Kornimate/medical-research-clean huggingface dataset:
development of a robotic minimally invasive pathway for cochlear implantation

Conditions: Cochlear Hearing Loss; Implant

Summary: cochlear implantation is a system developed to restore hearing in people with profound sensorineural hearing loss, whose classical hearing aids are ineffective. surgery is necessary to insert the internal part into the cochlea and requires milling the mastoid to access the round window. this approach is technically difficult, and is performed under a microscope by an experienced surgeon. the development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics.

the rosa robot coupled to the o-arm scanner will guide the milling to the round window, whose path has been previously modeled, with the identification of the facial nerve. milling will be done in 2 stages with a ct (computerised tomography scan) and electromyographic verification of the facial nerve. the insertion of the implant will be performed manually under endoscopic control. the preoperative and postoperative course of the patient will be identical.

Eligibility criteria:
inclusion criteria: * patients eligible for cochlear implantation in chu amiens * patient more than 18 years old. exclusion criteria: * malformation or significant antecedent of mastoidectomy

Keywords: cochlear implant robotic mini-invasive
evaluation of lactoferrin, procalcitonin and aution® urine dipsticks for the diagnosis of spontaneous bacterial peritonitis in cirrhotic patients

Conditions: Liver Cirrhosis

Summary: bacterial infections are a major cause of mortality in cirrhotic patients in the context of gastrointestinal bleeding or spontaneous bacterial peritonitis (sbp). rapid diagnosis of sbp is therefore an important research goal because the gold standard neutrophil count in ascitic fluid cannot be performed 24 hours a day in all healthcare structures. the use of urine dipsticks in ascites cannot be recommended at the present time due to their insufficient sensitivity with an unacceptable risk of false-negatives in the context of a fatal disease for which effective antibiotic therapy is available. ascitic fluid lactoferrin assay has recently been demonstrated to be a very good diagnostic test for sbp. the investigators plan to conduct a prospective study on lactoferrin as well as procalcitonin (pct) to determine the best laboratory test(s) for the rapid, automated diagnosis of sbp. these tests will be compared with the aution® urine dipstick, which has been shown to present better diagnostic sensitivity than the multistix® dipstick . this single-centre study (amiens university hospital) will be performed in the context of routine clinical practice on ascitic fluid that is usually incinerated.


Eligibility criteria:
inclusion criteria: * patients over 18 years, not unable major * cirrhosis diagnosed by liver histology (or a non-invasive test , biological, or fibrotest fibrometer , or physical fibroscan® ) , or a set of clinical, laboratory , ultrasound and endoscopy . * presence of ascites puncture in the clinical part of routine care exclusion criteria: * ascites noncirrhotic origins : heart , nephrotic syndrome, peritoneal dialysis, tuberculosis, cancer peritoneal carcinomatosis , acute and chronic pancreatitis * surgical peritonitis by perforation of hollow organ * haemoperitoneum pure or associated with ascites.

Keywords: spontaneous bacterial peritonitis lactoferrin procalcitonin aution® urine dipsticks
diabetic foot ulcers: shorter treatment period using custom felt relief?

Conditions: Diabetic Foot Ulcer

Summary: the surgical outpatient clinic at molde hospital has since 2015 offered specialized treatment for patients with diabetic foot ulcers. this treatment is given by an interdisciplinary diabetic foot ulcer team. the standard treatment for diabetic foot ulcers is relief, a method with good results. although the treatment as usual gives good results, the team wants to optimize this treatment. by using custom felt relief for each patient, the treatment period might be reduced considerably. the aim of this study is therefore to investigate whether custom felt relief gives shorter processing time compared to standard relief treatment.


Eligibility criteria:
inclusion criteria: * diagnosed with diabetes mellitus type 1 or 2 * has neuropathic wounds under the foot * understands and speaks norwegian well * competent to give consent exclusion criteria: * responds to the filament glue and/or the tape used in treatment * in need of vascular surgery intervention * to be admitted to the hospital * in need of intravenously administered antibiotics due to wound infection.

