Kornimate/medical-research-clean huggingface dataset:
effectiveness of detachment of the breathing circuit on the rate of dlt malposition after postural change

Conditions: Intratracheal Intubation; Patient Positioning

Summary: the goal of this clinical trial is to assess the incidence of double-lumen endobronchial tube displacement in patients undergoing thoracic surgery with a change in position, compared with double-lumen endobronchial tube malposition in chest surgery patients with a fixed breathing circuit. the study is to investigate: whether detaching the breathing circuit in patients undergoing thoracic surgery would reduce the rate of double-lumen endobronchial tube malposition, the incidence of postoperative pulmonary complications, and improve patient outcomes. participants will be randomly divided into a disconnected breathing circuit group and a breathing circuit connected group and after entering the operating room, the intravenous access will be opened, and blood pressure, heart rate, electrocardiogram, oxygen saturation, arterial pressure, and end-expiratory carbon dioxide will be monitored. anesthesia induction will be performed by an anesthesiologist, and then the double-lumen endobronchial tube will be inserted under laryngoscopic guidance. will the catheter be delivered to the expected depth, the double-lumen endobronchial tube will be connected to the anesthesia machine for mechanical ventilation. researchers will compare the malposition rate of the double-lumen endobronchial tube when the patient transitions from the supine to lateral decubitus position, the effect of single-lung ventilation, oxygen saturation at 5 and 10 minutes after single-lung ventilation, and postoperative recovery time.


Eligibility criteria:
inclusion criteria: * asa i-ii elective surgery for patients * patients undergoing thoracic surgery requiring a left-sided double-lumen endobronchial tube; * sign the informed consent form for this clinical study. exclusion criteria: * mouth opening \<3cm; * history of previous difficult intubation; * patients with diseases of the upper respiratory tract and main bronchi; * cardiac insufficiency; * people with liver dysfunction; * renal insufficiency; * previous stroke; * patients with severe obstructive ventilation dysfunction; * bronchial asthma or airway hyperresponsiveness; * patients who have participated in other clinical studies in the past 3 months.

Keywords: double-lumen endobronchial tube positional changes disengage breathing circuit malposition
ace1831 in adult subjects with relapsed/ refractory cd20-expressing b-cell malignancies

Conditions: B-cell Lymphoma; Non Hodgkin Lymphoma; DLBCL; Primary Mediastinal Large B Cell Lymphoma; Marginal Zone Lymphoma; Follicular Lymphoma

Summary: ace1831 is an off-the-shelf, allogeneic gamma delta t (gdt) cell therapy derived from healthy donors, that is under investigation for the treatment of cd20-expressing b-cell malignancies. the ace1831-001 study is an open-label, phase i, first-in-human (fih) study that aims to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, and efficacy of ace1831 in patients with cd20-expressing non-hodgkin lymphoma.


Eligibility criteria:
key inclusion criteria: * cd20-positive b-cell nhl that is persistent or progressive after having received at least 2 prior systemic therapies per nccn guidelines * at least 1 measurable lesion according to the revised international working group (iwg) response criteria for malignant lymphoma * eastern cooperative oncology group (ecog) performance status 0-1 * adequate hematologic and renal, hepatic, and cardiac function * oxygen saturation via pulse oxygenation ≥ 92% at rest on room air key exclusion criteria: * prior treatment with a genetically modified cell therapy product targeting cd20 * autologous stem cell transplant within 6 weeks of informed consent or history of allogeneic stem cell transplantation * history of central nervous system (cns) lymphoma or primary cns lymphoma * history or presence of clinically relevant cns disorder (e.g. epilepsy) * clinically significant active infection * currently active, clinically significant cardiovascular disease * human immunodeficiency virus (hiv) infection, active hepatitis b infection, or hepatitis c infection * history of other malignancies with the exception of certain treated malignancies with no evidence of disease * primary immunodeficiency disorder * pregnant or lactating female * any medical, psychological, familial, or sociological conditions that, in the opinion of the investigator or sponsor medical monitor, would impair the ability of the subject to receive study treatment, comply with study requirements, or understanding of the informed consent
effect of low-level laser prior to the induction of fatigue

Conditions: Temporomandibular Joint Disorders

Summary: the objective of this study is to perform an evaluation of the effect of lllt on the prevention of fatigue in the masseter and anterior temporal muscles in young individuals with and without tmd.

male and female individuals aged 18 to 23 years will be evaluated. the research diagnostic criteria for temporomandibular disorders will be applied for the determination of the presence or absence of temporomandibular disorder. each group (with and without temporomandibular disorder) will then be randomly allocated into a control group and experimental group submitted to pre-fatigue low-level laser therapy. before and after the induction of fatigue, all volunteers will be evaluated with regard to the range of mandibular movement, bite force, sensitivity to palpation of the muscles evaluated and muscle fatigue. low-level laser therapy will be administered to the masseter and anterior temporal muscles prior to the induction of fatigue, which will be induced with the use of chewing gum. the data will be submitted to descriptive statistical analysis. the chi-square test and fisher's exact test will be used to establish the associations of the categorical variables. pearson correlation coefficients will be calculated for the analysis of the correlation of the continuous variables.

