Kornimate/medical-research-clean huggingface dataset:
confocal laser microendoscopy (celltouch) for the diagnosis of early gastric cancer: a multicenter clinical study

Conditions: Early Gastric Cancer

Summary: this study is a prospective, randomized, multicenter clinical trial: the study intends to include subjects suspected of early gastric cancer, including 378 subjects with neoplastic lesions and 200 subjects with non-neoplastic lesions. the subjects are divided into two groups by random envelopes, a and b, and the endoscopic diagnosis in different groups is performed in different order (including: white light endoscopy,celltouch, magnifying endoscopy with nbi(me-nbi)). finally, the gold standard of histopathology was used to evaluate the diagnostic performance of celltouch in the diagnosis of early gastric cancer.the study hypothesized that the sensitivity and specificity of celltouch in the diagnosis of early gastric cancer could reach more than 90% and more than 95%.

objectives: 1. histopathology was used as the gold standard to evaluate the diagnostic performance of celltouch in the diagnosis of early gastric cancer. secondary objectives 1. using histopathology as the gold standard, the diagnostic performance of celltouch and me-nbi in the diagnosis of early gastric cancer was compared and analyzed. 2. histopathology was used as the gold standard to evaluate the diagnostic performance of celltouch combined with me-nbi and me-nbi alone in the diagnosis of early gastric cancer. 3. histopathology was used as the gold standard to evaluate the diagnostic performance of celltouch and me-nbi in the differential diagnosis of low-grade intraepithelial neoplasia and high-grade intraepithelial neoplasia.

Eligibility criteria:
inclusion criteria: 1. patients aged between 18 and 70 years; 2. patients who have recently found suspicious lesions by gastroscopy and need further intensive examination;(suspicious lesions refer to suspected superficial neoplastic lesions visible under white light endoscopy, including elevation type, flatness type and depression type. according to the paris classification standard); 3. patients who willing to provide written informed consent. exclusion criteria: 1. patients with absolute contraindications to gastroscopy; 2. patients with advanced gastric cancer; 3. patients who cannot undergo histopathological examination; 4. patients who cannot be given general anesthesia; 5. patients who are pregnant or lactating patients, or prepare to conceive or who are at risk of conception due to lack of effective contraception； 6. patients with history of drug allergies, such as anesthetics, fluorescein sodium, bowel preparation drugs, etc.
contrast enhanced mammography in diagnosing patients with suspicious breast findings

Conditions: Breast Neoplasms

Summary: this pilot trial studies how well contrast enhanced mammography works in diagnosing patients with suspicious breast findings. diagnostic procedures, such as contrast enhanced mammography, may help to reclassify findings seen on diagnostic mammography and ultrasound as benign or likely benign with what would otherwise require biopsy for confirmation.

primary objectives: i. to obtain preliminary data to support the hypothesis that contrast enhanced mammography (cem) can reduce benign tissue diagnosis (fp3) and therefore improve positive predictive value 3 (ppv3). secondary objectives: i. identify specific cem characteristics that accurately classify a finding as benign, high-risk or malignant. ii. assess the positive and negative predictive values for each digital breast tomosynthesis (dbt), breast ultrasound and cem. exploratory objectives: i. to compare the outcomes/endpoints stratified by age to determine if age affects the ability of cem to accurately define a lesion as benign, probably benign or suspicious. outline: patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day or up to 3 days later.

Eligibility criteria:
inclusion criteria: * women with digital breast tomosynthesis and/or ultrasound assessments of breast imaging reporting and data system (bi-rads) 4 and 5 lesions with recommendation of needle biopsy for tissue diagnosis. * abnormal findings include masses, focal, global or developing asymmetries, architecture distortions, or \> 1 cm of suspicious calcifications with or without associated ultrasound abnormal findings. * scheduled for imaging guided percutaneous needle biopsy. * provide signed and dated informed consent form. * if patient is of childbearing potential, a negative pregnancy test, urine or blood, within 14 days prior to the scan. exclusion criteria: * \< 1 cm span of calcifications without an ultrasound correlate. * pregnant patients. * patients with known allergy to iodinated contrast material. * if patient answers yes to any of the below questions they need glomerular filtration rate (gfr) prior to contrast administration regardless of their age: * have you ever been told you have renal problems? * have you ever been told you have protein in your urine? * do you have high blood pressure? * do you have diabetes? * do you have gout? * have you ever had kidney surgery?
study of two schedules of infliximab maintenance therapy in ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: continuous treatment with the anti-tumor necrosis factor alpha monoclonal antibody infliximab is efficacious in ankylosing spondylitis (as), whereas treatment discontinuation results in disease relapse, with variable delay. objective of this study was to compare efficacy between a continuous treatment with infliximab, and a treatment adapted to symptoms recurrence. addition of methotrexate (mtx)to infliximab was also tested.

patients with active as were randomly assigned to receive infliximab every 6 weeks (q6), or only upon symptoms recurrence (on-demand), following a loading regimen of infusions at weeks 0, 2, and 6. patients in the latter group were randomly assigned to receive mtx or not, starting 4 weeks prior to infliximab. monitoring was performed over one year. the primary end point was the proportion of patients with a 20% improvement response according to the assessment in ankylosing spondylitis (asas) criteria, at week 54.

