Kornimate/medical-research-clean huggingface dataset:
early surgical outcomes in the use of hybrid mesh for incisional hernia repair: results from a multicenter italian study

Conditions: Hernia; Incisional Hernia; Laparoscopic

Summary: background: ventral hernia repair poses challenges for surgeons due to controversies in approach, patient selection, and mesh selection. the gore® synecor intraperitoneal (ip) biomaterial, a hybrid mesh, aims to balance durability and infection risk. objective: to analyze extended-term outcomes of using the intaperitoneal device for ventral and incisional hernia repair. methods: retrospective analysis of patients undergoing surgery in eight italian surgery centers, evaluating pipom and sipom techniques with gore® synecor ip biomaterial. preoperative evaluations included anthropometric measurements, comorbidities, ct scans, and giqli assessments. surgical procedures and interventions were recorded. postoperative complications, giqli changes, cosmesis, hernia recurrence, and mesh bulging were assessed.

the management of ventral hernias, whether they are primary or incisional, presents a significant challenge for abdominal wall surgeons. laparoscopic ventral hernia repair has become a widely accepted technique on a global scale, with literature reporting favorable outcomes, even over the long term. nevertheless, various substantial controversies have emerged concerning the ideal approach and patient selection and "ideal mesh". permanent mesh materials with a macro-porous structure have demonstrated excellent durability, a low risk of infection in ventral hernia repair. nevertheless, hernia recurrences and complications can still occur. the use of absorbable mesh materials may reduce the risk of infectious complications and the need for mesh removal. however, it might be associated with a higher likelihood of long-term recurrence when compared to permanent materials. in response to these challenges, hybrid mesh materials, combining both absorbable and permanent components, have been developed to strike a balance between achieving long-term durability and minimizing the risk of infection or "mesh removal". these hybrid meshes can be utilized either intraperitoneally or extra-peritoneally depending on their composition. one example of such a hybrid mesh is the gore® synecor intraperitoneal biomaterial (referred to as the device), manufactured by w.l. gore \& associates, inc. in flagstaff, az. this composite mesh comprises a bioabsorbable 3d web scaffold and a permanent dense polytetrafluoroethylene (ptfe) monofilament macro-porous knit. the device is specifically designed for intraperitoneal placement, using either an underlay or intraperitoneal onlay technique.

Eligibility criteria:
inclusion criteria: * age \> 18 years * clean wounds * informed consent * patients affected by incisional and ventral hernia * elective surgery * hernia size between 3 e 10 cm exclusion criteria: * age \< 18 years; * life expectancy \< 24 months (as estimated by the operating surgeon), - * pregnancy * immunosuppressant therapy within 2 weeks before surgery * clean-contaminated and contaminated, dirty wounds * cirrhosis

Keywords: hernia
a study of ly3541860 in adult participants with relapsing multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the main purpose of this study is to evaluate the safety and efficacy of ly3541860 in adult participants with multiple sclerosis that gets worse and gets better. the study will last about 9 months with additional 6 months follow-up.


Eligibility criteria:
inclusion criteria: * participants must meet criteria for relapsing forms of multiple sclerosis, including relapsing-remitting multiple sclerosis based on the 2017 revision of the mcdonald diagnostic criteria (thompson et al. 2018) with a relapsing course (rms) activity according to klineova and lublin 2018. * participants must have 1 of these: * at least 1 documented relapse within the previous year * at least 2 documented relapses within the previous 2 years, or * at least 1 active gde brain lesion on an mri scan in the past 180 days prior to screening. * have an expanded disability status scale (edss) score of less than or equal to (≤) 5.5 at screening and randomization. exclusion criteria: * have had a diagnosis of: * primary progressive multiple sclerosis (ms) according to the 2017 revision of mcdonald diagnostic criteria (thompson et al. 2018), or * nonactive secondary progressive ms ( klineova and lublin 2018). * meet criteria for neuromyelitis optica spectrum disorder (wingerchuk and lucchinetti 2022). * have a history of clinically significant central nervous system (cns) disease. * have had a confirmed relapse with systemic corticosteroid administration \<30 days prior to randomization. * have more than 20 active gde brain lesions on screening mri scan. * have received any of these medications or treatments. * have a current or recent acute, active infection. * have current serious or unstable illnesses. * have any other clinically important abnormality at screening or baseline.

