Kornimate/medical-research-clean huggingface dataset:
nasopharyngeal packing and rhinologic surgery.

Conditions: Nasal Surgery; Tampons; PONV

Summary: the purpose of this study is to assess the efficacy of three different pharyngeal packing during routine rhinologic surgery in the prevention of postoperative nausea and vomiting, and to evaluate the influence of pharyngeal packing on postoperative throat pain.


Eligibility criteria:
inclusion criteria: * 18-60 years old adult patient * nasal and/or paranasal sinus surgeries * general anesthesia exclusion criteria: * patients submitted to another intervention at the same time (adenoidectomy, tonsillectomy) * patients with a serious systemic disease (acquired immunodeficiency syndrome,leukemia, lymphoma, or other neoplasias under chemotherapy treatment) * patients presenting contraindications for using nonsteroid anti-inflammatory drugs
quality assurance of electronic data capturing (edc) in pain treatment

Conditions: Pain

Summary: there are actually no standardized quality assurance procedures included in pain treatment processes. in this observational, feasibility study the use of tablet-personal computer (pc) is tested in pain therapy centres using the validated questionnaire "activity index". the acceptance of electronic data capturing is tested in patients and therapy teams (doctors and nurses).

regarding the demand for a duly documented efficacy of the therapy applied, a standardized procedure is imperative to show the medical and economic advantages of a given therapy. to obtain valid results, it is necessary to use a standardized process, monitored with a validated questionnaire. in this multi-center study the activity index questionnaire will be tested regarding its outcome quality regarding usability and patient acceptance. each center collects data of 10 patients with injection pain therapy. each patient is interviewed twice and after the 2nd interview each patient will fill out a feasibility questionnaire. during the whole study, the use and consumption of oral analgetic drugs are monitored in a diary. the statistical analysis is done descriptive. before entering the study, each patient has to give informed consent to participate. national registration guidelines for post market surveillance will be obtained.

Eligibility criteria:
inclusion criteria: * willingness for therapeutic pain injection in lumbar spine exclusion criteria: * cognitive impairment, technical problems in interviewing patients
study of opioid immunosuppressive effects

Conditions: Opioid Abuse or Dependence

Summary: this trial aims to investigate the effects of opioid-inducing immune suppression on opioid drug abused patients. the methods of the investigators research mainly includes the expression of morphine-related mirnas in peripheral blood mononuclear cells and cytokine in plasma.


Eligibility criteria:
inclusion criteria: * subjects were excluded if they had a chronic systemic illness (cardiac, renal, pulmonary, hepatic, endocrine, metabolic, or autoimmune disorders) or * a major psychiatric disorder or * if they were abusing substances other than heroin (as determined by urine drug test result). for women, pregnancy was also a reason for exclusion. exclusion criteria: * control subjects with no history of drug or alcohol abuse were also excluded if they had * major medical or psychiatric disorders

Keywords: opioid drug abuse morphine immune function
ischemic preconditioning at a distance in liver surgery

Conditions: Liver Diseases

Summary: during hepatic transection, it exists a high risk of perioperative blood loss. the haemorrhage and its consequences (hypovolemia and blood transfusion) might impact the short and long term morbidity the vascular control by hepatic pedicle clamping (pringle's maneuver) or total hepatic vascular exclusion, helps minimizing blood loss and leads to a more extensive hepatic resection. side effects of vascular control result of ischemia-reperfusion injury (iri) : these reperfusion lesions results of different mechanisms than those responsible for the ischemic one. iri cause lesions and postoperative dysfunction of the remaining liver. among strategies to reduce the adverse effects of iri : ischaemic preconditioning (ipc) has been described. it can be either mechanical (intermittent hepatic pedicle clamping) or pharmacological (sevoflurane inhalation). short intermittent vascular occlusions in a organ might produce a resistance to a longer ischaemic period. it is certainly a physiological organ adaptation to tissue hypoxemia, which has a therapeutic potential when targeted. during liver resection, ischaemic preconditioning is realised with periods of hepatic pedicle clamping and unclamping. it decrease morbidity and mortality and prevent postoperative hepatocellular insufficiency due to clamping and iri at day 5. ischaemic preconditioning may also be applied remotely. indeed, it is shown that short ischaemic periods in a target organ can also have a protective effect on distant others. this mechanism involve three signalling pathways : neuronal , humoral and systemic pathways. in a previous randomized study, kanoria and al, demonstrated that the remote ischaemic preconditioning group has shown significant lower rates of serum transaminases and higher liver clearance (spectrophotometry method) than the control group. a latest study, measuring postoperative prothrombin rates has shown improved liver recovery due to halogen agents such as sevoflurane.