Keywords: bandages wound healing time relief
reduce trial- reducing prolapse recurrence

Conditions: Prolapse; Female

Summary: this study will examine whether surgeons should add a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair.

the decision to perform a posterior colpoperineorrhaphy at the time of sacrocolpopexy is controversial. based on cohort data, some surgeons advocate that sacrocolpopexy alone is effective at treating posterior vaginal wall prolapse and the addition of posterior colpoperineorrhaphy only increases the likelihood of pain with defecation and dyspareunia. experts theorize that placement of posterior vaginal mesh down to the perineal body provides adequate posterior support and reduces genital hiatus size. others argue that placement of mesh too low on the posterior vagina may be associated with increased mesh exposure and pain secondary to mesh stiffness. no randomized trials exist comparing prolapse outcomes using new, ultra-light polypropylene mesh with and without posterior colpoperineorrhaphy. the investigators hypothesize that there will be no difference in prolapse outcomes after sacrocolpopexy using restorelle mesh with and without posterior colpoperineorrhaphy. however, patients with a posterior colpoperineorrhaphy will be more likely to report pain with defecation and dyspareunia. this will be the first multicenter randomized trial comparing outcomes of sacrocolpopexy with and without posterior colpoperineorrhaphy.

Eligibility criteria:
inclusion criteria: * women over the age of 18 * english or spanish speaking * symptomatic prolapse (stage ii or greater) undergoing minimally-invasive sacrocolpopexy with restorelle ultra lightweight mesh * preoperative genital hiatus with valsalva/strain greater than or equal to 4cm exclusion criteria: * patient has had prior prolapse surgery * patient has inflammatory bowel disease (crohn's, ulcerative colitis) * baseline dyspareunia (patient reports that they have pain with vaginal intercourse when asked as a yes/no) * patients with a score of 7 or greater in any one muscle on the meister pelvic floor exam * patient planning a concomitant burch procedure * pregnant
diagnostic performance of spot urine sample for the monoclonal components detection in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: the primary objective of the study is to evaluate at day 1 cycle 2, the detection sensitivity of the urinary monoclonal component on a spot urine sample, compared to the reference measurement on 24-hour urine, in patients with multiple myeloma.

to evaluate the detection sensitivity of the urinary monoclonal component on a spot urine sample, compared to the reference measurement on 24-hour urine, in multiple myeloma patients. 300 evaluable patients are required. for each of them, both spot urine sample and 24h urine sample will be collected at cycle1 day1, cycle 2 day 1 and cycle 4 day 1. the detection of urine monoclonal component will be performed by urine protein electrophoresis (quantitative) and urine immunofixation (qualitative).

Eligibility criteria:
inclusion criteria: * patient with multiple myeloma * patient starting new treatment line, whatever the line is, but with at least 3 induction cycles * urine monoclonal component ≥ 200mg/24h exclusion criteria: person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision

Keywords: multiple myeloma monoclonal components detection urine sample
clinical evaluator outcomes reliability study

Conditions: Dystrophinopathies

Summary: this study outlines structured clinical evaluator (ce) testing techniques that are proposed to be implemented across all sites participating in the cooperative international neuromuscular research group (cinrg) research studies. the study will determine if the selected techniques are reliable and reproducible across the cinrg network by evaluating the reliability and reproducibility of the measures between ces


Eligibility criteria:
dystrophinopathy participant inclusion criteria: * site confirmed genetic diagnosis of a dystrophinopathy * aged 6 years and older * able to transfer to testing table * able to walk 10 meters without an assistive device dystrophinopathy participant exclusion criteria: * investigator assessment of inability to comply with protocol assessments * participants who have attention deficient disorder or other cognitive conditions that may limit attention span to perform protocol assessments
a multicenter study to evaluate a risk-adapted strategy for treatment of extra cranial non seminomateous malignant germ cell tumour in children and adolescent

