Kornimate/medical-research-clean huggingface dataset:
impact of nicotinamide riboside (nr) on kidney function in patients undergoing cardiac surgery

Conditions: Acute Kidney Injury; Cardiac Valve Disease

Summary: acute kidney injury (aki) associated with cardiac surgery is the most important complication in adult patients undergoing open heart surgery and is associated with increased mortality and morbidity. in patients in intensive care units, it is the second most common type of aki after aki secondary to sepsis. there is currently no specific treatment for aki. supportive measures include renal support therapy for patients with severe aki, and mortality in this subgroup of patients exceeds 50%. increasing nad+ with niacinamide has been shown to prevent various etiologies of experimental aki in mice, and an early pilot study has shown both increased nad levels following administration of nicotinamide riboside with pterostilbene nprt and the safety of niacinamide in patients undergoing cardiac surgery.

aki associated with cardiac surgery is a condition with a high incidence of morbidity and mortality, without pharmacological interventions approved for its prevention or treatment. as far as we know, there is no study that evaluates the impact of the administration of nicotinamide riboside on renal function in patients undergoing cardiac surgery. implementation of this relatively low-cost intervention and adequate safety profile would reduce in-hospital complications in risk patients undergoing cardiac surgery. nicotinamide adenine dinucleotide (nad+) is a cellular factor related to metabolism and longevity. nad+ is a required cofactor of sirt1, a nuclear deacetylase that modulates chromatin structure, gene expression, prolongs lifespan in organisms, and ameliorates age-related diseases. experimental aki in mice rapidly leads to reduced nad+ levels in the kidney resulting from a combination of decreased nad+ biosynthesis and increased nad+ consumption. likewise, mice deficient in sirt1 are more susceptible to aki and when there is overexpression of sirt1 they are protected from aki. these studies describe the modulation of nad+ and sirt1 as a potential therapeutic approach in aki. similarly, in subjects with aki, there is evidence of a 50% reduction in plasma nad. increasing nad+ with niacinamide has been shown to prevent various etiologies of experimental aki in mice, and an early pilot study has shown both increased nad levels following administration of nicotinamide riboside with pterostilbene nprt and the safety of niacinamide in patients undergoing cardiac surgery.

Eligibility criteria:
inclusion criteria: * heart valve replacement surgery * sign of informed consent exclusion criteria: * allergy to any of the components * platelet count less than 100,000 * weight less than 50kg or over 100kg * any type of infectious disease (e. g, endocarditis) * gfr less or equal to 15ml/min/m2 or with renal replacement therapy * iv or oral contrast medium 72 hrs prior recruitment * lra 7 days prior to surgery

Keywords: nicotinamide riboside nad+ nadh sirt1 aki cardiac surgery timp-2 igfbp7 ngal
remote ischemic conditioning for the treatment of resistant hypertension

Conditions: Resistant Hypertension

Summary: this study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.

resistant hypertension is defined as a blood pressure of 140/90 mmhg or higher despite adherence to at least three antihypertensive drugs (including one diuretic), accounting for 20% to 30% of patients with hypertension. compared with patients with well-controlled blood pressure, the cardiovascular risk of resistant hypertension is increased by about 50%. limb remote ischemic conditioning (lric) triggers endogenous protective effects through transient and repeated ischemia in the limb to protect remote tissues and organs. the mechanisms of lric involve the regulation of the autonomic nervous system, the release of humoral factors, improvement of vascular endothelial function, and modulation of immune/inflammatory responses, which can antagonize the pathogenesis of hypertension through multiple pathways to lead to a drop in bp theoretically. this theory has been preliminarily confirmed by several small sample-size studies in non-resistant hypertension. this study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.

Eligibility criteria:
inclusion criteria: * aged 30\~80 years old; * taking ≥ 3 antihypertensive drugs (including one diuretic) for more than 4 weeks regularly; * office blood pressure ≥ 140/90mmhg, and 24 h average blood pressure ≥ 130/80 mmhg; * willing to participate in the study, follow the study protocol, and provide informed consent. exclusion criteria: * secondary hypertension; * egfr\<45ml/min/1.73m2； * office blood pressure ≥180/110 mmhg, and 24 h average blood pressure ≥ 170/100 mmhg； * hypertensive crisis occurred within 3 months; * type 1 diabetes; * cardiovascular events occurred within 3 months; * atrial fibrillation; * presence of any severe disease that adversely affects the subject or study; * patients with contraindication for remote ischemic conditioning, such as vascular injury, soft tissue injury, orthopedic injury, or arm infection; * pregnancy, lactation, or planned pregnancy; * patients not suitable for this trial considered by researchers for other reasons； * participation in another device or drug trial simultaneously.

