Kornimate/medical-research-clean huggingface dataset:
interest of the osa (obstructive sleep apnea) predictive scores in the prognosis of postoperative mortality of femoral neck fractures

Conditions: Femoral Neck Fracture

Summary: interest of the four major osa predictive scores (stop-bang, p-sap, des-osa, osa50) in the prognosis of postoperative mortality after femoral neck fracture.

* all patients incoming at the saint-luc bouge hospital with a femoral neck fracture * study between 15/09/2014 and 15/10/2015 * the four osa predictive scores will be collected * evaluation of mortality at 1 month

Eligibility criteria:
inclusion criteria: * all patients with femoral neck fractures * incoming at the saint-luc bouge hospital * between 15/09/2014 and 15/10/2015 exclusion criteria: * none

Keywords: femoral neck fractures obstructive sleep apnea perioperative complications
efficacy and safety of apixaban in korean frail atrial fibrillation patient

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is the most common arrhythmia, and its prevalence is increasing with the aging population \[1\]. as the prevalence of af is significantly rising among the population over 70-80 years old and considering the population is at high risk of af complications such as stroke, oral anticoagulation (oac) therapy is necessary among these subjects \[1-3\]. oac decreases the risk of stroke and systemic thromboembolism with improved mortality among af patients. the introduction of non-vitamin k antagonist oral anticoagulants (noac) has led to more effective and safe anticoagulation therapy among asian patients \[4,5\]. among different types of noac, the prescription of apixaban has been increasing based on robust safety data. the aristotle (apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation), phase three clinical trial on apixaban., showed efficacy and safety of apixaban compared to warfarin among 18,000 patients worldwide \[6\]. however, this study only included 5.5% (986) asian patients. of patients requiring oac, those of old age, low body weight, or decreased renal function are at 'high risk' of stroke, systemic thromboembolism, and major bleeding events \[4, 7-9\]. in korea, among patients prescribed with noac due to af, 35-40% were older than the age of 75 years old, 35% had bodyweight ≤ 60kg and 25-30% had decreased renal function (creatinine clearance ≤ 60ml/min) \[10\]. although apixaban has proved safe in old age, low bodyweight decreased renal function in aristotle subgroup analyses, the efficacy and safety data on asian af patients with high-risk factors is limited \[11-14\]. in this study, the investigators aimed to evaluate the efficacy and safety of apixaban among high-risk korean patients in old age, low bodyweight or decreased renal function using a multicenter observational study design


Eligibility criteria:
inclusion criteria: 1. patient must be ≥19 years. 2. patient has non-valvular atrial fibrillation necessitating the use of apixaban for stroke prevention. 3. subjects satisfies single dose reduction criterion for apixaban; (1) age 80 years or older (2) body weight 60kg or lower (3) serum creatinine 1.5mg/dl or higher. exclusion criteria: 1. patient is vulnerable (according to korean good clinical practice definition) or disagree with the study. 2. patient had a history of clinical events, defined as primary and secondary outcomes of the study, prior to study registration after taking apixaban. 3. patient satisfies two or more dose reduction criteria for apixaban.
what needle diameter should physician use when they perform lumbar puncture ? a randomized controlled trial

Conditions: Post-lumbar Puncture Headache; Backache

Summary: this study is intended to help guide the choice of needle diameter when performing a lumbar puncture. smaller spinal needles have been shown to decrease rate of adverse events such as post-lumbar puncture headache and hearing loss. the main drawback to using smaller needles is diminished flow rate; some textbooks recommend using needles no smaller than 22 gauge because of the slow flow rate though others recommend smaller needles, namely 22-24 gauge. some authors have described a successful use of spinal needles as small as 25 gauge when performing a lumbar puncture. the investigators do not believe that the flow-rate difference between 22 and 24 gauge needles is significant enough to justify using the larger needles. the investigators trial will compare the whitacre 22 gauge and whitacre 24 gauge needles for flow rate, and incidence of the known complications of pain during procedure and backache at 8 and 15 days post-procedure. the investigators will also look at whether smaller needles are associated with less pain during the procedure and less backache the next 2 weeks after the procedure.

