Kornimate/medical-research-clean huggingface dataset:
open preperitoneal mesh versus retromuscular mesh versus suture repair for abdominal wall hernias

Conditions: Ventral Hernia; Ventral Incisional Hernia; Umbilical Hernia

Summary: randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter

many techniques of ventral hernias repair have been reported. it is shown that open mesh hernia repairs have low recurrence and low complication rates then suture repair. but for hernias less than 3 cm some surgeons defend the treatment by suture. the main variable of interest is the location of mesh placement compared to suture repair. the investigator will compare in a prospective randomized clinical trial three techniques of abdominal wall hernia repair: preperitoneal polyester mesh, retromuscular polyester mesh and suture for hernias less than 3 cm. all patients underwent general anesthesia. the investigators used polyester-based mesh because it has shown minimal shrinkage and excellent tissue ingrowth in animal models. operative notes were physician-abstracted and the presence, type, and location of mesh prosthesis was recorded. independent variables of interest were patient-level demographics (age and sex), facility where hernia repair occurred, year of hernia repair, preoperative comorbid conditions, history of prior repair, and intraoperative variables. the results compared postoperative pain was evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit, operating time evaluated as skin-to-skin time, drain management and both of early and late complications including seroma and hematoma formation, wound infection, fistula formation and recurrence rates.

Eligibility criteria:
inclusion criteria: * vebtral hernia or post incisional hernia diameter \< 3 cm * male or female aged between 18 and 90 year-old * elective surgery for ventral hernia exclusion criteria: * any contraindication to the prosthetic treatment. * any hernia or incisional hernia with a collar strictly greater than 3 cm. * previous hernia mesh repaired * contraindication for general anaesthesia * pregnancy

Keywords: ventral hernia open mesh repair polyester mesh preperitoneal retromuscular
total cerebral protection with embolic protection devices thoracic aortic stenting

Conditions: Stroke; Silent Cerebral Infarct

Summary: stroke and silent cerebral infarction are a real risk with thoracic enodvascular aortic repair (tevar). the investigator propose to prospectively observational study with enrolment of all patients undergoing tevar for thoracic and thoracoabdominal conditions including aneurysmal degeneration, type b dissection and acute aortic syndromes over a 24 month period, equating to a minimum of 20-30 patients per year. patients undergoing juxtra-renal and infra-renal aortic stenting will form a control group.

tevar involves the insertion of a stent into the thoracic aorta to re-line it and prevent life-threatening haemorrhage from rupture, and ultimately death. the stent is inserted through a small cut in the femoral artery in the groin that is able to track to the desired location in the thoracic aorta over wires. the thoracic aorta and the branches it provides to supply the brain are diseased with atherosclerotic plaques and thrombus. the manipulation of wires and stents over these diseased locations can lead to small fragments breaking off and travelling to the brain to block the blood supply to areas of the brain (cerebral embolisation). cerebral embolic protection devices (cepds) consist of filters that can be placed into the branches of the thoracic aorta that supply the brain(supra-aortic branches) before tevar and can capture and remove solid debris, preventing it from reaching the brain.

Eligibility criteria:
inclusion criteria: * all patients requiring tevar as decided upon by a multidisciplinary meeting exclusion criteria: * contraindication to mri scanning * unable to give consent

Keywords: stroke cerebral embolic protection device
glycemic control with triple pathway approach through empagliflozin, linagliptin and metformin combination

Conditions: Diabetes Mellitus; Type 2 DM

Summary: the efficacy and safety of a triple-pill combination therapy for advanced type 2 diabetes care. the study aims to assess the impact of 3 oral anti diabetic (oad) drugs on metabolic control, patient compliance, weight management, quality of life, diabetic treatment satisfaction and frequency of hypoglycemic events by combining them into a fixed-dose single pill.

