Kornimate/medical-research-clean huggingface dataset:
peritoneal iliac flap and lymphocele formation after robotic radical prostatectomy

Conditions: Lymphocele After Surgical Procedure

Summary: lymphoceles are a potentially serious complication of radical prostatectomy (rp) with pelvic lymph node dissection. they are associated with abdominal pain, urinary tract symptoms, fever, lower extremity swelling and deep vein thrombosis. they can be severe enough to necessitate intervention in 5% of patients after rrp with plnd, with sequela that could include infection and nerve damage. studies evaluating strategies to preclude lymphocele formation after rp have included comparisons of the use of titanium clips vs bipolar coagulation to seal lymphatic vessels during pelvic lymph node dissection. in a recent prospective randomized trial comparing these approaches, no differences were observed in the rates of lymphocele formation as detected by ultrasound. there is a need to continue to test potential strategies to minimize the formation of lymphoceles after rrp. creation of a peritoneal iliac flap is one approach has potential towards this end. at the lahey hospital and medical center in burlington, ma surgeons routinely fold the bladder into a peritoneal flap to overlay the area of extended lymphadenectomy. it is thought that this method prevents the formation of lymphoceles because the flap creates a window, which allows drainage of the lymph fluid into the peritoneal cavity to be reabsorbed. while the lahey study supports the safety and effectiveness of the peritoneal flap approach, the procedure has never been evaluated through a randomized prospective trial and the practice is certainly not standard of care. we therefore propose a randomized, prospective clinical trial to be conducted in the hartford hospital urology department to examine the effectiveness of a peritoneal iliac flap on the formation of lymphoceles after rrp with pelvic lymph node dissection. hypotheses: 1. we hypothesize that, at 3 months after rp, rates of lymphocele formation (symptomatic and asymptomatic lymphoceles) will be significantly lower in patients who have pelvic lymph node dissection using the peritoneal iliac flap approach than in patients who have pelvic lymph node dissection using the standard approach. 2. lymphoceles are often associated with lower urinary tract symptoms. we hypothesize that, after rp, severity of urinary bother symptoms and urinary incontinence will be significantly lower at each measurement period for patients who had pelvic lymph node dissection using the peritoneal iliac flap approach relative to patients who had pelvic lymph node dissection using the standard approach.


Eligibility criteria:
inclusion criteria: * scheduled to undergo robotic assisted radical prostatectomy with pelvic lymph node dissection for prostate cancer at hartford hospital. * diagnosed with biopsy-proven prostate cancer, with intermediate or high risk features per d'amico risk stratification * ability to give informed consent to participate in the study exclusion criteria: * patients with prior prostate irradiation and peri-aortic lymph node dissections will be excluded
a prospective study to evaluate the clinical performance and safety of the sirius endoscope system in laparoscopic gynecological surgery.

Conditions: Ovarian Cancer; Cervical Cancer; Gynecologic Cancer

Summary: precision robotics' sirius robotic flexible endoscopic system is a new fully integrated compact 3d laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction. a prospective study to evaluate the clinical performance and safety of the sirius endoscope system in laparoscopic gynecological surgery. the study is a single-arm prospective study to evaluate the performance and safety of the sirius endoscope system.

minimally invasive surgery (mis) is well established in gynecological surgery. compared to laparotomy, mis is associated with reduced morbidity and quicker recovery. with advancement in laparoscopic technology and techniques, mis in gynecology has progressed from multi-port to single incision laparoscopic surgery (sils) and vaginal natural orifice transluminal endoscopic surgery (vnotes), thus further reducing morbidity and enhancing recovery. one of the challenges of mis is the restriction of the range of surgical movement. to overcome these technical challenges, articulated instruments are increasingly being used. the sirius endoscope system is a new, fully integrated compact 3d laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction. the articulated tip has three degrees of freedom, enabling c and s-shaped bending, and providing a wider field of view compared to conventional laparoscopes. this wider field of view is of advantage for sils and vnotes. presently available commercial systems do not have the same field of view or degrees of freedom. a first in-human, proof of concept, and early development study of the sirius endoscope system was done at ghk in 2021 (hku-ghk irb 2021-01, clinicaltrials.gov nct05048407). the successful completion of 11 of 13 (85%) planned procedures in this sequentially reported, prospective case series, shows that the sirius endoscope system can be used with indications of safety, and efficacy for intermediate and major mis laparoscopic procedures in gynecology. the findings have been submitted for consideration for publication. based on the outcome of this study, further improvements to the sirius endoscope system have been made to enhance safety, reliability, and usability. this proposed prospective study is a confirmatory study to evaluate the performance and safety of the sirius endoscope system in preparation for regulatory approval.

