Kornimate/medical-research-clean huggingface dataset:
a trial of pentoxifylline for the treatment of recurrent aphthous stomatitis

Conditions: Recurrent Aphthous Stomatitis

Summary: this is a randomized, double blind, placebo controlled trial of the use of pentoxifylline (oxpentifylline) for the treatment of recurrent mouth ulcers.

there are few effective treatments for recurrent aphthous stomatitis (cancer sores, recurrent mouth ulcers). most existing treatments are palliative topical treatments. some systemic drugs e.g. steroids and thalidomide can suppress the recurrence of mouth ulcers but have serious long term side effects. pentoxifylline (also known as oxpentifylline) has been used systemically for many years to treat peripheral vascular disease and has a good side effect profile. it shares several actions with thalidomide but does not share its serious side effects. furthermore, some small scale, open label clinical studies have indicated it may be very effective in treating recurrent aphthous stomatitis (ras). this study enrolled patients with ras for which no underlying cause could be identified. patients kept a diary of the pattern of their mouth ulcers for 60 days to confirm the pattern of ulceration and provide baseline data. those still qualified for the study were then randomized to treatment with pentoxifylline 400mg three times daily or an identical placebo tablet three times daily for a further 60 days during which they continued to keep a daily ulcer diary. at the end of this period, treatment was stopped and they kept the daily ulcer diary for a further 60 days to identify if any benefit from the treatment was continued after ceasing treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of minor recurrent aphthous stomatitis * 2 or more mouth ulcers per month for more than 6 * no current treatment for oral ulceration or willing to stop treatment * age 16 to 65 years exclusion criteria: * taking ketorolac, theophylline or anti-hypertensive medication except diuretics (contra-indicated in patients treated with pentoxifylline) * systemic diseases that contra-indicate the use of pentoxifylline i.e. pregnancy, hypotension, ischaemic heart disease, acute myocardial infarction, cerebral or occular hemorrhage, renal or hepatic failure, porphyria or allergy to pentoxifylline. * patients with an underlying deficiency state or systemic disease that could cause recurrent mouth ulcers e.g. iron, vitamin b12 or foliate deficience, coeliac disease, crohn's disease, ulcerative colitis, behcet's disease or aids.

Keywords: recurrent aphthous stomatitis recurrent mouth ulcers pentoxifylline clinical trial double blind placebo controlled randomized
study of cobimetinib in participants with solid tumors

Conditions: Solid Tumor

Summary: this non-randomized, open-label, study will determine the highest safe dose of cobimetinib, how often it should be taken, how well participants with cancer tolerate cobimetinib and will assess the pharmacokinetic effect of midazolam and dextromethorphan on the study drug.


Eligibility criteria:
inclusion criteria: * histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival * disease that is measurable according to response evaluation criteria in solid tumors (recist) * adequate organ and marrow function * sexually active participants must use medically acceptable methods of contraception during the course of the study and at least 11 days after the last dose of study treatment * female participants of childbearing potential must have a negative serum pregnancy test at screening * no other history of/or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assays exclusion criteria: * anticancer treatment (e.g., chemotherapy, radiotherapy, cytokines, or hormones) within 28 days (6 weeks for nitrosoureas or mitomycin c, or 14 days for hormonal therapy or kinase inhibitors) before the first dose of study drug * the participant has not recovered to grade \</=1 from adverse events (aes) or to within 10% of baseline values due to investigational or other agents administered more than 28 days prior to study enrollment * the participant has received another investigational agent within 28 days of the first dose of study drug * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia * the participant is pregnant or breastfeeding * the participant is known to be positive for the human immunodeficiency virus (hiv) * allergy or hypersensitivity to components of the cobimetinib formulation
dasotraline binge eating disorder extension study

Conditions: Binge Eating Disorder

Summary: binge eating disorder extension study.

this is a phase 3, 12 month, multicenter, open-label, flexibly-dosed, safety study in adults with binge eating disorder.

