Kornimate/medical-research-clean huggingface dataset:
comparison of apnea-hypopnea index in patients with or without preventive oxygen therapy after bariatric surgery

Conditions: Obstructive Sleep Apnea; Obesity; Bariatric Surgery Candidate

Summary: the best perioperative strategy for obstructive sleep apnea (osa) in bariatric surgery remains unclear. a strategy is to monitor patients and administer preventive oxygen therapy during the first postoperative night. however it is unknown what if preventive oxygen therapy is necessary. the goal of this trial is to compare the apnea-hypopnea index (ahi) in participants with or without preventive oxygen therapy. methods: participants are patients who underwent bariatric surgery without treated osa and will be will be randomized into arm a or arm b: arm a: first postoperative night in the hospital with preventive oxygen therapy (standard care), arm b: first postoperative night in hospital without preventive oxygen therapy (intervention).

rationale: the prevalence of obstructive sleep apnea (osa) in the bariatric surgery population is high and mostly undiagnosed. the best perioperative strategy to manage sleep apnea in bariatric patients remains unclear. a recent study found that monitoring patients with pulsoximetry and giving them preventive oxygen therapy during the first postoperative night is safe and cost effective. in a population with patients with osa but without obesity, no significant difference in apnea hypopnea index (ahi) was found between patients with and without oxygen therapy during the first postoperative night. the question was raised if preventive oxygen therapy during the first postoperative night after bariatric surgery is needed. objective: the primary objective of this study is to compare ahi in patients with potentially undiagnosed osa, treated with or without preventive oxygen therapy, during the first night after bariatric surgery. the secondary objective of this study is to compare sleep architecture in these patients study design: this is a randomized controlled non-inferiority trial consisting of two arms; arm a: first postoperative night in the hospital with preventive oxygen therapy (standard care), arm b: first postoperative night in hospital without preventive oxygen therapy (intervention). study population: patients scheduled for primary bariatric surgery without treated osa intervention: during the first postoperative night at the hospital patients in intervention arm b will not receive preventive oxygen therapy. main study parameters/endpoints: primary endpoint is ahi and secondary endpoints are 30 days complications rate, nursing intervention rate and parameters for sleep architecture and sleep related breathing, score of the epworth sleepiness scale (ess) and stop bang.

Eligibility criteria:
inclusion criteria: * undergo primary bariatric surgery (rygb or sg) * speak and read the dutch language exclusion criteria: * revisional bariatric surgery (e.g. sleeve conversion, rygb after gastric banding) * same-day discharge after bariatric surgery * diagnosed osa with treatment (cpap, oral appliances) * professional drivers * use of alpha blockers * unable to speak or read the dutch language
efficacy of direct selective laser trabeculoplasty in clinical practice in patients with glaucoma

Conditions: Glaucoma

Summary: prospective, single-arm, single-center, non-randomized, non-comparative study including naïve patients attending our center diagnosed with glaucoma, who have been recommended treatment with direct selective laser trabeculoplasty (dslt) by their ophthalmologist and who are under no hypotensive medication. dslt treatment will be performed with the voyager dslt system; it will consist of the application of 120 laser pulses of preset 3 ns and a preset 400 μm spot size, with an energy of 1.8 mj delivered to the limbus through a full 360 degrees. the study will evaluate the effect of dslt on intraocular pressure (iop). baseline iop will be the iop measured with goldman applanation tonometry by the investigator on the day of treatment, prior to the application of dslt. patients will be seen one week (±2 days), one month (±7 days), three months (±15 days), six months (±30 days) and 12 months (±40 days) after dslt treatment. in each of these visits, the attending ophthalmologist will measure iop with goldmann applanation tonometry and record the presence of any relevant ocular signs and query patients regarding potential adverse events. the study´s main end-point will be percentage reduction in iop six months after dslt compared to baseline.


