Kornimate/medical-research-clean huggingface dataset:
video-assisted umbilical fascial closure in laparoscopic cholecystectomy

Conditions: Cholelithiasis (Without Cholecystitis); Pain, Postoperative; Hernia Incisional

Summary: a prospective randomized study was performed including consecutive patients who underwent an elective laparoscopic cholecystectomy (lc) for symptomatic cholelithiasis during the 18 months period. this prospective randomized trial aims to compare two umbilical closure techniques for trocar site hernia (tsh) in laparoscopic cholecystectomy.

laparoscopic cholecystectomy (lc) is currently the gold standard in the treatment for symptomatic cholelithiasis that offers a variety of advantages over conventional open surgery such as shorter recovery time, better cosmesis, less wound complication rates, and less pain (1,2). despite these advantages, lc can result in unique complications. among these complications, trocar site hernia (tsh) is one of the most important complications because laparoscopic cholecystectomy promises smaller abdominal incisions and better cosmetic outcomes. a second surgical intervention due to tsh may overshadow the gains of the previous laparoscopic surgery. in studies conducted to date, the rate of trocar hernia in laparoscopic cholecystectomy has been presented at very different rates. many studies have shown that the most frequent site of tsh is the umbilical trocar site (3-6). to avoid this important complication of laparoscopic cholecystectomy, many different techniques have been described to date for trocar port fascia repair (7-12). most of these techniques require special devices. in addition, a few studies compare these techniques with standard fascial closure, which is mostly used by surgeons (11,12). we hypothesized that the fascial closure of the umbilical trocar incision under the intra-abdominal vision with the laparoscopic camera could be reduced tsh. this prospective randomized controlled study aims to assess whether fascial closure of umbilical trocar site under direct laparoscopic vision in lc can reduce the incidence of tsh.

Eligibility criteria:
inclusion criteria: * age above 18 years * symptomatic cholelithiasis exclusion criteria: * acute cholecystitis * age under 18 years * previous umbilical hernia repair * pre-existing umbilical hernia

Keywords: laparoscopic cholecystectomy pain trocar site hernia
efficacy and effectiveness of two types of aligners based on stratification by type of movement

Conditions: Crowding, Tooth; Tipped Tooth or Teeth; Rotation of Tooth; Malocclusion, Angle's Class

Summary: the purpose of this study is to evaluate the biomechanical behaviour of direct-printed and thermoformed aligners in different tooth movements, creating a biomechanical planning protocol based on a stratification of tooth movements according to the degree of predictability.

once the objectives, benefits, risks and follow-up of the study have been explained to each eligible patient, patients will be asked to sign an informed consent form. they will also be informed that they may cancel their participation in the study at any time. patient will be allocated randomly in two groups: the first group will receive orthodontic treatment with direct-printed aligner, while the second group will receive orthodontic treatment with conventional or gold standard thermoformed aligner.

Eligibility criteria:
inclusion criteria: * patients with malocclusion and invididual dental malpositions requiring orthodontic treatment * adequate oral and periodontal health, with absence of periodontal disease, periapical infection or untreated caries. * no history of previous orthodontic treatment. * complete permanent dentition (excluding third molars, their presence or absence being irrelevant). exclusion criteria: * altered bone metabolism (including use of antiresorptive, steroid or immunosuppressive drugs). * pregnant women.

Keywords: clear aligner therapy direct-printed aligner predictability shape memory stratification
nitric oxide generating gel dressing in patients with superficial partial thickness wounds

Conditions: Superficial Partial Thickness Burn; Skin Graft; Complications

Summary: this is a study to assess the safety and efficacy of a nitric oxide (nox) generating dressing on superficial partial thickness (spt) wounds. nitric oxide has a range of effects on the body including vasodilation and angiogenesis. it is also a potent antimicrobial. this 160 patient, randomised, controlled clinical study will assess the ability of a simple 2 part, nox generating dressing to improve healing in spt burn wounds and spt skin graft donor site wounds compared to standard of care.