Eligibility criteria:
inclusion criteria: * completion of the treatment period of a dasotraline core study (ie, sep360 221 or sep360-321) for the treatment of bed. * subject has agreed to participate by providing written informed consent and is willing and able to comply with the protocol, in the opinion of the investigator. * subject has not taken any medication other than the study drug for the purpose of controlling bed symptoms during the core study. * female subject must have a negative urine pregnancy test at open label (ol) baseline; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test. * female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use an effective and medically acceptable form of birth control (see section 22, appendix iii) throughout the study period. note: continued use of an effective and medically acceptable form of birth control is recommended for 30 days after study completion. * subject is judged by the investigator to be suitable for participation in a 12 month clinical trial involving open-label dasotraline treatment. * subject can read well enough to understand the informed consent form and other subject materials. exclusion criteria: * subject is considered by the investigator to be at imminent risk of suicide, injury to self or to others, or damage to property. * subject is considered a suicide risk in the investigator's opinion or has any previous history of suicide attempt within the past 12 months. * subject answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the c ssrs assessment at ol baseline. subjects who answer "yes" to this question must be referred to the investigator for follow up evaluation. * subject has a clinically significant abnormality including physical examination, vital signs, ecg, or laboratory tests that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study. * subject has a positive urine drug screen (uds) or breath alcohol test at ol baseline. * subject is breastfeeding. * subject is at high risk of non-compliance in the investigator's opinion.
characterization of early patients initiating ofatumumab for treatment of multiple sclerosis.

Conditions: Multiple Sclerosis

Summary: this was a retrospective cohort study utilizing secondary data from iqvia's open source pharmacy claims database (i.e., iqvia lrx) selecting patients with prescription claims for ofatumumab or other dmts of interest.

the date of first ofatumumab prescription claim or other dmt of interest was defined as the index date. no post-index requirements were imposed. patients were linked to iqvia's open source medical claims databases (dx) to obtain patient clinical characteristics. the initial data were extracted in october 2020. the data and results were refreshed in april 2021 and july 2021 to allow for assessment of changes in characteristics at 6 and 9 months post-launch.

Eligibility criteria:
inclusion criteria: * patients with ≥ 1 prescription for ofatumumab in the lrx/dx database were included. the date of the first observed prescription within the index window served as the index date. -. patients with a diagnosis of covid-19 or a covid-19 vaccination any time during the study period. * patients with linkage to the dx database. exclusion criteria - no exclusion criteria were applied to patients in the study.

Keywords: multiple sclerosis, ofatumumab, disease-modifying therapy, covid-19
ba duan jin for ci with hyperarousal/anxiety

Conditions: Mind-Body Therapies; Insomnia Chronic

Summary: this randomized controlled trial aims to evaluate the effectiveness of ba duan jin exercise in treating chronic insomnia (ci) with comorbid hyperarousal and anxiety symptoms.

chronic insomnia (ci) is a common sleep disorder characterized by persistent difficulties in initiating or maintaining sleep, leading to significant daytime dysfunction. many ci patients experience hyperarousal, both physiological and psychological, commonly manifested as anxiety, which further exacerbates sleep disturbances and reduces quality of life. while pharmacotherapy and cognitive behavioral therapy (cbt) are effective for some patients, they are limited by side effects, costs, and accessibility. traditional mind-body practices such as ba duan jin, a classic chinese qigong exercise, have been explored as alternative therapies to improve sleep quality and alleviate anxiety symptoms. ba duan jin consists of a sequence of gentle and flowing movements designed to promote physical and mental relaxation. preliminary studies suggest that mind-body exercises like ba duan jin can positively influence sleep patterns, psychological well-being, and overall health. this randomized controlled trial will recruit 84 participants diagnosed with ci and comorbid hyperarousal/anxiety symptoms. participants will be randomly assigned to either a ba duan jin plus sleep hygiene education (she) group or an she-only group. the intervention will last for 6 weeks, with participants in the ba duan jin group practicing once daily for 50 minutes.

Eligibility criteria:
inclusion criteria: 1. diagnosed with insomnia disorder according to dsm-5 criteria. 2. pittsburgh sleep quality index (psqi) total score \> 5. 3. age ≥ 8 years. 4. educational level of at least junior high school. 5. voluntarily agree to participate and sign informed consent. 6. presence of anxiety symptoms, defined as a hamilton anxiety rating scale (hama-14) score ≥ 14. exclusion criteria: 1. presence of severe physical illnesses or major psychiatric disorders, or assessed to be at risk of suicide. 2. diagnosis or suspicion of sleep breathing disorder, restless legs syndrome, circadian rhythm sleep disorder, or engaged in night-shift work. 3. pregnancy or breastfeeding. 4. currently undergoing any form of psychological therapy.
efficacy of oral sucrose and topical anesthetics to reduce pain during eye examination for retinopathy of prematurity

Conditions: Investigate the Efficacy of Sucrose During Eye Examination

Summary: oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. the purpose of this study was to determine the effectiveness of local anesthetic eye drops and a pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity.

oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. administration of oral sucrose with and without non-nutritive sucking is the most frequently studied non-pharmacological intervention for procedural pain relief in neonates.the purpose of this study was to determine the effectiveness of local anesthetic eye drops and a pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity.

