Kornimate/medical-research-clean huggingface dataset:
low-dose iti strategy for children in hemophilia a with high-titer inhibitor and poor iti risk in china

Conditions: Hemophilia A With Inhibitor

Summary: the study start on january 18, 2017. the severe(fⅷ\<1%) and moderate hemophilia a (fⅷ1%～5%)children with high titer inhibitor(historical peak inhibitor titer≥5bu ) combining with poor iti risk(s) were enrolled. the low-dose iti was alone or combined with immunosuppression.

poor risk(s) includes:①peak historical inhibitor titer≥200bu ②inhibitor titer≥10bu before iti initiation ③peak inhibitor titer during iti≥200bu ④time to titer decline to\<10bu before iti≥24 months ⑤age≥8 years at start of iti ⑥iti initiated ≥5 years after inhibitor diagnosis ⑦interruptions in iti≥2 weeks in duration. the low-dose iti strategy consist of fⅷ（25-50iu/kg）alone or combining with immunosuppression: prednisone and rituximab when the inhibitor titer ≥40bu ml/ml before or during iti.

Eligibility criteria:
inclusion criteria: * males * from 1 to 14 years old * severe or moderate hemophilia a; * inhibitors positive before iti started. exclusion criteria: * females * \ 14 years old * hemophilia b or mild haemophilia a; * inhibitor negative before iti started.
study to assess management strategies for the use of esomeprazole (nexium) in helicobacter pylori infected patients

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: the primary objective of this study is to investigate whether eradication treatment of helicobacter pylori followed by therapy with esomeprazole for a total of 8 weeks extends the time to relapse in patients with gastroesophageal reflux disease (gerd). a relapse is defined by two consecutive symptom scores of the eraflux questionnaire within 14 days that are equal or above the critical value of 25. the secondary objectives are 1. to compare the time to relapse in the two h. pylori positive study groups with the h. pylori negative control group 2. to compare the pattern of inflammation and atrophy in the two h. pylori positive treatment groups with the naturally h. pylori negative control group at relapse. 3. all the above objectives analyzed for the efficacy subset that is the per-protocol patients broken down by effective h. pylori-eradication. secondary endpoints will be analyzed by the following parameters and their interactions: 1. treatment : eradicated, non-eradicated, hp-negative control 2. esophagitis at study start: grades 0, a/b and c/d 3. gender 4. alcohol intake 5. nsaid/asa intake (for histological results) * trial with medicinal product


Eligibility criteria:
inclusion criteria: for inclusion in the study the subject must fulfill all of the following criteria: 1. patients aged between 18 and 70 years. 2. chronic symptoms (\>8 weeks) suggestive for gerd, as defined in table 2 with or without reflux esophagitis grade a-d (los angeles classification) 3. indication for endoscopy due to gerd symptoms is given 4. written informed consent table 2: lead gerd criteria for inclusion in the study, all of the following lead gerd criteria should hold: * at least one of the symptoms heartburn or regurgitation. * at least 8 weeks ongoing symptoms. * at least 3 times a week. * at least moderate intensity, corresponding to light impairment in daily life and occasional need for drugs. exclusion criteria: any of the following is regarded as a criterion for exclusion from the study: 1. severe organic esophageal disease other than reflux esophagitis (e.g. carcinoma, esophageal stenosis). 2. gastric or duodenal ulcers 3. patients with visible barrett's mucosa; no histological confirmation is required for exclusion 4. history of previous esophageal or gastric surgery 5. alcohol or drug abuse 6. severe organic or psychiatric disease 7. pregnancy or lactation 8. women with child-bearing potential if no medically accepted contraceptive measures are used 9. contra-indication to amoxicillin, clarithromycin or esomeprazole (nexium) 10. need for concomitant medication which could interfere with the investigational products (substrates of cyp3a4) 11. suspected or confirmed poor compliance 12. participation in a clinical study within 8 weeks prior to enrollment.

Keywords: h. pylori
corticosteroids as an additional treatment for mastoiditis in children

Conditions: Mastoiditis; Acute

Summary: the aim of the study is to assess the influence of adjuvant corticosteroid treatment in acute mastoiditis in children. we expect a better outcome in children treated with both corticosteroids and antibiotics including lower rates in complications and earlier decline in fever and inflammatory markers.

the research is a multi-centered, prospective, placebo-control, randomized controlled trial. the study group will be comprised of children diagnosed with acute mastoiditis and hospitalized in a pediatric medical center. the participating patients will be randomized divided into two groups. research group will be given dexamethasone treatment (course of 16 doses, 0.15 mg/kg/dose every 6 hours) in addition to antibiotic treatment. control group will be given 16 doses of 0.9% normal saline in addition to antibiotic treatment. management and treatment will be conducted according to clinical condition and laboratory findings as for routine institution protocols. it should be noted that the regular institutional management of children enrolled for the study will not be changed due to our research.