Eligibility criteria:
inclusion criteria: • age over 18 years • diagnosis of open angle glaucoma in eye study and scheduled for both eyes being treated after bilateral laser indication. the diagnosis of glaucoma will be based on the presence of optic nerve damage that is compatible with glaucoma in the absence of any other cause that could have produced this damage, with an iop value\>21 mmhg. exclusion criteria: * patients diagnosed with uveitis, angle closure or congenital glaucoma. * presence of anterior peripheral synechiae * patients unable to complete three, six- and 12-months follow-up. * patients having undergone intraocular surgery, save for uneventful phacoemulsification (performed at least 6 months prior to inclusion)

Keywords: glaucoma direct selective laser trabeculoplasty
stress factors and vaccine attitudes among dental students during covid-19

Conditions: Surveys and Questionnaires

Summary: background: the aim of this study is to investigate the impact of the covid-19 pandemic on the education of dental students in turkey, the reasons that affect the psychological attitudes of students towards this disease, stress factors and the effect of these factors on vaccine acceptance. methods: the survey was applied online and consisted of questions aimed to find out the demographic characteristics, educational status, anxiety-stress factors, and reasons for students' decision behind covid-19 vaccine administration. the psychological impact of covid-19 was assessed by means of the generalised anxiety disorder-7 scale (gad-7). standard descriptive statistics, the chi-square test and independent samples t test were used for statistical analysis.

an online survey was conducted among dentistry students in turkey between april-may 2021. participants were included in the survey on the condition that they were enrolled in a dental school in turkey at the time. participation in the survey was completely voluntary. participants got the link to the survey online and accessed it directly by clicking the link. at the beginning of the survey, participants were informed that their participation was voluntary, their answers were anonymous, and they could leave at any time. they were then explicitly asked if they wanted to participate in the research study before starting the survey. the survey was created using the free-to-access google forms app and took approximately 15 minutes to complete. survey consisted of questions about the effects of covid-19 epidemic on the education of dental students in turkey, stress factors, the reasons and factors affecting their psychological attitudes towards this disease. there were also questions about the effects of these reasons/factors on attitudes and behaviors related to vaccination.

Eligibility criteria:
inclusion criteria: to be a dental student in turkey - exclusion criteria: -

Keywords: covid-19 vaccine anxiety concern dental students
airway pressure release ventilation (aprv) versus ac/vc conventional ventilation

Conditions: Respiratory Failure; Acute Lung Injury (ALI); Acute Respiratory Distress Syndrome (ARDS)

Summary: aprv mode of ventilation will result in an improved partial pressure of arterial oxygenation/ fraction of inspired oxygen (p/f ratio) on day 3 of mechanical ventilation. sub hypotheses: aprv will be associated with a reduced amount of sedation used during the icu stay in patients with respiratory failure. aprv will be associated with a reduction in the amount of vasoactive medication used for blood pressure support in patients with respiratory failure.

this prospective un-blinded randomized trial will follow patients with respiratory failure and ali/ards who require invasive mechanical ventilation in select icus. patients will be allocated to respiratory support with either aprv mode or volume control (ac) mode of mechanical ventilation. qualifying patients will be randomized by permuted block randomization within 24 hours of admission to the icu. identical ventilation and oxygenation thresholds will be utilized to guide titration of each ventilator protocol. patients will remain on the assigned mode of ventilation until they are extubated and discharged from the icu. procedures for treatment evaluation include daily monitoring of the ventilator protocol in each arm. clinical coordinator and study respiratory therapist will perform 2 daily checks of the study patients to determine compliance with the protocol and if patient meets weaning criteria. the previously published ards network continuous positive airway pressure (cpap) weaning protocol will be used for all patients enrolled.

Eligibility criteria:
inclusion criteria: * hypoxemic respiratory failure requiring mechanical ventilation for \>24 hours. exclusion criteria: * age under 18 * severe chronic obstructive lung disease * patients in whom the only indication for mechanical ventilation is airway protection from poor neurological status.

