Kornimate/medical-research-clean huggingface dataset:
open-label study of oto-201 for treatment of aomt

Conditions: Acute Otitis Media; AOMT

Summary: this is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (aomt). eligible subjects will receive a single dose of 6 mg oto-201 to the affected ear(s). the study is designed to characterize safety, procedural factors and clinical effect of oto-201 administered in subjects with aomt.


Eligibility criteria:
inclusion criteria includes, but is not limited to: * subject is a male or female aged 6 months to 17 years, inclusive * subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (aomt) * subject's caregiver is willing to comply with the protocol an attend all study visits exclusion criteria includes, but is not limited to: * subject has a history of sensorineural hearing loss * subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation * subject has a history of known immunodeficiency disease

Keywords: acute otitis media with tympanostomy tubes
telehealth-enabled versus in-person parent-mediated behavioral treatment for challenging behaviors in children with asd

Conditions: Autism Spectrum Disorder

Summary: the purpose of the research is to determine whether parent-mediated behavior therapy for challenging behavior commonly displayed by children with autism spectrum disorder (asd) can be as effective when delivered via telehealth as when delivered in-person.


Eligibility criteria:
inclusion criteria: 1. child is aged 2 years 0 months to 7 years 11 months inclusive 2. child has a documented diagnosis of asd 3. child exhibits at least one form of daily or hourly self-injurious behavior and/or aggressive behavior on the behavior problems inventory - short form (bpi-s)71,72 4. family lives in one of the following counties in new mexico and texas: bernalillo, santa fe, valencia, sandoval, torrance, socorro, cibola, los alamos, el paso, hudspeth, otero, mckinley, san miguel, eddy, chaves, or dona ana. 5. caregiver is comfortable speaking and reading in english 6. the child's caregiver is at least 21 years old 7. the same caregiver is consistently available for one hour per week for a 12-week period in their home with their child between 9am and 7pm monday through friday to take part in the research 8. caregiver is willing to adhere to the study intervention regimen and be willing to have a clinician come into their home for 1 hour per week for 12 weeks 9. family lives in an area with consistent cell phone coverage exclusion criteria: 1. caregiver is currently receiving aba services or direct parent coaching to manage their child's challenging behaviors 2. child engages in behavior that may inflict moderate to severe damage on the individual or on other people (e.g. biting through the skin, eye gouging, fracturing bones, significant damage to property) with minor or major medical intervention required. 3. child has a sensory or physical impairment that precludes participation (e.g., epilepsy, vision or hearing impairment) or has a diagnosis of another genetic condition (e.g., fragile x syndrome) 4. activity restrictions that limit caregiver's ability to respond to their child's challenging behaviors 5. child has an underlying medical condition that is better treated with medical intervention 6. child only exhibits pica at a daily or hourly frequency on the bpi-s 7. the caregiver has another child already participating in the study
survey of osteoarthritis real world therapies (mk-0663-140)

Conditions: Osteoarthritis

Summary: this was a study to estimate the proportion of participants with osteoarthritis of the knee(s) who were treated with oral or topical analgesics for their symptoms, who did and did not report adequate pain relief at baseline and to characterize their pain level over a 12-month follow-up period.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary osteoarthritis of the knee(s) * presently receiving prescribed oral or topical analgesics for a minimum duration of two weeks prior to enrollment exclusion criteria: * arthritis other than primary osteoarthritis * treatment with disease-modifying antirheumatic drugs (dmards), methotrexate or biologics * subtotal or total joint replacement in the affected knee * chronic severe pain of other causes that in the opinion of the investigator may require long-term analgesia or confound the present study * currently enrolled in a clinical trial or who have participated in a clinical trial within the past 30 days

Keywords: osteoarthritis standard of care
ferumoxytol for magnetic resonance imaging of myocardial infarction

Conditions: Myocardial Infarction

Summary: the investigators wish to examine whether a novel 'nanoparticle' of iron oxide, administered intravenously allows an area of heart muscle damage after heart attack to be visualised using a magnetic resonance scanner.

using ferumoxtran (feraheme) as a uspio contrast agent for magnetic resonance imaging at 3 tesla, we aim to conduct the first clinical study to examine the utility of this novel contrast agent to image myocardial inflammation after myocardial infarction. we will test the following hypotheses in patients who have suffered recent acute myocardial infarction. 1. intravenous injection of ferumoxytol accumulates at the site of myocardial infarction and this can be visualised by magnetic resonance imaging. 2. the spatial extent of the mri signal change evoked by ferumoxytol in the myocardium is proportional to the volume of infarcted myocardium (as assessed by a gadolinium late-enhancement study). 3. myocardial mri signal change evoked by ferumoxytol is positively correlated with blood markers of systemic inflammation.

