Kornimate/medical-research-clean huggingface dataset:
tranexamic acid contribution in the prevention of perioperative bleeding in thoracic surgery

Conditions: Bleeding

Summary: bleeding after thoracic surgery is a major cause of perioperative hemodynamic instability and transfusion requirement, which can lead to a rise of morbidity, mortality and costs. the objective of this study is to evaluate the efficiency of tranexamic acid (ta) in the prevention of perioperative bleeding in thoracic hemorrhagic surgery.

it's a randomized, double-blind, prospective study including patients over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux. demographic, clinical, biological data as well as transfusion requirements, blood loss and perioperative complications were identified. two groups of patients: * ta group: receiving tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act. * serum saline isotonic (ssi) group: placebo with isotonic saline serum.

Eligibility criteria:
inclusion criteria: * over the age of 18 years old, programmed for potentially hemorrhagic thoracic surgery, such as pulmonary resection for aspergilloma, pulmonary tuberculosis, pleural decortication, lobectomy with parietectomy or redux. exclusion criteria: * patients who have had a major complication of surgery other than bleeding requiring revision within 24 hours or a complication related to anesthesia, and cases of non-compliance with the anesthetic protocol are excluded.

Keywords: tranexamic acid antifibrinolytic agents bleeding blood transfusion thoracic surgery.
safety study of gene-modified autologous fibroblasts in recessive dystrophic epidermolysis bullosa

Conditions: Recessive Dystrophic Epidermolysis Bullosa

Summary: recessive dystrophic epidermolysis bullosa (rdeb) is a severe form of blistering skin disease caused by mutations in col7a1 gene. this study aims to assess the safety of intradermal injections of gene-modified autologous fibroblasts in 5-10 adults with rdeb.

recessive dystrophic epidermolysis bullosa (rdeb) is a severe form of blistering skin disease caused by mutations in col7a1 gene. this study aims to assess the safety of intradermal injections of gene-modified autologous fibroblasts in 5-10 adults with rdeb. this is an open-label single-centre phase i study with primary objective to evaluate the adverse and serious adverse events over 12 months' follow-up period. secondary objectives include (1) analysis of type vii collagen (c7) expression and morphology of anchoring fibrils in the injected areas of the skin; (2) analysis of immune response to newly expressed c7. each study participant will receive three intradermal injections of col7a1 gene-modified autologous fibroblasts on day 0 only. each subject will undergo an initial screening including a physical examination and assessment of disease severity. blood analyses and skin biopsies will be performed at various time points as per the monitoring schedule over 12 months.

Eligibility criteria:
inclusion criteria: 1. clinical and genetic diagnosis of rdeb with confirmed bi-allelic col7a1 mutations. 2. a reduced number or morphologically abnormal anchoring fibrils confirmed by tem. 3. at least 5x8cm of intact skin on the trunk and/or extremities that is suitable for cell injections. 4. able to undergo local anaesthesia. 5. subjects aged ≥ 17 years and able to give informed consent prior to the first study intervention. exclusion criteria: 1. subjects who received other investigational medicinal products within 6 months prior to enrolment into this study. 2. past medical history of biopsy proven skin malignancy. 3. subjects who have received immunotherapy including oral corticosteroids (prednisolone \>1mg/kg) for more than one week (intranasal and topical preparations are permitted) or chemotherapy within 60 days of enrolment into this study. 4. known allergy to any of the constituents of the investigational medicinal product (imp). 5. subjects with both: * positive serum antibodies to c7 confirmed by elisa and * positive iif with binding to the base of salt split skin. 6. subjects who are pregnant or of child-bearing potential who are neither abstinent nor practising an acceptable means of contraception when this is in line with the usual and preferred lifestyle of the subject, as determined by the investigator, for 12 months after the cell injections. 7. subjects with positive results for hiv, hepatitis b, hepatitis c, htlv or syphilis.
an observational study of japanese participants with x-linked retinitis pigmentosa

Conditions: X-Linked Retinitis Pigmentosa

Summary: the purpose of the study is to identify a cohort of japanese participants with x-linked retinitis pigmentosa (xlrp) associated with pathogenic variants in the retinitis pigmentosa gtpase regulator (rpgr) gene and to investigate their associated phenotype.


