Kornimate/medical-research-clean huggingface dataset:
effect of a probiotic, lactobacillus gasseri bnr17, on body composition and weight management in overweight adults

Conditions: Weight Management

Summary: lactobacillus gasseri bnr17™ has shown promise in several pre-clinical and randomized controlled clinical trials for weight management outcomes. the current randomized, double-blind, placebo-controlled, parallel-arm trial will further assess l. gasseri bnr17™ on body composition and weight management, and in a study population that is distinct to prior randomized controlled trials on the strain. the study will recruit 126 overweight adult participants who will be randomly assigned to consume l. gasseri bnr17™ or placebo once daily for 12 weeks.


Eligibility criteria:
inclusion criteria: * written informed consent; * aged between 25 and 65 years inclusive; * body mass index between 25.0 to 29.9 kg/m2, inclusive; * waist-hip ratio of ≥0.91 for males and ≥0.81 for females; * sedentary lifestyle, exercising ≤2 times/week; * good general health, as determined by the investigator; * willing to consume the investigational product daily for the duration of the study; * outside the healthy parameters of visceral adipose tissue, defined as 762 cm3 for males and 256 cm3 for females. exclusion criteria: * females who are pregnant, lactating or wish to become pregnant during the study; * participant regularly takes probiotic supplements, or has within the 4-weeks prior to randomisation or plans to during the study; * participant is hypersensitive to any of the components of the investigational product; * participant is severely immuno-compromised (hiv positive, transplant patient, on antirejection medications, on a steroid for \>30 days, or has underwent chemotherapy or radiotherapy within the last year); * participant has type 1 or type 2 diabetes mellitus; * participant has a history of bariatric surgery; * participant has taken anti-obesity medication or supplements in the 12-weeks prior to randomisation or plans to during the study; * participant is actively or has recently (3 months prior to randomisation) participated in a weight loss program or weight change of 3 kg during the past 3 months; * participant has a life-threatening illness; * participant is on a glucose lowering medication, anti-psychotic drugs or any medication that the investigator determines could impact the results of the study; participant has commenced use, within 3-months of randomisation, anti-hypertensive drugs, anti-depressive drugs, statin or any other medication that the investigator determines could impact the results of the study; * participant has a history of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology (e.g. colon cancer, colitis, crohn's disease, celiac, endometriosis, prostate cancer) or lactose intolerance; * participant has a recent history of drug and/or alcohol abuse at the time of enrolment; * participant is currently, or planning to participate in another study during the study period; * participant has a history of non-compliance; * participant has taken antibiotics in the 12-weeks prior to randomisation.
efficacy of dlbs1033 in patients with acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: this is a 3-arm, prospective, randomized, double-blind, and controlled clinical study, with 3 months of treatment to evaluate efficacy of dlbs1033 in bleeding profile and clinical outcome in patients with acute ischemic stroke compared with aspirin and clopidogrel, as active controls.

there will be 3 groups of treatment; each group will consist of 43 subjects with the treatment regimens : * treatment i : 1 tablet of dlbs1033 490 mg thrice daily, after meal * treatment ii : 1 tablet of aspirin 80 mg once daily, after meal * treatment iii : 1 tablet of clopidogrel 75 mg once daily, after meal bleeding profile (by measuring inr value, pt, and aptt) and clinical outcome (by measuring gadjah mada stroke scale and barthel index) to evaluate the efficacy of the investigational drug will be performed at baseline and end of study (month 3rd). general condition of the subjects will be followed-up every month over three months of study medication. physiotherapy will be provided to the subjects by the assigned physiotherapist.

Eligibility criteria:
inclusion criteria: * male and female subjects aged 20-80 years old * having non-bleeding stroke in ct scan examination * having stroke attack onset ≤ 96 hours * living in 100 km from rsup dr sardjito jogjakarta exclusion criteria: * having recurrence stroke * having transient ischemic attack (tia) * have been regularly taking anti-aggregation agent * having intracerebral and subarachnoid bleeding stroke * subjects and their family do not know when the stroke symptoms appeared * history of haemostasis disorder * history of or will have surgery within 6 months prior to screening

Keywords: dlbs1033 lumbrokinase acute ischemic stroke bleeding profile clinical outcome aspirin clopidogrel
three restorative protocols in mih: a randomized controlled clinical study

