anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
###  Risk Summary

DRSP is present in human milk. After a single oral administration of 3 mg DRSP/0.03 mg EE tablets, DRSP concentration in breast milk over the 24-h period ranged from 1.4 to 7.0 ng/mL, with a mean ± standard deviation value of 3.7 ± 1.9 ng/mL. The estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose (see Data). There is limited information on the effects of drospirenone and ethinyl estradiol tablets on the breast-fed infant. CHCs can reduce milk production in breast¬-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding. [See also Dosage and Administration (2.2)]. 

The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for drospirenone and ethinyl estradiol tablets and any potential adverse effects on the breast-fed child from drospirenone and ethinyl estradiol tablets or from the underlying maternal condition. 

###  Data

####  Human Data

An open-label study evaluated the degree of DRSP transfer into milk within 72 hours following a single oral administration of 3 mg DRSP/0.03 mg EE tablets to 6 healthy lactating women who were 1 week to 3 months post¬-partum. DRSP was present in breast milk with a mean Cmax of 13.5 ng/mL, while the mean Cmax in serum of lactating women was 30.8 ng/mL. The DRSP concentration in breast milk over the 24-hour period following dosing ranged from 1.4 to 7.0 ng/mL, with a mean ± standard deviation value of 3.7 ± 1.9 ng/mL. Based on single dose data, the maximal daily infant dose of DRSP was calculated to be 0.003 mg/day, which represented a mean of 0.1% of the maternal dose.
The PBM therapy irradiance is about 0.60mW. It is asked subjects to look at the light binocularly with fusion through the pupils with natural pupils. The distance between the light and the pupils is about 5\~10cm. The treatment of each session is 3 minutes and twice daily administration while the interval time between two session is equal or larger than 4 hours with twice daily administration.
Despite significant advances in the prevention and treatment of stroke, it is still one of the leading causes of death and debilitating disease. Unfortunately, several neuroprotective strategies have failed in clinical trials. At present, it is reported that there are no pharmacological agents with putative neuroprotective actions that have demonstrated efficacy in improving outcomes after acute ischemic stroke (AIS) in humans. Previous stroke studies have confirmed that oxidative stress plays a vital role in stroke and in reperfusion following stroke. Therefore, the use of antioxidants could be a promising strategy for treating ischemia-reperfusion injury. Alpha-lipoic acid (aLA) is a potent antioxidant commonly used for the treatment of diabetic polyneuropathy (DPNP). The investigators previously demonstrated the neuroprotective and neurorestorative effects of aLA, mediated at least partially via insulin receptor activation, after cerebral ischemia in rats. Moreover, previous observational study of the investigators showed that patients with diabetes treated with aLA have better functional outcomes following AIS after reperfusion therapy than patients not using aLA.

