Kornimate/medical-research-clean huggingface dataset:
effect of combined incretin-based therapy plus canagliflozin on glycemic control and the compensatory rise in hepatic glucose production in type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: specific aim 1.to examine whether the combination of liraglutide plus canagliflozin can prevent the increase in hepatic glucose production (hgp) following institution of canagliflozin therapy and produce an additive or even synergistic effect to lower the plasma glucose concentration and a1c. specific aim 2: to examine whether combination therapy with liraglutide plus canagliflozin can produce an additive, or even synergistic, effect to promote weight loss and reduction in hepatic and visceral fat content. specific aim 3. to examine whether combination therapy with liraglutide plus canagliflozin can produce an additive or even synergistic effect to reduce systolic/diastolic blood pressure and 24-hour integrated blood pressure.

specific aim 1.to examine whether the combination of liraglutide plus canagliflozin can prevent the increase in hgp following institution of canagliflozin therapy and produce an additive or even synergistic effect to lower the plasma glucose concentration and a1c. we will examine this hypothesis by comparing the effect of administration of liraglutide alone, canagliflozin alone, and the combination of liraglutide plus canagliflozin on:(i) the rate of hgp; (ii) decrease in fasting plasma glucose concentration; (iii) counter-regulatory hormone response and (iv) a1c. we anticipate that the addition of liraglutide to canagliflozin will prevent the increase in plasma glucagon concentration, augment insulin secretion, and blunt/block the increase in hgp in response to canagliflozin, resulting in a greater decrease in fasting plasma glucose concentration and a1c than observed with each therapy alone. specific aim 2: to examine whether combination therapy with liraglutide plus canagliflozin can produce an additive, or even synergistic, effect to promote weight loss and reduction in hepatic and visceral fat content. specific aim 3. to examine whether combination therapy with liraglutide plus canagliflozin can produce an additive or even synergistic effect to reduce systolic/diastolic blood pressure and 24-hour integrated blood pressure.

Eligibility criteria:
inclusion criteria: * male and female subjects between the ages of 18-70 * subjects with type 2 diabetes mellitus (t2dm) * drug naïve or on stable dose (more than 3 months) of metformin with or without sulfonylurea * have an hba1c levels ≥7.0% and \<10.0% * stable weight (± 3 lbs) over the preceding 3 months exclusion criteria: * subjects taking drugs known to affect glucose metabolism (other than metformin) will be excluded. * individuals with evidence of proliferative diabetic retinopathy or plasma creatinine \>1.4 females or \>1.5 males or estimated glomerular filtration rate (egfr)\< 60 ml/min.172m2 will be excluded * unstable body weight (change of greater than ±3 lbs over the preceding 3 months) * participates in excessively heavy exercise program
evaluation of recombinant factor viia in patients with severe bleeding due to trauma

Conditions: Acquired Bleeding Disorder; Trauma

Summary: this trial is conducted in the united states of america (usa). the purpose of this study is to evaluate the treatment of recombinant faction viia in patients with severe bleeding due to trauma please note that this trial and trial f7trauma-1711 (nct00184548) have been merged.


Eligibility criteria:
inclusion criteria: * trauma injury (blunt and/or penetrating) with evidence of active torso hemorrhage refectory to standard treatment
dendritic cells (white blood cells) vaccination for advanced melanoma

Conditions: Melanoma

Summary: the purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.

eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production. all patients will be given cyclophosphamide 300mg/m2 iv three days prior to vaccine dose #1 in order to deplete regulatory t cells. all patients will receive mature dc for each dose of vaccine. for each dose all patients will receive autologous dendritic cells pulsed with 2 gp100 melanoma peptides (g209-2m and g280-9v) plus up to an additional 10 unique melanoma tumor-specific peptides. all patients will receive booster doses with mature dc. the dc vaccine will be given intravenously every three weeks for a total of six vaccine doses. peripheral blood (16 ml) will be taken weekly to monitor the immune response to each peptide by tetramer assay. apheresis is repeated after vaccine dose #3 and dose #6 in order to collect pbmc for immune monitoring. restaging is performed after three and six vaccine doses. patients with stable disease or better (partial response/complete response) after six doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.