Eligibility criteria:
inclusion criteria: * have rpgr-associated retinal dystrophy * are able to give informed consent or assent, with the guidance of their parent/guardian where appropriate * are able to undertake age-appropriate clinical assessments as specified in the protocol exclusion criteria: * are unable or unwilling to undertake consent or clinical testing * participated in another research study and had intraocular surgery within 3 months of screening * significant ophthalmologic diseases
effectiveness of chlorhexidine wipe for prevention of multidrug-resistant organisms in intensive care unit patients

Conditions: Antibiotic Resistant Infection

Summary: the purpose of this study is to determine 2% chlorhexidine wipes are effective in preventing of colonization of multi-drug resistant bacteria in intensive care unit patients.

the purpose of this study is to evaluate the usefulness of bathing with chlorhexidine wipe to reduce the risks of multidrug resistant bacteria acquisition and hospital-acquired bloodstream infection among icu patients

Eligibility criteria:
inclusion criteria: * age \> 18 years * admission in critical care unit eg. icu, respiratory care unit, cardiac care unit with in 24 hours * expected duration of critical care unit admission \> 48 hours exclusion criteria: * history of chlorhexidine allergy

Keywords: colonization
japanese efficacy and safety study of enoxaparin in patients with curative abdominal cancer surgery

Conditions: Abdominal Neoplasms

Summary: the primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal cancer surgery. the secondary objective is evaluate the incidence of adverse events of enoxaparin in these patients.


Eligibility criteria:
inclusion criteria: * malignant tumor patients undergoing laparotomy for which surgery is expected to take 45 minutes or more. exclusion criteria: * surgery under laparoscope and other endoscopic operations * clinical signs of deep vein thrombosis * use of non-steroidal anti-inflammatory drugs from surgery completion until initial administration * severe hepatic disease or renal disease * women of childbearing potential, pregnant or lactating.

Keywords: prevention venous thromboembolism curative surgery
remote ischemic preconditioning with postconditioning in heart transplantation surgery

Conditions: Myocardial Ischemic Reperfusion Injury; End Stage Heart Disease; Heart Failure; Cardiomyopathy

Summary: the purpose of this study is to determine whether remote ischemic preconditioning with postconditioning (ripc+ripostc) reduces myocardial injury and improves clinical outcomes in heart transplantation surgery.


Eligibility criteria:
inclusion criteria: * scheduled for elective orthotopic heart transplantation surgery exclusion criteria: * peripheral vascular disease affecting the upper arms * mechanical circulatory support before surgery * taking the antidiabetic sulphonylurea, glibenclamide * cold ischemic time of donor heart \> 12 hours * repeated heart surgery
unipedicular vs. bipedicular kyphoplasty for the treatment of osteoporotic vertebral fractures

Conditions: Vertebral Compression Fracture

Summary: balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression fractures has been shown to be successful in providing acute pain relief, enabling improved function, and restoring of vertebral body height. however, limited prospective data exists in the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to bipedicular balloon kyphoplasty. the purpose of this prospective randomized study was to compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon kyphoplasty.