Keywords: resistant hypertension remote ischemic conditioning
high frequency percussive ventilation in hypersecretive tracheostomized patients

Conditions: Acute Respiratory Failure; Pneumonia

Summary: the incidence of pulmonary complications such as pulmonary atelectasis, pneumonia (including ventilator-associated pneumonia), and acute respiratory failure is high in critical care patients. the incidence of ventilator-associated pneumonia can be as high as 27% amongst mechanically ventilated patients. studies have shown that 16% of critically ill patients have been reported to develop acute respiratory failure, which is associated with prolonged intensive care unit stay, resulting in significantly higher mortality than non-respiratory failure patients. increased morbidity and mortality contribute to the burden on the health care system and lead to poor health-related outcomes. multimodal physiotherapy plays a role in the management of these critically ill patients. high frequency percussive ventilation (hfpv) is used in patients with underlying pulmonary atelectasis, excessive airway secretions, and respiratory failure. hfpv is a non-continuous form of high-frequency ventilation delivered by a pneumatic device that provides small bursts of sub-physiological tidal breaths at a frequency of 60-600 cycles/minute superimposed on a patient's breathing cycle. the high-frequency breaths create shear forces causing dislodgement of the airway secretions. furthermore, the hfpv breath cycle has an asymmetrical flow pattern characterized by larger expiratory flow rates, which may propel the airway secretions towards the central airway. in addition, the applied positive pressure recruits the lung units, resulting in a more homogeneous distribution of ventilation and improved gas exchange. in acute care and critical care settings, hfpv intervention is used in a range of patients, from spontaneously breathing patients to those receiving invasive mechanical ventilation where hfpv breaths can be superimposed on a patient's breathing cycle or superimposed on breaths delivered by a mechanical ventilator. the most common indications for hfpv use are reported as removal of excessive bronchial secretions, improving gas exchange, and recruitment of atelectatic lung segments. this study aims to assess the lung physiological response to hfpv in terms of aeration and ventilation distribution.


Eligibility criteria:
inclusion criteria: * more than 48 hours of invasive mechanical ventilation * presence of tracheostomy * need for two or more broncoaspirations per hour in the previous 8 hours exclusion criteria: * life threatening cardiac arrythmia * pneumothorax * acute spinal injury * chest trauma * brain injury in the previous 15 days * hemodynamic instability * chest or abdominal surgery in the previous 7 days * pregnancy * enrollment in other study protocols

Keywords: secretions tracheostomized critically ill patients
cormet post-pma study: new enrollment

Conditions: Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis

Summary: the primary objective of this study is to evaluate the performance of the cormet hip resurfacing implant system in the post-approval environment.

this study tracks the performance of the cormet hip resurfacing system in the post-approval environment to see if there are significant changes in device performance from the pre-market ide setting as compared to the post-approval setting. specifically this study will compare the proportion of subjects achieving a month 24 composite clinical success (ccs) criterion and 24 month cumulative revision rate among the newly enrolled post-approval study subjects to the ide subjects' performance on ccs as reported in the pre-market application (pma).

Eligibility criteria:
inclusion criteria: * male or female patient who meets eligibility criteria consistent with product labeling * skeletally mature * mentally capable of completing follow-up forms * will be available for follow-up out to 2 years and annually thereafter until the last patient reaches the two-year evaluation * has been deemed a candidate for hip replacement by diagnosis of the investigator * consented to participate in the clinical study exclusion criteria: * patient with active or suspected infection in or around the hip joint; * patient with bone stock inadequate to support the device * patient with severe osteopenia * patient with a family history of severe osteoporosis or severe osteopenia; * patient with osteonecrosis or avascular necrosis (avn) with \>50% involvement of the femoral head (regardless of ficat grade) * patient with multiple cysts of the femoral head (\>1cm) * in cases of questionable bone stock, a dexa scan may be necessary to assess inadequate bone stock. * patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery; * female of child-bearing age due to unknown effects on the fetus of metal ion release. * patient with known moderate or severe renal insufficiency; * patient who is immunosuppressed with diseases such as aids or person receiving high doses of corticosteroids; * patient who is severely overweight; * patient with known or suspected metal sensitivity (e.g., jewelry).

