Kornimate/medical-research-clean huggingface dataset:
evaluate clinical research from commerical oral care products

Conditions: Gingival Diseases

Summary: the purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.

the purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.

Eligibility criteria:
inclusion criteria: * male or female volunteers 18-65 years of age * good general health * must sign informed consent form * minimum of 20 natural uncrowned teeth (excluding third molars) must be present. * no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study. exclusion criteria: * subjects unable or unwilling to sign the informed consent form. * medical condition which requires pre-medication prior to dental visits/procedures * moderate or advanced periodontal disease or heavy dental tartar (calculus) requiring more than one visit of cleaning sessions * 2 or more decayed untreated dental sites at screening. * other disease of the hard or soft oral tissues. * impaired salivary function (e.g. sjogren's syndrome or head and neck irradiation). * use of medications that can currently affect salivary flow. * use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1. * pregnant or nursing women. * participation in any other clinical study within 1 week prior to enrollment into this study. * allergy to chlorhexidine * use of tobacco products * subjects who must receive dental treatment during the study dates. * current use of antibiotics for any purpose. * presence of an orthodontic appliance. * history of allergy to common dentifrice ingredients. * immune compromised individuals (hiv, aids, immuno suppressive drug therapy)
efficacy study to evaluate the effectiveness of 3 concentrations of sar 1118 in allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to determine whether sar 1118 at three different concentrations, compared to placebo, is effective in the prevention of the signs and symptoms of allergic conjunctivitis


Eligibility criteria:
inclusion criteria: * signed informed consent form and hipaa document * willing and able to comply with all study procedures * be at least 18 years of age at the time of enrollment * 20/40 vision, or better, in each eye * history of ocular allergies, and a positive skin and ocular allergic reaction to allergens * a negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period exclusion criteria: * preauricular lymphadenopathy or any ocular condition that could affect study parameters (particularly, glaucoma, diabetic retinopathy, clinically significant blepharitis, follicular conjunctivitis and iritis) * have had any ocular infection within the last 30 days * a positive diagnosis of moderate to severe dry eye syndrome (i.e., requiring daily use of artificial tears) * any significant illness that could be expected to interfere with study parameters * manifest signs or symptoms of clinically active allergic conjunctivitis in either eye * use of any investigational product or device within one month prior to visit 1 or during the study period * concomitant use of any prohibited medication (antihistamines, corticosteroids, all ocular medications or anti-allergic therapies) during the trial or within the washout period * any blood donation or significant loss of blood within 56 days of visit 1 * any history of autoimmune disease, immunodeficiency disorder, positive hiv, hepatitis b, c, or evidence of acute active hepatitis a (anti-hav igm), or organ or bone marrow transplant. any known history of iritis/uveitis, glaucoma, or other chronic ophthalmologic disorder other than allergic conjunctivitis * history of laser-assisted in situ keratomileusis (lasik) or similar type of corneal refractive surgery within 12 months prior to visit 1, and/or any other ocular surgical procedure within 3 months prior to visit 1 * known history of alcohol abuse and/or drug abuse
single blind cross-over dose response study in subjects of two inhalers of salmeterol and fluticasone propionate

Conditions: Healthy

Summary: the purpose of this study is to test the body's response to several doses of two different inhalation products in healthy volunteers.

healthy subjects will be enrolled and will receive 2, 6, and 12 inhalations from both the test and reference pmdi products according to a six-period cross-over design. electrocardiograms (ecgs) and plasma potassium and glucose levels will be measured pre-dose and over 6 hours post-dose.

Eligibility criteria:
inclusion criteria: * healthy volunteer * willing and able to give informed consent * willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic * male and female subjects aged 18 to 55 years (inclusive) * subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration exclusion criteria: * evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders * any presence or history of a clinically significant allergy including any adverse reaction to study drug * history of drug or alcohol abuse within the past 2 years * smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked) * donation or loss of greater than 400 ml of blood within the previous 3 months * have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted) * have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days) * upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months * if female, nursing, lactating or pregnant * regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 ml of 40% spirit or a 125 ml glass of wine) * surgery scheduled during the study or within 3 weeks after last dose * history of familial long qt syndrome or history of sudden death in family members aged \< 30 years

Keywords: long-acting beta agonist (laba) corticosteroid pmdi inhaler
efficacy and safety of adalimumab in subjects with moderate to severe chronic plaque psoriasis

Conditions: Psoriasis

Summary: a phase iii, multicenter study of the efficacy and safety of adalimumab treatment in subjects with moderate to severe chronic plaque psoriasis


