Kornimate/medical-research-clean huggingface dataset:
fluid resuscitation with hydroxyethyl starch 130/0.4 in trauma patients

Conditions: Trauma

Summary: fluid therapy in trauma patients is considered one of the common challenges in daily practice. both crystalloids and colloids can be used to maintain adequate blood volume and tissue perfusion but there is an ongoing debate as both of them could affect coagulation and renal function. the latest generation of the commercially available hydroxy ethyl starch (hes) solutions was developed to improve pharmacokinetics and safety profile of hes, minimizing adverse effects such as impairment of blood coagulation or renal function. but data on early fluid resuscitation in trauma patients with these starches are limited and its safety on coagulation and renal function is still questioned.

fluid resuscitation is a fundamental of the initial management and resuscitation of trauma patients to preserve or restore normovolemia, cardiac output, tissue perfusion, and correcting coagulopathy and acid-base balance during massive blood loss, yet fluid therapy in trauma patients is considered one of the common challenges in our daily practice with a lot of controversies and recommendations changing from using crystalloids, colloids, and/or packed red blood cells. also, fluid availability which does not necessarily matches the best fluid needed for the patient impacts the physician choice of fluids especially when blood is not available.both crystalloids and colloids can be used to maintain adequate blood volume and tissue perfusion. but both of them could affect coagulation and renal function. both crystalloids and colloids decrease concentration of coagulation factors and number of platelets causing dilutional coagulopathy. moreover, synthetic colloids impair polymerization of fibrin and platelet function, aggravating coagulopathic state. so, their use may therefore increase blood loss. as, all hydroxyethyl starch (hes) colloid solutions are excreted through the kidneys and other ways of excretion are negligible a lot of clinical trials have raised concerns about the renal safety of hes due to observed high frequency of acute kidney injury and high mortality rates in critically ill patients.these effects depend on the pharmacokinetic properties of the hes used, which determines the hes plasma concentrations over time, in vivo molecular weight (mw), and maximum doses used. the latest generation of the commercially available hes solutions the medium-mw starch, hes 130/0.4 (6%, voluven®), was developed to improve pharmacokinetics and to improve the safety profile of hes, minimizing adverse effects such as impairment of blood coagulation or renal function.

Eligibility criteria:
inclusion criteria: * trauma patients in hemorrhagic shock * expected delay in blood and blood products transfusion for more than 40 minutes. exclusion criteria: * known chronic renal disease * known chronic liver disease * known coagulopathy * known allergy to hydroxyethyl starch * known pregnancy
transplantation of pancreatic islets in patients with type 1 diabetes mellitus and functional kidney graft

Conditions: Type 1 Diabetes Mellitus

Summary: this research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with type 1, insulin-dependent diabetes mellitus with kidney transplantation and to improve their metabolic control.

the main objective is to demonstrate the beneficial effect of islet allotransplantation in patients with type 1 diabetes with no endogenous insulin secretion, and with a functional kidney graft. the other objectives are to evaluate the conditions for the efficacy of islet cell transplantation, to assess the improvement in quality of life and the cost of the islet cell transplantation.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus * disease duration \> 5 years * ketose antecedents * basal and stimulated plasma c-\< 0.2 ng/ml,\<0.06 nmol/l (glycemia must be measured simultaneously_ 1.20 g/l or 6.6 mm, stimulation with glucagon iv 1 mg -measured at à t0 and t 6 min) * established kidney graft ≥ 6 months * current creatinine clearance: ≥ 50 ml/min/1.73 m² and proteinuria \< 0.5 g/24h * hba1c\< 12% exclusion criteria: * hemostasis problems * documented hepatic pathology * patient under 18 or over 65 year-old * women with body weight over 70 kg (tolerance of 2 kg between inclusion day and transplantation day) or bmi \> 26 * men with body weight \> 75 kg (tolerance of 3 kg between inclusion day and transplantation day) or bmi \> 26 * insuline needs \> 0.7 u/kg/j or 50 u/j * serious life-threatening pathology * untreated hyperlipidemia * hypersensitivity to drugs rapamycine-alike * liver disease (transaminases or total bilirubin ≥ 3n) * failure to communicate or cooperate with the investigator exclusion criteria that are specific to the use of rapamycine * hypercholesterolemia (\> 350mg/dl, 9,1 mmol/l) not controlled * hypertriglyceridemia (\> 500 mg/dl, 5,6 mmol/l) not controlled * leukocytes \> 4500 /mm3 , neutrophils \> 2000/ mm3, platelets \> 100000/ mm3 * any clinical or biological pathology that could interfere with the study * past or present neoplasia (with the exception of non melanoma skin cancers) * any hemostasis disorder needing a prolonged treatment with anticoagulation drugs. low-dose aspirin is permitted. * pregnancy, lactation, pregnancy project or absence of efficient contraception * any medical or psychosocial condition susceptible to interfere with the study, such as drug abuse or recent alcohol abuse
trial comparing tisseel as an adjunct to traditional hemostasis after redo cardiac surgery

Conditions: Hemorrhage

Summary: bleeding after redo cardiac surgery is a common, unresolved and consequences-heavy event as per present day. tisseel (baxter inc) sprayed on the already hemostased mediastinum jut before closing seems a promising technique to radically diminish bleeding. this study aims to verify this efficacy volume in chest drains) and possibly the consensual blood transfusion lessening.


