Kornimate/medical-research-clean huggingface dataset:
arnold chiari malformation: the otological assessment as an objective criteria for surgical treatment

Conditions: Arnold-Chiari Malformation, Type 1

Summary: the aim of this study is to compare the value of multifrequency tympanometry between patients with surgical indication of treatment for a chiari type i malformation and healthy volunteers.

prevalence of chiari type i malformation in population is between 0.1% and 0.5%. chiari type i malformation is responsive in perturbation of the cerebro spinal fluid flow at the cranio-cervical junction. those perturbations caused headaches, and various otological symptoms (dizziness, tinnitus, vertigo, nystagmus, hypoacousis...). the surgical treatment consists in an occipital craniotomy to restore the cerebro spinal fluid flow at the cranio-cervical junction. symptoms are due to increasing of the pressure in the cerebellar fossa. 81% of the patients with chiari type 1 malformation suffer of sub clinical otological perturbations especially alteration of the vestibular test. in the literature, hearing performance could be normalized after posterior fossa decompression. furthermore, the multifrequency tympanometry measurement and particularly the width of conductance tympanograms at 2 khz shows that variations of the cerebro spinal fluid pressure have consequences on the pressure of the perilymph. investigator's hypothesis is that tympanometry (conductance) could be an effective test to show the variation of the cerebro spinal fluid pressure.

Eligibility criteria:
inclusion criteria: * chiari type i malformation proved at mri or ct-scan with an indication of cranio cervical decompression. * patients between 18 and 60 years old. * patient should benefit of the national health care system * agreement of the patient inclusion criteria for healthy volunteers: * between 18 and 60 years old. * free of otologic pathology * benefit of the national health care system * agreement of the volunteers exclusion criteria: * acute hydrocephaly * other type of chiari disease (induced...) * medical history of neurosurgery * contraindication for mri * cophosis * chronic otitis * medical history of ontological surgery * tympanic perforation * disturbance of tonal audiometry with air bone more than 20db in 4 frequencies with abolition of stapedial reflex * pregnant women or nursing women * protected adults by french laws exclusion criteria for healthy volunteers: * medical history of neurosurgery * cophosis * chronic otitis * medical history of ontological surgery * tympanic perforation * disturbance of tonal audiometry with air bone more than 20db in 4 frequencies with abolition of stapedial reflex * pregnant women or nursing women * medical history of chiari malformation * chronic headaches or neck pain * protected adults by french laws

Keywords: arnold-chiari malformation, type 1 multifrequency tympanometry inner ear pressure
prospective clinical study of pcv and pcv-vg in patients undergoing bariatric surgery

Conditions: Bariatric Surgery; Mechanical Ventilation

Summary: this study compares the two mechanical ventilation strategies in obese patients undergoing bariatric surgery: pressure-controlled ventilation(pcv) and pressure-controlled ventilation volume-guaranteed（pcv-vg). this is a randomized controlled trial with a sample size of 100 patients whose body mass index(bmi) is over 30kg/m².

with the development of economy and changing of life style, obesity is becoming a common phenomenon. more and more obese patients are undergoing bariatric surgery every year. obesity results in a series of physiological changes particularly the respiratory system. the decrease of lung compliance and the limited total lung capacity, vital capacity, functional residual capacity are all contributed to intraoperative hypoxemia and postoperative lung complications. presently study mainly discuss lung protective ventilation strategies from four aspects: tidal volume,ventilation modes,positive end-expiratory pressures and lung recruitment maneuvers. this prospective study will compare two ventilation modes in obese patients undergoing bariatric surgery:pressure-controlled ventilation(pcv) and pressure-controlled ventilation volume-guaranteed（pcv-vg). the total of 100 patients will be divided into two groups randomly. the patients will be ventilated with pcv or pcv-vg modes plus positive end expiratory pressure (peep) of 5cmh2o throughout the whole operation. the respiratory and hemodynamic parameters in six time points will be recorded, and the postoperative chest computerized tomography (ct) will be checked to identify the postoperative lung complications.

