Kornimate/medical-research-clean huggingface dataset:
effect of volume guarantee-high frequency oscillatory ventilation on cerebral blood flow in neonates

Conditions: Infant, Premature, Diseases; Respiratory Tract Diseases; Cerebral Blood Flow

Summary: a randomized controlled clinical trial evaluates cerebral blood flow changes associated with hfov-vg in comparison to hfov alone in preterm neonates with respiratory insufficiency during the period of invasive respiratory support

neonatal respiratory distress (nrd) is one of the most common problems in the first few days of neonatal life. nrd has been reported to be prevalent in 5 - 29% of the nicu hospitalized neonates. high-frequency oscillatory ventilation (hfov) has been used for more than three decades, it is a rescue maneuver for failed conventional mechanical ventilation. it delivers small tidal volumes to improve gas exchange. as it uses a low tidal volume, under the anatomical dead space at supra-physiological respiratory frequencies hfov can reduce the risk of lung injury related to the ventilator and consequently reduce the risk of bronchopulmonary dysplasia hfov is indicated for patients with neonatal air leak syndrome, persistent pulmonary hypertension, and meconium aspiration several factors are known to influence cerebral perfusion during hfov. hypercapnia increases cerebral blood flow (cbf) while a reduction in paco2 leads to cerebral vasoconstriction and decreases cbf, hypoxia is also known to increase cbf via cerebral vasodilation hfov with volume guarantee (hfov-vg) is a promising new ventilator mode for the treatment of respiratory failure in newborns. hfov-vg is expected to result in less lung injury since it reduces fluctuations of high frequency tidal volume (vthf), reduces the number of out-of-target pco2 values and provides fewer hypoxia attacks compared with hfov alone

Eligibility criteria:
inclusion criteria: 1. preterm neonates with gestational age ≤ 35 weeks. 2. neonates with various causes of respiratory failure: respiratory distress syndrome (rds), air leak syndromes, pneumonia, or pulmonary hemorrhage, failing with conventional ventilation (i.e. when conventional ventilation failed to maintain either oxygenation or ventilation) and are switched to hfov as a rescue therapy. exclusion criteria: 1. preterm neonates with major upper or lower airway anomalies. 2. preterm neonates with significant congenital anomalies including cardiac, abdominal or respiratory

Keywords: high frequency oscillatory ventilation volume guarantee-high frequency oscillatory ventilation preterm cerebral blood flow
prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease

Conditions: Diabetes Mellitus

Summary: the use of acarbose in impaired glucose tolerance (igt) and type 2 diabetic subjects has been associated with a significant reduction of cardiovascular events. additionally, acarbose has been shown to have a beneficial influence on some of the other cardiovascular risk factors (metabolic syndrome components). thus, prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease. further studies are needed to confirm the influence of acarbose on cardiovascular risk factors in the real life setting.


Eligibility criteria:
inclusion criteria: * diabetes mellitus * age \>/= 18 years * naive to acarbose (minimum 3 months before inclusion) exclusion criteria: * hypersensitivity to acarbose or any of the excipients * age \<18 years * pregnancy and in nursing * inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction * chronic intestinal diseases associated with marked disorders of digestion or absorption * states which may deteriorate as a result of increased gas formation in the intestine, (e.g. roemheld's syndrome \[an angina pectoris-like syndrome or aggravation of an angina pectoris due to the postprandial filling of the stomach\] and larger hernias) * hepatic and severe renal impairment (creatinine clearance \<25 ml/min/ 1,73m2)

Keywords: diabetes acarbose
therapeutic efficacy of oral l-ornithine-l-aspartate on minimal encephalopathy

Conditions: Hepatic Encephalopathy

Summary: the study aimed to assess the effectiveness and safety of l-ornithine-l-aspartate in the management of hepatic encephalopathy.

hepatic encephalopathy continues to be a major clinical problem in cirrhosis. patients with minimal hepatic encephalopathy are at risk for accidents, had a decline in work performance, or complain of cognitive symptoms, with poor health-related quality of life. this study will compare l-ornithine-l-aspartate with placebo for 60 days to assess the effectiveness, safety and health-related quality of life of this drug.

