Kornimate/medical-research-clean huggingface dataset:
assessment of a probiotic to treat gingivitis in pediatric patients

Conditions: Gingivitis; Inflammation

Summary: this study investigates the efficacy of a proprietary probiotic formulation comprising 6 strains of bacteria in reducing inflammation and gingivitis in pediatric patients between 11 and 18 years old undergoing orthodontics treatment. patients will be recruited based on a prior diagnosis of mild to moderate gingivitis by gingival index score. participants in this study will be randomly assigned to receive either the probiotic treatment or a placebo, both in the form of a dissolving lozenge; for which the placebo is exactly the same shape, texture, taste, and composition as the probiotic treatment, but does not contain the active probiotic ingredients. the lozenges are to be taken orally at a certain prescribed regimen for 28 days. participants will be assessed for gingivitis scores, gum bleeding scores, plaque scores, overall periodontal health, and for precarious areas at baseline, 14, and 28 days. they will also be assessed for the same measures at day 56, following a 28-day wash-out phase. plaque and saliva samples will be collected at all timepoints for in vitro analyses of changes in microbial pathogens and/or inflammatory cytokines.


Eligibility criteria:
inclusion criteria: * are male or female between the ages of 11 to 18 years * have mild to moderate gingivitis as determined by dentist (gi of at least 1 to a maximum of 2) * are undergoing fixed orthodontic therapy on both arches with attachments on at least 20 teeth including bonded 1st molars for a minimum of 5 months. * have fully erupted teeth #16, #21, #23, #36, #41, and #43 * are caries inactive prior to study initiation. * are in a healthy systemic condition * have not used any antimicrobial mouth rinses, probiotics (unrelated to the study), antibiotics or anti-inflammatories medications with one month prior to and during the study * whose legal guardian has given informed consent to participate in the study and must be able to communicate in english exclusion criteria: * unable to make informed consent * subjects with allergies to milk or milk products, gluten or soy or any other ingredients present in the lozenge * immune compromised * major underlining medical condition * pregnancy * history of smoking or alcohol consumption * have major dental conditions such as periodontal disease, dental caries and/or xerostemia or systemic diseases which could directly or indirectly affect plaque formation * use of medications within 1 month (antibiotics, anti-inflammatory, mouth rinses) that can influence the outcome. * ongoing or recent (within 1 month) use of probiotics unrelated to the study * have within the past 30 days experienced any nausea, fever, vomiting, bloody diarrhea or severe abdominal pain

Keywords: gingivitis inflammation plaque orthodontics
characterizing upper extremity function in individuals with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: upper extremity (ue) function is critical to maintaining independence. better understanding of ue involvement in ms will provide necessary information to prioritize the design and selection of future interventions. the goal of the proposed project is to characterize ue involvement in a population of community-based persons with ms across the international classification of functioning, disability \& health (icf) domains and constructs.


Eligibility criteria:
inclusion criteria: * confirmed clinical clinical diagnosis of ms * receive ms care at the mandell ms center * cognitively able to understand directions and complete protocol * signed consent form approved by the saint francis institutional review board * 18 years of age or older exclusion criteria: * unwilling or unable to complete assessments
headache after diagnostic lumbar puncture

Conditions: Post-Lumbar Puncture Headache

Summary: the objectives of this study are to investigate the effects of needle design, needle size and stylet reinsertion on the risk for headache after diagnostic lp (lumbar puncture, post-lp headache). the following needles are used in the study: 1. sprotte 25 gauge (g) (0.5 mm) atraumatic needle with introducer 2. sprotte 22 g (0.7 mm) atraumatic needle with introducer 3. spinocan 25 g (0.5 mm) cutting needle


Eligibility criteria:
inclusion criteria: * subjects undergoing diagnostic lp during their neurological work-up at umeå university hospital, sweden, from 28 may 2013 until the study is fully recruited and; * willing to participate and * providing informed consent exclusion criteria: -subjects unable to participate in the study follow-up

Keywords: lumbar puncture headache
chronic heart failure - congestion evaluation

Conditions: Chronic Heart Failure

Summary: heart failure (hf) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. congestion is the main source of symptoms and the leading cause of hospitalization for hf. furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic hf. the literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation. the main objective of the chf-cov study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic hf that are associated with the risk of all-cause death or hospitalization for acute hf within 24 months after day hospitalization.