Eligibility criteria:
inclusion criteria: * bmi≥30kg/m² * asa classification ii-iii * bariatric surgery exclusion criteria: * patients combined restrictive or obstructive lung diseases,pneumonia, bullae of lung ; patients after pneumonectomy * patients combined with other severe internal medicine diseases * duration of pregnancy or suckling

Keywords: lung protective ventilation strategies obesity
study of milademetan in japanese patients with relapsed or refractory acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukemia

Summary: this is a phase 1, multicenter, open-label study to evaluate safety, tolerability and pharmacokinetics of milademetan in japanese patients with relapsed or refractory acute myeloid leukemia. the milademetan initial dose will be level 1: 90 mg. no increase in the milademetan dose will be made in the same participant. dose-limiting toxicity associated with milademetan occurring at each level will be assessed, and the maximum tolerated dose (mtd) will be decided using a modified continuous reassessment method (mcrm).


Eligibility criteria:
inclusion criteria: * relapsed or refractory aml * aml for which no standard treatment is available * eastern cooperative oncology group (ecog) performance status (ps) of 0 to 2 exclusion criteria: * acute promyelocytic leukemia * chronic myelogenous leukemia in blast crisis (bcr-abl fusion gene positive) * presence of central nervous system involvement of leukemia or a history of primary central nervous system leukemia

Keywords: oncology mdm2 escalation with overdose control (ewoc)
reducing pain in emergency department by using veinous blood gas instead of arterious blood gas

Conditions: Acid Base Disorder

Summary: blood gases are widely used in emergency and resuscitation services and are the key examination for exploring acid-base balance disorders (using ph, paco2 and hco3 ) and gas exchange disorders (using pao2 and paco2). this examination can be taken from both venous and arterial sample and its analysis depends on the type of blood sample. currently, several studies have already shown the existence of a good correlation of ph and bicarbonates level between a venous and arterial sample. thus, when this examination is prescribed for the purpose of highlighting and analyzing an acid-base disorder, venous blood gas is theoretically as efficient as arterial blood gas. due to the lack of evidence of benefit for the patient or the health care team of a venous blood gas rather than an arterial blood gas in the absence of suspicion of hypoxemia, arterial blood gas is currently the standard of care for the analysis of acid-base disorders. indeed, among the university hospitals affiliated to the paris diderot university, the emergency departments carry out in their vast majority (4 of 5 e.d.) arterial blood gases. demonstration of the superiority of veinous sample over arterial sample regarding pain could substantially modify current practices. the investigator's main hypothesis is that, in the absence of suspicion of hypoxemia (normal oxygen saturation measured by plethysmography), the realization of a venous blood gas for the evaluation of the acid-base balance in the context of emergencies is less painful for patients, simpler for the health care team and provides sufficient biochemical information for the doctor in comparison with an arterial blood gas.


Eligibility criteria:
inclusion criteria: * necessity of blood gas analysis * age \> 18 yo * spo2\>95% without supplemental oxygen * no altered level of consciousness: glasgow coma scale=15 exclusion criteria: * patient under guardianship or curatorship * confusional state or patient unable to understand the protocol * no social security
ketamine and postoperative analgesia in children

Conditions: Postoperative Analgesia

Summary: the benefit of small doses of ketamine has been demonstrated for postoperative analgesia in adults but remains unproved in children. the investigators' purpose is to evaluate the effects of continuous intravenous small doses of ketamine versus placebo to improve the quality of postoperative analgesia in children (6 months to 6 years of age). caudal anesthesia is performed for intraoperative analgesia and all children receive paracetamol, a non-steroidal anti-inflammatory and continuous intravenous nalbuphine.


Eligibility criteria:
inclusion criteria: * children between 6 months to 6 years of age * american society of anesthesiologists (asa) i or ii * undergoing elective surgery with intraoperative caudal analgesia exclusion criteria: * asa iii or iv * contraindication to caudal anesthesia * allergy to drugs used in the study * failure in caudal puncture * administration of morphine derivative

Keywords: pediatrics ketamine postoperative analgesia nalbuphine postoperative analgesia in children
prevention bundles for ssis (prebussi).