Eligibility criteria:
inclusion criteria: * male and female individuals aged 18 to 23 years with a signed statement of informed consent will be included in the study. exclusion criteria: * individuals in orthodontic or orthopedic treatment for the jaws, psychological treatment or physical therapy and those who make use of muscle relaxants, anti-inflammatory agents or bite plates will be excluded from the study.

Keywords: temporomandibular joint temporomandibular disorder muscle fatigue low-level laser therapy
[18f] lbt-999 pet compared to [123i]-fp/cit spect to distinguish between parkinson's diseases and essential tremor

Conditions: Parkinson Disease; Essential Tremor

Summary: clinical study to demonstrate an at least equivalent performance of a new pet molecular imaging radiopharmaceutical named \[18f\] lbt-999 in brain imaging compared to the spect reference method named \[123i\]-fp-cit to establish the differential diagnosis between parkinson's disease and essential tremor.


Eligibility criteria:
inclusion criteria: * patients aged 35 to 80 (male or female) * patients: * suffering from an essential tremor as defined by elble's criteria from 2000 (excluding head tremor in decubitus and compatible with the study by the investigator) * or with parkinson's disease as defined by the united kingdom parkinson's disease society brain bank (ukpdsbb) * patients diagnosed over 18 months ago * women of childbearing potential who must have effective contraception at baseline and up to 30 days after the last administration of the radiopharmaceutical (investigational medicinal product or comparator) * patients affiliated with or receiving a social security scheme * patients who have been fully informed about the organization of the research and who have signed their informed consent exclusion criteria: * patients with atypical non-idiopathic parkinson's syndrome (multi system atrophy, progressive supranuclear palsy, etc.) * patients treated with deep brain stimulation * patients with functional psychogenic movements * patients with severe and progressive psychiatric disorders * patients with disabling dyskinesia or essential tremor that are incompatible with imaging studies * patients who have had an ionizing radiation examination on the brain within the last 3 months * individuals with a contraindication to pet or spect imaging: * patients with claustrophobia * patients refusing to be informed in case of abnormalities detected during imaging tests * patients treated with amphetamines, benzatropine, amfebutamone, cocaine, mazindol, methylphenidate, phentermine or sertraline * individuals with a known allergy to the active substance or one of the excipients of the product under investigation or to the reference product or to or to thyroid treatment * woman of childbearing age without effective contraception in the opinion of the investigator * any other serious unstabilized chronic condition deemed incompatible with the study by the investigator * patients unable to sign the informed consent * patients participating in a protocol or in a period of exclusion from a protocol * patients who received compensation of more than 6000 € in the last 12 months prior to enrollment in clinical studies * patients in a period of exclusion from the national volunteer database during which they cannot participate in another clinical study * patients not affiliated with a social security scheme * patients refusing to participate * individuals referred to in articles l. 1121-5 to l. 1121-8 and l1122-2 of the french public health code
comparative effectiveness of school-based caries prevention

Conditions: Dental Caries; Quality of Life

Summary: dental caries (tooth decay) is the most prevalent childhood disease in the world. multiple interventions are available to treat and prevent caries. the aim of the proposed study is to compare the benefit of silver diamine fluoride (sdf) and fluoride varnish versus fluoride varnish and glass ionomer sealants. this study is a five-year, cluster randomized, pragmatic controlled trial conducted in public elementary schools in new york city.

dental caries is the most prevalent childhood disease in the world and can lead to infection, pain, reduced quality of life, and negative educational outcomes. multiple prevention agents are available to arrest and prevent dental caries, however little is known of the comparative effectiveness of combined treatments in pragmatic settings. the aim of the presented study is to compare the benefit of silver diamine fluoride and fluoride varnish versus fluoride varnish and glass ionomer therapeutic sealants in the arrest and prevention of dental caries. this is a longitudinal, pragmatic, cluster randomized, single-blind, non-inferiority trial to be conducted in low-income minority children enrolled in public elementary schools in new york city, new york, united states, from 2018-2023. the primary objective is to assess the non-inferiority of alternative agents in the arrest and prevention of dental caries. secondary objectives are to assess oral health-related quality of life and educational outcomes. caries arrest will be evaluated after two years, and caries prevention and secondary outcomes will be assessed at the completion of the study. data analysis will follow intent to treat, and statistical analyses will be conducted using a two-sided significance level of 0.05. notably, the standard of care for dental caries is office-based surgery, which presents multiple barriers to care including cost, fear, and geographic isolation. the simplicity and affordability of silver diamine fluoride may be a viable alternative for the arrest and prevention of dental caries in high-risk children.

