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

There are no data on the presence of olipudase alfa-rpcp in human milk, the effects on the breastfed infant, or the effects on milk production. Olipudase alfa-rpcp is present in animal milk. (see Data). When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XENPOZYME and any potential adverse effects on the breastfed infant from XENPOZYME or from the underlying maternal condition.

Data

Olipudase alfa-rpcp was administered as a single intravenous dose (3 mg/kg) to lactating CD1 mice on post-partum day 7. Milk was not evaluated until post-partum day 9, at which time concentrations of olipudase alfa-rpcp detected were approximately 1.3% the estimated maximal maternal plasma concentration.
Use of a carrier is provided. The use is for the preparation of a drug for treating a cancer. The carrier comprises an aqueous phase inner core including a hydrogen peroxide (H2O2); and an oil phase outer shell layer covering the aqueous phase inner core. The oil phase outer shell layer includes a metal ion provider and a polymer compound, wherein when the hydrogen peroxide contacts the metal ion provider, the hydrogen peroxide and a metal ion provided by the metal ion provider produce a Fenton reaction and generate a reactive oxygen species (ROS). In addition, use of another carrier is provided. The use is for the preparation of a drug for treating the cardiovascular diseases. The carrier comprises an aqueous phase inner core including the S-nitrosothiols (RSNO); and an oil phase outer shell layer covering the aqueous phase inner core. The oil phase outer shell layer includes a catalyst, wherein when the S-nitrosothiols contacts the catalyst, the S-nitrosothiols and the catalyst produce a catalytic reaction and generate a nitric oxide (NO).
The invention relates to a compound febantel gel composition and a preparation method thereof. The compound febantel gel composition is prepared from the following ingredients in percentage by weight: 10.0-30.0% of febantel, 8.0-30.0% of pyrantele pamoate, 3.0-15.0% of praziquantel, 4.0-24.0% of benzyl alcohol, 1.0-34.0% of ethanol, 2.0-15.0% of colloidal silicon dioxide, 1.0-20.0% of a surfactant and an oily matrix added up to 100%. The gel composition is mainly used for treating entozootic diseases in dogs, horses and other animals. The compound febantel gel is advantageous in broad-spectrum and long-acting protection against parasitic infection. Besides, the concentration of the effective component is higher under the condition of a single dose. Compared with conventional antiparasitic tablets, the compound febantel gel is convenient to feed and not liable to cause vomiting, can be rapidly absorbed to reach the maximum drug concentration, and prevents adverse reactions such as vomiting, head shaking and poor appetite after oral administration in animals.
This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) ERT. Eligible patients will enter a 12-week Stability Evaluation Period to establish the stability of their disease. Patients with stable disease will then be switched from their imiglucerase treatment to receive intravenous (IV) infusions of taliglucerase alfa every two weeks for a total of 20 IV infusions. The dose of taliglucerase alfa will be equal to each patient's previous imiglucerase dose. The infusions will be administered at the selected investigational site (clinic/hospital), infusion center, or at home. At the end of the 9-month treatment period (20 visits, 38 weeks) eligible patients will be offered enrollment in an open-label extension study.
The mouthwash water is designed for the hygiene and the prophylactics of the oral cavity. It has well-expressed refreshing effect and prevents the formation of plaque on the teeth and the development of gingivitis. Its active ingredients determine its antimicrobial, anti-plaque-formation and deodorizing properties. The mouthwash water is a coloured water-spirit solution, containing in wt. %: thymol 0.01-0.3, eucalyptol 0.01-0.3, peppermint oil 0.01-0.3, menthol 0.01-0.3, glycerin 6.00, colourant 0.03, ethyl alcohol from 25 to 35 and distilled water from 65 to 75. 11 claims
Idelalisib will be given orally continuously at 150 mg BID. On day 57, ofatumumab will begin with the 300 mg dose, given after idelalisib is taken. Ofatumumab will then be administered at 1000 mg weekly to complete 8 weeks (days 64, 71, 78, 85, 92, 99, 106) throughout Cycles 3 and 4. This will be followed by monthly ofatumumab on weeks 20, 24, 28, 32 to complete 4 additional cycles (5-8). The overall induction treatment period will then be 8 months, comprised of two months of single agent idelalisib followed by 6 months of ofatumumab with idelalisib. After the completion of the induction treatment, idelalisib will continue indefinitely in arbitrarily defined 28 day cycles in all participants who have not had excessive toxicity and do not have progressive disease.
Individuals with multiple disabilities are among the most challenging to serve and AAC teams often lack direction in determining effective interventions. The purpose of this scoping review was to summarize the research evidence on AAC interventions for individuals with complex communication needs and simultaneous motor, and visual impairments as part of their multiple disabilities; to consider implications for practice; and to determine gaps and directions for future research. A total of 27 studies were identified and reviewed, involving 55 unique participants with multiple disabilities. Most studies focused on direct intervention to increase requesting or choice-making, with little focus on social communication. Only two studies focused on training communication partners. Results indicated that AAC interventions can be highly effective to increase communication for individuals with multiple disabilities. However, there is an urgent need for increased rigor and more detailed participant information in future AAC intervention research with this population. Future research should investigate AAC intervention to improve social communication and increase language development, not just expression of needs and wants. Future research should focus on the needs of individuals with multiple disabilities from culturally and linguistically diverse backgrounds and on implementation of AAC within natural environments.
Early Onset Scoliosis (EOS) defines patients who develop deformities of the spine and/or thorax in the embryologic development or in the early childhood. The exact prevalence of EOS in Norway is unknown, but it is assumed to be approximately 200-300 new EOS patients every year. EOS is a severe condition, whereby some of the most common and also most severe consequences of the deformity are severe pulmonary problems. The patients may require extensive orthopedic treatment from early childhood and until maturity to avoid serious consequences with severe pulmonary problems and shortening of life.

