Kornimate/medical-research-clean huggingface dataset:
regional anesthesia versus general anesthesia

Conditions: Postoperative Pain; Anesthesia

Summary: patients undergoing laparoscopic gynecological surgery will receive regional anesthesia or general anesthesia with endotracheal intubation. the investigators aim to evaluate the feasibility and safety of regional anesthesia for laparoscopic gynecological procedures.

commonly, laparoscopic gynecological procedures are performed under general anesthesia with endotracheal intubation. the use of regional anesthesia in laparoscopy is reserved to patients declared unfit for general anesthesia because of severe comorbidities or it is applied in combination with general anesthesia to decrease postoperative pain. recently, growing literature evidence supports the use of regional anesthesia in patients undergoing laparoscopy. the combination of minimally invasive surgery with regional anesthesia could increase the advantages of laparoscopic operations (less postoperative pain, shorter hospital stay, etc).

Eligibility criteria:
inclusion criteria: * patients undergoing gynecological laparoscopic surgery; * expected surgical time shorter than 90 minutes; * informed consent to participate in the study. exclusion criteria: none.

Keywords: postoperative pain regional anesthesia general anesthesia gynecological laparoscopy
hr-lowering efficacy and respiratory safety of ivabradine in patients with obstructive airway disease

Conditions: Asthma, Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to investigate heart rate lowering efficacy and respiratory safety of ivabradine in patients with asthma and copd.

in this double blind, placebo-controlled, crossover study, 20 asthmatics and 20 copd patients received ivabradine 7,5 mg b.i.d. and placebo for 5 days in crossover manner. hr in ecg holter monitoring, peak expiratory flow rate (pefr), symptoms, rescue medication consumption and aes were evaluated in both periods of treatment.

Eligibility criteria:
inclusion criteria: * documented diagnosis of asthma or copd in accordance with guidelines * stable condition, defined as a disease without exacerbation for at least 1 month prior to study enrolment * mean hr in holter ecg recording of ≥ 60 bpm exclusion criteria: * disease exacerbation in previous month * inability to understand instructions on study procedures

Keywords: asthma, chronic obstructive pulmonary disease, copd, ivabradine, heart rate
comparison of visual outcomes after implantation of the pod ay gf f (physiol) and the pod ay 26p f (physiol)

Conditions: Cataract; Lens Opacity

Summary: the study is a prospective randomised controlled study. the patients get monolateral iol implantation of pod f gf and pod f in the contralateral eye. both iols are trifocal iols consisting of the same optical design. the difference between the iols is the material (hydrophilic and hydrophobic). to decide which eye receives pod f and which eye receives pod f gf, a randomization table will be provided to the principle investigator.

the examinations consist of visual acuity data, contrast sensitivity exams and slitlamp examinations. follow up will be up to 6 months postoperative.

Eligibility criteria:
inclusion criteria: * cataractous eyes with no comorbidity * patient older than 50 years old * regular corneal astigmatism \<0.75 dioptres by an automatic keratometer (regularity determined by the topography of the keratometry) or \<1.0 dioptres if the steep axis of cylinder is between 90° and 120° * spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation. * availability, willingness and sufficient cognitive awareness to comply with examination procedures * signed informed consent exclusion criteria: * unrealistic expectation * irregular astigmatism * difficulty for cooperation (distance from their home, general health condition) * acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...) * any ocular comorbidity * history of ocular trauma or prior ocular surgery including refractive procedures * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic uveitis, marfan's syndrome) * pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)

Keywords: intraocular lens trifocal cataract physiol
lung cancer mutation consortium protocol

Conditions: Adenocarcinoma of Lung, Stage IV

Summary: the primary objective of this protocol is to determine the frequency of oncogenic mutations in 1000 patients with advanced adenocarcinoma of the lung. the linked clinical and mutational analyses will be used to determine the frequency of each mutation, its association with clinical features and outcome, and its association with other mutations. as future therapeutic protocols specific for these mutations are developed, patients may be notified of their eligibility for these studies. future translational studies may be used to: a) unravel the complex biology of lung cancer; b) identify prognostic markers; c) define predictive markers of response/resistance to new therapies; d) identify new targets. a secondary goal is to establish a consortium of sites that have the capability of conducting multiple mutation testing in a clinical laboratory improvement amendments (clia) certified lab.


Eligibility criteria:
inclusion criteria: 1. subjects (=\> 18 years of age) who are undergoing further evaluation for the diagnosis or treatment of advanced adenocarcinoma of the lung. 2. diagnosed may 2012 or later 3. oral and written informed consent. exclusion criteria: 1. lung cancer histologies other than adenocarcinoma 2. lack of adequate tissue.
the replace registry for cholbam® (cholic acid)

Conditions: Bile Acid Synthesis Disorders

Summary: this is a prospective, observational, non-interventional patient registry study designed to document product safety and effectiveness outcomes for 10 years in patients treated with cholbam, including those who have been using cholbam for at least 30 days (existing users) and those who are first-time initiators of cholbam.

no experimental intervention is involved. patients in the registry undergo clinical assessments and receive care as determined by the patient's treating physician.

