Kornimate/medical-research-clean huggingface dataset:
cardiovascular risk assessment and dynamic monitoring-based prevention trial

Conditions: Cardiovascular Diseases

Summary: the critically study is a cluster randomized trial that will evaluate the effectiveness of a risk-based dynamic monitoring strategy for the primary prevention of cardiovascular high-risk chinese adults.

the objective of the study is to evaluate the effectiveness of a risk-based management strategy on cardiovascular risk scores (calculated by the 2019 who cardiovascular risk charts) in 24 months (phase i) and the incidence of major adverse cardiovascular events in 60 months (phase ii). totally 216 clinics in yinzhou district, china will be randomized to the intervention or the control arms with usual care. the interventions supported by the web-based decision support system include (1) cardiovascular risk assessment, (2) dynamic risk monitoring, and (3) regular visits by the general practitioner every three months. only usual care will be provided in the control arm. the primary outcome is the change in cardiovascular risk scores for phase i and the incidence of the composite endpoint of coronary heart disease, stroke, heart failure and all-cause mortality for phase ii. if the comprehensive strategy is proven effective, it could provide evidence for the primary prevention of cardiovascular diseases using digital health technology.

Eligibility criteria:
inclusion criteria: * residents in the yinzhou district have a unique health id; * aged 40 to 79 years at the baseline enrollment; * with high risk of cardiovascular disease evaluated by the 2019 who laboratory-based risk models (10-year risk≥10%); exclusion criteria: * have a history of coronary heart disease, stroke or heart failure; * patients with a diagnosis of cancer; * refused to provide written informed consent

Keywords: primary prevention cluster randomized trial cardiovascular risk assessment
protocol optimization in ct for the quantification of bmd

Conditions: Osteoporosis, Osteopenia; Bone Loss

Summary: bone mineral density is an important measurement to detect osteoporosis. the goal of this clinical trial is to compare bone mineral density measurements in ct examinations and dxa scans. the main question it aims to answer is: * how good is the measurement of bone mineral density in the new photon-counting ct in comparison to dxa * how can we optimize the ct scan for bone mineral density participants will undergo: * clinically indicated ct scan on day of inclusion * study related dxa scan on a separate appointment


Eligibility criteria:
inclusion criteria: * informed consent signed by the subject * referral to a regular clinically indicated ct examination covering the lumbar area (e.g., abdomen, thorax + abdomen, neck + thorax +abdomen) * informed written and oral consent (interpreter present in case of foreign language patients) * no contraindication to the clinically indicated ct examination exclusion criteria: * patients \< 18 years * pregnant women * vulnerable subjects * contraindications to the clinically indicated ct scan * multiple myeloma * diffuse bone metastasis * fixateur interne in the lumbar spine * kyphoplasty in the lumbar spine * enterally administrated contrast agent * obtaining informed consent is not possible * withdrawal of consent orally or in writing * inability to follow the procedures of the investigation, e.g., due to language problems, psychological disorders, dementia, etc. of the subject * immobility (patients confined to a wheelchair or to bed)
functional assessment of activities of daily living (adl) in patients who underwent mini-monovision correction

Conditions: Presbyopia

Summary: patients who underwent mini-monovision (with bilateral myopic defocus, mm-bmd) surgery for presbyopia correction with monofocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (adls) that require: a) distant vision(dv), (ie. driving), b) intermediate vision (iv), (ie. computer word processing), c) near vision (nv), (ie. book reading). primary objectives of the study are: 1) the development of a series of tasks in a research setting that will simulate common adls that require dv, iv, and nv. 2) the identification of potential correlations of the tasks in the research setting with demographic, clinical and other parameters of the study participants.

patients who underwent mini-monovision (with bilateral myopic defocus, mm-bmd) surgery for presbyopia correction with monofocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (adls) that require: a) distant vision(dv), (ie. driving), b) intermediate vision (iv), (ie. computer word processing), c) near vision (nv), (ie. book reading). primary objectives of the study are: 1) the development of a series of tasks in a research setting that will simulate common adls that require dv, iv, and nv. 2) the identification of potential correlations of the tasks in the research setting with demographic, clinical and other parameters of the study participants

Eligibility criteria:
inclusion criteria: * presbyopic patients that underwent mini-monovision correction with bilateral myopic defocus with monofocal intraocular lenses implantation exclusion criteria: * glaucoma * corneal pathology * fundus pathology * severe neurological/mental diseases that interfere with visual acuity

Keywords: presbyopia monovision activities of daily living, pseudophakic
aquesys microfistula implant in refractory glaucoma

Conditions: Glaucoma; Glaucoma, Open-Angle

Summary: to establish the safety and performance of the aquesys microfistula implant in eyes with refractory glaucoma.

a prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and iop lowering performance of the aquesys microfistula implant in refractory glaucoma patients who have previously failed a glaucoma procedure and who are not well-controlled on iop lowering medications.

