Kornimate/medical-research-clean huggingface dataset:
ultrafiltration efficacy of a pd solution containing icodextrin-xylitol-carnitine

Conditions: End Stage Renal Disease (ESRD)

Summary: randomized, cross-over, controlled, open label study. the aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal pd solution for long dwell exchange.

the use of a solution icodextrin, xylitol and carnitine (ixc) as the osmotic agent in dialysate for the long dwell exchange provides sustained ultrafiltration (uf) through colloid osmosis, allowing a consistent reduction in extracellular fluid volume without the expected fall in urine output. the other major advantage of ixc is the reduced exposure and absorption of glucose as the main osmotic agent in pd therapy. the aim of this study is to demonstrate that glucose may completely be replaced by a combination of xylitol and carnitine in the bimodal ixc-based pd solution. compared to glucose, indeed, carnitine and xylitol are extremely stable naturally occurring compounds, even at temperatures higher than those used to steam-sterilize infusional product. as a consequence, xylitol and carnitine may represent better alternatives than glucose as an osmotic ingredient both from the manufacturing and biocompatibility standpoints. moreover, xylitol and carnitine have an excellent safety profile and possess distinct systemic actions, which are more favorable than glucose.

Eligibility criteria:
inclusion criteria: * age ≥18 years * diagnosis of esrd and have been on continuous ambulatory peritoneal dialysis (capd) or automated peritoneal dialysis (apd) for at least 3 months * a stable clinical condition during the two weeks immediately prior to randomization * blood hemoglobin concentration above 8,5 g/100ml * has not experienced peritonitis episodes in the last 3 months * treated with extraneal for at least 1 month * peritoneal equilibration test (pet) performed in the last three months * has understood and signed the informed consent form. exclusion criteria: * history of drug or alcohol abuse in the six months prior to entering the protocol * acute infectious condition * history of severe congestive heart failure and clinically significant arrhythmia * malignancy within the past 5 years, including lymphoproliferative disorders * a medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug * a clinically relevant under-hydration as judged by the treating physician * history of l-carnitine therapy or use in the month before entering the study * received any investigational drug in the 3 months before entering the study * pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive measures
a study to test how a new long-acting insulin works in the body of patients with type 2 diabetes during exercise and prolonged fasting

Conditions: Diabetes Mellitus, Type 2

Summary: the study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (t2d). participants will first receive insulin decludec (tresiba®, a long-acting insulin taken once daily) for atleast one week. afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. the study will last for about 16-30 weeks. participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities. study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * male or female. * age 18-75 years (both inclusive) at the time of signing the informed consent. * body mass index between 18.0 and 38.0 kilogram per meter\^2 (kg/m\^2) (both inclusive). * glycated hemoglobin (hba1c) less than or equal to (\<=) 9 percent (75 millimoles per mole \[mmol/mol\]) at screening. * treated with basal insulin with or without any of the following anti-diabetic drugs/regimens with stable doses \>= 90 days prior to the day of screening: * metformin, * dipeptidyl peptidase 4 (dpp-4) inhibitors, * sodium-glucose transport protein 2 (sglt2) inhibitors * oral combination products (for the allowed individual oral antidiabetic drugs), injectable and oral glucagon-like peptide 1 (glp-1) receptor agonists. * physically active \>= 300 metabolic equivalent of task (met) minutes/week as determined by an international physical activity questionnaire (ipaq) at screening. * mass-specific oxygen volume (vo2) peak greater than (\>) 25 milliliters per kilogram per minute (ml/kg/min) as determined by cardiopulmonary testing (cpx) test at screening. exclusion criteria: * known or suspected hypersensitivity to study intervention(s) or related products. * female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method. * presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders within 180 days prior to the day of screening.
ease of use and safety of the new u300 pen injector in insulin-naïve patients with t2dm

Conditions: Diabetes Mellitus Type 2

Summary: primary objective: to demonstrate the ease of use of the u300 pen injector in pen-naïve and insulin-naïve type 2 diabetes mellitus (t2dm) patients in a 4-week once-daily dosing regimen with hoe901-u300. secondary objectives: to assess in a 4-week once-daily dosing regimen with hoe901-u300 in pen-naïve and insulin-naïve t2dm patients. the safety and usability of the u300 pen injector. the glycemic control with the u300 pen injector. the safety of hoe901-u300.

the total study duration for a participants can be approximately up to 10 weeks.

