Kornimate/medical-research-clean huggingface dataset:
study to evaluate glaxosmithkline (gsk) biologicals' menc-tt and hib-menc-tt or meningitec™ in healthy toddlers

Conditions: Infections, Meningococcal

Summary: the purpose of this booster vaccination study is to evaluate the persistence and immune memory induced by a three-dose primary vaccination course with gsk biologicals' menc-tt (neisseria meningitidis group c polysaccharide-tetanus toxoid) and gsk biologicals' hib-menc-tt (haemophilus influenzae type b-menc-tt) or meningitec™ vaccines in healthy toddlers aged 12-15 months by giving them a 1/5th dose of mencevax™ acwy.

the study is an extension of the primary vaccination study 711202/001 (menc-tt-001). it comprises 5 groups: 4 parallel groups of toddlers vaccinated in study 711202/001 (group vaccinated with meningitec™ is control group 1) and 1 group of naive subjects (no previous vaccination against menc disease, control group 2). all subjects receive 1/5th dose mencevax™ acwy and a concomitant dose of infanrix hexa®. 2 blood samples: prior to and 1 month after vaccination.

Eligibility criteria:
inclusion criteria: * healthy toddlers (12-15 m) with at least 1 dose of the 3-dose vaccination course of menc or hib-menc vaccine in study 711202/001, or without previous vaccination against menc disease but with completed primary vaccination according to the german standing committee on immunization (stiko) recommendation at least 6 months before enrolment exclusion criteria: * previous/intercurrent booster vaccination against or history of or exposure to diphtheria, pertussis, tetanus, polio, hepatitis b, hib and/or meningococcal disease. * planned administration/administration of a vaccine within 30 d preceding study vaccination and until study end with the exception of infanrix hexa®. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * history of any neurologic disorders or seizures, of allergic disease/reactions likely to be exacerbated by any component of the vaccines

Keywords: haemophilus influenzae type b/meningococcal (vaccine) prophylaxis meningococcal serogroup c disease, hib diseases
influence of didgeridoo practice on ua obstruction levels in moderate osa

Conditions: Sleep Apnea

Summary: didgeridoo practice has been shown to improve osa severity. the aim of our study is to assess the changes in upper airways obstruction levels before and after didgeridoo practice in moderate osa patients.

didgeridoo practice has been shown to improve obstructive sleep apnea (osa) severity. the aim of our study is to assess the changes in upper airways obstruction levels, evaluated by sleep endoscopy, before and after 3 months of didgeridoo practice in moderate non obese osa patients. severity of osa will also be documented by polysomnography.

Eligibility criteria:
inclusion criteria: * moderate osa, non obese exclusion criteria: * not willing play didgeridoo age\<18 significant lung, cardiac disease neuromuscular disease psychiatric disorders drugs with influence on respiratory drive

Keywords: didgeridoo sleep apnea drug induced sleep endoscopy
exbonadasia study: a study of once monthly bonviva (ibandronate) in women with post-menopausal osteoporosis.

Conditions: Post Menopausal Osteoporosis

Summary: this single arm study will continue drug safety surveillance, and assessment of adherence, in patients with postmenopausal osteoporosis who have received monthly oral bonviva in ml19930, the bonadasia study. all patients completing 6 months in ml19930 will continue to receive bonviva (150mg po, monthly) for an additional 6 months. the anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * patients responding to oral monthly bonviva during the bonadasia study; * willing to continue bonviva treatment for a further 6 months. exclusion criteria: * none specified.
childhood obesity treatment - telephone coaching vc usual care

Conditions: Childhood Obesity

Summary: this study evaluates if usual physical care visits to an outpatient pediatric clinic can be replaced with more frequent and shorter telephone coaching contacts during 18 months.

in this randomized controlled study, patients at age 5 to 14 and enrolled in obesity treatment, were randomized to either usual care according to regular routine or to telephone consultation.the randomization was done at the start of individual treatment and lasted for 18 months. we also studied working time required for the health care, and the families' experience of the telephone coaching.

