Kornimate/medical-research-clean huggingface dataset:
feasibility of hifu for management of placenta accreta (hifu-accreta)

Conditions: Placenta Accreta

Summary: placental accretion during pregnancy refers to an abnormally deep insertion of the placenta into the uterus, leading to the impossibility of removing the placenta without inducting uterine or surrounding organs lesions. the management of these patients is complex, with two options during caesarean section: hysterectomy or uterine conservative surgery in which the placenta is let in the uterine cavity. these are both at risk of complications, including severe hemorrhage. high intensity focused ultrasound (hifu) principle is based on the focusing of ultrasonic waves in a focal zone causing a rapid rise in temperature in the targeted area. this focus results in the creation of a coagulation necrosis tissue lesion. this procedure is guided in real time by an integrated ultrasound imaging cell. the investigators hypothesized that hifu shots would accelerate the process of placental involution when the placenta is let in the uterine cavity, increasing the chances of uterine preservation and reducing the infectious and hemorrhagic risks in the short and medium term. the aim of this study is to confirm the feasibility and safety of the use of hifu as a per-caesarean adjuvant treatment for management of placenta accrete let in the uterus for a conservative treatment.


Eligibility criteria:
inclusion criteria: * pregnant woman aged 18 years or older, with a suspicion of placental accretion observed with usual imaging tests (ultrasound, mri) * single pregnancy (singleton) * for whom a caesarean section has been scheduled * wishing to try to preserve her uterus * affiliated to a social security scheme or similar * having signed informed consent for participation in the study exclusion criteria: * major patient protected by law, under guardianship or curatorship * patient participating in other interventional research that may interfere with this research * placental tumor identified in antenatal * grade 3 placental calcification * presence of a catheter, stent or vascular prosthesis close to the uterus

Keywords: high intensity focused ultrasound (hifu) placenta accreta feasibility safety
safety and efficacy study of investigational pneumococcal vaccine in elderly population

Conditions: Prophylaxis Invasive Pneumococcal Diseases and Pneumonia

Summary: as the licensed pneumovax 23™ vaccine is not always satisfactory in elderly subjects, the safety and the immune response of the new investigational pneumococcal protein vaccine is evaluated in healthy elderly population.

since influenza vaccination is recommended in the age range of the study population, fluarix™ (glaxosmithkline biologicals) vaccine will be offered free of charge during the study period (for 3 consecutive years starting from september 2004), to be used by investigators according to national vaccination schedule/practice. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

Eligibility criteria:
inclusion criteria * subjects who the investigator believes will comply with the requirements of the protocol * a male or female ≥ 65 years at the time of the first vaccination. * written informed consent obtained from the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study. exclusion criteria * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * use of any anticoagulants. * planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccines. * previous vaccination against streptococcus pneumoniae. * bacterial pneumonia within 3 years prior to 1st vaccination. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * current serious neurologic or mental disorders. * currently smoking \> 25 cigarettes per day. * inflammatory processes such as known chronic active infections * all malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years. * history of administration of an experimental vaccine containing mpl or qs21. * acute disease at the time of enrolment. * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator. * history of chronic alcohol consumption and/or intravenous drug abuse.
brain imaging biomarkers for response to spinal cord stimulation in patients with chronic low back pain

Conditions: Chronic Low-back Pain

Summary: in this protocol, "brain imaging biomarkers for response to spinal cord stimulation in patients with chronic low back pain," the investigators plan to perform brain mapping studies in 42 patients who are undergoing spinal cord stimulation (scs) for chronic low back pain (clbp) as part of the participants normal clinical care during a 2-year period. this imagining study is completed for research purposes. there is no standard of care imaging for the participants. this study requires two visits in total. during the baseline visit, participants will undergo imaging acquisition protocol and corresponding assessments. participants will have another follow-up visit (potentially remotely) for final assessments two weeks after the scs treatment. the objective of the study is to investigate potential imaging biomarkers that can predict response to the scs treatment. specifically, the investigators hypothesize that the connectivity of a certain region of the brain (specifically the subgenual cingulate) prior to scs may serve as a possible pre-operative imaging-based biomarker on response to scs. the findings of the study may further enhance investigators understanding of the connectivity between brain areas that are critical to the therapeutic response to scs in clbp patients and that can be used as a putative biomarker to select patients who may respond to scs.