Eligibility criteria:
inclusion criteria: * adult patients (\> 18 years old) * with a diagnosis of as * with at least one of the following evidences for active inflammation, present within 3 months before inclusion: a serum c-reactive protein (crp) level above twice the upper limit value of the normal range, a positive magnetic resonance imaging of the spine or sacro-iliac joints, a vascularized enthesitis by power-doppler ultrasound technic. * presence of clinically active axial disease, as defined by 1) a bath as disease activity index (basdai) (18) of ≥ 3/10, and 2) a score of ≥ 3/10 for axial pain (second item of basdai). * disease-modifying antirheumatic drugs (dmards), such as sulphasalazine, methotrexate, hydroxychloroquine, intra-muscular gold, thiol compound, cyclosporin, intravenous biphosphonate had to be discontinued for at least 4 weeks before inclusion. * dosages of nsaids and corticosteroid were required to remain stable for at least 4 weeks before inclusion. * a negative pregnancy test result was required for non menopausal female patients, and contraception during the study period and for six months after the last infusion of infliximab was recommended to all patients of childbearing potential. exclusion criteria: * pregnancy. * breastfeeding. * vaccination with a live organism during the last month. * present infection or any episode of serious infection within the last three months. * active malignancy within the previous five years. * alcohol or drug addiction. * severe chronic concomitant disease. * administration of an investigational drug within the last three months, or of any known tnf inhibitor therapy in the past (such as thalidomide, infliximab or etanercept).

Keywords: ankylosing spondylitis infliximab systematic regimen on-demand regimen
study of microbiota in bile from patients with common bile duct stone during ercp

Conditions: Cholangiopancreatography, Endoscopic Retrograde; Common Bile Duct Calculi; Microbial Colonization

Summary: in this study, investigators will investigate the microbiota of bile in common bile duct stone participants. three key questions are of concern. the first one is whether there is bacteriria in bile in participants without common bile duct stone. the second one is whether the microbiota of bile is similar with that of gut mucosa in common bile duct stone participants. the third one is whether the bacteria in bile of common bile participants with intact papillar is the same as that of participants underwent sphinctomy.


Eligibility criteria:
inclusion criteria: * cbd tumor or cbd calculi exclusion criteria: * contraindication for ercp

Keywords: ercp cbd stone microbial colonization
family workshops for bipolar disorder

Conditions: Bipolar Disorder

Summary: this pilot study is looking at the effects of a brief psychoeducational workshop. these one day workshops are designed to increase family members knowledge about bipolar disorder and to help with processing emotions that go along with having a relative with bipolar disorder.


Eligibility criteria:
inclusion criteria: * self-identified adult relatives of people diagnosed with bipolar disorder between ages 18 and 64; up to two persons per family can participate in the multifamily group exclusion criteria: * relative with bipolar disorder will not be involved in the workshop

Keywords: relatives bipolar disorder psychoeducation
establishment of natural history of scorpion envenomation

Conditions: Scorpion Sting Envenomation

Summary: this retrospective study was conducted to collect data from approximately 100 patients from 6 months to 18 years of age who were stung by a scorpion but were not treated with antivenom. the study consisted of a review of hospital records of patients who were admitted for intensive care management of scorpion envenomation, at the only two hospitals in north america known to admit children routinely for scorpion sting management without antivenom. the standard of care consisted of symptomatic and supportive care, including airway maintenance, fluid and electrolyte support and, if necessary, sedation.

the study objective was to document the clinical syndrome of scorpion envenomation in the absence of antivenom treatment in pediatric patients. this was done to establish historical control data on the time from sting to the time of resolution of signs of envenomation. these historical control data are intended to be used for comparison with alacramyn treated patients in two prospective studies being conducted in mexico and the u.s.for which a control population could not otherwise be established. the total duration of clinically important systemic signs of envenomation was determined based upon overall investigator assessment of the last signs of any respiratory compromise, any pathological agitation or other indicator of continuing illness (e.g., continuing need for sedative administration). to facilitate comparison of these historical data with prospective open label trials, periodic assessments of the overall presence or absence of clinically important signs was performed. periodic assessments were also performed for each individual component indicator of respiratory compromise and of pathological agitation, when available. a research nurse reviewed hospital discharge diagnoses for all pediatric charts coded for "scorpion sting". for these cases demographic, diagnostic, and therapeutic data were entered on the case report form (crf) as well as data necessary to assess compliance with study inclusion and exclusion criteria. a physician subinvestigator reviewed the research nurse's findings for the key outcome indicators, which consisted of clinically important systemic signs of scorpion envenomation and adjunctive sedation treatment (dose and timing of dose) when medical judgment was required.