Eligibility criteria:
inclusion criteria: * diagnosis of refractory glaucoma * maximally-tolerated medicated iop at two preoperative visits of ≥20 mmhg and ≤35 mmhg * visual field mean deviation score of -3 db or worse * shaffer angle grade ≥ 3 * area of free, healthy and mobile conjunctiva in the targeted quadrant exclusion criteria: * active neovascular glaucoma * previous glaucoma shunt/valve in the targeted quadrant * history of corneal surgery, opacities or disease/pathology * anticipated need for ocular surgery * non-study eye with bcva of 20/200 or worse

Keywords: glaucoma implant trabeculectomy poag
evaluation of the analgesia by serratus plane block during pleural drainage in intensive care unit.

Conditions: Analgesia; Lidocaine; Intensive Care Unit

Summary: pleural drainage under local anesthesia is a frequent practice in resuscitation, experienced as an unpleasant and painful event for patients. pain management is an important issue for early rehabilitation, decrease hospitalisation's cost and shortening the length of stay in intensive care unit (icu). a new type of locoregional anesthesia called serratus plane block described by blanco in 2013 showed a benefit in per and postoperative analgesia in thoracic surgery and carcinologic breast surgery, allowing a decrease in morphine use and an improvement of the patient's general satisfaction. serratus plane block is a very effective technique in chest wall analgesia, easy and safe to perform, with few complications. no studies to date have evaluated this anesthetic practice in intensive care for pleural drainage. this technique could be used outside the operating room to improve the intensive care patients, who often have heavier pathologies and greater pain, such as patients with chest trauma or patients with cardiac or respiratory disease. the investigators would like to conduct a preliminary study of superiority in the chu amiens intensive care unit, to study the interest of the serratus plane block in comparison with local anesthesia on the management of acute pain during pleural drainage.


Eligibility criteria:
inclusion criteria: * patients over 18 years old. * non-intubated patient with spontaneous ventilation * free and informed consent of the patient, * affiliated to a social security scheme * hospitalized in icu unit including surgical icu, cardiothoracic and respiratory icu or cardiothoracic and respiratory continuous care unit. * requiring pleural drainage gas or fluid * conscious patient, not sedated. exclusion criteria: * patient under the age of 18 years old. * patient refusal * under curatorship or deprivation of liberty * pregnant, parturient or breastfeeding woman * contraindication to lidocaine or ropivacaine * coagulation disorders

Keywords: serratus plane block analgesia pleural drainage lidocaine intensive care unit
artificial intelligence for early diagnosis of esophageal squamous cell carcinoma

Conditions: Artificial Intelligence; Optical Enhancement Endoscopy; Magnifying Endoscopy

Summary: esophageal squamous cell carcinoma is one of the most common malignant tumor of upper digestive tract. however, the detection rate and diagnosis accuracy of early esophageal squamous cell cancer is low. the aim of this study is to develop a computer-assisted diagnosis tool combining with optical magnifying endoscopy for early detection and accurate diagnosis of it.


Eligibility criteria:
inclusion criteria: * high risk patients for esophageal cancer aged 18 years or older; * histologically verified early esophageal squamous cell cancer. exclusion criteria: * patients whose images of esophagus not suitable for the training, validation and testing the computer-assist diagnosis tool.
subtenon and intravenous dexmedetomidine effect on patients undergoing cataract surgery

Conditions: Acute Postoperative Pain

Summary: the study designed to compare the effects and the safety of adding dexmedetomidine to local anesthetics and its intravenous administration in subtenon block in patients undergoing cataract surgery.

ophthalmological surgery can be performed under topical, regional or general anesthesia. recently, the majority of ocular surgeries performed by regional rather than general anesthesia, because of the regional anesthesia is more economic, easy to perform, and the risk involved is less. orbital regional anesthesia can be done using a retrobulbar (intra-conal) block, peribulbar (extra-conal) block or sub-tenon's block. the stbs or episcleral block was first described by turnbull in 1884 and it was repopularized in the 1990s as a simple and safe alternative to needle-based eye blocks. the stb becomes the most widely practiced regional technique for cataract surgery, because it produces satisfactory anesthesia for most intraocular procedures, and avoids the inherent risks of needle-based blocks, such as globe perforation and optic nerve injury. dexmedetomidine is a selective α-2 receptor agonist that produces sedation and analgesia without causing respiratory depression. it also allows patients to respond to verbal commands during the sedation; easy conversion from sleeping to awakening is possible. therefore, dexmedetomidine has been used as sedative in various clinical fields in intensive care unit and surgery and an adjuvant to local anesthetics. many studies were done to evaluate its effect as sedative or anlgesic when administered either intravenously or when added to local anesthesia in ophthalmic block. but no one, till now comparing its effect when used as adjuvant to local anesthetics or administered intravenously in subtenon block.