EOS' secondary problems, including severe consequences on the pulmonary function might contribute to enhanced inactivity. Inactivity contributes to further negative impact on development of the musculoskeletal system, motor competence and pulmonary function. Considering the severity of EOS and children's reduced life expectancy, it is extremely important that EOS children achieve the favorable impact of physical activity during their growth. Insufficient level of activity might worsen the prognosis, thus counteracting the treatment's ambitions. The investigator's aim is to extend the knowledge about level of activity, motor competence, pulmonary function, and health related quality of life in Norwegian children, surgically treated for EOS.
The invention relates to the field of pharmaceutical chemistry, in particular to a new application of exenatide acetate and medicine aiming at the new application. The new application of exenatide acetate is that the exenatide acetate is taken as a medicine used for preventing and curing diabetes and coronary disease. The invention also provides a medicine aiming at the new application. The medicine contains active constituent (exenatide acetate) of 0.005-0.4g/100ml and appropriate amount of isotonic agent. The invention has the advantages that the exenatide acetate has better curative effecton patients suffering from diseases of diabetes and coronary disease than on patients suffering from one or none of the two diseases of diabetes and coronary disease. The exenatide acetate not only relieves the symptom of diabetes of patients, but also ameliorates the function of nervi vascularis, thus facilitating the complete recovery of patients.
The purpose of this study is to compare health-related quality of life (HRQOL) outcomes in older (60-80 years) advanced heart failure (HF) patients who undergo heart transplantation (HT) or mechanical circulatory support (MCS) as a permanent implant (i.e., destination therapy \[DT\]) and their caregivers, risk factors for poor HRQOL, adverse event and symptom burden, and quality-adjusted life years (QALYs). Advanced HF patients, 60-80 years of age, are an appropriate target group for this study because they are receiving HTs and MCS devices more frequently, and despite a greater risk for poor clinical outcomes, they have acceptable rates of survival. Using a prospective, longitudinal design, our multi-site comparative effectiveness research will compare HRQOL outcomes in patients who receive HT or DT MCS and their caregivers, from baseline to 2 years post-operatively. The primary aim of this proposed study is to determine whether older advanced HF patients who undergo DT MCS, as compared to patients who undergo HT, experience non-inferior change in overall HRQOL (primary), and domains of HRQOL (physical, mental, and social) from baseline through 2 years after surgery. Secondary Aims are (1.) to determine whether caregivers of older advanced HF patients who undergo DT MCS, compared to caregivers of older advanced HF patients who undergo HT, experience non-inferior change in overall HRQOL and domains from baseline through 2 years after surgery; (2.-3.) to identify risk factors related to poorer overall HRQOL in older DT MCS patients and their caregivers, as compared to older HT patients and their caregivers, at 2 years after surgery; (4.) to determine whether older advanced HF patients who undergo DT MCS, as compared to patients who undergo HT, have non-inferior rates of freedom from adverse events \& symptoms at 1 and 2 years after surgery; and (5) to evaluate the distribution of QALYs in older advanced HF patients who undergo DT MCS, as compared to patients who undergo HT at 2 years after surgery. Our proposed study will contribute to better patient-centered care of older advanced HF patients and their caregivers, by informing decision making and guiding strategies to enhance post-operative HRQOL.
The invention discloses a traditional Chinese medicine composition for treating piglet iron-deficiency anemia and belongs to the field of traditional Chinese medicines. Active ingredients of the traditional Chinese medicine composition comprise, by weight, 35 to 45 parts of prepared rehmannia root, 5 to 15 parts of red paeony root, 25 to 35 parts of pilose asiabell root, and 15 to 25 parts of brown sugar. The prepared rehmannia root, the red paeony root, the pilose asiabell root and the brown sugar have particle sizes of 20 to 200 meshes. The traditional Chinese medicine composition has the effects of nourishing yin and supplementing blood, and tonifying spleen and nourishing stomach, has a reasonable formula and can be prepared by simple processes. The traditional Chinese medicine composition have wide raw material sources, a low cost, no drug residue and no toxic and side effect and can be absorbed by animals easily. The traditional Chinese medicine composition has obvious effects of nourishing yin and supplementing blood, tonifying spleen and nourishing stomach, and adjusting body functions, can effectively treat piglet iron-deficiency anemia and can shorten a recovery phase. In use, the traditional Chinese medicine composition is taken according to a ratio of the traditional Chinese medicine composition to human body weight of 0.5g: 1kg. A clinical test proves that the traditional Chinese medicine composition has a cure rate of 83-93% and has a unique effect.
The invention belongs to the technical field of medicines, relates to a seven-element vibsan diterpenoid compound, and preparation and application thereof, and particularly relates to a seven-element vibsan diterpenoid compound, and preparation and application thereof in preparation of a medicine for treating tumors. The compound is isolated from leaf of Viburnum odoratissimum Ker-Gawl. var. odoratissimum of Viburnum of Caprifoliaceae. The invention uses coral tree leaves to obtain the compounds 1-7 by extraction, silica gel column chromatography, HP-20 column chromatography, ODS column chromatography, silica gel column chromatography and preparative HPLC. The compound has obvious antitumor activity, especiallyIt has obvious effect of resisting lung cancer.
This is a prospective randomized controlled study that collects data of patients with benign prostatic hyperplasia that are treated with prostatic artery embolization (PAE) or with Holmium laser enucleation of the prostate (HoLEP). For PAE a catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. The injected microspheres will slow the blood flow to the prostate. For HoLEP a Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra. Clinical follow-up include clinical visit after 1, 6 and 12 months. Acute as well as long term complications will be recorded. The patients fill in the questionnaires for urologic disease. Urodynamic examination will record functional outcome.
Prior to initiating testosterone cypionate injection, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.