Eligibility criteria:
inclusion criteria: * subject was age 18 or older and in good health (investigator discretion) with a recent stable medical history. * subject had a clinical diagnosis of psoriasis for at least 6 months, had moderate to severe plaque psoriasis. * subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections exclusion criteria: * subject had previously received anti-tnf therapy. * subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid uvb or puva phototherapy * subject cannot avoid excessive sun exposure * subject is taking or requires oral or injectable corticosteroids * subject considered by the investigator, for any reason, to be an unsuitable candidate for the study * female subject who is pregnant or breast-feeding or considering becoming pregnant

Keywords: psoriasis adalimumab
sympathetic nervous system modulation in hypertension

Conditions: Hypertension

Summary: this is a study of patients with high blood pressure who are already treated with an angiotensin converting enzyme inhibitor or receptor blocker and have achieved good or fair blood pressure control. the hypothesis is that addition of the beta-adrenergic receptor blocker, sustained-release metoprolol, will provide additional blockade of the sympathetic nervous system, thereby further improving left ventricular filling and blood pressure control.

patients were to receive sympathetic cardiac innervation testing with i-123 mibg at baseline and again after receiving a titrate dose of beta-blocker. data were to be assesses by repeated measures testing.

Eligibility criteria:
inclusion criteria: * essential hypertension with blood pressure less than 140/90 on either an ace inhibitor or angiotensin receptor blocker exclusion criteria: * known valvular heart disease of more than mild severity * known coronary artery disease defined by an angiographic coronary artery stenosis greater than or equal to 50% luminal diameter narrowing, acute or previous myocardial infarction, or previous coronary revascularization * known non-ischemic cardiomyopathy with left ventricular ejection fraction less than 50% * atrial fibrillation * current treatment with a β-adrenergic blocking drug or a calcium channel blocker * current treatment with a psychoactive or other drug known to alter 123i-mibg uptake * participation in another research study within the prior 30 days * a life-limiting disease process that is likely to preclude completion of study participation * pregnancy or breast feeding * inability or unwillingness to provide informed consent * baseline resting heart rate less than 65 beats per minute * diabetes * iodine allergy * unwilling to sign informed consent.

Keywords: hypertension sympathetic nervous system
comparison of botulinum toxin injection techniques in spasticity

Conditions: Spastic Hemiplegia

Summary: the aim of the study is to compare the effectiveness of the classical (2-4 points to the muscle proximal) application of botulinum toxin in the treatment of spasticity with the application along the length of the gastrecnemius muscle. the main question it aims to answer is botulinum toxin more effective in the treatment of spasticity than the classical application applied along the length of the gastrocnemius muscle? participants will be evaluated for spasticity before and 1 month after injection. researchers will compare classical versus application along the length of the muscle to see if there is a reduction in spasticity.


Eligibility criteria:
inclusion criteria: * diagnosed with spastic hemiplegia * spasticity in the gastrocnemius muscle exclusion criteria: * those who have spasticity in other muscles that will affect ankle movements * those who use myorelaxant or myospasm-effective drugs * those who have been applied botulinum toxin in the last 3 months * those who have contractures in the ankle and knee due to orthopedic reasons.
fractional co2 laser-assisted cutaneous delivery of methotrexate versus 5-fluorouracil in stable non-segmental vitiligo

Conditions: Vitiligo

Summary: vitiligo is a common acquired, depigmenting skin disease that affect the patient's psychological state and quality of life.

vitiligo is a common acquired, depigmenting skin disease that affect the patient's psychological state and quality of life. regarding treatment of vitiligo, several modalities are available but none are completely satisfactory. recently, fractional carbon dioxide (co2) laser has been introduced as an add-on treatment for vitiligo. fractional co2 laser acts by stimulating the release of cytokines and growth factors that act as mitogens for melanogenesis. also, microscopic ablative zones produced by it promote the trans-epidermal penetration of topical agents, providing additional benefits for re-pigmentation. recently topical methotrexate 1% gel was used in a case report of vitiligo and was applied to a single patch twice daily for 12 weeks with significant improvement in pigmentation without local or systemic side effects during the course of therapy. thus, it may prove to be an important steroid sparing agent in treatment of vitiligo. as methotrexate is a large, hydrophilic molecule that does not penetrate intact skin, several drug delivery systems are being developed e.g. nano-vehicle preparations and laser-assisted delivery. one study has evaluated fractional erbium laser-assisted delivery of topical methotrexate in porcine skin and found that methotrexate distribution and concentration in the mid-dermis was facilitated by ablative fractional laser, suggesting that ablative fractional laser-assisted topical methotrexate-delivery may be an appropriate alternative to systemic methotrexate for some skin disorders. ablative fractional laser-assisted delivery of topical 5-fluorouracil has been used in vitiligo in several studies with good results. serum interleukin-23 levels were significantly higher in vitiligo patients as compared with controls.