Eligibility criteria:
inclusion criteria: * patients with t2dm inadequately controlled with non-insulin, non-injectable anti-hyperglycemic drug(s) and for whom the investigator/treating physicians has decided that basal insulin is appropriate. * signed written informed consent. exclusion criteria: * glycated hemoglobin a1c (hba1c) \ 11% (97 mmol/mol) at screening. * age \<18 years at the time of screening. * body mass index (bmi) \>40 kg/m2. * diabetes other than t2dm. * history of t2dm for less than 1 year before screening. * less than 6 months anti-hyperglycemic treatment before screening. * initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit. * previous treatment with glucagon like peptide-1 (glp-1) agonist. * patients receiving only non-insulin anti-hyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinides. * current or previous insulin use except for a maximum of 8 consecutive days and a total of 14 days (eg, acute illness, surgery) during the last year prior to screening. * any contraindication to insulin glargine (lantus) according to the national product labeling or any excipients. * any contraindication to the mandatory background non-insulin anti-hyperglycemic medication according to the respective national product labeling. * latest eye examination by an ophthalmologist \>12 months prior to inclusion. * more than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months. * unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
iloprost in acute respiratory distress syndrome

Conditions: Respiratory Distress Syndrome, Adult

Summary: the patients will be randomized into one of two groups. both groups will receive standard care as is state of the art. the intervention group will receive iloprost nebulized as inhalative therapy.


Eligibility criteria:
inclusion criteria: * horowitz index \<300 * bilateral opacities on frontal chest radiograph * requirement of positive pressure ventilation * no clinical evidence of left atrial hypertension * enrollment within 48h of onset of ards * mechanical ventilation \<7 days exclusion criteria: * age \<18 years * mechanical ventilation \>7 days * patient, surrogate or physician not committed to full intensive care support * pregnancy

Keywords: acute respiratory distress syndrome
antithrombotic management of acute mesenteric ischaemia

Conditions: Acute Mesenteric Ischemia; Short Bowel Syndrome

Summary: guidelines on the acute and long-term pharmacological treatment of acute mesenteric ischaemia (ami) recommend the use of thrombolytic, antiplatelet or anticoagulant therapy depending on the aetiology of ami and the use of stenting but only few details are given on the choice of the drug, dose and duration of treatment. besides, recommendations are mainly based on data on coronary, cerebral and other peripheral artery diseases and do also not take into account the altered drug absorption in patients with short bowel syndrome, in which ami can result.this case-based survey will inform us on the current international clinical practice of long-term antithrombotic management of ami.


Eligibility criteria:
inclusion criteria: * gastro-enterologist or cardiologist with expertise in treating sbs patients resulting from ami exclusion criteria: * none
safety surveillance after immunization with ixiaro

Conditions: Japanese Encephalitis

Summary: this is an active electronic surveillance using data from the defense medical surveillance system (dmss) to detect and characterize serious, rare adverse events occurring within 42 days after vaccination with the japanese encephalitis vaccine ixiaro within the us military, to detect adverse events that occur more frequently after ixiaro and to electronically follow up pregnancies during or shortly before which ixiaro was administered. there will be no intervention and no individuals contacted.


Eligibility criteria:
inclusion criteria: * male and female active duty u.s. military personnel ≥ 17 years of age who either received at least one dose of ixiaro (ixiaro exposed group) or at least one dose of je-vax (comparison group). exclusion criteria: * individuals who have an icd-9-cm code suggestive of one of the predefined adverse events screened for in ic51-401 prior to vaccination with ixiaro cannot with certainty be classified as being "disease free" at study entry and will be excluded for that adverse event.
study of an exercise program (step) for youth with concussion

Conditions: Persistent Concussion Symptoms

Summary: to compare the efficacy of a sub-threshold aerobic exercise intervention provided with mobile health coaching (step-mhc) and a light stretching program (ls) to ls alone for 11-18 yo youth with persistent concussion symptoms.

this is a minimal risk randomized controlled trial whose aim is to test the efficacy of an exercise intervention (step) for youth 11-18 yo with persistent concussive symptoms (1-6 months inclusive). the investigators are utilizing an active control (light stretching). the primary outcome will be concussion symptoms measured with the health-behavior inventory (hbi) in the first month after randomization. long-term efficacy will be examined using standardized measures of quality of life and function over 6 months, and potential mediators will be explored including brain derived neurotrophic factor (bdnf), fear-avoidance and physical fitness. physical activity will be measured with accelerometry to evaluate fidelity.

