Kornimate/medical-research-clean huggingface dataset:
nutritional counseling vs. nutritional supplements for nash - a randomized prospective, open label pilot study

Conditions: Non-alcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic

Summary: the main aim of the study is to determine if an oral supplementation of the lcs has a beneficial effect by itself or even enhances the beneficial effects of a moderate life-style intervention on the progression of nafld in humans.


Eligibility criteria:
inclusion criteria: - elevated m30 antigen levels (cutoff: \>200 - 800 u/l) at screening and hepatic steatosis on ultrasound or histologically confirmed nash - age 18 to 75 years exclusion criteria: * alcohol intake of more than 30 g/d (men) or 20 g/d (women) * treatment with ursodeoxycholic acid (udca), vitamin e or other investigational nash drugs 3 months prior to randomization * treatment with medications or substances that may induce secondary nash (e.g., tamoxifen, corticosteroids, amiodarone, methotrexate) or ameliorate nash (tnf-antagonists) * treatment with phenprocoumon or warfarin * hepatocellular carcinoma or non-hepatic malignancy * decompensated cirrhosis (child b,c) or a history of decompensation * liver disease unrelated to nash, including chronic viral hepatitis b/d or c, autoimmune hepatitis, wilson's disease or clinical manifest iron overload * bariatric surgery within the last 5 years * bmi \ 45 kg/m2 * liver transplantation * heart failure (new york heart association class ii - iv) * myocardial infarction, instable coronary artery disease , coronary artery intervention or stroke in the previous 6 months * instable chronic obstructive pulmonary disease, chronic inflammatory bowel disease or rheumatoid arthritis. * instable renal insufficiency (changes in serum creatinin \> 50% in the last 3 month) or terminal renal insufficiency requiring dialysis * uncontrolled hypertension (blood pressure \> 180/90 despite therapy) * uncontrolled diabetes mellitus defined by hemoglobin a1c \> 9 * food allergies requiring strictly dietary adherence * pregnant or nursing women * chronic pancreatitis or history of recurring acute pancreatitis

Keywords: histologically confirmed nash hepatocyte injury determined by m30 antigen
evaluation of crb in prom patients

Conditions: Premature Rupture of Fetal Membranes

Summary: the crb study is designed to study the safety and effectiveness of the cook cervical ripening balloon (crb) for the induction of labor in term and near-term patients with premature rupture of membranes (prom).


Eligibility criteria:
inclusion criteria: * prom not in labor exclusion criteria: * contraindication to vaginal delivery * contraindication to labor induction * abnormal fetal heart-rate patterns * maternal heart disease * severe maternal hypertension * pelvic structural abnormality

Keywords: premature rupture of membrane (pregnancy) prom cervical ripening induced labor
open surgery for necrotizing pancreatitis

Conditions: Pancreatitis,Acute Necrotizing

Summary: retrospective analysis of the cases of traditional open surgery for acute necrotizing pancreatitis, with evaluation of indications for surgery, intraoperative findings, mortality rate and risk factors of mortality.

all cases of laparotomy/lumbotomy will be retrospectively analysed, with evaluation of mortality, complications, in-hospital stay, indications for surgery, findings during operation, combination with minimally invasive procedures (radiological drainage, necrosectomy). assessment of risk factors, like erosive bleeding, intraperitoneal perforation of collection, gut resection, splenectomy, relaparotomy will be done.

