-lymphoblastic lymphoma (t-lbl) according to modified bfm-95 regimen for acute lymphoblastic leukemia.

all patients received a modified bfm regimen which was derived from the nhl-bfm-95. the differences were as follows: (1) during the course of high-dose methotrexate therapy (hd-mtx), citrovorum folinate (cf) was used for rescue at 36 h after the administration of hd-mtx;(2) pirarubicin was used instead of daunorubicin (3) pegaspargase was used instead of l-asparaginase for patients.all patients received induction phase 1 and phase2, followed by the protocol m, reinduction phase 1 and phase2, and maintenance (mercaptopurine 50 mg/m2 daily and methotrexate \[mtx\] 20 mg/m2 weekly, both orally) for up to a total therapy duration of 24 months. cns-positive patients received two additional doses of intrathecal mtx at days 18 and 27 of induction and received crt after reinduction therapy. the dose was 18 gy.patients with identifiable blasts in csf-cytospin preparation but less than 5cells/ul in csf were not considered cns positive but received two additional doses of intrathecal mtx at days 18 and 27. for men with testicular involvement,orchiectomy was not performed, and irradiation (20 gy) of testes was to be confined to biopsy-proven persistent infiltration of testis after protocol m.response to treatment was evaluated on day 33 and at the end of induction in modifed bfm-95.sufficient response was defined as at least 70% tumor regression, less than 5% bm blasts, and no cns disease on day 33 and complete remission detected by pet / ct at the end of induction.for patients with insufficient response at day 33 or at the end of induction treatment was to be intensified according to the high-risk branch of trial all-bfm95, with local radiotherapy (30 gy) and allogeneic blood stem-cell transplantation.

Eligibility criteria:
inclusion criteria: * newly diagnosedt-lbl * age:18-65years * ann arbor stage ieto stage ive * at lease one measurable lesion * receive no chemotherapy or radiotherapy before * adequate renal function (eg, serum creatinine≤1.5 mg/dl and creatinine clearance ≥50 ml minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal) exclusion criteria: * mismatch the inclusion criteria * systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
prevention of maternal and fetal metabolic complications with diet and nutraceutical supplementation in pregnant women affected by gestational diabetes: a randomized, double-blind placebo controlled trial.

Conditions: Gestational Diabetes; Oxidative Stress

Summary: our trial aims to assess the effect of nutraceutical supplements (omega-3 fatty acids, anthocyanins and alpha-cyclodextrins) in patients affected by gestational diabetes. pregnant women with gestational diabetes at 24-28 weeks of gestation are enrolled in a double-blind trial and randomized to receive either nutraceutical supplements or a placebo for 12 weeks.

randomized, double-blind trial aims: evaluation of the metabolic effect on patients affected by gestational diabetes of anti-inflammatory, anti-oxidant nutraceutical supplementation with omega-3 fatty acids, anthocyanins and alpha-cyclodextrins for 12 weeks associated with appropriate nutritional coaching versus nutritional coaching and placebo. all women receive a personalized diet by a nutrition expert educator and should monitor capillary blood glucose levels. patients receive twice-weekly antenatal testing, including ultrasonography for fetal growth and well-being maternal weight body fat mass distribution evaluation using skinfold caliper, dietary counselling. blood and urine samples are drawn from all patients at recruitment and at the last study visit.

Eligibility criteria:
inclusion criteria: * patients between 24 and 28 weeks of gestation with positive result to an oral glucose tolerance test with 75 gr glucose performed after 24 gestational weeks, according to the international association of diabetes and pregnancy study group (iadpsg) recommendations (at least one of the following criteria: baseline glycemia ≥ 92 mg/dl, 1-h glycemia ≥ 180 mg/dl, 2-h glycemia ≥ 153 mg/dl) * maternal age ≥ 18 years. exclusion criteria: * multiple pregnancies * fetal malformation * maternal diseases (type 1 and type 2 diabetes, hypothyroidism and hyperthyroidism, immunological disorders) * abnormal blood glucose values before 24 weeks of gestation.
metformin and transient hyperglycemia

Conditions: Acute Lymphoblastic Leukemia; Hyperglycemia; Insulin Resistance; Diabetes Mellitus

Summary: the purpose of this study is to determine whether metformin is an effective adjunctive treatment for transient hyperglycemia in patients with acute lymphoblastic leukemia (all) undergoing induction chemotherapy

all is the most common childhood cancer, representing one fourth of all cancers diagnosed under the age of 15 years. one of the most common side effects of all chemotherapy is transient hyperglycemia. patients that develop this complication require treatment with insulin via injections to prevent severe medical complications such as dehydration, weight loss, ketoacidosis and life-threatening infections. although insulin therapy is effective, it adds a lot of physical and psychological burden to patients because multiple daily insulin injections are required to achieve adequate blood glucose control. in this pilot study, investigators aim to examine the effectiveness of metformin as an adjunctive treatment for transient hyperglycemia. investigators will be comparing two groups of subjects (up to 40 subjects per group). patients in the treatment group will be prospectively recruited, and they will be treated with metformin in addition to insulin therapy. investigators will compare the treatment group to a historical control group acquired via chart review. these patients will have been treated with insulin alone. statistical comparison will be made between the two groups in terms of the length of insulin treatment, the total daily dose of insulin required, number of insulin injections, hemoglobin a1c level (measure of glycemic control over preceding 8- 12 weeks), and fructosamine level (measure of glycemic control over preceding 2-3 weeks). investigators hypothesize that the use of metformin will result in fewer numbers of insulin injections and fewer days of insulin therapy.

