Kornimate/medical-research-clean huggingface dataset:
a novel concept for continuous peripheral nerve block - sciatic nerve

Conditions: Pain

Summary: to investigate the function of a novel catheter for continuous peripheral nerve blocks in the popliteal nerve: two key issues are investigated 1) successful primary placement and function of the catheter for continuous peripheral nerve blocks confirmed by a decrease in motor function following injection of local analgesics through the catheter; 2) the rate of displacement after standardized movement of the limb where the catheter for continuous peripheral nerve blocks is inserted.

although peripheral nerve blocks are known to provide superior postoperative analgesia. continuous peripheral nerve block (cpnb) are not used to the extent they deserve. this is predominantly due to variable success rates. furthermore, the existing techniques for placing catheters for cpnbs are technically complicated and time consuming.4,5 major problems include difficult insertion of the catheter tip past the needle, difficult visualization of catheter advancement, secondary displacement of the local anesthetic (la) injection orifice(s) and limited possibility of repositioning the catheter once it has been left in situ. we have developed a new catheter for cpnbs to address and overcome these limitations. hence, the new catheter should primarily provide precise initial placement of the catheter, less risk of secondary displacement and a possibility to readjust the new catheter at any time point after initial placement. furthermore, in-plane ultrasound (us) visualization during the entire procedure and during readjustment should be possible. the new catheter should also provide a simple and rapid technique with few components. initial proof of concept studies in cadavers are promising with success rates close to 100 % both for initial placement and readjustment

Eligibility criteria:
inclusion criteria: 1. male or female ≥18 years of age at visit x. 2. asa classification ≤ ii 3. written informed consent obtained from volunteer and ability for volunteer to comply with the requirements of the study. exclusion criteria: 1. bmi ≥ 30 2. previous or ongoing surgery, pain or other disability of investigated region. 3. prescriptive drugs other than anti-contraceptive. 4. sensory or neurologic deficits in the investigated region 5. allergy to la 6. pregnancy, breastfeeding, or unwilling to practice birth control during participation in the study.-

Keywords: peripheral nerve blocks
investigation of cortico-rectal pathways in healthy subjects and constipated patients

Conditions: Healthy Volunteers; Constipation

Summary: biofeedback therapy improves bowel symptoms and anorectal function in patients with dyssynergic defecation, however its mechanism of action is not known. the investigators hypothesize that biofeedback therapy enhances gut-brain-gut communication by altering cortical processing of information and improving cortically mediated neuromuscular function of the gut. however, in order to better understand these mechanisms in patients, the investigators need to examine and establish normative data and compare findings with healthy subjects. the investigators specific aims are to examine and evaluate the following 40 normal subjects; (1) to evaluate the afferent cortical evoked potentials in response to the electrical stimulation of the anorectum and (2) to evaluate the corticofugal tracts (efferent) by recording the anal and rectal electromyographic responses following noninvasive lumbosacral and transcranial magnetic stimulation.

1. cortical evoked potentials:a probe with 2 ring electrodes is placed in anus and rectum. a small amount of electrical current is passed. the cortical evoked responses to the anal and rectal electrical stimulation is measured from the scalp using a neurophysiology recorder. 2. motor evoked potentials: a magnetic coil is placed on the scalp at the anorectal cortical site and discharged using magnetic energy. the anal and rectal motor evoked potentials are then measured using a probe with 2 ring electrodes.

Eligibility criteria:
inclusion criteria: * right-handed adults between ages 18 years and 99 years, who are free of bowel disorders or other medical illnesses. exclusion criteria: * potential subjects with comorbid illnesses; severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy. * neurologic diseases e.g.; head injury, epilepsy, multiple sclerosis, strokes, spinal cord injuries. * people who have metal in their skull or under the skull, or have metal in the back or hips. * people who have a cardiac pacemaker, implanted defibrillator or medication pump. * impaired cognizance (mini mental score of \< 15) and/or legally blind. * pregnant or likely to conceive during the course of the study. women with potential for pregnancy must be willing to use contraceptive measures during the study. * previous pelvic surgery, rectocele repair, bladder repair, radical hysterectomy. * rectal prolapse or anal fissure or anal surgery.

Keywords: cortical evoked potentials, motor evoked potential responses
management strategy of polypoid lesions of the gallbladder

Conditions: Polyp Gallbladder

Summary: we retrospectively review a single-center cohort of gallbladder polyps from january 2015 to may 2020. univariate and multivariable analyses were performed to extract potential risky factors of neoplastic polyps. also, a comparison was conducted between laparoscopic cholecystectomy (lc) and laparoscopic polypectomy (lp) to explore factors affecting surgeons' decision on lc or lp.