Eligibility criteria:
inclusion criteria: * unresectable stage iii and stage iv m1a/m1b/m1c melanoma including patients with uveal melanoma * age ≥ 18 years * life expectancy ≥ 4 months * ecog performance status 0-2 * at least 28 days from prior treatment (including adjuvant interferon) except in cases of a braf inhibitor (such as vemurafenib); concurrent treatment with a braf inhibitor +/- mek inhibitor is permitted * required initial laboratory values (submitted within 14 days prior to registration): * wbc \>3,000/mm3 * hg ≥ 9.0 gm/dl * platelets \>75,000/mm3 * serum bilirubin \< 2.0 mg/dl * serum creatinine \< 2.0 mg/dl * sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy. exclusion criteria: * prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. prior treatment with targeted therapy (such as ipilumumab, anti-pd1, and braf inhibitor) is permitted. * active untreated cns metastasis * active infection * prior malignancy (except non-melanoma skin cancer) within 3 years * pregnant or nursing * concurrent treatment with corticosteroids; local (inhaled or topical) steroids are permitted. * inability to provide adequate informed consent * known allergy to eggs * prior history or uveitis or autoimmune inflammatory eye disease. * known positivity for hepatitis bsag, hepatitis c antibody, or hiv antibody.
the effects of renal denervation on insulin sensitivity

Conditions: Treatment Resistant Essential Hypertension; Insulin Resistance

Summary: renal sympathetic nerves contribute to development of hypertension. sympathetic overactivity also induces insulin resistance and it could therefore be assumed that a renal denervation might improve insulin sensitivity. studies have shown that glucose metabolism is improved in patients with treatment resistant essential hypertension both 1 and 3 months after renal denervation compared to a control group with treatment resistant essential hypertension. fasting glucose, insulin and c-peptide decreased significantly as did insulin resistance assessed by homa-ir. the investigators wish to investigate the effect of renal denervation on insulin sensitivity using the gold standard - the hyperinsulinemic euglycemic clamp and to investigate the degree of insulin resistance in muscle, liver and adipose tissue.


Eligibility criteria:
inclusion criteria: * systolic daytime ambulatory bp at least 145 mmhg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic exclusion criteria: * diabetes * pregnancy * non compliance * heart failure (nyha 3-4) * lv ejection fraction \< 50 % * renal insufficiency (egfr\<30) * unstable coronary heart disease * coronary intervention within 6 months * myocardial infarction within 6 months * claudication * orthostatic syncope within 6 months * secondary hypertension * permanent atrial fibrillation * significant heart valve disease * clinically significant abnormal electrolytes, haemoglobin, liver enzymes, tsh * second and third degree heart block * macroscopic haematuria * proximal significant coronary stenosis * renal artery anatomy not suitable for renal artery ablation (stenosis, small diameter \< 4 mm, length \< 2 cm, multiple renal arteries, severe calcifications)
sodium nitrite to treat arterial aging

Conditions: Vascular Aging

Summary: the proposed research will determine the effectiveness of nitrite, a naturally occurring compound in the body, for improving the health and function of arteries in middle-aged and older adults. the study also will provide insight into how sodium nitrite therapy improves artery health by determining the physiological mechanisms (biological reasons) involved. overall, the proposed research will provide important new scientific evidence on the effectiveness of sodium nitrite for decreasing the risk of developing cardiovascular diseases with aging.

the improvement in blood vessel function and stiffness will be determined over a 10 week period. subjects will be randomly assigned to either placebo (0 mg/day), low dose (80 mg/day) or high dose (160 mg/day) sodium nitrite. main outcome measures will be performed at baseline and week 10.

