Kornimate/medical-research-clean huggingface dataset:
laparascopic sleeve gastrectomy vs. endoscopic gastric plication in obesity

Conditions: Obesity

Summary: the project will describe the efficacy and safety of laparoscopic sleeve gastrectomy and endoscopic gastric plication procedures as compared to conservative therapy and clarify the mechanisms of action of these treatments. the project will also contribute to more precise indications of bariatric or endoscopic methods in clinical practice and enable personalized choice of therapy for particular patient.

bariatric surgery is the most efficacious treatment of obesity and type 2 diabetes mellitus. novel endoscopic methods based on the principles of bariatric surgery are also highly effective. no direct randomized comparison of both types of treatment has been performed to date and the mechanisms of action of both procedures are still only partially clarified. the aim of the project is to perform a randomized trial comparing efficacy and safety of three treatment options in patients with obesity: laparoscopic sleeve gastrectomy, endoscopic gastric plication and conservative treatment. a further aim is to characterize the influence of the three treatments on subclinical inflammation, gut microbiota composition and changes of gastrointestinal hormones. the results of the project will describe the efficacy and safety of these procedures as compared to conservative therapy and clarify the mechanisms of action of these treatments. the project will also contribute to more precise indications of bariatric or endoscopic methods in clinical practice and enable personalized choice of therapy for particular patient.

Eligibility criteria:
inclusion criteria: 1. bmi \> 35 kg/m2 2. for patients with type 2 diabetes - stable antidiabetic medication \> 1 month 3. age 18-60 years exclusion criteria: 1. other diabetes mellitus types (type 1 dm, monogenic dm, secondary dm) 2. prior gastrointestinal (git) surgery interfering with study procedure 3. severe gastroesophageal reflux, severe git motility disorder 4. active malignancy 5. acute myocardial infarction, unstable angina pectoris, acute stroke 3 months prior to enrolment 6. acute liver or kidney failure 7. transplantation of insulin producing tissue 8. gravidity or lactation 9. mental disorder 10. inability to sign informed consent 11. any other contraindication of bariatric surgery or bariatric endoscopy procedure 6. acute liver or kidney failure 7. transplantation of insulin producing tissue 8. gravidity or lactation 9. mental disorder 10. inability to sign informed consent 11. any other contraindication of bariatric surgery or bariatric endoscopy procedure

Keywords: obesity diabetes mellitus endoscopy surgery gut microbiota
non-invasive brain stimulation to improve quadriceps muscle function after anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Reconstruction; Quadriceps Muscle Weakness; Transcranial Direct Current Stimulation

Summary: quadriceps muscle dysfunction persists for years after anterior cruciate ligament reconstruction (aclr) and is related to poor self-reported outcomes, altered movement patterns and joint loading associated with post-traumatic knee osteoarthritis (oa), and higher risk of reinjury. emerging evidence indicates that central drive (pathway from the brain to the muscle of interest, i.e corticospinal excitability) to the quadriceps muscle is reduced as early as 2 weeks after surgery and can persist for years after aclr, meaning that current rehabilitation strategies may not be addressing potential maladaptive changes in central drive. anodal tdcs is a neurostimulation technology that increases brain excitability (i.e. central drive) and has the potential to address alterations in central drive and quadriceps muscle performance. the purpose of this study is twofold: 1) to determine the effects of anodal tdcs on central drive and quadriceps muscle performance in patients after aclr, and 2) determine the relationship between central drive and quadriceps muscle performance in patients after aclr. central drive will be defined by two measures: 1) active motor thresholds, and 2) slope of a stimulus response curve. quadriceps muscle performance will be defined by two measures: 1) isometric quadriceps strength, and 2) rate of torque development (rtd). for purpose 1 the investigators hypothesize that measures of central drive and quadriceps muscle performance will increase with administration of active anodal tdcs compared to no change with sham tdcs. for purpose 2 the investigators hypothesize that both measures of central drive will be associated with both measures of quadriceps performance, with a stronger association between central drive and rtd. following a cross-over design patients 3-6 months from aclr will receive active and sham anodal tdcs at different sessions separated by 7-10 days while they ride a stationary bike for 20 minutes. bike position and intensity will be standardized for all patients to maximize quadriceps activity. findings from this study will expand our basic science knowledge on how tdcs effects different aspects of corticospinal excitability and quadriceps strength, and lead to subsequent studies to determine the effects of multiple sessions of tdcs on corticospinal excitability and quadriceps muscle performance in patients recovering from aclr.


