Kornimate/medical-research-clean huggingface dataset:
innovations in hearing accessibility and technology (ihat) study

Conditions: Hearing Loss; Hearing Aids; OTC Hearing Aids

Summary: the research will explore outcomes of different service delivery models of over-the-counter (otc) hearing aids by comparing them to prescription hearing aids fitted by specialists in individuals with mild to moderate hearing loss. the investigators will examine how each type affects users' experiences, behavior, thinking skills, and brain activity related to hearing. additionally, the study will focus on what types of people prefer each hearing aid option, what helps or hinders these choices, and compare the costs of four different service options. this approach will help transition from research findings into real-world practice, providing useful information for healthcare providers and policymakers about otc hearing aid options.

the aim of the proposed project is to evaluate the effectiveness of emerging over-the-counter (otc) service delivery models with the gold standard traditional prescription hearing aids fit by hearing care professionals (hcp) using audiology best practices. otc service delivery models include otc ha fit to individual users using best practices with in person hcp support (otc-hpc), via remote consultation (otc-r) and self-fit otc has without any clinical support (otc-sf). the study will use a prospective four-arm randomized controlled trial design with longitudinal repeated measures.

Eligibility criteria:
inclusion criteria: * adult onset, bilateral, mild-to-moderate sensorineural hearing loss documented by audiological evaluation * aged 40 years or older * no previous ha experience greater than 3 months * able to read and understand patient education materials * willing to be randomized to one of the four groups, and * owns a smartphone exclusion criteria: * hearing loss that is too severe for otc has * middle ear disorders or conductive pathology present * asymmetrical hearing loss * diagnosed neurological condition such as dementia or parkinson's disease or a score lower than 25 on the moca * non-english speaking as it may impact the ability to complete our test battery

Keywords: hearing loss hearing aids otc hearing aids service delivery models effectiveness trial over-the-counter hearing aids
low dose ketamine as an adjunct to fentanyl in outpatient tonsillectomy

Conditions: Pain

Summary: comparing patients receiving subanesthetic doses of ketamine vs placebo to see if it can reduce narcotic needs for patients receiving a tonsillectomy and adenoidectomy


Eligibility criteria:
inclusion criteria:between 3 and 12 years of age * asa 1 or 2 exclusion criteria: * did not consent

Keywords: pain
effect of manual therapy on low back pain in osteopenic postmenopausal women

Conditions: Low Back Pain; Osteopenia

Summary: the purpose of this study is to determine the effect of manual therapy on low back pain in osteopenic postmenopausal women.

women spend nearly one-third of their life in menopause. in this period, besides other comorbid conditions, women suffer from various musculoskeletal disorders also. one such problem is chronic low back pain which is more prevalent in post-menopausal women. this condition affects daily living activities of a person ranging from standing up, walking, bending over, lifting, traveling, social interaction, dressing to sleeping, living with ongoing pain causes depression, anxiety, deterioration in quality of life for women themselves. despite this, little attention has been paid to pain in the spine/low back ache which are equally prevalent in this period of life. although this poses a great medical and socioeconomic challenge to such extent that some researchers call it a lifestyle disease. it is the main cause of absence in the workplace and the 2nd cause of visiting primary health-care professionals. spine pain has negative psychological consequences as it impairs daily functioning. therefore, finding an effective method for treatment is important. manual treatments are one of the most applied methods within physiotherapy approaches in recent years. manual treatment (in the form of craniosacral and visceral manipulation) claiming to release the tension of the muscles, ligaments, and fascia in the sacral area and activate central pain inhibitory centers. for this reason, we are conducting the present study with a new view to identify the effects of manual therapy practices in the form of craniosacral and visceral manipulation on pain, function, and bmd of the lumbar region, as well as quality of life in osteopenic post-menopausal women suffering from low back pain.