Eligibility criteria:
inclusion criteria: * children 5 to 14 years old who were patients at the outpatient pediatric centre * all families after that the parents had attended at least 4 of 7 meetings in a parental/education group. exclusion criteria: * obesity related syndromes * non-swedish speaking families

Keywords: behavioral treatment telephone coaching outpatient clinic
acupuncture in emergency delirium after tonsillectomy

Conditions: Emergence Delirium

Summary: emergence delirium (ed) (also called emergence agitation) can be defined as a "dissociated state of consciousness in which the child is irritable, uncompromising, uncooperative, incoherent and inconsolable crying, moaning, kicking or thrashing". tonsillectomy (with or without adenoidectomy) is a routinely performed operation. emergence agitation is a frequent phenomenon in children recovering from general anesthesia for tonsillectomy, and increases risk of self-injury. it's not unusual for the post-anesthesia care unit (pacu) staff look that a child, who was asleep just minutes before, starts screaming, pulling out his intravenous line, looks like he's about to fall out of his bed. this condition requires sedatives that may cause undesirable side effects. the cause of emergence delirium and the mechanism of agitation following general anesthesia is unknown. probably the volatile agents work on some pathways, possibly in the locus coeruleus or amygdala, in the setting of a specific neurodevelopmental stage of the brain. while emergence delirium can be seen into adulthood, its peak incidence is in younger children (2-7 years of age). the incidence of ed is unclear: anywhere from 2-80%, but when confounders like pain, nausea etc. are controlled, the incidence is probably around 20-30%. limited data suggest that acupuncture may be a safe, nonpharmacological treatment for the reduction of pain and agitation in term and preterm infants and that may be an alternative method for preventing ed. in particular a prospective, randomized, double-bind controlled study demonstrated a reduction of the ed in many surgeries, after the electrical stimulation of the heart 7 acupuncture site. nearly 400 acupuncture points are known on the body surface and they belong to 14 meridians, running along the human body. after the needle peeling, the nervous free terminations release some polypeptid (the most important is the substantia p) and it increases the excitability of the near nervous free terminations which cause vasodilatation. it has a myorelaxant effect, decreases the level for pain tolerance and make stronger the inhibitor effect of descendent fibers, with production of endogenous endorphins. this is the reason why acupuncture is considered valid in prevention and control of ed.


Eligibility criteria:
inclusion criteria 1. children scheduled to undergo tonsillectomy with or without adenoidectomy 2. american society of anesthesiologist (asa) physical status i or ii exclusion criteria 1. coagulation disorders (pro-hemorrhagic status) 2. neurological disorders (development delay)

Keywords: acupuncture emergency delirium tonsillectomy
clinical effect of platelet rich plasma combined with laser on scar

Conditions: Acne Scar

Summary: investigation of clinical effect of platelet rich plasma combined with laser on acne scar

platelet rich plasma may relieve the adverse effect of laser treatment. and it can be expected to improve acne treatment result.

Eligibility criteria:
inclusion criteria: * moderate to severe acne scar exclusion criteria: * taken procedures for acne scar within 6 months * underlying diabetes mellitus, keloid, or malignancy

Keywords: acne scar fractional carbon dioxide laser platelet rich plasma
handheld technology for speech development in students with autism

Conditions: Autism Spectrum Disorders

Summary: the proposed study will result in a software application compatible with the apple ipad, iphone and ipod touch (hereafter termed "ios devices") which addresses several aspects of prosodic deficits common in speakers with autism spectrum disorders (asds) and other communication disorders, using a developmentally appropriate, intuitive interface that requires little technical skill and which can be managed by educators and parents. the program will contain elements that aid in tracking and maintaining individual student progress records, and will be designed for use in the classroom, at home, and in other environments. this study's intended focus is on the feasibility and usability of the software application.