Keywords: relapsing remitting multiple sclerosis, clinically isolated syndrome, secondary progressive multiple sclerosis with disease activity.
determining depression treatment preferences of low-income latinos in primary care settings

Conditions: Depression

Summary: this study will determine ways to make depression care more responsive to the needs of consumers in primary care clinics serving low-income latinos.

depression is a serious illness that is difficult to diagnose and treat, especially in populations that underutilize mental health services. the latino population is one such group. accommodating patient preferences for care, provider capacities, and administrator priorities is essential to the development of effective depression care interventions that are sustainable in public sector systems. however, little is understood regarding the depression treatment preferences of low-income latinos who have not received quality depression care and who may not feel that they can voice their opinions about their health care. in addition, little is known about the preferences, capabilities, and priorities of providers and administrators in primary care clinics. this study will determine ways to make depression care more responsive to the needs of consumers in primary care clinics serving low-income latinos. the study will also evaluate the effectiveness of various treatments in reducing depression. following baseline assessments of depression treatment preferences and resources, participants in this open label study will be randomly assigned to receive collaborative care either immediately or after a waiting period. individuals assigned to receive immediate care will undergo treatment for 12 weeks. other participants will receive treatment at a later time. all participants will have the option to receive one of the following treatments: (1) medication management from the depression care specialist (dcs) and antidepressant medication from their primary care provider (pcp); (2) cognitive-behavioral therapy from the dcs; or (3) a combination of both treatments. depression treatment outcomes and preferences will be measured post-intervention. provider and administrator preferences will also be measured post-intervention and potential strategies for implementing patient-centered depression care programs will be identified.

Eligibility criteria:
inclusion criteria: for participating patients: * attending one of the study clinics for primary care * english or spanish-speaking * screens positive for major depressive disorder or dysthymia for providers: * all primary care providers providing at least one day of services at one of the study clinics for administrators: * administrative, medical, and nursing directors from each study site and directors of affiliated local mental health clinics exclusion criteria: for participating patients: * acutely suicidal * screens positive for bipolar disorder, psychotic disorder, or cognitive impairment

Keywords: treatment preferences public sector latino
nipocalimab in moderate to severe sjogren's disease

Conditions: Sjogrens Syndrome

Summary: the purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe sjogren's disease (sjd).

this clinical development program for nipocalimab in sjd includes 2 identical double blind, placebo-controlled studies to evaluate the efficacy, safety, and tolerability of nipocalimab in participants greater than or equal to (\>=) 18 years of age with moderate to severe sjd.

Eligibility criteria:
inclusion criteria: * medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ecg) performed at screening * meets criteria for diagnosis of sjd by the 2016 american college of rheumatology/european alliance of associations for rheumatology (acr/eular) classification criteria * seropositive for antibodies to ro/ssa (ro60 and/or ro52) at screening * total clinessdai score greater than or equal to (\>=) 5 at screening * participants of childbearing potential must have a negative highly sensitive serum (beta-hcg) pregnancy test at screening and a negative urine pregnancy test at week 0 prior to randomization exclusion criteria: * has a history of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder or clinically significant abnormalities in screening laboratory * known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients or excipients used in the placebo formulation * has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her sjd or has a family history of congenital or hereditary immunodeficiency * has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins (for example \[e.g.\], monoclonal antibodies, intravenous immunoglobulin) * has any unstable or progressive manifestation of sjd that is likely to warrant escalation in therapy beyond permitted background medications

Keywords: sjogrens disease
restit : evaluation of resorbable osteosynthesis devices versus titanium in maxillofacial surgery

Conditions: Maxillo-Facial Surgery

Summary: primary objective : to evaluate the quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device plla/pga compared with usual titanium plates. secondary objective : * to evaluate the resorbable device ergonomy versus titanium. * to evaluate the clinical tolerance of resorbable device versus titanium. hypothesis : osteosynthesis with resorbable device demonstrates a non inferiority success probability regarding the success observed in osteosynthesis with titanium, with a less important probability of re-operation. study duration : 14 months for each patient. study treatment : * group i : resorbable device plla/pga. * group ii : titanium device. study visits : - screening visit - baseline with randomization and surgery - day1 - day 21 - day 45(traumatology)/day 90 (orthognatic) - month 6,12 and 14. randomization : stratification by centres, mono or bimaxillar surgery and traumatologic or orthognatic criteria.


Eligibility criteria:
inclusion criteria: * 18\<age\<50. * one or more fractures of facial massif requiring a surgical setting with osteosynthesis plates. * one or more osteotomy of facial massif requiring a surgical setting with osteosynthesis plates. * orally and written informed patient. patient willing to participate the study. * signed informed consent. exclusion criteria: * any previous surgery at the same operative site. * patient suffering from chronic affection which could interfere with bone consolidation. * corticotherapy, immunosuppressive or anticonvulsant treatment or long term antibiotherapy. * nursing or pregnant female. * patient with a high risk of non compliance to sudy visits. * unconscious patient.

