Kornimate/medical-research-clean huggingface dataset:
a study to test the efficacy, safety, and tolerability of bepranemab (ucb0107) in patients with mild cognitive impairment or mild alzheimer's disease (ad)

Conditions: Alzheimer's Disease

Summary: the purpose of the study is to investigate the effect of bepranemab versus (vs) placebo on the clinical dementia rating scale sum of boxes (cdr-sb) up to week 80 in study participants with prodromal or mild alzheimer's disease (ad).


Eligibility criteria:
inclusion criteria: * 50 to 80 years of age * diagnosis of prodromal/mild cognitive impairment (mci) due to alzheimer's disease (ad) or mild ad according to national institute of aging-alzheimer's association (nia-aa) * a global clinical dementia rating (cdr) score of 0.5 to 1.0 and cdr-memory box (cdrmb) score ≥0.5 at screening and baseline * score of ≤85 for the delayed recall domain of the repeatable battery for the assessment of neuropsychological status (rbans) at screening * mini-mental state examination (mmse) score ≥20 at screening * participant has an identified informant that has and will maintain sufficient contact (minimum of 5 hours per week) with the participant to be able to provide accurate information on the participant's cognitive, functional, and emotional states and of the participant's personal care * at least 6 years of formal education after the age of 5 or work experience to exclude mental deficits other than prodromal or mild ad dementia * evidence of cerebral aβ accumulation by either positive amyloid assessment by either positron emission tomography (pet) scan or cerebrospinal fluid ptau181/aβ1-42 ratio assessment exclusion criteria: * any evidence of a condition that may affect cognition other than ad * contraindications to pet imaging * inability to tolerate or contraindication to magnetic resonance imaging * any serious medical condition or abnormality that in the opinion of the investigator would preclude safe participation in and completion of the study or interfere with study assessments and/or study interpretation * alcohol or drug abuse within 2 years of screening * use of any experimental therapy within the past 6 months (or 5 half lives) prior to screening * previous treatment with medication intended to treat a neurodegenerative disorder (other than ad) within 1 year of screening * chronic daily treatment with atypical antipsychotics, opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally acting antihistamine or anticholinergic activitiy * received treatment with monoclonal antibodies (mabs), cytokines, immunoglobulins, or other blood products within 3 months or 5 half-lives (whichever is longer) prior to first dosing

Keywords: alzheimer's disease bepranemab ucb0107 phase 2
assessment of maxillary stability in bimaxillary orthognathic patients using the inverted sequence approach

Conditions: Class III Malocclusion

Summary: the investigator will assess the inverted sequence approach in the treatment of class iii patient undergoing bimaxillary orthognathic surgery

the investigator will compare the maxillary stability in class iii orthognathic patients undergoing bimaxillary surgery by two surgical approaches ; the mandible-first (intervention) and the maxilla-first (control)

Eligibility criteria:
inclusion criteria: 1. patients with skeletal class iii malocclusion requiring bimaxillary orthognathic surgery 2. patients free from any systemic disease 3. patients who approved to be included in the trial and signed the informed consent 4. patients with no signs or symptoms of temporomandibular disorders. exclusion criteria: 1. patients with cleft lip and palate "can have an unfavorable effect on facial growth (larry m. wolford, 2002)" 2. patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing (jw, 2003) " 3. patients who refused to be included in the trial
treatment of chronic back pain with focused vibroacoustic stimulation