Eligibility criteria:
inclusion criteria: * patients who are planned for laparoscopic gynecological surgery (lgs) * patient is 18 years of age or older * signed written informed consent. exclusion criteria: * patient is pregnant, or planning on becoming pregnant * obese patients (bmi \>35) * patient with known contraindication(s) to laparoscopic gynecological surgery * patient with operations planned for longer than 4 hours * subjects are considered ineligible for the study as judged by the investigator.
transverse abdominis plane (tap) block versus transversalis fascia plane block (tfpb) after cesarean delivery

Conditions: Acute Pain Management; Caesarean Section

Summary: postoperative analgesia treatment methods are applied to the living in the operating room. it is a routine part of the process of these applications. it is necessary from medical and ethical perspectives. postoperative analgesia applications are started in the preoperative period and continue in the postoperative period. the analgesic treatment to be used is shaped according to the application and experience of the anesthesiologist. the scientifically accepted developed method is multimodal analgesia protocols. these protocols cover a wide range from paracetamol to opioids, peripheral and central blocks (such as transversalis fascial plane block (tfpb) and transversus abdominis plane (tap) block). the aim of this study is to continue the analgesia protocols applied in cesarean section surgeries on the first 24-hour pain scores, the amount of opioid consumed after surgery and the quality of obstetric recovery (obsqor-10) scale.

postoperative analgesia treatment methods are applied to the living in the operating room. it is a routine part of the process of these applications. it is necessary from medical and ethical perspectives. postoperative analgesia applications are started in the preoperative period and continue in the postoperative period. the analgesic treatment to be used is shaped according to the application and experience of the anesthesiologist. the scientifically accepted developed method is multimodal analgesia protocols. these protocols cover a wide range from paracetamol to opioids, peripheral and central blocks (such as transversalis fascial plane block (tfpb) and transversus abdominis plane (tap) block). in this study, transversus abdominis plane block or transversalis fascial plane block was applied to the participants immediately after surgery. the aim is to continue the analgesia protocols applied to the cesarean section surgeries on the pain scores in the first 24 hours, the amount of opioid consumed after surgery and the quality of obstetric recovery (obsqor-10) scale.

Eligibility criteria:
inclusion criteria: 1. \>18 years 2. term pregnancies (37-42 weeks) and those planned to undergo elective cesarean delivery under spinal anesthesia exclusion criteria: 1. \<18 years 2. emergency surgery 3. bmi \> 35 kg/m2 or anatomic conditions that would preclude spinal anesthesia 4. increased susceptibility to bleeding or coagulation disorders (platelet count below 80,000× 10\^3/mm\^3 or inr \> 1.5) 5. known allergy to any drug, such as local anesthetics, opioids, or nsaids 6. other relevant maternal or neonatal clinical conditions requiring treatment and at the discretion of the investigators, such as gestational hypertension, impaired renal or hepatic function, postpartum hemorrhage 7. chronic pain conditions and concomitant use of analgesics

Keywords: obsqor-10 transversalis fascia plane block caesarean section transverse abdominis plane block numeric rating scale
study assessing the reduction of pain felt during installation intra- uterine device by direct technique

Conditions: Contraception

Summary: intrauterine devices (iuds) are contraceptive methods of long-acting (from 3 to 10 years depending on the model) and among the most effective. however, there are many obstacles to the use of iuds including pain felt by patients during installation. several medical means were studied without evidence of their efficacy in pain related to iud insertion. in order to remove this brake, it's important to find another way to act against this pain. the direct technique is one of the techniques described by health professionals. it seems trusted by its users as a more reliable technique but also less painful for patients. however, there is no study available on its evaluation. the aim of this study is to investigate the interest of the direct technique in reducing the pain experienced by patients during installation.


Eligibility criteria:
inclusion criteria: * any major patient and consultant for iud insertion : hormonal or copper * signing of the information and consent form by the patient or, if under supervision by parents or guardian. * patient affiliated with or entitled to a social security scheme * no contraindication for iud insertion exclusion criteria: * patient consultant for iud insertion to side arms * contraindications for installation. * legal incapacity or limited legal capacity. medical or psychological conditions not allowing the subject to understand the study and sign the consent * refusal to sign the consent.

Keywords: intrauterine device contraceptive method direct technique torpedo technique verbal numeric scale
quality gaps in screening and monitoring for postoperative hyperglycemia in a canadian hospital

Conditions: Diabetes Mellitus; Surgery; Hyperglycemia

Summary: patients with and without diabetes who have postoperative hyperglycemia have worse outcomes than patients with in-target blood sugars. previous quality improvement work suggests numerous barriers and clinical inertia may contribute to quality gaps in glycemic management for surgical patients. using a framework for perioperative glycemic management, we sought to measure quality gaps in perioperative glycemic care. this cross-sectional study used administrative data to measure the proportion of surgical patients with and without known diabetes who underwent preoperative hemoglobin a1c measurement, postoperative point-of-care testing for glucose (poct), had hyperglycemia, and received basal bolus insulin regimens for treatment. we performed an exploratory analysis comparing length of stay (los) in patients with and without diabetes who had and did not have postoperative hyperglycemia.