Eligibility criteria:
inclusion criteria: * male or female ≥ 21 years of age at time of consent * subject has been recommended to undergo an scs trial for chronic back with or without leg pain by their pain management physician * chronic low back pain as defined by persistent low back pain despite prior treatments that continues for 12 weeks or longer * subject signs a valid, institutional review board (irb)-approved informed consent form (icf) provided exclusion criteria: * subject is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study * subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (implantable pulse generators (ipgs), implantable drug pump, etc.) or pacemaker or implantable cardiac defibrillator * subject is currently abusing alcohol or illicit drugs * contraindications to mris or the need for recurrent body mris * presence of cardiac pacemakers/defibrillators, implanted medication pumps, intra-cardiac lines, any intracranial implants (e.g., aneurysm clip, shunt, cochlear implant, electrodes) or other implanted stimulators
analgesia for clavicular fracture and surgery

Conditions: Clavicular Fractures

Summary: compared efficacy of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.

the primary objective of this study was to compare the effectiveness of ultrasound-guided combined interscalene-cervical plexus versus combined supraclavicular-cervical plexus block for surgical anesthesia in clavicular fractures.the hypothesis of this study was that the supraclavicular-cervical plexus block could provide better anesthesia with less anesthesia related complications.

Eligibility criteria:
inclusion criteria: * surgery of the clavicular fractures under combined cervical plexus plus brachial plexus block * urgent or planned surgery exclusion criteria: * refused to sign informed consent * pregnant women * allergic to the local anesthetic

Keywords: combined interscalene-cervical plexus block combined supraclavicular-cervical plexus block
clinical value of linear ablation without pulmonary vein isolation in persistent atrial fibrillation

Conditions: Atrial Fibrillation, Persistent; Atrial Fibrillation

Summary: based on previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional pvi ablation for persistent af. population size is 207. the participants will be randomized to the linear ablation group and pvi ablation group with a 2:1 ratio. the follow-up period is 12 months. the primary outcome is freedom from atrial fibrillation, the secondary outcome is complications related to ablation.

pulmonary vein isolation is recommended as the cornerstone of catheter ablation of atrial fibrillation by current guidelines, however, meta-analysis suggests that the success rate of continuous pulmonary vein isolation for persistent atrial fibrillation is only 43%. therefore, in addition to pulmonary vein isolation, further research on substrate modification in the treatment of atrial fibrillation is particularly important. based on our previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional pvi ablation for persistent af. the linear ablation is performed on the basis of ω-type linear ablation. further stepwise ablation of the left atrial anterior wall increases the blockage of the la roof and the mva isthmus. ablation in cs or ethanol ablation of vein of marshall. also, epicardial ablation on the roof or rigid between laa-lpvs may be applied if necessary.

Eligibility criteria:
inclusion criteria: * patients suffering from persistent atrial fibrillation and referred to catheter ablation therapy. * patients agreeing to be enrolled， with the informed consent signed exclusion criteria: 1. sinus rhythm at the time of recruitment; 2. age less than 18 years old or older than 75 years; 3. transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 55 mm; 4. history of previous radiofrequency ablation of atrial fibrillation or surgical ablation history; 5. left atrial thrombus recorded by ultrasound or ct; 6. combined with severe lung disease; 7. previous history of cardiac surgery; 8. patients with hyperthyroidism, atrial septal defect, mitral stenosis, or severe coronary heart disease requiring further treatment

Keywords: linear ablation
efficacy, immunogenicity and safety of s. flexneriza-s. sonnei bivalent conjugate vaccine in volunteers aged from 6 months to 5 years

Conditions: Dysentery; Shigellosis

Summary: the purpose of this study is to evaluate the efficacy, immunogenicity and safety of s. flexneriza-s. sonnei bivalent conjugate vaccine in infants and children aged from 6 months to 5 years.