Eligibility criteria:
inclusion criteria: * scheduled carcinogenic laparoscopy or laparotomy liver resection * insured under the social security system * inclined to comply to the study protocol and its duration. exclusion criteria: * patient under guardianship * pregnancy or breastfeeding * severe lower limb vascular disease * emergency surgery * contraindication of a treatment from the protocol * psychological disorder with difficulty to accede the protocol * absence of written informed consent * refusal to sign the protocol * non-registration to the social security system

Keywords: remote ischemic preconditioning liver resection liver clearance.
a study of topiramate in pediatric subjects with basilar/hemiplegic migraine

Conditions: Basilar Migraine

Summary: the objective of this study is to assess the long-term safety and effectiveness of topiramate in the prevention of basilar and hemiplegic migraine in children and adolescents.

this is a single-center, open-label study consisting of 3 phases: blinded transition phase, open-label maintenance phase, and taper/exit phase. subjects who have either succesfully completed the capss-271 protocol or who discontinued the capss-271 study due to lack of effectiveness after completing at least 2 weeks of maintenance treatment will be eligible to enroll.

Eligibility criteria:
inclusion criteria: * must have either completed the double-blind phase of capss-271 or discontinued the double-blind phase of capss-271 due to lack of efficacy after a minimum of 2 weeks of maintenance treatment. * must continue to meet the specific inclusion criteria outlined in capss-271. * female subjects must be premenarchal, surgically sterile (hysterectomy, tubal ligation or otherwise incapable of pregnancy); or practicing an effective method of birth control (e.g., intrauterine device, double-barrier method, male partner sterilization) at study entry and throughout the study; or hormonal contraceptives for at least a 3-month period prior to the start of the study and throughout the study, or be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence. in addition, female subjects of childbearing potential must have a negative urine pregnancy test at open-label visit 1 (day 1). * must be able to read and comprehend written instructions and be willing to complete all headache records and questionnaires as required by the protocol. * after full explanation of the study, subjects, or their parent/legally authorized representative(s), must demonstrate their willingness to participate by signing an informed consent form. if applicable, pediatric subjects capable of giving assent must sign the assent form. exclusion criteria: * subjects who have developed a more painful condition than their headache pain. * subjects taking any of the prohibited concomitant medications (see concomitant medications section). * subjects who are pregnant. * subjects with liver function tests ³ 2 times the upper limit of the normal range. * in the investigator's opinion, subjects with poor compliance during the capss-271 study

Keywords: basilar/hemiplegic migraine prophylaxis
clinical evaluation of vanguard dd rp

Conditions: Knee Osteoarthritis; Post-traumatic Osteoarthritis; Rheumatoid Arthritis

Summary: this is a single cohort, prospective study of performance and safety of the vanguard deep dish rotating platform (dd rp) cementless fixation with the goal to acquire clinical outcomes data and evaluate the performance of the device in an austrian patient population

this is a single cohort, prospective study of performance and safety of the vanguard deep dish rotating platform (dd rp) - cementless fixation with finned stem. the performance will be assessed by oxford knee score, and evaluation of aseptic loosening after 2 years follow up. patient benefit will be evaluated by means of knee injury and osteoarthritis outcome score (koos) and eq-5d patient questionnaire. the target enrollment is 113 patients in 1 clinical site in linz, austria.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo primary total knee replacement: * with painful and disabled knee joint resulting from any of the following diagnoses: * osteoarthritis, * traumatic arthritis, * rheumatoid arthritis with one or more compartments involved. * correction of varus, valgus, or posttraumatic deformity. * correction or revision of unsuccessful osteotomy or arthrodesis. * need to obtain pain relief and improve function. * ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations. * a good nutritional state of the patient. * full skeletal maturity of the patient, patients who are at least 18 years of age. * patients of either sex. * consent form read, understood, and signed by patient. exclusion criteria: * absolute contraindications include the following diagnoses: * infection * osteomyelitis * previous partial or total prosthetic knee replacement on the operative side * skeletal immaturity of the patient * sepsis * patients who are less than 18 years of age * relative contraindications include: * uncooperative patient or patient with neurologic disorders who are incapable of following directions, * osteoporosis, * metabolic disorders which may impair bone formation, * osteomalacia, * distant foci of infections which may spread to the implant site, * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, * vascular insufficiency, muscular atrophy, neuromuscular disease, * incomplete or deficient soft tissue surrounding the knee

Keywords: knee replacement knee osteoarthritis
"the effect of reduced fluid load after cardiac surgery"