Eligibility criteria:
inclusion criteria: * laparotomy or lumbotomy performed for acute necrotizing pancreatitis from january, 2008 to december, 2017 exclusion criteria: * n/a

Keywords: necrotizing pancreatitis laparotomy debridement
color doppler to confirm epidural catheter positioning in parturient

Conditions: Labor Pain

Summary: the aim of this study is to calculate the sensitivity and specificity of using color doppler with pulsed wave doppler to accurately detect the position of epidural catheter

patients will be divided into two groups group (c) control these are the patients with bmi less than 35 and group (o) for patients with bmi more than 35.all patients will be sitting to receive their epidural analgesia for labor pain. a 2.5 to 5 mhz curvilinear probe (sonosite x-porte, fujifilm industries) will be used to detect the desired level usually between l3-4 or l4-5. patients will be divided into two groups group (c) control these are the patients with bmi less than 35 and group (o) for patients with bmi more than 35. all patients will be sitting to receive their epidural analgesia for labor pain. a 2.5 to 5 mhz curvilinear probe (sonosite x-porte, fujifilm industries) will be used to detect the desired level usually between l3-4 or l4-5. initially a parasagittal oblique interlaminar view will be obtained and by tilting it medially to visualize the laminae and interlaminar spaces. starting by the sacral image, counting will start detecting the l5-s1, l4-l5 and l3-l4 levels. after marking the level another imaging in the transverse view will be attempted at the previous levels then the anesthetist will detect the posterior complex (ligamentum flavum, epidural space and dura) and anterior epidural complexes and according to the anesthetist preference a level will be this is followed by a test dose of 10 ml 0.125% bupivacaine and patient controlled epidural analgesia will be started by the following protocol (0.0625% bupivacaine) smith medical asd,inc. in intermittent dose (10 ml will be injected by the machine every 30 minutes.

Eligibility criteria:
inclusion criteria: * obstetric patients admitted for epidural analgesia in the labor department suite (lds) exclusion criteria: 1. patients suffering from coagulopathy. 2. patients on recent anticoagulant therapy. 3. patients suffering from sepsis or with local sepsis at the insertion site. 4. patients with platelet count less than 100,000/dl. 5. patient refusal. 6. patient with known allergy to local anesthetic drugs 7. patients delivered by forceps. 8. patients who have undergone a cesarean section delivery.
a study of ds-1211b in individuals with pseudoxanthoma elasticum

Conditions: Pseudoxanthoma Elasticum

Summary: this study was designed to evaluate the safety, tolerability, pharmacodynamics (pd) of ds-1211b, and pharmacokinetics (pk) in individuals with pseudoxanthoma elasticum (pxe). pxe is a rare disease that is associated with significant risks of visual impairments and comorbidity from peripheral and cardiovascular diseases, and adversely impacts the quality of life in afflicted individuals.

ds-1211b, a potent small-molecule inhibitor of tissue-nonspecific alkaline phosphatase, is being developed for the treatment ectopic calcification diseases such as pxe. this study will assess ds-1211b (low-, middle-, and high-dose tablets) administered once daily for 12 weeks in individuals with pxe.

Eligibility criteria:
key inclusion criteria: * signed and dated informed consent * male or female participants aged 18 to 75 years at screening * have an established diagnosis of pxe * fully vaccinated for coronavirus disease 2019 (covid-19) per current center for disease control and prevention guidelines key exclusion criteria: * have a history of bone fracture in the past 6 months * have a history of active metabolic bone disease, excluding osteopenia or osteoporosis without fragility fracture * have a history of calcium pyrophosphate deposit disease * have a history of hypophosphatasia * have a history of untreated hyperparathyroidism * participated in another interventional research study in the past 60 days. * used bisphosphonate in the preceding 12 months or had plans to use bisphosphonate during the study. * received vitamin b6 supplementation \>5 mg/day in the month prior to screening and during the study * initiated or changed dose of vitamin d in the preceding month prior to screening * have an alkaline phosphatase \<lower limit of normal (lln) range * have a qtcf interval duration \>450 ms at screening * have moderate to severe renal insufficiency * are pregnant or breast-feeding women * are female participants unwilling to use contraceptive methods * have any elective surgery planned during the study period * have any other significant condition (medical, psychiatric, social, or medication) that, in the judgment of the investigator, would prevent full participation or would be inappropriate for the study