Keywords: ali ards
selinexor treatment of advanced relapsed/refractory squamous cell carcinomas

Conditions: Squamous Cell Carcinoma

Summary: open-label, multi-center, single-arm, phase 2 study of oral selinexor in patients with scc of the head and neck (hn-scc; cohort 1), lung (l-scc; cohort 2), or esophagus (e-scc; cohort 3) who have relapsed or have metastasis following chemotherapy.

this is a multicenter, open-label, single-arm phase 2 study of the sine selinexor given orally to patients diagnosed with advanced scc of the head and neck, lung, or esophagus who have experienced relapse and/or metastasis following multiple prior chemotherapy treatments (\<2 lines of therapy). patients will receive fixed doses of selinexor tablets twice weekly in 28-day cycles. patients may continue from one cycle to the next without interruption as along as all criteria are met and no reason for discontinuation occurs.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * confirmed scc of the head and neck, lung, or esophagus * 1 to 2 prior therapies * measurable disease at screening and documented progression within the past 6 weeks exclusion criteria: * patients requiring total parenteral nutrition * unstable cardiovascular function * substantially impaired gastrointestinal function * symptomatic brain metastases * another malignancy within 3 years except adequately treated in situ carcinoma of any type, basal or non-melanomatous skin cancer

Keywords: squamous scc carcinoma kpt-330 sine selinexor karyopharm karyopharm therapeutics lung head neck esophageal
daw1033d in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea (OSA)

Summary: obstructive sleep apnea (osa) is common and has major health implications but treatment options are limited. osa patients show a marked reduction in upper airway (ua) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of ua compared to normal subjects. in this protocol the investigators will test the effect of daw1033d administered before sleep on osa phenotype traits and osa severity during sleep.


Eligibility criteria:
inclusion criteria: - ahi \> 15 exclusion criteria: * any medical condition other than well controlled hypertension, diabetes, hyperlipidemia * any medication known to influence breathing, sleep/arousal or muscle physiology. * claustrophobia. * inability to sleep supine. * allergy to lidocaine, oxymetazoline hcl, daw1033d. * individuals with underlying cardiac disease, such as arrhythmias. * individuals taking psychiatric medications, or any of the studied medications for medical care. * history of seizures * for women: pregnancy. * history of panic disorder / hyperventilation syndrome / attention deficit-hyperactivity disorder (adhd) / autism
expanded access program for tofersen in participants with superoxide dismutase 1-amyotropic lateral sclerosis

Conditions: Superoxide Dismutase 1-Amyotropic Lateral Sclerosis

Summary: the objective of this early access program (eap) is to provide access to tofersen to eligible participants with amyotrophic lateral sclerosis (als) associated with a mutation in the superoxide dismutase 1 (sod1) gene prior to an alternative access mechanism in order to address a high unmet medical need in this population.

treating healthcare professionals (hcps) of participants who meet the inclusion/exclusion criteria may request access by emailing medicineaccess@clinigengroup.com. the current eap structure does not limit participants to receive access at specific sites. treating hcps can submit requests on behalf of participants by emailing clinigen at the email address provided below. information on the eap eligibility criteria, including participants and center criteria, will be provided by clinigen as part of the enrollment request process.

Eligibility criteria:
key inclusion criteria: * medically able to undergo the program procedures, as determined by the treating healthcare professional (hcp). * weakness attributable to als and associated with a mutation in the sod1 gene (sod1-als). key exclusion criteria: * previous or current participation in a clinical trial of tofersen. * use of an investigational medicinal product (imp) for amyotrophic lateral sclerosis (als) within 5 half-lives of the imp before the first dose of tofersen. * participant's primary place of residence is outside of the country of treatment. note: other protocol defined inclusion/exclusion criteria may apply
analysis of pain and quality of life in patients with charcot-marie-tooth neuropathy (cmt)