Eligibility criteria:
inclusion criteria: -underwent primary acl reconstruction within 3-6 months exclusion criteria include: * multiple ligament reconstruction * osteo-chondral procedures * any previous lower extremity surgery * previous acl injury * metal or implants in the head or neck * history of neurological disease, seizures, severe migraines, and concussion within the last 6 months

Keywords: corticospinal excitability
effects of probiotics on microbial translocation and immune activation markers in hiv-positive patients on combined antiretroviral therapy

Conditions: HIV

Summary: combined antiretroviral therapy (cart)-treated patients have increased mortality and morbidity compared to age-matched seronegative individuals. this increased mortality and morbidity has been associated to immune activation that persists also in patients under cart even with undetectable levels of hiv-rna in blood. indeed, hiv-infected patients, irrespective of cart treatment, show higher levels of activated t cells, inflammatory monocytes and proinflammatory cytokines than seronegative individuals. several putative causes of this residual inflammation have been proposed and include ongoing hiv replication at low levels, the presence of coinfections such as cytomegalovirus, and microbial translocation. none of these causes are mutually exclusive and understanding the degree to which of these three cause residual inflammation in cart-treated individuals will require novel therapeutic interventions aimed at alleviated each putative cause. in this longitudinal study we aim: 1. to reduce microbial translocation induced inflammation in cart-treated individuals with supplementation of cart with the probiotics. 2. to investigate the potential benefits of 24 weeks of probiotics supplementation on immune function and on immune activation status indeed, the early stage of hiv infection is associated with dysbiosis of the gi tract microbiome with reducted levels of bifidobacteria and lactobacillus species with increased levels of potentially pathogenic proteobacteria species.


Eligibility criteria:
inclusion criteria: * hiv positive patients * hiv viral load \< 50 copies/ml * antiretroviral therapy from at least 2 years exclusion criteria: * intestinal diseases * opportunistic diseases * pregnancy

Keywords: hiv gut probiotics immune activation
enhancing shared decision-making to guide care for people with dementia and diabetes

Conditions: Diabetes; Alzheimer's Disease (Incl Subtypes); Dementia; Hypoglycemia

Summary: aim 1: characterize shared decision-making and unmet patient-caregiver dyads needs for patients with diabetes and alzheimer's disease and related dementias (adrd) while using a continuous glucose monitoring (cgm) device. aim 2: develop an interactive tool to enhance shared decision-making for diabetes management.

aim 1: patient-caregiver dyads will participant in a semi-structured interview to establish a baseline. the dyad will receive standard diabetes educational materials along with a cgm training and instructions for device use. patients will then wear the cgm device for 14 days. three follow-up interviews will take place during the 14-day scanning period, as well as a debrief interview following the scanning period for assessment and technical support. aim 2: patient-caregiver dyads and clinicians will participate in a user-centered design session to guide the design of interactive information displays to improve the interpretability of cgm data.

Eligibility criteria:
patient-caregiver dyad inclusion criteria (aims 1 + 2): * patient must have dual diagnosis of mci or adrd and diabetes (dm) * patient must have active prescriptions for dm * patient must have had at least one visit to an eskenazi or iu health primary care clinic within 12 months * patient must be able to provide assent and have a legally authorized representative (lar) consent on their behalf if patient lacks capacity to consent * patient must have a caregiver aged 18 years or older who interacts daily, or almost daily, with the patient * patient and caregiver must both speak english * patient and caregiver must both reside in the community * dyad must have internet access patient-caregiver dyad exclusion criteria (aims 1 +2): * patient has terminal illness * use of an automated insulin delivery system * patient is receiving dialysis * patient is taking ascorbic acid during monitoring period * patient has existing implanted medical devices * patient has a bleeding disorder * patient has a pre-existing arm skin lesions * patient has an allergy to medical adhesive or isopropyl alcohol * patient has plans for imaging or diathermy treatment during the study period clinician participant inclusion criteria (aim 2): * primary care physicians * nurses * pharmacists * nutritionists * psychologists * medical residents clinician participant exclusion criteria (aim 2): * only treats patients younger than 65 years * does not manage patients' dm

Keywords: continuous glucose monitoring shared decision-making human factors primary care
the effects of epidural anesthesia on the bioavailability of nitric oxide and renal function in patients undergoing laparoscopic surgery

Conditions: Prostate Cancer

Summary: this study was designed to investigate the effects of epidural anesthesia combined with general anesthesia during laparoscopic surgery. the investigators hypothesized that epidural anesthesia will effectively block the activation of the sympathetic nervous system during surgery, thus activating nitric oxide and reducing splanchnic ischemia and decrease in postoperative renal function.