this is a clinical study of a new wound dressing for superficial partial thickness (spt) wounds. the dressing consists of 2 stable layers that when placed together release nitric oxide. in preclinical studies nox delivery has caused significant vasodilation, angiogenesis and demonstrated potent anti-microbial activity. this is a multi-centre, 160 patient, randomised, controlled study. there are 2 arms to the study. 80 patients will have treatment applied to a spt burn wound and 80 patients will have treatment applied to a spt graft donor site wound. the controls will be intra-individual. each patient will have their wound divided into 2, half of the wound being treated with the nox dressing, the other half treated with standard of care. the positioning of the dressings will be randomised. the nox dressing will be changed at least every 2 days and the standard of care changed according to normal clinical practice and patients will be treated until the wound is healed. the study will evaluate: * the size of the wound * eepithelialisation * trans-epidermal water loss * infection status. there will be 3 and 12 month follow up with assessment of scarring.

Eligibility criteria:
inclusion criteria: * patients who have a superficial partial thickness wound (2a) either from a thermal injury or from a skin graft donor site under the care of st. andrews service, within the recruitment timeline. * wound area to be treated in study must be less than 5% of total body surface area (tbsa). * patients aged over 12 months and up to and including 80 years old. * informed consent exclusion criteria: * any inclusion criteria not met * unwilling to consent to investigation/ unable to provide consent * wounds deeper than superficial partial thickness (2b, 3 and 4) * chemical /electrical burns * already having received silver sulfadiazine * disease that could affect wound healing * previous participation in the study * females who are pregnant or breast-feeding. * relative, spouse or employee of the investigational site * known multiple allergic disorders * skin disorders * facial burns * patients who have taken part in any investigational studies within the last 30 days prior to participation.

Keywords: nitric oxide dressing nitric oxide superficial partial thickness wound burns skin graft donor sites improved healing vasodilation angiogenesis anti-microbial
a prediction model for 1-year mortality after valvular heart surgery

Conditions: Patients Undergoing Valvular Heart Surgery

Summary: the investigators aimed to develop a predictive model for mortality incorporating nutritional, inflammatory, and perioperative factors in patients undergoing valvular heart surgery. in this retrospective study, the investigators aimed to establish a comprehensive prediction model to predict the risk of 1-year mortality in valvular heart surgery patients through the identification of the inflammatory index most associated with 1-year mortality and developing a prognostic nomogram model incorporating perioperative risk factors with nutritional and inflammatory indices that would be verified by validation cohorts.


Eligibility criteria:
inclusion criteria: 1) patients who presented for surgery primarily due to valvular heart disease, including those who required concomitant coronary artery bypass surgery, aortic procedures, or other cardiac procedures. exclusion criteria: 1. patients aged \<18 years 2. undergoing transcatheter valve replacement, combined congenital heart surgery, or implantation of ventricular assist device, 3) lacking data required for calculating inflammatory indices, or 4) follow-up loss.
evaluation of a new czt system

Conditions: Parathyroid Adenoma; Thyroid Adenoma

Summary: the purpose of the study is to check if the new czt system has an advantage in detection of small osseous processes, thyroid adenomas, parathyroid adenomas and detection of sentinel node, in comparison with the techniques in use. participants: 100 subjects male and female that come to the institute of nuclear medicine for routine screening examinations. the czt screening takes 10 minutes and does not require any extra intervention to the routine screening.