Conditions: CMT

Summary: the study aims to qualitatively and quantitively evaluate pain in patients suffering from cmt with 3 standardized questionnaires (sf-36, npsi-g, pain detect) as well as its impact on the quality of life.

hereditary neuropathies are a group of clinically and genetically heterogeneous diseases of the peripheral nervous system. charcot-marie-tooth disease (cmt), also known as hereditary motor and sensory neuropathy (hmsn), is the most common form of hereditary neuropathy with a prevalence of approximately 1 in 2,500 and with approximately 30,000 affected persons in germany. there is no therapy known so far. in addition to the characteristic symptoms of a distal to proximal progressive symmetric muscular atrophy, especially of the lower extremities, there is a weakening of the muscles of the lower legs and feet, with emphasis on the "small" foot muscles and the peroneal muscle group, which clinically manifests as a so-called "stepper gait". it is also known that many cmt patients additionally suffer from pain, but more detailed studies on pain quality and quantity and their impact on patients' quality of life have not yet been systematically performed. these parameters will be investigated in this study, supported by the company grünenthal, in the form of a questionnaire survey with validated questionnaires on pain and quality of life for at least 200 cmt patients. a representative result could lead to further investigations of pain in cmt patients and ultimately to the development of an adequate pain therapy. recruitment of patients will occur mainly through a call of the germany-wide cmt registry, which is part of the national research network cmt-net (coordinator: prof. michael sereda). interested patients are invited to contact the study team at the umg. the patients will be informed about the study and if further interested 4 questionnaires (1 regarding the personal history as well as 3 standardized questionnaires from literature regarding quality of life and pain (sf-36, npsi-g, pain detect) will be sent to the patients together with obligatory study documents and a pre-franked return envelope. a personal visit at the umg is not planned, so that the patients don´t have any expenses. the data are pseudonymized at the umg and transferred to a database and finally statistically evaluated by gruenenthal.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cmt * genetic confirmation of cmt diagnosis * age between 18 and 65 years * signed consent form exclusion criteria: * other relevant neurological or psychiatric diseases, acute or past * serious internal medical illness * drug and / or alcohol dependence * participation in another clinical trial within 4 weeks prior to enrollment
safety and efficacy of ibuprofen in term newborns with patent ductus arteriosus (pda)

Conditions: Patent Ductus Arteriosus

Summary: the aim of current study is to evaluate the efficacy and safety of oral ibuprofen in term 20-28 days old newborn referred to bandarabbas children' hospital in 2011.

patent ductus arteriosus (pda) accounts for about 10% of congenital heart disease. surgical treatment in pda is associated with higher rate of complication than pharmacologic treatment. efficacy of ibuprofen is shown in preterm and low birth weights newborn with pda. studies in term neonates after the first days of birth are rare. the aim of current study is to evaluate the efficacy and safety of oral ibuprofen in term 20-28 days old newborn referred to bandarabbas children' hospital in 2011.

Eligibility criteria:
inclusion criteria: * term newborn (37 weeks of gestation or more) * age between 20-28 days * confirmed diagnosis of pda by echocardiography by pediatric cardiologist exclusion criteria: * asphyxia * hemorrhage * platelet count \< 150000 * renal or gastrointestinal malformations * associated congenital heart disease

Keywords: patent ductus arteriosus pda term newborns ibuprofen
retrograde femoral nail-advanced outcomes for fixation of distal femur and femoral shaft fractures

Conditions: Femoral Fracture

Summary: this project consists of a prospective and retrospective case series design. study candidates will include all patients 18 years or older, who were evaluated at ucsd and found to have a distal femur or femoral shaft fracture requiring surgical fixation. patients who consent to study participation will recieve the rfn-advanced retrograde femoral nailing system implant for fracture fixation. data on functional status, healing rates, complication rates, and pain levels will be collected for each participant. after 3 years of data collection, investigators will analyze this data to provide further insight on the utility of this new design of retrograde femoral nails. given the relatively high rate of complications, such as malalignment, with current femoral nail designs, it is imperative to evaluate novel systems to appropriately manage distal femur or femoral shaft fractures.