Eligibility criteria:
inclusion criteria: * slps, in connecticut public schools, who provide intervention to students with autism spectrum disorders. * students, ages 4 - 19, who attend school in connecticut and demonstrate prosodic difficulties secondary to a diagnosis of asd. exclusion criteria: * students with concommitant genetic disorders

Keywords: autism prosody speech autism spectrum disorder
testosterone replacement in middle-aged hypogonadal men with dysthymia: parallel group, double blind randomized trial

Conditions: Dysthymic Disorder

Summary: growing evidence supports the notion that late-onset dysthymic disorder in middle aged men may be associated with age-related hpg hypofunctioning. in this study we seek to examine the efficacy of testosterone replacement for this condition. hypothesis: testosterone replacement will be more effective than placebo, in treating men with late onset dysthymic disorder and hypo-gonadism.


Eligibility criteria:
inclusion criteria: 1. male, age 40-80 years. 2. diagnosed with hypogonadism (total t level below 350 ng/dl), but not previously treated. 3. diagnosis of dysthymic disorder with onset after age 40. 4. psa \< 4.0. 5. normal digital exam of the prostate in the preceding 1 year. 6. for subjects currently taking an antidepressant: current antidepressant treatment last 6 weeks or longer, with decent dose and with no remission (or with partial remission only ham-d \> 12). 7. able to give informed consent. exclusion criteria: 1. acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism. 2. currently being treated with testosterone. 3. meets lifetime criteria for schizophrenia, schizoaffective disorder, any bipolar disorder (i.e., bp-i, bp-ii, or bp nos); or a major depressive episode in the preceding 5 years. 4. current suicidal risk. 5. current (past year) substance abuse or dependence.

Keywords: dysthymic disorder hpg hypofunctioning testosterone replacement
zimura in combination with lucentis in patients with neovascular age related macular degeneration (nvamd)

Conditions: Neovascular Age-related Macular Degeneration

Summary: to assess the safety of intravitreal zimura™ (complement factor c5 inhibitor) administered in combination with lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (nvamd)


Eligibility criteria:
inclusion criteria: * active subfoveal nvamd exclusion criteria: * history or evidence of severe cardiac disease * any major surgical procedure within one month of trial entry * subjects with a clinically significant laboratory value * any treatment with an investigational agent in the past 60 days for any condition * women who are pregnant or nursing * known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the zimura formulation * any prior treatment for amd other than oral supplements of vitamins and minerals

Keywords: zimura (previous name) arc1905 lucentis ranibizumab wet amd avacincaptad pegol complement factor c5 inhibitor
assessment of efficacy and safety in patients with non-cancer-related pain and opioid-induced constipation

Conditions: Opioid-Induced Constipation (OIC)

Summary: the purpose of this study is to evaluate the effect and safety of nktr-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (lir).


Eligibility criteria:
inclusion criteria: * provision of written informed consent prior to any study-specific procedures. * self-reported active symptoms of oic at screening (\<3 sbms/week and experiencing ≥1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of bms over the previous 4 weeks); and documented confirmed oic (\<3 sbms/week on average over the 2-week oic confirmation period. * receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies for a minimum of 4 weeks prior to screening for non-cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression. * willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 2-week oic confirmation period and the 12-week treatment period, and to use only bisacodyl as rescue medication if a bm has not occurred within at least 72 hours of the last recorded bm. exclusion criteria: * patients receiving opioid regimen for treatment of pain related to cancer. * history of cancer within 5 years from first study visit with the exception of basal cell cancer and squamous cell skin cancer. * medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation. * other issues to the gastrointestinal tract that could impose a risk to the patient. * pregnancy or lactation.

Keywords: non-cancer-related pain opioid-induced constipation
treatment of distal radius fractures in elderly patients

Conditions: Distal Radius Fractures

Summary: the purpose of this study is to create and test a treatment algorithm to guide the treatment of distal radius fractures in patients 65 and older and to obtain level-one evidence to determine the best method of treating distal radius fractures in this growing population demographic.