Keywords: maxillo facial surgery, osteosynthesis, resorbable device
project bite: binge intervention target effectiveness

Conditions: Binge-Eating Disorder

Summary: the primary aim of this study is to determine how inhibitory neurobiological and neurocognitive processes relate to binge eating treatment outcome.

binge eating disorder (bed) is characterized by reoccurring binge eating episodes that consist of eating a subjectively or objectively large amount of food over a period of time accompanied by a sense of loss control over eating, in the absence of recurrent compensatory behaviors (e.g., purging). cognitive behavioral therapy (cbt) is the current gold-standard treatment for reducing binge eating episodes in bed patients. the first-line of recommended cbt treatment is a self-guided intervention called cbt-guided self-help (cbt-gsh). however, for a substantial minority of patients, cbt-gsh fails to reduce binge episodes after treatment. preliminary findings of the literature suggests that individuals with bed possess deficits in inhibitory control as it relates to food-stimuli. we are studying how inhibitory neurobiological and neurocognitive processes relate to binge eating treatment outcome. this study involves a brief phone screen and research assessment (approximately 5 hours) to determine eligibility. eligible participants will receive cbt-gsh, which will include a one-hour clinical intake followed by 6 therapy sessions (approximately 30 minutes each). participants will also complete research assessments at mid-treatment, post-treatment, and 3 month follow-up intervals. research assessments include a battery of questionnaires, computerized tasks, interviews, and a task using functional near infrared spectroscopy (fnir) imaging.

Eligibility criteria:
inclusion criteria: * speak, write, and understand english * body mass index (bmi) of 30 kg/m2 or greater * experience objectively or subjectively large binge eating episodes once per week or more for the past three months * if applicable, have stable psychiatric medication for the past three months * for the optional ecological momentary assessment, participants must own a smartphone compatible with paco mobile application exclusion criteria: * currently engage (in past three months) in any regular compensatory behaviors (e.g., self-induced vomiting, laxative/diuretic use) * acute suicide risk * are currently receiving psychological treatment for binge eating * are currently receiving weight loss treatment * co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (e.g., psychotic disorder, substance dependence) * diagnosis of intellectual disability or autism spectrum disorder * history of neurological condition or traumatic brain injury * current pregnancy * history of bariatric surgery * are currently using a stimulant medication
effect of local pressure on muscle activity and general relaxation in persons with hypertonia following stroke

Conditions: Deep Pressure; Muscle Activity; General Relaxation; Stroke; Hypertonia, Muscle

Summary: the purpose of this study is to examine the effect of - both constant as intermittent - local application of deep pressure on muscle activity and general relaxation in persons with hypertonia following stroke.

this study will be carried out in 20 persons with hypertonia following stroke. there will be one single test occasion, during which 6 test trials will be performed in random order. deep pressure will be applied by means of a johnstone air splint, that will be (1) not inflated, (2) inflated constantly, or (3) inflated intermittently. each of these 3 inflation conditions will be performed twice, i.e. with and without a non-hemiplegic arm movement (triggering hypertonia at hemiplegic side).

Eligibility criteria:
inclusion criteria: * subacute stroke (\<6 months) * hypertonia (modified ashworth scale score of ≥2 for arm flexors at the hemiplegic side)
use of thermography for the prevention and diagnosis of rheumatic foot

Conditions: Rheumatoid Arthritis; Rheumatoid Arthritis RA; Rheumatic Diseases

Summary: the aim of this observational study is to establish normal thermographic parameters in patients with rheumatoid arthritis, in order to prevent and diagnose rheumatic foot using thermography. the main question to be answered is: what are the normal thermographic parameters in rheumatic foot? if there is a comparison group: the researchers will compare the thermography of the foot in healthy subjects and in subjects with rheumatoid arthritis to see if there are any alterations in the thermographic image. patients who wish to participate in the study will undergo a thermographic study of the foot, which does not entail any risk to their health.