Conditions: Surgical Site Infection

Summary: surgical site infections (ssis) are the most complication after a surgical operation and their incidence reaches 20% worldwide. ssis have been associated to significant morbidity and mortality, high icu admission rates, increased length of hospital stay, high readmission rates and raised cost. however, there is no registry for ssis in greece so far. in addition, it has been considered that almost half of ssis could be prevented. therefore, several prevention strategies have been suggested by international health organizations, such as who and nice, that seem to be effective. the aim of the present study is to investigate the effect of 10 prevention bundles on the rate of ssis, as well their consequences on several financial parameters of the greek healthcare system.

* 1st phase (2 months) → ssis rate among abdominal surgical operations and reporting of patients' demographics (gender, age, comorbidities), type of surgery (upper gi, hpb, colorectal), surgical approach (open, laparoscopic), urgency classification, operation time, cost, pathogen cultures and antibiotic sensitivity test. * 2ο phase (10 months) → implementation of 10 prevention bundles: 1. antibiotic delivery 1-1.5 hours before surgical incision and repeat every 4 hours intraoperatively. 2. hair removal with electric hair clippers using single-use bladdes. 3. surgical scrub with povidone iodine solution 4% (betadine surgical scrub) 4. skin preparation with chlorexidine alcohol-based antiseptic solution 2%. 5. intraoperative and postoperative (4-6 hours) normothermia (\>36οc) using warmed forced-air blankets. 6. perioperative normoglycemia (glu\<200mg/dl) in diabetic patients. 7. single-use drapes and gowns. 8. surgical team glove changing by before skin incision closing. 9. single-layer surgical incision closure with triclosan plus antimicrobial-coated sutures. 10. wound irrigation (skin and subcutaneous fat) with povidone iodine solution (betadine) after abdominal wall closure. * implementation check of 10 prevention bundles preoperatively, intraoperatively and postoperatively. * clinical assessment on pod 1, 3, 7 and 1 month postoperatively for ssi presence (according to who 2018 definition). * reporting of patients' demographics (gender, age, comorbidities), type of surgery (upper gi, hpb, colorectal), surgical approach (open, laparoscopic), urgency classification, operation time, length of stay, cost, pathogen cultures and antibiotic sensitivity test.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. signed consent from patient or authorized representative 3. abdominal surgery 4. open or laparoscopic operations exclusion criteria: 1. age \< 18 years old 2. no signed consent from patient or authorized representative 3. neck, thoracic, anal, lumbar operations 4. no closure of abdominal wall or open abdomen

Keywords: ssi prevention bundles prebussi
primary care obesity prevention and treatment

Conditions: Obesity

Summary: the overall objective of this pilot is to demonstrate the feasibility of a low-cost intervention targeting obesity prevention among children in a primary care setting. specifically, the investigators aim to answer the following questions: can the investigators recruit and retain patients using the methods proposed, and how easy or difficult will this process be? can physicians deliver the proposed intervention messages in the time the investigators have proposed? can the phone counselor reach participants and accomplish the goals outlined for these calls? can the investigators obtain the data proposed and within the proposed time frame?


Eligibility criteria:
inclusion criteria: * child bmi ≥ 70th percentile for age and sex according to cdc growth tables * child scheduled for an upcoming well child visit
study of metronomic capecitabine and oxaliplatin versus xelox in egyptian metastatic colorectal cancer patients

Conditions: Clinical Response; Toxicity; Survival

Summary: colorectal cancer (crc) in egypt is advanced tumors at diagnosis. although, the dramatic increase in efficacy, reduction of mortality, and improvements in survival by the use of standard doses of chemotherapy, some crc patients suffer from severe toxicities besides disease progression. use of chemotherapy less than the maximum tolerated dose, with no prolonged drug free breaks incapacitates the cells to engage in progression mechanisms, suggesting that it could be a better alternative to standard dose therapy with better toxicity profile

this is a randomized phase ii prospective study that included 70 (35 in each arm) metastatic egyptian crc cancer patients diagnosed at the national cancer institute, cairo university between january 2016 and june 2018). patients were randomly treated with either classic xelox (arm a) or with capecitabine (2000 mg daily x 8 weeks) and oxaliplatin (30 mg/m2 weekly x 8 weeks) then 2 weeks rest (arm b). toxicities and the survival analysis after two years for both regimens were recorded. blood samples are taken from both groups to assess pharmacokinetics of capecitabine and its relation to dosing.

