Kornimate/medical-research-clean huggingface dataset:
blood glucose control over an extended glucose control range in postoperative cardiac surgery patients in the intensive care unit

Conditions: Critical Illness

Summary: hyperglycaemia is commonly found in critically ill patients. clinical studies demonstrated that tight blood glucose control in medical and surgical icu patients results in a significant better outcome for the patients. based on this emerging clinical evidence, there are increasing efforts worldwide to maintain strict glycaemic control in critically ill patients. however, achieving this goal requires extensive nursing efforts, including frequent bedside glucose monitoring and the implementation of complex intensive insulin infusion protocols. a fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. this study will investigate the performance of an empc algorithm adjusted to target the range 4.4 - 8.3 mmol/l in line with the surviving sepsis guidelines.


Eligibility criteria:
inclusion criteria: * age: \> 18 years of age * admitted following cardiac surgery * stay in the icu expected to be \> 20h * blood glucose \> 6.7 mmol/l within 4 hours of admission to intensive care or patient already receiving insulin treatment exclusion criteria: * patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency. * known or suspected allergy to insulin * any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e. liver failure, other fatal organ failures) * patients participating in another study * moribund patients likely to die within 24 hours * patients after organ transplantation within the last three months * patients under high dose cortisol treatment (cortisol \> 1000 mg/day or equivalent doses of hydrocortisol)

Keywords: algorithm tight glycemic control glucose control intensive care insulin icu
effects of pain neuroscience education and virtual reality in patients with chronic low back pain

Conditions: Chronic Low-back Pain

Summary: the objective of our study is to evaluate the effects of a therapeutic intervention including 1-hour of pain neuroscience education session, 30-minutes of exposure to exercise with virtual realit and therapeutic exercise in patients with chronic low back pain.

chronic low back pain is the world's leading cause of years of life lived with disability. negative thoughts and beliefs about pain experienced can lead to pain avoidance behaviours. fear of movement is a common behaviour in this type of patients and is associated with avoidance of exercise. virtual reality is a powerful distraction technique as it directs the patient's attention to an external stimulus rather than pain or body movement. therefore, it can be beneficial to avoid some pain-related problems, such as kinesiophobia and inactivity. moreover, pain neuroscience education aim to reconceptualise pain perceptions, beliefs, and avoidance behaviours. then, the use of these interventions may be beneficial in the treatment of patients with chronic low back pain. the objective of this study is to evaluate the effects of a therapeutic intervention using pain neuroscience education and virtual reality in patients with chronic low back pain.

Eligibility criteria:
inclusion criteria: * chronic musculoskeletal pain (≥ 3 months) * adults (≥ 18 years and less than 65 years) * score ≤18 points in pain detect scale * wish to participate in the study and sign the informed consent * speaking spanish exclusion criteria: * neuropathic pain (score ≥18 in pain detect scale) * physical or psychological pathology of any kind that imply an inability to understand the necessary instructions to carry out the study will be excluded.
sal067 treatment in patients with type 2 diabetes who are not controlled by metformin

Conditions: Diabetes Mellitus, Type 2

Summary: this is the phase 3 randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and long-term safety of sal067 in t2dm patients uncontrolled by metformin, comprising 24 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 52 weeks.

all eligible subjects would enter the 24 weeks of double-blind treatment period and were randomized into the sal067 group (12 mg once daily) or placebo group at a 2:1:1 ratio. after 24 weeks of double-blind treatment, subjects would enter the extended open-label treatment period. subjects in the placebo group were to be switched to sal067 (12 mg once daily) treatment, while patients in the sal067 groups continued the same treatment until the end of the whole 52 weeks.