Eligibility criteria:
inclusion criteria: * cirrhosis and diagnosis of minimal hepatic encephalopathy using psychometric tests and critical flicker frequency exclusion criteria: * hepatic encephalopathy grade 1 to 4 * use of drugs to treatment of hepatic encephalopathy (lactulose, neomycin) * psychoactive substance use within 72 hours

Keywords: minimal hepatic encephalopathy l-ornithine-l-aspartate psychometric test critical flicker frequency quality of life treatment health-related quality of life
exploring sarcopenia in parkinson's disease patients by combining serum biomarker levels

Conditions: Parkinson Disease

Summary: parkinson\&#39;s disease (pd) and sarcopenia are prevalent age-related syndromes, often occurring simultaneously within individuals. sarcopenia is notably common among pd patients, with severe cases affecting approximately one in every five individuals with pd. moreover, sarcopenia is closely linked to the accelerated progression of pd, diminished quality of life, heightened mortality risk, and increased susceptibility to falls and fractures. therefore, early detection of sarcopenia assumes particular significance as it offers an opportunity for interventions aimed at mitigating or delaying muscle degeneration, potentially influencing pd outcomes. this review will delve into the relationship between sarcopenia and pd, methods for screening and testing sarcopenia, and potential avenues for further research and the development of strategies for risk reduction and treatment

the onset of sarcopenia in pd may be intricately linked to both motor and non-motor symptoms. in terms of motor symptoms, sarcopenia exacerbates muscle weakness, impairs balance and gait, and may worsen symptoms like rigidity and bradykinesia in pd. numerous studies have shown that sarcopenia is strongly associated with disease duration, hoehn-yahr staging, and unified pd rating scale-iii(updrsiii) scores. regarding non-motor symptoms, sarcopenia contributes to increased fatigue due to muscle weakness, disrupts sleep patterns, exacerbates psychological distress including depression and anxiety, and may impact cognitive function. in addition, some studies supported that the incidence of falls, disability and death in pd with sarcopenia were higher than those in pd without sarcopenia. nevertheless, other studies have reported controversial results. some researchers believed that sarcopenia had no correlations with disease duration, hy, updrs-i/iii, cognition and depression. however, most of the current studies are small cross-sectional studies that are not very convincing about the relationship between diseases. thus, further studies with long-term follow up and large sample sizes are required to determine the causal direction of these relationships.

Eligibility criteria:
inclusion criteria: diagnosed as either ''definite'' or ''probable'' pd based on chinese diagnostic criteria of parkinson\&#39;s disease (2016 version) exclusion criteria: parkinson\&#39;s syndrome or parkinsonian superimposed syndrome due to encephalitis, cerebrovascular disease, poisoning, trauma, drugs or other factors
intraoperative placement of superficial erector spinae plane block; a new approach in spine surgery

Conditions: Postoperative Pain; Spine Deformity; Spine Injury; Spine Fracture; Spine Malformation

Summary: major spine surgery causes severe postoperative pain. the primary objective of this randomized controlled study is to compare the effect of ultrasound (us)-guided superficial erector spinae plane (esp) block on 48-hour postoperative cumulative opioid requirements with standard (opioid-based) analgesia.

46 patients (asa i-ii-iii) between 18 and 65 years of age, who were to undergo spine surgery, were randomized and divided into two groups. (23 patients in each of the control and superficial esp groups). superficial esp block was performed for sesp group and standard (opioid-based) analgesia performed in the control group. postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. postoperative numeric rating scale values were the primary outcome measure. 24-hour total morphine consumption was secondary outcome measure.