Eligibility criteria:
inclusion criteria: 1. ambulatory, sedentary, non-smoking women having natural menopause at least 1 year before participation in the study. 2. their ages will range from 50 to 60 years old. 3. their bmi will be \> 30 kg/m2. 4. pain before costal margin and above inferior gluteal fold. 5. osteopenia. exclusion criteria: 1. osteoporosis. 2. having osteoporotic fractures. 3. having a lumbar surgery previously. 4. neurological disorder. 5. known diseases affecting bone quality (hyperthyroidism, hyperparathyroidism, hypercortisolism, etc). 6. receiving any medical or hormonal therapies that could affect the bone metabolism. 7. receiving previous manual treatment.
antimicrobial stewardship in utis in nursing homes

Conditions: Urinary Tract Infections

Summary: background: the widespread inappropriate use of antimicrobial substances drives resistance development at the individual and population level all over the world. in long-term care facilities (ltcf), antibiotics are among the most frequently prescribed medications. more than one third of antibiotics prescribed in ltcfs are for urinary tract infections (uti). studies have shown that 30 - 40% of antibiotic courses prescribed in ltcfs were unnecessary and that more than two-thirds were inappropriate based on society guidelines. preliminary data: a surveillance study on healthcare-associated utis at ltcfs of the geriatric health centers graz revealed that guideline recommendations on antimicrobial choice were met in only 50% of patients. the most frequently used antimicrobial substances for uti were quinolones. aims: using a multifaceted bundle of antimicrobial stewardship interventions consisting of clinical practice guidelines, care pathways and local as well as web-based education and training targeting nursing staff as well as physicians we aim to improve the quality of antimicrobial prescriptions for utis in four ltcfs in graz, austria. design: non-randomized cluster controlled intervention study. setting: the geriatric health centers graz are a local institution comprising among others 4 ltcfs (total of 400 beds). these will serve as intervention group. four ltcfs located in the surroundings of graz will serve as control group. intervention: the main components of the intervention are 1) two sessions of voluntary continuing medical education on the urinary tract infection program in each ltcf for physicians and nursing staff, 2) distribution of educations materials such as written guidelines on antibiotic prescribing including a smart phone friendly version, 3) implementation of the project homepage as a platform to distribute guidelines and educational videos and to enable physicians to ask questions which will be answered by an infectious disease physician. outcomes: the primary outcome will be the proportion of adequate prescriptions (adequate in terms of antimicrobial choice). secondary outcomes include proportion of adequate prescriptions (adequate in terms of decision to treat), number of cases with clinical failure, number of admissions to hospital due to uti, number of adverse events attributed to antimicrobial treatment for uti, percentage of extended spectrum betalactamase (esbl) producing enterobacteria isolated from urinary cultures


Eligibility criteria:
inclusion criteria: * residents living in the participating long term care facilities who experience urinary tract infections (uti) exclusion criteria: * residents without uti

Keywords: uti antimicrobial stewardship long term care facility nursing home
first-in-man evaluation of a novel, microcrystalline paclitaxel coated balloon for treatment of femoropopliteal artery disease (pax-r)

Conditions: Peripheral Artery Disease; Femoropopliteal Artery Disease

Summary: the purpose of this pivotal, first in man study will be to evaluate safety and efficacy of the novel, microcrystalline paclitaxel coated balloon (mcpcb, pak, balton) in the treatment of femoropopliteal artery disease.

although clinically effective, the manufacturing process of first generation pcb coatings contributed to inconsistent drug concentrations, particulate formations on the balloon surface and their shedding during the interventional procedures. as a consequence developments of new pcb coatings have been proposed to address consistency, uniformity, small particle drug coverage, which may potentially contribute to improved vessel healing profile and improved clinical outcomes. nevertheless, data on the safety and efficacy of this novel coating developments in the clinical setting remain limited. previously in the experimental model, the investigators reported that delivery of paclitaxel via a novel mcpcb resulted in low long-term tissue retention of paclitaxel, however displayed reduced neointimal proliferation and favorable healing profile. therefore in current clinical trial the investigators will address the feasibility and safety of the mcpcb (pak, balton) in the treatment of femoropopliteal restenotic disease in a prospective, randomized manner when compared to plain balloon angioplasty (pba). the efficacy analysis will be observational and evaluated post-hoc, with no prespecified criteria.