Eligibility criteria:
inclusion criteria: 1. male and female patients, of any age. 2. the patient and/or the patient's parent/legal guardian is willing and able to provide signed informed consent, and the patient, if less than 18 years of age, is willing to provide assent as appropriate and in accordance with local regulatory, irb, and ec requirements. 3. the patient has a diagnosis for which cholbam is indicated. 4. the patient is or will be treated with cholbam at the time of signing the informed consent form (icf) (enrollment). exclusion criteria: 1. patients who, by judgement of the investigator, will not be able to comply with the requirements of the protocol will be excluded

Keywords: bile acid synthesis disorder zellweger spectrum disorder peroxisomal disorder cholic acid cholbam the replace registry
brief alcohol screening for community college students (basiccs)

Conditions: Alcohol; Use, Problem

Summary: the present study focuses on examining the feasibility, acceptability, and preliminary effects of an adapted alcohol intervention for high-risk college students attending community colleges. investigators adapted basics (an efficacious in-person intervention developed for high-risk drinkers attending 4-year colleges and universities) to a web-conferencing format that allows the facilitator and participant to see and discuss live web-based personalized feedback. sms text messages with protective behavioral strategies were also provided. the objective of the r34 was to establish feasibility and acceptability as well as to determine preliminary or likely effect sizes.

young adulthood (ages 18-29) is associated with increased risk for alcohol-related negative consequences; however, little is known about effective interventions for young adults attending community colleges (ccs). thus, it is critical to develop an intervention that meets the various needs and demanding lifestyles of cc students. the investigators proposed to develop a user-friendly and convenient intervention that addresses relevant social norms, the impact of high-risk alcohol use on health and well-being in relevant life domains beyond student life and academic achievement, and provides ongoing exposure to behavior change strategies. to address the notable differences between cc students and traditional 4-year students, the investigators adapted basics to a web-conferencing format that allows the facilitator and participant to see and discuss live web-based personalized feedback (fb). this intervention for cc students, basiccs, will focus on relevant normative feedback and alcohol's impact on multiple roles and personal goals of the cc student. providing tips and protective behavioral strategies (pbs) after basics interventions via handouts or mailed postcards is standard practice and with preliminary evidence supporting the use of mobile phone text messaging (tm) or short message service (sms) to reduce heavy-episodic drinking; thus, in this study sms text messages were used to deliver ongoing protective behavioral strategies (pbs) the month after participating in the basiccs session. the objective of this research was to establish feasibility and acceptability as well as to determine preliminary or likely effect sizes. cc student drinkers were recruited to participate and if eligible, they were randomized to one of two conditions (basiccs or assessment-only control) and completed 1- and 3-month follow-ups.

Eligibility criteria:
inclusion criteria: * being 18-29 years old; enrolled full- or part-time at one of the three community colleges where data collection took place; consuming 4+/5+ drinks for women/men on one occasion in the past month or exceeding weekly niaaa drinking recommendations (8+/15+ for women/men); and possessing a cell phone with text-messaging capability exclusion criteria: * not meeting inclusion criteria, not consenting to participate
inspire turkey :a research study looking at the clinical parameters associated with use and discontinuation of saxenda® in local clinical practice in turkey by analysing past patient medical records

Conditions: Obesity

Summary: the study is investigating the use of saxenda (liragltuide 3.0 milligrams (mg) once daily) for weight management. the primary objective is to investigate the change in body weight after initiation and use of saxenda ® according to local clinical practice for weight management, on adult participant's in a real world setting in turkey. the study will last for about 5 months.


Eligibility criteria:
inclusion criteria: * patients who have signed consent before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * patients who have polyclinic visits between 01 june 2022 and 31 october 2022 and who have received initial prescription of saxenda® for weight management at least 52 weeks prior to study enrolment. * patients who have maintained treatment with saxenda® for at least 16 weeks, without treatment break, following the initial prescription. * patients who have 12-month follow-up data, even if discontinued saxenda ® treatment. * patients who have body weight measurement at baseline and at least 1 more body weight measurement following the saxenda® prescription * age greater than or equal 18 years at the time of signing informed consent exclusion criteria: * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * patient charts lacking any follow-up information for at least 16 weeks. * patients who have been treated with anti-obesity medication for last 12 weeks prior to initiation of saxenda® treatment. * patients who receive glp-1 receptor agonist for treatment of type 2 diabetes. * patients who have undergone bariatric surgery or use of minimal-invasive weight loss devices (i.e. intragastric balloons, lap bands) within 1 year before starting saxenda® treatment.
influence of probiotics on clinical parameters, the oral microbiome and the immune system during an orthodontic treatment in adult patients

