Kornimate/medical-research-clean huggingface dataset:
the 1 year follow-up objective oral appliance compliance

Conditions: Sleep-disordered Breathing

Summary: the investigators will perform a 1-year clinical trial measuring objective compliance during mandibular advancement device (mad) treatment. the investigators will enroll 50 patients that received treatment with a titratable, duobloc mad (respident butterfly®, respident, nijlen, belgium) and participated in the original study "objective versus subjective compliance with oral appliance therapy for obstructive sleep apnea hypopnea syndrome", registered at clinical trials.gov (nct01284881). active microsensors (theramon®,handelsagentur gschladt, hargelsberg, austria) are provided by the handelsagentur gschladt without any costs. the sampling interval of the recording will be done at a rate of 1 measurement per 15 minutes (every 900 seconds). using this sample interval, the capacity of the active microsensor allows for data acquisition during a 100 day period. a follow-up appointment is scheduled +/- 265 days after the start of the original study. a second follow-up visit is scheduled again 1 year after the start of the original study. the objective measurement of mad wear time (total hours of wear time and the mean hours of wear per night over the respective period) will be based on the assumption that the mad has been worn when the chip records a temperature intraorally.

this clinical trial is an extension to trial 10/48/340, registered at clinical trials.gov (nct01284881).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of sleep-disordered breathing * started treatment with a titratable, duobloc mandibular advancement device * participated in original study 10/48/340 (3 month follow-up of compliance during treatment with mandibular advancement device) exclusion criteria: * dental exclusion criteria for mandibular advancement devices * medical contra-indications for mandibular advancement devices
factors associated with the complexity of dental implant surgery after alveolar ridge preservation: a retrospective cross-sectional study

Conditions: the Complexity of Implant Surgery

Summary: alcohol consumption, tooth position, and periodontitis-related tooth extraction affect the complexity of subsequent implant surgery after alveolar ridge preservation.

materials and methods we retrospectively analyzed the dentition of 165 alveolar ridge preservation sites in 116 patients. the bone width at three different vertical levels was measured on cone beam computed tomography images, and a comparison of bone regeneration requirements for subsequent dental implant surgery was performed for different socket types.

Eligibility criteria:
inclusion criteria: * teeth extraction in the premolar and molar regions, who underwent flapless tooth extraction with alveolat ridge preservation (arp) and filling with freeze-dried bone allograft (fdba) and platelet-rich fibrin (prf), who underwent cone beam computed tomography (cbct) followed by dental implant surgery after tooth extraction, and with adequate oral hygiene exclusion criteria: * untreated periodontitis, systemic disease, or the of medication that influences bone metabolism

Keywords: periodontitis, alveolar ridge preservation, implant surgery.
post-market clinical follow up of rotarex®s catheter

Conditions: Peripheral Arterial Disease

Summary: post-market clinical follow up of the rotarex®s catheter

a prospective, multi-center, non-randomized, multiple cohorts, observational, post market clinical follow-up study of the rotarex®s catheter to evaluate the safety, technical performance and medical efficacy of the rotarex®s catheter as a stand-alone and adjunctive therapy for the treatment of acute, subacute and chronic occlusions and sub-occlusions of arteries outside the cardiopulmonary, coronary and cerebral circulations, in accordance with rotarex®s catheter intended use.

Eligibility criteria:
inclusion criteria: 1. patient is ≥18 years old at the time of consent. 2. subject has provided written informed consent prior to participation in the study, understands the purpose of this study and agrees to comply with all protocol-specified examinations and follow-up appointments. 3. female patients of childbearing potential have negative pregnancy test ≤7 days before the procedure. 4. documented symptomatic peripheral arterial disease. 5. acute, subacute and chronic (sub-) occlusion, with ≥ 90% stenosis in native arteries and/or stents / stent grafts and/or bypass grafts and/or av fistula (dialysis access). 6. de novo or re-occluded lesion. 7. vessel and/or stent diameter within treatable range as per instruction for use. 8. occlusion crossed intraluminally by a guidewire. for patients requiring lower limb intervention: 9. patient presenting with a category from 2 to 5 according to the rutherford classification for chronic limb ischemia or a category from i to iib according to the rutherford classification for acute limb ischemia. exclusion criteria: 1. life expectancy \< 2 years. 2. pregnant or nursing a child. 3. contraindication, intolerance, or allergy to contrast media that, in the opinion of the investigator, cannot be adequately pre-medicated. 4. myocardial infarction within 60 days prior to index procedure. 5. history of severe trauma and/or sepsis within 60 days prior to index procedure. 6. cerebrovascular accident (cva) or transient ischemic attack (tia) within 60 days prior to index procedure. 7. evidence of intracranial or gastrointestinal bleeding or intracranial aneurysm within 90 days prior to index procedure. 8. abnormal electrocardiogram or blood test results and/or any other factor that would increase risk by participating in the study in the opinion of the investigator. 9. target lesion not crossed with guidewire or extraluminal guidewire crossing (even if in short segments only). 10. additional lesion that is located \>3cm away from the target lesion 11. treatment plan of the target lesion includes laser, brachytherapy, or atherectomy other than the rotarex®s catheter. 12. patient is currently participating in another investigational drug or device study that has not reached the primary endpoint. 13. patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics. 14. patients with uncorrected bleeding disorders. 15. thrombophlebitis or deep vein thrombosis within the past 30 days.
lbbap data collection registry