Eligibility criteria:
inclusion criteria: * males or females older than 50 years of age with acute vertebral compression fractures causing significant pain and functional limitations in their daily activities. exclusion criteria: * primary tumors of bone or evidence of metastasis at the index vertebrae * pre-existing chronic pain or functional disability unrelated to a vertebral compression fracture which would confound the data analysis * fracture secondary to a traumatic event * inability to fully visualize both pedicles of the fractured vertebrae on intraoperative fluoroscopy

Keywords: osteoporosis vertebral compression fractures
spectroscopy of breast tissue

Conditions: Breast Cancer

Summary: rationale: diagnostic procedures, such as laser spectroscopy, may help find and diagnose breast cancer. purpose: this phase i trial is studying laser spectroscopy to see how well it works in diagnosing breast cancer in women with breast lesions.

objectives: primary * to determine whether laser spectroscopy of breast tissue performed ex vivo can effectively distinguish between benign and malignant breast tumors in women undergoing needle biopsy or surgical excision of a breast lesion identified clinically. outline: patients undergo tissue sample collection via needle biopsy or surgical excision of a breast lesion. a radiogram of the sample may be obtained to identify target areas for spectroscopic evaluation. the freshly excised breast tissue samples are analyzed ex vivo by fluorescence, reflectance, and/or raman spectroscopy. after completion of the spectroscopic examination, the tissue samples are submitted for diagnostic pathologic evaluation. hematoxylin and eosin stained sections of the tissue samples are examined by light microscopy for histopathological analysis. the results of the pathological examination are then compared with the spectroscopic findings and radiological findings (if the biopsy was performed for a suspect lesion on mammography) to determine if any correlation can be established and which spectroscopic technique provides the most useful diagnostic information. additional histochemical, immunohistochemical, and fluorescence in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results. patients' medical charts are reviewed to obtain clinical information (e.g., age, sex, and race; results of pathology reports and reports of ancillary studies, including estrogen receptor, progesterone receptor, and her-2 receptor testing, for the surgical specimen being studied and for any other related surgical specimens; menstrual status and date of last menstrual period; clinical history of breast mass or abnormal mammogram and related mammography report; clinical history of hormone replacement therapy, birth control pills, or oophorectomy; and clinical history of chemotherapy or other adjuvant therapy for breast cancer).

Eligibility criteria:
disease characteristics: * clinically identified breast lesion * planning to undergo needle biopsy or surgical excision of the breast lesion patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: breast cancer
supraclavicular brachial plexus block as opioid sparing technique in pediatrics undergoing arteriovenous fistula creation

Conditions: Supraclavicular Brachial Plexus Block; Opioid Sparing; Pediatric; Arteriovenous Fistula

Summary: this study aims to evaluate the efficacy of supraclavicular brachial plexus block as an opioid-sparing technique in pediatric patients undergoing arteriovenous fistula creation.

the global incidence of end-stage renal failure (esrf) is increasing. the preferred procedure for patients with esrf undergoing maintenance haemodialysis (hd) is the placement of an arteriovenous fistula (avf). in patients with esrf, brachial plexus block (bpb) is frequently employed to administer anesthesia for the establishment or modification of avf. this technique offers pain relief, sympathetic blockade, ideal surgical conditions, and a sufficient duration of postoperative block, preventing arterial spasms and graft thrombosis

Eligibility criteria:
inclusion criteria: * age from 6 to 18 years. * both sexes. * american society of anesthesiology (asa) physical status i- iii. * undergoing arteriovenous fistula creation under general anesthesia. exclusion criteria: * allergy to local anesthetics. * infection at the site of block. * local infection. * coagulation disorder. * previously failed or revision of blocked arteriovenous fistula.
surgical management for suburethral slings

Conditions: Stress Urinary Incontinence

Summary: this is a prospective, non-randomized, observational, single center study in which subjects that have surgically-correctable stress urinary incontinence undergo a suburethral sling operative procedure.

the study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires. intraoperative procedural data will be collected. postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals. the anatomic position of the device will be characterize by introital ultrasound testing.