Keywords: pseudoxanthoma elasticum ds-1211b
efficacy and safety of transcranial magnetic stimulation in treatment of insomnia with subjective cognitive decline

Conditions: Insomnia Chronic; Subjective Cognitive Decline (SCD)

Summary: insomnia is the most common form of sleep disorder, and subjective cognitive decline (scd) in patients with insomnia may be an ultra-early manifestation of ad. repetitive transcranial magnetic stimulation (rtms) has emerged as a promising tool for the treatment of insomnia by modulating neural excitability and inducing plasticity. however, there is a lack of studies on rtms treatment of cognitive impairment associated with insomnia. the efficacy and safety of rtms for cognitive impairment in insomnia patients with scd will be assessed by a randomized controlled trial.


Eligibility criteria:
inclusion criteria: * (1) aged 30-80 years old; (2) diagnostic criteria for insomnia: dsm-v and icsd-3; (3) subjective cognitive decline. (4) regular use of non-benzodiazepines for insomnia. exclusion criteria: * (1) refuse participants; (2) presence of cognitive dysfunction; (3) combined with other diseases other than central nervous system non-neurodegenerative diseases; (4) use drugs that may affect cognition, degree of awakening and sleep quality due to other diseases; (5) contraindications to rtms treatment: (6) severe complications and immune diseases; (7) inability to cooperate; (8) pregnancy or lactation.
functional capacity of exercise and lung function in patients submitted early rehabilitation

Conditions: Funnel Chest

Summary: the aim of this study was to compare the functional capacity of exercise by six-minute walk test and lung function by spirometry, before and after nuss procedure in subjects who have undergone the early rehabiliation program with those who were under conventional care. researchers want to find out if early rehabilitation is a strategy to enhance recovery after nuss procedure.

the replacement of some traditional approaches in surgical care has demonstrated that surgical recovery can be accelerated and convalescence decreased. these multimodal approaches focuses on enhancing recovery and reducing morbidity by reduction of surgical stress,minimal invasive surgery, optimized pain relief, early nutrition and ambulation. in postoperative, the bed rest leads to the increase in muscle loss and weakness, impairs pulmonary function, predisposes to venous stasis and thromboembolism, increases infection complications and reduces functional capacity even in patients who are not restricted to bed. however, few studies have focused on when start the mobilization and which effects on functional capacity of exercise and lung function during hospital stay. in this trial the investigators will consider early rehabilitation to be safe and feasible in nuss procedure.

Eligibility criteria:
inclusion criteria: * children who are scheduled to undergo a surgical procedure for the correction of pectus excavatum * sign the informed consent form * independent ambulation * ability to understand and follow instructions * ability to perform lung function test exclusion criteria: * contraindications for epidural catheter placement * patients undergoing the open surgical repair of pectus excavatum * refusal to do physical exercises on postoperative * patients did not perform the six-minute walk test and lung function test on postoperative

Keywords: nuss procedure postoperative care early ambulation
ips cells of patients for models of retinal dystrophies

Conditions: Retinal Dystrophies

Summary: the investigators are focused on inherited retinal dystrophies with an aim to further understand disease pathophysiology and to elaborate novel treatments, as, to date, there is no effective treatment to prevent blindness. the main goal of this study is to generate human cellular models of healthy and disease retinas and perform studies to evaluate the efficiency of gene therapy approaches for different diseases. skin biopsies of volunteers are cultured to isolate fibroblasts that are then reprogrammed into ips cells. healthy and disease-specific ips cells are then differentiated into retinal models. this study should help to elucidate disease pathways and to provide proof-of-concept for various therapeutic approaches.