Eligibility criteria:
inclusion criteria: 1. type 2 diabetes patients who meet the diagnostic criteria for diabetes issued by the world health organization (who) in 1999; 2. men or women aged 18 to 75 years old at the day of signing the informed consent; 3. body mass index: bmi 19kg/m2 to 35kg/m2, \[bmi=weight (kg)/height 2 (m2)\]; 4. subjects treated with metformin≥ 1500mg/day constantly for at least 8 consecutive weeks before screnning; 5. glycated hemoglobin (hba1c): screening period: hba1c 7.5% to 10.5% (tested by the research center), when randomly enrolled: hba1c 7.0% to 10.0% (central laboratory test) measurement); 6. screening period and random time fasting blood glucose \<=13.9mmol/l. exclusion criteria: 1. drug compliance during the introduction period \ 120%; 2. use other hypoglycemic drugs other than test drugs during the introduction period; 3. the patient may have any contraindications, allergies or hypersensitivity to fuglitagliptin (including study drug and placebo) or its excipients, dpp4 drugs, metformin; 4. before screening, have any of the following endocrine-related medical history or evidence: * diabetes other than type 2 diabetes, such as type 1 diabetes, single-gene mutation diabetes, diabetes caused by pancreatic injury or secondary diabetes, such as diabetes caused by cushing's syndrome or acromegaly; * diabetic ketoacidosis, hyperglycemia and hyperosmolarity, lacticacidosis and other acute complications of diabetes within 6 months before screening; * severe hypoglycemia episodes (such as sleepiness caused by hypoglycemia, unconsciousness, nonsense, and even coma), or a serious history of unconscious hypoglycemia; 5. before screening, there is a history or evidence of any of the following diseases: * unstable angina, stroke or transient ischemic attack, myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention (diagnostic angiography is allowed of); * decompensated heart failure before screening (new york heart association nyha heart function grades iii and iv, persistent and clinically significant arrhythmia; * a history of acute and chronic pancreatitis, symptomatic gallbladder disease or history of pancreatic injury, etc. may lead to high risk factors for pancreatitis.
the effect of pandemic on children with cerebral palsy

Conditions: Cerebral Palsy; Covid19

Summary: cerebral palsy (cp), is the most common cause of physical disability that begins in childhood and lasts throughout life, affecting 1 in 500 newborns, with an estimated prevalence of 17 million worldwide. social isolation, economic conditions, interruption of treatments, etc. may cause physical, mental, behavioral and psychosocial changes in children with cerebral palsy. discontinuing regular physiotherapy can worsen functional skills and cause complications in children with cerebral palsy. our aim in this study is to investigate the sustainability of the treatments of children with cerebral palsy during the pandemic period, their physical and psychosocial effects, and the relationship between their parents' fear of covid-19.


Eligibility criteria:
inclusion criteria: * parents of children under the age of 18 with cerebral palsy who applied to our hospital between 01.01.2014-31.01.2021 exclusion criteria: * parents of cerebral palsy patients over 18 years of age * parents who cannot be reached by phone * parents who do not agree to fill out the questionnaire

Keywords: cerebral palsy covid19 pandemics
phase 1 trial for tumor treating field for drug/radiation resistant brain metastases

Conditions: Brain Metastases

Summary: brain metastasis is a very common disease with poor prognosis, 20% cancer will develop brain metastases(bm), up to 40% by autopsy. great advances have made with the application of targeting therapy, immunotherapy, chemotherapy, whole brain radiation and radiosurgery, however, treated patients were finally suffered from drug/radiation resistance and rapid recurrence. tumor treating fields (ttfields) is one of the standard combination treatment for gbm, and some researchers believe that ttfields can effectively inhibit patient-derived lung adenocarcinoma brain metastasis cells progression in vitro. in this study, the investigator attempts to evaluate the safety, and tolerability of ttfields in adult participants diagnosed with drug/radiation resistant bm.