Conditions: Gingivitis; Periodontal Inflammation; Orthodontic Appliance Complication

Summary: orthodontic treatment with fixed appliances can be necessary to correct malocclusions in adolescence or adulthood. it its known that orthodontic treatment induces aseptic pseudo-inflammatory reactions. however, studies could show that an increase of certain inflammatory cytokines during orthodontic treatment correlated with a higher risk of root resorption. moreover, it has been shown that orthodontic treatment leads to a dysbiosis of the oral microbiome especially during the first 3 months of the orthodontic treatment. this could be a potential risk factor as the inflammation of periodontitis during an orthodontic treatment could favor root resorption and progressive destruction of the periodontal apparatus. probiotics are already used successfully as an adjuvant therapy in the treatment of periodontitis to improve clinical parameters and to reduce local inflammation. however, there are only a few studies that investigated the influence of probiotics during an orthodontic treatment. therefore, the aim of our study is to investigate if the daily intake of lozenges containing probiotics versus placebo lozenges during the first 3 months of orthodontic treatment with fixed appliances can improve clinical parameters, reduce local inflammation, systemic inflammation and prevent a dysbiosis of the oral microbiome.


Eligibility criteria:
inclusion criteria: * adults (18 years and older) with fixed appliances undergoing orthodontic treatment. * signed declaration of consent by the patient exclusion criteria: * • systemic or metabolic disease that are related to gingivitis or (e.g. diabetes) or could possibly influence the oral microbiome • obesity: * body mass index (bmi) \> 30 kg/m² (weight and height will be measured) • eating disorder or underweight * bmi \< 18,5 kg/m² (weight and height will be measured) * above-average consumption of milk products: \> 3 portions/day = \>1,2 liters of milk or 1200g yoghurt/day (daily dose recommended by the german society for nutrition = 1-3 portions of milk products) * allergy to ingredients of the lozenges * intake of antibiotics or dietary supplementation (probiotics, vitamin c/d) in the last 6 months or during the study * regular use of antibacterial mouth wash * pregnancy * smoking * retraction of the declaration of consent by the patient

Keywords: orthodontics inflammation microbiome probiotics
supplemental oxygen in pulmonary embolism (so-pe)

Conditions: Pulmonary Embolism; Venous Thromboembolism; Metabolomics; Oxygen Inhalation Therapy

Summary: a study of how supplemental oxygen helps patients with acute pulmonary embolism (pe). hypothesis: oxygen affects right ventricular dysfunction (rvd) in patients with acute pulmonary embolism (pe) primarily by relieving hypoxic pulmonary vasoconstriction and reducing pulmonary pressure (pa) pressure, and that this process is metabolically driven.

in the emergency department (ed), investigators will perform a randomized, crossover trial of adult patients with acute pe. study subjects will be randomized to one of two interventions (supplemental oxygen delivered by facemask) vs. room air. therapy will be alternated at t=30, t=60, t=90 minutes, and then maintained for 180 minutes. after each treatment change, and at 180 minutes, investigators will: 1) perform echocardiograms to determine how oxygen affects right ventricular dysfunction (rvd) and, 2) draw blood for metabolomic analyses to determine the metabolic pathways that change in response to oxygen therapy.

Eligibility criteria:
inclusion criteria: * adults ≥18 years old * confirmed pulmonary embolism (pe) on imaging \<24 hours prior to enrollment * new symptom onset and / or worsening symptoms \<72 hours * confirmation of right ventricular dysfunction (rvd) by clinician * oxygen saturation ≥90% while breathing room air exclusion criteria: * hemodynamic instability * use of vasopressors or mechanical circulatory support * planned use of thrombolytics or plan for embolectomy * oxygen saturation \<90% while breathing room air * new onset arrhythmia * history of pulmonary hypertension, severe chronic obstructive pulmonary disease (copd) requiring home oxygen or chronic steroid use, hypoventilation syndrome requiring continuous positive airway pressure (cpap) or bilevel positive airway pressure (bipap), or congestive heart failure (chf) with lv ejection fraction \< 40% or chronic oxygen therapy * known pregnancy * vasodilator medication used in the past 24 hours * symptom onset ≥72 hours * inability to wear a face mask * inability to obtain adequate baseline echocardiogram

Keywords: pulmonary embolism pe right ventricular dysfunction
comparison of the functional properties of two injectable materials in posterior teeth: randomized clinical trial

Conditions: Class II Dental Caries; Dental Caries; Injectable Composite

Summary: using two different injectable materials in class ii cavities to compare functional properties