Eligibility criteria:
inclusion criteria: * presentation with myocardial infarction (either 'st-elevation' myocardial infarction or 'non-st-elevation' myocardial infarction * troponin i ≥ 10 iu/ml at 12 hours after the onset of chest pain * age 18 - 80 years inclusive exclusion criteria: * known critical (≥95%) left main stem coronary artery disease * continued symptoms of angina at rest or minimal exertion * atrial fibrillation * symptomatic heart failure; killip class ≥2. * hepatic failure (childs-pugh grade b or c) or renal failure (estimated glomerular filtration rate \<25 ml/min) * contraindication to magnetic resonance imaging * past history of systemic iron overload/haemochromatosis * patients with known allergy to dextran- or iron-containing compounds

Keywords: myocardial infarction magnetic resonance nanoparticle iron inflammation
effect of kinesiotaping on activation of abdominal muscles in female patients with stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: this study will be conducted to evaluate the effect of kinesiotaping on activation of abdominopelvic cavity for management of stress urinary incontinence females' patients.

stress urinary incontinence, the involuntary leakage of urine during exercise or certain movements, is a common pelvic floor disorder that can negatively impact quality of life. urinary incontinence is associated with reduced physical, social, and mental well-being. while alternative exercise regimens have been proposed, it was concluded there is insufficient evidence they reduce leakage in women with stress urinary incontinence. kinesio taping is a rehabilitative technique that provides support and stability to muscles using elastic tape. kinesio tape has no drugs/chemicals and allows normal skin function. limited studies have shown taping specific abdominal areas can stimulate skin-organ reflexes and improve pelvic organ function through interactions between the pelvis, pelvic floor muscles, and synergists. therefore, could suggested that kt application on abdominopelvic cavity might be emerged as a conservative treatment option for urinary incontinence there were couple of previous research investigated the kt efficacy on treating bladder over activity with promising results of improvements. till now, there is no previous study illustrating the effect of kinesio taping on abdominopelvic cavity in stress urinary incontinence females. so, this study will be the first one in this issue. therefore, it will have valuable benefits in physical therapy field and scientific research.

Eligibility criteria:
inclusion criteria: 1. women suffering from mild to moderate stress urinary incontinence, clinically diagnosed by the gynecologist. 2. their ages will be ranged from 30-50 years old. 3. their body mass index (bmi) will be ranged from (20-25 kg/m2). 4. they shouldn't have any musculoskeletal or neurological disorders. exclusion criteria: 1. current pregnancy. 2. malignant condition 3. history of acute infection 4. neurological problem 5. mental problem to prevent evaluation and cooperation 6. having allergies to kinesiotaping 7. having uncontrolled metabolic diseases like diabetes and thyroid disease. 8. athletic females

Keywords: kinesiotaping abdominal muscles female patients stress urinary incontinence
a multicenter, prospective study of diarrhea tolerance of pyrotinib combined with trastumab and taxane in the first-line treatment of her2-positive advanced breast cancer

Conditions: Breast Cancer

Summary: to explore a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib


Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years, ≤75 years 2. her2-positive recurrent or metastatic breast cancer; patients with local recurrence need to be confirmed by the investigator that radical surgical resection is not possible. 3. did not receive any systemic antitumor therapy in the advanced stage; 4. at least one measurable lesion was present according to recist1.1 criteria. 5. the ecog score is 0 to 1 6. the functional major organs must be normal 7. volunteer to participate in this study, sign informed consent, have good compliance and willing to cooperate with follow-up exclusion criteria: 1. have received any systematic antitumor therapy at the recurrence/metastasis stage; 2. tyrosine kinase inhibitor (tki) formulations targeting her have been used at any stage of breast cancer 3. patients judged by the investigators to be unsuitable for systematic chemotherapy. 4. patients with active brain metastases (meaning those requiring mannitol treatment or with symptomatic brain metastases); 5. had undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or were expected to undergo major surgical treatment. 6. serious heart disease or discomfort 7. inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect the use and absorption of medications.
allocare - support and management of late effects after allogeneic hematopoietic stem cell transplantation

Conditions: Hematological Diseases

Summary: a developed multimodal intervention targeting late effects in survivors of allogeneic hematopoietic stem cell transplantation (allo-hsct) will be evaluated in a two-arm randomized controlled trial with an internal pilot phase.

the study aims to investigate the effect of a multidisciplinary multimodal intervention in allo-hsct survivors on survivorship-specific health-related quality of life and late effects. method: this study is designed as a one-site, two-arm prospective randomized controlled trial proceeding an internal pilot phase. population/recruitment: recruitment, inclusion, and exclusion criteria as described in the eligibility section. included patients will be randomized and allocated 1:1 to an intervention group or a control group. intervention: a stepped-care multi-modal intervention

Eligibility criteria:
inclusion criteria: * adult patients (age\> 18 years) treated with myeloablative or non-myeloablative hsct in outpatient follow-up without recurrent disease are eligible for inclusion. exclusion criteria: * patients with recurrence or subsequent malignancy requiring cancer treatment or lack of access to email and the internet will be excluded.