Eligibility criteria:
inclusion criteria: * age \> 18 y.o. * claudication in rutherford class 1-5, * lesion in the femoropopliteal artery defined as \>50% and \< 99% diameter stenosis with length of up to 10 cm in vessel diameter of 3-7 mm * chronic total occlusions of length less than 100 mm * ability to cross the lesions with a guidewire. exclusion criteria: * critical acute or chronic limb ischemia * acute coronary syndrome * chronic kidney disease stage iii-v * restenotic lesion * femoropopliteal graft * known allergy to clopidogrel or aspirin * history of stroke within past 6 months * age \> 80 y.o. * life expectancy \< 2 years

Keywords: paclitaxel coated balloon restenosis femoropopliteal artery disease
s100 biomarker in the acute management of mild head injuries

Conditions: Brain Injury; Head Injury

Summary: a prospective validation study of the "scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults". enrolling a consecutive sample of 1000 adult head injury patients from the emergency department of the tampere university hospital (tampere, finland). a venous blood sample with s100 analytics (+storage blood) is drawn from every patient. the patients are head ct-scanned according to the snc guidelines. outcome assessment (gose, mrs, rivermead pcs questionnaire) is completed as follows: 1 week, 6 months, 1 year, and 2 years.

a prospective clinical head injury study conducted at the emergency department of the tampere university hospital, which is situated in tampere, finland. the hospital takes care of an catchment area of 524 447 inhabitants both from urban and rural areas. about 100 000 patients are treated in the emergency department annually. the study aims to improve the emergency evaluation of patients with an acute head injury, especially a mild head injury. about 80% of head ct scan performed on head injury patients in the emergency department of the tampere university hospital are negative (= no acute traumatic lesion). there is an urgent need to update the head ct imaging criteria/indications in the context of acute head injury in order to reduce the number of unnecessary scanning. more selective head ct indications result in considerable health care savings and decreased exposure to ionizing radiation, among other benefits. in this study, the investigators implement the "scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults" criteria as part of the emergency care of adults head injury patients. by enrolling a large consecutive sample of patients the investigators are validating this new guideline. emergency department assessment data is combined with long-term outcome parameters and blood-based biomarkers of neurotrauma. the main aims of the study are: 1. the validation of the scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults 2. the examination of novel blood-based biomarkers of acute brain injury that correlate with the radiological severity of the injury and the long-term outcome

Eligibility criteria:
inclusion criteria: * head injury exclusion criteria: * age under 18 years

Keywords: brain injury head injury computed tomography emergency department
safety and tolerability study of daily dosing rimegepant in episodic migraine prevention

Conditions: Migraine; Episodic Migraine; Phonophobia; Photophobia

Summary: the purpose of this study is to further evaluate the long-term safety and tolerability of daily dosing of rimegepant for the prevention of episodic migraine.

this is a post marketing required study being conducted to further evaluate the long-term safety and tolerability of a more frequent daily dosing regimen of rimegepant for the prevention of episodic migraine.

Eligibility criteria:
key inclusion criteria: * subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the international classification of headache disorders, 3rd edition, including the following: * age of onset of migraines prior to 50 years of age * migraine attacks, on average, lasting 4 -72 hours if untreated * per subject report, 4-14 migraine attacks per month within the last 3 months prior to the screening visit (month is defined as 4 weeks for the purpose of this protocol) * subjects ≥ 18 years key exclusion criteria: * subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. subjects with myocardial infarction (mi), acute coronary syndrome (acs), percutaneous coronary intervention (pci), cardiac surgery, stroke or transient ischemic attack (tia) during the 6 months (24 weeks) prior to the screening visit. * uncontrolled hypertension (high blood pressure) or uncontrolled diabetes. * the subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis b or c, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (ae) or interfere with assessments of safety or efficacy during the course of the study * history of use of opioid- or barbiturate- (e.g. butalbital) containing medication for 4 or more days per month during the 3 months (12 weeks) prior to the screening visit * wocbp who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 28 days after the last dose of study drug * women who are pregnant or breastfeeding * women with a positive pregnancy test at screening or prior to study drug administration
crt pilot study for children with heart failure