Eligibility criteria:
inclusion criteria: the patients will be enrolled in the study if they have: * non-segmental vitiligo * stable disease (a patient reporting no new lesions, no progression of existing lesions, and absence of koebner phenomenon during the past 1 year) exclusion criteria: 1. history of skin cancers, keloid, hypertrophic scars or photosensitivity. 2. use of any topical medications, phototherapy, or laser for vitiligo within 1 month prior to enrollment. 3. renal, hepatic, hematological or debilitating chronic diseases. 4. active inflammation or infection at site of treatment. 5. pregnant and lactating females. 6. age under 18 years old. 7. segmental vitiligo, active or extensive disease. 8. unrealistic expectation.
paracrine mechanisms of bone marrow stem cell signalling in chronic heart failure

Conditions: Heart Failure

Summary: the investigators hypothesize that chronic heart failure is associated with a general stem cell dysfunction, which translates into reduced paracrine function of adult stem cells from patients with chronic heart failure as compared to patients with preserved systolic function.


Eligibility criteria:
inclusion criteria: for all participants: 1. before any study-specific procedures, the appropriate written informed consent must be obtained. 2. male and female older than 18 years of age. for the cardiac patients: 3. being accepted for cardiothoracic surgery with the use of open chest surgery 4. a known left ventricular ejection fraction, either assessed by echocardiography, muga or mri. if lvef \ 40% a subject will be assigned to the control group. for the non-cardiac patients: 5. accepted for orthopedic surgery (e.g. total hip replacement) at the department of orthopedic surgery. exclusion criteria: 1. an unstable medical condition, defined as having been hospitalized for a non-cardiac condition within 4 weeks of screening, or otherwise unstable in the judgment of the investigator (e.g. at risk of complications or adverse events unrelated to study participation). 2. younger than 18 years of age. 3. clinical history of chronic kidney disease (at any point prior to registration). 4. any known hepatic disease. 5. recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report. 6. clinically significant abnormality in chemistry, hematology, or urinalysis parameters performed within the screening period. 7. participation in any investigational device or drug trial(s) or receiving investigational agent(s) within 30 days. 8. any condition (e.g. psychiatric illness, etc.) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study. 9. legally incompetent adults, for which reason what so ever. for the non-cardiac patients: 10. a known history of cardiovascular disease.

Keywords: heart failure bone marrow bone marrow mononuclear cells surgery orthopedic surgery cardiac surgery
global behavior and periodontal disease in down's syndrome patients

Conditions: Behavior; Periodontal Diseases

Summary: this study aimed at correlating global behavior of down's syndrome patients to periodontal disease status.

there is a higher prevalence and severity of periodontal disease in down's syndrome patients. plaque levels in these patients are high due to poor hygiene habits. behavior also may contribute to the overall periodontal condition.

Eligibility criteria:
inclusion criteria: * down's syndrome diagnose characterized by the whole chromosomal aneuploidy 15 to 52 years * absence of severe hearing loss could impair the comprehension about the dental treatment * absence of severe visual loss that could impair the comprehension about the dental treatment * presence of at least four teeth being one for hemiarch. * diagnose of gingivitis and periodontitis * absence of acute periodontal disease and necrotizing periodontal disease. exclusion criteria: * smokers * use of alcohol * menopause * pregnancy * absence of all teeth * uncontrolled diabetes mellitus * uncontrolled hyperthyroidism * angina * uncontrolled hypertension * coagulopathy * use of illicit drugs * head and neck radiotherapy * chemotherapy * non-cooperative patients or patients with other diseases as autism.

Keywords: social behavior gingivitis periodontitis down's syndrome
vapocoolant (pain ease medium stream) for intravenous lines in emergency department patients

Conditions: Pain

Summary: to determine the efficacy and safety of vapocoolant stream (pain ease medium stream ) in decreasing the pain of intravenous cannulation. to compare vapocoolant stream (pain ease medium stream) with control (e.g. sterile water) stream.

vapocoolant sprays have been used to decrease the pain associated with painful medical procedures such as immunizations, needle aspirations, injections, venipuncture and intravenous cannulation. in general, vapocoolant sprays , have been found to be effective in decreasing the pain of various medical procedures. moreover, the use of vapocoolant sprays ,unlike other local anesthetics , such as infiltrative lidocaine , is not associated with a painful injection and does affect the success rate of the procedure including intravenous cannulation and may even increase the success rate of the intravenous cannulation.