* distal radius fractures with borderline alignment will be randomized to surgical intervention or conservative treatment. * patients will fill out subjective questionnaires at 0, 6weeks, 3months, 6 months, and 1 year. * patients will perform objective strength tests, dexterity tests and have their range of motion tested at 12 weeks, 6 months and 12 months.

Eligibility criteria:
inclusion criteria: * distal radius fracture * between 10 and 20 degrees of dorsal angulation * between 3 and 5mm of ulnar positive variance * between 1 and 2mm intra articular step deformity * age 65 and older exclusion criteria: * pre-morbid medical conditions which preclude surgical intervention * patients who do not live independently. * patients with an open fracture * associated soft tissue or skeletal injury to the same limb. * pre-existing wrist arthrosis or disability

Keywords: distal radius fracture elderly prospective randomized trial outcomes pain and function surgical vs. conservative management fractures with borderline alignment
quetiapine to reduce post concussive syndrome after mild traumatic brain injury (mtbi)

Conditions: Mild Traumatic Brain Injury

Summary: a two site, 2-arm, phase iii randomized pragmatic clinical trial evaluating the effectiveness of quetiapine monotherapy in comparison to treatment as usual (tau) medication management for symptoms experienced by veterans receiving rehabilitation therapy for mild traumatic brain injury (mtbi) and comorbid symptoms of posttraumatic stress disorder (ptsd).


Eligibility criteria:
inclusion criteria: 1. male or female veterans seeking treatment for mtbi, aged 18-65 years 2. meet mtbi diagnosis and have pcs symptoms reported on the neurobehavioral symptom inventory (nsi). six months or more must elapse between the injury and screening. mtbi diagnosis will be determined using the provisional diagnostic convention recommended by the va/dod requiring loss of consciousness, or a period of altered consciousness, or posttraumatic amnesia; 3. be stable (i.e., no dose changes for \> 1 month) on at least three cns active psychotropic medications prescribed for symptom relief or psychiatric treatment. 4. have posttraumatic symptoms measured by ptsd checklist for dsm-5 (pcl-5) score ≥25. exclusion criteria: 1. moderate or severe tbi, or major neurocognitive disorder (dementia). 2. meet dsm-5 criteria for schizophrenia, bipolar disorder, schizoaffective disorder, or requiring inpatient hospitalization currently or within past 6 months. 3. currently taking any antipsychotics or prohibited medication within the past month . 4. known intolerance to quetiapine or a history of clinically unstable heart, lung, liver, renal, hematological, or endocrinological condition, diabetes mellitus, severe sleep apnea and/or seizure disorder. 5. substance use disorder severe enough to require medication treatment or medical detoxification or inpatient hospitalization within 6 months of screening. 6. reporting suicidal ideation of type 4 or 5 in the columbia suicide severity rating scale (cssrs) in the past 3 months prior to screening or at screening or baseline visit (i.e. active suicidal thought with method and intent but without specific plan, or active suicidal thought with method, intent, and plan); or homicidal ideation with intent or plan to harm others within 90 days or suicide attempt; or suicidal behavior within 6 months prior to screening. (note: study psychiatrist will be immediately notified when si or hi intent is positive) 7. current or known history of cardiac arrhythmia or qtc interval ≥ 470 milliseconds. 8. pregnant or lactating women and those of child-bearing potential not using a reliable method of contraception will be excluded from participating in the study.

Keywords: post concussive syndrome (pcs) posttraumatic stress disorder (ptsd) polypharmacy quetiapine veterans
muscle weakness duration after single botulinum toxin injection in masseter

Conditions: Bite Force; Botulinum Toxins, Type A

Summary: this study aimed to evaluate the duration of a reduced maximal voluntary bite force after a botulinum toxin intervention. methods: in an intervention group, 25 units of xeomin® (merz pharma gmbh \& co kgaa, frankfurt am main, germany) botulinum neurotoxin type a were injected into the masseter muscles bilaterally (to a total of 50 units).

this study aimed to evaluate the duration of a reduced maximal voluntary bite force (mvbf) after a botulinum toxin intervention. methods: in an intervention group, 25 units of xeomin® (merz pharma gmbh \& co kgaa, frankfurt am main, germany) botulinum neurotoxin type a were injected into the masseter muscles bilaterally (to a total of 50 units). a control group did not receive any intervention. mvbf was measured in newtons using a strain gauge meter at the incisors and first molars. the intervention group was comprised of individuals seeking aesthetic treatment for masseter reduction (n = 20), and the control group (n = 12) comprised of volunteers.