Testosterone cypionate injection is for intramuscular use only.

It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle.

The suggested dosage for testosterone cypionate injection varies depending on the age, sex, and diagnosis of the individual patient. Dosage is adjusted according to the patient's response and the appearance of adverse reactions.

Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose.

For replacement in the hypogonadal male, 50 to 400 mg should be administered every two to four weeks.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.
FIELD: veterinary medicine. SUBSTANCE: method involves per os administering preparation composed of organic and inorganic substances (10%-water-soluble ronidazole, finely dispersed silicon dioxide). The preparation is applied once a day during three days ronidazole at a dose of 2.5-5 mg/kg of body mass and finely dispersed silicon dioxide at a dose of 10-20 mg/kg of body mass. When treating a patient, the dose is dissolved in 100 ml of drinking water given in rubber bottle for being individually consumed. When applied as prophylaxis, the preparation is given in feeding a group of animals. EFFECT: enhanced therapeutic and prophylactic effectiveness of treatment course. 3 cl, 2 tbl
BACKGROUND: Inflammatory scores are known to reflect the systemic inflammatory burden. Despite this, the association between the inflammatory score and the risk of all-cause and cardiovascular mortality in patients with metabolic syndrome (MetS) remains poorly understood. To address this gap in the literature, this study investigated this potential association between these two factors.
METHODS: A total of 3401 patients with MetS from the National Health and Nutrition Examination Survey (1999-2010) were enrolled. Survival status and cause of death were obtained by linking data from the National Death Index (NDI). The inflammatory score was calculated based on the sum of the Z-scores for white blood cell (WBC) count and C-reactive protein (CRP) at baseline. The patients were divided into inflammatory score quartiles. Cox proportional hazards regression was used to determine the association between inflammatory score and mortality. Restricted cubic splines (RCS) were used to explore the dose-response relationship between inflammatory score and mortality. Stratified analyses and interaction tests were conducted according to sex, age, body mass index (BMI), alcohol consumption, smoking status, hypertension, diabetes, and stroke status.
RESULTS: After a mean follow-up of 145.9 months, 1039 all-cause deaths and 295 cardiovascular deaths were recorded. The results of multivariate Cox regression analysis showed that compared to the lowest quartile (Q1), patients in the highest quartile (Q4) had a 1.74-fold increased risk of all-cause mortality (Model 3: HR = 1.74, 95%CI 1.30-2.32, P < 0.001) and a 1.87-fold increased risk of cardiovascular mortality (Model 3: HR = 1.87, 95%CI 1.12-3.13, P = 0.020). There was a 'J'-shaped nonlinear relationship between the inflammatory score and all-cause mortality (P for nonlinearity = 0.001), and a marginally significant 'J'-shaped relationship with cardiovascular mortality (P for nonlinearity = 0.057). The threshold points of the inflammatory score for adverse outcomes were - 0.643 and - 0.621, respectively.
CONCLUSION: The inflammatory score is independently associated with increased all-cause and cardiovascular mortality in patients with MetS, and risk stratification of these patients using inflammatory scores may provide specific therapeutic strategies to improve their prognosis.