Eligibility criteria:
inclusion criteria: * patients are diagnosed as brain metastases by xiangya hospital multidisciplinary team; * age from 18 to 65 year-old; * patients have been progressed from standard therapy (drug/radiation resistance) * kps more than 70 score; * anticipated os more than 3 months; * signed consent form. exclusion criteria: * unable to take ttfields more than 18 hours each day; * unable to follow-up till progression; * the scalp wound is not well healed, the head skin condition is not good, the skull has a large area defect, or other situations that are not suitable for wearing electrodes * pregnant women; * last drug within 4 weeks, last radiation within 3 months, take other trials; * other heavy diseases like heavy infection; * other condition: such as breastfeeding, installation of cardiac pacemakers, brain stimulators, severe intracranial edema, increased intracranial pressure leading to midline structures exceeding 5 mm, optic nerve head edema, disturbance of consciousness, etc., allergies to conductive coupling agents, gels, etc. * blood and biochemical indicators in the following range: a. liver function impairment: ast or alt \> 3 times the upper limit of normal; b. total bilirubin\> upper limit of normal value; c. renal impairment: serum creatinine\>1.7mg /dl (\>150 mol/l); d. coagulopathy: pt or aptt \>1.5 times normal; e. platelets counts \< 100x10\^9/l; f. absolute neutrophils count \< 1x10\^9/l; g. hemoglobin \< 100g/l; * other conditions physicians not suggest to take the trial

Keywords: tumor treating fields; brain metastases;
corticosteroid injection versus nerve block

Conditions: Glenohumeral Arthritis; Rotator Cuff Arthropathy

Summary: the purpose of this study is to evaluate conservative pain relief measures for patients suffering from glenohumeral arthritis or rotator cuff arthropathy. conservative management of osteoarthritis is often first line treatment, and while a corticosteroid injection is frequently used, suprascapular nerve blocks have not often been described as an analgesic option in this population.


Eligibility criteria:
inclusion criteria: * diagnosis of glenohumeral osteoarthritis, rheumatoid arthritis, or rotator cuff arthropathy who are being offered injection exclusion criteria: * uncontrolled diabetes (patients will be excluded if no hba1c within a year or if it is 8 or greater" * known allergy to steroid or anesthetic * pregnant women * prisoners * patients with diminished capacity to consent to participation * children under 18 years of age * non-english speakers

Keywords: osteoarthritis glenohumeral arthritis rotator cuff arthropathy corticosteroid injection suprascapular nerve block
histopathological findings in symptomatizing patients after supracervical hysterectomy

Conditions: CIN; Cancer of Cervix; Cervicitis

Summary: supracervical hysterectomy is widely common and had many complications either immediate or delayed. in these patients bleeding, infection, chronic pelvic pain are common. in these patients cervical biopsy was done and histopathological examinations were done to evaluate the pathology in these patients.

* study design and settings: cross sectional descriptive studies conducted from december 2017 till january 2021. * patients: 80 patients with supracervical hysterectomy recruited at tanta university hospital, gynecology clinics will be recruited according inclusion and exclusion criteria. inclusion criteria include all symptomatizing patients following supracervical hysterectomy, of any age, of any complaints. the exclusion criteria were patients with total hysterectomy, hysterectomies for malignant indications, and refusal to participate. * methods: all patients' demographic data, history, indication of hysterectomy, duration since operation, postoperative complications and their main complaint. intervention: under general anesthesia cervical biopsy (4 quadrants) were taken from all patients and was sent for histopathological examinations.

Eligibility criteria:
inclusion criteria: * all symptomatizing patients following supracervical hysterectomy, exclusion criteria: * with total hysterectomy, * hysterectomies for malignant indications, * refusal to participate.
evaluation of the cognision(tm) system as an event-related potential (erp) collection system.