Conditions: Extra Cranial Non Seminomateous Malignant Germ Cell Tumour

Summary: the main objective is to assess the benefit-risk ratio of a risk-adapted strategy for treatment of extra cranial nsmgct in children and adolescent.

two different situations will be considered: * in nsmgct patients treated with cisplatin-based chemotherapy, the objective is to maintain a 2-year progression-free survival rate \>80% despite a limitation of the number of course of chemotherapy (≤4) after the achievement of a clinical and biological response (primary endpoint); * in children over 10 years with testicular or extragonadal nsmgct, the objective is to improve the overall survival by systematically classifying the patients in high-risk group to allow a dose intensification.

Eligibility criteria:
inclusion criteria: * extra cranial non seminomateous malignant germ cell tumour (nsmgct) except pure immature teratoma. * age ≤ 18 years. * affiliation with a social security scheme. * signed informed consent by parents * effective contraception during the study if relevant . exclusion criteria: * previous chemotherapy * contraindications to study treatments * patient who cannot follow medical surveillance due to geographical, social, or psychological reasons * pregnant and breast feeding women

Keywords: non seminomateous malignant germ cell tumour (nsmgct) dose de-escalation chemotherapy
quantification of autonomic nervous activity during hemodialysis

Conditions: Chronic Kidney Disease on Hemodialysis

Summary: this study assesses autonomic nervous system function by power spectral analysis of rr interval dynamics in ultrafiltration subjects without blood pressure variation.

variations over time in autonomic nervous activity due to differences in ultrafiltration rate will be evaluated by measuring heart rate variability in hemodialysis patients without blood pressure variations during hd session. the subjects will be divided into 3 groups, those with ufr \ 15 ml/hr/kg, and holter ecg are recorded continuously during hd session using frequency analysis of rr intervals.

Eligibility criteria:
inclusion criteria: * patients with stable undergoing hemodialysis without hanging in blood pressure during hemodialysis. exclusion criteria: * patients with chronic atrial fibrillation * patients with frequent ventricular premature beats * patients with a permanent pacemaker * patients with taking antihypertensive drugs * patients with medical treatment due to changes in blood pressure

Keywords: heart rate variability
utility of brain natriuretic peptide (bnp) in patients with type iv cardio-renal syndrome admitted to the intensive care unit (icu)

Conditions: Chronic Kidney Disease; Acute Heart Failure

Summary: admission bnp was a useful marker for diagnosing and predicting type iv cardio-renal syndrome type iv in patients with chronic kidney disease admitted to the icu for acute heart failure in a retrospective study. therefore, we aim to prospectively investigate the utility of serum bnp in evaluating the treatment adequacy and predicting future cardiac events in patients with type iv crs.


Eligibility criteria:
inclusion criteria: * adult patients aged \> 18 years, patients with chronic kidney disease (serum cr \> 2.0, documented medical history of chronic kidney disease exclusion criteria: * cardiopulmonary resuscitation, do-not-resuscitate state, acute kidney injury, icu stay \< 1 day

Keywords: brain natriuretic peptide cardio-renal syndrome
long-term outcomes of duodenal adenocarcinoma from a large cohort

Conditions: Gastrointestinal Disease

Summary: the investigators will conducted a hospital-based cohort study in our 15-year experience with da aimed at investigating the long-term outcomes of the patients with da, along with analyzing the impact of the tumor characteristics, operations and adjuvant therapy on survival outcomes.

numerous meta-analyses and systematic reviews have delved into the treatment of da, yet the majority of the studies retrospective, single-center, and small sample size series, particularly in china. to bridge this knowledge gap, the investigators will conduct a hospital-based cohort study designed to investigate the long-term survival outcomes of the participants with the non-ampulla duodenal adenocarcinoma, and the effects of tumor characteristics, surgery, and adjuvant therapy on survival outcomes.