Eligibility criteria:
inclusion criteria: * asa class 1 or 2 adult patients scheduled for endoscopic prostatectomy exclusion criteria: * patient refusal * patients on diuretics * patients with renal failure (egfr \< 60 ml/min/1.73 m2)
noninvasive assessment of tissue perfusion status in critically ill pediatric patients

Conditions: Sepsis; Shock

Summary: investigators are conducting research about oxygen levels in the body and whether it is possible to use a device to measure oxygen in the body's tissues noninvasively, without blood draws or a catheter (a plastic tube placed in a vein). investigators would like to know how this device compares to standard measurements using blood from a catheter. this may help treat patients who may not be getting enough oxygen to their body.

investigators will enroll patients in the pediatric intensive care unit who have an indwelling catheter that allows measurement of central venous oxygen saturation. measurements of central venous oxygen saturation using blood oximetry will be compared with measures of tissue oxygenation at the buccal mucosa using a raman spectroscopy tissue oximeter. investigators will also measure the status of the sublingual microcirculation utilizing sidestream dark field microscopy. basic demographic and clinical variables such as ongoing vasoactive infusions, mechanical ventilation, and laboratory data will also be collected.

Eligibility criteria:
inclusion criteria: * patients admitted to the pediatric intensive care unit (picu) or pediatric cardiothoracic unit (pctu) * age \>30 days and \<18 years -patients with a "high" central venous line (ie internal jugular, subclavian, peripherally inserted central catheter, broviac, port) capable of blood draw and with central venous catheter tip in the superior vena cava exclusion criteria: * age \ 18 years * known pregnancy or subsequently discovered pregnancy after admission * uncorrected cyanotic congenital heart disease relative exclusion criteria: * oral trauma preventing placement of raman sto2 oximeter probe or microcirculation video device * upper extremity trauma preventing placement of beam device

Keywords: tissue oxygenation perfusion status
deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas

Conditions: Keratoconus

Summary: the objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.

keratoconus is a common corneal disease characterized by progressive thinning and steepening resulting in significant visual impairment. with improved instrumentation and corneal imaging technology, deep anterior keratoplasty has been recognized as the preferred primary operative technique for cases of keratoconus requiring corneal transplantation. since corneas preserved through organ culture remain viable only for up to 4 weeks, techniques that can extend storage of corneas have been explored. the objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.

Eligibility criteria:
inclusion criteria: * keratoconus * surgical candidates for deep anterior lamellar keratoplasty exclusion criteria: * ocular comorbidities other than cataract (ie. visual significant optic nerve or macular disease) * previous corneal transplantations or other ocular surgeries except uncomplicated cataract surgery * inability to comply with study protocol or participate in follow-up visits
evaluating refractive and visual outcomes with the alcon toric restor +2.5 and +3.0 models

Conditions: Cataract

Summary: the study will evaluate visual acuity and visual function with a 'blended' restor toric intraocular lens (iol) implantation after cataract surgery.

the objective is to provide a normative standard for refractive and visual outcomes in eyes with significant corneal astigmatism undergoing cataract surgery with the alcon toric restor lens. patients will be bilaterally implanted, with the toric restor +2.5d model implanted in the dominant eye and the toric restor +3.0d model implanted in the non-dominant eye.

Eligibility criteria:
inclusion criteria: * subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in the eligible eye. * bilateral visually-significant cataracts * willing and able to provide written informed consent for participation in the study. * willing and able to comply with scheduled visits and other study procedures. * have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) * regular corneal astigmatism of 1.00d to 2.50d in both eyes * potential postoperative acuity of 20/25 or better exclusion criteria: * if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * irregular astigmatism (e.g. keratoconus) * corneal pathology (e.g. opacities, epithelial basement membrane dystrophy (ebmd), fuch's dystrophy, etc.) * monocular status (e.g. amblyopia) * previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, descemet stripping automated endothelial keratoplasty (dsaek), lamellar keratoplasty) * previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) * moderate-to-advanced glaucoma * strabismus * use of arcuate incisions for astigmatism management at the time of surgery * diabetic retinopathy * macular pathology (e.g. age-related macular degeneration, epiretinal membrane, etc.) * history of retinal detachment * subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity. * participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial. the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Keywords: astigmatism intraocular lens multifocal
study to assess the efficacy and safety of pf-06651600 in subjects with rheumatoid arthritis with an inadequate response to methotrexate

Conditions: Rheumatoid Arthritis

Summary: this is an 8 week study to assess the efficacy and safety profile of pf-06651600 in seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-tnf biologic).