Eligibility criteria:
inclusion criteria: * patients needing intravenous cannulation * adults age 18 years equal or greater than. * stable patient * mentally competent patient able to understand the consent form exclusion criteria: * patients with any allergies to the spray components ( e.g.1,1,3,3, pentafluoropropane or 1,1,1,2 tetrafluoroethane ) * critically ill or unstable patient (e.g. sepsis or shock) * infants and children of age , \<18 years. * pregnant * intravenous cannulation site located in area of compromised blood supply. (ex: patients with peripheral vascular disease , raynaud's disease, gangrene, buerger's disease) * intravenous cannulation site located in area of insensitive skin; such as , patients with a peripheral neuropathy including diabetic neuropathy. * patient intolerant of cold or with hypersensitivity to the cold. * patient unable or unwilling to give consent.

Keywords: vapocoolant
effect of complex weight-reducing interventions on rhythm control in obese subjects with atrial fibrillation

Conditions: Atrial Fibrillation; Obesity

Summary: obesity is a well-established risk factor for the development of atrial fibrillation (af), while the reduction of body weight was shown to reduce the risk of af. however, little is known about the effect of different weight-reducing interventions on af burden. the study will evaluate the effect of a complex program aimed at weight reduction on af burden in subjects after catheter ablation for af and at least 1st degree obesity. this will be investigated in randomized study design and compared with patients receiving standard care without specific obesity-related intervention. the weight loss program will consist of diet, lifestyle and exercise counselling and, in selected subjects, also bariatric surgery in order to achieve a sustained weight loss of \>10% of initial body weight. secondary aims include identification of patient phenotypes with the most benefits from weight reduction as well as elucidation of potential pathomechanisms linking obesity and af, with the main focus being on low-grade inflammation. the project will help to define the optimal weight-reducing regimen in af and to tailor the interventions to individual patient needs.


Eligibility criteria:
inclusion criteria: * paroxysmal or persistent af scheduled for primary rf ablation * bmi ≥30 kg/m2 * age 18-70 years * informed consent to the study exclusion criteria: * previous ablation for af * myocardial infarction, stroke or pulmonary embolism \< 3 months prior to inclusion * left ventricular ejection fraction \< 40% * left atrium diameter \> 55 mm * active thyroid disease * chronic kidney disease stage iv-v (egfr \< 0.5 ml/s) * chronic liver disease * active malignancy * inability to comply with study procedures
correlation mri - paraclinical examination in sudden deafness associated with vertigo

Conditions: Vertigo Labyrinthine

Summary: acute cochleo-vestibular syndrome or labyrinthitis is characterized clinically by the sudden appearance of a great rotatory vertigo and a unilateral sensorineural hearing loss. in this clinical context, mri is the examination to eliminate differential diagnoses and to make a positive diagnosis of labyrinthitis (supposedly infectious, immunologic or ischemic). the etiologies described are ischemic, infectious or autoimmune, so the risk factors are very variable (cardiovascular, autoimmune or infectious). labyrinthitis has been little studied as a clinical entity in its own right. indeed, studies mainly focus on sudden deafness with subgroups of patients with vertigo. the incidence of sudden deafness is of the order of 5 to 20 per 100,000 people per year but is probably under-diagnosed. the individual and medico-economic consequences are similar to those of hearing loss, with an increased risk of dementia, depression, premature death and an increase in health care consumption.

the objective of the study is to evaluate the performance of mri (sensitivity and specificity) to localize labyrinthine damage in the presence of an acute cochleovestibular syndrome (presumed to be infectious, ischemic or immunologic) compared to the reference paraclinical examinations for each of the structures.

Eligibility criteria:
inclusion criteria: * patient of legal age (≥18 years) * mri diagnosis of labyrinthitis (presumed to be viral, immunologic, or ischemic in origin) at the university hospitals (hus) of strasbourg between 01/01/2014 and 04/30/2021 * patient with abrupt deafness (a 30 db drop in hearing thresholds on at least 3 contiguous frequencies for at least 72 hours) associated with unilateral grand rotatory vertigo of abrupt onset * patient with severe unilateral acute onset rotary vertigo with acute unilateral hypoacusis. * subject who did not express his opposition, after information, to the reuse of his data for the purpose of this research. exclusion criteria: * subject who expressed opposition to participating in the study. * history of chronic vertigo, * chronic dizziness, * presence of a differential diagnosis on mri (intra-labyrinthine shwannoma, intra-labyrinthine hemorrhage or complicated cholestatoma) * history of surgery on the inner or middle ear.

Keywords: vertigo labyrinthine labyrinthitis sudden deafness cochlear diseases