Eligibility criteria:
inclusion criteria: surgical indications for lc included polyp diameter over 10 millimeters, or polyps accompanied by gb stones, or consideration of neoplastic polyps. surgical indications for gb-preserving surgery included gb with normal emptying function and polyp diameter smaller than 10 millimeters, or consideration of benign non-neoplastic polyps, or asymptomatic polyps. exclusion criteria: those do not fit for laparoscopic surgery.

Keywords: gallbladder polyp; laparoscopic cholecystectomy; polypectomy
routine use of negative pressure wound therapy thr tkr rct

Conditions: Knee Arthropathy; Hip Arthropathy; Negative Pressure Wound Therapy

Summary: negative pressure wound therapy (npwt) for post total joint arthroplasty incisions has demonstrated benefits in reducing wound complications. a prospective randomized trial will be conducted including 40 patients who will undergo total knee and total hip arthroplasty. the number of wound complications within 21 days will be recorded. as well, the aesthetic appearance and quality of scarring of the scar will be assessed.


Eligibility criteria:
inclusion criteria: * patients undergoing total knee or total hip arthroplasty at prince of wales hospital, hong kong. exclusion criteria: * patients using steroid, or other immune modulators that is known to affect wound healing, prior surgery to the knee or hip, skin condition such as eczema that would result in poor healing or widen scars, patients with a known significant history of hypertrophic scarring or keloid.

Keywords: knee arthropathy hip arthropathy tkr thr wound therapy
antiplaque/antigingivitis efficacy of essential oil mouthrinses in six-month study

Conditions: Plaque; Gingivitis; Gum Inflammation; Bleeding

Summary: the objective of this randomized, single-center, examiner-blind, controlled, parallel group, six-month clinical study is to compare the antiplaque/antigingivitis potential of a no-alcohol essential oil containing mouthrinse and an alcohol essential oil containing mouthrinse. a negative control group using only an ada accepted anticavity toothpaste will be included.


Eligibility criteria:
inclusion criteria: 1. males and females 18 years of age or older, in good general and oral health, except gingivitis. 2. able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment; 3. evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial. 4. a minimum of 20 natural teeth with scorable facial and lingual surfaces. teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count. 5. a mean gingival index ≥ 1.75 according to the modified gingival index. 6. a mean plaque index ≥ 1.95 according to the turesky modification of the quigley-hein plaque index scored on six surfaces per tooth. 7. absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the investigator. 8. absence of moderate/advanced periodontitis based on a clinical examination (ada type iii, iv). 9. absence of fixed or removable orthodontic appliance or removable partial dentures. exclusion criteria: 1. history of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouthrinses and red food dye. 2. history of serious medical conditions that, at the discretion of the investigator, will disqualify the subject. 3. history of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures. 4. antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the 2 weeks prior to the baseline exam. 5. regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouthrinses within the 2 weeks prior to baseline. 6. current or history of alcohol or drug abuse. 7. self reported pregnancy or lactation (this is an exclusion criterion due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).

Keywords: mouthrinse plaque gingivitis gum bleeding
european union registry in paediatric chronic kidney disease patients looking at safety and usage patterns of darbepoetin alfa

Conditions: Chronic Kidney Disease

Summary: this european study observes paediatric patients with chronic kidney disease using darbepoetin alfa to assess the drug's long term safety and profile the patterns of its use within this population.


Eligibility criteria:
inclusion criteria: * anaemia attributed to chronic kidney disease (ckd) * sixteen years of age or under * documented ckd as demonstrated by estimated glomerular filtration rate (egfr) \<60 ml/min/1.73m² (schwartz equation) for ≥3 months if not on dialysis, or: receiving dialysis * treatment with darbepoetin alfa * documented informed consent by a parent or authorised individual, if required, and assent by the patient if appropriate exclusion criteria: * active malignancy or current chemotherapy or radiation therapy * investigator unlikely to be able to obtain adequate follow-up information, or participant will not be available for follow-up assessment * currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study; subject receiving other investigational agents

Keywords: ckd paediatric darbepoetin alfa
lactate metabolism after an endotoxin challenge in healthy humans