Eligibility criteria:
inclusion criteria: * patients with chronic acute heart failure admitted in hospital for scheduled day hospitalization or consultation * age ≥18 years * patients having received complete information regarding the study design and having signed their informed consent form. * patient affiliated to or beneficiary of a social security scheme. exclusion criteria: * comorbidity for which the life expectancy is ≤ 3 months * dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate \<15 ml/min/m2 at inclusion. * history of lobectomy or pneumonectomy lung surgery * severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc. * pregnant woman, parturient or nursing mother * adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) * adult person who is unable to give consent * person deprived of liberty by a judicial or administrative decision, * person subject to psychiatric care pursuant to articles l. 3212-1 and l. 3213-1 of the public health code.
study to evaluate multiple doses in patients with nasal polyposis

Conditions: Nasal Polyposis

Summary: this is a phase 2 study to evaluate multiple doses of ak001 across 2 active doses. pharmacodynamic activity will also be evaluated.

ak001 is a monoclonal antibody which may be useful in the treatment of patients with moderate to severe nasal polyposis

Eligibility criteria:
inclusion criteria: * tps of ≥5 for both nostrils with presence on endoscopy of nasal polyps of grade ≥2 in each nostril according to the polyp grading scale * history of sinusitis symptoms * snot-22 ≥30 * no clinically significant screening 12-lead ecg, vital sign, hematology, chemistry, or urinalysis findings exclusion criteria: * use of systemic corticosteroids within 6 weeks of screening * chronic use of antibiotic therapy within 3 months prior to screening * nasal surgery (including polypectomy) within 6 months prior to screening * use of investigational drugs or participation in another clinical trial within 30 days prior to screening or 5 half-lives, whichever is longer
neurally adjusted ventilatory assist vs proportional assist ventilation

Conditions: Bronchopulmonary Dysplasia

Summary: this study aims to assess whether neurally adjusted ventilatory assist or proportional assist ventilation is more effective in infants born prematurely with evolving or established bronchopulmonary dysplasia

despite improvements in survival rates of extremely preterm born infants, the incidence of bronchopulmonary dysplasia (bpd) remains unchanged over the last two decades. as invasive ventilation is frequently necessary and indeed life saving, numerous ventilator strategies have been developed to reduce damage to the developing lung. synchronisation of mechanical breaths with the patient's respiratory effort offers the theoretical benefit of improving oxygenation and ventilation, requiring lower ventilator pressures, fewer air leaks and increased patient comfort. recently, novel modes of ventilation have been introduced that aim to improve upon conventional ventilation. during both proportional assist ventilation (pav) and neurally-adjusted ventilatory assist (nava), respiratory support is servo-controlled based on continuous input from the baby's respiratory effort. both aim to improve synchronization of the timing of the respiratory cycle and also to vary the level of support offered breath-to-breath in proportion to the respiratory effort of the patient. during proportional assist ventilation (pav), the ventilator can vary inflation pressure in phase with both volume change and flow change in order to offload both elastic and resistive components of the work of breathing. we have previously shown that pav, compared to acv, reduces the oxygenation index and improves respiratory muscle strength in infants born prematurely who remain ventilated at or beyond one week of life . neurally adjusted ventilatory assist (nava) utilises the electrical activity of the diaphragm to trigger the ventilator. a modified nasogastric feeding tube with a series of electrodes allows monitoring of the diaphragmatic electromyogram (edi). the waveform of the edi is used to trigger and control ventilator support. we have recently shown that nava compared to acv results in a lower oxygenation index in infants born prematurely who remain ventilated at or beyond one week of life. both pav and nava have been shown to have advantages above conventional triggered ventilation in neonates, but they have not been compared to each other. our aim is to determine whether nava or pav is more effective in prematurely born neonates with evolving or established bpd.

Eligibility criteria:
inclusion criteria: * born at less than 32 weeks gestation * ventilated at or beyond one week of life exclusion criteria: * major congenital abnormalities
a clinical study of 8mw2311 in subjects with locally advanced or metastatic solid tumors

Conditions: Solid Tumors

Summary: this study is a phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity and immunogenicity of 8mw2311 administered by intravenous (iv) infusion.