Eligibility criteria:
inclusion criteria: * asa grade i-iii * aged 18-70 years * both sex * scheduled for elective phacoemulsification cataract surgery exclusion criteria: * coagulation abnormalities * impaired mental status * refusal of the patient * uncontrolled glaucoma * recent surgical procedure on the same eye

Keywords: subtenon dexmedetomidine cataract surgery
the effect of perioperative lidocaine intravenous infusion on postoperative recovery after spine surgery.

Conditions: Spinal Diseases

Summary: the purpose of this study is to evaluate the effectiveness of perioperative lidocaine intravenous infusion in reducing postoperative pain for spine surgery patients.

study design: this study used a prospective, randomized, double-blinded, and placebo-controlled clinical trial. sixty patients scheduled for a spine surgery will be randomly assigned to two groups. lidocaine group will receive an intravenous bolus injection of lidocaine 1.5 mg/kg before intubation, followed by 2 mg/kg/h continuous infusion during the operation. placebo group will receive the same dosage of saline at the same time. analgesic requirement will be monitored using patient-controlled analgesia (pca protocol: demand dose is 2 mg of morphine, lockout 5 min, maximum dose 15 mg per hour). forty-eight hours after surgery, we will check the morphine consumption in two groups. quality of recovery after surgery will be assessed using q0r15 questionnaire.

Eligibility criteria:
inclusion criteria: * spine surgery with general anesthesia exclusion criteria: * lidocaine allergy * hepatic disease * dementia or cognitive decline
use of the insulin pump in cystic fibrosis patients with impaired glucose tolerance or cfrd and in type 1 diabetes patients.

Conditions: Cystic Fibrosis Related Diabetes

Summary: we hypothesize use of the insulin pump will improve body weight, lean body mass, whole body protein turnover, hepatic glucose production (hgp), and blood sugar control in cf patients with impaired glucose tolerance or patients with cf related diabetes (cfrd). we further hypothesize that hgp is also elevated in children/adolescents with type 1 diabetes and that the insulin pump will result in decreased hgp.

the insulin pump provides standard treatment for many patients with type 1 and type 2 diabetes and has been proven to be more effective in blood glucose control than subcutaneous injections. however, the pump has not been utilized for cf related diabetes. the insulin pump is connected to the patient via a small plastic catheter. the catheter is inserted with a 24 gauge needle (in a fashion similar to an iv catheter) just under the skin. the catheter is then changed every three days. the patient wearing the pump may then give himself or herself a "bolus dose" of insulin every time he or she eats, without needing to give a shot. a further advantage of the pump is that a very low dose of basal insulin may be given throughout the day. this low dose of insulin mimics the normal pancreas and may be especially advantageous for the insulin deficient cf patient. it is likely that bolus dosing will improve high hgp and will be more effective than subcutaneous insulin. furthermore, continuous basal insulin will likely improve protein catabolism. this is a pilot study to determine efficacy of the insulin pump. each subject will be provided with the pump and with all materials needed for use with the pump. each patient will also be provided with a glucose meter and test strips. he/she will be asked to wear the pump for six months and to check his/her blood sugar levels three to four times per day. prior to the pump placement and at the end of six months, each patient will undergo the following measurements: 1) whole body protein turnover using the stable isotope \[1-13c\] leucine; 2) dexa scan for measurement of lean body mass; 3) anthropometric measurements; 4) hemoglobin a1c.

Eligibility criteria:
inclusion criteria: * cystic fibrosis patients aged 12-32 years * impaired glucose tolerance or cfrd defined as fasting blood glucose (fbg) and post-prandial blood glucose (pp) equal to: fbg \ 200, or fbg \>126 and pp \>200. * type 1 diabetes control patients aged 12-32 years. exclusion criteria: * colonization with burkholderia cepacia * currently on corticosteroid medication * pregnant * medically unstable * unable to understand the insulin pump directions
a randomized controlled trial to evaluate the effectiveness of electromyography (emg)-biofeedback in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to determine whether emg-biofeedback is effective in the treatment of fibromyalgia.

the objective of this randomized controlled trial is to evaluate the effectiveness of emg-biofeedback in patients with fibromyalgia. the assessors are blinded to the group assignment. there are three time points of assessment: before intervention, at the end of treatment (t1) and 3-months follow-up (t2). patients are recruited from the waiting list of the fibromyalgia day hospital program at the university hospital munich fulfilling the inclusion criteria. the intervention group is treated with 14 sessions of emg-biofeedback during eight weeks in addition to usual care. the control group receives usual care only. the main specific aim is to assess the change in fibromyalgia specific health status.