Conditions: Sepsis

Summary: sepsis is characterized by hyperlactatemia, the severity of which is proportionate with sepsis severity. the pathophysiological mechanisms (increased lactate production vs decreased lactate utilization; tissues involved in sepsis-induced lactate production) remain largely unknown. in this study, the investigators will assess whole body and regional metabolism in healthy young male subjects on two occasions, once after administration of an intravenous bacterial endotoxin challenge, and once without intervention. in one group of subjects, whole body lactate metabolism will be measured over 10 hours after the endotoxin challenge * energy expenditure and net substrate oxidation rates (indirect calorimetry) * lactate kinetics (measured by means of a continuous, exogenous sodium lactate infusion) * glucose kinetics (measured with 6,6 d2 glucose) * hemodynamic parameters and body temperature * blood clinical chemistry in one group of subjects, whole body lactate metabolism will be measured over 10 hours after the endotoxin challenge * energy expenditure and net substrate oxidation rates (indirect calorimetry) * lactate kinetics (measured by means of a continuous, exogenous sodium lactate infusion) * glucose kinetics (measured with 6,6 d2 glucose) * hemodynamic parameters and body temperature * blood clinical chemistry in a second group of subjects, regional muscle lactate metabolism will be measured over 10 hours after the endotoxin challenge by means of muscle microdialysis


Eligibility criteria:
inclusion criteria: * gender male * body mass index (bmi) \< 25 kg/m2 * absence of known disease exclusion criteria: * any known pathology * abnormal cardio-pulmonary and hemodynamic status * electrocardiographic alterations * history of allergy * current medications * drug abuse * consumption of more than 20g/day alcohol

Keywords: bacterial lipopolysaccharides hyperlactatemia muscle lactate
study of obicetrapib & ezetimibe fixed dose combination on top of maximum tolerated lipid-modifying therapies

Conditions: Dyslipidemias; Hypercholesterolemia; Familial Hypercholesterolemia; ASCVD; High Cholesterol

Summary: the study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (hefh) and/or atherosclerotic cardiovascular disease (ascvd) or multiple ascvd risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.

this study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (hefh) and/or atherosclerotic cardiovascular disease (ascvd) or multiple ascvd risk factors to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy. the screening period for this study will take up to 14 days. afterwards patients will be randomized 1:1:1:1 to obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination, obicetrapib 10 mg, ezetimibe 10 mg or placebo for a 84 day treatment period. after the treatment period, patients will have an end of study follow-up visit.

Eligibility criteria:
inclusion criteria: * have underlying hefh and/or a history of ascvd or multiple ascvd risk factors * on maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle modifications * ldl-c ≥ 70 mg/dl * triglycerides \< 500 * estimated glomerular filtration rate ≥ 15 ml/min/1.73 m2 exclusion criteria: * history of new york heart association (nyha) class iii or iv heart failure of left ventricular ejection fraction \<30% * hospitalized for heart failure within the last 5 years * myocardial infarction, stroke, non-elective coronary revascularization or hospitalization for unstable angina or chest pain in the last 3 months * uncontrolled severe hypertension * diagnosis of homozygous fh * liver disease * hba1c ≥ 10.0% or fasting glucose ≥ 270 mg/dl * thyroid-stimulating hormone \>1.5 x upper limit of normal (uln) * history of malignancy * creatinine kinase (ck) \>3 x uln * alcohol abuse * treatment with investigational product * treatment with gemfibrozil or ezetimibe * previous participation in a trial evaluating obicetrapib * known allergy to study drugs, placebo or excipients in study drugs of placebo * other condition that would interfere with the conduct of the study

Keywords: obicetrapib statin ldl-c cholesterol atherosclerosis
evaluating the relationship between stress, ethnicity, and blood pressure

Conditions: Hypertension

Summary: high blood pressure is a common health problem among people in the united states. this study will examine the ways that stress and ethnicity play a role in the development of high blood pressure.