Eligibility criteria:
inclusion criteria : * signed informed consent and * choroideremia : * males * chm mutation * with multimodal imaging anomalies in line with chm * all other presumed inherited retinal dystrophies with bilateral and symmetrical involvement with identified mutations in one of the retnet gene * all presumed inherited optic neuropathy with bilateral and symmetrical involvement with identified mutations * and in all cases or pattern * age from 5 to 70 * with appropriate health insurance exclusion criteria : * patient under tutorship or curatorship
speckle-tracking tricuspid annular plane systolic excursion

Conditions: Ventricular Function, Right

Summary: the study is designed to validate the use of speckle-tracking echocardiography to measure tricuspid annular plane systolic excursion as a measurement of right ventricular function during transesophageal echocardiography.

1. use of speckle-tracking echocardiography to validate tricuspid annular plane systolic excursion measurements with transesophageal echocardiography. 2. this study intends to validate the use of speckle-tracking echocardiography to measure the distance the tricuspid annulus moves during the systolic phase. the guideline articles regarding right ventricular function suggest m-mode measurements from the transthoracic approach and the same measurements may underestimate the actual distance on transesophageal echocardiography. this speckle-tracking technology will allow this distance to be measured despite its often non-parallel motion to the ultrasound beam, which otherwise limits the reliability of the valve recorded. 3. all subjects undergoing a planned surgical procedure in which the use of transesophageal echocardiography would be used regardless for their management. 4. no interventions, only evaluation of the measurements obtained with transthoracic echocardiography compared to transesophageal echocardiography. 5. no follow-up, study will be completed at the time of image acquisition.

Eligibility criteria:
inclusion criteria: * all subjects who are scheduled to undergo general anesthesia and concurrently will be managed with intraoperative transesophageal echocardiography will be included in potential subjects. exclusion criteria: * subjects who do not have adequate transesophageal and/or transthoracic imaging windows to allow for accurate analysis of tricuspid annular motion.

Keywords: speckle-tracking echocardiography transthoracic echocardiography transesophageal echocardiography
the effect of glp-1 receptor agonist on bone metabolism in patients with diabetes mellitus

Conditions: Diabete Type 2; Bone Metabolism

Summary: through an one-year follow-up, to explore the effect of glp-1 receptor agonist on bone metabolism in patients with diabetes.

this study is a single-center observational study. after the patients were enrolled according to the standard of admission and exclusion, on the basis of the original scheme, glp-1 receptor agonists were added and followed up for one year. the indexes of bone metabolism and body fat were measured at several time points (3 months, 6 months, 9 months and 12 months after treatment). bone mineral density (bmd) was measured at several time points (6 months and 12 months after treatment) to explore the effect of glp-1 receptor agonists on bone metabolism in patients with diabetes.

Eligibility criteria:
inclusion criteria: 1. diagnosed patients with diabetes 2. hba1c≥7.5%； 3. willing to sign a written informed consent form and abide by the research plan exclusion criteria: 1. any of the following drugs or treatments were used within one month before screening: treated with glp-1ra, glp-1 analogues, dpp-4 inhibitors, or any other enterotropic insulin analogue 2. long-term intravenous, oral and intra-articular administration of corticosteroids within 2 months before screening (more than 7 days in a row) 3. use of weight control drugs or surgery that can lead to weight instability within the first 2 months of screening, or are currently in the weight loss plan and are not in the maintenance stage 4. history of acute and chronic pancreatitis; history of myeloid c cell carcinoma, men (multiple endocrine tumors) 2a or 2b syndrome, or related family history 5. there is a clinically significant abnormal gastric emptying. 6. screening of any organ system tumors that have been treated or untreated within the previous 5 years 7. underwent coronary angioplasty, coronary stent implantation and coronary artery bypass surgery within 6 months before selection, resulting in negligent compensatory heart failure (new york heart association nyha classification iii and iv), stroke or transient ischemic attack, unstable angina pectoris, myocardial infarction, persistent and clinically significant arrhythmias. 8. acute metabolic complications occurred within 6 months before screening. （9）before screening, any laboratory test index meets the following criteria: glutamic pyruvic transaminase \> 2.5 times or aspartate oxaloacetic transaminase \> 2.5 times; egfr \ 5.64mmol/l
childhood autism risks from genetics and the environment (the charge study)

