Kornimate/medical-research-clean huggingface dataset:
study of ag-120 and ag-881 in subjects with low grade glioma

Conditions: Glioma

Summary: study to evaluate the suppression of 2-hg (2-hydroxyglutarate) in idh-1 mutant gliomas in resected tumor tissue following pre-surgical treatment with ag-120 or ag-881.

a phase-1, multi-center study in recurrent non-enhancing gliomas with idh1 r132h mutation for patients who require surgery. the purpose of this study is to evaluate the suppression of 2-hg by comparing the concentration of 2-hg in resected tumors from idh1 mutant glioma subjects following ag-120 or ag-881 treatment with the 2-hg concentration in untreated, control tumors. the safety, tolerability, pk/pd, and anti tumor activity data from the study in subjects with recurrent non-enhancing grade 2/3 lgg with an idh1 r132h mutation for whom surgical resection is indicated will identify the recommended dose of ag-120 and ag-881 for future studies in glioma.

Eligibility criteria:
inclusion criteria: 1. be ≥18 years of age. 2. have histologically or cytologically confirmed recurrent grade 2 or 3 lgg (oligodendroglioma or astrocytoma according to world health organization 2016 classification). 3. have documented idh1 r132h gene mutation by local testing and known 1p19q or atrx mutation status by local testing. 4. have central confirmation of primarily non-enhancing disease by mri with less than or equal to 5 mm slice thickness and up to 1 mm interslice gap on either 2d t2 weighted image, 3d t2 weighted image, or flair, with at least 1 non-enhancing tumor measuring 1×1×1 cm. 5. be candidates for clinical resection but for whom surgery is not urgently indicated (eg, for whom surgery within the next 2-4 months is appropriate). 6. have kps of ≥60% 7. have expected survival of ≥12 months. exclusion criteria: 1. have received prior systemic anti-cancer therapy within 1 month of the first dose of ag-120 or ag-881 or have received an investigational agent \<14 days prior to their first dose of ag-120 or ag-881. in addition, the first dose of ag-120 or ag-881 should not occur before a period of ≥5 half-lives of the investigational agent has elapsed. 2. have had radiation within 6 months of the first dose of ag-120 or ag-881. (note: prior biopsy or surgery is allowed.) 3. have received any prior treatment with an idh inhibitor. 4. have received any prior treatment with bevacizumab (avastin).

Keywords: glioma idh1 ag-120 ag-881
vitamin a with bcg vaccine

Conditions: Mortality; Morbidity

Summary: two studies from asia have suggested a beneficial effect of vitamin a supplementation given at birth. hypotheses: vitamin a supplementation administered at birth together with bcg vaccination is associated with a 30% reduction in infant mortality and morbidity during the first year of life in normal birth weight children in an african setting.

vitamin a deficiency is common in low-income countries. vitamin a supplementation to children above 6 months of age reduces all-cause mortality with 23 % to 30 %. studies on vitamin a supplementation in infants younger than 6 months of age have reported inconsistent effects on mortality. studies providing supplementation between 1 and 5 months of age have found no effect or even a negative effect. however, the only two studies of supplementation at birth, both conducted in asia, showed substantial significant reductions in infant all-cause mortality. the beneficial effect of neonatal vitamin a supplementation may be a result of correcting the congenital vitamin a deficiency resulting from maternal vitamin a deficiency. on the other hand, it has been speculated that the beneficial effect of vitamin a supplementation given at birth may in part be explained by a synergistic effect of vitamin a supplementation and bcg vaccination given at the time of birth. the protective effect on mortality of vitamin a supplementation given at birth needs to be confirmed in an african population. furthermore, none of the two previous studies have reported data on vaccination status of the included infants. in this study, the effect on mortality and morbidity of given vitamin a supplementation simultaneously with bcg vaccination at birth to normal birth weight infants will be investigated in an african population. furthermore, the effects of vitamin a supplementation will be evaluated with respect to effect on growth, the response to bcg vaccination, infant vitamin a status and infant cytokine profile. furthermore the effect on specific diseases such as malaria, measles and rotavirus infections. the mechanisms behind the effects of vitamin a will be evaluated. we will include 4,800 normal birth weight infants (\> 2500 g) infants randomized to 50,000 iu of vitamin a or placebo given simultaneously with bcg vaccine. the study take place in guinea-bissau, west africa. the study area consists of five districts in the capital of guinea-bissau. the bandim health project has been working in the study area for almost 25 years, and a demographic surveillance system has been established and functioned for many years.