Conditions: Back Pain

Summary: chronic back and neck pain is the most common chronic condition worldwide. unfortunately, the current available treatment options are limited and largely unsuccessful, which is considered as one of the primary drivers for the high cost of back pain management. systematic reviews show that the results of common treatments including pain medications, surgery, exercise and psychological therapies for back pain demonstrate inconsistent results and moderate improvement. therefore, non-invasive adjunct therapies can be a useful addition to traditional back pain management. focused vibroacoustic treatment for back and neck pain is a non-invasive procedure that applies low frequency sound waves to the spine (50hz-110hz), and has shown consistent and positive results in early clinical and animal studies. the goal of this project is to test vibroacoustic sound waves delivered to the spine in a double blind randomized controlled trial to demonstrate the efficacy of focused vibroacoustics in treating chronic back pain. participants with back pain will be recruited and divided into a treatment and placebo group and will undergo treatment at a clinic over a one month period. outcome measures will be collected before and after the intervention period. placebo participants will be offered the full treatment without charge after the experiment is over.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic low back pain with a disease duration of more than 3 months (further diagnostic results were not required) * aged 18-75. * scored at least 4/10 in pain scale (vas or numerical) * written consent exclusion criteria: * acute back pain (\< 4 weeks) * history of spinal or vertebral surgery * history of any vertebral or spinal infection * history of significant trauma related to the spine * history of iv drug use * history of malignancy * congenital deformation of the spine (except mild scoliosis or kyphosis) * pregnancy * previous kkt treatment * undergoing concurrent treatment unable to complete all 12 treatment sessions due to travel, distance or transportation issues, etc.
the mutation profile and prognosis in aml with idh1/2 mutation

Conditions: AML

Summary: we have a prospective clinical cohort including 500 adult aml patients. and we have stored leukemia sample from these patients. in this program we will do mutation profile in these patients. also, we will elucidate the incidence of idh1/2 mutations in adult aml in china and elucidate the prognostic effect of idh1/2 mutation in aml.

in this program, first, we want to uncover mutation profiles in the 500 aml patients including aml1-eto cbfb-myh11, mll translocation, npm1, flt3, dnmt3a, cebpa, tet2, asxl1, u2af2, tp53, c-kit, runx1, nras, kras, ptpn11 genetic alteration in addition to idh1/2 mutation. these patients received regimen, which is consistent with nccn and eln guidelines. npm1, flt3, dnmt3a, cebpa, tet2, asxl1, u2af2, tp53, c-kit, runx1, nras, kras, ptpn11, and idh1/2 genetic alteration will be detected by targeted next generation sequencing. aml1-eto and cbfb-myh11 will be detected by rt-pcr. mll translocation will be detected by fish(fluorescence in situ hybridization).next, we will elucidate the incidence of idh1/2 mutations in adult aml in china. then we will investigate mutation profile in idh1/2 mutation aml patients. finally, we will elucidate the prognostic effect of idh1/2 mutation in aml. at last, we will instigate how mutation profile affects the prognosis in idh1/2 mutation aml patients.

Eligibility criteria:
inclusion criteria: 1. age of less than 60 years old; 2. patients that meet the diagnostic criteria(who 2008 criteria) of aml (except apl subtypes). 3. adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. patients under 18 years old willing to participate should have their legal guardians sign the informed consent. exclusion criteria: 1. patients with other blood diseases(for example, haemophiliacs) are excluded. 2. with mutation of breakpoint cluster region-abelson(bcr-abl) fusion gene and in need of tyrosine kinase inhibitors therapy; 3. acute panmyelosis with myelofibrosis and myeloid sarcoma patients; 4. had other malignant tumor in need of treatment; 5. patients with other factors which were considered unsuitable to participate in the study by the investigators.
fard (radico cohort) (radico-fard)

Conditions: Inherited Epidermolysis Bullosa; Ichthyosis; Ectodermal Dysplasia; Incontinentia Pigmenti; Neurofibromatosis Type 1; Albinism; Pemphigus; Mucous Membrane Pemphigoid; Palmoplantar Keratoderma

Summary: the goal of this observational study is to conduct a prospective assessment of the individual burden of 9 rare skin diseases to assess disability in the broadest sense of the term (psychological, social, economic and physical) for patients and/or families. two types of indicators will be used to reach this objective : 1. an individual burden score calculated based on a burden questionnaire created specifically, approved and designed to understand the tendency to changes in care and lifestyles. the burden questionnaire should be used by patients and/or their family themselves in self-assessment. 2. a descriptive analysis of all resources (medical and non-medical) used by the family unit to manage the disease.