Conditions: Alzheimer's Disease

Summary: this study will evaluate a handheld event-related potential (erp) testing device from neuronetrix, inc. as a method to collect erp data in an outpatient setting. an erp system records electrical signals at the scalp that are produced by the brain when performing cognitive tasks. by doing this study, we hope to evaluate various performance parameters of the cognision(tm) system.

patients who have a current diagnosis of mild-moderate dementia and suspected of having alzheimer's disease (ad) along with cognitively normal age-matched controls will be recruited for this study. the alzheimer's subjects either will have had a complete clinical and neuropsychiatric workup or will have those tests performed during the study. both groups, ad and controls will be asked to listen to a series of sounds and press a button on a handheld control box when a target sound is heard. the cognision(tm) headset on each subject's head will then record the electrical signals during this task. four important features of the cognision(tm) will be investigated: 1. patient tolerance 2. ease of use 3. data quality 4. network architecture

Eligibility criteria:
inclusion criteria for ad: * age 60 to 85 * mild to moderate diagnosis of alzhiemer's disease inclusion criteria for control: * age 60 to 85 * cognitively healthy with no complaints exclusion criteria: * subjects with advanced ad and severe impairment (cdr \> 2, mmse less than 15) * neurological disorders such as stroke, parkinson's disease, huntington's disease, multiple sclerosis, brain tumor, delirium, or psychiatric disorder other than depression (e.g. schizophrenia) * subjects with life threatening illnesses and subjects with significant hearing or visual impairments * subjects with a current prescription for psychoactive pharmaceuticals

Keywords: senile dementia
study of melphalan drug exposure in pediatric hematopoietic stem cell transplant patients

Conditions: Hematologic Malignancies; Nonmalignant Diseases; Immunodeficiencies; Hemoglobinopathies; Genetic Inborn Errors of Metabolism; Fanconi's Anemia; Thalassemia; Sickle Cell Disease

Summary: melphalan is a chemotherapy drug used extensively in bone marrow transplantation. the goal of this study is to determine what causes some children to have different drug concentrations of melphalan in their bodies and if drug levels are related to whether or not a child experiences severe side-effects during their bone marrow transplant. the hypothesis is that certain clinical and individual factors cause changes in melphalan drug levels in pediatric bone marrow transplant patients and that high levels may cause severe side-effects.

melphalan is an alkylating agent with potent antitumor and immunosuppressive properties used in conditioning regimens of pediatric allogeneic hematopoietic cell transplantation (allohct) to promote stem cell engraftment. this is a single-center, prospective, non-interventional pharmacokinetics (pk) study investigating the clinical pharmacology of melphalan in 24 children undergoing allogeneic hematopoietic stem cell transplant (allohct) at university of california, san francisco benioff children's hospital. patients would receive melphalan regardless of whether or not they decide to consent to pk sampling. melphalan doses will not be adjusted based on pk data. the investigators will apply the combination of a limited sampling strategy and population pk methodologies to determine specific factors influencing melphalan exposure in pediatric allohct recipients. population pk methodologies support the use of sparse sampling and therefore allow us to investigate drug levels in a pediatric population that would otherwise not be feasible using traditional intensive pk sampling. subjects will undergo pk sampling of plasma melphalan drug concentrations over the duration of melphalan therapy (3 to 5 days). to evaluate sources of variability impacting melphalan exposure clinical data will be obtained from the patient's medical chart on each day of pk sampling. to assess exposure-response relationships neutrophil engraftment, treatment-related toxicity, and survival data will be collected through day 100 post-transplant.

Eligibility criteria:
inclusion criteria: * children 0-17 years of age * undergoing allohct for the treatment of malignant or nonmalignant disorder * receiving melphalan-based preparative regimen exclusion criteria: * any child 7-17 years of age unwilling to provide assent

Keywords: melphalan pharmacokinetics pediatric allogeneic
validation of the stockholm3 test for detection of prostate cancer in the swiss population

Conditions: Prostate Cancer; Localized Carcinoma

Summary: the purpose of this study is to collect blood samples to investigate the prognostic performance of the sthlm3 test in a population of swiss and german men suspected of harbouring prostate cancer based on a combination of elevated psa levels (e.g. \>2.5 ng/ml) and/or pathological digital rectal examination and/or mri-findings.