Eligibility criteria:
inclusion criteria: * distal femur or femoral shaft fracture requiring surgery * evaluation and treatment at ucsd * age 18 years or older * ability to understand the content of the patient information/informed consent form * signed and dated irb-approved written informed consent exclusion criteria: * any not medically managed severe systemic disease * their doctor has decided that it is in the patient's best interest to receive a different method of fixation * their doctor has determined that the patient has a condition that would make them unsuitable for participation in the study * pregnancy or women planning to conceive within the subject participation period (1 year) note: pregnancy will be self-reported and no test will be performed to test for it * prisoner * participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study
neuro imaging and multimodal alzheimer's disease

Conditions: Alzheimer Disease

Summary: the present study aimed at measuring cerebral changes in alzheimer disease (ad) patients, who responded to strict physiological criteria typical of ad pathology. the objective of the present study was to identify the earliest alterations in cerebral connections that could contribute to the initial episodic memory impairment.


Eligibility criteria:
inclusion criteria: for all subjects : * capacities visual, auditory (authorized devices) and oral or written expression sufficient for the proper performance of tests * obtain informed written consent of the subject patients with ad : * outpatient accompanied by a "helping" * no parenchymal lesions allowing isolation explain the symptoms on brain mri (t1 and t2) carried more than 6 months prior to enrollment in the study. patients with more than three hyperintense white matter or visible lacunar infarction or t2 flair will not be included in the study. * probable alzheimer's disease diagnosis par with international standards * illness in a mild stage (cdr 1, 24 ≥ mini-mental state examination (mmse)\> 18) * activity of daily living (adl) 4 items\> 1/4 patients with alzheimer's disease at a pre-dementia stage: * alzheimer's diagnosis pre-dementia based on the search criteria * illness in a mild stage (cdr 0.5, 30 ≥ mmse ≥ 25) * adl items ≤ 4 1/4 control subjects : * 30 ≥ mmse ≥ 27 * perfect autonomy in daily living (iadl = 0, cdr = 0) * neuropsychological evaluation not highlighting of impaired cognitive performance with focus on memory performance * no parenchymal lesions on brain mri. * lack of family history (first degree) of alzheimer's disease exclusion criteria: * subjects with a contra-indication to mri (carrying a pacemaker or cardiac defibrillator, implanted a material activated by an electrical, magnetic or mechanical carriers hemostatic clips intracerebral aneurysms or carotid artery , holders of orthopedic implants, claustrophobia) * subjects with clinically significant gastrointestinal, renal, hepatic, endocrine, or cardiovascular * subjects with a psychiatric disorder or progressive neurological * french language level insufficient to be appropriately involved in neurophysiological evaluation * less than 5 years education (insufficient understanding level to participate in the study) * administrative problems: unable to give informed about information, not covered by a social security system * hypersensitivity to the active substance or to any of the excipients * unbalanced diabetes mellitus * subjects treated by a non-steroidal anti-inflammatory
voiding efficiency, a predictor of clean intermittent catheterization (cic)

Conditions: Urinary Bladder, Overactive

Summary: this study is a retrospective chart review of patients treated with onabotulinumtoxina (botox®) for idiopathic overactive bladder (oab) and will determine voiding efficiency (ve) cutoff ratios that predict post-procedure urinary retention requiring catheterization.


Eligibility criteria:
inclusion criteria: * patient with documented idiopathic oab diagnosis * patient was treated with 100-200u of botox® for oab * urodynamics assessment within prior to first botox® injection. exclusion criteria: * patient had received botulinum toxin formulations other than botox® in the bladder * patient had symptoms of oab associated with a neurological condition (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, alzheimer's disease, parkinson's disease, etc).