Eligibility criteria:
inclusion criteria: * acute mastoiditis exclusion criteria: * immunodeficiency (congenital or acquired) * significant chronic disease * hypertension * recurrent mastoiditis

Keywords: mastoiditis children corticosteroids
renal denervation in treatment resistant hypertension

Conditions: Hypertension

Summary: in patients with treatment resistant hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. decreased activity of the sympathetic nervous system is one of the major underlying pathogenetic mechanism of the fall in blood pressure but the precise mechanisms that causes the fall in blood pressure in the short-term and, in particular, long-term remains elusive. the objective of the study is to understand the pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic nervous system. in 100 hypertensive patients most advanced technology will be applied, before and repeatedly after renal denervation, throughout the follow-up period of 1 year. systemic activity of the renin angiotensin aldosterone system, renal perfusion (by mri spin labeling technique), local activity of the renin angiotensin system in the kidney (urinary angiotensinogen concentrations), sodium excretion and total sodium content (23 na-mri technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24 hours) will be assessed. identification of the pathogenetic mechanisms involved in the fall in blood pressure after renal denervation may help to identify those hypertensive patients that profit most from renal nerve ablation in terms of blood pressure reduction. the investigators propose the following hypotheses why a progressive decrease in blood pressure happens, in addition to the decreased activity of the central nervous system, after renal nerve ablation: short term effects: a)preservation of renal function and perfusion b)reduction of local ras activity in the kidney c)exaggerated sodium excretion immediately after renal nerve ablation long term effects: d)decrease of total sodium content after 6 and 12 months e)improvement of vascular wall properties after 6 and 12 months


Eligibility criteria:
inclusion criteria: * treatment resistant hypertension * male of female aged over 18 years * written informed consent * agreement to attend all study visits as planned in the protocol exclusion criteria: * chronic kidney disease 3 - 5 * any contradictions for mri * claustrophobia * strabismus * severe ocular diseases * history of epilepsia
feasibility trial of a multi-level media production and social marketing campaign to reduce hpv vaccine hesitancy

Conditions: Human Papillomavirus Infection; Vaccination Hesitancy

Summary: since 2019, the hpv working group of the university of virginia cancer center's southwest virginia community advisory board has developed and executed strategies to increase regional hpv vaccination rates. members collaboratively developed appalachian voices for health, a multi-level media production and social marketing intervention. this novel intervention builds on the past efforts of the working group and the engaged organizations; takes into account the impact of vaccine hesitancy on hpv vaccination uptake; and incorporates best practices. through the intervention, nursing and dental assistant students from mountain empire community college will develop psas after receiving training about hpv vaccination and health communication. these psas will be used in a social marketing campaign executed through a regional transportation system managed by mountain empire older citizens. specifically, the trial's aims are three-fold: assess the intervention's impact on community members' and students' hpv vaccine hesitancy (aim 1) and perceptions and actions related to hpv vaccination (aim 2) and evaluate other feasibility indicators at the community-, student-, organizational-, and process levels (aim 3). the research team will use a concurrent mix-methods approach to assess feasibility indicators. aims will be assessed using surveys, focus groups, meeting minutes, and implementation records. data will be analyzed using descriptive and inferential statistics and content coding. determination of the intervention's feasibility will consider the achievement benchmarks for feasibility indicators individually and collectively. data will be used to inform refinement and future testing of appalachian voices for health.


Eligibility criteria:
inclusion criteria: * age 18 or older * enrolled as a student in one of the regional community college's health sciences programs (phase 1 only) * ride the regional health services focused non-profit's rideshare buses or view their social media during one or more of the three survey periods (phase 2 only) * work for either the regional community college or non-profit and were involved in supporting the execution of the study components within their organization. exclusion criteria: * under 18
pregnancy women and individual oral prophylaxis in the control of gingival inflammation (pre-iop)

Conditions: Pregnant Woman

Summary: gingivitis in pregnant women is a common inflammatory periodontal disease that appears from the third month of pregnancy with an overall prevalence of 35 to 100%. this condition is induced by oral biofilm and exacerbated by increased levels of sex steroid hormones characteristic of pregnancy. strict bacterial plaque control with both professional and home oral hygiene is essential. manual toothbrushes require a more specific manual technique for women, while sonic electric toothbrushes, due to their ease of use, might be an excellent for oral individual prophylaxis. therefore, the question of which type of manual or electric toothbrush might be more effective in reducing gingival inflammation in pregnant women is still unresolved. in literature there are a large number of in vitro clinical studies on this topic, there are currently no clinical studies investigating this long-term clinical comparison. in this context, this study is a randomized clinical trial consisting of a comparative evaluation between two manual and two sonic electric toothbrushes in the efficacy of the control of plaque in order to reduce gingivitis in women during the period of pregnancy.