Eligibility criteria:
inclusion criteria: * 50-79 years of age * ability to provide informed consent * score greater than 22 on the mini mental state exam * blood pressure greater than 100/60 mmhg for past 3 months exclusion criteria: * are taking any of the following medications/drugs: hormone replacement therapy, anti-hypertensives, nitrates, nervous system depressants, allopurinol, phosphodiesterase-5 inhibitors, blood thinners * are currently sick/have chronic clinical diseases such as kidney disease, diabetes, or unstable cardiovascular disease * are hypersensitive to nitrates or nitrites * have glucose-6-phosphate dehydrogenase deficiency * have blood methemoglobin greater than 2% * have a bmi greater than 40 kg/m\^2 * have a baseline fmd of greater than 6% * have not been post-menopausal for at least 1 year * perform regular vigorous aerobic/endurance exercise

Keywords: endothelial function arterial stiffness flow-mediated dilation pulse wave velocity sodium nitrite aging vascular diseases
free iron and out of hospital cardiac arrest

Conditions: Arrest Cardio Respiratory

Summary: out of hospital cardiac arrest is associated with a poor prognosis. the aim of this study is to provide a better understanding of perturbations of iron metabolism after cardiac arrest and to analyze the impact on clinical centered outcome.


Eligibility criteria:
inclusion criteria: * patient admitted to icu for out of hospital cardiac arrest * therapeutic hypothermia exclusion criteria: * absence of consent
the effect of education given to women on cervical cancer on knowledge, attitude and belief

Conditions: Cancer of Cervix; HPV Infection

Summary: aim: the aim of this study is to reveal the effect of education given to women about cervical cancer on knowledge, attitude and belief. material and method: this randomized controlled study was conducted with 130 who had a public hospital located in southeast turkey (51 experimental, 51 control).

aim: the aim of this study is to reveal the effect of education given to women about cervical cancer on knowledge, attitude and belief. material and method: this randomized controlled study was conducted with 130 who had a public hospital located in southeast turkey (51 experimental, 51 control). in the first stage, the researcher participants were informed about the purpose of the researcher and the questionnaire, and their consent was obtained for participation in the study. in the second stage, pre-test data will be obtained with the face-to-face interview method of the research data and a questionnaire form. cervical cancer education will be provided. (the training is in three sessions, each session will last 20-30 minutes. in the training; cervical cancer, ppt presentation on hpv virus, question-answer method, female pelvic anatomy on the gynecological examination model, gynecological examination, how the pap test is done, and cervical cancer pathologies. will be explained )) after the training, the post-test data will be obtained by applying the questionnaire again.

Eligibility criteria:
inclusion criteria: * least literate, no communication problem women who agreed to participate in the study exclusion criteria: * literate are women who do not have communication problems (hearing impairment, visual impairment)

Keywords: cervical cancer, early diagnosis, pap smear,
door-through-door companion rideshare technology for individuals with alzheimer's disease and related dementias (ad/adrd)

Conditions: Alzheimer Disease or Associated Disorder; Dementia; Cognitive Decline

Summary: the goal of this pilot randomized controlled trial is to assess the impact of d2d rideshare services with a trained companion driver on the rate of medical appointments for older adults and individuals with ad/adrd. participants will be assigned either door-through-door (d2d) rideshare or curb-to-curb (c2c) rideshare services. he main question it aims to answer is: do d2d rideshare services reduce missed medical appointment rates compared to c2c rideshare services?

a pilot randomized controlled trial (stage 1). by stratifying on levels of cognitive impairment, i.e., no cognitive impairment vs. have mild to moderate cognitive impairment/mci or subjective cognitive decline/scd, the research team will randomly assign 120 riders, who have scheduled medical appointments at partner practices of onward, to one of two groups: onward d2d service (intervention) vs. c2c rideshare (control). intervention group (d2d): door-to-door rideshare services with a trained companion driver. control group (c2c): standard curb-to-curb rideshare services.