Eligibility criteria:
inclusion criteria: belonging to the study area exclusion criteria:overt illness, signs of vitamin a deficiency, previous bcg vaccination

Keywords: vitamin a bcg infant mortality morbidity low-income country
effect of social isolation on physical activity level, and kinesophobia in heart rhythm disorders during pandemic

Conditions: Heart Rhythm Disorder; Covid19; Social Isolation

Summary: the aim of our study is to examine the effect of social isolation on physical activity level, health literacy and kinesophobia in heart rhythm disorders.

to prevent the spread of covid-19, states are imposing quarantine measures and sanctions for all citizens to stay at home as much as possible. these measures severely limit physical activity. it is known that physical activity is an important preventive approach for many preventable diseases, especially cardiovascular diseases. restriction of physical activity, loss of usual routine, and reduced social and physical contact with others can cause feelings of distress, disappointment, and isolation. in the latest guidelines, increasing physical activity is recommended to prevent heart rhythm disorders and contribute to the effectiveness of treatment. the aim of our study is to examine the effect of social isolation on physical activity level, health literacy, and kinesophobia in heart rhythm disorders.

Eligibility criteria:
inclusion criteria: * having been diagnosed with heart rhythm disorders * being clinically stable * to comply with social isolation rules * volunteering to participate in the research exclusion criteria: * having a cognitive problem * not being literate

Keywords: heart rhythm disorder physical activity kinesophobia health literacy
study to evaluate the safety, pharmacokinetics and efficacy of sti-2020 (covi-amg™) in outpatients with covid-19

Conditions: Covid19

Summary: this is a randomized, placebo-controlled study to assess the safety, pk profile, and efficacy of covi-amg in subjects with covid-19.

this is a multi-center, randomized, double-blind, placebo-controlled study followed by an expansion cohort phase designed to investigate the safety, pk profile, and efficacy of a single injection of covi-amg in outpatient subjects with covid-19 but are not likely to require hospital admission within 24 hours. subjects will receive one of the following treatments: 40 mg covi-amg, 100 mg covi-amg, 200 mg covi-amg, or placebo. subjects will be followed for 60 days after dosing.

Eligibility criteria:
inclusion criteria: * must be covid-19 positive by rt-pcr or an equivalent test, using an appropriate sample such as nasopharyngeal \[np\], nasal, oropharyngeal \[op\], or salivary) ≤ 72 hours prior to randomization. a historical record of positive result from test conducted ≤ 72 hours prior to randomization is acceptable if it can be documented. * must be asymptomatic or have mild symptoms but not requiring imminent (within 24h) hospitalization. * must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by this protocol. * subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity. exclusion criteria: * have a documented infection other than covid-19 that requires systemic treatment or in the investigator's opinion could interfere with the participant's safety or interfere with the assessments if enrolled in the study. * have any medical condition that, in the investigator's opinion, could adversely impact safety. * be pregnant or lactating and breast feeding * has participated, or is participating, in a clinical research study evaluating covid-19 convalescent plasma, monoclonal antibodies (mabs) against sars-cov-2, or intravenous immunoglobulin (ivig) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit. note: subjects who have been prescribed hydroxychloroquine or chloroquine with or without azithromycin or other approved products for the off-label treatment of covid-19 prior to study enrollment may be included and may continue to receive these agents so long as the dose remains stable. additionally, any approved or authorized treatment (e.g., remdesivir, dexamethasone or treatments approved under an emergency use authorization) is allowed.