Eligibility criteria:
inclusion criteria: * all patients undergoing any kind of redo cardiac surgery with ati least one previous sternotomy exclusion criteria: * none

Keywords: bleeding heart surgery reoperation
the effect of inhaled lavender and bergamot oil on anxiety and sleep quality in intensive care patients.

Conditions: Patient Undergoing Surgery

Summary: this study was carried out as a randomized controlled experimental study to determine the effect of inhaled lavender and bergamot oil on anxiety and sleep quality in patients hospitalized in the intensive care unit who had undergone surgical intervention. the universe of the research; patients who were hospitalized in an intensive care unit in istanbul between may 2021 and october 2021, and the sample consisted of patients who met the criteria for inclusion in the study. fifty-four patients who agreed to participate in the study and met the inclusion criteria were included. lavender oil or bergamot oil or distilled water was administered to the patients 2 evenings by inhalation.

the universe of the research; patients who were hospitalized in the intensive care unit of a university hospital in istanbul between may 2021 and october 2021, and the sample consisted of patients who met the inclusion criteria of the study. data collection started after obtaining the ethics committee permission, institutional permission, and research permission from the ministry of health getat clinical research department. a simple computer-assisted randomization method was used to distribute the groups homogeneously. fifty-four patients who were hospitalized in the reanimation intensive care unit and accepted to participate in the study and met the inclusion criteria were included. the patients were randomly assigned to 3 groups of 18 people, each with distilled water, lavender oil, and bergamot oil. "patient information form", "patient follow-up form", "state-trait anxiety inventory" and "richard-campbell sleep scale (rcus)" were used to collect data.

Eligibility criteria:
inclusion criteria: * over 18 years old and under 70 years old. * staying in the intensive care unit for at least 3 nights after surgery. * ability to communicate ("richmond agitation sedation scale" +1, 0, -1 points). * glasgow coma scale score of 9 or higher. exclusion criteria: * having pain. * having any problems with smelling. * the need for mechanical ventilation. * systolic blood pressure below 100 mm hg. * having lung cancer, asthma and chronic obstructive pulmonary disease. * having allergies to known plants, flowers and related essential oils. * using any medication for anxiety and sleep problems.

Keywords: intensive care unit, sleep quality, anxiety aromatherapy, lavender oil, bergamot oil
phase i/ii study of curdlan sulfate

Conditions: HIV Infections

Summary: to assess the safety and tolerance of curdlan sulfate, as well as its anti-hiv activity, in hiv-infected patients with cd4 t-lymphocytes less than 500 cells/mm3, using first single doses and then, after fda review, daily doses for 7 days.

in phase i of the study, escalating single doses of intravenous curdlan sulfate are tested. in phase ii, curdlan sulfate is administered daily for 7 days. (note: phase i is completed.)

Eligibility criteria:
inclusion criteria patients must have: * hiv seropositivity. * no current aids-defining opportunistic infection, lymphoma, kaposi's sarcoma, or other malignancy. * cd4 count \< 500 cells/mm3. * no critical illness that would shorten life expectancy to \< 16 weeks. exclusion criteria concurrent medication: excluded: * antiretroviral or other experimental therapies. * anticoagulants. * steroids. * cytotoxic or immunosuppressive agents. concurrent treatment: excluded: * radiotherapy. patients with the following prior condition are excluded: history of heparin sensitivity. prior medication: excluded within 1 month prior to study entry: * antiretroviral or other experimental therapies. * anticoagulants. * steroids. * cytotoxic or immunosuppressive agents. prior treatment: excluded: * radiotherapy within 1 month prior to study entry. active iv drug abuse.