this study aims to demonstrate that a poly-pill approach combining metformin, linagliptin, and empagliflozin will provide an effective and safe treatment option for managing type 2 diabetes mellitus (t2dm). by focusing on the reduction of hba1c levels and enhancing patients' quality of life, this simplified approach is expected to streamline medication regimens, reduce pill burden, and improve treatment adherence. furthermore, the study anticipates that this combination therapy will positively influence weight management and lower the incidence of hypoglycemic events, addressing common challenges in t2dm management. as t2dm prevalence continues to rise, especially in low- and middle-income countries, the poly-pill strategy may offer significant benefits, promoting better compliance, affordable low-in-cost treatment, and facilitating improved long-term health outcomes. through this research, the study intends to provide strong evidence supporting the poly-pill regimen as a viable and impactful option for global t2dm management.

Eligibility criteria:
inclusion criteria 1. patients of any gender 2. patients aged between 18-80 years 3. patients having hba1c 8 % or above 4. patients diagnosed with type ii diabetes (more than at least 06 months) 5. patients already on at least 02 or more anti-diabetic agents 6. patients not allergic to empagliflozin, linagliptin, or metformin exclusion criteria 1. patients with age less than 18 2. patients with type-i diabetes 3. patients having diabetes for less than 06 months 4. patients on glp-1 and gip 5. patients who are pregnant or lactating females 6. patients with decompensated chronic liver disease (dcld) 7. patients with egfr less than 30 ml 8. patients with end-stage heart failure (nyha class 4) 9. patients who are allergic to empagliflozin, linagliptin, or metformin 10. patients who are not willing to consent 11. patients who are unable to give medical history

Keywords: combination empagliflozin metformin linagliptin compliance hypoglycemic events weight management quality of life treatment satisfaction glycemic control type 2 dm
association of easix in sepsis

Conditions: Sepsis; Septic Shock; Septic Syndrome

Summary: this prospective study aims to determine the relationship between the easix score and mortality and prognosis in sepsis.

sepsis is a life-threatening condition characterized by a dysregulated host response to infection, leading to organ dysfunction. despite advancements in medicine, sepsis remains a significant cause of death worldwide. an international study showed that 48.9 million sepsis cases were diagnosed in 195 countries between 1990 and 2017, resulting in 11 million deaths. recent studies have demonstrated that early diagnosis and treatment reduce sepsis mortality. therefore, research has focused on identifying biomarkers that aid in early diagnosis and prognosis. the endothelial activation and stress index (easix) was first defined by luft et al. as a biomarker reflecting endothelial damage. calculated using readily available laboratory parameters-serum lactate dehydrogenase (ldh) level (u/l) x creatinine level (mg/dl) / platelet count (10⁹/l)-it has been commonly used to predict mortality and prognosis in hematological malignancies. recently, its application in predicting sepsis mortality and prognosis has gained attention, although only limited retrospective studies have been published.

Eligibility criteria:
inclusion criteria: * • patients diagnosed with sepsis during intensive care admission or admitted to intensive care with a diagnosis of sepsis * all patients over the age of 18 exclusion criteria: * • patients under the age of 18 * patients with a history of multiple intensive care admissions * patients who died within 24 hours of diagnosis * patients diagnosed with crf or currently treated for arf * patients with deficient serum creatinine, ldh and platelet values at the time of diagnosis patients for whom consent could not be obtained from themselves or their relatives

Keywords: sepsis septic shock endothelium
treatment of discogenic back pain

Conditions: Discogenic Back Pain

Summary: discogenic low back pain is the most common form of chronic low back pain. its diagnosis is mainly based on mr imaging, showing modic i or ii changes in patients with concordant symptomatology. the treatment of discogenic low back pain is nevertheless difficult: intradiscal therapies (corticosteroids, methylene blue, radiofrequency) have a limited efficacy, and surgical procedures (arthrodesis or disc replacement) are a final recourse with notable risk of side-effects. in this study, the efficacy of intradiscal injection of gelified ethanol (discogel) in patients with disabling discogenic pain is assessed.