Eligibility criteria:
inclusion criteria: (1) histologically confirmed non-ampulla da; exclusion criteria: 1. had other gastrointestinal cancer; 2. had incomplete medical records, or lost follow-up shortly after diagnosis; 3. refused clinical data collection.
thin film spectacle coatings to reduce light sensitivity and headaches in child and adolescent patients with migraine

Conditions: Migraine Disorders; Photophobia

Summary: the purpose of this study is to determine if a special coating, applied to the surface of glasses can reduce the frequency and severity of migraine headaches in children and adolescents. this study is being conducted by researchers at primary children's medical center, the john moran eye center, and the university of utah department of electrical engineering. the investigators have determined that a specific frequency of light is particularly bothersome to migraine patients. the coating they've developed is designed to block this frequency of light. very few treatments are approved for the treatment of childhood migraine. the investigators hope that these glasses will provide a safe way to improve headaches in children.


Eligibility criteria:
inclusion criteria: 1. must be diagnosed with migraine with aura or migraine without aura 2. must have at least 10 headache days per month exclusion criteria: 1. currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity 2. pregnant 3. unwilling or unable in the judgment of the investigator to complete the study 4. unavailable for any of the study visits 5. light sensitive conditions: meningitis, iritis, blepharospasm, albinism 6. degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy 7. medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs 8. best corrected visual acuity less than 20/40 in either eye

Keywords: migraine photophobia light sensitivity melanopsin cells intrinsically photosensitive retinal ganglion cells
increasing vaccine uptake among veterans at the atlanta va health care system

Conditions: Influenza; Tetanus; Diphtheria; Pertussis; Pneumonia

Summary: the office of evaluation sciences is collaborating with emory university and the atlanta va health care system to increase adult immunizations uptake among veterans. the intervention targets patients of primary care providers (physicians, physician assistants and nurse practitioners) through a modification of the existing reminders in the va electronic health record system. the team will evaluate the intervention using a randomized controlled trial.

the office of evaluation sciences is collaborating with emory university and the atlanta va health care system to increase adult immunizations uptake among veterans. the intervention targets patients of primary care providers (physicians, physician assistants and nurse practitioners) through a modification of the existing reminders in the va electronic health record system. the intervention includes a bundled vaccination reminder for influenza, pneumococcal and tdap vaccines, an immunization dashboard that relays a patient's vaccination status and history, and talking points for providers to use in their dialogues with patients. this intervention was designed to mitigate potential bottlenecks to vaccination, based on conversations and observations with facility clinicians. the team will evaluate the intervention using a randomized controlled trial.

Eligibility criteria:
inclusion criteria: * all patients must have appointments with active primary care providers (physicians, physician assistants and nurse practitioners) in the atlanta va health care system

Keywords: vaccination ehr reminders nudge electronic medical records behavioral economics
peritoneal microdialysis in patients undergoing low anterior resection (lar) for recto-sigmoid cancer

Conditions: Cancer of Rectum

Summary: anastomotic leakage is a serious complication after lar with high morbidity and mortality rates. early diagnosis and treatment is mandatory. the primary aim of the present study is to investigate the clinical use of peritoneal microdialysis and whether is able to detect anastomotic leakage prior to clinical symptoms develops.

patients undergoing lar for recto-sigmoid cancer is subjected to peritoneal microdialyses during the postoperative period until discharge. subcutaneous microdialysis serve as control. samples are collected every 4-hour. samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient. patients undergoing abdomino-perineal rectal resection will serve as a control group. a total of 50 patients will be included in this pilot study. the results of the peritoneal microdialyses will be compared with the clinical course in each patient. the results form the uncomplicated courses will be used to define the normal variations in peritoneal microdialysis. this will be compared to results from patients with various complications. the study is approved by the local scientific ethical committee no. ------