Eligibility criteria:
inclusion criteria: * ages of 18-65 * patients who will undergo spine surgery (at least two level) * asa i-ii-iii patients exclusion criteria: * clinically known local anesthetic allergy * morbid obesity (body mass index\>40 kg m2) * clinically diagnosis of opioid, alcohol and substance dependence * clinically diagnosis of psychiatric disease * coagulopathy * patients with asa iv-v * single level surgery

Keywords: postoperative pain superficial erector spinae plane block spine surgery local anesthetic
safety, tolerability and pharmacokinetic and pharmacodynamic characteristics of explorative formulations of insulin degludec and idegasp 50 in healthy japanese subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to investigate safety, tolerability and pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin degludec (insulin 454) and insulin degludec/insulin aspart (idegasp) 50 - formerly siam), both explorative formulations, not similar to the proposed commercial formulation, in healthy male japanese subjects.


Eligibility criteria:
inclusion criteria: * japanese passport holder * japanese-born parents * body mass index (bmi) between 18.0 and 27.0 kg/m\^2 (both inclusive) * fasting blood glucose of below or equal to 6 mmol/l * healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data at screening, as assessment of medical history, physical exjudged by the investigator exclusion criteria: * the receipt of any investigational drug within 3 months prior to this trial * subjects with a history of significant multiple drug allergies or with a known allergy to the trialproduct or any medicine chemically related to the trial product, as judged by the investigator
feasibility of the blended care pirate group

Conditions: Cerebral Palsy

Summary: rationale: in 2010 aarts developed the pirate group in which children received constrained induced movement therapy (constrained with a sling) followed by bilateral therapy. during this pirate group children were dressed as a pirate to increase motivation and to make the sling more meaningful. this pirate group had a duration of eight weeks with three times three hour training sessions each week. however, due to covid-19 therapists were introduced to home-based rehabilitation. therefore they developed the blended care pirate group, which is in principle the same as the pirate group of aarts, however one training session each week is replaced by a home-based training session. it is however not yet clear how this blended care pirate group is perceived by parents and therapists. objective: the aim of the current study is to investigate the feasibility and effectiveness of the blended care pirate group. study population: children with unilateral cerebral palsy between 2.5 and 8 years old will participate. these children will participate in the blended care pirate group and are asked to participate in the study as well. intervention: the total duration of one blended care pirate group is eight weeks with two times three hour training sessions at the rehabilitation centre and additional training sessions at home. the training sessions on-site will be the same as the conventional pirate group. for the training sessions at home parents will receive instructions and material from the therapists. this intervention is developed and already planned by therapists without direct influence of the research department and can therefore be considered as standard treatment. main study parameters/endpoints: the primary outcome are the total training hours performed by parents at home. additionally after the blended care pirate group parents and therapists will participate in an interview about how they perceived the blended care pirate group. secondary outcomes are improvements in arm function during the blended care pirate group.


Eligibility criteria:
inclusion criteria: * receiving treatment at the sint maartenskliniek. care demand of parents that requires a more and better use of the affected arm and hand. * children with unilateral cerebral palsy * a manual ability classification system (macs) score of i, ii or iii exclusion criteria: * cognitive developmental age below 2 * child is not able to walk independently without a walking tool

Keywords: home-based rehabilitation constrained induced movement therapy
cannabidiol for treatment of non-affective psychosis and cannabis use

Conditions: Dual Diagnosis

Summary: this trial examines the efficacy of cannabidiol (cbd) versus risperidone for treatment of psychosis in patients with non affective-psychosis and lifetime use of cannabis.

people with psychosis and comorbid cannabis use are particularly difficult to treat because cannabis use worsens psychotic symptoms and increases the risk that a first-episode psychosis will progress to schizophrenia. it is the thc (tetrahydrocannabinol) content in cannabis that aggravates psychotic symptoms whereas the cbd content has potential therapeutic effects. this trial investigates treatment with cbd (without thc) versus risperidone (an antipsychotic agent) in people with psychosis and lifetime use of cannabis. we hypothesize that cbd will ameliorate psychotic symptoms and reduce the frequency of cannabis use to a larger extent than risperidone. sleep disturbances are often a limiting factor in the treatment of psychosis, and it is also examined how cbd affects objective and subjective sleep quality as well as circadian rest-activity cycles. based on previous studies investigating cbd as monotherapy in patients with schizophrenia, it is expected that cbd will be associated with fewer adverse events than risperidone.