Eligibility criteria:
inclusion criteria: * males and females 6 months to 18 years of age * presenting for emergency treatment with clinically important systemic signs of scorpion sting envenomation exclusion criteria: * use of any antivenom within the last month or concomitantly * signs and symptoms confined to local sting site * concurrent medical condition involving a baseline neurologic status mimicking envenomation (chorea, tardive dyskinesia, uncontrolled epilepsy) * incomplete or unavailable medical record

Keywords: scorpion sting envenomation antivenom
comparison between early excision and grafting versus dressing and delayed grafting in deep burn mangement.

Conditions: Burns

Summary: * all the patients will be included in the study will be resuscitated on arrival in our department. * detailed history will be taken and burn evaluation will take place in respect to tbsa according to lund and browder chart and burn depth. * dreesing will be done with topical antimicrobial agent. * fluid resuscitation with lactated ringer's solution according to modified parkland's formula. * injectable proton pump inhibitors, and analgesics will be started as initial drug therapy. * close follow up of the patients will be done then evaluation of the patients will be done in the fourth day and dividing the patients into two groups: the first group "early exicion and grafting " and the second group " dressing and delayed grafting ". * the first group will include patients with early surgery from 4 to 10 days since burn. * dressing will be done for the second group every other day until spontanous eschar seperation or after surgiacl debridrment of adherent eschar then for delayed grafting more than 10 days post burn. * then the data will be collected and analyzed for comparison between the two groups regarding : the timing of operation and its relation to the length of stay, functional outcome and cost of treatment

* the first group will include : 1. patients with good general condition and hemodynamically stable that fit for early surgery. 2. patients that accept the option of early surgery and can give consent for it . 3. patients with available donor site for early grafting. 4. patients with burn at certain sites may be of priority for early excision and grafting to avoid long term complication of delayed wound healing such as : on joint surface, hands, feet, and face. * the early excision will be done surgically within 4-10 days post burn by whatson knife by tangential excision of burned tissue until capillary bleeding appears to make a good bed to be covered with grafts" split thickness grafts stg" at the same time. * the first dressing will be in the fifth day post operative. * in the other hand the second group will include: 1. patients with bad general condition or hemodynamicaly unstable at the early excision period (4-10 days post burn). 2. patients that refuse early surgery and give no consent for early surgery. 3. patients with no available donner site for early excision and grafting during the fourth day evaluation .

Eligibility criteria:
inclusion criteria: 1. patients who had deep second and third degree burns. 2. patients with flame and scald burns. exclusion criteria: 1. patients who had only first or superficial second degree burns. 2. patients with high voltage contact electric burns and chemical burns.
the effect of backward walking training on balance, gait and functional mobility in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: backward walking training can be a useful treatment approach, providing novel balance and gait challenges. it can lead to improve balance, gait and functional mobility in neurologic populations. however, the effect of backward walking training has net been investigated in people with multiple sclerosis.

multiple sclerosis is a chronic autoimmune disease of the central nervous system. patients with multiple sclerosis have problems in balance, gait, and functional mobility. this problems can lead to falls, injuries, hospitalization, limited daily living activities, and decreased quality of life. backward walking is a popular training approach to improve balance, gait, and functional mobility in other neurological disease such as stroke, and parkinson's disease. moreover, backward walking performance decreases in multiple sclerosis. however, no study has been performed to determine the effectiveness of backward walking training in multiple sclerosis. therefore, this study aimed to investigate the effect of backward walking training on balance, gait, and functional mobility in patients with multiple sclerosis.