Eligibility criteria:
inclusion criteria: * age over 18 exclusion criteria: * pregnancy * patients unable to understand and sign an informed consent * age under 18

Keywords: czt sentinel node osseous processes
effects of fluid therapy on peripheral tissse perfusion during sepsis/septic shock

Conditions: Septic Shock; Sepsis

Summary: compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring index skin recoloration time (crt) at h0 and h1

this is a transversal study allowing to compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion design: • a multicentric, open-label, transversal study sample size : 60 patients assessement: between the admission to intensive care and 48 hours after admission, the patient will be included after collection of the non-opposition form. the patient will receive volume expansion either by 0.9% saline (500ml) or by 20% albumin (100ml) over 15 minutes. repeated clinical measurements will be performed at h0, h0.5 and h1 (respectively at 0, 30 and 60 minutes). a blood sample will be taken just before the volume expansion and 4 hours after, at the same time as the samples usually taken as part of the treatment. no interim analysis is planned. analysis will be performed at the end of the study after data review and freezing of data base.

Eligibility criteria:
inclusion criteria: * age\> 18 years old * sepsis or * septic shock within 24 hours of admission to intensive care with a stable dose of norepinephrine for at least 2 hours to maintain map\> 65mmhg * crt index\> 3 seconds despite the initial resuscitation (administration of antibiotics, volume expansion by crystalloids of 20 ml / kg, noradrenaline started) between the admission to intensive care and h48 from admission to intensive care * non-opposition of the patient collected by the doctor in charge of the patient between h0 and h6 after admission if the patient is vigilant, otherwise a procedure for collecting non-opposition from relatives will be carried out with collection of the non-opposition of the patient once he is able to give it. * affiliation to a social security regimen (excluding ame) exclusion criteria: * patient covid-19 (+) with respiratory impairment * pregnant and lactating woman * patient under guardianship / curatorship * refusal to participate * crt not evaluable (dark or damaged skin) * moribund patient * estimated life expectancy less than 1 month * participation in another interventional research involving the human person or period of exclusion at the end of a previous research involving the human person

Keywords: endothelial dysfunction albumin fluid therapy peripheral tissue perfusion septic shock microcirculatory effects hemodynamic effects sepsis
the effect of bioslife on serum lipids

Conditions: Hypercholesterolemia

Summary: this is a double-blind, placebo-controlled study to assess the effectiveness of bioslife in lowering serum ldl cholesterol and raising hdl cholesterol. bioslife is a natural supplement (mixed in water and taken twice daily) which contains guar gum and other natural soluble fibers, phytosterols, policosanol, and a proprietary chrysanthemum extract. approximately 100 subjects with baseline ldl cholesterol of 110-190 mg/dl will be randomized in a 2:1 ratio to bioslife or a look-alike placebo. changes in lipids from baseline will be assessed at 6 weeks and 12 weeks.


Eligibility criteria:
inclusion criteria: * ldl-c 110 - 190 mg/dl * for current lipid-lowering prescription therapy users, the dose of lipid-lowering medication must have been constant for 3 months with no current plan for change in dose. * age 18 - 85 years exclusion criteria: * type 1 diabetes * severe hypertension, defined as at least 180 / 100 mmhg * any other health condition that may interfere with the study results, as judged by the principle investigator * allergy against any of the ingredients in the tested product * any medical condition, in which fiber consumption is contraindicated (e.g. crohn's disease * the use of nutritional supplements during the last two months containing one or more similar ingredients, as the tested supplement. * history of alcohol or drug abuse, psychological or other mental issues that are likely to invalidate informed consent, or limit the ability of the patient to comply with the protocol requirements * participation in any other studies involving investigational or marketed product concomitantly or within one month prior to entry into the study * pregnant or breast feeding * persons who eat only 1 meal per day

Keywords: ldl cholesterol hdl cholesterol natural supplement guar gum phytosterols policosanol chrysanthemum
the effect of parenteral nutrition supplement on esophagectomy patients

Conditions: Esophagus Cancer

Summary: malnutrition is common in esophagus cancer patients, especially after surgery therapy. whether parenteral supplement with enteral nutrtion is benificial for patients after esophagectomy is controversial, when compared with enteral nutrition alone. in this study, the investigators are to examine the effect of enteral nutrition supplemented with parenteral nutrtion on nutrition status after esophagectomy.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of esophagus cancer * undergo esophagectomy * nasoenteral tube is placed or surgical jejunostomy is performed exclusion criteria: * contraindication for enteral nutrition or parenteral nutrition * malnutrition before surgery ( bmi \> 30 or \< 18.5) * hepatic dysfunction preoperatively * renal dysfunction preoperatively * infection before surgery * usage of corticosteroid before surgery