Eligibility criteria:
inclusion criteria: * patient age 18-70 years of both sexes. * ps 0-2 and histologically proven mcrc with unresectable metastases (rectal cancer is included to left side cancers). * they should have measurable lesions (that can be accurately measured in at least one dimension using calipers or ruler and measurement must be at least 20 mm using conventional techniques or 10 mm using spiral ct scan). * no previous treatment for metastatic disease and had ended adjuvant treatment \> 6 months. * peripheral neuritis less than grade 2. * normal organ functions:(creatinine ≤1.2, bilirubin ≤1.2, sgot/sgpt\ 9gm/dl, wbc\>3.5/dl with anc \>1.5/dl, plat ≥100/dl). * for patients with liver metastases, bilirubin should not be \>2.5n and transaminases not \>5n. (all patients were screened for hcv and hbs ag by pcr). * adequate cardiac functions (ef\>55%) exclusion criteria: * patients with only ascites or bone metastasis

Keywords: colorectal cancer metronomic capecitabine
efficacy and safety study of seroquel sr in the treatment of generalised anxiety disorder

Conditions: Anxiety Disorders

Summary: the primary purpose of this study is to evaluate whether treatment with (seroquel sr) quetiapine fumarate sustained release (sr) for 9 weeks compared to placebo will improve elderly patients with generalised anxiety disorder. please note: seroquel sr and seroquel extended release(xr) refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * male or female patients, 66 years or older, with a documented clinical diagnosis of generalised anxiety disorder (gad). * absence of current episode of major depression. exclusion criteria: * the presence of dementia or other mental disorder than gad. * serious suicidal risk, uncontrolled hypertension, substance or alcohol abuse. * a current diagnosis of cancer or current or past diagnosis of stroke.

Keywords: generalised anxiety disorder gad
effect of reparel knee sleeve with knee injection

Conditions: Osteoarthritis, Knee

Summary: the goals of treating knee osteoarthritis (oa) is to improve or maintain quality of life, mobility and function, pain relief, and improve inflammation. the different treatment options for knee oa have been extensively studied and implemented, but the optimum treatment is still undecided. there is a belief that anti-inflammatory sleeve technology may be beneficial in treating knee oa. the purpose of this study is to determine if the reparel™ knee sleeve results in superior mobility, functionality, and pain outcomes as compared to a placebo knee sleeve in managing knee oa.

patients who are recommended non-operative management of their knee osteoarthritis and have consented to participate in the study will be randomized into two groups to receive either of the following 1. reparel knee sleeve 2. placebo knee sleeve participants assigned to both groups will be given instructions on how to use/wear the sleeve while performing activities of daily living or sports that had previously resulted in knee pain and also be asked to do the follows: * wear the sleeve as much as they possibly can * not change their usual activities and diet during the time they are on this study. * record in a diary the number of hours sleeve was worn per day * record any adverse effects or discomfort due to sleeve use. * not to receive any injections in the subsequent 6 months following baseline randomization visit. participant background information that is relevant to this study will also be collected from their medical record including age, sex, and race and stored in a hospital secure computer database (redcap). participants will also be asked to complete the knee injury and osteoarthritis outcome score (koos), single assessment numeric evaluation (sane), oxford knee score (oks), lysholm score, ucla activity score and visual analog scale (vas) survey questionnaires at baseline randomization visit (t0), at 4 weeks (t1), at 3 months (t2), and at 6 months (t3) to assess the mobility, functionality, and pain associated with the affected leg. the responses to the surveys will be recorded on a password-protected laptop and all patient identifiers will be replaced with unique identifier numbers. only the study team will have access to the responses from the forms. the analysis of de-identified data will be done through spss 27, and scores for the questionnaires will be averaged and compared between the two groups.