Eligibility criteria:
inclusion criteria: * female, 18 to 40 years of age * 15-18 weeks pregnant * acceptance of study terms and conditions * signature of informed consent form exclusion criteria: * protected women * stage ii,iii periodontal disease (i.e. pd ≥ 4 mm, and/or cal ≥ 4 mm), generalized (\>30% od sites) * history or treatment of periodontal disease * current dental or orthodontic treatment * fewer than 20 natural teeth, excluding third molars * taking medication affecting the gums and/or oral mucosa * regular use (more than once a week) of interdental brushes and/or dental floss and/or mouthwash * removable prosthesis * dental implants * systemic disorder such as blood disorders, diabetes, and risk of endocarditis infections * anticoagulant treatment * inability to follow protocol or non-cooperation

Keywords: manual toothbrush electric sonic toothbrush oral prophylaxis pregnant woman gingival inflammation
moa study of ze 339 in seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: randomised, double-blind and prospective clinical study to examine the mechanism of action of the petasites hybridus leaf extract ig-rd-001 (ze-339, petasol butenoate complex) compared to desloratadine and placebo in patients with seasonal allergic rhinitis of all degrees of severity (provoked by grasses). the treatment arm with desloratadine is an established standard treatment and is intended to ensure the comparative methodology of the study.


Eligibility criteria:
inclusion criteria: * allergic rhinitis since at least 2 years * age: = \> 18 years * consent in accordance with the amg (=german drug law) * positive skin test, skin prick test or positive rast for grasses the skin prick test is positive if the wheal is \>= 3 mm greater than control; a skin test is positive if the wheal is \>= 7 mm greater than control * women of childbearing potential have to use a highly effective method of birth control (according cpmp/ich/286/95 note 3) during the duration of the study. a highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some iuds, sexual abstinence or vasectomised partner. exclusion criteria: * past or current psychological disease or disorder which can impair the study participant's ability to understand the study requirements, t take part in the study or give consent after briefing * past or current alcohol or medication dependency or abuse * bronchial asthma (fev \< 80 %) * glaucoma, cataract or ocular herpes simplex * clinically relevant deviations from normal laboratory parameters (if known) * antihistamines with a long-term effect * malignant diseases, including in the patient's case history * parasites * study participants who are taking part in another study or took an investigational product during the last 4 weeks before the start of treatment * progressive systemic diseases such as tuberculosis, leukoses, collagenoses, multiple sclerosis, aids, hiv infection and other autoimmune diseases * other types of rhinitis with different causes, acute or chronic sinusitis * pregnancy or lactation * serious internal diseases, e.g. serious decompensated diseases of the heart, liver, kidneys or diabetes mellitus * patients with rarely occurring hereditary problems galactose-intolerance, lapp-lactase-deficiency or glucose-galactose-malabsorption * pre-existing liver damage * the use of non-steroidal antirheumatic agents (nsar) * hypersensitivity towards one of the ingredients in the investigational product * not adhering to the following periods of abstention before the nasal provocation test: 3 days for dncg, nedocromil, nasal and oral antihistamines, and tricyclic psychotropic drugs, 1 months systemic treatment with glucocorticoids, 14 days for nasal and topical corticosteroids, 1 week for antihistamines, and 1 day for α-adrenergic drugs. the use of ace inhibitors or ß-blockers * previous organ transplants

Keywords: rhinomanometry mode of action grass pollen
switch study of existing atypical antipsychotics to bifeprunox

Conditions: Schizophrenia and Schizoaffective Disorder

Summary: the study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to bifeprunox.


Eligibility criteria:
inclusion criteria: * males or females, 18-65 years, meeting dsm-iv tr diagnosis of schizophrenia or schizoaffective disorder for whom a switch is indicated exclusion criteria: * acutely psychotic or with a current axis i primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on dsm-iv tr criteria

Keywords: switch study schizophrenia atypical antipsychotics
effects of thai massage on emg

Conditions: Myofascial Pain Syndrome

Summary: the purpose of this study is to determine the effect of thai massage on electromyogram in patients with chronic upper back pain associated with myofascial trigger points.