Eligibility criteria:
inclusion criteria: 1. male or female, aged≥18 years old; 2. histologically or cytologically confirmed locally advanced or metastatic solid tumor; 3. subjects must have measurable disease according to recist (version 1.1)； 4. eastern cooperative oncology group (ecog) performance status 0 to 1; 5. life expectancy \>3 months; 6. adequate organ performance based on laboratory blood tests; 7. sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy； 8. ability to understand and the willingness to sign a written informed consent document； exclusion criteria: 1. history of other malignancy within 3 years before the first dose of study drug. 2. history of il-2 or il-2 analogues anticancer therapy. 3. chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, or any other anticancer therapy within 14 days prior to the first dose of study drug. 4. major surgery within 28 days prior to first dose of study drug. 5. any live vaccines within 28 days before first dose of study drug or during the study. 6. systemic glucocorticoids or other immunosuppressants received within 14 days before first dose of study drug. 7. toxicity related to preexisting treatment ≥grade 2. 8. central nervous system metastasis and/or cancerous meningitis. 9. inadequately controlled body cavity effusions. 10. interstitial pneumonia or interstitial lung disease, other pneumonia history or active pneumonia that may interfere with the judgement of immune-related pulmonary toxicity. 11. active autoimmune disease, or autoimmune diseases history with recurrence possibility. 12. clinically significant cardiac or cerebrovascular disease. 13. use of any investigational drug within 28 days prior to the first dose of study drug. 14. known sensitivity to any of the ingredients of the study drug. 15. known active hepatitis b or c infection, or other serious infection. 16. history of drug abuse or drug addiction. 17. pregnancy or lactation. 18. other disease or condition which may put the subject at significant risk.
echocardiography predictive of the inefficacy and/or of the unsafeness of recruitment maneuvers in patients with acute respiratory distress syndrome.

Conditions: Acute Respiratory Distress Syndrome

Summary: the purpose of the study rvstar is to evaluate whether echocardiographic criteria exploring the right ventricle can predict the inefficacy and/or the unsafeness of recruitment maneuvers in patients suffering from acute respiratory distress syndrome


Eligibility criteria:
inclusion criteria: * endotracheal mechanical ventilation for acute hypoxemic respiratory failure lasting for one week or less * a ratio of the partial pressure of arterial oxygen (pao2 measured in millimeters of mercury) to the fraction of inspired oxygen (fio2 which is unitless) of 300 mmhg or less and inspired fraction of oxygen fio2 of more than 50 % * a positive end-expiratory pressure of 5 cm of water or higher * a tidal volume of 6 to 8 ml per kilogram of predicted body weight * bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules * respiratory failure not fully explained by cardiac failure or ﬂuid overload * written and informed consent * adult patients at least 18 years of age * ventilatory criteria (pao2/fio2 of 300 mmhg or less and positive end expiratory pressure of 5 cm of water or higher) and radiologic criteria (bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules) lasting more than 24 hours exclusion criteria: * endotracheal mechanical ventilation for acute hypoxemic respiratory failure lasting for more than one week * age younger than 18 years old * no written and informed consent * known pregnancy and/or breastfeeding * increased intracranial pressure * a ratio of the partial pressure of arterial oxygen (pao2 measured in millimeters of mercury) to the fraction of inspired oxygen (fio2 which is unitless) higher than 300 mmhg * positive end expiratory pressure of less than 5 mmhg * ventilatory criteria (pao2/fio2 of 300 mmhg or less and positive end expiratory pressure of 5 cm of water or higher) and radiologic criteria (bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules) lasting less than 24 hours * severe chronic respiratory disease requiring long-term oxygen therapy or mechanical ventilation at home * severe chronic liver disease * barotrauma such as pneumothorax * hemodynamic failure needing more than 3 milligrams per hour of noradrenalin and/or more than 2 milligrams per hour of adrenalin and or rising doses of vasopressors and/or vascular filling exceeding 500 milliliters in the preceding hour * arrhythmias such as : ventricular tachycardia, ventricular fibrillation, third degree atrioventricular block * atrial fibrillation

Keywords: acute respiratory distress syndrome echocardiography recruitment maneuver
popliteal plexus block for postoperative pain after acl reconstruction

Conditions: Anterior Cruciate Ligament Injury; Postoperative Pain

Summary: the study aims to investigate the effect of the popliteal plexus block (ppb) on postoperative pain in patients undergoing anterior cruciate ligament (acl) reconstruction.

postoperative pain following acl reconstruction can be alleviated with an ultrasound-guided femoral triangle block (ftb). however, it is the investigators' observation that 10-20 % of the patients still complain of intense pain localized in the center of the knee. cadaver dissection studies have shown that an injection into the distal part of the adductor canal will spread to the popliteal fossa, and one dissection study showed consistent spread to the popliteal plexus. the study team hypothesized that a ppb will reduce the postoperative pain, when it is used as a supplement to the ftb in patients undergoing acl reconstruction.

Eligibility criteria:
inclusion criteria: * patients undergoing acl reconstruction on one of the two trial sites * age ≥ 18 * american society of anesthesiologists (asa) status i-iii * informed consent exclusion criteria: * patients unable to cooperate * patients not able to speak danish or with other communication problems * pregnancy * contraindication towards any medical product used in the study * preoperatively reduced sensation on the medial and lateral part of the lower leg * patients with diabetes requiring medical treatment * preoperative intake of opioids (dosed \> once daily) * acl revision

Keywords: peripheral nerve block ultrasound
dxflex 10c clinical study

Conditions: Hematological Malignancy

Summary: a multi-center method comparison study is designed per clsi-ep09 a3. this study compares the qualitative immunophenotype agreement between dxflex and navios ex to demonstrate the accuracy of the dxflex-10c system. a series of precision studies will be conducted with each focusing on different aspects of the dxflex-10c system.