Eligibility criteria:
inclusion criteria: * underwent inpatient surgical procedure at the foothills medical centre between apr 1 2019 and march 31 2020 * stayed in hospital for more than 24-hours after surgery exclusion criteria: * younger than 18 years of age
functional bioactive supplement effect in lost weight treatment

Conditions: Obesity and Overweight

Summary: the purpose this study is to evaluate the therapeutic effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet to treat obese and overweight individuals. the functional bioactive supplement, containing antioxidant extracted from rosemary, oligosaccharides derived from lactulose and bioactive peptides, was developed to satiety control, improves of anti-inflammatory response and antioxidant defense mechanisms as well as to weight loss.

a randomized, parallel, double-blind, controlled was performed to evaluate the therapeutic effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet to treatment of obesity and overweight. women aged between 18 and 65 years with obesity and overweight diagnosis (imc \>25\<35 kg/m2) were included in the study. the clinical trial will be performed in the clinical nutrition department of la paz university hospital, in madrid. all of the volunteers will receive a dietetic treatment with 1500 kcal/day and physical activity recommendations during the study.

Eligibility criteria:
inclusion criteria: * women from 45 to 75 years old; * overweight (imc ≥25\<30 kg/m2) or obese (imc ≥30\<35 kg/m2) volunteers * signed informed consent. exclusion criteria: * subjects with drug consumption (lipid-lowering, oral hypoglycemic agents and / or hypertensive) in less than one month period; * subjects with diabetes mellitus insulin dependent; * individuals that stop smoking in the next 12 weeks (during the study); * subjects with increased alcohol consumption (\> 1 glass of vine); * subjects that consume drugs, vitamins, minerals, prebiotics or/and probiotics that interfere with the body's response to the extracts in the 2 weeks before to baseline; * subjects with drugs consumption special diet due to disease as celiac disease, chronic renal failure, etc; * subjects with disorders associated with eating behaviour; * subjects with drugs or supplements consumption to weight lost; * subjects with physical problems complying with the recommendations of physical activity and diet indicated; * subjects who refuse to perform the indicated dietary changes throughout the study; * subjects with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.); * subjects with mental disease or low cognitive function; * subjects with severe diseases (hepatic, kidney, cancer...); * pregnant women or lactating; * subjects with physical problems complying with the recommendations of physical activity. * subjects with intensive physical activity;

Keywords: clinical trials adult women functional food dietary supplements overweight obese absorptiometry, dual x-ray rosmarinus oligosaccharides lactulose bioactive peptide
quality assessment of orotracheal intubation without neuromuscular blocking agents in obese patients

Conditions: Obesity; Bariatric Surgery Candidate; Intubation Complication

Summary: this study will assess the condition of orotracheal intubation in obese patients undergoing an elective bariatric surgery without the use of neuromuscular blocking agents. during the induction of general anesthesia, propofol - remifentanil combination will be used. the patients will be randomized in 2 groups with different doses of remifentanil.

the prevalence of obesity increases steadily. for anesthesiologists, the airway management of obese patients is known to be difficult and at risk. tracheal intubation needs to be successful quickly. neuromuscular blocking agents allow this option but with a risk of anaphylaxis and respiratory complications. in fact, for many surgical procedures those drugs are not necessary. numerous studies in non-obese patients with the combination of remifentanil and propofol have shown adequate conditions for tracheal intubation without neuromuscular blocking drugs. this combination has never been studied in obese patient. after randomization, induction of general anesthesia will be performed with 2,5 mg/kg of propofol in association with either 3 µg/kg of ideal body weight of remifentanil, or 3 µg/kg + 30% of ideal body weight of remifentanil. minutes after the induction, orotracheal intubation will be performed, and the intubation difficulty scale recorded. other data on hemodynamic, respiratory and airway management will be are collected during the surgery. in the post anaesthetic care unit (pacu),any symptoms of traumatic airway management or aspiration are collected. those data will be again looked for and collected on the day of the patient's discharge.

Eligibility criteria:
inclusion criteria: * patient over 18 and under 60 years old. * asa score ≤ 3 * elective bariatric surgery for patient with bmi between 35 and 60 or elective revision of a bariatric surgery for patient with a bmi over 30. * patient with a written consent obtained with accurate information. exclusion criteria: * patient with risk of aspiration * difficult airway known (cormack score 3 ou 4). * opioids addiction. * alcoholism * chronic use of opioids * confirmed allergy to propofol or remifentanil * severe chronic hepatic, kidney or respiratory failure * patient already enrolled in another clinical study interfering with this study.