Eligibility criteria:
inclusion criteria: * infants and children aged from 3 months to 5 years old; * the legal representative voluntarily agrees to participate in the study and signed the informed consent form; * the legal representative voluntarily agrees to comply with the requirements of the clinical study protocol, and they can participate in all planned follow-up; * subjects who didn't immuned with attenuated live vaccine within 14 days and inactivated vaccine within 7 days before vaccination; * axillary temperature ≤37.0℃; * according to the medical history, physical examination and the judgment of the researcher, it is determined that the subject is in good physical condition. exclusion criteria: * previous proven history of bacillary dysentery; * subjects who are allergic to tetanus toxoid, and have any history of other vaccination or drug allergy, or a fever above 39.5 ℃ after previous vaccination; * within 3 days before vaccination, suffering from acute diseases or in the acute episode of chronic disease or using antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, etc.); * had severe bowel disease, and had symptoms such as diarrhea, abdominal pain, pus and blood stool and other symptoms in the past 3 days; * with pathological jaundice confirmed by existing diagnosis; * history of thrombocytopenia or other coagulation disorders with definite diagnosis; * known or suspected immunological deficiency (such as perianal abscess, which indicates that infants may have immune deficiency), and received long-term (≥14 days) immunosuppressive therapy (radiotherapy, chemotherapy, systemic glucocorticosteroids≥2 mg/kg/day, antimetabolic drugs and cytotoxic drugs) within half a year before vaccination, or confirmed that the parents were hiv infected; * received immunoglobulin / blood products treatment within 3 months before vaccination; * severe congenital malformations (functional impairment of important organs), severe malnutrition, developmental disorders and serious genetic diseases (such as severe thalassemia); * subjects with the following diseases: 1. serious liver and kidney diseases, cardiovascular diseases, malignant tumors and other chronic diseases; 2. diagnosis with infectious diseases such as tuberculosis, viral hepatitis and so on; 3. severe asthma; 4. systemic rash, dermatophyte, skin suppuration or blister; 5. history or family history of convulsion, epilepsy, encephalopathy, mental illness; * planning to participate or currently participating in clinical trials of other vaccines or drugs; * any situation that the investigator believed may affect the study evaluation.
early intervention in allergic patients

Conditions: Allergic Rhinitis Due to Weed Pollen; Montelukast

Summary: as many as 250 million people suffer from allergic rhinitis in china, which has a large population, early use of drugs may help better control the symptoms.this study aimed to investigate the effects of early interventional treatment with the leukotriene receptor antagonist (ltra) montelukast on seasonal allergic rhinitis.


Eligibility criteria:
inclusion criteria: * patients showed distinct nasal symptoms (rhinorrhea, congestion, itching, and sneezing), and demonstrated sensitization to one of the grass pollen allergens (artemisia, chenopodium, and humulus scandens) with an immunoglobulin (ig) e ≥ 0.7 iu/ml, measured using the pharmacia unicap system (thermo fisher scientific china co., ltd., shanghai, china). * had not received any therapies for ar or antibiotics for at least 4 weeks before their outpatient clinic visit prior to the study * all of the subjects in the study reside in beijing. exclusion criteria: * patients diagnosed with bronchial asthma, suffering from rhinitis outside the pollen season, chronic sinusitis, deviated nasal septum, using specific immunotherapy, or participating in another drug efficacy trial during the 4-week period preceding the study. * pregnant women and minors
video laryngeal mask versus endotracheal tube undergoing laparoscopic cholecystectomy surgery

Conditions: Cholecystitis

Summary: the aim of this study is to investigate the effectiveness of using a video laryngeal mask for airway management in patients undergoing laparoscopic cholecystectomy.

the investigators will compare the time required to secure the airway when inserting a video laryngeal mask (lma) versus performing endotracheal intubation.

Eligibility criteria:
inclusion criteria: * patients over 19 years old * patients planned for elective laparoscopic cholecystectomy exclusion criteria: * high risk of aspiration (e.g. gastro-esophageal reflux disease, hiatus hernia, pregnancy, history of gastrectomy) * difficult airway (e.g. limitation of mouth opening, limitation of neck extension, oropharyngeal pathology) * obesity (bmi \> 30 kg/m2) * tooth mobility
back muscle function in adolescents with idiopathic scoliosis

Conditions: Scoliosis Idiopathic; Scoliosis; Adolescence

Summary: the function and asymmetry of back muscles will be examined in different positions and with specific spinal corrections based on scoliosis pattern and according to the "schroth method" in adolescents with idiopathic scoliosis.

the study aim is to examine function and asymmetry of back muscles in different positions and with and without specific spinal corrections based on scoliosis pattern and according to "schroth ethod" in adolescenet idiopathic scoliosis. the will include adolescents aged 10-14 years diagnosed on x-ray with idiopathic scoliosis of 15-400 cobb angle. participants will undergo an assessment that includes: demographic questionnaire, pain severity measured by the visual analog scale , quality of life questionnaire for patients with scoliosis (srs-22), adam's forward bend test, spine rotation angle assessment using a scoliometer, leg length measurement, hip range of motion using goniometer, risser sign, coronal trunk balance and sagittal vertical axis- according to x-ray, scoliosis classification. following examination, participants will perform three exercises that activate back muscles in three different positions: supine lying, side lying and standing. each exercise will be performed twice: the first time without and the second time with specific corrections of the scoliosis. the exercises will be performed according to "schroth" method implying that the corrections of the spine will be determined according to the scoliosis pattern and classification for the scoliosis (single / double, thoracic, lumbar etc.) and will be conducted via belts, cushions, and bars. during each exercise, back muscles thickness will be examined and measured via portable diagnostic ultrasound. the muscles will be measured at t7 and l4 levels in resting and contracting positions. back muscle function will be evaluated by calculating percentage of change between positions rest and contraction position. comparison between muscle function with and without correction and correlation of muscle function to quality of life and other morphological parameters will be assessed.

