anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
PURPOSE: To summarize evidence on levonorgestrel releasing intrauterine system (LNG-IUS) in the treatment of adenomyosis (AM) and to identify potential research gaps.
METHODS: Search was conducted in MEDLINE, The Cochrane Library, EMBASE, CBM, CNKI, and Wanfang. We included studies investigating patients with AM treated with LNG-IUS combined with conservative therapy.
RESULTS: Thirty-nine studies compared LNG-IUS with other conservative therapeutic drugs. The most common comparison was GnRH-a + LNG-IUS vs. LNG-IUS alone, followed by LNG-IUS vs. mifepristone, expected treatment, and GnRH-a. GnRH-a + LNG-IUS was more beneficial in reducing the intensity of dysmenorrhea than LNG-IUS alone at the 6-month follow-up in patients with an enlarged uterus and moderate to severe dysmenorrhea. Large and well-designed studies are needed to confirm the efficacy of LNG-IUS and GnRH-a on reducing uterine volume at 6-month follow-up. Thirty-two studies investigated LNG-IUS as the postoperative management. The most common comparison was surgical excision + LNG-IUS vs. surgical excision. Results showed VAS scores were lower in the surgical excision + LNG-IUS group than in the surgical excision group at the 1-year follow-up. Evidence on endometrial thickness, quality of life, adverse events and beneficial effect at 3 and 5 years are needed.
CONCLUSIONS: Combined GnRH-a and LNG-IUS treatment was more efficacious than LNG-IUS alone for patients with an enlarged uterus and moderate to severe dysmenorrhea. Moreover, LNG-IUS seemed to show potential long-term benefits in postoperative therapy, warranting further meta-analysis for confirmation.
Patients with histologically confirmed metastatic or unresectable solid tumors will have one tube of whole blood (\~6mL) collected at the time of venipuncture for routine sample collection. The sample will undergo in vitro stimulation of TEMs with ANG 1 and 3 in the presence or absence of pharmalogic inhibitors, and flow cytometry analysis.
System for determining real-world effectiveness of various prescribed medications. Here a variety of different types of patient pulse wave measurements (e.g. blood pressure, pulse oximeter, ECG) and other physiological measurements are obtained. This actual data is compared to calculated measurements that would be expected based on the various patient baseline measurements in the absence of medication, schedule of medications, and impact of medications the various patient baseline measurements. If the actual data meets expectations, then the medication is likely acting as anticipated. Depending on which types of data do not meet expectations, problems with one or more previously described medications may be reported. Other types of patient physiological readings, such as temperature, motion, lung function, brain wave function (EEG) and the like may also be obtained, and these additional types of readings can be used to extend the range of different types of drugs/medications that the system can successfully monitor.
Zavegepant is a novel gepant administered as a nasal spray approved in the United States at a 10 mg dose for the acute treatment of migraine with or without aura in adults. The cardiovascular safety of zavegepant nasal spray was assessed in both single-ascending dose (SAD) and multiple-ascending dose (MAD) studies in healthy participants. The SAD study included 72 participants (54 active/18 placebo) who received 0.1-40 mg zavegepant or placebo. The MAD study included 72 participants (56 active/16 placebo) who received 5-40 mg zavegepant or placebo for 1-14 days. Plasma zavegepant pharmacokinetics and electrocardiographic (ECG) parameters (Fridericia-corrected QT interval [QTcF], heart rate, PR interval, ventricular depolarization [QRS], T-wave morphology, and U-wave presence) were analyzed pre- and post-zavegepant administration. Using pooled data from the SAD and MAD studies, the relationship between time-matched plasma zavegepant concentrations and QTc interval was assessed using a linear mixed-effects model to evaluate the potential for QTc interval prolongation. Results showed that single and multiple doses of zavegepant had no significant impact on ECG parameters versus placebo, and there was no concentration-dependent effect on QTcF interval. The estimated slope of the plasma zavegepant concentration-QTcF model was -0.053 ms per ng/mL with a 90% confidence interval of -0.0955 to -0.0110 (p = 0.0415), which is not considered clinically meaningful. At doses up to four times the recommended daily dose, zavegepant does not prolong the QT interval to any clinically relevant extent.