Eligibility criteria:
inclusion criteria: -vlbw infants \<32 weeks of gestational age exclusion criteria: * infants \>32 weeks of gestational age * neuromuscular abnormality * major abnormality

Keywords: eye examination, oral sucrose, premature infant pain scale
safety of electrotherapy in patients with knee osteoarthritis and cardiac diseases

Conditions: Knee Osteoarthritis

Summary: this study aimed to asses whether physyical therapy (e.g. electrotherapy in the form of low, medium or high frequency currents, massage and kinetotherapy) for treatment of knee osteoarthritis can induce or aggravate certain cardiac diseases during or immediately after therapy. the physyical treatment described is not a new method, is currently used and recommended in all guidelines for non-pharmacological and non-surgical therapy of knee osteoarthritis. what is not clear is whether application of electrotherapy in the knee area can alter the preexisting cardiac condition.

an analytical and transversal study was carried out between march 2013 and august 2017. the study included a total of 46 patients previously diagnosed with degenerative knee oa. all the patients included in the study were recruited during inpatient visit in the clinical rehabilitation hospital in cluj-napoca, romania. each patient was clinically evaluated and was furthermore prescribed a pt program (et, massage and kinesiotherapy). they were monitored by 24 hour-holter ecg in 2 separate days, at the beginning of treatment, before applying the pt methods (day 1), and after completing a 10-day pt program (day 2). pt modalities prescribed for each patient after clinical evaluation included different types of et, all currently used and included in the national and international treatment guidelines, as in low frequency currents (galvanic or tens), medium frequency currents (interferential) and high frequency currents (short wave diathermy), all combined with an individualized exercise program and massage therapy. the program was performed on a daily basis, for 10 days. the aim of the pt program was to decrease pain and increase range of motion in the affected joints and did not lead to increases in cardiac frequencies. no hydrotherapy was applied, given that that the holter ecg was not waterproof. no technical incidents were reported during the study. no alternate positioning of the patient wearing a holter ecg for et procedures was necessary, as the region of interest was the knee. no change in current drug therapy was allowed for the whole duration of the study.

Eligibility criteria:
inclusion criteria: * clinical diagnosis and imaging diagnosis of knee osteoarthrtitis based on acr 2000 diagnostic criteria exclusion criteria: * known cardiac arrhythmias (atrial fibrillation, atrial flutter) * congestive heart failure class nyha ii, iii or iv * any other general contraindications for pt (infections, psychiatric disorders etc)
disease management in adolescents with type 1 diabetes

Conditions: type1diabetes; Adolescent Behavior; Self Efficacy

Summary: adolescence period; it is a transition period of rapid growth, development and maturation in biochemical, physical, social and spiritual terms, which lasts from the beginning of puberty to young adulthood. adolescence is a predictable developmental transition period for the individual. they also encounter unpredictable situations (such as childhood illnesses). one of these conditions is type 1 diabetes mellitus, which is the most common metabolic endocrine system disease in adolescents. type 1 diabetes is an important health/disease transition in the life of a child and adolescent. therefore, this study aimed to determine the effect of the "adaptation to adolescence and type 1 diabetes management training programme", prepared in line with meleis's transition theory, on the adolescent's developmental transition adaptation, self-efficacy for diabetes management and glycemic control.


Eligibility criteria:
inclusion criteria: * having been diagnosed with type 1 diabetes in the last 6 months * hba1c level \>7.5 exclusion criteria: * presence of a diagnosis of intellectual disability, autism spectrum disorder and psychotic disorder

Keywords: type 1 diabetes transition theory diabetes management pediatric nurse randomized controlled trial
listening to mom 2: neural, clinical and language outcomes

Conditions: Premature Birth

Summary: the purpose of this study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for promoting healthy brain and language development in infants born preterm.