Eligibility criteria:
inclusion criteria: * adolescents who have been diagnosed by x-ray with idiopathic scoliosis of 15-40°, * risser sign zero to four, * have recent x-rays. exclusion criteria: * previous back surgery * have been treated with physical therapy in the past year,
endurance and walking training by nordic walking in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: walking capacity is one of the most valuable body functions among persons with multiple sclerosis (ms) and it is one of the most frequently affected, even in early stages of the disease. inactivity and deconditioning can accelerate gait impairment and promote other pathologies related with sedentary lifestyle. nordic walking (nw) is a fun and effective fitness and rehabilitation activity. the benefits of nw have been extensively described in healthy and elderly population (tschentscher, 2013; kappor, 2013) and it is proving to be highly recommended to different neurological conditions, specially to parkinson disease (reuter 2006; van eijkeren 2008; fritz 2011; ebersbach 2014). there is no evidence on nw and ms, although it's supposed to be an ideal physical activity for many reasons: it tones the upper and lower body at the same time, uses 90% of the skeletal muscles, burns up to 46% more calories than ordinary walking, reduces the pressure on knees and joints, poles propel the walker along easier and faster and it is one of the most effective cross training techniques for people who require improve cardiovascular and endurance conditioning.

a simple blinded randomized controlled trial as designed to assess if an endurance training (20 sessions of 45 minutes x 2 times/week x 10 weeks) using nw improves: walking capacity, balance, fatigue, mood and health-related quality of life of people with ms. 66 people with ms will be randomly allocated in nw group or conventional endurance training group (treadmill and cycloergometer). assessments will take place before starting the training, after the training and 3 months after.

Eligibility criteria:
inclusion criteria: * people over 18 diagnosed of ms following the mc donald criteria, clinically stable who: * show mild to moderate balance disorder (bbs\>45). mild risk of falls. * refer fatigue during walking and restriction on their usual walking distance during the last 6 months. * accept to participate in the study and signed the informed consent. exclusion criteria: * other neurological disorders. * moderate to severe spasticity (ashworth\>2) * non stable heart diseases, diabetes mellitus, arthritis in lower limbs, acute pain in lower limbs, peripheral neuropathies, severe orthopedics problems, psychiatric problems, pregnancy. * incapacity to maintain a minimum walking rhythm at least during 15 minutes. * cognitive disability or body schema disorder that limits to fill in the assessment questionaires or understanding and applying the technique. * to be training in other physical activities that can modify the level of fatigue or walking ability.

Keywords: endurance training nordic walking walking ability fatigue
tylenol levels in bariatric patients

Conditions: Obesity

Summary: the current study is designed to measure and evaluate the pharmacokinetic profiling of acetaminophen in the young obese patient population.

this will be a descriptive study carried out by study staff from the anesthesiology department. the patient population will include obese patients scheduled for robot-assisted or laparoscopic bariatric surgery. there will be no change in our usual anesthetic care for these patients. volume of distribution and elimination half-life of acetaminophen in serum samples are the primary measurements of the study. if detected, a significant reduction in opioid requirements may lead to improved patient satisfaction and decreased opiate side effects.

Eligibility criteria:
inclusion criteria: * patients older than 12, but younger than 21 years of age undergoing robotic assisted or laparoscopic bariatric surgery * american society of anesthesiologists physical status classification system (asa) i, ii or iii * parent/guardian willing and able to give consent * patient willing to give assent, or consent * patients that are otherwise healthy at the discretion of the study staff * patients with bmi \>95th percentile exclusion criteria: * patients with severe right heart failure or severe asthma * patients with deficient hepatic function that can affect drug metabolism * systemic steroid use within the last 3 months * patients who have taken acetaminophen containing medications within 24 hours of surgery date * patients younger than 12, but older than 21 years of age undergoing robotic assisted or laparoscopic bariatric surgery * patients having other procedures in addition to robotic assisted or laparoscopic bariatric surgery * american society of anesthesiologists physical status classification system (asa) iv and above * females testing positive for pregnancy * parent/guardian not willing and able to give assent, or consent * patient not willing to give assent, or consent * patients with bmi \< 95th percentile

Keywords: obesity bariatrics acetaminophen robot-assisted or laparoscopic bariatric surgery pharmacokinetics