Adult and adolescent participants (12 to less than \[\<\] 18 years and weighing greater than or equal to \[\>=\] 40 kilogram \[kg\]) with moderate-to-severe AD will receive lebrikizumab 250 milligrams (mg) subcutaneous (SC) injection via pre-filled syringe (PFS) for every fourth week (Q4W) for up to Week 104. If participants response is below EASI50 at any visit, lebrikizumab dosing frequency may be increased to every two weeks (Q2W) at any time during the course of the study; thereafter, lebrikizumab Q4W dosing may be resumed at the Investigator's discretion. Lebrikizumab will be administered up to Week 106 for participants who continue Q2W dosing, and these participants will undergo a safety follow-up assessment at Week 110.
OBJECTIVES: To evaluate the natural history and to highlight the possible masqueraders causing diagnostic delay and iatrogenic interventions in Fibrodysplasia Ossificans Progressiva (FOP).
METHODS: Patient details with suspected FOP were retrieved from the patient registry from 2012 through 2021. Clinical records, X-rays, clinical photographs, and molecular testing results were captured. Follow-up was recorded where available.
RESULTS: A total of 16 patients with a clinical diagnosis of FOP were found. Twelve patients with both clinical and molecular records were included in this study. The median age of onset and diagnosis was 1.5 y and 6.5 y respectively with a median diagnostic delay of 3.5 y. The disease course was progressive in ten patients. Seven out of twelve patients were subjected to invasive procedures due to misdiagnosis, which exacerbated their disease progression.
CONCLUSIONS: Clinical suspicion followed by molecular testing is straightforward for a confirmed diagnosis of FOP. It is not only diagnostic, cost-effective, and saves time but also avoids unnecessary interventions in these patients.
Patients receive oral tributyrin every 8 hours for 3 weeks. Treatment continues every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease may receive additional courses at the discretion of the protocol chairperson. Cohorts of 3-6 patients receive escalating doses of tributyrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PCT No. PCT/JP94/00798 Sec. 371 Date Nov. 13, 1995 Sec. 102(e) Date Nov. 13, 1995 PCT Filed May 18, 1994 PCT Pub. No. WO94/26768 PCT Pub. Date Nov. 24, 1994An osteogenesis promoter and/or osteoporosis remedy comprising, as an active ingredient, an androgen derivative represented by the following formula (1):    <IMAGE>  (1)  wherein each broken line indicates that the relevant carbon-to-carbon bond is a single bond or a double bond or a salt thereof. The compound (1) activates osteoblasts, promotes osteogenesis and increases the bone mass, so that it is used for the treatment of a morbid condition of lowered osteogenesis due to aging, immobilization, administration of glucocorticoids and so forth. Further, it can increase the bone mass by its osteogenesis promoting effect so that it is useful for the treatment of osteoporosis accompanying the above morbid condition or occurring after ovariectony or menopause.
Manufacturers of oral cholera vaccine (OCV) recommend a 7- or 14-days interval between two doses. To carry out two rounds of mass vaccination within this delay is not always feasible and many campaigns implemented to date have used a longer interval. Recent evidence indicates that an extended interval between OCV doses might result in equivalent seroconversion rates and in an improved boosting of mucosal immune responses following the second dose. To guide future OCV vaccination campaigns and improve cholera prevention, it is important to demonstrate the non-inferior immune response of an extended interval between OCV doses.

The Investigators aim to demonstrate the non-inferiority of the humoral immune response between individuals receiving a second Euvichol-Plus® pre-qualified OCV dose either 6 or 12 months after the initial dose and individuals receiving a second pre-qualified OCV dose 14 days after the initial dose. The humoral immune response will be assessed as the post-vaccination titer of serum vibriocidal antibodies at 14 days post-2nd dose vaccination. Secondary outcomes include the comparison of the overall rate of vibriocidal seroconversion 14 days after either the first or the second vaccine dose. A subsample of individuals ≥ 18 years will have additional serological evaluation to characterize the kinetics of their antibody responses up to 6 months after the second OCV vaccine dose. Although the vaccine has an established and safe profile, occurrence of adverse events and serious adverse events following vaccination will be assessed (safety evaluation).