Conditions: Bradycardia; Sinus Node Dysfunction; Heart Block; Syncope; Cardiomyopathies; Heart Failure

Summary: the purpose of this registry is to evaluate the safety and effectiveness of lbba pacing/sensing in patients already implanted with the tendril sts 2088 lead.

this registry is a retrospective, observational, non-controlled chart review conducted to support an indication expansion of the tendril sts 2088 lead to include pacing/sensing in the left bundle branch area. data from a minimum of 220 attempted subjects will be included in order to have 190 evaluable subjects in this registry. the chart review will be conducted at up to 20 participating centers worldwide.

Eligibility criteria:
inclusion criteria: 1. subject has a de novo attempted implant of the tendriltm sts 2088 lead in the left bundle branch area on or before january 31, 2023 and subject's medical records contain data through at least 6 months (+/- 3 months) after lbbap implant attempt 2. subject is ≥ 18 years of age or the legal age, whichever age is greater 3. for sites where the governing irb/ec has not granted a waiver of informed consent, subject has either been informed of the nature of the clinical investigation using a privacy notice or has provided a signed written informed consent, as approved by the irb/ec (note: this inclusion criterion is not applicable for sites where the governing irb/ec or applicable regulation has granted a waiver of patient consent) exclusion criteria: 1. subject was enrolled in another clinical trial during this data collection period that might impact the outcomes of the present registry
multicentric study comparing carcinological and functional results of surgery

Conditions: Cancer of the PROSTATE

Summary: national multicentric prospective open study, comparing two current surgical methods: laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.

the aim of this study is to show that radical prostatectomy by laparoscopic way could obtain carcinological results not lower than theses with radical retropubic surgery.

Eligibility criteria:
inclusion criteria: * male, old patient of less than 70 years, * having a prostate cancer proven histologically, requiring a radical prostatectomy. * clinical stage t1c and rate of psa (with 20 ng/ml). * osseous scintiscanning and abdomen-pelvic scanner negative. * patient informed of the study and its participation. * patient affiliated to a social security system. exclusion criteria: * contra-indication with the surgery or the anaesthesia. * antecedent of prostate resection or adenomectomy. * antecedent of inguinal hernia treatment. * antecedent of deep venous thrombosis of the lower limbs or pulmonary embolism * patient privatized of freedom.

Keywords: retropubic prostatectomy surgical procedures laparoscopic
evaluation of the efficacy and safety of the fixed-dose combination sofosdac® 400mg/60mg in patients with chronic hepatitis c (hcv)

Conditions: Chronic Hepatitis c

Summary: a multicentric, observational, open-design study conducted to evaluate the efficacy and safety of sofosdac® 400mg/60mg tablets treatment in 100 patients with chronic hepatitis c (hcv)

beker laboratories developed the generic drug sofosdac® 400 mg/60 mg tablets as fixed dose combination that contains two direct antiviral agents (400 mg sofosbuvir and 60 mg daclatasvir) known to be pangenotypic in order to fulfill who plan to eradicate hcv by 2030. beker conducted an observational clinical trial to evaluate the efficacy and safety of fdc sofosdac® 400 mg/60 mg treatment in algerian patients with chronic hepatitis c (hcv).

Eligibility criteria:
inclusion criteria: * men and women age of 18 years old and older. * hcv chronic infection, genotype 1 or 2 or 3 or 4 or 5 or 6 * naive * bi-therapy failure, tri-therapy 1st generation telaprévir and boceprevir, sofosbuvir - pegifn - rbv failure * evaluation of fibrosis by non-invasive methods (fibroscan, fib 4, apri) performed during the pre-inclusion period (of at least one month) or a liver biopsy puncture of at least 24 months before the inclusion visit. * fibrosis according to metavir score: f0, f1, f2, f3, f4. * compensated cirrhosis child-pugh a or * decompensated cirrhosis (this point is applicable for patients who have cirrhosis) exclusion criteria: * patient under amiodarone * hepatocellular carcinoma hcc * haemodialysis * creatinine clearance \< 30ml/min * breastfeeding * impossibility of using effective masculine or feminine contraception during the study and 6 months after treatment cessation. * medications triggering conduction disturbances with long qt, 30 days prior to inclusion * qt prolongation \> 450 ms * personal or familial history of torsade de pointes * allergies to nucleosi(ti)des analogues. * advanced cardiopulmonary pathology * malignant neoplasia * the intake of anticonvulsants: carbamazepine, eslicarbazepine, fosphenytoin, phenytoin, oxcarbazepine, pentobarbital, phenobarbital, primidone or the antimycobacterial agents: rifabutin, rifampin