Keywords: covid-19
treatment of postoperative delirium with continuous theta burst stimulation

Conditions: Postoperative Delirium

Summary: to determine whether continuous theta burst stimulation can cure postoperative delirium in senior patients.

postoperative delirium(pod), a syndrome characterized by an acute change in attention, awareness and cognition, is one of the most common postoperative complications among elderly patients. impaired neuronal network connectivity is likely one of the several neurobiological processes that contribute to pod pathogenesis. recently, continuous theta burst stimulation (ctbs) was demonstrated to improve cognitive function in patients with mild cognitive impairment.recent research suggests that ctbs has positive effect on improving the connectivity and reorganization of the brain network. therefore, we plan to conduct an exploratory study in participants undergoing elective surgeries to determine whether ctbs can cure pod in this senior patient population.

Eligibility criteria:
inclusion criteria: * aged between 60 to 80 years; * having delirium after elective surgery; * being able to complete cognitive assessment and confusion assessment methods (cam); * willing to participate before surgery and being competent to provide informed consent. exclusion criteria: * having brain tumor, stroke, or mental disorders (e.g., depression or dementia); * having contraindications of ctbs (e.g., head trauma, history of epilepsy or metal implants in the head or heart); * participating in other clinical studies.
evaluation of topical riboflavin exposed to uva radiation and implantation of corneal ring

Conditions: Keratoconus

Summary: the purpose of this study is to postpone the corneal transplantation in keratoconus and promote the stiffness of the cornea across the riboflavin-uva corneal collagen crosslinking , and after, corneal ring surgery.

keratoconus is a progressive disease where cornea is thin and has a higher curvature.in early conditions, it may be corrected by glasses or contact lens.when these possibilities are not more possibles, it may be corrected by corneal ring surgery ore corneal transplantation depending your degree. in this study, the patients with a degree of keratoconus on i or ii, will be submitted to corneal collagen crosslinking and then a corneal ring surgery. the corneal collagen crosslinking promote the stiffness of the cornea across the riboflavin-uva irradiation, avoid the progression of the keratoconus.after three months of crosslinking, these patients will be submitted a corneal ring surgery. these patients will be allowed by two years and various exams will realized them.

Eligibility criteria:
inclusion criteria: * patients with keratoconus * patients that aren't using contact lenses * pachymetry more than 400um * best visual acuity less or equal 20/30 exclusion criteria: * ocular surgeries before * other eye diseases * corneal curvature more than 65 dioptres

Keywords: keratoconus riboflavin cornea crosslinking
study of temozolomide in the treatment of brain metastasis from non-small-cell lung cancer (study p02143)

Conditions: Metastases, Neoplasm; Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Summary: brain metastases from solid tumors are diagnosed in more than 300,000 patients annually. nonsmall cell lung cancer accounts for the majority of cns mets. treatment with whole brain radiation and steroids will improve neurologic symptoms in about 50% of patients although survival is short. this study will test the safety and efficacy of temozolomide in combination with radiation therapy in the treatment of patients with brain mets form nonsmall cell lung cancer.


Eligibility criteria:
inclusion criteria: * histologic confirmation of non-small-cell lung cancer * stable systemic disease * maximum of one prior chemotherapy regimen for metastatic systemic disease * radiotherapy for local control or palliative bony lesions is allowed * karnofsky of greater than or equal to 70% * adequate hematologic, renal and liver function exclusion criteria: * patients eligible for surgery of the brain * any previous chemotherapy for the brain metastasis * chemotherapy within 4 weeks or previous temozolomide * prior radiotherapy to the brain * radiation therapy to greater than 50% of the bone marrow * insufficient recovery from previous therapies * active nonmalignant systemic disease * inability to take oral medication * pregnant or nursing women * non use of adequate contraceptive techniques, negative urine pregnancy test is required * known aids related illness

Keywords: brain mets non-small cell lung cancer
immunotherapy with autologous dexosomes for patients with stage iv melanoma

Conditions: Melanoma

Summary: the objective is to determine the safety and efficacy of dexosome immunotherapy in patients with stage iv malignant melanoma


