Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of palonosetron iv to prevent postoperative nausea and vomiting in pediatric patients

Conditions: Postoperative Nausea and Vomiting

Summary: the objective of the study is to assess the safety and efficacy of two doses of iv palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general endotracheal inhalation anesthesia.


Eligibility criteria:
main inclusion criteria * male or female patient aged more than 28 days (full term) up to and including 16 years. * inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia, including: * ear, nose and throat surgery; * eye surgery; * orchidopexy; * plastic reconstructive surgery; * herniorraphy; * orthopedic surgery). * american society of anesthesiologists (asa) physical status i, ii or iii. * patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia. * patient scheduled to be hospitalized for at least 72 hours after wake up of surgery * for female of childbearing potential: the patient and her parent(s)/legal guardian(s) were counseled on the importance of not becoming pregnant before or during the study and the patient must have a negative pregnancy test at the pre-treatment visit and at the study treatment visit. main exclusion criteria * for infant aged more than 12 months: a history of gastro-esophageal reflux. * for patient aged 28 days to 6 years: patient who received any investigational drugs within 90 days prior to day 1. for patient aged 6 up to 16 years inclusive: patient who received any investigational drugs within 30 days prior to day 1. * patient scheduled to undergo emergency surgery. * patient scheduled to receive regional (spinal) anesthesia in conjunction with general endotracheal anesthesia. * patient scheduled to receive propofol during the maintenance phase of anesthesia. * patient with vomiting from any organic cause. * any drug with a potential anti-emetic effect within 24 hours prior to the administration of anesthesia. * any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia.

Keywords: postoperative nausea and vomiting palonosetron pediatric
the effect of hydrogen water in oral mucositis in head and neck cancer patients after therapy

Conditions: Head and Neck Cancer; Oral Mucositis; Pain; Quality of Life

Summary: inpatients or outpatients diagnosed with head and neck cancer who met the inclusion and exclusion criteria were referred to the co-investigator(dr. chih-jen huang and dr. hui-ching wang), who then personally explained to each participant, the purpose and conduct of the study, so that they all understood their rights and interests before giving a written consent.

the study design was a randomized controlled trial and a longitudinal study with structured questionnaires (17-question basic information questionnaire、 the world health organization scale, who、nci-ctcae v5.0、brief pain inventory-taiwan、oral frailty checklist、european organization for research and treatment of cancer quality of life questionnaire-head \& neck). the participants were randomly assigned to the experimental group (gargling with hydrogen water) and the control group (gargling with boiled water) by block randomization through a questionnaire administered by the investigator. at the end of cancer treatment (chemotherapy, radiotherapy, or chemoradiotherapy), a hydrogen water gargle (dissolved for 12 hours or longer) or boiled water gargle was administered by the investigator or a researcher every monday through friday. the changes in six scales described above were tracked in the experimental and control groups on days 1 (t1), 3 (t2), 7 (t3), and 14 (t4) after the end of treatment. the data from these scales were entered into a computer and analyzed using statistical software, and the overall data are presented to demonstrate the efficacy of hydrogen water.

Eligibility criteria:
inclusion criteria: 1. pathological diagnosed with head and neck cancer 2. adults over the age of 20 3. have normal cognition 4. can use mandarin or taiwanese to communicate 5. received radiation therapy or combined chemotherapy exclusion criteria: 1. eastern cooperative oncology group (ecog) performance status 2, 3 and 4 2. received oral cancer surgery within two months

Keywords: head and neck cancer hydrogen water cancer related symptom
augmenting rtms with cognitive control training in major depressive disorder

Conditions: Major Depressive Disorder

Summary: repetitive transcranial magnetic stimulation (rtms) is an effective treatment for mdd, but the overall effect sized of the treatment is equivalent to antidepressant pharmacotherapy, and responses are highly variable. given that rtms is usually given to patients who have failed pharmacotherapy, a more effective alternative is needed. therefore, this study will combine computerized cognitive training (cct) during standard rtms treatments and assess its feasibility, tolerability, and changes in cognitive control performance and depression symptoms. participants that agree to the study and meet eligibility will receive standard rtms (generally 25-36 daily treatments) along with cct (starting on day 5 of treatment until the pre-taper treatment). in addition, to cct participants will be asked to complete assessments before and after treatment

this project will also have a registry for participants that are approached to be in the clinical trial with the cct but don't wish to be enrolled. although the registry will be available for these participants, the information entered into this clinicaltrials.gov registration will reflect the clinical trial portion of this project.