children born preterm are at-risk for developmental language delays. language problems in preterm children are thought to be related to neurobiological factors, including injuries to white matter structures of the brain and environmental factors, including decreased exposure to maternal speech in the hospital nursery. there is evidence to suggest that maternal speech input may be important for promoting healthy brain and language development. participants will be randomly assigned to one of two study groups. each infant has a 50% chance of being assigned to the group that will listen to a recording of his/her mother's voice and a 50% chance of being assigned to the group that will not be played a voice recording. mother's of participating infants will have her voice recorded as she reads a common children's storybook. recordings will be played to infants each day until s/he is discharged from the hospital. to assess the long term impacts of this treatment, research participants and their families will be asked to return for follow-up visiting to perform an mri brain scan and complete questionnaires and test that assess language development. follow-up visit occur when infants are between 12 to 18 months of age.

Eligibility criteria:
inclusion criteria: * infants born preterm at stanford children's hospital between 24 0/7 - 31 6/7 weeks gestational age exclusion criteria: * congenital anomalies * recognizable malformation syndromes * active seizure disorders * history of central nervous system infections * hydrocephalus * major sensori-neural hearing loss * likelihood to be transferred from nicu to alternate care facility or home environment prior to 36 weeks pma and/or brain mri scan * intraventricular hemorrhage grades iii-iv * cystic periventricular leukomalacia (pvl) * surgical treatment for necrotizing enterocolitis * small for gestational age (sga) \<3 percentile and/or intra-uterine growth restriction (iugr) no head sparing * twin-to-twin transfusions

Keywords: premature birth obstetric labor, premature obstetric labor complications pregnancy complications
effects of myofascial release and tens over pain, hand prehensile strength and functionality of superior extremity in women with lateral epicondylalgia

Conditions: Musculoskeletal Manipulations

Summary: this study evaluated the additive effect of myofascial release therapy on the brachial biceps on conventional management (tens) in pain intensity, hand prehensile strength and upper limb functionality of individuals with lateral epicondylalgia.

this study determined the additive effect of the myofascial release therapy of brachial biceps on tens in the variables pain intensity, hand prehensile strength and upper limb functionality of individuals with lateral epicondylalgia, compared to a group that received only tens. this was done in a sample of 32 individuals, assigned in two groups: group a that received an application of tens and group b that received an application of tens plus myofascial release therapy. contrary to the hypothesis, the application of myofascial release therapy added to the application of tens proved to generate a significant change only in the prehensile hand force with respect to the group that received only tens.

Eligibility criteria:
inclusion criteria: * female between 30 and 50 years old. * belong to the administrative staff of the university in question * have a symptomatic diagnosis of chronic lateral epicondylitis (\> 6 weeks) exclusion criteria: * being pregnant * have done moderate or intense aerobic or anaerobic sport activities of any kind 72 hours before the registrations * have an orthopedic, rheumatologic, neuropsychiatric or associated comorbidities diagnosed. * have suffered a fracture or trauma involving the upper extremity 4 months before the intervention. * be in medical, pharmacological or kinesthetic treatment during the intervention or 2 weeks before this.

Keywords: manual therapy myofascial release lateral epicondylitis transcutaneous electrical nerve stimulation pain strength functionality
three-dimensional analysis of emmprin on conjunctival epithelial cells surface in severe dry eye syndrome (altesse)

Conditions: Conjunctival Diseases; Dry Eye Syndromes

Summary: modifications of cell surface markers (including emmprin) were observed in conjunctival epithelial cells during dry eye syndrome ; this study aims to describe the modifications of the repartition of these cell surface markers before and after initiation of a treatment.


Eligibility criteria:
patients: inclusion criteria * 18 years and over * severe eye dryness (grade 3 or 4) as defined by the international dry eye work shop (2007): frequent symptoms, impregnation of fluorescein at the conjunctival level, marked fluorescein staining at the corneal level, tear break up time ≤ 5 seconds (fluorescein test) schirmer's test score without anesthesia ≤ 5mm at 5 minutes exclusion criteria * treatment with topical ciclosporin * autologous serum treatment * wearer of scleral lenses * known pregnancy or breastfeeding control subjects: inclusion criteria * 18 years and over * tear break up time \> 5 seconds (fluorescein test) exclusion criteria * wearer of contact lenses * functional ocular signs * anomalies of the ocular surface observed during examination with the slit lamp * fluorescein staining of the ocular surface (cornea, conjunctiva) * topical ocular treatment * known pregnancy or breastfeeding

Keywords: conjunctival diseases dry eye syndromes antigens cd147