Eligibility criteria:
inclusion criteria: * all participants (or their surrogate) have the capacity to agree to allow onward service for transportation; * have scheduled medical appointments at partner practices of onward; * ages 60+ * community-dwelling; * 60 participants who self-reported cognitive problems, such as memory issue, or have mild cognitive impairment, subjective cognitive decline, or ad/adrd diagnosis exclusion criteria: * current enrollment in another transportation study; * already using any type of transportation service; * enrollees with comfort care only; * not wheelchair bound, e.g. if using a wheelchair must be foldable and must be able to transfer * transient, lacking consistent long term housing

Keywords: transportation
continuous positive airway pressure decreased lung collapse during general anesthesia induction in pediatric patients

Conditions: Atelectasis

Summary: anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of pediatric patients undergoing general anesthesia. infants and young children are more susceptible to this lung collapse due to their small functional residual capacity. thus, intrapulmonary shunting caused by those atelectasis are more likely to occur during general anesthesia in infants and younger children than in adults. this problem predisposes children to hypoxemic episodes that can persist in the early postoperative period. beyond the negative impact of atelectasis on gas exchange, mechanical ventilation induces a local inflammatory response in atelectatic lungs, even in healthy patients undergoing general anesthesia. therefore, the diagnosis, prevention and active treatment of anesthesia-induced atelectasis are mandatory, not only to avoid hypoxemic episodes and atelectasis-related post-operative pulmonary complications, but also to protect the lungs during mechanical ventilation. nowadays, the diagnosis of anesthesia-induced atelectasis is easily and accurately accomplished by lung ultrasound (lus). lus is a simple and non-invasive tool useful to detect atelectasis in children, to assess lung aeration and for monitoring ventilator settings or strategies. regarding to the prevention of atelectasis, it was demonstrated that the application of continuous positive airway pressure (cpap) during the induction of general anesthesia decreases atelectasis formation in adult morbidly obese patients. the investigators hypothesized that the use of cpap during general anesthesia induction in pediatric patients can prevent or decrease atelectasis formation.

compare lung aeration between two different strategies of induction to general anesthesia: breathing throughout a facial mask without cpap and breathing with 5 cmh20 of cpap in pediatric patients scheduled for surgery under general anesthesia, using ultrasound imaging and a four-point-aeration score to assess the lung aeration.

Eligibility criteria:
inclusion criteria: * written informed consent by parents. * patients aged 6 months to 7 years old * scheduled for surgery under general anesthesia with tracheal intubation. * american society of anesthesiologists classification: physical status i-ii exclusion criteria: * acute airway infection * cardiovascular or pulmonary disease * previous thoracic procedure

Keywords: atelectasis children ultrasound
explaining sedentary behavior with planning (the revised hapa model)

Conditions: Sedentary Behavior

Summary: this study would investigate the effects of forming action plans on a reduction of sedentary behaviors. participants will be randomly assigned to either active control group (education on sedentary behaviors and physical activity) or the intervention group (forming action plans referring to replacing sedentary activities with physical activity. the effects of the intervention will be evaluated at the 2-month follow-up and at the 8-month follow-up.

the effects of three sessions (3 education sessions versus 3 education sessions+ forming plans to replace sedentary behavior with physical activity) will be investigated among participants from three age groups: adolescents (12-17 years old), adults (18-60 years old), and older adults (\>60 years old). compared to education only, forming plans about how to replace time spent on sedentary activities with physical activity is expected to result in a significantly larger change (a reduction) of sedentary time at the follow-up. accelerometers will be used to evaluate short-term and mid-term changes in total sedentary time and the relative proportion of time spent on sedentary behavior vs light-intensity and moderate-to-vigorous- intensity physical activity. additionally, the study will observe changes in if the cognitions included in the health action process approach model (hapa), such risk perception, self-efficacy, outcome expectancies, intention, action control, as well as changes in behavioral habit, presence of sedentary behavior cues in physical environment, and physical activity behavior. the observations will be conducted three times, at the baseline (before the intervention), the 2-month follow up, and at the 8-month follow-up.