Eligibility criteria:
inclusion criteria : * adults or children with a confirmed diagnosis of one of the 9 following rare skin disease: inherited epidermolysis bullosa, ichthyosis, ectodermal dysplasia, incontinetia pigmenti, neurofibromatosis type 1, albinism, pemphigus, mucous membrane pemphigoid or palmoplantar keratoderma. * prevalent or incident and followed in one the reference/competence centers of the fimarad healthcare network, * able to understand a survey (for child, survey should be understood by parents), * having given their signed consent to participate to the cohort radico-fard (parents' consent for child). non-inclusion criteria : * patients, for whom regular care follow-up is not feasible with the fimarad healthcare network sites, * unconfirmed diagnosis (according to criteria for each disease), * patients (and/or parents) not able to understand a survey * patients (and/or parents) not having given their signed consent to participate to the study
cxcl2/cxcl8 promote intervertebral disc degeneration

Conditions: Cytokine; Intervertebral Disc, Degenerative

Summary: low back pain (lbp) is the largest cause of morbidity in the world, and about 80% of chinese people are affected in their lifetime. although the prevalence of idd gradually increases with age, idd is very common among subjects under 30 years old. in addition to age, there are other factors, such as excessive or uneven mechanical load, obesity, genetics, nutrition, trauma and gender. in addition, it is not clear whether the heavy physical load associated with occupation is an important risk factor for idd. some studies have found that idd is more common among athletes than the general population. due to the complexity and multifactorial nature of idd, its pathogenesis and risk factors are still unclear, which seriously hinders the rational stratification of lbp patients and limits the development of personalized treatment.


Eligibility criteria:
inclusion criteria: * it meets the diagnostic criteria of lumbar disc degeneration; no previous history of spinal surgery; good ability of independent behavior and cooperation in completing research; the patient is aware of this study and has signed the consent form. exclusion criteria: * patients with spinal tumor, infection, tuberculosis and other diseases; patients with claustrophobia; parkinson's syndrome patients; poor cooperation, poor image quality; patients with osteoporosis.

Keywords: cytokine chemokine intervertebral disc degeneration
improving compliance with metformin

Conditions: Diabetes

Summary: this is a randomized controlled trial of adherence. the study involves monitoring and managing focused intervention in patients prescribed metformin.

the active intervention, mems feedback, involves review of patients' medication-taking over the preceding weeks

Eligibility criteria:
inclusion criteria: * metformin has been prescribed * willing to use medication containers with mems caps * capable of giving informed consent exclusion criteria:

Keywords: compliance mems metformin
quality of life in asthmatic children at school age

Conditions: Asthma

Summary: asthma is the most common chronic disease in childhood \[1\]. the advantage of an educational program in a global strategy of care has been established in asthma (decrease of nocturnal asthma, absence from work and school) \[2, 3\]. therapeutic education of the patient permits the reduction of the rate of hospitalization, of the rate of emergencies visits and non-programmed visits. \[3\]. the who defines quality of life as an individual's perception of its place in existence, in the context of culture and value system in which he lives, in relation to its objectives, expectations, standards and concerns \[4\]. the basic point of this concept is the notion of perception, emphasizing the perspective of the person. it is a broad concept affected in a complex way by the subject's physical health, psychological state, level of independence, social relationships, and its relations with its environment. in the field of health, analyzing the quality of life includes objective aspects (living conditions, functional health) and subjective aspects (satisfaction, happiness, well-being) that allow to understand the situation of people in whole. as defined by the who-europe report published in 1996 \[5\], the therapeutic education aims to help patients acquire or maintain the competencies they need to best manage their lives with a chronic disease. it is entirely part of the management of the patient. it includes organized activities designed to make patients aware and informed of their disease, of care organization and hospital procedures, and the behaviors related to health and disease. this is to help them and their families understand their illness and treatment, to work together and to gain autonomy from their disease in order to help maintain and improve their quality of life \[6\]. however, studies demonstrating the effectiveness of therapeutic patient education are still very few, especially in children. the need for prospective studies including the evaluation of the impact on quality of life was highlighted in a recent cochrane meta-analysis \[7\]. it seems interesting for the authors to assess the improvement of the quality of life after educational sessions in children at school-age.