Keywords: malnutrition parenteral supplement rest metabolic rate postoperative complications
recent and non united odontoid fractures

Conditions: Odontoid Process

Summary: the purpose of this study was to determine the clinical and radiographic long - term results in geriatric patients who had undergone surgical or non - operative treatment of odontoid non - unions, with particular regards to late bony fusion, cervical spine motion, neurological sequela, and patient's quality of life.


Eligibility criteria:
inclusion criteria: patients aged 65 years or older who had undergone surgical or non - operative management of odontoid non-unions were sorted and their dataset of follow - up monitoring was examined for completeness and accuracy. according to our inclusion criteria, patients with complete sets of collected data and a follow-up examination of at least five years after treatment of the non - union were finally enrolled in this study. collected data included variables, such as age, gender, mechanism of injury, fracture type, associated injuries, presence and severity of primary neurological deficits, primary treatment, clinical and neurological outcome after primary treatment, methods of treatment, clinical and radiographic outcome after treatment of the non-union, as well as morbidity and mortality of the patients. exclusion criteria: exclusion criteria for this study contain patients with previous or subsequent surgery at the cervical spine level, patients with incomplete data sets, as well as patients with penetrating mechanism of injury or congenital cervical spine anomalies. incomplete data set was determined, if pertinent clinical or radiographic data of follow - up monitoring (e.g. documents of clinical findings or functional results, radiographs, ct-scanning, e.g.) were missing.
impact of phytosterol-rich extract on lipid profile

Conditions: Cholesterol, Elevated; Hypercholesterolaemia; Lipid Metabolism Disorders; Dyslipidemias

Summary: the aim of this randomized, parallel, two-arm, placebo-controlled, triple-blind clinical trial is to evaluate the efficacy of a phytosterol- and phytostanol-rich extract on lipid profile parameters in individuals with hypercholesterolemia, focusing primarily on total cholesterol and ldl cholesterol levels.

the duration of the study will be 56 days during which the investigational product or placebo will be consumed according to the assignment. subjects will be randomized to each of the study arms (consumption of the experimental product or control product).

Eligibility criteria:
inclusion criteria: * adults (age \> 18 yo) * total cholesterol levels at screening ≥ 200 mg/dl exclusion criteria: * history of allergic hypersensitivity or poor tolerance to any component of the products under study. * use of prescribed medication which may interfere with study measurements. * unwillingness or inability to comply with clinical trial procedures. * subjects whose condition makes them ineligible for the study at the investigator's discretion. * pregnant or having the wish to become pregnant, or lactating. * recent participation in another nutritional or medical trial

Keywords: cholesterol cholesterol, elevated hypercholesterolaemia lipid metabolism disorders dyslipidemias
study to assess the safety, tolerability, pharmacokinetics, and effect on disease progression of biib078 administered to previously treated adults c9orf72-associated amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: the primary objective is to evaluate the long-term safety and tolerability of biib078 in participants with chromosome 9 open reading frame 72-amyotrophic lateral sclerosis (c9orf72-als). the secondary objective is to evaluate the pharmacokinectic (pk) of biib078 in participants with c9orf72-als.

this study is an extension study of nct03626012.