Eligibility criteria:
inclusion criteria: * planned prostate biopsy due to suspicion of prostate cancer (usually due to a combination of elevated psa levels \[e.g. \>2.5 ng/ml\] and/or pathological digital rectal examination and/or mri-findings) * written informed consent by the participant exclusion criteria: * severe anemia (hb \<60g/l) * previously already established diagnosis of prostate cancer.
basimglurant (noe-101) in children, adolescents, and young adults with tsc

Conditions: Tuberous Sclerosis Complex

Summary: the study intends to show that basimglurant (noe-101) provides effective seizure control in children, adolescents and young adults with tuberous sclerosis complex (tsc).

the study drug (noe-101, basimglurant) is a potent inhibitor of metabotropic glutamate receptor 5 (mglur5) which controls a wide range of processes in the brain, spinal cord, retina, and peripheral nervous system. in animal studies, the inhibition of this receptor has shown therapeutic potential for the treatment of tuberous sclerosis complex (tsc). this receptor's inhibition decreases the frequency of seizures. in previous clinical trials, the study drug has shown an advantageous safety profile in children and adolescents. the objective of this study is to find an optimal dose at which the study drug will lead to a decrease in the duration, frequency and intensity of seizures in children, adolescents and young adults with tsc, while being well tolerated. all patients who positively respond and tolerate the medicine will be offered the possibility to continue in an open label extension.

Eligibility criteria:
inclusion criteria (summary): * ability and willingness to provide informed assent or written consent or consent from their legal representative. * fluency in the language of the study staff * age 5 to 30 years at study entry * a documented history of tsc * refractory seizure history * currently receiving one or more anti-epileptic drugs (aeds) * stable medications or interventions for epilepsy * willingness to complete patient reported outcome assessments * for female patients of childbearing potential: 1. willingness to undergo serum or urinary pregnancy testing at screening and during the trial period. 2. willingness to use contraception. exclusion criteria (summary): * neurologic disease other than tsc * recent anoxic episode * patient weight below 15kg * clinically significant unstable medical condition(s) * pregnancy or lactation

Keywords: basimglurant tsc seizures noe-101
the impact of early pulmonary rehabilitation on multidimensional aspect of dyspnea in copd patients after exacerbation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: acute exacerbations of chronic obstructive pulmonary disease (aecopd) are associated with severe dyspnea and exercise intolerance. early pulmonary rehabilitation (epr) may lead to improvements in dyspnea and exercise tolerance, as it does in stable copd patients.

one hundred and six patients admitted in a university hospital with aecopd were randomized after discharge to either epr for 8 weeks (epr group) or usual care (uc) (uc group). all patients carried out the following initially and after 8 weeks: spirometry, 6minute walk test (smwt), and a symptom-limited incremental cycle cardiopulmonary exercise test (cpet), and different dyspnea dimensions evaluation as following: dyspnea intensity during incremental exercise using borg scale, dyspnea 12 questionnaire and copd assessment test (cat) to assess sensory perceptual, affective distress, and symptom impact domains respectively.

Eligibility criteria:
inclusion criteria: * hospitalized copd patients with a diagnosis of aecopd with no clinically significant arterial hypoxemia at rest or on exercise (resting percutaneous oxygen saturation (spo2) \> 90% or a sustained decrease of \< 4% during exercise) were recruited. diagnosis of copd, aecopd and spirometric assessment of airflow limitation severity was based on global initiative for chronic obstructive lung disease (gold) exclusion criteria: * patients with a prior diagnosis of other cardiorespiratory conditions (i.e., bronchial asthma, interstitial lung diseases, primary pulmonary hypertension, chronic congestive heart failure), as well as other conditions such as orthopedic, muscular and peripheral vascular diseases that could cause or contribute to breathlessness and exercise intolerance and/or could interfere with carrying out of exercise testing, were excluded.