Kornimate/medical-research-clean huggingface dataset:
a study of clinical outcomes of the realize adjustable gastric band-c

Conditions: Morbid Obesity

Summary: the purpose of this study is to evaluate the results patients are obtaining with the realize™ adjustable gastric band-c during the first 24 months after surgery.


Eligibility criteria:
inclusion criteria: 1. received an implant with the realize band-c according to the following indications for use: 1. body mass index (bmi) of at least 40 kg/m2, or a bmi of at least 35 kg/m2 with one or more co-morbid conditions. 2. male and female adult patients (adult is defined as 18 years of age or older) 3. failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs. 2. able to comprehend, follow, and give signed informed consent. exclusion criteria: 1. inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as crohn's disease; 2. severe cardiopulmonary disease or other serious organic disease; 3. upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases; 4. portal hypertension; 5. anomalies of the gastrointestinal tract such as atresia or stenosis; 6. cirrhosis of the liver; 7. chronic pancreatitis; 8. localized or systemic infection; 9. on chronic, long-term systemic steroid treatment or systemic steroids within 15 days of surgery; 10. unable or unwilling to comply with dietary restrictions required by this procedure; 11. known allergy to materials contained in the gastric band or its injection port; 12. women who are pregnant; 13. women at childbearing potential planning to get pregnant within 2 years or not using acceptable methods of contraception.
vitamin d status and dose response in infants

Conditions: Vitamin D; Prematurity

Summary: this study will examine the relationship of serum 25(oh)d levels in infants 32 weeks and greater gestation who are fed infant formula to markers of inflammation and bone metabolism.

it is hypothesized that serum 25(oh)d levels in infants 32 weeks and greater gestation are not maintained at optimal levels of greater than 32 ng/ml with currently available infant formulas, and that this will have an inverse relationship with markers of inflammation and bone metabolism.

Eligibility criteria:
inclusion criteria: * greater than 32 weeks gestation, * exclusively formula fed. exclusion criteria: * less than 32 weeks gestation, * less than 1500 grams, * recieving maternal breast milk, * recieving parenteral nutrition, * congenital anomolies, * disorders of vitamin d metabolism, * inborn errors of metabolism, * seizure disorders, * parathroid disease, * liver, gi tract, or kidney disease, and * disorders of calcium metabolism.

Keywords: vitamin d prematurity 25(oh)d infant crp pth
controlled attenuation parameter (cap) in liver allografts

Conditions: Liver Transplant; Liver Steatosis; Liver Disease; Primary Non-function; Early Allograft Dysfunction

Summary: the primary aim is to determine the accuracy of cap in the quantification of liver steatosis using liver biopsies as reference. secondarily, investigators will correlate transient elastography (te) and cap results, analyze possible associations between cap/te and post-liver transplant (lt) clinical outcomes, and evaluate the change in cap after lt. the study aims to include as many donors as needed to achieve at least 120 transplanted liver allografts.

this is a coordinated study utilizing 3 recruitment centers (university of arkansas for medical sciences \[uams\], stanford university, and mayo clinic) 2 liver pathology reading centers (university of michigan and mayo clinic), and 1 coordinating center (university of arkansas). the cohort study with a cross-sectional component for the primary aim has been completed (through independent institutional review board \[irb\] agreements) at uams, stanford university, and the mayo clinic. the samples collected at the three recruitment centers will be sent to the biopsy center at the university of michigan and mayo clinic for evaluation. the liver transplant program at each of the 3 recruiting centers will identify study subjects during the process of liver allocation to their listed recipients. criteria for recruitment are as follows: inclusion criteria - liver recipient * men and women, age 18-years old to 80-years old inclusive inclusion criteria - liver donor * valid te with fibroscan 530, defined as: * at least 10 valid measurements * interquartile range (iqr)/median stiffness value \ 7.1 kpa) exclusion criteria - liver recipient * patient did not undergo liver transplantation exclusion criteria - liver donor * donation after circulatory death (dcd) * no liver biopsy obtained during organ procurement process

Eligibility criteria:
inclusion criteria - liver recipient * men and women, age 18-years old to 80-years old inclusive inclusion criteria - liver donor * valid te with fibroscan 402/530, defined as: * at least 10 valid measurements * iqr/median stiffness value \ 7.1 kpa) exclusion criteria - liver recipient * patient did not undergo liver transplantation exclusion criteria - liver donor * donation after circulatory death (dcd) * no liver biopsy obtained during organ procurement process
specified drug-use survey on vedolizumab for iv infusion 300 mg [ulcerative colitis]

Conditions: Ulcerative Colitis

Summary: the purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (iv) infusion 300 milligrams (mg) in ulcerative colitis (uc) patients in the routine clinical setting.

the drug being tested in this survey is called vedolizumab for iv infusion 300 mg. this drug is being tested to treat patients who have uc. this survey is an observational (non-interventional) study and will look at the long-term safety and effectiveness of vedolizumab for iv infusion 300 mg in the routine clinical setting. the planned number of observed patients will be approximately 1,000. this multi-center observational trial will be conducted in japan.