Keywords: acquired immunodeficiency syndrome aids-related complex curdlan sulfate
efficacy of aerobic exercise added to alprazolam in panic disorder treatment

Conditions: Panic Disorder

Summary: the purpose of this study is to determine whether the combination of aerobic physical exercise and alprazolam in patients with panic disorder has a better therapeutic response than the treatment with alprazolam alone.

we have observed in our clinical practice that patients who practiced aerobic physical exercise had faster remissions and better improvement in their treatments that those who did not. there are also some scientific studies that included physical exercise in the treatment for panic disorder and compared them to other single pharmacological treatments. so our objective will be to compare the efficacy of a pharmacological monotherapy (alprazolam), that is one of the options for the pharmacological treatment of panic disorder, with other treatment such as the combination of aerobic physical exercise and alprazolam, and to determine if this combination results in a better therapeutic response.

Eligibility criteria:
inclusion criteria: * patients with panic disorder scored between 20 and 30 by the hamilton anxiety rating scale/14. (baseline scale scores were measured during the first interview and diagnoses were made by a psychiatrist using the structured clinical interview for dsm iv). * good physical health and normal results determined on a previous physical examination and routine laboratory tests (renal, hepatic, hematological and thyroid function). * patients who completed a written informed consent form (which was obtained from every included patient and had been fully explained before the procedure). exclusion criteria: * a history of some kind of recent somatic disease. * diagnosis of some other type of associated or psychiatric disease of axis i of dsm iv, such as affective disorders, drug dependency. * hamilton anxiety scale lower than 20 points or higher than 30. * use of some other type of medication or treatment (including psychotherapy) or having received it during last past 3 months. * patients who could not complete the clinical examination * patients who have not accepted to complete or sign the written informed consent. * pregnant patients or in lactation. (a pregnancy test was performed for women in fertile age) * patients with history of rejection to the used drug.

Keywords: panic disorder exercise alprazolam aerobic
hyperglycemia in patients with stroke and indication of enteral nutrition

Conditions: Hyperglycaemia (Non Diabetic); Enteral Feeding Intolerance; Stroke

Summary: the purpose of this study is to evaluate the effect of a specific nutritional formula for diabetics on the development of hyperglycemia in patients with recent non-diabetic stroke who require admission and enteral nutritional support by nasogastric tube. as well as the effect on metabolic control, development of comorbidities, hospital stay, readmissions, mortality and tolerance of the formula under study.

main goal: to evaluate the effect on the development of hyperglycemia diagnosed as glycemia\> 126 mg / dl on an empty stomach or\> 150 mg / dl during the infusion of enteral nutrition determined by capillary glycemia during the admission of a specific formula in patients with a first episode of ischemic stroke or hemorrhagic entry into the non-diabetic hcuv stroke unit requiring enteral nutrition by nasogastric tube.

Eligibility criteria:
inclusion criteria: * admitted for a first episode of ischemic or hemorrhagic stroke. * requiring total enteral nutrition by tube for at least 7 days exclusion criteria: * contraindication to enteral nutrition * diabetes mellitus * gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting, abdominal pain * need for admission to the icu * previous neurodegenerative disease * antibiotherapy for 7 days prior to the inclusion visit * allergies or intolerances to any of the components of the formula under study * pregnant patients
microfluidic organotypic model for monocyte transendothelial migration to the joint in obese osteoarthritic patients

Conditions: Osteoarthritis

Summary: osteoarthritis (oa) is the fastest growing cause of disability worldwide due to population ageing and increasing obesity incidence. obese individuals have a higher risk of oa insurgence and severe progression due to several risk factors, including their systemic inflammation state and superior migratory ability of monocytes. in the present project we aim at the development of a novel 3d microfluidic organotypic model resembling the joint to investigate the migration ability of monocytes from obese and non-obese oa patients. we hypothesize that monocytes from obese oa patients display superior migration ability and a specific pattern of chemokine surface receptors compared to monocytes from non-obese oa patients. we also hypothesize that these features lead to a superior infiltration of monocytes/macrophages to the synovial membrane in obese oa patients. based on this, our main aim will be to highlight differences between mo from obese and non-obese oa patients in terms of surface receptors and migration ability in a microfluidic organotypic model.


Eligibility criteria:
inclusion criteria obese oa patients * subscription of informed consent * bmi ≥ 30 * age between 60-80 years included * kelgrenn-lawrence equal or superior to grade iii * presence of synovitis * patients undergoing knee replacement * suspension of nsaids from one week before the surgical procedure according to the standard clinical practice non-obese oa patients * subscription of informed consent * bmi ≤ 28 * age between 60-80 years included * kelgrenn-lawrence equal or superior to grade iii * presence of synovitis * patients undergoing knee replacement * suspension of nsaids from one week before the surgical procedure according to the standard clinical practice exclusion criteria obese oa patients - hcv, hiv, hbv, tpha infection non-obese oa patients - hcv, hiv, hbv, tpha infection
lifestyle intervention and prevention of gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus

Summary: the number of women with gestational diabetes mellitus (gdm) had been increasing. maternal gdm has a great impact on both the health of the mothers and the offspring. antenatal lifestyle interventions, in particular dietary intervention appear to be feasible to improve maternal gdm and weight gain. to the best of our knowledge, there has been no such trial examining the feasibility of a lifestyle intervention in pregnant women in hong kong. therefore, we plan to conduct a randomized controlled trial comparing a lifestyle modification program (lmp) in early pregnancy and the usual antenatal care in high risk chinese pregnant women in hong kong. intervention group subjects (n=110) will participate in a dietitian-led lmp including dietary and exercise component from the first antenatal (an) booking to 24 weeks gestation. 110 women in the control group will receive routine hospital antenatal care. the primary endpoint will be the prevalence of gdm measured using a 75 g oral glucose tolerance test at 24-28 weeks gestation. the secondary endpoints will be the proportion of infant born with large for gestational age (\>=95th percentile of the customized birth weight) and macrosomia (\>=4 kg at birth). the intervention group involves dietary and exercise advice and monitoring. no drug or invasive procedure is involved. the control group will receive routine antenatal care and will be provided with an educational pamphlet on diet and exercise during pregnancy.


Eligibility criteria:
inclusion criteria: * chinese origin * reside normally in hong kong * singleton pregnancy * gestational age \<= 12 weeks at the time of recruitment * could speak and understand chinese * fulfill at least one of the following criteria for high risk of gdm at the time of recruitment based on the update hospital protocol implemented since 1st may 2014 * maternal age \>= 35 years old at expected date of confinement. * prior history of gdm or birth of child \>= 4 kg * pre-pregnant bmi or bmi at 1st trimester \>= 25 kg/m2 * family history of diabetes at 1st degree relatives * willing to give informed written consent and follow the study procedures exclusion criteria: * concurrent participation in any clinical trial or study * with renal, liver or thyroid dysfunction, cognitive impairment, or any other indication of a major medical or psychological illness, as judged by the investigators as ineligible to participate the study * multiple pregnancies * pre-existing dm * with physical restriction that prevents from exercising * substance abuse

Keywords: lifestyle intervention gestational diabetes mellitus chinese prevention
effects of early sleep after action observation therapy on balance in elderly

Conditions: Old Age; Debility; Balance; Distorted

Summary: the study aims at investigating the effects of an early sleep window after action observation therapy (aot) on balance in elderly. forty-five healthy-like elderly will be enrolled and randomized into 3 groups (aot-sleep, aot-control and control) performing a 3-week aot. aot-sleep and aot-control will be asked to watch video-clips showing motor contents before sleeping or at least 12 hours before sleeping, respectively, whereas control will be asked to watch landascape video-clips before sleeping. participants will be assessed before and after training and at 1 month follow-up for balance outcomes.


Eligibility criteria:
inclusion criteria: * ability to walk for at least 100 meters with no assistance or aids exclusion criteria: * musculoskeletal disorders able to affect balance * traumas and/or injuries and/or surgery at the level of the lower limbs, spine in the previous year * sleep disorders * drugs able to affect sleep * dementia or cognitive decline (mci) * psychiatric or neurological disorders
therapy optimization in multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to determine if higher compliance and adherence rates to drug therapy for ms result in better health outcomes than lower rates of therapy compliance and adherence.


Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or older, with a diagnosis of ms. * being treated with glatiramer acetate (ga) or (ifn)-β * receiving therapy from a participating specialty pharmacy exclusion criteria: * has any contraindication to ga or ifn-β therapy, including pregnancy, trying to become pregnant, or breast feeding during the study * has received an experimental drug in the last thirty (30) days other than fampridine sr (4-aminopyridine or 4-ap) * unlikely to be able to participate for the full two years of the study

Keywords: specialty pharmacy therapy management medication compliance medication adherence medication persistence health outcomes
efficacy and safety of dwc202404 and dwc202314 in patients with hypertension

Conditions: Hypertension; Essential Hypertension

Summary: a multicenter, randomized, double-blind, phase iii study to evaluate the efficacy and safety of dwc202404 and dwc202314 combination therapy in patients with essential hypertension inadequately controlled on dwc202404 monotherapy


Eligibility criteria:
inclusion criteria: * average systolic blood pressure (mssbp) measured at the time of screening meet the following criteria (a) if anti-hypertensive drugs are not being administered: 140 mmhg ≤ mssbp \< 180 mmhg (b) if anti-hypertensive drugs are being administered: 130 mmhg ≤ mssbp \< 180 mmhg exclusion criteria: * if the blood pressure measured at the time of screening and randomization is msdbp ≥ 110 mmhg * those whose blood pressure differences measured on both arms at the time of screening are mssbp ≥ 20 mmhg and msdbp ≥ 10 mmhg