Eligibility criteria:
inclusion criteria: healthy subjects seeking aesthetical treatment to reduce masseter muscle volume. exclusion criteria: conditions or drugs affecting the central nervous system.
education intervention in patients with rash due to epidermal growth factor receptor (egfr) treatment.

Conditions: Consent Form; Lung Cancer; Colon Cancer; Pancreas Cancer; Head and Neck Cancer; Breast Cancer

Summary: the main adverse reaction of egfr seen in patients is rash. egfr treated patients have a 24-95% incidence of rash depending on the type of treatment they receive. skin toxicity may occur in more than 80% of patients treated with cetuximab. if a severe rash (grade 3 or 4) occurs, a dose reduction or discontinuation of treatment may be required. also, infections are the main secondary side effect caused by the rash. the aim of the study is through a randomized clinical trial feasibility study to investigate the effectiveness of an educational intervention in patients receiving egfri therapy. it will be randomly selected which patients will belong to the intervention group and who in the control group. the type of program involves educational intervention.

in recent years, egfri (epidermal growth factor receptor inhibitor) have evolved as effective anti-cancer drugs. they are distinguished in monoclonal antibodies (cetuximab and panitumumab) and egfr (tkis) kinase inhibitors gefitinib, erlotinib and lapatinib, where they are used in the treatment of colon, rectal, head and neck, lung, pancreas and of breast. according to studies, the usual treatment for the prevention and treatment of skin rash refers to the use of antibiotics such as doxycycline, tetracycline and cortisone products such as hydrocortisone. it is also recommended to use moisturizing cream. the study of carmine p. et al., 2011 mentions the need to investigate educational measures for the rash due to egfr treatment.

Eligibility criteria:
1. adult cancer patients (\>18). 2. patients who suffered with pruritus, or rash or photosensitivity, in the onset of the symptoms. 3. willing to participate. 4. ability to complete the questionnaires. 5. a performance status of two or less on the eastern cooperative oncology group (ecog). 6. patients with no pre-existing dermatological condition that may limit the interpretation of results.

Keywords: rash, photosensitivity, pruritus, educational, chemotherapy, egfri, immunotherapy
stroke registration of young adults in china

Conditions: Ischemic Stroke

Summary: this is a multi-center, prospective,continuous registry study. the investigators will include 3000 young adult (18-45 years old) patients with confirmed first-ever acute ischemic stroke in china. the main purpose of this study is to build the study cohort of young ischemic stroke patients in china, and to compare the prognosis and stroke recurrence of young patients with different ischemic stroke subtypes. secondary objectives are trying to find biomarkers of stroke recurrence.

approximately 10%-14% of all ischemic strokes occur in young adults ages 18 to 45 years old. stroke etiology in this population differs by geographic region and has greater heterogeneity than in older individuals. ascertain the definite etiologic classification in this young patients might be the key point to prevent the stroke recurrence and reduce the stroke burden. advances in stroke diagnostic tests, particularly neuroimaging, refinement in classification schema. in this multi-center registry study conducted in china, we determine to explore the difference of prognosis and stroke recurrence of young patients with different ischemic stroke subtypes.

Eligibility criteria:
inclusion criteria: * age 18 through 45 years, both genders * first-ever acute ischemic stroke * onset of symptoms within 72 hours of inclusion * willing to participate in follow-up visits exclusion criteria: * silent stroke * failure to give their informed consent

Keywords: youth; etiology; prognosis; recurrence; biomarkers