Keywords: hip resurfacing osteoarthritis avascular necrosis rheumatoid arthritis
anesthesia-induced hypotension and fluid responsiveness

Conditions: Hypotension on Induction

Summary: the purpose of this study is to find out which of the variables related to fluid responsiveness (e. g., perfusion index \[pi\], pleth variability index \[pvi\], pulse oximetry plethysmographic variance \[δpop\]) can best predict hypotension during induction of anesthesia.

propofol is a widely used intravenous agent for induction of anesthesia in children aged 3 years and more. a well-known adverse effect of propofol is hypotension, which can be properly dealt with hydration and/or administration of inotropics and vasopressors. however, severe hypotension during anesthetic induction may not be immediately cured if anesthesiologist should concentrate on ventilation of the patient. since pediatric patients have smaller reservoir for oxygen supply and perfusion to various organs of the body, delayed handling of severe hypotension may result in irreversible damage to the vital organs. hypotension during anesthesia is caused, though not entirely, by dehydration. there are a variety of non-invasive variables that are related to the severity of dehydration, but which of the variables can best predict anesthesia-induced hypotension in pediatric patients. in this study, we will measure the preoperative values of non-invasive variables related to fluid status, and find out which of them are most closely related to the occurrence of hypotension during anesthesia induction.

Eligibility criteria:
inclusion criteria: * children aged 3-6 years * scheduled to undergo elective surgery under general anesthesia exclusion criteria: * american society of anesthesiologists (asa) physical status classification iii or more * contraindication of laryngeal mask airway (lma) insertion: (1) esophagitis, gastritis, peptic ulcer, pyloric or intestinal stenosis, history of upper gastrointestinal tract surgery, body mass index \[bmi\] \> 30, expected anesthesia time \> 2 hours) * arrhythmia * left ventricular failure (ejection fraction \< 40%) * congenital syndromes which are known to affect cardiopulmonary function * use of inotropics/vasopressors before anesthesia * history of allergic reaction to drugs used in general anesthesia

Keywords: dehydration
a clinical trial of the effect of midazolam on the cerebral metabolism and inflammatory response in patients with moderate and severe traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: to explore the cerebral protective effect of midazolam in patients with traumatic brain injury, we will collect blood samples from patients treated with or without midazolam when the patient is admitted to icu, 24 h, 48 h and 72 h after the admission before the use of midazolam for patients in group n1, and before the patient is treated with midazolam, 24 h， 48 h, 72 h after the use of midazolam for patients in group n2. parameters of cerebral metabolism and inflammatory response will be obtained from the blood samples or the cerebrospinal fluid. with the aforementioned parameters, the relationship between clinical outcome and cerebral metabolism and inflammatory response will be detected with statistical method.


Eligibility criteria:
inclusion criteria: * aged 18 or older; * hospitalized in icu within 6 hours after the injury or after the operation; * traumatic brain injury is confirmed by computed tomography scan or magnetic resonance imaging, glasgow coma scale is 3 to 12, and the patient should meet the diagnostic standard of severe traumatic brain injury; * informed consent is obtained. exclusion criteria: * aged less than 18; * death is expected in 24 hours; * history of neurological disease or history of drug abuse which may affect the outcome of the study; * failed to obtain informed consent.

Keywords: traumatic brain injury sedation midazolam
precision medicine for colorectal cancer liver metastasis guided by multi-omics data under the umbrella theory

Conditions: Colorectal Cancer Metastatic

Summary: in order to more accurately discover the cause of drug resistance in tumor treatment, and to provide a new basis for precise treatment. therefore, based on the umbrella theory of precision medicine, we carried out this single-center, prospective, and observational study to include patients with liver metastases from colorectal cancer. by combining genome, transcriptome, and proteomic sequencing data, we established a basis for colorectal cancer liver transfer the multi-omics data of the sample, describe the reason for the resistance of the first-line treatment, and search for new therapeutic targets.


Eligibility criteria:
inclusion criteria: * ecog score 0-2 points * pathologically diagnosed patients with colorectal cancer * combined with liver metastases confirmed by imaging, and the lesion is measurable (recist standard) * the lesion is available * first-line treatment failed; hematology, liver and kidney function tests are suitable for back-line treatment * informed consent exclusion criteria: * with brain metastases * history of other malignancies * pregnancy or breastfeeding * have received other drug clinical studies within 30 days before the start of this study
safety, tolerability, and pharmacokinetics study of turoctocog alfa pegol injected under the skin in patients with haemophilia a

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: the trial is conducted in asia, europe and north america. the aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (sc n8-gp) in patients with severe haemophilia a.