Eligibility criteria:
inclusion criteria: * not meeting physical activity guidelines proposed by the world health organization exclusion criteria: * any existing diseases with contraindications for moderate intensity physical activity, confirmed by patient's primary care physician or a specialist in cardiovascular diseases/endocrinology/rehabilitation medicine providing care for the patient during the recruitment and follow-ups

Keywords: planning physical activity
liberation from acute dialysis

Conditions: Acute Kidney Injury; Kidney; Disease, Acute; Dialysis Related Complication

Summary: the goal of the liberate-d clinical trial is to improve outcomes for patients recovering from dialysis-requiring acute kidney injury (aki-d). the impact of a conservative dialysis strategy compared to standard clinical practice of thrice-weekly dialysis will be examined to help generate knowledge for how to guide delivery of dialysis to facilitate renal recovery.

dialysis-requiring acute kidney injury (aki-d) is a devastating complication among hospitalized patients for which there are no treatments other than supportive care. recovery of sufficient renal function to stop dialysis is an unequivocally important clinical and patient-oriented outcome. shortening dialysis duration and increasing the number of aki-d patients who recover would have a major clinical, public health and cost-saving impact. however, there is currently no evidence to guide the delivery of dialysis to facilitate recovery. the investigators hypothesize that in patients who have aki-d and who are hemodynamically stable, a conservative dialysis strategy--in which hemodialysis is not continued unless specific metabolic or clinical indications for renal replacement therapy (rrt) are present--will improve the likelihood of renal recovery compared with the current standard clinical practice of thrice-weekly intermittent dialysis. the investigators have conducted a pilot clinical trial to demonstrate the feasibility of this approach. the investigators propose here a 2-center randomized controlled trial to test a conservative dialysis strategy in a larger aki-d population (n = 220).

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * inpatient with aki-d (intermittent hemodialysis or continuous renal replacement therapy received on at least one calendar day) at least partially due t acute tubular necrosis per the clinical nephrology team * hemodynamic stability: not requiring vasopressor support and with planned intermittent dialysis * baseline estimated glomerular filtration rate (egfr) ≥ 15 ml/min/1.73 m2 exclusion criteria: * nontraditional indication for dialysis (end-stage liver disease awaiting transplantation, fulminant hepatic failure, intoxication) * complete nephrectomy as cause of aki-d * kidney transplant during index hospitalization * dialysis \> 3 months * decompensated heart failure requiring left ventricular assist device or continuous inotropic support * mechanical ventilation via endotracheal tube * hypoxemia requiring significant oxygen support: \>5 liters/min via nasal cannula or equivalent via face mask/tracheostomy mask to maintain oxygen saturation \> 95%, or requiring fraction of inspired oxygen \>50% in patients with tracheostomy requiring invasive or non-invasive ventilation * unable to consent and no surrogate decisionmaker available * pregnant * prisoner * clinical team declines to allow study participation * anticipated discharge or transfer from study hospital within 48 hours
assessment of novel intraocular injection guide

Conditions: Retinal Disease

Summary: to determine if a novel intraocular injection guide (iig) reduces patient discomfort during and after intravitreal injections.

this study is being conducted to assess the potential for an intraocular injection guide to increase comfort levels both during and after such injections. the hypothesis is that patients will feel increased comfort from a device which eliminates the need for a speculum while still keeping the eyelids apart, allowing a physician to deliver treatment. the results of this study will allow physicians to select the optimal device for patient comfort and well-being during intravitreal injections

Eligibility criteria:
inclusion criteria: * subjects must be receiving bilateral injections of the same dose of vascular endothelial growth factor (vegf) inhibitor * injections in both eyes must be given on the same day * male or female age 18 years or older exclusion criteria: -any condition or reason that precludes the subject's ability to comply with the study -

Keywords: diabetic retinopathy age-related macular edema