the purpose of this randomized, double-blinded clinical trial is to assess whether a 24 gauge spinal needle can provide an acceptable flow rate of cerebrospinal fluid (csf) when compared to the traditionally used 22 gauge needle. smaller needles, according to the therapeutics and technology assessment subcommittee of the american academy of neurology are 'associated with reduced frequency of post-lumbar puncture headache (level a recommendation).' given that flow rate of csf is the limiting factor when choosing a spinal needle gauge, two previous studies have compared various needle sizes for adequacy of flow. these studies, however, have important limitations and have not led to a clear consensus in clinical practice. for instance, one study used a 0,9 % solution of sodium chloride at room temperature, the other used an 'artificial csf solution' of unknown viscosity and nature. patients referred to the neurological day center of the montreal neurological institute/hospital for lumbar puncture will be recruited to the study. participants will be randomized to have the puncture with a whitacre 22 or 24 gauge needle.

Eligibility criteria:
inclusion criteria: * all adult patients (\>= 18 years old) referred at the neurological day center to get a lumbar puncture exclusion criteria: * contraindication to get a lumbar puncture

Keywords: lumbar puncture flow rate backache pain undifferentiated headache post-lumbar puncture headache
the effect of oral vitamin d supplements on fusion outcome in patients receiving elective lumbar spinal fusion

Conditions: Vitamin D; Spinal Fusion; Lumbar Spine Disease

Summary: the process of bony fusion is a dynamic bone remodeling process and a variety of risk factors have been identified to contribute to pseudoarthrosis.vitamin d deficiency has been reported to be associated with more pseudoarthrosis, prolonged time to fusion, and poorer spine function and quality of life after spinal fusion.however, as the review article presented, it lacks high-quality evidence to investigate the role of vitamin d supplements in spinal fusion. therefore, this randomized controlled trial aimed to evaluate the effectiveness of oral vitamin d supplements on fusion outcomes in patients receiving elective lumbar spinal fusion.


Eligibility criteria:
inclusion criteria: * age between 20 and 80 years * indicated of elective spine fusion surgery for spinal stenosis or degenerative spondylolisthesis at the study hospital from january 2016 to december 2017. exclusion criteria: * spinal instability due to trauma, infection, or malignancy * history of previous spine surgery * hemodialysis * long-term steroid use * history of medical treatments for osteoporosis * postoperative follow-up for less than 12 months * newly-onset compression fracture after study procedure
a multiple-center study on the effect of different ways of lymph node dissection on the prognosis of ground glass nodules smaller than 3cm and with more than 50% solid components

Conditions: Progression

Summary: a multiple-center study on the effect of different ways of lymph node dissection on the prognosis of less than 3cm ground glass nodules with more than solid components


Eligibility criteria:
inclusion criteria: 1. aged between 18 and 75 years; 2. ggo is diagnosed by lung ct and failure to subside after 3 months (the patient having been re-examined by thin-section ct); 3. the maximum diameter of the ggo is smaller than 3cm; 4. the maximum diameter of the solid component in the ggo is more than 50%; 5. the patient is able to undergo the lobectomy 6. the patient is able to understand and comply with the study and has provided written informed consent. exclusion criteria: - patients meeting any of the following criteria are not eligible for this trial: 1. patients with a history of using immunosuppressive or hormonal drugs; 2. patients receiving radiotherapy or chemotherapy; 3. patients who fail to comply with our follow-up strategy; 4. other situations that are not in conformity with the standards and requirements of this trial.
neural correlates of stress reduction

Conditions: Stress; Psychological Stress; Life Stress; Emotional Stress; Social Stress

Summary: this study will identify neural mechanisms associated with changes in emotion regulation following participation in stress reduction programs.