Keywords: late effects. survivorship. allo-hsct
culturally adapted psychoeducation (cape) for bipolar disorders in nigeria

Conditions: Bipolar Disorder

Summary: bipolar disorders are chronic mental health disorders that often result in functional impairment, constituting a significant disease burden. it also accounts for seven per cent of disability-adjusted life years caused by mental disorders. four out of ten persons with a probable diagnosis of bipolar disorders received no mental health care within the preceding twelve months. compared to the general population, individuals with bipolar disorders tend to have a significantly higher rate of associated suicide mortality. within the last decade, these mortality rates have substantially increased, suggesting the need for targeted research to address the unresolved needs of individuals suffering from bipolar disorders. a recent meta-analysis found that compared to the general population, bipolar patients had reduced life expectancy with about thirteen years of potential life loss. bipolar disorders are historically under-researched compared to other mental health disorders, especially in sub-saharan africa and nigeria. our recent study on bipolar disorders in nigeria provided insight into contextual knowledge and beliefs about bipolar disorders, including the lived experiences of patients with bipolar disorders, their caregivers, and clinicians in nigeria. the study recommended culturally adapted psychosocial intervention for bipolar patients, hence the proposed research.


Eligibility criteria:
inclusion criteria: * diagnosis of dsm iv bipolar affective disorder * currently euthymic (bdi \< 12 and ymrs \< 8) * age 18-65 years, participants engaged with the mental health services for the preceding 6 months * able to give written informed consent * resident of the trial catchment area and * the ability to speak english. exclusion criteria: * severe cognitive impairment * currently experiencing relapse (mania, hypomania, mixed or depressive) * being actively suicidal * the presence of any comorbid psychiatric illness such as substance misuse or alcohol dependence according to dsm iv criteria.
metal and plastic biliary stents to drain malignant distal biliary strictures.

Conditions: Biliary Stricture; Stent Stenosis

Summary: multicentric italian registry aimed to evaluated the role and results of plastic and metal stents in the treatment of malignant distal biliary strictures


Eligibility criteria:
inclusion criteria: * malignant distal biliary stricture * need for palliative and pre-operative biliary drainage * age \> 18 * signature of the informed consent exclusion criteria: * previous endoscopic/radiological biliary drainage * stricture close to the main hepatic confluence(\< 2 cm) * duodenal stenosis * post- surgical altered anatomy * benign disease

Keywords: biliary stricture plastic stent self expandable metal stent
resection vs. best supportive care for hepatocellular carcinoma (hcc) with portal venous thrombus

Conditions: Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Summary: the purpose of this study is to evaluate the long-term efficacy and safety of surgical resection compared with best supportive care in patients with resectable hepatocellular carcinoma (hcc) with portal venous thrombus (pvtt) in the first branch of portal vein.

advances in surgical techniques have made it possible to remove all macroscopic tumors in more hepatocellular carcinoma (hcc) patients with portal venous thrombus (pvtt). however, the benefit of such surgery remains largely controversial. on one hand, many clinicians believe that surgical resection offers the only chance for long term survival. many studies reported a median survival of 6-40 months after liver resection and thrombectomy, and some cases achieved long term survival.on the other hand, the strength of evidences arising from these studies was widely questioned because of their retrospective nature and study design. most of them were single arm cohort study. a few studies used control groups consisted of patients with unresectable hcc and pvtt underwent transarterial chemoembolization. this led to obvious selection bias. because patients with unresectable hcc and pvtt have a much poorer prognosis compared with resectable disease because of more widespread tumor focus and less residual liver, even if their baseline characters are comparable.

Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was made according to aasld guidelines * main tumor ≥ 7 cm * imaging confirmed the presence of pvtt in the first branches but not * extend into the main trunk of portal vein * eastern co-operative group performance * resectable disease exclusion criteria: * child-pugh class b or c liver cirrhosis * an american society of anesthesiologists (asa) score ≥ 3 * extrahepatic metastasis * patients had access to sorafenib.