Eligibility criteria:
inclusion criteria: 1. have moderate or severe active uc 2. have inadequate response to existing therapies exclusion criteria: patients with any contraindication for vedolizumab
a study of bitopertin (ro4917838) in combination with selective serotonin reuptake inhibitors (ssris) in participants with obsessive-compulsive disorder (ocd)

Conditions: Obsessive-Compulsive Disorder

Summary: this multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of bitopertin in combination with ssri in participants with obsessive-compulsive disorder. participants will be randomized to receive either bitopertin 30 milligrams (mg) or bitopertin 10 mg or placebo orally daily in addition to their background therapy with an ssri. participants will be allocated to one of two strata. participants in stratum 1 will start study drug on day 1. participants in stratum 2 will receive placebo from day 1 (placebo lead-in) and will then start study drug at the week 2 visit. participants in both strata will receive the study drug in addition to their background therapy with an ssri until week 16.


Eligibility criteria:
inclusion criteria: * primary diagnosis of ocd as per diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) * on a stable dose of ssri for at least 8 weeks prior to screening an between screening and day 1 * an insufficient response to current treatment with an ssri given at an adequate dose for at least 12 weeks prior to day 1 * females who are not postmenopausal or surgically sterile and who have (or may have) male sexual partners must agree to use two adequate methods of contraception as defined by protocol from the start of screening until 90 days after the last dose of study drug exclusion criteria: * primary ocd symptom of hoarding * more than two unsatisfactory trials within the last 2 years with different serotonin reuptake inhibitors (not including the current treatment with an ssri) given in an adequate dose for at least 12 weeks * failure of more than three augmentation therapies within the last 2 years * undergoing acute behavioral therapy or having acute behavioral therapy that was completed less than 4 weeks prior to day 1 * any primary dsm-iv-tr axis i disorder other than ocd * current or prior history of bipolar disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, or gilles de la tourette syndrome if symptoms have persisted into adulthood * any eating disorder within the last 6 months * history of dsm-iv-tr-defined substance dependence and/or substance abuse in the last 6 months, with the exception of nicotine * previous treatment with bitopertin or another glycine transporter 1 inhibitor * positive urine drug screening for cannabis, amphetamines (including 3,4-methylenedioxymethamphetamine \[mdma\]/ecstasy), cocaine, barbiturate, and/or opiates * prior or current general medical condition that may impair cognition or other neuropsychiatric functioning * body mass index less than (\ ) 40 kg/m\^2 * pregnant or lactating women
improving risk stratification of emergency department patients with acute heart failure

Conditions: Heart Failure

Summary: the primary goal is to build and test a previously developed and validated risk model and clinical decision support tool embedded within the electronic health record to improve risk stratification of emergency department (ed) patients with acute heart failure (ahf).

the study team will build an electronic health record-embedded clinical decision support tool using a recently developed risk prediction model that curates patient-specific data in real-time, accurately estimates short-term patient risk, and presents tailored clinical recommendations. this will be a regional implementation study in which the tool is turned on at 21 emergency departments (ed) across kaiser permanente northern california (kpnc). the study team will validate risk predictions and study key clinical outcomes as part of this trial.

Eligibility criteria:
inclusion criteria: * adult (≥18y) kpnc members treated in the ed for presumed acute heart failure exclusion criteria: * children (\<18y). * patients who left against medical advice or eloped prior to ed physician evaluation.

Keywords: emergency department risk prediction
fmt for remission of active ulcerative colitis in adults

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases

Summary: the goal of this study is to establish the safety and effectiveness of lyophilized (lyo) fecal microbiota transplant (fmt) for treating ulcerative colitis (uc) in adults. the protocol is being re-designed to address relevant, current research questions in the context of fmt treatment for uc. once a final protocol is approved, this webpage will be updated.