Keywords: hcv cirrhotic non-cirrhotic sofosdac sofosbuvir daclatasvir fixed-dose combination fdc hepatitis c pangenotypic genotype
reliability of pvi changes during tidal volume challenge in icu patients

Conditions: Shock; Septic Shock; Sepsis; Hemodynamic Instability

Summary: the aim of this study is to assess whether changes in the plethysmography variability index, during a tidal volume challenge, can reliably detect simultaneous changes in arterial blood pressure pulsatility, in patients hospitalized in intensive care unit. if results will be positive, this will allow the test to be performed even in the absence of an invasive arterial catheter.

among patients in a state of shock one of the first treatments is volume expansion, consisting in a fast intravenous injection of crystalloid or colloid solutions in order to increase cardiac preload and consequently cardiac output. however, this augmentation of the cardiac output happens only in half of the patients.to avoid ineffective fluid administration several tests have been developed. one of these tests is called the "tidal volume challenge" (tvc). it consists of transiently increasing for 1 minute the volume of air inhaled with each breath, in mechanically ventilated patients, and then evaluating whether this change impacts the pulsatility of the arterial blood pressure, detected by an arterial catheter. this test seems reliable, but it requires an arterial catheter to be in place. it has been suggested in previous studies that pulsatility of blood pressure can be estimated by the pulsatility of the plethysmography signal ("plethysmography variability index"), obtained from the oxygen saturation signal that's measured in all intensive care patients. the advantage is that this measurement only requires a sensor placed at the end of a finger, on the earlobe or on the forehead. the aim of the study is to assess whether changes in the plethysmography variability index (pvi) during a tvc can reliably detect simultaneous changes in blood pressure pulsatility. this study will include patients hospitalized in intensive care unit, mechanically ventilated, in whom physicians have decided to perform a tvc as common practice. changes, occurred during this test, in arterial blood pressure pulsatility and in plethysmography pulsatility index will be measured and compared. if results will show that changes in pvi during tvc are reliable for measuring blood pressure pulsatility changes during this test, this will allow the test to be used even in the absence of an arterial catheter.

Eligibility criteria:
inclusion criteria: * patients hospitalized in intensive care unit * physicians' decision to perform a tidal volume challenge * hemodynamic monitoring with a calibrated pulse contour analysis device (picco2) in place * monitoring of oxygen saturation with masimo set * mechanical ventilation with tidal volume of 6 ml/kg on ideal body weight exclusion criteria: * thoracic drainage * patient under judicial protection

Keywords: tidal volume challenge pleth variability index
comparison of the effects of remifentanil and dexmedetomidine administered under general anesthesia in rhinoplasty

Conditions: Rhinoplasty; Dexmedetomidine; Remifentanil

Summary: the investigators compared the effects of remifentanil and dexmedetomidine administered under general anesthesia on hemodynamics, postoperative pain, recovery, postoperative nausea, vomiting, shivering, patient's and surgeon's satisfaction in patients undergoing elective rhinoplasty. a single-center, prospective, blinded, randomized controlled trial. after the approval of the hospital ethics committee (ka22/12), fifty volunteers aged 18-65 years who underwent rhinoplasty under elective conditions accepted the study in the american society of anesthesiologists (asa) i-iii class. the patients were randomly divided into the remifentanil group (group r) and the dexmedetomidine group (group d). group r (n=25) was initially to receive remifentanil 0.01-0.2 g/kg/min without intraoperative loading. group d (n=25) dexmedetomidine, was initiated with a bolus of 1 mg/kg and received 0.2-0.7 g/kg per hour as an infusion during surgery.