Eligibility criteria:
inclusion criteria: * 1-adult patients (20-50) 2-good oral hygiene good oral hygiene (plaque index ≤2 (moderate accumulation with plaque in the sulcus)) 3-patient approval 4-absence of parafunctional habits and/or bruxism 5-no endodontic treatment or abscess 6- class ii either mesial or distal (no mod cavities) exclusion criteria: * 1. systematic disease that may affect participation. 2. xerostomic patients. 3. bad oral hygiene (plaque index 2 or 3) 14 4. heavy smokers 5. patients undergoing or will start orthodontic treatment 6. signs and symptoms of irreversible pulpitis.
safety of and tolerability to a sodium-free peritoneal dialysis solution

Conditions: Chronic Kidney Diseases

Summary: this study will evaluate the safety and tolerability profile of a dwell time (bath) of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose in patients with chronic kidney failure undergoing peritoneal dialysis

phase i clinical trial which will include ten patients currently undergoing chronic peritoneal dialysis treatment. patients will be hospitalized for the study. the study will consist of replacing conventional peritoneal dialysis solution with a sodium-free 500 ml solution with 30% icodextrin and 10% dextrose with a dwell time of 24 hours.

Eligibility criteria:
inclusion criteria: 1. patients covered by the mexican social security department. 2. adults over the age of eighteen. 3. patients with chronic kidney failure undergoing replacement therapy with peritoneal dialysis. 4. patients with a functional peritoneal dialysis catheter. 5. patients undergoing peritoneal dialysis that was stable in the most recent month (ongoing peritoneal dialysis as an outpatient or ongoing cyclic peritoneal dialysis) 6. patients who wish to participate and who sign the informed consent. 7. if the peritoneal dialysis catheter and the transfer line are compatible with the peritoneal dialysis bag that has a simple luer male connector. 8. if treating doctors consider their patient to be clinically euvolemic. 9. if patients have undergone a peritoneal equilibrium test and their dialysis prescription has not been changed since the test was carried out exclusion criteria: 1. diabetes mellitus type 1 or uncontrolled diabetes (a1c hemoglobin greater than 8%). 2. active infection. 3. serum sodium prior to the study less than 130 mmol/l. 4. serum bicarbonate prior to the study less than 18 mmol/l. 5. patients who have been prescribed standard peritoneal dialysis who only use solutions with the lowest amount of dextrose 6. hemoglobin less than 8 g/dl. 7. active bleeding. 8. patients prescribed peritoneal dialysis who use a 4.25% dextrose solution at least once a day. 9. patients with a membrane defect or mechanical defect. 10. diastolic dysfunction with an increase in filling pressure according to the echocardiogram. 11. patients with active or suspected peritonitis according to the clinical criterion or their treating doctor.
acetaminophen's efficacy for post-operative pain

Conditions: Tonsillitis; Airway Obstruction; Difficulty Swallowing

Summary: the purpose of this study is to compare iv acetaminophen to oral acetaminophen for pain control in children undergoing tonsillectomy with or without adenoidectomy.

tonsillectomy with or without adenoidectomy is a common surgical procedure in children and adolescents. usually performed for recurrent tonsillitis or symptoms of airway obstruction, the procedure can result in significant post-operative pain. common analgesic techniques include the use of oral acetaminophen, non-steroidal anti-inflammatory drugs (nsaids), such as ibuprofen by mouth (po) or ketorolac intravenous (iv), and narcotics. acetaminophen has been shown to be effective in reducing pain and post-operative opioid requirements. its administration can be oral, rectal, or intravenous. nsaids, though effective for pain control, have been shown to increase bleeding risk and disrupt hemostasis. narcotics are effective for pain control but increase the risk of nausea and vomiting. they also have the potential to cause respiratory depression. iv acetaminophen (ofirmev) is indicated for management of mild to moderate pain, and as an adjunct to opioids for severe pain. several studies have examined the efficacy of iv acetaminophen vs placebo and/or active controls (meperidine, rectal acetaminophen (pr), tramadol). iv acetaminophen has been shown to be superior to placebo for pain control. though there is data regarding peak plasma and cerebral spinal fluid (csf) concentration of acetaminophen when given by different routes (po vs iv vs pr), there is no data comparing the efficacy of oral vs iv administration for pain control post-tonsillectomy in children.

Eligibility criteria:
inclusion criteria: * children 5-13 years of age * surgical procedure: tonsillectomy with or without adenoidectomy * american society of anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness or mild systemic disease that is well-controlled, e.g. mild asthma) exclusion criteria: * known allergy to study medication(s) * known genetic abnormality * known hepatitis * children with other physical, mental or medical conditions which, in the opinion of the pi, make study participation inadvisable or impairs pain assessment * children who have taken any analgesic within 24 hours prior to surgery * enrollment in concurrent research study * pregnant patients\* * students/trainees/staff\* * mentally disabled/cognitively impaired\*

Keywords: tonsillitis recurrent tonsillitis obstructed air passages swallowing difficulties