Eligibility criteria:
inclusion criteria: * mr imaging : modic 1or modic 2 changes limited to one single lumbar disc; * x rays: normal disc height, no instability; * back pain for at least 3 months, without argument for another etiology; * mean pain on 5 days vas ≥ 5 exclusion criteria: * age \ 50 ; concomitant radicular pain ; * psychiatric pathology that may modify the perception or the evolution of pain; * mr imaging: multi-level discopathy, modic 3 changes; * x ray: loss of disc height \> 50%, segmental instability; * previous history of lumbar surgery with or without instrumentation.

Keywords: back pain discogel
buprenorphine pharmacology related to addiction treatment - 21

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to examine if chronic buprenorphine administration will generate supersensitivity to opiates.


Eligibility criteria:
please contact site for information.
purple grape juice in improving vascular health in childhood cancer survivors

Conditions: Cardiovascular Disease

Summary: rationale: survivors of childhood cancer are at an increased risk of developing cardiovascular risk factors as well as early cardiovascular disease, likely due to the intensive therapeutic regimen used to treat their cancer. purple grape juice (pgj) is a rich source of flavonoids and a powerful antioxidant. clinical studies in both diseased and healthy adults suggest that daily consumption of pgj contributes to increased antioxidant capacity, reduced low-density lipoprotein (ldl) oxidation, and improved vasodilation. purpose: this randomized clinical trial is evaluating whether purple grape juice can reduce oxidative stress and improve the vascular health of survivors of childhood cancer in the early stages of cardiovascular disease.

primary objective: * to evaluate the effect of pgj on endothelial function, a key measure of vascular health and considered a barometer for cardiovascular disease risk. secondary objective: * to evaluate the effect of pgj on biomarkers of vascular and systemic oxidative stress. outline: patients undergo a 4-week washout period and refrain from consuming any type of juice, juice drink (less than 100% juice), wine or grapes. patients are then randomized to 1 of 2 arms. arm 1: beginning in week 4, patients consume 6 ounces of purple grape juice (pgj) twice daily for 4 weeks. beginning in week 12, after a 4 week washout period, patients crossover to consume apple juice (aj) as in arm 2. arm 2: beginning in week 4, patients consume 6 ounces of aj twice daily for 4 weeks. beginning in week 12, after a 4 week washout period, patients crossover to consume pgj as in arm 1.

Eligibility criteria:
inclusion criteria: * diagnosed with cancer \> 5 years ago * off-maintenance therapy for \> 36 months * age 10-30 years * reside within a 50 mile radius of the university of minnesota exclusion criteria: * pregnant or planning to become pregnant * start of oral contraceptives \< or = 3 months prior to study enrollment * current smoker * diabetes (type 1 and 2) * antibiotic use \< 2 weeks prior to study enrollment

Keywords: childhood cancers cardiovascular disease childhood cancer survivor
effectiveness of healthy habits for hospitalized older adults to optimize rehabilitation

Conditions: Insomnia; Pain; Osteoarthritis, Knee; Osteoarthritis, Hip

Summary: this study aims to evaluate behavioral interventions in conjunction with medical rehabilitation to promote functional health in patients recovering from orthopedic surgery. half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits. the other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. both groups will undergo several physical and cognitive assessments.

improving healthy habits such as sleep, nutrition or physical activity is expected to enhance rehabilitation in knee or hip arthroplasty patients, by increasing their ability to attend and adhere to rehabilitation recommendations following surgery. half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits (physical activity, nutrition, pain-coping techniques, etc). the other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. both groups will undergo several physical and cognitive assessments at baseline (prior to surgery), post-hospital, post-intervention and at a 6 month follow-up visit.