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder * eligible to receive and recommended for rtms for depression * willingness to complete computerized cognitive training and undergo brain stimulation procedures * must be enrolled as a michigan medicine patient and currently receiving tms treatment as part of your clinical care. exclusion criteria: * history of serious neurological illness or brain injury (e.g., stroke) * poor visual acuity impairing performance on the computerized tasks (eyeglasses must be removed for rtms treatment, but contacts are permissible) * diagnosed intellectual disability * inability to manipulate a tablet device while seated in the rtms chair

Keywords: transcranial magnetic stimulation computerized cognitive training
optimal dosage of ticagrelor in korean patients with ami

Conditions: Acute Myocardial Infarction; Ticagrelor

Summary: east asian patients will be required optimal dose of newer p2y12 inhibitor (ticagrelor) to determine the safer treatment and better outcome. whether low dose of ticagrelori is more adequate for clinical practice in korea is unclear. therefore, the investigators aim to evaluate efficacy and safety of low dose of ticagrelor in acute myocardial infarction (ami) undergoing percutaneous coronary intervention(pci).

in recent years, newer oral p2y12 receptor blocker (ticagrelor) has been strong recommendations for management of patients with ami undergoing (pci). this drug provided more profound inhibitory effects than clopidogrel, which could lead to marked reduction in ischemic events, with relatively increase in bleeding complication, specific to low body weight, especially in women and east asian patients.

Eligibility criteria:
inclusion criteria: * patients present with acute myocardial infarction undergoing pci. * patients receiving ticagrelor; male or female gender; age 20-75 years. * patients provide written informed consent prior to enrollment. exclusion criteria: * low body weight (\<60kg). * history of hemorrhagic stroke. * history of upper gastrointestinal bleeding in recent 6 months. * bleeding tendency. * thrombocytopenia defined by platelet \< 100,000/ml. * anemia defined by hemoglobin \< 10 g/dl. * renal dysfunction defined as serum creatinine \> 2.5 mg/dl. * severe hepatic dysfunction defined as serum transaminase \> 3 times normal limit. * known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (sss) or high degree av block without pacemaker protection). * current treatment with drugs interfering with cyp3a4 metabolism (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin.

Keywords: ticagrelor de-escalation strategy korean
investigation of milk peptides on postprandial blood glucose profile

Conditions: Postprandial Hyperglycemia

Summary: aim of the study is to investigate the effect of two different dosages of milk peptides on postprandial blood glucose profile in prediabetic subjects compared to placebo. this will be investigated in a cross-over double blind randomized placebo controlled study design. additionally, long term effects on glucose status, insulin sensitivity and postprandial blood glucose profile will be investigated in a follow up 6-week open label phase with the low dose only.


Eligibility criteria:
inclusion criteria: * male and female subjects with prediabetic hba1c values between 5.7% - 6.4% and/or fasting blood glucose ≥ 5.6 mmol/l (≥ 100 mg/dl) und \< 7.0 mmol/l (\< 125 mg/dl) (in venous plasma) * age: 30-70 years * body mass index 19-35 kg/m2 * non-smoker * caucasian * availability and presence in the study unit for approx. 3.5 hours/ week for 3 times in a row with approx. 1 week of washout in between. * signed informed consent form * no changes in food habits or physical activity 3 months prior to screening and during the study exclusion criteria: * presence of disease or drug(s) influencing digestion and absorption of nutrients or bowel habits * intake of medications known to affect glucose tolerance, e.g., diabetic medication, steroids, protease inhibitors or antipsychotics * diagnosed typ 2-diabetics with medical treatment * chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the investigator's opinion would impact patient safety * severe liver, renal or cardiac disease * acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks * known inflammatory and malignant gastrointestinal diseases (i.e. colitis ulcerosa, morbus crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis) * clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs * major medical or surgical event requiring hospitalization within the previous 3 months * intake of antibiotics within 4 weeks before the test days * known alcohol abuse or drug abuse * pregnant or breast feeding women * known or suspected allergy to any component of the investigational product(s) (e.g. milk protein) * known hiv-infection * known acute or chronic hepatitis b and c infection * blood donation within 4 weeks prior to visit 1 or during the study * subject unable to co-operate adequately * participation in a clinical study with an investigational product within one month before start of study
comparison of a new formulation of insulin glargine with lantus in patients with type 2 diabetes on basal insulin with oral antidiabetic therapy