high blood pressure affects nearly one third of all people in the united states. it can be caused by many factors, including obesity, sodium intake, genetics, and stress. ethnicity appears to also play a role, because african americans are more susceptible to developing high blood pressure than other ethnic groups, with more than 40% of african americans diagnosed with this condition. this study will examine the underlying reasons of why stress and african-american ethnicity contribute to high blood pressure risk and how ethnicity and stress interact with each other to increase this risk. specifically, study researchers will examine how stress increases blood pressure, how people from different ethnic groups respond to stress differently, and how sleep plays a role in regulating blood pressure levels. this study will enroll african americans and caucasians who have high blood pressure, as well as african americans and caucasians who have normal blood pressure. potential participants will go through a screening process that involves a medical history review, questionnaires, and blood pressure monitoring. eligible participants will then be admitted to the research clinic for a 2-night stay. participants' nutrition history and body measurements will be obtained, and a catheter will be inserted into the arm so that blood can be easily collected during the clinic stay. during the night, participants' breathing habits and movements will be monitored while they sleep. during the day, blood pressure and heart activity will be monitored frequently, including when participants are asked to perform mildly stressful tasks, such as giving a short speech. various medications that affect heart rate and blood pressure will be given at different times during the study, and researchers will monitor participants' reactions to each medication. lastly, participants will also complete psychological questionnaires.

Eligibility criteria:
inclusion criteria: * self-identifies as african american or caucasian * weighs 85% to 150% of ideal weight (approximate bmi of 17.5 to 30) * in good physical health exclusion criteria: * blood pressure greater than 180/110 mm hg at any point in the past * currently works less than half-time * currently is employed doing shift work * currently takes prescription medication, other than anti-hypertensive medication * currently smokes

Keywords: high blood pressure stress
a study of tocilizumab plus non-biological dmard in patients with moderate to severe rheumatoid arthritis and an inadequate response to non-biological dmards

Conditions: Rheumatoid Arthritis

Summary: this randomized, double-blind, placebo-controlled study will use magnetic resonance imaging (mri) to assess the efficacy of tocilizumab plus non-biological dmard in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological dmards. patients will be randomized to receive either intravenous tocilizumab at 8mg/kg (minimal dose 480mg, maximum dose 800mg) or placebo every 4 weeks, in addition to their stable dose of non-biological dmard. anticipated time on study treatment is 24 weeks, and target sample size is \<100.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * moderate to severe rheumatoid arthritis of \>/=6 months duration * synovitis (swollen and tender joint) in the wrist of the dominant hand * non-biologic dmards at stable dose for \>/=12 weeks prior to baseline * oral corticosteroids at stable dose for at least 25 out of 28 days prior to baseline exclusion criteria: * rheumatic autoimmune disease other than ra * history of or current inflammatory joint disease other than ra * functional class iv (acr classification) * intraarticular or parenteral corticosteroids within 6 weeks prior to baseline * previous treatment with a biologic agent for ra
evaluation of the level of expression of cd45rc on t lymphocytes as a predictive biomarker of acute rejection after renal transplantation

Conditions: End-stage Renal Disease

Summary: chronic renal failure is a major public health problem in industrialized countries, due to its frequency - about 3 million patients in france - and its socio-economic impact. at the end stage of renal failure, renal transplantation is the best treatment, allowing an improvement in patient survival compared to treatment by extra-renal purification. despite improved immunosuppressive strategies, allograft rejection is common in transplantation - between 15% and 25% in the first year - and is associated with lower renal graft survival. different risk factors for rejection have been well identified, such as the young age of the recipient or a high number of human leukocyte antigen (hla) incompatibilities between the donor and the recipient. however, these risk factors do not accurately identify the risk of acute rejection in order to optimize and individualize immunosuppressive strategies. also, the search for biomarkers to predict allograft tolerance prior to transplant is a major goal in renal transplantation. the onset of acute rejection is caused by the ability of the recipient's t cells to recognize alloantigens. the cd45 molecule is a highly expressed tyrosine phosphatase on the surface of the lymphocytes that plays an important role in the activation of the t cell. investigators showed that the level of expression of cd45rc on t lymphocytes was associated with the risk of acute rejection. thus, from a retrospective cohort of 89 renal transplant patients followed, recipients with a high percentage of circulating cd8 lymphocytes expressing high cd45rc (cd45rchigh) before transplant had a 5 to 8-fold higher risk of developing acute rejection of allograft during follow-up (11-year average follow-up) compared to recipients with a low percentage of cd8+cd45rchigh. the purpose of this study is to confirm the first retrospective results on a larger prospective and contemporary regional cohort.


Eligibility criteria:
inclusion criteria: * patients over 18 and under 70 years old * patients in care for a first priority renal transplant. * patients with low immunological risk * patients with prior written informed consent exclusion criteria: * poor understanding of the french language * pregnant, breastfeeding or partying women * persons deprived of liberty by an administrative or judicial decision * persons undergoing psychiatric care under duress * adults who are subject to a legal or non-state protection measure to express their consent