Therefore, the investigators investigate whether patients with diabetes treated with aLA have better functional outcomes after AIS and reperfusion therapy than patients not treated with aLA in this prospective randomized trial.
Concussion, the mildest form of traumatic brain injury, is an important public health concern. Recent studies estimate that persistent post-concussion symptoms (PCS) are present in almost half of the affected citizens at one year post-injury. Prospective studies have demonstrated that these citizens are at risk of developing long-lasting symptoms which are associated with high societal burden due to long-term impact on labour market attachment and increased use of health care and social benefits. In Denmark, there has in recent years been an increasing awareness on societal impact and personal consequences of PCS. Accordingly, clinicians as well as social workers and therapists in the municipalities point to the gab in knowledge concerning PCS and advocate urgently for evidence-based treatment for these citizens. Recently, the research group behind this application developed a novel early intervention - "Get going After concussIoN" (GAIN 1.0) - for citizens who experience persistent PCS three to six months post-concussion. The intervention was tested in a randomized controlled trial (RCT) with promising results. However, it was delivered in a single hospital setting in which these citizens are normally not cared for. In this study the intention is to test the results of GAIN 1.0 in a larger RCT (GAIN 2.0) which takes place in the municipalities of Central Denmark Region where citizens live their daily lives and whose health- and social care systems support citizens who experience persisting PCS.
PROBLEM TO BE SOLVED: To obtain a preparation for external use for the skin extremely excellent in lipid degradation facilitative effect on fat cells and skin-roughening improvement effect by blending an extract from a specific seaweed with a specific compound. SOLUTION: This preparation for external use for the skin contains (A) an extract from Laminaria angustata, Undaria pinnatifida, Eucheuma muricatum, Phyllymenia sparsa or Enteromorpha linza and (B) a compound selected from serine, alanine or trimethyl glycine. As the component A, the extract extracted with water, a lower alcohol, 1,3-butylene glycol or the like is favorable. The components A and B are preferably blended in proportions of 0.01-10 wt.% in the dry basis and 0.005-10 wt.%, respectively, based on the whole weight of the preparation for external use for the skin. In addition to the above essential components, the component usually using as a preparation for external use for the skin, e.g. powder component, higher fatty acid, silicone, surfactant, moisturizer, ultraviolet ray absorbent or nutrition agent for the skin, can be blended.
BACKGROUND: We report four pediatric subjects with Cushing's disease (CD) diagnosed in the Czech Republic. We focus on initial symptoms of Cushing's syndrome (CS) which can lead to early diagnosis, on typical symptoms of CS in children, their age and sex distribution, the mean length of symptoms prior to diagnosis, indication for examination, post-cure growth, sexual development and pituitary function in our four CD patients after transsphenoidal pituitary surgery (TSS). We describe the diagnostic process leading to confirmation of CD and we emphasize the biochemical and radiological diagnostic difficulties.
CONCLUSIONS: Pediatric CD has a number of features distinct from adult CD. Our retrospective analysis confirmed the presence of growth retardation and change in facial appearance with development of moon face as the first symptoms of CS. According to our observation, growth retardation is prior to development of moon face. The other typical symptoms frequently seen in pediatric patients are pseudo-precocious puberty in both sexes, hirsutism in pubertal girls due to excessive adrenal androgen secretion and pubertal delay. A corticotropin-releasing hormone (CRH) test and especially bilateral inferior petrosal sinus sampling for ACTH (BIPSS) contribute to confirming the diagnosis of CD and excluding ectopic ACTH syndrome in children with unvisible adenoma on pituitary magnetic resonance imaging (MRI).
Matrix stiffness is a crucial factor in the tumor microenvironment, impacting tumor progression and development. TET2 is vital for epigenetic regulation in melanoma and is significantly reduced in advanced melanomas compared with nevi and thin melanomas. However, it is unclear how TET2 mediates the effect of matrix stiffness on melanoma cells. This study utilized A2058 cell lines and prepared different stiffness collagen hydrogels to evaluate TET2 overexpression (TET2OE) and mutant (TET2M) melanoma cells' activity, proliferation, and invasion. A2058 melanoma cells' viability and invasion decreased with increased matrix stiffness, with TET2OE cells experiencing a more significant impact than TET2M cells. Methylation analysis revealed that TET2 determines gene methylation levels, influencing cell-ECM interactions. Transcriptome analysis confirmed that TET2 promotes matrix stiffness's effect on melanoma cell fate. This research provides promising directions and opportunities for melanoma treatment.