Eligibility criteria:
inclusion criteria * subjects between the ages of 18 and 75 years, inclusive * must have moderate-to-severe, active rheumatoid arthritis * must have had an inadequate response to methotrexate * subjects may have received one approved tnf inhibiting biologic agent that was inadequately effective and/or not tolerated exclusion criteria * subjects with any acute or chronic infections or infection history * have acute or active chronic dermatological disorders prior to study start * any major illness/condition(s) or evidence of an unstable clinical condition that in the judgment of the investigator would make the subject inappropriate for entry into this study * known immunodeficiency disorder or a first degree relative with hereditary immunodeficiency * any live (attenuated) vaccines or current routine household contact with anyone who has received live (attenuated) vaccine
evaluation of the efficacy and safety of suppressive therapy with dalbavancine in device infections

Conditions: Prosthesis-related Infections

Summary: the aim of this retrospective observational study is to evaluate the efficacy of antibiotic therapy with dalbavancin in patients presenting with infection on prosthetic devices. the main questions the study aims to answer are: what is the proportion of patients with early discontinuation of dalbavancin therapy? what are the reasons for early discontinuation of antibiotic treatment? what adverse events do patients report? the study is based on data collected as part of routine care practices. translated with www.deepl.com/translator (free version)


Eligibility criteria:
inclusion criteria: * patients with inextricable and/or inoperable osteoarticular or vascular prosthetic material. * patients requiring suppressive antibiotic therapy (\>6 months) with dalbavancin. exclusion criteria: * patients who are protected adult; * patients who are minors; * patients having expressed their opposition
cost-effectiveness of multidisciplinary management of tinnitus

Conditions: Tinnitus

Summary: background: tinnitus is a common chronic health condition that affects 10% to 20% of the general population. among severe sufferers it causes disability in various areas. as a result of the tinnitus quality of life is often impaired. at present there is no cure or uniformly effective treatment, leading to fragmentized and costly tinnitus care. evidence suggests an integral multidisciplinary approach in treating tinnitus is effective. the main objective of this study is to examine the effectiveness, costs, and cost-effectiveness of an integral treatment provided by a specialized tinnitus center versus usual care. this paper describes the study protocol. methods/design: in a randomized controlled clinical trial 198 tinnitus patients will be randomly assigned to a specialized tinnitus care group or a usual care group. adult tinnitus sufferers referred to the audiological centre are eligible. included patients will be followed for 12 months. primary outcome measure is generic quality of life (measured with the health utilities index mark iii). secondary outcomes are severity of tinnitus, general distress, tinnitus cognitions, tinnitus specific fear, and costs. based on health state utility outcome data the number of patients to include is 198. economic evaluation will be from a societal perspective. discussion/ conclusion: this is, to our knowledge, the first randomized controlled trial that evaluates an integral treatment of tinnitus that includes a full economic evaluation from a societal perspective. if this intervention proves to be effective and cost-effective, implementation of this intervention is considered and anticipated.


Eligibility criteria:
inclusion criteria: * subjective tinnitus complaints * referred to tinnitus centre limburg exclusion criteria: * not being able to write and read in dutch

Keywords: objective tinnitus tinnitus rct specialised treatment usual care cost-effectiveness
improving coordination and transitions of care in stroke patients

Conditions: Stroke; Transient Ischemic Attack

Summary: this study will examine if the attending nurse model will enhance critical patient-centered elements of care that will in turn improve patient education and shared decision-making, medication adherence, stroke-related health literacy, and reduce early readmissions to ultimately yield improved patient quality of life. our primary objective is to determine whether the attending nurse model of care improves stroke patients' health at 7 days, 30 days, and 90 days after hospital discharge as assessed through questionnaires.


Eligibility criteria:
inclusion criteria: * \> 18 years of age * admission to the hospital of the university of pennsylvania vascular neurology service * incident or recurrent: * ischemic stroke: focal neurological deficit of likely ischemic vascular origin * intracerebral hemorrhage: blood seen on initial head ct * transient ischemic attack: focal neurological deficit of likely ischemic vascular origin that has clinically resolved exclusion criteria: * pregnancy * comfort or hospice care * severe dementia prior to stroke * non-communicative and have no family/social support