Eligibility criteria:
inclusion criteria: * male or female * age between 18 - 50 years old * the participants have experienced spontaneous upper pain for longer than 12 weeks (chronic) and that at least one trigger point will be present in the s trapezius muscles. trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition. * the participants will be able to follow instructions. * good communication and cooperation. exclusion criteria: * a history of the following diseases or disorders: * cervical radiculopathy * contraindications of traditional thai massage * contagious skin disease * injury or inflammation of muscle * bone fracture and/or joint dislocation * open wound * uncontrolled hypertension * drug and/or alcohol intoxication
post market surveillance study to confirm safety and performance of silicone phmb foam

Conditions: Wound

Summary: post market surveillance study to confirm the safety and performance of silicone subcategory of phmb foam dressings in chronic and acute wounds.

the design of the study is an open label, multicentre, single arm trial with subjects with moderate to heavily exuding chronic and acute wounds consisting of pressure ulcers, leg ulcers, diabetic leg and foot ulcers, surgical wounds first degree superficial and partial thickness burns. the performance data from this study will support clinically meaningful rates of successful improvement in the signs and symptoms of infection, without refection during 6- week treatment and follow up period.

Eligibility criteria:
inclusion criteria: * have a pressure ulcer, leg ulcer, diabetic leg and foot ulcer, surgical wound, first degree superficial burns or partial thickness second degree burns that are infected following assessment of signs and symptoms of infection with moderate to heavy levels of exudate. * have wounds at high risk of infection. * males or females, age 18 years or above. * subjects who are able to understand and give informed consent to take part in the study. exclusion criteria: * subjects who are known to be non compliant with medical treatment. * subjects who are known to be sensitive to any of the device components, known sensitivity to phmb. * subject is pregnant or actively breastfeeding. * subject has any significant or unstable medical or psychiatric condition, that in the opinion of the investigator, would interfere with his/her ability to participate in the study. * subject is currently in another clinical study. * patients who have a current illness or condition, or who have had an illness in the last 30 days which in the opinion of the investigator may interfere with wound healing (e.g. carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse). * life expectancy of \<6 months. * maximum burn area of \>20% total body area in adults.

Keywords: antimicrobial phmb silicone foam chronic wounds acute wounds
20 week bridging study in type ii dm

Conditions: Diabetes Mellitus Type II

Summary: a multicenter, non-comparative, one arm, open, phase iii study to evaluate the efficacy and safety of insulin glargine on subjects with type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus diagnosed at least 3 years ago * treated concomitantly with insulin once a day and su over at least 3 months prior to study entry * treated with oha monotherapy over at least 1 year * hba1c greater than or equal to 7.5% and less than or equal to 12.0%, at visit 1 (screening visit) * bmi \< 40 kg/m2 * no history of ketonemia * women of childbearing potential using the medically approved contraceptive method * ability and willingness to perform blood glucose monitoring using a blood glucose meter as per the requirement of protocol the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
minimally invasive trocar placement in obesity surgery

Conditions: Obesity

Summary: during surgery for obesity, minimally invasive endoscopy can be performed and can assist the surgeon in determining surgical incision sites.

transgastric endoscopic access, without laparoscopic guidance, to the peritoneal cavity can be performed safely and guide trocar placement in morbidly obese patients undergoing roux-en-y gastric bypass.

Eligibility criteria:
inclusion criteria: * elective laparoscopic roux-en-y gastric bypass (lrygb) surgery exclusion criteria: * lack of consent * history of previous gastric surgery * contraindication to upper endoscopy

Keywords: notes transgastric endoscopy obesity surgery roux-en-y surgery
mobility disorders assessment in patients with mild cognitive disorders

Conditions: Cognitive Dysfunction

Summary: mild cognitive impairment (mci) is defined by lower performance in one or more cognitive domains with preservation of independence in functional abilities. sixteen percent of community-dwelling older people (over 65 years) live with mci. they are both cognitively and physically vulnerable. from a cognitive perspective, they are susceptible to converting to the dementia stage at an annual rate of 10%. from a physical perspective, the proportion of slow gait or neurological gait abnormalities can reach 46% in the population with mci. falls in turn increase the risk of accelerated cognitive decline and the risk of institutionalization. in the absence of a curative treatment for dementia, it is essential to have an effective and personalized prevention strategy by identifying the predictive factors for falls in this at-risk population with mci. the research goals of this project are 1) to identify specific predictors for falls in clinic attendees with mci in preparation for a definitive, fully powered study across france, and 2) to demonstrate the feasibility of a pragmatic fall risk assessment in mcs, whatever its setting and location. we aim to prospectively follow-up people diagnosed with mci and aged above 65 years old in four mcs in france (three in the north (one community-based mc), and one in the centre) for one year.


Eligibility criteria:
inclusion criteria: * patient being diagnosed with mci, according to the 2011 criteria * able to walk 4 meters with or without technical assistance * comprehension of french language allowing the realization of the neuropsychological assessment exclusion criteria: * severe visual or hearing impairment that does not allow the assessment * severe pathology that makes follow-up impossible * administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security insurance, refusal to sign consent form * under legal protection (guardianship, curatorship, safeguard of justice)

Keywords: mild cognitive impairement falls predictive factors elderly gait disorders assessment.