Eligibility criteria:
inclusion criteria: * all patients on induction chemotherapy who develop transient hyperglycemia(definition of transient hyperglycemia: random blood glucose \> 200 mg/dl x 2) * adequate renal function (serum cr \< 1.5 mg/dl in males, \< 1.2 mg/dl in females) * adequate hepatic function (ast \< 5x upper limit of normal) exclusion criteria: * patients with known diagnosis of diabetes or those that are already on oral hypoglycemic agents or insulin * allergy to metformin or any component of the formulation * patients with pancreatitis (lipase level \> 300 units/l) * patients with active infection (positive blood culture within 48 hours of study registration) * patients with hemodynamic instability (picu status, need for vasopressors within 48 hours of study entry) * elevated hemoglobin a1c (greater than 6.0%)

Keywords: induction chemotherapy transient hyperglycemia metformin acute lymphoblastic leukemia insulin resistance hyperglycemia insulin
study of multiplexed heptapeptides for detection of neoplasia in the esophagus

Conditions: Barrett Esophagus

Summary: the overall aim of this feasibility study is to develop new technologies for improved detection of barrett's neoplasia using the scanning fiber endoscope(sfe) multiplexed imaging system. this study will combine the use of fluorescent-labeled peptides that bind specifically to pre-cancerous mucosa in the esophagus for use as novel imaging agents to guide endoscopic biopsy or endoscopic mucosal resection (emr). this phase 1 study will be used to provide early evidence of efficacy for the topical application of a panel of two peptides that bind to molecular targets that are specific for esophageal dysplasia. a panel is needed because cancer in the esophagus is genetically heterogeneous. the study will look at peptide binding in subjects with known or suspected barrett's esophagus.


Eligibility criteria:
inclusion criteria: * known or suspected barrett's esophagus * scheduled for a clinically-indicated upper endoscopy * medically cleared for the procedure * willing and able to sign informed consent exclusion criteria: * known allergy or negative reaction to the near infrared fluorophores cy5, li-cor irdye800cw, or derivatives * one active chemotherapy or radiation treatment * pregnant or trying to conceive
brown seaweed extract on glycemic control and body weight

Conditions: PreDiabetes; Insulin Resistance

Summary: the overall goal of this study is to investigate the effects of a daily dietary supplement of brown seaweed (2 capsules of insea2®) on body weight, glycemic control and insulin secretion in overweight prediabetic men and women in association with a moderate weight loss intervention.

diets that produce lower glucose and insulin responses may reduce diabetes and cardiovascular risk. they may also facilitate weight control by promoting satiety, insulin sensitivity and optimal insulin secretion after a meal. food ingredients may indeed reduce postprandial glucose and insulin response through an inhibition of α-amylase and α-glucosidase activity that may slow down the absorption of carbohydrates. insea2® is a unique combination of polyphenolic extracts of brown algae (ascophyllum nodosum and fucus vesiculosus) which has been shown to inhibit the action of α-amylase and α-glucosidase. preliminary data in healthy men and women have demonstrated a reducing effect on plasma insulin of a single intake of insea2® consumed with a high-carbohydrate meal. the main objective is to evaluate the effects of a daily dietary supplement of 500 mg (2 capsules) of brown algae extract powder (insea2®) on body weight and blood glucose homeostasis (glucose, insulin, c-peptide) measured in the fasting state and during a 2-hour oral glucose tolerance test (ogtt) in overweight prediabetic men and women. the secondary objectives are to assess the contribution of a daily consumption of this supplement (insea2®) on weight loss when associated with a daily caloric restriction of 500 kcal due to individualized nutritional intervention on markers of lipid profile, blood pressure, inflammation, oxidative stress and gut barrier integrity. the investigators expect that insea2® lowers body weight and blood glucose homeostasis (glucose, insulin or c-peptide, as marker of insulin secretion, in the fasting state or during a 2-hour oral glucose tolerance test) in association with metabolic and inflammatory markers in the context of moderate weight loss in overweight prediabetic human subjects.

Eligibility criteria:
inclusion criteria: * overweight (bmi \> 25; waist circumference ≥ 80cm for women and ≥ 94 cm for men) * fasting insulin (≥ 60 pmol/l) * impaired fasting glycemia with or without impaired glucose tolerance * hba1c between 5.6 and 6.4 * non-smoking * stable weight in the past 3 months exclusion criteria: * diabetes * chronic disease (thyroid dysfunction, hepatic or gastrointestinal disorder, uncontrolled hypertension) * taking drugs that could affect glucose or lipid metabolism or weight and appetite * taking dietary supplements (protein powders, fish oil, omega-3 or any marine supplements) or natural health products that could affect glucose, lipid, weight or appetite * major surgery 3 months prior to the study * pregnancy * fish, seafood or iodine allergy