The study will be an open-label, randomized, controlled, non-inferiority immunogenicity trial comparing the humoral immune responses to OCV in two interventions arms (6 and 12 months interval between OCV doses) compared with a control arm (standard 14-day interval). In each arm, the aim is to recruit 152 individuals aged 1 to 40 year-old eligible for OCV vaccination from the general population (ie. 456 individuals in total). The sub-sample allowing characterizing the kinetics of the humoral response up to 6 months after the administration of the second dose will include 38 participants in each intervention and control arm, among the participants aged ≥ 18 years. In total, 456 individuals will be recruited.

The study will be conducted in Conakry, in the Republic of Guinea. Participants will be primarily enrolled in the commune of Dixinn on a voluntary basis. All participants in the intervention and control arms will be invited to a first visit for assessment of eligibility and 1st OCV dose, followed by a visit 14 days after the 1st OCV dose for blood sampling. According to the study arm, the 2nd OCV dose will be administered at 14 days, 6 months or 1 year after the 1st dose and will be followed by a visit 14 days later for blood sampling. Participants in the sub-study will be invited to additional study visits (up to twelve visits in total) for blood sampling. At each visit, blood will be drawn for immunologic analyses.
In this arm + PS SBT' arm, RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hrs daily. If a screening period is missed inadvertently or due to an investigation or intervention (operation/procedure) necessitating absence from the ICU, it may be conducted later on the same day and ideally within 6 hrs of the scheduled screening period. Regardless of group assignment, if the SBT screening assessment is passed, an SBT will be conducted as per protocol. RTs will conduct SBTs using only T-piece (off the ventilator).
INTRODUCTION: Pisa syndrome (PS) is a postural abnormality that frequently manifests in various neurological disorders. In recent years, the dangers associated with Parkinson's disease (PD) and PS have been increasingly acknowledged, leading to heightened research efforts directed toward the treatment of PS. Nevertheless, the underlying causes of PS remain complex, and no clinically effective treatments have been established. While several studies have demonstrated the significant effects of Qigong in treating PD, there is currently no evidence to support the efficacy of Qigong in the treatment of PS.
OBJECTIVE: To assess the immediate and long-term effects of Zhan Zhuang Qigong on PS in participants with PD using a rigorous randomised, parallel-control design with assignment concealment and evaluator-blinding methodologies.
METHODS: 60 PD participants meeting the inclusion criteria will be recruited and randomly assigned to one of two groups: conventional treatment (n=30) or Zhan Zhuang Qigong (n=30). The conventional treatment group will receive standard medications and physical therapy. The Zhan Zhuang Qigong group will receive conventional medicine plus 30 min of Zhan Zhuang Qigong practiced five times per week. The long-term effects of Qigong on PS will be evaluated after 6 months and 1 year of follow-up. Assessment tools will include the NeuroPostureApp, the B-PHY(A model of a balance testing system) balance check training system, the Unified Parkinson's Disease Rating Scale and the Parkinson's Disease Quality of Life Questionnaire, which will measure total camptocormia, upper hump degree, Pisa angles, plantar pressure distribution, motor function and quality of life in participants with PD.
ETHICS AND DISSEMINATION: The local ethics committee approved this study (approval number: 2023-K068). The committee will oversee the study throughout its duration and will be notified of any protocol modifications. The results of the study will be disseminated through publication in an international journal or presentation at a conference.
TRIAL REGISTRATION NUMBER: ChiCTR2400079696.
This is a pilot open-label, non-randomized, single institution study of BMAC administration in patient's with moderate to severe osteoarthritis of the knee who will undergo total knee replacement. Several weeks prior to total knee replacement, patients will have a sample of bone marrow taken from their pelvic region and concentrated using an investigational device called the Arthrex Angel Concentrated Platelet Rich Plasma (cPRP) System also known as the Angel System. The concentrated bone marrow will be immediately delivered back to the patient arthroscopically to the knee of interest. Blood and tissues samples will be collected at scheduled visits for molecular and histological analysis. Adverse events will be monitored throughout the trial. Assessment of healing will be performed by physical exam and standardized questionnaires related to the health of the patient.