Eligibility criteria:
inclusion criteria: * histological verified cancer * the cancer must be located in rectum or the sigmoid colon * diverting stoma is allowed * perioperative radio-chemotherapy is allowed exclusion criteria: * disseminated cancer * asa-group 4 ore higher

Keywords: peritoneal microdialysis low anterior resection recto-sigmoid cancer anastomotic leakage
african american community health project on cardiovascular disease

Conditions: Cardiovascular Diseases; Cardiovascular Risk Factor

Summary: the investigators seek to demonstrate that interactive physician-led education through partnership with an african american church will improve awareness and knowledge of cardiovascular disease in the african american community and will result in objective improvement in major risk factors associated with cardiovascular disease (cvd).

cardiovascular disease causes significant morbidity and mortality in the african american community. among african americans adults almost 1/3 have hypertension, 1/10 have heart disease, 1/20 have coronary heart disease, and 1/30 have had a stroke. compared to their caucasian american counterparts, african americans are 3 times more times as likely to die from cardiovascular diseases than caucasians, 1.5 times more likely to die from heart failure, and 1.8 times more likely to die from stroke. in addition, both lower socioeconomic position and minority race/ethnicity are associated with poorer health and shortened survival. these alarming statistics highlight the health disparities in the african american community. in our study, the investigators propose that interactive physician-led education through partnership with an african american church will improve awareness and knowledge of cvd in the african american community and will result in objective improvement in major risk factors associated with cardiovascular disease.

Eligibility criteria:
inclusion criteria: * african american adults \> 18 years old
phase 3 study of aztreonam for inhalation solution (azli) in a continuous alternating therapy regimen for the treatment of chronic pseudomonas aeruginosa infection in patients with cf

Conditions: Cystic Fibrosis

Summary: the primary objective of this study is to evaluate the safety and efficacy of a cat regimen with aztreonam for inhalation solution (azli) and tobramycin inhalation solution (tis) in adult and pediatric subjects with cystic fibrosis (cf) and pulmonary pseudomonas aeruginosa (pa) infection. participants will be enrolled in a 28 day tis run-in phase, and will be eligible for randomization in the comparative phase if they have not received non-study oral antibiotics for a respiratory event, or iv or inhaled antibiotics for any indication between visits 2 and 3, have not developed a condition requiring hospitalization or other change in clinical status which, in the opinion of the investigator would preclude their ability to continue in the study, and have demonstrated at least 50% tis compliance. participants enrolled in the comparative phase will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: azli or placebo for 28 days followed by tis for 28 days.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf * presence of pa in 2 lower respiratory tract cultures in the 12 months prior to screening * forced expiratory volume (fev)1 ≥ 25 and ≤ 75% predicted * history of 1 hospitalization or 1 course of iv antibiotics for an acute respiratory exacerbation in the 12 months prior to screening exclusion criteria: * concurrent use of oral, iv or inhaled antibiotics at enrollment * concurrent hospitalization at enrollment * history of local or systemic hypersensitivity to monobactams or aminoglycoside antibiotics or history of aminoglycoside antibiotic associated toxicity
slide tracheoplasty versus tracheal resection anastomosis in acquired tracheal stenosis

Conditions: Tracheal Stenosis; Subglottic Stenosis

Summary: aim of the work to compare the clinical outcomes between patients will undergo slide tracheoplasty and those will undergo tracheal resection anastomosis for acquired tracheal stenosis.


Eligibility criteria:
inclusion criteria: * all patients with grade iii, iv acquired tracheal stenosis (e.g., due to trauma, prolonged intubation) regardless their age or sex. * patient with symptomatic high grade ii acquired laryngotracheal stenosis after failure of endoscopic interventions. * clinical indications for surgical intervention (symptoms of airway obstruction). * feasible for surgical intervention. exclusion criteria: * congenital tracheal stenosis * malignant stenosis. * severe comorbidities that contraindicate the surgery. * patients refusing to sign the consent.

Keywords: slide tracheoplasty tracheal resection anastomosis