Conditions: Molar Incisor Hypomineralization

Summary: molar-incisive hipomineralization (mih) is defined as a qualitative change in tooth enamel of systemic origin, which affects one or more permanent first molars, and may or may not involve permanent incisors. mih has several clinical repercussions, such as presence of hypersensitivity, difficulty in local anesthesia, reduction of restorations longevity, among others, making it difficult to perform dental treatment. therefore, the present study will evaluate, through a randomized controlled clinical study, three restorative protocols for the treatment of severe mih (with post eruptive enamel fracture and dentin exposure). the following groups will be evaluated: direct restoration with composite resin; restoration with composite resin with diode laser application and temporary restoration with glass ionomer cement followed by restoration with composite resin). the restorations will be evaluated after 1 week, 1, 6, 12, 18 and 24 months. the main outcome will be evaluation of restoration longevity, presence of caries lesion and wear of the restoration surface. other outcomes such as patient satisfaction with treatment, patient discomfort, anxiety, assessment of dentin sensitivity and impact on participants' quality of life, as well as the duration and cost of treatment, as well as their cost-effectiveness ratio will also be evaluated . multilevel statistical analyzes will be performed to verify the effectiveness of diode laser treatment compared to sealing, in addition to possible factors associated with this efficacy.


Eligibility criteria:
inclusion criteria: - at least one permanent first molar with occlusal surface with severe mih grade (with post eruptive enamel fracture and dentin exposure), it may not be reported hypersensitivity in the selected tooth. exclusion criteria: -

Keywords: lasers hipomineralization of dental enamel preventive dentistry glass ionomer cement
a comparison of 188-0551 spray versus vehicle spray in subjects with plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this phase 3 study (study 305) has been designed to determine and compare the efficacy and safety of 188-0551 spray and vehicle spray applied twice daily for up to four weeks in subjects with plaque psoriasis. subjects will be instructed to apply the test article (188-0551 spray or vehicle spray) to all psoriasis plaques within the designated treatment area twice daily for four weeks (study day 29), unless the investigator verifies the subject's psoriasis has cleared at day 15, then test article application will be for 2 weeks (study day 15).


Eligibility criteria:
inclusion criteria: 1. subject is male or non-pregnant female and is at least 18 years of age at time of informed consent. 2. subject has provided written informed consent. 3. subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 10% body surface area (bsa) (excluding the face, scalp, groin, axillae, and other intertriginous areas). 4. subject has moderate to severe plaque psoriasis. 5. subject is willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. 6. females must be post-menopausal , surgically sterile , or use an effective method of birth control. , women of childbearing potential (wocbp) must have a negative urine pregnancy test (upt) at the baseline visit. exclusion criteria: 1. subject has spontaneously improving or rapidly deteriorating plaque psoriasis. 2. subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis. 3. subject has palmar/plantar psoriasis. 4. subject is pregnant, lactating, or is planning to become pregnant during the study. 5. subject is currently enrolled in an investigational drug or device study. 6. subject has been previously enrolled in this study and treated with a test article. other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
geniculate artery embolization for the treatment of knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: osteoarthritis (oa) is a highly prevalent degenerative joint disease that contributes to chronic pain and disability in approximately 10% of people over the age of 55. with 25% of canadians expected to be aged 55 or older by 2036, an increasing number of canadians will be impacted by knee oa. in affected individuals the risk of medical co-morbidities is increased which can lead to adverse cardiovascular outcomes, depression, and poorer quality of life. current conservative therapy includes oral analgesia, lifestyle modification, corticosteroid injection, and viscosupplementation. these current conservative measures have variable responses. in patients who would prefer to avoid surgery or are not surgical candidates safe and consistently effective treatment options are lacking. geniculate artery embolization (gae) is a minimally invasive alternative with low risk of complications that has shown promise in exploratory studies. gae provides benefit by disrupting angiogenesis in the knee which can contribute to chronic inflammation of the affected joint, and helps prevent the growth of new sensory nerve fibers which can reduce the pain associated with osteoarthritis.


Eligibility criteria:
inclusion criteria: 1. vas score of at least 50 mm for knee pain 2. pain resistant to at least 3 months of conservative therapy (including medical therapy, physiotherapy, intra-articular cortisone or viscosupplement injection). 3. age \> 40 years 4. radiographs demonstrating knee osteoarthritis on same side as pain 5. patient not a surgical candidate or declines surgical management exclusion criteria: 1. radiographically severe knee osteoarthritis (kellgren-lawrence grade \>2) 2. severe non-knee related lower limb pain with vas \> 50 mm. 3. local infection and inflammatory arthritis. 4. malignancy 5. previous knee surgery 6. bleeding risk - known hematologic disease increasing risk of bleeding, pre-procedure inr \> 1.4, pre-procedure ptt \> 40 seconds or pre-procedure platelets \< 50,000/ul 7. known chronic renal failure or egfr \< 45 8. ecog grade \> 2 9. patient weight \> 300 lbs 10. patient unreliable for follow up

Keywords: embolization
intravitreal bevacizumab in recalcitrant inflammatory ocular neovascularization

Conditions: Neovascularization; Tuberculosis; Multifocal Serpiginous Choroiditis; Harada Toxoplasmosis