BACKGROUND: Infiltration and extravasation are common complications during peripheral intravenous infusion in the neonatal intensive care unit, and diagnosis is usually clinical, by inspection and palpation. Delay in diagnosis due to poor surveillance or misinterpretation of clinical signs may carry serious damage to the tissues of the neonate. Recently, a novel technology based on optical detection of infiltration has become available.
METHODS: We have studied two groups of term and preterm infants receiving non-vesicant intravenous infusions by the peripheral route (24G short peripheral cannulas), and we evaluated the incidence of infiltration. In the first group, we have compared the clinical detection of infiltration versus the detection obtained by a novel optical device, blinding the alarms of the device. In the second group, the comparison was carried out without blinding the alarms.
RESULTS: Of the neonates included in this study, 60% were female, 86% had a gestational age <37 weeks (34 ± 2.5 weeks) and a mean birth weight of 2.08 ± 0.4 g. Total recorded monitoring time was 1318 h and average monitoring time for each short peripheral cannula was 26.4 h. The incidence of infiltration was 80%, most of them having a Millam score <2. The novel device showed an overall sensitivity of 88.9% in detecting infiltration. Specificity was 84.4%, as evaluated assuming as standard the clinical diagnosis. Interestingly, in cases of documented infiltration, the event was diagnosed by the optical device approximately 6 h before the clinical diagnosis.
CONCLUSIONS: Continuous monitoring of the insertion site, as automatically ensured by this novel optical device, may play a complementary role in early detection of infiltration, even if the percentage of false positives and false negatives suggests that periodic clinical assessment by expert nurses cannot be omitted.
Parental mosaicism is important in families with de novo mutations. Herein, we report a case of fetal CHARGE syndrome (CS) with a CHD7 variant inherited from maternal CHD7 gonosomal mosaicism. The variant was detected through trio-based whole-exome sequencing and Sanger sequencing. High-depth whole-exome sequencing was performed for the identification of parental mosaicism. A novel heterozygous CHD7 nonsense mutation (c.5794G>T/ p.E1932*) was detected in the tissue from the aborted fetus. The parents were wild-type, indicating that the mutation was a de novo variant. The mutation was suspected to be the cause of the fetal CS. However, high-depth whole-exome sequencing revealed maternal gonosomal mosaicism at a variant allele frequency of 3.2%-23.3%. The variant was identified in various tissues (peripheral blood, hair follicles, buccal epithelia, and pharyngeal epithelia) from the asymptomatic mother. We confirmed maternal CHD7 gonosomal mosaicism as a genetic cause of fetal CS. Our results emphasize the importance of clinical analysis in accurately determining the parents' status in detecting the CHD7 de novo variant in fetal CS, as this analysis has vital implications for evaluating the recurrence risk for genetic counseling.
The reliability and validity of the Single-item Food Choice Questionnaire was planned in eight stages. 1) Translation into Target Language 2) Synthesis of translations 3) Back translation to Original Language 4) Expert assessment 5) Pilot study 6) Reporting 7) Testing 8) Retesting. The development of the Impact of Food Inflation on Consumer Behavioural Change (TIF-Con) scale was planned in eight stages too. 1) Generating an item pool 2) Determining the format for measurement 3) Initial item pool reviewed by experts 4) Pretesting 5) Optimizing scale length 6) Testing 7) Retesting 8) Reporting. A cross-sectional survey will be conducted by questioning food security and socioeconomic status, along with the developed TIF-Con and the adapted food choice questionnaire. This stage will be combined with the sixth stage of scale development in order to act economically. Simultaneously, the CoRD will be calculated with the collection of food prices with fieldwork and the recommendations of the offical Turkey's dietary guideline. The obtained results will be analyzing to assesment of the change in consumer behaviours during the food inflation period in order to afford the dietary cost according to food security status and food choice motives.