Eligibility criteria:
inclusion criteria: * sports-related concussion that occurred 1-6 months inclusive prior to the start of the study, and was diagnosed by a clinician trained in concussion management consistent with the zurich definition of concussion ("a complex pathophysiological process affecting the brain, induced by biomechanical forces \[that\] results in a graded set of clinical symptoms that may or may not involve loss of consciousness") * persistent symptoms as defined by the presence of at least 2 concussive symptoms (from the health behavior inventory, or hbi) at the time of recruitment which were not present prior to injury * 11 to 18 years of age (inclusive) at time of recruitment exclusion criteria: * non-english speaking youth or parents * unwilling or unable to travel to seattle children's hospital or seattle children's research institute twice during the course of the study * cervical spine or vestibular issues requiring further targeted intervention * other injuries or medical conditions in addition to concussion which would preclude vigorous exercise * psychiatric hospitalization in the year prior to enrollment * significant cognitive deficits such as mental retardation or autism * lack of worsening of concussive symptoms with exertion * significant abnormalities on routine brain imaging.

Keywords: concussion mild traumatic brain injury post concussion syndrome child
bioavailability of apixaban crushed tablet

Conditions: Thrombosis

Summary: the purpose of this study is to determine whether the bioavailability of apixaban crushed tablets suspended in water or mixed with applesauce is similar to the bioavailability of apixaban whole tablets administered orally.

this study will investigate the bioavailability of apixaban administered as crushed tablets suspended in water and as crushed tablets mixed with applesauce compared with that of whole tablets. the study results may allow enhancement of the apixaban label to include alternative methods of apixaban administration, which may be of benefit to patients who have difficulty swallowing.

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy participants as determined by no clinically significant deviation from normal in findings of medical history, physical examination, electrocardiograms, vital signs, and clinical laboratory tests. * women of childbearing potential allowed. must be following highly effective methods of contraception exclusion criteria: * any significant acute or chronic medical illness * history of significant head injury within the last 2 years, including individuals with base of skull fractures * any major surgery within 4 weeks of study drug administration or anticipated within 2 weeks after completion of the study * any gastrointestinal (gi) surgery or gi disease that could impact absorption of study drug * history of gilbert's syndrome * inability to tolerate oral medication * inability to be venipunctured and/or tolerate venous access * use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study drug administration * any laboratory test results outside of the range of normal, confirmed by repeat results of: * platelet count \<150,000 cells/µl * activated partial thromboplastin time \>upper limit of normal (uln) * international normalized ratio \>uln * alanine aminotransferase \>uln * aspartate aminotransferase \>uln * total bilirubin \>uln * serum creatinine ≥1.5 mg/dl * hemoglobin \<lower limit of normal (lln) * hematocrit \<lln
to evaluate the effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of a single dose of azd1656

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of a single dose of azd1656


Eligibility criteria:
inclusion criteria: * patients with confirmed type 2 diabetes mellitus for at least 1 year and treated with metformin. * body mass index between ≥19 and ≤42 kg/m2. exclusion criteria: * intake of another investigational drug within the last 30 days prior to enrolment. * clinically significant illness or clinically relevant trauma.

Keywords: type 2 diabetes mellitus gemfibrozil
a handwriting intervention program for children with tic disorders

Conditions: Tourette Syndrome; Tic Disorders

Summary: the purpose of this study is to evaluate the effectiveness of a computerized handwriting training protocol (movalyzer), through daily practice of handwriting on an electronic device to improve handwriting skills in children with tic disorders (td).