Eligibility criteria:
* patients with stage iv metastatic melanoma with 0-1 prior treatments for metastatic disease. * all patients must have distant skin, subcutaneous, or nodal metastases (m1a) or lung metastases (m1b), measurable disease, normal lactate dehydrogenase levels, and hla type a1, a2, or b35. * patients must have adequate organ function and an estimated life expectancy of at least 3 months.
continuous positive airway pressure (cpap) treatment in coronary artery disease and sleep apnea

Conditions: Coronary Artery Disease; Obstructive Sleep Apnea

Summary: obstructive sleep apnea (osa) worsens the prognosis in patients with coronary artery disease (cad). many of these subjects do not report daytime sleepiness, and therefore, are not considered for osa treatment with continuous positive airway pressure (cpap). there is lack of evidence regarding the impact of cpap on the long-term prognosis of cad patients with osa. the randomized intervention with cpap in cad and osa (riccadsa) trial is designed to address if cpap treatment reduces the combined rate of new revascularization, myocardial infarction, stroke and cardiovascular mortality over mean follow-up period of 3-years in cad patients with osa without daytime sleepiness.secondary outcomes include cardiovascular biomarkers, cardiac function, maximal exercise capacity and quality of life at baseline, 3-month- and 1-year follow-up as well as polysomnographic findings and adherence to cpap therapy.

rationale: osa is a common condition in cad with a poor prognosis.many of these subjects do not report daytime sleepiness, and therefore, are not considered for osa treatment with cpap. there is lack of evidence regarding the impact of cpap on the long-term prognosis of cad patients with osa. objective: the riccadsa trial is designed to address if cpap treatment reduces the combined rate of new revascularization, myocardial infarction, stroke and cardiovascular mortality over a mean follow-up period of 3-years in cad patients with osa (apnea-hypopnea-index \[ahi\]\>=15 per h) without daytime sleepiness (epworth sleepiness scale \[ess\]\<10). secondary outcomes include cardiovascular biomarkers, cardiac function, maximal exercise capacity and quality of life at baseline, 3-month- and 1-year follow-up as well as polysomnographic findings and adherence to cpap therapy. patients and methods: a sample of 511 cad patients (122 non-sleepy osa patients randomized to cpap, 122 to non-cpap; 155 sleepy osa patients \[ess\>=10\] on cpap, and 112 cad patients without osa \[ahi \<5 per h\]) were included. the trial has 80% power to detect a risk reduction from an assumed composite end-point rate of 25% to 12% for the primary outcome at intention-to-treat basis.

Eligibility criteria:
inclusion criteria: * patients with angiographically-verified cad who have newly undergone pci or cabg treatment * written, informed study consent * osa (ahi\>=15 per hour) or non-osa (ahi\<5 per hour) diagnosis on the unattended sleep recording at home exclusion criteria: * patients with already treated osas * patients presenting mainly central apneas (cheynes-stokes breathing) * patients with borderline osa (ahi \ =5 per hour) upon the unattended sleep recording at home

Keywords: coronary artery disease sleep apnea cpap revascularization mortality
neonatal resuscitation in zambia

Conditions: Asphyxia Neonatorum; Neonatal Mortality; Hypoxic Ischemic Encephalopathy

Summary: asphyxia is a leading cause of neonatal death in zambia. this study will be conducted in two cities in zambia to determine if the combined neonatal resuscitation program/essential newborn care program compared to the new world health organization (w.h.o.) basic perinatal care education of health care providers (essential newborn care program) results in reduced mortality due to perinatal asphyxia.