Eligibility criteria:
inclusion criteria: * icd-10 diagnosis of schizophrenia (df20.x), paranoid psychosis (df22.x), acute/intermittent psychotic disorder (df23.x), schizoaffective psychosis (df25.x), other/not specified nonorganic psychotic disorder (df28/df29), or cannabis induced psychotic disorder (df12.5) * panss ≥ 60 and score of ≥ 4 on ≥ 2 panss-positive subscale items: delusions (p1), conceptual disorganization (p2), hallucinatory behaviour (p3), grandiosity (p5), suspiciousness (p6) * lifetime cannabis use * age 18-45 years * female patients of childbearing potential need to utilize a proper method of contraception exclusion criteria: * treatment resistance as defined by treatment (ever) with clozapine * dependence syndrome of alcohol or psychoactive substances other than cannabis (df1x.2 other than df12.2) * psychotic disorder induced by alcohol or psychoactive substances other than cannabis (df1x.5 other than df12.5) * treatment with a long-acting injectable antipsychotic within the past month (or corresponding to the usual interval between two injections) * treatment with an oral antipsychotic within the past 7 days * use of self-administered cbd products during the trial * patients involuntarily admitted * pregnancy or lactation * severe physical illness that might influence the ability to comply with the protocol

Keywords: psychosis cannabis clinical trial
protocol to obtain blood samples for leukemia research

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to collect a blood sample in patients with chronic lymphocytic leukemia (cll).

the blood sample will be used in the laboratory to perform studies focusing on chronic lymphocytic leukemia (cll).

Eligibility criteria:
inclusion criteria: * patients undergoing routine blood draws as part of their ongoing follow-up for chronic lymphocytic leukemia (cll) at the norris cotton cancer center of dhmc. exclusion criteria: * patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for cll or other disease process within the past 6 months are excluded. use of intravenous immunoglobulin (ivig) is not a reason for exclusion.

Keywords: cll
a dyadic sleep health approach for persons with alzheimer's disease and caregivers

Conditions: Sleep

Summary: this is a randomized controlled trial over 5 years, using stage ii of the nih-defined stage model for behavioral intervention development. we will evaluate the efficacy of the sleep intervention program (care2sleep) on sleep, health status measures, and quality of life (for dyads), and inflammation (for caregivers only). eligible participants will be randomly assigned to in-person care2sleep, telehealth care2sleep, or to an in-person education control group. the care2sleep programs and the control education program will consist of five sessions. the intervention and control programs will begin after baseline assessment and randomization. posttreatment assessments will be performed immediately after the last session and at 6-month follow-up.


Eligibility criteria:
inclusion criteria for patients * have a diagnosis of alzheimer's disease (probable or possible) or other related dementia as documented in an electronic medical record * community-dwelling * \>1 sleep problems \>3x/week on the neuropsychiatric inventory nighttime behavior scale, - - aged \>60 years * have no untreated sleep disorders (e.g., sleep apnea, restless legs syndrome) * able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound) * have no severe medical conditions with a life expectancy of less than 6 months * have an eligible caregiver inclusion criteria for caregivers * live with an eligible patient * aged \>18 years * is related to the patient as a family member, a significant other, or a friend * have regularly assisted patient with \>1 of 6 basic activities of daily living (adls; i.e., bathing, dressing, toileting, transferring, continence, feeding) or \>1 of 8 instrumental adl (iadls; i.e., using the telephone, shopping, food preparation, housekeeping, laundry, transportation, taking medications, managing money) for the past 6 months * pittsburgh sleep quality index (psqi) total score \>5 * montreal cognitive assessment (moca) ≥23 * can communicate in english exclusion criteria: * patients will be excluded if they are bedbound or have severe medical conditions with a life expectancy of less than 6 months. * paid, professional caregivers will also be excluded. * if the eligibility criteria for either a patient or a caregiver are not met, the dyads will be excluded for this study.