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: * to compare the efficacy of insulin glargine new formulation and lantus in terms of change in glycated hemoglobin a1c (hba1c) from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus secondary objective: * to compare the efficacy of insulin glargine new formulation and lantus in terms of occurrence of nocturnal hypoglycemia

the maximum study duration was up to approximately 58 weeks per participants, consisting of: * up to 2 week screening period * 6-month comparative efficacy and safety treatment period * 6-month comparative safety extension period * 4-week safety follow-up period in a subset of participants * a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to hoe901-u300

Eligibility criteria:
inclusion criteria : * participants with type 2 diabetes mellitus * substudy inclusion criteria: * completion of the 6-month study period in main study (visit 10) * randomized and treated with insulin glargine new formulation during the 6- month treatment period (baseline - month 6) exclusion criteria: * age less than (\<) 18 years * hba1c \ ) 10% at screening * diabetes other than type 2 diabetes mellitus * less than 6 months on basal insulin treatment together with oral antihyperglycemic drug(s) and self-monitoring of blood glucose * participants using sulfonylurea in the last 2 months before screening visit * any contraindication to use of insulin glargine as defined in the national product label * use of insulin pump in the last 6 months before screening * initiation of new glucose-lowering medications in the last 3 months before screening visit * history or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period * pregnant or breast-feeding women or women who intend to become pregnant during the study period * substudy exclusion criteria: * participant not willing to use the adaptable injection intervals on at least two days per week the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
musculoskeletal plasticity after spinal cord injury

Conditions: Spinal Cord Injuries

Summary: patients with spinal cord injury (sci) experience metabolic syndrome, diabetes, obesity, pressure ulcers, and cardiovascular disease at far greater rates than the general population. a rehabilitation method to prevent or reverse the systemic metabolic consequences of sci is a pressing need. the purpose of this study is to determine the dose of muscle activity that can enhance an oxidative muscle phenotype and improve clinical markers of metabolic health and bone turnover in patients with sci. the long-term goal of this research is to develop exercise-based interventions to prevent secondary health conditions such as diabetes and to ultimately protect health-related quality of life (qol). specific aim 1: to compare changes in skeletal muscle gene regulation in individuals who receive high frequency (hf) active-resisted stance and low frequency (lf) active-resisted stance for 3 years. hypothesis 1: the expression of genes regulating skeletal muscle metabolism will support that hf and lf both instigate a shift toward an oxidative muscle phenotype. a novel finding will be that lf is a powerful regulator of oxidative pathways in skeletal muscle. specific aim 2: to compare changes in systemic markers of metabolic health and bone turnover in individuals with sci who receive hf or lf for 3 years. hypothesis 2: hf and lf will both reduce glucose/insulin levels and homa (homeostasis model assessment) score. secondary aim: to measure subject-reported qol using the eq-5d survey metric. hypothesis 3: hf and lf subjects will show a trend toward improved self-reported qol after 3 years. there will be an association between metabolic improvement and improved perception of qol. these observations will support that this intervention has strong feasibility for future clinical translation.


Eligibility criteria:
inclusion criteria: * motor complete sci (ais a-b) exclusion criteria: 1. pressure ulcers 2. chronic infection 3. lower extremity muscle contractures 4. deep vein thrombosis 5. bleeding disorder 6. recent limb fractures 7. any comorbid disease known to affect bone metabolism (such as parathyroid dysfunction) 8. pregnancy 9. anti-osteoporosis medications 10. vitamin d supplements 11. metformin or other medications for diabetes.