Eligibility criteria:
inclusion criteria: * male, age above or equal to 18 years at the time of signing informed consent,(part a). * male, age above or equal to 12 years at the time of signing informed consent,(part b). * diagnosis of congenital haemophilia a based on medical records (fviii activity \<1%). * history of more than 150 exposure days to any fviii containing products. exclusion criteria: * previous participation in this trial. participation is defined as signed informed consent. (patients who have completed part a are allowed to also participate in part b. if so, a separate informed consent covering part b must be signed.) * immune compromised patients due to human immunodeficiency virus (hiv) infection (defined as viral load greater than or equal to 400.000 copies/ml and/or cluster of differentiation 4+ (cd4+) lymphocyte count less than or equal to 200/μl performed at screening or defined by medical records no older than 6 months) * any history of fviii inhibitors (defined by medical records within 8 years of randomisation) * inhibitors to fviii (greater than or equal to 0.6 bethesda unit (bu)) at screening, measured by nijmegen modified bethesda method at central laboratory.
neonatal erythropoietin in asphyxiated term newborns

Conditions: Hypoxic-ischemic Encephalopathy

Summary: the purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.

newborn infants with birth asphyxia are at high risk of death or long-term neurologic disability; yet therapies for birth asphyxia are currently limited. erythropoietin (epo) is a fda-approved drug that is an effective neuroprotective agent in animal models of birth asphyxia. this is a phase i dose finding multi-center trial that will test the safety and pharmacokinetics of epo in human infants with birth asphyxia. the long-term objectives of the proposed research are to reduce mortality and to decrease the risk of long-term disabilities in infants who survive beyond the newborn period.

Eligibility criteria:
inclusion criteria: 1. ≥ 36 weeks gestational age 2. perinatal depression (low apgar score, need for resuscitation) 3. moderate to severe encephalopathy exclusion criteria: 1. specific aeeg findings 2. intrauterine growth restriction 3. severe congenital anomaly, genetic syndrome, metabolic disorder, arthrogryposis, torch infection 4. microcephaly 5. infant older than 23.5 hours of age at the time of consent 6. infant judged by an attending physician to be likely to die due to the severity of illness 7. polycythemia 8. hypertension 9. no in-dwelling line

Keywords: birth asphyxia neonatal encephalopathy hypoxic-ischemic encephalopathy neuroprotection neonate
femoral nerve block for femur fracture repair in pediatrics

Conditions: Traumatic Femur Fracture

Summary: the purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing traumatic femur fracture repair who have received either a femoral nerve block with a lateral femoral cutaneous nerve block or a standard anesthetic for analgesia.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i or ii * weight greater than or equal to 10kg * presenting for repair of traumatic femur fracture exclusion criteria: * asa physical status \> ii * co-morbid diseases (cardiac, pulmonary, neurological disease) * patients having concomitant procedures * abnormal neurovascular examination in the injured leg * presence of vascular compromise in the affected lower extremity * mechanism of sustained injury via crush injury * use of therapeutic dose anticoagulants or presence of a bleeding disorder
study of safety and efficacy of genome-edited hematopoietic stem and progenitor cells in sickle cell disease (scd)

Conditions: Sickle Cell Disease

Summary: this study evaluated a genome-edited, autologous, hematopoietic stem and progenitor cell (hspc) product - otq923 to reduce the biologic activity of bcl11a, increasing fetal hemoglobin (hbf) and reducing complications of sickle cell disease.

cadpt03a12101 was a multicenter, multi-part, first-in-human, proof-of-concept, open label non-randomized, clinical study in sickle cell disease (scd) subjects. this study included apheresis of mobilized hematopoietic stem and progenitor cells (hspcs), ex vivo crispr/cas9-mediated genome editing and expansion, followed by myeloablative conditioning and autologous hematopoietic stem cell transplant (hsct) with follow-up for a minimum of one year and up to two years. the study was divided into the following parts: * part a - adult subjects were dosed with otq923. * part b - assessment of otq923 in pediatric patients, however part b was not opened.

Eligibility criteria:
inclusion criteria: 1. male or female subjects age 2-40 years inclusive 2. confirmed diagnosis of sickle cell disease with globin typing (e.g. hbss, hbsc, hbs/β0-thalassemia or others) 3. performance status \>70% (karnofsky for subjects \>16 years of age and lansky for subjects \<16 years of age) 4. at least one of the following indicators of disease severity as defined in the protocol - vaso-occlusive pain crisis, acute chest syndrome, recurrent priapism, prior stroke, receive chronic transfusions, red cell alloimmunization 5. subjects, who have failed, not tolerated or refused hydroxyurea therapy. exclusion criteria: 1. available matched related donor for hsct 2. clinically significant active infection 3. seropositive for hiv or htlv 4. active known malignancy, myelodysplasia, abnormal cytogenetics or immunodeficiency 5. prior hsct or gene therapy 6. known hepatic cirrhosis, bridging hepatic fibrosis or active hepatitis 7. protocol defined iron overload 8. cerebrovascular procedure within one year, including pial synangiosis for moyamoya 9. severe or progressive arteriopathy or cerebrovascular disease, including moyamoya other protocol defined inclusion/exclusion criteria may apply

Keywords: gene therapy genome-edited hematopoietic stem and progenitor cellular therapy sickle cell autologous transplant bcl11a