Eligibility criteria:
inclusion criteria: * patients with rheumatoid arthritis of more than 5 years\&#39; duration * healthy patients without diagnosed systemic disease * patients between 40 and 80 years of age exclusion criteria: * patients who are pregnant or may become pregnant * patients with degenerative diseases or significant cognitive impairment * patients with rheumatic diseases without a diagnosis of rheumatoid arthritis

Keywords: rheumatic foot rheumatoid arthritis rheumatic diseases thermoghrapy
the influence of prescribed exercise on pain related fear following concussion in collegiate athletes

Conditions: Concussion, Brain

Summary: the goal of this clinical trial is to compare the effects of acute aerobic exercise at two different intensities on psychological measures, symptomology, and time to symptom free in collegiate student athletes with concussion. the main questions it aims to answer are: * does prescribed, acute aerobic exercise influence measures of pain related fear, anxiety, depression, symptoms, and recovery time? * does the intensity of the exercise prescription also influence the aforementioned outcomes? participants will be randomly assigned into either a light intensity or moderate intensity aerobic exercise (treadmill walking) group. they will initiate the exercise protocol 48 hours following their concussion diagnosis, and complete exercise sessions 5 times per week until they report symptom-free. researchers will compare the light intensity group to the moderate intensity group to see if intensity of exercise influences psychological measures of pain related fear, anxiety, depression, symptomology, and time to symptom-free.


Eligibility criteria:
inclusion criteria: * collegiate athlete (varsity) * symptomatic at time of exercise prescription exclusion criteria: * if advanced neuroimaging was performed, any subject with a structural abnormality will be excluded * history of traumatic brain injury requiring hospitalization * not cleared to play their sport by a physician due to some other injury such as an ankle sprain or muscle strain * if individual is diagnosed with any condition that is a contraindication to aerobic exercise. please note that all participants will have already been cleared to participate in their respective collegiate sport after extensive pre-participation physical examinations upon entering the university.

Keywords: kinesiophobia exercise anxiety
study to evaluate the efficacy and safety of dwp14012 in patients with erosive gastroesophageal reflux disease (phase 3)

Conditions: Erosive Esophagitis

Summary: the purpose of study is to confirm the efficacy of dwp14012 xmg, once daily, compared to esomeprazole 40mg in patients with erosive gastroesophageal reflux disease.


Eligibility criteria:
inclusion criteria: * adults between 20 and 75 years old based on the date of written agreement * those who have been diagnosed with erosive gastroesophageal reflux disease(egrd) of la grade a-d on the upper gastrointestinal endoscopy * those who experienced symptoms of heartburn or acid regurgitation within the last 7 days exclusion criteria: * those who have undergone gastric acid suppression or gastric, esophageal surgery * those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
canadian e-platform to promote behavioral self-management in chronic heart failure: chf-cepport

Conditions: Heart Failure

Summary: chronic heart failure (chf) is a growing public health issue in canada. hospital re-admission within 1-year after diagnosis is 25-40%, and the 5-year rate of chf death is 50%. counseling by multidisciplinary health care teams helps chf patients to improve self-care behaviors (for medications, diet, exercise, smoking cessation and symptom monitoring), and this reduces the rate of death and chf hospitalization. in the absence of intervention, patient adherence to these behaviors is below recommended standards and quality of life among chf patients becomes progressively compromised. a major challenge is to make self-care counseling available without overtaxing health care resources. this year multicenter clinical trial will establish and evaluate a canadian e-platform that provides multidisciplinary e-counseling to help patients with chf to initiate and maintain recommended self-care behaviors. the investigators will recruit 298 chf patients in toronto, montreal and vancouver. the investigators hypothesize that a 12-month program of e-counseling + usual care versus general einfo + usual care will improve quality of life, self-care behaviors, program engagement, and heart health. this proposal is based upon previous clinical trials in chf, e-health and preventive lifestyle counseling by our team. the novel contribution of this research is that it will establish an infrastructure for a pan-canadian e-platform in preventive e-counseling for chf. a key feature of this proposal is that our multidisciplinary team will work with professional heart health organizations to share our findings and e-health resources with the public and other health care professionals in canada, which will help to galvanize research and clinical work in ecounseling. our clinical trial will strengthen ecounseling services in order to improve the quality of life of patients with chf.


Eligibility criteria:
inclusion criteria: 1. male and female patients 18 years of age who are diagnosed with heart failure with reduced ejection fraction ("systolic hf") corresponding to new york heart association class ii-iii for 3 months prior to enrolment; 2. documentation of lvef 40%; 3. subject has access to a personal computer; exclusion criteria: 1. documentation at enrolment of renal failure, significant liver disease or poorly controlled diabetes mellitus; 2. persistent systolic or diastolic hypertension \[systolic \> 170 mmhg or diastolic \> 100 mmhg despite antihypertensive therapy; 3. chf secondary to cardiovascular co-morbidities/procedures; 4. previous heart transplant or wait listed for heart transplant at time of enrolment

Keywords: heart failure e-counseling quality of life self-care