Keywords: metabolism glucose osteoporosis secondary health conditions quality of life standing electrical stimulation diabetes insulin skeletal muscle
the headwind study - part 4

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: to analyse driving behavior of individuals with type 1 diabetes in eu- and mild hypoglycaemia while driving in a real car. based on the in-vehicle variables, the investigators aim at establishing algorithms capable of discriminating eu- and hypoglycaemic driving patterns using machine learning classifiers.

hypoglycaemia is among the most relevant acute complications of diabetes mellitus. during hypoglycaemia physical, psychomotor, executive and cognitive function significantly deteriorate. these are important prerequisites for safe driving. accordingly, hypoglycaemia has consistently been shown to be associated with an increased risk of driving accidents and is, therefore, regarded as one of the relevant factors in traffic safety. therefore, this study aims at evaluating a machine-learning based approach using in-vehicle data to detect hypoglycaemia during driving. during controlled eu- and hypoglycaemia, participants with type 1 diabetes mellitus drive in a driving school car on a closed test-track while in-vehicle data is recorded. based on this data, the investigators aim at building machine learning classifiers to detect hypoglycemia during driving.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * type 1 diabetes mellitus as defined by who for at least 1 year or confirmed c-peptide negative (\ 4 mmol/l) * age between 21-60 years * hba1c ≤ 9.0 % * functional insulin treatment with good knowledge of insulin self-management * passed driver's examination at least 3 years before study inclusion. possession of a valid, definitive swiss driver's license. * active driving in the last 6 months. exclusion criteria: * contraindications to the drug used to induce hypoglycaemia (insulin aspart), known hypersensitivity or allergy to the adhesive patch used to attach the glucose sensor. * pregnancy or intention to become pregnant during the course of the study, lactating women or lack of safe contraception * other clinically significant concomitant disease states as judged by the investigator * physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator * renal failure * hepatic dysfunction * coronary heart disease * other cardiovascular disease * epilepsy * drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * participation in another study with an investigational drug within the 30 days preceding and during the present study * total daily insulin dose \>2 iu/kg/day * specific concomitant therapy washout requirements prior to and/or during study participation * current treatment with drugs known to interfere with metabolism or driving performance

Keywords: automotive technology hypoglycemia hypoglycaemia driving car
high flow nasal cannula therapy in bronchiolitis : early vs rescue

Conditions: Bronchiolitis; Respiratory Syncytial Virus (RSV)

Summary: the enrolled rsv-bronchiolitis patients will be randomized into two arms , the early hhhfnc group and the standard therapy group with rescue hhhfnc to study the efficacy of this treatment.

setting: the study will be conducted between june 2017 and june 2020 in the short stay unit of the pediatric emergency center (pec) of hamad general hospital, the only pediatric emergency facility in the state of qatar. infants aged ≤3 months presenting to the unit for treatment of viral bronchiolitis with positive rsv test will be eligible for the study. procedure: eligible patients will be enrolled after obtaining written consent. for patients who consent, plain chest radiography, and nasopharyngeal swabs will be taken for rsv detection. if the patient has a positive rsv rapid antigen test, patients will be randomized in one of the study arms. adverse effects in each group will be carefully monitored and documented. study intervention: patients will be randomized into two treatment arms group 1: early hhhfnc group patients in this group will be treated by using heated humidified high flow oxygen /air via nasal cannula; investigators will keep the patient on hhhfnc until he/she becomes clinically ready for discharge. group 2: standard therapy and rescue hhhfnc group: patients in this group will be treated by usual therapy,investigators will use low flow nasal cannula oxygen therapy only if oxygenation needed to maintain oxygen saturation (spo2) ≥ 92% , if the patient deteriorate and require icu, rescue hhhfnc will be started before admission to the icu.

Eligibility criteria:
inclusion criteria: * previously healthy infants with age 0-3 months and gestational age ≥30 weeks admitted to the short stay unit with rsv positive bronchiolitis and clinical severity score ≥4 on wang clinical severity scale. exclusion criteria: 1. gestational age less than 30 weeks. 2. previous history of wheezing. 3. use of steroid within 48 hours of presentation. 4. history of chronic lung disease. 5. infants admitted directly to icu. 6. prior invasive or non-invasive ventilatory support. 7. tracheostomy. 8. nasogastric tubes in situ on admission. 9. upper airway abnormality (like choanal atresia and midfacial anomalies). 10. immunodeficient children. 11. history of cardiac disease, renal disease or liver disease. 12. history of neuromuscular disorder.

Keywords: heated humidified high flow nasal cannula (hhhfnc) low flow nasal cannula bronchiolitis respiratory syncytial virus (rsv) respiratory failure high flow nasal cannula (hfnc) lung diseases, obstructive