The invention relates to a Chinese traditional medicine prescription used for insomnia, belonging to the technical field of Chinese traditional medicine. The prescription consists of 30 to 80g of liquorice, 20 to 50g of rhizoma ligustici wallichii, 20 to 50g of rhizoma anemarrhenae of, 40 to 70g of Tuckahoe, 100 to 300g of spina date seed and 20 to 50g of caulis spatholobi. The method is that the raw materials according to the prescription are mixed and ground into100 to 300 meshes to obtain the Chinese traditional medicine powder. The Chinese traditional medicine powder is added with honey with half of the weight of the powder to obtain Chinese traditional medicine honey cream which is made into the Chinese traditional medicine honeyed pill of 10g per pill. The Chinese traditional medicine powder is added with water to obtain the Chinese traditional medicine powder water cream to prepare the Chinese traditional medicine watered pill of 5g per pill after drying. The invention is used for the patients who suffer from insomnia; either a Chinese traditional medicine honey pill or a Chinese traditional medicine water pill is chosen and taken before every breakfast, lunch and supper. The invention has the advantages of good curative, short time, small dosage and low cost.
A system for presenting alternative therapy information to a patient and/or the patient's caregivers (e.g. loved ones, medical staff, etc.) includes a medication manager that keeps track of medications that need to be taken and the time at which the medication is to be taken. Both the patient and caregiver(s) are informed of what needs to be taken and when. After the patient acknowledges taking the medication, the caregivers are also notified. The alternative therapy is presented in such a way as to not disclose any confidential medical information regarding the patient so as to not violate any government rules or laws related to the release of patient information (e.g. complies with HIPPA). Therefore, the alternative therapy is provided in a “blind format,” in that, the advertiser does not know the identity of the patient or caregiver that is receiving/viewing the advertisements.
BACKGROUND: Epilepsy contributes to high morbidity among children and adolescents in developing countries. A quarter of all children with epilepsy will be resistant to anti-seizure medications (ASMs), with associated neurocognitive impairments and risk of higher mortality. This study aimed to estimate and characterize drug-resistant epilepsy (DRE) (defined as failure to achieve sustained remission after adequate trials of two tolerated and appropriately chosen ASMs) and its associated factors among children and adolescents with epilepsies attending the pediatric neurology clinic at Muhimbili National Hospital (MNH), Dar es Salaam Tanzania.
METHODS: This cross-sectional study was conducted from June 2020 to June 2021. Children with epilepsies and who had been treated with ASMs for at least 3 months were eligible for inclusion. Exclusion criteria included children whose caregivers denied consent and those who exhibited acute medical conditions necessitating admission on the scheduled visit day. Data on demographic characteristics, perinatal history, detailed history of the seizures semiology, drug history, magnetic resonance imaging (MRI), and electroencephalography (EEG) results were obtained from caregivers and medical records available during recruitment. Seizures and epilepsies were classified using the 2017 International League Against Epilepsy (ILAE) classification. Logistic regression was used to determine factors associated with DRE.
RESULTS: A total of 236 children and adolescents aged between 4 months and 15 years (Median age 72 months (IQR = 42-78)) were enrolled in this study. We found the proportion of DRE to be 14.8% in this cohort. Of the thirty-five patients with DRE, 60% had generalized epilepsy and almost 25% had a diagnosis of an epilepsy syndrome, the most common being Lennox-Gastaut syndrome (LGS). Structural abnormalities on brain MRI were seen in almost 80% of all patients with DRE, the most prevalent being cystic encephalomalacia, which was observed in 34% of patients. Patients using both ASMs and alternative therapies accounted for 9% of this cohort. The onset of seizures during the first month of life (aOR = 1.99; 95%CI 1.7-4.6; p = 0.031) and high initial seizure frequency (aOR = 3.6; 95%CI 1.6-8;p = 0.002) were found to be independently associated with DRE.
CONCLUSION: The proportion of DRE in Tanzania is high. Patients with neonatal onset seizures and high initial seizure frequency should be followed up closely to ensure early diagnosis of DRE.
Participants will be treated with Venlafaxine XR for 6 weeks. The dose of Venlafaxine XR will begin at 37.5 mg/day and be gradually increased to a maximum of 225 mg/day. The dose may be kept as low as 75 mg/day if necessary. Study doctor will be assessing mood to determine if some patients respond more quickly than the several weeks often required for an antidepressant to begin working. On the first day of treatment with Venlafaxine XR, participant will be randomly assigned (similar to a flip of a coin) to receive hydrocortisone 15 mg /day or placebo for two days. Placebo is an inactive substance, like a sugar pill. This dose of hydrocortisone is less than a typical replacement dose for patients who are not producing cortisol (hydrocortisone) naturally. The hydrocortisone is administered intravenously (in a vein) over the course of 2 hours for two consecutive days. Neither participant nor study doctor will know which treatment participant is receiving. However, this information is available to study doctor if it is needed.
Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10-15 mm from the fundus using pipelle endometrial sampling (Pipelle).
Every year millions of children begin a compromised developmental trajectory resulting from exposure to maternal depression. In recent years, compelling evidence that maternal depression leads to worse developmental outcomes in the child has prompted a dramatic increase in efforts to ameliorate it. However, empirical evidence linking depression treatment to improved developmental trajectories in offspring is far from robust. The evidence is lacking due to several methodological limitations of previous studies, namely, insufficient follow-up, lack of appropriate control group, and/or lack of attention to the psychological and behavioral mechanisms underlying the impact of interventions on both the mother and child.