OPANA ER is contraindicated in patients with a known hypersensitivity to oxymorphone hydrochloride or to any of the other ingredients in OPANA ER, or with known hypersensitivity to morphine analogs such as codeine.

OPANA ER is not indicated for pain in the immediate post-operative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. OPANA ER is only indicated for post-operative use if the patient is already receiving the drug prior to surgery or if the post-operative pain is expected to be moderate or severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines).

OPANA ER is contraindicated in any situation where opioids are contraindicated such as: patients with respiratory depression (in the absence of resuscitative equipment or in unmonitored settings), and in patients with acute or severe bronchial asthma or hypercarbia.

OPANA ER, like all opioids, is contraindicated in any patient who has or is suspected of having paralytic ileus.

OPANA ER is contraindicated in patients with moderate and severe hepatic impairment (see CLINICAL PHARMACOLOGY,PRECAUTIONS and DOSAGE AND ADMINISTRATION).
The invention relates to a compound for treating non-small cell lung cancer, in particular to a compound for treating non-small cell lung cancer by an ALK kinase inhibitor. The invention provides a new generation of ALK kinase inhibitor which can be successfully used for treating various related cancers driven by ALK kinase. The ALK kinase inhibitor is more significant to Asian race, because the mutation of ALK kinase gene is twice higher in Asian race than in European and American race, and can reach 8-10% in non-small cell lung cancer patients. Therefore, the successful development of the ALK kinase inhibitor has certain good economic benefit and social benefit. The development of third-generation ALK inhibitors in China is still blank. Therefore, the successful development of the ALK kinase inhibitor can fill the domestic blank and reach the advanced level in the world.
PURPOSE:To improve the absorbability of a fat-soluble agent or a physiologically active peptide scarcely soluble or insoluble in water by using a fat globule membrane in the milk of mammal as an emulsifying agent, preparing an O/W- type emulsion and fractionating and purifying the emulsion particles. CONSTITUTION:A stable pharmaceutical composition having improved peroral absorbability of a fat-soluble agent or a physiologically active peptide scarcely soluble or insoluble in water is prepared by using a fat globule membrane in the milk of mammal, especially fat globule membrane in cow's milk as an emulsifying agent, preparing an O/W-type emulsion of the fat-soluble agent or physiologically active peptide with the emulsifier and subjecting the emulsion to fractionation and separation steps such as centrifugal separation under two or more different conditions. The obtained composition has further improved emulsion stability. The particle diameter of the separated fraction is preferably 1-5mum. Since the composition has high lipase resistance, it can maintain high concentration in blood by oral administration to improve the absorbability. It has high safety because the emulsifier is originated from natural material.
Patients receiving the standard of care. Due to safety concerns, the patients are followed every 6 months after a first follow-up, which is performed between 1 and 3 months after implantation.
Detailed heart rate (HR) response patterns during exercise in patients with heart failure (HF) and sinus rhythm remain uncertain. We screened consecutive patients with HF who underwent cardiopulmonary exercise tests at a large academic center from November 2013 to July 2023. HR response during exercise was statistically classified using logistic differential equation models. A total of 99 patients were included. Of them, 75 patients were assigned to "sigmoidal pattern" and the other 24 to "exponential pattern." Patients with the sigmoidal pattern were older and exhibited higher plasma B-type natriuretic peptide levels. Increases in HR and oxygen consumption (V̇o2)/kg up to the anaerobic threshold level were not different between both patterns. However, beyond the threshold, the sigmoidal pattern group showed no further increase in HR and significantly lower V̇o2/kg than their counterparts (interactions for P < 0.001). HR response during exercise in patients with heart failure and sinus rhythm was categorized into two unique groups: sigmoidal and exponential patterns. More detailed clarification of the sigmoidal pattern, potentially indicating sinus node dysfunction, should offer new clinical insights for chronotropic incompetence.NEW & NOTEWORTHY Heart rate response patterns can be classified into two groups among patients with chronic heart failure reaching maximal exertion: sigmoidal and exponential.