Eligibility criteria:
inclusion criteria: patients who will have rhinoplasty surgery american society of anesthesiologists (asa) i- ii class exclusion criteria: patients with end-stage liver or kidney disease uncontrolled hypertension any type of atrioventricular block, pacemaker heart failure diabetes mellitus chronic obstructive or interstitial lung disease, severe asthma neurological or psychiatric disease, substance abuse pregnant or lactating women

Keywords: remifentanil dexmedetomidine pain recovery shivering
levetiracetam treatment of neonatal seizures: safety and efficacy phase ii study

Conditions: Neonatal Seizures

Summary: levneonat is a multicentre french clinical trials with the aim to develop new treatment strategies for the treatment of neonatal seizures using levetiracetam. the purpose of this study is to determine the correct dosing, safety and efficacy for intravenous levetiracetam as first line treatment in term newborn babies with seizures in hypoxic-ischemic encephalopathy context. this new anticonvulsivant drug is a promising treatment for seizures in newborns.

article focus * the principal aim of levneonat-1 is to determine the levetiracetam optimal dose defined as the highest efficient dose under toxicity restrictions for treating neonatal seizures. * levneonat-1 is an open-label, sequential dose-finding study with 3 increasing dose levels of levetiracetam. strenghts and limitation of study * for the first time, levetiracetam will be used as the first-line treatment of neonatal seizures and not as an add-on therapy. * statistical model is designed for a rare clinical situation with a sequential adaptive method updating in real time the dose allocation for next patient by using all available data from previous participants. * the targeted population, i.e. the newborn less than 3 days of life, is particularly sensitive and the written consent of both parents is required before the levetiracetam administration.

Eligibility criteria:
eligibility criteria: 1. male or female term baby with gestational age of 36-43 weeks and postnatal age \< or= 72 hours 2. one or more of the following : * apgar score \< 5 at 5 mins * umbilical cord or arterial blood sample (within one hour after birth): ph \ or = 16 mmol/l or lactates \> or equal to 11 mmol/l * abnormal neurological examination before 6 hours of life 3. suspected clinical or eeg seizures inclusion criteria: * a seizure lasting more than 3 minutes or more than 2 seizures lasting more than 20 seconds on a 1 hour-period on standard eeg recording 4 hours before the levetiracetam loading dose * availability of 8 electrode eeg recording * written informed consent of both parents or the authorized guardians * subscription to social security health insurance are required exclusion criteria: * suspected or confirmed brain malformation, inborn error of metabolism, genetic syndrome or major congenital malformation * congenital (in utero) infection (torch) * babies who have received phenobarbital or any other anticonvulsive medication other than a bolus of midazolam for intubation * anuria/renal failure defined as serum creatinine \> 150 micromol/l * seizures secondary to treatable metabolic etiology as hypoglycemia and hypocalcemia * corrected qt interval (qtc) greater than 450 milliseconds on the electrocardiogram (ecg) prior to inclusion in the presence or absence of a condition that promotes qt prolongation (hypokalemia, maternal treatment during childbirth or treatment of the child with drugs known to prolong qt), * participation to an interventional research study

Keywords: seizures neonates anticonvulsant treatment levetiracetam hypoxic-ischemic encephalopathy electroencephalography
obstructive sleep apnea syndrome after oropharyngeal cancer treatment

Conditions: Obstructive Sleep Apnea Syndrome; Oropharyngeal Cancer

Summary: the level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor. because of a high level of risk of developing an obstructive sleep apnea syndrome (osas), an accurate evaluation of the prevalence, of the risk factors and of the impact on quality of life is important in order to propose preventive and therapeutic solutions to these patients.

obstructive sleep apnea syndrome (osas) remains poorly documented in head and neck cancer cancer population, who have a higher risk than the general population. osas is a risk factor for quality of life impairment and cardiovascular morbidity and mortality. this study proposes to carry out an osas prevalence study among a locally advanced head and neck cancer population, already treated and to compare the consequences of current therapeutic options in sleep quality.the primary research objective will be a prevalence determination in a locally advanced stages treated population of oropharyngeal cancer. secondary objectives will be the comparison of the prevalence between the surgical group and the radio-chemotherapy group, the research of predictive factors of presenting an osas and the precision of the impact on quality of life.

Eligibility criteria:
inclusion criteria: * patient aged over 18 years old, male or female; * patient treated for a first oropharyngeal cancer located in upper airways (velum, side walls, back wall, base of tongue, vallecules), locally advanced, rated t3 or t4, whatever the stage n and m0; * patient who received curative treatment either surgical (excision and reconstruction free flap) with adjuvant radiotherapy or concurrent chemoradiotherapy; * treatment completed at least 12 months prior to study entry; * patient whose cancer disease is under control at exam time; * subject affiliated to a social security scheme; * subject agreeing to participate in the study and who signed the informed consent form. exclusion criteria: * minor patient * no affiliation to a social security scheme (beneficiary or assignee); * patient who did not signed the informed consent form * patient with neurological disease that can affect the upper airways function * patient has already been treated for head and neck cancer; * patient has a lesion classified t1 or t2 or m1; * patient has received different treatments: surgical resection without reconstruction, only radiotherapy * unweaned alcoholic patients