longitudinal prospective study

Eligibility criteria:
inclusion criteria: * school-aged (from 5 to 10 years old) asthmatic children consulting for the first time a paediatric pulmonologist exclusion criteria: * other non-atopic chronic disease

Keywords: asthma educational program quality of life school-aged children
multimodal imaging assessment of the inflammatory atheromatous plaque

Conditions: Inflammation; Atheromatous Plaques; Carotid Artery Diseases

Summary: the present study aims at assessing the ability of 68ga-nodaga-rgd pet/ct for the detection of inflammatory atheromatous plaques in the carotid arteries, compared to 18f-fdg pet/ct, mri and us and to determine the contribution of each imaging technique. current gold standard for inflammation is histopathology. hypothesis : 68ga-nodaga-rgd might give a better initial evaluation of patients with atheromatous plaques in the carotid artery eligible for endarterectomy.

patients with indication for endarterectomy will be presented the present protocol. if inclusion criteria are fulfilled, patients will have a 18f-fdg pet/ct + carotid us performed 6 to 2 days before endarterectomy and 68ga-nodaga-rgd pet/ct + mri performed the day before endarterectomy. histopathological sample will be analyzed to measure plaque inflammation. all imaging results and histopathology results will be pooled and compared.

Eligibility criteria:
inclusion criteria: * age \<= 85 years * karnofsky \>= 80% * patient with indication ofr carotid endarterectomy * signed consent form exclusion criteria: * indication for surgery other than endarterectomy \<14 days * contraindication to surgery * contraindication to mri * contraindication to gadolinium injection (stage 4/5 kidney insufficiency, gfr\<30ml/min/1.73m2) * pregnancy, breastfeeding * lack of discernment

Keywords: pet/ct 68ga-nodaga-rgd 18f-fdg mri us ultrasound inflammatory atheromatous plaque endarterectomy
effects of a supplement containing fucoidan on basal body temperature

Conditions: Low Basal Body Temperature

Summary: we aim to determine whether a supplement containing fucoidan isolated from mekabu (sporophyll of undaria pinnatifida), epa, and dha has effects of elevating basal body temperature in subjects with low basal body temperature.


Eligibility criteria:
inclusion criteria: * postmenopausal women with basal body temperature \< 36.0 ºc * healthy as based on medical history and physical examination * willing not to donate blood during the study * informed consent signed exclusion criteria: * renal or hepatic dysfunction * heart disease * participation in any clinical trial within 90 days of the commencement of the trial * subjects who are taking medicines or functional food that may affect basal body temperature
aromasin® interventional study of early invasive breast cancer patients in china

Conditions: Breast Neoplasms

Summary: aromasin® (exemestane) was approved in china for adjuvant treatment of postmenopausal women with estrogen receptor (er) positive early invasive breast cancer who have received 2-3 years of tamoxifen \& are switched to aromasin® for completion of a total of 5 consecutive years of adjuvant hormonal therapy by state food and drug administration (sfda) with clinical trial waive. while aromasin® has been used in china for adjuvant therapy of breast cancer since then, there is currently lack of systematic collection and analysis for the efficacy and safety data of aromasin® adjuvant setting in chinese population. the aromasin® interventional study is being proposed to collect data systematically and to assess the efficacy and safety of aromasin® adjuvant setting in chinese population.

this is interventional study and single arm study. n/a

Eligibility criteria:
inclusion criteria: * early invasive breast cancer (t1-4n1-3m0) confirmed by histology or cytology. * er positive. * the patient must be postmenopausal woman. * the patient has received adjuvant tamoxifen therapy for up to 2-3 years and will switch to receive aromasin® treatment (the decision to prescribe aromasin® will necessarily precede and will be independent of the decision to enroll patients in the study). exclusion criteria: * following the adjuvant tamoxifen therapy for 2-3 years and prior to receiving aromasin® treatment, there is evidence of a local relapse or distant metastasis of breast cancer, or a second primary cancer. * following the adjuvant tamoxifen therapy for 2-3 years and received other aromatase inhibitors (not aromasin®).