Eligibility criteria:
inclusion criteria: 1. patient has objective demonstrable signs of stress urinary incontinence (sui), including patients with intrinsic sphincter deficiency (isd). objective testing includes: standing stress test, urodynamics evaluation, or pad test. 2. patient is age 18 or older. 3. patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the irb/ec-approved informed consent. 4. patient is able to fill in all questionnaires (on judgement of investigator) exclusion criteria: 1. patient has an associated or suspected neurological disease. 2. patient has an active lesion or present injury to perineum or urethra. 3. patient has a urethral obstruction. 4. patient has significant pelvic organ prolapse (grade iii/iv) requiring surgical treatment. 5. the subject has current urinary tract infection.

Keywords: stress urinary incontinence suburethral sling
thoracoscopic versus endocardial ablation in patient with paroxysmal af after failed initial endocardial ablation

Conditions: Paroxysmal Atrial Fibrillation

Summary: the investigators aimed to compare two approaches thoracoscopic epicardial ablation and endocardial catheter ablation after failed initial catheter ablation in patients with paroxysmal atrial fibrillation.


Eligibility criteria:
inclusion criteria: * failed initial catheter ablation * paroxysmal atrial fibrillation exclusion criteria: * chronic lung disease * body mass index \>35 * longstanding atrial fibrillation 1 year * previous stroke or transient ischemic attack * left atrial thrombus * left atrial size \>65 mm * left ventricular ejection fraction \<35%
evaluation of progression of myopia in children treated with vitamin b2 and outdoor sunlight exposure

Conditions: Axial Myopia; Refractive Errors

Summary: the investigators plan on using riboflavin (a vitamin that can easily be taken orally each day) and having the children involved in the study play outside (where there is uv light created by the sun) in order to prevent the eye from becoming progressively more near-sighted.

myopia is equivalent to the colloquial term known as near-sightedness. this, in short, means that the image of one's environment is projected in front of the retina (rather than directly on the retina, which is ideal). of course, glasses can be used to correct the image disparity that is created by being near-sighted (that is why a lot of people need glasses for blurry vision). however, glasses and spectacles and contacts do not correct the underlying problem. most near-sightedness is due to the eye being "too long" and therefore the image projects in front of the retina. ideally, if we could prevent the eye from becoming abnormally "long", then we could prevent the progression of near-sightedness. indeed, a child may only be slightly near-sighted early in life, but as he/she continues to perform activities within an arms length of their environment, they can become progressively near-sighted. besides spectacle correction, people have tried topical atropine drops (medicated eye drops) and rigid contact lenses (orthokeratology) to attempt to correct near-sightedness. atropine drops take a lot of cooperation from parent and child. orthokeratology also requires a lot of cooperation, but also, does not permanently stall myopic progression. the investigators suggest a different means of potentially preventing near-sightedness from getting worse (and thus prevent the eye from getting "too long"). the investigators plan on using riboflavin (a vitamin that can easily be taken orally each day) and having the children involved in the study play outside (where there is uv light created by the sun) in order to prevent the eye from becoming progressively more near-sighted.

Eligibility criteria:
inclusion criteria: * healthy children ages 6-12 years old with myopia more than 0.50 d and astigmatism no more than 1.5 d. * caretakers who choose to enroll their child in the study must agree to participate in the study on their own will after knowledge of potential alternatives (spectacle correction, orthokeratology, atropine eye drops, etc.) are explained to the patient's caretaker. exclusion criteria: * known allergy to riboflavin * birth history of premature birth * developmental delay or other neurological or mental conditions * major systemic health problems * significant anisometropia more than 1.5 diopters * any other eye condition which may complicate interpretation of data including: congenital glaucoma, congenital cataract, ectatic corneal condition, amblyopia or strabismus.

Keywords: myopia axial myopia children refractive error riboflavin vitamin b2
frequency and predictors of recurrent sbp in cirrhotic patients in al rajhi university hospital

Conditions: Spontaneous Bacterial Peritonitis

Summary: * assess the frequency of recurrent sbp in ascitic cirrhotic patients. * determine the predictive factors of recurrence after the first episode of sbp in ascitic cirrhotic patients

spontaneous bacterial peritonitis (sbp) is a common complication in cirrhotic patients. the prevalence of sbp in hospitalized patients and the mortality rate were reported to be 10%-30% and 30%-50%, respectively. sbp has been considered a life-threatening infection that requires a prompt diagnosis and treatment.