Keywords: dementia caregivers
variability of healthy people and people after stroke results in the box and block test

Conditions: Motor Activity

Summary: main aim of the study is to find out how many attempts of each subtest in the box and block test should be done in clinical practice during testing people after stroke who are 20-64 years old.


Eligibility criteria:
inclusion criteria: * people after stroke 20 - 64 years old * signed informed consent for probation with inclusion to research and consent to the collection and processing of personal data during the study at the general university hospital in prague * ability to sit independently for 15 minutes * ability to grasp and move at least one 25 mm wide cube placed on a table using the dominant and then the non-dominant upper limb across the test partition * ability to perform a simple task following verbal instructions * retained ability to understand - according to psychological examination * completion of testing during hospitalization in the beroun rehabilitation hospital exclusion criteria: * severe hearing impairment not corrected by a hearing aid * severe visual impairment not corrected by glasses * severe comprehension impairment * other reasons not allowing the completion of the entire testing using the box and block test

Keywords: box and block test stroke czech extended version of manual for the box and block test
tranexamic acid for reduction of transfusion in abdominal surgery

Conditions: Surgical Blood Loss; Transfusion-dependent Anemia; Abdomen Disease

Summary: the goal of this clinical trial is to learn if the administration of tranexamic acid can reduce the necessity of blood transfusions in adult patients undergoing major abdominal surgery. . it will also inform about safety of tranexamic acid in this setting. the main question it aims to answer is: does tranexamic acid lower the probability of receiving at least one blood transfusion during or after surgery? participants will compare tranexamic acid o a placebo (a look-alike substance that contains no drug) to see if tranexamic acid works to reduce the necessity of a blood transfusion.


Eligibility criteria:
inclusion criteria: 1. age 18 years or above 2. planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy 3. adequate renal function with serum creatinine \<250 µmol/l (2.82 mg/dl) 4. written informed consent obtained before randomization 5. negative pregnancy test for women of childbearing potential within 14 days of commencing study treatment. females of reproductive potential must agree to practice highly effective contraceptive measures during the study. these comprise measures with a failure rate of \<1% per year when used consistently and correctly, such as intravaginal and transdermal combined (oestrogen and progestogen containing) hormonal contraception, injectable and implantable progestogen-only hormonal contraception, intrauterine device (iud), intrauterine hormone-releasing system (ius), bilateral tubal occlusion; vasectomised partner, sexual abstinence (defined as refraining from heterosexual intercourse during the entire study period). exclusion criteria: 1. severe anaemia, defined as a haemoglobin concentration \<8 g/dl (\<5 mmol/l) or anaemia with haemoglobin concentration ≥8 to \<10 g/dl (≥5,0 to \<6,2 mmol/l) and one or several of the following symptoms suggesting hypoxemia: * clinical signs of tachycardia, e.g., resting heart rate \>100 beats/minute, palpitation etc. * clinical signs of hypotension, e.g., resting systolic blood pressure \<100 mmhg, orthostatic dysregulation etc. * clinical signs of dyspnea, e.g., speech dyspnea, resting respiratory rate \>20 breaths/min. 2. thrombocytopenia with platelets \<60 x 109 /l 3. confirmed bleeding disorder with the need for specific preventive perioperative treatment (e.g., factor deficiency with the need of perioperative substitution) 4. a priori refusal of blood transfusions 5. confirmed thrombophilia with a pertinent need for perioperative anticoagulation 6. allergy / hypersensitivity to tranexamic acid 7. recent (\<30 days) thromboembolic event 8. history of medically confirmed convulsions 9. in female subjects: pregnancy or lactation