We propose an innovative, cost-effective extension to an NIMH-funded perinatal depression cluster randomized controlled intervention trial (RCT) in Pakistan (SHARE: U19MH095687). The SHARE RCT includes individual and community-wide components and follows mothers with prenatal depression until 6 months postpartum. Our proposal, SHARE CHILD, builds on this trial in several critical ways. We (1) focus on child outcomes, (2) extend follow-up to 36 months postpartum, (3) include mothers who did not screen positive for depression in the 3rd trimester, thus enabling additional comparisons, and (4) investigate factors that mediate and modify the effect of the intervention on child outcomes. A unique window of opportunity is made possible due to the anticipated spring 2014 enrollment start date of the SHARE trial.

Our long-term goal is to identify key modifiable factors in the intergenerational transmission of risk from depressed mothers to their children. The overall objective of this proposal is to rigorously evaluate the impact of a community based perinatal depression intervention on child development by expanding the sample of an already funded RCT and extending the follow-up period to 36 months postpartum. Our central hypothesis is that the perinatal depression intervention will lead to improved child socio-emotional, cognitive, and physical outcomes. Including the non-depressed dyads in our analyses will enable us to further determine (a) how much of the excess risk due to maternal depression exposure the intervention can mitigate and (b) whether this community based intervention has an impact on all children living in the intervention clusters, even if their mothers were not depressed prenatally. Such insights would not otherwise be possible without this expanded sample given the dearth of information on child developmental norms in this setting. Together, the unique opportunity to extend the SHARE trial to the broader SHARE CHILD study and the approaches we propose will yield novel and definitive evidence of the impact of treating perinatal depression on child developmental outcomes.
Simultaneous use of alternative or complementary medical therapies by cancer patients undergoing conventional medical treatment is extremely common and may not always be disclosed to the patient's treating physician. Cancer patients undergoing Phase I therapy on clinical trials constitute a special population of patients, since by definition, their prescribed therapy is scientifically unproven in terms of efficacy. Phase I patients are closely monitored for adverse effects in order to identify and characterize the toxicities and to define a tolerable dose of their experimental treatment. Thus, the unrecognized use of alternative therapies by patients actively enrolled in phase I trials may potentially confound rational drug development by causing adverse side effects or by contributing to drug interactions. Examples of clinical toxicities induced by alternative medical treatments include liver dysfunction or renal failure caused by herbal preparations, or hematologic abnormalities, such as eosinophilia-myalgia syndrome caused by tryptophan food supplements. Therefore, it is important to document and determine the prevalence of alternative therapy use in this specific patient population; however, this issue has not previously been examined in a scientifically rigorous manner. We propose to conduct a survey and interview study of phase I cancer patients enrolled in ongoing clinical trials at the National Cancer Institute to determine the prevalence of alternative therapy use in this population. This study will also examine patient attitudes and perceptions regarding their use of alternative therapy as compared with their scientifically-sanctioned phase I experimental therapy. This information has important implications for drug development.
A selection system free of antibiotic resistance genes, which is based on the use of an araD gene as a selection marker carried on a vector which is inserted in a bacterial strain deficient of the araD gene. The araD gene from  E. coli  encodes the L-ribulose-5-phosphate-4-epimerase. A method of selecting the cells transformed with a plasmid, which contains the araD gene. The non-antibiotic selection marker makes the system suitable for producing therapeutics. The araD gene is not essential for growth of the host but manipulation of it affects the growth under certain selective conditions. Deletion of araD leads to accumulation of substance which is toxic to the host but not to humans. The araD gene is relatively small and therefore a small plasmid may be constructed, which requires less energy for replication, and leads to increased growth rate and yield.
Patients in this group will receive self-management education during the 3 days when they are in the hospital. On the first day of the training, COPD disease, causes of the disease, symptoms, reasons for alleviating complaints, practical information for living comfortably with COPD will be given. On the second day, emergency situations in COPD, what is an exacerbation and prevention suggestions and diaphragmatic breathing-cough exercises will be taught. On the last day, training will be given on puckered lip breathing, medication use, oxygen and nebulizer treatments. Patients in this group will not receive telephone follow-up. All scales are planned to be re-administered at 1, 3, and 6 months.
Teratogenic Effects: Pregnancy Category B. Lidocaine has not been studied in pregnancy. Reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg subcutaneously and have revealed no evidence of harm to the fetus due to lidocaine. There are, however, no adequate and well- controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, lidocaine should be used during pregnancy only if clearly needed.   
Labor and Delivery   
Lidocaine has not been studied in labor and delivery. Lidocaine is not contraindicated in labor and delivery. Should lidocaine be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered.
In this arm, treatment consists of the bi-hormonal closed-loop system. A short acting insulin analogue (Humalog, 3 ml pre-filled cartridge, Eli Lilly) and glucagon (Glucagen, Novo Nordisk; 3.15 ml cartridge Accu-Chek Spirit, Roche) will be administered according to the closed-loop algorithm. Additionally, patients will wear a blinded DexcomG6 for data collection during the closed loop period.
Atorvastatin calcium is metabolized by cytochrome P450 3A4. Concomitant administration of atorvastatin calcium with strong inhibitors of CYP 3A4 can lead to increases in plasma concentrations of atorvastatin. The extent of interaction and potentiation of effects depend on the variability of effect on CYP 3A4. 