Eligibility criteria:
inclusion criteria: * 18-50 years of age * right-handed * stressed exclusion criteria: * lifetime history of schizophrenia or psychosis * psychiatric illness * history of seizure or significant head trauma * use of psychotropic medications * metallic implants or devices contraindicating magnetic resonance imaging * claustrophobia * pregnancy
maintenance therapy with autologous cytokine-induced killer cells for small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the role of maintenance therapy in the management of small cell lung cancer (sclc) has not been confirmed. many treatment modalities like chemotherapy, interferons and other biological agents have been tested as maintenance therapy in sclc, but the results are disappointing. a marginal survival advantage is seen in maintenance with chemotherapy and interferon-alpha, however, the functioning status and immune system may get worse, which subsequently has a negative impact on patient's quality-of-life. immunotherapy with autologous cytokine-induced killer (cik) cells can activate the antitumor defense mechanism through stimulating immune response and altering the interaction between tumor and its host. this effect may result in improved tumor control and survival, as well as a better quality of life. to test the hypothesis, a randomized controlled study was conducted to compare cik cells with best supportive care as maintenance therapy for sclc.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven small cell lung cancer * patients currently receiving 4-6 cycles of chemotherapy regimen with vp-16 and a platinum-based drug as first-line therapy in the absence of disease progression * age between 18-75 * performance status ≤2 * no uncontrolled metabolic disease, infection, and neurological disorders * no congestive heart failure, severe arrhythmia, and coronal atherosclerosis heart disease * life expectancy more than three months. * without contraindication of immunotherapy with autologous cytokine-induced killer cells * no other malignancies * signed study-specific consent form prior to study entry exclusion criteria: * patients receiving other anti-tumor therapy (like thermotherapy) * pregnant or lactating women * allergy or unacceptable toxicity of immunotherapy with autologous cytokine-induced killer cells * uncontrolled mental disorder * patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases

Keywords: small cell lung cancer maintenance therapy immunotherapy autologous cytokine-induced killer cell
effect of quetiapine on negative symptoms and cognition

Conditions: Schizophrenia

Summary: the purpose of the study is to investigate the outcome on negative symptoms of schizophrenic patients during therapy with quetiapine or risperidone.


Eligibility criteria:
inclusion criteria: * signed informed consent * men and women aged 18 to 65 years with diagnosis of schizophrenia * score of at least 4 cgi, panss negative subscale score \> 21 * fulfil the criterion to be right-handed for inclusion in the fmri investigations exclusion criteria: * substance or alcohol dependence * female patients who are pregnant, lactating or at risk of pregnancy * history of organic cns-trauma, epilepsy, meningoencephalitis, psychosurgery, instable somatic conditions * risk of suicide or aggressive behaviour * history of electroconvulsive therapy, parkinson's disease, prolactin-dependent tumor for the subset of subjects for the fmri investigations the following additional exclusion criteria is valid as: * existence of metal in the body as by cardiac pacemaker, coil, total prosthesis, metal splinter, metal articulation, metal balls.
association between venous excess ultrasound grading system and acute kidney injury in the icu population

Conditions: Fluid Overload; Kidney Injury; Make-30

Summary: fluid resuscitation is one of the cornerstones of treatment in icu patients. nonetheless, excessive fluid administration can lead to fluid overload which has been associated with worse outcomes in the icu. to prevent this, assessments of fluid responsiveness are commonly employed. however, fluid responsiveness does not take fluid tolerance into account. fluid tolerance is the idea that a patient might still be fluid responsive but might already be at risk of the detrimental effects of fluid therapy. recent developments in point of care ultrasound e.g. the venous excess ultrasound might help identify patients at risk of fluid overload. however its association with patient relevant outcomes in the icu remains unclear.

this study will investigate the association between the venous excess ultrasound grading system (vexus) and patient relevant outcomes such as acute kidney injury, mortality and length of stay. a secondary analysis is planned where the association between vexus and the lung ultrasound score will be investigated

Eligibility criteria:
inclusion criteria: * all patients admitted to the icu 18 years or older expected to stay in the icu for more than 24 hours exclusion criteria: * any obstruction between the righ atrium and structures assessed by vexus * a medical history of: major cardiac shunts (e.g. atrial septum defect), tricuspid regurgitation, dialysis, portal hypertension, pulmonary hypertension, interstitial lung disease, recipients of a kidney of liver transplant. * patients in whom an ultrasound assesment is unfeasible e.g. a bmi over 40
immune checkpoint inhibitor combined with pemetrexed intrathecal injection for leptomeningeal metastasis from solid tumors