Eligibility criteria:
inclusion criteria: patient specimens targeted for this study will be residual samples with sufficient volume from whole blood, bone marrow, and lymph node meeting the following criteria: 1. specimens from new cases or follow up patients for myeloid/lymphoid fci testing. 2. hematologically abnormal specimens 3. subjects of any range, ethnicities, and racial backgrounds 4. specimens from patients with the following medical indications presenting for testing by flow cytometry based on the bethesda consensus guidelines. exclusion criteria: there are two (2) groups of exclusion criteria to detail the specimens that should not be counted for the study: 1. pre-analytical/pre-screen exclusion criteria 2. post-acquisition exclusion criteria.
registry study on "control nocturnal hypertension to reach the target "

Conditions: Nocturnal Hypertension

Summary: ambulatory blood pressure monitoring (abpm) is a major innovation in the history of hypertension diagnosis. in clinical practice, the most well established indication for using abpm is to identify patients who have high bp readings in the office but normal readings during usual daily activities outside of this setting or vice versa, and to identify varying 24-h bp profiles. however, in recent years, there has been increasing interest in bp values during sleep, and nocturnal bp is now recognized to be superior to daytime bp in predicting fatal and nonfatal cardiovascular events (stroke, myocardial infarction, and cardiovascular death), especially in medicated patients. the current direction in the management of hypertension is toward earlier and lower bp control for 24 hours, including the nocturnal and morning periods. therefore, it may be of great significance to pay attention to the management of nocturnal blood pressure so as to reduce the increased cardiovascular risks. information of nocturnal hypertensive patients defined by abpm was prospectively registered nationwide, and then to investigate whether there was difference in cardiovascular prognosis according to the control of ambulatory nocturnal blood pressure.


Eligibility criteria:
inclusion criteria: * age 50-79 years old * clinical diagnosed hypertension with the use of antihypertensive drugs * nocturnal hypertension ( nocturnal systolic blood pressure ≥ 130 mmhg and/or nocturnal diastolic blood pressure ≥ 80 mmhg) * a 24-hour ambulatory blood pressure monitoring was performed with validated equipment. * willing to provide information about disease history and blood biochemical test data within 6 months. * sign the informed consent exclusion criteria: * without antihypertensive drug use * hospitalized hypertension patients * non-compliant patient

Keywords: ambulatory blood pressure monitoring nocturnal hypertension cardiovascular risk
type 2 diabetes secondary prevention

Conditions: Type 2 Diabetes

Summary: three hundred and ninety height diabetic patients were educated during a week of hospitalisation (nutritional and physical-activity advices). after that, they were randomized in two groups : frequent follow-up (each three month) by educational nurses and dieteticians, versus no follow-up (control group). all patients were evaluated one year after their inclusion,by hba1c (primary outcome), anthropometry, other cardiovascular risk factors, nutritionnal and physical-activity behaviours.


Eligibility criteria:
inclusion criteria: * type 2 diabetes patient aged \>=18 years exclusion criteria: * incapacity to a moderate physical activity

Keywords: type 2 diabetes secondary prevention physical activity nutritional education hba1c reunion island diabetic patients, both female and male, age >=18 years, able to practise a physical activity, in saint pierre (ghsr) and saint denis (chd)
turkish version of the pediatric anesthesia emergency delirium

Conditions: Emergence Delirium, Anesthesia

Summary: emergence delirium (ed) is a mental disorder seen in children during recovery from general anesthesia. the pediatric anesthesia emergence delirium (paed) scale is the only valid scale to assess ed in pediatric patients undergoing general anesthesia. the aim of this study is to translate and adapt the paed scale to turkish. a five-stage translation and adaptation process will be performed. the reliability of the turkish version of the paed scale was independently assessed by a group of two raters (anesthesiologists or postanesthesia care unit nurses) in pediatric patients after general anesthesia. ed was defined by a cut-off point of ≥ 10 points on the paed scale


Eligibility criteria:
inclusion criteria: 1. parents consented to the study, 2. transferred to pacu after general anesthesia, 3. between 2-16 years of age, 4. asa physical status class i-ii, 5. cognitively intact children. exclusion criteria: 1. children without parental consent, 2. children under 2 years of age and over 16 years of age, 3. children with asa physical status class iii and above, 4. children who underwent surgery under general anesthesia under emergency conditions, 5. children with cognitive and behavioral disorders, 6. children who developed major complications after the operation, 7. children who are expected to require postoperative mechanical ventilation.