Eligibility criteria:
inclusion criteria: * any primary school in new york city with a hispanic/latino student population greater than 50% and, * a low-income population (defined as a student receiving free or reduced price lunch) of at least 80%. * within participating schools, all children are eligible to participate in the study. exclusion criteria: * schools that already have a pre-existing school-based dental health program. * within participating schools, exclusion criteria for children include those without informed consent or those with consent but without assent.

Keywords: dental caries caries arrest caries prevention quality of life silver diamine fluoride sealants interim therapeutic restorations student achievement school attendance
open label, healthy volunteers, bioequivalence study with naloxegol

Conditions: Opioid Induced Constipation

Summary: the purpose of this study is to demonstrate the bioequivalence, assess food administration on the pharmacokinetics with naloxegol.

a phase i, randomised, open-label, 3 way cross-over study in healthy volunteers to demonstrate the bioequivalence of the naloxegol 25 mg commercial and phase iii formulations and to assess the effect of food administration on the pharmacokinetics of the commercial formulation.

Eligibility criteria:
inclusion criteria: * female non-pregnant, non-lactating. * volunteers with suitable veins for cannulation or repeated venipuncture. * male healthy volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the investigational product. * the female partner should use contraception during this period. exclusion criteria: * history of any clinically significant disease or disorder. * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product. * volunteers who have smoked or used nicotine products within the previous 3 months from the date of screening. * any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the investigator .

Keywords: phase 1 healthy volunteers naloxegol bioequivalence
trial to compare time to response in the symptoms of anxiety to concomitant treatment with niravam™ and an ssri or snri to treatment with an ssri or snri alone in subjects with generalized anxiety disorder or panic disorder

Conditions: Generalized Anxiety Disorder; Panic Disorder

Summary: an 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in symptoms of anxiety in subjects treated with niravam™ and a newly prescribed selective serotonin reuptake inhibitor (ssri)or serotonin and norepinephrine reuptake inhibitor (snri) to that in subjects treated with a newly prescribed ssri/snri alone. subjects must be at least 18 years of age and positive for generalized anxiety disorder (gad)or panic disorder. subjects will be randomized to receive concomitant niravam™ and an ssri/snri or an ssri/snri alone during the study. most symptom evaluations will be done using an automated phone interview system. there are 4 clinic visits.


Eligibility criteria:
inclusion criteria: * must be at least 18 years of age. * diagnosed by the investigator with primary generalized anxiety disorder (gad) and/or primary panic disorder with or without agoraphobia, either primary episode or recurrence, and is positive for gad or panic disorder by the mhs (mental health screener)). * receiving a new prescription for all ssri or snri as indicated for gad or panic disorder with or without agoraphobia. definition of a new prescription in case of a recurrence in symptoms is no prescription or refill of prescription of ssri or snri for the past 6 months. * subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent. exclusion criteria: * presence of medical condition or presence of schizophrenia, bipolar disorder, alcohol abuse/dependence or any other primary major psychiatric disorder that, in the opinion of the investigator, would jeopardize the subject or compromise the subject's ability to participate in the trial. * is a current suicide risk in the opinion of the investigator. * has initiated cognitive therapy within two months of study day 1. * does not speak english or does not hear well enough to be able to perform the hamilton anxiety (ham-a) rating scale and mental health screener (mhs) by interactive voice response system (ivrs). * has taken a benzodiazepine within the past 30 days. * history of hypersensitivity or allergic response to any of the components of ssris, snris, benzodiazepines, or related drugs. * if a female of child-bearing potential, is pregnant, nursing, or not using appropriate birth control methods. * presence of contraindications to the ssri or snri to be prescribed per the specific package insert. * presence of acute narrow angle glaucoma or taking ketoconazole or itraconazole,which are contraindications to niravam per the package insert. * history of phenylketonuria (pku). * participation in a previous clinical trial within 30 days prior to study day 1.
effect of cpp-acp paste on dental caries in primary teeth

Conditions: Dental Caries

Summary: the purpose of this study is to determine if adding daily application of cpp-acp containing paste for one year is superior to regular fluoride tooth brushing in preventing dental caries in high caries risk thai preschool children.

the 6th national oral health survey in thailand 2006-2007 reported that 3-year-old children who resided in central part have the highest dental caries prevalence of 69.8 percent with dmft affecting 3.63 teeth on average. fluoride is widely accepted as the most effective tool to caries prevention for initial caries lesions. current best practice recommends twice-daily tooth brushing with fluoride toothpaste for dentate children. cpp-acp can bolster the effects of fluoridated toothpaste alone to prevent caries.currently, almost all clinical trials have investigated the effectiveness of cpp-acp containing products in dental caries prevention and enhancing remineralization of initial carious lesion in the permanent dentition of young adolescents. there are no clinical studies of the effect of a cpp-acp containing product to prevent dental caries in the primary dentition of young children.

