Kornimate/medical-research-clean huggingface dataset:
trial comparing early laparoscopic enterolysis versus nonoperative management for high-grade sbo

Conditions: Small Bowel Obstruction

Summary: the goal is to assess the appropriateness of the standard practice of a trial of nonoperative management for high grade small bowel obstruction (currently up to 72 hours based on available literature). the investigator will offer early laparoscopic enterolysis (within 24 hours of admission) as the comparator group.

small bowel obstruction is a common disorder without a clearly superior management strategy. there are an estimated 300,000 surgeries performed annually with a health care expenditure burden in excess of 2.8 billion dollars. the investigators propose a new management paradigm including early laparoscopic management. contemporary management of sbo includes a trial of nonoperative management (tnom) reportedly with resolution in upwards of 70% of patients. although it is one of the most common diagnosis for surgical admissions, there are few prospective, clinical trials to address the question surgical timing. additionally, there are no prospective, randomized trials comparing early laparoscopy versus tnom for high grade sbo. the hypothesis is that early laparoscopic enterolysis will result in decreased overall complications, shorter length of stay, decreased health care cost, and lower conversion rate to open laparotomy.

Eligibility criteria:
inclusion criteria: * ct a/p showing high grade obstruction (all patients will obtain a ct a/p as per level 1 recommendations based on east practice guidelines) . * high grade bowel obstruction is defined as: * transition point * distal small collapse with proximal dilatation * small bowel feces sign * 50% difference in caliber change between proximal dilated bowel and distal decompressed bowel * intra-abdominal free fluid without clinical signs of ischemia exclusion criteria: * hemodynamic instability (sbp\<90) * peritonitis * enterocutaneous fistula * cirrhosis * previous enterolysis (more than 1) * contraindication to laparoscopic surgery * pregnancy
renal atherosclerotic revascularization evaluation: rave study

Conditions: Hypertension, Renovascular

Summary: the rave study will compare renal revascularization to medical management for people with atherosclerotic renal vascular disease (arvd) and the indication for revascularization.

it is uncertain whether patients with renal vascular disease will have renal or mortality benefits from re-establishing renal blood flow with renal revascularization procedures. patients will be assessed for the standard nephrology research outcomes of progression to doubling of creatinine, need for dialysis, and death, as well as other cardiovascular outcomes. the investigators will also establish whether the use of a new inexpensive, simple and available ultrasound test, the renal resistance index (rri), can identify patients with renal vascular disease who will not benefit from renal revascularization procedures.

Eligibility criteria:
inclusion criteria: * systolic blood pressure \> 140 mmhg and/or diastolic blood pressure \> 90 mmhg despite at least 3 antihypertensive medications * systolic blood pressure \>140 mmhg and/or diastolic blood pressure \> 90 mmhg on two antihypertensives with: a rise in creatinine \> 20% after initiation of an angiotensin-converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb); the sudden onset of hypertension occurring after age 55; hypokalemia or the presence of an abdominal bruit; a history of flash pulmonary edema; or any three of: peripheral vascular disease, coronary artery disease, cerebrovascular disease, smoking, hyperlipidemia, diabetes or male gender. exclusion criteria: * serum creatinine \> 220 umol/l or estimated glomerular filtration rate (gfr) by cockroft-gault equation \< 20 ml/min * patients who are unwilling or unable to give informed consent * known contraindication to renal revascularization such as anaphylactic allergy to contrast dye * an abdominal aortic aneurysm requiring surgery * a single functioning kidney; a total occlusion of the renal artery or renal artery stenosis due to fibromuscular dysplasia. * previous revascularization

Keywords: hypertension renal artery stenosis kidney disease renal vascular disease atherosclerosis
kinematic analysis: posterior stabilized, fixed bearing total knee arthroplasty with attune knee system - phase 2

Conditions: Total Knee Arthroplasty; Osteoarthritis

Summary: a better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (tkas) and to help design a prosthesis that most closely approximates the normal knee. specifically, posterior stabilizing (ps) knees have been found to be associated with lower amounts of posterior femoral rollback, higher occurrence of reverse axial rotation and increased amount of condylar lift-off. the depuy synthes joint reconstruction's attune ps fixed bearing (fb) knee system has incorporated subtle changes in its design to address restoration of kinematics that more closely resemble those of a normal knee. to understand if this design is able to effectively restore kinematics in the implanted knee, further in vivo analysis is necessary. this continuation of the study will analyze 30 subjects with the attune ps fb 3 months post-operatively using the university of tennessee's mobile fluoroscopy unit while performing three daily activities, level walking, ramp down and deep knee bend.