Conditions: Leptomeningeal Metastasis

Summary: this is an open-label, single-arm, phase i/ii trial of immune checkpoint inhibitor combined with pemetrexed intrathecal injection for leptomeningeal metastasis from solid tumors.

this is an open-label, single-arm, phase i/ii trial of immune checkpoint inhibitor combined with pemetrexed intrathecal injection for leptomeningeal metastasis from solid tumors. the primary objective was to assess recommended dose and safety based on adverse events (aes). all participants were observed to evaluate the clinical response rate (crr), disease control rate (dcr) and overall survival (os). patients underwent cerebrospinal fluid (csf) and blood specimen collection to evaluate potential clinical, molecular, and/or immune predictors of treatment efficacy and safety.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed diagnosis of solid tumors; cerebrospinal fluid cytopathology is positive. 2. male or female aged between 18 and 75 years; normal liver and kidney function; wbc≥4000/mm3, plt≥100000/mm3. 3. no history of severe nervous system disease; no severe dyscrasia. exclusion criteria: 1. any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and glasgow coma score less than 11. 2. any evidence of extensive and lethal progressive systemic diseases without effective treatment. 3. a history of hiv or aids, acute or chronic hepatitis b or c infection, previous anti-pd1 therapy-induced pneumonitis, or have ongoing \>grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years. 4. patients with poor compliance or other reasons that were unsuitable for this study.

Keywords: leptomeningeal metastasis intrathecal chemotherapy immune checkpoint inhibitor pemetrexed
dexmedetomidine neuroprotection in pediatric cardiac surgery

Conditions: Congenital Heart Disease

Summary: neurodevelopmental disability is the most significant complication for survivors of infant surgery for congenital heart disease. in this study we sought to determine if intraoperative continuous infusion of dexmedetomidine are associated with neurodevelopmental outcomes at 12 months.


Eligibility criteria:
inclusion criteria: * neonates undergoing cardiac surgery * infants undergoing cardiac surgery with cardiopulmonary bypass (atrial septal defect repair, ventricular septal defect repair, or tetralogy of fallot repair) exclusion criteria: * history of hypersensitivity of any drug * presence of hypotension or bradycardia considering age bradycardia (heart rate \< 80 beats/min) or hypotension (systolic blood pressure \< 70mmhg for infants, \< 60mmhg for neonates) * elevated liver enzyme levels (aspartate transaminase \>100unit/l, alanine aminostrasferase \> 50 unit/l) * surgery with deep hypothermic circulatory arrest * presence of complex cardiac defect * single ventricular physiology * plan of additional operation within a year * preoperative use of beta-agonists * presence of history of any neurological disorder
effect of oral carbohydrate on serum s-100β protein and development of postoperative delirium in elderly patients

Conditions: Insulin Resistance; Inflammation; Delirium

Summary: this study is to evaluate the effects of preoperative carbohydrate intake on perioperative neuroinflammation and development of delirium.

perioperative insulin resistance may primarily contribute to development of postoperative delirium in high risk patients. preoperative administration of oral carbohydrate reduces insulin resistance. the investigators aimed to investigate the influence of carbohydrate loading on the serum level of s-100β, a surrogate marker of delirium, and the incidence of postoperative delirium in elderly patients.

Eligibility criteria:
inclusion criteria: * patients undergoing total hip replacement or total knee replacement surgery exclusion criteria: * diabetes * dementia * gastro-esophageal reflux * upper gastrointestinal motility disorder * inflammatory bowel disease * intraperitoneal malignancy history * inability to perform cognitive function test
prescreening study to identify potential stargardt participants for acdn-01 clinical trials

Conditions: Stargardt Disease; Stargardt Disease 1; Cone Rod Dystrophy; Juvenile Macular Degeneration

Summary: this is an observational prescreening study. individuals who are eligible for prescreening will undergo testing procedures that may be used to determine eligibility in acdn-01 clinical trials.

the prescreening process will be used to help determine the initial eligibility and interest of potential participants in acdn-01 clinical trials by conducting assessments of key eligibility criteria before the clinical trial screening procedures are performed.