Clarithromycin

Atorvastatin AUC was significantly increased with concomitant administration of atorvastatin 80 mg with clarithromycin (500 mg twice daily) compared to that of atorvastatin calcium alone [see Clinical Pharmacology (12.3)]. Therefore, in patients taking clarithromycin, caution should be used when the atorvastatin dose exceeds 20 mg [see Dosage and Administration (2.6) and Warnings and Precautions (5.1)].

Combination of Protease Inhibitors

Atorvastatin AUC was significantly increased with concomitant administration of atorvastatin calcium with several combinations of HIV protease inhibitors, as well as with the hepatitis C protease inhibitor telaprevir, compared to that of atorvastatin calcium alone [see Clinical Pharmacology (12.3)]. Therefore, in patients taking the HIV protease inhibitor tipranavir plus ritonavir, or the hepatitis C protease inhibitor telaprevir, concomitant use of atorvastatin calcium should be avoided. In patients taking the HIV protease inhibitor lopinavir plus ritonavir, caution should be used when prescribing atorvastatin calcium and the lowest dose necessary should be used. In patients taking the HIV protease inhibitors saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, the dose of atorvastatin should not exceed 20 mg and should be used with caution [see Dosage and Administration (2.6) and Warnings and Precautions (5.1)]. In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, the dose of atorvastatin should not exceed 40 mg and close clinical monitoring is recommended.

Itraconazole 

Atorvastatin AUC was significantly increased with concomitant administration of atorvastatin 40 mg and itraconazole 200 mg [see Clinical Pharmacology (12.3)]. Therefore, in patients taking itraconazole, caution should be used when the atorvastatin dose exceeds 20 mg [see Dosage and Administration (2.6) and Warnings and Precautions (5.1)].