Eligibility criteria:
inclusion criteria: * at least three (3) months post-operative with no other surgical procedures conducted within the past six months * between 30-80 years of age * body weight of less than 280 lbs * must be between 160cm (5'3) and 193cm (6'4) tall * body mass index (bmi) \>18.5 and \<35 * judged clinically successful with a knee society score (kss) of greater than 80 * have good-to-excellent post-operative passive flexion with no ligamentous laxity or pain * must be able to walk on level ground without aid of any kind, perform a ramp descent, and a deep knee bend (dkb), all without assistance * will have a depuy attune ps tka exclusion criteria: * pregnant or potentially pregnant females will be excluded from the study.
clinical validation of the c-arm rotational view (carv) to avoid rotational malalignment after intramedullary nailing of tibial shaft fractures.

Conditions: Tibial Fractures; Surgery; Complication,Postoperative

Summary: tibia shaft fractures are common long bone fractures in the field of orthopaedic trauma. in the usa, a total of 492.000 tibial fractures were reported per year by the national center of health statistics (nchs). intramedullary nailing (imn) is the treatment of choice for shaft fractures. however, rotational malalignment (rm) remains an iatrogenic pitfall with a prevalence up to 30%. from a clinical point of view, there is limited knowledge on how to avoid rm during imn. clinical estimation of tibial alignment is difficult, resulting frequently in rm following imn. low-dose ct-assessment is considered the gold standard to objectify rm, but is performed after surgery when the opportunity for direct revision has passed. both difficulties in intraoperative clinical judgement of tibial alignment as well as postoperative detection of rm when the possibility for direct revision has passed, do support the need for an easy-to-use intraoperative fluoroscopy protocol to minimize the risk for rm during imn of tibial shaft fractures. recently, a standardized intraoperative fluoroscopy protocol named the 'c-arm rotational view (carv)' was determined in order to improve the accuracy of alignment control during imn of tibial shaft fractures. carv includes predefined fluoroscopy landmarks of the uninjured side to correct for rotational malalignment of the injured side in which the rotation of the c-arm image intensifier is used. promising preliminary results were found to reduce the risk on rm following imn of tibia fractures. however, a prospective trial is needed to determine the performance of carv in clinical practice. therefore, a prospective multi-center randomized controlled trial is designed to assess the clinical feasibility and potential benefits of the carv-protocol. the following primary research question was defined: can the risk for rm following imn of tibial shaft fractures be minimized by use of the carv-protocol?


Eligibility criteria:
inclusion criteria: * all consecutive patients (≥18 years) with an open or closed tibia shaft fracture, who are eligible for imn, will be asked to enroll in the study exclusion criteria: * the following exclusion criteria will be used: age \<18 years, fractures not suitable for imn and pathological fractures.

Keywords: intramedullary nailing tibia shaft fractures rotational malalignment c-arm rotational view multi-center randomized controlled trial.
development of a manual-based, interdisciplinary intervention for youth with asd and obesity

Conditions: Autism; Obesity

Summary: the purpose of the proposed study is to develop and pilot test a manual-based, interdisciplinary intervention for youth, ages 3 to 10 years, with autism spectrum disorder (asd) and overweight called the changing health in autism through nutrition, getting fit, and expanding variety (change) obesity program.

the purpose of the study is to develop and test the feasibility of a structured, innovative approach to treat obesity in 16 children (age 3 to 10 years) with autism spectrum disorder (asd). this 16-week program integrates behavioral psychology and nutrition science to meet the challenges of obesity in children with autism spectrum disorder (asd). the pi will apply an evidence-based behavioral intervention to increase food variety,15 use applied behavior analytic strategies to teach physical activities in a developmentally-appropriate manner, employ biometrics to assess progress, utilize dietetic interventions to improve nutritional balance, and train caregivers to use behavior management strategies.

Eligibility criteria:
inclusion criteria: * a diagnosis of asd confirmed by a clinical psychologist using a "gold standard" diagnostic tools * overweight status, as evidenced by a bmi percentile \> 85% to 94%, and 4) mild to no food selectivity, as evidenced by either history of consuming some fruits and vegetable, tolerating new foods near their plate, and/or trying new foods exclusion criteria: * children being treated with atypical antipsychotics (e.g., olanzapine, aripiprazole, risperidone) or other medications known to cause weight gain will be excluded from the study due to the weight gain associated with these medications * children with unstable medical conditions will be excluded for safety concerns * children presenting with severe aggression, self injury, or other disruptive behaviors that require intensive behavioral intervention will be excluded and referred to other services as needed

Keywords: asd
intrapulmonary percussive ventilation (ipv) versus nasal continuous positive airway pressure ventilation (ncpap) in transient respiratory distress of the newborn

Conditions: Respiratory Distress Syndrome, Newborn

Summary: during caesarean section, transient respiratory distress which occurs frequently (3%) with possible complications are at present managed by non invasive nasal continuous positive airway pressure ventilation (ncpap) associated with oxygen therapy. intrapulmonary percussive ventilation (ipv) is a non-invasive ventilatory mode used in some intensive care units to treat some respiratory distress syndrome of the newborn with a good tolerance, but without evaluation in prospective studies