Eligibility criteria:
inclusion criteria: * any cirrhotic patient above the age of 18 years old of both sexes, having a first episode of sbp will be included in our study. 1. the diagnosis of cirrhosis was based on clinical manifestation (ascites, splenomegaly, lower limb edema and/or esophageal varices by upper gastrointestinal endoscopy), laboratory findings and radiological (abdominal ultrasonography), or liver histology. 2. the diagnosis of sbp was based on a neutrophil cell count of 250 cell or more per mm3 with or without culture positivity of ascitic fluid, in the absence of hemorrhagic ascites and secondary peritonitis. exclusion criteria: * any patient with one or more of the following criteria will be excluded: 1. patients with bacterial ascites defined by a positive culture of ascitic fluid associated with a neutrophil cell count less than 250 cell per mm3 in the ascitic fluid. 2. patients presenting with empyema or bacterial peritonitis secondary to an intra-abdominal organ perforation or surgical operation
vitamin d supplementation and tibia fracture. does it improve healing rate?

Conditions: Tibial Fractures; Vitamin D Deficiency; Fracture Healing

Summary: this study evaluates the effect of vitamin d3 supplementation in healing rate of tibia fractures in adult patients with low vitamin d. half of participants will receive vitamin d3 supplementation while the other will receive placebo.


Eligibility criteria:
inclusion criteria: * tibial fracture * asa physical status classification system i-ii. * 25 hydroxyvitamin d below 30ng/ml) * fracture treatment with reamed intramedullary nail exclusion criteria: * open fractures gustillo iii b and iii c * closed soft tissue injury with tscherne classification of iii * acute compartment syndrome * pathology fractures (that occur in abnormal bone, for example in the presence of tumor, cyst or paget disease) * other fractures in lower limbs or spine that does not allow full weight bearing of the operated tibia after 4 weeks * more than 7 days of evolution from fracture occurrence * diabetes mellitus with hba1c more or equal than 7% * peripheral vascular disease * rickets * pre-existing disorders of the metabolism of vitamin d and/or homeostasis of calcium and phosphorous (ie. hepatic insufficiency, congenital defects of the vitamin d metabolism, disorders of the parathyroid glands, hypo or hyper calcemia) * renal failure with glomerular filtration rate below 60ml/min according to mdrd-4. * patients using nephrotoxic medications in high doses, requiring periodical monitoring of glomerular filtration rate * patients undergoing with nephrotic syndrome or that suffered it in the past * patients that suffered nephrolithiasis or urolithiasis * pregnant women * patients with allergy to vitamin d or other contraindications for vitamin d3 prescription * patients that are taking multivitamin supplements containing vitamin d and will not suspend taking them during the study. * patients that are not able to swallow a cup of water
drug interaction study with ns2359 and cocaine in cocaine experienced volunteers - 1

Conditions: Cocaine-Related Disorders; Drug Administration Schedule; Infusions, Intravenous

Summary: the purpose of this study is to conduct a drug interaction study with ns2359 and cocaine in cocaine experienced volunteers.

this is a single-center, double-blind, placebo-controlled, randomized, single dose, fixed order, dose escalating inpatient design that will study oral ns2359 in cocaine experienced volunteers.

Eligibility criteria:
inclusion criteria: male or female, 18-45 yrs of age; females of child-bearing potential using appropriate method of birth control; be able to understand the procedure and agrees to participate via informed consent; must be cocaine dependent according to dsm-4 criteria; must be capable of providing written consent; must be able to comply with protocol requirement, cpu rules and regulations; must not be currently seeking treatment for cocaine abuse. exclusion criteria: incapable of understanding the informed consent process; additional criteria available during screening at the site.