Summary: one complication of uveitis which is driven by an increase in vegf is the formation of inflammatory ocular neovascularization (ion). here, we analyze the therapeutic role of intravitreal bevacizumab in ion not responding to standard therapy (systemic and ocular corticosteroids and systemic immunosuppressants) in a multicenter retrospective study.the natural history of subfoveal choroidal new vessels histoplasmosis, multifocal choroiditis, harada and other inflammatory chorioretinal disorders has been very guarded, but with this new approach, we hope to stop the visual loss in these relatively young patients.

members of the american society of retinal specialists, the american uveitis society and the international uveitis society were invited to contribute their consecutive cases of ion not responding to standard therapy (corticosteroids (cst) 4 or immunosuppression) and treated with intravitreal anti-vegf agents. cases with concomitant or prior cystoid macular edema, diabetes mellitus, or age-related macular degeneration were excluded. most of the patients had initially been treated in a stepwise fashion with high doses of oral cst, with or without intraocular or subtenon cst or immunosuppressive therapy (as monitored by a rheumatologist). all patients opted to intravitreal anti-vegf treatment after detailed information about the limited experience, potential side effects and the off-label character of the drug. the risks and benefits of intravitreal therapy were discussed with the patients (or their guardians) who signed an informed consent. primary outcome measure: best corrected visual acuity measured as logmar. secondary outcome measures:macular thickness on oct, and stoppage of leakage by ivfa.

Eligibility criteria:
inclusion criteria: * inflammatory ocular neovascularization (ino) exclusion criteria: * eyes with age-related macular degeneration * diabetes mellitus * prior cystoid macular edema * uncontrolled systemic hypertension * cardiovascular disease

Keywords: tuberculosis multifocal serpiginous choroiditis histoplasmosis harada toxoplasmosis
procalcitonin-guided decision making to shorten antibiotic therapy in suspected neonatal early-onset sepsis

Conditions: Sepsis

Summary: neonatal bacterial sepsis is a major cause of mortality and morbidity and early antibiotic therapy is crucial for treatment success. objective: to evaluate the effect of procalcitonin-guided decision making on duration opf antibiotic therapy in suspected neonatal early-onset sepsis.

this single-centre, prospective randomized intervention study was conducted in a tertiary neonatal and paediatric intensive care unit in the children's hospital of lucerne, switzerland between june 1, 2005 and december 31, 2006. all term and near term infants with suspected early-onset sepsis were randomly assigned either to standard treatment based on conventional laboratory parameters (standard group) or to procalcitonin-guided treatment (procalcitonin-group). minimum duration of antibiotic therapy was (48)-72 hours in the standard group, whereas in the procalcitonin group antibiotic therapy was discontinued when two consecutive procalcitonin values were below predefined age-adjusted cut-off values.

Eligibility criteria:
inclusion criteria: * term and near-term infants with a gestational age of more than 34 weeks * admitted to the children's hospital of lucerne, switzerland * suspected neonatal early-onset sepsis * antibiotic therapy * parental consent exclusion criteria: * surgery in the first 3 days of life * severe congenital malformations * chromosomal abnormalities

Keywords: antibiotic therapy early-onset sepsis interventions study procalcitonin term and near-term neonates
pep breathing versus incentive spirometry on dyspnea and sputum profile in bronchiolectasis patients

Conditions: Bronchiolectasis

Summary: bronchiolectasis is the manifestation of chronic bronchitis characterized by saccular dilatation of the terminal bronchioles \& bronchiectasis refers to abnormal dilatation of the bronchi. in bronchiolectasis more proximal bronchi may or may not show radiological changes. airway dilatation can lead to failure of mucus clearance and increased risk of infection. pathophysiological mechanism of bronchiectasis/bronchiolectasis include persistent bacterial infections, deregulated immune responses, impaired mucociliary clearance and airway obstruction. treatment is directed at reducing the frequency of exacerbations, improving quality of life. although no therapy is licensed for bronchiectasis by regulatory agencies, evidence supports the effectiveness of airway clearance techniques, antibiotics and mucolytic agents. enhancing effective expectoration of stagnated bronchopulmonary secretions, usually with physiotherapy support, is key to management. there are different methods for delivering chest physiotherapy, such as the active cycle of breathing technique, postural drainage, (pep) and oscillating pep devices. the objective of the study is to compare the effects of pep \& incentive spirometry techniques on bronchiolectasis patients. the study will be a randomized clinical trial. total 24 subjects will be assigned randomly into two groups by using convenient sampling technique. baseline treatment will be same (chest physiotherapy) in both groups. group a will use pep and group b will use incentive spirometry technique for total 60 repetitions (15 repetitions 2 sets, two times per a day) 5 sessions per week and total 4 weeks. dyspnea severity index and cough \& sputum assessment questionnaire (casa-q) would be used as an outcome measurement tools. measurements will be taken at baseline, and at the end of the 4 weeks treatment session. after assessing the normality, data will be analyzed by using parametric and non-parametric tests.