Eligibility criteria:
inclusion criteria: 1. patients with a minimum age of 40 years, no maximum age limit, planning on having a hip or knee arthroplasty. 2. the ability to communicate during the screening process (e.g., no aphasia or other severe language impairment). 3. meet dsm-5 criteria for insomnia disorder assessed by duke structured interview for sleep disorders. 4. score ≥8 on the insomnia severity index (isi) or ≥5 on the pittsburgh sleep quality index (psqi). 5. referral and attendance of medical rehabilitation post-discharge. exclusion criteria: 1. evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year). 2. presence of psychotic disorder, substance abuse or dependence, or bipolar disorder assessed by mini international neuropsychiatric inventory (to increase generalizability other psychiatric comorbidities such as depression or anxiety will not be excluded). 3. untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk. 4. cognitive impairment defined as \<20 on the mini mental status exam (mmse) that could potentially limit comprehension of the intervention. note, while an mmse of \<24 is often used as a cutoff for cognitive impairment, we do not wish to exclude those with mild cognitive problems from this study as there is evidence that individuals with mild cognitive problems still benefit from insomnia treatments.

Keywords: knee arthroplasty hip arthroplasty rehabilitation
ancillary effects of oral naloxegol (movantik)

Conditions: Pain, Postoperative

Summary: the purpose of this study is to find out whether oral naloxegol can reduce the side effects of opioid painkillers following surgery. this study aims to explore whether naloxegol can similarly reduce opioid-induced side effects in post-surgical patients. about 130 surgery patients will participate in this study which is being conducted at cleveland clinic main campus.

opioids are the gold standard for postoperative pain management, but they have been shown to produce uncomfortable side effects such as urinary retention (an inability to completely empty the bladder), constipation and nausea/vomiting. clinical evidence demonstrates that naloxegol can safely and effectively block these undesirable side effects while maintaining the painkilling effects of opioids in outpatients suffering from opioid-induced constipation.

Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedures 2. female or male aged at least 18 years 3. american society of anesthesiologists physical status 1-4; 4. scheduled for elective primary hip or knee surgery under spinal anesthesia; 5. expected to receive intravenous patient-controlled analgesia (iv pca) 6. expected to have significant postoperative pain 7. negative pregnancy test exclusion criteria: 1. severe hepatic impairment, with/or twice the upper normal levels of liver enzymes 2. severe renal impairment, or creatinine level \> 2.0 3. history of bladder cancer 4. patients receiving perioperative regional anesthesia blocks 5. presence of a sacral nerve stimulator 6. medications (anticholinergic agents such as antihistamines, phenothiazines, antidepressants, antipsychotics), conditions or comorbidity causing urinary retention 7. patient with requirement of urinary catheter insertion before or immediately post-surgery due to immobility 8. urinary tract infections and other urogenital comorbidity (incontinence, cysto-ureteric reflux, known bladder retention) or conditions which can cause urinary retention 9. severe peptic ulcer disease, diverticular disease, infiltrative gastrointestinal tract malignancies, or peritoneal metastases 10. patients with known or suspected disruption of blood brain barrier, which may include but not limited to: alzheimer's disease, stroke, poliomyelitis, cerebral palsy, multiple sclerosis, spinal lesions, and parkinson's disease 11. gastrointestinal obstruction/gastrointestinal perforation 12. strong cyp3a4 inhibitors (some antibiotics, antifungals, protease inhibitors, and antidepressants), strong cyp3a4 inducers, other opioid antagonists 13. hypersensitivity to movantik (naloxegol) or any of its excipients
ultrasound-guided suprazygomatic maxillary nerve block as a part of multimodal analgesic regimens

Conditions: Suprazygomatic Maxillary Nerve Block

Summary: inadequate peri-operative analgesia may contribute to an increased risk of bleeding, suture dehiscence and unacceptable surgical outcomes. moreover, these patients are at high risk of postoperative airway obstruction and respiratory failure. opioids may contribute to these complications. appropriate use of regional anaesthesia may mitigate or eliminate many of these concerns. the maxillary nerve is responsible for the sensory innervation of the midface, including the hard and soft palates, upper jaw, upper dental arch and upper lip.recently, the successful use of maxillary nerve block by the suprazygomatic approach has been reported in children undergoing cleft palate surgery. however, the use of this block has not been described in large series of patients, and the effectiveness of the suprazygomatic approach has not been evaluated in patients undergoing tonsillectomy .