Eligibility criteria:
inclusion criteria: * able to provide informed consent. * willing and able to comply with all the required trial procedures * active ulcerative colitis as defined by mayo score \> 3 and mayo endoscopic sub-score \> 1 (within 30 days before enrollment, or at baseline) exclusion criteria: * planned or actively taking another investigational product * abdominal surgery within the past 60 days * patients with neutropenia with absolute neutrophil count \<0.5 x 109/l at - evidence of toxic megacolon or gastrointestinal perforation on imaging * peripheral white blood cell count \> 35.0 x 109/l at enrollment and temperature \> 38.0oc * active infectious diarrhea at the time of enrolment * increase in medical therapy for uc within 3 months of enrollment. continued treatment with stable dose of 5-asa, azathioprine, 6-mercaptopurine, cyclosporine, prednisone and/or anti- tnf agents for at least 3 months of is allowed * severe uc requiring hospitalization at the time of enrolment * pregnant or lactating * history of anaphylaxis to any food * requiring oral and/or intravenous systemic antibiotic therapy at the time of study enrolment * unwilling to discontinue probiotic (yogurt is allowed) * severe underlying disease such that the patient is not expected to survive for at least 30 days. * any condition that in the opinion of the investigator that would pose harm to the participant or the research staff for the potential participant to take part in the trial

Keywords: ulcerative colitis fecal microbiota transplant fmt inflammatory bowel disease ibd
effectiveness of chinese handwriting intervention program for children with asd

Conditions: Autism Spectrum Disorder

Summary: this research aims to investigate the effectiveness and acceptability of the newly developed chinese handwriting performance intervention program


Eligibility criteria:
inclusion criteria: 1. first or second grader 2. reported problems with poor handwriting legibility or performed less readable handwriting as claimed by their school teachers or caregivers 3. score at most 33 scores in overall legibility dimension or at-least 45 incorrect strokes in chinese handwriting legibility assessment for children (chlac) 4. previously diagnosed with asd 5. and score at least seven scores in autism behavior checklist taiwan version (abc-t) will be included in this study. exclusion criteria: 1. any physical disability affecting the upper limb 2. any hearing or visual impairment 3. intelligence quotient below 70 or previously diagnosed with intellectual disability 4. unable to follow the evaluation instruction.

Keywords: handwriting performance neurodevelopmental disorder visual perceptual skills fine motor skills visual motor integration skills
a study in japanese children with short bowel syndrome who completed shp633-302

Conditions: Short Bowel Syndrome

Summary: the purpose of this clinical study is to evaluate the long-term safety and tolerability of teduglutide treatment in japanese pediatric participants with short bowel syndrome (sbs) who completed study shp633-302 (nct02980666).


Eligibility criteria:
inclusion criteria: * informed consent by a parent or guardian prior to any study-related procedures. * when applicable, informed assent (as deemed appropriate by the institutional review board \[irb\]) by the participant prior to any study-related procedures. * participant completed study shp633-302 (nct02980666). * participant (and/or parent/guardian) understands and is willing and able to fully adhere to study requirements as defined in this protocol. exclusion criteria: there are no exclusion criteria for this study.
postoperative osteopathic manipulative treatment in bariatric surgery

Conditions: Pain; Bariatric Surgery Candidate

Summary: context pain control is one of the most challenging problems encountered in postoperative period in bariatric patients. currently there are no published studies evaluating osteopathic manipulative treatment in bariatric surgery patients. objective the primary objective of this study is to determine whether osteopathic manipulative treatment (omt) can decrease pain score in bariatric patients. the secondary objective is whether omt can improve patient satisfaction with overall treatment. design: a prospective randomized group controlled study. setting: a 293-bed non-for-profit teaching community hospital. methods thirty-six patients scheduled for bariatric surgery as per asmbs criteria were eligible for study from january 2017 through august 2018 at flushing hospital medical center, new york. twelve patients were excluded. twenty-four patients were included into study and randomized to receive omt(n=12) vs control (n=12) intervention. in control group, patients received standard pain control protocol with morphine patient controlled analgesia pump (pca) in omt group, patients received standard postoperative pain protocol and omt on postoperative day one. three techniques were used (sub-occipital release, thoracic outlet release, and rib raising). all patients received survey to complete prior to discharge measuring pain score (1-10), patient satisfaction score 1-4 (poor, fair, good, excellent) and data was analyzed.