* principal objective: to show that ipv ventilation can decrease the duration of transient respiratory distress as well as the risk of complications. * secondary objective: comparison between the two groups regarding: length of oxygen therapy, complications (pneumothorax, pulmonary infections), need for intensive care hospitalization * study design: open, prospective randomized trial. * inclusion criteria: neonates with gestational age ≥ 35 weeks and weight ≥ 2000g, caesarean section, respiratory distress syndrome (modified silverman score \> 5, spo2 \< 90%), management within 20 minutes after birth. * exclusion criteria: clinical thoracic retraction, congenital lung malformation, meconium aspiration, neonatal infection, other congenital malformations. * study plan: after the screening evaluation and written consent document, neonates will be randomized into two groups: ncpap ventilation or ipv. during the 6 hours after randomization, clinical data will be monitored: cardiac and respiratory frequency (cf -rf), saturation (sao2), oxygenotherapy, silverman score. then, neonates will be supervised 3 days after normalization of the respiratory distress. * number of subjects: 100 (50 in each group)

Eligibility criteria:
inclusion criteria: * caesarean newborn * gestational age ≥ 35 weeks * weight ≥ 2 kg * sao2 \< 90% after 10 min of life * silverman score ≥ 5 * treated less than 20 min after birth * social security affiliation (parents) * informed consent signed (parents) exclusion criteria: * thoracic retraction * congenital intrathoracic malformations * meconium aspiration * early neonatal infections with hemodynamic troubles * severe neonatal asphyxia * polymalformative syndrome

Keywords: hfpv neonatal respiratory distress
effect of rituximab on immunological recall response to specific antigens in the treatment of non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to provide treatment for patients who have relapsed non-hodgkin's lymphoma (nhl) or refractory nhl, and to test the immunity of study subjects after receiving four treatments with rituximab.


Eligibility criteria:
inclusion criteria: * signed irb-approved informed consent. * age \>/=40 years. * men and women of reproductive potential who are following accepted birth control methods. * histologic confirmation of low-grade or follicular, b-cell nhl prior to study entry. * relapsed (maximum of 5 relapses) or refractory, low-grade or follicular, cd20+,b-cell nhl. * who performance status \</= 2. * expected survival \>/= 1 year. * acceptable hematologic status, liver function, renal function, and pulmonary function. * patients must be recovered from all nonhematological toxicities associated with prior surgery, radiation treatments, chemotherapy, biological therapy, bone marrow transplant, investigational drugs, or immunotherapy. * known history of tetanus toxoid immunization or positive tetanus titer at the screening visit. exclusion criteria: * active autoimmune disease. * exposure to rituximab within 12 months prior to day 1. * chemotherapy within 3 months prior to day 1. * previous immunization with tetanus toxoid within 2 years prior to day 1. * previous exposure to klh. * receipt of intravenous or intramuscular immunoglobulin (ivig or imig) within 30 days of day 1. * known history of hepatitis or other hepatic disease, hiv infection, or aids. * current use (including "recreational use") of any illicit drugs or history of drug or alcohol abuse within the 5 years prior to day 1. * prior diagnosis of aggressive nhl or mantle-cell lymphoma. * chronic lymphocytic leukemia (cll). * small lymphocytic lymphoma (iwf a) with peripheral blood lymphocyte count \> 5,000 cells/mm3. * history of other primary malignancy, with the exception of squamous cell carcinoma or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer for which the subject has not been disease free for at least 3 years. * serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active, uncontrolled bacterial, viral, or fungal infection; or any other condition that would compromise protocol objectives in the opinion of the investigator and/or sponsor. * known allergies or contraindications to tetanus toxoid or klh. * known allergy to shellfish. * presence of protein-losing enteropathy. * major surgery, other than diagnostic surgery, within 4 weeks prior to day 1. * participation in another clinical study with an investigational agent or device within the last year. the subject cannot participate in any other clinical study with an investigational agent or device during the course of this study. * pregnant or lactating female subjects
a study assessing the efficacy and safety of de-117 ophthalmic solution in subjects with primary open angle glaucoma or ocular hypertension -ayame study-

Conditions: Primary Open Angle Glaucoma; Ocular Hypertension

Summary: the purposes of this study are to determine the optimal concentration of de-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with de-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%.