Conditions: Autism; Developmental Disabilities

Summary: the purpose of this study is to understand how genes, environment, and the interplay between the two, influences the development of autism and other neurodevelopmental disorders.

the causes and contributing factors for autism are poorly understood. evidence suggests that incidence is increasing, but diagnostic changes and improvements may be playing a role. both genetic and environmental factors appear to play a role. autopsy studies demonstrate structural changes in the brain and clinical investigations reveal neurophysiologic differences in information processing in autistic versus normal children. members of our team recently demonstrated altered levels of certain neuropeptides at birth in children who later developed autism. this case-control study is the first large-scale epidemiologic investigation of underlying causes for autism and triggers of regression. this study capitalizes on the strengths of the case-control design, which is well suited to examine a broad array of factors for rare conditions that are thought to be multifactorial. comparisons will be made with both general population controls and mentally retarded children. the aims are to assess the influence of exogenous exposures, the role of susceptibility factors, and the interplay between these two in the etiology of autism and its phenotypic variation. chemicals with known or suspected neurodevelopmental toxicity, such as pcb's, certain pesticides, and metals, are being investigated. this study pursues several hypotheses that have recently gained attention, including the combined measles, mumps, rubella vaccine and mercury present in vaccines given during infancy and early childhood. additionally, biochemical susceptibility is examined through characterization of metabolic, immunologic, and neuronal gene expression profiles and genetic polymorphisms.

Eligibility criteria:
inclusion criteria: * children between 2 and 5 years old * born in california * parents must speak either english or spanish * children must be living with at least one biologic parent exclusion criteria: * children not meeting eligibility criteria listed above * children not residing in selected geographical areas (please contact for more information about specific study locations)

Keywords: autism neurodevelopment neurotoxicology perinatology teratology
evaluation of the safety, tolerability and efficacy of a gene therapy drug for the treatment of pediatric fabry disease

Conditions: Fabry Disease

Summary: this is a single-arm, open label, single-dose clinical study to evaluate the safety, tolerability and efficacy of bbm-f101 injection in the pediatric fabry disease participants up to 52 weeks after infusion, and the long-term safety and efficacy of bbm-f101 injection up to 5 years after infusion. bbm-f101 injection is an adeno-associated virus (aav) gene therapy product for the treatment of pediatric fabry disease.


Eligibility criteria:
inclusion criteria: 1. the participant's legal guardian fully understands the objectives, nature, methods and potential risks of the study and signs a written informed consent; if the participant is \>= 8 years old, the participant must also agree to participate in the study and sign a written informed consent; 2. decreased α-gal a (α-galactosidase a) and confirmed diagnosis of fabry disease by genetic testing; 3. males or females aged ≥7 years and \<18 years old; 4. acceptable egfr (estimated glomerular filtration rate) result in screening period; 5. participants had at least one of the clinical manifestations for fabry disease; 6. acceptable capsid antibody titers; 7. acceptable anti α-gal a antibody titers; 8. acceptable laboratory values; 9. participant's legal guardian and participant with good cooperation and compliance; 10. use of reliable contraception methods during the study for adolescence. exclusion criteria: 1. positive for hepatitis b surface antigen (hbsag) or hepatitis b virus dna (hbv-dna), positive for hepatitis c virus rna (hcv-rna), positive for hiv or syphilis; 2. have potential liver diseases; 3. heart failure and severe arrhythmias; 4. severe allergic reactions for enzyme replacement drugs or other medications; 5. acute/chronic infections; 6. end-stage renal disease; 7. have a vaccination history within 30 days prior to screening, or have a vaccination plan during the screening period and the main study period; 8. have received gene therapy or used other investigational drugs within four weeks prior to dosing; 9. other conditions that make the participant not eligible for the study according to the investigator.

Keywords: fabry