Eligibility criteria:
inclusion criteria: * osteoarthritis visible on knee radiograph * patient opting for non-surgical treatment exclusion criteria: * bilateral symptomatic knee osteoarthritis * prior surgery on the knee of interest * hardware present on the knee of interest * gross instability detected on physical exam * malignancy in the knee of question
identification of the pathogenetic mechanisms underlying squamous cell carcinomas

Conditions: Squamous Cell Carcinoma of the Head and Neck; Squamous Cell Carcinoma of the Anus

Summary: this is a multicentric, retrospective, and prospective biomarker study.

this is a multicentric, retrospective, and prospective biomarker study, involving a total of 170 patients with scc (squamous cell carcinoma) of the mucosa of the anogenital tract and head-neck region, recruited from int-na (n=50), upo (n=40), aoup (n=40), and itb (n=40). specifically, retrospective and prospective samples will be collected and analyzed for the study of molecular and viral biomarkers. simultaneously, fibroblastic tumor-associated cells (cafs) will be isolated from prospective samples. through co-cultivation with immortalized cell lines derived from anogenital and head-neck sccs, these cafs will enable the production of 3d organoids for use in experiments assessing the response to telomerase and deacetylase sirt1 inhibitors, both in vitro and in preclinical models.

Eligibility criteria:
inclusion criteria: patients aged ≥ 18 years, candidates for surgical treatment for squamous cell carcinoma of the anus, uterine cervix, vulva, and head-neck region (including microinvasive and invasive carcinomas) who are capable of understanding and willing to sign the informed consent form. prospective patients must provide written informed consent before any procedures. exclusion criteria: patients presenting any of the following criteria are not eligible for inclusion in this study. exclusion criteria include: 1. metastatic neoplasia 2. treatment for other oncological pathologies 3. congenital or acquired immunosuppression (hiv, organ transplant, pharmacological)
a health promotion intervention for vulnerable school

Conditions: Obesity; Health Promotion; Noncommunicable Diseases; Child Development; Life Style

Summary: the bee-school (be empowered in school) is a cluster-randomised trial that addresses the complexity of the social challenge (vulnerable school-age children). it aims to analyse the effectiveness of the intervention program, based on the promotion of health literacy and lifestyles, specifically on children's: 1-health literacy and infodemic resilience (aim 1); 2- lifestyles (e.g. dietary intake, 24hmovement behaviour) (aim 2); 3-overweight and obesity (aim 3); 4-blood pressure (aim 4). the project converges multiple disciplines (e.g. public health, informatics, law) and researchers with proven expertise in these fields to provide comprehensive and innovative answers. 478 children (6 schools) aged 6-12years old will participate in this cluster-randomised trial, having schools as the unit of randomisation, assigned into intervention (239-3schools) and the control arm (239 - 3 schools). this project will perform a social listening (online and offline) and bottom-up approach to tackling ncds, focusing on health literacy and health promotion and recognising children's systems in daily life (e.g. family, teachers). stakeholders' involvement goes far beyond a merely consultative approach; the researchers are committed to a genuine codevelopment process. data collection includes sociodemographics, health literacy and infodemic resilience, dietary intake and children's 24-h movement behaviour (e.g. accelerometry), anthropometry (e.g. weight, height and waist circumference) and blood pressure. data collection will occur at baseline and after the intervention (follow-up, 6 months after the beginning of the intervention). expected outputs and outcomes include the creation of a model for characterising ncds and health topics based on artificial intelligence techniques (e.g. deep learning, and social network analysis methods); improved health literacy and infodemic resilience of children, families and teachers; enhanced children's lifestyles (e.g. dietary intake, 24-h movement behaviour); reduction of ncds' physical risk factors (e.g. overweight, raised blood pressure); feasible intervention program about health promotion and ncds' prevention for school-aged children with vulnerabilities, and advocacy- policies about health promotion and ncds' prevention.


Eligibility criteria:
inclusion criteria: * children from teip schools * ages between 5 to 12 years old exclusion criteria: * children/families who don't speak/understand portuguese