Keywords: breast cancer aromasin adjuvant chemotherapy endocrine therapy
real-life use of niraparib in a patient access program in norway

Conditions: Ovarian Cancer; Peritoneal Cancer

Summary: retrospective observational study of patients treated with niraparib in an individual patient access program in norway.

poly (adp-ribose) polymerase (parp) inhibitors have emerged as new treatment options in ovarian cancer. while there is now also evidence for the efficacy in the first line setting, they were initially studied in recurrent disease both as maintenance after chemotherapy but also as treatment on its own. the nova study was conducted in the maintenance setting of patients with recurrent high-grade serous ovarian-, tube or peritoneal cancer who had responded to platinum-based chemotherapy. in 2017 tesaro opened an individual patient access program in norway, and in july 2017 the first norwegian patient was enrolled. we performed a retrospective observational study of patients treated with niraparib in the individual patient access program in norway. the objective of the study is to provide preliminary efficacy and safety data in a rather unselected population of non-gbrca patients with recurrent ovarian-, tube-, or peritoneal cancer.

Eligibility criteria:
inclusion criteria: * patients enrolled in the individual patient access program since 2017. * patients who have received at least one dose of niraparib will be included. * patients will be identified and recruited from the following participating sites: oslo university hospital, haukeland university hospital, stavanger university hospital, st. olavs hospital, university hospital of northern norway and sørlandet sykehus.

Keywords: poly(adp-ribose) polymerase inhibitors real life data ovarian cancer niraparib
different doses of sevoflurane during induction of anesthesia on emergence delirium in children

Conditions: Delirium

Summary: the investigators aim to reduce the incidence of emergence delirium in children aged 2-7 years old by using two different doses of sevoflurane during inhalatory induction of anesthesia.

sevoflurane is an inhalational agent widely used in general anesthesia, both for induction and maintenance of anesthesia. it is not irritative on the airways and has a pleasant smell. within their properties are: low partition coefficient blood / gas (rapid induction and awakening), low heart, liver and kidney toxicity. inhalational induction in pediatric anesthesia with this agent is frequent to avoid vein puncture in awake patients and is generally done with maximum doses available to obtain a fast loss of consciousness. emergence delirium (ed) is frequent in children. it is defined as a mental disorder during recovery from general anesthesia that may include hallucinations, delusions and confusion expressed by crying, restlessness and involuntary physical activity. it usually lasts for 30 minutes and is not necessarily related to pain. during this episodes, children can hurt themselves or others, lose vascular catheters or other invasive devices. ed can generate anxiety and stress in caretakers, delay transfer from post-anesthesia care units (pacu), increase costs of medical attention and increase use of opioids or other sedatives. many interventions have been used to decrease the appearance of ed such as dexmedetomidine, clonidine, benzodiazepines, propofol among others but with no consistent results. the use of sevoflurane has been linked with ed in children and it can induce seizures in high doses (over 2 mac). the aim of this study is to test whether using a lower dose of sevoflurane (5%) during induction of anesthesia in children results in less ed than using higher doses (8%).

Eligibility criteria:
inclusion criteria: * surgery with caudal block: circumcision (phimosis), hernioplasty (inguinal hernia) * american society of anesthesiologists (asa) classification of i or ii exclusion criteria: * use of total intravenous anesthesia (tiva) * familiar or personal history of malignant hyperthermia * contraindication to caudal block * parents or legal guardians do not sign informed consent

Keywords: emergence delirium sevoflurane pediatric anesthesia
dermoscopy and histopathology in non-melanocytic skin tumors

Conditions: Non-melanoma Skin Cancer

Summary: the main aim of the study is to investigate the relation between dermoscopic findings in pre-operative diagnosis of non-melanocytic skin tumors and post-operative histopathology findings .


Eligibility criteria:
inclusion criteria: * all patients with nmst clinically of both genders in all ages with positive dermoscopic findings and definite histopathologic diagnosis of nmst exclusion criteria: * no exclusion criteria