Conditions: Fluid Overload; Organ Edema; Organ Function

Summary: the purpose of this study is to verify that an infusion of hypertonic saline/colloids during cardio-pulmonary-bypass will reduce fluid overload and organ edema for cardiac patients with expected long-cpb-time. expected beneficial effects are improved organ function for heart and lungs.

fluid overloading with oedema formation is a regular finding following on-pump cardiac surgery and may contribute to postoperative organ dysfunction. myocardial oedema has been reported to impair both systolic and diastolic function. an association between intraoperative fluid loading and postoperative adverse outcome has been demonstrated in cardiac patients. our group has experience with the use of hypertonic saline/colloids in several experimental studies (pigs). in these animal studies we have used hypertonic saline/colloids both as an infusion during cpb or as an additive to cpb-prime. both administration methods resulted in significant reduction in fluid loading due to better intravascular volume preservation. one clinical study from our group observed reduced fluid load and an improved cardiac index when an infusion of hypertonic saline/colloids was used during cardiac surgery. patients included in this study had a normal left ventricular function and no co-morbidity. the planned study includes patients with combination procedures, both aorta coronary bypass and valve implantation, and expected long cpb-time.time spent on cpb is a individual risk factor negatively associated with increased mortality and morbidity. the investigators believe high-risk patients will have even more benefit of reduced fluid loading. their tolerance for hypovolemia is lower and the incidence for hemodynamic instability first hours postoperatively is greater. the patients will be randomized to receive either a continuous infusion of hypertonic saline/colloids or acetated ringer's solution during cpb. accurate accounts of fluid additions, blood loss and diuresis will be kept. determination of cardiac output (c.o.), intrathoracic blood volume (itbv), extravascular lung water (evlw) and global end diastolic volume (gedv) will be monitored by use of the transpulmonary thermodilution technique picco®plus system. preoperative and postoperative echo cor will be performed.

Eligibility criteria:
inclusion criteria: * patients scheduled for combination surgery, both elective coronary bypass and valve surgery, with expected long cpb-time, and who after orally and written information agrees to participate in the study. exclusion criteria: * age less than 18 years * serum-sodium higher than 145 mmol/l * hematocrit less than 30 % * estimated gfr less than 60 * bmi more than 30 or bmi less than 18

Keywords: cardiac surgery cardio-pulmonary-bypass
the effect of synbiotic consumption on glycemic, inflammatory markers and body composition on prediabetic and diabetic patients

Conditions: Dietary Supplements

Summary: this is a randomized controlled trial that will be conducted on saudi prediabetic and diabetic adults aged 18 to 70 years. the aim of the study is to investigate the effect of synbiotic consumption on gut microbiome, glycemic control, and other diabetes-related outcomes in patients with prediabetes and diabetes. a total of 160 participants will be recruited from king fahd hospital of the university, eastern province, saudi arabia and randomly assigned to synbiotic group (prediabetic and diabetic, n=40 each group) or control group (prediabetic and diabetic, n=40 each group) for a 6-month trial. a structured questionnaire will be used for data collection from subjects. the questionnaire will include data related to socioeconomic status, health and diet related history. primary outcomes including gut microbiome sequencing, glycemic control related parameters and secondary outcomes including inflammatory markers, food intolerance and anthropometric measurements will be measured before the study, after 3 months and after 6 months. the findings of the current study will shed light on the significance of synbiotic consumption on glycemic control and other diabetes-related outcomes and their relation to food allergy and autoimmunity.


Eligibility criteria:
inclusion criteria: * patients diagnosed with type 1 diabetes * patients on insulin therapy * patients on antibiotics * pregnant and lactating women * smoking individuals * patients with comorbidities (except for hyperlipidemia and blood pressure) * patients taking immunosuppressants * patients taking probiotics, prebiotics or synbiotics exclusion criteria: * patients with prediabetes (hba1c of 5.7- 6.4% or a fasting plasma glucose of 100 -125 mg/dl) * patients with type 2 diabetes (hba1c of ≥ 6.5% or a fasting plasma glucose of ≥ 126 mg/dl * male and female patients aged (18-70) years * patients with hba1c of ≥ 5.7 or a fasting plasma glucose of ≥100 mg/dl * bmi ≥ 25
venous sinus thrombosis : clinical picture and outcome

Conditions: Cerebral Vein Thrombosis

Summary: cerebral venous sinus thrombosis (cvst) is an underdiagnosed neurological condition with variable clinical presentations and variable risk factors cvst is often an underdiagnosed cause of acute or slowly progressive neurological deficit. with increasing awareness of the entity and easy accessibility to the non-invasive test like ct and mri scans,cvst cases are now being diagnosed more frequently and it is now thought to occur more commonly than previously assumed.it is also probably true that this condition is more frequent in underdeveloped countries