Keywords: hepatectomy thrombectomy hepatocellular carcinoma portal vein tumor thrombus
a study pilot about the contribution of pleuropulmonary echography iin acute bronchiolitis among infants

Conditions: Bronchiolitis

Summary: pleuropulmonary echography remains an almost non-existent tool in routine pediatric practice. our study is part of a desire to develop its use in pediatrics, in particular for the diagnosis of acute bacterial pneumonitis associated with acute bronchiolitis among infants.


Eligibility criteria:
inclusion criteria: * infants aged \<= 2 years old * medical diagnosis of acute bronchiolitis requiring hospitalization in the pediatric departments of the besançon university hospital * no opposition from the parents for performing the pleuropulmonary echography. exclusion criteria: * children aged \> 2 years old * infants aged \< 2 years old consultant in pediatric emergencies for acute bronchiolitis without subsequent hospitalization. * previous chronic lung disease (including pulmonary bronchodysplasia), unoperated congenital heart disease or neuromuscular disease.
pain after intravitreal therapy

Conditions: Pain

Summary: this randomized clinical trial is comparing two different needles (27 gauge versus 30 gauge) for intravitreal therapy (ivt). standardized questionnaires and pain scales should allow for standard recommendation regarding the optimal needle size for ivt.

purpose: to evaluate the influence of the type of the needle on pain scores after intravitreal therapy (ivt). design: randomized clinical trial methods: a total of 200 patients, treated with an ivt for exudative age-related macular degeneration (amd) or a vascular retinal disease, will be included and randomly assigned to be treated with either a 27-gauge needle (group 1) or a 30-gauge needle (group 2). after ivt the patient has to fill out a standardized questionnaire including pain scores on the visual analog scale after the surgical procedure. regression analysis of the scaled questionnaires should allow for a standard recommendation regarding the optimal needle size for minimal subjective pain during ivt.

Eligibility criteria:
inclusion criteria: * vitrearetinal disease including age-related macular degeneration, * clinical significant macular edema due to diabetic retinopathy or other vascular disorders * treatment with intravitreal therapy exclusion criteria: * missing informed consent * age under 50 years

Keywords: intravitreal therapy pain scales gauge pain scores visual analog scale
disability, mri lesions and thickness of retinal fibers: evaluation 15 years after a first episode of demyelination

Conditions: Multiple Sclerosis; Pathologic Processes; Tomography, Optical Coherence; Magnetic Resonance Imaging; Prognosis

Summary: knowledge of the evolution of multiple sclerosis (ms) and its long-term prognostic factors is essential to guide the therapeutic management. however, it remains partial and concerns above all data collected during the first years of the disease. the evolution towards disability can only be assessed after a follow-up of more than 10 years and does not depend solely on the initial inflammatory activity of the disease. we propose to realize a standardized clinical assessment, an optical coherence tomography (oct) and a cerebral mri 15 years after the first clinical manifestation of the disease. clinical and paraclinical assessment will consist in the realization of additional mri sequences in order to obtain more precise information on cerebral lesions (unconventional parameters). optical coherence tomography (new generation device) will also be performed on both eyes to describe the thickness of the different layers of the retina. a clinical evaluation will be performed with the expanded disability status scale (edss). this study aims: 1. to describe the current clinical situation of patients (e.g. percentage of patients with moderate or severe disability) 2. to explore the associations between mri parameters, those measured with oct and clinical characteristics (disability) 3. to explore clinical and paraclinical prognostic factors of pejorative evolution (disability, severe cerebral atrophy, etc.)


Eligibility criteria:
inclusion criteria: * first episode of demyelination occurred at least 10 years ago * hospitalized in the neurology department during this episode * insured with a social security scheme * having given his consent to participate in the study exclusion criteria: * contraindications to 3 tesla mri and injection of contrast media * benefiting from a legal protection measure * pregnant or nursing mother
efficacy and safety study of jtt-705 in combination with pravastatin 40 mg in patients with type ii hyperlipidemia

Conditions: Type II Hyperlipidemia

Summary: the purpose of this study is to evaluate the effect of two dose levels of jtt-705 when co-administered with pravastatin 40 mg on hdl-c and ldl-c and the inhibition rate of cetp activity and to document short term safety.


Eligibility criteria:
inclusion criteria: * patients having lipid values as indicated below: * hdl-c less than 1.6 mmol/l (60 mg/dl) * tg less than 4.5 mmol/l (400 mg/dl) * ldl more than 4.0 mmol/l (160 mg/dl) * patients with chd or chd risk equivalent * male and females between 18 and 65 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception) exclusion criteria: * body mass index of ≥ 35 kg/m2 * females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception * concomitant use of medications identified in the protocol