Conditions: Chronic Pediatric Heart Failure

Summary: to collect information on pediatric patients receiving cardiac resynchronization therapy (crt) with permanent biventricular pacing (bvp) as a method of treating chronic heart failure.


Eligibility criteria:
inclusion criteria: 1. chronic and severe heart failure, nyha class iii or iv 2. patients optimized and stable on diuretics and afterload reducing agents (with or without inotropes) for at least 1 week prior to enrollment 3. chronic systemic ventricular dysfunction as defined in the protocol. 4. intra ventricular conduction delay defined by spontaneous qrs duration \> uln for age. 5. all children from 1 to 18 years of age, both male and female, and all ethnic backgrounds. 6. signed and dated informed consent. 7. able to receive pectoral or abdominal implant. exclusion criteria: 1. suspected acute myocarditis. 2. significant ventricular dysfunction, secondary to acquired or congenital heart defects amenable to surgical correction. 3. acute coronary syndrome. 4. adolescents who are pregnant. 5. patient with bvp device implanted previously. 6. patient has had prior/past heart transplantation.
the impact of obesity on nonsurgical periodontal therapy

Conditions: Periodontitis; Periodontal Diseases; Obesity

Summary: the purpose of this study is to investigate the effect that obesity may have on the nonsurgical treatment (with and without the adjunct use of metronidazole) of destructive periodontal diseases (chronic periodontitis).

normal weight (bmi 18.5-24.9 kg/m2) and obese (bmi \>30 kg/m2) women will be randomly assigned to two nonsurgical periodontal treatments: 1. scaling and root planing + placebo 2. scaling and root planing + metronidazole

Eligibility criteria:
inclusion criteria: * normal weight or obese (according to bmi) * nonsmokers or former smokers (3 or more years) * no systemic diseases that may affect periodontal treatment (diabetes, osteoporosis, steroid use) * have 10 teeth present * have at least 2 teeth with probing depth 6+mm and attachment loss 4+mm exclusion criteria: * pregnancy * development of diabetes or other conditions that may impair periodontal healing

Keywords: periodontitis periodontal diseases obesity metronidazole prognosis probing depth periodontal attachment loss
efficacy of adipose tissue derived stem cells for the treatment of diabetic foot ulcers

Conditions: Diabetic Foot Ulcer; Diabetes Mellitus; Diabetic Foot; Diabetic Foot Infection; Diabetic Foot Ulcer Neuropathic; Foot Ulcer Due to Type 1 Diabetes Mellitus; Foot Ulcer Due to Type 2 Diabetes Mellitus; Foot Ulcer; Diabetes Complications; Chronic Diabetic Ulcer of Left Foot; Chronic Diabetic Foot Ulcer of Right Foot

Summary: the aim of this study is to evaluate the therapeutic efficacy of uncultured adipose derived stromal vascular fraction (svf) and cultured adipose derived stem cells (ascs) both supplemented with platelet rich plasma (prp) to treat chronic diabetic foot ulcers. it will increase the pragmatic potential of both types of cells as prp is rich in survival and chemotactic factors. moreover, the autologous nature of the proposed study will ensure safety of its use in diabetic patients and will unveil the more effective therapeutic option for treatment of foot ulcer wounds.