Eligibility criteria:
inclusion criteria: * age group of 22 to 85 years * both gendercovid-19 negative * indoor patients * ability to use pep devices * diagnosed bronchiolectasis patients (through ct scan, x-ray) exclusion criteria: * rib fracture * neurological problems * lungs carcinomas * any other serious comorbidity

Keywords: bronchiolectasis dyspnea severity index incentive spirometry positive expiratory pressure (pep) saccular dilation
multiple sclerosis treatment with autologous hematopoietic stem cell transplantation in the netherlands

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the goal of this observational study is to study the long-term effects of autologous hematopoietic stem cell transplantation (ahsct) in people with highly active relapsing-remitting multiple sclerosis. the study will evaluate the following items: 1. disease activity 2. safety and tolerability of ahsct 3. changes in the immune system participants will be subjected to frequent visits for five years after treatment with ahsct. during these visits, clinical testing, evaluation by questionnaires, mri scans and blood sampling will be performed.


Eligibility criteria:
inclusion criteria: * all patients approved for treatment with ahsct in the netherlands in accordance with the dutch criteria for ahsct treatment for rrms exclusion criteria: * contra-indications for treatment with ahsct such as known hypersensitivity to the medication used for ahsct * clinically relevant comorbidities preventing safe use of medication used for ahsct * severe clinical depression * active addiction to drugs or alcohol * active infections such as but not limited to tuberculosis, cytomegalovirus, epstein-barr virus, herpes simplex, varicella zoster, viral hepatitis, toxoplasmosis, hiv or syphilis. * active malignancy or history of malignancy with the exception of local basal cell carcinoma or carcinoma in situ of the cervix
source xt registry

Conditions: Severe Aortic Stenosis

Summary: this registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing treatment with the commercially available edwards sapien xt™ valve, and delivery devices.

consecutive patient data should be collected at discharge, 30 days and 12 months post-implant. subsets of patients may undergo additional follow-up.

Eligibility criteria:
inclusion criteria: * the sapien xt™ thv is indicated for use in patients with symptomatic aortic stenosis requiring tavi who have a high risk for operative mortality, or are "non-operable" exclusion criteria: * non-valvular or congenital aortic stenosis * pre-existing prosthetic heart valve in the aortic position or a non-calcified aortic valve * severe (\>3+) mitral insufficiency or aortic regurgitation \> 3+ * active bacterial endocarditis or other active infections * severe ventricular dysfunction with ejection fraction \< 20% * coronary artery disease-related unstable angina * inability to tolerate anticoagulation / antiplatelet therapy

Keywords: sapien xt™ transfemoral novaflex novaflex+ nf nf+ transapical transaortic ascendra2 ascendra+ asc+ aortic stenosis aortic valve transcatheter heart valve thv
in vivo endomicroscopic description of pulmonary microcirculation in systemic sclerosis and emphysema patients

Conditions: Pulmonary Disease; Pulmonary Emphysema

Summary: systemic sclerosis (ssc) is a generalized disorder of connective tissue, arterioles and microvessels, characterized by the occurrence of fibrosis and vascular obliteration phenomena. the alterations in lung microvessels are found in pulmonary involvement of scleroderma, which are the most serious complications of the disease. in pulmonary emphysema, there are also changes in pulmonary microvasculature, which are involved in the onset and development of the disease. the confocal endomicroscopy is an endoscopic technique which can be performed during a bronchoscopy. this technique makes it possible to observe in real time the most distal pulmonary elements at the microscopic scale. after injection of fluorescein, then the technique of observing the pulmonary microvasculature, in vivo and in situ. the characterization of microvascular lesions in these two pathologies could improve understanding of their mechanisms and ultimately improve the early management of patients.


Eligibility criteria:
inclusion criteria: * patients with scleroderma with diffuse interstitial pneumonia, indicating a bronchoscopy. * patients with pulmonary emphysema indication for bronchoscopy. * age greater than 18 years. * having an affiliation to social security. * signed informed consent. exclusion criteria: * severe chronic respiratory insufficiency against-indicating the completion of a bronchoscopy * hypercapnia defined by a paco2 ≥ 6 kpa * disorders of hemostasis against-indicating performing a bronchoscopy * anticoagulant therapy can not be interrupted time of completion of the examination * a history of pneumonectomy or contralateral exploration in a nonfunctional lung * contraindication to the injection of fluorescein (including treatment with beta-blocker eye drops or po) or one of its excipients * history of an injection poorly tolerated fluorescein * a history of food allergy or drug known * myocardial infarction \<1 month * unstable angina * pregnant or lactating woman, premenopausal women without adequate contraception * person under guardianship * patient participating in another trial / participating in another trial within 4 weeks