Eligibility criteria:
key inclusion criteria: * participants must have completed study nct03626012 through the first follow-up clinic visit that follows the final dosing visit without missing more than 1 dose of study treatment. * participants taking concomitant riluzole at study entry must be on a stable dose for ≥30 days prior to the first dose of study treatment (day 1). participants taking concomitant riluzole must be willing to continue with the same dose regimen throughout the study, unless the investigator determines that riluzole should be discontinued for medical reasons, in which case it may not be restarted during the study. * participants taking concomitant edaravone at study entry must be on a stable dose for ≥60 days prior to the first dose of study treatment (day 1). participants taking concomitant edaravone must be willing to continue with the same dose regimen throughout the study, unless the investigator determines that edaravone should be discontinued for medical reasons, in which case it may not be restarted during the study. edaravone may not be administered on dosing days of this study. key exclusion criteria: * history of drug abuse or alcoholism ≤6 months before study enrollment that would limit participation in the study, as determined by the investigator. * presence of an implanted shunt for the drainage of csf or an implanted central nervous system (cns) catheter. * history of or positive test result at screening for human immunodeficiency virus. the requirement for testing at screening may be omitted if it is not permitted by local regulations. * treatment with another investigational drug (including investigational drugs for als through compassionate use programs) or biological agent within 1 month of screening or 5 half-lives of study agent, whichever is longer. note: other protocol-specific inclusion/exclusion criteria may apply.
prediction of sudden cardiac death in dilated cardiomyopathy

Conditions: Cardiomyopathy, Dilated; Sudden Cardiac Death

Summary: predict-dcm trial is a multi-centre, prospective observational trial including patients with dcm undergoing cardiac magnetic resonance imaging (cmr) prior to icd or event recorder implantation.

prophylactic icd implantation was recently found to be non-beneficial over usual clinical care in non-ischemic systolic heart failure (lvef≤35%) and 60-70% percent of scd cases even occur in individuals with levf\>35%. a growing evidence, that emphasizes the urgent need to improve the prediction of sudden cardiac death (scd) in dilated cardiomyopathy (dcm). cmr provides unique information on myocardial mechanics, fibrotic burden, inflammation and microvascular dysfunction, thereby allowing to quantify key substrates for myocardial arrhythmogenic potential. predict-dcm trial is a multi-centre, prospective observational trial including patients with dcm undergoing cardiac magnetic resonance imaging (cmr) prior to icd or event recorder implantation. acquired candidate predictors are among others: * global and regional t1/t2 * t1/t2 inhomogeneity * extracellular volume fraction * microvascular dysfunction * la function and filling fraction * global and regional circumferential, radial or longitudinal myocardial strain * biomarkers

Eligibility criteria:
inclusion criteria: * dilated cardiomyopathy * icd indication * age ≥ 18 years * signed informed consent exclusion criteria: * severe claustrophobia * rest dyspnea * tachycardia or severe arrhythmia * intolerance to gadolinium-based contrast agent
prospective, non-interventional, multi-center safety study of mirena for heavy menstrual bleeding and dysmenorrhea

Conditions: Menorrhagia, Dysmenorrhea

Summary: the primary objective in this study is collecting post-marketing information on the safety. thus, it includes information under the routine clinical practice on adverse events (aes) and adverse drug reactions (adrs) including expulsion and abnormal bleeding that occur within the first 12 months mirena insertion. the secondary objective(s) in this study is/are collecting information on mirena effectiveness, such as periodic blood loss and quality of life (qol), use of analgesic and dysmenorrhea pain as far as these are recorded under routine clinical practice.

this local, non-interventional, multicenter, single-cohort study using primary data includes patients treated with mirena for heavy menstrual bleeding(hmb) and/or dysmenorrhea (contraception is not included). a total of 600 patients (valid for safety analysis) is planned to be enrolled in two years. no formal sample size estimation was conducted, it was determined based on feasibility. target population is patients with hmb and/or dysmenorrhea diagnosis. the treatment should be performed based on the product label in japan. the standard observation period will last for 12 months from starting mirena treatment.

Eligibility criteria:
inclusion criteria: * female patients diagnosed with hmb or/and dysmenorrhea. * patients for whom newly starting treatment with mirena was made as per investigator's routine treatment practice * written informed consent exclusion criteria: * patient whose purpose is only contraception

Keywords: mirena heavy menstrual bleeding dysmenorrhea japan post-marketing surveillance