Olfactory dysfunctions decrease daily quality of life (QOL) in part by reducing the pleasure of eating. Olfaction plays an essential role in flavor sensation and palatability. The decreased QOL due to olfactory dysfunction is speculated to result from abnormal neural activities in the olfactory and limbic areas of the brain, as well as peripheral odorant receptor dysfunctions. However, the specific underlying neurobiological mechanisms remain unclear. As the olfactory tubercle (OT) is one of the brain's regions with high expression of endogenous opioids, we hypothesize that the mechanism underlying the decrease in QOL due to olfactory dysfunction involves the reduction of neural activity in the OT and subsequent endogenous opioid release in specialized subregions. In this review, we provide an overview and recent updates on the OT, the endogenous opioid system, and the pleasure systems in the brain and then discuss our hypothesis. To facilitate the effective treatment of olfactory dysfunctions and decreased QOL, elucidation of the neurobiological mechanisms underlying the pleasure of eating through flavor sensation is crucial.
Patients receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Celecoxib

Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. If a patient treated with SEGLENTIS has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.

In controlled clinical trials the incidence of anemia was 0.6% with celecoxib and 0.4% with placebo. Patients on long-term treatment with SEGLENTIS should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia or blood loss.

NSAIDs, including SEGLENTIS, may increase the risk of bleeding events. Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients for signs of bleeding [see Drug Interactions (7)].
Participants will receive the study intervention immediately after study enrollment has been completed. The intervention will be delivered in 12, 20-30 minute sessions and text messaging over 4 months (1st session in person, remaining 11 sessions will be remote). The investigators will asses feasibility, acceptability and preliminary clinical outcomes of the Y2TEC intervention at 4 months and 6 months. During the waiting period, participants will receive text messages.
The effects of PENNSAID on platelet function were studied in 10 healthy subjects administered 80 drops four times a day for 7 days. There was no significant change in platelet aggregation following one week of treatment [see Clinical Pharmacology (12.4)].

Anemia is sometimes seen in patients receiving NSAIDs. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Check hemoglobin or hematocrit of patients on PENNSAID if they exhibit any signs or symptoms of anemia or blood loss.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration and reversible. Carefully monitor patients receiving PENNSAID who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants.
This is a prospective study to test the safety and efficacy of a three different light and laser handpieces for the improvement of skin color, tone, texture and laxity. All subjects will receive up to four treatments, administered in intervals of 28 +/- 2 days. Each full face treatment duration will be approximately 60 minutes. The initial power and number of passes parameters shall be set according to the clinical indication and skin type of the subject treated. The treatment area will be cleaned and photographed before each treatment. Photographs will be taken at baseline, prior to each treatment and during each follow-up visit. Before the initiation of the first treatment each subject will undergo clinical evaluation.

Clinical improvement will be assessed by the investigator from the visual appearance of the treated area and from the fixed magnification clinical photographs according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement. Adverse side effects will be scored by clinical evaluation of erythema, edema, and burns. Treatments and results will be documented in a Case Report Form at each treatment session and follow-up session (1 month and 3 months after the last treatment). In case of adverse side effects and symptoms other than erythema or edema appear during or following a treatment, the next treatment may be skipped by two weeks or treatment parameters reduced until symptoms resolve. If adverse side effects are observed, the investigator should provide the subject with the proper care and remedy and will document it in the Case Report Form.