Eligibility criteria:
* inclusion criteria 1. pediatric patients aged 4-12 years 2. genders eligible for study: both sexes 3. asa physical status i and ii 4. undergoing tonsillectomy surgery exclusion criteria * parents' refusal * contraindications to regional anesthesia * known allergy to local anesthetics * bleeding disorders * children with diabetes mellitus, obstructive sleep apnea syndrome, cardiac, renal, liver or blood diseases, swallowing disorders or peritonsillar abscess, * children receiving regular analgesia within the last week before surgery, * children undergoing simultaneous procedure in the field of surgery like adenoidectomy or tongue tie will be all excluded from the study.
medi-port pilot randomized controlled trial

Conditions: Actively Undergoing Cancer Treatment; 4-9 Years of Age; At Least 1 Month From Diagnosis; Able to Speak and Understand English; Presenting to Clinic for at Least a 2nd Subcutaneous Port Needle Insertion

Summary: pain is a frequent and significant problem related to cancer-directed treatment in children. children with cancer often cite needle procedures as the most distressing experience caused by cancer and its treatment. recently it has been shown that an interactive humanoid robot is capable of facilitating distraction and reducing distress during childhood immunizations. our research objectives are to: (1) assess the feasibility of implementing the robot (medi-port) for effectiveness testing in a future rct (measured as implementation outcomes) and (2) determine treatment effectiveness estimates (measured as preliminary effectiveness outcomes), compared to standard medical care.

a sample of 40 children with cancer between the ages of 4-9 years (20 participants per treatment arm; 10 boys and 10 girls per treatment arm) will be recruited. the feasibility of the trial protocol to evaluate the impact of distraction via the humanoid robot on pain intensity and distress during scp needle insertion compared to an active control in children with cancer will be explored. the effectiveness outcome includes the examination of the robot programmed to distract children during the procedure, reduce pain intensity and distress compared to an active control intervention (i.e. dancing robot).

Eligibility criteria:
inclusion criteria: * 4-9 years * able to speak and understand english, * actively undergoing cancer treatment * presenting to clinic for at least a 2nd subcutaneous port needle insertion * being at least 1 month from diagnosis. exclusion criteria: * visual, auditory or cognitive impairments precluding interaction with medi-port * end-of-life patients * patients who are nil per os pre-sedation.
study of recovery and blood rheology changes in ultra-endurance runners (eruption-3)

Conditions: Physiology

Summary: while the acute consequences of an ultratrail are beginning to be well documented, data on the study of recovery in the aftermath of an event are much rarer. in order to overcome these various limitations, the main study of the eruption-3 project is set up on the grand raid de la réunion 2022 races. in the context of exercise responses, the rheological properties of blood can impact the endurance performance. in contrast to short-distance events, the study of blood rheology and red blood cells integrity in long-distance events such as ultra-endurance races is poorly documented in the literature. in the ancillary study, the work that is intended to be carried y out will complement the initial results found by a previous research on 23 runners during the ultra trail du mont blanc. this ancillary study will also be an opportunity to complete the data from the main study by studying the kinetics of biomarker recovery.


Eligibility criteria:
inclusion criteria: * \>18 years * participating in the grand raid de la réunion race (mascareignes, trail de bourbon or diagonale des fous) * affiliated or beneficiary of a social security scheme * not opposed to the research for the main study * having given their written consent for the participants of the ancillary study exclusion criteria: * not understanding french * protected adult (guardianship or curatorship) or under court protection * who have difficulty swallowing paracetamol capsules and for whom it will therefore be difficult to swallow the e-celsius® performance capsules (for the ancillary study)