birth asphyxia (defined as "failure to initiate and sustain breathing at birth") has been identified by the world health organization (who) as the most frequent cause of early deaths worldwide, accounting for about 20% of neonatal mortality. although prompt resuscitation after birth can prevent many of the deaths and reduce disabilities in survivors from birth asphyxia, the who has concluded that resuscitation is often not initiated or the methods used are inadequate or wrong. the neonatal resuscitation program (nrp) has been universally accepted in the developed world but has had limited dissemination in many developing countries, including zambia. the primary hypothesis of this study is that implementation of the combined neonatal resuscitation program/who essential newborn care (enc) program, compared to basic neonatal care education of health care providers (enc only) will result in reduced neonatal 7-day mortality. this trial will be performed in two zambian cities: lusaka and ndola. training in data collection will be conducted in order to establish baseline data on mortality and asphyxia. following this time period, all centers will receive the enc training and continue to collect data for 7 months. the clinics will then receive nrp training and collect data for a 12-month period. the primary outcome will be a decrease in neonatal 7-day mortality following the nrp training when compared to the enc-only time period. secondary outcomes will include neonatal mortality due to perinatal asphyxia, mortality or hypoxic ischemic encephalopathy (hie) at 7 days, need for advanced resuscitation, apgar scores at 5 minutes, sustainability of the program, as well as providers' self efficacy, competence, and performance in neonatal resuscitation.

Eligibility criteria:
inclusion criteria: * live birth infants with birth weight ≥ 1500 g * infants who are born at participating health centers in lusaka and ndola, zambia * no lethal malformations exclusion criteria: * stillbirths * infants with suspected/confirmed lethal malformations (e.g. anencephaly, trisomy 13 or 18, or cyanotic or left sided congenital heart disease that will not be repaired) * any infant who is transported/brought to the center after delivery

Keywords: asphyxia neonatal mortality neonatal morbidity hypoxic ischemic encephalopathy neurodevelopmental impairment neonatal resuscitation global network zambia africa cerebral palsy child health international
zincoxide-propolis vs zincoxide-eugenol pulpectomy

Conditions: Pulp Necroses

Summary: the clinical trial aims to evaluate the clinical and radiographic success of zinc oxide- propolis versus zinc oxide -eugenol as obturating material in pulpectomy of non-vital primary teeth.

pulpectomy is considered the most convenient way to treat the non-vital primary teeth as it preserves the affected tooth to maintain the length and integrity of the dental arch until exfoliation4. zinc oxide-eugenol cement (zoe) has been used as a root canal filling material for primary teeth and has long been the material of choice of pediatric dentists worldwide, although it fails to meet the ideal requirements of root canal filling material for primary teeth due to limited antimicrobial action, and a slower rate of resorption than the roots of the primary teeth. concerns about these drawbacks of zoe directed to search for alternative obturating materials for primary teeth. propolis, a natural resinous substance, is collected by honey bees with potent antimicrobial and anti-inflammatory properties. the main chemical constituents present in propolis are flavonoids, phenolics, and other aromatic compounds. considering these beneficial effects of propolis, a zinc oxide-propolis mixture is suggested to increase the survival rate and improve the treatment prognosis of non-vital primary teeth.

Eligibility criteria:
inclusion criteria: * children 4-6 years * non-vital primary molars * teeth with radiographic evidence of minimum bone loss. exclusion criteria: * primary molars with less than two-thirds of the remaining root length * molars demonstrating extensive external or internal resorption, * teeth exhibiting greater than grade i mobility * non-restorable with stainless steel * children whose parents or caregivers did not give consent for the study
safety and efficacy of dnk333 in atopic dermatitis patients

Conditions: Pruritus in Patients With Atopic Dermatitis

Summary: this study will assess the safety and efficacy of dnk333 in patients with atopic dermatitis suffering from pruritus, who require systemic treatment of the disease.


Eligibility criteria:
inclusion criteria: * male and female atopic dermatitis patients,18 to 60 years of age inclusive, who fulfill the following criteria: * requirement of systemic therapy * itch vas score higher than 50 mm * easi score higher than 8 exclusion criteria: * women of child-bearing potential who are not willing to use two highly effective methods of contraception are not allowed in the study. similarly, men who are not willing to use two acceptable methods of contraception are not allowed in the study. * any systemic immunosuppressive treatment and/or phototherapy within 4 weeks prior to the first dosing. * use of any systemic antihistamines or topical corticosteroids within one week prior to first dosing and for the duration of the treatment period. any other topical or oral treatment for atopic dermatitis (except emollients prescribed by the investigator) within 2 weeks prior to the first dosing will also be excluded. other protocol-defined inclusion/exclusion criteria may apply

Keywords: dermatitis inflammatory skin disease itch eczema