Eligibility criteria:
inclusion criteria: * primary open angle glaucoma or ocular hypertension exclusion criteria: * patients at risk of progression of visual field loss * patients with severe visual field defect * patients with any diseases that preclude participation in this study for safety reasons
analysis of cervical spinal mri with deep learning

Conditions: Cervical Disc Disease; Cervical Spine Disease

Summary: the aim of this study is analyzing the pathologies in cervical spinal mri images by using image processing algorithms. determination of these pathological cases which taught to the system with deep learning and determination of their levels. finally; verification of the system by comparing radiologist reports and automated system outputs.

neck pain is a very common health problem with a worldwide prevalence ranging from 16.7% to 75.1%. the source of neck pain is often considered - although there is no strong evidence - the cervical intervertebral disc. radiological imaging methods are used for the detection of degeneration of the discs and the end plaque changes in the vertebral body corresponding to this degeneration.magnetic resonance imaging (mri) gives information about the structure of intervertebral disc, width of spinal canal and tissues outside the canal. however, there is no standardization in the identification and evaluation of radiological images, and interobserver variability is high. studies have been initiated on automated systems that analyze mri images to increase the accuracy and consistency of reporting procedures. examining mri images with deep learning can lead to the production of systems that help clinical decision making and also allows the evaluation of large data in a short time.

Eligibility criteria:
inclusion criteria: * 18-75 years of age * having result of a cervical spinal mri, which was performed for neck pain in the hospital records in the last 5 years. exclusion criteria: * malignancy * signs of active infection * significant spinal vertebral deformity (advanced scoliosis, congenital vertebral defects) * spinal surgery
intestinal microbiota and arterial stiffness

Conditions: Arterial Stiffness; Dysbiosis

Summary: this is an observational case-control study which objective is to analyse differences in intestinal microbiota between patients with and without arterial stiffness, measured by pulse wave velocity. it will take place in two different research units located in portugal and spain.

aim: analyse differences in intestinal microbiota between patients with and without arterial stiffness, measured by pulse wave velocity. design and setting: an observational case-control study. study population: the investigators will select 324 subjects, between 30 to 75 years-old, from a database that combine data from four different studies: triple a, early vascular aging (eva) and improving intermediate risk management (mark) that took place in the research unit of la alamedilla primary care center, and guimarães/ vizela study promoted by the life and health sciences research institute in minho university. measurements: 162 cases will be defined by a carotid-femoral pulse wave velocity (cf-pwv)\>10 mm/s determined using the sphygmocor system. 162 controls will be selected by the propensity score. the composition of the gut microbiome in faecal samples will be determined by ribosomal ribonucleic acid (16s rrna) gene sequencing. other measurements: demographic data, lifestyle assessment (physical activity, adherence to the mediterranean diet, alcohol and tobacco consumption). anthropometric variables: weight, body composition by bioimpedance, size, body mass index (bmi), waist and hip perimeter, peripheral and central arterial pressure. analysis of structure and vascular function and organ lesions target: pulse wave velocity, cardio-ankle vascular index and ankle-brachial index; intimal median carotid thickness, central and peripheral rate of increase, renal and cardiac organic lesion. blood analysis: short chain fatty acids, total bile acids, ursodeoxycholic acid

Eligibility criteria:
inclusion criteria: • patients with more than 40 years old who agree to participate in the study and do not meet any of the exclusion criteria. exclusion criteria: * participants who are in terminal condition, * participants with a history of cardiovascular disease (ischaemic heart disease or stroke, peripheral arterial disease or heart failure), * people with diabetes, * diagnosed renal failure in terminal stages (glomerular filtration rate below 30%), * chronic inflammatory disease or acute inflammatory process in the past 3 months. * patients treated with oestrogens, testosterone or growth hormone,

Keywords: pulse wave velocity intestinal microbiota cardiovascular disease short chain fatty acids multicentric study
the effect of pre surgery dog visits on post surgery consumption of pain medication

Conditions: Post Tonsillectomy Pain

Summary: the objective of this study is to examine the effects of pre surgery dog visits as compared to a costumed character or parents-only on the consumption of pain medication after surgery. it is hypothesized that pre surgery dog visits will reduce post surgical stress and anxiety.

recent research has revealed that children who are highly anxious prior to surgery experienced more problems post surgery. these problems included reporting of more pain and requested more pain medication during hospitalization and home follow up. consumption of pain medication may not be the optimal pain management program. in contrast, numerous human-animal interaction studies have shown that animals tend to have a calming effect on people, reduce stress, and lesson anxiety. therefore, the primary objective of this study is to examine the effect of pre surgery dog visits as compared to a costumed character or parents-only on the consumption of pain medication after surgery.

Eligibility criteria:
inclusion criteria: * tonsillectomy and adenoidectomy (t/a) * 4-7 years old * prescribed codeine and/or analgesics for postoperative pain exclusion criteria: * participant must not be afraid of dogs, or allergic to animal dander * chronic medical conditions other than t/a * developmentally delayed * on psychotropic medications

Keywords: animal-assisted intervention pre surgery anxiety post surgery pain medication consumption