Eligibility criteria:
inclusion criteria: * fibromyalgia according to the american congress of rheumatology (acr)-criteria and the criteria. * female gender * age between 18 and 65 * cognitive ability and sufficient german language skills to fill in health status questionnaires * signed informed consent exclusion criteria: * major medical disorders, i.e. cancer, chronic heart failure new york heart association (nyha) iv or asthma requiring cortisone medication * suffering from psychosis or major affective disorders * substance abuse * co-medication with opiates or benzodiazepine * transmeridian flight in the last weeks * shift-work * gravity

Keywords: fibromyalgia complementary therapies biofeedback randomized controlled trial relaxation therapy
respiration and the airway with supraglottic airway devices

Conditions: Laryngeal Masks Comparison

Summary: the investigators aim to compare the airway seal pressure( oropharyngeal leak pressure) of the self pressurized airway device with blocker® with the prosealtm laryngeal mask airway (p-lma)in anesthetized paralyzed adult female patients undergoing elective gynecological operations. the investigators aim at assessment of fitting of both devices against the glottic region that detected by the flexible fiberoptic bronchoscope( pentex corporation, medical division, singapore)and assessment of any associated postoperative complications. hypothesis: the investigators hypothesize that the self-pressurized air-q with blocker has a greater seal pressure compared to proseal, easier and faster in insertion with less morbidity and complications during and after its insertion.

the study will be carried on adult female patients to reduce variability in size of the chosen device to enable the investigators to analyze the performance parameters of the two devices with greater authority. the study will be done on anesthetized paralyzed adult female patients undergoing elective gynecological operations that require neuromuscular block but not necessarily tracheal intubation. the investigators will recruit 150 adult female(18-55 years old, asai\&ii) patients to a prospective randomized comparative controlled two-arm parallel clinical trial. patients with history of upper respiratory tract infections, obstructive sleep apnea, potentially full stomach (trauma, morbid obesity bmi\> 35, pregnancy, history of gastric regurgitation and heart burn), those with esophageal reflux (hiatus hernia), and those of coagulation disorders will be excluded from the study. all patients will be assessed pre-operatively el-ganzouri airway score to assess the expected difficulty of intubation and patients with airway scores ≥ 5 will be excluded from the study. the patients will be randomly allocated into two groups(the sp-blocker group \& the p-lma group; each group is 75 patients) using computer generated program . an online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the study groups. random allocation numbers will be concealed in opaque closed envelops. the patient and investigator assessing study outcomes will all be blinded to the study groups allocation.

Eligibility criteria:
inclusion criteria: * adult female patients asa i\&ii * age: 18- 55 years old * bmi \< 35 * undergoing elective gynecological operations. exclusion criteria: * patients with history of upper respiratory tract infections and obstructive sleep apnea. * patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation \&heart burn, those with esophageal reflux or hiatus hernia. * patients with coagulation disorders. * patients with el-ganzouri airway score ≥ 5 will.
japan-working groups of acute myocardial infarction for the reduction of necrotic damage by anp

Conditions: Acute Myocardial Infarction

Summary: to evaluate whether anp as an adjunctive therapy for ami reduces myocardial infarct size and improves regional wall motion.

the benefits of percutaneous coronary intervention (pci) in acute myocardial infarction (ami) are limited by reperfusion injury. in animal models, atrial natriuretic peptide (anp) reduces infarct size, so the japan-working groups of acute myocardial infarction for the reduction of necrotic damage by anp(j-windanp) designed a prospective, randomized, multicenter study, to evaluate whether anp as an adjunctive therapy for ami reduces myocardial infarct size and improves regional wall motion. twenty hospitals in japan will participate in the j-wind-anp study. patients with ami who are candidates for pci are randomly allocated to receive either intravenous anp or placebo administration. the primary end-points are (1) estimated infarct size (σcreatine kinase and troponin t) and (2) left ventricular function (left ventriculograms). single nucleotide polymorphisms (snps) that may be associated with the function of anp and susceptibility of ami will be examined. furthermore, a data mining method will be used to design the optimal combinational therapy for post-mi patients. j-wind-anp will provide important data on the effects of anp as an adjunct to pci for ami and the snps information will open the field of tailor-made therapy. the optimal therapeutic drug combination will also be determined for post-mi patients.

Eligibility criteria:
inclusion criteria: 1. age 20-79 years 2. chest pain of more than 30 min 3. 0.1 mv st-segment elevation in 2 contiguous ecg leads 4. admission to hospital within 12 h of symptom onset 5. first episode of ami 6. candidates for pci exclusion criteria: 1. history of old myocardial infarction 2. left main coronary artery stenosis 3. severe liver and/or kidney dysfunction 4. suspected aortic dissection 5. history of coronary artery bypass graft 6. history of allergic response to drugs 7. severe hypovolemia 8. right ventricular infarction

Keywords: acute myocardial infarction atrial natriuretic peptide data mining randomized clinical trial snps