Eligibility criteria:
inclusion criteria: 1. all patients admitted to the neurology department and er of an assuit university hospital with the diagnosis of venous sinus thrombosis 2. accepting to participate in the study 3. of both sex above 18 years and below 70 years exclusion criteria: * 1. any case evident to have neurological deficit due to cause other than venous sinus thrombosis 2. patients refused to participate in this study 3-patients with uncertainty about her imaging study
a new portable device for non-invasive ventilatory support

Conditions: Healthy; Respiratory Disease

Summary: acute respiratory failure is a medical emergency rapidly leading to death, if not timely treated. prompt continuous positive airway pressure (cpap) improves patient outcomes. however, pre-hospital cpap is currently limited to healthcare providers due to the absence of easy-to-use and immediate devices specifically designed for the non-medical population. the efficacy and usability of a new portable cpap device will be assessed. this device is specifically designed for potential use in out-of-hospital scenarios involving acute respiratory failure. the evaluation will focus not only on the performance of the device but also on its easiness of use.

the efficacy and usability of a new portable cpap device will be assessed in different clinical settings. the study will take place in three hospitals in italy, with the objective of collecting data to support the future implementation of the device as a first-aid support tool for patients with respiratory failure in real-world scenarios.

Eligibility criteria:
arm 1 inclusion criteria: 1. age ≥65 years 2. clinically stable: non-hospitalized and not in acute illness 3. no professional medical knowledge: no experience as a health care provider 4. ability to express informed consent as requested by the ethical committee arm 1 exclusion criteria: none arm 2 inclusion criteria: 1. hospitalized adult patient 2. spo2 of 90-93% in room air arm 2 exclusion criteria: 1. facial burns/trauma/recent facial or upper airway surgery 2. vomiting 3. fixed upper airway obstruction 4. undrained pneumothorax 5. recent upper gastrointestinal surgery 6. inability to protect the airway 7. bowel obstruction 8. patient refusal

Keywords: cpap niv respiratory failure
the merit wrapsody av access efficacy study (wave)

Conditions: Venous Stenosis; Venous Occlusion

Summary: the purpose of the study is to demonstrate the safety and efficacy of the merit wrapsody endovascular stent graft for treatment of stenosis or occlusion within the dialysis access outflow circuit


Eligibility criteria:
inclusion criteria: * subject provides written informed consent * subject is male or female, with an age ≥ 18 years at date of enrollment. * subject is willing to undergo all follow-up assessments. * subject has a life expectancy ≥ 12 months. * subject is undergoing chronic hemodialysis. * subject has either a mature avf or avg in the arm. * target lesion(s) involves a de novo stenotic or non-stented restenotic lesion. * target lesion has ≥50% stenosis. * target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm exclusion criteria: * subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia. * subject has a stroke diagnosis within 3 months prior to enrollment. * subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment. * subject is pregnant, breastfeeding, or intending to become pregnant within the next year. * target lesion is located within a stent / stent graft.

Keywords: avf avg av fistula av graft
study of the facial nerve in mri 3t in the preoperative assessment of parotid tumors

Conditions: Parotid Tumor

Summary: preoperative evaluation of the precise localization of the intrapartotic facial nerve is essential for the ent surgeon to assess the risk of nerve damage during parotid tumor excision, and inform the patient of the risk of post-paralyzed facial nerve palsy. procedure

1. st visit: inclusion, parotid mri 3tesla high resolution with specific sequences and gadolinium injection performed at the a. de rothschild foundation. evaluation by two radiologists of the exact position of the parotid tumor with respect to the trunk of the facial nerve and its first branches, classified into two categories: contact (≤ 5 mm) or distance (\> 5 mm). 2. nd visit: surgical intervention of the parotid tumor. the surgeon will specify the same data as those collected by the radiologists after the mri. the surgeon will not be aware of the data concerning the ratios of parotid tumor to facial nerve collected on mri sequences for research purposes.

Eligibility criteria:
inclusion criteria: * patient over 18 years old * patient seeking first-line surgery for a parotid tumor (single or multiple, benign or malignant) * parotidian tumor located near the trunk of the facial nerve and / or its first division branches (temporofacial and cervicofacial), during a clinical evaluation performed by the surgeon in preoperative consultation * patient affiliated or beneficiary of a social security scheme * written consent to participate in the study exclusion criteria: * personal history of ipsilateral parotid surgery * contraindication to mri (electronic device, metallic foreign body, claustrophobia) * known hypersensitivity to gadolinium contrast agents * renal impairment known: glomerular filtration rate \<30 ml / min * pre or post-operative period of liver transplantation * patient benefiting from a legal protection measure * pregnant or lactating woman