Keywords: tracheal intubation obese patient neuromuscular blocking agent remifentanil
a prospective clinical outcomes registry

Conditions: Pain

Summary: this is a prospective non-interventional 24 month post implant registry. any patient that receives a st. jude medical fda approved implantable neuromodulation system is eligible for enrollment. a minimum of 600 patients will be enrolled from a minimum of 30 sites. patients will be enrolled post-implant and followed for 24 months. data are collected at enrollment (within 30 days of device implant), and routine care follow-up visits at 3 months, 6 months, 12 months, 18 months and 24 months.


Eligibility criteria:
inclusion criteria: 1. patient has signed and received a copy of the informed consent form; 2. patient has been implanted with a st. jude medical neuromodulation system, including battery and/or scs leads; 3. patient is 18 years of age or older. 4. patient is not currently participating in another clinical trial. exclusion criteria: * none

Keywords: scs st. jude medical neuromodulation
apemesh ii - perineal reconstruction

Conditions: Rectal Cancer

Summary: the objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.

several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. preoperative radiotherapy seems to be a strong predictor for perineal complications. musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity.

Eligibility criteria:
inclusion criteria: * curative intent abdominoperineal resection and permanent colostomy exclusion criteria: * patient with a comorbid illness or condition that would preclude the use of surgery (asa 4- 5) * immunosupression (cortisone \>10mg/day) or severe malnutrition (bmi \<20) * diabetes with 1 or more organ damage * dialysis treatment * hepatic cirrhosis child-bugh b-c * potentially curable resection not possible * patient undergoing emergency procedures * metastatic disease * vaginal resection, pelvic exenteration and sacrum resection * vaginal perforation * pelvic abscess or perforated tumor * pregnant or suspected pregnancy

Keywords: abdominoperineal resection perineal reconstruction
investigation of pressure pain threshold and pinch grip strength in individuals with and without chronic neck pain

Conditions: Neck Pain

Summary: this study aims to determine whether there is a difference in pressure pain threshold and pinch grip strength in individuals with and without chronic neck pain.

neck pain is a common musculoskeletal disease. in chronic pain clinics, neck pain ranks second in frequency after low back pain. lifetime prevalence is higher in workers. 51-80% of workers experience at least one episode of neck and arm pain. neck pain symptoms may disappear spontaneously within a few weeks, while 30% of them continue as chronic neck pain. today, studies are planned with the theory that pathology leads to deficiencies, deficiencies lead to functional limitations, and functional limitations lead to disability. chronic neck pain increases the cost of treatment and reduces work capacity. in addition, neck pain in industrial workplaces causes loss of work days as much as low back pain. the aim of this study is to determine whether there is a difference in pressure pain threshold and pinch grip strength in individuals with and without chronic neck pain. in addition, it is aimed to examine the relationship of these parameters with quality of life.

Eligibility criteria:
inclusion criteria: * complaining of neck pain for more than three months, * with any chronic disease diagnosed, * no past or present mental illness, * individuals who can speak, read and write turkish. exclusion criteria: * having any neurological, psychiatric or cognitive disorder, * individuals who cannot speak, read or write turkish.

Keywords: pressure pain threshold neck neck pain pinch grip strength quality of life
anthracycline induced cardiotoxicity - early detection by combination of diastolic strain and t2-mapping

Conditions: Breast Cancer; Myocardial Damage; Cardiotoxicity

Summary: anthracyclines (e.g. doxorubicin) are an important and highly effective chemotherapeutic. they are used in various tumor entities and are established for breast cancer treatment. the most significant prognostic side effect is cardiotoxicity, which occurs in up to 50 patients. female gender must be considered an independent risk factor for the incidence and severity of associated heart failure. the aim of this study is to demonstrate that dose-dependent anthracycline-induced cardiotoxicity has a measurable effect on t2 mapping on mri. the second aim is to demonstrate if the combination of diastolic strain (echo and mri) and t2 mapping can detect earlier anthracycline-induced myocardial damage than via the established method of the echocardiographic measurement of lv-ef and the conventional quantification of diastolic function.

in order to answer the question, patients with breast cancer, who will undergo a chemotherapeutic treatment with antracycline, will be examined before chemotherapy (including cmr and echocardiography) and after chemotherapy at different times within one year.

Eligibility criteria:
inclusion criteria: * planned therapy with an anthracycline and at least 1 year follow up * \>18 years of age * written informed consent exclusion criteria: * prior cardiovascular disease * diabetes mellitus * previous therapy with anthracyclines

Keywords: breast cancer antracyclines cardiotoxity myocardial damage mri t2 mapping diastolic function echocardiography early detection strain analysis