Eligibility criteria:
inclusion criteria: * healthy thai boys and girl aged between 2 1/2 - 3 1/2 * normal development of dentition * diagnosed as high caries risk by using the caries-risk assessment tool(cat) exclusion criteria: * chronic use of medications or antibiotics. * lack of cooperation in oral examination * milk protein allergy and/or benzoate preservatives * presence at baseline oral soft tissue lesion and enamel hypoplasia. * receive fluoride supplement and professional topical fluoride application at least three months before the beginning of study or during study period

Keywords: caries detection/diagnosis/prevention preventive dentistry casien phosphopeptide remineralization clinical trial
heparin binding protein in patients with acute respiratory failure treated with gcsf (filgrastim)

Conditions: Acute Respiratory Failure; Critically Ill

Summary: this is a study of plasma hbp -levels of a previously published trial of g-csf in critically ill patients (pettila et al. critical care medicine 2000). the original study was a prospective, randomised, double-blind, placebo-controlled trial of filgrastim in patients with acute respiratory failure requiring intubation. in this substudy, the investigators evaluated the effect of filgrastim on hbp -concentrations in critically ill patients.


Eligibility criteria:
criteria for original study. for the substudy, all these patients were included. inclusion criteria: * age \> 18 years * admitted to the icu no longer than 12 hrs before study entry * intubated because of ventilation insufficiency no longer than 48 hrs before study entry * clinically expected stay in the icu \> 48 hrs * informed consent exclusion criteria: * pregnant or nursing * total leukocyte count of \> 50,000/mm3 * administration of filgrastim, sargramostim, or other biological response modifiers within 7 days before study entry * known hypersensitivity or allergic reaction to escherichia coli-derived products * participation in another drug study

Keywords: filgrastim g-csf heparin-binding protein critically ill acute respiratory failure
home-based exercise program for recovery after transcatheter aortic valve replacement

Conditions: Aortic Valve Stenosis

Summary: transcatheter aortic valve replacement (tavr) is a minimally invasive procedure for older adults with severe symptomatic aortic stenosis who are considered high risk for surgical aortic valve replacement. despite symptomatic and survival benefits, many patients experience functional decline after tavr. this pilot study aims to test the feasibility of a home-based exercise intervention targeting endurance, strength, and balance as well as cognitive behavioral intervention to improve physical functioning and disability after tavr.

we hypothesize that a home-based exercise program with cognitive behavioral intervention is more effective than home-based exercise alone; home-based exercise program with and without cognitive behavioral intervention is more effective than attention control educational intervention in preventing decline in physical function and disability after tavr.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years * underwent transcatheter aortic valve replacement * lives within 20-mile radius of the recruiting site * plan to be discharged home * able to provide informed consent exclusion criteria: * stroke or any other medical disease that precludes participation in the exercise program * severe cognitive impairment (mini-mental state examination \< 15) * current enrollment in another clinical trial

Keywords: transcatheter aortic valve replacement exercise frailty functional outcomes cognitive behavioral intervention
effects of a telerehabilitation approach in children with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: patients with cystic fibrosis aged 6-13 will be recruited and randomized into two groups: one will receive telerehabilitation sessions including postural, breathing and high-intensity interval training exercises and one will be subject to routine follow up. exercise program will be applied three days a week for three months. children will be assessed by pulmonary function tests, cystic fibrosis quality of life questionnaire, six minute walking test and anxiety and depression scale in children, while caregivers will be assessed by beck depression scale and situational anxiety inventory.


Eligibility criteria:
inclusion criteria: * patients with diagnosed cystic fibrosis exclusion criteria: * current pulmonary exacerbation * musculoskeletal problems hinder exercising * no internet access * patients and parents do not consent to intervention

Keywords: anxiety depression cystic fibrosis caregiver telerehabilitation
biod-531 vs. humalog mix 75/25 vs. humulin r u-500 post-meal glucose control in patients with severe insulin resistance

Conditions: Diabetes Mellitus

Summary: the study is designed to compare meal time glucose control associated with biod-531, a rapidly absorbed concentrated insulin to that associated with humalog mix 75/25 and humulin r u-500 in patients with diabetes and severe insulin resistance.


Eligibility criteria:
inclusion criteria: * bmi \> 25 kg/m2 * diabetes mellitus using ≥ 150 units of insulin or insulin analog per day and/or ≥ 100 units of insulin or insulin analog at a single dosing session for at least 1 month prior to screening * hba1c \< 10.0% exclusion criteria: * history of bariatric surgery * corticosteroid therapy * significant cardiovascular or other major organ disease * females who are breast feeding or pregnant * a sexually active person not using adequate contraceptive methods