Eligibility criteria:
inclusion criteria: * adults age 18 and older eligible for bariatric surgery as per american society for metabolic and bariatric surgery guidelines: * bmi of at least 40, or greater than 100 pounds overweight. * bmi of 35 or above and at least one or more obesity-related comorbidity such as type ii diabetes, hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, lipid abnormalities, gastrointestinal disorders, heart disease, or osteoarthritis. * inability to achieve a healthy weight loss sustained for a period of time with prior weight loss efforts. exclusion criteria: * age less than 18. * pregnant patients. * patients with history of chronic pain. * patients with diagnosed psychiatric disorders. * patients actively taking pain medication before surgery. * patients with prior surgical history
new mri techniques for diagnosis and treatment of patients with abdominal aortic aneurysms

Conditions: Abdominal Aortic Aneurysm Without Rupture

Summary: an abdominal aortic aneurysm (aaa) is a pathological dilatation of the aorta in the belly which can rupture leading to bleeding within the belly. to prevent rupture elective surgery can be performed. endovascular repair (evar) is a surgical intervention whereby a stent is inserted into the aaa to prevent it from further growth and rupture. standard aaa management has several drawbacks. to start: maximum aaa diameter is used to determine upon timing of elective repair but is imprecise in predicting the risk of rupture resulting in an unmet clinical need. secondly, evar outcome and complication occurrence remain unpredictable due to poor prediction ability of computed tomography (ct) and ultrasound (us) utilised in the follow-up protocol. lastly, patients and physicians are being repeatedly exposed to cumulative radiation toxicity. all these drawbacks could be solved by trading the standard imaging modalities by magnetic resonance imaging (mri). within the marvy, advanced mri techniques are used to find out if standard imaging techniques could be replaced by mri in three phases of the aaa management (surveillance, surgery planning and post-operative follow-up). the two most important mri techniques that will be used are 4d flow mri and dynamic contrast enhanced (dce) mri which give respectively information about the blood flow within the aaa and perfusion of the aortic wall.


Eligibility criteria:
inclusion criteria: * diagnosed with aaa * provision of written informed consent inclusion criteria for surveillance part: * maximum aaa diameter between 3-5 cm * not scheduled for aneurysm repair at the time of inclusion inclusion criteria for planning part: * planned for elective evar inclusion criteria for follow-up part: * ten complication free years after evar or sac regression after evar; or * type i endoleak after evar; or * type ii endoleak after evar; exclusion criteria: * supra- or pararenal aaa * inflammatory, infectious or mycotic aaa * vasculitis and connective tissue disease * patients that underwent open surgical repair for their aaa * patients with ruptured aaas * patients that previously presented with allergic reactions to intravenous contrast agents exclusion criteria for surveillance part: * previous aaa repair * severely reduced renal function * previous allergic reactions to intravenous contrast agents exclusion criteria for planning part: * previous aaa repair exclusion criteria for follow-up part: * severely reduced renal function * previous allergic reactions to intravenous contrast agents

Keywords: abdominal aortic aneurysm magnetic resonance imaging 4d flow mri dce mri
a comparison of 122-0551 foam versus vehicle foam in subjects with plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this phase 3 study has been designed to determine and compare the efficacy and safety of 122-0551 foam and vehicle foam applied twice daily for two weeks in subjects with plaque psoriasis.


Eligibility criteria:
inclusion criteria: * subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% affected body surface area. * subject has an investigator's global assessment (iga) score of at least three (moderate) at study start. * if subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study. exclusion criteria: * subject has spontaneously improving or rapidly deteriorating plaque psoriasis. * subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis. * subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation. * subject has used any phototherapy (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to study start. * subject has used any systemic methotrexate, retinoids, systemic corticosteroids \[including intralesional, intra-articular, and intramuscular corticosteroids\], cyclosporine or analogous products within 90 days prior to study start. * subject has used any systemic biologic therapy (i.e., fda-approved or experimental therapy) within five half-lives of the biologic prior to study start.
how do i perform a laparoscopic removal of a pelvic retroperitoneal schwannoma

Conditions: Endometriosis Pelvic

Summary: schwannomas are mainly benign tumors, which develop mainly in the skull or in the cervical region. retroperitoneal location is rare, since it represents between 0.5 and 5% of scwhanomas. the malignant retroperitoneal form is, however, more common than in other locations. retroperitoneal schwannoma is often discovered during the exploration of unexplained lumbo-pelvic pain, or in the face of compression of nearby organs. abdominopelvic ct and magnetic resonance imaging are essential to characterize the mass and verify its extension. the precise diagnosis is based on the pathological examination of the part, and complete surgical excision is the standard treatment. acquiring the surgical techniques and skills necessary to carry out these types of procedures is essential to providing optimal patient care.


Eligibility criteria:
inclusion criteria: * adult patient (≥18 years old) * suffering from symptomatic deep pelvic endometriosis * having received treatment at the strasbourg university hospital during 2021 for a retro-peritoneal pelvic carcinoma * having not expressed, after information, the reuse of their data for the purposes of this research. exclusion criteria: * patient who expressed her opposition to participating in the study

Keywords: endometriosis pelvic schwannomas