Eligibility criteria:
inclusion criteria: * at least 18 years, * neurologist-diagnosed multiple sclerosis, * expanded disability status scale (edss) score between 0 and 5.5, * no ms exacerbation within the last 3 months, * use of stable medication in the last 3 months, * not received immunomodulator treatment within the last 6 months, exclusion criteria: * other neurologic disorder, * pregnancy, * cardiovascular, orthopedic, or systemic any disease hindering the participation of exercise program

Keywords: multiple sclerosis backward walking training balance gait functional mobility
genomic predictors of recurrent pregnancy loss

Conditions: Recurrent Pregnancy Loss

Summary: the overall goals of this proposal are to determine the genetic architecture of recurrent pregnancy loss (rpl) and to discover genomic predictors of rpl.

the following specific aims are proposed: aim 1: collect clinically well-characterized samples from trios (product of conception (poc), biological mother, and biological father) with unexplained rpl. specifically, a cohort of 1,000 trios that are rigorously-phenotyped will be recruited, and for which couples' rpl is not attributable to known causes. the poc and parental dna samples will be collected. if it is necessary for the purpose of determining the pathogenicity of sequence variants from the trio, collecting dna samples from other family members after consent will also be considered. the study team may also request dna or poc tissues from a prior pregnancy loss(es) if available. aim 2: a whole genome sequencing (wgs) at the yale center for genome analysis (ycga) will be performed and bioinformatic analyses to identify pathogenic variants in included trios will performed as well. pathogenic variants will be comprehensively defined and fully annotated variant maps in all included trios to provide the substrate for subsequent novel gene discovery, and ultimately, the development of clinical diagnostic tests will be generated.

Eligibility criteria:
1. women with loss of a current singleton pregnancy at \< 20 0/7 weeks gestation (documented by ultrasonography or histopathological examination) and one or more prior pregnancy losses. 2. euploid current pregnancy by karyotype or microarray (a limited number of aneuploid losses will be included as part of the pilot) 3. no history of parental karyotype abnormalities 4. no history of antiphospholipid antibody syndrome 5. no evidence of uncontrolled diabetes 6. no evidence of uncontrolled thyroid disease 7. no history of autoimmune disease (sle, ra) 8. no history of uterine anomalies 9. no history of cervical insufficiency
tranexamic acid during excisional burn surgery

Conditions: Burns; Blood Loss, Surgical; Blood Loss; Tranexamic Acid; Burn Excisional Surgery

Summary: the purpose of this study is to access the efficacy of the drug tranexamic acid in reducing blood loss during burn excision surgery.

this study is a double-blinded, randomized placebo-controlled trial. after informed consent patients will be randomized in either the placebo or the tranexamic acid group (1500 mg). the intervention will be conducted during burn excisional surgery. first, the participant with be anesthetized, whereafter the study medication is administered.

Eligibility criteria:
inclusion criteria: * patients scheduled for burn excisional surgery * an expected blood loss of ≥250ml based on the estimation by the performing surgeon on the basis of: (1) ≥ 2 % body surface area excision planned (100-200 cc / % total body surface area, (2) operation technique used (some techniques show more blood loss than others), (3) time after burn trauma (i.e. expected healing) * ≥18 year * informed consent of patient or legal representative * patients or legal representative should have enough knowledge of dutch to provide informed consent exclusion criteria: * patients with a recorded coagulopathy in their history * the use of anticoagulants (except acetylsalicylic acid or (intensive) prophylaxis low molecular weight heparin \>12 hours before surgery) * severe kidney failure (creatinine \>500 μmol/l) * allergy for tranexamic acid * diagnosis of acute venous-/arterial thrombosis within 3 months before inclusion * diffuse intravascular coagulation (based on the diffuse intranasal coagulation-score \>5) * pregnancy * active breastfeeding * history of epilepsy

Keywords: blood loss tranexamic acid burn excisional surgery burns
the university of michigan owl (online wellness and lifestyle) study

Conditions: Obesity

Summary: the goal of this trial is to pilot test our existing very low carbohydrate diet intervention, adapted for young adults.

obesity increases the risk of a variety of illnesses such as heart disease, type 2 diabetes, cancer, sleep apnea, asthma, and depression. while advice from the centers for disease control, american heart association, and the national institutes of health recommend a low-fat diet with a focus on whole grains and lean meats, research shows that a very low-carbohydrate diet may be more effective at reducing body mass index (bmi). given the disconnect between recommendations and research, higher quality, long term, large trials are needed. in preparation for that research, the investigators plan to pilot test a very low-carbohydrate diet program, the owl study (online wellness and lifestyle study), for 30 young adults followed over 4 months.

Eligibility criteria:
inclusion criteria: * age 18-25 * obese (bmi ≥ 30) * sufficient control over diet * access to internet and texting * living in the united states * willing and able to follow intervention and complete measurements exclusion criteria: * non-english speaking * pregnant, breastfeeding, or planning to be in the next 6 months * vegan or vegetarian * currently enrolled in weight loss program * taking medications known to cause weight loss or gain * taking glucose-lowering medications other than metformin * type 1 diabetes * cancer * heart failure * kidney failure * history of eating disorders * untreated psychiatric disorder * history of or planned weight loss surgery * consumption of greater than 30 alcoholic beverages per week

Keywords: nutrition diet, ketogenic diet, carbohydrate-restricted