under local or general anesthesia, autologous fat will be harvested by using a manual aspiration or syringe-assisted technique. svf and ascs isolation from autologous lipoaspirates will be done by enzymatic digestion method (collagenase type-1 solution for 45 minutes at 37°c). cell quality assessment will be done prior to transplantation by trypan blue exclusion assay and total populations and fractions of cells identified by immunocytochemistry / flow cytometry. prp will be derived by centrifugation from 50-100ml blood collected in anticoagulant carrying bag, from patient at the day of transplantation. the injection volume will depend on the wound area of each patient. 2 million cells/ 0.5 ml prp will be mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus * age 20-60 years (male/female) * body mass index 20-30 kg/m2 * suitable for liposuction * condition or disease: diabetic neuropathy * wound type: chronic foot ulcer * approx. wound area: 2 cm2 - 8 cm2 * wound condition should be of wagner's grade i (limited to soft tissue) * duration of wound persistence: 6-24 weeks * transcutaneous oxygen pressure \> 30 mmhg, and an ankle brachial pressure index \> 0.5. * already following an adequate off-loading method * provided signed informed consent exclusion criteria: * uncontrolled hyperglycemia (hbalc \> 9%) * presence of severe clinical sign of infection * inability to tolerate off-loading, and poor prognosis diseases including malignant tumors. * serious chronic disease i.e hepatic, heart, renal, pulmonary diseases * patients with critical limb ischemia and osteomylitis * withdrawal of informed consent

Keywords: stromal vascular fraction (svf), adipose derived stem cells (ascs), diabetic foot ulcer (dfu), platelet rich plasma (prp)
efficacy of a probiotic lozenges in chronic periodontitis patients.

Conditions: Chronic Periodontitis

Summary: periodontal disease is an infectious disease resulting in inflammation within supporting tissues of the teeth, progressive attachment loss, and bone loss. epidemiological studies reveal that about 10% of the adult population suffer from severe periodontitis.it comprises of two distinct but interconnected etiologic components: the periodontopathic bacteria adjacent to the periodontal tissues, and the host-mediated connective tissue-destructive responses to the causative bacteria and their metabolic products. in the arena of periodontics, the probiotics pose a great potential of plaque modification, halitosis management, altering anaerobic bacteria colonization, improvement of pocket depth, and clinical attachment gain. aim of the study is to analyze the beneficial effect of probiotic lozenges as an adjunct to scaling and root planing, on clinical and biochemical parameters.


Eligibility criteria:
inclusion criteria: * subject of both sexes * age group of 25-65 years * subjects with generalized moderate to severe chronic periodontitis * signed informed consent exclusion criteria: * any known history of systemic diseases * patients already on anti-inflammatory drugs or antibiotics * patients allergic to any material used in the study * pregnant and lactating women * periodontal therapy in past 6 months * current smoker or smoker in the past
an extension study of jr-141-br21 in patients with mucopolysaccharidosis ii

Conditions: Mucopolysaccharidosis II

Summary: a phase ii open-label, parallel group, 2 sites (brazil), designed to evaluate the long term safety and efficacy of study drug for the treatment of the mps ii.


Eligibility criteria:
inclusion criteria: * patients who will have completed clinical trial jr-141-br21. * capable of providing written consent by himself, unless the patient is under the age of 18 years at the time of informed consent process, or it is not possible to obtain consent from the patient himself due to his intellectual disabilities associated with mps ii. * in the case of a patient who is under the age of 18 years or from whom it is not possible to obtain consent due to his intellectual disabilities associated with msp ii, he may be included if written consent can be provided by legal representative; however written consent should be obtained from the patient himself too, wherever possible. exclusion criteria: * refusal to sign the informed consent form. * unable to perform the study procedures, except for neurocognitive testing. * previous engrafted bmt/hsct. * judged by the investigator or subinvestigator as being unable to undergo lumbar puncture, including those who have difficulties in taking a position for lumber puncture due to joint contracture or those who are likely to experience difficulty breathing during the lumbar puncture process. * judged by the investigator or subinvestigator to be ineligible to participate in the study due to a history of a serious drug allergy or sensitivity. * otherwise judged by the investigator or subinvestigator to be ineligible to participate in the study out of consideration for the subject safety.