Eligibility criteria:
key inclusion criteria: * presence of mutations in the abca4 gene * abca4 retinopathy phenotype (stargardt disease type 1 or cone-rod dystrophy) key exclusion criteria: * the presence of pathogenic or likely pathogenic mutations in other genes known to cause cone-rod dystrophy or stargardt maculopathy * retinal disease other than abca4-related retinopathy * presence of a medical condition (systemic or ophthalmic), psychiatric condition, including substance abuse disorder, or physical examination or laboratory finding that may in the opinion of the principal investigator and sponsor preclude adherence to the scheduled study visits, safe participation in the study, or affect the results of the study.

Keywords: abca4 abca4-related retinopathy stargardt disease stargardt macular dystrophy cone rod dystrophy gene editing rna gene therapy exon editing ird inherited retinal disease inherited retinal dystrophy inherited retinal degeneration
first event of infection by hiv-1 of uterine vaginal tissue

Conditions: HIV Infection of the Uterine Vaginal Tissues

Summary: this non-interventional study aims to characterize the cells infected with hiv over time in different types of vagino-uterine tissue.


Eligibility criteria:
inclusion criteria: * patients whose age ≤50 years and ≥18 years * patients for which surgery like laparoscopy or hysterectomy is necessary as part of a benign pathology. exclusion criteria: * patients under 18 years

Keywords: hiv infection vaginal tissues uterine tissues
short stitch monomax®

Conditions: Dehiscence of Laparotomy Wound; Surgical Wound Infection

Summary: a number of studies identifies abdominal hernia as the most frequent postoperative complication following laparotomy with percentages of 9-20% - depending on duration of follow-up. it is based on a multifactorial basis, including factors concerning individual, patient-specific factors, factors related to the operational technique as well as particular surgical factors. wound complications have been reported by 7-12%, burst abdomen rate (dehiscence) \< 5 days being 2-4%, wound infection rate (+/- wound dehiscence) ≥ 5 days being 6-10%. in emergency procedures (e.g. ileus, perforation of hollow organ) a wound complication rate of up to 50 % has to be expected. according to new, first findings from recent studies the rates of wound healing complication and burst abdomen can be reduced significantly. depending on the study, to almost 50%. the principle is based on the reduction of the stitch length and type of the inserted suture. the stitches are closer and with less distance to the edge of fascia. due to the much thinner suture it still comes here to a quantitative reduction of the inserted suture. the data collected using the monomax® suture in the short stitch technique will be compared to the results of the issaac trial, in which the monomax® suture was used in the long stitch suture technique. the generated data are thus subject of retrospective comparison with a historical control group (issaac study).


Eligibility criteria:
inclusion criteria: * age 18 years and older * primary elective and primary emergency laparotomy * written informed consent exclusion criteria: - pregnant women

Keywords: abdominal wall closure short stitch technique
safety and initial performance of the diagone device on type 2 diabetes patients

Conditions: Diabetes Mellitus, Type 2

Summary: this is a multi-center, prospective, open label study of the duodenal glycemic control™ procedure on type 2 diabetes patients sub-optimally controlled, to examine the safety and initial performance of the diagone™ system.

this study is a multi-center, prospective, open label trial of type 2 diabetes patients sub-optimally controlled on at least one oral anti-diabetic medication. subjects who meet all inclusion and exclusion criteria after screening are hospitalized and go through the duodenal glycemic control™ treatment. duodenal glycemic control™ treatment is conducted by a gastroenterologist, in an endoscopic suite, with an off-the-shelf endoscope, using the diagone™ system. patients are followed for 6 months for ae and sae. patients are followed for 12 months for glycemic control parameters.

Eligibility criteria:
inclusion criteria: * subjects who are ≥ 18 years and ≤ 75 years of age. * hba1c at 7.5%-12% * on oral glucose lowering drugs in a stable medication regimen * fasting plasma glucose level at ≥125mg/dl * bmi 25-40 kg/m2 exclusion criteria: * diagnosed type i diabetes * serum c peptide \<1ng/ml