handwriting is a functional skill underlying almost all academic performance of school-aged children, and handwriting impairment is highlighted by the world health organization as a barrier to school participation. the available evidence mentioned in the literature suggests handwriting skills are academically crucial, and handwriting deficits may lead to challenges in performing various academic activities both in and outside the classroom. given that children with td are more likely to have handwriting deficits as suggested in a recent study, they are also more likely to have challenges in their academic performance and success as evidenced in the literature. in the context of education, strong evidence indicated that handwriting has more cognitive and neurological benefits than using a keyboard when taking notes in the classroom. therefore, reducing tics and improving handwriting skills rather than an adaptation approach using a word processor or computer may be the goal of intervention. results of the investigator's previous study showed that children with tourette syndrome (ts) or tic disorders (td) demonstrated handwriting deficits when compared to the general children population, and were consistent with a recent study conducted in france showing that children with ts exhibited handwriting problems. in addition to illegibility issues in handwriting as indicated by the low score on the test of handwriting skills (ths-r), children with ts or td also demonstrated writing deficits in the areas of speed of writing and correct letter case formation. since handwriting deficit is an area of concern among children with ts or td, one way to improve these children's handwriting skills is through handwriting practice. neuroscript, llc., has developed a software program (movalyzer) that allows children to practice handwriting on an electronic device (such as tablet, laptop, etc). given that the practice is completed on an electronic device with immediate feedback, this handwriting program may serve as a strong incentive to motivate children practicing handwriting. in order to provide evidence for the educators and therapists on the effectiveness of this software program, it is important to evaluate its effectiveness on improving handwriting skills among children with ts or td.

Eligibility criteria:
inclusion criteria: * tourette syndrome * diagnosed tic disorder exclusion criteria: * diagnosed anxiety disorder * diagnosed learning disability * diagnosed dysgraphia

Keywords: handwriting pediatrics
study of occipital nerve stimulation for drug refractory migraine

Conditions: Migraine

Summary: the purpose of this study is to evaluate the safety and effectiveness of an implantable device to treat migraine. there are a significant number of patients who have drug refractory migraine and alternative therapies are needed.


Eligibility criteria:
inclusion criteria: * be diagnosed with multiple migraines per month of moderate to severe intensity; * be refractory to medication; * be an appropriate candidate for the surgical procedures required fo this study; * be willing and able to comply with all study related procedures; * be capable of reading and understanding patient information materials and giving written informed consent. exclusion criteria: * have onset of headache after age 50; * are current substance abusers (including alcohol and illicit drugs); * have a significant psychiatric disorder; * have previously been treated with occipital nerve stimulation (either temporary trial or permanent implant); * have had nerve stimulation for pain relief. * have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment; * have previously undergone destructive ganglionectomy affecting c2/c3 occipital and/or trigeminal distribution or have an occipital blockade or radiofrequency procedure currently in effect. * have a condition currently requiring or likely to require the use of mri or diathermy; * have an active implantable device; * are pregnant or lactating or planning to become pregnant in the next 14 months; * have participated in any drug or device trial in the last 4 weeks or plant to participate in any other study during the next 14 months.

Keywords: headache migraine refractory chronic pain
procedures of locoregional analgesia and quality of life in palliative care units

Conditions: Pain

Summary: number of patients in mobile palliative care units have pain of both nociceptive and neuropathic origin. in certain cases, procedures of locoregional analgesia can be helpful. the purpose of this study is to evaluate the impact of techniques of locoregional analgesia in a palliative population

cancer pain is a serious problem in the palliative population. in particular, pain due to compression or invasion of nerve tissue by metastasis is frequent and often unresponsive to oral drug therapy and even to epidural administration of opioids. in such refractory pain in a palliative setting, one modality that could be helpful is the use of technics of locoregional analgesia. currently, they are routinely used for the management of acute postoperative pain and become to be more widely used for cancer surgery. for example, intrapleural intercostal nerve blocks after major lung resection or preincisional paravertebral blocks after breast surgery have been shown to improve pain control. however, locoregional analgesia is only occasionally used in chronic cancer pain. the procedures used are epidural analgesia, rachianesthesia, or continuous nerve blocks. l-bupivacaine will be used. the procedure will be performed only if the injection test is positive. the patients will be evaluated before and after the procedure, the patient being his/her own control. evaluations will take place immediately before the procedure, then at 48 hours, 1 week and 1 month after the procedure.

Eligibility criteria:
inclusion criteria: * patient ≥ 18 years-old, male or female, whatever his/her ethnic group * patient with untreatable cancer * patient hospitalized in a palliative care unit, with a life expectancy ≥ 1 week * pain unresponsive to conventional treatments * effectiveness of the injection test * signed informed consent exclusion criteria: * patients \> 18 years-old * patients with pain other than cancer pain * patient's refusal * coagulation disorders * local infection * known hypersensitivity to local analgesics * inefficacy of the injection test. * contraindication for analgesics

Keywords: cancer pain